High-throughput Identification of Bacteria Repellent Polymers for Medical Devices

PubMed Central

Wu, Mei; Hardman, Ailsa; Lilienkampf, Annamaria; Pernagallo, Salvatore; Blakely, Garry; Swann, David G.; Bradley, Mark; Gallagher, Maurice P.

2016-01-01

Medical devices are often associated with hospital-acquired infections, which place enormous strain on patients and the healthcare system as well as contributing to antimicrobial resistance. One possible avenue for the reduction of device-associated infections is the identification of bacteria-repellent polymer coatings for these devices, which would prevent bacterial binding at the initial attachment step. A method for the identification of such repellent polymers, based on the parallel screening of hundreds of polymers using a microarray, is described here. This high-throughput method resulted in the identification of a range of promising polymers that resisted binding of various clinically relevant bacterial species individually and also as multi-species communities. One polymer, PA13 (poly(methylmethacrylate-co-dimethylacrylamide)), demonstrated significant reduction in attachment of a number of hospital isolates when coated onto two commercially available central venous catheters. The method described could be applied to identify polymers for a wide range of applications in which modification of bacterial attachment is important. PMID:27842360

High-density antimicrobial peptide coating with broad activity and low cytotoxicity against human cells.

PubMed

Rai, Akhilesh; Pinto, Sandra; Evangelista, Marta B; Gil, Helena; Kallip, Silvar; Ferreira, Mario G S; Ferreira, Lino

2016-03-01

Medical device-associated infections are a multi-billion dollar burden for the worldwide healthcare systems. The modification of medical devices with non-leaching coatings capable of killing microorganisms on contact is one of the strategies being investigated to prevent microorganism colonization. Here we developed a robust antimicrobial coating based on the chemical immobilization of the antimicrobial peptide (AMP), cecropin-melittin (CM), on gold nanoparticles coated surfaces. The concentration of AMP immobilized (110 μg/cm(2)) was higher than most of the studies reported so far (<10 μg/cm(2)). This translated onto a coating with high antimicrobial activity against Gram positive and negative bacteria sp., as well as multi-drug resistant bacteria. Studies with E. coli reporter bacteria showed that these coatings induced the permeability of the outer membrane of bacteria in less than 5 min and the inner membrane in approximately 20 min. Importantly, the antimicrobial properties of the coating are maintained in the presence of 20% (v/v) human serum, and have low probability to induce bacteria resistance. We further show that coatings have low toxicity against human endothelial and fibroblast cells and is hemocompatible since it does not induce platelet and complement activation. The antimicrobial coating described here may be promising to prevent medical device-associated infections. In recent years, antimicrobial peptides (AMPs) have been chemically immobilized on surfaces of medical devices to render them with antimicrobial properties. Surfaces having immobilized cationic peptides are susceptible to be adsorbed by plasma proteins with the subsequent loss of antimicrobial activity. Furthermore, with the exception of very few studies that have determined the cytotoxicity of surfaces in mammalian cells, the effect of the immobilized AMP on human cells is relatively unknown. Here we report a coating based on cecropin-melittin peptide (CM) that maintains its antimicrobial activity against Gram-positive and negative bacteria including multi-drugs resistance bacteria in the presence of serum and has relatively low cytotoxicity against human cells. The reported coatings may be translated on to variety of substrates (glass and titanium) and medical devices to prevent device-associated microbial infection. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

A Rat Model of Central Venous Catheter to Study Establishment of Long-Term Bacterial Biofilm and Related Acute and Chronic Infections

PubMed Central

Chauhan, Ashwini; Lebeaux, David; Decante, Benoit; Kriegel, Irene; Escande, Marie-Christine; Ghigo, Jean-Marc; Beloin, Christophe

2012-01-01

Formation of resilient biofilms on medical devices colonized by pathogenic microorganisms is a major cause of health-care associated infection. While in vitro biofilm analyses led to promising anti-biofilm approaches, little is known about their translation to in vivo situations and on host contribution to the in vivo dynamics of infections on medical devices. Here we have developed an in vivo model of long-term bacterial biofilm infections in a pediatric totally implantable venous access port (TIVAP) surgically placed in adult rats. Using non-invasive and quantitative bioluminescence, we studied TIVAP contamination by clinically relevant pathogens, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Staphylococcus epidermidis, and we demonstrated that TIVAP bacterial populations display typical biofilm phenotypes. In our study, we showed that immunocompetent rats were able to control the colonization and clear the bloodstream infection except for up to 30% that suffered systemic infection and death whereas none of the immunosuppressed rats survived the infection. Besides, we mimicked some clinically relevant TIVAP associated complications such as port-pocket infection and hematogenous route of colonization. Finally, by assessing an optimized antibiotic lock therapy, we established that our in vivo model enables to assess innovative therapeutic strategies against bacterial biofilm infections. PMID:22615964

Prevention and management of cochlear implant infections.

PubMed

Gluth, Michael B; Singh, Rajesh; Atlas, Marcus D

2011-11-01

Understanding the issues of infection related to an implantable medical device is crucial to all cochlear implant teams. Furthermore, given the risk of central nervous system complications and the relatively high quantity of underlying resource investment associated with cochlear implantation, the stakes of infection are high. The optimal strategies to prevent and manage such infections are still evolving as good-quality prospective data to guide such management decisions are not yet abundant within the medical literature and many recommendations are based on retrospective reviews or anecdotal evidence. We will outline a general strategy to deal with cochlear implant-related infection based on both the authors' experience and the published literature.

Polymeric nanofiber coating with tunable combinatorial antibiotic delivery prevents biofilm-associated infection in vivo

PubMed Central

Ashbaugh, Alyssa G.; Jiang, Xuesong; Zheng, Jesse; Tsai, Andrew S.; Kim, Woo-Shin; Thompson, John M.; Miller, Robert J.; Shahbazian, Jonathan H.; Wang, Yu; Dillen, Carly A.; Ordonez, Alvaro A.; Chang, Yong S.; Jain, Sanjay K.; Jones, Lynne C.; Sterling, Robert S.; Mao, Hai-Quan; Miller, Lloyd S.

2016-01-01

Bacterial biofilm formation is a major complication of implantable medical devices that results in therapeutically challenging chronic infections, especially in cases involving antibiotic-resistant bacteria. As an approach to prevent these infections, an electrospun composite coating comprised of poly(lactic-coglycolic acid) (PLGA) nanofibers embedded in a poly(ε-caprolactone) (PCL) film was developed to locally codeliver combinatorial antibiotics from the implant surface. The release of each antibiotic could be adjusted by loading each drug into the different polymers or by varying PLGA:PCL polymer ratios. In a mouse model of biofilm-associated orthopedic-implant infection, three different combinations of antibiotic-loaded coatings were highly effective in preventing infection of the bone/joint tissue and implant biofilm formation and were biocompatible with enhanced osseointegration. This nanofiber composite-coating technology could be used to tailor the delivery of combinatorial antimicrobial agents from various metallic implantable devices or prostheses to effectively decrease biofilm-associated infections in patients. PMID:27791154

Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

NASA Astrophysics Data System (ADS)

Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

2012-03-01

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

Electroenhanced Antimicrobial Coating Based on Conjugated Polymers with Covalently Coupled Silver Nanoparticles Prevents Staphylococcus aureus Biofilm Formation.

PubMed

Gomez-Carretero, Salvador; Nybom, Rolf; Richter-Dahlfors, Agneta

2017-10-01

The incidence of hospital-acquired infections is to a large extent due to device-associated infections. Bacterial attachment and biofilm formation on surfaces of medical devices often act as seeding points of infection. To prevent such infections, coatings based on silver nanoparticles (AgNPs) are often applied, however with varying clinical success. Here, the traditional AgNP-based antibacterial technology is reimagined, now forming the base for an electroenhanced antimicrobial coating. To integrate AgNPs in an electrically conducting polymer layer, a simple, yet effective chemical strategy based on poly(hydroxymethyl 3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT-MeOH:PSS) and (3-aminopropyl)triethoxysilane is designed. The resultant PEDOT-MeOH:PSS-AgNP composite presents a consistent coating of covalently linked AgNPs, as shown by scanning electron microscopy and surface plasmon resonance analysis. The efficacy of the coatings, with and without electrical addressing, is then tested against Staphylococcus aureus, a major colonizer of medical implants. Using custom-designed culturing devices, a nearly complete prevention of biofilm growth is obtained in AgNP composite devices addressed with a square wave voltage input. It is concluded that this electroenhancement of the bactericidal effect of the coupled AgNPs offers a novel, efficient solution against biofilm colonization of medical implants. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Use of portable electronic devices in a hospital setting and their potential for bacterial colonization.

PubMed

Khan, Amber; Rao, Amitha; Reyes-Sacin, Carlos; Hayakawa, Kayoko; Szpunar, Susan; Riederer, Kathleen; Kaye, Keith; Fishbain, Joel T; Levine, Diane

2015-03-01

Portable electronic devices are increasingly being used in the hospital setting. As with other fomites, these devices represent a potential reservoir for the transmission of pathogens. We conducted a convenience sampling of devices in 2 large medical centers to identify bacterial colonization rates and potential risk factors. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Synthesis and surface immobilization of antibacterial hybrid silver-poly(l-lactide) nanoparticles

NASA Astrophysics Data System (ADS)

Taheri, Shima; Baier, Grit; Majewski, Peter; Barton, Mary; Förch, Renate; Landfester, Katharina; Vasilev, Krasimir

2014-08-01

Infections associated with medical devices are a substantial healthcare problem. Consequently, there has been increasing research and technological efforts directed toward the development of coatings that are capable of preventing bacterial colonization of the device surface. Herein, we report on novel hybrid silver loaded poly(L-lactic acid) nanoparticles (PLLA-AgNPs) with narrowly distributed sizes (17 ± 3 nm) prepared using a combination of solvent evaporation and mini-emulsion technology. These particles were then immobilized onto solid surfaces premodified with a thin layer of allylamine plasma polymer (AApp). The antibacterial efficacy of the PLLA-AgNPs nanoparticles was studied in vitro against both gram-positive (Staphylococcus epidermidis) and gram-negative (Escherichia coli) bacteria. The minimal inhibitory concentration values against Staphylococcus epidermidis and Escherichia coli were 0.610 and 1.156 μg · mL-1, respectively. The capacity of the prepared coatings to prevent bacterial surface colonization was assessed in the presence of Staphylococcus epidermidis, which is a strong biofilm former that causes substantial problems with medical device associated infections. The level of inhibition of bacterial growth was 98%. The substrate independent nature and the high antibacterial efficacy of coatings presented in this study may offer new alternatives for antibacterial coatings for medical devices.

Healthcare Associated Infections in a Resource Limited Setting

PubMed Central

Doradla, Saikumar; Belgode, Harish Narasimha; Kumar, Harichandra; Swaminathan, Rathinam Palamalai

2017-01-01

Introduction Health Care associated Infections (HAI) are the most common complications affecting the hospitalized patients. HAI are more common in developing and under developed countries. However, there are no systematic surveillance programs in these countries. Aim To find out the burden, predisposing factors and multidrug resistant organisms causing HAI in a resource limited setting. Materials and Methods This prospective observational study was done at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). Patients aged 13 years or more with stay of more than 48 hours in a 16 bedded Medical Intensive Care Unit (MICU) between November 2011 and April 2013 were included in the study. Patients were prospectively followed up till discharge or death for the development of HAI. Device associated HAI like Ventilator Associated Pneumonia (VAP), Catheter Related-Blood Stream Infection (CR-BSI) and Catheter Associated-Urinary Tract Infections (CA-UTI) were studied. Standard laboratory methods were used for identification of microorganisms causing HAI and to test their antibiotic sensitivity. Results A total of 346 patients were included in the study with median age of 38 years. Common indications for admission to Medical Intensive Care Unit (MICU) were poisoning (31.5%); neurological illness (23.4%) like Guillian-Barre syndrome, tetanus, meningitis, encephalitis; respiratory illness (14.5%) like pneumonia, acute respiratory distress syndrome and tropical infections (7.2%) like malaria, scrub typhus, leptospirosis. Fifty percent (174/346) patients developed one or more HAI with VAP being the most common. The rates of HAI per 1000 device days for VAP, CR-BSI, CA-UTI were 72.56, 3.98 and 12.4, respectively. Acinetobacter baumannii was the most common organism associated with HAI. Multidrug resistance was seen in 74% of the isolates. Conclusion The burden of HAI, especially with MDR organisms, in resource constrained setting like ours is alarming. There is urgent need for infection control and monitoring system to reduce HAI. PMID:28273989

Healthcare Associated Infections in a Resource Limited Setting.

PubMed

Bammigatti, Chanaveerappa; Doradla, Saikumar; Belgode, Harish Narasimha; Kumar, Harichandra; Swaminathan, Rathinam Palamalai

2017-01-01

Health Care associated Infections (HAI) are the most common complications affecting the hospitalized patients. HAI are more common in developing and under developed countries. However, there are no systematic surveillance programs in these countries. To find out the burden, predisposing factors and multidrug resistant organisms causing HAI in a resource limited setting. This prospective observational study was done at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). Patients aged 13 years or more with stay of more than 48 hours in a 16 bedded Medical Intensive Care Unit (MICU) between November 2011 and April 2013 were included in the study. Patients were prospectively followed up till discharge or death for the development of HAI. Device associated HAI like Ventilator Associated Pneumonia (VAP), Catheter Related-Blood Stream Infection (CR-BSI) and Catheter Associated-Urinary Tract Infections (CA-UTI) were studied. Standard laboratory methods were used for identification of microorganisms causing HAI and to test their antibiotic sensitivity. A total of 346 patients were included in the study with median age of 38 years. Common indications for admission to Medical Intensive Care Unit (MICU) were poisoning (31.5%); neurological illness (23.4%) like Guillian-Barre syndrome, tetanus, meningitis, encephalitis; respiratory illness (14.5%) like pneumonia, acute respiratory distress syndrome and tropical infections (7.2%) like malaria, scrub typhus, leptospirosis. Fifty percent (174/346) patients developed one or more HAI with VAP being the most common. The rates of HAI per 1000 device days for VAP, CR-BSI, CA-UTI were 72.56, 3.98 and 12.4, respectively. Acinetobacter baumannii was the most common organism associated with HAI. Multidrug resistance was seen in 74% of the isolates. The burden of HAI, especially with MDR organisms, in resource constrained setting like ours is alarming. There is urgent need for infection control and monitoring system to reduce HAI.

Device-associated infections in the pediatric intensive care unit at the American University of Beirut Medical Center.

PubMed

Ismail, Ali; El-Hage-Sleiman, Abdul-Karim; Majdalani, Marianne; Hanna-Wakim, Rima; Kanj, Souha; Sharara-Chami, Rana

2016-06-30

Device-associated healthcare-associated infections (DA-HAIs) are the principal threat to patient safety in intensive care units (ICUs).  The primary objective of this study was to identify the most common DA-HAIs in the pediatric intensive care unit (PICU) at the American University of Beirut Medical Center (AUBMC). Length of stay (LOS) and mortality, antimicrobial resistance patterns, and suitability of empiric antibiotic choices for DA-HAIs according to the local resistance patterns were also studied. This was a retrospective study that included all patients admitted to the PICU at AUBMC between January 2007 and December 2011. All patients admitted to the PICU having a placed central line, an endotracheal tube, and/or a Foley catheter were included. Data was extracted from the patients' medical records through chart review. A total of 22 patients were identified with 25 central line-associated bloodstream infections (CLABSI), 25 ventilator-associated pneumonia (VAP), and 9 catheter-associated urinary tract infections (CAUTIs). The causing organisms, their resistance patterns, and the appropriateness of empiric antimicrobial therapy were reported. Gram-negative pathogens were found in 53% of the DA-HAIs, Gram-positive ones in 27%, and fungal organisms in 20%. A total of 80% of K. pneumonia isolates were extended-spectrum beta-lactamases (ESBL) producers, and 30% of Pseudomonas isolates were multidrug resistant. No methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) were isolated. Based on culture results, the choice of empiric antimicrobial therapy was appropriate in 64% of the DA-HAIs. After the care bundle approach is adopted in our PICU, DA-HAIs are expected to decrease further.

Variables associated with peripherally inserted central catheter related infection in high risk newborn infants 1

PubMed Central

Rangel, Uesliz Vianna; Gomes, Saint Clair dos Santos; Costa, Ana Maria Aranha Magalhães; Moreira, Maria Elisabeth Lopes

2014-01-01

OBJECTIVE: to relate the variables from a surveillance form for intravenous devices in high risk newborn infants with peripherally inserted central catheter related infection. METHODOLOGY: approximately 15 variables were studied, being associated with peripherally inserted central catheter related infection, this being defined by blood culture results. The variables analyzed were obtained from the surveillance forms used with intravenous devices, attached to the medical records of newborn infants weighing between 500 and 1,499 g. The statistical association was defined using the Chi-squared and Student t tests. The study was approved by the Research Ethics Committee of the Instituto Fernandes Figueira under process N. 140.703/12. RESULTS: 63 medical records were analyzed. The infection rate observed was 25.4%. Of the variables analyzed, only three had a statistically-significant relationship with the blood culture - the use of drugs capable of inhibiting acid secretion, post-natal steroid use, and undertaking more than one invasive procedure (p-value of 0.0141, 0.0472 and 0.0277, respectively). CONCLUSION: the absence of significance of the variables of the form may be related to the quality of the records and to the absence of standardization. It is recommended that the teams be encouraged to adhere to the protocol and fill out the form. PMID:25493681

Fortified interpenetrating polymers – bacteria resistant coatings for medical devices† †Electronic supplementary information (ESI) available: Supporting figures and tables, and additional experimental procedures. See DOI: 10.1039/c6tb01110a Click here for additional data file.

PubMed Central

Venkateswaran, Seshasailam; Henrique Dos Santos, Orlando David; Scholefield, Emma; Lilienkampf, Annamaria; Gwynne, Peter J.; Swann, David G.; Dhaliwal, Kevin

2016-01-01

Infections arising from contaminated medical devices are a serious global issue, contributing to antibiotic resistance and imposing significant strain on healthcare systems. Since the majority of medical device-associated infections are biofilm related, efforts are being made to generate either bacteria-repellent or antibacterial coatings aimed at preventing bacterial colonisation. Here, we utilise a nanocapsule mediated slow release of a natural antimicrobial to improve the performance of a bacteria repellent polymer coating. Poly(lauryl acrylate) nanocapsules containing eugenol (4-allyl-2-methoxyphenol) were prepared and entrapped within a interpenetrating network designed to repel bacteria. When coated on a catheter and an endotracheal tube, this hemocompatible system allowed slow-release of eugenol, resulting in notable reduction in surface-bound Klebsiella pneumoniae and methicillin resistant Staphylococcus aureus. PMID:27746915

The Staphylococcal Biofilm: Adhesins, regulation, and host response

PubMed Central

Paharik, Alexandra E.; Horswill, Alexander R.

2015-01-01

The Staphylococci comprise a diverse genus of Gram-positive, non-motile commensal organisms that inhabit the skin and mucous membranes of humans and other mammals. In general, Staphylococci are benign members of the natural flora, but many species have the capacity to be opportunistic pathogens, mainly infecting individuals who have medical device implants or are otherwise immunocompromised. S. aureus and S. epidermidis are a major source of hospital-acquired infections and are the most common causes of surgical site infections and central line-associated bloodstream infections. The ability of Staphylococci to form biofilms in vivo makes them highly resistant to chemotherapeutics and leads to chronic diseases. These biofilm infections include osteomyelitis, endocarditis, medical device implants, and persistence in the cystic fibrosis lung. Here, we provide a comprehensive analysis of our current understanding of Staphylococcal biofilm formation, with an emphasis on adhesins and regulation, while also addressing how Staphylococcal biofilms interact with the immune system. On the whole, this review will provide a thorough picture of biofilm formation of the Staphylococcus genus and how this mode of growth impacts the host. PMID:27227309

Recent Nanotechnology Approaches for Prevention and Treatment of Biofilm-Associated Infections on Medical Devices.

PubMed

Ramasamy, Mohankandhasamy; Lee, Jintae

2016-01-01

Bacterial colonization in the form of biofilms on surfaces causes persistent infections and is an issue of considerable concern to healthcare providers. There is an urgent need for novel antimicrobial or antibiofilm surfaces and biomedical devices that provide protection against biofilm formation and planktonic pathogens, including antibiotic resistant strains. In this context, recent developments in the material science and engineering fields and steady progress in the nanotechnology field have created opportunities to design new biomaterials and surfaces with anti-infective, antifouling, bactericidal, and antibiofilm properties. Here we review a number of the recently developed nanotechnology-based biomaterials and explain underlying strategies used to make antibiofilm surfaces.

Recent Nanotechnology Approaches for Prevention and Treatment of Biofilm-Associated Infections on Medical Devices

PubMed Central

2016-01-01

Bacterial colonization in the form of biofilms on surfaces causes persistent infections and is an issue of considerable concern to healthcare providers. There is an urgent need for novel antimicrobial or antibiofilm surfaces and biomedical devices that provide protection against biofilm formation and planktonic pathogens, including antibiotic resistant strains. In this context, recent developments in the material science and engineering fields and steady progress in the nanotechnology field have created opportunities to design new biomaterials and surfaces with anti-infective, antifouling, bactericidal, and antibiofilm properties. Here we review a number of the recently developed nanotechnology-based biomaterials and explain underlying strategies used to make antibiofilm surfaces. PMID:27872845

Medical biofilms--nanotechnology approaches.

PubMed

Neethirajan, Suresh; Clond, Morgan A; Vogt, Adam

2014-10-01

Biofilms are colonies of bacteria or fungi that adhere to a surface, protected by an extracellular polymer matrix composed of polysaccharides and extracellular DNA. They are highly complex and dynamic multicellular structures that resist traditional means of killing planktonic bacteria. Recent developments in nanotechnology provide novel approaches to preventing and dispersing biofilm infections, which are a leading cause of morbidity and mortality. Medical device infections are responsible for approximately 60% of hospital acquired infections. In the United States, the estimated cost of caring for healthcare-associated infections is approximately between $28 billion and $45 billion per year. In this review, we will discuss our current understanding of biofilm formation and degradation, its relevance to challenges in clinical practice, and new technological developments in nanotechnology that are designed to address these challenges.

Sterilization, high-level disinfection, and environmental cleaning.

PubMed

Rutala, William A; Weber, David J

2011-03-01

Failure to perform proper disinfection and sterilization of medical devices may lead to introduction of pathogens, resulting in infection. New techniques have been developed for achieving high-level disinfection and adequate environmental cleanliness. This article examines new technologies for sterilization and high-level disinfection of critical and semicritical items, respectively, and because semicritical items carry the greatest risk of infection, the authors discuss reprocessing semicritical items such as endoscopes and automated endoscope reprocessors, endocavitary probes, prostate biopsy probes, tonometers, laryngoscopes, and infrared coagulation devices. In addition, current issues and practices associated with environmental cleaning are reviewed. Copyright © 2011. Published by Elsevier Inc.

Déjà vu: Ralstonia mannitolilytica infection associated with a humidifying respiratory therapy device, Israel, June to July 2011.

PubMed

Block, C; Ergaz-Shaltiel, Z; Valinsky, L; Temper, V; Hidalgo-Grass, C; Minster, N; Weissman, C; Benenson, S; Jaffe, J; Moses, A E; Bar-Oz, B

2013-05-02

Following a bloodstream infection in June 2011 with Ralstonia mannitolilytica in a premature infant treated with a humidifying respiratory therapy device, an investigation was initiated at the Hadassah Medical Centres in Jerusalem. The device delivers a warmed and humidified mixture of air and oxygen to patients by nasal cannula. The investigation revealed colonisation with R. mannitolilytica of two of 15 patients and contamination of components of five of six devices deployed in the premature units of the Hadassah hospitals. Ten isolates from the investigation were highly related and indistinguishable from isolates described in an outbreak in 2005 in the United States (US). Measures successful in containing the US outbreak were not included in user instructions provided to our hospitals by the distributor of the device.

Multistate Point-Prevalence Survey of Health Care–Associated Infections

PubMed Central

Magill, Shelley S.; Edwards, Jonathan R.; Bamberg, Wendy; Beldavs, Zintars G.; Dumyati, Ghinwa; Kainer, Marion A.; Lynfield, Ruth; Maloney, Meghan; McAllister-Hollod, Laura; Nadle, Joelle; Ray, Susan M.; Thompson, Deborah L.; Wilson, Lucy E.; Fridkin, Scott K.

2015-01-01

BACKGROUND Currently, no single U.S. surveillance system can provide estimates of the burden of all types of health care–associated infections across acute care patient populations. We conducted a prevalence survey in 10 geographically diverse states to determine the prevalence of health care–associated infections in acute care hospitals and generate updated estimates of the national burden of such infections. METHODS We defined health care–associated infections with the use of National Healthcare Safety Network criteria. One-day surveys of randomly selected inpatients were performed in participating hospitals. Hospital personnel collected demographic and limited clinical data. Trained data collectors reviewed medical records retrospectively to identify health care–associated infections active at the time of the survey. Survey data and 2010 Nationwide Inpatient Sample data, stratified according to patient age and length of hospital stay, were used to estimate the total numbers of health care–associated infections and of inpatients with such infections in U.S. acute care hospitals in 2011. RESULTS Surveys were conducted in 183 hospitals. Of 11,282 patients, 452 had 1 or more health care–associated infections (4.0%; 95% confidence interval, 3.7 to 4.4). Of 504 such infections, the most common types were pneumonia (21.8%), surgical-site infections (21.8%), and gastrointestinal infections (17.1%). Clostridium difficile was the most commonly reported pathogen (causing 12.1% of health care–associated infections). Device-associated infections (i.e., central-catheter–associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which have traditionally been the focus of programs to prevent health care–associated infections, accounted for 25.6% of such infections. We estimated that there were 648,000 patients with 721,800 health care–associated infections in U.S. acute care hospitals in 2011. CONCLUSIONS Results of this multistate prevalence survey of health care–associated infections indicate that public health surveillance and prevention activities should continue to address C. difficile infections. As device- and procedure-associated infections decrease, consideration should be given to expanding surveillance and prevention activities to include other health care–associated infections. PMID:24670166

Emergency department visits for medical device-associated adverse events among children.

PubMed

Wang, Cunlin; Hefflin, Brock; Cope, Judith U; Gross, Thomas P; Ritchie, Mary Beth; Qi, Youlin; Chu, Jianxiong

2010-08-01

The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further. ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted. National estimates for pediatric MDAEs were determined according to medical specialty, device category and class, injury diagnosis, and patient characteristics and outcome. The total estimated number of pediatric MDAEs during the 24-month period was 144,799 (95% confidence interval: 113,051-183,903), involving devices from 13 medical specialties. Contact lenses accounted for most MDAEs (23%), followed by hypodermic needles (8%). The distribution of MDAEs according to medical specialty varied according to age subgroup. The most-prevalent types of injuries included contusions/abrasions, foreign-body intrusions, punctures, lacerations, and infections. The most-frequently affected body parts were the eyeball, pubic region, finger, face, and ear. The majority of pediatric MDAEs involved class II (moderate-risk) devices. The incidence of pediatric MDAEs decreased with increasing age from early to late childhood and then spiked after 10 years of age. More girls than boys were affected at older ages (16-21 years) and more boys than girls at younger ages (< or =10 years). Hospitalizations were more likely to involve invasive or implanted devices. This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries.

A Chimeric Peptide Composed of a Dermaseptin Derivative and an RNA III-Inhibiting Peptide Prevents Graft-Associated Infections by Antibiotic-Resistant Staphylococci

PubMed Central

Balaban, Naomi; Gov, Yael; Giacometti, Andrea; Cirioni, Oscar; Ghiselli, Roberto; Mocchegiani, Federico; Orlando, Fiorenza; D'Amato, Giuseppina; Saba, Vittorio; Scalise, Giorgio; Bernes, Sabina; Mor, Amram

2004-01-01

Staphylococcal bacteria are a prevalent cause of infections associated with foreign bodies and indwelling medical devices. Bacteria are capable of escaping antibiotic treatment through encapsulation into biofilms. RNA III-inhibiting peptide (RIP) is a heptapeptide that inhibits staphylococcal biofilm formation by obstructing quorum-sensing mechanisms. K4-S4(1-13)a is a 13-residue dermaseptin derivative (DD13) believed to kill bacteria via membrane disruption. We tested each of these peptides as well as a hybrid construct, DD13-RIP, for their ability to inhibit bacterial proliferation and suppress quorum sensing in vitro and for their efficacy in preventing staphylococcal infection in a rat graft infection model with methicillin-resistant Staphylococcus aureus (MRSA) or S. epidermidis (MRSE). In vitro, proliferation assays demonstrated that RIP had no inhibitory effect, while DD13-RIP and DD13 were equally effective, and that the chimeric peptide but not DD13 was slightly more effective than RIP in inhibiting RNA III synthesis, a regulatory RNA molecule important for staphylococcal pathogenesis. In vivo, the three peptides reduced graft-associated bacterial load in a dose-dependent manner, but the hybrid peptide was most potent in totally preventing staphylococcal infections at the lowest dose. In addition, each of the peptides acted synergistically with antibiotics. The data indicate that RIP and DD13 act in synergy by attacking bacteria simultaneously by two different mechanisms. Such a chimeric peptide may be useful for coating medical devices to prevent drug-resistant staphylococcal infections. PMID:15215107

Eradication of Pseudomonas aeruginosa cells by cathodic electrochemical currents delivered with graphite electrodes.

PubMed

Niepa, Tagbo H R; Wang, Hao; Gilbert, Jeremy L; Ren, Dacheng

2017-03-01

Antibiotic resistance is a major challenge to the treatment of bacterial infections associated with medical devices and biomaterials. One important intrinsic mechanism of such resistance is the formation of persister cells that are phenotypic variants of microorganisms and highly tolerant to antibiotics. Recently, we reported a new approach to eradicating persister cells of Pseudomonas aeruginosa using low-level direct electrochemical current (DC) and synergy with the antibiotic tobramycin. To further understand the underlying mechanism and develop this technology toward possible medical applications, we investigated the electricidal activities of non-metallic biomaterial on persister and biofilm cells of P. aeruginosa using graphite-based TGON™ 805 electrodes. We employed both single and dual chamber systems to compare electrochemical factors of TGON and stainless steel 304 electrodes. The results revealed that TGON-based treatments were highly effective against P. aeruginosa persister cells. In the single chamber system, complete eradication of planktonic persister cells (corresponding to a 7-log killing) was achieved with 70μA/cm 2 DC using TGON electrodes within 40min of treatment, while the cell viability in biofilms was reduced by 2 logs within 1h. The killing effects were dose and time dependent with higher current densities requiring less time. Moreover, reduction reactions were found more effective than oxidation reactions, confirming that metal cations are not indispensable, although they may facilitate cell killing. The findings of this study can help develop electrochemical technologies to eradicate persister and biofilm cells for more effective treatment of medical device and biomaterial associated infections. Infections associated with medical devices and biomaterials present a major challenge due to high-level tolerance of microbes to conventional antibiotics. It is well established that such tolerance is due to the formation of dormant persister cells and multicellular structures known as biofilms. Recent studies have demonstrated electrochemical treatment as a promising alternative to eradicate bacterial infections, since the killing mechanism is independent of the growth phase of bacterial cells, but relies on various electrochemical species interplaying during the treatment. The current study investigated major bactericidal properties of the electrochemical currents mediated via TGON, a carbon-based electrode material. Up to total eradication of Pseudomonas aeruginosa persister cells was achieved. The new knowledge of electrochemical properties and the bioactivity of TGON may help develop new methods/devices to eradicate bacterial infections by delivering safe levels of electrochemical currents. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Feasibility of using an iPod touch device and acceptability of a stigma reduction intervention with HIV-infected women in the Deep South.

PubMed

Relf, Michael V; Silva, Susan G; Williams, Megan Scull; Moore, Elizabeth; Arscott, Joyell; Caiola, Courtney; Barroso, Julie

2015-10-01

As with many infectious diseases throughout history, stigma is a part of the trajectory of the HIV disease process. HIV-related stigma impedes women from being tested for HIV. Once infected, HIV-related stigma hinders women from disclosing their HIV status to sexual partners and health care providers, engaging in medical care, effectively self-managing the disease after infection, and adhering to anti-retroviral therapy. After three decades of the HIV epidemic, no evidenced-based, culturally relevant, gender-specific interventions exist to help women infected with HIV manage the stigma associated with HIV infection. This manuscript reports the feasibility of using an iPod touch device and acceptability of a stigma reduction intervention with HIV-infected women in the Deep South in a mixed-method, randomized clinical trial. Results from the study demonstrate that it is feasible to utilize an iPod touch device to deliver an HIV-related stigma intervention to women. Further, women report that the HIV-related stigma intervention is acceptable and meaningful.

Device Cleaning and Infection Control in Aerosol Therapy.

PubMed

O'Malley, Catherine A

2015-06-01

Aerosol delivery equipment used to administer inhaled medications includes the nebulizer, positive expiratory pressure devices added to the nebulizer, and valved holding chambers (spacers). These devices are semi-critical medical devices, and as such, infection prevention and control (IPC) guidelines recommend that they be cleaned, disinfected, rinsed with sterile water, and air-dried. There is confusion surrounding the care of aerosol devices because of inconsistencies in the various published IPC guidelines, lack of a standard of practice among institutions and respiratory therapists (RTs), and manufacturer's instructions for use of these devices are not always compatible with guidelines or practice. Challenges lie in awareness of IPC guidelines and establishing a standard for the care of aerosol delivery devices among all stakeholders/manufacturers, governments, vendors, and users. The latest IPC guideline from the Cystic Fibrosis Foundation, reviewed and endorsed by the Society for Healthcare Epidemiology of America and the Association for Professionals in Infection Control, has a recommendation for disposable nebulizers and a recommendation for reusable nebulizers. Reusable nebulizers should be cleaned, disinfected, rinsed with sterile water (if using a cold disinfectant), and air-dried between uses. The mouthpiece/mask of disposable nebulizers should be wiped with an alcohol pad, the residual volume should be rinsed out with sterile water after use, and the nebulizer should be replaced every 24 h. The RT plays a significant and responsible role in providing and teaching aerosol therapy to patients. The RT and all stakeholders need to work together to provide a standard of care for the safe use of aerosol delivery devices. Copyright © 2015 by Daedalus Enterprises.

Antimicrobial activity, cytotoxicity and inflammatory response of novel plastics embedded with silver nanoparticles.

PubMed

Martínez-Gutiérrez, Fidel; Guajardo-Pacheco, Jesús M; Noriega-Trevino, María E; Thi, Emily P; Reiner, Neil; Orrantia, Erasmo; Av-Gay, Yossef; Ruiz, Facundo; Bach, Horacio

2013-03-01

Infections associated with medical devices are an important cause of morbidity and mortality. Microorganisms are responsible for catheter infections that may then result in the local or systemic dissemination of the microorganism into the bloodstream. The aim of this study was to evaluate the antimicrobial activity of silver nanoparticles (AgNPs) embedded in polyurethane plastics, commonly used for catheter fabrication. AgNPs in the range of 25-30 nm were synthesized and embedded in polyurethane plastics at different concentrations. The antimicrobial activities of these plastics were tested against the three pathogenic microorganisms, Escherichia coli, Staphylococcus epidermidis and Candida albicans, frequently associated with catheter infections. The cytotoxicity of the plastics was evaluated on human-derived macrophages using propidium iodide and the secretion of the pro- and anti-inflammatory cytokines IL-6, IL-10 and TNF-a was measured using ELISA. A significant reduction of 6- to 7-log in the number of bacteria was measured, while a reduction of 90% was measured in the case of C. albicans. Neither cytotoxic effect on macrophages nor immunological response was observed. Plastics embedded with AgNPs have great potential to limit microbial colonization of implanted medical devices.

A review of the clinical implications of anti-infective biomaterials and infection-resistant surfaces.

PubMed

Campoccia, Davide; Montanaro, Lucio; Arciola, Carla Renata

2013-11-01

Infection is currently regarded as the most severe and devastating complication associated to the use of biomaterials. The important social, clinical and economic impacts of implant-related infections are promoting the efforts to obviate these severe diseases. In this context, the development of anti-infective biomaterials and of infection-resistant surfaces is being regarded as the main strategy to prevent the establishment of implant colonisation and biofilm formation by bacteria. In this review, the attention is focused on the biomaterial-associated infections, from which the need for anti-infective biomaterials originates. Biomaterial-associated infections differ markedly for epidemiology, aetiology and severity, depending mainly on the anatomic site, on the time of biomaterial application, and on the depth of the tissues harbouring the prosthesis. Here, the diversity and complexity of the different scenarios where medical devices are currently utilised are explored, providing an overview of the emblematic applicative fields and of the requirements for anti-infective biomaterials. © 2013 Elsevier Ltd. All rights reserved.

Chronic Actinomyces Infection Caused by Retained Cervical Cerclage: A Case Report.

PubMed

Lyttle, Brianna; Johnson, Julia V

2016-01-01

Historically, Actinomyces infection has been associated primarily with the intrauterine device. Recently, case reports associating Actinomyces with other implants have been described, including nonwoven polypropylene mesh used for urethral slings and Mersilene cerclage placements. However, there are no reported cases of chronic Actinomyces infections associated with retained Mersilene cerclage. A 51-year-old woman, gravida 3, para 3, presented with a 10-year history of vaginal discharge and Actinomyces identified on endometrial biopsy. After failing medical treatment and undergoing a hysterectomy, the patient was found to have a retained Mersilene cerclage. This is the first case to report persistent Actinomyces infection with a retained Mersilene cerclage. No current recommendations exist for assessing full removal of cerclage. Clinicians should have a high suspicion of Actinomyces infection in a patient who presents with persistent vaginal discharge and history of cerclage placement.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Scintigraphic imaging of Staphylococcus aureus infection using 99mTc radiolabeled aptamers.

PubMed

Santos, Sara Roberta Dos; de Sousa Lacerda, Camila Maria; Ferreira, Iêda Mendes; de Barros, André Luís Branco; Fernandes, Simone Odília; Cardoso, Valbert Nascimento; de Andrade, Antero Silva Ribeiro

2017-10-01

Staphylococcus aureus is a specie of great medical importance associated with many infections as bacteremia and infective endocarditis as well as osteoarticular, skin and soft tissue, pleuropulmonary, and device related infections. Early identification of infectious foci is crucial for successful treatment. Scintigraphy could contribute to this purpose since specific radiotracers were available. Aptamers due to their high specificity have great potential for radiopharmaceuticals development. In the present study scintigraphic images of S. aureus infectious foci were obtained using specific S. aureus aptamers radiolabeled with 99m Tc. Copyright © 2017 Elsevier Ltd. All rights reserved.

Multicenter prospective study on device-associated infection rates and bacterial resistance in intensive care units of Venezuela: International Nosocomial Infection Control Consortium (INICC) findings.

PubMed

Empaire, Gabriel D; Guzman Siritt, Maria E; Rosenthal, Victor D; Pérez, Fernando; Ruiz, Yvis; Díaz, Claudia; Di Silvestre, Gabriela; Salinas, Evelyn; Orozco, Nelva

2017-01-01

Device-associated healthcare-acquired infections (DA-HAI) pose a threat to patient safety in the intensive care unit (ICU). A DA-HAI surveillance study was conducted by the International Nosocomial Infection Control Consortium (INICC) in two adult medical/surgical ICUs at two hospitals in Caracas, Venezuela, in different periods from March 2008 to April 2015, using the US Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definitions and criteria, and INICC methods. We followed 1041 ICU patients for 4632 bed days. Central line-associated bloodstream infection (CLABSI) rate was 5.1 per 1000 central line days, ventilator-associated pneumonia (VAP) rate was 7.2 per 1000 mechanical ventilator days, and catheter-associated urinary tract infection (CAUTI) rate was 3.9 per 1000 urinary catheter days, all similar to or lower than INICC rates (4.9 [CLABSI]; 16.5 [VAP]; 5.3 [CAUTI]), and higher than CDC/NHSN rates (0.8 [CLABSI]; 1.1 [VAP]; and 1.3 [CAUTI]). Device utilization ratios were higher than INICC and CDC/NHSN rates, except for urinary catheter, which was similar to INICC. Extra length of stay was 8 days for patients with CLABSI, 9.6 for VAP and 5.7 days for CAUTI. Additional crude mortality was 3.0% for CLABSI, 4.4% for VAP, and 16.9% for CAUTI. DA-HAI rates in our ICUs are higher than CDC/NSHN's and similar to or lower than INICC international rates. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.

Multicenter outbreak of infections by Saprochaete clavata, an unrecognized opportunistic fungal pathogen.

PubMed

Vaux, Sophie; Criscuolo, Alexis; Desnos-Ollivier, Marie; Diancourt, Laure; Tarnaud, Chloé; Vandenbogaert, Matthias; Brisse, Sylvain; Coignard, Bruno; Dromer, Françoise

2014-12-16

Rapidly fatal cases of invasive fungal infections due to a fungus later identified as Saprochaete clavata were reported in France in May 2012. The objectives of this study were to determine the clonal relatedness of the isolates and to investigate possible sources of contamination. A nationwide alert was launched to collect cases. Molecular identification methods, whole-genome sequencing (WGS), and clone-specific genotyping were used to analyze recent and historical isolates, and a case-case study was performed. Isolates from thirty cases (26 fungemias, 22 associated deaths at day 30) were collected between September 2011 and October 2012. Eighteen cases occurred within 8 weeks (outbreak) in 10 health care facilities, suggesting a common source of contamination, with potential secondary cases. Phylogenetic analysis identified one clade (clade A), which accounted for 16/18 outbreak cases. Results of microbiological investigations of environmental, drug, or food sources were negative. Analysis of exposures pointed to a medical device used for storage and infusion of blood products, but no fungal contamination was detected in the unused devices. Molecular identification of isolates from previous studies demonstrated that S. clavata can be found in dairy products and has already been involved in monocentric outbreaks in hematology wards. The possibility that S. clavata may transmit through contaminated medical devices or can be associated with dairy products as seen in previous European outbreaks is highly relevant for the management of future outbreaks due to this newly recognized pathogen. This report also underlines further the potential of WGS for investigation of outbreaks due to uncommon fungal pathogens. Several cases of rapidly fatal infections due to the fungus Saprochaete clavata were reported in France within a short period of time in three health care facilities, suggesting a common source of contamination. A nationwide alert collected 30 cases over 1 year, including an outbreak of 18 cases over 8 weeks. Whole-genome sequencing (WGS) was used to analyze recent and historical isolates and to design a clade-specific genotyping method that uncovered a clone associated with the outbreak, thus allowing a case-case study to analyze the risk factors associated with infection by the clone. The possibility that S. clavata may transmit through contaminated medical devices or can be associated with dairy products as seen in previous European outbreaks is highly relevant for the management of future outbreaks due to this newly recognized pathogen. Copyright © 2014 Vaux et al.

Analytical Chemistry in the Regulatory Science of Medical Devices.

PubMed

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

Dipeptide cis-cyclo(Leucyl-Tyrosyl) produced by sponge associated Penicillium sp. F37 inhibits biofilm formation of the pathogenic Staphylococcus epidermidis.

PubMed

Scopel, Marina; Abraham, Wolf-Rainer; Henriques, Amélia T; Macedo, Alexandre J

2013-02-01

Infections associated to microbial biofilms are involved in 80% of human infections and became a challenge concerning public health. Infections related to Staphylococcus epidermidis biofilms are presently commonly associated to medical devices, increasing treatment costs for this type of infection. Alternatives to eliminate this kind of disease have been employed in screening programs using diverse marine-derived fungi source of bioactive compounds capable to combat biofilm formation. In this work was isolated the dipeptide cis-cyclo(Leucyl-Tyrosyl) from a sponge associated Penicillium sp. possessing a remarkable inhibition up to 85% of biofilm formation without interfering with bacterial growth, confirmed by scanning electron microscopy. This is the first demonstration that cis-cyclo(Leucyl-Tyrosyl) is able to specifically inhibit biofilm formation adding another aspect to the broad spectrum of bioactivities of cyclic dipeptides. Copyright © 2012 Elsevier Ltd. All rights reserved.

Hybrid nanostructured coating for increased resistance of prosthetic devices to staphylococcal colonization

NASA Astrophysics Data System (ADS)

Anghel, Ion; Grumezescu, Alexandru Mihai

2013-01-01

Prosthetic medical device-associated infections are responsible for significant morbidity and mortality rates. Novel improved materials and surfaces exhibiting inappropriate conditions for microbial development are urgently required in the medical environment. This study reveals the benefit of using natural Mentha piperita essential oil, combined with a 5 nm core/shell nanosystem-improved surface exhibiting anti-adherence and antibiofilm properties. This strategy reveals a dual role of the nano-oil system; on one hand, inhibiting bacterial adherence and, on the other hand, exhibiting bactericidal effect, the core/shell nanosystem is acting as a controlled releasing machine for the essential oil. Our results demonstrate that this dual nanobiosystem is very efficient also for inhibiting biofilm formation, being a good candidate for the design of novel material surfaces used for prosthetic devices.

Socioeconomic impact on device-associated infections in pediatric intensive care units of 16 limited-resource countries: international Nosocomial Infection Control Consortium findings.

PubMed

Rosenthal, Victor D; Jarvis, William R; Jamulitrat, Silom; Silva, Cristiane Pavanello Rodrigues; Ramachandran, Bala; Dueñas, Lourdes; Gurskis, Vaidotas; Ersoz, Gulden; Novales, María Guadalupe Miranda; Khader, Ilham Abu; Ammar, Khaldi; Guzmán, Nayide Barahona; Navoa-Ng, Josephine Anne; Seliem, Zeinab Salah; Espinoza, Teodora Atencio; Meng, Cheong Yuet; Jayatilleke, Kushlani

2012-07-01

We report the results of the International Nosocomial Infection Control Consortium prospective surveillance study from January 2004 to December 2009 in 33 pediatric intensive care units of 16 countries and the impact of being in a private vs. public hospital and the income country level on device-associated health care-associated infection rates. Additionally, we aim to compare these findings with the results of the Centers for Disease Control and Prevention National Healthcare Safety Network annual report to show the differences between developed and developing countries regarding device-associated health care-associated infection rates. A prospective cohort, active device-associated health care-associated infection surveillance study was conducted on 23,700 patients in International Nosocomial Infection Control Consortium pediatric intensive care units. The protocol and methodology implemented were developed by International Nosocomial Infection Control Consortium. Data collection was performed in the participating intensive care units. Data uploading and analyses were conducted at International Nosocomial Infection Control Consortium headquarters on proprietary software. Device-associated health care-associated infection rates were recorded by applying Centers for Disease Control and Prevention National Healthcare Safety Network device-associated infection definitions, and the impact of being in a private vs. public hospital and the income country level on device-associated infection risk was evaluated. None. Central line-associated bloodstream infection rates were similar in private, public, or academic hospitals (7.3 vs. 8.4 central line-associated bloodstream infection per 1,000 catheter-days [p < .35 vs. 8.2; p < .42]). Central line-associated bloodstream infection rates in lower middle-income countries were higher than low-income countries or upper middle-income countries (12.2 vs. 5.5 central line-associated bloodstream infections per 1,000 catheter-days [p < .02 vs. 7.0; p < .001]). Catheter-associated urinary tract infection rates were similar in academic, public and private hospitals: (4.2 vs. 5.2 catheter-associated urinary tract infection per 1,000 catheter-days [p = .41 vs. 3.0; p = .195]). Catheter-associated urinary tract infection rates were higher in lower middle-income countries than low-income countries or upper middle-income countries (5.9 vs. 0.6 catheter-associated urinary tract infection per 1,000 catheter-days [p < .004 vs. 3.7; p < .01]). Ventilator-associated pneumonia rates in academic hospitals were higher than private or public hospitals: (8.3 vs. 3.5 ventilator-associated pneumonias per 1,000 ventilator-days [p < .001 vs. 4.7; p < .001]). Lower middle-income countries had higher ventilator-associated pneumonia rates than low-income countries or upper middle-income countries: (9.0 vs. 0.5 per 1,000 ventilator-days [p < .001 vs. 5.4; p < .001]). Hand hygiene compliance rates were higher in public than academic or private hospitals (65.2% vs. 54.8% [p < .001 vs. 13.3%; p < .01]). Country socioeconomic level influence device-associated infection rates in developing countries and need to be considered when comparing device-associated infections from one country to another.

Optimal culture incubation time in orthopedic device-associated infections: a retrospective analysis of prolonged 14-day incubation.

PubMed

Schwotzer, Nora; Wahl, Peter; Fracheboud, Dominique; Gautier, Emanuel; Chuard, Christian

2014-01-01

Accurate diagnosis of orthopedic device-associated infections can be challenging. Culture of tissue biopsy specimens is often considered the gold standard; however, there is currently no consensus on the ideal incubation time for specimens. The aim of our study was to assess the yield of a 14-day incubation protocol for tissue biopsy specimens from revision surgery (joint replacements and internal fixation devices) in a general orthopedic and trauma surgery setting. Medical records were reviewed retrospectively in order to identify cases of infection according to predefined diagnostic criteria. From August 2009 to March 2012, 499 tissue biopsy specimens were sampled from 117 cases. In 70 cases (59.8%), at least one sample showed microbiological growth. Among them, 58 cases (82.9%) were considered infections and 12 cases (17.1%) were classified as contaminations. The median time to positivity in the cases of infection was 1 day (range, 1 to 10 days), compared to 6 days (range, 1 to 11 days) in the cases of contamination (P < 0.001). Fifty-six (96.6%) of the infection cases were diagnosed within 7 days of incubation. In conclusion, the results of our study show that the incubation of tissue biopsy specimens beyond 7 days is not productive in a general orthopedic and trauma surgery setting. Prolonged 14-day incubation might be of interest in particular situations, however, in which the prevalence of slow-growing microorganisms and anaerobes is higher.

Impact of Discontinuing Contact Precautions for Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus: An Interrupted Time Series Analysis.

PubMed

Bearman, Gonzalo; Abbas, Salma; Masroor, Nadia; Sanogo, Kakotan; Vanhoozer, Ginger; Cooper, Kaila; Doll, Michelle; Stevens, Michael P; Edmond, Michael B

2018-06-01

OBJECTIVETo investigate the impact of discontinuing contact precautions among patients infected or colonized with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) on rates of healthcare-associated infection (HAI). Single-center, quasi-experimental study conducted between 2011 and 2016.METHODSWe employed an interrupted time series design to evaluate the impact of 7 horizontal infection prevention interventions across intensive care units (ICUs) and hospital wards at an 865-bed urban, academic medical center. These interventions included (1) implementation of a urinary catheter bundle in January 2011, (2) chlorhexidine gluconate (CHG) perineal care outside ICUs in June 2011, (3) hospital-wide CHG bathing outside of ICUs in March 2012, (4) discontinuation of contact precautions in April 2013 for MRSA and VRE, (5) assessments and feedback with bare below the elbows (BBE) and contact precautions in August 2014, (6) implementation of an ultraviolet-C disinfection robot in March 2015, and (7) 72-hour automatic urinary catheter discontinuation orders in March 2016. Segmented regression modeling was performed to assess the changes in the infection rates attributable to the interventions.RESULTSThe rate of HAI declined throughout the study period. Infection rates for MRSA and VRE decreased by 1.31 (P=.76) and 6.25 (P=.21) per 100,000 patient days, respectively, and the infection rate decreased by 2.44 per 10,000 patient days (P=.23) for device-associated HAI following discontinuation of contact precautions.CONCLUSIONThe discontinuation of contact precautions for patients infected or colonized with MRSA or VRE, when combined with horizontal infection prevention measures was not associated with an increased incidence of MRSA and VRE device-associated infections. This approach may represent a safe and cost-effective strategy for managing these patients.Infect Control Hosp Epidemiol 2018;39:676-682.

Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System.

PubMed

Koff, Matthew D; Brown, Jeremiah R; Marshall, Emily J; O'Malley, A James; Jensen, Jens T; Heard, Stephen O; Longtine, Karen; O'Neill, Melissa; Longtine, Jaclyn; Houston, Donna; Robison, Cindy; Moulton, Eric; Patel, Hetal M; Loftus, Randy W

2016-08-01

BACKGROUND Healthcare provider hands are an important source of intraoperative bacterial transmission events associated with postoperative infection development. OBJECTIVE To explore the efficacy of a novel hand hygiene improvement system leveraging provider proximity and individual and group performance feedback in reducing 30-day postoperative healthcare-associated infections via increased provider hourly hand decontamination events. DESIGN Randomized, prospective study. SETTING Dartmouth-Hitchcock Medical Center in New Hampshire and UMass Memorial Medical Center in Massachusetts. PATIENTS Patients undergoing surgery. METHODS Operating room environments were randomly assigned to usual intraoperative hand hygiene or to a personalized, body-worn hand hygiene system. Anesthesia and circulating nurse provider hourly hand decontamination events were continuously monitored and reported. All patients were followed prospectively for the development of 30-day postoperative healthcare-associated infections. RESULTS A total of 3,256 operating room environments and patients (1,620 control and 1,636 treatment) were enrolled. The mean (SD) provider hand decontamination event rate achieved was 4.3 (2.9) events per hour, an approximate 8-fold increase in hand decontamination events above that of conventional wall-mounted devices (0.57 events/hour); P<.001. Use of the hand hygiene system was not associated with a reduction in healthcare-associated infections (odds ratio, 1.07 [95% CI, 0.82-1.40], P=.626). CONCLUSIONS The hand hygiene system evaluated in this study increased the frequency of hand decontamination events without reducing 30-day postoperative healthcare-associated infections. Future work is indicated to optimize the efficacy of this hand hygiene improvement strategy. Infect Control Hosp Epidemiol 2016;37:888-895.

Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy

PubMed Central

Peters, Frans T. M.; van der Mei, Henny C.; Degener, John E.

2013-01-01

SUMMARY Flexible endoscopy is a widely used diagnostic and therapeutic procedure. Contaminated endoscopes are the medical devices frequently associated with outbreaks of health care-associated infections. Accurate reprocessing of flexible endoscopes involves cleaning and high-level disinfection followed by rinsing and drying before storage. Most contemporary flexible endoscopes cannot be heat sterilized and are designed with multiple channels, which are difficult to clean and disinfect. The ability of bacteria to form biofilms on the inner channel surfaces can contribute to failure of the decontamination process. Implementation of microbiological surveillance of endoscope reprocessing is appropriate to detect early colonization and biofilm formation in the endoscope and to prevent contamination and infection in patients after endoscopic procedures. This review presents an overview of the infections and cross-contaminations related to flexible gastrointestinal endoscopy and bronchoscopy and illustrates the impact of biofilm on endoscope reprocessing and postendoscopic infection. PMID:23554415

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

PubMed

Essebag, Vidal; Verma, Atul; Healey, Jeff S; Krahn, Andrew D; Kalfon, Eli; Coutu, Benoit; Ayala-Paredes, Felix; Tang, Anthony S; Sapp, John; Sturmer, Marcio; Keren, Arieh; Wells, George A; Birnie, David H

2016-03-22

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Bactericidal activity of biomimetic diamond nanocone surfaces.

PubMed

Fisher, Leanne E; Yang, Yang; Yuen, Muk-Fung; Zhang, Wenjun; Nobbs, Angela H; Su, Bo

2016-03-17

The formation of biofilms on implant surfaces and the subsequent development of medical device-associated infections are difficult to resolve and can cause considerable morbidity to the patient. Over the past decade, there has been growing recognition that physical cues, such as surface topography, can regulate biological responses and possess bactericidal activity. In this study, diamond nanocone-patterned surfaces, representing biomimetic analogs of the naturally bactericidal cicada fly wing, were fabricated using microwave plasma chemical vapor deposition, followed by bias-assisted reactive ion etching. Two structurally distinct nanocone surfaces were produced, characterized, and the bactericidal ability examined. The sharp diamond nanocone features were found to have bactericidal capabilities with the surface possessing the more varying cone dimension, nonuniform array, and decreased density, showing enhanced bactericidal ability over the more uniform, highly dense nanocone surface. Future research will focus on using the fabrication process to tailor surface nanotopographies on clinically relevant materials that promote both effective killing of a broader range of microorganisms and the desired mammalian cell response. This study serves to introduce a technology that may launch a new and innovative direction in the design of biomaterials with capacity to reduce the risk of medical device-associated infections.

An Essential Role for Coagulase in Staphylococcus aureus Biofilm Development Reveals New Therapeutic Possibilities for Device-Related Infections.

PubMed

Zapotoczna, Marta; McCarthy, Hannah; Rudkin, Justine K; O'Gara, James P; O'Neill, Eoghan

2015-12-15

High-level resistance to antimicrobial drugs is a major factor in the pathogenesis of chronic Staphylococcus aureus biofilm-associated, medical device-related infections. Antimicrobial susceptibility analysis revealed that biofilms grown for ≤ 24 hours on biomaterials conditioned with human plasma under venous shear in iron-free cell culture medium were significantly more susceptible to antistaphylococcal antibiotics. Biofilms formed under these physiologically relevant conditions were regulated by SaeRS and dependent on coagulase-catalyzed conversion of fibrinogen into fibrin. In contrast, SarA-regulated biofilms formed on uncoated polystyrene in nutrient-rich bacteriological medium were mediated by the previously characterized biofilm factors poly-N-acetyl glucosamine, fibronectin-binding proteins, or autolytic activity and were antibiotic resistant. Coagulase-mediated biofilms exhibited increased antimicrobial resistance over time (>48 hours) but were always susceptible to dispersal by the fibrinolytic enzymes plasmin or nattokinase. Biofilms recovered from infected central venous catheters in a rat model of device-related infection were dispersed by nattokinase, supporting the important role of the biofilm phenotype and identifying a potentially new therapeutic approach with antimicrobials and fibrinolytic drugs, particularly during the early stages of device-related infection. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Medical injuries among hospitalized children

PubMed Central

Meurer, J R; Yang, H; Guse, C E; Scanlon, M C; Layde, P M

2006-01-01

Background Inpatient medical injuries among children are common and result in a longer stay in hospital and increased hospital charges. However, previous studies have used screening criteria that focus on inpatient occurrences only rather than on injuries that also occur in ambulatory or community settings leading to hospital admission. Objective To describe the incidence and outcomes of medical injuries among children hospitalized in Wisconsin using the Wisconsin Medical Injury Prevention Program (WMIPP) screening criteria. Methods Cross sectional analysis of discharge records of 318 785 children from 134 hospitals in Wisconsin between 2000 and 2002. Results The WMIPP criteria identified 3.4% of discharges as having one or more medical injuries: 1.5% due to medications, 1.3% to procedures, and 0.9% to devices, implants and grafts. After adjusting for the All Patient Refined‐Diagnosis Related Groups disease category, illness severity, mortality risk, and clustering within hospitals, the mean length of stay (LOS) was a half day (12%) longer for patients with medical injuries than for those without injuries. The similarly adjusted mean total hospital charges were $1614 (26%) higher for the group with medical injuries. Excess LOS and charges were greatest for injuries due to genitourinary devices/implants, vascular devices, and infections/inflammation after procedures. Conclusions This study reinforces previous national findings up to 2000 using Wisconsin data to the end of 2002. The results suggest that hospitals and pediatricians should focus clinical improvement on medications, procedures, and devices frequently associated with medical injuries and use medical injury surveillance to track medical injury rates in children. PMID:16751471

International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: Device-associated module.

PubMed

Rosenthal, Víctor Daniel; Al-Abdely, Hail M; El-Kholy, Amani Ali; AlKhawaja, Safa A Aziz; Leblebicioglu, Hakan; Mehta, Yatin; Rai, Vineya; Hung, Nguyen Viet; Kanj, Souha Sami; Salama, Mona Foda; Salgado-Yepez, Estuardo; Elahi, Naheed; Morfin Otero, Rayo; Apisarnthanarak, Anucha; De Carvalho, Braulio Matias; Ider, Bat Erdene; Fisher, Dale; Buenaflor, Maria Carmen S G; Petrov, Michael M; Quesada-Mora, Ana Marcela; Zand, Farid; Gurskis, Vaidotas; Anguseva, Tanja; Ikram, Aamer; Aguilar de Moros, Daisy; Duszynska, Wieslawa; Mejia, Nepomuceno; Horhat, Florin George; Belskiy, Vladislav; Mioljevic, Vesna; Di Silvestre, Gabriela; Furova, Katarina; Ramos-Ortiz, Gloria Y; Gamar Elanbya, May Osman; Satari, Hindra Irawan; Gupta, Umesh; Dendane, Tarek; Raka, Lul; Guanche-Garcell, Humberto; Hu, Bijie; Padgett, Denis; Jayatilleke, Kushlani; Ben Jaballah, Najla; Apostolopoulou, Eleni; Prudencio Leon, Walter Enrique; Sepulveda-Chavez, Alejandra; Telechea, Hector Miguel; Trotter, Andrew; Alvarez-Moreno, Carlos; Kushner-Davalos, Luis

2016-12-01

We report the results of International Nosocomial Infection Control Consortium (INICC) surveillance study from January 2010-December 2015 in 703 intensive care units (ICUs) in Latin America, Europe, Eastern Mediterranean, Southeast Asia, and Western Pacific. During the 6-year study period, using Centers for Disease Control and Prevention National Healthcare Safety Network (CDC-NHSN) definitions for device-associated health care-associated infection (DA-HAI), we collected prospective data from 861,284 patients hospitalized in INICC hospital ICUs for an aggregate of 3,506,562 days. Although device use in INICC ICUs was similar to that reported from CDC-NHSN ICUs, DA-HAI rates were higher in the INICC ICUs: in the INICC medical-surgical ICUs, the pooled rate of central line-associated bloodstream infection, 4.1 per 1,000 central line-days, was nearly 5-fold higher than the 0.8 per 1,000 central line-days reported from comparable US ICUs, the overall rate of ventilator-associated pneumonia was also higher, 13.1 versus 0.9 per 1,000 ventilator-days, as was the rate of catheter-associated urinary tract infection, 5.07 versus 1.7 per 1,000 catheter-days. From blood cultures samples, frequencies of resistance of Pseudomonas isolates to amikacin (29.87% vs 10%) and to imipenem (44.3% vs 26.1%), and of Klebsiella pneumoniae isolates to ceftazidime (73.2% vs 28.8%) and to imipenem (43.27% vs 12.8%) were also higher in the INICC ICUs compared with CDC-NHSN ICUs. Although DA-HAIs in INICC ICU patients continue to be higher than the rates reported in CDC-NSHN ICUs representing the developed world, we have observed a significant trend toward the reduction of DA-HAI rates in INICC ICUs as shown in each international report. It is INICC's main goal to continue facilitating education, training, and basic and cost-effective tools and resources, such as standardized forms and an online platform, to tackle this problem effectively and systematically. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

In vivo surface roughness evolution of a stressed metallic implant

NASA Astrophysics Data System (ADS)

Tan, Henry

2016-10-01

Implant-associated infection, a serious medical issue, is caused by the adhesion of bacteria to the surface of biomaterials; for this process the surface roughness is an important property. Surface nanotopography of medical implant devices can control the extent of bacterial attachment by modifying the surface morphology; to this end a model is introduced to facilitate the analysis of a nanoscale smooth surface subject to mechanical loading and in vivo corrosion. At nanometre scale rough surface promotes friction, hence reduces the mobility of the bacteria; this sessile environment expedites the biofilm growth. This manuscript derives the controlling equation for surface roughness evolution for metallic implant subject to in-plane stresses, and predicts the in vivo roughness changes within 6 h of continued mechanical loading at different stress level. This paper provides analytic tool and theoretical information for surface nanotopography of medical implant devices.

Enzyme-mimicking polymer brush-functionalized surface for combating biomaterial-associated infections

NASA Astrophysics Data System (ADS)

Jiang, Rujian; Xin, Zhirong; Xu, Shiai; Shi, Hengchong; Yang, Huawei; Song, Lingjie; Yan, Shunjie; Luan, Shifang; Yin, Jinghua; Khan, Ather Farooq; Li, Yonggang

2017-11-01

Biomaterial-associated infections critically compromise the functionality and performance of the medical devices, and pose a serious threat to human healthcare. Recently, natural DNase enzyme has been recognized as a potent material to prevent bacterial adhesion and biofilm formation. However, the vulnerability of DNase dramatically limits its long-term performance in antibacterial applications. In this work, DNase-mimicking polymer brushes were constructed to mimic the DNA-cleavage activity as well as the macromolecular scaffold of the natural DNase. The bacteria repellent efficacy of DNase-mimicking polymer brush-functionalized surface was comparable to that of the DNase-functionalized surface. More importantly, due to their inherent stability, DNase-mimicking polymer brushes presented the much better performance in inhibiting bacterial biofilm development for prolonged periods of time, as compared to the natural DNase. The as-developed DNase-mimicking polymer brush-functionalized surface presents a promising approach to combat biomaterial-associated infections.

21 CFR 862.1510 - Nitrite (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... diagnosis and treatment of uninary tract infection of bacterial origin. (b) Classification. Class I (general...

Strategy to reduce E. coli bacteraemia based on cohort data from a London teaching hospital.

PubMed

Hsu, Desmond; Melzer, Mark

2018-04-01

In 2017, National Health Service Improvement set a 10% reduction target for Escherichia coli bacteraemia by 2018, followed by a 50% reduction in healthcare-associated Gram-negative bacteraemias by 2022. We analysed consecutive cases of E. coli bacteraemia and devised a strategy to achieve these targets. From December 2012 to November 2013, demographic, clinical and microbiological data were prospectively collected on all patients with bacteraemia at the Royal London Hospital in East London, UK. There were 594 significant bacteraemic episodes and 207 (34.8%) were E. coli . Twenty-four (11.6%) of the E. coli isolates were extended spectrum beta-lactamase producers, 22 (10.6%) gentamicin resistant and 2 (1.0%) amikacin resistant. The three most common sites of infection were pyelonephritis 105 (56.7%), catheter-associated urinary tract infection 22 (10.6%), and other medical devices and procedures that cause bacteraemia 32 (15.5%). In the pyelonephritis group, trimethoprim resistance in urinary isolates was 16/47 (34.0%) compared with 3/47 (6.4%) for nitrofurantoin. Twelve months postbacteraemia, recurrent bacteraemia rates were 10/105 (9.5%). There were 44 medical device-associated E. coli bacteraemias, and 22 (50%) were urinary catheter associated. There were 10 patients with E. coli bacteraemia caused by procedures, seven genitourinary or biliary tract instrumentation and three postgastrointestinal surgery. E. coli bacteraemias related to urosepsis could have been prevented by better empirical treatment and targeted prophylaxis. Urinary catheter quality improvement programmes should contribute to a further reduction. For patients undergoing high-risk urinary or biliary tract procedures or device manipulation, we advocate single-dose amikacin prophylaxis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Quality management for the processing of medical devices

PubMed Central

Klosz, Kerstin

2008-01-01

Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

Materials Advances for Next-Generation Ingestible Electronic Medical Devices.

PubMed

Bettinger, Christopher J

2015-10-01

Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Listeria monocytogenes: a Rare Complication of Ventriculoperitoneal Shunt in Children ▿

PubMed Central

Le Monnier, Alban; Blanot, Stéphane; Abachin, Eric; Beretti, Jean-Luc; Berche, Patrick; Kayal, Samer

2011-01-01

We report a case of ventriculoperitoneal (VP) shunt infection in a 3-year-old boy caused by the food-borne pathogen Listeria monocytogenes, subsequent to acute peritonitis. This unusual presentation of central nervous system (CNS) listeriosis underlines the ability of the bacteria to form and survive within biofilms on indwelling medical devices. Bacterial persistence may lead to treatment failure and spreading. We highlight the helpfulness of specific quantitative real-time PCR for the hly gene (PCR-hly) for the diagnosis and follow-up of such infections in detecting bacterial persistence within medical devices despite effective antibiotic treatment. Only the surgical replacement of the VP shunt will resolve the infection. PMID:21918024

Polymorphisms in Fibronectin Binding Protein A of Staphylococcus Aureus are Associated with Infection of Cardiovascular Devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lower, Steven; Lamlertthon, Supaporn; Casillas-Ituarte, Nadia

Medical implants, like cardiovascular devices, improve the quality of life for countless individuals but may become infected with bacteria like Staphylococcus aureus. Such infections take the form of a bio-film, a structured community of bacterial cells adherent to the surface of a solid substrate. Every bio-film begins with an attractive force or bond between bacterium and substratum. We used atomic force microscopy to probe experimentally forces between a fibronectin-coated surface (i.e., proxy for an implanted cardiac device) and fibronectin-binding receptors on the surface of individual living bacteria from each of 80 clinical isolates of S. aureus. These isolates originated frommore » humans with infected cardiac devices (CDI; n = 26), uninfected cardiac devices (n = 20), and the anterior nares of asymptomatic subjects (n = 34). CDI isolates exhibited a distinct bindingforce signature and had speci!c single amino acid polymorphisms in fibronectin-binding protein A corresponding to E652D, H782Q, and K786N. In silico molecular dynamics simulations demonstrate that residues D652, Q782, and N786 in fibronectin-binding protein A form extra hydrogen bonds with fibronectin, complementing the higher binding force and energy measured by atomic force microscopy for the CDI isolates. This study is significant, because it links pathogenic bacteria biofilms from the length scale of bonds acting across a nanometer-scale space to the clinical presentation of disease at the human dimension.« less

Lessons Learned from the Evolution of Mandatory Adverse Event Reporting Systems

DTIC Science & Technology

2005-05-01

related to treatment, such as nosocomial infections and unintended effects of drugs and medical devices, is collected by the Centers for Disease...Nontreatment-related events (such as criminal acts, specified statutory events, and nosocomial infection outbreaks) • Treatment and procedure...1.8 Ventilator death/injury 38 1.5 Anesthesia-related event 35 1.4 Infection -related event 34 1.4 Medical equipment-related 32 1.3 Maternal death

High-level disinfection of gastrointestinal endoscope reprocessing

PubMed Central

Chiu, King-Wah; Lu, Lung-Sheng; Chiou, Shue-Shian

2015-01-01

High level disinfection (HLD) of the gastrointestinal (GI) endoscope is not simply a slogan, but rather is a form of experimental monitoring-based medicine. By definition, GI endoscopy is a semicritical medical device. Hence, such medical devices require major quality assurance for disinfection. And because many of these items are temperature sensitive, low-temperature chemical methods, such as liquid chemical germicide, must be used rather than steam sterilization. In summarizing guidelines for infection prevention and control for GI endoscopy, there are three important steps that must be highlighted: manual washing, HLD with automated endoscope reprocessor, and drying. Strict adherence to current guidelines is required because compared to any other medical device, the GI endoscope is associated with more outbreaks linked to inadequate cleaning or disinfecting during HLD. Both experimental evaluation on the surveillance bacterial cultures and in-use clinical results have shown that, the monitoring of the stringent processes to prevent and control infection is an essential component of the broader strategy to ensure the delivery of safe endoscopy services, because endoscope reprocessing is a multistep procedure involving numerous factors that can interfere with its efficacy. Based on our years of experience in the surveillance of culture monitoring of endoscopic reprocessing, we aim in this study to carefully describe what details require attention in the GI endoscopy disinfection and to share our experience so that patients can be provided with high quality and safe medical practices. Quality management encompasses all aspects of pre- and post-procedural care including the efficiency of the endoscopy unit and reprocessing area, as well as the endoscopic procedure itself. PMID:25699232

Chitosan-based coatings in the prevention of intravascular catheter-associated infections.

