Microchips and controlled-release drug reservoirs.

PubMed

Staples, Mark

2010-01-01

This review summarizes and updates the development of implantable microchip-containing devices that control dosing from drug reservoirs integrated with the devices. As the expense and risk of new drug development continues to increase, technologies that make the best use of existing therapeutics may add significant value. Trends of future medical care that may require advanced drug delivery systems include individualized therapy and the capability to automate drug delivery. Implantable drug delivery devices that promise to address these anticipated needs have been constructed in a variety of ways using micro- and nanoelectromechanical systems (MEMS or NEMS)-based technology. These devices expand treatment options for addressing unmet medical needs related to dosing. Within the last few years, advances in several technologies (MEMS or NEMS fabrication, materials science, polymer chemistry, and data management) have converged to enable the construction of miniaturized implantable devices for controlled delivery of therapeutic agents from one or more reservoirs. Suboptimal performance of conventional dosing methods in terms of safety, efficacy, pain, or convenience can be improved with advanced delivery devices. Microchip-based implantable drug delivery devices allow localized delivery by direct placement of the device at the treatment site, delivery on demand (emergency administration, pulsatile, or adjustable continuous dosing), programmable dosing cycles, automated delivery of multiple drugs, and dosing in response to physiological and diagnostic feedback. In addition, innovative drug-medical device combinations may protect labile active ingredients within hermetically sealed reservoirs. Copyright (c) 2010 John Wiley & Sons, Inc.

A multidisciplinary approach to paediatric hearing loss: programme at the centre for hearing intervention and language development, National University Hospital, Singapore.

PubMed

Lim, Lynne H Y

2008-12-01

The objective is to describe the multidisciplinary management programme at the National University Hospital (NUH) in Singapore for children with hearing impairment (HI). Over 99.95% of babies born at NUH have hearing tested with both otoacoustic emission and automated auditory brainstem response tests by 6 weeks of age. The referral rate to Otolaryngology is 0.5%. Acquired causes of congenital HI are decreasing. Thirty percent of patients at NUH with idiopathic congenital sensorineural HI have DFNB1/ GJB6 Connexin 26 HI. CT scan or MRI imaging has a higher diagnostic yield when there is unilateral, fluctuating or non-Connexin 26 related HI. Routine electrocardiogram and Opthalmology evaluations will exclude associations of fatal cardiac rhythm anomaly and retinopathy. Other investigations are directed by history and clinical examination. There is now a very wide range of increasingly sophisticated medication, neuro-otologic external, middle and inner ear surgery, hearing aids, middle ear implants and cochlear implants available to improve hearing. A multidisciplinary team from neonatology, paediatrics, otolaryngology, audiology, auditory verbal and speech therapy, ophthalmology, radiology, and psychology working closely with the child, family and schools is needed to develop a cost-effective and comprehensive management programme for paediatric HI.

A physically transient form of silicon electronics.

PubMed

Hwang, Suk-Won; Tao, Hu; Kim, Dae-Hyeong; Cheng, Huanyu; Song, Jun-Kyul; Rill, Elliott; Brenckle, Mark A; Panilaitis, Bruce; Won, Sang Min; Kim, Yun-Soung; Song, Young Min; Yu, Ki Jun; Ameen, Abid; Li, Rui; Su, Yewang; Yang, Miaomiao; Kaplan, David L; Zakin, Mitchell R; Slepian, Marvin J; Huang, Yonggang; Omenetto, Fiorenzo G; Rogers, John A

2012-09-28

A remarkable feature of modern silicon electronics is its ability to remain physically invariant, almost indefinitely for practical purposes. Although this characteristic is a hallmark of applications of integrated circuits that exist today, there might be opportunities for systems that offer the opposite behavior, such as implantable devices that function for medically useful time frames but then completely disappear via resorption by the body. We report a set of materials, manufacturing schemes, device components, and theoretical design tools for a silicon-based complementary metal oxide semiconductor (CMOS) technology that has this type of transient behavior, together with integrated sensors, actuators, power supply systems, and wireless control strategies. An implantable transient device that acts as a programmable nonantibiotic bacteriocide provides a system-level example.

Contemporary undergraduate implant dentistry education: a systematic review.

PubMed

Koole, S; De Bruyn, H

2014-03-01

Consensus reports recommend that students upon graduation should possess a significant level of knowledge and competence in implant dentistry, including basic competences in diagnostics, treatment planning, restorative, straightforward surgical and maintenance procedures. In response, undergraduate curricula need to integrate implant dentistry. This narrative review explores educational programmes in terms of competences, related research and barriers or reflections, regarding implementation in undergraduate curricula. Publications (2008-2013) were searched systematically in WoS, PubMed and ERIC and screened independently by two authors in four stages: removal of duplicates, title screening, abstract screening and full-text reading. Inclusion criteria encompassed implant dentistry in undergraduate education. Finally, 37 of 420 papers were included. Detailed information regarding programme content, number of participants, staff input, logistics/funding issues is scattered. Theoretical education is predominant, and pre-clinical/clinical training is offered minimally, often carried out in elective programmes. However, selected straightforward cases treated by undergraduates yield positive outcomes with low failure rates, few complications, high patient satisfaction and student appreciation. Barriers to implementing implant dentistry in the undergraduate curriculum include funding issues, limitations in time or staff availability/competence and lack of suitable patients. Overcoming these barriers is worthwhile as experience-based implant education affects future practice as well-informed students propose more restorative alternatives to their patients. Although implant dentistry is increasingly integrated in undergraduate curricula, challenges remain in developing strategies to implement existing competence profiles and the extent of experience-based education. To support further advancement, universities should report comprehensively on their implant programmes to allow comparison and reproduction in other environments. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

First-in-human testing of a wirelessly controlled drug delivery microchip.

PubMed

Farra, Robert; Sheppard, Norman F; McCabe, Laura; Neer, Robert M; Anderson, James M; Santini, John T; Cima, Michael J; Langer, Robert

2012-02-22

The first clinical trial of an implantable microchip-based drug delivery device is discussed. Human parathyroid hormone fragment (1-34) [hPTH(1-34)] was delivered from the device in vivo. hPTH(1-34) is the only approved anabolic osteoporosis treatment, but requires daily injections, making patient compliance an obstacle to effective treatment. Furthermore, a net increase in bone mineral density requires intermittent or pulsatile hPTH(1-34) delivery, a challenge for implantable drug delivery products. The microchip-based devices, containing discrete doses of lyophilized hPTH(1-34), were implanted in eight osteoporotic postmenopausal women for 4 months and wirelessly programmed to release doses from the device once daily for up to 20 days. A computer-based programmer, operating in the Medical Implant Communications Service band, established a bidirectional wireless communication link with the implant to program the dosing schedule and receive implant status confirming proper operation. Each woman subsequently received hPTH(1-34) injections in escalating doses. The pharmacokinetics, safety, tolerability, and bioequivalence of hPTH(1-34) were assessed. Device dosing produced similar pharmacokinetics to multiple injections and had lower coefficients of variation. Bone marker evaluation indicated that daily release from the device increased bone formation. There were no toxic or adverse events due to the device or drug, and patients stated that the implant did not affect quality of life.

Hacking medical devices a review - biomed 2013.

PubMed

Frenger, Paul

2013-01-01

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.

Medical devices of the head, neck, and spine.

PubMed

Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G

2004-01-01

There are many medical devices used for head, neck, and spinal diseases and injuries, and new devices are constantly being introduced. Many of the newest devices are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function as well as to be able to recognize the complications associated with its use. The article discusses the most common and important devices of the head, neck, and spine, including cerebrospinal fluid shunts and the Codman Hakim programmable valve; subdural drainage catheters, subdural electrodes, intracranial electrodes, deep brain stimulators, and cerebellar electrodes; coils, balloons, adhesives, particles, and aneurysm clips; radiation therapy catheters, intracranial balloons for drug installation, and carmustine wafers; hearing aids, cochlear implants, and ossicular reconstruction prostheses; orbital prostheses, intraocular silicone oil, and lacrimal duct stents; anterior and posterior cervical plates, posterior cervical spine wiring, odontoid fracture fixation devices, cervical collars and halo vests; thoracic and lumbar spine implants, anterior and posterior instrumentation for the thoracic and lumbar spine, vertebroplasty, and artificial disks; spinal column stimulators, bone stimulators, intrathecal drug delivery pumps, and sacral stimulators; dental and facial implant devices; gastric and tracheal tubes; vagus nerve stimulators; lumboperitoneal shunts; and temperature- and oxygen-sensing probes. Copyright RSNA, 2004

Drug Delivery: Enabling Technology for Drug Discovery and Development. iPRECIO® Micro Infusion Pump: Programmable, Refillable, and Implantable

PubMed Central

Tan, Tsung; Watts, Stephanie W.; Davis, Robert Patrick

2011-01-01

Successful drug delivery using implantable pumps may be found in over 12,500 published articles. Their versatility in delivering continuous infusion, intermittent or complex infusion protocols acutely or chronically has made them ubiquitous in drug discovery and basic research. The recent availability of iPRECIO®, a programmable, refillable, and implantable infusion pump has made it possible to carry out quantitative pharmacology (PKPD) in single animals. When combined with specialized catheters, specific administration sites have been selected. When combined with radiotelemetry, the physiologic gold standard, more sensitive and powerful means of detecting drug induced therapeutic, and/or adverse effects has been possible. Numerous application examples are cited from iPRECIO® use in Japan, United States, and Europe with iPRECIO® as an enabling drug delivery device where the refillable and programmability functionality were key benefits. The ability to start/stop drug delivery and to have control periods prior dosing made it possible to have equivalent effects at a much lower dose than previously studied. Five different iPRECIO® applications are described in detail with references to the original work where the implantable, refillable, and programmable benefits are demonstrated with their different end-points. PMID:21863140

Educational, employment, and social participation of young adult graduates from the paediatric Southern Cochlear Implant Programme, New Zealand.

PubMed

Goh, Terence; Bird, Philip; Pearson, John; Mustard, Jill

2016-01-01

The purpose of this study is to observe the education and vocational achievements and social participation of cochlear implant recipients as they graduate from a paediatric cochlear implant programme and identify any significant associations that might exist. This study identified 56 patients from the Southern Cochlear Implant Programme (SCIP) who received cochlear implants before the age of 19 (paediatric) and are now over the age of 19 (adult). A questionnaire investigated their education, employment, and identity with the hearing and deaf communities. Also included were the satisfaction with life scale and Hearing Participation Scale (HPS). Subjects ranged in age from 19 to 32. Twenty-six patients responded to the questionnaire, including one non-user. Twenty identified strongly or very strongly with the hearing community. There was weak evidence of a linear association between strong identity with the hearing community and a higher HPS score. No other statistically significant associations were detected. Interestingly, 12 out of 26 participants found employment through family. Positive outcome trends in education and employment were seen in this study although no statistical significance was achieved. There is a strong bias for those who use their cochlear implants regularly, and there are no data available for those who do not use their cochlear implants for comparison as only one non-user completed the survey, despite efforts to include this group. This study shows that there is perceived benefit in implantation for patients who use it regularly but further research is needed with a more diverse group of cochlear implant recipients.

The combination of a programmable valve and a subclavicular anti-gravity device in hydrocephalus patients at high risk for hygromas.

PubMed

Zachenhofer, Iris; Donat, Markus; Roessler, Karl

2012-04-01

In order to avoid occurrence of post-operative hygromas in specific hydrocephalus patients being at high risk of overdrainage, a combination of programmable valve and anti-gravity device is widely recommended. We analyzed our series of hydrocephalus patients implanted with such a shunt configuration focusing on complications in relation to over-/underdrainage and neurological outcome. In 28 hydrocephalic patients (14 women and 14 men; mean age 65 years, range from 14 to 82 years; 11 normal pressure, 7 post-traumatic, and 4 post-hemorrhagic hydrocephalus), a Codman Medos programmable valve combined with a Miethke shunt assistant (SA) was implanted at the Department of Neurosurgery of the Academic Teaching Hospital Feldkirch. Implantation was performed simultaneously in 20 patients during the primary procedure: in five patients, SA was placed during revision surgery, and in three patients, the patent system was completed by additional implantation of an SA. Subdural hematoma occurred in one out of 20 patients with SA implantation during primary procedure and in two out of eight patients with SA implantation as secondary procedure, respectively. Shunt occlusion occurred in one patient out of the patients with SA implantation during primary procedure, but was seen in three patients with pre-existing shunt without SA. Shunt infection occurred in one case. Our results suggest the combination of an adjustable valve and SA as an effective treatment for a specific group of hydrocephalus patients being at high risk for overdrainage.

Implantation of programmable infusion pumps for insulin delivery in type I diabetic patients.

PubMed

Walter, H; Günther, A; Kronski, D; Flaschenträger, T; Mehnert, H

1989-06-01

Five type I diabetic patients were followed prospectively during treatment with continuous subcutaneous insulin infusion by externally worn pumps and during the first 12 months after implantation of a remote-controlled insulin infusion device (ID1, Siemens AG). Stabilized insulin (Hoe 21 GH, Hoechst AG) was infused intravenously in two and intraperitoneally in three patients. Total observation time was 47.2 patient-months after implantation. Two devices had to be explanted prematurely, one because of a technical failure after 101 days, one due to a skin necrosis over the implant after 236 days. HbA1, frequency of hypoglycemia, total insulin dose, and basal rate infusion did not change after implantation. There was a reduction in the insulin antibodies 6 months after start of intravenous or intraperitoneal insulin delivery. Fasting plasma free insulin levels could be normalized only by intraperitoneal insulin infusion. Although a technical and a surgical problem was observed, our data show the successful implantation and clinical use of programmable dosing devices and stabilized insulin.

Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society….

PubMed

Parma, Radosław; Zembala, Michał O; Dąbrowski, Maciej; Jagielak, Dariusz; Witkowski, Adam; Suwalski, Piotr; Dudek, Dariusz; Olszówka, Piotr; Wojakowski, Wojciech; Przybylski, Roman; Gil, Robert; Kuśmierczyk, Mariusz; Lesiak, Maciej; Sadowski, Jerzy; Dobrzycki, Sławomir; Ochała, Andrzej; Hoffman, Piotr; Kapelak, Bogusław; Kaźmierczak, Jarosław; Jasiński, Marek; Stępińska, Janina; Szymański, Piotr; Hryniewiecki, Tomasz; Kochman, Janusz; Grygier, Marek; Zembala, Marian; Legutko, Jacek; Różański, Jacek

2017-01-01

Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and surgical aortic valve replacement can improve symptoms and survival. In recent years, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival in inoperable patients and to be an alternative treatment in patients in whom the risk of surgical morbidity or mortality is high or intermediate. A representative expert committee, summoned by the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons, devel-oped this Consensus Statement in transcatheter aortic valve implantation. It endorses the important role of a multi-disciplinary "TAVI team" in selecting patients for TAVI and defines operator and institutional requirements fundamental to the establish-ment of a successful TAVI programme. The article summarises current evidence and provides specific recommendations on organisation and conduct of transcatheter treatment of patients with aortic valve disease in Poland.

47 CFR 95.1209 - Permissible communications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... to which the MedRadio implant or body-worn transmitter is used. (c) MedRadio programmer/control...Radio programmer/control transmitters may transmit only non-voice data containing operational... shall transmit except in response to a transmission from a MedRadio programmer/control transmitter or in...

Technological innovations in implants used for pain therapies.

PubMed

Shaw, Andrew; Sharma, Mayur; Deogaonkar, Milind; Rezai, Ali

2014-10-01

The field of pain management has experienced tremendous growth in implantable therapies secondary to the innovations of bioengineers, implanters, and industry. Every aspect of neuromodulation is amenable to innovation from implanting devices to anchors, electrodes, programming, and even patient programmers. Patients with previously refractory neuropathic pain syndromes have new and effective pain management strategies that are a direct result of innovations in implantable devices. Copyright © 2014 Elsevier Inc. All rights reserved.

The challenges of starting a cochlear implant programme in a developing country.

PubMed

Krishnamoorthy, Kumaresh; Samy, Ravi N; Shoman, Nael

2014-10-01

Deafness is indeed a silent disability in many parts of the world, and the majority of people who have hearing impairment live in developing countries. With rising economy and developing nations becoming hub of industrialization, hearing loss may increase in these countries. In this review, the authors have elected to focus the discussion on India to frame the challenges of cochlear implants in a developing country. This article reviews the common causes of hearing loss, the challenges faced by those with hearing impairment and why the penetration of these devices is low and also reviews some reasons for the inability of the government to support the implant programme in India. Early identification of hearing is crucial towards ensuring appropriate hearing rehabilitation; it is, however, challenged by various factors, including public awareness, absence of a national new born screening programme, accessibility to diagnostic centres, availability of trained personnel and equipment and patient affordability. Cochlear implants are a proven auditory rehabilitative option for individuals with severe to profound sensorineural hearing loss, who otherwise do not benefiting from hearing aids. Nevertheless, only a small percentage of these individuals receive cochlear implants, and cost remains a leading prohibitive factor, particularly in developing countries. For example, in India, the personal average annual income is well below US $2000, whereas these devices cost between $12,000 and $25,000, exclusive of hospital and staff fees. Hence, the technology is virtually unavailable to the masses. To overcome the cost limitation of those who would benefit from cochlear implants countries such as India and China have started to develop their own indigenous implants.

Ten years of clinical experience in the use of fixed-pressure versus programmable valves: a retrospective study of 159 patients.