PubMed

Mendoza, Gracia; Regiel-Futyra, Anna; Tamayo, Alejandra; Monzon, Marta; Irusta, Silvia; de Gregorio, Miguel Angel; Kyzioł, Agnieszka; Arruebo, Manuel

2018-01-01

Central venous access devices play an important role in patients with prolonged intravenous administration requirements. In the last years, the coating of these devices with bactericidal compounds has emerged as a potential tool to prevent bacterial colonization. Our study describes the modification of 3D-printed reservoirs and silicone-based catheters, mimicking central venous access devices, through different approaches including their coating with the well known biocompatible and bactericidal polymer chitosan, with the anionic polysaccharide alginate; also, plasma treated surfaces were included in the study to promote polymer adhesion. The evaluation of the antimicrobial action of those surface modifications compared to that exerted by a model antibiotic (ciprofloxacin) adsorbed on the surface of the devices was carried out. Surface characterization was developed by different methodologies and the bactericidal effects of the different coatings were assayed in an in vitro model of Staphylococcus aureus infection. Our results showed a significant reduction in the reservoir roughness (≤73%) after coating though no changes were observed for coated catheters which was also confirmed by scanning electron microscopy, pointing to the importance of the surface device topography for the successful attachment of the coating and for the subsequent development of bactericidal effects. Furthermore, the single presence of chitosan on the reservoirs was enough to fully inhibit bacterial growth exerting the same efficiency as that showed by the model antibiotic. Importantly, chitosan coating showed low cytotoxicity against human keratinocytes, human lung adenocarcinoma epithelial cells, and murine colon carcinoma cells displaying viability percentages in the range of the control samples (>95%). Chitosan-based coatings are proposed as an effective and promising solution in the prevention of microbial infections associated to medical devices.

Photochemical coatings for the prevention of bacterial colonization.

PubMed

Dunkirk, S G; Gregg, S L; Duran, L W; Monfils, J D; Haapala, J E; Marcy, J A; Clapper, D L; Amos, R A; Guire, P E

1991-10-01

Biomaterials are being used with increasing frequency for tissue substitution. Implantable, prosthetic devices are instrumental in the saving of patients' lives and enhancing the quality of life for many others. However, the greatest barrier to expanding the use of biomedical devices is the high probability of bacterial adherence and proliferation, causing very difficult and often untreatable medical-device centered infections. The difficulty in treating such infections results in great danger to the patient, and usually retrieval of the device with considerable pain and suffering. Clearly, development of processes that make biomedical devices resistant to bacterial adherence and colonization would have widespread application in the field of biomedical technology. A photochemical surface modification process is being investigated as a generic means of applying antimicrobial coatings to biomedical devices. The photochemical process results in covalent immobilization of coatings to all classes of medical device polymers. A discussion of the photochemical surface modification process and preliminary results demonstrating the success of photochemical coatings in formulating microbial-resistant surfaces are presented in this paper.

Effect of Winemaking on the Composition of Red Wine as a Source of Polyphenols for Anti-Infective Biomaterials

PubMed Central

Di Lorenzo, Arianna; Bloise, Nora; Meneghini, Silvia; Sureda, Antoni; Tenore, Gian Carlo; Visai, Livia; Arciola, Carla Renata; Daglia, Maria

2016-01-01

Biomaterials releasing bactericides have currently become tools for thwarting medical device-associated infections. The ideal anti-infective biomaterial must counteract infection while safeguarding eukaryotic cell integrity. Red wine is a widely consumed beverage to which many biological properties are ascribed, including protective effects against oral infections and related bone (osteoarthritis, osteomyelitis, periprosthetic joint infections) and cardiovascular diseases. In this study, fifteen red wine samples derived from grapes native to the Oltrepò Pavese region (Italy), obtained from the winemaking processes of “Bonarda dell’Oltrepò Pavese” red wine, were analyzed alongside three samples obtained from marc pressing. Total polyphenol and monomeric anthocyanin contents were determined and metabolite profiling was conducted by means of a chromatographic analysis. Antibacterial activity of wine samples was evaluated against Streptococcus mutans, responsible for dental caries, Streptococcus salivarius, and Streptococcus pyogenes, two oral bacterial pathogens. Results highlighted the winemaking stages in which samples exhibit the highest content of polyphenols and the greatest antibacterial activity. Considering the global need for new weapons against bacterial infections and alternatives to conventional antibiotics, as well as the favorable bioactivities of polyphenols, results point to red wine as a source of antibacterial substances for developing new anti-infective biomaterials and coatings for biomedical devices. PMID:28773444

Wireless communication with implanted medical devices using the conductive properties of the body.

PubMed

Ferguson, John E; Redish, A David

2011-07-01

Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

Factors affecting microbial adhesion to stainless steel and other materials used in medical devices.

PubMed

Verran, J; Whitehead, K

2005-11-01

The role of biofilm in medical device associated infections is well documented. Biofilms are more resistant to antibiotics than planktonic cells, these are extremely difficult to treat. Prevention strategies include efforts to insert implants under stringent aseptic conditions, and also encompass the development of novel materials which interfere with the initial attachment of microorganisms to the surface of the device. Microbial cells also attach onto hygienic surfaces in the hospital setting, and thereby pose a cross-infection problem. In this case, vigorous cleaning and sanitizing regimes may be employed in addition to any surface modifications. Many factors affect the initial attachment of organisms to inert substrata, and their subsequent retention or removal/detachment, including the physical and chemical nature and location of the substratum, the type of organic material and microorganisms potentially fouling the surface, and the nature of the interface (solid-liquid in the body; solid-air on environmental surfaces). Focusing on one factor, surface topography, it is apparent that many further variables need to be defined in order to fully understand the interactions occurring between the cell and surface. It is therefore important when modifying one substratum surface property in order to reduce adhesion, to also consider other potentially confounding factors.

Sustained Nitric Oxide-Releasing Nanoparticles Interfere with Methicillin-Resistant Staphylococcus aureus Adhesion and Biofilm Formation in a Rat Central Venous Catheter Model

PubMed Central

Mihu, Mircea Radu; Cabral, Vitor; Pattabhi, Rodney; Tar, Moses T.; Davies, Kelvin P.; Friedman, Adam J.

2016-01-01

ABSTRACT Staphylococcus aureus is frequently isolated in the setting of infections of indwelling medical devices, which are mediated by the microbe's ability to form biofilms on a variety of surfaces. Biofilm-embedded bacteria are more resistant to antimicrobial agents than their planktonic counterparts and often cause chronic infections and sepsis, particularly in patients with prolonged hospitalizations. In this study, we demonstrate that sustained nitric oxide-releasing nanoparticles (NO-np) interfere with S. aureus adhesion and prevent biofilm formation on a rat central venous catheter (CVC) model of infection. Confocal and scanning electron microscopy showed that NO-np-treated staphylococcal biofilms displayed considerably reduced thicknesses and bacterial numbers compared to those of control biofilms in vitro and in vivo, respectively. Although both phenotypes, planktonic and biofilm-associated staphylococci, of multiple clinical strains were susceptible to NO-np, bacteria within biofilms were more resistant to killing than their planktonic counterparts. Furthermore, chitosan, a biopolymer found in the exoskeleton of crustaceans and structurally integrated into the nanoparticles, seems to add considerable antimicrobial activity to the technology. Our findings suggest promising development and translational potential of NO-np for use as a prophylactic or therapeutic against bacterial biofilms on CVCs and other medical devices. PMID:27821454

Sustained Nitric Oxide-Releasing Nanoparticles Interfere with Methicillin-Resistant Staphylococcus aureus Adhesion and Biofilm Formation in a Rat Central Venous Catheter Model.

PubMed

Mihu, Mircea Radu; Cabral, Vitor; Pattabhi, Rodney; Tar, Moses T; Davies, Kelvin P; Friedman, Adam J; Martinez, Luis R; Nosanchuk, Joshua D

2017-01-01

Staphylococcus aureus is frequently isolated in the setting of infections of indwelling medical devices, which are mediated by the microbe's ability to form biofilms on a variety of surfaces. Biofilm-embedded bacteria are more resistant to antimicrobial agents than their planktonic counterparts and often cause chronic infections and sepsis, particularly in patients with prolonged hospitalizations. In this study, we demonstrate that sustained nitric oxide-releasing nanoparticles (NO-np) interfere with S. aureus adhesion and prevent biofilm formation on a rat central venous catheter (CVC) model of infection. Confocal and scanning electron microscopy showed that NO-np-treated staphylococcal biofilms displayed considerably reduced thicknesses and bacterial numbers compared to those of control biofilms in vitro and in vivo, respectively. Although both phenotypes, planktonic and biofilm-associated staphylococci, of multiple clinical strains were susceptible to NO-np, bacteria within biofilms were more resistant to killing than their planktonic counterparts. Furthermore, chitosan, a biopolymer found in the exoskeleton of crustaceans and structurally integrated into the nanoparticles, seems to add considerable antimicrobial activity to the technology. Our findings suggest promising development and translational potential of NO-np for use as a prophylactic or therapeutic against bacterial biofilms on CVCs and other medical devices. Copyright © 2016 American Society for Microbiology.

Evaluation of a polymer implanted port access device.

PubMed

Brown, J M

1996-01-01

The implanted port vascular access system has provided many patients with safe and reliable vascular access. Its implanted design provides improved body image, reduced maintenance and a better quality of life. The Huber needle has been the standard means of accessing the implanted port system. Because of the problems associated with the Huber needle system, current standards recommend that the Huber needle be changed every 7 days. This evaluation examines the use of a polymer cannula to access the implanted port system. This polymer cannula eliminates many of the problems associated with the Huber needle and provides longer dwell times without increased complications. Seventy nine patients were accessed for a total of 1533 days with the mean dwell time being 19.4 days with no increase in complications associated with port access. To establish implanted port access times of greater than 7 days without increased complications. A multicenter voluntary enrollment evaluation of a medical device. Patients were offered the opportunity to participate in the evaluation if they had an implanted port and were going to be accessed for therapy for periods of 7 days or more. Patients were observed for adverse cutaneous reactions at the insertion site and any port access complications such as sepsis, leakage, changes in portal chamber integrity, and implant pocket integrity. From October 1994 through November 1995, 79 L-Cath for Ports (Luther Medical Products) polymer catheter port access devices (Illustration 1) were inserted in 54 patients. This polymer port access device was used instead of a rigid metal Huber needle for port access. The total number of access days was 1533 days with the mean duration of access being 19.4 days. Two patients experienced blood stream infections while they were accessed with the polymer port access device. These infections ensued with fever of unknown origin as the presenting symptom during neutropenic episodes after chemotherapy treatment. The port access device was removed and the port access device tip was cultured with culture results being negative. No other patients experienced complications related to the port access device. The polymer port access device provided a safe and effective means of extending port access times. This reduced the number of restarts for the patients and could extend portal septum life by exposing the portal septum to fewer accesses.

Fungal Biofilms, Drug Resistance, and Recurrent Infection

PubMed Central

Desai, Jigar V.; Mitchell, Aaron P.; Andes, David R.

2014-01-01

A biofilm is a surface-associated microbial community. Diverse fungi are capable of biofilm growth. The significance of this growth form for infection biology is that biofilm formation on implanted devices is a major cause of recurrent infection. Biofilms also have limited drug susceptibility, making device-associated infection extremely difficult to treat. Biofilm-like growth can occur during many kinds of infection, even when an implanted device is not present. Here we summarize the current understanding of fungal biofilm formation, its genetic control, and the basis for biofilm drug resistance. PMID:25274758

Xyloglucan, hibiscus and propolis for the prevention of urinary tract infections: results of in vitro studies.

PubMed

Fraile, Benito; Alcover, Javier; Royuela, Mar; Rodríguez, David; Chaves, Concepción; Palacios, Ricardo; Piqué, Núria

2017-06-01

To assess the properties of a medical device containing xyloglucan, propolis and hibiscus to create a bioprotective barrier to avoid the contact of uropathogenic Escherichia coli strains on cell walls in models of intestinal (CacoGoblet) and uroepithelial (RWPE-1) cells (derived from normal human prostate epithelium). Two uropathogenic E. coli strains (expressing type 1 fimbriae and P fimbriae) were used to assess, by electronic microscopy and ELISA, the barrier properties of the medical device. The antimicrobial activity was assessed in broth dilution assays. The three components (xyloglucan, propolis and hibiscus) did not alter E. coli cell integrity in intestinal and uroepithelial cell models and were devoid of antibacterial activity. The three components avoided bacterial contact in both cell monolayers. The nonpharmacological barrier properties of xyloglucan, propolis and hibiscus confirm the role of the medical device for the management of urinary tract infections.

Low temperature plasma biomedicine: A tutorial review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Graves, David B., E-mail: graves@berkeley.edu

2014-08-15

Gas discharge plasmas formed at atmospheric pressure and near room temperature have recently been shown to be potentially useful for surface and wound sterilization, antisepsis, bleeding cessation, wound healing, and cancer treatment, among other biomedical applications. This tutorial review summarizes the field, stressing the likely role of reactive oxygen and nitrogen species created in these plasmas as the biologically and therapeutically active agents. Reactive species, including radicals and non-radical compounds, are generated naturally within the body and are now understood to be essential for normal biological functions. These species are known to be active agents in existing therapies for woundmore » healing, infection control, and cancer treatment. But they are also observed at elevated levels in persons with many diseases and are associated with aging. The physical and chemical complexity of plasma medical devices and their associated biochemical effects makes the development of safe, effective plasma medical devices and procedures a challenge, but encouragingly rapid progress has been reported around the world in the last several years.« less

Low temperature plasma biomedicine: A tutorial reviewa)

NASA Astrophysics Data System (ADS)

Graves, David B.

2014-08-01

Gas discharge plasmas formed at atmospheric pressure and near room temperature have recently been shown to be potentially useful for surface and wound sterilization, antisepsis, bleeding cessation, wound healing, and cancer treatment, among other biomedical applications. This tutorial review summarizes the field, stressing the likely role of reactive oxygen and nitrogen species created in these plasmas as the biologically and therapeutically active agents. Reactive species, including radicals and non-radical compounds, are generated naturally within the body and are now understood to be essential for normal biological functions. These species are known to be active agents in existing therapies for wound healing, infection control, and cancer treatment. But they are also observed at elevated levels in persons with many diseases and are associated with aging. The physical and chemical complexity of plasma medical devices and their associated biochemical effects makes the development of safe, effective plasma medical devices and procedures a challenge, but encouragingly rapid progress has been reported around the world in the last several years.

Cerebrovascular accidents in patients with a ventricular assist device.

PubMed

Tsukui, Hiroyuki; Abla, Adib; Teuteberg, Jeffrey J; McNamara, Dennis M; Mathier, Michael A; Cadaret, Linda M; Kormos, Robert L

2007-07-01

A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P < .0001). Sixty-six percent of cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

Rothia mucilaginosa Prosthetic Device Infections: a Case of Prosthetic Valve Endocarditis

PubMed Central

Tokarczyk, Mindy J.; Jungkind, Donald; DeSimone, Joseph A.

2013-01-01

Rothia mucilaginosa is increasingly recognized as an emerging opportunistic pathogen associated with prosthetic device infections. Infective endocarditis is one of the most common clinical presentations. We report a case of R. mucilaginosa prosthetic valve endocarditis and review the literature of prosthetic device infections caused by this organism. PMID:23467598

Characterization of the effect of serum and chelating agents on Staphylococcus aureus biofilm formation; chelating agents augment biofilm formation through clumping factor B

NASA Astrophysics Data System (ADS)

Abraham, Nabil Mathew

Staphylococcus aureus is the causative agent of a diverse array of acute and chronic infections, and some these infections, including infective endocarditis, joint infections, and medical device-associated bloodstream infections, depend upon its capacity to form tenacious biofilms on surfaces. Inserted medical devices such as intravenous catheters, pacemakers, and artificial heart valves save lives, but unfortunately, they can also serve as a substrate on which S. aureus can form a biofilm, attributing S. aureus as a leading cause of medical device-related infections. The major aim of this work was take compounds to which S. aureus would be exposed during infection and to investigate their effects on its capacity to form a biofilm. More specifically, the project investigated the effects of serum, and thereafter of catheter lock solutions on biofilm formation by S. aureus. Pre-coating polystyrene with serum is frequently used as a method to augment biofilm formation. The effect of pre-coating with serum is due to the deposition of extracellular matrix components onto the polystyrene, which are then recognized by MSCRAMMs. We therefore hypothesized that the major component of blood, serum, would induce biofilm formation. Surprisingly, serum actually inhibited biofilm formation. The inhibitory activity was due to a small molecular weight, heat-stable, non-proteinaceous component/s of serum. Serum-mediated inhibition of biofilm formation may represent a previously uncharacterized aspect of host innate immunity that targets the expression of a key bacterial virulence factor: the ability to establish a resistant biofilm. Metal ion chelators like sodium citrate are frequently chosen to lock intravenous catheters because they are regarded as potent inhibitors of bacterial biofilm formation and viability. We found that, while chelating compounds abolished biofilm formation in most strains of S. aureus, they actually augmented the phenotype in a subset of strains. We investigated the molecular basis of this phenomenon. Deletion and complementation analysis and thereafter antibody based inhibition assays confirmed a functional role for the surface adhesin clumping factor B as the causative determinant associated with the increased biofilm phenotype. Finally, we investigated the regulation of clumping factor B-mediated biofilm formation and the basis for the strain dependence. Regulation was determined to occur via two novel post-translational networks- one affecting ClfB activity, mediated by Ca2+ binding to the EF-Hand domain, and the other affecting protein stability, mediated by the enzymatic activity of the metalloprotease-aureolysin. Polymorphisms within the aureolysin gene sequence, between strains, was identified as the basis for some strains forming robust biofilms within chelated media versus other than do not exhibit this phenotype.

47 CFR 95.1209 - Permissible communications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1209 Permissible..., diagnostic and therapeutic information associated with a medical implant device or medical body-worn device... that is not included with a medical implant or medical body-worn device. Wireless retransmission of...

Cardiac Implantable Electronic Device-Related Infection and Extraction Trends in the U.S.

PubMed

Sridhar, Arun Raghav Mahankali; Lavu, Madhav; Yarlagadda, Vivek; Reddy, Madhu; Gunda, Sampath; Afzal, Rizwan; Atkins, Donita; Gopinathanair, Rakesh; Dawn, Buddhadeb; Lakkireddy, Dhanunjaya R

2017-03-01

Implantation of cardiac implanted electronic device (CIED) has surged lately. This resulted in a rise in cardiac device-related infections (CDI) and inevitably, lead extractions. We examined the recent national trend in the incidence of CIED infections and lead extractions in hospitalized patients and associated mortality. Using the Nationwide Inpatient Sample for the years 2003-2011 we identified patients diagnosed with a CDI-associated infection as determined by discharge ICD-9 diagnostic codes. We examined the trend of device-related infections overall and in different subgroups. We studied mortality associated with device infections, lead extractions, associated costs, and length of stay. There is a significant increase in the number of hospitalizations due to CDI from 5,308 in the year 2003 to 9,948 in 2011. Males (68%), Caucasians (77%), and age group 65-84 years (56.4%) accounted for majority of CDI. The mortality associated with CDI was 4.5 %, and was worse in higher age groups (2.5% in 18-44 years compared to 5.3% in 85+ years, P < 0.001). Average length of stay was unchanged over the years remaining at 13.6 days; however, mean hospitalization charges increased from $91,348 in 2003 to $173,211 in 2011 (P < 0.001). Among all lead extraction procedures, the percentage of patients undergoing lead extraction secondary to CDI also increased from 2003 (59.1%) to 2011 (76.7%), P-value < 0.001. Healthcare burden associated with CDI infections and associated lead extractions has significantly increased in the recent years. Despite an increase in cost associated with CIED infections, mortality remains the same, and is higher in older patients. © 2017 Wiley Periodicals, Inc.

A Cellular Automata Model of Infection Control on Medical Implants

PubMed Central

Prieto-Langarica, Alicia; Kojouharov, Hristo; Chen-Charpentier, Benito; Tang, Liping

2011-01-01

S. epidermidis infections on medically implanted devices are a common problem in modern medicine due to the abundance of the bacteria. Once inside the body, S. epidermidis gather in communities called biofilms and can become extremely hard to eradicate, causing the patient serious complications. We simulate the complex S. epidermidis-Neutrophils interactions in order to determine the optimum conditions for the immune system to be able to contain the infection and avoid implant rejection. Our cellular automata model can also be used as a tool for determining the optimal amount of antibiotics for combating biofilm formation on medical implants. PMID:23543851

Multicenter Outbreak of Infections by Saprochaete clavata, an Unrecognized Opportunistic Fungal Pathogen

PubMed Central

Vaux, Sophie; Criscuolo, Alexis; Desnos-Ollivier, Marie; Diancourt, Laure; Tarnaud, Chloé; Vandenbogaert, Matthias; Brisse, Sylvain; Coignard, Bruno; Garcia-Hermoso, Dea; Blanc, Catherine; Hoinard, Damien; Lortholary, Olivier; Bretagne, Stéphane; Thiolet, Jean-Michel; de Valk, Henriette; Courbil, Rémi; Chabanel, Anne; Simonet, Marion; Maire, Francoise; Jbilou, Saadia; Tiberghien, Pierre; Blanchard, Hervé; Venier, Anne-Gaëlle; Bernet, Claude; Simon, Loïc; Sénéchal, Hélène; Pouchol, Elodie; Angot, Christiane; Ribaud, Patricia; Socié, G.; Flèche, M.; Brieu, Nathalie; Lagier, Evelyne; Chartier, Vanessa; Allegre, Thierry; Maulin, Laurence; Lanic, Hélène; Tilly, Hervé; Bouchara, Jean-Philippe; Pihet, Marc; Schmidt, Aline; Kouatchet, Achille; Vandamme, Yves-Marie; Ifrah, Norbert; Mercat, Alain; Accoceberry, Isabelle; Albert, Olivier; Leguay, Thibaut; Rogues, Anne-Marie; Bonhomme, Julie; Reman, Oumédaly; Lesteven, Claire; Poirier, Philippe; Chabrot, Cécile Molucon; Calvet, Laure; Baud, Olivier; Cambon, Monique; Farkas, Jean Chistophe; Lafon, Bruno; Dalle, Frédéric; Caillot, Denis; Lazzarotti, Aline; Aho, Serge; Combret, Sandrine; Facon, Thierry; Sendid, Boualem; Loridant, Séverine; Louis, Terriou; Cazin, Bruno; Grandbastien, Bruno; Bourgeois, Nathalie; Lotthé, Anne; Cartron, Guillaume; Ravel, Christophe; Colson, Pascal; Gaudard, Philippe; Bonmati, Caroline; Simon, Loic; Rabaud, Christian; Machouart, Marie; Poisson, Didier; Carp, Diana; Meunier, Jérôme; Gaschet, Anne; Miquel, Chantal; Sanhes, Laurence; Ferreyra, Milagros; Leibinger, Franck; Geudet, Philippe; Toubas, Dominique; Himberlin, Chantal; Bureau-Chalot, Florence; Delmer, Alain; Favennec, Loïc; Gargala, Gilles; Michot, Jean-Baptiste; Girault, Christophe; David, Marion; Leprêtre, Stéphane; Jardin, Fabrice; Honderlick, Pierre; Caille, Vincent; Cerf, Charles; Cassaing, Sophie; Recher, Christian; Picard, Muriel; Protin, Caroline; Huguet, Françoise; Huynh, Anne; Ruiz, Jean; Riu-Poulenc, Béatrice; Letocart, Philippe; Marchou, Bruno; Verdeil, Xavier; Cavalié, Laurent; Chauvin, Pamela; Iriart, Xavier; Valentin, Alexis; Bouvet, Emmanuelle; Delmas-Marsalet, Béatrice; Jeblaoui, Asma; Kassis-Chikhani, Najiby; Mühlethaler, Konrad; Zimmerli, Stefan; Zalar, Polona; Sánchez-Reus, Ferran; Gurgui, Merce

2014-01-01

ABSTRACT Rapidly fatal cases of invasive fungal infections due to a fungus later identified as Saprochaete clavata were reported in France in May 2012. The objectives of this study were to determine the clonal relatedness of the isolates and to investigate possible sources of contamination. A nationwide alert was launched to collect cases. Molecular identification methods, whole-genome sequencing (WGS), and clone-specific genotyping were used to analyze recent and historical isolates, and a case-case study was performed. Isolates from thirty cases (26 fungemias, 22 associated deaths at day 30) were collected between September 2011 and October 2012. Eighteen cases occurred within 8 weeks (outbreak) in 10 health care facilities, suggesting a common source of contamination, with potential secondary cases. Phylogenetic analysis identified one clade (clade A), which accounted for 16/18 outbreak cases. Results of microbiological investigations of environmental, drug, or food sources were negative. Analysis of exposures pointed to a medical device used for storage and infusion of blood products, but no fungal contamination was detected in the unused devices. Molecular identification of isolates from previous studies demonstrated that S. clavata can be found in dairy products and has already been involved in monocentric outbreaks in hematology wards. The possibility that S. clavata may transmit through contaminated medical devices or can be associated with dairy products as seen in previous European outbreaks is highly relevant for the management of future outbreaks due to this newly recognized pathogen. This report also underlines further the potential of WGS for investigation of outbreaks due to uncommon fungal pathogens. PMID:25516620

Frequent accesses to totally implanted vascular ports in pediatric oncology patients are associated with higher infection rates.

PubMed

Gapany, Christophe; Tercier, Stéphane; Diezi, Manuel; Clement, Chantal; Lemay, Katy; Joseph, Jean-Marc

2011-01-01

Totally implanted vascular (TIVA) ports are used in children for repeated blood samples or intravenous treatments. We have recently published a prospective evaluation of surgical incidents and early complications associated with these devices. This work is the final part of the same study, assessing late complications over a follow-up of 2 yrs. From January 2006 to January 2008, children older than 1 yr of age with a diagnosis of solid or blood cell malignancy were included. Insertion technique and care of the device were standardized. Every manipulation was prospectively recorded by specialized nurses. Obstruction was documented clinically. When bacteremia was suspected, routine central and peripheral blood cultures were drawn. Forty-five consecutive patients were enrolled in the study. Mean age at the time of the procedure was 8.5 yrs. There was no catheter-related infection within the first 4 weeks post-surgery. No device had to be removed because of infection or obstruction during follow-up. Frequent accesses to the port (=3 per day over a 10-day period) were associated with an 8-fold risk of infection. Insertion and use of TIVA devices were frequently associated with complications. No device had to be removed because of infection or obstruction over the follow-up period, although no prophylactic antibiotic agent was used. Restrictive use of antibiotics may prevent opportunistic infection. Frequent access to the device was significantly associated with line infection (odds ratio=8.43). No risk factor was identified for obstruction which occurred at a rate of 5.3 per 10,000 accesses.

In-vivo orthopedic implant diagnostic device for sensing load, wear, and infection

DOEpatents

Evans, III, Boyd McCutchen; Thundat, Thomas G.; Komistek, Richard D.; Dennis, Douglas A.; Mahfouz, Mohamed

2006-08-29

A device for providing in vivo diagnostics of loads, wear, and infection in orthopedic implants having at least one load sensor associated with the implant, at least one temperature sensor associated with the implant, at least one vibration sensor associated with the implant, and at least one signal processing device operatively coupled with the sensors. The signal processing device is operable to receive the output signal from the sensors and transmit a signal corresponding with the output signal.

A pre-therapeutic coating for medical devices that prevents the attachment of Candida albicans.

PubMed

Vargas-Blanco, Diego; Lynn, Aung; Rosch, Jonah; Noreldin, Rony; Salerni, Anthony; Lambert, Christopher; Rao, Reeta P

2017-05-19

Hospital acquired fungal infections are defined as "never events"-medical errors that should never have happened. Systemic Candida albicans infections results in 30-50% mortality rates. Typically, adhesion to abiotic medical devices and implants initiates such infections. Efficient adhesion initiates formation of aggressive biofilms that are difficult to treat. Therefore, inhibitors of adhesion are important for drug development and likely to have a broad spectrum efficacy against many fungal pathogens. In this study we further the development of a small molecule, Filastatin, capable of preventing C. albicans adhesion. We explored the potential of Filastatin as a pre-therapeutic coating of a diverse range of biomaterials. Filastatin was applied on various biomaterials, specifically bioactive glass (cochlear implants, subcutaneous drug delivery devices and prosthetics); silicone (catheters and other implanted devices) and dental resin (dentures and dental implants). Adhesion to biomaterials was evaluated by direct visualization of wild type C. albicans or a non-adherent mutant edt1 -/- that were stained or fluorescently tagged. Strains grown overnight at 30 °C were harvested, allowed to attach to surfaces for 4 h and washed prior to visualization. The adhesion force of C. albicans cells attached to surfaces treated with Filastatin was measured using Atomic Force Microscopy. Effectiveness of Filastatin was also demonstrated under dynamic conditions using a flow cell bioreactor. The effect of Filastatin under microfluidic flow conditions was quantified using electrochemical impedance spectroscopy. Experiments were typically performed in triplicate. Treatment with Filastatin significantly inhibited the ability of C. albicans to adhere to bioactive glass (by 99.06%), silicone (by 77.27%), and dental resin (by 60.43%). Atomic force microcopy indicated that treatment with Filastatin decreased the adhesion force of C. albicans from 0.23 to 0.017 nN. Electrochemical Impedance Spectroscopy in a microfluidic device that mimic physiological flow conditions in vivo showed lower impedance for C. albicans when treated with Filastatin as compared to untreated control cells, suggesting decreased attachment. The anti-adhesive properties were maintained when Filastatin was included in the preparation of silicone materials. We demonstrate that Filastatin treated medical devices prevented adhesion of Candida, thereby reducing nosocomial infections.

Assessment of infection control practices in teaching hospitals of Quetta.

PubMed

Anwar, Muhammad; Majeed, Abdul; Saleem, Rana Muhammad; Manzoor, Farkhanda; Sharif, Saima

2016-08-01

To identify the gaps in infection control and prevention practices in teaching hospitals. This cross-sectional study was conducted at Bolan Medical Complex and Sandeman Medical College Hospital, Quetta, from August 2012 to January 2013.The study comprised members (n=7) of infection control committee who were interviewed through a self-developed, closed-ended questionnaire and their perception regarding infection control and prevention was recorded. Data was analysed using SPSS 16. Only 3(42.9%) of the committee members believed that the administrative factors for causing hospital-acquired infections were nurse-patient ratio. On the patient care side, 1(14.3%) participants at one of the hospitals attributed infections to antibiotic use, 5(71.4%) to invasive medical device and 1(14.3%) to other factors. Poor perception held by the members of infection control committee was the basic cause of bad outcome. Capacity-building of all the stakeholders is required.

An Improved Medium for Growing Staphylococcus aureus Biofilm

DTIC Science & Technology

2012-04-19

implantitis, chronic wound infections , chronic rhinosinusitis, endocarditis , and ocular infections (Archer et al., 2011). In addition, emerging evidence...causes of human bacterial infections , Staphylococcus aureus, a gram positive organism, is a ubiquitous oppor tunistic pathogen that commonly colonizes...resistant to antibiotic therapy. It has been shown that S. aureus biofilms are involved in oste omyelitis; indwelling medical device infections ; and peri

Medical Device Guidebook: A browser information resource for medical device users.

PubMed

Clarkson, Douglas M

2017-03-01

A web based information resource - the 'Medical Device Guidebook' - for the enabling of safe use of medical devices is described. Medical devices are described within a 'catalogue' of specific models and information on a specific model is provided within a consistent set of information 'keys'. These include 'user manuals', 'points of caution', 'clinical use framework', 'training/assessment material', 'frequently asked questions', 'authorised user comments' and 'consumables'. The system allows identification of known risk/hazards associated with specific devices, triggered, for example, by national alerts or locally raised safety observations. This provides a mechanism for more effective briefing of equipment users on the associated hazards of equipment. A feature of the system is the inclusion of a specific 'Operational Procedure' for each device, where the lack of this focus is shown in the literature to often be a key factor in equipment misuse and associated patient injury. The 'Guidebook' provides a mechanism for the development of an information resource developed within local clinical networks and encourages a consistent approach to medical device use. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

Clinical manifestations and management of left ventricular assist device-associated infections.

PubMed

Nienaber, Juhsien Jodi C; Kusne, Shimon; Riaz, Talha; Walker, Randall C; Baddour, Larry M; Wright, Alan J; Park, Soon J; Vikram, Holenarasipur R; Keating, Michael R; Arabia, Francisco A; Lahr, Brian D; Sohail, M Rizwan

2013-11-01

Infection is a serious complication of left ventricular assist device (LVAD) therapy. Published data regarding LVAD-associated infections (LVADIs) are limited by single-center experiences and use of nonstandardized definitions. We retrospectively reviewed 247 patients who underwent continuous-flow LVAD implantation from January 2005 to December 2011 at Mayo Clinic campuses in Minnesota, Arizona, and Florida. LVADIs were defined using the International Society for Heart and Lung Transplantation criteria. We identified 101 episodes of LVADI in 78 patients (32%) from this cohort. Mean age (± standard deviation [SD]) was 57±15 years. The majority (94%) underwent Heartmate II implantation, with 62% LVADs placed as destination therapy. The most common type of LVADIs were driveline infections (47%), followed by bloodstream infections (24% VAD related, and 22% non-VAD related). The most common causative pathogens included gram-positive cocci (45%), predominantly staphylococci, and nosocomial gram-negative bacilli (27%). Almost half (42%) of the patients were managed by chronic suppressive antimicrobial therapy. While 14% of the patients had intraoperative debridement, only 3 underwent complete LVAD removal. The average duration (±SD) of LVAD support was 1.5±1.0 years. At year 2 of follow-up, the cumulative incidence of all-cause mortality was estimated to be 43%. Clinical manifestations of LVADI vary on the basis of the type of infection and the causative pathogen. Mortality remained high despite combined medical and surgical intervention and chronic suppressive antimicrobial therapy. Based on clinical experiences, a management algorithm for LVADI is proposed to assist in the decision-making process.

Pathogenic Mechanisms and Host Interactions in Staphylococcus epidermidis Device-Related Infection.

PubMed

Sabaté Brescó, Marina; Harris, Llinos G; Thompson, Keith; Stanic, Barbara; Morgenstern, Mario; O'Mahony, Liam; Richards, R Geoff; Moriarty, T Fintan

2017-01-01

Staphylococcus epidermidis is a permanent member of the normal human microbiota, commonly found on skin and mucous membranes. By adhering to tissue surface moieties of the host via specific adhesins, S. epidermidis is capable of establishing a lifelong commensal relationship with humans that begins early in life. In its role as a commensal organism, S. epidermidis is thought to provide benefits to human host, including out-competing more virulent pathogens. However, largely due to its capacity to form biofilm on implanted foreign bodies, S. epidermidis has emerged as an important opportunistic pathogen in patients receiving medical devices. S. epidermidis causes approximately 20% of all orthopedic device-related infections (ODRIs), increasing up to 50% in late-developing infections. Despite this prevalence, it remains underrepresented in the scientific literature, in particular lagging behind the study of the S. aureus . This review aims to provide an overview of the interactions of S. epidermidis with the human host, both as a commensal and as a pathogen. The mechanisms retained by S. epidermidis that enable colonization of human skin as well as invasive infection, will be described, with a particular focus upon biofilm formation. The host immune responses to these infections are also described, including how S. epidermidis seems to trigger low levels of pro-inflammatory cytokines and high levels of interleukin-10, which may contribute to the sub-acute and persistent nature often associated with these infections. The adaptive immune response to S. epidermidis remains poorly described, and represents an area which may provide significant new discoveries in the coming years.

Grazing incidence angle based sensing approach integrated with fiber-optic Fourier transform infrared (FO-FTIR) spectroscopy for remote and label-free detection of medical device contaminations.

PubMed

Hassan, Moinuddin; Ilev, Ilko

2014-10-01

Contamination of medical devices has become a critical and prevalent public health safety concern since medical devices are being increasingly used in clinical practices for diagnostics, therapeutics and medical implants. The development of effective sensing methods for real-time detection of pathogenic contamination is needed to prevent and reduce the spread of infections to patients and the healthcare community. In this study, a hollow-core fiber-optic Fourier transform infrared spectroscopy methodology employing a grazing incidence angle based sensing approach (FO-FTIR-GIA) was developed for detection of various biochemical contaminants on medical device surfaces. We demonstrated the sensitivity of FO-FTIR-GIA sensing approach for non-contact and label-free detection of contaminants such as lipopolysaccharide from various surface materials relevant to medical device. The proposed sensing system can detect at a minimum loading concentration of approximately 0.7 μg/cm(2). The FO-FTIR-GIA has the potential for the detection of unwanted pathogen in real time.

Grazing incidence angle based sensing approach integrated with fiber-optic Fourier transform infrared (FO-FTIR) spectroscopy for remote and label-free detection of medical device contaminations

NASA Astrophysics Data System (ADS)

Hassan, Moinuddin; Ilev, Ilko

2014-10-01

Contamination of medical devices has become a critical and prevalent public health safety concern since medical devices are being increasingly used in clinical practices for diagnostics, therapeutics and medical implants. The development of effective sensing methods for real-time detection of pathogenic contamination is needed to prevent and reduce the spread of infections to patients and the healthcare community. In this study, a hollow-core fiber-optic Fourier transform infrared spectroscopy methodology employing a grazing incidence angle based sensing approach (FO-FTIR-GIA) was developed for detection of various biochemical contaminants on medical device surfaces. We demonstrated the sensitivity of FO-FTIR-GIA sensing approach for non-contact and label-free detection of contaminants such as lipopolysaccharide from various surface materials relevant to medical device. The proposed sensing system can detect at a minimum loading concentration of approximately 0.7 μg/cm2. The FO-FTIR-GIA has the potential for the detection of unwanted pathogen in real time.

Grazing incidence angle based sensing approach integrated with fiber-optic Fourier transform infrared (FO-FTIR) spectroscopy for remote and label-free detection of medical device contaminations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hassan, Moinuddin, E-mail: moinuddin.hassan@fda.hhs.gov; Ilev, Ilko

2014-10-15

Contamination of medical devices has become a critical and prevalent public health safety concern since medical devices are being increasingly used in clinical practices for diagnostics, therapeutics and medical implants. The development of effective sensing methods for real-time detection of pathogenic contamination is needed to prevent and reduce the spread of infections to patients and the healthcare community. In this study, a hollow-core fiber-optic Fourier transform infrared spectroscopy methodology employing a grazing incidence angle based sensing approach (FO-FTIR-GIA) was developed for detection of various biochemical contaminants on medical device surfaces. We demonstrated the sensitivity of FO-FTIR-GIA sensing approach for non-contactmore » and label-free detection of contaminants such as lipopolysaccharide from various surface materials relevant to medical device. The proposed sensing system can detect at a minimum loading concentration of approximately 0.7 μg/cm{sup 2}. The FO-FTIR-GIA has the potential for the detection of unwanted pathogen in real time.« less

Inhibition of Staphylococcus epidermidis Biofilm by Trimethylsilane Plasma Coating

PubMed Central

Ma, Yibao; Jones, John E.; Ritts, Andrew C.; Yu, Qingsong

2012-01-01

Biofilm formation on implantable medical devices is a major impediment to the treatment of nosocomial infections and promotes local progressive tissue destruction. Staphylococcus epidermidis infections are the leading cause of biofilm formation on indwelling devices. Bacteria in biofilms are highly resistant to antibiotic treatment, which in combination with the increasing prevalence of antibiotic resistance among human pathogens further complicates treatment of biofilm-related device infections. We have developed a novel plasma coating technology. Trimethylsilane (TMS) was used as a monomer to coat the surfaces of 316L stainless steel and grade 5 titanium alloy, which are widely used in implantable medical devices. The results of biofilm assays demonstrated that this TMS coating markedly decreased S. epidermidis biofilm formation by inhibiting the attachment of bacterial cells to the TMS-coated surfaces during the early phase of biofilm development. We also discovered that bacterial cells on the TMS-coated surfaces were more susceptible to antibiotic treatment than their counterparts in biofilms on uncoated surfaces. These findings suggested that TMS coating could result in a surface that is resistant to biofilm development and also in a bacterial community that is more sensitive to antibiotic therapy than typical biofilms. PMID:22964248

Multiple nosocomial infections: a risk of modern intensive care.

PubMed

Leviten, D L; Shulman, S T

1980-03-01

Many components of modern medical care greatly predispose subjects to nosocomial infection. These include cancer chemotherapy, organ transplantation, immunosuppression, and intensive supportive care, particularly in conjunction with mechanical ventilatory support, invasive monitoring devices and prolonged central or peripheral intravenous therapy. The hazard of nosocomial infection associated with residence in a modern intensive care unit is dramatized by the case history of a near-drowning victim whose hospital course was complicated by an unusually large number and variety of nosocomial bacterial infections. Sixteen different bacterial organisms were isolated from cultures of blood, purulent thoracostomy tube drainage, or purulent tracheal secretions during the patient's prolonged hospital course. Factors which predisposed this patient to nosocomial infections included prolonged positive pressure mechanical ventilation, long-term broad spectrum antibiotics, indwelling arterial and central venous lines, violation of anatomic barriers by foreign bodies such as multiple thoracostomy tubes, and residence in an intensive care unit. This patient's case demonstrates that effective means to prevent nosocomial colonization and infection are urgently needed.

Device-Associated Healthcare-Associated Infections (DA-HAI) and the caveat of multiresistance in a multidisciplinary intensive care unit.

PubMed

Khan, Inam Danish; Basu, Atoshi; Kiran, Sheshadri; Trivedi, Shaleen; Pandit, Priyanka; Chattoraj, Anupam

2017-07-01

Device-Associated Healthcare-Associated Infections (DA-HAI), including Ventilator-Associated Pneumonia (VAP), Central-Line-Associated Blood Stream Infection (CLABSI), and Catheter-Related Urinary Tract Infection (CAUTI), are considered as principal contributors to healthcare hazard and threat to patient safety as they can cause prolonged hospital stay, sepsis, and mortality in the ICU. The study intends to characterize DA-HAI in a tertiary care multidisciplinary ICU of a teaching hospital in eastern India. This prospective outcome-surveillance study was conducted among 2157 ICU patients of a 760-bedded teaching hospital in Eastern India. Clinical, laboratory and environmental surveillance, and screening of HCPs were conducted using the US Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) definitions and methods. With 8824 patient/bed/ICU days and 14,676 device days, pooled average device utilization ratio was 1.66, total episodes of DA-HAI were 114, and mean monthly rates of DA-HAI, VAP, CLABSI, and CAUTI were 4.75, 2, 1.4, and 1.25/1000 device days. Most common pathogens isolated from DA-HAI patients were Klebsiella pneumoniae (24.6%), Escherichia coli (21.9%), and Pseudomonas aeruginosa (20.2%). All Acinetobacter baumanii , >80% K. pneumoniae and E. coli , and >70% P. aeruginosa were susceptible only to colistin and tigecycline. One P. aeruginosa isolate was panresistant. Mean rates of VAP, CLABSI, and CAUTI were 14.4, 8.1, and 4.5 per 1000 device days, which are comparable with Indian and global ICUs. Patients and HCPs form important reservoirs of infection. Resolute conviction and sustained momentum in Infection Control Initiatives are an essential step toward patient safety.

Eradication of Pseudomonas aeruginosa Biofilms by Atmospheric Pressure Non-Thermal Plasma

PubMed Central

Alkawareek, Mahmoud Y.; Algwari, Qais Th.; Laverty, Garry; Gorman, Sean P.; Graham, William G.; O'Connell, Deborah; Gilmore, Brendan F.

2012-01-01

Bacteria exist, in most environments, as complex, organised communities of sessile cells embedded within a matrix of self-produced, hydrated extracellular polymeric substances known as biofilms. Bacterial biofilms represent a ubiquitous and predominant cause of both chronic infections and infections associated with the use of indwelling medical devices such as catheters and prostheses. Such infections typically exhibit significantly enhanced tolerance to antimicrobial, biocidal and immunological challenge. This renders them difficult, sometimes impossible, to treat using conventional chemotherapeutic agents. Effective alternative approaches for prevention and eradication of biofilm associated chronic and device-associated infections are therefore urgently required. Atmospheric pressure non-thermal plasmas are gaining increasing attention as a potential approach for the eradication and control of bacterial infection and contamination. To date, however, the majority of studies have been conducted with reference to planktonic bacteria and rather less attention has been directed towards bacteria in the biofilm mode of growth. In this study, the activity of a kilohertz-driven atmospheric pressure non-thermal plasma jet, operated in a helium oxygen mixture, against Pseudomonas aeruginosa in vitro biofilms was evaluated. Pseudomonas aeruginosa biofilms exhibit marked susceptibility to exposure of the plasma jet effluent, following even relatively short (∼10′s s) exposure times. Manipulation of plasma operating conditions, for example, plasma operating frequency, had a significant effect on the bacterial inactivation rate. Survival curves exhibit a rapid decline in the number of surviving cells in the first 60 seconds followed by slower rate of cell number reduction. Excellent anti-biofilm activity of the plasma jet was also demonstrated by both confocal scanning laser microscopy and metabolism of the tetrazolium salt, XTT, a measure of bactericidal activity. PMID:22952948

International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries, for 2004-2009.

PubMed

Rosenthal, Victor D; Bijie, Hu; Maki, Dennis G; Mehta, Yatin; Apisarnthanarak, Anucha; Medeiros, Eduardo A; Leblebicioglu, Hakan; Fisher, Dale; Álvarez-Moreno, Carlos; Khader, Ilham Abu; Del Rocío González Martínez, Marisela; Cuellar, Luis E; Navoa-Ng, Josephine Anne; Abouqal, Rédouane; Guanche Garcell, Humberto; Mitrev, Zan; Pirez García, María Catalina; Hamdi, Asma; Dueñas, Lourdes; Cancel, Elsie; Gurskis, Vaidotas; Rasslan, Ossama; Ahmed, Altaf; Kanj, Souha S; Ugalde, Olber Chavarría; Mapp, Trudell; Raka, Lul; Yuet Meng, Cheong; Thu, Le Thi Anh; Ghazal, Sameeh; Gikas, Achilleas; Narváez, Leonardo Pazmiño; Mejía, Nepomuceno; Hadjieva, Nassya; Gamar Elanbya, May Osman; Guzmán Siritt, María Eugenia; Jayatilleke, Kushlani

2012-06-01

The results of a surveillance study conducted by the International Nosocomial Infection Control Consortium (INICC) from January 2004 through December 2009 in 422 intensive care units (ICUs) of 36 countries in Latin America, Asia, Africa, and Europe are reported. During the 6-year study period, using Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN; formerly the National Nosocomial Infection Surveillance system [NNIS]) definitions for device-associated health care-associated infections, we gathered prospective data from 313,008 patients hospitalized in the consortium's ICUs for an aggregate of 2,194,897 ICU bed-days. Despite the fact that the use of devices in the developing countries' ICUs was remarkably similar to that reported in US ICUs in the CDC's NHSN, rates of device-associated nosocomial infection were significantly higher in the ICUs of the INICC hospitals; the pooled rate of central line-associated bloodstream infection in the INICC ICUs of 6.8 per 1,000 central line-days was more than 3-fold higher than the 2.0 per 1,000 central line-days reported in comparable US ICUs. The overall rate of ventilator-associated pneumonia also was far higher (15.8 vs 3.3 per 1,000 ventilator-days), as was the rate of catheter-associated urinary tract infection (6.3 vs. 3.3 per 1,000 catheter-days). Notably, the frequencies of resistance of Pseudomonas aeruginosa isolates to imipenem (47.2% vs 23.0%), Klebsiella pneumoniae isolates to ceftazidime (76.3% vs 27.1%), Escherichia coli isolates to ceftazidime (66.7% vs 8.1%), Staphylococcus aureus isolates to methicillin (84.4% vs 56.8%), were also higher in the consortium's ICUs, and the crude unadjusted excess mortalities of device-related infections ranged from 7.3% (for catheter-associated urinary tract infection) to 15.2% (for ventilator-associated pneumonia). Copyright © 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... running to unintended areas, etc. Wound dehiscence Bench Testing, Shelf Life Testing, Animal Testing, Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing, Clinical Studies. Infection Bench Testing, Biocompatibility Animal Testing, Clinical Studies, Sterility...

Prosthetic Device Infections.

PubMed

Martinez, Raquel M; Bowen, Thomas R; Foltzer, Michael A

2016-08-01

The immunocompromised host is a particularly vulnerable population in whom routine and unusual infections can easily and frequently occur. Prosthetic devices are commonly used in these patients and the infections associated with those devices present a number of challenges for both the microbiologist and the clinician. Biofilms play a major role in device-related infections, which may contribute to failed attempts to recover organisms from routine culture methods. Moreover, device-related microorganisms can be difficult to eradicate by antibiotic therapy alone. Changes in clinical practice and advances in laboratory diagnostics have provided significant improvements in the detection and accurate diagnosis of device-related infections. Disruption of the bacterial biofilm plays an essential role in recovering the causative agent in culture. Various culture and nucleic acid amplification techniques are more accurate to guide directed treatment regimens. This chapter reviews the performance characteristics of currently available diagnostic assays and summarizes published guidelines, where available, for addressing suspected infected prosthetic devices.

Cardiac implantable electronic device infection due to Mycobacterium species: a case report and review of the literature.

PubMed

Al-Ghamdi, Bandar; Widaa, Hassan El; Shahid, Maie Al; Aladmawi, Mohammed; Alotaibi, Jawaher; Sanei, Aly Al; Halim, Magid

2016-08-24

Infection of cardiac implantable electronic devices is a serious cardiovascular disease and it is associated with a high mortality. Mycobacterium species may rarely cause cardiac implantable electronic devices infection. We are reporting a case of miliary tuberculosis in an Arab patient with dilated cardiomyopathy and a cardiac resynchronization therapy-defibrillator device that was complicated with infection of his cardiac resynchronization therapy-defibrillator device. To our knowledge, this is the third case in the literature with such a presentation and all patients died during the course of treatment. This underscores the importance of early diagnosis and management. We also performed a literature review of reported cases of cardiac implantable electronic devices infection related to Mycobacterium species. Cardiac implantable electronic devices infection due to Mycobacterium species is an uncommon but a well-known entity. Early diagnosis and prompt management may result in a better outcome.

Red selenium nanoparticles and gray selenium nanorods as antibacterial coatings for PEEK medical devices.

PubMed

Wang, Qi; Mejía Jaramillo, Alejandra; Pavon, Juan J; Webster, Thomas J

2016-10-01

Bacterial infections are commonly found on various poly(ether ether ketone) (PEEK) medical devices (such as orthopedic instruments, spinal fusion devices, and segments in dialysis equipment), and thus, there is a significant need for introducing antibacterial properties to such materials. The objective of this in vitro study was to introduce antibacterial properties to PEEK medical devices by coating them with nanosized selenium. In this study, red selenium (an elemental form of selenium) nanoparticles were coated on PEEK medical devices through a quick precipitation method. Furthermore, with heat treatment at 100°C for 6 days, red selenium nanoparticles were transferred into gray selenium nanorods on the PEEK surfaces. Bacteria test results showed that both red and gray selenium-coated PEEK medical devices significantly inhibited the growth of Pseudomonas aeruginosa compared with uncoated PEEK after either 1, 2, or 3 days. Red selenium nanoparticle-coated PEEK showed less bacteria growth on its surface than gray selenium nanorod-coated PEEK after 3 days. This study demonstrated that red, and to a lesser extent gray, nanosized selenium could be used as potential antibacterial coatings to prevent bacteria function on PEEK medical devices. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1352-1358, 2016. © 2015 Wiley Periodicals, Inc.

Endocarditis in left ventricular assist device

PubMed Central

Thyagarajan, Braghadheeswar; Kumar, Monisha Priyadarshini; Sikachi, Rutuja R; Agrawal, Abhinav

2016-01-01

Summary Heart failure is one of the leading causes of death in developed nations. End stage heart failure often requires cardiac transplantation for survival. The left ventricular assist device (LVAD) has been one of the biggest evolvements in heart failure management often serving as bridge to transplant or destination therapy in advanced heart failure. Like any other medical device, LVAD is associated with complications with infections being reported in many patients. Endocarditis developing secondary to the placement of LVAD is not a frequent, serious and difficult to treat condition with high morbidity and mortality. Currently, there are few retrospective studies and case reports reporting the same. In our review, we found the most common cause of endocarditis in LVAD was due to bacteria. Both bacterial and fungal endocarditis were associated with high morbidity and mortality. In this review we will be discussing the risk factors, organisms involved, diagnostic tests, management strategies, complications, and outcomes in patients who developed endocarditis secondary to LVAD placement. PMID:27672540

Intrauterine device infection causing concomitant streptococcal toxic shock syndrome and pelvic abscess with Actinomyces odontolyticus bacteraemia

PubMed Central

Wu, Carolyn M Yu; Noska, Amanda

2016-01-01

Intrauterine devices (IUDs) are rarely associated with serious infections. We report an unusual concomitant infection of group A Streptococcus (GAS) causing toxic shock syndrome and pelvic abscess with Actinomyces odontolyticus associated with an IUD in a healthy 50-year-old patient. The IUD was subsequently removed and the patient recovered on the appropriate antibiotics. This case highlights the importance of clinicians’ high index of suspicion of an IUD infection and prompt removal of the infected foreign body to obtain source control. PMID:26965406

Intrauterine device infection causing concomitant streptococcal toxic shock syndrome and pelvic abscess with Actinomyces odontolyticus bacteraemia.

PubMed

Wu, Carolyn M Yu; Noska, Amanda

2016-03-10

Intrauterine devices (IUDs) are rarely associated with serious infections. We report an unusual concomitant infection of group A Streptococcus (GAS) causing toxic shock syndrome and pelvic abscess with Actinomyces odontolyticus associated with an IUD in a healthy 50-year-old patient. The IUD was subsequently removed and the patient recovered on the appropriate antibiotics. This case highlights the importance of clinicians' high index of suspicion of an IUD infection and prompt removal of the infected foreign body to obtain source control. 2016 BMJ Publishing Group Ltd.

Preventing device-associated infections in US hospitals: national surveys from 2005 to 2013.

PubMed

Krein, Sarah L; Fowler, Karen E; Ratz, David; Meddings, Jennifer; Saint, Sanjay

2015-06-01

Numerous initiatives have focused on reducing device-associated infections, contributing to an overall decrease in infections nationwide. To better understand factors associated with this decline, we assessed the use of key practices to prevent device-associated infections by US acute care hospitals from 2005 to 2013. We mailed surveys to infection preventionists at a national random sample of ∼600 US acute care hospitals in 2005, 2009 and 2013. Our survey asked about the use of practices to prevent the 3 most common device-associated infections: central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI). Using sample weights, we estimated the per cent of hospitals reporting regular use (a score of 4 or 5 on a scale from 1 (never use) to 5 (always use)) of prevention practices from 2005 to 2013. The response rate was about 70% in all 3 periods. Use of most recommended prevention practices increased significantly over time. Among those showing the greatest increase were use of an antimicrobial dressing for preventing CLABSI (25-78%, p<0.001), use of an antimicrobial mouth rinse for preventing VAP (41-79%, p<0.001) and use of catheter removal prompts for preventing CAUTI (9-53%, p<0.001). Likewise, a significant increase in facility-wide surveillance was found for all three infections. Practices for which little change was observed included use of antimicrobial catheters to prevent either CLABSI or CAUTI. US hospitals have responded to the call to reduce infection by increasing use of key recommended practices. Vigilance is needed to ensure sustained improvement and additional strategies may still be required, given an apparent continuing lag in CAUTI prevention efforts. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The role of biofilms in persistent infections and factors involved in ica-independent biofilm development and gene regulation in Staphylococcus aureus.

PubMed

Figueiredo, Agnes Marie Sá; Ferreira, Fabienne Antunes; Beltrame, Cristiana Ossaille; Côrtes, Marina Farrel

2017-09-01

Staphylococcus aureus biofilms represent a unique micro-environment that directly contribute to the bacterial fitness within hospital settings. The accumulation of this structure on implanted medical devices has frequently caused the development of persistent and chronic S. aureus-associated infections, which represent an important social and economic burden worldwide. ica-independent biofilms are composed of an assortment of bacterial products and modulated by a multifaceted and overlapping regulatory network; therefore, biofilm composition can vary among S. aureus strains. In the microniches formed by biofilms-produced by a number of bacterial species and composed by different structural components-drug refractory cell subpopulations with distinct physiological characteristics can emerge and result in therapeutic failures in patients with recalcitrant bacterial infections. In this review, we highlight the importance of biofilms in the development of persistence and chronicity in some S. aureus diseases, the main molecules associated with ica-independent biofilm development and the regulatory mechanisms that modulate ica-independent biofilm production, accumulation, and dispersion.

Clinical characteristics and outcome of infective endocarditis involving implantable cardiac devices.

PubMed

Athan, Eugene; Chu, Vivian H; Tattevin, Pierre; Selton-Suty, Christine; Jones, Phillip; Naber, Christoph; Miró, José M; Ninot, Salvador; Fernández-Hidalgo, Nuria; Durante-Mangoni, Emanuele; Spelman, Denis; Hoen, Bruno; Lejko-Zupanc, Tatjana; Cecchi, Enrico; Thuny, Franck; Hannan, Margaret M; Pappas, Paul; Henry, Margaret; Fowler, Vance G; Crowley, Anna Lisa; Wang, Andrew

2012-04-25

Infection of implantable cardiac devices is an emerging disease with significant morbidity, mortality, and health care costs. To describe the clinical characteristics and outcome of cardiac device infective endocarditis (CDIE) with attention to its health care association and to evaluate the association between device removal during index hospitalization and outcome. Prospective cohort study using data from the International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), conducted June 2000 through August 2006 in 61 centers in 28 countries. Patients were hospitalized adults with definite endocarditis as defined by modified Duke endocarditis criteria. In-hospital and 1-year mortality. CDIE was diagnosed in 177 (6.4% [95% CI, 5.5%-7.4%]) of a total cohort of 2760 patients with definite infective endocarditis. The clinical profile of CDIE included advanced patient age (median, 71.2 years [interquartile range, 59.8-77.6]); causation by staphylococci (62 [35.0% {95% CI, 28.0%-42.5%}] Staphylococcus aureus and 56 [31.6% {95% CI, 24.9%-39.0%}] coagulase-negative staphylococci); and a high prevalence of health care-associated infection (81 [45.8% {95% CI, 38.3%-53.4%}]). There was coexisting valve involvement in 66 (37.3% [95% CI, 30.2%-44.9%]) patients, predominantly tricuspid valve infection (43/177 [24.3%]), with associated higher mortality. In-hospital and 1-year mortality rates were 14.7% (26/177 [95% CI, 9.8%-20.8%]) and 23.2% (41/177 [95% CI, 17.2%-30.1%]), respectively. Proportional hazards regression analysis showed a survival benefit at 1 year for device removal during the initial hospitalization (28/141 patients [19.9%] who underwent device removal during the index hospitalization had died at 1 year, vs 13/34 [38.2%] who did not undergo device removal; hazard ratio, 0.42 [95% CI, 0.22-0.82]). Among patients with CDIE, the rate of concomitant valve infection is high, as is mortality, particularly if there is valve involvement. Early device removal is associated with improved survival at 1 year.

Evaluating Device Design and Cleanability of Orthopedic Device Models Contaminated with a Clinically Relevant Bone Test Soil.

PubMed

Lucas, Anne D; Nagaraja, Srinidhi; Gordon, Edward A; Hitchins, Victoria M

2015-01-01

Reusable medical devices need to be cleaned prior to disinfection or sterilization and subsequent use to prevent infections. The cleanability of medical devices depends in part on the design of the device. This study examined how models of orthopedic medical devices of increasing complexity retain calcium phosphate bone cement, a relevant test soil for these devices. The dye Alizarin Red S and micro-computed tomography (μCT) were used to assess the amount and location of bone cement debris in a series of model orthopedic devices. Testing was performed after soiling and cleaning once, and soiling and cleaning 10 times. The color change of the dye after reacting with the bone cement was useful for indicating the presence of bone cement in these models. High-resolution μCT analysis provided the volume and location of the bone cement. Models that were more complex retained significantly more bone debris than simpler designs. Model devices repeatedly soiled and cleaned 10 times retained significantly more bone debris than those soiled and cleaned once. Significantly more bone cement was retained in the more complex lumen structures. This information may be useful in designing reusable orthopedic devices, and other complex medical devices with lumens.

Clinical, economic, and humanistic burden of needlestick injuries in healthcare workers

PubMed Central

Cooke, Catherine E; Stephens, Jennifer M

2017-01-01

Introduction Needlestick injuries (NSIs) from a contaminated needle put healthcare workers (HCWs) at risk of becoming infected with a blood-borne virus and suffering serious short- and long-term medical consequences. Hypodermic injections using disposable syringes and needles are the most frequent cause of NSIs. Objective To perform a systematic literature review on NSI and active safety-engineered devices for hypodermic injection. Methods MEDLINE, EMBASE, and COCHRANE databases were searched for studies that evaluated the clinical, economic, or humanistic outcomes of NSI or active safety-engineered devices. Results NSIs have been reported by 14.9%–69.4% of HCWs with the wide range due to differences in countries, settings, and methodologies used to determine rates. Exposure to contaminated sharps is responsible for 37%–39% of the worldwide cases of hepatitis B and C infections in HCWs. HCWs may experience serious emotional effects and mental health disorders after a NSI, resulting in work loss and post-traumatic stress disorder. In 2015 International US$ (IntUS$), the average cost of a NSI was IntUS$747 (range IntUS$199–1,691). Hypodermic injections, the most frequent cause of NSI, are responsible for 32%–36% of NSIs. The use of safety devices that cover the needle-tip after hypodermic injection lowers the risk of NSI per HCW by 43.4%–100% compared to conventional devices. The economic value of converting to safety injective devices shows net savings, favorable budget impact, and overall cost-effectiveness. Conclusion The clinical, economic, and humanistic burden is substantial for HCWs who experience a NSI. Safety-engineered devices for hypodermic injection demonstrate value by reducing NSI risk, and the associated direct and indirect costs, psychological stress on HCWs, and occupational blood-borne viral infection risk. PMID:29033615

Healthcare-associated outbreaks due to Mucorales and other uncommon fungi.

PubMed

Davoudi, Setareh; Graviss, Linda S; Kontoyiannis, Dimitrios P

2015-07-01

Healthcare-associated outbreaks of fungal infections, especially with uncommon and emerging fungi, have become more frequent in the past decade. Here, we reviewed the history and definition of healthcare-associated outbreaks of uncommon fungal infections and discussed the principles of investigating, containing and treatment of these outbreaks. In case of these uncommon diseases, occurrence of two or more cases in a short period is considered as an outbreak. Contaminated medical devices and hospital environment are the major sources of these outbreaks. Care must be taken to differentiate a real infection from colonization or contamination. Defining and identifying cases, describing epidemiologic feature of cases, finding and controlling the source of the outbreak, treating patients, and managing asymptomatic exposed patients are main steps for outbreak elimination. These fungal outbreaks are not only difficult to detect but also hard to treat. Early initiation of appropriate antifungal therapy is strongly associated with improved outcomes in infected patients. Choice of antifungal drugs should be made based on spectrum, pharmacodynamic and pharmacokinetic characteristics and adverse effects of available drugs. Combination antifungal therapy and surgical intervention may be also helpful in selected cases. A multidisciplinary approach and close collaboration between all key partners are necessary for successful control of fungal outbreaks. © 2015 Stichting European Society for Clinical Investigation Journal Foundation.

International Nosocomial Infection Control Consortium (INICC) report, data summary of 43 countries for 2007-2012. Device-associated module.

PubMed

Rosenthal, Víctor Daniel; Maki, Dennis George; Mehta, Yatin; Leblebicioglu, Hakan; Memish, Ziad Ahmed; Al-Mousa, Haifaa Hassan; Balkhy, Hanan; Hu, Bijie; Alvarez-Moreno, Carlos; Medeiros, Eduardo Alexandrino; Apisarnthanarak, Anucha; Raka, Lul; Cuellar, Luis E; Ahmed, Altaf; Navoa-Ng, Josephine Anne; El-Kholy, Amani Ali; Kanj, Souha Sami; Bat-Erdene, Ider; Duszynska, Wieslawa; Van Truong, Nguyen; Pazmino, Leonardo N; See-Lum, Lucy Chai; Fernández-Hidalgo, Rosalia; Di-Silvestre, Gabriela; Zand, Farid; Hlinkova, Sona; Belskiy, Vladislav; Al-Rahma, Hussain; Luque-Torres, Marco Tulio; Bayraktar, Nesil; Mitrev, Zan; Gurskis, Vaidotas; Fisher, Dale; Abu-Khader, Ilham Bulos; Berechid, Kamal; Rodríguez-Sánchez, Arnaldo; Horhat, Florin George; Requejo-Pino, Osiel; Hadjieva, Nassya; Ben-Jaballah, Nejla; García-Mayorca, Elías; Kushner-Dávalos, Luis; Pasic, Srdjan; Pedrozo-Ortiz, Luis E; Apostolopoulou, Eleni; Mejía, Nepomuceno; Gamar-Elanbya, May Osman; Jayatilleke, Kushlani; de Lourdes-Dueñas, Miriam; Aguirre-Avalos, Guadalupe

2014-09-01

We report the results of an International Nosocomial Infection Control Consortium (INICC) surveillance study from January 2007-December 2012 in 503 intensive care units (ICUs) in Latin America, Asia, Africa, and Europe. During the 6-year study using the Centers for Disease Control and Prevention's (CDC) U.S. National Healthcare Safety Network (NHSN) definitions for device-associated health care-associated infection (DA-HAI), we collected prospective data from 605,310 patients hospitalized in the INICC's ICUs for an aggregate of 3,338,396 days. Although device utilization in the INICC's ICUs was similar to that reported from ICUs in the U.S. in the CDC's NHSN, rates of device-associated nosocomial infection were higher in the ICUs of the INICC hospitals: the pooled rate of central line-associated bloodstream infection in the INICC's ICUs, 4.9 per 1,000 central line days, is nearly 5-fold higher than the 0.9 per 1,000 central line days reported from comparable U.S. ICUs. The overall rate of ventilator-associated pneumonia was also higher (16.8 vs 1.1 per 1,000 ventilator days) as was the rate of catheter-associated urinary tract infection (5.5 vs 1.3 per 1,000 catheter days). Frequencies of resistance of Pseudomonas isolates to amikacin (42.8% vs 10%) and imipenem (42.4% vs 26.1%) and Klebsiella pneumoniae isolates to ceftazidime (71.2% vs 28.8%) and imipenem (19.6% vs 12.8%) were also higher in the INICC's ICUs compared with the ICUs of the CDC's NHSN. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Comparative activity of silver based antimicrobial composites for urinary catheters.

PubMed

Thokala, Nikhil; Kealey, Carmel; Kennedy, James; Brady, Damien B; Farrell, Joseph

2018-04-04

Biomedical polymers are an integral component in a wide range of medical device designs due to their range of desirable properties. However, extensive use of polymer materials in medical devices have also been associated with an increasing incidence of patient infections. Efforts to address this issue have included the incorporation of antimicrobial additives for developing novel antimicrobial polymeric materials. Silver with its high toxicity towards bacteria, oligodynamic effect and good thermal stability has been employed as an additive for polymeric medical devices. In the present study, commercially available elemental (Biogate) and ionic (Ultrafresh 16) silver additives were incorporated into a Polyamide 11 (PA 11) matrix using a compression press. These polymer composites were evaluated for their antimicrobial and ion release properties. Elemental silver composites were determined to retain their antimicrobial properties for extended periods and actively release silver ions for 84 days; whereas the ionic silver composites lost their ion release activity and therefore antibacterial activity after 56 days. Bacterial log reduction units of 3.87 for ionic silver and 2.41 for elemental silver was identified within 24 hr, when tested in accordance with ISO 22196 test standard; indicating that ionic silver is more efficient for short-term applications compared to elemental silver. Copyright © 2018 Elsevier Ltd. All rights reserved.

Synergistic Activity of Dispersin B and Cefamandole Nafate in Inhibition of Staphylococcal Biofilm Growth on Polyurethanes▿

PubMed Central

Donelli, G.; Francolini, I.; Romoli, D.; Guaglianone, E.; Piozzi, A.; Ragunath, C.; Kaplan, J. B.

2007-01-01

Antibiotic therapies to eradicate medical device-associated infections often fail because of the ability of sessile bacteria, encased in their exopolysaccharide matrix, to be more drug resistant than planktonic organisms. In the last two decades, several strategies to prevent microbial adhesion and biofilm formation on the surfaces of medical devices, based mainly on the use of antiadhesive, antiseptic, and antibiotic coatings on polymer surfaces, have been developed. More recent alternative approaches are based on molecules able to interfere with quorum-sensing phenomena or to dissolve biofilms. Interestingly, a newly purified β-N-acetylglucosaminidase, dispersin B, produced by the gram-negative periodontal pathogen Actinobacillus actinomycetemcomitans, is able to dissolve mature biofilms produced by Staphylococcus epidermidis as well as some other bacterial species. Therefore, in this study, we developed new polymeric matrices able to bind dispersin B either alone or in combination with an antibiotic molecule, cefamandole nafate (CEF). We showed that our functionalized polyurethanes could adsorb a significant amount of dispersin B, which was able to exert its hydrolytic activity against the exopolysaccharide matrix produced by staphylococcal strains. When microbial biofilms were exposed to both dispersin B and CEF, a synergistic action became evident, thus characterizing these polymer-dispersin B-antibiotic systems as promising, highly effective tools for preventing bacterial colonization of medical devices. PMID:17548491

Health care-associated infections in the neonatal intensive care unit.

PubMed

Brady, Michael T

2005-06-01

Neonates represent a unique and highly vulnerable patient population. Advances in medical technology that have occurred over the last few decades have improved the survival and quality of life for neonates, particularly those infants born with extreme prematurity or with congenital defects. Although immunologic immaturity and altered cutaneous barriers play some role in the vulnerability of neonates to nosocomial infections, clearly, therapeutic interventions that have proven to be lifesaving for these fragile infants also appear to be associated with the majority of infectious complications resulting in neonatal morbidity and mortality. Rates of infections in neonatal intensive care units (NICUs) have varied from 6% to 40% of neonatal patients, with the highest rates in those facilities having larger proportions of very low-birth-weight infants (birthweight < or =1000 grams) or neonates requiring surgery. Efforts to protect the vulnerable NICU infants include the following: (1) optimal infection control practices, especially good hand hygiene and good nursery design; (2) prudent use of invasive interventions with particular attention to early removal of invasive devices after they are no longer essential; and (3) judicious use of antimicrobial agents, with an emphasis on targeted (narrow spectrum) rather than broad-spectrum antibiotics and appropriate indications (proven or suspected bacterial infections).

Infective and thrombotic complications of central venous catheters in patients with hematological malignancy: prospective evaluation of nontunneled devices.

PubMed

Worth, Leon J; Seymour, John F; Slavin, Monica A

2009-07-01

Central venous catheter (CVC)-related bloodstream infection (CR-BSI) is a significant complication in hematology patients. A range of CVC devices may be used, and risks for the development of complications are not uniform. The objectives of this study were to determine the natural history and rate of CVC-related complications and risk factors for CR-BSI and to compare device-specific complications in a hematology population. An observational cohort of patients with hematologic malignancy was prospectively studied following CVC insertion. Participants were reviewed until a CVC-related complication necessitated device removal, completion of therapy, death, or defined end-of-study date. The National Nosocomial Infection Surveillance definition for CR-BSI was used. Overall and device-specific rates of infective and noninfective complications were calculated and potential risk factors were captured. One hundred six CVCs (75 peripherally inserted central venous catheters [PICCs], 31 nontunneled CVCs) were evaluated in 66 patients, over 2,399 CVC days. Thrombosis occurred in 16 cases (15.1%), exit-site infection in two (1.9%), and CR-BSI in 18 (7.5 per 1,000 CVC days). No significant differences were found when complication rates in PICC and nontunneled devices were compared. An underlying diagnosis of acute myeloid leukemia was negatively associated with CR-BSI (odds ratio (OR) 0.14, p = 0.046), and a previous diagnosis of fungal infection was associated with infection (OR 22.82, p = 0.031). CR-BSI rates in our hematology population are comparable to prior reports. A low rate of exit-site infection and high proportion of thrombotic complications were observed. No significant differences in thrombotic or infective complications were evident when PICC and nontunneled devices were compared. PICC devices are a practical and safe option for management of hematology patients.

21 CFR 884.5300 - Condom.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Condom. 884.5300 Section 884.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility...

21 CFR 884.5300 - Condom.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Condom. 884.5300 Section 884.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility...

Multi-centre point prevalence survey of hospital-acquired infections in Ghana.

PubMed

Labi, Appiah-Korang; Obeng-Nkrumah, Noah; Owusu, Enid; Bjerrum, Stephanie; Bediako-Bowan, Antoinette; Sunkwa-Mills, Gifty; Akuffo, Christiana; Fenny, Ama Pokua; Opintan, Japheth Awuletey; Enweronu-Laryea, Christabel; Debrah, Samuel; Damale, Nelson; Bannerman, Cynthia; Newman, Mercy Jemima

2018-05-03

There is a paucity of data describing hospital acquired infections (HAIs) in Africa. To describe the prevalence and distribution of HAIs in acute care hospitals in Ghana. Between September and December 2016, point prevalence surveys were conducted in participating hospitals using protocols of the European Centre for Disease Prevention and Control. We reviewed medical records of eligible inpatients at or before 8am on the day of survey to identify HAIs present at the time of survey. Ten hospitals were surveyed, representing 32.9% of all acute care beds in government hospitals. Of 2107 inpatients surveyed, 184 HAIs were identified among 172 patients, corresponding to an overall prevalence of 8.2%. The prevalence values in hospitals ranged from 3.5 to 14.4% with higher proportion of infections in secondary and tertiary care facilities. The most frequent HAIs were surgical site infections (32.6%), bloodstream infections (19.5%), urinary tract infections (18.5%), and respiratory tract infections (16.3%). Device-associated infections accounted for 7.1% of HAIs. For 12.5% of HAIs, a microorganism was reported; the most isolated microorganism was Escherichia coli. Approximately 61% of all patients surveyed were on antibiotics; 89.5% of patients with an HAI received at least one antimicrobial agent on the day of survey. The strongest independent predictors for HAI were the presence of invasive device before onset of infection and duration of hospital stay. We recorded a low HAI burden compared to findings from other low and middle income countries. Copyright © 2018. Published by Elsevier Ltd.

Prevention, identification, and management of post-operative penile implant complications of infection, hematoma, and device malfunction

PubMed Central

O’Rourke, Timothy K.; Erbella, Alexander; Zhang, Yu

2017-01-01

Penile prosthesis implant surgery is an effective management approach for a number of urological conditions, including medication refractory erectile dysfunction (ED). Complications encountered post-operatively include infection, bleeding/hematoma, and device malfunction. Since the 1970s, modifications to these devices have reduced complication rates through improvement in antisepsis and design using antibiotic coatings, kink-resistant tubing, lock-out valves to prevent autoinflation, and modified reservoir shapes. Device survival and complication rates have been investigated predominately by retrospective database-derived studies. This review article focuses on the identification and management of post-operative complications following penile prosthetic and implant surgery. Etiology for ED, surgical technique, and prosthesis type are variable among studies. The most common post-operative complications of infection, bleeding, and device malfunction may be minimized by adherence to consistent technique and standard protocol. Novel antibiotic coatings and standard antibiotic regimen may reduce infection rates. Meticulous hemostasis and intraoperative testing of devices may further reduce need for revision surgery. Additional prospective studies with consistent reporting of outcomes and comparison of surgical approach and prosthesis type in patients with variable ED etiology would be beneficial. PMID:29238663

Stimuli-responsive polymers for antimicrobial therapy: drug targeting, contact-killing surfaces and competitive release.

PubMed

Alvarez-Lorenzo, Carmen; Garcia-Gonzalez, Carlos A; Bucio, Emilio; Concheiro, Angel

2016-08-01

Polymers can be designed to modify their features as a function of the level and nature of the surrounding microorganisms. Such responsive polymers can endow drug delivery systems and drug-medical device combination products with improved performance against intracellular infections and biofilms. Knowledge on microorganism growth environment outside and inside cells and formation of biofilm communities on biological and synthetic surfaces, together with advances in materials science and drug delivery are prompting strategies with improved efficacy and safety compared to traditional systemic administration of antimicrobial agents. This review deals with antimicrobial strategies that rely on: (i) polymers that disintegrate or undergo phase-transitions in response to changes in enzymes, pH and pO2 associated to microorganism growth; (ii) stimuli-responsive polymers that expose contact-killing groups when microorganisms try to adhere; and (iii) bioinspired polymers that recognize microorganisms for triggered (competitive/affinity-driven) drug release. Prophylaxis and treatment of infections may benefit from polymers that are responsive to the unique changes that microbial growth causes in the surrounding environment or that even recognize the microorganism itself or its quorum sensing signals. These polymers may offer novel tools for the design of macrophage-, bacteria- and/or biofilm-targeted nanocarriers as well as of medical devices with switchable antibiofouling properties.

Pathogen Distribution and Antimicrobial Resistance Among Pediatric Healthcare-Associated Infections Reported to the National Healthcare Safety Network, 2011-2014.

PubMed

Lake, Jason G; Weiner, Lindsey M; Milstone, Aaron M; Saiman, Lisa; Magill, Shelley S; See, Isaac

2018-01-01

OBJECTIVE To describe pathogen distribution and antimicrobial resistance patterns for healthcare-associated infections (HAIs) reported to the National Healthcare Safety Network (NHSN) from pediatric locations during 2011-2014. METHODS Device-associated infection data were analyzed for central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infections (CAUTI), ventilator-associated pneumonia (VAP), and surgical site infection (SSI). Pooled mean percentage resistance was calculated for a variety of pathogen-antimicrobial resistance pattern combinations and was stratified by location for device-associated infections (neonatal intensive care units [NICUs], pediatric intensive care units [PICUs], pediatric oncology and pediatric wards) and by surgery type for SSIs. RESULTS From 2011 to 2014, 1,003 hospitals reported 20,390 pediatric HAIs and 22,323 associated pathogens to the NHSN. Among all HAIs, the following pathogens accounted for more than 60% of those reported: Staphylococcus aureus (17%), coagulase-negative staphylococci (17%), Escherichia coli (11%), Klebsiella pneumoniae and/or oxytoca (9%), and Enterococcus faecalis (8%). Among device-associated infections, resistance was generally lower in NICUs than in other locations. For several pathogens, resistance was greater in pediatric wards than in PICUs. The proportion of organisms resistant to carbapenems was low overall but reached approximately 20% for Pseudomonas aeruginosa from CLABSIs and CAUTIs in some locations. Among SSIs, antimicrobial resistance patterns were similar across surgical procedure types for most pathogens. CONCLUSION This report is the first pediatric-specific description of antimicrobial resistance data reported to the NHSN. Reporting of pediatric-specific HAIs and antimicrobial resistance data will help identify priority targets for infection control and antimicrobial stewardship activities in facilities that provide care for children. Infect Control Hosp Epidemiol 2018;39:1-11.

Lithium battery fires: implications for air medical transport.

PubMed

Thomas, Frank; Mills, Gordon; Howe, Robert; Zobell, Jim

2012-01-01

Lithium-ion batteries provide more power and longer life to electronic medical devices, with the benefits of reduced size and weight. It is no wonder medical device manufacturers are designing these batteries into their products. Lithium batteries are found in cell phones, electronic tablets, computers, and portable medical devices such as ventilators, intravenous pumps, pacemakers, incubators, and ventricular assist devices. Yet, if improperly handled, lithium batteries can pose a serious fire threat to air medical transport personnel. Specifically, this article discusses how lithium-ion batteries work, the fire danger associated with them, preventive measures to reduce the likelihood of a lithium battery fire, and emergency procedures that should be performed in that event. Copyright © 2012 Air Medical Journal Associates. Published by Elsevier Inc. All rights reserved.

Accuracy of vaginal symptom self-diagnosis algorithms for deployed military women.

PubMed

Ryan-Wenger, Nancy A; Neal, Jeremy L; Jones, Ashley S; Lowe, Nancy K

2010-01-01

Deployed military women have an increased risk for development of vaginitis due to extreme temperatures, primitive sanitation, hygiene and laundry facilities, and unavailable or unacceptable healthcare resources. The Women in the Military Self-Diagnosis (WMSD) and treatment kit was developed as a field-expedient solution to this problem. The primary study aims were to evaluate the accuracy of women's self-diagnosis of vaginal symptoms and eight diagnostic algorithms and to predict potential self-medication omission and commission error rates. Participants included 546 active duty, deployable Army (43.3%) and Navy (53.6%) women with vaginal symptoms who sought healthcare at troop medical clinics on base.In the clinic lavatory, women conducted a self-diagnosis using a sterile cotton swab to obtain vaginal fluid, a FemExam card to measure positive or negative pH and amines, and the investigator-developed WMSD Decision-Making Guide. Potential self-diagnoses were "bacterial infection" (bacterial vaginosis [BV] and/or trichomonas vaginitis [TV]), "yeast infection" (candida vaginitis [CV]), "no infection/normal," or "unclear." The Affirm VPIII laboratory reference standard was used to detect clinically significant amounts of vaginal fluid DNA for organisms associated with BV, TV, and CV. Women's self-diagnostic accuracy was 56% for BV/TV and 69.2% for CV. False-positives would have led to a self-medication commission error rate of 20.3% for BV/TV and 8% for CV. Potential self-medication omission error rates due to false-negatives were 23.7% for BV/TV and 24.8% for CV. The positive predictive value of diagnostic algorithms ranged from 0% to 78.1% for BV/TV and 41.7% for CV. The algorithms were based on clinical diagnostic standards. The nonspecific nature of vaginal symptoms, mixed infections, and a faulty device intended to measure vaginal pH and amines explain why none of the algorithms reached the goal of 95% accuracy. The next prototype of the WMSD kit will not include nonspecific vaginal signs and symptoms in favor of recently available point-of-care devices that identify antigens or enzymes of the causative BV, TV, and CV organisms.

A multistate investigation of health care-associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January-October 2016.

PubMed

Glowicz, Janet; Crist, Matthew; Gould, Carolyn; Moulton-Meissner, Heather; Noble-Wang, Judith; de Man, Tom J B; Perry, K Allison; Miller, Zachary; Yang, William C; Langille, Stephen; Ross, Jessica; Garcia, Bobbiejean; Kim, Janice; Epson, Erin; Black, Stephanie; Pacilli, Massimo; LiPuma, John J; Fagan, Ryan

2018-06-01

Outbreaks of health care-associated infections (HAIs) caused by Burkholderia cepacia complex (Bcc) have been associated with medical devices and water-based products. Water is the most common raw ingredient in nonsterile liquid drugs, and the significance of organisms recovered from microbiologic testing during manufacturing is assessed using a risk-based approach. This incident demonstrates that lapses in manufacturing practices and quality control of nonsterile liquid drugs can have serious unintended consequences. An epidemiologic and laboratory investigation of clusters of Bcc HAIs that occurred among critically ill, hospitalized, adult and pediatric patients was performed between January 1, 2016, and October 31, 2016. One hundred and eight case patients with Bcc infections at a variety of body sites were identified in 12 states. Two distinct strains of Bcc were obtained from patient clinical cultures. These strains were found to be indistinguishable or closely related to 2 strains of Bcc obtained from cultures of water used in the production of liquid docusate, and product that had been released to the market by manufacturer X. This investigation highlights the ability of bacteria present in nonsterile, liquid drugs to cause infections or colonization among susceptible patients. Prompt reporting and thorough investigation of potentially related infections may assist public health officials in identifying and removing contaminated products from the market when lapses in manufacturing occur. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Cold Plasmas for Biofilm Control: Opportunities and Challenges.

PubMed

Gilmore, Brendan F; Flynn, Padrig B; O'Brien, Séamus; Hickok, Noreen; Freeman, Theresa; Bourke, Paula

2018-06-01

Bacterial biofilm infections account for a major proportion of chronic and medical device associated infections in humans, yet our ability to control them is compromised by their inherent tolerance to antimicrobial agents. Cold atmospheric plasma (CAP) represents a promising therapeutic option. CAP treatment of microbial biofilms represents the convergence of two complex phenomena: the production of a chemically diverse mixture of reactive species and intermediates, and their interaction with a heterogeneous 3D interface created by the biofilm extracellular polymeric matrix. Therefore, understanding these interactions and physiological responses to CAP exposure are central to effective management of infectious biofilms. We review the unique opportunities and challenges for translating CAP to the management of biofilms. Copyright © 2018. Published by Elsevier Ltd.

[Role of the hospital environment and equipment in the transmission of nosocomial infections].

PubMed

López-Cerero, Lorena

2014-01-01

The hospital environment is both a reservoir and source of infection for the hospital patient. Several areas around the patient should be considered: air, toilet water coming into contact with the patient, staff and medical devices, food, surfaces, and instruments contacting the patient's skin and mucosa, and sterile solutions. There are pathogens classically associated with each mode of transmission and environmental reservoir, but multi-resistant microorganisms have also been recently been associated with environmental acquisition. Protocols are currently available for the prevention of some classic environmental pathogens, as well as recommendations for the prevention of contamination in some procedures. However, these situations do not cover all forms of transmission, and most investigations of reservoirs or environmental sources are restricted to outbreak situations. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Healthcare-associated infective endocarditis: an undesirable effect of healthcare universalization.

PubMed

Lomas, J M; Martínez-Marcos, F J; Plata, A; Ivanova, R; Gálvez, J; Ruiz, J; Reguera, J M; Noureddine, M; de la Torre, J; de Alarcón, A

2010-11-01

Invasive medical technology has led to an increase in the incidence of healthcare-associated infective endocarditis (HAIE). A prospective multicentre cohort study was conducted at seven hospitals in Andalusia, Spain, to establish the characteristics of HAIE and to compare them with those of community-acquired infective endocarditis (CAIE). HAIE was defined as either infective endocarditis (IE) manifesting >48 h after admission to hospital, or IE associated with a significant invasive procedure performed in the 6 months before diagnosis. Seven hundred and ninety-three cases of IE were investigated, and HAIE accounted for 127 (16%). As compared with patients with CAIE, patients with HAIE were older (60.1 ± 14.4 years vs. 53.6 ± 17.5 years) and had more comorbidities (Charlson index 3.3 ± 2.3 vs. 1.8 ± 2.3) and staphylococcal infections (58.3% vs. 24.8%). Vascular manipulation was the main cause of bacteraemia responsible for HAIE (63%). Peripheral vein catheter-associated bacteraemia accounted for 32.8% of the catheter-related bacteraemias. In-hospital mortality (44.9% vs. 24.2%) was higher in the HAIE group. Septic shock (OR 2.2, 95% CI 2.9-30.2) and surgery not performed because of high surgical risk (OR 1.6, 95% CI 1.2-20) were independent predictors of mortality in HAIE. The present study demonstrates that HAIE is a growing health problem associated with high mortality. Careful management of vascular devices is essential to minimize the risk of bacteraemias leading to HAIE.

Reducing bacteria and macrophage density on nanophase hydroxyapatite coated onto titanium surfaces without releasing pharmaceutical agents

NASA Astrophysics Data System (ADS)

Bhardwaj, Garima; Yazici, Hilal; Webster, Thomas J.

2015-04-01

Reducing bacterial density on titanium implant surfaces has been a major concern because of the increasing number of nosocomial infections. Controlling the inflammatory response post implantation has also been an important issue for medical devices due to the detrimental effects of chronic inflammation on device performance. It has recently been demonstrated that manipulating medical device surface properties including chemistry, roughness and wettability can control both infection and inflammation. Here, we synthesized nanophase (that is, materials with one dimension in the nanoscale) hydroxyapatite coatings on titanium to reduce bacterial adhesion and inflammatory responses (as measured by macrophage functions) and compared such results to bare titanium and plasma sprayed hydroxyapatite titanium coated surfaces used clinically today. This approach is a pharmaceutical-free approach to inhibit infection and inflammation due to the detrimental side effects of any drug released in the body. Here, nanophase hydroxyapatite was synthesized in sizes ranging from 110-170 nm and was subsequently coated onto titanium samples using electrophoretic deposition. Results indicated that smaller nanoscale hydroxyapatite features on titanium surfaces alone decreased bacterial attachment in the presence of gram negative (P. aeruginosa), gram positive (S. aureus) and ampicillin resistant gram-negative (E. coli) bacteria as well as were able to control inflammatory responses; properties which should lead to their further investigation for improved medical applications.

Modification of the surfaces of medical devices to prevent microbial adhesion and biofilm formation.

PubMed

Desrousseaux, C; Sautou, V; Descamps, S; Traoré, O

2013-10-01

The development of devices with surfaces that have an effect against microbial adhesion or viability is a promising approach to the prevention of device-related infections. To review the strategies used to design devices with surfaces able to limit microbial adhesion and/or growth. A PubMed search of the published literature. One strategy is to design medical devices with a biocidal agent. Biocides can be incorporated into the materials or coated or covalently bonded, resulting either in release of the biocide or in contact killing without release of the biocide. The use of biocides in medical devices is debated because of the risk of bacterial resistance and potential toxicity. Another strategy is to modify the chemical or physical surface properties of the materials to prevent microbial adhesion, a complex phenomenon that also depends directly on microbial biological structure and the environment. Anti-adhesive chemical surface modifications mostly target the hydrophobicity features of the materials. Topographical modifications are focused on roughness and nanostructures, whose size and spatial organization are controlled. The most effective physical parameters to reduce bacterial adhesion remain to be determined and could depend on shape and other bacterial characteristics. A prevention strategy based on reducing microbial attachment rather than on releasing a biocide is promising. Evidence of the clinical efficacy of these surface-modified devices is lacking. Additional studies are needed to determine which physical features have the greatest potential for reducing adhesion and to assess the usefulness of antimicrobial coatings other than antibiotics. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Best practices to minimize risk of infection with intrauterine device insertion.

PubMed

Caddy, Sheila; Yudin, Mark H; Hakim, Julie; Money, Deborah M

2014-03-01

Intrauterine devices provide an extremely effective, long-term form of contraception that has the benefit of being reversible. Historically, the use of certain intrauterine devices was associated with increased risk of pelvic inflammatory disease. More recent evidence suggests that newer devices do not carry the same threat; however, certain risk factors can increase the possibility of infection. To review the risk of infection with the insertion of intrauterine devices and recommend strategies to prevent infection. The outcomes considered were the risk of pelvic inflammatory disease, the impact of screening for bacterial vaginosis and sexually transmitted infections including chlamydia and gonorrhea; and the role of prophylactic antibiotics. Published literature was retrieved through searches of PubMed, Embase, and The Cochrane Library on July 21, 2011, using appropriate controlled vocabulary (e.g., intrauterine devices, pelvic inflammatory disease) and key words (e.g., adnexitis, endometritis, IUD). An etiological filter was applied in PubMed. The search was limited to the years 2000 forward. There were no language restrictions. Grey (unpublished) literature was identified through searching the web sites of national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventative Health Care (Table). Recommendations 1. All women requesting an intrauterine device should be counselled about the small increased risk of pelvic inflammatory disease in the first 20 days after insertion. (II-2A) 2. All women requesting an intrauterine device should be screened by both history and physical examination for their risk of sexually transmitted infection. Women at increased risk should be tested prior to or at the time of insertion; however, it is not necessary to delay insertion until results are returned. (II-2B) 3. Not enough current evidence is available to support routine screening for bacterial vaginosis at the time of insertion of an intrauterine device in asymptomatic women. (II-2C) 4. Routine use of prophylactic antibiotics is not recommended prior to intrauterine device insertion, although it may be used in certain high-risk situations. (I-C) 5. Standard practice includes cleansing the cervix and sterilizing any instruments that will be used prior to and during insertion of an intrauterine device. (III-C) 6. In treating mild to moderate pelvic inflammatory disease, it is not necessary to remove the intrauterine device during treatment unless the patient requests removal or there is no clinical improvement after 72 hours of appropriate antibiotic treatment. In cases of severe pelvic inflammatory disease, consideration can be given to removing the intrauterine device after an appropriate antibiotic regimen has been started. (I-B) 7. An intrauterine device is a safe, effective option for contraception in an HIV-positive woman. (I-B) 8. An intrauterine device can be considered a first-line contraceptive agent in adolescents. (I-A).

Face shields for infection control: A review

PubMed Central

Roberge, Raymond J.

2016-01-01

Face shields are personal protective equipment devices that are used by many workers (e.g., medical, dental, veterinary) for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are generally not used alone, but in conjunction with other protective equipment and are therefore classified as adjunctive personal protective equipment. Although there are millions of potential users of face shields, guidelines for their use vary between governmental agencies and professional societies and little research is available regarding their efficacy. PMID:26558413

Physician-industry cooperation in the medical device industry.

PubMed

Chatterji, Aaron K; Fabrizio, Kira R; Mitchell, Will; Schulman, Kevin A

2008-01-01

Anecdotal evidence suggests that innovative medical devices often arise from physicians' inventive activity, but no studies have documented the extent of such physician-engaged innovation. This paper uses patent data and the American Medical Association Physician Masterfile to provide evidence that physicians contribute to medical device innovation, accounting for almost 20 percent of approximately 26,000 medical device patents filed in the United States during 1990-1996. Moreover, two measures indicate that physician patents had more influence on subsequent inventive activity than nonphysician patents. This finding supports the maintenance of an open environment for physician-industry collaboration in the medical device discovery process.

Adherence of coagulase-negative staphylococci to plastic tissue culture plates: a quantitative model for the adherence of staphylococci to medical devices.

PubMed Central

Christensen, G D; Simpson, W A; Younger, J J; Baddour, L M; Barrett, F F; Melton, D M; Beachey, E H

1985-01-01

The adherence of coagulase-negative staphylococci to smooth surfaces was assayed by measuring the optical densities of stained bacterial films adherent to the floors of plastic tissue culture plates. The optical densities correlated with the weight of the adherent bacterial film (r = 0.906; P less than 0.01). The measurements also agreed with visual assessments of bacterial adherence to culture tubes, microtiter plates, and tissue culture plates. Selected clinical strains were passed through a mouse model for foreign body infections and a rat model for catheter-induced endocarditis. The adherence measurements of animal passed strains remained the same as those of the laboratory-maintained parent strain. Spectrophotometric classification of coagulase-negative staphylococci into nonadherent and adherent categories according to these measurements had a sensitivity, specificity, and accuracy of 90.6, 80.8, and 88.4%, respectively. We examined a previously described collection of 127 strains of coagulase-negative staphylococci isolated from an outbreak of intravascular catheter-associated sepsis; strains associated with sepsis were more adherent than blood culture contaminants and cutaneous strains (P less than 0.001). We also examined a collection of 84 strains isolated from pediatric patients with cerebrospinal fluid (CSF) shunts; once again, pathogenic strains were more adherent than were CSF contaminants (P less than 0.01). Finally, we measured the adherence of seven endocarditis strains. As opposed to strains associated with intravascular catheters and CSF shunts, endocarditis strains were less adherent than were saprophytic strains of coagulase-negative staphylococci. The optical densities of bacterial films adherent to plastic tissue culture plates serve as a quantitative model for the study of the adherence of coagulase-negative staphylococci to medical devices, a process which may be important in the pathogenesis of foreign body infections. Images PMID:3905855

A Targeted Infection Prevention Intervention in Nursing Home Residents With Indwelling Devices

PubMed Central

Mody, Lona; Krein, Sarah L.; Saint, Sanjay K.; Min, Lillian C.; Montoya, Ana; Lansing, Bonnie; McNamara, Sara E.; Symons, Kathleen; Fisch, Jay; Koo, Evonne; Rye, Ruth Anne; Galecki, Andrzej; Kabeto, Mohammed U.; Fitzgerald, James T.; Olmsted, Russell N.; Kauffman, Carol A.; Bradley, Suzanne F.

2015-01-01

IMPORTANCE Indwelling devices (eg, urinary catheters and feeding tubes) are often used in nursing homes (NHs). Inadequate care of residents with these devices contributes to high rates of multidrug-resistant organisms (MDROs) and device-related infections in NHs. OBJECTIVE To test whether a multimodal targeted infection program (TIP) reduces the prevalence of MDROs and incident device-related infections. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at 12 community-based NHs from May 2010 to April 2013. Participants were high-risk NH residents with urinary catheters, feeding tubes, or both. INTERVENTIONS Multimodal, including preemptive barrier precautions, active surveillance for MDROs and infections, and NH staff education. MAIN OUTCOMES AND MEASURES The primary outcome was the prevalence density rate of MDROs, defined as the total number of MDROs isolated per visit averaged over the duration of a resident's participation. Secondary outcomes included new MDRO acquisitions and new clinically defined device-associated infections. Data were analyzed using a mixed-effects multilevel Poisson regression model (primary outcome) and a Cox proportional hazards model (secondary outcome), adjusting for facility-level clustering and resident-level variables. RESULTS In total, 418 NH residents with indwelling devices were enrolled, with 34 174 device-days and 6557 anatomic sites sampled. Intervention NHs had a decrease in the overall MDRO prevalence density (rate ratio, 0.77; 95% CI, 0.62–0.94). The rate of new methicillin-resistant Staphylococcus aureus acquisitions was lower in the intervention group than in the control group (rate ratio, 0.78; 95% CI, 0.64–0.96). Hazard ratios for the first and all (including recurrent) clinically defined catheter-associated urinary tract infections were 0.54 (95% CI, 0.30–0.97) and 0.69 (95% CI, 0.49–0.99), respectively, in the intervention group and the control group. There were no reductions in new vancomycin-resistant enterococci or resistant gram-negative bacilli acquisitions or in new feeding tube–associated pneumonias or skin and soft-tissue infections. CONCLUSIONS AND RELEVANCE Our multimodal TIP intervention reduced the overall MDRO prevalence density, new methicillin-resistant S aureus acquisitions, and clinically defined catheter-associated urinary tract infection rates in high-risk NH residents with indwelling devices. Further studies are needed to evaluate the cost-effectiveness of this approach as well as its effects on the reduction of MDRO transmission to other residents, on the environment, and on referring hospitals. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01062841 PMID:25775048

Silk-based resorbable electronic devices for remotely controlled therapy and in vivo infection abatement

PubMed Central

Tao, Hu; Hwang, Suk-Won; Marelli, Benedetto; An, Bo; Moreau, Jodie E.; Yang, Miaomiao; Brenckle, Mark A.; Kim, Stanley; Kaplan, David L.; Rogers, John A.; Omenetto, Fiorenzo G.

2014-01-01

A paradigm shift for implantable medical devices lies at the confluence between regenerative medicine, where materials remodel and integrate in the biological milieu, and technology, through the use of recently developed material platforms based on biomaterials and bioresorbable technologies such as optics and electronics. The union of materials and technology in this context enables a class of biomedical devices that can be optically or electronically functional and yet harmlessly degrade once their use is complete. We present here a fully degradable, remotely controlled, implantable therapeutic device operating in vivo to counter a Staphylococcus aureus infection that disappears once its function is complete. This class of device provides fully resorbable packaging and electronics that can be turned on remotely, after implantation, to provide the necessary thermal therapy or trigger drug delivery. Such externally controllable, resorbable devices not only obviate the need for secondary surgeries and retrieval, but also have extended utility as therapeutic devices that can be left behind at a surgical or suturing site, following intervention, and can be externally controlled to allow for infection management by either thermal treatment or by remote triggering of drug release when there is retardation of antibiotic diffusion, deep infections are present, or when systemic antibiotic treatment alone is insufficient due to the emergence of antibiotic-resistant strains. After completion of function, the device is safely resorbed into the body, within a programmable period. PMID:25422476

Silk-based resorbable electronic devices for remotely controlled therapy and in vivo infection abatement.

PubMed

Tao, Hu; Hwang, Suk-Won; Marelli, Benedetto; An, Bo; Moreau, Jodie E; Yang, Miaomiao; Brenckle, Mark A; Kim, Stanley; Kaplan, David L; Rogers, John A; Omenetto, Fiorenzo G

2014-12-09

A paradigm shift for implantable medical devices lies at the confluence between regenerative medicine, where materials remodel and integrate in the biological milieu, and technology, through the use of recently developed material platforms based on biomaterials and bioresorbable technologies such as optics and electronics. The union of materials and technology in this context enables a class of biomedical devices that can be optically or electronically functional and yet harmlessly degrade once their use is complete. We present here a fully degradable, remotely controlled, implantable therapeutic device operating in vivo to counter a Staphylococcus aureus infection that disappears once its function is complete. This class of device provides fully resorbable packaging and electronics that can be turned on remotely, after implantation, to provide the necessary thermal therapy or trigger drug delivery. Such externally controllable, resorbable devices not only obviate the need for secondary surgeries and retrieval, but also have extended utility as therapeutic devices that can be left behind at a surgical or suturing site, following intervention, and can be externally controlled to allow for infection management by either thermal treatment or by remote triggering of drug release when there is retardation of antibiotic diffusion, deep infections are present, or when systemic antibiotic treatment alone is insufficient due to the emergence of antibiotic-resistant strains. After completion of function, the device is safely resorbed into the body, within a programmable period.

78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third... notice solicits comments on the information collection associated with medical devices third-party review... that members of the public submit reports, keep records, or provide information to a third party...

[Medical technologist as a member of infection control team].

PubMed

Okuzumi, Katsuko; Ieiri, Tamio

2005-11-01

For the prevention of infection at institutions, an Anti-nosocomial Infection Committee or an Infection Control Team (ICT) is organized at each institution according to its scale. We report the present status of the ICT managed mainly by medical technologists engaged in microbiological examination (certified medical microbiological technologists) at Dokkyo University School of Medicine. Since this hospital is an educational hospital, the department of clinical laboratory medicine cooperates with the microbiological laboratory of the clinical laboratory in infection control education of medical workers (such as medical students, nursing students, physicians and nurses) in infection diagnosis, infection control/infection management. Since infection control is achieved by improvement in hygiene knowledge and its practice in all citizens, we also attached importance to publicity activities associated with microbiology for patients, their families, and all medical workers.

Mycobacterium chimaera left ventricular assist device infections.

PubMed

Balsam, Leora B; Louie, Eddie; Hill, Fred; Levine, Jamie; Phillips, Michael S

2017-06-01

A global outbreak of invasive Mycobacterium chimaera infections after cardiac surgery has recently been linked to bioaerosols from contaminated heater-cooler units. The majority of cases have occurred after valvular surgery or aortic graft surgery and nearly half have resulted in death. To date, infections in patients with left ventricular assist devices (LVADs) have not been characterized in the literature. We report two cases of device-associated M. chimaera infection in patients with continuous-flow LVADs and describe challenges related to diagnosis and management in this population. © 2017 Wiley Periodicals, Inc.

Medical care related laboratory-confirmed bloodstream infections in paediatrics.

PubMed

Virano, Silvia; Scolfaro, Carlo; Garazzino, Silvia; De Intinis, Carlo; Ghisetti, Valeria; Raffaldi, Irene; Calitri, Carmelina; Tovo, Pier Angelo

2015-06-01

The aim of this survey was to describe the incidence, epidemiology, microbiology, risk factors and outcome of medical care related laboratory-confirmed bloodstream infections (LCBIs) observed during a twelve-month prospective study in a Paediatric Teaching Hospital in Turin, Italy. Inclusion criteria were clinical signs of sepsis and positivity of one or more of the following tests: blood culture, polymerase chain reaction for bacterial and fungal DNA on blood, and culture on intravascular device tips. In all, 140 episodes of sepsis were documented in 131 children: 37 (26.4%) were healthcare outpatient-associated, 91 (65.0%) healthcare-associated and 12 (8.6%) community-acquired. The overall incidence of healthcare-associated LCBIs was 13.6/1,000 hospitalized patients and incidence density 1.4/1,000 inpatient days. The overall mortality was 3.9%. Forty-seven (36.7%) episodes involved newborns and 107 (83.6%) episodes were observed in children with an indwelling central venous catheter. Coagulase-negative staphylococci (26.8%), Staphylococcus aureus (15.2%), Escherichia coli (8.7%) and Candida spp. (7.2%) were responsible for the majority of cases. 9.5% of S. aureus isolates were methicillin-resistant and 6.5% of Gram negatives were extended-spectrum beta-lactamase-producing. Incidence and epidemiology of medical care related LCBIs were similar to the existing literature data. LCBIs caused by antibiotic-resistant microorganisms were fewer and mortality rate was lower. Most of the LCBIs recorded involved newborns and oncological children.

Staphylococcus epidermidis Biofilms: Functional Molecules, Relation to Virulence, and Vaccine Potential

NASA Astrophysics Data System (ADS)

Mack, Dietrich; Davies, Angharad P.; Harris, Llinos G.; Knobloch, Johannes K. M.; Rohde, Holger

Medical device-associated infections, most frequently caused by Staphylococcus epidermidis and Staphylococcus aureus, are of increasing importance in modern medicine. The formation of adherent, multilayered bacterial biofilms is crucial in the pathogenesis of these infections. Polysaccharide intercellular adhesin (PIA), a homoglycan of β-1,6-linked 2-acetamido-2-deoxy-d-glucopyranosyl residues, of which about 15% are non-N-acetylated, is central to biofilm accumulation in staphylococci. It transpires that polysaccharides - structurally very similar to PIA - are also key to biofilm formation in a number of other organisms including the important human pathogens Escherichia coli, Aggregatibacter (Actinobacillus) actinomycetemcomitans, Yersinia pestis, and Bordetella spp. Apparently, synthesis of PIA and related polysaccharides is a general feature important for biofilm formation in diverse bacterial genera. Current knowledge about the structure and biosynthesis of PIA and related polysaccharides is reviewed. Additionally, information on their role in pathogenesis of biomaterial-related and other type of infections and the potential use of PIA and related compounds for prevention of infection is evaluated.

Sterilization of Biofilm on a Titanium Surface Using a Combination of Nonthermal Plasma and Chlorhexidine Digluconate.

PubMed

Gupta, Tripti Thapa; Karki, Surya B; Matson, Jyl S; Gehling, Daniel J; Ayan, Halim

2017-01-01

Nosocomial infections caused by opportunistic bacteria pose major healthcare problem worldwide. Out of the many microorganisms responsible for such infections, Pseudomonas aeruginosa is a ubiquitous bacterium that accounts for 10-20% of hospital-acquired infections. These infections have mortality rates ranging from 18 to 60% and the cost of treatment ranges from $20,000 to $80,000 per infection. The formation of biofilms on medical devices and implants is responsible for the majority of those infections. Only limited progress has been made to prevent this issue in a safe and cost-effective manner. To address this, we propose employing jet plasma to break down and inactivate biofilms in vitro . Moreover, to improve the antimicrobial effect on the biofilm, a treatment method using a combination of jet plasma and a biocide known as chlorhexidine (CHX) digluconate was investigated. We found that complete sterilization of P. aeruginosa biofilms can be achieved after combinatorial treatment using plasma and CHX. A decrease in biofilm viability was also observed using confocal laser scanning electron microscopy (CLSM). This treatment method sterilized biofilm-contaminated surfaces in a short treatment time, indicating it to be a potential tool for the removal of biofilms present on medical devices and implants.

Carbapenemase-producing Enterobacteriaceae: Risk factors for infection and impact of resistance on outcomes

PubMed Central

Mariappan, Shanthi; Sekar, Uma; Kamalanathan, Arunagiri

2017-01-01

Background: Carbapenemase-producing Enterobacteriaceae (CPE) have increased in recent years leading to limitations of treatment options. The present study was undertaken to detect CPE, risk factors for acquiring them and their impact on clinical outcomes. Methods: This retrospective observational study included 111 clinically significant Enterobacteriaceae resistant to cephalosporins subclass III and exhibiting a positive modified Hodge test. Screening for carbapenemase production was done by phenotypic methods, and polymerase chain reaction was performed to detect genes encoding them. Retrospectively, the medical records of the patients were perused to assess risk factors for infections with CPE and their impact. The data collected were duration of hospital stay, Intensive Care Unit (ICU) stay, use of invasive devices, mechanical ventilation, the presence of comorbidities, and antimicrobial therapy. The outcome was followed up. Univariate and multivariate analysis of the data were performed using SPSS software. Results: Carbapenemase-encoding genes were detected in 67 isolates. The genes detected were New Delhi metallo-β-lactamase, Verona integron-encoded metallo-β-lactamase, and oxacillinase-181.Although univariate analysis identified risk factors associated with acquiring CPE infections as ICU stay (P = 0.021), mechanical ventilation (P = 0.013), indwelling device (P = 0.011), diabetes mellitus (P = 0.036), usage of multiple antimicrobial agents (P = 0.007), administration of carbapenems (P = 0.042), presence of focal infection or sepsis (P = 0.013), and surgical interventions (P = 0.016), multivariate analysis revealed that all these factors were insignificant. Mortality rate was 56.7% in patients with CPE infections. By both univariate and multivariate analysis of impact of the variables on mortality in these patients, the significant factors were mechanical ventilation (odds ratio [OR]: 0.141, 95% confidence interval [CI]: 0.024–0.812) and presence of indwelling invasive device (OR: 8.034; 95% CI: 2.060–31.335). Conclusion: In this study, no specific factor was identified as an independent risk for acquisition of CPE infection. However, as it is evident by multivariate analysis, there is an increased risk of mortality in patients with CPE infections when they are ventilated and are supported by indwelling devices. PMID:28251105

Multi-Center, Community-Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes.

PubMed

Gupta, Nigel; Kiley, Mary Lou; Anthony, Faith; Young, Charlie; Brar, Somjot; Kwaku, Kevin

2016-03-09

The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry. This is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% (ICD), 55.0% (PM), and 66.7% (CRT), with mean patient age 63.2 years (ICD), 75.2 (PM), and 67.2 (CRT). The 30-day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% (ICD), ≤0.6% (PM), and ≤0.4% (CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% (ICD), 0.5% (PM), and 1.0% (CRT). Results were used to monitor vendor-specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls. The Kaiser Permanente-Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Concerns about usage of smartphones in operating room and critical care scenario

PubMed Central

Attri, JP; Khetarpal, R; Chatrath, V; Kaur, J

2016-01-01

Smartphones and tablets have taken a central place in the lives of health care professionals. Their use has dramatically improved the communication and has become an important learning tool as the medical information can be assessed online at anytime. In critical care settings, use of smartphone facilitates quick passage of information through E-mail messaging and getting feedback from the concerned physician quickly, thereby reducing medical errors. However, in addition to the benefits offered, these devices have become a significant source of nosocomial infections, distraction for medical professionals and interfere with medical equipments. They may also put privacy and security of patients at stake. The benefits could be severely undermined if abuse and over use are not kept in check. This review article focuses on various applications of smartphones in healthcare practices, drawback of the use of these devices and the recommendations regarding the safe use of these devices. PMID:26952181

Concerns about usage of smartphones in operating room and critical care scenario.

PubMed

Attri, J P; Khetarpal, R; Chatrath, V; Kaur, J

2016-01-01

Smartphones and tablets have taken a central place in the lives of health care professionals. Their use has dramatically improved the communication and has become an important learning tool as the medical information can be assessed online at anytime. In critical care settings, use of smartphone facilitates quick passage of information through E-mail messaging and getting feedback from the concerned physician quickly, thereby reducing medical errors. However, in addition to the benefits offered, these devices have become a significant source of nosocomial infections, distraction for medical professionals and interfere with medical equipments. They may also put privacy and security of patients at stake. The benefits could be severely undermined if abuse and over use are not kept in check. This review article focuses on various applications of smartphones in healthcare practices, drawback of the use of these devices and the recommendations regarding the safe use of these devices.

Triclosan loaded ureteral stents decrease proteus mirabilis 296 infection in a rabbit urinary tract infection model.

PubMed

Cadieux, Peter A; Chew, Ben H; Knudsen, Bodo E; Dejong, Kathy; Rowe, Elaine; Reid, Gregor; Denstedt, John D

2006-06-01

Infection and encrustation remain major limitations of ureteral stent use and to our knowledge no device has completely overcome these obstacles to date. Triclosan is a biocide currently used in a plethora of consumer and medical products that has recently been loaded into a ureteral stent. Using a rabbit model of UTI we examined the effects of triclosan impregnated stent segments on the growth and survival of Proteus mirabilis, a uropathogen commonly associated with device related UTI and encrustation. A total of 48 male New Zealand White rabbits were instilled transurethrally with 1 x 10(6) P. mirabilis 296. A stent curl from a triclosan eluting, Percuflex Plus or Optima ureteral stent was placed intravesically. Urine was cultured on days 1, 3 and 7. On day 7 the stents were assessed for encrustation and viable organisms, while the bladders were scored for the degree of inflammation. Throughout the study urine isolated from the triclosan group contained significantly fewer viable organisms than controls with 7 of 13 animals completely clearing the infection by day 7. Similarly 9 of 13 triclosan eluting stents showed no viable organisms upon recovery and the remaining 4 showed significantly fewer organisms than controls. Urine and stents in all controls were positive for P. mirabilis at all time points. Although there was no significant difference in encrustation among the groups, bladders harvested from the triclosan group demonstrated significantly less inflammation. Triclosan eluting stents greatly decreased P. mirabilis growth and survival in a rabbit UTI model compared to controls. These stents may prove useful for decreasing device related P. mirabilis UTIs.

Assessment of the types of catheter infectivity caused by Candida species and their biofilm formation. First study in an intensive care unit in Algeria

PubMed Central

Seddiki, Sidi Mohammed Lahbib; Boucherit-Otmani, Zahia; Boucherit, Kebir; Badsi-Amir, Souad; Taleb, Mourad; Kunkel, Dennis

2013-01-01

Nosocomial candidiasis remains a potential risk in intensive care units (ICUs), wherein Candida albicans is most responsible for its occurrence. Equally, non-C. albicans species, especially C. glabrata, are also involved. These infections are frequently associated with biofilms that contaminate medical devices, such as catheters. These biofilms constitute a significant clinical problem, and cause therapeutic failures, because they can escape the immune response and considerably decrease sensitivity to antifungal therapy. The diagnosis of catheter-related candidiasis is difficult; however, the differentiation between an infection of the catheter (or other medical implant) and a simple contamination is essential to start an antifungal treatment. Among the methods used for this type of study is the Brun-Buisson method, but this method only examines the infectivity of catheters caused by bacteria. For this reason, we wanted to adapt this method to the yeast cells of Candida spp. To assess the various types of infectivity of catheters (contamination, colonization, or infection) and their corresponding rates, as well as the responsible yeast species, we conducted our study, between February 2011 and January 2012, in the ICU at the University Hospital Center of Sidi Bel Abbes, Algeria; during this study, we took photographic images of the tongue of one patient and of that patient’s implanted orobronchial catheter. In addition, catheters contaminated by C. albicans biofilms were observed by scanning electron microscopy. PMID:23345986

Surveillance of hospital-acquired infections: a model for settings with resource constraints.

PubMed

Brusaferro, Silvio; Regattin, Laura; Faruzzo, Alda; Grasso, Adriana; Basile, Marco; Calligaris, Laura; Scudeller, Luigia; Viale, Pierluigi

2006-08-01

Surveillance activities have been considered of paramount importance for effective infection control programs in health care organizations. Our objective was to design a capture system able to assure surveillance of hospital-acquired infections (HAI) in acute hospitals with few resources devoted to infection control. We performed 4 biweekly repeated prevalence studies to identify major HAI (urinary tract infections, surgical site infections, lower respiratory tract infection, bloodstream infections) as defined by the Centers for Disease Control and Prevention (CDC) criteria in 3 large hospitals in northeastern Italy (6 internal medicine departments, 5 general surgery departments, 3 intensive care units, and 1 bone marrow transplant unit). One thousand five hundred fifty-four patients were screened (63.9% in medical wards, 27.5% in surgical wards, and 8.5% in intensive care units and bone transplant unit). The overall prevalence of infection was 4.9% (77/1,554); 4.5% (70/1,554) of patients were infected. A capture system based on the presence of fever >or=38 degrees C, antibiotic use, and presence of devices guarantees 100% sensitivity in detecting HAI but requires an assessment of 62% of the population. Using the presence of fever and devices as criteria guarantees a sensitivity of 98%, requiring an assessment of 41.4% of patients, whereas presence of fever and antibiotic use has the same sensitivity but requires an assessment of 50% of patients. Using nursing records, physician records, and direct patient examination as sources of documentation guarantees that all necessary data are collected while requiring a mean of 4 minutes and 42 seconds per patient (standard deviation, 1 minute and 30 seconds). A capture system based on biweekly repeated prevalence studies that select patients for the presence of fever, antibiotics, and medical devices ensures the detection of all HAI in a resource-limited environment.

Penile measurements in Tanzanian males: guiding circumcision device design and supply forecasting.

PubMed

Chrouser, Kristin; Bazant, Eva; Jin, Linda; Kileo, Baldwin; Plotkin, Marya; Adamu, Tigistu; Curran, Kelly; Koshuma, Sifuni

2013-08-01

Voluntary medical male circumcision decreases the risk in males of HIV infection through heterosexual intercourse by about 60% in clinical trials and 73% at post-trial followup. In 2007 WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS) recommended that countries with a low circumcision rate and high HIV prevalence expand voluntary medical male circumcision programs as part of a national HIV prevention strategy. Devices for adult/adolescent male circumcision could accelerate the pace of scaling up voluntary medical male circumcision. Detailed penile measurements of African males are required for device development and supply size forecasting. Consenting males undergoing voluntary medical male circumcision at 3 health facilities in the Iringa region, Tanzania, underwent measurement of the penile glans, shaft and foreskin. Age, Tanner stage, height and weight were recorded. Measurements were analyzed by age categories. Correlations of penile parameters with height, weight and body mass index were calculated. In 253 Tanzanian males 10 to 47 years old mean ± SD penile length in adults was 11.5 ± 1.6 cm, mean shaft circumference was 8.7 ± 0.9 cm and mean glans circumference was 8.8 ± 0.9 cm. As expected, given the variability of puberty, measurements in younger males varied significantly. Glans circumference highly correlated with height (r = 0.80) and weight (r = 0.81, each p <0.001). Stretched foreskin diameter moderately correlated with height (r = 0.68) and weight (r = 0.71, each p <0.001). Our descriptive study provides penile measurements of males who sought voluntary medical male circumcision services in Iringa, Tanzania. To our knowledge this is the first study in a sub-Saharan African population that provides sufficiently detailed glans and foreskin dimensions to inform voluntary medical male circumcision device development and size forecasting. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Preventing healthcare-associated infections through human factors engineering.

PubMed

Jacob, Jesse T; Herwaldt, Loreen A; Durso, Francis T

2018-05-24

Human factors engineering (HFE) approaches are increasingly being used in healthcare, but have been applied in relatively limited ways to infection prevention and control (IPC). Previous studies have focused on using selected HFE tools, but newer literature supports a system-based HFE approach to IPC. Cross-contamination and the existence of workarounds suggest that healthcare workers need better support to reduce and simplify steps in delivering care. Simplifying workflow can lead to better understanding of why a process fails and allow for improvements to reduce errors and increase efficiency. Hand hygiene can be improved using visual cues and nudges based on room layout. Using personal protective equipment appropriately appears simple, but exists in a complex interaction with workload, behavior, emotion, and environmental variables including product placement. HFE can help prevent the pathogen transmission through improving environmental cleaning and appropriate use of medical devices. Emerging evidence suggests that HFE can be applied in IPC to reduce healthcare-associated infections. HFE and IPC collaboration can help improve many of the basic best practices including use of hand hygiene and personal protective equipment by healthcare workers during patient care.

Material-mediated pyrogens in medical devices: Applicability of the in vitro Monocyte Activation Test.

PubMed

Borton, Lindsey K; Coleman, Kelly P

2018-06-14

Pyrogenicity presents a challenge to clinicians, medical device manufactures, and regulators. A febrile response may be caused by endotoxin contamination, microbial components other than endotoxin, or chemical agents that generate a material-mediated pyrogenic response. While test methods for the assessment of endotoxin contamination and some microbial components other than endotoxin are well-established, material-mediated pyrogens remain elusively undefined. This review presents the findings of literature searches conducted to identify material-mediated pyrogens associated with medical devices. The in vivo rabbit pyrogen test (RPT) is considered to be the "gold standard" for medical device pyrogenicity testing, despite the fact that few medical device-derived material-mediated pyrogens are known. In line with global efforts to reduce the use of research animals, an in vitro monocyte activation test (MAT) has the potential to replace the RPT. The MAT is used to detect substances that activate human monocytes to release cytokines. This review will also describe the potential opportunities and challenges associated with MAT adoption for the detection of material-mediated pyrogens in medical device testing.

Infection prevention and control in deployed military medical treatment facilities.

PubMed

Hospenthal, Duane R; Green, Andrew D; Crouch, Helen K; English, Judith F; Pool, Jane; Yun, Heather C; Murray, Clinton K

2011-08-01

Infections have complicated the care of combat casualties throughout history and were at one time considered part of the natural history of combat trauma. Personnel who survived to reach medical care were expected to develop and possibly succumb to infections during their care in military hospitals. Initial care of war wounds continues to focus on rapid surgical care with debridement and irrigation, aimed at preventing local infection and sepsis with bacteria from the environment (e.g., clostridial gangrene) or the casualty's own flora. Over the past 150 years, with the revelation that pathogens can be spread from patient to patient and from healthcare providers to patients (including via unwashed hands of healthcare workers, the hospital environment and fomites), a focus on infection prevention and control aimed at decreasing transmission of pathogens and prevention of these infections has developed. Infections associated with combat-related injuries in the recent operations in Iraq and Afghanistan have predominantly been secondary to multidrug-resistant pathogens, likely acquired within the military healthcare system. These healthcare-associated infections seem to originate throughout the system, from deployed medical treatment facilities through the chain of care outside of the combat zone. Emphasis on infection prevention and control, including hand hygiene, isolation, cohorting, and antibiotic control measures, in deployed medical treatment facilities is essential to reducing these healthcare-associated infections. This review was produced to support the Guidelines for the Prevention of Infections Associated With Combat-Related Injuries: 2011 Update contained in this supplement of Journal of Trauma.

The globalization of healthcare: implications of medical tourism for the infectious disease clinician.

PubMed

Chen, Lin H; Wilson, Mary E

2013-12-01

Travel abroad for healthcare has increased rapidly; interventions include organ transplant; cardiac surgery; reproductive care; and joint, cosmetic, and dental procedures. Individuals who receive medical care abroad are a vulnerable, sentinel population, who sample the local environment and can carry home unusual and resistant infections, documented in many reports. Medical tourists are at risk for hospital-associated and procedure-related infections as well as for locally endemic infections. Patients may not volunteer details about care abroad, so clinicians must inquire about medical procedures abroad as well as recent travel. Special infection control measures may be warranted. Healthcare abroad is associated with diverse financial, legal, ethical, and health-related issues. We focus on problems the infectious disease clinician may encounter and provide a framework for evaluating returned medical tourists with suspected infections. A better system is needed to ensure broad access to high-quality health services, continuity of care, and surveillance for complications.

Evaluation of a French medical multi-terminology indexer for the manual annotation of natural language medical reports of healthcare-associated infections.

PubMed

Sakji, Saoussen; Gicquel, Quentin; Pereira, Suzanne; Kergourlay, Ivan; Proux, Denys; Darmoni, Stéfan; Metzger, Marie-Hélène

2010-01-01

Surveillance of healthcare-associated infections is essential to prevention. A new collaborative project, namely ALADIN, was launched in January 2009 and aims to develop an automated detection tool based on natural language processing of medical documents. The objective of this study was to evaluate the annotation of natural language medical reports of healthcare-associated infections. A software MS Access application (NosIndex) has been developed to interface ECMT XML answer and manual annotation work. ECMT performances were evaluated by an infection control practitioner (ICP). Precision was evaluated for the 2 modules and recall only for the default module. Exclusion rate was defined as ratio between medical terms not found by ECMT and total number of terms evaluated. The medical discharge summaries were randomly selected in 4 medical wards. From the 247 medical terms evaluated, ECMT proposed 428 and 3,721 codes, respectively for the default and expansion modules. The precision was higher with the default module (P1=0.62) than with the expansion (P2=0.47). Performances of ECMT as support tool for the medical annotation were satisfactory.

Nanosilver and global public health: international regulatory issues.

PubMed

Faunce, Thomas; Watal, Aparna

2010-06-01

Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings, in dressings as a treatment for external wounds, burns and ulcers. Nanosilver is also an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. In addition, nanosilver is widely used for its antibacterial properties in food processing and packaging, as well as in consumer products used for domestic cleaning and clothing. This article argues that medical devices, therapeutic products, and domestic food and goods containing nanosilver, although offering therapeutic benefits, must be subject to precautionary regulation owing to associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. The article first examines the use of nanosilver in a variety of contemporary medical and domestic products, the utilization of which may assist in resolving global public health problems, such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the USA, EU, UK and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver.

Medications not intended for treatment of dyslipidemias and with a variable effect on lipids.

PubMed

Whayne, Thomas F; Mukherjee, Debabrata

2014-01-01

Many therapeutically active medications have significant side effects, some of which can compromise the intended therapeutic goal. The development of plasma lipid abnormalities or a dyslipidemia as the result of a medication intended for an unrelated effect has been reported. Human immunodeficiency virus (HIV) infection can cause dyslipidemia as can the medications used to treat this infection. Such dyslipidemia can be a significant problem made more relevant by the already increased risk of cardiovascular (CV) disease faced by these patients. Some hypoglycemic medications used to treat diabetes can also be associated with dyslipidemia, most notably rosiglitazone. Antihypertensive medications are intended to decrease CV risk but are not free of dyslipidemia problems with thiazides able to cause hypertriglyceridemia and older beta-blockers without an alpha-blocking effect associated with moderate plasma lipid abnormalities and altered glucose metabolism. Estrogen administered orally can be associated with a severe hypertriglyceridemia. Currently-used antipsychotic medications have a significant association with hypertriglyceridemia. Clinicians must be aware of the dyslipidemias caused by these medications and know how to manage them, even treating a secondary dyslipidemia with another medication as in the case of HIV infection rather than trying to switch treatment of the infection in many cases. Mention is also made of lipid lowering effects of medications intended for other purposes (e.g. angiotensin receptor blockers and orlistat).

Persistent blood stream infection in patients supported with a continuous-flow left ventricular assist device is associated with an increased risk of cerebrovascular accidents.

PubMed

Trachtenberg, Barry H; Cordero-Reyes, Andrea M; Aldeiri, Molham; Alvarez, Paulino; Bhimaraj, Arvind; Ashrith, Guha; Elias, Barbara; Suarez, Erik E; Bruckner, Brian; Loebe, Matthias; Harris, Richard L; Zhang, J Yi; Torre-Amione, Guillermo; Estep, Jerry D

2015-02-01

Common adverse events in patients supported with Continuous-flow left ventricular assist devices (CF-LVAD) include infections and cerebrovascular accidents (CVA). Some studies have suggested a possible association between blood stream infection (BSI) and CVA. Medical records of patients who received Heartmate II (HMII) CF-LVADs in 2008-2012 at a single center were reviewed. CVA was categorized as either hemorrhagic (HCVA) or ischemic (ICVA). BSI was divided into persistent (pBSI) and nonpersistent (non-pBSI). pBSI was defined as BSI with the same organism on repeated blood culture >72 hours from initial blood culture despite antibiotics. Univariate and multivariate analyses were performed to determine predictors. A total of 149 patients had HMII implanted; 76% were male, and the overall mean age was 55.4 ± 13 years. There were a total of 19 (13%) patients who had CVA (7 HCVA and 12 ICVA) at a median of 295 days (range 5-1,096 days) after implantation. There were a total of 28 (19%) patients with pBSI and 17 (11%) patients with non-pBSI. Patients with pBSI had a trend toward greater BMI (31 kg/m(2) vs 27 kg/m(2); P = .09), and longer duration of support (1,019 d vs 371 d; P < .001) compared with those with non-pBSI. Persistent BSI was associated with an increased risk of mortality and with all-cause CVA on multivariate analysis (odds ratio [OR] 5.97; P = .003) as well as persistent Pseudomonas aeruginosa infection (OR 4.54; P = .048). Persistent BSI is not uncommon in patients supported by CF-LVAD and is highly associated with all-cause CVA and increased all-cause mortality. Copyright © 2015 Elsevier Inc. All rights reserved.

Scientific evaluation and pricing of medical devices and associated procedures in France.

PubMed

Gilard, Martine; Debroucker, Frederique; Dubray, Claude; Allioux, Yves; Aper, Eliane; Barat-Leonhardt, Valérie; Brami, Michèle; Carbonneil, Cédric; Chartier-Kastler, Emmanuel; Coqueblin, Claire; Fare, Sandrine; Giri, Isabelle; Goehrs, Jean-Marie; Levesque, Karine; Maugendre, Philippe; Parquin, François; Sales, Jean-Patrick; Szwarcensztein, Karine

2013-01-01

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented. © 2013 Société Française de Pharmacologie et de Thérapeutique.

Whether a novel drug delivery system can overcome the problem of biofilms in respiratory diseases?

PubMed

Dua, Kamal; Shukla, Shakti D; Tekade, Rakesh K; Hansbro, Philip M

2017-02-01

Biofilm comprises a community of microorganisms which form on medical devices and can lead to various threatening infections. It is a major concern in various respiratory diseases like cystic fibrosis, chronic obstructive pulmonary disease, etc. The treatment strategies for such infections are difficult due to the resistance of the microflora existing in the biofilms against various antimicrobial agents, thus posing threats to the patient population. The present era witnesses the beginning of research to understand the biofilm physiology and the associated microfloral diversity by applying -omics approaches. There is very limited information about how the deposition of biofilm on the respiratory devices and lung itself affects the drug delivered, the delivery system, and other implications. The present mini review summarizes the basic introduction to the biofilms and its avoidance using various drug delivery systems with special emphasis on the respiratory diseases. Understanding the approaches, principles, and modes of drug delivery involved in preventing biofilm deposition will be of interest to both biological and formulation scientists, thereby opening avenues to explore the new vistas in biofilm research for identifying better treatments for pulmonary infectious diseases.

Elimination of Mycobacterium chimaera in a heater cooler device used during on-pump cardiothoracic surgery.

PubMed

Nielsen, Conny; Winther, Conni L; Thomsen, Philip K; Andreasen, Jan J

2017-09-01

Since 2014, several infections with non-tuberculous mycobacteria (NTM) belonging to the species Mycobacterium ( M.) chimaera have been associated with the use of heater-cooler devices during on-pump cardiothoracic surgery both in European countries and the United States of America. Infections have been detected after surgery, with a delay of a few months and up to five years. Bacterial contamination of heater-cooler devices has also been described without any associated infections. In many centres, it has been a challenging task to eliminate NTM from the heater-cooler devices in order to reduce the risk to patients. In this case-report, we describe how we managed to achieve negative cultures for M. chimaera by changing the cleaning procedure of the Sorin Group Heater-Cooler System with three tanks.

Mycobacterium chimaera Infections Associated With Contaminated Heater-Cooler Devices for Cardiac Surgery: Outbreak Management.

PubMed

Marra, Alexandre R; Diekema, Daniel J; Edmond, Michael B

2017-08-15

The global outbreak of Mycobacterium chimaera infections associated with heater-cooler devices (HCDs) presents several important, unique challenges for the infection prevention community. The primary focus of this article is to assist hospitals in establishing a rapid response for identification, notification, and evaluation of exposed patients, and management of HCDs with regard to placement and containment, environmental culturing, and disinfection. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Staphylococcus aureus Infections: Epidemiology, Pathophysiology, Clinical Manifestations, and Management

PubMed Central

Davis, Joshua S.; Eichenberger, Emily; Holland, Thomas L.

2015-01-01

SUMMARY Staphylococcus aureus is a major human pathogen that causes a wide range of clinical infections. It is a leading cause of bacteremia and infective endocarditis as well as osteoarticular, skin and soft tissue, pleuropulmonary, and device-related infections. This review comprehensively covers the epidemiology, pathophysiology, clinical manifestations, and management of each of these clinical entities. The past 2 decades have witnessed two clear shifts in the epidemiology of S. aureus infections: first, a growing number of health care-associated infections, particularly seen in infective endocarditis and prosthetic device infections, and second, an epidemic of community-associated skin and soft tissue infections driven by strains with certain virulence factors and resistance to β-lactam antibiotics. In reviewing the literature to support management strategies for these clinical manifestations, we also highlight the paucity of high-quality evidence for many key clinical questions. PMID:26016486

The use of subcutaneous infusion in medication administration.

PubMed

Gabriel, Janice

The subcutaneous administration of medications is an area that receives little attention compared with other types of parenteral therapy. Parenteral administration is used by many thousands of patients who self-administer their medication on a daily basis-for example, those using insulin to manage diabetes, recipients of some types of hormone therapy and so on. It is also an effective route for the continuous administration of medication(s) in individuals who are terminally ill. Patients approaching the end of their life may be unable to tolerate the administration of oral medication to control their symptoms and make them more comfortable. This paper will discuss how subcutaneous infusion can be used to deliver these medications, but at the same time how important the selection of the most appropriate subcutaneous infusion device is to the overall comfort of the patient, and to reduce the potential for sharps-related injuries to healthcare workers. Appropriate device selection, together with its management, is an important contributing factor to patient safety and comfort. It will diminish the potential for premature device loss, which can lead to repeated insertion procedures for the patient, as well as delaying their medication. There is also a resource implication for the NHS, as the replacement of any device involves the use of additional equipment and staff time. Additionally, the use of any infusion device poses a risk to healthcare workers of acquiring a bloodborne infection should they experience a percutaneous injury. Knowledge of what equipment is available will reduce the potential risk to these staff.

Environmental Contaminants in Hospital Settings and Progress in Disinfecting Techniques

PubMed Central

Ceriale, Emma; Lenzi, Daniele; Burgassi, Sandra; Azzolini, Elena; Manzi, Pietro

2013-01-01

Medical devices, such as stethoscopes, and other objects found in hospital, such as computer keyboards and telephone handsets, may be reservoirs of bacteria for healthcare-associated infections. In this cross-over study involving an Italian teaching hospital we evaluated microbial contamination (total bacterial count (TBC) at 36°C/22°C, Staphylococcus spp., moulds, Enterococcus spp., Pseudomonas spp., E. coli, total coliform bacteria, Acinetobacter spp., and Clostridium difficile) of these devices before and after cleaning and differences in contamination between hospital units and between stethoscopes and keyboards plus handsets. We analysed 37 telephone handsets, 27 computer keyboards, and 35 stethoscopes, comparing their contamination in four hospital units. Wilcoxon signed-rank and Mann-Whitney tests were used. Before cleaning, many samples were positive for Staphylococcus spp. and coliforms. After cleaning, CFUs decreased to zero in most comparisons. The first aid unit had the highest and intensive care the lowest contamination (P < 0.01). Keyboards and handsets had higher TBC at 22°C (P = 0.046) and mould contamination (P = 0.002) than stethoscopes. Healthcare professionals should disinfect stethoscopes and other possible sources of bacterial healthcare-associated infections. The cleaning technique used was effective in reducing bacterial contamination. Units with high patient turnover, such as first aid, should practise stricter hygiene. PMID:24286078

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

[Subcutaneously inserted central intravascular devices in the pediatric oncology patient: can we minimize their infection].

PubMed

Tardáguila, A R; Del Cañizo, A; Santos, M M; Fanjul, M; Corona, C; Zornoza, M; Parente, A; Carrera, N; Beléndez, C; Cerdá, J; Saavedra, J; Molina, E; García-Casillas, M A; Peláez, D

2011-10-01

Long-term indwelling central venous access devices are frequently used in pediatric patients. Their main complication is infection, that can even mean their removal. We try to identify the risk factors really involved in this complication and in their removal. We have made a retrospective review of 120 oncologic pediatric patients who received a central venous device between 2003 and 2009. We searched for epidemiologic, clinic, microbiologic and surgical risk factors. We made a comparative data analysis among: GROUP A, children who suffered device infection, GROUP B the others. Group A was divided into early infection (first month after implantation)/late infection, removed/not removed. Data were analized with statistical program SPSS. 29 suffered from leukemia, 19 from lymphoma and the main part, 72, from solid tumour. 31% experienced infection (GROUP A), being early in the 36% of them. 16% had to be withdrawn. Data analysis revealed statistical association with the age (p=0.015) and with the reception of chemiotherapic treatment the week before the surgical insertion. The rest of the studied factors did not revealed a real association, but could be guess a relationship among infection and leukemia, subclavian catheters, those patients whose deviced was introduced using a guide over a previous catheter and also transplanted. Related to early infection the only associateon founded was with the subclavian access (p=0.018). In conclusion, in our serie long-term central venous access infection was more frequent in the younger patients and also in those who had received chemotherapy the week before the catheter implantation. The tendency towards infection in leukemia, transplanted and subclavian carriers has to be studied in a prospective way with a larger number of oncologic children.

Positive predictive value of infective endocarditis in the Danish National Patient Registry: a validation study.

PubMed

Østergaard, Lauge; Adelborg, Kasper; Sundbøll, Jens; Pedersen, Lars; Loldrup Fosbøl, Emil; Schmidt, Morten

2018-05-30

The positive predictive value of an infective endocarditis diagnosis is approximately 80% in the Danish National Patient Registry. However, since infective endocarditis is a heterogeneous disease implying long-term intravenous treatment, we hypothesiszed that the positive predictive value varies by length of hospital stay. A total of 100 patients with first-time infective endocarditis in the Danish National Patient Registry were identified from January 2010 - December 2012 at the University hospital of Aarhus and regional hospitals of Herning and Randers. Medical records were reviewed. We calculated the positive predictive value according to admission length, and separately for patients with a cardiac implantable electronic device and a prosthetic heart valve using the Wilson score method. Among the 92 medical records available for review, the majority of the patients had admission length ⩾2 weeks. The positive predictive value increased with length of admission. In patients with admission length <2 weeks the positive predictive value was 65% while it was 90% for admission length ⩾2 weeks. The positive predictive value was 81% for patients with a cardiac implantable electronic device and 87% for patients with a prosthetic valve. The positive predictive value of the infective endocarditis diagnosis in the Danish National Patient Registry is high for patients with admission length ⩾2 weeks. Using this algorithm, the Danish National Patient Registry provides a valid source for identifying infective endocarditis for research.

First In-Human Experience With Complete Integration of Neuromodulation Device Within a Customized Cranial Implant.

PubMed

Gordon, Chad R; Santiago, Gabriel F; Huang, Judy; Bergey, Gregory K; Liu, Shuya; Armand, Mehran; Brem, Henry; Anderson, William S

2017-10-06

Neuromodulation devices have the potential to transform modern day treatments for patients with medicine-resistant neurological disease. For instance, the NeuroPace System (NeuroPace Inc, Mountain View, California) is a Food and Drug Administration (FDA)-approved device developed for closed-loop direct brain neurostimulation in the setting of drug-resistant focal epilepsy. However, current methods require placement either above or below the skull in nonanatomic locations. This type of positioning has several drawbacks including visible deformities and scalp pressure from underneath leading to eventual wound healing difficulties, micromotion of hardware with infection, and extrusion leading to premature explantation. To introduce complete integration of a neuromodulation device within a customized cranial implant for biocompatibility optimization and prevention of visible deformity. We report a patient with drug-resistant focal epilepsy despite previous seizure surgery and maximized medical therapy. Preoperative imaging demonstrated severe resorption of previous bone flap causing deformity and risk for injury. She underwent successful responsive neurostimulation device implantation via complete integration within a clear customized cranial implant. The patient has recovered well without complication and has been followed closely for 180 d. Device interrogation with electrocorticographic data transmission has been successfully performed through the clear implant material for the first time with no evidence of any wireless transmission interference. Cranial contour irregularities, implant site infection, and bone flap resorption/osteomyelitis are adverse events associated with implantable neurotechnology. This method represents a novel strategy to incorporate all future neuromodulation devices within the confines of a low-profile, computer-designed cranial implant and the newfound potential to eliminate contour irregularities, improve outcomes, and optimize patient satisfaction. Copyright © 2017 by the Congress of Neurological Surgeons

Pelvic infection: a comparison of the Dalkon shield and three other intrauterine devices.

PubMed Central

Snowden, R; Pearson, B

1984-01-01

A detailed analysis was undertaken of reports of possible pelvic infection in relation to the use of four commonly fitted intrauterine contraceptive devices during 1971 to 1978 in the United Kingdom. The four devices were the Dalkon shield, Lippes loops 3C and 2D, and the Gravigard (copper 7), and data used were those collected systematically through the UK intrauterine device research network. Prospective reports that the Dalkon shield was uniquely related to high levels of infection when compared with other intrauterine devices were not substantiated in this prospective study among 13 349 users. Though some factors such as social class and previous experience of abortion appeared to influence the rate of infection, the type of intrauterine device being worn did not appear to be a significant factor. Various methods of analysis were used including life table, regression, and discriminant analysis, using information relating to the type of intrauterine device worn, the characteristics of the user, the fitting centre, and the pattern of diagnosis and treatment of reported or suspected pelvic infection. The results of this study suggest that fears that the Dalkon shield may be associated with a higher incidence of pelvic infection than other intrauterine devices may have been unjustified. PMID:6426647

Psychiatric disorders, HIV infection and HIV/hepatitis co-infection in the correctional setting.

PubMed

Baillargeon, J G; Paar, D P; Wu, H; Giordano, T P; Murray, O; Raimer, B G; Avery, E N; Diamond, P M; Pulvino, J S

2008-01-01

Psychiatric disorders such as bipolar disorder, schizophrenia and depression have long been associated with risk behaviors for HIV, hepatitis C virus (HCV) and hepatitis B virus (HBV). The US prison population is reported to have elevated rates of HIV, hepatitis and most psychiatric disorders. This study examined the association of six major psychiatric disorders with HIV mono-infection, HIV/HCV co-infection and HIV/HBV co-infection in one of the nation's largest prison populations. The study population consisted of 370,511 Texas Department of Criminal Justice inmates who were incarcerated for any duration between January 1, 2003 and July 1, 2006. Information on medical conditions and sociodemographic factors was obtained from an institution-wide electronic medical information system. Offenders diagnosed with HIV mono-infection, HIV/HCV, HIV/HBV and all HIV combined exhibited elevated rates of major depression, bipolar disorder, schizophrenia, schizoaffective disorder, non-schizophrenic psychotic disorder and any psychiatric disorder. In comparison to offenders with HIV mono-infection, those with HIV/HCV co-infection had an elevated prevalence of any psychiatric disorder. This cross-sectional study's finding of positive associations between psychiatric disease and both HIV infection and hepatitis co-infection among Texas prison inmates holds both clinical and public health relevance. It will be important for future investigations to examine the extent to which psychiatric disorders serve as a barrier to medical care, communication with clinicians and adherence to prescribed medical regimens among both HIV-mono-infected and HIV/hepatitis-co-infected inmates.