PubMed

Mpakopoulou, Maria; Brotis, Alexandros G; Gatos, Haralampos; Paterakis, Konstantinos; Fountas, Kostas N

2012-01-01

The aim of this study was to present our 10-year experience with the use of fixed-pressure and programmable valves in the treatment of adult patients requiring cerebrospinal fluid (CSF) diversion. Patients (n = 159; 89 male and 70 female) suffering from hydrocephalus of various causes underwent CSF shunt implantation. Forty fixed-pressure and 119 programmable valves were initially implanted. The observed revision rate was 40% in patients with fixed-pressure valves. In 20% of these patients, a revision due to valve mechanism malfunction was undertaken, and the initial valve was replaced with a programmable one. The revision rate in the adjustable-pressure valve subgroup was 20%. The infection rate for the fixed-pressure and programmable valve subgroups were 3%, and 1.7%, respectively. Similarly, subdural fluid collections were noticed in 17% and 4% of patients with fixed-pressure valves and programmable valves, respectively. The revision and over-drainage rates were significantly lower when using programmable valves, and thus, this type of valve is preferred whenever CSF has to be diverted.

Dental implants in medically complex patients-a retrospective study.

PubMed

Manor, Yifat; Simon, Roy; Haim, Doron; Garfunkel, Adi; Moses, Ofer

2017-03-01

Dental implant insertion for oral rehabilitation is a worldwide procedure for healthy and medically compromised patients. The impact of systemic disease risks on the outcome of implant therapy is unclear, since there are few if any published randomized controlled trials (RCTs). The objective of this study is to investigate the rate of complications and failures following dental implantation in medically compromised patients in order to elucidate risk factors and prevent them. A retrospective cohort study was conducted from patient files treated with dental implantation between the years 2008-2014. The study group consisted of medically complex patients while the control group consisted of healthy patients. Preoperative, intraoperative, and post operative clinical details were retrieved from patients' files. The survival rate and the success rate of the dental implants were evaluated clinically and radiographically. A total of 204 patients (1003 dental implants) were included in the research, in the study group, 93 patients with 528 dental implants and in the control group, 111 patients with 475 dental implants. No significant differences were found between the groups regarding implant failures or complications. The failure rate of dental implants among the patients was 11.8 % in the study group and 16.2 % in the control group (P = 0.04). It was found that patients with a higher number of implants (mean 6.8) had failures compared with patients with a lower number of implants (mean 4.2) regardless of their health status (P < 0.01). We found a similar rate of failure and complications of dental implantation in medically complex patients and in healthy patients. Medically complex patients can undergo dental implantation. There are similar rates of complications and failures of dental implants in medically complex patients and in healthy patients.

Prosepective Study to Evaluate Rate and Frequency of Perturbations of Implanted Programmable Hakim Codman Valve After 1.5-Tesla Magnetic Resonance Imaging.

PubMed

Capitanio, Jody Filippo; Venier, Alice; Mazzeo, Lucio Aniello; Barzaghi, Lina Raffaella; Acerno, Stefania; Mortini, Pietro

2016-04-01

Exposure to magnetic fields may alter the settings of programmable ventriculoperitoneal shunt valves or even cause permanent damages to these devices. There is little information about this topic, none on live patients. To investigate the effects of 1.5-tesla magnetic resonance imaging (MRI) on Hakim-Codman (HC) pressure programmable valves implanted in our hospital. A single-center prospective study to assess the rate of perturbations of HC programmable valve implanted. One hundred consecutive patients implanted for different clinical reasons between 2008 and 2012 were examined. A conventional skull x-ray before and after a standard MRI on 1.5 tesla. We evaluated before and after results, analyzed modification rate, and verified eventual damages to the implanted devices. Implanted HC valves are extremely handy and durable, even if they are likely to change often due to the exposure to magnetic fields. None of the patients complained of heating effects. Oscillations range from 10-30 mm H2O with a patient who reached 50 mm H2O and 1 who reached 60 mm H2O. Global alteration rate was 40%: 10 patients (10%) experienced a 10 mm H2O change; 14 patients (14%) had a 20 mm H2O change; 6 patients (6%) had a 30 mm H2O change; 8 patients (8%) had a 40 mm H2O change; 1 patient had a 50 mm H2O change; and 1 patient had a 60 mm H2O change. HC valves presented a variable perturbation rate, with an alteration rate of 40% with 1.5-telsa MRI. We have not observed malfunctioning hardware as a result of magnetic influence. We claim ​ a cranial x-ray immediately after the MRI because of a high risk (40%) of decalibration, especially in patients with low ventricles compliance. Copyright © 2016 Elsevier Inc. All rights reserved.

[Design and application of implantable medical device information management system].

PubMed

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

Advanced Pacemaker

NASA Technical Reports Server (NTRS)

1990-01-01

Synchrony, developed by St. Jude Medical's Cardiac Rhythm Management Division (formerly known as Pacesetter Systems, Inc.) is an advanced state-of-the-art implantable pacemaker that closely matches the natural rhythm of the heart. The companion element of the Synchrony Pacemaker System is the Programmer Analyzer APS-II which allows a doctor to reprogram and fine tune the pacemaker to each user's special requirements without surgery. The two-way communications capability that allows the physician to instruct and query the pacemaker is accomplished by bidirectional telemetry. APS-II features 28 pacing functions and thousands of programming combinations to accommodate diverse lifestyles. Microprocessor unit also records and stores pertinent patient data up to a year.

Development of Implantable Medical Devices: From an Engineering Perspective

PubMed Central

2013-01-01

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

[Contraception with levonorgestrel (Norplant) subcutaneous implants. African experience in Burkina Faso].

PubMed

Koné, B; Lankoandé, J; Ouédraogo, C M; Ouédraogo, A; Bonané, B; Dao, B; Sanou, J

1999-02-01

The subcutaneous implants from the levonorgestrel (Norplant) has been introduced in Burkina Faso in September 1992 within the context of a project assisted by a non-governmental organization (the Population Council). The aim was to reinforce the family planning programme in Burkina Faso by increasing the number of family planning methods available for the clients. 4 years after its introduction, we propose to make a report of our experience in terms of the contraception through subcutaneous implants in order to better set up an IEC campaign on this method. Within 4 years, 1,660 users benefitted from that contraceptive method. They were housewives in 65% of the cases. The age-group of 30-34 years old most used this method with 28.6%. Multipares most benefitted from this method with 64.3%. In 72% of the cases, the insertion was made during the premenstrual period. On the whole, 247 withdrawals have been made before the fourth years for various reasons. Among those reasons are cycle disorders (60 withdrawals), medical reasons (53 withdrawals), personal conveniences (47 withdrawals), weight gaining (14 withdrawals), failures (2 withdrawals). Regarding the side effects, they were mainly represented by the menstrual cycle disorders such as amenorrhoea, spotting, hypermenorrhoea in 51% of the cases. A good information and sensitization campaign should reduce the number of implants withdrawals before the fourth year of use. Moreover, a perfect knowledge of contraindications is indispensable before any prescription.

A low power flash-FPGA based brain implant micro-system of PID control.

PubMed

Lijuan Xia; Fattah, Nabeel; Soltan, Ahmed; Jackson, Andrew; Chester, Graeme; Degenaar, Patrick

2017-07-01

In this paper, we demonstrate that a low power flash FPGA based micro-system can provide a low power programmable interface for closed-loop brain implant inter- faces. The proposed micro-system receives recording local field potential (LFP) signals from an implanted probe, performs closed-loop control using a first order control system, then converts the signal into an optogenetic control stimulus pattern. Stimulus can be implemented through optoelectronic probes. The long term target is for both fundamental neuroscience applications and for clinical use in treating epilepsy. Utilizing our device, closed-loop processing consumes only 14nJ of power per PID cycle compared to 1.52μJ per cycle for a micro-controller implementation. Compared to an application specific digital integrated circuit, flash FPGA's are inherently programmable.

Cochlear implants and medical tourism.

PubMed

McKinnon, Brian J; Bhatt, Nishant

2010-09-01

To compare the costs of medical tourism in cochlear implant surgery performed in India as compared to the United States. In addition, the cost savings of obtaining cochlear implant surgery in India were compare d to those of other surgical interventions obtained as a medical tourist. Searches were conducted on Medline and Google using the search terms: 'medical tourism', 'medical offshoring', 'medical outsourcing', 'cochlear implants' and 'cochlear implantation'. The information regarding cost of medical treatment was obtained from personal communication with individuals familiar with India's cochlear implantation medical tourism industry. The range of cost depended on length of stay as well as the device chosen. Generally the cost, inclusive of travel, surgery and device, was in the range of $21,000-30,000, as compared to a cost range of $40,000-$60,000 in the US. With the escalating cost of healthcare in the United States, it is not surprising that some patients would seek to obtain surgical care overseas at a fraction of the cost. Participants in medical tourism often have financial resources, but lack health insurance coverage. While cardiovascular and orthopedic surgery performed outside the United States in India at centers that cater to medical tourists are often performed at one-quarter to one-third of the cost that would have been paid in the United States, the cost differential for cochlear implants is not nearly as favorable.

Postgraduation retention of medical students from Otago and Auckland medical programmes.

PubMed

Shelker, William; Poole, Phillippa; Bagg, Warwick; Wood, Ian; Glue, Paul

2014-01-24

Auckland and Otago medical programmes have different methods for selecting students. This study compared postgraduate retention in New Zealand (NZ) of medical graduates from the two medical programmes, to assess whether different selection methods influenced retention. Other variables assessed included entrance category and age at graduation. Anonymised databases were created of all graduates from the Otago Faculty of Medicine (1999-2011) and the Auckland medical programme (2000-2012). Demographic and entry category data were recorded. Retention was defined as presence on the NZ Medical Register in December 2012. Risk differences (RD) were calculated to compare retention between the two medical programmes using the Mantel-Haenszel method. The influence of medical programme entrance category on retention was also tested. The influence of covariates on retaining graduates on the register was evaluated using a multiple logistic regression model. The postgraduate retention of graduates of the two medical programmes over 13 years was identical (Auckland 74.9%, Otago 73.6%, P=0.48). Retention of graduate and non-graduate entry students from both medical programmes was similar by 6 years after graduation. Age during medical school did not affect retention. University of attendance had no effect on postgraduation retention of students on the NZ Medical Register, suggesting that retention is not influenced by the different student selection methods at each programme. The data presented shows that New Zealand graduates regardless of programme completed show a similar profile in terms of retention.

Nano

Science.gov Websites

inspire light-manipulating surface for medical implants Butterfly wings inspire light-manipulating surface for medical implants Inspired by tiny nanostructures on transparent butterfly wings, engineers at -manipulating surface for medical implants Our phones could soon be sending data by light Scalable manufacturing

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.

Evaluation of 39 medical implants at 7.0 T

PubMed Central

Feng, David X; McCauley, Joseph P; Morgan–Curtis, Fea K; Salam, Redoan A; Pennell, David R; Loveless, Mary E

2015-01-01

Objective: With increased signal to noise ratios, 7.0-T MRI has the potential to contribute unique information regarding anatomy and pathophysiology of a disease. However, concerns for the safety of subjects with metallic medical implants have hindered advancement in this field. The purpose of the present research was to evaluate the MRI safety for 39 commonly used medical implants at 7.0 T. Methods: Selected metallic implants were tested for magnetic field interactions, radiofrequency-induced heating and artefacts using standardized testing techniques. Results: 5 of the 39 implants tested may be unsafe for subjects undergoing MRI at 7.0 T. Conclusion: Implants were deemed either “MR Conditional” or “MR Unsafe” for the 7.0-T MRI environment. Further research is needed to expand the existing database categorizing implants that are acceptable for patients referred for MRI examinations at 7.0 T. Advances in knowledge: Lack of MRI testing for common metallic medical implants limits the translational potential of 7.0-T MRI. For safety reasons, patients with metallic implants are not allowed to undergo a 7.0-T MRI scan, precluding part of the population that can benefit from the detailed resolution of ultra-high-field MRIs. This investigation provides necessary MRI testing of common medical implants at 7.0 T. PMID:26481696

The medically compromised patient: Are dental implants a feasible option?

PubMed

Vissink, A; Spijkervet, Fkl; Raghoebar, G M

2018-03-01

In healthy subjects, dental implants have evolved to be a common therapy to solve problems related to stability and retention of dentures as well as to replace failing teeth. Although dental implants are applied in medically compromised patients, it is often not well known whether this therapy is also feasible in these patients, whether the risk of implant failure and developing peri-implantitis is increased, and what specific preventive measures, if any, have to be taken when applying dental implants in these patients. Generally speaking, as was the conclusion by the leading review of Diz, Scully, and Sanz on placement of dental implants in medically compromised patients (J Dent, 41, 2013, 195), in a few disorders implant survival may be lower, and the risk of a compromised peri-implant health and its related complications be greater, but the degree of systemic disease control outweighs the nature of the disorder rather than the risk accompanying dental implant treatment. So, as dental implant treatment is accompanied by significant functional benefits and improved oral health-related quality of life, dental implant therapy is a feasible treatment in almost any medically compromised patient when the required preventive measures are taken and follow-up care is at a high level. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved.

A programmable and self-adjusting class E amplifier for efficient wireless powering of biomedical implants.

PubMed

Stoecklin, S; Volk, T; Yousaf, A; Reindl, L

2015-01-01

In this paper, an enhanced approach of a class E amplifier being insensitive to coil impedance variations is presented. While state of the art class E amplifiers widely being used to supply implanted systems show a strong degradation of efficiency when powering distance, coil orientation or the implant current consumption deviate from the nominal design, the presented concept is able to detect these deviations on-line and to reconfigure the amplifier automatically. The concept is facilitated by a new approach of sensing the load impedance without interruption of the power supply to the implant, while the main components of the class E amplifier are programmable by software. Therefore, the device is able to perform dynamic impedance matching. Besides presenting the operational principle and the design equations, we show an adaptive prototype reader system which achieves a drain efficiency of up to 92% for a wide range of reflected coil impedances from 1 to 40 Ω. The integrated communication concept allows downlink data rates of up to 500 kBit/s, while the load modulation based uplink from implant to reader was verified of providing up to 1.35 MBit/s.

The Potential Role of Polymethyl Methacrylate as a New Packaging Material for the Implantable Medical Device in the Bladder

PubMed Central

Kim, Su Jin; Choi, Bumkyoo; Kim, Kang Sup; Bae, Woong Jin; Hong, Sung Hoo; Lee, Ji Youl; Hwang, Tae-Kon; Kim, Sae Woong

2015-01-01

Polydimethylsiloxane (PDMS) is used in implantable medical devices; however, PDMS is not a completely biocompatible material for electronic medical devices in the bladder. To identify novel biocompatible materials for intravesical implanted medical devices, we evaluated the biocompatibility of polymethyl methacrylate (PMMA) by analyzing changes in the levels of macrophages, macrophage migratory inhibitory factor (MIF), and inflammatory cytokines in the bladder. A ball-shaped metal coated with PMMA or PDMS was implanted into the bladders of rats, and after intravesical implantation, the inflammatory changes induced by the foreign body reaction were evaluated. In the early period after implantation, increased macrophage activity and MIF in the urothelium of the bladder were observed. However, significantly decreased macrophage activity and MIF in the bladder were observed after implantation with PMMA- or PDMS-coated metal in the later period. In addition, significantly decreased inflammatory cytokines such as IL-1β, IL-6, and TNF-α were observed with time. Based on these results, we suggest that MIF plays a role in the foreign body reaction and in the biocompatible packaging with PMMA for the implanted medical devices in the bladder. PMID:25705692

Digital music players cause interference with interrogation telemetry for pacemakers and implantable cardioverter-defibrillators without affecting device function.

PubMed

Webster, Gregory; Jordao, Ligia; Martuscello, Maria; Mahajan, Tarun; Alexander, Mark E; Cecchin, Frank; Triedman, John K; Walsh, Edward P; Berul, Charles I

2008-04-01

Concern exists regarding the potential electromagnetic interaction between pacemakers, implantable cardioverter-defibrillators (ICDs) and digital music players (DMPs). A preliminary study reported interference in 50% of patients whose devices were interrogated near Apple iPods. Given the high prevalence of DMP use among young patients, we sought to define the nature of interference from iPods and evaluate other DMPs. Four DMPs (Apple Nano, Apple Video, SanDisk Sansa and Microsoft Zune) were evaluated against pacemakers and ICDs (PM/ICD). Along with continuous monitoring, we recorded a baseline ECG strip, sensing parameters and lead impedance at baseline and for each device. Among 51 patients evaluated (age 6 to 60 years, median 22), there was no interference with intrinsic device function. Interference with the programmer occurred in 41% of the patients. All four DMPs caused programmer interference, including disabled communication between the PM/ICD and programmer, noise in the ECG channel, and lost marker channel indicators. Sensing parameters and lead impedances exhibited no more than baseline variability. When the DMPs were removed six inches, there were no further programmer telemetry interactions. Contrary to a prior report, we did not identify any evidence for electromagnetic interference between a selection of DMPs and intrinsic function of PM/ICDs. The DMPs did sometimes interfere with device-programmer communication, but not in a way that compromised device function. Therefore, we recommend that DMPs not be used during device interrogation, but suggest that there is reassuring counterevidence to mitigate the current high level of concern for interactions between DMPs and implantable cardiac rhythm devices.

Enhancing the Performance of Medical Implant Communication Systems through Cooperative Diversity

PubMed Central

Hegyi, Barnabás; Levendovszky, János

2010-01-01

Battery-operated medical implants—such as pacemakers or cardioverter-defibrillators—have already been widely used in practical telemedicine and telecare applications. However, no solution has yet been found to mitigate the effect of the fading that the in-body to off-body communication channel is subject to. In this paper, we reveal and assess the potential of cooperative diversity to combat fading—hence to improve system performance—in medical implant communication systems. In the particular cooperative communication scenario we consider, multiple cooperating receiver units are installed across the room accommodating the patient with a medical implant inside his/her body. Our investigations have shown that the application of cooperative diversity is a promising approach to enhance the performance of medical implant communication systems in various aspects such as implant lifetime and communication link reliability. PMID:20379346

Interference of GSM mobile phones with communication between Cardiac Rhythm Management devices and programmers: A combined in vivo and in vitro study.