Strategies for prevention of ventilator-associated pneumonia: bundles, devices, and medications for improved patient outcomes.

PubMed

Alroumi, Fahad; Sarwar, Akmal; Grgurich, Philip E; Lei, Yuxiu; Hudcova, Jana; Craven, Donald E

2012-02-01

Ventilator-associated pneumonia is associated with significant patient morbidity, mortality, and increased health care costs. In the current economic climate, it is crucial to implement cost-effective prevention strategies that have proven efficacy. Multiple prevention measures have been proposed by various expert panels. Global strategies have focused on infection control, and reduction of lower airway colonization with bacterial pathogens, intubation, duration of mechanical ventilation, and length of stay in the intensive care unit. Routine use of the Institute for Healthcare Improvement ventilator care bundle is widespread, and has been clearly demonstrated to be an effective method for reducing the incidence of ventilator-associated pneumonia. In this article, we examine specific aspects of the Institute for Healthcare Improvement bundle, better-designed endotracheal tubes, use of antibiotics and probiotics, and treatment of ventilator-associated tracheobronchitis to prevent ventilator-associated pneumonia.

Burn Wound Infections

PubMed Central

Church, Deirdre; Elsayed, Sameer; Reid, Owen; Winston, Brent; Lindsay, Robert

2006-01-01

Burns are one of the most common and devastating forms of trauma. Patients with serious thermal injury require immediate specialized care in order to minimize morbidity and mortality. Significant thermal injuries induce a state of immunosuppression that predisposes burn patients to infectious complications. A current summary of the classifications of burn wound infections, including their diagnosis, treatment, and prevention, is given. Early excision of the eschar has substantially decreased the incidence of invasive burn wound infection and secondary sepsis, but most deaths in severely burn-injured patients are still due to burn wound sepsis or complications due to inhalation injury. Burn patients are also at risk for developing sepsis secondary to pneumonia, catheter-related infections, and suppurative thrombophlebitis. The introduction of silver-impregnated devices (e.g., central lines and Foley urinary catheters) may reduce the incidence of nosocomial infections due to prolonged placement of these devices. Improved outcomes for severely burned patients have been attributed to medical advances in fluid resuscitation, nutritional support, pulmonary and burn wound care, and infection control practices. PMID:16614255

NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

PubMed Central

Songara, Raiendra K.; Sharma, Ganesh N.; Gupta, Vipul K.; Gupta, Promila

2010-01-01

Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements. PMID:22247840

Health-care-associated infections in neonates, children, and adolescents: an analysis of paediatric data from the European Centre for Disease Prevention and Control point-prevalence survey.

PubMed

Zingg, Walter; Hopkins, Susan; Gayet-Ageron, Angèle; Holmes, Alison; Sharland, Mike; Suetens, Carl

2017-04-01

In 2011-12, the European Centre for Disease Prevention and Control (ECDC) held the first Europe-wide point-prevalence survey of health-care-associated infections in acute care hospitals. We analysed paediatric data from this survey, aiming to calculate the prevalence and type of health-care-associated infections in children and adolescents in Europe and to determine risk factors for infection in this population. Point-prevalence surveys took place from May, 2011, to November, 2012, in 1149 hospitals in EU Member States, Iceland, Norway, and Croatia. Patients present on the ward at 0800 h on the day of the survey and who were not discharged at the time of the survey were included. Data were collected by locally trained health-care workers according to patient-based or unit-based protocols. We extracted data from the ECDC database for all paediatric patients (age 0-18 years). We report adjusted prevalence for health-care-associated infections by clustering at the hospital and country level. We also calculated risk factors for development of health-care-associated infections with use of a generalised linear mixed-effects model. We analysed data for 17 273 children and adolescents from 29 countries. 770 health-care-associated infections were reported in 726 children and adolescents, corresponding to a prevalence of 4·2% (95% CI 3·7-4·8). Bloodstream infections were the most common type of infection (343 [45%] infections), followed by lower respiratory tract infections (171 [22%]), gastrointestinal infections (64 [8%]), eye, ear, nose, and throat infections (55 [7%]), urinary tract infections (37 [5%]), and surgical-site infections (34 [4%]). The prevalence of infections was highest in paediatric intensive care units (15·5%, 95% CI 11·6-20·3) and neonatal intensive care units (10·7%, 9·0-12·7). Independent risk factors for infection were age younger than 12 months, fatal disease (via ultimately and rapidly fatal McCabe scores), prolonged length of stay, and the use of invasive medical devices. 392 microorganisms were reported for 342 health-care-associated infections, with Enterobacteriaceae being the most frequently found (113 [15%]). Infection prevention and control strategies in children should focus on prevention of bloodstream infections, particularly among neonates and infants. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluation of reticulated gelatin-hibiscus-propolis against intestinal commensal species commonly associated with urinary tract infections.

PubMed

Olier, Maïwenn; Sekkal, Soraya; Harkat, Cherryl; Eutamene, Hélène; Theodorou, Vassilia

2017-05-01

Reticulated gelatin (RG), hibiscus and propolis (RGHP) is a medical device that can reduce the bacterial adherence to epithelial cultured cells and invasion by enteropathogens, thus gathering relevant properties to decrease the risk of urinary tract infections (UTIs). We aimed at evaluating in Wistar rats the efficacy of RGHP, RG and vehicle against intestinal commensals commonly involved in UTIs. Animals received orally (with supplemental Na 2 CO 3 ): RGHP 1540 mg/day/rat; RG 500 mg/day/rat or vehicle. RGHP significantly reduced fecal Escherichia coli and Enterococcus spp. levels without affecting other targeted Enterobacteriaceae. The antagonistic property of RGHP was confirmed in streptomycin-pretreated rats highly colonized with a human commensal E. coli strain with uropathogenic potential. RGHP may decrease the risk of UTIs by reducing colonization by opportunistic uropathogens.

FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.

PubMed

Reed, Terrie L; Kaufman-Rivi, Diana

2010-01-01

The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

PubMed

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Effects of bacteriocins on methicillin-resistant Staphylococcus aureus biofilm.

PubMed

Okuda, Ken-ichi; Zendo, Takeshi; Sugimoto, Shinya; Iwase, Tadayuki; Tajima, Akiko; Yamada, Satomi; Sonomoto, Kenji; Mizunoe, Yoshimitsu

2013-11-01

Control of biofilms formed by microbial pathogens is an important subject for medical researchers, since the development of biofilms on foreign-body surfaces often causes biofilm-associated infections in patients with indwelling medical devices. The present study examined the effects of different kinds of bacteriocins, which are ribosomally synthesized antimicrobial peptides produced by certain bacteria, on biofilms formed by a clinical isolate of methicillin-resistant Staphylococcus aureus (MRSA). The activities and modes of action of three bacteriocins with different structures (nisin A, lacticin Q, and nukacin ISK-1) were evaluated. Vancomycin, a glycopeptide antibiotic used in the treatment of MRSA infections, showed bactericidal activity against planktonic cells but not against biofilm cells. Among the tested bacteriocins, nisin A showed the highest bactericidal activity against both planktonic cells and biofilm cells. Lacticin Q also showed bactericidal activity against both planktonic cells and biofilm cells, but its activity against biofilm cells was significantly lower than that of nisin A. Nukacin ISK-1 showed bacteriostatic activity against planktonic cells and did not show bactericidal activity against biofilm cells. Mode-of-action studies indicated that pore formation leading to ATP efflux is important for the bactericidal activity against biofilm cells. Our results suggest that bacteriocins that form stable pores on biofilm cells are highly potent for the treatment of MRSA biofilm infections.

Effects of Bacteriocins on Methicillin-Resistant Staphylococcus aureus Biofilm

PubMed Central

Zendo, Takeshi; Sugimoto, Shinya; Iwase, Tadayuki; Tajima, Akiko; Yamada, Satomi; Sonomoto, Kenji

2013-01-01

Control of biofilms formed by microbial pathogens is an important subject for medical researchers, since the development of biofilms on foreign-body surfaces often causes biofilm-associated infections in patients with indwelling medical devices. The present study examined the effects of different kinds of bacteriocins, which are ribosomally synthesized antimicrobial peptides produced by certain bacteria, on biofilms formed by a clinical isolate of methicillin-resistant Staphylococcus aureus (MRSA). The activities and modes of action of three bacteriocins with different structures (nisin A, lacticin Q, and nukacin ISK-1) were evaluated. Vancomycin, a glycopeptide antibiotic used in the treatment of MRSA infections, showed bactericidal activity against planktonic cells but not against biofilm cells. Among the tested bacteriocins, nisin A showed the highest bactericidal activity against both planktonic cells and biofilm cells. Lacticin Q also showed bactericidal activity against both planktonic cells and biofilm cells, but its activity against biofilm cells was significantly lower than that of nisin A. Nukacin ISK-1 showed bacteriostatic activity against planktonic cells and did not show bactericidal activity against biofilm cells. Mode-of-action studies indicated that pore formation leading to ATP efflux is important for the bactericidal activity against biofilm cells. Our results suggest that bacteriocins that form stable pores on biofilm cells are highly potent for the treatment of MRSA biofilm infections. PMID:23979748

From Nano to Micro: using nanotechnology to combat microorganisms and their multidrug resistance.

PubMed

Natan, Michal; Banin, Ehud

2017-05-01

The spread of antibiotic resistance and increasing prevalence of biofilm-associated infections is driving demand for new means to treat bacterial infection. Nanotechnology provides an innovative platform for addressing this challenge, with potential to manage even infections involving multidrug-resistant (MDR) bacteria. The current review summarizes recent progress over the last 2 years in the field of antibacterial nanodrugs, and describes their unique properties, mode of action and activity against MDR bacteria and biofilms. Biocompatibility and commercialization are also discussed. As opposed to the more common division of nanoparticles (NPs) into organic- and inorganic-based materials, this review classifies NPs into two functional categories. The first includes NPs exhibiting intrinsic antibacterial properties and the second is devoted to NPs serving as a cargo for delivering antibacterial agents. Antibacterial nanomaterials used to decorate medical devices and implants are reviewed here as well. © FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Quick-release medical tape

PubMed Central

Laulicht, Bryan; Langer, Robert; Karp, Jeffrey M.

2012-01-01

Medical tape that provides secure fixation of life-sustaining and -monitoring devices with quick, easy, damage-free removal represents a longstanding unmet medical need in neonatal care. During removal of current medical tapes, crack propagation occurs at the adhesive–skin interface, which is also the interface responsible for device fixation. By designing quick-release medical tape to undergo crack propagation between the backing and adhesive layers, we decouple removal and device fixation, enabling dual functionality. We created an ordered adhesive/antiadhesive composite intermediary layer between the medical tape backing and adhesive for which we achieve tunable peel removal force, while maintaining high shear adhesion to secure medical devices. We elucidate the relationship between the spatial ordering of adhesive and antiadhesive regions to create a fully tunable system that achieves strong device fixation and quick, easy, damage-free device removal. We also described ways of neutralizing the residual adhesive on the skin and have observed that thick continuous films of adhesive are easier to remove than the thin islands associated with residual adhesive left by current medical tapes. PMID:23112196

Polymer Multilayers Loaded with Antifungal β-Peptides Kill Planktonic Candida albicans and Reduce Formation of Fungal Biofilms on the Surfaces of Flexible Catheter Tubes

PubMed Central

Raman, Namrata; Lee, Myung-Ryul

2014-01-01

Candida albicans is the most common fungal pathogen responsible for hospital-acquired infections. Most C albicans infections are associated with the implantation of medical devices that act as points of entry for the pathogen and as substrates for the growth of fungal biofilms that are notoriously difficult to eliminate by systemic administration of conventional antifungal agents. In this study, we report a fill-and-purge approach to the layer-by-layer fabrication of biocompatible, nanoscale ‘polyelectrolyte multilayers’ (PEMs) on the luminal surfaces of flexible catheters, and an investigation of this platform for the localized, intraluminal release of a cationic β-peptide-based antifungal agent. We demonstrate that polyethylene catheter tubes with luminal surfaces coated with multilayers ~700 nm thick fabricated from poly-L-glutamic acid (PGA) and poly-L-lysine (PLL) can be loaded, post-fabrication, by infusion with β-peptide, and that this approach promotes extended intraluminal release of this agent (over ~4 months) when incubated in physiological media. The β-peptide remained potent against intraluminal inoculation of the catheters with C albicans and substantially reduced the formation of C albicans biofilms on the inner surfaces of film-coated catheters. Finally, we report that these β-peptide-loaded coatings exhibit antifungal activity under conditions that simulate intermittent catheter use and microbial challenge for at least three weeks. We conclude that β-peptide-loaded PEMs offer a novel and promising approach to kill C albicans and prevent fungal biofilm formation on surfaces, with the potential to substantially reduce the incidence of device-associated infections in indwelling catheters. β-Peptides comprise a promising new class of antifungal agents that could help address problems associated with the use of conventional antifungal agents. The versatility of the layer-by-layer approach used here thus suggests additional opportunities to exploit these new agents in other biomedical and personal care applications in which fungal infections are endemic. PMID:24862322

Electronic medication packaging devices and medication adherence: a systematic review.

PubMed

Checchi, Kyle D; Huybrechts, Krista F; Avorn, Jerry; Kesselheim, Aaron S

2014-09-24

Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices (adherence-monitoring devices incorporated into the packaging of a prescription medication). To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Systematic review of peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, International Pharmaceutical Abstracts, and Sociological Abstracts databases from searches conducted to June 13, 2014, with extraction of associations between the interventions and adherence, as well as other key findings. Each study was assessed for bias using the Cochrane Handbook for Systematic Reviews of Interventions; features of EMP devices and interventions were qualitatively assessed. Thirty-seven studies (32 randomized and 5 nonrandomized) including 4326 patients met inclusion criteria (10 patient interface-only "simple" interventions and 29 "complex" interventions integrated into the health care system [2 qualified for both categories]). Overall, the effect estimates for differences in mean adherence ranged from a decrease of 2.9% to an increase of 34.0%, and the those for differences in the proportion of patients defined as adherent ranged from a decrease of 8.0% to an increase of 49.5%. We identified 5 common EMP characteristics: recorded dosing events and stored records of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and feedback on adherence performance. Many varieties of EMP devices exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices. Devices integrated into the care delivery system and designed to record dosing events are most frequently associated with improved adherence, compared with other devices. Higher-quality evidence is needed to determine the effect, if any, of these low-cost interventions on medication nonadherence and to identify their most useful components.

Indications for cardiac surgery in patients with active infective endocarditis.

PubMed

Alsip, S G; Blackstone, E H; Kirklin, J W; Cobbs, C G

1985-06-28

Currently, absolute indications for valve replacement during active infective endocarditis include severe heart failure, the presence of an infecting microorganism that is not susceptible to available antimicrobial agents, and, in patients with an infected prosthetic valve, an unstable device. Relative indications include an etiologic microorganism other than a susceptible Streptococcus, relapse after presumed effective therapy, evidence of intracardiac extension of the infection, two or more systemic emboli, vegetations large enough to be demonstrated by echocardiography, and, in patients with an infected prosthetic device, early disease and periprosthetic leak. With use of data from the medical literature, a study generated by the cardiovascular surgical group at the University of Alabama School of Medicine, and a brief cost analysis, a point system was constructed to assist in decision-making concerning surgery in patients with active infective endocarditis. The usefulness of this system will depend on experience generated from its utilization in a larger number of patients as well as new data relative to a more complete understanding of the risks and benefits of surgery in this condition.

Peripherally Inserted Central Catheter Use in Skilled Nursing Facilities: A Pilot Study.

PubMed

Chopra, Vineet; Montoya, Ana; Joshi, Darius; Becker, Carol; Brant, Amy; McGuirk, Helen; Clark, Jordyn; Harrod, Molly; Kuhn, Latoya; Mody, Lona

2015-09-01

To describe patterns of use, care practices, and outcomes related to peripherally inserted central catheter (PICC) use in skilled nursing facilities (SNFs). Prospective cohort study. Two community SNFs. Adult SNF residents with PICCs (N = 56). Information on indication for PICC use, device characteristics (e.g., lumens, gauge), and participant data (comorbidities, medications) were obtained from medical records. Care practices (e.g., frequency of flushing, dressing care) and problems related to PICCs were recorded. Major (central line-associated bloodstream infection, venous thromboembolism, catheter dislodgement) and minor (migration, dressing disruption, lumen occlusion, exit site infection) complications and process measures (flushing of PICC, assessment of necessity) were recorded. Bivariate analyses with t-tests, chi-square tests, or Fischer exact tests were used for continuous and categorical data. Participants were enrolled from two SNFs. The most common indication for PICC use was intravenous antibiotic delivery. The average PICC dwell time was 43 days, and most devices were single-lumen PICCs. Major and minor complications were common and occurred in 11 (20%) and 18 (32%) participants, respectively. Occlusion (23%, n = 13), accidental dislodgement (12%, n = 7), and dressing disruption (11%, n = 6) were the commonest complications observed. Documentation regarding catheter care practices occurred in 41% of cases. Quality improvement efforts that seek to benchmark practice, identify gaps, and institute efforts to improve PICC care and practice in SNFs appear necessary. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Toward Pride and Professionalism: Increasing Personal Responsibility. Facilitator Guide.

DTIC Science & Technology

1985-05-22

Stress Intervention. Richmond, CA: New Harbinger, 1981. 6. Medical Device Corporation, 1555 Bellefontaine, North Drive, Indianapolis, Indiana, 46202. (317...impair one’s cellular building and repair, as well as immune responses, making him or her less able to withstand bacterial and viral infection. Cancer ...facilitator should begin a collection of ads--perhaps those from medical magazines, treatment magazines, or other professional sources not ordinarily

29 CFR 1910.1030 - Bloodborne pathogens.

Code of Federal Regulations, 2013 CFR

2013-07-01

... including highly resistant bacterial endospores. Universal Precautions is an approach to infection control... paragraph (b) of this section shall establish a written Exposure Control Plan designed to eliminate or... available and effective safer medical devices designed to eliminate or minimize occupational exposure. (v...

Microbiological problems and biofilms associated with Mycobacterium chimaera in heater-cooler units used for cardiopulmonary bypass.

PubMed

Walker, J; Moore, G; Collins, S; Parks, S; Garvey, M I; Lamagni, T; Smith, G; Dawkin, L; Goldenberg, S; Chand, M

2017-07-01

The role of heater-cooler units (HCUs) in the transmission of Mycobacterium chimaera during open heart surgery has been recognized since 2013. Subsequent investigations uncovered a remarkable global outbreak reflecting the wide distribution of implicated devices. HCUs are an essential component of cardiopulmonary bypass operations and their withdrawal would severely affect capacity for life-saving cardiac surgery. However, studies have demonstrated that many HCUs are contaminated with a wide range of micro-organisms, including M. chimaera and complex biofilms. Whole genome sequencing of M. chimaera isolates recovered from one manufacturer's HCUs, worldwide, has demonstrated a high level of genetic similarity, for which the most plausible hypothesis is a point source contamination of the devices. Dissemination of bioaerosols through breaches in the HCU water tanks is the most likely route of transmission and airborne bacteria have been shown to have reached the surgical field even with the use of ultraclean theatre ventilation. Controlling the microbiological quality of the water circulating in HCUs and reducing biofilm formation has been a major challenge for many hospitals. However, enhanced decontamination strategies have been recommended by manufacturers, and, although they are not always effective in eradicating M. chimaera from HCUs, UK hospitals have not reported any new cases of M. chimaera infection since implementing these mitigation strategies. Water safety groups in hospitals should be aware that water in medical devices such as HCUs may act as a vector in the transmission of potentially fatal water-borne infections. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Enzymatic Detachment of Staphylococcus epidermidis Biofilms

PubMed Central

Kaplan, Jeffrey B.; Ragunath, Chandran; Velliyagounder, Kabilan; Fine, Daniel H.; Ramasubbu, Narayanan

2004-01-01

The gram-positive bacterium Staphylococcus epidermidis is the most common cause of infections associated with catheters and other indwelling medical devices. S. epidermidis produces an extracellular slime that enables it to form adherent biofilms on plastic surfaces. We found that a biofilm-releasing enzyme produced by the gram-negative periodontal pathogen Actinobacillus actinomycetemcomitans rapidly and efficiently removed S. epidermidis biofilms from plastic surfaces. The enzyme worked by releasing extracellular slime from S. epidermidis cells. Precoating surfaces with the enzyme prevented S. epidermidis biofilm formation. Our findings demonstrate that biofilm-releasing enzymes can exhibit broad-spectrum activity and that these enzymes may be useful as antibiofilm agents. PMID:15215120

Unexpected Listeria monocytogenes detection with a dithiothreitol-based device during an aseptic hip revision.

PubMed

Banche, Giuliana; Bistolfi, Alessandro; Allizond, Valeria; Galletta, Claudia; Iannantuoni, Maria Rita; Marra, Elisa Simona; Merlino, Chiara; Massè, Alessandro; Cuffini, Anna Maria

2018-06-18

Prosthetic joint infection diagnosis is often difficult since biofilm-embedded microorganisms attach well to the prosthetic surfaces and resist their detection by conventional methods. DL-dithiothreitol has been described as a valid method for biofilm detachment on orthopedic devices. We report the case of an occasional detection of Listeria monocytogenes in a non immuno-compromised patient with a preoperative diagnosis of aseptic loosening. The infection diagnosis due to such rare bacteria was made postoperatively, thanks to a DL-dithiothreitol-based device. This may be considered a feasible approach for the microbiological analysis of prosthetic joint infection, considering that a prompt diagnosis of such biofilm-associated infections could bring some advantages, such as an early and appropriate antibiotic therapy administration and a reduction of undiagnosed infections.

Clinical and molecular epidemiology of community-acquired methicillin-resistant Staphylococcus aureus infections among children with risk factors for health care-associated infection: 2001-2003.

PubMed

Zaoutis, Theoklis E; Toltzis, Philip; Chu, Jaclyn; Abrams, Tara; Dul, Michael; Kim, Jason; McGowan, Karin L; Coffin, Susan E

2006-04-01

Methicillin-resistant Staphylococcus aureus (MRSA) has recently emerged as a common cause of infection in children in many parts of the world. The epidemiology of community-acquired MRSA (CA-MRSA) among healthy children has been recently described. However, little is known about CA-MRSA in children with underlying medical conditions. To compare the clinical and molecular epidemiology of CA-MRSA in children with and without risk factors for health care-associated infections (RF-HAI). We conducted a 3-year retrospective cohort study of children with CA-MRSA infection. RF-HAI, including hospitalization within the past year, indwelling medical devices or chronic medical condition, were identified by chart review. Genetic relatedness of CA-MRSA strains was assessed by pulsed field gel electrophoresis. Polymerase chain reaction was used to detect Panton-Valentine leukocidin and determine staphylococcal chromosomal cassette carrying the mecA methicillin-resistant gene (SCCmec) type. We identified 446 episodes of community-acquired S. aureus infections, of which 134 (30%) were caused by MRSA. During the 3-year study period, the proportion of S. aureus infections caused by MRSA rose from 15% (12 of 80) to 40% (93 of 235) (P < 0.001) with the increase noted predominately in children with skin and soft tissue infections. RF-HAI were identified in 56 (42%) patients with CA-MRSA. Among subjects with CA-MRSA, children with RF-HAI were more likely to have had an invasive infection than healthy children (32% versus 5%; P < 0.001). CA-MRSA isolates from children with RF-HAI were similar to those without RF-HAI; all laboratory-retained CA-MRSA isolates harbored the SCCmec type IV cassette, and almost all isolates were susceptible to trimethoprim-sulfamethoxazole and clindamycin. However, pulsed field gel electrophoresis revealed greater molecular diversity among CA-MRSA isolates recovered from children with RF-HAI compared with those from otherwise healthy children (P = 0.001). Additionally CA-MRSA isolates from children with RF-HAI were less likely to contain sequences for Panton-Valentine leukocidin (P < 0.001) and more likely to be resistant to 3 or more classes of antibiotics (P = 0.033). CA-MRSA strains recovered from children with RF-HAI were phenotypically similar to those recovered from healthy children The absence of SCCmec type II or III MRSA among children with RF-HAI suggests that CA-MRSA strains might have become endemic within pediatric health care facilities.

Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial.

PubMed

Rickard, Claire M; Marsh, Nicole; Webster, Joan; Playford, E Geoffrey; McGrail, Matthew R; Larsen, Emily; Keogh, Samantha; McMillan, David; Whitty, Jennifer A; Choudhury, Md Abu; Dunster, Kimble R; Reynolds, Heather; Marshall, Andrea; Crilly, Julia; Young, Jeanine; Thom, Ogilvie; Gowardman, John; Corley, Amanda; Fraser, John F

2015-09-23

Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure. A multicentre, parallel group, superiority randomised controlled trial with 4 arms, 3 experimental groups (tissue adhesive, bordered polyurethane dressing, sutureless securement device) and 1 control (standard polyurethane dressing) is planned. There will be a 3-year recruitment of 1708 adult patients, with allocation concealment until randomisation by a centralised web-based service. The primary outcome is PIV failure which includes any of: dislodgement, occlusion/infiltration, phlebitis and infection. Secondary outcomes include: types of PIV failure, PIV dwell time, costs, device colonisation, skin colonisation, patient and staff satisfaction. Relative incidence rates of device failure per 100 devices and per 1000 device days with 95% CIs will summarise the impact of each dressing, and test differences between groups. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare device failure over time. p Values of <0.05 will be considered significant. Secondary end points will be compared between groups using parametric or non-parametric techniques appropriate to level of measurement. Ethical approval has been received from Queensland Health (HREC/11/QRCH/152) and Griffith University (NRS/46/11/HREC). Results will be published according to the CONSORT statement and presented at relevant conferences. Australian New Zealand Clinical Trial Registry (ACTRN); 12611000769987. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Securing All intraVenous devices Effectively in hospitalised patients—the SAVE trial: study protocol for a multicentre randomised controlled trial

PubMed Central

Rickard, Claire M; Marsh, Nicole; Webster, Joan; Playford, E Geoffrey; McGrail, Matthew R; Larsen, Emily; Keogh, Samantha; McMillan, David; Whitty, Jennifer A; Choudhury, Md Abu; Dunster, Kimble R; Reynolds, Heather; Marshall, Andrea; Crilly, Julia; Young, Jeanine; Thom, Ogilvie; Gowardman, John; Corley, Amanda; Fraser, John F

2015-01-01

Introduction Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure. Methods and analysis A multicentre, parallel group, superiority randomised controlled trial with 4 arms, 3 experimental groups (tissue adhesive, bordered polyurethane dressing, sutureless securement device) and 1 control (standard polyurethane dressing) is planned. There will be a 3-year recruitment of 1708 adult patients, with allocation concealment until randomisation by a centralised web-based service. The primary outcome is PIV failure which includes any of: dislodgement, occlusion/infiltration, phlebitis and infection. Secondary outcomes include: types of PIV failure, PIV dwell time, costs, device colonisation, skin colonisation, patient and staff satisfaction. Relative incidence rates of device failure per 100 devices and per 1000 device days with 95% CIs will summarise the impact of each dressing, and test differences between groups. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare device failure over time. p Values of <0.05 will be considered significant. Secondary end points will be compared between groups using parametric or non-parametric techniques appropriate to level of measurement. Ethics and dissemination Ethical approval has been received from Queensland Health (HREC/11/QRCH/152) and Griffith University (NRS/46/11/HREC). Results will be published according to the CONSORT statement and presented at relevant conferences. Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN); 12611000769987. PMID:26399574

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease. FDA intends to make background material available to the public no later than 2 business...

Sterilization and reprocessing of materials and medical devices--reusability.

PubMed

Jayabalan, M

1995-07-01

Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.

An optical microfluidic platform for spatiotemporal biofilm treatment monitoring

NASA Astrophysics Data System (ADS)

Kim, Young Wook; Mosteller, Matthew P.; Subramanian, Sowmya; Meyer, Mariana T.; Bentley, William E.; Ghodssi, Reza

2016-01-01

Bacterial biofilms constitute in excess of 65% of clinical microbial infections, with the antibiotic treatment of biofilm infections posing a unique challenge due to their high antibiotic tolerance. Recent studies performed in our group have demonstrated that a bioelectric effect featuring low-intensity electric signals combined with antibiotics can significantly improve the efficacy of biofilm treatment. In this work, we demonstrate the bioelectric effect using sub-micron thick planar electrodes in a microfluidic device. This is critical in efforts to develop microsystems for clinical biofilm infection management, including both in vivo and in vitro applications. Adaptation of the method to the microscale, for example, can enable the development of localized biofilm infection treatment using microfabricated medical devices, while augmenting existing capabilities to perform biofilm management beyond the clinical realm. Furthermore, due to scale-down of the system, the voltage requirement for inducing the electric field is reduced further below the media electrolysis threshold. Enhanced biofilm treatment using the bioelectric effect in the developed microfluidic device elicited a 56% greater reduction in viable cell density and 26% further decrease in biomass growth compared to traditional antibiotic therapy. This biofilm treatment efficacy, demonstrated in a micro-scale device and utilizing biocompatible voltage ranges, encourages the use of this method for future clinical biofilm treatment applications.

Combined efficacy of clarithromycin plus cefazolin or vancomycin against Staphylococcus aureus biofilms formed on titanium medical devices.

PubMed

Fujimura, Shigeru; Sato, Tetsuro; Mikami, Takeshi; Kikuchi, Toshiaki; Gomi, Kazunori; Watanabe, Akira

2008-12-01

In this study, we investigated the in vitro efficacy of clarithromycin (CLA) combined with cefazolin (CFZ) or vancomycin (VCM) against Staphylococcus aureus biofilms formed on titanium devices in order to confirm the efficacy of eradication therapies against device-related infection. The distribution of CLA in muscle tissue surrounding bone was also investigated by liquid chromatography/tandem mass spectrometry in 10 orthopaedic patients. Biofilm formation and eradication of S. aureus were monitored by scanning electron microscopy and using double-staining dyes, respectively. Although S. aureus biofilms were not eradicated by CLA, CFZ or VCM alone, CLA combined with CFZ or VCM destroyed biofilms, and S. aureus eradication was clearly observed 72 h later. This in vitro study showed that treatment with CLA plus CFZ or VCM destroyed staphylococcal biofilms formed on medical devices and eradicated S. aureus.

[Comparison of port needle with safety device between Huber Plus (HP) and Poly PERF Safe (PPS)].

PubMed

Shimono, Chigusa; Tanaka, Atsuko; Fujita, Ai; Ishimoto, Miki; Oura, Shoji; Yamaue, Hiroki; Sato, Morio

2010-05-01

An embedded port is frequently used for outpatients with advanced cancer in central venous chemotherapy or hepatic arterial chemoinfusion. The port needle with a safety device in an ambulatory treatment center is indispensable for medical employees and patient plus family to reduce the risk of a needle puncture accident and to prevent iatrogenic infection. The port needle with safety system has been already introduced in our chemotherapy center. There are two types of port needle with safety device; Huber Plus (HP, Medicon Co., Ltd.) and POLY PERF Safe (PPS, Pyolax Device, Co., Ltd.). The comparison of the feasibility between HP and PPS was conducted by both medical employees and patients plus family using an inquiry score method. HP was highly regarded for its stability plus fixation and PPS for its usefulness in puncture and extraction of the needle. PPS was found to be preferable to HP based on the overall evaluation.

The pharmacotherapy implications of ventricular assist device in the patient with end-stage heart failure.

PubMed

Von Ruden, Serena A S; Murray, Margaret A; Grice, Jennifer L; Proebstle, Amy K; Kopacek, Karen J

2012-04-01

Advances in mechanical circulatory support, such as the use of ventricular assist devices (VADs), have become a means for prolonging survival in end-stage heart failure (HF). VADs decrease the symptoms of HF and improve quality of life by replacing some of the work of a failing heart. They unload the ventricle to provide improved cardiac output and end-organ perfusion, resulting in improvement in cardiorenal syndromes and New York Heart Association functional class rating. VADs are currently used asa bridge to heart transplantation, a bridge to recovery of cardiac function, or as destination therapy. Complications of VAD include bleeding, infections, arrhythmias, multiple organ failure, right ventricular failure, and neurological dysfunction. Patients with VAD have unique pharmacotherapeutic requirements in terms of anticoagulation, appropriate antibiotic selection, and continuation of HF medications. Pharmacists in acute care and community settings are well prepared to care for the patient with VAD. These patients require thorough counseling and follow-up with regard to prevention and treatment of infections, appropriate levels of anticoagulation, and maintenance of fluid balance. A basic understanding of this unique therapy can assist pharmacists in attending to the needs of patients with VAD.

Factors associated with suitability of empiric antibiotic therapy in hospitalized patients with bloodstream infections.

PubMed

Grossman, Chagai; Keller, Nathan; Bornstein, Gil; Ben-Zvi, Ilan; Koren-Morag, Nira; Rahav, Galia

2017-06-01

Bacteremia is associated with high morbidity and mortality rates. Initiation of inadequate empiric antibiotic therapy is associated with a worse outcome. The aim of this study was to establish the prevalence and the factors associated with inappropriate empiric antibiotic therapy in patients hospitalized with bacteremia. A cross-sectional study was conducted during January 2010-December 2011 at the medical wards of the Chaim Sheba Medical Center, Israel. The records of all patients with bacteremia were reviewed. Clinical and laboratory characteristics, bacteremic pathogens and antimicrobial agents were retrieved from the medical records. Factors associated with appropriateness of empiric antibiotic therapy were assessed. A total of 681 eligible adults were included in the study. Antibiotic therapy was found to be inappropriate in 138 (20.2%) patients (95% C.I. 17.2-23.2). The rate of appropriateness was not related to the type of antibiotic regimen and the type of bacteria. Patients with healthcare-associated infections were more likely to be administrated inappropriate antibiotic therapy. Patients with primary bloodstream infections were also more likely to be administrated inappropriate antibiotic therapy. Empiric combination therapy was more likely to be appropriate than monotherapy, except for an aminoglycosides-based combination. Combination empiric antibiotic therapy should be considered in patients with healthcare-associated infections and in those with primary bloodstream infections.

Trapezius placement of implanted ports: understanding the procedure.

PubMed

Hill, Steve

Totally implantable vascular access devices (TIVADs) are indicated for intermittent long-term intravenous access. It is widely accepted within medical literature that TIVADs are associated with statistically significant lower infection rates than other central venous access devices. Typical sites for implantation are on the anterior chest wall, using the internal jugular, axillary, cephalic or a subclavian vein. This article follows on from a previous discussion of the benefits of this approach, which illustrated and examined clinical outcomes of trapezius-placement versus anterior chest wall placed ports, for patients with metastatic subcutaneous disease on the anterior chest wall. The procedure provides a unique challenge for the clinician. This article focuses on the process of trapezius port implantation, providing an illustrative guide to understand the procedure. Trapezius port placement is a viable option for patients for whom routine sites are excluded and who require long-term intermittent vascular access.

Microbiology of Explanted Suture Segments from Infected and Noninfected Surgical Patients

PubMed Central

Krepel, Candace J.; Marks, Richard M.; Rossi, Peter J.; Sanger, James; Goldblatt, Matthew; Graham, Mary Beth; Rothenburger, Stephen; Collier, John; Seabrook, Gary R.

2013-01-01

Sutures under selective host/environmental factors can potentiate postoperative surgical site infection (SSI). The present investigation characterized microbial recovery and biofilm formation from explanted absorbable (AB) and nonabsorbable (NAB) sutures from infected and noninfected sites. AB and NAB sutures were harvested from noninfected (70.9%) and infected (29.1%) sites in 158 patients. At explantation, devices were sonicated and processed for qualitative/quantitative bacteriology; selective sutures were processed for scanning electron microscopy (SEM). Bacteria were recovered from 85 (53.8%) explanted sites; 39 sites were noninfected, and 46 were infected. Suture recovery ranged from 11.1 to 574.6 days postinsertion. A significant difference in mean microbial recovery between noninfected (1.2 isolates) and infected (2.7 isolates) devices (P < 0.05) was noted. Staphylococcus epidermidis, Staphylococcus aureus, coagulase-negative staphylococci (CNS), Peptostreptococcus spp., Bacteroides fragilis, Escherichia coli, Enterococcus spp., Pseudomonas aeruginosa, and Serratia spp. were recovered from infected devices, while commensal skin flora was recovered from noninfected devices. No significant difference in quantitative microbial recovery between infected monofilament and multifilament sutures was noted. Biofilm was present in 100% and 66.6% of infected and noninfected devices, respectively (P < 0.042). We conclude that both monofilament and braided sutures provide a hospitable surface for microbial adherence: (i) a significant difference in microbial recovery from infected and noninfected sutures was noted, (ii) infected sutures harbored a mixed flora, including multidrug-resistant health care-associated pathogens, and (iii) a significant difference in the presence or absence of a biofilm in infected versus noninfected explanted devices was noted. Further studies to document the benefit of focused risk reduction strategies to minimize suture contamination and biofilm formation postimplantation are warranted. PMID:23175247

Basic Microbiologic and Infection Control Information to Reduce the Potential Transmission of Pathogens to Patients via Computer Hardware

PubMed Central

Neely, Alice N.; Sittig, Dean F.

2002-01-01

Computer technology from the management of individual patient medical records to the tracking of epidemiologic trends has become an essential part of all aspects of modern medicine. Consequently, computers, including bedside components, point-of-care testing equipment, and handheld computer devices, are increasingly present in patients’ rooms. Recent articles have indicated that computer hardware, just as other medical equipment, may act as a reservoir for microorganisms and contribute to the transfer of pathogens to patients. This article presents basic microbiological concepts relative to infection, reviews the present literature concerning possible links between computer contamination and nosocomial colonizations and infections, discusses basic principles for the control of contamination, and provides guidelines for reducing the risk of transfer of microorganisms to susceptible patient populations. PMID:12223502

Superbugs on Duodenoscopes: the Challenge of Cleaning and Disinfection of Reusable Devices

PubMed Central

McDonnell, Gerald

2015-01-01

Inadequate flexible endoscope reprocessing has been associated with infection outbreaks, most recently caused by carbapenem-resistant Enterobacteriaceae. Lapses in essential device reprocessing steps such as cleaning, disinfection/sterilization, and storage have been reported, but some outbreaks have occurred despite claimed adherence to established guidelines. Recommended changes in these guidelines include the use of sterilization instead of high-level disinfection or the use of routine microbial culturing to monitor efficacy of reprocessing. This review describes the current standards for endoscope reprocessing, associated outbreaks, and the complexities associated with both microbiological culture and sterilization approaches to mitigating the risk of infection associated with endoscopy. PMID:26202125

[Rules and regulations concerning contact lens-related infection].

PubMed

Feys, J

2004-04-01

Contact lens-related infectious keratitis is a potentially sight-threatening complication. Bacterial keratitis, mostly due to Gram-negative bacteria, is associated with poor lens hygiene, overnight wear, and contaminated lens care solutions. Contamination of the lens storage case may cause fungal keratitis. Acanthamoeba infection is related to the use of tap water or swimming while wearing soft lenses. Viruses are of less concern among contact lens wearers. Possible transmission of Creutzfeldt-Jakob disease by multi-patient trial lenses must be taken in account. To minimize these risk factors, regulations are applied at various levels: CE marking of contact lenses and care products as they are medical devices; contact lens fitting only by health care professionals; distribution of contact lenses by opticians and lens care solutions by opticians and pharmacists; hygienic management of trial lenses following official recommendations. Contact lens-related keratitis must be reported to health care Authorities.

Prevention of Device-Related Healthcare-Associated Infections

PubMed Central

Septimus, Edward J.; Moody, Julia

2016-01-01

Healthcare-associated infections (HAIs) are a leading cause of morbidity and mortality in hospitalized patients. Up to 15% of patients develop an infection while hospitalized in the United States, which accounts for approximately 1.7 million HAIs, 99,000 deaths annually and over 10 billion dollars in costs per year. A significant percentage of HAIs are preventable using evidenced-based strategies. In terms of device-related HAIs it is estimated that 65-70% of catheter-line associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) are preventable. To prevent CLABSIs a bundle which includes hand hygiene prior to insertion and catheter manipulation, use of chlorhexidene alcohol for site preparation and maintenance, use of maximum barrier for catheter insertion, site selection, removing nonessential lines, disinfect catheter hubs before assessing line, and dressing changes are essential elements of basic practices. To prevent CAUTIs a bundle that includes hand hygiene for insertion and catheter or bag manipulation, inserting catheters for appropriate indications, insert using aseptic technique, remove catheters when no longer needed, maintain a close system keeping bag and tubing below the bladder are the key components of basic practices. PMID:26918162

Risk factors for colonization and infection by Pseudomonas aeruginosa in patients hospitalized in intensive care units in France.

PubMed

Hoang, S; Georget, A; Asselineau, J; Venier, A-G; Leroyer, C; Rogues, A M; Thiébaut, R

2018-01-01

To assess the role of environment, medical care and individual risks factors for P. aeruginosa colonization and infection. A French multicentric prospective study involved ten ICUs for a five months period. Every adult patient newly hospitalized in ICUs with no P. aeruginosa carriage up to 48 hours after admission was included and weekly screened before discharge or death. Screening swabs were either rectal, sputum or oropharyngeal samples. Hydric environment was also sampled each week. Data on patient clinical features, environmental and device exposures, and antibiotics supports were regularly collected. Multivariate analysis was performed with a multistate model. The overall prevalence of P. aeruginosa carriage was 15.3% (201/1314). Risk factors associated with patient colonization were: use of inactive antibiotics against P. aeruginosa (HR = 1.60 [1.15-2.21] p<0.01), tap water contamination at the entry in the room (HR = 1.66 [1.01-2.27] p<0.05) and mechanical invasive ventilation (HR = 4.70 [2.66-8.31] p<0.0001). Active antibiotics prevented from colonization (HR = 0.67 [0.48-0.93] p = 0.02) and from infection (HR = 0.64 [0.41-1.01] p = 0.05). Interaction between hydric environment antibiotics support was not statistically associated with patient colonization. Hydric contamination and antibiotics pressure seem to remain key independent risk factors in P. aeruginosa colonization. These results advocate the need to carry on preventive and targeted interventions toward healthcare associated infections.

Disease burden and related medical costs of rotavirus infections in Taiwan

PubMed Central

Lu, Chun-Yi; Lauderdale, Tsai-Ling; Fang, Yin-Hua; Wang, Chung-Yi; Ho, Yu-Huai; Hung, Che-Lun; Chang, Luan-Yin; Lee, Chin-Yun; Huang, Li-Min

2006-01-01

Background The disease burden and associated medical costs of rotavirus infections in inpatient and outpatient sectors in Taiwan were examined in anticipation of the availability of new rotavirus vaccines. Methods The yearly national case number and medical costs for all for inpatients and outpatients with acute gastroenteritis (AGE) were extracted from the Bureau of National Health Insurance database in Taiwan according to ICD-9-CM codes. A retrospective study was also performed using records of children with AGE seen at three hospitals in Taiwan in 2001 to identify laboratory confirmed rotavirus infection cases. The annual incidence and related medical costs of AGE due to rotavirus infection were then estimated. Results Children <5 years old comprised 83.6% of inpatient and 62.0% of outpatient pediatric AGE cases in Taiwan in 2001. Rotavirus was the most common agent detected among AGE patients in this age group in the three hospitals, and was detected in 32.9% (221/672) of inpatient and 24% (23/96) of outpatient stool specimens tested for microbial etiologies. An estimated 277,400 to 624,892 cases of rotavirus infections sought medical care in Taiwan in 2001, equaling one in 2 to 5 children <5 years old required medical care due to rotavirus infection. The incidence of hospitalization due to rotavirus infections was 1,528–1,997/100,000 for children <5 years old. The total associated medical costs due to rotavirus infection were estimated at US $10–16 millions in Taiwan in 2001. Although the per-capita medical cost of rotavirus infection was lower in Taiwan than in the United States or Hong Kong, the personal economic burden was similar among the three places when normalized for gross national incomes per capita. Conclusion Infections caused by rotavirus constitute an important human and economic burden among young children in Taiwan. A safe and effective vaccine is urgently needed. PMID:17173677

Nursing Workload as a Risk Factor for Healthcare Associated Infections in ICU: A Prospective Study

PubMed Central

Daud-Gallotti, Renata M.; Costa, Silvia F.; Guimarães, Thais; Padilha, Katia Grillo; Inoue, Evelize Naomi; Vasconcelos, Tiago Nery; da Silva Cunha Rodrigues, Fernanda; Barbosa, Edizângela Vasconcelos; Figueiredo, Walquíria Barcelos; Levin, Anna S.

2012-01-01

Introduction Nurse understaffing is frequently hypothesized as a potential risk factor for healthcare-associated infections (HAI). This study aimed to evaluate the role of nursing workload in the occurrence of HAI, using Nursing Activities Score (NAS). Methods This prospective cohort study enrolled all patients admitted to 3 Medical ICUs and one step-down unit during 3 months (2009). Patients were followed-up until HAI, discharge or death. Information was obtained from direct daily observation of medical and nursing rounds, chart review and monitoring of laboratory system. Nursing workload was determined using NAS. Non-compliance to the nurses’ patient care plans (NPC) was identified. Demographic data, clinical severity, invasive procedures, hospital interventions, and the occurrence of other adverse events were also recorded. Patients who developed HAI were compared with those who did not. Results 195 patients were included and 43 (22%) developed HAI: 16 pneumonia, 12 urinary-tract, 8 bloodstream, 2 surgical site, 2 other respiratory infections and 3 other. Average NAS and average proportion of non compliance with NPC were significantly higher in HAI patients. They were also more likely to suffer other adverse events. Only excessive nursing workload (OR: 11.41; p: 0.019) and severity of patient’s clinical condition (OR: 1.13; p: 0.015) remained as risk factors to HAI. Conclusions Excessive nursing workload was the main risk factor for HAI, when evaluated together with other invasive devices except mechanical ventilation. To our knowledge, this study is the first to evaluate prospectively the nursing workload as a potential risk factor for HAI, using NAS. PMID:23300645

Improving the work efficiency of healthcare-associated infection surveillance using electronic medical records.

PubMed

Lo, Yu-Sheng; Lee, Wen-Sen; Chen, Guo-Bin; Liu, Chien-Tsai

2014-11-01

In this study, we developed an integrated hospital-associated urinary tract infection (HAUTI) surveillance information system (called iHAUTISIS) based on existing electronic medical records (EMR) systems for improving the work efficiency of infection control professionals (ICPs) in a 730-bed, tertiary-care teaching hospital in Taiwan. The iHAUTISIS can automatically collect data relevant to HAUTI surveillance from the different EMR systems, and provides a visualization dashboard that helps ICPs make better surveillance plans and facilitates their surveillance work. In order to measure the system performance, we also created a generic model for comparing the ICPs' work efficiency when using existing electronic culture-based surveillance information system (eCBSIS) and iHAUTISIS, respectively. This model can demonstrate a patient's state (unsuspected, suspected, and confirmed) and corresponding time spent on surveillance tasks performed by ICPs for the patient in that state. The study results showed that the iHAUTISIS performed better than the eCBSIS in terms of ICPs' time cost. It reduced the time by 73.27 s, when using iHAUTISIS (114.26 s) and eCBSIS (187.53 s), for each patient on average. With increased adoption of EMR systems, the development of the integrated HAI surveillance information systems would be more and more cost-effective. Moreover, the iHAUTISIS adopted web-based technology that enables ICPs to online access patient's surveillance information using laptops or mobile devices. Therefore, our system can further facilitate the HAI surveillance and reduce ICPs' surveillance workloads. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Use of electronic monitoring in clinical nursing research.

PubMed

Ailinger, Rita L; Black, Patricia L; Lima-Garcia, Natalie

2008-05-01

In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.

Antimicrobial and osteogenic properties of a hydrophilic-modified nanoscale hydroxyapatite coating on titanium.

PubMed

Murakami, Asuka; Arimoto, Takafumi; Suzuki, Dai; Iwai-Yoshida, Misato; Otsuka, Fukunaga; Shibata, Yo; Igarashi, Takeshi; Kamijo, Ryutaro; Miyazaki, Takashi

2012-04-01

Hydroxyapatite (HA)-coated titanium (Ti) is commonly used for implantable medical devices. This study examined in vitro osteoblast gene expression and antimicrobial activity against early and late colonizers of supra-gingival plaque on nanoscale HA-coated Ti prepared by discharge in a physiological buffered solution. The HA-coated Ti surface showed super-hydrophilicity, whereas the densely sintered HA and Ti surfaces alone showed lower hydrophilicity. The sintered HA and HA-coated Ti surfaces enhanced osteoblast phenotypes in comparison with the bare Ti surface. The HA-coated Ti enabled antimicrobial activity against early colonizers of supra-gingival plaques, namely Streptococcus mitis and Streptococcus gordonii. Such antimicrobial activity may be caused by the surface hydrophilicity, thereby leading to a repulsion force between the HA-coated Ti surface and the bacterial cell membranes. On the contrary, the sintered HA sample was susceptible to infection of microorganisms. Thus, hydrophilic-modified HA-coated Ti may have potential for use in implantable medical devices. From the Clinical Editor: This study establishes that Hydroxyapatite (HA)-coated titanium (Ti) surface of implanted devices may result in an optimal microenvironment to control and prevent infections and may have potential future clinical applications. Copyright © 2012 Elsevier Inc. All rights reserved.

Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE).

PubMed

Sandoe, Jonathan A T; Barlow, Gavin; Chambers, John B; Gammage, Michael; Guleri, Achyut; Howard, Philip; Olson, Ewan; Perry, John D; Prendergast, Bernard D; Spry, Michael J; Steeds, Richard P; Tayebjee, Muzahir H; Watkin, Richard

2015-02-01

Infections related to implantable cardiac electronic devices (ICEDs), including pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices, are increasing in incidence in the USA and are likely to increase in the UK, because more devices are being implanted. These devices have both intravascular and extravascular components and infection can involve the generator, device leads and native cardiac structures or various combinations. ICED infections can be life-threatening, particularly when associated with endocardial infection, and all-cause mortality of up to 35% has been reported. Like infective endocarditis, ICED infections can be difficult to diagnose and manage. This guideline aims to (i) improve the quality of care provided to patients with ICEDs, (ii) provide an educational resource for all relevant healthcare professionals, (iii) encourage a multidisciplinary approach to ICED infection management, (iv) promote a standardized approach to the diagnosis, management, surveillance and prevention of ICED infection through pragmatic evidence-rated recommendations, and (v) advise on future research projects/audit. The guideline is intended to assist in the clinical care of patients with suspected or confirmed ICED infection in the UK, to inform local infection prevention and treatment policies and guidelines and to be used in the development of educational and training material by the relevant professional societies. The questions covered by the guideline are presented at the beginning of each section. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Evaluating a medical error taxonomy.

PubMed

Brixey, Juliana; Johnson, Todd R; Zhang, Jiajie

2002-01-01

Healthcare has been slow in using human factors principles to reduce medical errors. The Center for Devices and Radiological Health (CDRH) recognizes that a lack of attention to human factors during product development may lead to errors that have the potential for patient injury, or even death. In response to the need for reducing medication errors, the National Coordinating Council for Medication Errors Reporting and Prevention (NCC MERP) released the NCC MERP taxonomy that provides a standard language for reporting medication errors. This project maps the NCC MERP taxonomy of medication error to MedWatch medical errors involving infusion pumps. Of particular interest are human factors associated with medical device errors. The NCC MERP taxonomy of medication errors is limited in mapping information from MEDWATCH because of the focus on the medical device and the format of reporting.

iPads, droids, and bugs: Infection prevention for mobile handheld devices at the point of care.

PubMed

Manning, Mary Lou; Davis, James; Sparnon, Erin; Ballard, Raylene M

2013-11-01

Health care providers are increasingly using wireless media tablets, such as the Apple iPad, especially in the hospital setting. In the absence of specific tablet disinfection guidelines the authors applied what is known about the contamination of other nonmedical mobile communication devices to create a "common sense" bundle to guide wireless media tablet infection prevention practices. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Medical consequences of drug abuse and co-occurring infections: research at the National Institute on Drug Abuse.

PubMed

Khalsa, Jag H; Treisman, Glenn; McCance-Katz, Elinore; Tedaldi, Ellen

2008-01-01

Substance abuse still remains one of the major problems in the world today, with millions of people abusing legal and illegal drugs. In addition, a billion people may also be infected with one or more infections. Both drugs of abuse and infections are associated with enormous burden of social, economic, and health consequences. This article briefly discusses a few medical consequences of drugs of abuse and infections such as human immunodeficiency virus, hepatitis C virus, psychiatric complications in hepatitis C infection, pharmacokinetic drug-drug interactions among medications used in the treatment of addiction and infections, and new drugs in development for the treatment of infections. Research is encouraged to study interactions between infections, drugs of abuse, and underlying pathophysiologic and molecular/genetic mechanisms of these interactions.

[Gas analyzer "HelicoSense" as a new device for diagnosis of the Helicobacter infection].

PubMed

Kozlov, A V; Evstratova, Iu S; Novikova, V P; Tkachenko, E I; Khochinskaia, O Iu

2006-01-01

According to recommendations of the European Health Committee, noninvasive methods should be preferred for diagnosis of Helicobacter pylori (HP) infection in children. Equipment and reagents for respiration diagnostic tests available from foreign manufacturers have rather high cost, which hinders their use in domestic medical institutions. A new noninvasive electrochemical technique for HP detection is based on the use of HelicoSense gas analyzer. 150 patients (100 children 6-17 years old and 50 adults 18-78 years old) participated in mulicenter testing of the developed technique. Chronic gastritis was previously diagnosed by endoscopic and morphological examination in all patients. HP status was studied using bacteriological, serological, and cytological methods, as well as the Helpil test. The obtained results were compared to the results of examination with HelicoSense gas analyzer. Our study showed that HelicoSense gas analyzer provides easy use, patient's safety, and possibility of rapid testing. Its application does not require specially trained medical personnel. The device provides high specificity (86.7%) and high sensitivity (93.7%).

[Hygiene in otorhinolaryngology: Requirements and reality].

PubMed

Jager, E; Heudorf, U

2015-12-01

Considering the physiological contamination of skin and mucous membranes in the ear, nose, and throat region by facultative pathogen microorganisms, as well as the increase in multidrug resistant organisms (MDRO), it is mandatory that hygienic procedures be observed in ENT institutions, in order to prevent transmission of bacteria and infections in patients. General guidelines for hygiene in otorhinolaryngology are presented based on the recommendations published by the German Commission on Hospital Hygiene and Infection Prevention (KRINKO). These encompass hand hygiene, surface disinfection, and reprocessing of medical devices. The correct reprocessing of the various components of ENT treatment units (including endoscopes, water bearing systems) is reported. Although law requires and KRINKO recommends that manufacturers of medical devices publish instructions for reprocessing their products, these reprocessing recommendations are often insufficient. Manufacturers should thus be called upon to improve their recommendations. In this paper, the requirements for handling of ENT treatment units are compared with the observations made by the Public Health Department in 7 ENT clinics and 32 ENT practices in Frankfurt/Main, Germany, in 2014.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

PubMed

Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

2016-06-27

Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

The importance of inhaler devices: the choice of inhaler device may lead to suboptimal adherence in COPD patients.

PubMed

Darbà, Josep; Ramírez, Gabriela; Sicras, Antoni; Francoli, Pablo; Torvinen, Saku; Sánchez-de la Rosa, Rainel

2015-01-01

This study aims to identify factors associated with poor adherence to COPD treatment in patients receiving a fixed-dose combination (FDC) of inhaled corticosteroids and long-acting β2-agonist (ICS/LABA), focusing on the importance of inhaler devices. We conducted a retrospective and multicenter study based on a review of medical registries between 2007 and 2012 of COPD patients (n=1,263) treated with ICS/LABA FDC, whose medical devices were either dry powder inhalers (DPIs) or pressurized metered-dose inhalers (pMDI). Medication adherence included persistence outcomes through 18 months and medication possession ratios. Data on exacerbations, comorbidities, demographic characteristics, and health care resource utilization were also included as confounders of adherence. The analyses revealed that COPD patients whose medication was delivered through a DPI were less likely to have medication adherence compared to patients with pMDI, after adjusting for confounding factors, especially active ingredients. Younger groups of patients were less likely to be adherent compared to the oldest group. Smoker men were less likely to be adherent compared to women and non-smokers. Comorbidities decreased the probability of treatment adherence. Those patients that visited their doctor once a month were more likely to adhere to their medication regimen; however, suboptimal adherence was more likely to occur among those patients who visited more than three times per month their doctor. We also found that worsening of COPD is negatively associated with adherence. According to this study, inhaler devices influence patients' adherence to long-term COPD medication. We also found that DPIs delivering ICS/LABA FDC had a negative impact on adherence. Patients' clinic and socioeconomic characteristics were associated with adherence.

Do methicillin resistant staphylococcus (MRSA) carrier patients influence MRSA infection more than MRSA-carrier medical officers and MRSA-carrier family?

PubMed

Dilogo, Ismail H; Arya, Abikara; Phedy; Loho, Tony

2013-07-01

to determine the rate of MRSA-carrier among patients, family members and health care providers, and the association between MRSA-carrier family members and health care providers on MRSA infection patient after orthopaedic surgery. this is a cross-sectional analytical study. Samples were taken consecutively during December 2010 to December 2011, consisting of postoperative patients infected with MRSA, attending family members, and the medical officers with history of contact with the patient. Swab culture were taken from nasal and axilla of all subjects. The incidence of MRSA infection, and MRSA-carrier on the patient, family members and medical officers were presented descriptively, while their association with MRSA infection was statistically tested using Fischer exact test. during the study period, there were 759 surgeries, with 4 (0.5%) patients were identified to have MRSA infection. Of these four cases, 48 subjects were enrolled. The rate of MRSA-carrier among patients, family and health care providers were 50%, 25% and 0% respectively. There were no significant association between MRSA and the rates of MRSA-carrier on the family member or health care providers. the incidence of MRSA infection, MRSA-carrier patient, MRSA-carrier health care providers, and family member carrier were 0.5%, 50%, 0%, and 25% respectively. No significant association found between MRSA-carrier on the family member or health care providers and MRSA infection patient. There were no MRSA infection found on the health care provider.

Sensory Overload and Technology in Critical Care.

PubMed

Wung, Shu-Fen; Malone, Daniel C; Szalacha, Laura

2018-06-01

In this focus group study, we identified issues associated with sensory overload from medical technology alarms/alerts for intensive care unit nurses. Participants indicated that alarms from cardiopulmonary monitors, ventilators, and intravenous pumps contributed the most to sensory overload and, yet, these alarms were also deemed the most helpful. Alerts/alarms from electronic health records and medication dispensing systems were rated low in contributing to sensory overload, as well as being the least helpful. Specific device/technology barriers, related to device alerts/alarms, are detailed. Future user-centered and integrated improvements in alarm systems associated with medical devices in the intensive care unit are needed. Copyright © 2018 Elsevier Inc. All rights reserved.

Fiber-optic Fourier transform infrared spectroscopy for remote label-free sensing of medical device surface contamination.

PubMed

Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko

2013-05-01

As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ≤0.0025% (≤4 × 10(11) molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.

Fiber-optic Fourier transform infrared spectroscopy for remote label-free sensing of medical device surface contamination

NASA Astrophysics Data System (ADS)

Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko

2013-05-01

As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ≤0.0025% (≤4 × 1011 molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.

An effective intervention to improve the cleanliness of medical lead clothes in an orthopedic specialized hospital.

PubMed

Chen, Lu; Xu, YingJun; Zhang, Fengxia; Yang, Qingfeng; Yuan, Juxiang

2016-11-01

Dirty medical lead clothes, contaminated with blood or other infected material, may carry ongoing bioburden, which increase the risk of hospital-acquired infection. In this study, we investigated medical lead clothes contamination levels and assessed the effectiveness of the intervention that was constructed to improve the cleanliness of lead clothes. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit

PubMed Central

Li, Xixi; He, Mei; Wang, Haiyan

2017-01-01

Abstract In this study, failure mode and effect analysis (FMEA), a proactive tool, was applied to reduce errors associated with the process which begins with assessment of patient and ends with treatment of complications. The aim of this study is to assess whether FMEA implementation will significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in intensive care unit. The FMEA team was constructed. A team of 15 medical staff from different departments were recruited and trained. Their main responsibility was to analyze and score all possible processes of central venous catheterization failures. Failure modes with risk priority number (RPN) ≥100 (top 10 RPN scores) were deemed as high-priority-risks, meaning that they needed immediate corrective action. After modifications were put, the resulting RPN was compared with the previous one. A centralized nursing care system was designed. A total of 25 failure modes were identified. High-priority risks were “Unqualified medical device sterilization” (RPN, 337), “leukopenia, very low immunity” (RPN, 222), and “Poor hand hygiene Basic diseases” (RPN, 160). The corrective measures that we took allowed a decrease in the RPNs, especially for the high-priority risks. The maximum reduction was approximately 80%, as observed for the failure mode “Not creating the maximal barrier for patient.” The averaged incidence of CRBSIs was reduced from 5.19% to 1.45%, with 3 months of 0 infection rate. The FMEA can effectively reduce incidence of CRBSIs, improve the security of central venous catheterization technology, decrease overall medical expenses, and improve nursing quality. PMID:29390515

Comparison of human papillomavirus infection and cervical cytology in women using copper-containing and levonorgestrel-containing intrauterine devices.

PubMed

Lekovich, Jovana P; Amrane, Selma; Pangasa, Misha; Pereira, Nigel; Frey, Melissa K; Varrey, Aneesha; Holcomb, Kevin

2015-05-01

To investigate whether there is a difference in cervical cytology and high-risk human papillomavirus (HPV) infection clearance between levonorgestrel- and copper-containing intrauterine device (IUD) users. The electronic medical record system was searched by the appropriate procedural code for IUD insertion for all patients undergoing IUD placement during the study period (January 31, 2005 to January 31, 2012). Patients who received treatment for cervical dysplasia, had their IUDs removed, or conceived during the study period were excluded. High-risk HPV and cervical cytology results immediately preceding and after IUD placement were obtained. One hundred fifty patients had a copper-containing and 152 patients a levonorgestrel-containing IUD placed. The groups were comparable in terms of age, body mass index, duration of follow-up, and percentage of smokers. Sixty-six patients were high-risk HPV-positive before IUD insertion (30 in copper compared with 36 in the levonorgestrel IUD group, P=.4), and the groups had similar follow-up times (364.1±26.3 compared with 357.2±29.7 days, respectively, between the IUD placement and a repeat Pap test with high-risk HPV cotesting, P=.2). Of those, 21 (70%; 95% confidence interval [CI] 53.6-86.4%) cleared the infection after copper-containing IUD placement compared with 15 (42%; 95% CI 25.6-57.8%) in the levonorgestrel group (P=.04). There were only two (1.7%) new high-risk HPV infections in the copper compared with eight (6.9%) in the levonorgestrel group (P=.056). Our data suggest that levonorgestrel-containing IUD could be associated with decreased high-risk HPV infection clearance and possibly increased acquisition compared with the copper-containing IUD. II.

Sustained prevention of biofilm formation on a novel silicone matrix suitable for medical devices.

PubMed

Steffensen, Søren Langer; Vestergaard, Merete Hedemark; Groenning, Minna; Alm, Martin; Franzyk, Henrik; Nielsen, Hanne Mørck

2015-08-01

Bacterial colonization and biofilm formation on medical devices constitute major challenges in clinical long-term use of e.g. catheters due to the risk of (re)infection of patients, which would result in additional use of antibiotics risking bacterial resistance development. The aim of the present project was to introduce a novel antibacterial approach involving an advanced composite material applicable for medical devices. The polymeric composites investigated consisted of a hydrogel network of cross-linked poly(2-hydroxyethyl methacrylate) (PHEMA) embedded in a poly(dimethylsiloxane) (PDMS) silicone elastomer produced using supercritical carbon dioxide (scCO2). In these materials, the hydrogel may contain an active pharmaceutical ingredient while the silicone elastomer provides the sufficient mechanical stability of the material. In these conceptual studies, the antimicrobial agent ciprofloxacin was loaded into the polymer matrix by a post-polymerization loading procedure. Sustained release of ciprofloxacin was demonstrated, and the release could be controlled by varying the hydrogel content in the range 13-38% (w/w) and by changing the concentration of ciprofloxacin during loading in the range of 1-20mg/mL. Devices containing 25% (w/w) hydrogel and loaded with ciprofloxacin displayed a strong antibacterial effect against Staphylococcus aureus bacterial colonization and subsequent biofilm formation on the device material was inhibited for 29days. In conclusion, the hydrogel/silicone composite represents a promising candidate material for medical devices that prevent bacterial colonization during long-term use. Copyright © 2015 Elsevier B.V. All rights reserved.

Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

PubMed

Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

2017-06-01

Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device.

PubMed

Kim, Hosan; Park, Soon; Housler, Greggory; Marcel, Vanessa; Cross, Sue; Izadjoo, Mina

2016-05-01

Novel approaches including nonpharmacological methodologies for prevention and control of microbial pathogens and emerging antibiotic resistance are urgently needed. Procellera is a wound care device consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots held in position on a polyester substrate with a biocompatible binder. This electroceutical medical device is capable of generating a direct current voltage (0.5-0.9 Volts). Wound dressings containing metals such as Ag and/or Zn as active ingredients are being used for control of colonized and infected wounds. Reports on the presence of electric potential field across epithelium and wound current on wounding have shown that wound healing is enhanced in the presence of an external electrical field. However, majority of the electrical devices require an external power source for delivering pulsed or continuous electric power at the wound site. A microelectric potential-generating system without an external power source is an ideal treatment modality for application in both clinical and field settings. The research presented herein describes efficacy evaluation of a wireless bioelectric dressing against both planktonic and biofilm forms of wound pathogens including multidrug resistant organisms. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Superbugs on Duodenoscopes: the Challenge of Cleaning and Disinfection of Reusable Devices.

PubMed

Humphries, Romney M; McDonnell, Gerald

2015-10-01

Inadequate flexible endoscope reprocessing has been associated with infection outbreaks, most recently caused by carbapenem-resistant Enterobacteriaceae. Lapses in essential device reprocessing steps such as cleaning, disinfection/sterilization, and storage have been reported, but some outbreaks have occurred despite claimed adherence to established guidelines. Recommended changes in these guidelines include the use of sterilization instead of high-level disinfection or the use of routine microbial culturing to monitor efficacy of reprocessing. This review describes the current standards for endoscope reprocessing, associated outbreaks, and the complexities associated with both microbiological culture and sterilization approaches to mitigating the risk of infection associated with endoscopy. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Device-related infections in critically ill patients. Part II: Prevention of ventilator-associated pneumonia and urinary tract infections.

PubMed

Di Filippo, A; De Gaudio, A R

2003-12-01

Device utilization in critically ill patients is responsible for a high risk of complications such as catheter-related bloodstream infections (CRBSI), ventilator-associated pneumonia (VAP) and urinary tract infections (UTI). In this article we will review the current status of data regarding the prevention of VAP and UTI. The results of the more recent (5 years) randomized controlled trials are reviewed and discussed. General recommendations include staff education and use of a surveillance program with a restrictive antibiotic policy. Adequate time must be allowed for hand washing and barrier precautions must always be used during device manipulation. Specific measures for VAP prevention are: 1) use of multi-use, closed-system suction catheters; 2) no routine change of the breathing circuit; 3) lubrication of the cuff of the endotracheal tube (ET) with a water-soluble gel; 4) maintenance of patient in semi-recumbent position to improve chest physiotherapy in intubated patients. Specific measures for UTI prevention include: 1) use of a catheter-valve instead of a standard drainage system; 2) use of a silver-alloy, hydro gel-coated latex urinary catheter instead of uncoated catheters. Biofilm represents a new variable: the capacity of bacteria to organize a biofilm on a device surface can explain the difficulty in preventing and eradicating an infection in a critically ill patient. More clinical trials are needed to verify the efficacy of prevention measures of ICU infections.

Review of mobile communication devices as potential reservoirs of nosocomial pathogens.

PubMed

Brady, R R W; Verran, J; Damani, N N; Gibb, A P

2009-04-01

Innovation in mobile communication technology has provided novel approaches to the delivery of healthcare and improvements in the speed and quality of routine medical communication. Bacterial contamination of mobile communication devices (MCDs) could be an important issue affecting the implementation of effective infection control measures and might have an impact on efforts to reduce cross-contamination. This review examines recent studies reporting bacterial contamination of MCDs, most demonstrating that 9-25% of MCDs are contaminated with pathogenic bacteria. We examine previously investigated risk factors for MCD contamination in addition to work on surface decontamination of the device. Recommendations to reduce contamination risks include staff education, strict hand hygiene measures, guidelines on device cleaning and consideration of the restrictions regarding use of mobile phone technology in certain high risk areas, for example, operating theatres, intensive care units and burns units. Further work is required to evaluate the benefit of such interventions on MCD contamination and to determine whether a link exists between contamination and subsequent patient infection.

Effects of polysaccharide intercellular adhesin (PIA) in an ex vivo model of whole blood killing and in prosthetic joint infection (PJI): A role for C5a.

PubMed

Al-Ishaq, Rand; Armstrong, Jayne; Gregory, Martin; O'Hara, Miriam; Phiri, Kudzai; Harris, Llinos G; Rohde, Holger; Siemssen, Nicolaus; Frommelt, Lars; Mack, Dietrich; Wilkinson, Thomas S

2015-12-01

A major complication of using medical devices is the development of biofilm-associated infection caused by Staphylococcus epidermidis where polysaccharide intercellular adhesin (PIA) is a major mechanism of biofilm accumulation. PIA affects innate and humoral immunity in isolated cells and animal models. Few studies have examined these effects in prosthetic joint infection (PJI). This study used ex vivo whole blood modelling in controls together with matched-serum and staphylococcal isolates from patients with PJI. Whole blood killing of PIA positive S. epidermidis and its isogenic negative mutant was identical. Differences were unmasked in immunosuppressed whole blood pre-treated with dexamethasone where PIA positive bacteria showed a more resistant phenotype. PIA expression was identified in three unique patterns associated with bacteria and leukocytes, implicating a soluble form of PIA. Purified PIA reduced whole blood killing while increasing C5a levels. In clinically relevant staphylococcal isolates and serum samples from PJI patients; firstly complement C5a was increased 3-fold compared to controls; secondly, the C5a levels were significantly higher in serum from PJI patients whose isolates preferentially formed PIA-associated biofilms. These data demonstrate for the first time that the biological effects of PIA are mediated through C5a in patients with PJI. Copyright © 2015 Elsevier GmbH. All rights reserved.

Nano-thick calcium oxide armed titanium: boosts bone cells against methicillin-resistant Staphylococcus aureus

NASA Astrophysics Data System (ADS)

Cao, Huiliang; Qin, Hui; Zhao, Yaochao; Jin, Guodong; Lu, Tao; Meng, Fanhao; Zhang, Xianlong; Liu, Xuanyong

2016-02-01

Since the use of systemic antibiotics for preventing acute biomaterial-associated infections (BAIs) may build up bacterial resistance and result in huge medical costs and unpredictable mortality, new precaution strategies are required. Here, it demonstrated that titanium armed with a nano-thick calcium oxide layer was effective on averting methicillin-resistant Staphylococcus aureus (MRSA) infections in rabbits. The calcium oxide layer was constructed by, firstly, injecting of metallic calcium into titanium via a plasma immersion ion implantation process, and then transforming the outer most surface into oxide by exposing to the atmosphere. Although the calcium oxide armed titanium had a relative low reduction rate (~74%) in growth of MRSA in vitro, it could markedly promote the osteogenic differentiation of bone marrow stem cells (BMSCs), restore local bone integration against the challenge of MRSA, and decrease the incidence of MRSA infection with a rate of 100% (compared to the titanium control). This study demonstrated for the first time that calcium, as one of the major elements in a human body, could be engineered to avert MRSA infections, which is promising as a safe precaution of disinfection for implantable biomedical devices.

Nano-thick calcium oxide armed titanium: boosts bone cells against methicillin-resistant Staphylococcus aureus

PubMed Central

Cao, Huiliang; Qin, Hui; Zhao, Yaochao; Jin, Guodong; Lu, Tao; Meng, Fanhao; Zhang, Xianlong; Liu, Xuanyong

2016-01-01

Since the use of systemic antibiotics for preventing acute biomaterial-associated infections (BAIs) may build up bacterial resistance and result in huge medical costs and unpredictable mortality, new precaution strategies are required. Here, it demonstrated that titanium armed with a nano-thick calcium oxide layer was effective on averting methicillin-resistant Staphylococcus aureus (MRSA) infections in rabbits. The calcium oxide layer was constructed by, firstly, injecting of metallic calcium into titanium via a plasma immersion ion implantation process, and then transforming the outer most surface into oxide by exposing to the atmosphere. Although the calcium oxide armed titanium had a relative low reduction rate (~74%) in growth of MRSA in vitro, it could markedly promote the osteogenic differentiation of bone marrow stem cells (BMSCs), restore local bone integration against the challenge of MRSA, and decrease the incidence of MRSA infection with a rate of 100% (compared to the titanium control). This study demonstrated for the first time that calcium, as one of the major elements in a human body, could be engineered to avert MRSA infections, which is promising as a safe precaution of disinfection for implantable biomedical devices. PMID:26899567

Nano-thick calcium oxide armed titanium: boosts bone cells against methicillin-resistant Staphylococcus aureus.

PubMed

Cao, Huiliang; Qin, Hui; Zhao, Yaochao; Jin, Guodong; Lu, Tao; Meng, Fanhao; Zhang, Xianlong; Liu, Xuanyong

2016-02-22

Since the use of systemic antibiotics for preventing acute biomaterial-associated infections (BAIs) may build up bacterial resistance and result in huge medical costs and unpredictable mortality, new precaution strategies are required. Here, it demonstrated that titanium armed with a nano-thick calcium oxide layer was effective on averting methicillin-resistant Staphylococcus aureus (MRSA) infections in rabbits. The calcium oxide layer was constructed by, firstly, injecting of metallic calcium into titanium via a plasma immersion ion implantation process, and then transforming the outer most surface into oxide by exposing to the atmosphere. Although the calcium oxide armed titanium had a relative low reduction rate (~74%) in growth of MRSA in vitro, it could markedly promote the osteogenic differentiation of bone marrow stem cells (BMSCs), restore local bone integration against the challenge of MRSA, and decrease the incidence of MRSA infection with a rate of 100% (compared to the titanium control). This study demonstrated for the first time that calcium, as one of the major elements in a human body, could be engineered to avert MRSA infections, which is promising as a safe precaution of disinfection for implantable biomedical devices.

The hydrophilic-coated inflatable penile prosthesis: 1-year experience.

PubMed

Wolter, Christopher E; Hellstrom, Wayne J G

2004-09-01

Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices, and available on the internet. The infection rate for the coated Titan IPP was 1.06% (25/2,357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed in intraoperatively gives the implanting surgeon distinct advantages with this new product.

Effectiveness of ultraviolet devices and hydrogen peroxide systems for terminal room decontamination: Focus on clinical trials.

PubMed

Weber, David J; Rutala, William A; Anderson, Deverick J; Chen, Luke F; Sickbert-Bennett, Emily E; Boyce, John M

2016-05-02

Over the last decade, substantial scientific evidence has accumulated that indicates contamination of environmental surfaces in hospital rooms plays an important role in the transmission of key health care-associated pathogens (eg, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, Clostridium difficile, Acinetobacter spp). For example, a patient admitted to a room previously occupied by a patient colonized or infected with one of these pathogens has a higher risk for acquiring one of these pathogens than a patient admitted to a room whose previous occupant was not colonized or infected. This risk is not surprising because multiple studies have demonstrated that surfaces in hospital rooms are poorly cleaned during terminal cleaning. To reduce surface contamination after terminal cleaning, no touch methods of room disinfection have been developed. This article will review the no touch methods, ultraviolet light devices, and hydrogen peroxide systems, with a focus on clinical trials which have used patient colonization or infection as an outcome. Multiple studies have demonstrated that ultraviolet light devices and hydrogen peroxide systems have been shown to inactivate microbes experimentally plated on carrier materials and placed in hospital rooms and to decontaminate surfaces in hospital rooms naturally contaminated with multidrug-resistant pathogens. A growing number of clinical studies have demonstrated that ultraviolet devices and hydrogen peroxide systems when used for terminal disinfection can reduce colonization or health care-associated infections in patients admitted to these hospital rooms. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Percutaneous Lead Extraction in Infection of Cardiac Implantable Electronic Devices: a Systematic Review

PubMed Central

Menezes Júnior, Antônio da Silva; Magalhães, Thaís Rodrigues; Morais, Alana de Oliveira Alarcão

2018-01-01

Introduction In the last two decades, the increased number of implants of cardiac implantable electronic devices has been accompanied by an increase in complications, especially infection. Current recommendations for the appropriate treatment of cardiac implantable electronic devices-related infections consist of prolonged antibiotic therapy associated with complete device extraction. The purpose of this study was to analyze the importance of percutaneous extraction in the treatment of these devices infections. Methods A systematic review search was performed in the PubMed, BVS, Cochrane CENTRAL, CAPES, SciELO and ScienceDirect databases. A total of 1,717 studies were identified and subsequently selected according to the eligibility criteria defined by relevance tests by two authors working independently. Results Sixteen studies, describing a total of 3,354 patients, were selected. Percutaneous extraction was performed in 3,081 patients. The average success rate for the complete percutaneous removal of infected devices was 92.4%. Regarding the procedure, the incidence of major complications was 2.9%, and the incidence of minor complications was 8.4%. The average in-hospital mortality of the patients was 5.4%, and the mortality related to the procedure ranged from 0.4 to 3.6%. The mean mortality was 20% after 6 months and 14% after a one-year follow-up. Conclusion Percutaneous extraction is the main technique for the removal of infected cardiac implantable electronic devices, and it presents low rates of complications and mortality related to the procedure.

Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United States.

PubMed

Perkins, Kiran M; Lawsin, Adrian; Hasan, Nabeeh A; Strong, Michael; Halpin, Alison L; Rodger, Rachael R; Moulton-Meissner, Heather; Crist, Matthew B; Schwartz, Suzanne; Marders, Julia; Daley, Charles L; Salfinger, Max; Perz, Joseph F

2016-10-14

In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation (1). In July 2015, a Pennsylvania hospital also identified a cluster of invasive nontuberculous mycobacterial infections among open-heart surgery patients. Similar to the Swiss report, a field investigation by the Pennsylvania Department of Health, with assistance from CDC, used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) (2). M. chimaera was described as a distinct species of M. avium complex in 2004 (3). The results of the field investigation prompted notification of approximately 1,300 potentially exposed patients.* Although heater-cooler devices are used to regulate patients' blood temperature during cardiopulmonary bypass through water circuits that are closed, these reports suggest that aerosolized M. chimaera from the devices resulted in the invasive infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer's instructions for use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports from the United States and overseas (2).

Feasibility results of an electromagnetic compatibility test protocol to evaluate medical devices to radio frequency identification exposure

PubMed Central

2014-01-01

Background The use of radio frequency identification (RFID) systems in healthcare is increasing, and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have demonstrated that RFID systems can interfere with medical devices; however, the majority of past studies relied on time-consuming and burdensome test schemes based on ad hoc test methods applied to individual RFID systems. Methods This paper presents the results of using an RFID simulator that allows for faster evaluation of RFID-medical device EMC against a library of RFID test signals at various field strengths. Results The results of these tests demonstrate the feasibility and adequacy of simulator testing and can be used to support its incorporation into applicable consensus standards. Conclusions This work can aid the medical device community in better assessing the risks associated with medical device exposure to RFID. PMID:25086451

Feasibility results of an electromagnetic compatibility test protocol to evaluate medical devices to radio frequency identification exposure.

PubMed

Seidman, Seth J; Bekdash, Omar; Guag, Joshua; Mehryar, Maryam; Booth, Paul; Frisch, Paul

2014-08-03

The use of radio frequency identification (RFID) systems in healthcare is increasing, and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have demonstrated that RFID systems can interfere with medical devices; however, the majority of past studies relied on time-consuming and burdensome test schemes based on ad hoc test methods applied to individual RFID systems. This paper presents the results of using an RFID simulator that allows for faster evaluation of RFID-medical device EMC against a library of RFID test signals at various field strengths. The results of these tests demonstrate the feasibility and adequacy of simulator testing and can be used to support its incorporation into applicable consensus standards. This work can aid the medical device community in better assessing the risks associated with medical device exposure to RFID.

21 CFR 866.6010 - Tumor-associated antigen immunological test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tumor-associated antigen immunological test system... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Tumor Associated Antigen immunological Test Systems § 866.6010 Tumor-associated antigen immunological test system. (a) Identification. A...

The role of enacted stigma in parental HIV disclosure among HIV-infected parents in China.

PubMed

Qiao, Shan; Li, Xiaoming; Zhou, Yuejiao; Shen, Zhiyong; Tang, Zhenzhu; Stanton, Bonita

2015-01-01

Existing studies have delineated that HIV-infected parents face numerous challenges in disclosing their HIV infection to the children ("parental HIV disclosure"), and practices of parental HIV disclosure vary with individual characteristics, family contexts, and social environment. Using cross-sectional data from 1254 HIV-infected parents who had children aged 5-16 years in southwest China, the current study examined the association of parental HIV disclosure with mental health and medication adherence among parents and explored the possible effect of enacted stigma on such association. Multivariate analysis of variance revealed that parents who had experienced disclosure to children reported higher level enacted stigma, worse mental health conditions, and poorer medication adherence. Enacted stigma partially mediated the associations between disclosure and both mental health and medication adherence after controlling basic background characteristics. Our findings highlight the importance of providing appropriate disclosure-related training and counseling service among HIV-infected parents. In a social setting where HIV-related stigma is still persistent, disclosure intervention should address and reduce stigma and discrimination in the practice of parental HIV disclosure.

Infection prevention and control in pediatric ambulatory settings.

PubMed

2007-09-01

Since the American Academy of Pediatrics published a statement titled "Infection Control in Physicians' Offices" (Pediatrics. 2000;105[6]:1361-1369), there have been significant changes that prompted this updated statement. Infection prevention and control is an integral part of pediatric practice in ambulatory medical settings as well as in hospitals. Infection prevention and control practices should begin at the time the ambulatory visit is scheduled. All health care personnel should be educated regarding the routes of transmission and techniques used to prevent transmission of infectious agents. Policies for infection prevention and control should be written, readily available, updated annually, and enforced. The standard precautions for hospitalized patients from the Centers for Disease Control and Prevention, with a modification from the American Academy of Pediatrics exempting the use of gloves for routine diaper changes and wiping a well child's nose or tears, are appropriate for most patient encounters. As employers, pediatricians are required by the Occupational Safety and Health Administration to take precautions to identify and protect employees who are likely to be exposed to blood or other potentially infectious materials while on the job. Key principles of standard precautions include hand hygiene (ie, use of alcohol-based hand rub or hand-washing with soap [plain or antimicrobial] and water) before and after every patient contact; implementation of respiratory hygiene and cough-etiquette strategies for patients with suspected influenza or infection with another respiratory tract pathogen to the extent feasible; separation of infected, contagious children from uninfected children when feasible; safe handling and disposal of needles and other sharp medical devices and evaluation and implementation of needle-safety devices; appropriate use of personal protective equipment such as gloves, gowns, masks, and eye protection; and appropriate sterilization, disinfection, and antisepsis.

Questions on causality and responsibility arising from an outbreak of Pseudomonas aeruginosa infections in Norway

PubMed Central

Iversen, Bjørn G; Hofmann, Bjørn; Aavitsland, Preben

2008-01-01

In 2002, Norway experienced a large outbreak of Pseudomonas aeruginosa infections in hospitals with 231 confirmed cases. This fuelled intense public and professional debates on what were the causes and who were responsible. In epidemiology, other sciences, in philosophy and in law there is a long tradition of discussing the concept of causality. We use this outbreak as a case; apply various theories of causality from different disciplines to discuss the roles and responsibilities of some of the parties involved. Mackie's concept of INUS conditions, Hill's nine viewpoints to study association for claiming causation, deterministic and probabilistic ways of reasoning, all shed light on the issues of causality in this outbreak. Moreover, applying legal theories of causation (counterfactual reasoning and the "but-for" test and the NESS test) proved especially useful, but the case also illustrated the weaknesses of the various theories of causation. We conclude that many factors contributed to causing the outbreak, but that contamination of a medical device in the production facility was the major necessary condition. The reuse of the medical device in hospitals contributed primarily to the size of the outbreak. The unintended error by its producer – and to a minor extent by the hospital practice – was mainly due to non-application of relevant knowledge and skills, and appears to constitute professional negligence. Due to criminal procedure laws and other factors outside the discourse of causality, no one was criminally charged for the outbreak which caused much suffering and shortening the life of at least 34 people. PMID:18947429

Ventilator-associated nosocomial pneumonia in intensive care units in Malaysia.

PubMed

Gopal Katherason, Supaletchimi; Naing, Lin; Jaalam, Kamarudin; Imran Musa, Kamarul; Nik Mohamad, Nik Abdullah; Aiyar, Subramaniar; Bhojani, Kavita; Harussani, Najah; Abdul Rahman, Aisai; Ismail, Asma

2009-10-22

The outcome indicator of nosocomial infection (NI) in the intensive care unit (ICU) is used to benchmark the quality of patient care in Malaysia. We conducted a three-year prospective study on the incidences of ventilator-associated pneumonia (VAP), risk factors, and patterns of the microorganisms isolated in three ICUs. A follow-up in prospective cohort surveillance was conducted on patients admitted to an adult medical-surgical ICU of a university hospital and two governmental hospitals in Malaysia from October 2003 to December 2006. VAP was detected using CDC criteria which included clinical manifestation and confirmed endotracheal secretion culture results. In total, 215 patients (2,306 patient-days) were enrolled into the study. The incidence of ICU-acquired device-related NI was 29.3 % (n = 63). The device-related VAP infection rate was 27.0 % (n = 58), with a mechanical ventilator utilization rate of 88.7%. The death rate due to all ICU-acquired NI including sepsis was 6.5%. The most common causative pathogen was Klebsiella pneumoniae (n = 27). Multivariate analysis using Cox regression showed that the risk factors identified were aspiration pneumonia (HR = 4.09; 95% CI = 1.24, 13.51; P = 0.021), cancer (HR = 2.51; 95% CI = 1.27, 4.97; P = 0.008), leucocytosis (HR=3.43; 95% CI= 1.60, 7.37; P=0.002) and duration of mechanical ventilation (HR=1.04; 95% CI = 1.00, 1.08; P = 0.030). Age, gender and race were not identified as risk factors in the multivariable analysis performed. The incidence of VAP was comparable to that found in the National Nosocomial Infection Surveillance (NNIS) System report of June 1998. The incidence of VAP was considered high for the three hospitals studied.

Management of Candida biofilms: state of knowledge and new options for prevention and eradication.

PubMed

Bujdáková, Helena

2016-01-01

Biofilms formed by Candida species (spp.) on medical devices represent a potential health risk. The focus of current research is searching for new options for the treatment and prevention of biofilm-associated infections using different approaches including modern nanotechnology. This review summarizes current information concerning the most relevant resistance/tolerance mechanisms to conventional drugs and a role of additional factors contributing to these phenomena in Candida spp. (mostly Candida albicans). Additionally, it provides an information update in prevention and eradication of a Candida biofilm including experiences with 'lock' therapy, potential utilization of small molecules in biomedical applications, and perspectives of using photodynamic inactivation in the control of a Candida biofilm.

Infections and systemic lupus erythematosus

PubMed Central

Skare, Thelma Larocca; Dagostini, Jéssica Scherer; Zanardi, Patricia Imai; Nisihara, Renato Mitsunori

2016-01-01

ABSTRACT Objective To determine the incidence of infections in a population of systemic lupus erythematosus individuals and the characteristics of infections regarding original site, as well as to study the possible associations between infections and treatment. Methods An analytical retrospective study using data from medical charts of systemic lupus erythematosus patients from a single university hospital. A total of 144 patients followed up for five years were included. Data collected comprised age of patients and age at onset of lupus, sex and ethnicity, disease duration before the study period, medications, cumulative dose of prednisone, occurrence of infections and their original site. Results The most frequent infections were urinary tract infections (correlated to use of prednisone − p<0.0001 and cyclophosphamide − p=0.045), upper airways infections (correlated to use of prednisone − p=0.0004, mycophenolate mofetil − p=0.0005, and cyclosporine − p=0.025), and pneumonia (associated to prednisone − p=0.017). Conclusion Prednisone was the drug more often associated with presence of infections, pointing to the need for a more judicious management of this drug. PMID:27074234

Management of complications related to central venous catheters in cancer patients: an update.

PubMed

Linnemann, Birgit

2014-04-01

Central venous catheters (CVCs) are important for the treatment of patients with cancer, especially in the perioperative and palliative care settings. These devices not only allow for the administration of chemotherapy, parenteral nutrition, and other intravenous therapies, but they may also improve the patients' quality of life by reducing the need for repeated peripheral venipunctures. Thrombotic and infectious complications are common, especially in the long-term use of CVCs. There are different types of thrombotic complications associated with CVCs, that is, a thrombotic occlusion of the catheter, a mural thrombus at the catheter tip and classical deep vein thrombosis, which occurs most frequently in the upper extremity where the majority of long-term catheters are inserted. Infections are common complications associated with CVCs. Patients with cancer who receive intensive chemotherapy and those patients who undergo hematopoietic stem cell transplantation have a markedly increased risk for insertion site and bloodstream infections. In this review, the epidemiology and risk factors that predispose patients to CVC-related thrombosis and infection are discussed. The diagnostic and therapeutic options according to the published data and the current guidelines are summarized and data for establishing primary and secondary preventative strategies are provided. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Prospective surveillance of device-associated health care-associated infection in an intensive care unit of a tertiary care hospital in New Delhi, India.

PubMed

Kumar, Shilpee; Sen, Poornima; Gaind, Rajni; Verma, Pardeep Kumar; Gupta, Poonam; Suri, Prem Rose; Nagpal, Sunita; Rai, Anil Kumar

2018-02-01

Surveillance of health care-associated infections (HAIs) plays a key role in the hospital infection control program and reduction of HAIs. In India, most of the surveillance of HAIs is reported from private sector hospitals that do not depict the situation of government sector hospitals. Other studies do not confirm with the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN) surveillance criterion, or deal with ventilator-associated pneumonia (VAP) instead of ventilator-associated event (VAE). The aim of this study was to identify the incidences of 3 device-associated HAIs (DA-HAIs) (VAE, central line-associated bloodstream infection [CLABSI], and catheter-associated urinary tract infection [CAUTI]) by active surveillance using CDC's NHSN surveillance criteria and to identify the pathogens associated with these DA-HAIs. This was a prospective surveillance study (January 2015-December 2016) conducted in an intensive care unit (ICU) of a large, tertiary care, government hospital situated in Delhi, India. Targeted surveillance was done as per the CDC's NHSN 2016 surveillance criteria. There were 343 patients admitted to the ICU that were included in the study. The surveillance data was reported over 3,755 patient days. A DA-HAIs attack rate of 20.1 per 100 admissions and incidence of 18.3 per 1,000 patient days was observed. The duration of use for each device for patients with DA-HAIs was significantly longer than for patients without DA-HAIs. The device utilization ratios of central line, ventilator, and urinary catheters were 0.57, 0.85, and 0.72, respectively. The crude excess length of stay for patients with DA-HAI was 13 days, and crude excess mortality rate was 11.8%. VAE, CLABSI, and CAUTI rates were 11.8, 7.4, and 9.7 per 1,000 device days, respectively. Among 69 DA-HAIs reported, pathogens could be identified for 49 DA-HAI cases. Klebsiella spp was the most common organism isolated, accounting 28.5% for all DA-HAI cases, followed by Enterococcus spp (24.4%). The most common organisms causing VAE, CAUTI, and CLABSI were Acinetobacter (6/15, 40%), Enterococcus spp (11/31, 35.4%), and Candida spp (5/19, 26.3%), respectively. Most of the gram-negative organisms were carbapenem resistant; however, none of the isolates were colistin resistant. To reduce the risk of infection in hospitalized patients, DA-HAI surveillance is of primary importance because it effectively describes and addresses the importance and characteristics of the threatening situation created by DA-HAIs. The present surveillance shows high rates of ICU-onset DA-HAIs and high resistance patterns of organisms causing HAIs, representing a major risk to patient safety. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Impact of active screening for methicillin-resistant Staphylococcus aureus (MRSA) and decolonization on MRSA infections, mortality and medical cost: a quasi-experimental study in surgical intensive care unit.

PubMed

Lee, Yuarn-Jang; Chen, Jen-Zon; Lin, Hsiu-Chen; Liu, Hsin-Yi; Lin, Shyr-Yi; Lin, Hsien-Ho; Fang, Chi-Tai; Hsueh, Po-Ren

2015-04-08

Methicillin-resistant Staphylococcus aureus (MRSA) is a leading pathogen of healthcare-associated infections in intensive care units (ICUs). Prior studies have shown that decolonization of MRSA carriers is an effective method to reduce MRSA infections in ICU patients. However, there is currently a lack of data on its effect on mortality and medical cost. Using a quasi-experimental, interrupted time-series design with re-introduction of intervention, we evaluated the impact of active screening and decolonization on MRSA infections, mortality and medical costs in the surgical ICU of a university hospital in Taiwan. Regression models were used to adjust for effects of confounding variables. MRSA infection rate decreased from 3.58 (baseline) to 0.42‰ (intervention period) (P <0.05), re-surged to 2.21‰ (interruption period) and decreased to 0.18‰ (re-introduction of intervention period) (P <0.05). Patients admitted to the surgical ICU during the intervention periods had a lower in-hospital mortality (13.5% (155 out of 1,147) versus 16.6% (203 out of 1,226), P = 0.038). After adjusting for effects of confounding variables, the active screening and decolonization program was independently associated with a decrease in in-hospital MRSA infections (adjusted odds ratio: 0.3; 95% CI: 0.1 to 0.8) and 90-day mortality (adjusted hazard ratio: 0.8; 95% CI: 0.7 to 0.99). Cost analysis showed that $22 medical costs can be saved for every $1 spent on the intervention. Active screening for MRSA and decolonization in ICU settings is associated with a decrease in MRSA infections, mortality and medical cost.

Surgical site infection and timing of prophylactic antibiotics for appendectomy.

PubMed

Wu, Wan-Ting; Tai, Feng-Chuan; Wang, Pa-Chun; Tsai, Ming-Lin

2014-12-01

Pre-operative prophylactic antibiotics may decrease the frequency of surgical site infection after appendectomy. However, the optimal timing for administration of pre-operative prophylactic antibiotics is unknown. The purpose of this study was to evaluate the effect of timing of prophylactic antibiotics on the frequency of surgical site infection after appendectomy. Medical records were reviewed retrospectively for 577 consecutive patients who had appendectomy for acute appendicitis from 2006 to 2009. Quality assurance guidelines for timing of prophylactic antibiotics before the skin incision were changed from 0 to 30 min before the skin incision (before June 2008) to 30 to 60 min before the skin incision (after June 2008). Surgical site infection occurred in 28 patients (4.9%). There was no difference in frequency of surgical site infection with different timing of pre-operative prophylactic antibiotic (pre-operative time 0 to 30 min: 9 infections [3.6%]; 31 to 60 min: 13 infections [5.4%]; 61 to 120 min: 5 infections [7.0%]; >120 min: 1 infection [6.6%]). Multivariable analysis showed that surgical site infection was associated significantly with medical comorbidity but not perforated appendicitis. The frequency of surgical site infection was independent of timing of preoperative prophylactic antibiotics but was associated with the presence of medical comorbidity.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

PubMed Central

Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

2016-01-01

Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

Serratia Infections: from Military Experiments to Current Practice

PubMed Central

Mahlen, Steven D.

2011-01-01

Summary: Serratia species, in particular Serratia marcescens, are significant human pathogens. S. marcescens has a long and interesting taxonomic, medical experimentation, military experimentation, and human clinical infection history. The organisms in this genus, particularly S. marcescens, were long thought to be nonpathogenic. Because S. marcescens was thought to be a nonpathogen and is usually red pigmented, the U.S. military conducted experiments that attempted to ascertain the spread of this organism released over large areas. In the process, members of both the public and the military were exposed to S. marcescens, and this was uncovered by the press in the 1970s, leading to U.S. congressional hearings. S. marcescens was found to be a certain human pathogen by the mid-1960s. S. marcescens and S. liquefaciens have been isolated as causative agents of numerous outbreaks and opportunistic infections, and the association of these organisms with point sources such as medical devices and various solutions given to hospitalized patients is striking. Serratia species appear to be common environmental organisms, and this helps to explain the large number of nosocomial infections due to these bacteria. Since many nosocomial infections are caused by multiply antibiotic-resistant strains of S. marcescens, this increases the danger to hospitalized patients, and hospital personnel should be vigilant in preventing nosocomial outbreaks due to this organism. S. marcescens, and probably other species in the genus, carries several antibiotic resistance determinants and is also capable of acquiring resistance genes. S. marcescens and S. liquefaciens are usually identified well in the clinical laboratory, but the other species are rare enough that laboratory technologists may not recognize them. 16S rRNA gene sequencing may enable better identification of some of the less common Serratia species. PMID:21976608

Serratia infections: from military experiments to current practice.

PubMed

Mahlen, Steven D

2011-10-01

Serratia species, in particular Serratia marcescens, are significant human pathogens. S. marcescens has a long and interesting taxonomic, medical experimentation, military experimentation, and human clinical infection history. The organisms in this genus, particularly S. marcescens, were long thought to be nonpathogenic. Because S. marcescens was thought to be a nonpathogen and is usually red pigmented, the U.S. military conducted experiments that attempted to ascertain the spread of this organism released over large areas. In the process, members of both the public and the military were exposed to S. marcescens, and this was uncovered by the press in the 1970s, leading to U.S. congressional hearings. S. marcescens was found to be a certain human pathogen by the mid-1960s. S. marcescens and S. liquefaciens have been isolated as causative agents of numerous outbreaks and opportunistic infections, and the association of these organisms with point sources such as medical devices and various solutions given to hospitalized patients is striking. Serratia species appear to be common environmental organisms, and this helps to explain the large number of nosocomial infections due to these bacteria. Since many nosocomial infections are caused by multiply antibiotic-resistant strains of S. marcescens, this increases the danger to hospitalized patients, and hospital personnel should be vigilant in preventing nosocomial outbreaks due to this organism. S. marcescens, and probably other species in the genus, carries several antibiotic resistance determinants and is also capable of acquiring resistance genes. S. marcescens and S. liquefaciens are usually identified well in the clinical laboratory, but the other species are rare enough that laboratory technologists may not recognize them. 16S rRNA gene sequencing may enable better identification of some of the less common Serratia species.

Comparative Analysis of Bacterial Community Composition and Structure in Clinically Symptomatic and Asymptomatic Central Venous Catheters

PubMed Central

Stressmann, Franziska A.; Couve-Deacon, Elodie; Chainier, Delphine; Chauhan, Ashwini; Wessel, Aimee; Durand-Fontanier, Sylvaine; Escande, Marie-Christine; Kriegel, Irène; Francois, Bruno; Ploy, Marie-Cécile

2017-01-01

ABSTRACT Totally implanted venous access ports (TIVAPs) are commonly used catheters for the management of acute or chronic pathologies. Although these devices improve health care, repeated use of this type of device for venous access over long periods of time is also associated with risk of colonization and infection by pathogenic bacteria, often originating from skin. However, although the skin microbiota is composed of both pathogenic and nonpathogenic bacteria, the extent and the consequences of TIVAP colonization by nonpathogenic bacteria have rarely been studied. Here, we used culture-dependent and 16S rRNA gene-based culture-independent approaches to identify differences in bacterial colonization of TIVAPs obtained from two French hospitals. To explore the relationships between nonpathogenic organisms colonizing TIVAPs and the potential risk of infection, we analyzed the bacterial community parameters between TIVAPs suspected (symptomatic) or not (asymptomatic) of infection. Although we did not find a particular species assemblage or community marker to distinguish infection risk on an individual sample level, we identified differences in bacterial community composition, diversity, and structure between clinically symptomatic and asymptomatic TIVAPs that could be explored further. This study therefore provides a new view of bacterial communities and colonization patterns in intravascular TIVAPs and suggests that microbial ecology approaches could improve our understanding of device-associated infections and could be a prognostic tool to monitor the evolution of bacterial communities in implants and their potential susceptibility to infections. IMPORTANCE Totally implanted venous access ports (TIVAPs) are commonly used implants for the management of acute or chronic pathologies. Although their use improves the patient’s health care and quality of life, they are associated with a risk of infection and subsequent clinical complications, often leading to implant removal. While all TIVAPs appear to be colonized, only a fraction become infected, and the relationship between nonpathogenic organisms colonizing TIVAPs and the potential risk of infection is unknown. We explored bacteria present on TIVAPs implanted in patients with or without signs of TIVAP infection and identified differences in phylum composition and community structure. Our data suggest that the microbial ecology of intravascular devices could be predictive of TIVAP infection status and that ultimately a microbial ecological signature could be identified as a tool to predict TIVAP infection susceptibility and improve clinical management. PMID:28959736

Prospective study of device-related complications in intensive care unit detected by virtual autopsy.

PubMed

Wichmann, D; Heinemann, A; Zähler, S; Vogel, H; Höpker, W; Püschel, K; Kluge, S

2018-06-01

There has been increasing use of invasive techniques, such as extracorporeal organ support, in intensive care units (ICU), and declining autopsy rates. Thus, new measures are needed to maintain high-quality standards. We investigated the potential of computed tomography (CT)-based virtual autopsy to substitute for medical autopsy in this setting. We investigated the potential of virtual autopsy by post-mortem CT to identify complications associated with medical devices in a prospective study of patients who had died in the ICU. Clinical records were reviewed to determine the number and types of medical devices used, and findings from medical and virtual autopsies, related and unrelated to the medical devices, were compared. Medical and virtual autopsies could be performed in 61 patients (Group M/V), and virtual autopsy only in 101 patients (Group V). In Group M/V, 41 device-related complications and 30 device malpositions were identified, but only with a low inter-method agreement. Major findings unrelated to a device were identified in about 25% of patients with a high level of agreement between methods. In Group V, 8 device complications and 36 device malpositions were identified. Device-related complications are frequent in ICU patients. Virtual and medical autopsies showed clear differences in the detection of complications and device malpositions. Both methods should supplement each other rather than one alone for quality control of medical devices in the ICU. Further studies should focus on the identification of special patient populations in which virtual autopsy might be of particular benefit. NCT01541982. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Infective endocarditis in children: an update.

PubMed

Dixon, Garth; Christov, Georgi

2017-06-01

Infective endocarditis in children remains a clinical challenge. Here, we review the impact of the updated 2015 American Heart Association and European Society of Cardiology guidelines on management as well as the significance of the new predisposing factors, diagnostic and treatment options, and the impact of the 2007-2008 change in prophylaxis recommendations. The new 2015 infective endocarditis guidelines introduced the endocarditis team, added the new imaging modalities of computer tomography and PET-computer tomography into the diagnostic criteria and endorsed the concept of safety of relatively early surgical treatment. The impact of the restriction of infective endocarditis prophylaxis since the 2007-2008 American Heart Association and National Institute for Health and Care Excellence recommendations is uncertain, with some studies showing no change and other more recent studies showing increased incidence. The difficulties in adjusting for varying confounding factors are discussed. The relative proportion of the device-related infective endocarditis is increasing. Special attention is paid to relatively high incidence of percutaneous pulmonary valve implantation-related infective endocarditis with low proportion of positive echo signs, disproportionate shift in causative agents, and unusual complication of acute obstruction. The significance of incomplete neoendothelialization on the risk of infective endocarditis on intracardiac devices is also discussed. The impact of changes in the infective endocarditis prophylaxis recommendations in pediatric patients is still uncertain. The device-related infective endocarditis has increasing importance, with the incidence on transcatheter implanted bovine jugular vein pulmonary valves being relatively high. The use of novel imaging, laboratory diagnostic techniques, and relatively early surgery in particular circumstances is important for management of paediatric infective endocarditis.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

PubMed

Carrasco, Francisco; Anguita, Manuel; Ruiz, Martín; Castillo, Juan Carlos; Delgado, Mónica; Mesa, Dolores; Romo, Elias; Pan, Manuel; Suárez de Lezo, Jose

2016-06-01

Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Methicillin-resistant Staphylococcus aureus and Acinetobacter baumannii on computer interface surfaces of hospital wards and association with clinical isolates.

PubMed

Lu, Po-Liang; Siu, L K; Chen, Tun-Chieh; Ma, Ling; Chiang, Wen-Gin; Chen, Yen-Hsu; Lin, Sheng-Fung; Chen, Tyen-Po

2009-10-01

Computer keyboards and mice are potential reservoirs of nosocomial pathogens, but routine disinfection for non-water-proof computer devices is a problem. With better hand hygiene compliance of health-care workers (HCWs), the impact of these potential sources of contamination on clinical infection needs to be clarified. This study was conducted in a 1600-bed medical center of southern Taiwan with 47 wards and 282 computers. With education and monitoring program of hand hygiene for HCWs, the average compliance rate was 74% before our surveillance. We investigated the association of methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Acinetobacter baumannii, three leading hospital-acquired pathogens, from ward computer keyboards, mice and from clinical isolates in non-outbreak period by pulsed field gel electrophoresis and antibiogram. Our results revealed a 17.4% (49/282) contamination rate of these computer devices by S. aureus, Acinetobacter spp. or Pseudomonas spp. The contamination rates of MRSA and A. baumannii in the ward computers were 1.1% and 4.3%, respectively. No P. aeruginosa was isolated. All isolates from computers and clinical specimens at the same ward showed different pulsotypes. However, A. baumannii isolates on two ward computers had the same pulsotype. With good hand hygiene compliance, we found relatively low contamination rates of MRSA, P. aeruginosa and A. baumannii on ward computer interface, and without further contribution to nosocomial infection. Our results suggested no necessity of routine culture surveillance in non-outbreak situation.

Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term-care facilities--Mississippi, North Carolina, and Los Angeles County, California, 2003-2004.

PubMed

2005-03-11

Regular monitoring of blood glucose levels is an important component of routine diabetes care. Capillary blood is typically sampled with the use of a fingerstick device and tested with a portable glucometer. Because of outbreaks of hepatitis B virus (HBV) infections associated with glucose monitoring, CDC and the Food and Drug Administration (FDA) have recommended since 1990 that fingerstick devices be restricted to individual use. This report describes three recent outbreaks of HBV infection among residents in long-term-care (LTC) facilities that were attributed to shared devices and other breaks in infection-control practices related to blood glucose monitoring. Findings from these investigations and previous reports suggest that recommendations concerning standard precautions and the reuse of fingerstick devices have not been adhered to or enforced consistently in LTC settings. The findings underscore the need for education, training, adherence to standard precautions, and specific infection-control recommendations targeting diabetes-care procedures in LTC settings.

'Real-time' burden of community and healthcare-related infections in medical and rehabilitation patients in a public hospital in Auckland, New Zealand.

PubMed

Read, Kerry; Bhally, Hansan; Sapsford, Sabrina; Sapsford, Thomas

2015-12-04

To determine the prevalence and spectrum of infections on admission, or acquired during hospitalisation (HAI) at Waitakere Hospital, Auckland. A questionnaire was completed on two separate days for all adult in-patients admitted to medical and rehabilitation wards for greater than 24 hours. Information obtained included patient characteristics, the presence and type of infection on admission or acquired during hospitalisation, as well as information on indwelling devices. Infection was the admitting diagnosis in 81 (41%) of 195 patients reviewed, with lower respiratory tract infection (LRTI) diagnosed in 50%, urine infections in 22% and cellulitis 18%. Only 40% LRTIs were supported by radiology or microbiological criteria. Twenty-five HAIs occurred in 21 patients (cumulative and point prevalence of 10.7% and 5.0% respectively). Urinary tract infection (UTI) was the most common HAI in 13 patients (62%), including 4 catheter-related infections. Patients with HAI were older and appeared to have had longer hospital stays, and higher urinary catheter usage. This study highlights the ongoing high burden of infections contributing to hospitalisation of adult patients in a developed country. The prevalence of HAI, patient characteristics and risk factors are comparable to previous studies in similar settings.

Physiological and Medical Monitoring for En Route Care of Combat Casualties

DTIC Science & Technology

2008-04-01

Houston, TX 78234-6315; email: victor.convertino@amedd.army.mil. DOI: 10.1097/TA.0b013e31816c82f4 The Journal of TRAUMA Injury, Infection , and...device (A) and the LBNP protocol (B). The Journal of TRAUMA Injury, Infection , and Critical Care S344 April Supplement 2008 negative pressure induces...saturation ( SpO2 ; pulse oximetry), and tissue (muscle) PO2 and pH (near-infrared spectroscopy) in con- scious human subjects exposed to progressive

[Using TRM to Enhance the Accuracy of Ventilator-Associated Pneumonia Preventive Measures Implemented by Neonatal Intensive Care Unit Medical Staffs].

PubMed

Huang, Yu-Ting; Huang, Chao-Ya; Su, Hsiu-Ya; Ma, Chen-Te

2018-06-01

Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the neonatal intensive care unit (NICU). The average VAP infection density was 4.7‰ in our unit between June and August 2015. The results of a status survey indicated that in-service education lacked specialization, leading to inadequate awareness among staffs regarding the proper care of newborns with VAP and a lack of related care guides. This, in turn, resulted in inconsistencies in care measures for newborns with VAP. To improve the accuracy of implementation of preventive measures for VAP among medical staffs and reduce the density of VAP infections in the NICU. Conduct a literature search and adopt medical team resources management methods; establish effective team communication; establish monitoring mechanisms and incentives; establish mandatory in-service specialization education contents and a VAP preventive care guide exclusively for newborns as a reference for medical staffs during care execution; install additional equipment and aids and set reminders to ensure the implementation of VAP preventive measures. The accuracy rate of preventive measure execution by medical staffs improved from 70.1% to 97.9% and the VAP infection density in the NICU decreased from 4.7‰ to 0.52‰. Team integration effectively improved the accuracy of implementation of VAP-prevention measures, reduced the density of VAP infections, enhanced quality of care, and ensured that newborns received care that was more in line with specialization needs.

[Healthcare-Associated Infection Control with Awareness of Patient Safety].

PubMed

Murakami, Nobuo

2016-03-01

In order to provide safe and secure medical care for patients, health care-associated infections (HAI) must not occur. HAI should be considered as incidents, and countermeasures should be viewed as a patient safety management itself. Healthcare-associated infection control (HAIC) is practiced by the infection control team (ICT), which is based on multidisciplinary cooperation. Team members have to recognize that it is the most important to make use of the expertise of each discipline. In addition, all members must try to respond quickly, to help the clinic staff. Visualized rapid information provision and sharing, environmental improvement, outbreak factor analysis, hand hygiene compliance rate improvement, proper antibiotic use (Antimicrobial Stewardship Program: ASP), and regional cooperation & leadership comprise the role of the ICT in the flagship hospital. Regarding this role, we present our hospital's efforts and the outcomes. In conclusion, for medical practice quality improvement, healthcare-associated infection control should be conducted thoroughly along with an awareness of patient safety.

Medical Device Integration Model Based on the Internet of Things

PubMed Central

Hao, Aiyu; Wang, Ling

2015-01-01

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner. PMID:26628938

Medical Device Integration Model Based on the Internet of Things.

PubMed

Hao, Aiyu; Wang, Ling

2015-01-01

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner.

A Systematic Evaluation of the Two-Component Systems Network Reveals That ArlRS Is a Key Regulator of Catheter Colonization by Staphylococcus aureus

PubMed Central

Burgui, Saioa; Gil, Carmen; Solano, Cristina; Lasa, Iñigo; Valle, Jaione

2018-01-01

Two-component systems (TCS) are modular signal transduction pathways that allow cells to adapt to prevailing environmental conditions by modifying cellular physiology. Staphylococcus aureus has 16 TCSs to adapt to the diverse microenvironments encountered during its life cycle, including host tissues and implanted medical devices. S. aureus is particularly prone to cause infections associated to medical devices, whose surfaces coated by serum proteins constitute a particular environment. Identification of the TCSs involved in the adaptation of S. aureus to colonize and survive on the surface of implanted devices remains largely unexplored. Here, using an in vivo catheter infection model and a collection of mutants in each non-essential TCS of S. aureus, we investigated the requirement of each TCS for colonizing the implanted catheter. Among the 15 mutants in non-essential TCSs, the arl mutant exhibited the strongest deficiency in the capacity to colonize implanted catheters. Moreover, the arl mutant was the only one presenting a major deficit in PNAG production, the main exopolysaccharide of the S. aureus biofilm matrix whose synthesis is mediated by the icaADBC locus. Regulation of PNAG synthesis by ArlRS occurred through repression of IcaR, a transcriptional repressor of icaADBC operon expression. Deficiency in catheter colonization was restored when the arl mutant was complemented with the icaADBC operon. MgrA, a global transcriptional regulator downstream ArlRS that accounts for a large part of the arlRS regulon, was unable to restore PNAG expression and catheter colonization deficiency of the arlRS mutant. These findings indicate that ArlRS is the key TCS to biofilm formation on the surface of implanted catheters and that activation of PNAG exopolysaccharide production is, among the many traits controlled by the ArlRS system, a major contributor to catheter colonization. PMID:29563900

Engaging Frontline Staff in Central Line-Associated Bloodstream Infection Prevention Practice in the Wake of Superstorm Sandy.

PubMed

Rosenberg, Rebecca E; Devins, Lea; Geraghty, Gail; Bock, Steven; Dugan, Christina A; Transou, Marjorie; Phillips, Michael; Lighter-Fisher, Jennifer

2015-10-01

Central venous catheters are crucial devices in the care of hospitalized children, both in and out of critical care units, but the concomitant risk of central line-associated bloodstream infection (CLABSI) affects 15,000 Americans annually. In 2012, CLABSI rates varied among units from 6.8/1,000 to 1.0/1,000 in a 109-bed children's service within NYU Langone Medical Center (NYULMC; New York City), a 1,069-bed tertiary care academic medical center. In response to variation in central line-related practices and infection prevention rates, a CLABSI Prevention Core Team began an effort to standardize central venous catheter (CVC) care across all pediatric units (ICU and non-ICU). Momentum in this quality improvement (QI) work was interrupted when Superstorm Sandy shuttered the flagship hospital, but the relatively decreased clinical load provided a "downtime" opportunity to address CLABSI prevention. The first phase of the collaborative effort, Booster 1, Planning/Initial Phase: Development of a Pediatric Central Venous Catheter Working Group, was followed by Booster 2, Maintenance/Sustaining Phase: Transitioning for Sustainability and Adopting Model for Improvement. Data in the subsequent 21 months after the temporary closure of the facility (January 2013-September 2014) showed an increase in maintenance bundle reliability. The inpatient CLABSI rate for patients<18 years decreased from an annual rate of 2.7/1,000 line days (2012) to 0.6/1,000 line days (2013) to 0.5/1,000 line days as of August 2014. There was a decrease in pediatric CLABSI events and no significant change in line days. Key elements contributing to initial success with evolving QI capacity and resources were likely multi-factorial, including staff and leadership engagement, culture change, consistent guidelines, and accountability by individuals and by our multidisciplinary core team.

Polymer multilayers loaded with antifungal β-peptides kill planktonic Candida albicans and reduce formation of fungal biofilms on the surfaces of flexible catheter tubes.

PubMed

Raman, Namrata; Lee, Myung-Ryul; Palecek, Sean P; Lynn, David M

2014-10-10

Candida albicans is the most common fungal pathogen responsible for hospital-acquired infections. Most C. albicans infections are associated with the implantation of medical devices that act as points of entry for the pathogen and as substrates for the growth of fungal biofilms that are notoriously difficult to eliminate by systemic administration of conventional antifungal agents. In this study, we report a fill-and-purge approach to the layer-by-layer fabrication of biocompatible, nanoscale 'polyelectrolyte multilayers' (PEMs) on the luminal surfaces of flexible catheters, and an investigation of this platform for the localized, intraluminal release of a cationic β-peptide-based antifungal agent. We demonstrate that polyethylene catheter tubes with luminal surfaces coated with multilayers ~700nm thick fabricated from poly-l-glutamic acid (PGA) and poly-l-lysine (PLL) can be loaded, post-fabrication, by infusion with β-peptide, and that this approach promotes extended intraluminal release of this agent (over ~4months) when incubated in physiological media. The β-peptide remained potent against intraluminal inoculation of the catheters with C. albicans and substantially reduced the formation of C. albicans biofilms on the inner surfaces of film-coated catheters. Finally, we report that these β-peptide-loaded coatings exhibit antifungal activity under conditions that simulate intermittent catheter use and microbial challenge for at least three weeks. We conclude that β-peptide-loaded PEMs offer a novel and promising approach to kill C. albicans and prevent fungal biofilm formation on surfaces, with the potential to substantially reduce the incidence of device-associated infections in indwelling catheters. β-Peptides comprise a promising new class of antifungal agents that could help address problems associated with the use of conventional antifungal agents. The versatility of the layer-by-layer approach used here thus suggests additional opportunities to exploit these new agents in other biomedical and personal care applications in which fungal infections are endemic. Copyright © 2014 Elsevier B.V. All rights reserved.

Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.

PubMed

Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis

2013-11-25

Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction rates, and broadening the scope of the model to include ancillary measures for hospital conversion to SED usage, outpatient and paramedic device use, and transmission of other blood-borne diseases, would strengthen the model.

Use of Silver in the Prevention and Treatment of Infections: Silver Review

PubMed Central

Campbell, Kristin T.; Rosenberger, Laura H.; Sawyer, Robert G.

2013-01-01

Abstract Background The use of silver for the treatment of various maladies or to prevent the transmission of infection dates back to at least 4000 b.c.e. Medical applications are documented in the literature throughout the 17th and 18th centuries. The bactericidal activity of silver is well established. Silver nitrate was used topically throughout the 1800s for the treatment of burns, ulcerations, and infected wounds, and although its use declined after World War II and the advent of antibiotics, Fox revitalized its use in the form of silver sulfadiazine in 1968. Method Review of the pertinent English-language literature. Results Since Fox's work, the use of topical silver to reduce bacterial burden and promote healing has been investigated in the setting of chronic wounds and ulcers, post-operative incision dressings, blood and urinary catheter designs, endotracheal tubes, orthopedic devices, vascular prostheses, and the sewing ring of prosthetic heart valves. The beneficial effects of silver in reducing or preventing infection have been seen in the topical treatment of burns and chronic wounds and in its use as a coating for many medical devices. However, silver has been unsuccessful in certain applications, such as the Silzone heart valve. In other settings, such as orthopedic hardware coatings, its benefit remains unproved. Conclusion Silver remains a reasonable addition to the armamentarium against infection and has relatively few side effects. However, one should weigh the benefits of silver-containing products against the known side effects and the other options available for the intended purpose when selecting the most appropriate therapy. PMID:23448590

Surgical site infections following craniotomy focusing on possible post-operative acquisition of infection: prospective cohort study.

PubMed

Sneh-Arbib, O; Shiferstein, A; Dagan, N; Fein, S; Telem, L; Muchtar, E; Eliakim-Raz, N; Rubinovitch, B; Rubin, G; Rappaport, Z H; Paul, M

2013-12-01

Neurosurgery is characterized by a prolonged risk period for surgical site infection (SSI), mainly related to the presence of cerebrospinal fluid (CSF) drains. We aimed to examine factors associated with post-neurosurgical SSIs, focusing on post-operative factors. A prospective cohort study was conducted in a single center over a period of 18 months in Israel. Included were adult patients undergoing clean or clean-contaminated craniotomy, including craniotomies with external CSF drainage or shunts. SSIs were defined by the Centers for Disease Control and Prevention (CDC) criteria for healthcare-associated infections. All patients were followed up for 90 days and those with foreign body insertion for 1 year. We compared patients with and without SSI. A multivariable regression analysis for SSI was conducted including uncorrelated variables significantly associated with SSI. A total of 502 patients were included, with 138 (27.5%) undergoing emergent or urgent craniotomy. The overall SSI rate was 5.6% (28 patients), of which 3.2% (16 patients) were intracerebral. Non-elective surgery, external CSF drainage/monitoring devices, re-operation, and post-operative respiratory failure were independently associated with subsequent SSI. External CSF devices was the only significant risk factor for intracerebral SSIs (p < 0.001). Internal shunts or other foreign body insertions were not associated with SSIs. A phenotypically identical isolate to that causing the SSI was isolated from respiratory secretions prior to the SSI in 4/9 patients with microbiologically documented intracerebral SSIs. Patients with SSIs had longer hospital stay, poorer functional capacity on discharge, and higher 90-day mortality. We raise the possibility of post-operative infection acquisition through external CSF devices. Standard operating procedures for their maintenance are necessary.

Understanding the Mechanism of Bacterial Biofilms Resistance to Antimicrobial Agents

PubMed Central

Singh, Shriti; Singh, Santosh Kumar; Chowdhury, Indrajit; Singh, Rajesh

2017-01-01

A biofilm is a group of microorganisms, that causes health problems for the patients with indwelling medical devices via attachment of cells to the surface matrix. It increases the resistance of a microorganism for antimicrobial agents and developed the human infection. Current strategies are removed or prevent the microbial colonies from the medical devices, which are attached to the surfaces. This will improve the clinical outcomes in favor of the patients suffering from serious infectious diseases. Moreover, the identification and inhibition of genes, which have the major role in biofilm formation, could be the effective approach for health care systems. In a current review article, we are highlighting the biofilm matrix and molecular mechanism of antimicrobial resistance in bacterial biofilms. PMID:28553416

["Getting to zero infections" in hemodialysis].

PubMed

Leonardi, Gianluca; Finotto, Giuseppe; Talaia, Marinella; Nappo, Angelo; Dolla, Caterina; Di Vico, Maria Cristina; Diena, Davide; Linsalata, Antonio; Guarena, Cesare; Barbaro, Silvana; Biancone, Luigi

2015-01-01

We describe two measures adopted in hemodialysis outpatient population in order to reduce Central Venous Catheter (CVC) related infections. The first is a nurse staff training in the field project and the second deals with the employment of chlorhexidine-impregnated dressing devices. These actions were performed after high infection rates were observed through a dedicated register. In the limited assistance dialysis center, direct observation (12/2012-02/2013) quantified the gap between the observed and expected health care behaviour. Training needs were defined and a 40 hours nurse staff training in the field was performed on two occasions. In the hospital dialysis center, we introduced alcoholic 2% chlorhexidine solution and chlorhexidine-impregnated dressing devices to the exit site (CHG-Tegaderm and BioPatch). Infections (cumulatively bacteremia/sepsis/skin exit/subcutaneous tunnel) were monitored continuously. Infection rates at the two locations were progressively reduced, reaching a value of zero at the limited assistance center. Nurse staff training in the field produced: two patient reports and three CVC management protocols, Italian language translation of the "The 5 moments of dialysis" WHO poster, alcoholic 2% chlorhexidine adoption to exit-site medication and improvement of environment cleaning/sanitation actions. Our experience shows that continuously monitoring infection rates represents the first step for timely corrective action. The continuous updating of health personnel, codified prevention measures and an ongoing commitment to raise awareness in a routine practice, allows us to obtain the goal of "getting to zero infections". The staff training produced equal or superior results compared to the isolated use of new chlorhexidine-impregnated dressing devices.

Depressive Symptoms Mediate the Effect of HIV-Related Stigmatization on Medication Adherence Among HIV-Infected Men Who Have Sex with Men.

PubMed

Mitzel, Luke D; Vanable, Peter A; Brown, Jennifer L; Bostwick, Rebecca A; Sweeney, Shannon M; Carey, Michael P

2015-08-01

This study tested the hypothesis that depressive symptoms would mediate the association of HIV-related stigma to medication adherence. We recruited HIV-infected men who have sex with men (MSM; N = 66; 66 % White, 23 % African-American) from an outpatient infectious disease clinic, and asked them to complete self-report measures. Mediational analyses showed that depressive symptoms fully mediated the association between HIV-related stigma and adherence. That is, stigma-related experiences were positively associated with depressive symptoms and negatively associated with adherence, and, in the final model, depressive symptoms remained a significant correlate of adherence while stigma did not. A test of the indirect effect of stigma on adherence through depressive symptoms was also significant (unstandardized b = -0.19; bootstrap 95 % CI -0.45 to -0.01). These results highlight the importance of treating depressive symptoms in interventions aiming to improve medication adherence among HIV-infected MSM.

Do single-use medical devices containing biopolymers reduce the environmental impacts of surgical procedures compared with their plastic equivalents?

PubMed

Unger, Scott R; Hottle, Troy A; Hobbs, Shakira R; Thiel, Cassandra L; Campion, Nicole; Bilec, Melissa M; Landis, Amy E

2017-01-01

Background While petroleum-based plastics are extensively used in health care, recent developments in biopolymer manufacturing have created new opportunities for increased integration of biopolymers into medical products, devices and services. This study compared the environmental impacts of single-use disposable devices with increased biopolymer content versus typically manufactured devices in hysterectomy. Methods A comparative life cycle assessment of single-use disposable medical products containing plastic(s) versus the same single-use medical devices with biopolymers substituted for plastic(s) at Magee-Women's Hospital (Magee) in Pittsburgh, PA and the products used in four types of hysterectomies that contained plastics potentially suitable for biopolymer substitution. Magee is a 360-bed teaching hospital, which performs approximately 1400 hysterectomies annually. Results There are life cycle environmental impact tradeoffs when substituting biopolymers for petroplastics in procedures such as hysterectomies. The substitution of biopolymers for petroleum-based plastics increased smog-related impacts by approximately 900% for laparoscopic and robotic hysterectomies, and increased ozone depletion-related impacts by approximately 125% for laparoscopic and robotic hysterectomies. Conversely, biopolymers reduced life cycle human health impacts, acidification and cumulative energy demand for the four hysterectomy procedures. The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects. However, the significant agricultural inputs associated with manufacturing biopolymers exacerbate environmental impacts of products and devices made using biopolymers. Conclusions The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects; however, the significant agricultural inputs associated with manufacturing biopolymers exacerbate environmental impacts.

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

PubMed

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

[Ten years' German Protection against Infection Act. Evaluation of the implementation of infection control visits in the ambulatory medical setting].

PubMed

Heudorf, U; Eikmann, T; Exner, M

2013-03-01

In 2001, the German Protection against Infection Act came into force, implementing a variety of new regulations. For the first time, obligatory infection control visits of the public health departments in surgical ambulatory practices were implemented, as well as optional infection control visits in all medical, dental and paramedical practices using invasive methods. Based on the data of the public health department of the city of Frankfurt am Main, Germany, an evaluation of this new regulation is given in this paper. First, prioritization of these new tasks was mandatory. First priority was given to the obligatory visits in surgical practices, second priority to the hygiene visits in practices performing endoscopy in gastroenterology as well as in urology and in practices of traditional healers, and third priority was given to all other doctors' practices. After receiving preliminary information and further training of the doctors etc., the control visits were performed by members of the public health department, using a checklist based on the guidelines of the German Commission on Hospital Infection Prevention ("Kommission für Krankenhaushygiene und Infektionsprävention"). Since 2001, more than 1100 infection control visits in medical practices in Frankfurt am Main were documented. Not only in surgical, but also in gastroenterological and urological practices great improvement could be achieved, regarding not only hand hygiene and reprocessing surface areas, but especially in reprocessing medical devices. In practices for internal medicine and those of general practitioners, errors in hand hygiene, skin antiseptic and surface disinfection also decreased. According to our results, especially regarding the improved quality of structure as well as quality of process and with regard to the public discussion on this hygiene topic, our evaluation is absolutely positive. The new regulation proved worthwhile.

A cardiac implantable device infection by Raoultella planticola in an immunocompromized patient.

PubMed

Adjodah, Chandra; D'Ivernois, Chistophe; Leyssene, David; Berneau, Jean-Baptiste; Hemery, Yann

2017-02-01

Introduction. Infection of cardiac implantable electronic devices is a severe condition associated with high mortality, particularly in patients who are dependent upon heart-pacing devices. Staphylococci are found in 70 % of reported cases. Case presentation. We report the case of a cardiac-pacemaker infection in a 79-year-old man, cumulating a history of rheumatoid arthritis treated by corticosteroids and methotrexate by a recently identified micro-organism: Raoultella planticola . He presented local signs of infection on his VVI pacemaker implantation site and underwent urgent pocket device replacement under cefamandole antibioprophylaxis. On incision thick pus oozed out. It was necessary to perform a complete hardware extraction comprising the pulse generator and the ancient lead. Pus was inoculated into aerobic and anaerobic culture vials and Gram staining unveiled Gram-negative rods. Microbiology analysis identified the organism as R. planticola. A new pacing device was inserted on the contrlateral pectoral region. Ciprofloxacin enabled full recovery. A literature review concerning this pathogen revealed that it is involved in severe infections such as bloodstream infections, peritonitis, cellulitis, pneumonia and lung abscesses, and urinary tract infections. In these case reports, underlying co-morbidities were identified such as solid active neoplasia, recent chemotherapy, corticosteroids, solid-organ-recipient patients and recent open surgery. Conclusion. R. planticola is a serious emerging pathogen and contributes to the burden of various infectious conditions. Its pathogenicity and occurrence should be known by clinicians and a high level of awareness is necessary to precisely identify it provide the correct antibiotic regimen.

Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit.

PubMed

Li, Xixi; He, Mei; Wang, Haiyan

2017-12-01

In this study, failure mode and effect analysis (FMEA), a proactive tool, was applied to reduce errors associated with the process which begins with assessment of patient and ends with treatment of complications. The aim of this study is to assess whether FMEA implementation will significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in intensive care unit.The FMEA team was constructed. A team of 15 medical staff from different departments were recruited and trained. Their main responsibility was to analyze and score all possible processes of central venous catheterization failures. Failure modes with risk priority number (RPN) ≥100 (top 10 RPN scores) were deemed as high-priority-risks, meaning that they needed immediate corrective action. After modifications were put, the resulting RPN was compared with the previous one. A centralized nursing care system was designed.A total of 25 failure modes were identified. High-priority risks were "Unqualified medical device sterilization" (RPN, 337), "leukopenia, very low immunity" (RPN, 222), and "Poor hand hygiene Basic diseases" (RPN, 160). The corrective measures that we took allowed a decrease in the RPNs, especially for the high-priority risks. The maximum reduction was approximately 80%, as observed for the failure mode "Not creating the maximal barrier for patient." The averaged incidence of CRBSIs was reduced from 5.19% to 1.45%, with 3 months of 0 infection rate.The FMEA can effectively reduce incidence of CRBSIs, improve the security of central venous catheterization technology, decrease overall medical expenses, and improve nursing quality. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Translational models of infection prevention and control: lessons from studying high risk aging populations.

PubMed

Mody, Lona

2018-06-13

The present review describes our research experiences and efforts in advancing the field of infection prevention and control in nursing facilities including postacute and long-term care settings. There are over two million infections in postacute and long-term care settings each year in the United States and $4 billion in associated costs. To define a target group most amenable to infection prevention and control interventions, we sought to quantify the relation between indwelling device use and microbial colonization in nursing facility patients. Using various methodologies including survey methods, observational epidemiology, randomized controlled studies, and collaboratives, we showed that indwelling device type is related to the site of multidrug-resistant organism (MDRO) colonization; multianatomic site colonization with MDROs is common; community-associated methicillin-resistant Staphylococcus aureus (MRSA) appeared in the nursing facility setting almost immediately following its emergence in acute care; (4) MDRO prevalence and catheter-associated infection rates can be reduced through a multimodal targeted infection prevention intervention; and (5) using a collaborative approach, such an intervention can be successfully scaled up. Our work advances the infection prevention field through translational research utilizing various methodologies, including quantitative and qualitative surveys, patient-oriented randomized controlled trials, and clinical microbiologic and molecular methods. The resulting interventions employ patient-oriented methods to reduce infections and antimicrobial resistance, and with partnerships from major national entities, can be implemented nationally.

The network approach for prevention of healthcare-associated infections: long-term effect of participation in the Duke Infection Control Outreach Network.

PubMed

Anderson, Deverick J; Miller, Becky A; Chen, Luke F; Adcock, Linda H; Cook, Evelyn; Cromer, A Lynn; Louis, Susan; Thacker, Paul A; Sexton, Daniel J

2011-04-01

To describe the rates of several key outcomes and healthcare-associated infections (HAIs) among hospitals that participated in the Duke Infection Control Outreach Network (DICON). Prospective, observational cohort study of patients admitted to 24 community hospitals from 2003 through 2009. The following data were collected and analyzed: incidence of central line-associated bloodstream infections (CLABSIs), ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTIs), and HAIs caused by methicillin-resistant Staphylococcus aureus (MRSA); employee exposures to bloodborne pathogens (EBBPs); physician EBBPs; patient-days; central line-days; ventilator-days; and urinary catheter-days. Poisson regression was used to determine whether incidence rates of these HAIs and exposures changed during the first 5 and 7 years of participation in DICON; nonrandom clustering of each outcome was controlled for. Cost saved and lives saved were calculated on the basis of published estimates. In total, we analyzed 6.5 million patient-days, 4,783 EBPPs, 2,948 HAIs due to MRSA, and 2,076 device-related infections. Rates of employee EBBPs, HAIs due to MRSA, and device-related infections decreased significantly during the first 5 years of participation in DICON (P< .05 for all models; average decrease was approximately 50%); in contrast, physician EBBPs remained unchanged. In aggregate, 210 CLABSIs, 312 cases of VAP, 332 CAUTIs, 1,042 HAIs due to MRSA, and 1,016 employee EBBPs were prevented. Each hospital saved approximately $100,000 per year of participation, and collectively the hospitals may have prevented 52-105 deaths from CLABSI or VAP. The 7-year analysis demonstrated that these trends continued with further participation. Hospitals with long-term participation in an infection control network decreased rates of significant HAIs by approximately 50%, decreased costs, and saved lives.

The role of antibiotics in preventing totally implantable venous access device (TIVAD) infections; is there a population that would benefit?

PubMed

Jo, Jonathan E; Tang, Eve Y; Pua, Bradley B

2018-05-28

To assess the role for prophylactic antibiotics in preventing totally implantable venous access device (TIVAD) infections and identify populations that may benefit from antibiotics. 1284 patients undergoing TIVAD placement were retrospectively reviewed to determine association between infection rate, prophylactic antibiotics, and clinical data including white blood cell (WBC) count, platelets, and coagulation profile. Patients were further sub-categorized based on hospital admission status and leukopenia. Patients who received antibiotics were compared to those who did not using chi-square test or Fisher's exact tests and Student's t-tests. Additionally, multivariable logistic regression analysis was used to determine factors associated with infections. A total of 7 infections were identified with an infection rate of 0.5%. 1010 patients received antibiotics (78.7%), and infection rate in these patients was 0.7% compared to 0% in patients who did not receive antibiotics. 21 patients were under the age of 18, eight of which received antibiotics. No infections occurred in the pediatric group. Upon multivariate analysis, developing TIVAD infection was significantly associated with inpatient placement (p < 0.0001, OR 29.1, 95% CI 3.1-272.1), while utilization of double lumen ports was not (OR 3.0, 95% CI 0.5-17.4). There were no significant associations between infections and antibiotic use (p = 0.36), leukopenia (p = 0.47), pediatric patients (p = 1) or other demographic or laboratory data. Routine use of prophylactic antibiotics with TIVAD placement should be avoided. Antibiotics may not benefit even those with greater risk for infection. Copyright © 2018. Published by Elsevier Inc.

Critical analysis of common canister programs: a review of cross-functional considerations and health system economics.

PubMed

Larson, Trent; Gudavalli, Ravindra; Prater, Dean; Sutton, Scott

2015-04-01

Respiratory inhalers constitute a large percentage of hospital pharmacy expenditures. Metered-dose inhaler (MDI) canisters usually contain enough medication to last 2 to 4 weeks, while the average hospital stay for acute hospitalizations of respiratory illnesses is only 4-5 days. Hospital pharmacies are often unable to operationalize relabeling of inhalers at discharge to meet regulatory requirements. This dilemma produces drug wastage. The common canister (CC) approach is a method some hospitals implemented in an effort to minimize the costs associated with this issue. The CC program uses a shared inhaler, an individual one-way valve holding chamber, and a cleaning protocol. This approach has been the subject of considerable controversy. Proponents of the CC approach reported considerable cost savings to their institutions. Opponents of the CC approach are not convinced the benefits outweigh even a minimal risk of cross-contamination since adherence to protocols for hand washing and disinfection of the MDI device cannot be guaranteed to be 100% (pathogens from contaminated devices can enter the respiratory tract through inhalation). Other cost containment strategies, such as unit dose nebulizers, may be useful to realize similar reductions in pharmacy drug costs while minimizing the risks of nosocomial infections and their associated medical costs. The CC strategy may be appropriate for some hospital pharmacies that face budget constraints, but a full evaluation of the risks, benefits, and potential costs should guide those who make hospital policy decisions.

Healthcare acquired infection (HAIs): a deadly problem that is preventable: UV can help, what's holding it back?

NASA Astrophysics Data System (ADS)

Cowan, Troy E.

2018-02-01

Healthcare Acquired Infections (HAIs) pose a significant health risk to our nation, especially to those most in need of healthcare. One in every 25 people admitted to a hospital will be infected by one or more HAIs. Significant reductions in HAI risks can be advanced through innovative technologies, such as UV antimicrobial disinfecting devices. Development of such technologies, along with the associated Behavioral, Chemical and Technological protocols to combat infectious HAIs is a worthwhile pursuit for the public good. A significant good will be accomplished by engaging optical scientists and engineers as well as healthcare professionals in opportunities to advance light-driven antimicrobial devices to halt infections. Fundamental change can be effected through a path of advancing standards and methods including optical measurements, and testing the efficacy of UV light antimicrobial devices and related technologies.

Venous Access Ports: Indications, Implantation Technique, Follow-Up, and Complications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Walser, Eric M., E-mail: walser.eric@mayo.edu

The subcutaneous venous access device (SVAD or 'port') is a critical component in the care of patients with chronic disease. The modern SVAD provides reliable access for blood withdrawal and medication administration with minimal disruption to a patient's lifestyle. Because of improved materials and catheter technology, today's ports are lighter and stronger and capable of high-pressure injections of contrast for cross-sectional imaging. The majority of SVAD placement occurs in interventional radiology departments due to their ability to provide this service at lower costs, lower, complication rates, and greater volumes. Port-insertion techniques vary depending on the operator, but all consist ofmore » catheter placement in the central venous circulation followed by subcutaneous pocket creation and port attachment to the catheter with fixation and closure of the pocket. Venous access challenges occasionally occur in patients with central vein occlusions, necessitating catheterization of collateral veins or port placement in alternate locations. Complications of SVADs include those associated with the procedure as well as short- (<30 days) and long-term problems. Procedural and early complications are quite rare due to the near-universal use of real-time ultrasound guidance for vein puncture, but they can include hematoma, catheter malposition, arrhythmias, and pneumothorax. Late problems include both thrombotic complications (native venous or port-catheter thrombosis) and infections (tunnel or pocket infections or catheter-associated bloodstream infections). Most guidelines suggest that 0.3 infections/1000 catheter days is an appropriate upper threshold for the insertion of SVADs.« less

Dating Violence Against HIV-Infected Youth in South Africa: Associations With Sexual Risk Behavior, Medication Adherence, and Mental Health.

PubMed

Kidman, Rachel; Violari, Avy

2018-01-01

As perinatal HIV-infected youth become sexually active, the potential for onward transmission becomes an increasing concern. In other populations, intimate partner violence (IPV) is a risk factor for HIV acquisition. We build on this critical work by studying the role of IPV in facilitating onward transmission among HIV-infected youth-an important step toward effective intervention. Soweto, South Africa. Self-report surveys were completed by 129 perinatal HIV-infected female youth (aged 13-24 years). We calculated the IPV prevalence and used logistic models to capture the association between IPV and health outcomes known to facilitate onward HIV transmission (eg, risky sex, poor medication adherence, depression, and substance abuse). A fifth of perinatal HIV-infected participants reported physical and/or sexual IPV in the past year; one-third reported lifetime IPV. Childhood adversity was common and positively associated with IPV. Past-year physical and/or sexual IPV was positively correlated with high-risk sex [odds ratio (OR) = 8.96; 95% confidence interval (CI): 2.78 to 28.90], pregnancy (OR = 6.56; 95% CI: 1.91 to 22.54), poor medication adherence to antiretroviral therapy (OR = 5.37; 95% CI: 1.37 to 21.08), depression (OR = 4.25; 95% CI: 1.64 to 11.00), and substance abuse (OR = 4.11; 95% CI: 1.42 to 11.86). Neither past-year nor lifetime IPV was associated with viral load or HIV status disclosure to a partner. We find that IPV may increase risk for onward HIV transmission in perinatal HIV-infected youth by both increasing engagement in risky sexual behaviors and lowering medication adherence. HIV clinics should consider integrating primary IPV prevention interventions, instituting routine IPV screening, and collocating services for victims of violence.

Photothermal inactivation of bacteria on plasmonic nanostructures

NASA Astrophysics Data System (ADS)

Santos, Greggy M.; Ibañez de Santi Ferrara, Felipe; Zhao, Fusheng; Rodrigues, Debora F.; Shih, Wei-Chuan

2016-03-01

Hospital-acquired bacterial infections are frequently associated with the pathogenic biofilms on surfaces of devices and instruments used in medical procedures. The utilization of thermal plasmonic agents is an innovative approach for sterilizing hospital equipment and for in vivo therapeutic treatment of bacterial infection. A photothermal inactivation technique via array of nanoporous gold disks (NPGDs) has been developed by irradiating near infrared (NIR) light onto deposited bacterial cells (Escherichia coli, Bacillus subtilis, Exiguobacterium AT1B) on the surface of metal nanostructure. The physical and photothermal properties of the NPGD substrate were investigated using topographical scanning electron microscopy (SEM) and thermographic infrared imaging. Bacterial viability studies on NPGD substrates irradiated with and without NIR light were evaluated using a fluorescence-based two-component stain assay. The results show that the heat generated from the NPGD substrate promotes high cell death counts (~100%) at short exposure durations (<25 s) even for thermally-resistant bacterial strains. The photothermal effects on NPGD substrate can lead to point-of-care applications.

Controlling urinary tract infections associated with intermittent bladder catheterization in geriatric hospitals.