PubMed

Huang, Dong; Dong, Zhi-Feng; Chen, Yan; Wang, Fa-Bin; Wei, Zhi; Zhao, Wen-Bin; Li, Shuai; Liu, Ming-Ya; Zhu, Wei; Wei, Meng; Li, Jing-Bo

2015-07-01

To investigate interference, and how to avoid it, by high-frequency electromagnetic fields (EMFs) of Global System for Mobile Communications (GSM) mobile phone with communication between cardiac rhythm management devices (CRMs) and programmers, a combined in vivo and in vitro testing was conducted. During in vivo testing, GSM mobile phones interfered with CRM-programmer communication in 33 of 65 subjects tested (50.8%). Losing ventricle sensing was representative in this study. In terms of clinical symptoms, only 4 subjects (0.6%) felt dizzy during testing. CRM-programmer communication recovered upon termination of mobile phone communication. During in vitro testing, electromagnetic interference by high-frequency (700-950 MHz) EMFs reproducibly occurred in duplicate testing in 18 of 20 CRMs (90%). During each interference, the pacing pulse signal on the programmer would suddenly disappear while the synchronous signal was normal on the amplifier-oscilloscope. Simulation analysis showed that interference by radiofrequency emitting devices with CRM-programmer communication may be attributed to factors including materials, excitation source distance, and implant depth. Results suggested that patients implanted with CRMs should not be restricted from using GSM mobile phones; however, CRMs should be kept away from high-frequency EMFs of GSM mobile phone during programming. © 2015 Wiley Periodicals, Inc.

Developing a music programme for preschool children with cochlear implants.

PubMed

Koşaner, Julie; Kilinc, Aynur; Deniz, Murat

2012-11-01

Although music perception is especially challenging for cochlear implant (CI) users, young CI users' musical perception abilities are improved by participation in structured musical activities. To design, implement, evaluate, and publish a music training programme with a monitoring tool for preschool CI users, for use in family-centred habilitation programmes. We devised a programme of musical activities, Musical EARS®, and a curriculum-related hierarchical Evaluation Form to represent performance. The programme included sections on singing; recognizing songs, tunes, and timbre; and responding appropriately to music and rhythm. It was implemented over 18 months at Ilkses Rehabilitation Centre, with 25 paediatric MED-EL CI users split into three groups of varying age, duration of CI use, and ability. Mean total scores increased significantly for all groups. Scores increased unevenly across subscales. Participation in and enjoyment of musical activities increased for both children and parents. Significant correlations were found between scores and length of CI use. The training programme effectively enriches child CI users' musical experience. To varying degrees, children learned to perform the Musical EARS® activities. The study allowed us to validate the lesson content and the hierarchical nature of the Evaluation Form. We conclude that prelingually deafened CI users should be systematically involved in musical activities to help them acquire skills acquired more easily by hearing peers.

Y2K: effects on pacemaker and implantable defibrillator programmers.

PubMed

Flynn, D P; Daubert, J P; Huang, D T; Ocampo, C M; O'Gorman, E

1999-01-01

All permanent pacemakers and implantable defibrillators (PPM/ICDs) will continue to function as programmed without regard to the date in the year 2000 (Y2K). All manufacturers contacted reassured us that some of these devices incorporate a day/year clock in the circuitry; however, these are not involved in sensing or delivering programmed therapy. Some manufacturers' device programmers will roll over to the year 2000 without any problems at all, whereas others may have difficulty with date and time stamping on printed reports. We tested 14 different types of PPM/ICD programmers for Y2K compliance using 8 tests. Five of the 14 models passed each test and were labeled at our institution with a green "Y2K" sticker to identify them as Y2K compatible and needing no special attention after December 31, 1999. The most common test failed was the ability to roll the date forward from December 31, 1999, with the programmer power off. Organizations should consider testing and replacing noncompliant device programmers or placing a red sticker with "Y2K" crossed out on noncompliant pieces. The red sticker alerts the advanced practice nurse or physician to the need to confirm the appropriate date and time in the programmer after startup in the year 2000 and before interrogating or programming any PPM/ICD, to avoid inappropriate date and time stamping on printed reports from that programmer.

A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation.

PubMed

Xu, Qi; Hu, Dingyin; Duan, Bingyu; He, Jiping

2015-07-01

Epidural spinal cord stimulation (ESCS) combined with partial weight-bearing therapy (PWBT) has been shown to facilitate recovery of functional walking for individuals after spinal cord injury (SCI). The investigation of neural mechanisms of recovery from SCI under this treatment has been conducted broadly in rodent models, yet a suitable ESCS system is still unavailable. This paper describes a practical, programmable, and fully implantable stimulator for laboratory research on rats to explore fundamental neurophysiological principles for functional recovery after SCI. The ESCS system is composed of a personal digital assistant (PDA), an external controller, an implantable pulse generator (IPG), lead extension, and stimulating electrodes. The stimulation parameters can be programmed and adjusted through a graphical user interface on the PDA. The external controller is placed on the rat back and communicates with the PDA via radio-frequency (RF) telemetry. An RF carrier from the class-E power amplifier in the external controller provides both data and power for the IPG through an inductive link. The IPG is built around a microcontroller unit to generate voltage-regulated pulses delivered to the bipolar electrode for ESCS in rats. The encapsulated IPG measures 22 mm × 23 mm × 7 mm with a mass of  ∼  3.78 g. This fully implantable batteryless stimulator provided a simplified and efficient method to carry out chronic experiments in untethered animals for medical electro-neurological research.

Nanomaterials and synergistic low intensity direct current (LIDC) stimulation technology for orthopaedic implantable medical devices

PubMed Central

Samberg, Meghan E.; Cohen, Paul H.; Wysk, Richard A.; Monteiro-Riviere, Nancy A.

2012-01-01

Nanomaterials play a significant role in biomedical research and applications due to their unique biological, mechanical, and electrical properties. In recent years, they have been utilised to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopaedic residual hardware devices (e.g. hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopaedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopaedic implants is also discussed,, the focus being on a low intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The paper concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. PMID:23335493

Effects of high-intensity power-frequency electric fields on implanted modern multiprogrammable cardiac pacemakers.

PubMed

Butrous, G S; Meldrum, S J; Barton, D G; Male, J C; Bonnell, J A; Camm, A J

1982-05-01

The effect on an implanted, multiprogrammable pacemaker of power-frequency (50 Hz) electric fields up to an intensity (unperturbed value measured at 1.7 m) of 20 kV/m were assessed in ten paced patients. Radiotelemetric monitoring of the electrocardiogram allowed supervision of the electrocardiogram throughout exposure to the alternating electric field. Displacement body currents of up to 300μA were achieved depending on the position and height of the patient. None of the pacemakers was inhibited, triggered or reverted to fixed rate operation during the exposure. The programmable functions, programmability or output characteristics were not affected. Small changes in cardiac rate and rhythm elicited the correct pacemaker responses. Unlike earlier models of pacemaker, this modern implanted pacemaker, which represents `the state of the art', is not affected by 50 Hz electric fields likely to be encountered when standing underneath power lines.

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...

Evaluation of the medical student research programme in Norwegian medical schools. A survey of students and supervisors

PubMed Central

Hunskaar, Steinar; Breivik, Jarle; Siebke, Maje; Tømmerås, Karin; Figenschau, Kristian; Hansen, John-Bjarne

2009-01-01

Background The Medical Student Research Programme is a national education and grant scheme for medical students who wish to carry out research in parallel with their studies. The purpose of the programme is to increase recruitment of people with a standard medical degree to medical research. The Research Programme was established in 2002 and underwent a thorough evaluation during the spring of 2007. The evaluation should investigate if the programme had fulfilled its objectives of increased recruitment to medical research, in addition to the students' and supervisors' satisfaction of the programme, and unwanted differences between the universities. Methods Data was collected from students, supervisors and administrative staff via web-based questionnaires. Information about admission, implementation, results achieved and satisfaction was analysed and compared between the four Norwegian medical schools. In addition, the position of the scheme in relation to the national Quality Reform of Higher Education was analysed. Results At the end of 2006, the Medical Student Research Programme had recruited 265 medical students to research. These consisted of 214 active students, 35 who had completed their studies and only 17 who had dropped out. Both students and supervisors were generally very satisfied with the scheme, including the curriculum, the results achieved and the administrative service. The majority of students wanted to continue their research towards a PhD and, of those who had completed the Medical Student Research Programme, practically all had published one or several scientific papers. The survey showed only small differences between the four medical schools, despite their choice of somewhat different solutions in terms of administration and organisation. The Medical Student Research Programme satisfies the majority of the demands of the Quality Reform, however as an integrated research programme aimed at a PhD it presupposes access to PhD courses before the completion of medical studies, as well as the ability to include undergraduate scientific work in a PhD thesis. Conclusion The Medical Student Research Programme has led to an increase in the recruitment of graduated physicians to medical research in Norway. It will only be possible to evaluate whether this in turn will result in a larger number of PhDs in 3–5 years; this will also depend on the access to grants and fellowships. PMID:19602226

Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants.

PubMed

Yildirimer, L; Seifalian, A M; Butler, P E

2013-05-01

The recent events surrounding Poly Implant Prosthèse (PIP) breast implants have renewed the debate about the safety profile of silicone implants. The intentional use of industrial-grade instead of certified medical-grade silicone is thought to be responsible for reportedly higher frequencies of implant rupture in vivo. The differences in mechanical and viscoelastic properties between PIP and medical-grade silicone implant shells were investigated. Surface characterization of shells and gels was carried out to determine structural changes occurring after implantation. Breast implants were obtained from women at the Royal Free Hospital (London, UK). PIP implants were compared with medical-grade control silicone implants. Tensile strength, tear resistance and elongation at break were assessed using a tensile tester. Surfaces were analysed using attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopy. Spearman correlation analyses and Kruskal-Wallis one-way statistical tests were performed for mechanical data. There were 18 PIP and four medical-grade silicone implants. PIP silicone shells had significantly weaker mechanical strength than control shells (P < 0·009). There were negative correlations between mechanical properties of PIP shells and implantation times, indicative of deterioration of PIP shells over time in vivo (r(s) = -0·75, P = 0·009 for tensile strength; r(s) = -0·76, P = 0·001 for maximal strain). Comparison of ATR-FTIR spectra of PIP and control silicones demonstrated changes in material characteristics during the period of implantation suggestive of time-dependent bond breakage and degradation of the material. This study demonstrated an increased weakness of PIP shells with time and therefore supports the argument for prophylactic removal of PIP breast implants. © 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd.

A microcontroller-based implantable nerve stimulator used for rats.

PubMed

Sha, Hong; Zheng, Zheng; Wang, Yan; Ren, Chaoshi

2005-01-01

A microcontroller-based stimulator that can be flexible programmed after it has been implanted into a rat was studied. Programmability enables implanted stimulators to generate customized, complex protocols for experiments. After implantation, a coded light pulse train that contains information of specific identification will unlock a certain stimulator. If a command that changing the parameters is received, the microcontroller will update its flash memory after it affirms the commands. The whole size of it is only 1.6 cubic centimeters, and it can work for a month. The devices have been successfully used in animal behavior experiments, especially on rats.

Device closure of secundum atrial septal defect's and the risk of cardiac erosion.

PubMed

Thomson, J D R; Qureshi, S A

2015-12-01

Cardiac erosion related to transcatheter atrial septal defect closure devices is of increasing concern. Erosion is reported to have occurred with most of currently available occluder devices. Perhaps due to the very large number of implants worldwide, the Amplatzer (St Jude) occluder is associated with the majority of cardiac erosion events reported in the literature. Best current estimates of the incidence of erosion with the St Jude device are between one and three cases per 1000 implants. Most events occur early after implantation and it is rare, although not unheard of, for events to occur after a year following device insertion. It is important that those involved with closure programmes are vigilant for the problem, because device-related erosion is associated with a significant mortality risk. Despite considerable debate, the risk factors (either patient or device) for erosion remain unclear and require further investigation. Currently available data sets have focussed largely on erosion cohorts and are unable to place these cases in appropriate context with non-erosion closure cases. What is certain is that programmes implanting these devices must take care to implant appropriately sized devices and have in place plans to ensure that patients are both well informed and can access help and advice in the event of developing symptoms.

Convex optimization of MRI exposure for mitigation of RF-heating from active medical implants.

PubMed

Córcoles, Juan; Zastrow, Earl; Kuster, Niels

2015-09-21

Local RF-heating of elongated medical implants during magnetic resonance imaging (MRI) may pose a significant health risk to patients. The actual patient risk depends on various parameters including RF magnetic field strength and frequency, MR coil design, patient's anatomy, posture, and imaging position, implant location, RF coupling efficiency of the implant, and the bio-physiological responses associated with the induced local heating. We present three constrained convex optimization strategies that incorporate the implant's RF-heating characteristics, for the reduction of local heating of medical implants during MRI. The study emphasizes the complementary performances of the different formulations. The analysis demonstrates that RF-induced heating of elongated metallic medical implants can be carefully controlled and balanced against MRI quality. A reduction of heating of up to 25 dB can be achieved at the cost of reduced uniformity in the magnitude of the B(1)(+) field of less than 5%. The current formulations incorporate a priori knowledge of clinically-specific parameters, which is assumed to be available. Before these techniques can be applied practically in the broader clinical context, further investigations are needed to determine whether reduced access to a priori knowledge regarding, e.g. the patient's anatomy, implant routing, RF-transmitter, and RF-implant coupling, can be accepted within reasonable levels of uncertainty.

Histamine release and fibrinogen adsorption mediate acute inflammatory responses to biomaterial implants in humans

PubMed Central

Zdolsek, Johann; Eaton, John W; Tang, Liping

2007-01-01

Background Medical implants often fail as a result of so-called foreign body reactions during which inflammatory cells are recruited to implant surfaces. Despite the clinical importance of this phenomenon, the mechanisms involved in these reactions to biomedical implants in humans are not well understood. The results from animal studies suggest that both fibrinogen adsorption to the implant surface and histamine release by local mast cells are involved in biomaterial-mediated acute inflammatory responses. The purpose of this study was to test this hypothesis in humans. Methods Thirteen male medical student volunteers (Caucasian, 21–30 years of age) were employed for this study. To assess the importance of fibrinogen adsorption, six volunteers were implanted with polyethylene teraphthalate disks pre-coated with their own (fibrinogen-containing) plasma or (fibrinogen-free) serum. To evaluate the importance of histamine, seven volunteers were implanted with uncoated disks with or without prior oral administration of histamine receptor antagonists. The acute inflammatory response was estimated 24 hours later by measuring the activities of implant-associated phagocyte-specific enzymes. Results Plasma coated implants accumulated significantly more phagocytes than did serum coated implants and the recruited cells were predominantly macrophage/monocytes. Administration of both H1 and H2 histamine receptor antagonists greatly reduced the recruitment of macrophages/monocytes and neutrophils on implant surfaces. Conclusion In humans – as in rodents – biomaterial-mediated inflammatory responses involve at least two crucial events: histamine-mediated phagocyte recruitment and phagocyte accumulation on implant surfaces engendered by spontaneously adsorbed host fibrinogen. Based on these results, we conclude that reducing fibrinogen:surface interactions should enhance biocompatibility and that administration of histamine receptor antagonists prior to, and shortly after, medical device implantation should improve the functionality and longevity of medical implants. PMID:17603911

Medical implants and methods of making medical implants

DOEpatents

Shaw, Wendy J; Yonker, Clement R; Fulton, John L; Tarasevich, Barbara J; McClain, James B; Taylor, Doug

2014-09-16

A medical implant device having a substrate with an oxidized surface and a silane derivative coating covalently bonded to the oxidized surface. A bioactive agent is covalently bonded to the silane derivative coating. An implantable stent device including a stent core having an oxidized surface with a layer of silane derivative covalently bonded thereto. A spacer layer comprising polyethylene glycol (PEG) is covalently bonded to the layer of silane derivative and a protein is covalently bonded to the PEG. A method of making a medical implant device including providing a substrate having a surface, oxidizing the surface and reacting with derivitized silane to form a silane coating covalently bonded to the surface. A bioactive agent is then covalently bonded to the silane coating. In particular instances, an additional coating of bio-absorbable polymer and/or pharmaceutical agent is deposited over the bioactive agent.

Programmable Hydrogel Ionic Circuits for Biologically Matched Electronic Interfaces.

PubMed

Zhao, Siwei; Tseng, Peter; Grasman, Jonathan; Wang, Yu; Li, Wenyi; Napier, Bradley; Yavuz, Burcin; Chen, Ying; Howell, Laurel; Rincon, Javier; Omenetto, Fiorenzo G; Kaplan, David L

2018-06-01

The increased need for wearable and implantable medical devices has driven the demand for electronics that interface with living systems. Current bioelectronic systems have not fully resolved mismatches between engineered circuits and biological systems, including the resulting pain and damage to biological tissues. Here, salt/poly(ethylene glycol) (PEG) aqueous two-phase systems are utilized to generate programmable hydrogel ionic circuits. High-conductivity salt-solution patterns are stably encapsulated within PEG hydrogel matrices using salt/PEG phase separation, which route ionic current with high resolution and enable localized delivery of electrical stimulation. This strategy allows designer electronics that match biological systems, including transparency, stretchability, complete aqueous-based connective interface, distribution of ionic electrical signals between engineered and biological systems, and avoidance of tissue damage from electrical stimulation. The potential of such systems is demonstrated by generating light-emitting diode (LED)-based displays, skin-mounted electronics, and stimulators that deliver localized current to in vitro neuron cultures and muscles in vivo with reduced adverse effects. Such electronic platforms may form the basis of future biointegrated electronic systems. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

International recognition of basic medical education programmes.