PubMed

Girard, R; Gaujard, S; Pergay, V; Pornon, P; Martin Gaujard, G; Vieux, C; Bourguignon, L

2015-07-01

Controlling urinary tract infections (UTIs) associated with intermittent catheterization in geriatric patients. After a local epidemiological study identified high rates of UTI, a multi-disciplinary working group implemented and evaluated corrective measures. In 2009, a one-month prospective study measured the incidence of UTI, controlled for risk factors and exposure, in six geriatric hospitals. In 2010, a self-administered questionnaire on practices was administered to physicians and nurses working in these geriatric units. In 2011, the working group developed a multi-modal programme to: improve understanding of micturition, measurement of bladder volume and indications for catheter drainage; limit available medical devices; and improve prescription and traceability procedures. Detailed training was provided to all personnel on all sites. The epidemiological study was repeated in 2012 to assess the impact of the programme. Over 1500 patients were included in the 2009 study. The incidence of acquired infection was 4.8%. The infection rate was higher in patients with intermittent catheters than in patients with indwelling catheters (29.7 vs 9.9 UTI per 100 patients, P = 0.1013) which contradicts the literature. In 2010, the 269 responses to the questionnaire showed that staff did not consider catheterization to place patients at risk of infection, staff had poor knowledge of the recommended indications and techniques, and the equipment varied widely between units. Following implementation of the programme, the study was repeated in 2012 with over 1500 patients. The frequency of UTI in patients with intermittent catheters fell to rates in the published literature. Multi-modal programmes are an effective means to control UTI. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Detection limit of Mycobacterium chimaera in water samples for monitoring medical device safety: insights from a pilot experimental series.

PubMed

Schreiber, P W; Köhler, N; Cervera, R; Hasse, B; Sax, H; Keller, P M

2018-07-01

A growing number of Mycobacterium chimaera infections after cardiosurgery have been reported by several countries. These potentially fatal infections were traced back to contaminated heater-cooler devices (HCDs), which use water as a heat transfer medium. Aerosolization of water contaminated with M. chimaera from HCDs enables airborne transmission to patients undergoing open chest surgery. Infection control teams test HCD water samples for mycobacterial growth to guide preventive measures. The detection limit of M. chimaera in water samples, however, has not previously been investigated. To determine the detection limit of M. chimaera in water samples using laboratory-based serial dilution tests. An M. chimaera strain representative of the international cardiosurgery-associated M. chimaera outbreak was used to generate a logarithmic dilution series. Two different water volumes, 50 and 1000mL, were inoculated, and, after identical processing (centrifugation, decantation, and decontamination), seeded on mycobacteria growth indicator tube (MGIT) and Middlebrook 7H11 solid media. MGIT consistently showed a lower detection limit than 7H11 solid media, corresponding to a detection limit of ≥1.44 × 10 4 cfu/mL for 50mL and ≥2.4cfu/mL for 1000mL water samples. Solid media failed to detect M. chimaera in 50mL water samples. Depending on water volume and culture method, major differences exist in the detection limit of M. chimaera. In terms of sensitivity, 1000mL water samples in MGIT media performed best. Our results have important implications for infection prevention and control strategies in mitigation of the M. chimaera outbreak and healthcare water safety in general. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

[Role of medium-sized independent laboratories in control of healthcare-associated infection].

PubMed

Anzai, Eiko; Fukui, Toru

2009-05-01

In 2006, the Ministry of Health and Welfare revised the regulations regarding the Medical Service Law. The amendments stipulate that all healthcare institutions are required to implement infection control programs. However, small hospitals and clinics have no clinical microbiology laboratories, whereas medium-sized hospitals have few medical technologists and the outsourcing of microbiology tests to independent laboratories is common. The decreasing number of laboratories and recent outsourcing tendency reflect the increasing commercialization, and, with it, the escalating number of commercially operating chains. Each independent laboratory is responsible for supporting activities related to the surveillance, control, and prevention of healthcare-associated infections in the associated small and medium-sized hospitals. The people responsible for infection control in these hospitals usually do not have a background in microbiology. The evaluation of communication between independent laboratory staff and hospital personnel, and rapid turnaround time of microbiology laboratory test reports are important elements ensuring the quality of independent laboratory work. With the pressures of financial constraints in the Japanese medical insurance system, the development of a cost-effective and practical protocol for quality assurance is a real dilemma.

Crystal methamphetamine, its analogues, and HIV infection: medical and psychiatric aspects of a new epidemic.

PubMed

Urbina, Antonio; Jones, Kristina

2004-03-15

The use of the recreational drug crystal methamphetamine among younger homosexual men is expanding, and with it, unsafe sex behaviors that increase the transmission of human immunodeficiency virus (HIV). This article reviews available literature on the medical and psychiatric morbidities associated with methamphetamine abuse in HIV-infected patients. Medical complications include hypertension, hyperthermia, rhabdoymyolysis, and stroke. One fatal case of ingestion of methamphetamine with HIV medication has been documented. Two fatal cases of ingestion of HIV medication with the amphetamine analogue n-methyl-3,4 methylenedioxymethamphetamine (MDMA, or "ecstasy") have also been reported. Some molecular researchers suggest that dopaminergic systems are vulnerable to the combined neurotoxicity of HIV infection and methamphetamine. Population surveys indicate high rates of HIV infection among methamphetamine abusers and high rates of unprotected anal intercourse during drug intoxication. Intoxication can sometimes produce paranoia, auditory hallucinations, and, occasionally, violent behavior. Amphetamine withdrawal commonly results in symptoms of depression. Methamphetamine is a new challenge related to treatment and prevention of HIV infection.

Disaster-Related Injury Management: High Prevalence of Wound Infection After Super Typhoon Haiyan.

PubMed

Kim, Yong Won; Kim, Seong Yeop; Kim, Hoon; Ahn, Moo Eob; Lee, Kang Hyun; Hong, Eun Seok

2016-02-01

After Super Typhoon Haiyan, a category 5 tropical cyclone, insufficient resources were available for medical management. Many patients in the Philippines were wounded as a result of the disaster. We examined the prevalence, risk factors, and consequences of disaster-related wounds and wound infection in the post-disaster period. We performed a retrospective review of consecutive patients admitted to a Korean Disaster Relief Team clinic at St. Paul's Hospital, Tacloban City, Republic of Philippines, between December 9 and 13, 2013. Traumatic injury patients were included; patients not exhibiting a wound were excluded. Of the 160 patients enrolled in the study, 71 (44.4%) had infected wounds. There were no significant differences in the age, sex, past medical history, wound site, wound depth, injury mechanism, or inducer of injury between the uninfected and infected groups. In the univariate analysis, a foreign-body-contaminated wound, a chronic wound, elapsed time from injury to medical contact, an inadequately cared for wound, and need for subsequent wound management were associated with wound infection (P<0.05). The multivariate analysis revealed that foreign body contamination and having an inadequately cared for wound were associated with wound infection (odds ratio [OR]: 10.12, 95% confidence interval [CI]: 3.59-28.56; OR: 3.51, 95% CI: 1.07-11.51, respectively). In the post-disaster situation, many wound infections required definitive care. Wound infection was associated with inadequately cared for wounds and foreign-body-contaminated wounds.

Two Reports of the AAMC Committee on AIDS and the Academic Medical Center.

ERIC Educational Resources Information Center

Academic Medicine, 1989

1989-01-01

Association of American Medical Colleges' reports concerning Acquired Immune Deficiency Syndrome include "Policy Guidelines for Addressing HIV [human immunodeficiency virus] Infection in the Academic Medical Community" and "The HIV Epidemic and Medical Education." (MSE)

Characterization of Acinetobacter baumannii biofilm associated components

NASA Astrophysics Data System (ADS)

Brossard, Kari A.

Acinetobacter baumannii is a Gram-negative aerobic coccobaccillus that is a major cause of nosocomial infections worldwide. Infected individuals may develop pneumonia, urinary tract, wound, and other infections that are associated with the use of indwelling medical devices such as catheters and mechanical ventilation. Treatment is difficult because many A. baumannii isolates have developed multi-drug resistance and the bacterium can persist on abiotic surfaces. Persistence and resistance may be due to formation of biofilms, which leads to long-term colonization, evasion of the host immune system and resistance to treatment with antibiotics and disinfectants. While biofilms are complex multifaceted structures, two bacterial components that have been shown to be important in formation and stability are exopolysaccharides (EPS) and the biofilm-associated protein (Bap). An EPS, poly-beta-1,6-N-acetylglucosamine, PNAG, has been described for E. coli and S. epidermidis. PNAG acts as an intercellular adhesin. Production of this adhesin is dependent on the pga/icaABCD locus. We have identified a homologous locus in A. baumannii 307-0294 that is involved in production of an exopolysaccharide, recognized by an anti-PNAG antibody. We hypothesized that the A. baumannii pgaABCD locus plays a role in biofilm formation, and protection against host innate defenses and disinfectants suggesting that PNAG is a possible virulence factor for the organism. The first aim of this thesis will define the pgaABCD locus. We have previously identified Bap, a protein with similarity to those described for S. aureus and we have demonstrated that this protein is involved in maintaining the stability of biofilms on glass. We hypothesized that A. baumannii Bap plays a role in persistence and pathogenesis and is regulated by quorum sensing. In our second aim we will examine the role of Bap in attachment and biofilm formation on medically relevant surfaces and also determine if Bap is involved in epithelial cell surface attachment and invasion. Finally we will determine the effects of quorum sensing on the expression of Bap.

Effects of Material Properties on Bacterial Adhesion and Biofilm Formation.

PubMed

Song, F; Koo, H; Ren, D

2015-08-01

Adhesion of microbes, such as bacteria and fungi, to surfaces and the subsequent formation of biofilms cause multidrug-tolerant infections in humans and fouling of medical devices. To address these challenges, it is important to understand how material properties affect microbe-surface interactions and engineer better nonfouling materials. Here we review the recent progresses in this field and discuss the main challenges and opportunities. In particular, we focus on bacterial biofilms and review the effects of surface energy, charge, topography, and stiffness of substratum material on bacterial adhesion. We summarize how these surface properties influence oral biofilm formation, and we discuss the important findings from nondental systems that have potential applications in dental medicine. © International & American Associations for Dental Research 2015.

Device-associated infection rates, mortality, length of stay and bacterial resistance in intensive care units in Ecuador: International Nosocomial Infection Control Consortium’s findings

PubMed Central

Salgado Yepez, Estuardo; Bovera, Maria M; Rosenthal, Victor D; González Flores, Hugo A; Pazmiño, Leonardo; Valencia, Francisco; Alquinga, Nelly; Ramirez, Vanessa; Jara, Edgar; Lascano, Miguel; Delgado, Veronica; Cevallos, Cristian; Santacruz, Gasdali; Pelaéz, Cristian; Zaruma, Celso; Barahona Pinto, Diego

2017-01-01

AIM To report the results of the International Nosocomial Infection Control Consortium (INICC) study conducted in Quito, Ecuador. METHODS A device-associated healthcare-acquired infection (DA-HAI) prospective surveillance study conducted from October 2013 to January 2015 in 2 adult intensive care units (ICUs) from 2 hospitals using the United States Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) definitions and INICC methods. RESULTS We followed 776 ICU patients for 4818 bed-days. The central line-associated bloodstream infection (CLABSI) rate was 6.5 per 1000 central line (CL)-days, the ventilator-associated pneumonia (VAP) rate was 44.3 per 1000 mechanical ventilator (MV)-days, and the catheter-associated urinary tract infection (CAUTI) rate was 5.7 per 1000 urinary catheter (UC)-days. CLABSI and CAUTI rates in our ICUs were similar to INICC rates [4.9 (CLABSI) and 5.3 (CAUTI)] and higher than NHSN rates [0.8 (CLABSI) and 1.3 (CAUTI)] - although device use ratios for CL and UC were higher than INICC and CDC/NSHN’s ratios. By contrast, despite the VAP rate was higher than INICC (16.5) and NHSN’s rates (1.1), MV DUR was lower in our ICUs. Resistance of A. baumannii to imipenem and meropenem was 75.0%, and of Pseudomonas aeruginosa to ciprofloxacin and piperacillin-tazobactam was higher than 72.7%, all them higher than CDC/NHSN rates. Excess length of stay was 7.4 d for patients with CLABSI, 4.8 for patients with VAP and 9.2 for patients CAUTI. Excess crude mortality in ICUs was 30.9% for CLABSI, 14.5% for VAP and 17.6% for CAUTI. CONCLUSION DA-HAI rates in our ICUs from Ecuador are higher than United States CDC/NSHN rates and similar to INICC international rates. PMID:28289522

Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics.

PubMed

Parvinian, Bahram; Scully, Christopher; Wiyor, Hanniebey; Kumar, Allison; Weininger, Sandy

2018-06-01

Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advocates, academia, and other government agencies navigate the regulatory landscape for medical devices. This is particularly important for innovative physiological closed-loop controlled (PCLC) devices used in critical care environments, such as intensive care units, emergency settings, and battlefield environments. CDRH's current working definition of a PCLC medical device is a medical device that incorporates physiological sensor(s) for automatic manipulation of a physiological variable through actuation of therapy that is conventionally made by a clinician. These emerging devices enable automatic therapy delivery and may have the potential to revolutionize the standard of care by ensuring adequate and timely therapy delivery with improved performance in high workload and high-stress environments. For emergency response and military applications, automatic PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during surge scenarios (ie, events that exceed the capability of the normal medical infrastructure). CDRH held an open public workshop on October 13 and 14, 2015 with the aim of fostering an open discussion on design, implementation, and evaluation considerations associated with PCLC devices used in critical care environments. CDRH is currently developing regulatory recommendations and guidelines that will facilitate innovation for PCLC devices. This article highlights the contents of the white paper that was central to the workshop and focuses on the ensuing discussions regarding the engineering, clinical, and human factors considerations.

Suboptimal Addiction Interventions for Patients Hospitalized with Injection Drug Use-Associated Infective Endocarditis.

PubMed

Rosenthal, Elana S; Karchmer, Adolf W; Theisen-Toupal, Jesse; Castillo, Roger Araujo; Rowley, Chris F

2016-05-01

Infective endocarditis is a serious infection, often resulting from injection drug use. Inpatient treatment regularly focuses on management of infection without attention to the underlying addiction. We aimed to determine the addiction interventions done in patients hospitalized with injection drug use-associated infective endocarditis. This is a retrospective review of patients hospitalized with injection drug use-associated infective endocarditis from January, 2004 through August, 2014 at a large academic tertiary care center in Boston, Massachusetts. For the initial and subsequent admissions, data were collected regarding addiction interventions, including consultation by social work, addiction clinical nurse and psychiatry, documentation of addiction in the discharge summary plan, plan for medication-assisted treatment and naloxone provision. There were 102 patients admitted with injection drug use-associated infective endocarditis, 50 patients (49.0%) were readmitted and 28 (27.5%) patients had ongoing injection drug use at readmission. At initial admission, 86.4% of patients had social work consultation, 23.7% had addiction consultation, and 24.0% had psychiatry consultation. Addiction was mentioned in 55.9% of discharge summary plans, 7.8% of patients had a plan for medication-assisted treatment, and naloxone was never prescribed. Of 102 patients, 26 (25.5%) are deceased. The median age at death was 40.9 years (interquartile range 28.7-48.7). We found that patients hospitalized with injection drug use-associated infective endocarditis had high rates of readmission, recurrent infective endocarditis and death. Despite this, addiction interventions were suboptimal. Improved addiction interventions are imperative in the treatment of injection drug use-associated infective endocarditis. Copyright © 2016 Elsevier Inc. All rights reserved.

Body Implanted Medical Device Communications

NASA Astrophysics Data System (ADS)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

Integration of outpatient infectious diseases clinic pharmacy services and specialty pharmacy services for patients with HIV infection.

PubMed

Gilbert, Elise M; Gerzenshtein, Lana

2016-06-01

The integration of specialty pharmacy services and existing outpatient clinical pharmacy services within an infectious diseases (ID) clinic to optimize the care of patients with human immunodeficiency virus (HIV) infection is described. The management of HIV-infected patients is a highly specialized area of practice, often requiring use of complex medication regimens for reduction of HIV-associated morbidity and mortality prophylaxis and treatment of opportunistic infections, and prevention of HIV transmission. To maximize the effectiveness and safety of treatment with antiretroviral agents and associated pharmacotherapies, an interdisciplinary team is often involved in patient care. At Chicago-based Northwestern Medicine (NM), the outpatient ID clinic has long worked with an interdisciplinary care team including physicians, clinical pharmacists, nurses, and social workers to care for patients with HIV infection. In April 2014, specialty pharmacy services for patients with HIV infection were added to the NM ID clinic's care model to help maintain continuity of care and enhance patient follow-up. The care model includes well-defined roles for clinical pharmacists, pharmacy residents and students on rotation, and licensed pharmacy technicians. Specialty pharmacy services, including medication education, prescription fulfillment, assistance with medication access (e.g., navigation of financial assistance programs, completion of prior-authorization requests), and treatment monitoring, allow for closed-loop medication management of the HIV-infected patient population. Integration of specialty pharmacy services with the interdisciplinary care provided in the outpatient NM ID clinic has enhanced continuity of care for patients with HIV infection in terms of prescription filling, medication counseling, and adherence monitoring. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Animal models to investigate fungal biofilm formation.

PubMed

Chandra, Jyotsna; Pearlman, Eric; Ghannoum, Mahmoud A

2014-01-01

Microbial biofilms play an essential role in several infectious diseases and are defined as extensive communities of sessile organisms irreversibly associated with a surface, encased within a polysaccharide-rich extracellular matrix (ECM), and exhibiting enhanced resistance to antimicrobial drugs. Forming a biofilm provides the microbes protection from environmental stresses due to contaminants, nutritional depletion, or imbalances, but is dangerous to human health due to their inherent robustness and elevated resistance.The use of indwelling medical devices (e.g., central venous catheters, CVCs) in current therapeutic practice is associated with 80-90 % of hospital-acquired bloodstream and deep tissue infections. Most cases of catheter-related bloodstream infections (CRBSIs) involve colonization of microorganisms on catheter surfaces where they form a biofilm. Additionally, Fusarium solani and F. oxysporum were the causative organisms of the 2005/2006 outbreak of contact lens-associated fungal keratitis in the United States, Europe, the UK, and Singapore, and these infections involved formation of biofilms on contact lens. Fungal biofilm formation is studied using a number of techniques, involving the use of a wide variety of substrates and growth conditions. In vitro techniques involving the use of confocal scanning laser/scanning electron microscopy, metabolic activity assay, dry weight measurements, and antifungal susceptibility assays are increasingly used by investigators to quantify and evaluate biofilm morphology. However, there are not many in vivo models used to validate biofilm-associated infections. In this protocol, we describe a clinically relevant rabbit model of C. albicans biofilm-associated catheter infection to evaluate the morphology, topography, and architecture of fungal biofilms. We also describe a murine model of contact lens-associated Fusarium keratitis.Evaluation of the formation of fungal biofilms on catheters in vivo, their analysis using scanning electron microscopy (SEM) and quantitative catheter culture (QCC), and treatment of biofilms using antimicrobial lock therapy can be completed in ~20-25 days using the described methods. The rabbit model has utility in evaluating the efficacy of lock solutions. In addition, the murine model of contact lens-associated Fusarium keratitis enables characterizing/comparing the formation of Fusarium biofilms on contact lenses in vitro and determining their role in vivo.

Crystal methamphetamine use and HIV medical outcomes among HIV-infected men who have sex with men accessing support services in New York.

PubMed

Feldman, Matthew B; Thomas, Jacinthe A; Alexy, Emily R; Irvine, Mary K

2015-02-01

Drug use poses multiple challenges to maintaining physical health among HIV-infected individuals, particularly with regard to disease progression. Few studies, however, have examined the association between the use of crystal methamphetamine ("crystal meth") and HIV disease progression specifically among HIV-infected men who have sex with men (MSM). Understanding this relationship among HIV-infected MSM is particularly critical because of the high rates of crystal meth use reported in the population. Associations between recent crystal meth use and poor HIV medical outcomes (viral load>200 copies/mL, CD4 count <350 cells/mm(3)) were analyzed for 2896 HIV-infected MSM enrolled in Ryan White Part A programs in the greater New York metropolitan area between November 2010 and June 2012. Crystal meth use (reported by 4%) was independently associated with unsuppressed viral load (AOR=1.8, CI=1.1-2.9) in multivariate analyses controlling for sociodemographic characteristics. There was no significant relationship between crystal meth use and low CD4 counts. To date, little research has examined how crystal meth use influences HIV medical outcomes among HIV-infected MSM. This analysis showed a significant independent association between crystal meth use and unsuppressed viral load among MSM in an HIV service population. Future studies should examine biological and psychosocial mediators, moderators and confounders of this relationship to inform intervention development for MSM crystal meth users in HIV care settings. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Penile Prosthesis Surgery: Current Recommendations From the International Consultation on Sexual Medicine.

PubMed

Levine, Laurence A; Becher, Edgardo; Bella, Anthony; Brant, William; Kohler, Tobias; Martinez-Salamanca, Juan Ignacio; Trost, Landon; Morey, Allen

2016-04-01

Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.

PubMed

Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E

2018-02-01

The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Global Health Estimate of Invasive Mycobacterium chimaera Infections Associated with Heater-Cooler Devices in Cardiac Surgery.

PubMed

Sommerstein, Rami; Hasse, Barbara; Marschall, Jonas; Sax, Hugo; Genoni, Michele; Schlegel, Matthias; Widmer, Andreas F

2018-03-01

Investigations of a worldwide epidemic of invasive Mycobacterium chimaera associated with heater-cooler devices in cardiac surgery have been hampered by low clinical awareness and challenging diagnoses. Using data from Switzerland, we estimated the burden of invasive M. chimaera to be 156-282 cases/year in 10 major cardiac valve replacement market countries.

Identification of proteins involved in the adhesionof Candida species to different medical devices.

PubMed

Núñez-Beltrán, Arianna; López-Romero, Everardo; Cuéllar-Cruz, Mayra

2017-06-01

Adhesion is the first step for Candida species to form biofilms on medical devices implanted in the human host. Both the physicochemical nature of the biomaterial and cell wall proteins (CWP) of the pathogen play a determinant role in the process. While it is true that some CWP have been identified in vitro, little is known about the CWP of pathogenic species of Candida involved in adhesion. On this background, we considered it important to investigate the potential role of CWP of C. albicans, C. glabrata, C. krusei and C. parapsilosis in adhesion to different medical devices. Our results indicate that the four species strongly adher to polyvinyl chloride (PVC) devices, followed by polyurethane and finally by silicone. It was interesting to identify fructose-bisphosphate aldolase (Fba1) and enolase 1 (Eno1) as the CWP involved in adhesion of C. albicans, C. glabrata and C. krusei to PVC devices whereas phosphoglycerate kinase (Pgk) and Eno1 allow C. parapsilosis to adher to silicone-made implants. Results presented here suggest that these CWP participate in the initial event of adhesion and are probably followed by other proteins that covalently bind to the biomaterial thus providing conditions for biofilm formation and eventually the onset of infection. Copyright © 2017 Elsevier Ltd. All rights reserved.

Health care-associated infection outbreaks in pediatric long-term care facilities.

PubMed

Murray, Meghan T; Pavia, Marianne; Jackson, Olivia; Keenan, Mary; Neu, Natalie M; Cohen, B; Saiman, Lisa; Larson, Elaine L

2015-07-01

Children in pediatric long-term care facilities (pLTCFs) have complex medical conditions and increased risk for health care-associated infections (HAIs). We performed a retrospective study from January 2010-December 2013 at 3 pLTCFs to describe HAI outbreaks and associated infection control interventions. There were 62 outbreaks involving 700 cases in residents and 250 cases in staff. The most common interventions were isolation precautions and education and in-services. Further research should examine interventions to limit transmission of infections in pLTCFs. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Patient characteristics and costs associated with dyslipidaemia and related conditions in HIV-infected patients: a retrospective cohort study.

PubMed

Richter, A; Pladevall, M; Manjunath, R; Lafata, J E; Xi, H; Simpkins, J; Brar, I; Markowitz, N; Iloeje, U H; Irish, W

2005-03-01

Metabolic abnormalities are common in HIV-infected individuals and, although multifactorial in origin, have been strongly associated with antiretroviral therapy. Using automated claims and clinical databases, combined with medical record data, we evaluated the burden of dyslipidaemia (DYS) and associated metabolic abnormalities among a cohort of 900 HIV-infected patients aged 18 years and older who received their care from a large multispecialty medical group between 1 January 1996 and 30 June 2002. A Cox proportional hazards model for DYS was developed. Resource use was compiled and subsequently costed with stratification to account for variable length of follow-up. Mean follow-up time was 3.3 years. DYS was present in 54% of the cohort and 3.4% experienced a cardiovascular (CV) event. Both unadjusted and adjusted results found patients with dyslipidaemia and cardiovascular events significantly more likely to have received protease inhibitor (PI) treatment for longer periods of time. In the Cox proportional hazards model the following factors were significantly associated with an increased risk for DYS: older age, white race, PI use and male sex. Diagnoses of hypertension, hepatitis C virus infection, depression or opportunistic infections were all negatively associated with a DYS diagnosis. When controlled for length of follow up, patients with DYS (and no CV-related events) incurred greater median and mean total average costs than patients without DYS or CV-related events. For patients with more than 2 years of follow up, these total cost differences were statistically significant (P<0.05). These findings indicate that DYS is common among patients with HIV infection and is associated with increased use of medical resources.

Outcomes for Patients With Diabetes After Continuous-Flow Left Ventricular Assist Device Implantation.

PubMed

Vest, Amanda R; Mistak, Stanley M; Hachamovitch, Rory; Mountis, Maria M; Moazami, Nader; Young, James B

2016-10-01

Diabetes mellitus (DM) is a risk factor for mortality among patients with heart failure as well as for patients who undergo cardiothoracic surgery. However it is unknown whether DM is associated with increased mortality or major complications during continuous-flow left ventricular assist device (CF-LVAD) support. We retrospectively reviewed 300 consecutive adults who received CF-LVADs at a single center in the years 2006-2013; 129 patients had DM before LVAD, as defined by American Diabetes Association criteria (HbA1c ≥6.5% and/or taking DM medications). Compared with the non-DM group, DM patients were older, with a higher pre-LVAD body mass index, more ischemic heart failure etiology, and higher pre-LVAD creatinine. Ninety-three patients died on LVAD support, 43 with DM and 50 without DM (P = .4526). After control for 9 covariates in a Cox proportional hazards model, DM was unassociated with all-cause mortality (hazard ratio 0.883, 95% confidence interval 0.571-1.366; P = .5768). Diabetes was also unassociated with the adverse event end points of stroke/transient ischemic attack, intracerebral hemorrhage, pump thrombosis, and device-related infections. Diabetes is common in LVAD recipients (43% of the present cohort) but does not increase mortality or rates of major adverse events during CF-LVAD support. Copyright © 2016 Elsevier Inc. All rights reserved.

To develop an aerosoling immunomagnetic device for rapid medical diagnosis from clinical samples. Midterm report, 26 July 1993-30 September 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bruno, J.G.; Kilian, J.P.; Moore, A.S.

1994-10-15

A system for immunomagnetic capture, fluorescent staining, purification and diagnosis of at least bacterial (if not viral) septicemias is described. The system consists of a semi-automated computer-controlled immunomagnetic column collector and washing device as well as a semi-automated fluorescence microscope which will assist physicians in rapid diagnosis. This system will be used to investigate the efficiency of capture of nonpathogenic (Sterne) Anthrax vegetative cells and spores and possibly other agents of septicemia and body fluid infection.

Zinc oxide nanoparticle suspensions and layer-by-layer coatings inhibit staphylococcal growth.

PubMed

McGuffie, Matthew J; Hong, Jin; Bahng, Joong Hwan; Glynos, Emmanouil; Green, Peter F; Kotov, Nicholas A; Younger, John G; VanEpps, J Scott

2016-01-01

Despite a decade of engineering and process improvements, bacterial infection remains the primary threat to implanted medical devices. Zinc oxide nanoparticles (ZnO-NPs) have demonstrated antimicrobial properties. Their microbial selectivity, stability, ease of production, and low cost make them attractive alternatives to silver NPs or antimicrobial peptides. Here we sought to (1) determine the relative efficacy of ZnO-NPs on planktonic growth of medically relevant pathogens; (2) establish the role of bacterial surface chemistry on ZnO-NP effectiveness; (3) evaluate NP shape as a factor in the dose-response; and (4) evaluate layer-by-layer (LBL) ZnO-NP surface coatings on biofilm growth. ZnO-NPs inhibited bacterial growth in a shape-dependent manner not previously seen or predicted. Pyramid shaped particles were the most effective and contrary to previous work, larger particles were more effective than smaller particles. Differential susceptibility of pathogens may be related to their surface hydrophobicity. LBL ZnO-NO coatings reduced staphylococcal biofilm burden by >95%. From the Clinical Editor: The use of medical implants is widespread. However, bacterial colonization remains a major concern. In this article, the authors investigated the use of zinc oxide nanoparticles (ZnO-NPs) to prevent bacterial infection. They showed in their experiments that ZnO-NPs significantly inhibited bacterial growth. This work may present a new alternative in using ZnO-NPs in medical devices. Copyright © 2015 Elsevier Inc. All rights reserved.

The Respiratory Protection Effectiveness Clinical Trial (ResPECT): a cluster-randomized comparison of respirator and medical mask effectiveness against respiratory infections in healthcare personnel.

PubMed

Radonovich, Lewis J; Bessesen, Mary T; Cummings, Derek A; Eagan, Aaron; Gaydos, Charlotte; Gibert, Cynthia; Gorse, Geoffrey J; Nyquist, Ann-Christine; Reich, Nicholas G; Rodrigues-Barradas, Maria; Savor-Price, Connie; Shaffer, Ronald E; Simberkoff, Michael S; Perl, Trish M

2016-06-02

Although N95 filtering facepiece respirators and medical masks are commonly used for protection against respiratory infections in healthcare settings, more clinical evidence is needed to understand the optimal settings and exposure circumstances for healthcare personnel to use these devices. A lack of clinically germane research has led to equivocal, and occasionally conflicting, healthcare respiratory protection recommendations from public health organizations, professional societies, and experts. The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is a prospective comparison of respiratory protective equipment to be conducted at multiple U.S. study sites. Healthcare personnel who work in outpatient settings will be cluster-randomized to wear N95 respirators or medical masks for protection against infections during respiratory virus season. Outcome measures will include laboratory-confirmed viral respiratory infections, acute respiratory illness, and influenza-like illness. Participant exposures to patients, coworkers, and others with symptoms and signs of respiratory infection, both within and beyond the workplace, will be recorded in daily diaries. Adherence to study protocols will be monitored by the study team. ResPECT is designed to better understand the extent to which N95s and MMs reduce clinical illness among healthcare personnel. A fully successful study would produce clinically relevant results that help clinician-leaders make reasoned decisions about protection of healthcare personnel against occupationally acquired respiratory infections and prevention of spread within healthcare systems. The trial is registered at clinicaltrials.gov, number NCT01249625 (11/29/2010).

Singled out?

PubMed

Waller, Frank

2004-03-01

The increasing use of single use medical devices is being driven by a growing awareness of iatrogenic (from the Greek; caused by the doctor) and nosocomial infections. Public health perceptions relating to transmissible spongiform encephalopathies, specifically variant Creutzfeldt-Jakob disease (vCJD), the Human Immunodeficiency Virus (HIV) and Hepatitis B are high on the political agenda and a matter of concern to healthcare professionals.

APIC position paper: Safe injection, infusion, and medication vial practices in health care.

PubMed

Dolan, Susan A; Arias, Kathleen Meehan; Felizardo, Gwen; Barnes, Sue; Kraska, Susan; Patrick, Marcia; Bumsted, Amelia

2016-07-01

The transmission of bloodborne viruses and other microbial pathogens to patients during routine health care procedures continues to occur because of the use of improper injection, infusion, medication vial, and point-of-care testing practices by health care personnel. These unsafe practices occur in various clinical settings and result in unacceptable and devastating events for patients. This document updates the Association for Professionals in Infection Control and Epidemiology 2010 position paper on safe injection, infusion, and medication vial practices in health care. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Scaffold-based Anti-infection Strategies in Bone Repair

PubMed Central

Johnson, Christopher T.; García, Andrés J.

2014-01-01

Bone fractures and non-union defects often require surgical intervention where biomaterials are used to correct the defect, and approximately 10% of these procedures are compromised by bacterial infection. Currently, treatment options are limited to sustained, high doses of antibiotics and surgical debridement of affected tissue, leaving a significant, unmet need for the development of therapies to combat device-associated biofilm and infections. Engineering implants to prevent infection is a desirable material characteristic. Tissue engineered scaffolds for bone repair provide a means to both regenerate bone and serve as a base for adding antimicrobial agents. Incorporating anti-infection properties into regenerative medicine therapies could improve clinical outcomes and reduce the morbidity and mortality associated with biomaterial implant-associated infections. This review focuses on current animal models and technologies available to assess bone repair in the context of infection, antimicrobial agents to fight infection, the current state of antimicrobial scaffolds, and future directions in the field. PMID:25476163

A comparative study: do "clickers" increase student engagement in multidisciplinary clinical microbiology teaching?

PubMed

Stevens, Niall T; McDermott, Hélène; Boland, Fiona; Pawlikowska, Teresa; Humphreys, Hilary

2017-04-08

Audience response devices, or "clickers", have been used in the education of future healthcare professionals for several years with varying success. They have been reported to improve the learning experience by promoting engagement and knowledge retention. In 2014, our department evaluated the use of "clickers" in a newly introduced multidisciplinary approach to teaching large groups of third year medical students clinical cases developed around a microbiology theme. Six multidisciplinary teaching sessions covering community-acquired pneumonia, tuberculosis, infective endocarditis, peritonitis, bloodstream infection with pyelonephritis and bacterial meningitis were included in the study. Three involved the use of the "clickers" and three did not. Consenting undergraduate students attended the designated classes and afterwards answered a short online quiz relating to the session. Students also answered a short questionnaire about the "clickers" to gauge their attitudes on the use of these devices. Of 310 students, 294 (94.8%) agreed to participate in the study. Interestingly, the grades of online quizzes after a session where a "clicker" was used were slightly lower. Looking only at the grades of students who engaged completely with the process (n = 19), there was no statistical difference to suggest that the devices had a positive or negative impact on knowledge retention. However, student attitudes to using the devices were positive overall. Fifty-five percent strongly agreed and 27% agreed that teaching sessions where the "clickers" were used were more engaging. Thirty-four percent strongly agreed and 36% agreed that the "clickers" made important concepts more memorable and 54% felt the device enhanced their understanding of the topic being covered. Overall, it appears that "clickers" help in improving student engagement in large classroom environments, enhance the learning experience, and are received positively by medical students but their impact on knowledge retention is variable.

The association of psychiatric disorders and HIV infection in the correctional setting.

PubMed

Baillargeon, Jacques; Ducate, Suzanne; Pulvino, John; Bradshaw, Patrick; Murray, Owen; Olvera, Rene

2003-10-01

Psychiatric disorders, such as bipolar disorder, schizophrenia, and depression, have been associated with both HIV-associated risk behaviors and HIV infection. While the US prison population is reported to exhibit elevated rates of HIV/AIDS and most psychiatric disorders, scarce information currently exists on the association of these conditions in the prison setting. The present study examined the association of six major psychiatric disorders with HIV infection in one of the nation's largest prison populations. The study population consisted of 336,668 Texas Department of Criminal Justice inmates who were incarcerated for any duration between January 1, 1999 and December 31, 2001. Information on medical conditions and sociodemographic factors was obtained from an institution-wide medical information system. Inmates diagnosed with HIV infection exhibited elevated rates of major depression, dysthymia, bipolar disorder, schizophrenia, schizoaffective disorder, and non-schizophrenic psychotic disorder. These rates persisted in stratified analyses and in a multivariate analysis that statistically adjusted for gender, race, and age category. The present cross-sectional study's finding of a positive association between HIV infection and psychiatric diagnoses among inmates holds both clinical and public health relevance. It will be important for future investigations to prospectively assess the underlying mechanisms of these associations in the correctional setting.

Deadly distractions.

PubMed

Zuzek, Crystal

2013-04-01

In 2011, the National Transportation Safety Board urged all states to ban the use of portable electronic devices while driving, including hand-held and hands-free devices. Texting while driving concerns several Texas legislators, who have filed bills, backed by the Texas Medical Association, to ban the practice. TMA physicians recognize that the use of hand-held and hands-free devices and other factors associated with distracted driving affect their patients' safety.

Structure-based discovery of inhibitors of the YycG histidine kinase: New chemical leads to combat Staphylococcus epidermidis infections

PubMed Central

Qin, Zhiqiang; Zhang, Jian; Xu, Bin; Chen, Lili; Wu, Yang; Yang, Xiaomei; Shen, Xu; Molin, Soeren; Danchin, Antoine; Jiang, Hualiang; Qu, Di

2006-01-01

Background Coagulase-negative Staphylococcus epidermidis has become a major frequent cause of infections in relation to the use of implanted medical devices. The pathogenicity of S. epidermidis has been attributed to its capacity to form biofilms on surfaces of medical devices, which greatly increases its resistance to many conventional antibiotics and often results in chronic infection. It has an urgent need to design novel antibiotics against staphylococci infections, especially those can kill cells embedded in biofilm. Results In this report, a series of novel inhibitors of the histidine kinase (HK) YycG protein of S. epidermidis were discovered first using structure-based virtual screening (SBVS) from a small molecular lead-compound library, followed by experimental validation. Of the 76 candidates derived by SBVS targeting of the homolog model of the YycG HATPase_c domain of S. epidermidis, seven compounds displayed significant activity in inhibiting S. epidermidis growth. Furthermore, five of them displayed bactericidal effects on both planktonic and biofilm cells of S. epidermidis. Except for one, the compounds were found to bind to the YycG protein and to inhibit its auto-phosphorylation in vitro, indicating that they are potential inhibitors of the YycG/YycF two-component system (TCS), which is essential in S. epidermidis. Importantly, all these compounds did not affect the stability of mammalian cells nor hemolytic activities at the concentrations used in our study. Conclusion These novel inhibitors of YycG histidine kinase thus are of potential value as leads for developing new antibiotics against infecting staphylococci. The structure-based virtual screening (SBVS) technology can be widely used in screening potential inhibitors of other bacterial TCSs, since it is more rapid and efficacious than traditional screening technology. PMID:17094812

Methicillin-resistant Staphylococcus aureus and Acinetobacter baumannii on computer interface surfaces of hospital wards and association with clinical isolates

PubMed Central

2009-01-01

Background Computer keyboards and mice are potential reservoirs of nosocomial pathogens, but routine disinfection for non-water-proof computer devices is a problem. With better hand hygiene compliance of health-care workers (HCWs), the impact of these potential sources of contamination on clinical infection needs to be clarified. Methods This study was conducted in a 1600-bed medical center of southern Taiwan with 47 wards and 282 computers. With education and monitoring program of hand hygiene for HCWs, the average compliance rate was 74% before our surveillance. We investigated the association of methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Acinetobacter baumannii, three leading hospital-acquired pathogens, from ward computer keyboards, mice and from clinical isolates in non-outbreak period by pulsed field gel electrophoresis and antibiogram. Results Our results revealed a 17.4% (49/282) contamination rate of these computer devices by S. aureus, Acinetobacter spp. or Pseudomonas spp. The contamination rates of MRSA and A. baumannii in the ward computers were 1.1% and 4.3%, respectively. No P. aeruginosa was isolated. All isolates from computers and clinical specimens at the same ward showed different pulsotypes. However, A. baumannii isolates on two ward computers had the same pulsotype. Conclusion With good hand hygiene compliance, we found relatively low contamination rates of MRSA, P. aeruginosa and A. baumannii on ward computer interface, and without further contribution to nosocomial infection. Our results suggested no necessity of routine culture surveillance in non-outbreak situation. PMID:19796381

Careers in Medical Physics and the American Association of Physicists in Medicine

NASA Astrophysics Data System (ADS)

Amols, Howard

2006-03-01

The American Association of Physicists in Medicine (AAPM), a member society of the AIP is the largest professional society of medical physicists in the world with nearly 5700 members. Members operate in medical centers, university and community hospitals, research laboratories, industry, and private practice. Medical physics specialties include radiation therapy physics, medical diagnostic and imaging physics, nuclear medicine physics, and medical radiation safety. The majority of AAPM members is based in hospital departments of radiation oncology or radiology and provide technical support for patient diagnosis and treatment in a clinical environment. Job functions include support of clinical care, calibration and quality assurance of medical devices such as linear accelerators for cancer therapy, CT, PET, MRI, and other diagnostic imaging devices, research, and teaching. Pathways into a career in medical physics require an advanced degree in medical physics, physics, engineering, or closely related field, plus clinical training in one or more medical physics specialties (radiation therapy physics, imaging physics, or radiation safety). Most clinically based medical physicists also obtain certification from the American Board of Radiology, and some states require licensure as well.

Antibacterial and antibiofouling clay nanotube-silicone composite.

PubMed

Boyer, C J; Ambrose, J; Das, S; Humayun, A; Chappidi, D; Giorno, R; Mills, D K

2018-01-01

Invasive medical devices are used in treating millions of patients each day. Bacterial adherence to their surface is an early step in biofilm formation that may lead to infection, health complications, longer hospital stays, and death. Prevention of bacterial adherence and biofilm development continues to be a major healthcare challenge. Accordingly, there is a pressing need to improve the anti-microbial properties of medical devices. Polydimethylsiloxane (PDMS) was doped with halloysite nanotubes (HNTs), and the PDMS-HNT composite surfaces were coated with PDMS-b-polyethylene oxide (PEO) and antibacterials. The composite material properties were examined using SEM, energy dispersive spectroscopy, water contact angle measurements, tensile testing, UV-Vis spectroscopy, and thermal gravimetric analysis. The antibacterial potential of the PDMS-HNT composites was compared to commercial urinary catheters using cultures of E. coli and S. aureus . Fibrinogen adsorption studies were also performed on the PDMS-HNT-PEO composites. HNT addition increased drug load during solvent swelling without reducing material strength. The hydrophilic properties provided by PEO were maintained after HNT addition, and the composites displayed protein-repelling properties. Additionally, composites showed superiority over commercial catheters at inhibiting bacterial growth. PDMS-HNT composites showed superiority regarding their efficacy at inhibiting bacterial growth, in comparison to commercial antibacterial catheters. Our data suggest that PDMS-HNT composites have potential as a coating material for anti-bacterial invasive devices and in the prevention of institutional-acquired infections.

Antibacterial and antibiofouling clay nanotube–silicone composite

PubMed Central

Boyer, CJ; Ambrose, J; Das, S; Humayun, A; Chappidi, D; Giorno, R; Mills, DK

2018-01-01

Introduction Invasive medical devices are used in treating millions of patients each day. Bacterial adherence to their surface is an early step in biofilm formation that may lead to infection, health complications, longer hospital stays, and death. Prevention of bacterial adherence and biofilm development continues to be a major healthcare challenge. Accordingly, there is a pressing need to improve the anti-microbial properties of medical devices. Materials and Methods Polydimethylsiloxane (PDMS) was doped with halloysite nanotubes (HNTs), and the PDMS-HNT composite surfaces were coated with PDMS-b-polyethylene oxide (PEO) and antibacterials. The composite material properties were examined using SEM, energy dispersive spectroscopy, water contact angle measurements, tensile testing, UV-Vis spectroscopy, and thermal gravimetric analysis. The antibacterial potential of the PDMS-HNT composites was compared to commercial urinary catheters using cultures of E. coli and S. aureus. Fibrinogen adsorption studies were also performed on the PDMS-HNT-PEO composites. Results HNT addition increased drug load during solvent swelling without reducing material strength. The hydrophilic properties provided by PEO were maintained after HNT addition, and the composites displayed protein-repelling properties. Additionally, composites showed superiority over commercial catheters at inhibiting bacterial growth. Conclusion PDMS-HNT composites showed superiority regarding their efficacy at inhibiting bacterial growth, in comparison to commercial antibacterial catheters. Our data suggest that PDMS-HNT composites have potential as a coating material for anti-bacterial invasive devices and in the prevention of institutional-acquired infections. PMID:29713206

Device-associated infections among neonatal intensive care unit patients: incidence and associated pathogens reported to the National Healthcare Safety Network, 2006-2008.

PubMed

Hocevar, Susan N; Edwards, Jonathan R; Horan, Teresa C; Morrell, Gloria C; Iwamoto, Martha; Lessa, Fernanda C

2012-12-01

To describe rates and pathogen distribution of device-associated infections (DAIs) in neonatal intensive care unit (NICU) patients and compare differences in infection rates by hospital type (children's vs general hospitals). Neonates in NICUs participating in the National Healthcare Safety Network from 2006 through 2008. We analyzed central line-associated bloodstream infections (CLABSIs), umbilical catheter-associated bloodstream infections (UCABs), and ventilator-associated pneumonia (VAP) among 304 NICUs. Differences in pooled mean incidence rates were examined using Poisson regression; nonparametric tests for comparing medians and rate distributions were used. Pooled mean incidence rates by birth weight category (750 g or less, 751-1,000 g, 1,001-1,500 g, 1,501-2,500 g, and more than 2,500 g, respectively) were 3.94, 3.09, 2.25, 1.90, and 1.60 for CLABSI; 4.52, 2.77, 1.70, 0.91, and 0.92 for UCAB; and 2.36, 2.08, 1.28, 0.86, and 0.72 for VAP. When rates of infection between hospital types were compared, only pooled mean VAP rates were significantly lower in children's hospitals than in general hospitals among neonates weighing 1,000 g or less; no significant differences in medians or rate distributions were noted. Pathogen frequencies were coagulase-negative staphylococci (28%), Staphylococcus aureus (19%), and Candida species (13%) for bloodstream infections and Pseudomonas species (16%), S. aureus (15%), and Klebsiella species (14%) for VAP. Of 673 S. aureus isolates with susceptibility results, 33% were methicillin resistant. Neonates weighing 750 g or less had the highest DAI incidence. With the exception of VAP, pooled mean NICU incidence rates did not differ between children's and general hospitals. Pathogens associated with these infections can pose treatment challenges; continued efforts at prevention need to be applied to all NICU settings.

Sustained Nitric Oxide-Releasing Nanoparticles Induce Cell Death in Candida albicans Yeast and Hyphal Cells, Preventing Biofilm Formation In Vitro and in a Rodent Central Venous Catheter Model

PubMed Central

Ahmadi, Mohammed S.; Lee, Hiu Ham; Sanchez, David A.; Friedman, Adam J.; Tar, Moses T.; Davies, Kelvin P.; Nosanchuk, Joshua D.

2016-01-01

Candida albicans is a leading nosocomial pathogen. Today, candidal biofilms are a significant cause of catheter infections, and such infections are becoming increasingly responsible for the failure of medical-implanted devices. C. albicans forms biofilms in which fungal cells are encased in an autoproduced extracellular polysaccharide matrix. Consequently, the enclosed fungi are protected from antimicrobial agents and host cells, providing a unique niche conducive to robust microbial growth and a harbor for recurring infections. Here we demonstrate that a recently developed platform comprised of nanoparticles that release therapeutic levels of nitric oxide (NO-np) inhibits candidal biofilm formation, destroys the extracellular polysaccharide matrices of mature fungal biofilms, and hinders biofilm development on surface biomaterials such as the lumen of catheters. We found NO-np to decrease both the metabolic activity of biofilms and the cell viability of C. albicans in vitro and in vivo. Furthermore, flow cytometric analysis found NO-np to induce apoptosis in biofilm yeast cells in vitro. Moreover, NO-np behave synergistically when used in combination with established antifungal drug therapies. Here we propose NO-np as a novel treatment modality, especially in combination with standard antifungals, for the prevention and/or remediation of fungal biofilms on central venous catheters and other medical devices. PMID:26810653

Sustained Nitric Oxide-Releasing Nanoparticles Induce Cell Death in Candida albicans Yeast and Hyphal Cells, Preventing Biofilm Formation In Vitro and in a Rodent Central Venous Catheter Model.

PubMed

Ahmadi, Mohammed S; Lee, Hiu Ham; Sanchez, David A; Friedman, Adam J; Tar, Moses T; Davies, Kelvin P; Nosanchuk, Joshua D; Martinez, Luis R

2016-04-01

Candida albicansis a leading nosocomial pathogen. Today, candidal biofilms are a significant cause of catheter infections, and such infections are becoming increasingly responsible for the failure of medical-implanted devices.C. albicansforms biofilms in which fungal cells are encased in an autoproduced extracellular polysaccharide matrix. Consequently, the enclosed fungi are protected from antimicrobial agents and host cells, providing a unique niche conducive to robust microbial growth and a harbor for recurring infections. Here we demonstrate that a recently developed platform comprised of nanoparticles that release therapeutic levels of nitric oxide (NO-np) inhibits candidal biofilm formation, destroys the extracellular polysaccharide matrices of mature fungal biofilms, and hinders biofilm development on surface biomaterials such as the lumen of catheters. We found NO-np to decrease both the metabolic activity of biofilms and the cell viability ofC. albicansin vitroandin vivo Furthermore, flow cytometric analysis found NO-np to induce apoptosis in biofilm yeast cellsin vitro Moreover, NO-np behave synergistically when used in combination with established antifungal drug therapies. Here we propose NO-np as a novel treatment modality, especially in combination with standard antifungals, for the prevention and/or remediation of fungal biofilms on central venous catheters and other medical devices. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Exploring the applications of invertebrate host-pathogen models for in vivo biofilm infections.

PubMed

Edwards, Sarah; Kjellerup, Birthe V

2012-07-01

In the natural environment, microorganisms exist together in self-produced polymeric matrix biofilms. Often, several species, which can belong to both bacterial and fungal kingdoms, coexist and interact in ways which are not completely understood. Biofilm infections have become prevalent largely in medical settings because of the increasing use of indwelling medical devices such as catheters or prosthetics. These infections are resistant to common antimicrobial therapies because of the inherent nature of their structure. In terms of infectious biofilms, it is important to understand the microbe-microbe interactions and how the host immune system reacts in order to discover therapeutic targets. Currently, single infection immune response studies are thriving with the use of invertebrate models. This review highlights the advances in single microbial-host immune response as well as the promising aspects of polymicrobial biofilm study in five invertebrate models: Lemna minor (duckweed), Arabidopsis thaliana (thale cress), Dictyostelium discoideum (slime mold), Drosophila melanogaster (common fruit fly), and Caenorhabditis elegans (roundworm). © 2012 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved.

The influence of proton pump inhibitors and other commonly used medication on the gut microbiota.

PubMed

Imhann, Floris; Vich Vila, Arnau; Bonder, Marc Jan; Lopez Manosalva, Ailine G; Koonen, Debby P Y; Fu, Jingyuan; Wijmenga, Cisca; Zhernakova, Alexandra; Weersma, Rinse K

2017-07-04

Proton pump inhibitors (PPIs), used to treat gastro-esophageal reflux and prevent gastric ulcers, are among the most widely used drugs in the world. The use of PPIs is associated with an increased risk of enteric infections. Since the gut microbiota can, depending on composition, increase or decrease the risk of enteric infections, we investigated the effect of PPI-use on the gut microbiota. We discovered profound differences in the gut microbiota of PPI users: 20% of their bacterial taxa were statistically significantly altered compared with those of non-users. Moreover, we found that it is not only PPIs, but also antibiotics, antidepressants, statins and other commonly used medication were associated with distinct gut microbiota signatures. As a consequence, commonly used medications could affect how the gut microbiota resist enteric infections, promote or ameliorate gut inflammation, or change the host's metabolism. More studies are clearly needed to understand the role of commonly used medication in altering the gut microbiota as well as the subsequent health consequences.

Measuring the quality of infection control in Dutch nursing homes using a standardized method; the Infection prevention RIsk Scan (IRIS)

PubMed Central

2014-01-01

Background We developed a standardised method to assess the quality of infection control in Dutch Nursing Home (NH), based on a cross-sectional survey that visualises the results. The method was called the Infection control RIsk Infection Scan (IRIS). We tested the applicability of this new tool in a multicentre surveillance executed June and July 2012. Methods The IRIS includes two patient outcome-variables, i.e. the prevalence of healthcare associated infections (HAI) and rectal carriage of Extended-Spectrum Beta-Lactamase (ESBL) producing Enterobacteriaceae (ESBL-E); two patient-related risk factors, i.e. use of medical devices, and antimicrobial therapy; and three ward-related risk factors, i.e. environmental contamination, availability of local guidelines, and shortcomings in infection prevention preconditions. Results were categorised as low-, intermediate- and high risk, presented in an easy-to-read graphic risk spider-plot. This plot was given as feedback to management and healthcare workers of the NH. Results Large differences were found among most the variables in the different NH. Common shortcomings were the availability of infection control guidelines and the level of environmental cleaning. Most striking differences were observed in the prevalence of ESBL carriage, ranged from zero to 20.6% (p < 0.001). Conclusions The IRIS provided a rapid and easy to understand assessment of the infection control situation of the participating NH. The results can be used to improve the quality of infection control based on the specific needs of a NH but needs further validation in future studies. Repeated measurement can determine the effectiveness of the interventions. This makes the IRIS a useful tool for quality systems. PMID:25243067

Characterization of bacterial etiologic agents of biofilm formation in medical devices in critical care setup.

PubMed

Revdiwala, Sangita; Rajdev, Bhaumesh M; Mulla, Summaiya

2012-01-01

Background. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim. Critical care units of any healthcare institute follow various interventional strategies with use of medical devices for the management of critical cases. Bacteria contaminate medical devices and form biofilms. Material and Methods. The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate. All the isolates were subjected to antibiotic susceptibility testing by VITEK 2 compact automated systems. Results. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. A 16-20-hour incubation period was found to be optimum for biofilm development. 85% isolates were multidrug resistants and different mechanisms of bacterial drug resistance like ESBL, carbapenemase, and MRSA were found among isolates. Conclusion. Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Time and availability of glucose are important factors for assessment of biofilm progress. It is an alarm for those who are associated with invasive procedures and indwelling medical devices especially in patients with low immunity.

[Harm related to medical device use - legal and organisational risks].

PubMed

Hölscher, U M

2014-12-01

The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the systematic exchange of much safety-relevant information. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk management in health-care facilities without risk policy is dangerously incomplete. © Georg Thieme Verlag KG Stuttgart · New York.

Bioactive glass-coated silicone for percutaneous devices with improved tissue interaction

NASA Astrophysics Data System (ADS)

Marotta, James Scott

The discovery of bioactive glasses, in the early 1970s, has produced a material that develops a strong adherent bond with soft tissue. Many medical applications currently use silicone as an implant material, but are hindered by the formation of fibrous scar tissue surrounding the device. This fibrous scar tissue can lead to pain, infection, and/or extrusion of these devices. Bioactive ceramic materials are inherently brittle and can not be used in applications where a flexible material is needed. Therefore, the coating of existing flexible silicone medical devices, like catheters, with a bioactive glass material would give the advantages of both. The research presented here is of methods used to coat silicone with a bioactive glass powder (Bioglass°ler) and the in vitro testing of those coatings. The bioactivity of these coatings was measured using scanning electron microscopy, inductively coupled plasma spectroscopy, and Fourier transform infrared spectroscopy. It was observed that hydroxyapatite, a bonelike apatite, was formed in vitro on both the bioactive glass particles and the silicone surface between these particles. From these results a new theory was developed that related the distance between particles on a surface with the formation of an apatite layer. A critical distance between particles for the formation of an apatite layer on the substrate exists. This critical distance is a function of both the particle size and composition. In addition, a method to coat silicone catheters with bioactive glass powder is also discussed. This coated catheter could ultimately be used for improved percutaneous access in peritoneal dialysis. The one barrier to greater peritoneal dialysis use and the reason many patients switch from peritoneal to hemodialysis is recurrent exit-site infections and subsequent peritonitis. These infections are caused by the lack of a tight seal and downgrowth of epidermal tissue around the catheter at the catheter-skin interface.

Global Health Estimate of Invasive Mycobacterium chimaera Infections Associated with Heater–Cooler Devices in Cardiac Surgery

PubMed Central

Hasse, Barbara; Marschall, Jonas; Sax, Hugo; Genoni, Michele; Schlegel, Matthias; Widmer, Andreas F.

2018-01-01

Investigations of a worldwide epidemic of invasive Mycobacterium chimaera associated with heater–cooler devices in cardiac surgery have been hampered by low clinical awareness and challenging diagnoses. Using data from Switzerland, we estimated the burden of invasive M. chimaera to be 156–282 cases/year in 10 major cardiac valve replacement market countries. PMID:29460746

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1994-06-17

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

PubMed

Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

2018-05-01

Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p < 0.001). By contrast, ventricular assist device was associated with improved outcomes for ages 12-18 (hazard ratio, 0.3; 95% CI, 0.1-0.7; p = 0.003). For candidates 1-5 and 6-11 years old, there were no differences in outcomes between the ventricular assist device and MED groups (hazard ratio, 0.8 and 1.0, p = 0.43 and 0.9). The interaction between ventricular assist devices and age group was strongly significant (p < 0.001). This is a comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

Personal hygiene and methicillin-resistant Staphylococcus aureus infection.

PubMed

Turabelidze, George; Lin, Mei; Wolkoff, Barbara; Dodson, Douglas; Gladbach, Stephen; Zhu, Bao-Ping

2006-03-01

Methicillin-resistant Staphylococcus aureus (MRSA) infections outside the healthcare setting are an increasing concern. We conducted a case-control study to investigate an MRSA outbreak during 2002-2003 in a Missouri prison and focused on hygiene factors. Information on sociodemographic characteristics, medical history, and hygiene practices of study participants was collected by interview and medical record review. Logistic regression was used to evaluate MRSA infection in relation to hygiene factors individually and as a composite hygiene score; potential confounding factors were controlled. Selected MRSA isolates were analyzed by pulsed-field gel electrophoresis (PFGE). MRSA infection was significantly associated with a low composite hygiene score. Transmission among prison inmates appeared to be responsible for this outbreak. PFGE analysis showed that isolates were indistinguishable and associated with community-onset MRSA infections in other US prisons. Improving hygiene practices and environmental conditions may help prevent and interrupt future MRSA outbreaks in prison settings.

Improving acute care through use of medical device data.

PubMed

Kennelly, R J

1998-02-01

The Medical Information Bus (MIB) is a data communications standard for bedside patient connected medical devices. It is formally titled IEEE 1073 Standard for Medical Device Communications. MIB defines a complete seven layer communications stack for devices in acute care settings. All of the design trade-offs in writing the standard were taken to optimize performance in acute care settings. The key clinician based constraints on network performance are: (1) the network must be able to withstand multiple daily reconfigurations due to patient movement and condition changes; (2) the network must be 'plug-and-play' to allow clinicians to set up the network by simply plugging in a connector, taking no other actions; (3) the network must allow for unambiguous associations of devices with specific patients. A network of this type will be used by clinicians, thus giving complete, accurate, real time data from patient connected devices. This capability leads to many possible improvements in patient care and hospital cost reduction. The possible uses for comprehensive automatic data capture are only limited by imagination and creativity of clinicians adapting to the new hospital business paradigm.

Complications after surgery for lumbar stenosis in a veteran population.

PubMed

Deyo, Richard A; Hickam, David; Duckart, Jonathan P; Piedra, Mark

2013-09-01

Secondary analysis of the prospectively collected Veterans Affairs National Surgical Quality Improvement Program database. Determine rates of major medical complications, wound complications, and mortality among patients undergoing surgery for lumbar stenosis and examine risk factors for these complications. Surgery for spinal stenosis is concentrated among older adults, in whom complications are more frequent than among middle-aged patients. Many studies have focused on infections or device complications, but fewer studies have focused on major cardiopulmonary complications, using prospectively collected data. We identified patients who underwent surgery for a primary diagnosis of lumbar stenosis between 1998 and 2009 from the Veterans Affairs National Surgical Quality Improvement Program database. We created a composite of major medical complications, including acute myocardial infarction, stroke, pulmonary embolism, pneumonia, systemic sepsis, coma, and cardiac arrest. Among 12,154 eligible patients, major medical complications occurred in 2.1%, wound complications in 3.2%, and 90-day mortality in 0.6%. Major medical complications, but not wound complications, were strongly associated with age. American Society of Anesthesiologists (ASA) class was a strong predictor of complications. Insulin use, long-term corticosteroid use, and preoperative functional status were also significant predictors. Fusion procedures were associated with higher complication rates than with decompression alone. In logistic regressions, ASA class and age were the strongest predictors of major medical complications (odds ratio for ASA class 4 vs. class 1 or 2: 2.97; 95% confidence interval, 1.68-5.25; P = 0.0002). After adjustment for comorbidity, age, and functional status, fusion procedures remained associated with higher medical complication rates than were decompressions alone (odds ratio = 2.85; 95% confidence interval, 2.14-3.78; P < 0.0001). ASA class, age, type of surgery, insulin or corticosteroid use, and functional status were independent risk factors for major medical complications. These factors may help in selecting patients and planning procedures, improving patient safety.

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

PubMed Central

2014-01-01

Background According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). Methods The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. Results The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. Conclusions The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers. PMID:24655818

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit.

PubMed

Höss, Angelika; Lampe, Christian; Panse, Ralf; Ackermann, Benjamin; Naumann, Jakob; Jäkel, Oliver

2014-03-21

According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.

[Surveillance of healthcare associated infections, bacterial resistance and antibiotic consumption in high-complexity hospitals in Colombia, 2011].

PubMed

Villalobos, Andrea Patricia; Barrero, Liliana Isabel; Rivera, Sandra Milena; Ovalle, María Victoria; Valera, Danik

2014-04-01

Preventing healthcare associated infections, especially for resistant microorganisms, is a priority. In Colombia, the surveillance of such events was started through a national pilot study. To describe the epidemiology of device-associated infections, bacterial resistance and antibiotic consumption patterns in institutions with intensive care units (ICU), 2011. Descriptive observational study in 10 health institutions from three Colombian provinces: Antioquia, Valle del Cauca, and Bogotá. Surveillance protocols were designed and implemented by trained health professionals in each hospital. A web tool was designed for data reporting and analysis. Infection rates, device-use percentages and antibiotics defined daily dose (DDD) were calculated. Bacterial resistance phenotypes and profiles were reported and analyzed using Whonet 5.6. The most common event was bloodstream infection (rate > 4.8/1000 catheter-days) followed by ventilator-associated pneumonia (VAP) and catheter-related urinary tract infection, showing a wide variability among institutions. A high consumption of meropenem in the ICU (DDD 22.5/100 beds-day) was observed, as well as a high carbapenem resistance (> 11.6%) and a high frequency of third generation cephalosporins resistance (> 25.6%) in Enterobacteriaceae in ICUs and hospitalization wards. The percentage of methicillin-resistant Staphylococcus aureus was higher in hospitalization wards (34.3%). This is the first experience in measuring these events in Colombia. It is necessary to implement a national surveillance system aimed at guiding governmental and institutional actions oriented to infection prevention and control, to resistance management and to the promotion of antibiotics rational use, along with a follow-up and monitoring process.

New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: positron emission tomography in suspected cardiac implantable electronic device-related infection.

PubMed

Marciniak-Emmons, Marta Barbara; Sterliński, Maciej; Syska, Paweł; Maciąg, Aleksander; Farkowski, Michał Mirosław; Firek, Bohdan; Dziuk, Mirosław; Zając, Dariusz; Pytkowski, Mariusz; Szwed, Hanna

2016-01-01

Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753). The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland. Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT. Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.

Mycobacterium chimaera - a new threat for cardiac surgical patients?

PubMed

Jaworski, Radosław; Naumiuk, Łukasz; Paczkowski, Konrad; Formella, Danuta; Pek, Renata; Zieliński, Jacek; Haponiuk, Ireneusz

2017-03-01

An outbreak of invasive Mycobacterium chimaera infections associated with "heater-cooler" devices in patients treated with cardiac surgery has been described worldwide. The authors summarize the current state of knowledge regarding the epidemiology, diagnostics, treatment, and prevention of Mycobacterium chimaera infections in patients after cardiothoracic surgery.

Mobile device for disease diagnosis and data tracking in resource-limited settings.

PubMed

Chin, Curtis D; Cheung, Yuk Kee; Laksanasopin, Tassaneewan; Modena, Mario M; Chin, Sau Yin; Sridhara, Archana A; Steinmiller, David; Linder, Vincent; Mushingantahe, Jules; Umviligihozo, Gisele; Karita, Etienne; Mwambarangwe, Lambert; Braunstein, Sarah L; van de Wijgert, Janneke; Sahabo, Ruben; Justman, Jessica E; El-Sadr, Wafaa; Sia, Samuel K

2013-04-01

Collection of epidemiological data and care of patients are hampered by lack of access to laboratory diagnostic equipment and patients' health records in resource-limited settings. We engineered a low-cost mobile device that combines cell-phone and satellite communication technologies with fluid miniaturization techniques for performing all essential ELISA functions. We assessed the device's ability to perform HIV serodiagnostic testing in Rwanda and synchronize results in real time with electronic health records. We tested serum, plasma, and whole blood samples collected in Rwanda and on a commercially available sample panel made of mixed antibody titers. HIV testing on 167 Rwandan patients evaluated for HIV, viral hepatitis, and sexually transmitted infections yielded diagnostic sensitivity and specificity of 100% and 99%, respectively. Testing on 40 Rwandan whole-blood samples-using 1 μL of sample per patient-resulted in diagnostic sensitivity and specificity of 100% and 100%. The mobile device also successfully transmitted all whole-blood test results from a Rwandan clinic to a medical records database stored on the cloud. For all samples in the commercial panel, the device produced results in agreement with a leading ELISA test, including detection of weakly positive samples that were missed by existing rapid tests. The device operated autonomously with minimal user input, produced each result 10 times faster than benchtop ELISA, and consumed as little power as a mobile phone. A low-cost mobile device can perform a blood-based HIV serodiagnostic test with laboratory-level accuracy and real-time synchronization of patient health record data. © 2012 American Association for Clinical Chemistry

[Skin symptoms associated with human immunodeficiency virus infection].

PubMed

Tamási, Béla; Marschalkó, Márta; Kárpáti, Sarolta

2015-01-04

The recently observed accelerated increase of human immunodeficiency virus infection in Hungary poses a major public concern for the healthcare system. Given the effective only but not the curative therapy, prevention should be emphasized. Current statistics estimate that about 50% of the infected persons are not aware of their human immunodeficiency virus-positivity. Thus, early diagnosis of the infection by serological screening and timely recognition of the disease-associated symptoms are crucial. The authors' intention is to facilitate early infection detection with this review on human immunodeficiency virus-associated skin symptoms, and highlight the significance of human immunodeficiency virus care in the everyday medical practice.

Response to Alert on Possible Infections with Mycobacterium chimaera From Contaminated Heater-Cooler Devices in Hospitals Participating in the Canadian Nosocomial Infection Surveillance Program (CNISP).

PubMed

Mertz, Dominik; Macri, Jennifer; Hota, Susy; Amaratunga, Kanchana; Davis, Ian; Johnston, Lynn; Lee, Bonita; Pelude, Linda; Science, Michelle; Smith, Stephanie; Wong, Alice

2018-04-01

Canadian hospitals were made aware of the risk of Mycobacterium chimaera infection associated with heater-cooler units (HCUs) through alerts issued by the US food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC). In response, most hospitals conducted retrospective reviews for infections, informed exposed patients, and initiated a requirement for informed consent with HCU use. Infect Control Hosp Epidemiol 2018;39:482-484.

Bluetooth Communication for Battery Powered Medical Devices

NASA Astrophysics Data System (ADS)

Babušiak, Branko; Borik, Štefan

2016-01-01

wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

Antimicrobial resistance challenged with metal-based antimicrobial macromolecules.

PubMed

Abd-El-Aziz, Alaa S; Agatemor, Christian; Etkin, Nola

2017-02-01

Antimicrobial resistance threatens the achievements of science and medicine, as it deactivates conventional antimicrobial therapeutics. Scientists respond to the threat by developing new antimicrobial platforms to prevent and treat infections from these resistant strains. Metal-based antimicrobial macromolecules are emerging as an alternative to conventional platforms because they combine multiple mechanisms of action into one platform due to the distinctive properties of metals. For example, metals interact with intracellular proteins and enzymes, and catalyse various intracellular processes. The macromolecular architecture offers a means to enhance antimicrobial activity since several antimicrobial moieties can be conjugated to the scaffold. Further, these macromolecules can be fabricated into antimicrobial materials for contact-killing medical implants, fabrics, and devices. As volatilization or leaching out of the antimicrobial moieties from the macromolecular scaffold is reduced, these medical implants, fabrics, and devices can retain their antimicrobial activity over an extended period. Recent advances demonstrate the potential of metal-based antimicrobial macromolecules as effective platforms that prevent and treat infections from resistant strains. In this review these advances are thoroughly discussed within the context of examples of metal-based antimicrobial macromolecules, their mechanisms of action and biocompatibility. Copyright © 2016 Elsevier Ltd. All rights reserved.

Frequency and Nature of Infectious Risk Moments During Acute Care Based on the INFORM Structured Classification Taxonomy.

PubMed

Clack, Lauren; Passerini, Simone; Wolfensberger, Aline; Sax, Hugo; Manser, Tanja

2018-03-01

OBJECTIVE In this study, we sought to establish a comprehensive inventory of infectious risk moments (IRMs), defined as seemingly innocuous yet frequently occurring care manipulations potentially resulting in transfer of pathogens to patients. We also aimed to develop and employ an observational taxonomy to quantify the frequency and nature of IRMs in acute-care settings. DESIGN Prospective observational study and establishment of observational taxonomy. SETTING Intensive care unit, general medical ward, and emergency ward of a university-affiliated hospital. PARTICIPANTS Healthcare workers (HCWs) METHODS Exploratory observations were conducted to identify IRMs, which were coded based on the surfaces involved in the transmission pathway to establish a structured taxonomy. Structured observations were performed using this taxonomy to quantify IRMs in all 3 settings. RESULTS Following 129.17 hours of exploratory observations, identified IRMs involved HCW hands, gloves, care devices, mobile objects, and HCW clothing and accessories. A structured taxonomy called INFORM (INFectiOus Risk Moment) was established to classify each IRM according to the source, vector, and endpoint of potential pathogen transfer. We observed 1,138 IRMs during 53.77 hours of structured observations (31.25 active care hours) for an average foundation of 42.8 IRMs per active care hour overall, and average densities of 34.9, 36.8, and 56.3 IRMs in the intensive care, medical, and emergency wards, respectively. CONCLUSIONS Hands and gloves remain among the most important contributors to the transfer of pathogens within the healthcare setting, but medical devices, mobile objects, invasive devices, and HCW clothing and accessories may also contribute to patient colonization and/or infection. The INFORM observational taxonomy and IRM inventory presented may benefit clinical risk assessment, training and education, and future research. Infect Control Hosp Epidemiol 2018;39:272-279.

Erythema Nodosum and Mycoplasma pneumoniae Infections in Childhood: Further Observations in Two Patients and a Literature Review.

PubMed

Greco, Filippo; Catania, Roberta; Pira, Alice Le; Saporito, Marco; Scalora, Luisa; Aguglia, Maria Giovanna; Smilari, Pierluigi; Sorge, Giovanni

2015-04-01

Erythema nodosum (EN) is the most frequent panniculitis in childhood and has been associated with various conditions, such as infectious and autoimmune disorders, medications, and malignancies. The author reports on two children affected with EN associated with Mycoplasma pneumoniae infection, which occurred in one patient without pulmonary detection. The available literature on EN and M. pneumoniae infection in childhood is also reviewed.