PubMed

Karle, Hans

2008-01-01

This document aims to formulate a World Federation for Medical Education (WFME) policy and to open debate on the subject on international recognition of basic medical education institutions and programmes. We carried out a systematic review of international quality assurance of medical education and recognition methodology, including accreditation procedures and alternative quality assurance methods, with a focus on the role of the WFME in international recognition of basic medical education programmes. In order to further the intentions of the WFME, the Federation will: continue its activity to establish new Global Directories of Health Professions Education Institutions (GDHPEI); set up a planning working group to prepare the work of the international advisory committee for GDHPEI; develop a database of relevant accrediting and recognising agencies; continue its project on the promotion of proper national accreditation; establish a working group to develop principles to be used in the evaluation of medical schools and other health professions education institutions and their programmes for the purpose of international recognition, especially when proper accreditation is not feasible, and work with partners on training programmes for advisors and assessors. The new directory for medical schools, which will include qualitative information about basic medical education programmes, will provide a basis for the meta-recognition of medical schools' programmes by stimulating the establishment of national accreditation systems and other quality assurance instruments.

Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

PubMed

Blessing, Melissa M; Lin, Peter T

2018-05-01

Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

Antimicrobial and Antifouling Polymeric Agents for Surface Functionalization of Medical Implants.

PubMed

Zeng, Qiang; Zhu, Yiwen; Yu, Bingran; Sun, Yujie; Ding, Xiaokang; Xu, Chen; Wu, Yu-Wei; Tang, Zhihui; Xu, Fu-Jian

2018-05-09

Combating implant-associated infections is an urgent demand due to the increasing numbers in surgical operations such as joint replacements and dental implantations. Surface functionalization of implantable medical devices with polymeric antimicrobial and antifouling agents is an efficient strategy to prevent bacterial fouling and associated infections. In this work, antimicrobial and antifouling branched polymeric agents (GPEG and GEG) were synthesized via ring-opening reaction involving gentamicin and ethylene glycol species. Due to their rich primary amine groups, they can be readily coated on the polydopamine-modified implant (such as titanium) surfaces. The resultant surface coatings of Ti-GPEG and Ti-GEG produce excellent in vitro antibacterial efficacy toward both Staphylococcus aureus and Escherichia coli, while Ti-GPEG exhibit better antifouling ability. Moreover, the infection model with S. aureus shows that implanted Ti-GPEG possessed excellent antibacterial and antifouling ability in vivo. This study would provide a promising strategy for the surface functionalization of implantable medical devices to prevent implant-associated infections.

Subcutaneous ICD screening with the Boston Scientific ZOOM programmer versus a 12-lead ECG machine.

PubMed

Chang, Shu C; Patton, Kristen K; Robinson, Melissa R; Poole, Jeanne E; Prutkin, Jordan M

2018-02-24

The subcutaneous implantable cardioverter-defibrillator (S-ICD) requires preimplant screening to ensure appropriate sensing and reduce risk of inappropriate shocks. Screening can be performed using either an ICD programmer or a 12-lead electrocardiogram (ECG) machine. It is unclear whether differences in signal filtering and digital sampling change the screening success rate. Subjects were recruited if they had a transvenous single-lead ICD without pacing requirements or were candidates for a new ICD. Screening was performed using both a Boston Scientific ZOOM programmer (Marlborough, MA, USA) and General Electric MAC 5000 ECG machine (Fairfield, CT, USA). A pass was defined as having at least one lead that fit within the screening template in both supine and sitting positions. A total of 69 subjects were included and 27 sets of ECG leads had differing screening results between the two machines (7%). Of these sets, 22 (81%) passed using the ECG machine but failed using the programmer and five (19%) passed using the ECG machine but failed using the programmer (P < 0.001). Four subjects (6%) passed screening using the ECG machine but failed using the programmer. No subject passed screening with the programmer but failed with the ECG machine. There can be occasional disagreement in S-ICD patient screening between an ICD programmer and ECG machine, all of whom passed with the ECG machine but failed using the programmer. On a per lead basis, the ECG machine passes more subjects. It is unknown what the inappropriate shock rate would be if an S-ICD was implanted. Clinical judgment should be used in borderline cases. © 2018 Wiley Periodicals, Inc.

Bacterial adherence and biofilm formation on medical implants: a review.

PubMed

Veerachamy, Suganthan; Yarlagadda, Tejasri; Manivasagam, Geetha; Yarlagadda, Prasad Kdv

2014-10-01

Biofilms are a complex group of microbial cells that adhere to the exopolysaccharide matrix present on the surface of medical devices. Biofilm-associated infections in the medical devices pose a serious problem to the public health and adversely affect the function of the device. Medical implants used in oral and orthopedic surgery are fabricated using alloys such as stainless steel and titanium. The biological behavior, such as osseointegration and its antibacterial activity, essentially depends on both the chemical composition and the morphology of the surface of the device. Surface treatment of medical implants by various physical and chemical techniques are attempted in order to improve their surface properties so as to facilitate bio-integration and prevent bacterial adhesion. The potential source of infection of the surrounding tissue and antimicrobial strategies are from bacteria adherent to or in a biofilm on the implant which should prevent both biofilm formation and tissue colonization. This article provides an overview of bacterial biofilm formation and methods adopted for the inhibition of bacterial adhesion on medical implants. © IMechE 2014.

Clinician-scientist MB/PhD training in the UK: a nationwide survey of medical school policy.

PubMed

Barnett-Vanes, Ashton; Ho, Guiyi; Cox, Timothy M

2015-12-30

This study surveyed all UK medical schools regarding their Bachelor of Medicine (MB), Doctor of Philosophy (PhD) (MB/PhD) training policy in order to map the current training landscape and to provide evidence for further research and policy development. Deans of all UK medical schools registered with the Medical Schools Council were invited to participate in this survey electronically. The number of medical schools that operate institutional MB/PhD programmes or permit self-directed student PhD intercalation. Medical school recruitment procedures and attitudes to policy guidance. 27 of 33 (81%) registered UK medical schools responded. Four (14%) offer an institutional MB/PhD programme. However, of those without institutional programmes, 17 (73%) permit study interruption and PhD intercalation: two do not (one of whom had discontinued their programme in 2013), three were unsure and one failed to answer the question. Regarding student eligibility, respondents cited high academic achievement in medical studies and a bachelor's or master's degree. Of the Medical schools without institutional MB/PhD programmes, 5 (21%) have intentions to establish a programme, 8 (34%) do not and 3 were unsure, seven did not answer. 19 medical schools (70%) considered national guidelines are needed for future MB/PhD programme development. We report the first national survey of MB/PhD training in the UK. Four medical schools have operational institutional MB/PhD programmes, with a further five intending to establish one. Most medical schools permit study interruption and PhD intercalation. The total number MB/PhD students yet to graduate from medical school could exceed 150, with 30 graduating per year. A majority of medical school respondents to this survey believe national guidelines are required for MB/PhD programme development and implementation. Further research should focus on the MB/PhD student experience. Discussion regarding local and national MB/PhD policies between medical schools and academic stakeholders are needed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.

PubMed

Halimi, Franck; Clémenty, Jacques; Attuel, Patrick; Dessenne, Xavier; Amara, Walid

2008-12-01

The OEDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4-6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI -2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure.

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial

PubMed Central

Halimi, Franck; Clémenty, Jacques; Attuel, Patrick; Dessenne, Xavier; Amara, Walid

2008-01-01

Aims The ŒDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. Methods and results Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4–6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI −2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. Conclusion Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure. PMID:18775878

Silicone Gel-Filled Breast Implants

MedlinePlus

... and Medical Procedures Implants and Prosthetics Breast Implants Silicone Gel-Filled Breast Implants Share Tweet Linkedin Pin ... sharing options Linkedin Pin it Email Print Description: Silicone gel-filled breast implants have a silicone outer ...

Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

PubMed

Morken, Ingvild M; Norekvål, Tone M; Bru, Edvin; Larsen, Alf I; Karlsen, Bjørg

2014-09-01

To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. A cross-sectional survey design. A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance. © 2014 John Wiley & Sons Ltd.

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

78 FR 41125 - Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... Brachytherapy Medical Event Reporting AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement; revision... medical events occurring under an NRC licensee's permanent implant brachytherapy program. This interim..., ``Adequacy of Medical Event Definitions in 10 CFR [Title 10 of the Code of Federal Regulations] 35.3045, and...

[Longitudinal survey and analysis among Chengdu residents on cognition and acceptance of implant dentures].

PubMed

Zuo, Yanping; Wang, Yongyue; Wang, Luming; Du, Bing

2014-08-01

This study aims to survey the cognition and acceptance of implant dentures among Chengdu residents in 2005 and 2013 and to comparatively analyze the differences and influencing factors. A questionnaire was designed for this study. Its main content included basic demographics of respondents (gender, age, cultural level, and income level), cognition level of implant dentures (concept and main characteristics of implant dentures), main concern of respondents regarding implant dentures and medical institutions, and acceptance level of the price of implant dentures, among others. The sampling survey was carried out among Chengdu residents in 2005 and 2013 using the designed questionnaire. The results were then statistically analyzed. Up to 908 valid questionnaires in 2005 and 905 valid questionnaires in 2013 were obtained. The level of cognition of implant dentures was higher in 2013 than in 2005, and the correlation between cognition and cultural level and that between cognition and income level were both positive. However, the correlation between cognition and age was negative. The success rate for implant dentures and medical treatment technology of medical institutions were the factors that the respondents were mainly concerned with. The main methods for disseminating information on implant dentures were the internet, television, newspapers, magazines, and introduction by friends. With the development of the society's economy and the improvement of culture and income level of Chengdu residents, the cognition and acceptance level of implant dentures have gradualy increased. Meanwhile, health education and medical technology still need to be strengthened.

Convex optimization of MRI exposure for mitigation of RF-heating from active medical implants

NASA Astrophysics Data System (ADS)

Córcoles, Juan; Zastrow, Earl; Kuster, Niels

2015-09-01

Local RF-heating of elongated medical implants during magnetic resonance imaging (MRI) may pose a significant health risk to patients. The actual patient risk depends on various parameters including RF magnetic field strength and frequency, MR coil design, patient’s anatomy, posture, and imaging position, implant location, RF coupling efficiency of the implant, and the bio-physiological responses associated with the induced local heating. We present three constrained convex optimization strategies that incorporate the implant’s RF-heating characteristics, for the reduction of local heating of medical implants during MRI. The study emphasizes the complementary performances of the different formulations. The analysis demonstrates that RF-induced heating of elongated metallic medical implants can be carefully controlled and balanced against MRI quality. A reduction of heating of up to 25 dB can be achieved at the cost of reduced uniformity in the magnitude of the B1+ field of less than 5%. The current formulations incorporate a priori knowledge of clinically-specific parameters, which is assumed to be available. Before these techniques can be applied practically in the broader clinical context, further investigations are needed to determine whether reduced access to a priori knowledge regarding, e.g. the patient’s anatomy, implant routing, RF-transmitter, and RF-implant coupling, can be accepted within reasonable levels of uncertainty.

Pacemakers and implantable cardioverter-defibrillators in pediatric patients.

PubMed

Silka, Michael J; Bar-Cohen, Yaniv

2006-11-01

The use of pacemakers and implantable cardioverter-defibrillators (ICDs) in infants, children, and patients with congenital heart disease presents unique challenges and considerations. They include uncommon indications for device implantation, innovative approaches to lead implantation and configuration, and age-dependent and disease-specific aspects of device programming. In this review, the current indications for pacemaker and ICD implantation in young patients are discussed, followed by consideration of the approaches to lead and device placement in very small patients and those with complex congenital heart disease, in whom unique problems may be encountered. The limitations of programmability of current pacemakers and ICDs when used in young patients are discussed, followed by an analysis of long-term device follow-up and potential late complications.

Development and perceived effects of an educational programme on quality and safety in medication handling in residential facilities.

PubMed

Mygind, Anna; El-Souri, Mira; Rossing, Charlotte; Thomsen, Linda Aagaard

2018-04-01

To develop and test an educational programme on quality and safety in medication handling for staff in residential facilities for the disabled. The continuing pharmacy education instructional design model was used to develop the programme with 22 learning objectives on disease and medicines, quality and safety, communication and coordination. The programme was a flexible, modular seven + two days' course addressing quality and safety in medication handling, disease and medicines, and medication supervision and reconciliation. The programme was tested in five Danish municipalities. Municipalities were selected based on their application for participation; each independently selected a facility for residents with mental and intellectual disabilities, and a facility for residents with severe mental illnesses. Perceived effects were measured based on a questionnaire completed by participants before and after the programme. Effects on motivation and confidence as well as perceived effects on knowledge, skills and competences related to medication handling, patient empowerment, communication, role clarification and safety culture were analysed conducting bivariate, stratified analyses and test for independence. Of the 114 participants completing the programme, 75 participants returned both questionnaires (response rate = 66%). Motivation and confidence regarding quality and safety in medication handling significantly improved, as did perceived knowledge, skills and competences on 20 learning objectives on role clarification, safety culture, medication handling, patient empowerment and communication. The programme improved staffs' motivation and confidence and their perceived ability to handle residents' medication safely through improved role clarification, safety culture, medication handling and patient empowerment and communication skills. © 2017 Royal Pharmaceutical Society.

Implantable power generation system utilizing muscle contractions excited by electrical stimulation.

PubMed

Sahara, Genta; Hijikata, Wataru; Tomioka, Kota; Shinshi, Tadahiko

2016-06-01

An implantable power generation system driven by muscle contractions for supplying power to active implantable medical devices, such as pacemakers and neurostimulators, is proposed. In this system, a muscle is intentionally contracted by an electrical stimulation in accordance with the demands of the active implantable medical device for electrical power. The proposed system, which comprises a small electromagnetic induction generator, electrodes with an electrical circuit for stimulation and a transmission device to convert the linear motion of the muscle contractions into rotational motion for the magneto rotor, generates electrical energy. In an ex vivo demonstration using the gastrocnemius muscle of a toad, which was 28 mm in length and weighed 1.3 g, the electrical energy generated by the prototype exceeded the energy consumed for electrical stimulation, with the net power being 111 µW. It was demonstrated that the proposed implantable power generation system has the potential to replace implantable batteries for active implantable medical devices. © IMechE 2016.

A national survey of medical education fellowships.

PubMed

Thompson, Britta M; Searle, Nancy S; Gruppen, Larry D; Hatem, Charles J; Nelson, Elizabeth A

2011-04-04

The purpose of our study was to determine the prevalence, focus, time commitment, graduation requirements and programme evaluation methods of medical education fellowships throughout the United States. Medical education fellowships are defined as a single cohort of medical teaching faculty who participate in an extended faculty development programme. A 26-item online questionnaire was distributed to all US medical schools (n=127) in 2005 and 2006. The questionnaire asked each school if it had a medical education fellowship and the characteristics of the fellowship programme. Almost half (n=55) of the participating schools (n=120, response rate 94.5 %) reported having fellowships. Duration (10-584 hours) and length (<1 month-48 months) varied; most focused on teaching skills, scholarly dissemination and curriculum design, and required the completion of a scholarly project. A majority collected participant satisfaction; few used other programme evaluation strategies. The number of medical education fellowships increased rapidly during the 1990s and 2000s. Across the US, programmes are similar in participant characteristics and curricular focus but unique in completion requirements. Fellowships collect limited programme evaluation data, indicating a need for better outcome data. These results provide benchmark data for those implementing or revising existing medical education fellowships.

A national survey of medical education fellowships

PubMed Central

Thompson, Britta M.; Searle, Nancy S.; Gruppen, Larry D.; Hatem, Charles J.; Nelson, Elizabeth A.

2011-01-01

Purpose The purpose of our study was to determine the prevalence, focus, time commitment, graduation requirements and programme evaluation methods of medical education fellowships throughout the United States. Medical education fellowships are defined as a single cohort of medical teaching faculty who participate in an extended faculty development programme. Methods A 26-item online questionnaire was distributed to all US medical schools (n=127) in 2005 and 2006. The questionnaire asked each school if it had a medical education fellowship and the characteristics of the fellowship programme. Results Almost half (n=55) of the participating schools (n=120, response rate 94.5 %) reported having fellowships. Duration (10–584 hours) and length (<1 month–48 months) varied; most focused on teaching skills, scholarly dissemination and curriculum design, and required the completion of a scholarly project. A majority collected participant satisfaction; few used other programme evaluation strategies. Conclusions The number of medical education fellowships increased rapidly during the 1990s and 2000s. Across the US, programmes are similar in participant characteristics and curricular focus but unique in completion requirements. Fellowships collect limited programme evaluation data, indicating a need for better outcome data. These results provide benchmark data for those implementing or revising existing medical education fellowships. PMID:21475643

Association between hospital procedure volume and early complications after pacemaker implantation: results from a large, unselected, contemporary cohort of the German nationwide obligatory external quality assurance programme.

PubMed

Nowak, Bernd; Tasche, Karl; Barnewold, Linda; Heller, Günther; Schmidt, Boris; Bordignon, Stefano; Chun, K R Julian; Fürnkranz, Alexander; Mehta, Rajendra H

2015-05-01

Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems. We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84). Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

New developments in functional medical textiles and their mechanism of action

USDA-ARS?s Scientific Manuscript database

Functional medical textiles are undergoing a revolution in structural design. Medical textiles as non-implantables, implantables, and extracorporeals, are playing central roles in healthcare improvements enhancing and prolonging the quality of life. Developments in the design of materials that funct...

[Application of digital design and three-dimensional printing technique on individualized medical treatment].

PubMed

Qin, Mian; Liu, Yaxiong; He, Jiankang; Wang, Ling; Lian, Qin; Li, Dichen; Jin, Zhongmin; He, Sanhu; Li, Gang; Liu, Yanpu; Wang, Zhen

2014-03-01

To summarize the latest research development of the application of digital design and three-dimensional (3-D) printing technique on individualized medical treatment. Recent research data and clinical literature about the application of digital design and 3-D printing technique on individualized medical treatment in Xi'an Jiaotong University and its cooperation unit were summarized, reviewed, and analyzed. Digital design and 3-D printing technique can design and manufacture individualized implant based on the patient's specific disease conditions. And the implant can satisfy the needs of specific shape and function of the patient, reducing dependence on the level of experience required for the doctor. So 3-D printing technique get more and more recognition of the surgeon on the individualized repair of human tissue. Xi'an Jiaotong University is the first unit to develop the commercial 3-D printer and conduct depth research on the design and manufacture of individualized medical implant. And complete technological processes and quality standards of product have been developed. The individualized medical implant manufactured by 3-D printing technique can not only achieve personalized match but also meet the functional requirements and aesthetic requirements of patients. In addition, the individualized medical implant has the advantages of accurate positioning, stable connection, and high strength. So 3-D printing technique has broad prospects in the manufacture and application of individualized implant.

[Applying a teaching programme in community-based medical education].

PubMed

Al-Faisal, W

2006-01-01

A community-based medical education programme at Damascus University was applied in a local setting from 2 to 12 July 2004 to assess the advantages and disadvantages. Three families and 10 medical students participated. The programme included teaching objectives, health education and approaches to application and evaluation. The design of the programme was appropriate for the community setting, but it needed a longer period to run and for contact between the students and the community. The students agreed with the structure of the programme and the role of the tutor and community, but were concerned about difficulties in implementation. Community members were enthusiastic about the programme.

Essential Tremor

MedlinePlus

... individuals. Deep brain stimulation uses a surgically implanted, battery-operated medical device called a neurostimulator to delivery ... individuals. Deep brain stimulation uses a surgically implanted, battery-operated medical device called a neurostimulator to delivery ...

Should an implanted defibrillator be considered in patients with vasospastic angina?

PubMed

Eschalier, Romain; Souteyrand, Géraud; Jean, Frédéric; Roux, Antoine; Combaret, Nicolas; Saludas, Yannick; Clerfond, Guillaume; Barber-Chamoux, Nicolas; Citron, Bernard; Lusson, Jean-René; Brugada, Pedro; Motreff, Pascal

2014-01-01

Vasospastic angina is a frequent and well-recognized pathology with a high risk of life-threatening ventricular arrhythmias and sudden cardiac death. The diagnosis of vasospastic angina requires the combination of clinical and electrocardiographic variables and the results of provocation tests, such as ergonovine administration. Smoking cessation is the first step in the management of vasospastic angina. Optimal medical treatment using calcium-channel blockers and/or nitrate derivatives can provide protection, but life-threatening ventricular arrhythmias may occur despite optimal medical treatment and several years after the start of treatment. In this review, we evaluate the role of implantable defibrillators as a complement to optimal medical management in patients with life-threatening ventricular arrhythmias due to vasospastic angina; this role is not well characterized in the literature or guidelines. We discuss the role of implantable defibrillators in secondary prevention in light of three recent cases managed in our departments and a review of the literature. An implantable defibrillator was implanted in two of the three cases of vasospastic angina with ventricular arrhythmias that we managed. We considered secondary prevention by implantable defibrillator to be justified even in the absence of any obvious risk factor. Ventricular arrhythmias recurred during implantable defibrillator follow-up in the two patients implanted. In patients with life-threatening ventricular arrhythmias due to vasospastic angina, an implantable defibrillator should be considered because of the risk of recurrence despite optimal medical management. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Establishment and implementation of a psychiatry enrichment programme for medical students.

PubMed

Lyons, Zaza

2017-02-01

There has been a growing interest in psychiatry enrichment programmes such as summer schools and institutes for medical students in the last 10 years. Evaluation of enrichment programmes shows that they can be an effective method of increasing students' interest in psychiatry as a career. However, despite initial enthusiasm and motivation within an academic department, establishing a programme can be a daunting task. The aim of this paper is to provide a background of how to establish and implement a psychiatry summer school or institute. The steps that can be taken to establish and implement a psychiatry enrichment programme such as a summer school or institute are described and discussed. This includes how to structure a programme, content to include, costs and budget, programme promotion, selection of students and programme evaluation. Establishing an enrichment programme can provide academic departments of psychiatry with the opportunity to demonstrate excellence and innovation in teaching and positively promote psychiatry to students and other non-medical academics involved in medical education. For students interested in psychiatry, enrichment programmes have the potential to extend interest and knowledge beyond the curriculum and encourage serious consideration of psychiatry as a career.

The value of mentorship in medical education.

PubMed

Dalgaty, Faith; Guthrie, Greg; Walker, Heather; Stirling, Kevin

2017-04-01

The transition from senior medical student to working safely and effectively as a new junior doctor is one of the biggest challenges that a new graduate will face. In 2014 the General Medical Council published The state of medical education and practice in the UK, reporting that some new doctors continue to struggle with increased responsibilities. We classify these instances as a 'performance gap', describing occasions in clinical practice where an individual exceeds their performance capacity. The Medical Mentorship Programme addressed identified performance gaps through a structured curriculum of simulation-based education and facilitated clinical practice. Programme content was based on the experiences of the authors and their peers in graduating from their undergraduate training programme and becoming junior doctors. A questionnaire was disseminated to junior doctors in their first clinical rotation. The questionnaire asked doctors to describe instances where they experienced a performance gap. These data informed the development of the Medical Mentorship Programme. The effect of this programme was then evaluated via focus group discussion. The Medical Mentorship Programme has been shown to be an effective conduit for supporting the transfer of learning needed to address performance gaps in students. The programme increased the confidence of students in preparation for clinical practice and allowed junior doctors to reflect on their professional development. The programme combined complementary teaching techniques - mentorship, simulation and direct clinical experience - to aid the professional development of both students and mentors. Some new doctors continue to struggle with increased responsibilities. © 2016 John Wiley & Sons Ltd.

Dental Implant Surgery

MedlinePlus

... supplements. If you have certain heart conditions or orthopedic implants, your doctor may prescribe antibiotics before surgery ... trademarks of Mayo Foundation for Medical Education and Research. © 1998-2018 Mayo Foundation for Medical Education and ...

Health-related quality of life of medical students in a Brazilian student loan programme.

PubMed

Lins, Liliane; Carvalho, Fernando Martins; Menezes, Marta Silva; Porto-Silva, Larissa; Damasceno, Hannah

2016-08-01

This study aimed to evaluate the health-related quality of life of medical students participating in a large Brazilian government loan programme for undergraduate students in private schools.A cross-sectional study in a stratified sample of students from a private medical school in Salvador, Brazil, evaluated their health-related quality of life by using a Brazilian Portuguese version of the 36-item Short Form Health Survey questionnaire (SF-36).Students supported by the loan programme consistently presented lower mean scores in all SF-36 domains and in the physical and mental component summary scores than those who were not in the programme. Students supported by the loan programme presented systematically lower physical and mental component mean scores, after stratification by age, gender, school year, physical activity, sleepiness, headache, having a car, having a housemaid, living with family, and living in a rented house.The loan programme has enabled less wealthy undergraduate students to attend private medical schools in Brazil. However, this support is insufficient to improve students' health-related quality of life during medical school, as compared with students who do not participate in the programme. Because of a poorer health-related quality of life, students supported by the loan programme deserve special attention from private medical schools.

Diagnostic procedures for catheter malfunction in programmable implantable intraperitoneal insulin infusion devices.

PubMed

Olsen, C L; Turner, D S; Iravani, M; Waxman, K; Selam, J L; Charles, M A

1995-01-01

To evaluate the roles of 1) abdominal radiography, 2) a pressure diagnostic procedure (PDP) using a standardized diluent infusion into the catheter sideport, and 3) radiocontrast imaging of the catheter lumen as procedures for diagnosing catheter malfunction in diabetic patients implanted with a programmable intraperitoneal infusion device. Sixteen type I diabetic patients implanted with Infusaid programmable intraperitoneal insulin pumps were studied. The ability of the above three procedures to assist diagnosis of catheter malfunction and distinguish between occlusion and catheter breakage was retrospectively analyzed. Glycated hemoglobin was measured to determine the clinical importance of catheter malfunctions and decreases in pump flow due to insulin aggregation in the pump chamber. Mean glycated hemoglobin levels increased significantly from 8.0 +/- 0.3 to 9.0 +/- 0.4% (P < 0.05) before and after catheter malfunction, but not during pump flow slowdowns. Mean peak pressure during PDP was 1.96 +/- 0.14 psi (P < 0.01 vs. normal) in reversibly occluded catheters and 1.86 +/- 0.35 psi (P < 0.05 vs. normal) in broken catheters, compared with 1.32 +/- 0.23 psi in normal catheters. Decay times during PDP were > 50 s for both reversibly occluded and broken catheters (P < 0.001 vs. normal of 3.6 +/- 0.82 s). Abdominal radiographs and sideport injections of contrast material were used to distinguish the types of broken catheters. Catheter breakage and occlusion are complications in implantable insulin infusion systems and result in metabolic deterioration. The presence of a sideport allows pressure data and radiographic procedures to assist in determining the cause of catheter malfunction. A diagnostic algorithm was generated to improve efficiency in investigating catheter problems.

78 FR 19271 - Special Fraud Alert: Physician-Owned Entities

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for..., implantable medical devices ordered by their physician-owners for use in procedures the physician-owners... medical device manufacturers and distributors in an October 6, 2006 letter.\\3\\ In that letter, we noted...

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.

Orthopedic implant devices: prevalence and sociodemographic findings from the 1988 National Health Interview Survey.

PubMed

Moore, R M; Hamburger, S; Jeng, L L; Hamilton, P M

1991-01-01

National population-based estimates on the magnitude and distribution of orthopedic implant devices in the United States have not been available to date. The Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) collaborated with the Centers for Disease Control's National Center for Health Statistics (CDC/NCHS) in the design and conduct of a nationwide medical device implant survey to generate the first national population-based prevalence estimates of orthopedic implant devices. A Medical Device Implant Supplement to the 1988 National Health Interview Survey was administered in personal household interviews to a national sample of 47,485 households, which included 122,310 individuals. An estimated 6.5 million orthopedic implants were in use in the general US population in 1988, including 1.6 million artificial joints and 4.9 million fixation devices. As a group, orthopedic implants comprised nearly half of all medical device implants in use, 43.4%. The majority of artificial joint recipients were 65 years of age or older, white, and male. The majority of fixation device recipients were less than 45 years of age, white, and male. The limitations and strengths of these population-based estimates are discussed.

Prosthetically directed implant placement using computer software to ensure precise placement and predictable prosthetic outcomes. Part 2: rapid-prototype medical modeling and stereolithographic drilling guides requiring bone exposure.

PubMed

Rosenfeld, Alan L; Mandelaris, George A; Tardieu, Philippe B

2006-08-01

The purpose of this paper is to expand on part 1 of this series (published in the previous issue) regarding the emerging future of computer-guided implant dentistry. This article will introduce the concept of rapid-prototype medical modeling as well as describe the utilization and fabrication of computer-generated surgical drilling guides used during implant surgery. The placement of dental implants has traditionally been an intuitive process, whereby the surgeon relies on mental navigation to achieve optimal implant positioning. Through rapid-prototype medical modeling and the ste-reolithographic process, surgical drilling guides (eg, SurgiGuide) can be created. These guides are generated from a surgical implant plan created with a computer software system that incorporates all relevant prosthetic information from which the surgical plan is developed. The utilization of computer-generated planning and stereolithographically generated surgical drilling guides embraces the concept of collaborative accountability and supersedes traditional mental navigation on all levels of implant therapy.

Initial Clinical Experience with Ahmed Valve Implantation in Refractory Pediatric Glaucoma

PubMed

Novak-Lauš, Katia; Škunca Herman, Jelena; Šimić Prskalo, Marija; Jurišić, Darija; Mandić, Zdravko

2016-12-01

The purpose is to report on the safety and efficacy of Ahmed Glaucoma Valve (AGV, New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation for the management of refractory pediatric glaucoma observed during one-year follow up period. A retrospective chart review was conducted on 10 eyes, all younger than 11 years, with pediatric glaucoma that underwent AGV implantation for medicamentously uncontrolled intraocular pressure (IOP) between 2010 and 2014. Outcome measures were control of IOP below 23 mm Hg (with or without antiglaucoma medications) and changes in visual acuity. Complications were recorded. After AGV implantation, IOP values ranged from 18 mm Hg to 23 mm Hg (except for one eye with postoperative hypotonia due to suprachoroid hemorrhage, where the postoperative IOP value was 4 mm Hg). The number of antiglaucoma medications was reduced, i.e. four patients had two medications, one patient had one medication, and the others did not need antiglaucoma medication on the last follow-up visit. One eye had suprachoroid hemorrhage, one eye had long-term persistent uveitic membrane, and two eyes had tube-cornea touch. In conclusion, AGV implantation appears to be a viable option for the management of refractory pediatric glaucoma and shows success in IOP control. However, there was a relatively high complication rate limiting the overall success rate.

A media player causes clinically significant telemetry interference with implantable loop recorders.

PubMed

Thaker, Jay P; Patel, Mehul B; Shah, Ashok J; Liepa, Valdis V; Jongnarangsin, Krit; Thakur, Ranjan K

2009-03-01

The implantable loop recorder is a useful diagnostic tool for intermittent cardiovascular symptoms because it can automatically record arrhythmias as well as a patient-triggered ECG. Media players have been shown to cause telemetry interference with pacemakers. Telemetry interference may be important in patients with implantable loop recorders because capturing a patient-triggered ECG requires a telemetry link between a hand-held activator and the implanted device. The purpose of this study was to determine if a media player causes interference with implantable loop recorders. Fourteen patients with implantable loop recorders underwent evaluation for interference with a 15 GB third generation iPod (Apple, Inc.) media player. All patients had the Reveal Plus (Medtronic, Inc.) implantable loop recorder. We tested for telemetry interference on the programmer by first establishing a telemetry link with the loop recorder and then, the media player was placed next to it, first turned off and then, on. We evaluated for telemetry interference between the activator and the implanted device by placing the activator over the device (normal use) and the media player next to it, first turned off and then, on. We made 5 attempts to capture a patient-triggered ECG by depressing the activator switch 5 times while the media player was off or on. Telemetry interference on the programmer screen, consisting of either high frequency spikes or blanking of the ECG channel was seen in all patients. Telemetry interference with the activator resulted in failure to capture an event in 7 patients. In one of these patients, a green indicator light on the activator suggested that a patient-triggered event was captured, but loop recorder interrogation did not show a captured event. In the remaining 7 patients, an event was captured and appropriately recognized by the device at least 1 out of 5 times. A media player playing in close proximity to an implanted loop recorder may interfere with capture of a patient-triggered event. Patients should be advised to keep media players away from their implanted loop recorder.

Capacitive Feedthroughs for Medical Implants

PubMed Central

Grob, Sven; Tass, Peter A.; Hauptmann, Christian

2016-01-01

Important technological advances in the last decades paved the road to a great success story for electrically stimulating medical implants, including cochlear implants or implants for deep brain stimulation. However, there are still many challenges in reducing side effects and improving functionality and comfort for the patient. Two of the main challenges are the wish for smaller implants on one hand, and the demand for more stimulation channels on the other hand. But these two aims lead to a conflict of interests. This paper presents a novel design for an electrical feedthrough, the so called capacitive feedthrough, which allows both reducing the size, and increasing the number of included channels. Capacitive feedthroughs combine the functionality of a coupling capacitor and an electrical feedthrough within one and the same structure. The paper also discusses the progress and the challenges of the first produced demonstrators. The concept bears a high potential in improving current feedthrough technology, and could be applied on all kinds of electrical medical implants, even if its implementation might be challenging. PMID:27660602

Capacitive Feedthroughs for Medical Implants.

PubMed

Grob, Sven; Tass, Peter A; Hauptmann, Christian

2016-01-01

Important technological advances in the last decades paved the road to a great success story for electrically stimulating medical implants, including cochlear implants or implants for deep brain stimulation. However, there are still many challenges in reducing side effects and improving functionality and comfort for the patient. Two of the main challenges are the wish for smaller implants on one hand, and the demand for more stimulation channels on the other hand. But these two aims lead to a conflict of interests. This paper presents a novel design for an electrical feedthrough, the so called capacitive feedthrough, which allows both reducing the size, and increasing the number of included channels. Capacitive feedthroughs combine the functionality of a coupling capacitor and an electrical feedthrough within one and the same structure. The paper also discusses the progress and the challenges of the first produced demonstrators. The concept bears a high potential in improving current feedthrough technology, and could be applied on all kinds of electrical medical implants, even if its implementation might be challenging.

[Health behavior of medical students. Introduction of mental hygienic skills in the medical education in Hungary].

PubMed

Rosta, Eszter; Almási, Zsuzsanna; Karácsony, István; Konkolÿ Thege, Barna; Hegedűs, Katalin

2012-07-22

HuMania Training Programme is a voluntary peer training course. to measure the efficiency of HuMania Training Programme and to analyse social relations of medical students. WHO Well-being Index, Bergen Social Relationship Scale, Lazarus's Ways of Coping Questionnaire and the Maslach Burnout Inventory for undergraduate students were used. The results of HuMania Training Programme established in 2009 were compared with those obtained from controls and HuMania Training Programme of the forthcoming year. At the beginning, participants of the HuMania Training Programme had fewer well-being scores (p = 0.01), whereas their social anxiety (p = 0.01) and emotion-based coping (p = 0.05) were greater as compared to controls. After the HuMania Training Programme course, well-being showed an increasing tendency (p = 0.072), and burnout-level decreased (p = 0.040). Fifty percent of medical students had a minimum of three stressors, and 57% of them said that there was a person in their environment, who needed help, but they cannot provide it. Medical students display poor mental hygienic state. and HuMania Training Programme tries to fight this situation.