Advancing infection control in dental care settings: factors associated with dentists' implementation of guidelines from the Centers for Disease Control and Prevention.

PubMed

Cleveland, Jennifer L; Bonito, Arthur J; Corley, Tammy J; Foster, Misty; Barker, Laurie; Gordon Brown, G; Lenfestey, Nancy; Lux, Linda

2012-10-01

The authors set out to identify factors associated with implementation by U.S. dentists of four practices first recommended in the Centers for Disease Control and Prevention's Guidelines for Infection Control in Dental Health-Care Settings-2003. In 2008, the authors surveyed a stratified random sample of 6,825 U.S. dentists. The response rate was 49 percent. The authors gathered data regarding dentists' demographic and practice characteristics, attitudes toward infection control, sources of instruction regarding the guidelines and knowledge about the need to use sterile water for surgical procedures. Then they assessed the impact of those factors on the implementation of four recommendations: having an infection control coordinator, maintaining dental unit water quality, documenting percutaneous injuries and using safer medical devices, such as safer syringes and scalpels. The authors conducted bivariate analyses and proportional odds modeling. Responding dentists in 34 percent of practices had implemented none or one of the four recommendations, 40 percent had implemented two of the recommendations and 26 percent had implemented three or four of the recommendations. The likelihood of implementation was higher among dentists who acknowledged the importance of infection control, had practiced dentistry for less than 30 years, had received more continuing dental education credits in infection control, correctly identified more surgical procedures that require the use of sterile water, worked in larger practices and had at least three sources of instruction regarding the guidelines. Dentists with practices in the South Atlantic, Middle Atlantic or East South Central U.S. Census divisions were less likely to have complied. Implementation of the four recommendations varied among U.S. dentists. Strategies targeted at raising awareness of the importance of infection control, increasing continuing education requirements and developing multiple modes of instruction may increase implementation of current and future Centers for Disease Control and Prevention guidelines.

Infection risk and intrauterine devices.

PubMed

Martínez, Francisca; López-Arregui, Eduardo

2009-01-01

For most women, intrauterine contraceptive devices (IUCD) are a safe option. Upper genital tract infections (pelvic inflammatory disease, PID) occur when pathogenic microorganisms ascend from the cervix and invade the endometrium and the fallopian tubes, causing an inflammatory reaction. Evidence-based recommendations regarding intrauterine contraception and risk of infection were presented at the Congress of the European Society of Contraception, in Prague, 2008: A clinical history (including sexual history) should be taken as part of the routine assessment for intrauterine contraception to identify women at high risk of sexually transmitted infections (STI); if appropriate a test should be offered; if symptoms or signs are present, appropriate diagnostic tests should be done, results awaited, necessary treatment completed, and IUCD insertion postponed until resolution. Prophylactic antibiotics are not recommended (evidence level II-3). STI screening is not routinely recommended. PID among IUCD users is most strongly related to the insertion process and to the background risk of STI (evidence level II-2). Conditions which represent an unacceptable health risk if an IUCD is inserted (WHO Medical Eligibility Criteria, MEC, Categories 3-4) are current PID, current purulent cervicitis, chlamydial or gonorrheal infection. For continuation as well as initiation, WHO MEC categories 3-4 are allotted to women with known pelvic tuberculosis, puerperal sepsis and septic abortion.

Antimicrobial Efficacy of a New Chlorhexidine-based Device Against Staphylococcus aureus Colonization of Venous Catheters

PubMed Central

Kowalewska, Paulina M.; Petrik, Shawn M.; Di Fiore, Attilio E.; Fox-Robichaud, Alison E.

2018-01-01

Vascular catheters are a major cause of nosocomial bloodstream infections. ChloraLock (ATTWILL Medical Solutions, Inc, West Jordan, UT, and ICU Medical, Inc, San Clemente, CA) is a novel antimicrobial device containing chlorhexidine digluconate (CHG) that is fitted onto a syringe and infuses CHG into the catheter lumen during locking. The objective of this study was to evaluate the antimicrobial efficacy of ChloraLock with in vitro tests and its ability to reduce Staphylococcus aureus contamination of catheters in the external jugular veins of Yorkshire swine. ChloraLock significantly reduced the bacterial load in the in vitro tests by up to 6 log10 colony-forming units (CFU) and by 3 to 4 log10 CFU/lumen in vivo in a swine model with 0.9% NaCl catheter locks. PMID:29489705

Antimicrobial Efficacy of a New Chlorhexidine-based Device Against Staphylococcus aureus Colonization of Venous Catheters.

PubMed

Kowalewska, Paulina M; Petrik, Shawn M; Di Fiore, Attilio E; Fox-Robichaud, Alison E

Vascular catheters are a major cause of nosocomial bloodstream infections. ChloraLock (ATTWILL Medical Solutions, Inc, West Jordan, UT, and ICU Medical, Inc, San Clemente, CA) is a novel antimicrobial device containing chlorhexidine digluconate (CHG) that is fitted onto a syringe and infuses CHG into the catheter lumen during locking. The objective of this study was to evaluate the antimicrobial efficacy of ChloraLock with in vitro tests and its ability to reduce Staphylococcus aureus contamination of catheters in the external jugular veins of Yorkshire swine. ChloraLock significantly reduced the bacterial load in the in vitro tests by up to 6 log10 colony-forming units (CFU) and by 3 to 4 log10 CFU/lumen in vivo in a swine model with 0.9% NaCl catheter locks.

5-Episinuleptolide Decreases the Expression of the Extracellular Matrix in Early Biofilm Formation of Multi-Drug Resistant Acinetobacter baumannii.

PubMed

Tseng, Sung-Pin; Hung, Wei-Chun; Huang, Chiung-Yao; Lin, Yin-Shiou; Chan, Min-Yu; Lu, Po-Liang; Lin, Lin; Sheu, Jyh-Horng

2016-07-29

Nosocomial infections and increasing multi-drug resistance caused by Acinetobacter baumannii have been recognized as emerging problems worldwide. Moreover, A. baumannii is able to colonize various abiotic materials and medical devices, making it difficult to eradicate and leading to ventilator-associated pneumonia, and bacteremia. Development of novel molecules that inhibit bacterial biofilm formation may be an alternative prophylactic option for the treatment of biofilm-associated A. baumannii infections. Marine environments, which are unlike their terrestrial counterparts, harbor an abundant biodiversity of marine organisms that produce novel bioactive natural products with pharmaceutical potential. In this study, we identified 5-episinuleptolide, which was isolated from Sinularia leptoclados, as an inhibitor of biofilm formation in ATCC 19606 and three multi-drug resistant A. baumannii strains. In addition, the anti-biofilm activities of 5-episinuleptolide were observed for Gram-negative bacteria but not for Gram-positive bacteria, indicating that the inhibition mechanism of 5-episinuleptolide is effective against only Gram-negative bacteria. The mechanism of biofilm inhibition was demonstrated to correlate to decreased gene expression from the pgaABCD locus, which encodes the extracellular polysaccharide poly-β-(1,6)-N-acetylglucosamine (PNAG). Scanning electron microscopy (SEM) indicated that extracellular matrix of the biofilm was dramatically decreased by treatment with 5-episinuleptolide. Our study showed potentially synergistic activity of combination therapy with 5-episinuleptolide and levofloxacin against biofilm formation and biofilm cells. These data indicate that inhibition of biofilm formation via 5-episinuleptolide may represent another prophylactic option for solving the persistent problem of biofilm-associated A. baumannii infections.

Applying quantitative benefit-risk analysis to aid regulatory decision making in diagnostic imaging: methods, challenges, and opportunities.

PubMed

Agapova, Maria; Devine, Emily Beth; Bresnahan, Brian W; Higashi, Mitchell K; Garrison, Louis P

2014-09-01

Health agencies making regulatory marketing-authorization decisions use qualitative and quantitative approaches to assess expected benefits and expected risks associated with medical interventions. There is, however, no universal standard approach that regulatory agencies consistently use to conduct benefit-risk assessment (BRA) for pharmaceuticals or medical devices, including for imaging technologies. Economics, health services research, and health outcomes research use quantitative approaches to elicit preferences of stakeholders, identify priorities, and model health conditions and health intervention effects. Challenges to BRA in medical devices are outlined, highlighting additional barriers in radiology. Three quantitative methods--multi-criteria decision analysis, health outcomes modeling and stated-choice survey--are assessed using criteria that are important in balancing benefits and risks of medical devices and imaging technologies. To be useful in regulatory BRA, quantitative methods need to: aggregate multiple benefits and risks, incorporate qualitative considerations, account for uncertainty, and make clear whose preferences/priorities are being used. Each quantitative method performs differently across these criteria and little is known about how BRA estimates and conclusions vary by approach. While no specific quantitative method is likely to be the strongest in all of the important areas, quantitative methods may have a place in BRA of medical devices and radiology. Quantitative BRA approaches have been more widely applied in medicines, with fewer BRAs in devices. Despite substantial differences in characteristics of pharmaceuticals and devices, BRA methods may be as applicable to medical devices and imaging technologies as they are to pharmaceuticals. Further research to guide the development and selection of quantitative BRA methods for medical devices and imaging technologies is needed. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

Hydrophilic Polymer-associated Ischemic Enterocolitis.

PubMed

Chavez, Jesus A; Chen, Wei; Frankel, Wendy L; Arnold, Christina A

2017-02-01

Hydrophilic polymer coating of medical devices serves to lubricate the device and prevent device-related complications. The coating can be mechanically disrupted and result in downstream injury via presumed thromboembolism. This process has been reported in the brain, heart, lung, and skin, and has been replicated through animal studies and in vitro histologic processing of the polymer coating. We report the first description of hydrophilic polymer-associated ischemic enterocolitis in a series of 7 specimens (small bowel=2, colon=4, aortic thrombus=1) from 3 patients. We report a 4% incidence among all patients with an ischemic bowel resection between April 29, 2014 and August 8, 2016. All patients developed bowel ischemia within 1 day of aortic repair, and all bowel resection specimens showed polymers, mainly in the submucosal vessels in areas of extensive ischemia. The polymers appeared as basophilic, intravascular, serpiginous structures. In a patient who developed acute paralysis after the aortic repair, identical polymers were identified in the aortic thrombus and the ischemic bowel segment. We demonstrate that the polymers display an altered morphology over time and with various graft types, and that the degrading polymers are associated with a foreign body giant cell reaction. Special stains can aid in diagnosis, with the polymers turquoise on a colloidal iron stain, pink on von Kossa and mucicarmine stains, and pale blue on trichrome. Clinical follow-up was available up to 115 weeks: 1 patient died, and 2 are alive and well. In summary, we report a new diagnostic entity to be considered in the differential diagnosis of iatrogenic ischemic injuries in the gastrointestinal tract. Awareness of this entity is important to elucidate the cause of ischemia and to prevent misdiagnosis of the polymers and their associated giant cell reaction as a parasitic infection, granulomatous vasculitis, sarcoidosis, and idiopathic inflammatory bowel disease.

[Totally implantable venous access ports: frequency of complications and analysis of bacterial contamination after ablation].

PubMed

Barbut, F; Soukouna, S; Lalande, V; Garcia, M-L; Neyme, D; de Gramont, A; Petit, J-C

2004-12-01

Totally implantable venous access ports (TIVAP) are valuable medical devices for long-term intravenous treatment such as parenteral nutrition, cancer chemotherapy or antiviral therapy. Implantation and use of these devices are each associated with infectious or mechanical complications. To determine the frequency of complications and to analyze bacterial contamination of different parts of TIVAP (tip, septum, internal lumen of the port). Clinical charts of patients, which TIVAP was removed between April 20th to December 31st 2003, were retrospectively reviewed. Infectious complications (local and septicemic) and non-infectious complications (i.e. obstruction, thrombosis, drug extravasation...) were defined using clinical and/or microbiological criteria. Quantitative culture from different parts of the TIVAP was performed. One hundred and ten patients (age 57 +/- 14-years-old, 94.3% cancers) were included, corresponding to 57,018 catheter-days: 39.1% had one or more non-infectious complications (density incidence: 0.86 for 1000 catheter-days). Among the 49 complications, obstruction, thrombosis, extravasations and malposition accounted for 30.6%, 30.6% 4.1% and 6% of cases. Twenty-one patients (19.1%) had an infectious complication: 11 were local and 14 were systemic (density incidence 0.43 for 1000 catheter-days). Bacteria responsible for TIVAP-associated bacteraemia were coagulase negative staphylococci (N = 2), Staphylococcus aureus susceptible to methicilline (N = 3), micrococci (N = 1), corynebacteria (N = 1) or Gram-negative bacilli (N = 8). Comparison of quantitative culture of the different parts of TIVAP with a threshold at 10(3) CFU/ml showed that culture of tip, septum and port has a sensitivity of 47.6% 57.1% and 61.9 %, respectively and a specificity of 100% 92.1% and 92.1%, respectively for the diagnosis of TIVAP infection. Complications associated to TIVAP are frequent but incidence that we have reported is comparable with previous studies. Analysis of internal lumen of the port is the most sensitive method for the diagnosis of TIVAP-associated infections.

Prevention of Medical Device-Related Pressure Injuries Associated With Respiratory Equipment Use in a Critical Care Unit: A Quality Improvement Project.

PubMed

Padula, Cynthia A; Paradis, Heidi; Goodwin, Robert; Lynch, Judith; Hegerich-Bartula, Deborah

Medical devices have been identified as an extrinsic risk factor for development of pressure injuries, with as many as 30% to 70% of medical device-related pressure injuries resulting from respiratory equipment. This article describes a quality improvement project undertaken to reduce the occurrence of respiratory device-related pressure injuries in a critically care unit. Multiple actions were implemented to achieve this goal. Respiratory therapists were trained to document occurrences on a daily basis, and apparent cause analyses were conducted on each occurrence. An interdisciplinary team conducted biweekly rounds on patients with respiratory devices and consulted other professionals as indicated. Nurses and respiratory therapists attended an evidence-based, collaborative, educational offering and completed a measure of team functioning before the program and at the end of the study period. The occurrence rates of respiratory device-related pressure injuries were reduced over the project period, and these changes were sustained over the subsequent 12 months.

Venous Access Devices: Clinical Rounds

PubMed Central

Matey, Laurl; Camp-Sorrell, Dawn

2016-01-01

Nursing management of venous access devices (VADs) requires knowledge of current evidence, as well as knowledge of when evidence is limited. Do you know which practices we do based on evidence and those that we do based on institutional history or preference? This article will present complex VAD infection and occlusion complications and some of the controversies associated with them. Important strategies for identifying these complications, troubleshooting, and evaluating the evidence related to lack of blood return, malposition, infection, access and maintenance protocols, and scope of practice issues are presented. PMID:28083553

Factors associated with syphilis infection: a comprehensive analysis based on a case-control study.

PubMed

Xiao, Y; Li, S-L; Lin, H-L; Lin, Z-F; Zhu, X-Z; Fan, J-Y; Gao, K; Zhang, H-L; Lin, L-R; Liu, L-L; Tong, M-L; Niu, J-J; Yang, T-C

2016-04-01

This study aimed to comprehensively evaluate factors that influence the likelihood of syphilis infection from risk-taking behaviours and medical conditions. A retrospective case-control study was conducted by enrolling 664 syphilis inpatients (excluding 11 congenital syphilis patients) and 800 sex- and age-matched controls. Medical histories, clinical data and patient interview data were collected and subjected to logistic regression analyses. The prevalence of syphilis in the study population was 3·9% (675/17,304). By univariate analysis, syphilis infection was associated with migration between cities, marital status, smoking, reproductive history, hypertension, elevated blood urea nitrogen (BUN) and infection with hepatitis B virus (HBV) (P < 0·05). A high rate of syphilis-HBV co-infection was observed in HIV-negative patients and further research revealed an association between syphilis and specific HBV serological reactivity. Syphilis was also associated with the frequency, duration and status of tobacco use. Multivariate analysis indicated that syphilis infection was independently associated with migration between cities [adjusted odds ratio (aOR) 1·368, 95% confidence interval (CI) 1·048-1·785], current smoking (aOR 1·607, 95% CI 1·177-2·195), elevated BUN (aOR 1·782, 95% CI 1·188-2·673) and some serological patterns of HBV infection. To prevent the spread of infectious diseases, inpatients and blood donors should be tested for HIV, syphilis, HBV and HCV simultaneously.

Contributing risk factors for orthopedic device related infections in sina hospital, tehran, iran.

PubMed

Hadadi, A; Zehtab, M J; Babagolzadeh, H; Ashraf, H

2011-02-01

In spite of decreasing incidence of orthopedic device-related infections to 1%, nowadays, device-related infection still remains a diagnostic, therapeutic and cost-related problem. The objective of this study is to evaluate the contributing risk factors for orthopedic device-related infections in Sina Hospital, Tehran, Iran. Three hundred and thirty patients who underwent orthopedic device implantation from 2002-2006 were enrolled; among them, 110 patients were complicated with infection. Descriptive and logistic regression analyses were performed to determine the risk factors for device related infections. Patients with infection were older compared to those without infection. The Staphylococcus aureus was the commonest organism. A correlation was observed between wound infection and external fixation, an underlying health condition, and addiction which were independent risk factors for a device related infection. Orthopedic device-related infection puts a great financial burden on patients and hospital resources and could lead to morbidity and mortality in patients. So, appropriate pre and postoperative wound care for dirty wounds, especially when external fixators are used, and in patients with poor conditions or addiction should be done with more caution.

Infectious disease complications of combat-related injuries.

PubMed

Murray, Clinton K

2008-07-01

: Strategies currently used to prevent morbidity and mortality associated with combat-related injuries include better training of frontline medical personnel, improved personal protective equipment, and deployment of fast-forward surgical assets with state-of-the-art equipment. These strategies allow patients to survive near-catastrophic injuries, placing a greater emphasis on the medical infrastructure to mitigate short- and long-term complications associated with these injuries. : Wounds have certain characteristics that promote the development of infections: the presence of devitalized tissue, foreign bodies, clots, fluid collections, and contamination of wounds with bacteria from the casualty's skin, the environment, and the hospital. All of these factors culminate in placing the casualty at risk of developing an infection. : This article reviews the lessons learned from combat-related wound infections throughout history and in the current conflicts in Iraq and Afghanistan. Many of the management strategies used to prevent infections of combat-related injuries are applicable to the management of civilian trauma, whether associated with small arms fire or related to natural disasters such as earthquakes or tornadoes.

Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits.

PubMed

Tippett, Elizabeth

2015-01-01

This study examined the medical information contained in a sample of television ads soliciting consumers for lawsuits against drug and medical device manufactures. Almost all such ads involved drugs or devices that have not been recalled and remain on the market. These ads raise important public health questions because they may influence the prospective medical decisions of viewers. The ads contained extensive descriptions of serious adverse events associated with the drugs or devices but almost uniformly failed to disclose information relating to the likelihood of such events. They also failed to effectively advise viewers to consult a doctor. Results also identified a subset of ads that mimicked public service announcements, claiming to be. a "medical alert" "consumer alert" or "FDA warning" at the start of the ad. Most such ads did not disclose the attorney source of the advertising until the final few seconds.

Adhesins in Human Fungal Pathogens: Glue with Plenty of Stick

PubMed Central

de Groot, Piet W. J.; Bader, Oliver; de Boer, Albert D.; Weig, Michael

2013-01-01

Understanding the pathogenesis of an infectious disease is critical for developing new methods to prevent infection and diagnose or cure disease. Adherence of microorganisms to host tissue is a prerequisite for tissue invasion and infection. Fungal cell wall adhesins involved in adherence to host tissue or abiotic medical devices are critical for colonization leading to invasion and damage of host tissue. Here, with a main focus on pathogenic Candida species, we summarize recent progress made in the field of adhesins in human fungal pathogens and underscore the importance of these proteins in establishment of fungal diseases. PMID:23397570

Cryptococcus laurentii fungaemia in a cervical cancer patient.

PubMed

Neves, Rejane Pereira; Lima Neto, Reginaldo Gonçalves de; Leite, Melyna Chaves; Silva, Vanessa Karina Alves da; Santos, Franz de Assis Graciano dos; Macêdo, Danielle Patrícia Cerqueira

2015-01-01

Infections caused by emerging Cryptococcus non-neoformans species are being reported with increasingly frequency. Here, we present a case of fungaemia by Cryptococcus laurentii in a woman receiving aggressive immunosuppressive therapy for cervical neoplasia. Three venous blood samples were aseptically collected on consecutive days and C. laurentii was isolated and identified through phenotypic and molecular methods. After central venous catheter removal and appropriate antifungal therapy, the patient showed significant improvement and blood culture became negative. Thus, patients following immunosuppressive therapies and using invasive medical devices are at risk of C. laurentii blood infections. Copyright © 2015 Elsevier Editora Ltda. All rights reserved.

In vivo efficacy of a silicone–cationic steroid antimicrobial coating to prevent implant-related infection

PubMed Central

Williams, Dustin L.; Haymond, Bryan S.; Beck, James P.; Savage, Paul B.; Chaudhary, Vinod; Epperson, Richard T.; Kawaguchi, Brooke; Bloebaum, Roy D.

2012-01-01

Active release antimicrobial coatings for medical devices have been developed to prevent and treat biofilm implant-related infections. To date, only a handful of coatings have been put into clinical use, with limited success. In this study, a novel antimicrobial compound was incorporated into a silicone (polydimethylsiloxane or PDMS) polymer to develop a novel active release coating that addressed several limitations of current device coatings. The efficacy of this coating was optimized using an in vitro flow cells system, then translated to an animal model of a simulated Type IIIB open fracture wherein well-established biofilms were used as initial inocula. Results indicated that the novel coating was able to prevent infection in 100% (9/9) of animals that were treated with biofilms and the novel coating (treatment group). In contrast, 100% (9/9) of animals that were inoculated with biofilms and not treated with the coating (positive control), did develop infection. Nine animals were used as negative controls, i.e., those that were not treated with biofilms, and showed a rate of infection of 11% (1/9). Eight animals were treated with the novel coating only to determine its effect on host tissue. Results indicated that the novel active release coating may have significant promise for future application to prevent biofilm implant-related infections in patients. PMID:22940221

Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

DTIC Science & Technology

2007-02-01

threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

Promising silicones modified with cationic biocides for the development of antimicrobial medical devices.

PubMed

Ghamrawi, Sarah; Bouchara, Jean-Philippe; Tarasyuk, Oksana; Rogalsky, Sergiy; Lyoshina, Lyudmila; Bulko, Olga; Bardeau, Jean-François

2017-06-01

We have tested silicones containing 2% or 5% of the cationic biocides polyhexamethylene guanidine dodecylbenzenesulfonate (PHMG-DBS), 1-octyl-3-methylimidazolium tetrafluoroborate (OMIM-BF 4 ) or 1-dodecyl-3-methylimidazolium tetrafluoroborate (DMIM-BF 4 ) against the major relevant bacterial and yeast species in health care-associated infections (HCAI). Study conducted according to the international standard ISO 22196 revealed that silicones containing 2% or 5% DMIM-BF 4 or 5% PHMG-DBS presented the highest antimicrobial activity, leading to a logarithmic growth reduction of 3.03 to 6.46 and 3.65 to 4.85 depending on the bacterial or fungal species. Heat-pretreated silicones containing 2% DMIM-BF 4 kept a high activity, with at least a 3-log reduction in bacterial growth, except against P. aeruginosa where there was only a 1.1-log reduction. After 33days, the release ratio of cationic biocide from silicone films containing 5% of DMIM-BF 4 was found to be 5.6% in pure water and 1.9% in physiological saline solution, respectively. No leaching of PHMG-DBS polymeric biocide was detected under the same conditions. These results demonstrate unambiguously that silicones containing 2% DMIM-BF 4 or 5% PHMG-DBS present high antimicrobial activity, as well as high leaching resistance and therefore may be good candidates for the development of safer medical devices. Copyright © 2017 Elsevier B.V. All rights reserved.

Risk factors associated with hypovitaminosis D in HIV/aids-infected adults.

PubMed

Canuto, Juliana Maria Palmeira; Canuto, Virginia Maria Palmeira; de Lima, Matheus Henrique Alves; de Omena, Ana Luiza Costa Silva; Morais, Thayná Melo de Lima; Paiva, Arthur Maia; Diniz, Erik Trovão; de Almeida, David Joseph Ferreira Tenório; Ferreira, Sonia Maria Soares

2015-02-01

To investigate risk factors associated with hypovitaminosis D in adult patients infected with HIV/aids, at a referral hospital in Maceió, Brazil. This cross-sectional study involved 125 patients evaluated from April to September 2013 by means of interviews, review of medical records, physical examination, and laboratory tests. The data were analyzed using the SPSS® software, version 17.0; the prevalence of hypovitaminosis D and mean levels of vitamin D were determined. The association between hypovitaminosis D and the independent variables was assessed using the Chi-square or the Fisher's exact tests; mean vitamin D concentrations were analyzed using Kolmogorov-Smirnov, Mann-Whitney, and Kruskal-Wallis tests. The level of significance was set at 5% across tests. The prevalence of hypovitaminosis D was 24%, with a significant association with higher household income (p < 0.05). Higher vitamin D levels were associated with female gender (p < 0.001), no use of sunscreen (p < 0.05), and previous opportunistic infections (p < 0.01). Lower values were associated with the use of antiretroviral medication (p < 0.05), overweight and obesity (p < 0.01). Lower vitamin D concentrations were significantly associated with well-known risk factors for hypovitaminosis D: use of sunscreen, antiretroviral medication, overweight, and obesity. The prevalence of hypovitaminosis D in this study, considering values > 20 ng/mL or > 30 ng/mL as vitamin D sufficiency, was lower to that of previous studies with HIV-infected patients, a fact that might be related to the low latitude and high intensity of solar radiation of the location of the present study.

Preoperative counseling and expectation management for inflatable penile prosthesis implantation.

PubMed

Narang, Gopal L; Figler, Bradley D; Coward, Robert M

2017-11-01

The inflatable penile prosthesis (IPP) is the gold standard surgical treatment for medical refractory erectile dysfunction (ED). While the modern IPP has enjoyed high satisfaction rates as a product of its continued innovation, reliability, and performance, patient dissatisfaction can still occur. IPP implantation restores physiologic function with cosmetic and psychological consequences, both of which place inherent emphasis on preoperative counseling and expectation management. This review aims to highlight the complex nature of such counseling and provide practitioners with a roadmap to navigate the landscape. Preoperative counseling begins with appropriate patient selection and identification of those patients who are at risk for dissatisfaction as a result of personality characteristics. The informed consent provides a natural framework to discuss the host of complications and risks that are associated with surgery, including infection, device malfunction, damage to nearby structures, and device erosion. Device selection is a nuanced process that merges patient preference with clinical factors and consideration. We address device selection through a description of cylinder construction, pump design, and reservoir placement in the context of preoperative counseling. Lastly, we draw attention to expectation management with a specific focus on possible post-operative changes to penile length and sensation as well as partner involvement. The modern IPP provides excellent results with high patient and partner satisfaction. Ultimately, satisfaction is dependent on multiple factors, but providing accurate, realistic counseling and expectation management prepares patients for the best possible outcomes.

Gradient titanium and silver based carbon coatings deposited on AISI316L

NASA Astrophysics Data System (ADS)

Batory, Damian; Reczulska, Malgorzata Czerniak-; Kolodziejczyk, Lukasz; Szymanski, Witold

2013-06-01

The constantly growing market for medical implants and devices caused mainly due to a lack of proper attention attached to the physical condition as well as extreme sports and increased elderly population creates the need of new biocompatible biomaterials with controlled bioactivity and certain useful properties. According to many literature reports, regarding the modifications of variety of different biomaterials using the surface engineering techniques and their biological and physicochemical examination results, the most promising material for great spectra of medical applications seem to be carbon layers. Another issue is the interaction between the implant material and surrounding tissue. In particular cases this interface area is directly exposed to air. Abovementioned concern occurs mainly in case of the external fixations, thus they are more vulnerable to infection. Therefore a crucial role has the inhibition of bacterial adhesion that may prevent implant-associated infections, occurrence of other numerous complications and in particular cases rejection of the implant. For this reason additional features of carbon coatings like antibacterial properties seem to be desired and justified. Silver doped diamond-like carbon coatings with different Ag concentrations were prepared by hybrid RF PACVD/MS (Radio Frequency Plasma Assisted Chemical Vapor Deposition/Magnetron Sputtering) deposition technique. Physicochemical parameters like chemical composition, morphology and surface topography, hardness and adhesion were determined. Examined layers showed a uniform distribution of silver in the amorphous DLC matrix, high value of H/E ratio, good adhesion and beneficial topography which make them a perfect material for medical applications e.g. modification of implants for the external fixations.

77 FR 74197 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... section entitled ``Agenda'', the product name ``NeuroPace Responsive Neurostimulation (RNS) System'' is corrected to read ``NeuroPace RNS System''. Dated: December 7, 2012. Jill Hartzler Warner, Acting Associate...

Modern technologies for improving cleaning and disinfection of environmental surfaces in hospitals.

PubMed

Boyce, John M

2016-01-01

Experts agree that careful cleaning and disinfection of environmental surfaces are essential elements of effective infection prevention programs. However, traditional manual cleaning and disinfection practices in hospitals are often suboptimal. This is often due in part to a variety of personnel issues that many Environmental Services departments encounter. Failure to follow manufacturer's recommendations for disinfectant use and lack of antimicrobial activity of some disinfectants against healthcare-associated pathogens may also affect the efficacy of disinfection practices. Improved hydrogen peroxide-based liquid surface disinfectants and a combination product containing peracetic acid and hydrogen peroxide are effective alternatives to disinfectants currently in widespread use, and electrolyzed water (hypochlorous acid) and cold atmospheric pressure plasma show potential for use in hospitals. Creating "self-disinfecting" surfaces by coating medical equipment with metals such as copper or silver, or applying liquid compounds that have persistent antimicrobial activity surfaces are additional strategies that require further investigation. Newer "no-touch" (automated) decontamination technologies include aerosol and vaporized hydrogen peroxide, mobile devices that emit continuous ultraviolet (UV-C) light, a pulsed-xenon UV light system, and use of high-intensity narrow-spectrum (405 nm) light. These "no-touch" technologies have been shown to reduce bacterial contamination of surfaces. A micro-condensation hydrogen peroxide system has been associated in multiple studies with reductions in healthcare-associated colonization or infection, while there is more limited evidence of infection reduction by the pulsed-xenon system. A recently completed prospective, randomized controlled trial of continuous UV-C light should help determine the extent to which this technology can reduce healthcare-associated colonization and infections. In conclusion, continued efforts to improve traditional manual disinfection of surfaces are needed. In addition, Environmental Services departments should consider the use of newer disinfectants and no-touch decontamination technologies to improve disinfection of surfaces in healthcare.

Engineered Chimeric Peptides as Antimicrobial Surface Coating Agents toward Infection-Free Implants

PubMed Central

Yazici, Hilal; O'Neill, Mary B.; Kacar, Turgay; Wilson, Brandon R.; Oren, E. Emre; Sarikaya, Mehmet; Tamerler, Candan

2016-01-01

Prevention of bacterial colonization and consequent biofilm formation remains a major challenge in implantable medical devices. Implant-associated infections are not only a major cause of implant failures but also their conventional treatment with antibiotics brings further complications due to the escalation in multidrug resistance to a variety of bacterial species. Owing to their unique properties, antimicrobial peptides (AMPs) have gained significant attention as effective agents to combat colonization of microorganisms. These peptides have been shown to exhibit a wide spectrum of activities with specificity to a target cell while having a low tendency for developing bacterial resistance. Engineering biomaterial surfaces that feature AMP properties, therefore, offer a promising approach to prevent implant infections. Here, we engineered a chimeric peptide with bifunctionality that both forms a robust solid-surface coating while presenting antimicrobial property. The individual domains of the chimeric peptides were evaluated for their solid-binding kinetics to titanium substrate as well as for their antimicrobial properties in solution. The antimicrobial efficacy of the chimeric peptide on the implant material was evaluated in vitro against infection by a variety of bacteria, including Streptococcus mutans, Staphylococcus. epidermidis, and Escherichia coli, which are commonly found in oral and orthopedic implant related surgeries. Our results demonstrate significant improvement in reducing bacterial colonization onto titanium surfaces below the detectable limit. Engineered chimeric peptides with freely displayed antimicrobial domains could be a potential solution for developing infection-free surfaces by engineering implant interfaces with highly reduced bacterial colonization property. PMID:26795060

Engineered Chimeric Peptides as Antimicrobial Surface Coating Agents toward Infection-Free Implants.

PubMed

Yazici, Hilal; O'Neill, Mary B; Kacar, Turgay; Wilson, Brandon R; Oren, E Emre; Sarikaya, Mehmet; Tamerler, Candan

2016-03-02

Prevention of bacterial colonization and consequent biofilm formation remains a major challenge in implantable medical devices. Implant-associated infections are not only a major cause of implant failures but also their conventional treatment with antibiotics brings further complications due to the escalation in multidrug resistance to a variety of bacterial species. Owing to their unique properties, antimicrobial peptides (AMPs) have gained significant attention as effective agents to combat colonization of microorganisms. These peptides have been shown to exhibit a wide spectrum of activities with specificity to a target cell while having a low tendency for developing bacterial resistance. Engineering biomaterial surfaces that feature AMP properties, therefore, offer a promising approach to prevent implant infections. Here, we engineered a chimeric peptide with bifunctionality that both forms a robust solid-surface coating while presenting antimicrobial property. The individual domains of the chimeric peptides were evaluated for their solid-binding kinetics to titanium substrate as well as for their antimicrobial properties in solution. The antimicrobial efficacy of the chimeric peptide on the implant material was evaluated in vitro against infection by a variety of bacteria, including Streptococcus mutans, Staphylococcus. epidermidis, and Escherichia coli, which are commonly found in oral and orthopedic implant related surgeries. Our results demonstrate significant improvement in reducing bacterial colonization onto titanium surfaces below the detectable limit. Engineered chimeric peptides with freely displayed antimicrobial domains could be a potential solution for developing infection-free surfaces by engineering implant interfaces with highly reduced bacterial colonization property.

Study of the nanomaterials and their antimicrobial activities

NASA Astrophysics Data System (ADS)

Ramadi, Muntaha

In the last decade, the world faced huge problems associated with the spread of antimicrobial resistant infections that are essentially untreatable such as methicillin resistant Staphylococcus aureus (MRSA) infection. These infections have begun to occur in both hospital and community environments. Developing new antimicrobial surface coatings can hold a great promise to minimize and control various problems that associated with the spreading of infections and biofilms formation, these coatings can be used in medicine where medical devices associated with severe infections, in construction industry and the in food packaging industry. It has been established that single-walled CNTs exhibit a strong antimicrobial activity and can pierce bacterial cell walls. Recently, nanomaterial structures that made from pure carbon such as CNTs have been seen as promising candidates for many potential applications in Biotechnology and bioscience due to the combination of their extraordinary properties that arise from surface area, light weight, strength, flexibility, unique electrical conductivity and many more novel physical and chemical properties at nanoscale level. CNTs have been used widely in biomedical field including drug delivery, gene therapy and creating new biomedical devices with novel properties. Researchers have now made a first step to add carbon nanotubes to antimicrobial agents list. There are two types of CNTs have been used in biomedical research. The first one is a single-walled carbon nanotube (SWNT) and the second is a multi-walled carbon nanotube (MWNT). Recent in vitro studies suggest that carbon nanotubes have antimicrobial activity and coating CNTs with nickel nanoparticle could enhance the antimicrobial activity of cabon nanotubes. In order to test this hypothesis, nickel nanoparticles were deposited on carbon nanotubes (CNTs) by electrochemical deposition. The carbon nanotubes used in this study were XD-CNTs, SWNTs and Ni-coated CNTs. The structure and the morphology of Ni-coated CNTs were investigated by scanning electron microscopy (SEM), dispersive x-ray analysis (EDX) and thermo gravimetric analysis (TGA). The SEM results revealed that CNTs provide an excellent surface for electrochemical deposition of nanomaterials. Ni nanoparticles were homogeneously electrodeposited on the surfaces of SWNTs. Antimicrobial activity of CNTs was determined by broth dilution method using six different bacterial strains, three strains of gram negative and three strains of gram positive bacteria. The gram positive bacteria include Staphylococcus aureus, Staphylococcus epidermidis and Bacillus subtilis . The gram negative bacteria include Eshericia coli, Klebsiella pneumonia and Pseudomonas aerugenosa. Bactericidal rate was calculated. Based on the results Ni-coated CNTs show much stronger bactericidal property comparing to SWNTs and XD-grade CNTs.

Guidelines for handling radioactively contaminated decedents.

PubMed

Wood, Charles M; DePaolo, Frank; Whitaker, Doggett

2008-05-01

The Centers for Disease Control and Prevention recently issued guidelines for medical examiners, coroners, and morticians in dealing with decedents after detonation of an improvised nuclear device (IND) or radiological dispersal device (RDD) (). Partners in this effort included the New York City Office of Chief Medical Examiner and the National Funeral Directors' Association. This paper describes the handling techniques required for loose surface contamination, radioactive shrapnel, and internal contamination caused by inhaling or ingesting radioactive materials from an IND or RDD, and provides suggested guidelines for medical examiners, coroners, and morticians to deal with these situations.

Erythema Nodosum and Mycoplasma pneumoniae Infections in Childhood: Further Observations in Two Patients and a Literature Review

PubMed Central

Greco, Filippo; Catania, Roberta; Pira, Alice Le; Saporito, Marco; Scalora, Luisa; Aguglia, Maria Giovanna; Smilari, Pierluigi; Sorge, Giovanni

2015-01-01

Erythema nodosum (EN) is the most frequent panniculitis in childhood and has been associated with various conditions, such as infectious and autoimmune disorders, medications, and malignancies. The author reports on two children affected with EN associated with Mycoplasma pneumoniae infection, which occurred in one patient without pulmonary detection. The available literature on EN and M. pneumoniae infection in childhood is also reviewed. PMID:25699127

Radiological protection, safety and security issues in the industrial and medical applications of radiation sources

NASA Astrophysics Data System (ADS)

Vaz, Pedro

2015-11-01

The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.

Registration of Medical Devices

PubMed Central

George, Bobby

2010-01-01

Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries. PMID:21814626

Negative pressure wound therapy reduces incidence of postoperative wound infection and dehiscence after long-segment thoracolumbar spinal fusion: a single institutional experience.

PubMed

Adogwa, Owoicho; Fatemi, Parastou; Perez, Edgar; Moreno, Jessica; Gazcon, Gustavo Chagoya; Gokaslan, Ziya L; Cheng, Joseph; Gottfried, Oren; Bagley, Carlos A

2014-12-01

Wound dehiscence and surgical site infections (SSIs) can have a profound impact on patients as they often require hospital readmission, additional surgical interventions, lengthy intravenous antibiotic administration, and delayed rehabilitation. Negative pressure wound therapy (NPWT) exposes the wound site to negative pressure, resulting in the improvement of blood supply, removal of excess fluid, and stimulation of cellular proliferation of granulation tissue. To assess the incidence of wound infection and dehiscence in patients undergoing long-segment thoracolumbar fusion before and after the routine use of NPWT. Retrospective study. One hundred sixty patients undergoing long-segment thoracolumbar spine fusions were included in this study. Postoperative incidence of wound infection and dehiscence. All adult patients undergoing thoracolumbar fusion for spinal deformity over a 6-year period at Duke University Medical Center by the senior author (CB) were included in this study. In 2012, a categorical change was made by the senior author (CB) that included the postoperative routine use of incisional NPWT devices after primary wound closure in all long-segment spine fusions. Before 2012, NPWT was not used. After primary wound closure, a negative pressure device is contoured to the size of the incision and placed over the incision site for 3 postoperative days. We retrospectively review the first 46 cases in which NPWT was used and compared them with the immediately preceding 114 cases to assess the incidence of wound infection and dehiscence. One hundred sixty (NPWT: 46 cases, non-NPWT: 114 cases) long-segment thoracolumbar spine fusions were performed for deformity correction. Baseline characteristics were similar between both cohorts. Compared with the non-NPWT cohort, a 50% decrease in the incidence of wound dehiscence was observed in the NPWT patient cohort (6.38% vs. 12.28%, p=.02). Similarly, compared with the non-NPWT cohort, the incidence of postoperative SSIs was significantly decreased in the NPWT cohort (10.63% vs. 14.91%, p=.04). Routine use of incisional NPWT was associated with a significant reduction in the incidence of postoperative wound infection and dehiscence. Copyright © 2014 Elsevier Inc. All rights reserved.

A review of heterogeneous photocatalysis for water and surface disinfection.

PubMed

Byrne, John Anthony; Dunlop, Patrick Stuart Morris; Hamilton, Jeremy William John; Fernández-Ibáñez, Pilar; Polo-López, Inmaculada; Sharma, Preetam Kumar; Vennard, Ashlene Sarah Margaret

2015-03-30

Photo-excitation of certain semiconductors can lead to the production of reactive oxygen species that can inactivate microorganisms. The mechanisms involved are reviewed, along with two important applications. The first is the use of photocatalysis to enhance the solar disinfection of water. It is estimated that 750 million people do not have accessed to an improved source for drinking and many more rely on sources that are not safe. If one can utilize photocatalysis to enhance the solar disinfection of water and provide an inexpensive, simple method of water disinfection, then it could help reduce the risk of waterborne disease. The second application is the use of photocatalytic coatings to combat healthcare associated infections. Two challenges are considered, i.e., the use of photocatalytic coatings to give "self-disinfecting" surfaces to reduce the risk of transmission of infection via environmental surfaces, and the use of photocatalytic coatings for the decontamination and disinfection of medical devices. In the final section, the development of novel photocatalytic materials for use in disinfection applications is reviewed, taking account of materials, developed for other photocatalytic applications, but which may be transferable for disinfection purposes.

The influence of proton pump inhibitors and other commonly used medication on the gut microbiota

PubMed Central

Imhann, Floris; Vich Vila, Arnau; Bonder, Marc Jan; Koonen, Debby P.Y.; Fu, Jingyuan; Zhernakova, Alexandra; Weersma, Rinse K.

2017-01-01

ABSTRACT Proton pump inhibitors (PPIs), used to treat gastro-esophageal reflux and prevent gastric ulcers, are among the most widely used drugs in the world. The use of PPIs is associated with an increased risk of enteric infections. Since the gut microbiota can, depending on composition, increase or decrease the risk of enteric infections, we investigated the effect of PPI-use on the gut microbiota. We discovered profound differences in the gut microbiota of PPI users: 20% of their bacterial taxa were statistically significantly altered compared with those of non-users. Moreover, we found that it is not only PPIs, but also antibiotics, antidepressants, statins and other commonly used medication were associated with distinct gut microbiota signatures. As a consequence, commonly used medications could affect how the gut microbiota resist enteric infections, promote or ameliorate gut inflammation, or change the host's metabolism. More studies are clearly needed to understand the role of commonly used medication in altering the gut microbiota as well as the subsequent health consequences. PMID:28118083

Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence.

PubMed

Edlich, Richard F; Long, William B; Gubler, K Dean; Rodeheaver, George T; Thacker, John G; Borel, Lise; Chase, Margot E; Cross, Catherine L; Fisher, Allyson L; Lin, Kant Y; Cox, Mary J; Zura, Robert B

2009-02-01

During the last 25 years, scientific experimental and clinical studies have documented the dangers of cornstarch powder on examination and surgical gloves because the cornstarch promotes wound infection, causes serious peritoneal adhesions and granulomatous peritonitis, and is a well-documented vector of the latex allergy epidemic in the world. Realizing the dangers of cornstarch on examination and surgical gloves, Germany's regulations of personal protective equipment banned the use of surgical glove powder cornstarch in 1997. In 2000, the Purchasing and Supply agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch. Realizing the dangers of cornstarch-powdered gloves, many hospitals and clinics in the United States have banned the use of cornstarch-powdered examination and surgical gloves. Hospitals that have banned cornstarch in their examination and surgical gloves have noted a marked reduction in the latex allergy epidemic in their facilities. Realizing the dangers of cornstarch-powdered examination and surgical gloves, Dr Sheila A. Murphey, branch chief, Infection Control Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation, Center for Devices and Radiological Health of the Food and Drug Administration (FDA), recommended that a Citizen's Petition be filed to the FDA to ban cornstarch on surgical and examination gloves. The 12 authors of this report have attached the enclosed petition to the FDA to ban the use of cornstarch on all synthetic and latex examination and surgical gloves used in the United States.

The complications and the position of the Codman MicroSensor™ ICP device: an analysis of 549 patients and 650 Sensors.

PubMed

Koskinen, Lars-Owe D; Grayson, David; Olivecrona, Magnus

2013-11-01

Complications of and insertion depth of the Codman MicroSensor ICP monitoring device (CMS) is not well studied. To study complications and the insertion depth of the CMS in a clinical setting. We identified all patients who had their intracranial pressure (ICP) monitored using a CMS device between 2002 and 2010. The medical records and post implantation computed tomography (CT) scans were analyzed for occurrence of infection, hemorrhage and insertion depth. In all, 549 patients were monitored using 650 CMS. Mean monitoring time was 7.0 ± 4.9 days. The mean implantation depth was 21.3 ± 11.1 mm (0-88 mm). In 27 of the patients, a haematoma was identified; 26 of these were less than 1 ml, and one was 8 ml. No clinically significant bleeding was found. There was no statistically significant increase in the number of hemorrhages in presumed coagulopathic patients. The infection rate was 0.6 % and the calculated infection rate per 1,000 catheter days was 0.8. The risk for hemorrhagic and infectious complications when using the CMS for ICP monitoring is low. The depth of insertion varies considerably and should be taken into account if patients are treated with head elevation, since the pressure is measured at the tip of the sensor. To meet the need for ICP monitoring, an intraparenchymal ICP monitoring device should be preferred to the use of an external ventricular drainage (EVD).

Lightweight Portable Plasma Medical Device - Plasma Engineering Research Laboratory

DTIC Science & Technology

2012-10-01

cut fruit surfaces contaminated with migrating microorganisms," Journal of Food Protection, vol. 71, pp. 1619-1625, Aug 2008. [31] H. L. Chen, et...foodborne and opportunistic nosocomial pathogens is a major problem in food industry, biomedical and hospital applications, respectively. The resistive...source is very efficient in decontaminating wide range of infection and contamination causing bacteria. The direct and indirect exposure of the RBP

Inhibitory effect of 2‑mercaptoethane sulfonate on the formation of Escherichia coli biofilms in vitro.

PubMed

Chen, Sheng; He, Nianhai; Yu, Jialin; Li, Luquan; Sun, Fengjun; Hu, Ying; Deng, Rui; Zhong, Shiming; Shen, Leilei

2015-10-01

The biofilms (BF) formed by Escherichia coli (E. coli) is an important cause of chronic and recurrent infections due to its capacity to persist on medical surfaces and indwelling devices, demonstrating the importance of inhibiting the formation of E. coli BF and reducing BF infection. Although 2‑mercaptoethane sulfonate (MESNA) exhibits a marked mucolytic effect clinically, the effect of MESNA on the inhibition of E. coli BF formation remains to be elucidated. The present study investigated whether MESNA inhibits the formation of E. coli BF in vitro. The minimum inhibitory concentration of MESNA on E. coli was determined to be 10 mg/ml. Subsequently, the effect of MESNA on BF early adhesion, extracellular polysaccharide (EPS) and extracellular protein were detected. The effect of a subinhibitory concentration of MESNA on BF formation was evaluated, and the inhibitory potency of MESNA against matured BF was assayed. The results revealed that MESNA inhibited early stage adhesion and formation of the E. coli BF, destroyed the mature BF membrane and reduced the EPS and extracellular proteins levels of the BF. In addition, the present study investigated the effects of MESNA on the expression of EPS‑ and adhesion protein‑associated genes using quantitative polymerase chain reaction analysis, which demonstrated that MESNA effectively inhibited the expression of these genes. These results suggested that MESNA possesses anti‑BF formation capability on E. coli in vitro and may be used as a potential reagent for the clinical treatment of E. coli BF‑associated infections.

Evaluation of a pulsed xenon ultraviolet light device for isolation room disinfection in a United Kingdom hospital.

PubMed

Hosein, Ian; Madeloso, Rosie; Nagaratnam, Wijayaratnam; Villamaria, Frank; Stock, Eileen; Jinadatha, Chetan

2016-09-01

Pathogen transmission from contaminated surfaces can cause hospital-associated infections. Although pulsed xenon ultraviolet (PX-UV) light devices have been shown to decrease hospital room bioburden in the United States, their effectiveness in United Kingdom (UK) hospitals is less understood. Forty isolation rooms at the Queens Hospital (700 beds) in North London, UK, were sampled for aerobic bacteria after patient discharge, after manual cleaning with a hypochlorous acid-troclosene sodium solution, and after PX-UV disinfection. PX-UV device efficacy on known organisms was tested by exposing inoculated agar plates in a nonpatient care area. Turnaround times for device usage were recorded, and a survey of hospital staff for perceptions of the device was undertaken. After PX-UV disinfection, the bacterial contamination measured in colony forming units (CFU) decreased by 78.4%, a 91% reduction from initial bioburden levels prior to terminal cleaning. PX-UV exposure resulted in a 5-log CFU reduction for multidrug-resistant organisms (MDROs) on spiked plates. The average device turnaround time was 1 hour, with minimal impact on patient throughput. Ward staff were enthusiastic about device deployment, and device operators reported physical comfort in usage. PX-UV use decreased bioburden in patient discharge rooms and on agar plates spiked with MDROs. The implementation of the PX-UV device was well received by hospital cleaning and ward staff, with minimal disruption to patient flow. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Mycobacterium chimaera Outbreak Associated With Heater-Cooler Devices: Piecing the Puzzle Together.

PubMed

Sommerstein, Rami; Schreiber, Peter W; Diekema, Daniel J; Edmond, Michael B; Hasse, Barbara; Marschall, Jonas; Sax, Hugo

2017-01-01

An outbreak of invasive Mycobacterium chimaera infections associated with heater-cooler devices (HCDs) has now affected patients in several countries on different continents. Clinical infections are characterized by delayed diagnosis, inadequate treatment response to antimicrobial agents, and poor prognosis. Outbreak investigators found M. chimaera in HCD water circuits and air samples while HCDs were running, suggesting that transmission from the HCD to the surgical site occurs via the airborne route. New HCDs at the manufacturing site were also contaminated with M. chimaera, and recent whole-genome sequencing data suggest a point source. Some guidance on screening for M. chimaera colonization in HCD water and exhaust air is available. In contrast, reliable disinfection procedures are not well described, and it is not yet known whether eradication of M. chimaera from a contaminated HCD can be achieved. Meanwhile, strict separation of the HCD from operating room air is necessary to ensure patient safety, and these efforts may require engineering solutions. While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling, and risk mitigation still require clarification. Infect Control Hosp Epidemiol 2016;1-6.

Clinical characteristics of Staphylococcus epidermidis: a systematic review

PubMed Central

Namvar, Amirmorteza Ebrahimzadeh; Bastarahang, Sara; Abbasi, Niloufar; Ghehi, Ghazaleh Sheikhi; Farhadbakhtiarian, Sara; Arezi, Parastoo; Hosseini, Mahsa; Baravati, Sholeh Zaeemi; Jokar, Zahra; Chermahin, Sara Ganji

2014-01-01

Staphylococci are known as clustering Gram-positive cocci, nonmotile, non-spore forming facultatively anaerobic that classified in two main groups, coagulase-positive and coagulase-negative. Staphylococcus epidermidis with the highest percentage has the prominent role among coagulase-negative Staphylococci that is the most important reason of clinical infections. Due to various virulence factors and unique features, this microorganism is respected as a common cause of nosocomial infections. Because of potential ability in biofilm formation and colonization in different surfaces, also using of medical implant devices in immunocompromised and hospitalized patients the related infections have been increased. In recent decades the clinical importance and the emergence of methicillin-resistant Staphylococcus epidermidis strains have created many challenges in the treatment process. PMID:25285267

Risk factors for explantation due to infection after sacral neuromodulation: a multicenter retrospective case-control study.

PubMed

Myer, Emily N B; Petrikovets, Andrey; Slocum, Paul D; Lee, Toy Gee; Carter-Brooks, Charelle M; Noor, Nabila; Carlos, Daniela M; Wu, Emily; Van Eck, Kathryn; Fashokun, Tola B; Yurteri-Kaplan, Ladin; Chen, Chi Chiung Grace

2018-04-07

Sacral neuromodulation is an effective therapy for overactive bladder, urinary retention, and fecal incontinence. Infection after sacral neurostimulation is costly and burdensome. Determining optimal perioperative management strategies to reduce the risk of infection is important to reduce this burden. We sought to identify risk factors associated with sacral neurostimulator infection requiring explantation, to estimate the incidence of infection requiring explantation, and identify associated microbial pathogens. This is a multicenter retrospective case-control study of sacral neuromodulation procedures completed from Jan. 1, 2004, through Dec. 31, 2014. We identified all sacral neuromodulation implantable pulse generator implants as well as explants due to infection at 8 participating institutions. Cases were patients who required implantable pulse generator explantation for infection during the review period. Cases were included if age ≥18 years old, follow-up data were available ≥30 days after implantable pulse generator implant, and the implant was performed at the institution performing the explant. Two controls were matched to each case. These controls were the patients who had an implantable pulse generator implanted by the same surgeon immediately preceding and immediately following the identified case who met inclusion criteria. Controls were included if age ≥18 years old, no infection after implantable pulse generator implant, follow-up data were available ≥180 days after implant, and no explant for any reason <180 days from implant. Controls may have had an explant for reasons other than infection at >180 days after implant. Fisher exact test (for categorical variables) and Student t test (for continuous variables) were used to test the strength of the association between infection and patient and surgery characteristics. Significant variables were then considered in a multivariable logistic regression model to determine risk factors independently associated with infection. Over a 10-year period at 8 academic institutions, 1930 sacral neuromodulator implants were performed by 17 surgeons. In all, 38 cases requiring device explant for infection and 72 corresponding controls were identified. The incidence of infection requiring explant was 1.97%. Hematoma formation (13% cases, 0% controls; P = .004) and pocket depth of ≥3 cm (21% cases, 0% controls; P = .031) were independently associated with an increased risk of infection requiring explant. On multivariable regression analysis controlling for significant variables, both hematoma formation (P = .006) and pocket depth ≥3 cm (P = .020, odds ratio 3.26; 95% confidence interval, 1.20-8.89) remained significantly associated with infection requiring explant. Of the 38 cases requiring explant, 32 had cultures collected and 24 had positive cultures. All 5 cases with a hematoma had a positive culture (100%). Of the 4 cases with a pocket depth ≥3 cm, 2 had positive cultures, 1 had negative cultures, and 1 had a missing culture result. The most common organism identified was methicillin-resistant Staphylococcus aureus (38%). Infection after sacral neuromodulation requiring device explant is low. The most common infectious pathogen identified was methicillin-resistant S aureus. Demographic and health characteristics did not predict risk of explant due to infection, however, having a postoperative hematoma or a deep pocket ≥3 cm significantly increased the risk of explant due to infection. These findings highlight the importance of meticulous hemostasis as well as ensuring the pocket depth is <3 cm at the time of device implant. Copyright © 2018 Elsevier Inc. All rights reserved.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

PubMed

Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

2011-07-01

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

Infection Prevention and Control in Deployed Military Medical Treatment Facilities

DTIC Science & Technology

2011-08-01

Targeted intranasal mupi- rocin to prevent colonization and infection by community-associated methicillin - resistant Staphylococcus aureus strains in...Natural history of community-acquired methicillin - resistant Staphylococcus au- reus colonization and infection in soldiers. Clin Infect Dis. 2004;39...coli and Klebsiella pneumoniae), P. aeruginosa, and methicillin - resistant S. au- reus (MRSA), have most commonly been reported as the cause of these

Non-nosocomial healthcare-associated left-sided Pseudomonas aeruginosa endocarditis: a case report and literature review.

PubMed

Hagiya, Hideharu; Tanaka, Takeshi; Takimoto, Kohei; Yoshida, Hisao; Yamamoto, Norihisa; Akeda, Yukihiro; Tomono, Kazunori

2016-08-20

With the development of invasive medical procedures, an increasing number of healthcare-associated infective endocarditis cases have been reported. In particular, non-nosocomial healthcare-associated infective endocarditis in outpatients with recent medical intervention has been increasingly identified. A 66-year-old man with diabetes mellitus and a recent history of intermittent urethral self-catheterization was admitted due to a high fever. Repeated blood cultures identified Pseudomonas aeruginosa, and transesophageal echocardiography uncovered a new-onset severe aortic regurgitation along with a vegetative valvular structure. The patient underwent emergency aortic valve replacement surgery and was successfully treated with 6 weeks of high-dose meropenem and tobramycin. Historically, most cases of P. aeruginosa endocarditis have occurred in the right side of the heart and in outpatients with a history of intravenous drug abuse. In the case presented, the repeated manipulations of the urethra may have triggered the infection. Our literature review for left-sided P. aeruginosa endocarditis showed that non-nosocomial infection accounted for nearly half of the cases and resulted in fatal outcomes as often as nosocomial cases. A combination therapy with anti-pseudomonal beta-lactams or carbapenems and aminoglycosides may be the preferable treatment. Medical treatment alone may be effective, and surgical treatment should be carefully considered. We presented a rare case of native aortic valve endocarditis caused by P. aeruginosa. This case illustrates the importance of identifying the causative pathogen(s), especially for outpatients with a recent history of medical procedures.

Low CD4+ T cell count as a major atherosclerosis risk factor in HIV-infected women and men

PubMed Central

Kaplan, Robert C; Kingsley, Lawrence A; Gange, Stephen J; Benning, Lorie; Jacobson, Lisa P; Lazar, Jason; Anastos, Kathryn; Tien, Phyllis C; Sharrett, A Richey; Hodis, Howard N

2009-01-01

Objective To assess the association of HIV infection, HIV disease parameters (including CD4+ T-cell counts, HIV viral load, and AIDS) and antiretroviral medication use with subclinical carotid artery atherosclerosis. Design Cross-sectional study nested within a prospective cohort study Methods Among participants in the Women's Interagency HIV Study (1,331 HIV-infected women, 534 HIV-uninfected women) and Multicenter AIDS Cohort Study (600 HIV-infected men, 325 HIV-uninfected men), we measured subclinical carotid artery lesions and common carotid artery intima-media thickness (CIMT) using B-mode ultrasound. We estimated adjusted mean CIMT differences and prevalence ratios (PRs) for carotid lesions associated with HIV-related disease and treatments, with multivariate adjustment to control for possible confounding variables. Results Among HIV-infected individuals, a low CD4+ T cell count was independently associated with an increased prevalence of carotid lesions. Compared to the reference group of HIV-uninfected individuals, the adjusted PR for lesions among HIV-infected individuals with CD4+ T-cell count <200 cells/mm3 was 2.00 (95% confidence interval 1.22, 3.28) in women and 1.74 (95% confidence interval 1.04, 2.93) in men. No consistent association of antiretroviral medications with carotid atherosclerosis was observed, except for a borderline significant association between protease inhibitor use and carotid lesions in men (with no association among women). History of clinical AIDS and HIV viral load were not significantly associated with carotid atherosclerosis. Conclusions Beyond traditional cardiovascular disease risk factors, low CD4+ T-cell count is the most robust risk factor for increased subclinical carotid atherosclerosis in HIV-infected women and men. PMID:18670221

Nursing home facility risk factors for infection and hospitalization: importance of registered nurse turnover, administration, and social factors.

PubMed

Zimmerman, Sheryl; Gruber-Baldini, Ann L; Hebel, J Richard; Sloane, Philip D; Magaziner, Jay

2002-12-01

Determine the relationship between a broad array of structure and process elements of nursing home care and (a) resident infection and (b) hospitalization for infection. Baseline data were collected from September 1992 through March 1995, and residents were followed for 2 years; facility data were collected at the midpoint of follow-up. A stratified random sample of 59 nursing homes across Maryland. Two thousand fifteen new admissions aged 65 and older. Facility-level data were collected from interviews with facility administrators, directors of nursing, and activity directors; record abstraction; and direct observation. Main outcome measures included infection (written diagnosis, a course of antibiotic therapy, or radiographic confirmation of pneumonia) and hospitalization for infection (indicated on medical records). The 2-year rate of infection was 1.20 episodes per 100 resident days, and the hospitalization rate for infection was 0.17 admissions per 100 resident days. Except for registered nurse (RN) turnover, which related to both infection and hospitalization, different variables related to each outcome. High rates of incident infection were associated with more Medicare recipients, high levels of physical/occupational therapist staffing, high licensed practical nurse staffing, low nurses' aide staffing, high intensity of medical and therapeutic services, dementia training, staff privacy, and low levels of psychotropic medication use. High rates of hospitalization for infection were associated with for-profit ownership, chain affiliation, poor environmental quality, lack of resident privacy, lack of administrative emphasis on staff satisfaction, and low family/friend visitation rates. Adjustment for resident sex, age, race, education, marital status, number of morbid diagnoses, functional status, and Resource Utilization Group, Version III score did not alter the relationship between the structure and process of care and outcomes. The association between RN turnover and both outcomes underscores the relationship between nursing leadership and quality of care in these settings. The relationship between hospitalization for infection and for-profit ownership and chain affiliation could reflect policies not to treat acute illnesses in house. The link between social factors of care (environmental quality, prioritizing staff satisfaction, resident privacy, and facility visitation) and hospitalization indicates that a nonmedical model of care may not jeopardize, and may in fact benefit, health-related outcomes. All of these facility characteristics may be modifiable, may affect healthcare costs, and may hold promise for other, less-medical, forms of residential long-term care.

An intervention to improve the catheter associated urinary tract infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure.

PubMed

Galiczewski, Janet M; Shurpin, Kathleen M

2017-06-01

Healthcare associated infections from indwelling urinary catheters lead to increased patient morbidity and mortality. The purpose of this study was to determine if direct observation of the urinary catheter insertion procedure, as compared to the standard process, decreased catheter utilization and urinary tract infection rates. This case control study was conducted in a medical intensive care unit. During phase I, a retrospective data review was conducted on utilsiation and urinary catheter infection rates when practitioners followed the institution's standard insertion algorithm. During phase II, an intervention of direct observation was added to the standard insertion procedure. The results demonstrated no change in utilization rates, however, CAUTI rates decreased from 2.24 to 0 per 1000 catheter days. The findings from this study may promote changes in clinical practice guidelines leading to a reduction in urinary catheter utilization and infection rates and improved patient outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Changing panorama for surveillance of device-associated healthcare infections: Challenges faced in implementation of current guidelines.

PubMed

Gupta, Renu; Sharma, Sangeeta; Saxena, Sonal

2018-01-01

Healthcare-associated infections (HAI) are preventable in up to 30% of patients with evidence-based infection prevention and control (IPC) activities. IPC activities require effective surveillance to generate data for the HAI rates, defining priority areas, identifying processes amenable for improvement and institute interventions to improve patient's safety. However, uniform, accurate and standardised surveillance methodology using objective definitions can only generate meaningful data for effective execution of IPC activities. The highly exhaustive, complex and ever-evolving infection surveillance methodology pose a challenge for effective data capture, analysis and interpretation by ground level personnel. The present review addresses the gaps in knowledge and day-to-day challenges in surveillance faced by infection control team for effective implementation of IPC activities.

Influence of nanohydroxyapatite surface properties on Staphylococcus epidermidis biofilm formation.

PubMed

Barros, J; Grenho, L; Manuel, C M; Ferreira, C; Melo, L; Nunes, O C; Monteiro, F J; Ferraz, M P

2014-05-01

Nanohydroxyapatite (nanoHA), due to its chemical properties, has appeared as an exceptionally promising bioceramic to be used as bone regeneration material. Staphylococcus epidermidis have emerged as major nosocomial pathogens associated with infections of implanted medical devices. In this work, the purpose was to study the influence of the nanoHA surface characteristics on S. epidermidis RP62A biofilm formation. Therefore, two different initial inoculum concentrations (Ci) were used in order to check if these would affect the biofilm formed on the nanoHA surfaces. Biofilm formation was followed by the enumeration of cultivable cells and by scanning electron microscopy. Surface topography, contact angle, total surface area and porosimetry of the biomaterials were studied and correlated with the biofilm data. The surface of nanoHA sintered at 830 (nanoHA830) showed to be more resistant to S. epidermidis attachment and accumulation than that of nanoHA sintered at 1000 (nanoHA1000). The biofilm formed on nanoHA830 presented differences in terms of structure, surface coverage and EPS production when compared to the one formed on nanoHA1000 surface. It was observed that topography and surface area of nanoHA surfaces had influence on the bacterial attachment and accumulation. Ci influenced bacteria attachment and accumulation on nanoHA surfaces over time. The choice of the initial inoculum concentration was relevant proving to have an effect on the extent of adherence thus being a critical point for human health if these materials are used in implantable devices. This study showed that the initial inoculum concentration and surface material properties determine the rate of microbial attachment to substrata and consequently are related to biofilm-associated infections in biomaterials.

Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan☆

PubMed Central

Handa, Nobuhiro; Ishii, Kensuke; Matsui, Yutaka; Ando, Yuki

2015-01-01

Background Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated. Results AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30. Comments Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential. PMID:26501120

Central venous catheter infection-related glomerulonephritis under long-term parenteral nutrition: a report of two cases.

PubMed

Okada, Mari; Sato, Mai; Ogura, Masao; Kamei, Koichi; Matsuoka, Kentaro; Ito, Shuichi

2016-03-31

Advances in long-term parenteral nutrition via indwelling central venous catheter have improved the quality of life and mortality in patients with life-threatening gastrointestinal diseases complicated with severely impaired absorption. However, infection to central venous catheter is still a common and critical complication for such patients. We encountered two patients under long-term parenteral nutrition who developed glomerulonephritis associated with central venous catheter infection. Persistent bacterial infection in indwelling medical devices placed in the blood-stream such as a ventricular-atrial shunt is known to cause glomerulonephritis, a condition termed shunt nephritis. We reported the clinical manifestations, treatment and their pathological findings in the two patients with glomerulonephritis associated with central venous catheter infection. Both patients suffered from megacystis microcolon intestinal hypoperistalsis syndrome, a form of pseudo-Hirschsprung's disease. They had been receiving home parenteral nutrition via central venous catheter because of severe malabsorption. They presented proteinuria, hematuria, hypocomplementemia and positive PR3-antineutrophilic cytoplasmic antibody accompanied by Staphylococcus epidermidis infection in the central venous catheter. Their renal biopsy revealed membranoproliferative glomerulonephritis with positive C3 deposition. One of them recovered completely following the removal of catheter and administration of antibiotics, while another did not respond to the treatments. We then treated her with methylprednisolone pulse therapy followed by prednisolone. She responded well, and achieved complete remission. As central venous catheter infection-related glomerulonephritis has a similar etiology to shunt nephritis, removal of the catheter and administration of antibiotics is fundamental to the treatment. If a patient is resistant to such conventional therapy, additional steroid and/or immunosuppressive agent could be considered. Although the number of patients with classical shunt nephritis is decreasing since the ventricular-peritoneal shunt has become became the major procedure for hydrocephalus, central venous catheter infection-related glomerulonephritis may increase in the future due to a marked increase in the number of patients receiving long-term parenteral nutrition. Routine urinalysis should be considered in such patients for early detection of central venous catheter infection-related glomerulonephritis.

Anti-biofilm peptides as a new weapon in antimicrobial warfare.

PubMed

Pletzer, Daniel; Coleman, Shannon R; Hancock, Robert Ew

2016-10-01

Microorganisms growing in a biofilm state are very resilient in the face of treatment by many antimicrobial agents. Biofilm infections are a significant problem in chronic and long-term infections, including those colonizing medical devices and implants. Anti-biofilm peptides represent a very promising approach to treat biofilm-related infections and have an extraordinary ability to interfere with various stages of the biofilm growth mode. Anti-biofilm peptides possess promising broad-spectrum activity in killing both Gram-positive and Gram-negative bacteria in biofilms, show strong synergy with conventional antibiotics, and act by targeting a universal stringent stress response. Understanding downstream processes at the molecular level will help to develop and design peptides with increased activity. Anti-biofilm peptides represent a novel, exciting approach to treating recalcitrant bacterial infections. Copyright © 2016 Elsevier Ltd. All rights reserved.

Humidifiers for oxygen therapy: what risk for reusable and disposable devices?

PubMed

La Fauci, V; Costa, G B; Facciolà, A; Conti, A; Riso, R; Squeri, R

2017-06-01

Nosocomial pneumonia accounts for the vast majority of healthcare-associated infections (HAI). Although numerous medical devices have been discussed as potential vehicles for microorganisms, very little is known about the role played by oxygen humidifiers as potential sources of nosocomial pathogens. The purpose of this research was to evaluate the safety of the reuse of humidifiers by analysing the rate of microbial contamination in reusable and disposable oxygen humidifiers used during therapy, and then discuss their potential role in the transmission of respiratory pathogens. Water samples from reusable and disposable oxygen humidifiers were collected from different wards of the University Hospital of Messina, Italy, where nosocomial pneumonia has a higher incidence rate due to the "critical" clinical conditions of inpatients. In particular, we monitored the Internal Medicine and Pulmonology wards for the medical area; the General Surgery and Thoracic and Cardiovascular Surgery wards for the surgical area and the Intensive Care Unit and Neonatal Intensive Care Unit for the emergency area. The samples were always collected after a period of 5 days from initial use for both types of humidifiers. Samples were processed using standard bacteriological techniques and microbial colonies were identified using manual and automated methods. High rates of microbial contamination were observed in samples from reusable oxygen humidifiers employed in medical (83%), surgical (77%) and emergency (50%) areas. The most relevant pathogens were Pseudomonas aeruginosa, amongst the Gram-negative bacteria, and Staphylococcus aureus, amongst the Gram-positive bacteria. Other pathogens were detected in lower percentage. The disposable oxygen humidifier samples showed no contamination. This research presents evidence of the high rate and type of microbial contamination of reusable humidifiers employed for oxygen therapy. These devices may thus be involved in the transmission of potential pathogens. It could be important, for the prevention of nosocomial pneumonia, to replace them with singleuse humidifiers for which the absence of microbial contamination has been confirmed.

[VR and AR Applications in Medical Practice and Education].

PubMed

Hsieh, Min-Chai; Lin, Yu-Hsuan

2017-12-01

As technology advances, mobile devices have gradually turned into wearable devices. Furthermore, virtual reality (VR), augmented reality (AR), and mixed reality (MR) are being increasingly applied in medical fields such as medical education and training, surgical simulation, neurological rehabilitation, psychotherapy, and telemedicine. Research results demonstrate the ability of VR, AR, and MR to ameliorate the inconveniences that are often associated with traditional medical care, reduce incidents of medical malpractice caused by unskilled operations, and reduce the cost of medical education and training. What is more, the application of these technologies has enhanced the effectiveness of medical education and training, raised the level of diagnosis and treatment, improved the doctor-patient relationship, and boosted the efficiency of medical execution. The present study introduces VR, AR, and MR applications in medical practice and education with the aim of helping health professionals better understand the applications and use these technologies to improve the quality of medical care.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

Fungal nail infection

MedlinePlus

... 268. Review Date 10/24/2016 Updated by: David L. Swanson, MD, Vice Chair of Medical Dermatology, Associate Professor of Dermatology, Mayo Medical School, Scottsdale, AZ. Also reviewed by David Zieve, MD, MHA, Isla Ogilvie, PhD, and the ...