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.

Towards a Better Corrosion Resistance and Biocompatibility Improvement of Nitinol Medical Devices

NASA Astrophysics Data System (ADS)

Rokicki, Ryszard; Hryniewicz, Tadeusz; Pulletikurthi, Chandan; Rokosz, Krzysztof; Munroe, Norman

2015-04-01

Haemocompatibility of Nitinol implantable devices and their corrosion resistance as well as resistance to fracture are very important features of advanced medical implants. The authors of the paper present some novel methods capable to improve Nitinol implantable devices to some marked degree beyond currently used electropolishing (EP) processes. Instead, a magnetoelectropolishing process should be advised. The polarization study shows that magnetoelectropolished Nitinol surface is more corrosion resistant than that obtained after a standard EP and has a unique ability to repassivate the surface. Currently used sterilization processes of Nitinol implantable devices can dramatically change physicochemical properties of medical device and by this influence its biocompatibility. The Authors' experimental results clearly show the way to improve biocompatibility of NiTi alloy surface. The final sodium hypochlorite treatment should replace currently used Nitinol implantable devices sterilization methods which rationale was also given in our previous study.

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.

Power Approaches for Implantable Medical Devices.

PubMed

Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

2015-11-13

Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

Effectiveness of a computer based medication calculation education and testing programme for nurses.

PubMed

Sherriff, Karen; Burston, Sarah; Wallis, Marianne

2012-01-01

The aim of the study was to evaluate the effect of an on-line, medication calculation education and testing programme. The outcome measures were medication calculation proficiency and self efficacy. This quasi-experimental study involved the administration of questionnaires before and after nurses completed annual medication calculation testing. The study was conducted in two hospitals in south-east Queensland, Australia, which provide a variety of clinical services including obstetrics, paediatrics, ambulatory, mental health, acute and critical care and community services. Participants were registered nurses (RNs) and enrolled nurses with a medication endorsement (EN(Med)) working as clinicians (n=107). Data pertaining to success rate, number of test attempts, self-efficacy, medication calculation error rates and nurses' satisfaction with the programme were collected. Medication calculation scores at first test attempt showed improvement following one year of access to the programme. Two of the self-efficacy subscales improved over time and nurses reported satisfaction with the online programme. Results of this study may facilitate the continuation and expansion of medication calculation and administration education to improve nursing knowledge, inform practise and directly improve patient safety. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

A review of nanostructured surfaces and materials for dental implants: surface coating, patterning and functionalization for improved performance.

PubMed

Rasouli, Rahimeh; Barhoum, Ahmed; Uludag, Hasan

2018-05-10

The emerging field of nanostructured implants has enormous scope in the areas of medical science and dental implants. Surface nanofeatures provide significant potential solutions to medical problems by the introduction of better biomaterials, improved implant design, and surface engineering techniques such as coating, patterning, functionalization and molecular grafting at the nanoscale. This review is of an interdisciplinary nature, addressing the history and development of dental implants and the emerging area of nanotechnology in dental implants. After a brief introduction to nanotechnology in dental implants and the main classes of dental implants, an overview of different types of nanomaterials (i.e. metals, metal oxides, ceramics, polymers and hydrides) used in dental implant together with their unique properties, the influence of elemental compositions, and surface morphologies and possible applications are presented from a chemical point of view. In the core of this review, the dental implant materials, physical and chemical fabrication techniques and the role of nanotechnology in achieving ideal dental implants have been discussed. Finally, the critical parameters in dental implant design and available data on the current dental implant surfaces that use nanotopography in clinical dentistry have been discussed.

A software upgrade method for micro-electronics medical implants.

PubMed

Cao, Yang; Hao, Hongwei; Xue, Lin; Li, Luming; Ma, Bozhi

2006-01-01

A software upgrade method for micro-electronics medical implants is designed to enhance the devices' function or renew the software if there are some bugs found, the software updating or some memory units disabled. The implants needn't be replaced by operations if the faults can be corrected through reprogramming, which reduces the patients' pain and improves the safety effectively. This paper introduces the software upgrade method using in-application programming (IAP) and emphasizes how to insure the system, especially the implanted part's reliability and stability while upgrading.

Electrically induced energy transmission used for implantable medical devices deep inside the body: Measurement of received voltage in consideration of biological effect.

PubMed

Shiba, Kenji

2015-08-01

We proposed an electrically induced energy transmission method for implantable medical devices deep inside the body. This method makes it possible to transmit energy deep inside the body using only a couple of titanium electrodes attached to the surface of the implantable medical device. In this study, electromagnetic simulations in which the area and distance of the receiving electrodes were changed were conducted. Then, experimental measurements of the received voltage were conducted in which electric energy was transmitted from the surface of the human phantom to an implantable device inside it (transmitting distance: 12 cm). As a result of the electromagnetic simulation, the area and distance of the receiving electrodes were roughly proportional to the received voltage, respectively. As a result of the experimental measurement, a received voltage of 2460 mV could be obtained with a load resistance of 100 Ω. We confirmed that our energy transmission method could be a powerful method for transmitting energy to a deeply implanted medical device.

Bacterial colonization of the implant-abutment interface of conical connection with an internal octagon: an in vitro study using real-time PCR.

PubMed

Baj, A; Beltramini, G A; Bolzoni, A; Cura, F; Palmieri, A; Scarano, A; Ottria, L; Giannì, A B

2017-01-01

Bacterial leakage at the implant-abutment connection of a two-piece implant system is considered the main cause of peri-implantitis. Prevention of bacterial leakage at the implant-abutment connection is mandatory for reducing inflammation process around implant neck and achieving bone stability. Micro-cavities at implant-abutment connection level can favour bacterial leakage, even in modern two-piece implant systems. The conical connection with an internal octagon (CCIO) is considered to be more stable mechanically and allows a more tight link between implant and abutment. As P. gingivalis and T. forsythia penetration might have clinical relevance, it was the purpose of this investigation to evaluate molecular leakage of these two bacteria in a new two-implant system with an internal conical implant-abutment connection with internal octagon (Shiner XT, FMD Falappa Medical Devices S.p.A. Rome, Italy). To verify the ability of the implant in protecting the internal space from the external environment, the passage of genetically modified Escherichia c oli across implant-abutment interface was evaluated. Four Shiner XT implants (FMD, Falappa Medical Devices®, Rome, Italy) were immerged in a bacterial culture for 24 h and bacteria amount was measured inside implant-abutment interface with Real-time PCR. Bacteria were detected inside all studied implants, with a median percentage of 6% for P. gingivalis and 5% for T. forsythia. Other comparable studies about the tightness of the tested implant system reported similar results. The gap size at the implant-abutment connection of CCIOs was measured by other authors discovering a gap size of 1–2μm of the AstraTech system and of 4μm for the Ankylos system. Bacterial leakage along implant-abutment connection of cylindrical and tapered implants, Shiner XT, (FMD Falappa Medical Devices S.p.A. Rome, Italy) showed better results compared to other implants. Additional studies are needed to explore the relationship in terms of microbiota of the CCIO. In addition, the dynamics of internal colonization needs to be thoroughly documented in longitudinal in vivo studies.

[Medical rehabilitation group-programmes concerning health promotion, patient education and psychoeducation - a 2010 national survey].

PubMed

Reusch, A; Schug, M; Küffner, R; Vogel, H; Faller, H

2013-08-01

High quality demands are being placed on concepts of educational group programmes in medical rehabilitation as well as the related trainer qualifications. A nationwide survey of German medical rehabilitation clinics in 2005 had revealed a need for improving educational practice according to these quality criteria. An updated investigation was performed in 2010 aiming at describing group programmes used in medical rehabilitation. 1 473 inpatient and outpatient medical rehabilitation clinics were invited to participate. 908 clinics reported on their training programmes. Data from clinics caring for patients with somatic disorders could be compared to the 2005 survey. Data from clinics for both psychosomatic and substance abuse disorders was collected for the first time in 2010. Overall, psychologists and physicians were reported to be the most frequent conductors of educative programmes. In somatic clinics, psychologists, dieticians and occupational therapists or physiotherapists were the most common conductors. Two-thirds of the institutions reported no training prerequisites for staff members to perform patient education. 80% of the education programmes were categorized post hoc into 3 classes: "generic health education", "disorder-specific patient education", and "psychoeducational group programmes". Almost two-thirds of all programmes were carried out with 8-15 participants, and many used several interactive didactic methods. Programmes conducted in small groups (<8 participants) used significantly more interactive methods than those conducted in larger groups did (>15 participants). Only half of the programmes were manualized. Significantly more interactive methods were used in completely manualized programmes. Only about half of the programmes were evaluated, and only very few evaluation studies were published. The institutions wished additional support by workshops especially concerning qualification of their staff and concerning educational concepts. A need for further improvement and support exists relative to the training of educators and the development of manuals as well as evaluation and publication of the programmes. © Georg Thieme Verlag KG Stuttgart · New York.

Goserelin Implant

MedlinePlus

Goserelin implant is used in combination with radiation therapy and other medications to treat localized prostate cancer ... and other symptoms) and to help with the treatment of abnormal bleeding of the uterus. Goserelin implant ...

Virtual Humans for Implantable Device Safety Assessment in MRI: Mitigating Magnetic Resonance Imaging Hazards for Implanted Medical Devices.

PubMed

Brown, James E; Qiang, Rui; Stadnik, Paul J; Stotts, Larry J; Von Arx, Jeffrey A

2017-01-01

Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation [1]. In recent years, AIMD manufacturers, such as Biotronik, have assessed the conditional safety of devices in MRI.

Finding glenoid surface on scapula in 3D medical images for shoulder joint implant operation planning: 3D OCR

NASA Astrophysics Data System (ADS)

Mohammad Sadeghi, Majid; Kececi, Emin Faruk; Bilsel, Kerem; Aralasmak, Ayse

2017-03-01

Medical imaging has great importance in earlier detection, better treatment and follow-up of diseases. 3D Medical image analysis with CT Scan and MRI images has also been used to aid surgeries by enabling patient specific implant fabrication, where having a precise three dimensional model of associated body parts is essential. In this paper, a 3D image processing methodology for finding the plane on which the glenoid surface has a maximum surface area is proposed. Finding this surface is the first step in designing patient specific shoulder joint implant.

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

Flexible-Device Injector with a Microflap Array for Subcutaneously Implanting Flexible Medical Electronics.

PubMed

Song, Kwangsun; Kim, Juho; Cho, Sungbum; Kim, Namyun; Jung, Dongwuk; Choo, Hyuck; Lee, Jongho

2018-06-25

Implantable electronics in soft and flexible forms can reduce undesired outcomes such as irritations and chronic damages to surrounding biological tissues due to the improved mechanical compatibility with soft tissues. However, the same mechanical flexibility also makes it difficult to insert such implants through the skin because of reduced stiffness. In this paper, a flexible-device injector that enables the subcutaneous implantation of flexible medical electronics is reported. The injector consists of a customized blade at the tip and a microflap array which holds the flexible implant while the injector penetrates through soft tissues. The microflap array eliminates the need of additional materials such as adhesives that require an extended period to release a flexible medical electronic implant from an injector inside the skin. The mechanical properties of the injection system during the insertion process are experimentally characterized, and the injection of a flexible optical pulse sensor and electrocardiogram sensor is successfully demonstrated in vivo in live pig animal models to establish the practical feasibility of the concept. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant.

PubMed

Ali, Moazzam; Akin, Ayse; Bahamondes, Luis; Brache, Vivian; Habib, Ndema; Landoulsi, Sihem; Hubacher, David

2016-11-01

Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5-6.5]. Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. The trial was registered as ISRCTN33378571. The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

Post-graduate education for medical specialists focused on patients with medically unexplained physical symptoms; development of a communication skills training programme.

PubMed

Weiland, Anne; Blankenstein, Annette H; Willems, Mariëtte H A; Van Saase, Jan L C M; Van der Molen, Henk T; Van Dulmen, Alexandra M; Arends, Lidia R

2013-09-01

Stepwise description of the development of a post-graduate communication skills training programme for medical specialists focused on patients with medically unexplained physical symptoms (MUPS) to improve specialist interaction with MUPS patients. Using the 'intervention mapping approach' we accomplished a needs assessment (literature study and pilot) to formulate intervention objectives and identify methods and techniques for a MUPS-focused communication skills training programme for medical specialists. A 14-h training programme which consists of experiential learning, role-play and feedback. Using skills from Cognitive Behavioural Therapy, medical specialists are stimulated to explore interrelating factors that reinforce symptoms, to reassure patients effectively and to provide plausible and understandable explanations for MUPS. Dealing with complex referrals and informing GPs properly are also practiced. By applying the 'intervention mapping approach' we were able to create a feasible and promising intervention to improve specialist interaction with MUPS patients. Intervention effects are currently being assessed in a randomized controlled trial. If the RCT demonstrates sufficient effectiveness and efficiency of the MUPS focused communication skills training programme for medical specialists the intervention could be embedded in post-graduate education of medical specialists and residents. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 886.3340 - Extraocular orbital implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment...

What's new in graduate medical education?

PubMed

Hernandez, Raquel G

2016-12-01

The development of new graduate medical education programmes provides both opportunities and challenges. Efforts to address physician workforce shortages as well as a realisation that curricula need to be updated to adjust to our rapidly changing healthcare environment have resulted in more educators considering the "how to" and "what's new" of programme development. Understanding the Next Accreditation System, an accreditation system introduced by the Accreditation Council of Graduate Medical Education in 2012, is critical to the success of new as well as existing residency and fellowship programmes. Although many educators are aware of the general rational for the Next Accreditation System, an in-depth understanding of the meaning of Next Accreditation System is necessary from an experiential and theoretical perspective to be able to successfully launch new programmes and moves towards accreditation. A new paediatric categorical residency programme and a new paediatric surgical programme were developed at our institution immediately following the implementation of Next Accreditation System. We provide a series of insights and perspectives based on our experience relative to what priorities we saw outlined from both the programmatic and the institutional perspective to have our graduate medical education programmes reviewed for accreditation. During this discussion, the following objectives are outlined: to overview the Next Accreditation System as a framework and priorities, to discuss the opportunities and challenges that may exist in developing new programmes, and to discuss future directions in the evaluation of trainees and assessment of training competency. Although challenges are outlined, we hope to relay the continued excitement and opportunities that exist relative to enhancing training curricula for future graduate medical education programme builders.

Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma.

PubMed

Yadgarov, Arkadiy; Liu, Dan; Crane, Elliot S; Khouri, Albert S

2017-01-01

To describe postoperative surgical success of either Ahmed or Baerveldt tube shunt implantation for eyes with medically uncontrolled traumatic glaucoma. A review was carried out to identify patients with traumatic glaucoma that required tube shunt implantation between 2009 and 2015 at Rutgers University in Newark, New Jersey, USA. Seventeen eyes from 17 patients met inclusion criteria, including at least 3-month postoperative follow-up. The main outcome measure was surgical success at 1-year follow-up after tube implantation. Mean preoperative intraocular pressure (IOP) was 34.1 ± 8.2 mm Hg on 3.1 ± 1.6 ocular hypotensive medications. Nine eyes (53%) sustained closed globe injury. Ten eyes (59%) received an Ahmed valve shunt and seven eyes (41%) received a Baerveldt tube shunt. Surgical success rate at 1 year postoperatively was 83%. Compared to preoperative, the mean postoperative IOP was significantly lower (16.1 ± 3.5 mm Hg, p < 0.001) on significantly fewer ocular hypertensive medications (1.3 ± 1.6, p = 0.001) at a mean follow-up of 10 months. Mean IOP reduction at last follow-up was 49%. There were three cases of surgical failures: One case of hypotony, one case of tube extrusion with subsequent explan-tation, and one case requiring second tube insertion for IOP control. Implantation of an Ahmed or Baerveldt tube shunt provided successful control of IOP in patients with medically uncontrollable traumatic glaucoma. Yadgarov A, Liu D, Crane ES, Khouri AS. Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma. J Curr Glaucoma Pract 2017;11(1):16-21.

Performance of a radio link between a base station and a medical implant utilising the MICS standard.

PubMed

Johansson, Anders J

2004-01-01

Modern medical implants are of increasing complexity and with that, the need for fast and flexible communication with them grows. A wireless system is preferable and an inductive link is the most commonly used. But it has the drawback of a very short range, essentially limited to having the external transceiver touching the patient. The Medical Implant Communication System, MICS, is a standard aimed at improving the communication distance. It operates at a higher frequency band between 402 MHz and 405 MHz. We have by simulations and measurements investigated the channel properties of this band and calculated the link performance for a typical implant application. The result is a link speed between a base station and a bedridden patient of 600 kbit bits per second with a bit error rate of 2% in the downlink to the implant and 1 % in the uplink to the base station. Conclusions on the necessary complexity of the base station are also given.

Implant healing in experimental animal models of diabetes.

PubMed

Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

2011-05-01

Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that influence wound healing and infection in diabetic patients, to review research concerning diabetes and biomedical implants and device infection, and to critically analyze which diabetic animal model might be advantageous for assessing internal healing adjacent to implanted devices. © 2011 Diabetes Technology Society.

Implant Healing in Experimental Animal Models of Diabetes

PubMed Central

Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

2011-01-01

Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that influence wound healing and infection in diabetic patients, to review research concerning diabetes and biomedical implants and device infection, and to critically analyze which diabetic animal model might be advantageous for assessing internal healing adjacent to implanted devices. PMID:21722576

Predictors of long-term compliance in attending a worksite hypertension programme.

PubMed

Landers, R; Riccobene, A; Beyreuther, M; Neusy, A J

1993-12-01

Variables such as patient's anxiety, knowledge, number of medication changes, medication-induced side-effects and programme-derived benefits and conveniences have been reported or theorised to be important determinants of patient's attendance at worksite hypertension programmes. This study investigates whether these variables have predictive value in differentiating compliers from noncompliers attending a union-sponsored worksite hypertension programme for at least five years. Scores were created from a questionnaire distributed to 243 patients with a response rate of 98%. Compliance was defined as missing < or = 25% of scheduled clinic appointments. By discriminant statistical analysis scores for patient's anxiety, knowledge, number of medication changes, medication side-effects, perceived benefits and conveniences failed to show any predictive value for patient's compliance with appointment keeping.

Formal mentoring programmes for medical students and doctors--a review of the Medline literature.

PubMed

Buddeberg-Fischer, Barbara; Herta, Katja-Daniela

2006-05-01

Mentoring programmes have been implemented as a specific career-advancement tool in the training and further education of various groups in the medical profession. The main focus of our investigation was to examine what types of structured mentoring programmes exist for doctors as well as for medical students, what short- and long-term goals these projects pursue, and whether statements can be made on the effectiveness and efficiency of these programmes. A literature-search strategy was applied to Medline for 1966-2002 using the keyword combinations: (a) mentor* [AND] program* [AND] medical students, and (b) mentor* [AND] program* [AND] physicians. Although a total of 162 publications were identified, only 16 papers (nine for medical students and seven for doctors) met the selected methodological criteria. The majority of the programmes lack a concrete structure as well as a short- and long-term evaluation. Main goals are to increase professional competence in research and in further specialization and to build up a professional network for the mentees; no statements are to be found on the advantages for the mentors. Programme evaluation is for the most part presented descriptively in terms of great interest and high level of satisfaction. No publication contains statements on the effectiveness or the efficiency of the programme. Although the results of mentoring are promising, more formal programmes with clear setup goals and a short- and long-term evaluation of the individual successes of the participants as well as the cost-benefit analysis are needed.

Carbon offers advantages as implant material in human body

NASA Technical Reports Server (NTRS)

Benson, J.

1969-01-01

Because of such characteristics as high strength and long-term biocompatability, aerospace carbonaceous materials may be used as surgical implants to correct pathological conditions in the body resulting from disease or injury. Examples of possible medical uses include bone replacement, implantation splints and circulatory bypass implants.

Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma.

PubMed

Ko, Sung Ju; Hwang, Young Hoon; Ahn, Sang Il; Kim, Hwang Ki

2016-06-01

To evaluate the surgical outcomes of the implantation of an additional Ahmed glaucoma valve (AGV) into the eyes of patients with refractory glaucoma following previous AGV implantation. This study is a retrospective review of the clinical histories of 23 patients who had undergone a second AGV implantation after a failed initial implantation. Age, sex, prior surgery, glaucoma type, number of medications, intraocular pressure (IOP), visual acuity, and surgical complications were analyzed. Surgical success was defined as IOP maintained below 21 mm Hg, with at least a 20% overall reduction in IOP, regardless of the use of IOP-lowering medications. Following the implantation of a second AGV, the mean IOP decreased from 39.3 to 18.5 mm Hg (52.9% reduction, P<0.001). The mean number of postoperative IOP-lowering medications administered decreased from 2.8 to 1.7 after the second AGV implantation (P<0.001). The cumulative probability of success for the procedure was 87% after 1 year and 52% after 3 years. Three patients (13.0%) experienced bullous keratopathy after the second AGV implantation. None of the patients showed any evidence of diplopia or ocular movement limitation as a result of the presence of 2 AGVs in the same eye. Prior trabeculectomy was found to be a significant risk factor for failure (P=0.027). A second AGV implantation can be a good choice of surgical treatment when the first AGV has failed to control IOP.

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority.

PubMed

Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

2015-01-01

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority

PubMed Central

Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

2015-01-01

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel. PMID:26543648

The combined medical/PhD degree: a global survey of physician-scientist training programmes.

PubMed

Alamri, Yassar

2016-06-01

Typically lasting 7-9 years, medical-scientist training programmes (MSTPs) allow students a unique opportunity to simultaneously intercalate medical (MBBS, MBChB or MD) and research (PhD) degrees. The nature of both degrees means that the combined programme is arduous, and selection is often restricted to a few highly motivated students. Despite the many successes of MSTPs, enthusiasm about MSTPs and the number of intercalating students, at least in some countries, appear to be diminishing. In this review, I shed light on MSTPs around the world, highlight the plethora of successes such programmes have had and provide insights on the setbacks experienced and solutions offered, with the aim of reigniting interest in these programmes. © 2016 Royal College of Physicians.

Novel Biomaterials Used in Medical 3D Printing Techniques.

PubMed

Tappa, Karthik; Jammalamadaka, Udayabhanu

2018-02-07

The success of an implant depends on the type of biomaterial used for its fabrication. An ideal implant material should be biocompatible, inert, mechanically durable, and easily moldable. The ability to build patient specific implants incorporated with bioactive drugs, cells, and proteins has made 3D printing technology revolutionary in medical and pharmaceutical fields. A vast variety of biomaterials are currently being used in medical 3D printing, including metals, ceramics, polymers, and composites. With continuous research and progress in biomaterials used in 3D printing, there has been a rapid growth in applications of 3D printing in manufacturing customized implants, prostheses, drug delivery devices, and 3D scaffolds for tissue engineering and regenerative medicine. The current review focuses on the novel biomaterials used in variety of 3D printing technologies for clinical applications. Most common types of medical 3D printing technologies, including fused deposition modeling, extrusion based bioprinting, inkjet, and polyjet printing techniques, their clinical applications, different types of biomaterials currently used by researchers, and key limitations are discussed in detail.

Power Approaches for Implantable Medical Devices

PubMed Central

Ben Amar, Achraf; Kouki, Ammar B.; Cao, Hung

2015-01-01

Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

[Fax Survey to Elucidate the Information Needs of General Practitioners in Lower Saxony Regarding the Topic of Medical Implants].

PubMed

Schaper, M; Berndt, M; Schrimpf, C; Wilhelmi, M; Elff, M; Haverich, A; Wilhelmi, M

2016-12-01

Background: Medial implants help a multitude of patients to gain more health, mobility and thus, quality of life. In collaboration with a still growing expectation of life especially, i.e., within Western industrial countries, this has led to an increasing use of implants over the last years. However, although biomechanical characteristics of modern implant materials have improved considerably, one big challenge still exists - the implant-associated infection. Early diagnostic and therapeutic interventions could clearly mitigate this issue, but are general practitioners sufficiently informed regarding this topic? Material and Methods: In March 2013 and in close cooperation with the Lower Saxony association of general practitioners, we initiated a survey to elucidate the information demands of general practitioners regarding the topic of medical implants. A total of 939 members of the association were contacted via fax and 101 (10.8 %) responded. Based on the obtained data, we then evaluated which topics are most interesting for this group of medical professionals. Results: The survey clearly indicates that general practitioners request more general implant-related data, e.g., type and specification of an implant as well as its location within the individual patient and contact addresses of the implanting hospital, but also want more specific information regarding diagnostic and therapeutic strategies in the case of implant-associated complications. Conclusion: The present article reports in detail on the conducted fax survey and shows some initial strategies as to how the identified challenges might be faced. Georg Thieme Verlag KG Stuttgart · New York.

The power of sound: miniaturized medical implants with ultrasonic links

NASA Astrophysics Data System (ADS)

Wang, Max L.; Chang, Ting Chia; Charthad, Jayant; Weber, Marcus J.; Arbabian, Amin

2017-05-01

Miniaturized wirelessly powered implants capable of operating and communicating deep in the body are necessary for the next-generation of diagnostics and therapeutics. A major challenge in developing these minimally invasive implants is the tradeoff between device size, functionality, and operating depth. Here, we review two different wireless powering methods, inductive and ultrasonic power transfer, examine how to analyze their power transfer efficiency, and evaluate their potential for powering implantable medical devices. In particular, we show how ultrasonic wireless power transfer can address these challenges due to its safety, low attenuation, and millimeter wavelengths in the body. Finally, we demonstrate two ultrasonically powered implants capable of active power harvesting and bidirectional communication for closed-loop operation while functioning through multiple centimeters of tissue.

Building capacity for medical education research in family medicine: the Program for Innovation in Medical Education (PIME).

PubMed

Archibald, Douglas; Hogg, William; Lemelin, Jacques; Dahrouge, Simone; St Jean, Mireille; Boucher, François

2017-10-23

Despite the apparent benefits to teaching, many faculty members are reluctant to participate in medical education research (MER) for a variety of reasons. In addition to the further demand on their time, physicians often lack the confidence to initiate MER projects and require more support in the form of funding, structure and guidance. These obstacles have contributed to a decline in physician participation in MER as well as to a perceived decay in its quality. As a countermeasure to encourage physicians to undertake research, the Department of Family Medicine at the University of Ottawa implemented a programme in which physicians receive the funding, coaching and support staff necessary to complete a 2-year research project. The programme is intended primarily for first-time researchers and is meant to serve as a gateway to a research career funded by external grants. Since its inception in 2010, the Program for Innovation in Medical Education (PIME) has supported 16 new clinician investigators across 14 projects. We performed a programme evaluation 3 years after the programme launched to assess its utility to participants. This evaluation employed semi-structured interviews with physicians who performed a research project within the programme. Programme participants stated that their confidence in conducting research had improved and that they felt well supported throughout their project. They appreciated the collaborative nature of the programme and remarked that it had improved their willingness to solicit the expertise of others. Finally, the programme allowed participants to develop in the scholarly role expected by family physicians in Canada. The PIME may serve as a helpful model for institutions seeking to engage faculty physicians in Medical Education Research and to thereby enhance the teaching received by their medical learners.

Near-Field Inductive-Coupling Link to Power a Three-Dimensional Millimeter-Size Antenna for Brain Implantable Medical Devices.

PubMed

Manoufali, Mohamed; Bialkowski, Konstanty; Mohammed, Beadaa Jasem; Mills, Paul C; Abbosh, Amin

2018-01-01

Near-field inductive-coupling link can establish a reliable power source to a batteryless implantable medical device based on Faraday's law of induction. In this paper, the design, modeling, and experimental verification of an inductive-coupling link between an off-body loop antenna and a 0.9  three-dimensional (3-D) bowtie brain implantable antenna is presented. To ensure reliability of the design, the implantable antenna is embedded in the cerebral spinal fluid of a realistic human head model. Exposure, temperature, and propagation simulations of the near electromagnetic fields in a frequency-dispersive head model were carried out to comply with the IEEE safety standards. Concertedly, a fabrication process for the implantable antenna is proposed, which can be extended to devise and miniaturize different 3-D geometric shapes. The performance of the proposed inductive link was tested in a biological environment; in vitro measurements of the fabricated prototypes were carried in a pig's head and piglet. The measurements of the link gain demonstrated   in the pig's head and   in piglet. The in vitro measurement results showed that the proposed 3-D implantable antenna is suitable for integration with a miniaturized batteryless brain implantable medical device (BIMD).

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

The manufacturing of TiAl6V4 implants using selective laser melting technology

NASA Astrophysics Data System (ADS)

Lykov, P. A.; Baitimerov, R. M.; Panfilov, A. V.; Guz, A. O.

2017-10-01

In this article we study the technique for creating medical implants using additive technologies. A plastic skull model was made. The affected part of the skull was identified and removed. An implant was made of titanium alloy. The implant was installed in the model skull.

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.

Use of subdermal contraceptive implants in a community-based family planning program. Experience after two years.

PubMed

Mittelmark, M B; Hansen, W B; Shiferaw, B; Bradham, D D

1995-10-01

In North Carolina, the Rutherford County Family Planning Council obtained funds from a special grant for levonorgestrel implants for women not eligible for medical assistance benefits. The Council approved the following approaches to promoting responsible sexual behavior and preventing unwanted pregnancy: creation of an interagency council to monitor the program, education in the schools on responsible sexual behavior, establishment of an information-sharing network for social service agencies, and expanded, low-cost or free family planning services. During 1992-1993, clinicians at the county health department and in private practices inserted implants in 287 women aged 13-37 living mainly in Rutherford County but also in McDowell and Polk counties. A survey was also conducted in the public high school to obtain self-assessment and information about family planning from female adolescents. Age distribution of the acceptors of the contraceptive implants was 40% for 13-19 year olds (the initiative's target group), 34% for 21-25 year olds, and 32% for 18-20 year olds (32%). The two-year insertion rate for women aged 10-19 was 17.3/1000 compared to 20.8/1000 for women aged 20-29. The implantation rate was greatest among 18-25 year olds and lowest among women aged 26 and older. The method of payment for implantation was medical assistance in 69% of cases and a philanthropic foundation for women not eligible for medical assistance in 29% of cases. 8% had the implants removed during the study period. The leading reason for removal was psychological distress (25%), followed by headaches (20.8%), desire to conceive (16.7%), bleeding (12.5%), and medical contraindication (12.5%). The interval between implantation and removal ranged from less than 3 months to more than 12 months. 2.3% of the female high school students used implants. Among the 596 students who were sexually active, 4.2% used implants, 1.85% used a diaphragm, 27.5% used condoms, and 15% used oral contraceptives. The implant acceptors attended 65% of scheduled 3-month follow-up visits.

A new multiprogrammable isotopic powered cardiac pacemaker

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

Smyth, N.P.; Purdy, D.L.; Sager, D.

1982-09-01

A new multiprogrammable, isotopic-powered cardiac pacemaker was implanted in six patients as a custom device. Five were initial implants and one was a replacement. The patients were studied for up to two years. In five of the six cases it was found advantageous to change one of the programmable parameters. Multiprogrammability is obviously as important in an isotopic pulse generator as in a lithium unit, if not more so, because of the unit's greater longevity. Further studies are continuing in an FDA approved clinical trial.

Poly Implants Prosthèse Breast Implants: A Case Series and Review of the Literature.

PubMed

Klein, Doron; Hadad, Eran; Wiser, Itay; Wolf, Omer; Itzhaki Shapira, Ortal; Fucks, Shir; Heller, Lior

2018-01-01

Silicone breast implants from the French manufacturer Poly Implants Prosthèse (PIP) were recalled from the European market after the French regulator has revealed the implants contain non-medical-grade silicone filler. In December 2011, following a large increase in reported rupture rate and a possible cancer risk, the French Ministry of Health recommended consideration of the PIP explantation, regardless of their condition. In 2012, the Israel Ministry of Health recommended to replace the implants only upon suspected implant rupture. The aims of this study were to characterize breast-augmented Israeli patients with PIP implants, compare their outcomes with those of breast-augmented patients with different implant types, and review the current PIP literature. Breast-augmented patients who underwent an elective breast implant exchange in Israel between January 2011 and January 2017 were included in the study. Data were collected from electronic and physical medical files. There were 73 breast-augmented female patients with 146 PIP breast implants included in this study. Average implant age was 6.7 ± 2.79 years. Mean implant size was 342.8 ± 52.9 mL. Fourteen women (19 implants [16%]) had a high-grade capsular contracture (Baker grade 3-4). During exchange, 28 implants were found to be ruptured (19.2%). Less than 10 years following breast augmentation, PIP implants demonstrated higher rupture rate compared with other implants. Our data are comparable to overall available rupture rate. Among patients with definitive rupture diagnosis, an elective implant removal should be recommended. In cases of undamaged implants, plastic surgeons should also seriously consider PIP implant explantation. When the patient does not desire to remove the implant, an annual physical examination and breast ultrasound are recommended, beginning a year after augmentation.

Group purchasing of pharmaceuticals and medical supplies by the Gulf Cooperation Council states.

PubMed

Khoja, T A M; Bawazir, S A

2005-01-01

An important issue in health care today is the cost of essential pharmaceuticals and medical supplies. To control the increase of health care expenses, in 1976 the Gulf Cooperation Council states began to study the idea of establishing a group purchasing programme for pharmaceuticals and medical supplies. This paper demonstrates the elements of the programme, how it works, what obstacles it faces and how other countries can profit from this experience. It also discusses the future of the group purchasing programme in the light of globalization and how the international changes under the World Trade Organization agreements will affect the programme in future.

Batteries used to Power Implantable Biomedical Devices

PubMed Central

Bock, David C.; Marschilok, Amy C.; Takeuchi, Kenneth J.; Takeuchi, Esther S.

2012-01-01

Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease. PMID:24179249

Batteries used to Power Implantable Biomedical Devices.

PubMed

Bock, David C; Marschilok, Amy C; Takeuchi, Kenneth J; Takeuchi, Esther S

2012-12-01

Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease.

Generation of electrical power under human skin by subdermal solar cell arrays for implantable bioelectronic devices.

PubMed

Song, Kwangsun; Han, Jung Hyun; Yang, Hyung Chae; Nam, Kwang Il; Lee, Jongho

2017-06-15

Medical electronic implants can significantly improve people's health and quality of life. These implants are typically powered by batteries, which usually have a finite lifetime and therefore must be replaced periodically using surgical procedures. Recently, subdermal solar cells that can generate electricity by absorbing light transmitted through skin have been proposed as a sustainable electricity source to power medical electronic implants in bodies. However, the results to date have been obtained with animal models. To apply the technology to human beings, electrical performance should be characterized using human skin covering the subdermal solar cells. In this paper, we present electrical performance results (up to 9.05mW/cm 2 ) of the implantable solar cell array under 59 human skin samples isolated from 10 cadavers. The results indicate that the power densities depend on the thickness and tone of the human skin, e.g., higher power was generated under thinner and brighter skin. The generated power density is high enough to operate currently available medical electronic implants such as pacemakers that require tens of microwatt. Copyright © 2016 Elsevier B.V. All rights reserved.

Superior versus inferior Ahmed glaucoma valve implantation.