Genome-Wide Association Study Identifies Risk Variants for Lichen Planus in Patients With Hepatitis C Virus Infection.

PubMed

Nagao, Yumiko; Nishida, Nao; Toyo-Oka, Licht; Kawaguchi, Atsushi; Amoroso, Antonio; Carrozzo, Marco; Sata, Michio; Mizokami, Masashi; Tokunaga, Katsushi; Tanaka, Yasuhito

2017-06-01

There is a close relationship between hepatitis C virus (HCV) infection and lichen planus, a chronic inflammatory mucocutaneous disease. We performed a genome-wide association study (GWAS) to identify genetic variants associated with HCV-related lichen planus. We conducted a GWAS of 261 patients with HCV infection treated at a tertiary medical center in Japan from October 2007 through January 2013; a total of 71 had lichen planus and 190 had normal oral mucosa. We validated our findings in a GWAS of 38 patients with HCV-associated lichen planus and 7 HCV-infected patients with normal oral mucosa treated at a medical center in Italy. Single-nucleotide polymorphisms in NRP2 (rs884000) and IGFBP4 (rs538399) were associated with risk of HCV-associated lichen planus (P < 1 × 10 -4 ). We also found an association between a single-nucleotide polymorphism in the HLA-DR/DQ genes (rs9461799) and susceptibility to HCV-associated lichen planus. The odds ratios for the minor alleles of rs884000, rs538399, and rs9461799 were 3.25 (95% confidence interval, 1.95-5.41), 0.40 (95% confidence interval, 0.25-0.63), and 2.15 (95% confidence interval, 1.41-3.28), respectively. In a GWAS of Japanese patients with HCV infection, we replicated associations between previously reported polymorphisms in HLA class II genes and risk for lichen planus. We also identified single-nucleotide polymorphisms in NRP2 and IGFBP4 loci that increase and reduce risk of lichen planus, respectively. These genetic variants might be used to identify patients with HCV infection who are at risk for lichen planus. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Potential negative consequences of non-consented switch of inhaled medications and devices in asthma patients.

PubMed

Björnsdóttir, U S; Gizurarson, S; Sabale, U

2013-09-01

Asthma requires individually tailored and careful management to control and prevent symptoms and exacerbations. Selection of the most appropriate treatment is dependent on both the choice of drugs and inhaler device; however, financial pressures may result in patients being switched to alternative medications and devices in an attempt to reduce costs. This review aimed to examine the published literature in order to ascertain whether switching a patient's asthma medications or device negatively impacts clinical and economic outcomes. A literature search of MEDLINE (2001-13 September 2011) was conducted to identify English-language articles focused on the direct impact of switching medications and inhaler devices and switching from fixed-dose combination to monocomponent therapy via separate inhalers in patients with asthma; the indirect impacts of switching were also assessed. Evidence showed that non-consented switching of medications and inhalers in patients with asthma can be associated with a range of negative outcomes, at both individual and organisational levels. Factors that reduce adherence may lead to compromised symptom control resulting in increased healthcare resource utilisation and poorer patient quality of life. The consequences of a non-consented switch should be weighed carefully against arguments supporting an inhaler switch without the patient's consent for non-medical/budgetary reasons, such as potential reductions in initial acquisition costs, which may be associated with subsequent additional healthcare needs. Given the increasing pressure for reduced costs and efficient allocation of limited healthcare resources, an additional investment in ensuring high medication adherence may lead to greater savings due to a potentially decreased demand for healthcare services. In contrast, savings achieved in acquisition costs may result in a greater net loss due to increased healthcare consumption caused by decreased asthma control. © 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

Association of Rapid Care Process Implementation on Reperfusion Times Across Multiple ST-Segment-Elevation Myocardial Infarction Networks.

PubMed

Fordyce, Christopher B; Al-Khalidi, Hussein R; Jollis, James G; Roettig, Mayme L; Gu, Joan; Bagai, Akshay; Berger, Peter B; Corbett, Claire C; Dauerman, Harold L; Fox, Kathleen; Garvey, J Lee; Henry, Timothy D; Rokos, Ivan C; Sherwood, Matthew W; Wilson, B Hadley; Granger, Christopher B

2017-01-01

The Mission: Lifeline STEMI Systems Accelerator program, implemented in 16 US metropolitan regions, resulted in more patients receiving timely reperfusion. We assessed whether implementing key care processes was associated with system performance improvement. Hospitals (n=167 with 23 498 ST-segment-elevation myocardial infarction patients) were surveyed before (March 2012) and after (July 2014) program intervention. Data were merged with patient-level clinical data over the same period. For reperfusion, hospitals were grouped by whether a specific process of care was implemented, preexisting, or never implemented. Uptake of 4 key care processes increased after intervention: prehospital catheterization laboratory activation (62%-91%; P<0.001), single call transfer protocol from an outside facility (45%-70%; P<0.001), and emergency department bypass for emergency medical services direct presenters (48%-59%; P=0.002) and transfers (56%-79%; P=0.001). There were significant differences in median first medical contact-to-device times among groups implementing prehospital activation (88 minutes implementers versus 89 minutes preexisting versus 98 minutes nonimplementers; P<0.001 for comparisons). Similarly, patients treated at hospitals implementing single call transfer protocols had shorter median first medical contact-to-device times (112 versus 128 versus 152 minutes; P<0.001). Emergency department bypass was also associated with shorter median first medical contact-to-device times for emergency medical services direct presenters (84 versus 88 versus 94 minutes; P<0.001) and transfers (123 versus 127 versus 167 minutes; P<0.001). The Accelerator program increased uptake of key care processes, which were associated with improved system performance. These findings support efforts to implement regional ST-segment-elevation myocardial infarction networks focused on prehospital catheterization laboratory activation, single call transfer protocols, and emergency department bypass. © 2017 American Heart Association, Inc.

Prevention of Community-Associated Methicillin-Resistant Staphylococcus aureus Infection Among Asian/Pacific Islanders: A Qualitative Assessment

PubMed Central

Kim, Mary; Tice, Alan D; Nakata, Michele; Effler, Paul; Jernigan, Daniel B; Cardo, Denise M; Sinkowitz-Cochran, Ronda L

2010-01-01

Background Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has been increasingly reported over the past decade, including in Asian/Pacific Islanders (A/PIs). Methods We conducted ethnographic interviews in O‘ahu and Kaua‘i, Hawai‘i, with 10 Asian/Pacific Islanders identified as having a history of CA-MRSA infections. Results Most (7/10) thought skin infections were not a new problem in Hawai‘i. Most (8/9) attempted to self-treat the infection prior to seeking medical care with a range of home remedies and store-bought solutions. Most respondents did not initially comprehend the severity of their infection and only sought medical treatment after concern from family, unbearable pain, and/or other symptoms of illness. Conclusion Clinicians should be aware of the reportedly frequent use of home remedies by this population, as it may potentially contribute to interactions when treatments are combined. If clinicians and public health professionals do not address perceptions and misperceptions of how MRSA is acquired, it will be very difficult to prevent infection, and may also delay individuals from seeking treatment. PMID:20535687

Achromobacter species endocarditis: A case report and literature review

PubMed Central

Derber, Catherine; Elam, Kara; Forbes, Betty A; Bearman, Gonzalo

2011-01-01

Endocarditis due to Achromobacter species is a rare, yet serious, endovascular infection. Achromobacter species infective endocarditis is associated with underlying immunodeficiencies or prosthetic heart valves and devices. A case of prosthetic pulmonary valve endocarditis secondary to Achromobacter xylosoxidans subspecies denitrificans is described in the present report. This life-threatening infection was successfully treated with combined valve replacement and prolonged antibiotic therapy. A Medline/PubMed literature review of Achromobacter endocarditis was also performed. Achromobacter species are an uncommon, yet important, cause of nosocomial endocarditis. Given the significant associated morbidity and mortality, along with a high degree of intrinsic antibiotic resistance, Achromobacter species infective endocarditis remains a clinical treatment challenge. PMID:22942890

A suspicious reason for Raynaud's phenomenon: Intrauterine device.

PubMed

Diken, Adem I; Yalçınkaya, Adnan; Aksoy, Eray; Yılmaz, Seyhan; Çağlı, Kerim

2015-06-01

Primary Raynaud's phenomenon may be insistent in patients under medical therapy, and intrauterine devices may be an unnoticed reason in these patients. Fluctuations in female sex hormone status were reported to be associated with the emergence of primary Raynaud's phenomenon symptoms. The use of intrauterine devices was not reported to be associated with Raynaud's phenomenon previously. Intrauterine device may stimulate vascular hyperactivity regarding hormonal or unknown mechanisms that result in Raynaud's phenomenon. We present a postmenopausal patient who complained of primary Raynaud's phenomenon symptoms and had recovery after the removal of her copper intrauterine device. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

[Compliance with the treatment by patients with the co-infection HIV/tuberculosis: integrative literature review].

PubMed

Neves, Lis Aparecida de Souza; Reis, Renata Karina; Gir, Elucir

2010-12-01

This is an integrative review whose objective was to evaluate the evidences available in the literature about the factors associated to the compliance with the treatment by patients with the co-infection HIV/TB. Articles published in the period from 2002 to 2008, in the databases LILACS and MEDLINE were analyzed. The material was categorized according to the year of publication, periodical, study location and factors related to the compliance. The final sample included eight articles. The factors found, associated to the compliance with the treatment of the co-infection HIV/TB, related to: the individual and his lifestyle (previous TB treatment, fear of stigma and discrimination, use of chemical substances, depression, social support); the disease and the medication (type of medication regime, use of other medication, adverse effects, difficulty to diagnose TB in these patients); and the health services (operational problems to follow up the treatment, training of the professionals, supervision, different locations to treat TB and HIV).

[Biofilms and their significance in medical microbiology].

PubMed

Cernohorská, L; Votava, M

2002-11-01

Microorganisms are able to adhere to various surfaces and to form there a three-dimensional structure known as biofilm. In biofilms, microbial cells show characteristics and behaviours different from those of plankton cells. Intercellular signalizations of the quorum-sensing type regulate interaction between members of the biofilm. Bacteria embedded in the biofilm can escape and form well known planktonic forms, that are obviously only a part of the bacterial life cycle. Bacteria adhere also to medically important surfaces such as catheters, either urinary or intravenous ones, artificial heart valves, orthopedic implants and so on and contribute to device-related infections like cystitis, catheter-related sepsis, endocarditis etc. Once a biofilm has been established on a surface, the bacteria harboured inside are less exposed to the host's immune response and less susceptible to antibiotics. As an important cause of nosocomial infections the biofilm must remain in the centre of the microbiologist's attention.

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

Prevalence and clinical aspects of CMV congenital Infection in a low-income population.

PubMed

Marin, Lauro Juliano; Santos de Carvalho Cardoso, Emanuelle; Bispo Sousa, Sandra Mara; Debortoli de Carvalho, Luciana; Marques Filho, Marcílio F; Raiol, Mônica Regina; Gadelha, Sandra Rocha

2016-08-31

CMV is the most common cause of congenital infection in the whole world (0.2 to 2.2 %). That infection may be symptomatic or asymptomatic at birth and, although asymptomatic cases at birth are more common, some children may develop late sequelae, and require medical intervention. This study aimed to determine the prevalence of CMV congenital infections in children who were born in a public hospital in Ilhéus, Brazil, and to evaluate the clinical progression in infected newborns. CMV congenital infection was determined by detecting viral DNA through nested PCR. The viral DNA was detected in 25 newborns, showing a prevalence of 1.19 % (25/2100) of CMV congenital infection. In regards to the risk factors from mothers, only the variables: age of mothers (p = 0.003), number of children (p = 0.011), and use of medications (p < 0.001) were associated with the congenital infection. Approximately 12 % of children presented symptoms. One death and two auditory alterations were detected during the monitored period. Only 50 % of children diagnosed attended their medical follow. The prevalence found confirms the findings from other studies which involved other poor populations. Two children presented impaired hearing during the monitored period; that was one of the main sequelae from the infection. It is noteworthy that there was low adherence to medical follow-up which may underestimate data on complications of the infection CMV. Late symptoms can be mistaken for other diseases or even go unnoticed.

APPLICATIONS OF BIOTECHNOLOGY IN DEVELOPMENT OF BIOMATERIALS: NANOTECHNOLOGY AND BIOFILMS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brigmon, R.; Berry, T.; Narayan, R.

2010-11-29

Biotechnology is the application of biological techniques to develop new tools and products for medicine and industry. Due to various properties including chemical stability, biocompatibility, and specific activity, e.g. antimicrobial properties, many new and novel materials are being investigated for use in biosensing, drug delivery, hemodialysis, and other medical applications. Many of these materials are less than 100 nanometers in size. Nanotechnology is the engineering discipline encompassing designing, producing, testing, and using structures and devices less than 100 nanometers. One of the challenges associated with biomaterials is microbial contamination that can lead to infections. In recent work we have examinedmore » the functionalization of nanoporous biomaterials and antimicrobial activities of nanocrystalline diamond materials. In vitro testing has revealed little antimicrobial activity against Pseudomonas fluorescens bacteria and associated biofilm formation that enhances recalcitrance to antimicrobial agents including disinfectants and antibiotics. Laser scanning confocal microscopy studies further demonstrated properties and characteristics of the material with regard to biofilm formation.« less

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

Alternative approaches to ventilator-associated pneumonia prevention.

PubMed

Berra, L; Sampson, J; Fumagalli, J; Panigada, M; Kolobow, T

2011-03-01

Ventilator-associated pneumonia (VAP), which develops in patients receiving mechanical ventilation, is the most common nosocomial infection in patients with acute respiratory failure. The major mechanism of lower respiratory tract colonization is aspiration of bacteria-colonized secretions from the oropharynx into the lower airways. The hydrostatic pressure of the secretions that collect in the subglottic space, which is the area above the endotracheal tube (ETT) cuff, or aerosolization of bacteria from the secretions collected within the respiratory tubing may facilitate the leakage into the lower airways. Ideally, the elimination of the mechanisms responsible for aspiration would decrease the incidence of VAP. Several preventive measures have been tested in clinical trials with little success.Here we present the results of our efforts to develop novel approaches for the prevention of VAP. Specifically, we found that keeping ventilated patients in a lateral position, which eliminates gravitational forces, is feasible and possibly advantageous. Additionally, several novel medical devices have been recently developed to prevent bacterial biofilm formation from the ETT and breathing tubing. These devices include coated ETTs, mucus shavers and mucus slurpers. Prevention of ETT bacterial colonization showed decreased bacterial colonization of the respiratory circuit and of the lower respiratory tract in laboratory studies and clinical trials. Future large studies should be designed to test the hypothesis that VAP can be prevented with these novel strategies. While there is a current focus on the use of respiratory devices to prevent biofilm formation and microaspiration, it is important to remember that lower respiratory tract colonization is multifactorial. Prevention of VAP cannot be achieved solely by eliminating bacterial biofilm on respiratory devices, and more comprehensive care of the intubated patient needs to be implemented.

Actinomyces bacteremia in association with tubo-ovarian abscesses and hysteroscopic sterilization.

PubMed

Pakish, Janelle B; West, Loyd

2014-08-01

Actinomyces infection is well-documented in intrauterine devices but has not been previously associated with hysteroscopic sterilization using coil inserts. Additionally, abscesses associated with these implants have been observed in few cases. A 31-year-old multiparous woman with a history of hysteroscopic sterilization with coil inserts 18 months previously presented with several weeks of pelvic pain. Despite percutaneous drainage of intra-abdominal abscesses, her pain and fevers persisted. Blood cultures were positive for Actinomyces infection, and exploratory laparotomy demonstrated abscesses at both coil sites. When a causative organism cannot be identified or the when patient does not respond to standard antibiotic therapy, Actinomyces infection should be considered because prolonged antibiotic therapy is necessary.

Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging

NASA Astrophysics Data System (ADS)

Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun

2014-02-01

Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

Cannulae and infection control in theatre.

PubMed

Aziz, Ann-Marie

Healthcare-associated infections (HAIs) are those that are not present or incubating when an individual enters hospital, but are acquired while in hospital. At any one time, 8% of patients have an infection acquired in hospital (Department of Health (DH), 2008). On average, an infection adds 3-10 days to the length of a patient's stay in hospital. It can cost pound4000- pound10 000 more to treat a patient with an infection than one without an infection (DH, 2008). It is not surprising, then, that attention has been focused on tackling HAIs and, in particular, in-dwelling devices such as cannulae that have a potential for causing infections.

Effects of patterned topography on biofilm formation

NASA Astrophysics Data System (ADS)

Vasudevan, Ravikumar

2011-12-01

Bacterial biofilms are a population of bacteria attached to each other and irreversibly to a surface, enclosed in a matrix of self-secreted polymers, among others polysaccharides, proteins, DNA. Biofilms cause persisting infections associated with implanted medical devices and hospital acquired (nosocomial) infections. Catheter-associated urinary tract infections (CAUTIs) are the most common type of nosocomial infections accounting for up to 40% of all hospital acquired infections. Several different strategies, including use of antibacterial agents and genetic cues, quorum sensing, have been adopted for inhibiting biofilm formation relevant to CAUTI surfaces. Each of these methods pertains to certain types of bacteria, processes and has shortcomings. Based on eukaryotic cell topography interaction studies and Ulva linza spore studies, topographical surfaces were suggested as a benign control method for biofilm formation. However, topographies tested so far have not included a systematic variation of size across basic topography shapes. In this study patterned topography was systematically varied in size and shape according to two approaches 1) confinement and 2) wetting. For the confinement approach, using scanning electron microscopy and confocal microscopy, orienting effects of tested topography based on staphylococcus aureus (s. aureus) (SH1000) and enterobacter cloacae (e. cloacae) (ATCC 700258) bacterial models were identified on features of up to 10 times the size of the bacterium. Psuedomonas aeruginosa (p. aeruginosa) (PAO1) did not show any orientational effects, under the test conditions. Another important factor in medical biofilms is the identification and quantification of phenotypic state which has not been discussed in the literature concerning bacteria topography characterizations. This was done based on antibiotic susceptibility evaluation and also based on gene expression analysis. Although orientational effects occur, phenotypically no difference was observed between the patterned topography tested. Another potential strategy for biofilm control through patterned topography is based on the design of robust non-wetting surfaces with undercut feature geometries, characterized by 1) breakthrough pressure and 2) triple phase contact line model. It was found that height and presence of undercut had statistically significant effects, directly proportional to breakthrough pressures, whereas extent of undercut did not. A predictive triple phase contact line model was also developed. (Full text of this dissertation may be available via the University of Florida Libraries web site. Please check http://www.uflib.ufl.edu/etd.html)

Saksenaea erythrospora infection after medical tourism for esthetic breast augmentation surgery.

PubMed

Rodríguez, José Y; Rodríguez, Gerson J; Morales-López, Soraya E; Cantillo, Carlos E; Le Pape, Patrice; Álvarez-Moreno, Carlos A

2016-08-01

Mucormycosis caused by Saksenaea erythrospora is rarely reported in humans. Three previous cases have been reported in the literature, two associated with trauma (a sailing accident in Argentina and a combat trauma in Iraq) and one as a cause of invasive rhinosinusitis (India), all in immunocompetent patients . The first case of mucormycosis following esthetic surgery, associated with medical tourism, is reported herein. A case study of an S. erythrospora infection in an immunocompetent woman after the completion of esthetic surgery (dermolipectomy and breast augmentation) is reported. The infection presented as a rapidly progressive necrotizing infection of the skin and soft tissue, which required a bilateral mastectomy and extensive surgical debridement associated with prolonged antifungal therapy. The organism was identified phenotypically and confirmed biologically after rDNA amplification and sequencing. Two months later, the patient remains hospitalized awaiting the start of reconstructive surgeries. The present case is, to the best of the authors' knowledge, the first report from Colombia. Mucormycosis should be considered in the differential diagnosis of necrotizing infections of the skin and soft tissue that evolve rapidly after cosmetic surgery performed in tropical or subtropical countries. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Association of Hospital Construction with the Development of Healthcare Associated Environmental Mold Infections (HAEMI) in Pediatric Patients with Leukemia

PubMed Central

Pokala, Hanumantha R.; Leonard, David; Cox, Jennifer; Metcalf, Pat; McClay, John; Siegel, Jane; Winick, Naomi

2014-01-01

Background Healthcare associated mold infections (HAEMI) increase morbidity and mortality in children with leukemia. Excavation adjacent to Children’s Medical Center Dallas (CMCD) April 2006–February 2007 provided an opportunity to determine if excavation adjacent to a hospital building is associated with increased risk of developing HAEMI in children receiving intensive chemotherapy for acute leukemia. Methods Children who began receiving intensive chemotherapy for acute leukemia at CMCD from 2004–2008 were identified (N=275). Exposures to the CMCD campus during intensive chemotherapy and duration of neutropenia per exposure were recorded. Proven, probable or possible invasive fungal disease (IFD) was classified using EORTC/MSG guidelines. Institutional guidelines categorized mold infections as definite or possible HAEMI. A bivariate time-to-event model compared the association of excavation with HAEMI and yeast infections, controlling for neutropenia. Results There were 7454 CMCD exposures, 1007(13.5%) during excavation. Of 50 cases of IFD, 31 were HAEMI. By time-to-event analysis exposure to the CMCD campus during the excavation period was significantly associated with HAEMI (HR=2.8, P=0.01) but not yeast infections (HR=0.75, P=0.75). Neutropenia was significantly associated with both HAEMI and yeast infections (P<0.001). Voriconazole prophylaxis did not prevent HAEMI in 42% of the 14 patients with AML who had been receiving this agent. Conclusion This study is the first to demonstrate an association between exposure to hospital construction that includes excavation and HAEMI in pediatric oncology patients. Since neutropenic patients need protection from aerosolized fungal spores during visits to expanding medical centers, preventive strategies with adherence monitoring need additional study. PMID:23970381

Medical diagnostics for indoor mold exposure.

PubMed

Hurraß, Julia; Heinzow, Birger; Aurbach, Ute; Bergmann, Karl-Christian; Bufe, Albrecht; Buzina, Walter; Cornely, Oliver A; Engelhart, Steffen; Fischer, Guido; Gabrio, Thomas; Heinz, Werner; Herr, Caroline E W; Kleine-Tebbe, Jörg; Klimek, Ludger; Köberle, Martin; Lichtnecker, Herbert; Lob-Corzilius, Thomas; Merget, Rolf; Mülleneisen, Norbert; Nowak, Dennis; Rabe, Uta; Raulf, Monika; Seidl, Hans Peter; Steiß, Jens-Oliver; Szewszyk, Regine; Thomas, Peter; Valtanen, Kerttu; Wiesmüller, Gerhard A

2017-04-01

In April 2016, the German Society of Hygiene, Environmental Medicine and Preventative Medicine (Gesellschaft für Hygiene, Umweltmedizin und Präventivmedizin (GHUP)) together with other scientific medical societies, German and Austrian medical societies, physician unions and experts has provided an AWMF (Association of the Scientific Medical Societies) guideline 'Medical diagnostics for indoor mold exposure'. This guideline shall help physicians to advise and treat patients exposed indoors to mold. Indoor mold growth is a potential health risk, even without a quantitative and/or causal association between the occurrence of individual mold species and health effects. Apart from the allergic bronchopulmonary aspergillosis (ABPA) and the mycoses caused by mold, there is only sufficient evidence for the following associations between moisture/mold damages and different health effects: Allergic respiratory diseases, asthma (manifestation, progression, exacerbation), allergic rhinitis, exogenous allergic alveolitis and respiratory tract infections/bronchitis. In comparison to other environmental allergens, the sensitizing potential of molds is estimated to be low. Recent studies show a prevalence of sensitization of 3-10% in the total population of Europe. The evidence for associations to mucous membrane irritation and atopic eczema (manifestation, progression, exacerbation) is classified as limited or suspected. Inadequate or insufficient evidence for an association is given for COPD, acute idiopathic pulmonary hemorrhage in children, rheumatism/arthritis, sarcoidosis, and cancer. The risk of infections from indoor molds is low for healthy individuals. Only molds that are capable to form toxins can cause intoxications. The environmental and growth conditions and especially the substrate determine whether toxin formation occurs, but indoor air concentrations are always very low. In the case of indoor moisture/mold damages, everyone can be affected by odor effects and/or impairment of well-being. Predisposing factors for odor effects can be given by genetic and hormonal influences, imprinting, context and adaptation effects. Predisposing factors for impairment of well-being are environmental concerns, anxieties, conditioning and attributions as well as a variety of diseases. Risk groups that must be protected are patients with immunosuppression and with mucoviscidosis (cystic fibrosis) with regard to infections and individuals with mucoviscidosis and asthma with regard to allergies. If an association between mold exposure and health effects is suspected, the medical diagnosis includes medical history, physical examination, conventional allergy diagnosis, and if indicated, provocation tests. For the treatment of mold infections, it is referred to the AWMF guidelines for diagnosis and treatment of invasive Aspergillus infections. Regarding mycotoxins, there are currently no validated test methods that could be used in clinical diagnostics. From the perspective of preventive medicine, it is important that mold damages cannot be tolerated in indoor environments. Copyright © 2016 Elsevier GmbH. All rights reserved.

Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies.

PubMed

Henrikson, Charles A; Sohail, M Rizwan; Acosta, Helbert; Johnson, Eric E; Rosenthal, Lawrence; Pachulski, Roman; Dan, Dan; Paladino, Walter; Khairallah, Farhat S; Gleed, Kent; Hanna, Ibrahim; Cheng, Alan; Lexcen, Daniel R; Simons, Grant R

2017-10-01

This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.0% to 0.9%), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and p = 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [Centurion]; NCT01043861/NCT01043705). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

75 FR 10294 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

...] Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension...). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k... premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment...

The impact of oral herpes simplex virus infection and candidiasis on chemotherapy-induced oral mucositis among patients with hematological malignancies.

PubMed

Chen, Y-K; Hou, H-A; Chow, J-M; Chen, Y-C; Hsueh, P-R; Tien, H-F

2011-06-01

The aim of this study was to evaluate the influences of oral candidiasis and herpes simplex virus 1 (HSV-1) infections in chemotherapy-induced oral mucositis (OM). The medical records of 424 consecutive patients with hematological malignancies who had received chemotherapy at a medical center in Taiwan from January 2006 to November 2007 were retrospectively reviewed. The results of swab cultures of fungus and HSV-1 for OM were correlated with associated clinical features. Younger age, myeloid malignancies, and disease status other than complete remission before chemotherapy were significantly correlated with the development of OM. Risks of fever (p < 0.001) and bacteremia were higher in patients with OM. Among 467 episodes of OM with both swab cultures available, 221 were non-infection (47.3%) and 246 were related to either fungal infections, HSV-1 infections, or both (52.7%); of the 246 episodes, 102 were associated with fungal infections alone (21.8%), 98 with HSV-1 infections alone (21%), and 46 with both infections (9.9%). Patients who had received antifungal agents prior to OM occurrence tended to have HSV-1 infection (p < 0.001). Our results suggest that Candida albicans and HSV-1 play an important role in chemotherapy-induced OM in patients with hematological malignancies.

Development of formulation device for periodontal disease.

PubMed

Sato, Yasuhiko; Oba, Takuma; Watanabe, Norio; Danjo, Kazumi

2012-01-01

In addition to providing standard surgical treatment that removes the plaque and infected tissues, medications that can regenerate periodontal tissue are also required in the treatment of periodontal disease. As a form of regenerative medication, various growth factors are expected to be used while treating periodontal disease. A protein-like growth factor is often developed as a lyophilized product with dissolution liquid, considering its instability in the solution state. We have clarified that the formulation for periodontal disease needs to be viscous. When the lyophilized product was dissolved using a sticky solution, various problems were encountered, difficulty in dissolving and air bubbles, for example, and some efforts were needed to prepare the formulation. In this research, to identify the problem of preparing a viscous formulation, a lyophilized product (placebo) and sticky liquid were prepared by using vial and ampoule as the conventional containers. Based on these problems, a prototype administration device was developed, and its functionality was confirmed. As a result, it was suggested that the device with a useful mixing system that could shorten the preparation time was developed.

[In search of a travel guide-results from a survey of E‑health startup companies].

PubMed

Hagen, Julia; Lauer, Wolfgang

2018-03-01

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

Identification of factors involved in medication compliance: incorrect inhaler technique of asthma treatment leads to poor compliance

PubMed Central

Darbà, Josep; Ramírez, Gabriela; Sicras, Antoni; García-Bujalance, Laura; Torvinen, Saku; Sánchez-de la Rosa, Rainel

2016-01-01

Objective To identify the impact of delivery device of inhaled corticosteroids and long-acting β2-agonist (ICS/LABA) on asthma medication compliance, and investigate other factors associated with compliance. Materials and methods We conducted a retrospective and multicenter study based on a review of medical registries of asthmatic patients treated with ICS/LABA combinations (n=2,213) whose medical devices were either dry powder inhalers (DPIs, such as Accuhaler®, Turbuhaler®, and NEXThaler®) or pressurized metered-dose inhalers (pMDI). Medication compliance included persistence outcomes through 18 months and medication possession ratios. Data on potential confounders of treatment compliance such as asthma exacerbations, comorbidities, demographic characteristics, and health care resource utilization were also explored. Results The probability of asthma medication compliance in case of DPIs was lower compared to pMDIs, which suggests that inhaler devices influence inhalation therapies. There were additional confounding factors that were considered as explanatory variables of compliance. A worse measure of airflow obstruction (forced expiration volume in 1 second), comorbidities and general practitioner (GP) consultations more than once per month decreased the probability of compliance. Within comorbidities, alcoholism was positively associated with compliance. Patients of 29–39, 40–50, and 51–61 age groups or suffering from more than two exacerbations during the study period were more likely to comply with their medication regime. The effects of DPIs toward compliance varied with the different DPIs. For instance, Accuhaler® had a greater negative effect on compliance compared to Turbuhaler® and Nexthaler® in cases of patients who suffered exacerbations. We found that GP consultations reduced the probability of medication compliance for patients treated with formoterol/budesonide combination. For retired patients, visiting the GP increased the probability of medication compliance. Conclusion We concluded that inhaler devices influence patients’ compliance for long-term asthma medication. The impact of Accuhaler®, Turbuhaler®, and NEXThaler® on medication compliance was negative. We also identified some confounders of medication compliance such as patient’s age, severity of asthma, comorbidities, and health care costs. PMID:26929605

Design of a portable imager for near-infrared visualization of cutaneous wounds

PubMed Central

Peng, Zhaoqiang; Zhou, Jun; Dacy, Ashley; Zhao, Deyin; Kearney, Vasant; Zhou, Weidong; Tang, Liping; Hu, Wenjing

2017-01-01

Abstract. A portable imager developed for real-time imaging of cutaneous wounds in research settings is described. The imager consists of a high-resolution near-infrared CCD camera capable of detecting both bioluminescence and fluorescence illuminated by an LED ring with a rotatable filter wheel. All external components are integrated into a compact camera attachment. The device is demonstrated to have competitive performance with a commercial animal imaging enclosure box setup in beam uniformity and sensitivity. Specifically, the device was used to visualize the bioluminescence associated with increased reactive oxygen species activity during the wound healing process in a cutaneous wound inflammation model. In addition, this device was employed to observe the fluorescence associated with the activity of matrix metalloproteinases in a mouse lipopolysaccharide-induced infection model. Our results support the use of the portable imager design as a noninvasive and real-time imaging tool to assess the extent of wound inflammation and infection. PMID:28114448

Mycobacterium chimaera infections in post–operative patients exposed to heater–cooler devices: An overview

PubMed Central

Ogunremi, T; Taylor, G; Johnston, L; Amaratunga, K; Muller, M; Coady, A; Defalco, K; Dunn, K; Johnstone, J; Smith, S; Embree, J; Henry, B; Stafford, J

2017-01-01

A multi-country outbreak of Mycobacterium chimaera infection associated with contaminated heater–cooler devices (HCDs) has been reported, with more than 70 cases in Europe and the United States and two cases in Canada to date. The epidemiological and microbiological characteristics of this outbreak provide evidence for common-source transmission of M. chimaera from the exhaust air of intrinsically contaminated HCDs to patients during cardiac surgery. To date, all reported cases have been associated with Stöckert 3T HCDs manufactured at one plant by LivaNova prior to September 2014. Implantation of prosthetic material increases the risk of infection. Infections usually present as prosthetic valve endocarditis, vascular graft infection or disseminated infection. Reported mortality rates have varied, but were often over 40%. Several measures are recommended to facilitate case-finding and mitigate risk of exposure. The feasibility of some risk mitigation measures and their effectiveness in reducing the risk of exposure are yet to be determined. Until HCDs are redesigned in a manner that prevents water contamination and aerosolization, separating the HCD exhaust air from the operating room air during surgery may be the most effective risk mitigation strategy. However, possible unintended consequences of this approach should be considered. This overview summarizes findings from peer-reviewed and other relevant national documents on key features of the outbreak, including the source, identified risk factors for infection, signs and symptoms of infection, burden of disease, risk mitigation measures, management challenges and knowledge gaps.

Mycobacterium chimaera infections in post-operative patients exposed to heater-cooler devices: An overview.

PubMed

Ogunremi, T; Taylor, G; Johnston, L; Amaratunga, K; Muller, M; Coady, A; Defalco, K; Dunn, K; Johnstone, J; Smith, S; Embree, J; Henry, B; Stafford, J

2017-05-04

A multi-country outbreak of Mycobacterium chimaera infection associated with contaminated heater-cooler devices (HCDs) has been reported, with more than 70 cases in Europe and the United States and two cases in Canada to date. The epidemiological and microbiological characteristics of this outbreak provide evidence for common-source transmission of M. chimaera from the exhaust air of intrinsically contaminated HCDs to patients during cardiac surgery. To date, all reported cases have been associated with Stöckert 3T HCDs manufactured at one plant by LivaNova prior to September 2014. Implantation of prosthetic material increases the risk of infection. Infections usually present as prosthetic valve endocarditis, vascular graft infection or disseminated infection. Reported mortality rates have varied, but were often over 40%. Several measures are recommended to facilitate case-finding and mitigate risk of exposure. The feasibility of some risk mitigation measures and their effectiveness in reducing the risk of exposure are yet to be determined. Until HCDs are redesigned in a manner that prevents water contamination and aerosolization, separating the HCD exhaust air from the operating room air during surgery may be the most effective risk mitigation strategy. However, possible unintended consequences of this approach should be considered. This overview summarizes findings from peer-reviewed and other relevant national documents on key features of the outbreak, including the source, identified risk factors for infection, signs and symptoms of infection, burden of disease, risk mitigation measures, management challenges and knowledge gaps.

Ventricular assist devices as bridge to heart transplantation: impact on post-transplant infections.

PubMed

Héquet, Delphine; Kralidis, Georg; Carrel, Thierry; Cusini, Alexia; Garzoni, Christian; Hullin, Roger; Meylan, Pascal R; Mohacsi, Paul; Mueller, Nicolas J; Ruschitzka, Frank; Tozzi, Piergiorgio; van Delden, Christian; Weisser, Maja; Wilhelm, Markus J; Pascual, Manuel; Manuel, Oriol

2016-07-08

Ventricular assist devices (VAD) are valuable options for patients with heart failure awaiting cardiac transplantation. We assessed the impact of pre-transplant VAD implantation on the incidence of post-transplant infections in a nationwide cohort of heart transplant recipients. Heart transplant recipients included in the Swiss Transplant Cohort Study between May 2008 and December 2012 were analyzed. Cumulative incidence curves were used to calculate the incidence of bacterial or Candida infections (primary endpoint) and of other infections (secondary endpoint) after transplant. Cox regression models treating death as a competing risk were used to identify risk factors for the development of infection after transplant. Overall, 119 patients were included in the study, 35 with a VAD and 84 without VAD. Cumulative incidences of post-transplant bacterial or Candida infections were 37.7 % in VAD patients and 40.4 % in non-VAD patients. In multivariate analysis, the use of cotrimoxazole prophylaxis was the only variable associated with bacterial/Candida infections after transplant (HR 0.29 [95 % CI 0.15-0.57], p < 0.001), but presence of a VAD was not (HR 0.94, [95 % CI 0.38-2.32], p = 0.89, for continuous-flow devices, and HR 0.45 [0.15 - 1.34], p = 0.15, for other devices). Risk for post-transplant viral and all fungal infections was not increased in patients with VAD. One-year survival was 82.9 % (29/35) in the VAD group and 82.1 % (69/84) in the non-VAD group. All 6 patients in the VAD group that died after transplant had a history of pre-transplant VAD infection. In this nationwide cohort of heart transplant recipients, the presence of VAD at the time of transplant had no influence on the development of post-transplant infections.

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database.

PubMed

Naumann, R Wendel; Brown, Jubilee

2015-01-01

To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database. Retrospective analysis of an established database (Canadian Task Force classification III). A search of the MAUDE database for terms associated with commercially available electromechanical morcellation devices was undertaken for events leading to injury or death between 2004 and 2014. Data, including the types of injury, need for conversion to open surgery, type of open surgery, and clinical outcomes, were extracted from the records. Over a 10-year period, 9 events associated with death and 215 events associated with patient injury or significant delay of the surgical procedure were recorded. These involved 137 device failures, 51 organ injuries, and the morcellation of 27 previously undiagnosed malignancies. Of the 9 deaths, 1 was associated with organ injury, and the other 8 were associated with morcellation of cancer. Of the 27 undiagnosed cancers, 5 were reported by the manufacturer, 8 were reported by the patient or family, 9 were reported by medical or news reports, 2 were reported by medical professionals, and 3 were due to litigation. Morcellation of an undiagnosed malignancy was first reported to the database in December 2013. The MAUDE database appears to detect perioperative events, such as device failures and organ injury at the time of surgery, but appears to be poor at detecting late events after surgery, such as the potential spread of cancer. Outcome registries are likely a more efficient means of tracking potential long-term adverse events associated with surgical devices. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

Pediatric Obesity and Ear, Nose, and Throat Disorders

MedlinePlus

... Although there is no proven medical link between middle ear infections and pediatric obesity there may be a behavioral association between the two conditions. Some studies have found that when a child is rubbing or massaging the infected ear the ...

Knowledge and perceptions of HIV-infected patients regarding HIV transmission and treatment in Ho Chi Minh City, Vietnam.

PubMed

Hoang, Don; Dinh, An T; Groce, Nora; Sullivan, Lynn E

2015-03-01

Patient education concerning HIV and antiretroviral (ARV) medications is important for optimal outcomes. The authors assessed the knowledge and perceptions of HIV-infected patients in an ARV education program in Ho Chi Minh City, Vietnam. Of 185 patients, 64 (35%) receiving ARV medications, nearly 80% correctly answered questions regarding HIV. Correct responses were associated with higher education (P < .05) and longer duration of HIV diagnosis (P < .05). A lack of knowledge was observed in 40% of respondents who believed HIV and AIDS were the same and 70% of respondents who believed ARV medications cured HIV. Greater embarrassment of living with HIV was associated with female gender (P < .05) and lower education (P < .05). Patients were concerned over ARV medication use (27%) and its side effects (38%). The study population's knowledge of HIV/AIDS and ARV medications, perceived stigmatization, and areas of knowledge deficits underscore the need for effective patient education programs addressing poorly understood issues around HIV/AIDS. © 2011 APJPH.

Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: a survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems.

PubMed

Tatsumi, Eisuke; Nakatani, Takeshi; Imachi, Kou; Umezu, Mitsuo; Kyo, Shun-Ei; Sase, Kazuhiro; Takatani, Setsuo; Matsuda, Hikaru

2007-01-01

A series of guidelines for development and assessment of next-generation medical devices has been drafted under an interagency collaborative project by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. The working group for assessment guidelines of next-generation artificial hearts reviewed the trend in the prevalence of heart failure and examined the potential usefulness of such devices in Japan and in other countries as a fundamental part of the process of establishing appropriate guidelines. At present, more than 23 million people suffer from heart failure in developed countries, including Japan. Although Japan currently has the lowest mortality from heart failure among those countries, the number of patients is gradually increasing as our lifestyle becomes more Westernized; the associated medical expenses are rapidly growing. The number of heart transplantations, however, is limited due to the overwhelming shortage of donor hearts, not only in Japan but worldwide. Meanwhile, clinical studies and surveys have revealed that the major causes of death in patients undergoing long-term use of ventricular assist devices (VADs) were infection, thrombosis, and mechanical failure, all of which are typical of VADs. It is therefore of urgent and universal necessity to develop next-generation artificial hearts that have excellent durability to provide at least 2 years of event-free operation with a superior quality of life and that can be used for destination therapy to save patients with irreversible heart failure. It is also very important to ensure that an environment that facilitates the development, testing, and approval evaluation processes of next-generation artificial hearts be established as soon as possible.

Medical adhesive-related skin injuries associated with vascular access.

PubMed

Hitchcock, Jan; Savine, Louise

2017-04-27

Establishing vascular access and preventing infection, both at insertion and during ongoing care is generally the top priority; the maintenance of optimal skin integrity is often a distant secondary consideration. Skin can react to different types of dressings or adhesives, or problems can arise relating to the securement of lines or the development of sensitivities to cleaning solutions. Clearly, these scenarios are not limited to the securement of vascular access devices; however, a patient with a long-term vascular access device may not have other options for vascular access, which makes this a very important and yet largely unrecognised area. A review of the limited literature that existed up to March 2015 showed it was typically concerned with skin tears connected with dressings and removal, and contact irritant dermatitis. The tissue viability team and vascular access team reviewed the current products associated with a typical vascular access dressing to ensure it was fit for purpose and where at all possible had good scientific literature for validation. The team worked proactively to recognise those patients at risk with the early identification of potential medical adhesive-related skin injuries (MARSI). To facilitate this an algorithm was developed that offers a step-by-step approach, clearly outlining what to do to prevent MARSI and its treatment should it develop. These reactions can result from other factors than the dressing alone, and an increase in these kinds of skin reaction in patients who are on chemotherapy regimens is being explored further. Through the implementation of an algorithm, education for both staff and patients and collaborative working between vascular access and tissue viability teams, a reduction in these phenomena has been seen despite an increasing number of at-risk patients.

Management of Human Immunodeficiency Virus Infection in Advanced Age

PubMed Central

Greene, Meredith; Justice, Amy C.; Lampiris, Harry W.; Valcour, Victor

2013-01-01

Importance Human immunodeficiency virus (HIV)-positive patients treated with antiretroviral therapy now have increased life expectancy and develop chronic illnesses that are often seen in older HIV-negative patients. Objective To address emerging issues related to aging with HIV. Screening older adults for HIV, diagnosis of concomitant diseases, management of multiple comorbid medical illnesses, social isolation, polypharmacy, and factors associated with end-of-life care are reviewed. Evidence Acquisition Published guidelines and consensus statements were reviewed. PubMed and PsycINFO were searched between January 2000 and February 2013. Articles not appearing in the search that were referenced by reviewed articles were also evaluated. Findings The population of older HIV-positive patients is rapidly expanding. It is estimated that by 2015 one-half of the individuals in the United States with HIV will be older than age 50. Older HIV-infected patients are prone to having similar chronic diseases as their HIV-negative counterparts, as well as illnesses associated with co-infections. Medical treatments associated with these conditions, when added to an antiretroviral regimen, increase risk for polypharmacy. Care of aging HIV-infected patients involves a need to balance a number of concurrent comorbid medical conditions. Conclusions and Relevance HIV is no longer a fatal disease. Management of multiple comorbid diseases is a common feature associated with longer life expectancy in HIV-positive patients. There is a need to better understand how to optimize the care of these patients. PMID:23549585

Chlorhexidine salt-loaded polyurethane orthodontic chains: in vitro release and antibacterial activity studies.

PubMed

Padois, Karine; Bertholle, Valérie; Pirot, Fabrice; Hyunh, Truc Thanh Ngoc; Rossi, Alessandra; Colombo, Paolo; Falson, Françoise; Sonvico, Fabio

2012-12-01

The widespread use of indwelling medical devices has enormously increased the interest in materials incorporating antibiotics and antimicrobial agents as a means to prevent dangerous device-related infections. Recently, chlorhexidine-loaded polyurethane has been proposed as a material suitable for the production of devices which are able to resist microbial contamination. The aim of the present study was to characterize the in vitro release of chlorhexidine from new polymeric orthodontic chains realized with polyurethane loaded with two different chlorhexidine salts: chlorhexidine diacetate or chlorhexidine digluconate. The orthodontic chains constituted of three layers: a middle polyurethane layer loaded with chlorhexidine salt inserted between two layers of unloaded polymer. In vitro release of chlorhexidine diacetate and digluconate from orthodontic chains loaded with 10% or 20% (w/w) chlorhexidine salt was sustained for 42 days and followed Fickian diffusion. The drug diffusion through the polyurethane was found to be dependent not only on chlorhexidine loading, but also on the type of chlorhexidine salt. The antibacterial activity of 0.2% (w/w) chlorhexidine diacetate-loaded orthodontic chain was successfully tested towards clinically isolated biofilm forming ica-positive Staphylococcus epidermidis via agar diffusion test. In conclusion, the chlorhexidine salt-loaded chains could provide an innovative approach in the prevention of oral infections related to the use of orthodontic devices.

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

Development of antibacterial and high light transmittance bulk materials: Incorporation and sustained release of hydrophobic or hydrophilic antibiotics.

PubMed

Wang, Bailiang; Liu, Huihua; Zhang, Binjun; Han, Yuemei; Shen, Chenghui; Lin, Quankui; Chen, Hao

2016-05-01

Infection associated with medical devices is one of the most frequent complications of modern medical biomaterials. Bacteria have a strong ability to attach on solid surfaces, forming colonies and subsequently biofilms. In this work, a novel antibacterial bulk material was prepared through combining poly(dimethyl siloxane) (PDMS) with either hydrophobic or hydrophilic antibiotics (0.1-0.2 wt%). Scanning electron microscopy, water contact angle and UV-vis spectrophotometer were used to measure the changes of surface topography, wettability and optical transmission. For both gentamicin sulfate (GS) and triclosan (TCA), the optical transmission of the PDMS-GS and PDMS-TCA blend films was higher than 90%. Drug release studies showed initial rapid release and later sustained release of GS or TCA under aqueous physiological conditions. The blend films demonstrated excellent bactericidal and sufficient biofilm inhibition functions against Gram-positive bacteria (Staphylococcus aureus, S. aureus) measured by LIVE/DEAD bacterial viability kit staining method. Kirby-Bauer method showed that there was obvious zone of inhibition (7.5-12.5mm). Cytocompatibility assessment against human lens epithelial cells (HLECs) revealed that the PDMS-GS blend films had good cytocompatibility. However, the PDMS-TCA blend films showed certain cytotoxicity against HLECs. The PDMS-0.2 wt% GS blend films were compared to native PDMS in the rabbit subcutaneous S. aureus infection model. The blend films yielded a significantly lower degree of infection than native PDMS at day 7. The achievement of the PDMS-drug bulk materials with high light transmittance, excellent bactericidal function and good cytocompatibility can potentially be widely used as bio-optical materials. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

Cost analysis of a growth guidance system compared with traditional and magnetically controlled growing rods for early-onset scoliosis: a US-based integrated health care delivery system perspective.

PubMed

Luhmann, Scott J; McAughey, Eoin M; Ackerman, Stacey J; Bumpass, David B; McCarthy, Richard E

2018-01-01

Treating early-onset scoliosis (EOS) with traditional growing rods (TGR) is effective but requires periodic surgical lengthening, risking complications. Alternatives include magnetically controlled growing rods (MCGR) that lengthen noninvasively and the growth guidance system (GGS), which obviate the need for active, distractive lengthenings. Previous studies have reported promising clinical effectiveness for GGS; however the direct medical costs of GGS compared to TGR and MCGR have not yet been explored. To estimate the cost of GGS compared with MCGR and TGR for EOS an economic model was developed from the perspective of a US integrated health care delivery system. Using dual-rod constructs, the model estimated the cumulative costs associated with initial implantation, rod lengthenings (TGR, MCGR), revisions due to device failure, surgical-site infections, device exchange, and final spinal fusion over a 6-year episode of care. Model parameters were from peer-reviewed, published literature. Medicare payments were used as a proxy for provider costs. Costs (2016 US$) were discounted 3% annually. Over a 6-year episode of care, GGS was associated with fewer invasive surgeries per patient than TGR (GGS: 3.4; TGR: 14.4) and lower cumulative costs than MCGR and TGR, saving $25,226 vs TGR. Sensitivity analyses showed that results were sensitive to changes in construct costs, rod breakage rates, months between lengthenings, and TGR lengthening setting of care. Within the model, GGS resulted in fewer invasive surgeries and deep surgical site infections than TGR, and lower cumulative costs per patient than both MCGR and TGR, over a 6-year episode of care. The analysis did not account for family disruption, pain, psychological distress, or compromised health-related quality of life associated with invasive TGR lengthenings, nor for potential patient anxiety surrounding the frequent MCGR lengthenings. Further analyses focusing strictly on current generation technologies should be considered for future research.

Cost analysis of a growth guidance system compared with traditional and magnetically controlled growing rods for early-onset scoliosis: a US-based integrated health care delivery system perspective

PubMed Central

Luhmann, Scott J; McAughey, Eoin M; Ackerman, Stacey J; Bumpass, David B; McCarthy, Richard E

2018-01-01

Purpose Treating early-onset scoliosis (EOS) with traditional growing rods (TGR) is effective but requires periodic surgical lengthening, risking complications. Alternatives include magnetically controlled growing rods (MCGR) that lengthen noninvasively and the growth guidance system (GGS), which obviate the need for active, distractive lengthenings. Previous studies have reported promising clinical effectiveness for GGS; however the direct medical costs of GGS compared to TGR and MCGR have not yet been explored. Methods To estimate the cost of GGS compared with MCGR and TGR for EOS an economic model was developed from the perspective of a US integrated health care delivery system. Using dual-rod constructs, the model estimated the cumulative costs associated with initial implantation, rod lengthenings (TGR, MCGR), revisions due to device failure, surgical-site infections, device exchange, and final spinal fusion over a 6-year episode of care. Model parameters were from peer-reviewed, published literature. Medicare payments were used as a proxy for provider costs. Costs (2016 US$) were discounted 3% annually. Results Over a 6-year episode of care, GGS was associated with fewer invasive surgeries per patient than TGR (GGS: 3.4; TGR: 14.4) and lower cumulative costs than MCGR and TGR, saving $25,226 vs TGR. Sensitivity analyses showed that results were sensitive to changes in construct costs, rod breakage rates, months between lengthenings, and TGR lengthening setting of care. Conclusion Within the model, GGS resulted in fewer invasive surgeries and deep surgical site infections than TGR, and lower cumulative costs per patient than both MCGR and TGR, over a 6-year episode of care. The analysis did not account for family disruption, pain, psychological distress, or compromised health-related quality of life associated with invasive TGR lengthenings, nor for potential patient anxiety surrounding the frequent MCGR lengthenings. Further analyses focusing strictly on current generation technologies should be considered for future research. PMID:29588607

‘It's on my iPhone’: attitudes to the use of mobile computing devices in medical education, a mixed-methods study

PubMed Central

Wallace, Sean; Clark, Marcia; White, Jonathan

2012-01-01

Objective The last decade has seen the introduction of new technology which has transformed many aspects of our culture, commerce, communication and education. This study examined how medical teachers and learners are using mobile computing devices such as the iPhone in medical education and practice, and how they envision them being used in the future. Design Semistructured interviews were conducted with medical students, residents and faculty to examine participants’ attitudes about the current and future use of mobile computing devices in medical education and practice. A thematic approach was used to summarise ideas and concepts expressed, and to develop an online survey. A mixed methods approach was used to integrate qualitative and quantitative findings. Setting and participants Medical students, residents and faculty at a large Canadian medical school in 2011. Results Interviews were conducted with 18 participants (10 students, 7 residents and 1 faculty member). Only 213 participants responded to the online survey (76 students, 65 residents and 41 faculty members). Over 85% of participants reported using a mobile-computing device. The main uses described for mobile devices related to information management, communication and time management. Advantages identified were portability, flexibility, access to multimedia and the ability to look up information quickly. Challenges identified included: superficial learning, not understanding how to find good learning resources, distraction, inappropriate use and concerns about access and privacy. Both medical students and physicians expressed the view that the use of these devices in medical education and practice will increase in the future. Conclusions This new technology offers the potential to enhance learning and patient care, but also has potential problems associated with its use. It is important for leadership in medical schools and healthcare organisations to set the agenda in this rapidly developing area to maximise the benefits of this powerful new technology while avoiding unintended consequences. PMID:22923627

'It's on my iPhone': attitudes to the use of mobile computing devices in medical education, a mixed-methods study.

PubMed

Wallace, Sean; Clark, Marcia; White, Jonathan

2012-01-01

The last decade has seen the introduction of new technology which has transformed many aspects of our culture, commerce, communication and education. This study examined how medical teachers and learners are using mobile computing devices such as the iPhone in medical education and practice, and how they envision them being used in the future. Semistructured interviews were conducted with medical students, residents and faculty to examine participants' attitudes about the current and future use of mobile computing devices in medical education and practice. A thematic approach was used to summarise ideas and concepts expressed, and to develop an online survey. A mixed methods approach was used to integrate qualitative and quantitative findings. Medical students, residents and faculty at a large Canadian medical school in 2011. Interviews were conducted with 18 participants (10 students, 7 residents and 1 faculty member). Only 213 participants responded to the online survey (76 students, 65 residents and 41 faculty members). Over 85% of participants reported using a mobile-computing device. The main uses described for mobile devices related to information management, communication and time management. Advantages identified were portability, flexibility, access to multimedia and the ability to look up information quickly. Challenges identified included: superficial learning, not understanding how to find good learning resources, distraction, inappropriate use and concerns about access and privacy. Both medical students and physicians expressed the view that the use of these devices in medical education and practice will increase in the future. This new technology offers the potential to enhance learning and patient care, but also has potential problems associated with its use. It is important for leadership in medical schools and healthcare organisations to set the agenda in this rapidly developing area to maximise the benefits of this powerful new technology while avoiding unintended consequences.

Artificial-intelligence-based hospital-acquired infection control.

PubMed

Adlassnig, Klaus-Peter; Blacky, Alexander; Koller, Walter

2009-01-01

Nosocomial or hospital-acquired infections (NIs) are a frequent complication in hospitalized patients. The growing availability of computerized patient records in hospitals permits automated identification and extended monitoring for signs of NIs. A fuzzy- and knowledge-based system to identify and monitor NIs at intensive care units (ICUs) according to the European Surveillance System HELICS (NI definitions derived from the Centers of Disease Control and Prevention (CDC) criteria) was developed and put into operation at the Vienna General Hospital. This system, named Moni, for monitoring of nosocomial infections contains medical knowledge packages (MKPs) to identify and monitor various infections of the bloodstream, pneumonia, urinary tract infections, and central venous catheter-associated infections. The MKPs consist of medical logic modules (MLMs) in Arden syntax, a medical knowledge representation scheme, whose definition is part of the HL7 standards. These MLM packages together with the Arden software are well suited to be incorporated in medical information systems such as hospital information or intensive-care patient data management systems, or in web-based applications. In terms of method, Moni contains an extended data-to-symbol conversion with several layers of abstraction, until the top level defining NIs according to HELICS is reached. All included medical concepts such as "normal", "increased", "decreased", or similar ones are formally modeled by fuzzy sets, and fuzzy logic is used to process the interpretations of the clinically observed and measured patient data through an inference network. The currently implemented cockpit surveillance connects 96 ICU beds with Moni and offers the hospital's infection control department a hitherto unparalleled NI infection survey.

Retrospective comparative analysis of cardiovascular implantable electronic device infections with and without the use of antibacterial envelopes.

PubMed

Hassoun, A; Thottacherry, E D; Raja, M; Scully, M; Azarbal, A

2017-03-01

Cardiovascular implantable electronic device (CIED) infections are associated with morbidity and mortality. Peri-operative systemic intravenous antibiotic prophylaxis reduces the rate of CIED infections. AIGIS Rx , a polymer envelope implanted with the CIED, releases minocycline and rifampin, and has been introduced to reduce infections. Retrospective review of 184 patients who underwent CIED implantation was conducted. Ninety-two patients were implanted with an AIGIS Rx envelope (AIGIS Rx group) and 92 patients were not implanted with an AIGIS Rx envelope (control group). Data were collected on demographics and risk factors for CIED infections (i.e. congestive heart failure, renal insufficiency, chronic kidney disease, oral anticoagulant use, chronic steroid use, need for lead replacement or revision, temporary pacing, early re-intervention, and having more than two leads in place). Rates of implantation success, major infections and mortality were compared between the AIGIS Rx group and the control group. The AIGIS Rx group had longer hospitalizations (6.8±10.7 days vs 3.1±5.2 days; P=0.001), higher chronic corticosteroid use, higher rates of replacement or revision (51.1% vs 8.7%; P=0.001), and a greater proportion of devices with more than two intracardiac leads (42.4% vs 29.3%; P=0.03) than the control group. Successful implantation occurred in 97% of patients in both groups. Major infection was seen in 5.4% of cases in the AIGIS Rx group and 1.1% of cases in the control group (P=0.048). Device removal was conducted in 3.3% of cases in the AIGIS Rx group compared with 1.1% of cases in the control group (P=0.16). There were two deaths in the AIGIS Rx group. Organisms cultured were meticillin-resistant Staphylococcus aureus, meticillin-susceptible S. aureus and Enterococcus faecalis. The AIGIS Rx group had higher rates of major infection but also higher risk factors compared with the control group. The rate of device extraction and CIED-related mortality was higher in the AIGIS Rx group than in the control group. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Effect of ototopical medications on tympanostomy tube biofilms.

PubMed

Oxley, K Scott; Thomas, John G; Ramadan, Hassan H

2007-10-01

Examine how ototopical medications affect biofilms on fluoroplastic tympanostomy tubes. In vitro comparison of different ototopical medications against a clinical isolate of Pseudomonas aeruginosa biofilm on tympanostomy tubes treated for 5, 10, 14, and 21 days. Under sterile conditions 21 tympanostomy tubes were cut in half. These were attached to pegs of two Calgary Biofilm Devices via rubber cement. Device 1 evaluated microbial growth as colony forming units (CFUs). Device 2 evaluated presence of biofilms. Tubes were prepped for biofilm growth, incubated, and stressed for 72 hours. Afterward, one tube per device was removed and forcefully washed. One was sonificated for 5 minutes, serially diluted, and plated for CFUs. Formalin preserved the other for biofilm evaluation by scanning electron microscopy. Next, tubes were exposed to five drops of Ciprofloxacin, Ciprofloxacin/Dexamethasone, Dexamethasone, Ofloxacin, or saline for 1 hour. Afterward, the ototopicals were removed and sterile broth was placed in the wells as a nutrient. This was repeated every 12 hours for 5, 10, 14, and 21 days of treatment. Prior to the last dose of treatment intervals, a streak plate was performed to evaluate for microbial growth in the wells. The tubes were evaluated for CFUs and biofilms at each interval as previously described. Microbial activity in CFUs decreased by day 5 and continued through day 21 for the antibiotic containing drops. Despite treatment, the biofilm was never eradicated and continued to progress. Infectivity of the biofilm is neutralized by antibiotic ototopicals; however, the biofilm will progress despite treatment.

A cloud-based home management system for patients with a left ventricular assist device: a case report.

PubMed

Nomoto, Shinichi; Utsumi, Momoe; Minakata, Kenji

2016-07-04

Since implantable left ventricular assist devices (LVAD) with smaller configurations became available for bridge-to-transplant or even destination therapy in patients with end-stage heart failure, an increasing number of patients with these devices are receiving home medical management. However, these patients may be anxious about potential complications such as pump failure, thromboembolism, and infections that may occur during home management. To provide a sense of security during home management of patients with LVAD and to establish an ideal shared-care system, we developed a patient-centered cloud-based home management system for patients with LVAD. In this case report, we describe this system and report a trial of it in a 64-year-old patient with an LVAD.

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial.

PubMed

Ullman, Amanda J; Kleidon, Tricia; Gibson, Victoria; McBride, Craig A; Mihala, Gabor; Cooke, Marie; Rickard, Claire M

2017-08-30

Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. ACTRN12614000280606 ; prospectively registered on 17/03/2014.

Association of Airborne Microorganisms in the Operating Room With Implant Infections: A Randomized Controlled Trial.

PubMed

Darouiche, Rabih O; Green, David M; Harrington, Melvyn A; Ehni, Bruce L; Kougias, Panagiotis; Bechara, Carlos F; O'Connor, Daniel P

2017-01-01

OBJECTIVE To evaluate the association of airborne colony-forming units (CFU) at incision sites during implantation of prostheses with the incidence of either incisional or prosthesis-related surgical site infections. DESIGN Randomized, controlled trial. SETTING Primary, public institution. PATIENTS Three hundred patients undergoing total hip arthroplasty, instrumented spinal procedures, or vascular bypass graft implantation. METHODS Patients were randomly assigned in a 1:1 ratio to either the intervention group or the control group. A novel device (Air Barrier System), previously shown to reduce airborne CFU at incision sites, was utilized in the intervention group. Procedures assigned to the control group were performed without the device, under routine operating room atmospheric conditions. Patients were followed up for 12 months to determine whether airborne CFU levels at the incision sites predicted the incidence of incisional or prosthesis-related infection. RESULTS Data were available for 294 patients, 148 in the intervention group and 146 in the control group. CFU density at the incision site was significantly lower in the intervention group than in the control group (P<.001). The density of airborne CFU at the incision site during the procedures was significantly related to the incidence of implant infection (P=.021). Airborne CFU densities were 4 times greater in procedures with implant infection versus no implant infection. All 4 of the observed prosthesis infections occurred in the control group. CONCLUSION Reduction of airborne CFU specifically at the incision site during operations may be an effective strategy to reduce prosthesis-related infections. clinicaltrials.gov Identifier: NCT01610271 Infect Control Hosp Epidemiol 2016;1-8.

Cutibacterium (formerly Propionibacterium) acnes infections associated with implantable devices.

PubMed

Gharamti, Amal A; Kanafani, Zeina A

2017-12-01

Cutibacterium acnes (C. acnes), a Gram-positive biofilm-forming rod implicated in acne vulgaris, is increasingly recognized for its role in implant-associated infections. The diagnosis of C. acnes implant-associated infections remains challenging. The optimal treatment is a combination of both surgical intervention and antibiotic therapy. Areas covered: In this review, we discuss the different types of implant-associated infections caused by C. acnes. We also highlight the clinical manifestations pertaining to the various sites of infection, and identify several risk factors previously reported in the literature. We then cover the diagnostic laboratory markers, such as IL-6 and AD-1, optimizing C. acnes recovery in culture, and the specific molecular techniques. Finally, we examine the various effective antibiotic regimens and identify some preventive methods against C. acnes infections. Expert commentary: Biomarkers such as IL-6 and AD-1 should be further investigated for the diagnosis of C. acnes implant-associated infections. The use of 16S rRNA gene sequencing and other molecular techniques should be further explored in this setting. Longer incubation periods should be requested whenever C. acnes infection is suspected. If the clinical suspicion is high, sonication of the excised implant should be encouraged. Research should focus on developing effective anti-biofilm agents. Finally, preventive methods such as hair removal prior to surgery should be further explored.

Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS): an indication for tonsillectomy.

PubMed

Alexander, Alan A Z; Patel, Nitin J; Southammakosane, Cathy A; Mortensen, Melissa M

2011-06-01

Children with obsessive compulsive disorder or tic disorders that are associated with streptococcal infections (Group A beta-hemolytic) in the oro-pharyngeal region are given the diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS). Tonsillectomy has been reported to resolve the neuro-psychiatric symptoms in these children. We have a case of a 9-year-old boy who was seen in our clinic with multiple recurrent streptococcal infections of the oro-pharyngeal cavity. He also exhibited neuro-psychiatric symptoms including agitation, hyperactivity, and tics. These symptoms followed his recurrent infections. Tonsillectomy was performed and in one year follow-up the patient did not have any recurrent streptococcal infections, and his neuro-psychiatric symptoms resolved completely. Guidelines for medical and surgical management of recurrent strep infections in the face of PANDAS are reviewed. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Rat Indwelling Urinary Catheter Model of Candida albicans Biofilm Infection

PubMed Central

Nett, Jeniel E.; Brooks, Erin G.; Cabezas-Olcoz, Jonathan; Sanchez, Hiram; Zarnowski, Robert; Marchillo, Karen

2014-01-01

Indwelling urinary catheters are commonly used in the management of hospitalized patients. Candida can adhere to the device surface and propagate as a biofilm. These Candida biofilm communities differ from free-floating Candida, exhibiting high tolerance to antifungal therapy. The significance of catheter-associated candiduria is often unclear, and treatment may be problematic considering the biofilm drug-resistant phenotype. Here we describe a rodent model for the study of urinary catheter-associated Candida albicans biofilm infection that mimics this common process in patients. In the setting of a functioning, indwelling urinary catheter in a rat, Candida proliferated as a biofilm on the device surface. Characteristic biofilm architecture was observed, including adherent, filamentous cells embedded in an extracellular matrix. Similar to what occurs in human patients, animals with this infection developed candiduria and pyuria. Infection progressed to cystitis, and a biofilmlike covering was observed over the bladder surface. Furthermore, large numbers of C. albicans cells were dispersed into the urine from either the catheter or bladder wall biofilm over the infection period. We successfully utilized the model to test the efficacy of antifungals, analyze transcriptional patterns, and examine the phenotype of a genetic mutant. The model should be useful for future investigations involving the pathogenesis, diagnosis, therapy, prevention, and drug resistance of Candida biofilms in the urinary tract. PMID:25183731

Analysis of the causes of medical evacuation of injured and sick soldiers of the Polish Military Contingent in the Islamic State of Afghanistan taking part in International Security Assistance Force operations.

PubMed

Ziemba, Radosław

2012-04-01

Military casualties in Afghanistan arise in part from climatic and natural conditions that are difficult for European soldiers to endure, as well as from intense guerrilla combat with mass use of IEDs (improvised explosive devices), thus posing numerous and diverse medical problems requiring evacuation to the home country. A search of the literature revealed no comprehensive studies of the causes of medical evacuation from this theater of operations. This article is a review of medical reports of the Polish Military Contingent taking part in Operation Enduring Freedom during the period from 01 January 2010 to 31 December 2011, including an analysis of causes of all ROLE 4 medical evacuations (to the military base in Germany or to the home country). As many as 565 (5.49%) of the total of 10 294 contingent soldiers were evacuated during the analyzed period. Of these, 29% of evacuation cases were due to combat injuries, 23% to complications of respiratory tract infection, 11% to mental health problems, 11% to chronic neuralgias, 12% to complications of acute gastrointestinal infections, 4% to non-combat injuries, 3% to dental and maxillofacial problems, 2% to dermatological problems and 2% to leishmaniasis. The remaining causes included chronic organic/systemic diseases manifested during service. The main causes of medical evacuations to the home country were the consequences of combat injuries, mainly due to IED attacks. Appropriate diagnosis and early treatment of infections is also an important problem in the face of a significant number of complications resulting in evacuation of soldiers to their home country.

Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tenforde, T.S.; Budinger, T.F.

1985-08-01

An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fieldsmore » produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.« less

Perspectives Regarding Adherence to Prescribed Treatment in Highly Adherent HIV-Infected Gay Men.

PubMed

Brion, John M; Menke, Edna M

2008-01-01

Focus group methodology was used to describe the medication adherence experience of 24 HIV-infected gay men who reported being adherent to their medication regimens. A conceptualization of medication adherence as an evolving process consisted of challenges to adherence (learning the diagnosis, starting the medications, struggling with the medications, dealing with side effects, coping with stigma) as well as those factors supportive of adherence (believing in medications, finding motivating factors, using reminders, depending on others, owning the disease). Themes associated with challenges to adherence focused on diagnosis and the physical and emotional adjustments individuals made to incorporate antiretroviral medications into their daily lives and move toward medication adherence. The factors supportive of adherence were related to the ongoing behaviors identified with establishing and maintaining adherence behaviors. What can be taken from the study is that adherence is a complex and dynamic process rather than a static behavior.

Children With Special Health Care Needs: Child Health and Functioning Outcomes and Health Care Service Use.

PubMed

Caicedo, Carmen

This study describes health, functioning, and health care service use by medically complex technology-dependent children according to condition severity (moderately disabled, severely disabled, and vegetative state). Data were collected monthly for 5 months using the Pediatric Quality of Life Generic Core Module 4.0 Parent-Proxy Report. Health care service use measured the number of routine and acute care office visits (including primary and specialty physicians), emergency department visits, hospitalizations, nursing health care services, special therapies, medications, medical technology devices (MTDs), and assistive devices. Child physical health was different across the condition severity groups. The average age of the children was 10.1 years (SD, 6.2); the average number of medications used was 5.5 (SD, 3.7); the average number of MTDs used was 4.2 (SD, 2.9); and the average number of assistive devices used was 4.3 (SD, 2.7). Severely disabled and vegetative children were similar in age (older) and had a similar number of medications, MTDs, and assistive devices (greater) than moderately disabled children. The advanced practice nurse care coordinator role is necessary for the health and functioning of medically complex, technology-dependent children. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Medical communication companies and industry grants.

PubMed

Rothman, Sheila M; Brudney, Karen F; Adair, Whitney; Rothman, David J

2013-12-18

Medical communication companies (MCCs) are among the most significant health care stakeholders, supported mainly by drug and device companies. How MCCs share or protect physicians' personal data requires greater transparency. To explore the financial relationships between MCCs and drug and device companies, to describe the characteristics of the large MCCs, and to explore whether they accurately represent themselves to physicians. We combined data from the 2010 grant registries of 14 pharmaceutical and device companies; grouped recipients into categories such as MCCs, academic medical centers, disease-targeted advocacy organizations, and professional associations; and created a master list of 19,272 grants. Determine the distribution of funds from drug and device companies to various entities and assess the characteristics of large MCCs. Of the 6493 recipients of more than $657 million grant awards from drug and device companies, 18 of 363 MCCs received 26%, academic medical centers received 21%, and disease-targeted organizations received 15%. For-profit MCCs received 77% of funds (208 of 363). Among the top 5% of MCCs, 14 of 18 were for-profit. All 18 offered continuing medical education: 14 offered live and 17 offered online CME courses. All required physicians to provide personal data. Ten stated that they shared information with unnamed third parties. Eight stated they did not share information, but almost all added exceptions. None required explicit physician consent to their sharing policies. Medical communication companies receive substantial support from drug and device companies. Physicians who interact with MCCs should be aware that all require personal data from the physician and some share these data with unnamed third parties.

[Industry regulation and its relationship to the rapid marketing of medical devices].

PubMed

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

A short history of the Foley catheter: from handmade instrument to infection-prevention device.

PubMed

Carr, H A

2000-02-01

Although it is one of the most frequently utilized devices in the hospitalized patient, the Foley catheter has often been taken for granted. This lack of attention is unfortunate, as the Foley catheter remains one of the primary sources of hospital-acquired infections, which increase morbidity, mortality, and the financial burden on the healthcare system. Although education on the appropriate techniques, proper use, and early removal of Foley catheters is important, such measures unfortunately result in transient benefits. Current technologic advancements have moved the coating technology to a state where bacterial adhesion and migration can be limited and the frequency of catheter-associated urinary tract infections can be reduced. Future technological advances in the Foley catheter will help provide better care and comfort for the catheterized patient.