PubMed

Pakravan, Mohammad; Yazdani, Shahin; Shahabi, Camelia; Yaseri, Mehdi

2009-02-01

To compare the efficacy and safety of Ahmed glaucoma valve (AGV) (New World Medical Inc., Rancho Cucamonga, CA) implantation in the superior versus inferior quadrants. Prospective parallel cohort study. A total of 106 eyes of 106 patients with refractory glaucoma. Consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included intraocular pressure (IOP) and rate of complications. Other outcome measures included best corrected visual acuity (BCVA), number of glaucoma medications, and success rate (defined as at least 30% IOP reduction and 50.122). After 1 year, statistically significant but comparable IOP reduction from baseline (P<0.001) was achieved in both groups (47.0%+/-27.2% and 43.0%+/-24.5% reduction for superior and inferior groups, respectively, P = 0.725). The mean number of glaucoma medications was comparable after 1 year (1.3+/-1.2 vs. 1.9+/-0.8 for superior and inferior implants, respectively, P = 0.256). Success rates were also similar at 1 year: 27 eyes (81.8%) versus 20 eyes (95.2%) for superior and inferior implants, respectively (P = 0.227). However, the overall rate of complications, such as implant exposure necessitating removal, cosmetically unappealing appearance, and endophthalmitis, was higher in the inferior group: 12 eyes (25%) versus 3 eyes (5.2%) for superior and inferior groups, respectively, (P = 0.004). Superior and inferior AGV implants have similar intermediate efficacy in terms of IOP reduction, decrease in number of glaucoma medications, and preservation of vision. However, the inferior quadrants entail significantly more complications. It may be prudent to avoid AGV implantation in the inferior quadrants if the superior quadrants have no contraindications to surgery. Proprietary or commercial disclosure may be found after the references.

Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin.

PubMed

Ordia, Joe I; Fischer, Edward; Adamski, Ellen; Chagnon, Kimberly G; Spatz, Edward L

2002-01-01

We began this study to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the treatment of severe spasticity of spinal cord origin. One hundred fifty two patients with severe spasticity of spinal origin, refractory to oral baclofen, or who experienced intolerable side-effects were given a test dose of ITB. Only those who had a satisfactory response were considered to be appropriate for pump implantation. All but one of the 152 patients had a satisfactory response, and the pump was implanted in 131 patients. Pre- and postoperative spasticity scores were compared and analyzed. The mean Ashworth score for rigidity decreased from 4.2 preoperatively to 1.3 (p < 0.0005) on ITB. The spasm score decreased from a mean of 3.4 to 0.6 (p < 0.0005). Reduction of spasticity resulted in improved levels of physical activity, decreased pain, and augmentation of sleep. Drug-related complications included constipation, muscular hypotonia, urinary retention, erectile dysfunction, nausea, dizziness, drowsiness, hypotension and bradycardia as well as tolerance to baclofen. Some patients experienced post-spinal puncture headaches. Catheter-related problems included occlusions, breaks, punctures, and dislodgments. Superficial pump pocket infection, pocket erosion, cerebrospinal fluid (CSF) leak, post-spinal puncture headache, and meningitis were some of the procedure-related complications. Two pumps flipped and another pump valve was stuck. We conclude that long-term intrathecal baclofen by an implanted programmable pump is a safe and effective method of treating severe intractable spinal spasticity.

Comparative durability and costs analysis of ventricular shunts.

PubMed

Agarwal, Nitin; Kashkoush, Ahmed; McDowell, Michael M; Lariviere, William R; Ismail, Naveed; Friedlander, Robert M

2018-05-11

OBJECTIVE Ventricular shunt (VS) durability has been well studied in the pediatric population and in patients with normal pressure hydrocephalus; however, further evaluation in a more heterogeneous adult population is needed. This study aims to evaluate the effect of diagnosis and valve type-fixed versus programmable-on shunt durability and cost for placement of shunts in adult patients. METHODS The authors retrospectively reviewed the medical records of all patients who underwent implantation of a VS for hydrocephalus at their institution over a 3-year period between August 2013 and October 2016 with a minimum postoperative follow-up of 6 months. The primary outcome was shunt revision, which was defined as reoperation for any indication after the initial procedure. Supply costs, shunt durability, and hydrocephalus etiologies were compared between fixed and programmable valves. RESULTS A total of 417 patients underwent shunt placement during the index time frame, consisting of 62 fixed shunts (15%) and 355 programmable shunts (85%). The mean follow-up was 30 ± 12 (SD) months. The shunt revision rate was 22% for programmable pressure valves and 21% for fixed pressure valves (HR 1.1 [95% CI 0.6-1.8]). Shunt complications, such as valve failure, infection, and overdrainage, occurred with similar frequency across valve types. Kaplan-Meier survival curve analysis showed no difference in durability between fixed (mean 39 months) and programmable (mean 40 months) shunts (p = 0.980, log-rank test). The median shunt supply cost per index case and accounting for subsequent revisions was $3438 (interquartile range $2938-$3876) and $1504 (interquartile range $753-$1584) for programmable and fixed shunts, respectively (p < 0.001, Wilcoxon rank-sum test). Of all hydrocephalus etiologies, pseudotumor cerebri (HR 1.9 [95% CI 1.2-3.1]) and previous shunt malfunction (HR 1.8 [95% CI 1.2-2.7]) were found to significantly increase the risk of shunt revision. Within each diagnosis, there were no significant differences in revision rates between shunts with a fixed valve and shunts with a programmable valve. CONCLUSIONS Long-term shunt revision rates are similar for fixed and programmable shunt pressure valves in adult patients. Hydrocephalus etiology may play a significant role in predicting shunt revision, although programmable valves incur higher supply costs regardless of initial diagnosis. Utilization of fixed pressure valves versus programmable pressure valves may reduce supply costs while maintaining similar revision rates. Given the importance of developing cost-effective management protocols, this study highlights the critical need for large-scale prospective observational studies and randomized clinical trials of ventricular shunt valve revisions and additional patient-centered outcomes.

Economic benefit of the PHLAME wellness programme on firefighter injury.

PubMed

Kuehl, K S; Elliot, D L; Goldberg, L; Moe, E L; Perrier, E; Smith, J

2013-04-01

Work-related injuries and illness are prevalent and costly. Firefighting is especially hazardous and many firefighters sustain work-related injuries. Workplace health promotion programmes have shown positive return on investment (ROI). Little is known about how similar programmes would impact injury and cost among firefighters. To evaluate the impact of a workplace health promotion intervention on workers' compensation (WC) claims and medical costs among Oregon fire departments participating in the PHLAME (Promoting Healthy Lifestyles: Alternative Models' Effects) health promotion programme compared with Oregon fire departments not participating in PHLAME. Data from firefighters from four large urban fire departments in Oregon were evaluated using a retrospective quasi-experimental study design. Outcomes were (i) total annual firefighter WC claims, (ii) total annual incurred medical costs prior to and after implementation of the PHLAME firefighter worksite health promotion programme (iii) and an ROI analysis. Data were obtained from 1369 firefighters (mean age of 42 years, 91% white, 93% male). WC claims (P < 0.001) and medical costs (P < 0.01) were significantly lower among PHLAME fire departments compared with Oregon fire departments not participating in the programme. Fire departments participating in the PHLAME TEAM programme demonstrated a positive ROI of 4.61-1.00 (TEAM is used to indicate the 12-session peer-led health promotion programme). Fire department WC claims and medical costs were reduced after implementation of the PHLAME workplace health promotion programme. This is a low cost, team-based, peer-led, wellness programme that may provide a feasible, cost-effective means to reduce firefighter injury and illness rates.

Economic benefit of the PHLAME wellness programme on firefighter injury

PubMed Central

2013-01-01

Background Work-related injuries and illness are prevalent and costly. Firefighting is especially hazardous and many firefighters sustain work-related injuries. Workplace health promotion programmes have shown positive return on investment (ROI). Little is known about how similar programmes would impact injury and cost among firefighters. Aims To evaluate the impact of a workplace health promotion intervention on workers’ compensation (WC) claims and medical costs among Oregon fire departments participating in the PHLAME (Promoting Healthy Lifestyles: Alternative Models’ Effects) health promotion programme compared with Oregon fire departments not participating in PHLAME. Methods Data from firefighters from four large urban fire departments in Oregon were evaluated using a retrospective quasi-experimental study design. Outcomes were (i) total annual firefighter WC claims, (ii) total annual incurred medical costs prior to and after implementation of the PHLAME firefighter worksite health promotion programme (iii) and an ROI analysis. Results Data were obtained from 1369 firefighters (mean age of 42 years, 91% white, 93% male). WC claims (P < 0.001) and medical costs (P < 0.01) were significantly lower among PHLAME fire departments compared with Oregon fire departments not participating in the programme. Fire departments participating in the PHLAME TEAM programme demonstrated a positive ROI of 4.61–1.00 (TEAM is used to indicate the 12-session peer-led health promotion programme). Conclusions Fire department WC claims and medical costs were reduced after implementation of the PHLAME workplace health promotion programme. This is a low cost, team-based, peer-led, wellness programme that may provide a feasible, cost-effective means to reduce firefighter injury and illness rates. PMID:23416849

Biocompatible medical implant materials with binding sites for a biodegradable drug-delivery system

PubMed Central

Al-Dubai, Haifa; Pittner, Gisela; Pittner, Fritz; Gabor, Franz

2011-01-01

Feasibility studies have been carried out for development of a biocompatible coating of medical implant materials allowing the binding of biodegradable drug-delivery systems in a way that their reloading might be possible. These novel coatings, able to bind biodegradable nanoparticles, may serve in the long run as drug carriers to mediate local pharmacological activity. After biodegradation of the nanoparticles, the binding sites could be reloaded with fresh drug-delivering particles. As a suitable receptor system for the nanoparticles, antibodies are anchored. The design of the receptor is of great importance as any bio- or chemorecognitive interaction with other components circulating in the blood has to be avoided. Furthermore, the binding between receptor and the particles has to be strong enough to keep them tightly bound during their lifetime, but on the other hand allow reloading after final degradation of the particles. The nanoparticles suggested as a drug-delivery system for medical implants can be loaded with different pharmaceuticals such as antibiotics, growth factors, or immunosuppressives. This concept may enable the changing of medication, even after implantation of the medical device, if afforded by patients’ needs. PMID:24198488

Design and simulation of printed spiral coil used in wireless power transmission systems for implant medical devices.

PubMed

Wu, Wei; Fang, Qiang

2011-01-01

Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medical devices. PSC for implant medical device should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation of power transfer efficiency of PSC in air medium is 77.5% and 71.1%, respectively. The simulation results show that the printed spiral coil which is optimized for air will keep 15.2% power transfer efficiency in human subcutaneous tissues. In addition, the Specific Absorption Ratio (SAR) for this coil antenna in subcutaneous at 13.56 MHz is below 1.6 W/Kg, which suggests this coil is implantable safe based on IEEE C95.1 safety guideline.

A Binaural CI Research Platform for Oticon Medical SP/XP Implants Enabling ITD/ILD and Variable Rate Processing

PubMed Central

Adiloğlu, K.; Herzke, T.

2015-01-01

We present the first portable, binaural, real-time research platform compatible with Oticon Medical SP and XP generation cochlear implants. The platform consists of (a) a pair of behind-the-ear devices, each containing front and rear calibrated microphones, (b) a four-channel USB analog-to-digital converter, (c) real-time PC-based sound processing software called the Master Hearing Aid, and (d) USB-connected hardware and output coils capable of driving two implants simultaneously. The platform is capable of processing signals from the four microphones simultaneously and producing synchronized binaural cochlear implant outputs that drive two (bilaterally implanted) SP or XP implants. Both audio signal preprocessing algorithms (such as binaural beamforming) and novel binaural stimulation strategies (within the implant limitations) can be programmed by researchers. When the whole research platform is combined with Oticon Medical SP implants, interaural electrode timing can be controlled on individual electrodes to within ±1 µs and interaural electrode energy differences can be controlled to within ±2%. Hence, this new platform is particularly well suited to performing experiments related to interaural time differences in combination with interaural level differences in real-time. The platform also supports instantaneously variable stimulation rates and thereby enables investigations such as the effect of changing the stimulation rate on pitch perception. Because the processing can be changed on the fly, researchers can use this platform to study perceptual changes resulting from different processing strategies acutely. PMID:26721923

A Binaural CI Research Platform for Oticon Medical SP/XP Implants Enabling ITD/ILD and Variable Rate Processing.

PubMed

Backus, B; Adiloğlu, K; Herzke, T

2015-12-30

We present the first portable, binaural, real-time research platform compatible with Oticon Medical SP and XP generation cochlear implants. The platform consists of (a) a pair of behind-the-ear devices, each containing front and rear calibrated microphones, (b) a four-channel USB analog-to-digital converter, (c) real-time PC-based sound processing software called the Master Hearing Aid, and (d) USB-connected hardware and output coils capable of driving two implants simultaneously. The platform is capable of processing signals from the four microphones simultaneously and producing synchronized binaural cochlear implant outputs that drive two (bilaterally implanted) SP or XP implants. Both audio signal preprocessing algorithms (such as binaural beamforming) and novel binaural stimulation strategies (within the implant limitations) can be programmed by researchers. When the whole research platform is combined with Oticon Medical SP implants, interaural electrode timing can be controlled on individual electrodes to within ±1 µs and interaural electrode energy differences can be controlled to within ±2%. Hence, this new platform is particularly well suited to performing experiments related to interaural time differences in combination with interaural level differences in real-time. The platform also supports instantaneously variable stimulation rates and thereby enables investigations such as the effect of changing the stimulation rate on pitch perception. Because the processing can be changed on the fly, researchers can use this platform to study perceptual changes resulting from different processing strategies acutely. © The Author(s) 2015.

Recall management of patients with Rofil Medical breast implants.

PubMed

Schott, Sarah; Bruckner, Thomas; Golatta, Michael; Wallwiener, Markus; Küffner, Livia; Mayer, Christine; Paringer, Carmen; Domschke, Christoph; Blumenstein, Maria; Schütz, Florian; Sohn, Christof; Heil, Joerg

2014-07-01

Some Rofil Medical breast implants are relabelled Poly Implant Prothèse (PIP) implants, and it is recommended that Rofil implants be managed in the same way as PIP implants. We report the results of a systematic recall of patients who had received Rofil implants. All patients who received Rofil implants at our centre were identified and invited for specialist consultation. In patients who opted for explantation, preoperative and intraoperative work-up was performed in accordance with national guidelines and analysed. In cases suspicious for rupture, an MRI scan was performed. Two-hundred and twenty-five patients (average age 56; range 28-80) received a total of 321 Rofil implants an average of 5.8 (range 1-11) years previously, 225/321 (70%) implants were used for reconstruction after breast cancer. A total of 43 implants were removed prior to 2011, mainly due to capsular contracture (CC). A total of 188 patients were still affected at the time of recall. Of the 188 patients, 115 (61%) attended for specialist consultation, of which 50 (44%) requested immediate implant removal. To date, 72 of 115 (63%) women attending consultation (38% of all affected) have chosen explantation, 66 of 72 (92%) opting for new implants. Of the 108 explanted implants, 25 (23%) had capsular rupture and 57 (53%) had implant bleeding. Preoperative clinical assessment was unreliable for predicting CC or rupture. The majority of patients attended for consultation and requested explantation. The quality of the explanted Rofil implants was comparable to PIP implants, with a higher rupture prevalence compared with other, non-affected implants. Nevertheless, the acceptance of breast implants for reimplantation remained high. Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Frailty and cardiac rehabilitation: A call to action from the EAPC Cardiac Rehabilitation Section.

PubMed

Vigorito, Carlo; Abreu, Ana; Ambrosetti, Marco; Belardinelli, Romualdo; Corrà, Ugo; Cupples, Margaret; Davos, Constantinos H; Hoefer, Stefan; Iliou, Marie-Christine; Schmid, Jean-Paul; Voeller, Heinz; Doherty, Patrick

2017-04-01

Frailty is a geriatric syndrome characterised by a vulnerability status associated with declining function of multiple physiological systems and loss of physiological reserves. Two main models of frailty have been advanced: the phenotypic model (primary frailty) or deficits accumulation model (secondary frailty), and different instruments have been proposed and validated to measure frailty. However measured, frailty correlates to medical outcomes in the elderly, and has been shown to have prognostic value for patients in different clinical settings, such as in patients with coronary artery disease, after cardiac surgery or transvalvular aortic valve replacement, in patients with chronic heart failure or after left ventricular assist device implantation. The prevalence, clinical and prognostic relevance of frailty in a cardiac rehabilitation setting has not yet been well characterised, despite the increasing frequency of elderly patients in cardiac rehabilitation, where frailty is likely to influence the onset, type and intensity of the exercise training programme and the design of tailored rehabilitative interventions for these patients. Therefore, we need to start looking for frailty in elderly patients entering cardiac rehabilitation programmes and become more familiar with some of the tools to recognise and evaluate the severity of this condition. Furthermore, we need to better understand whether exercise-based cardiac rehabilitation may change the course and the prognosis of frailty in cardiovascular patients.

The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a meta-analysis.

PubMed

Wang, Shiming; Gao, Xiaoming; Qian, Nana

2016-06-08

The purpose of this study was to compare the efficacy and tolerability of the Ahmed glaucoma valve (AGV) implant and the Baerveldt implant for the treatment of refractory glaucoma. We comprehensively searched four databases, including PubMed, EMBASE, Web of Science, and the Cochrane Library databases, selecting the relevant studies. The continuous variables, namely, intraocular pressure reduction (IOPR) and a reduction in glaucoma medication, were pooled by the weighted mean differences (WMDs), and the dichotomous outcomes, including success rates and tolerability estimates, were pooled by the odds ratio (ORs). A total of 929 patients from six studies were included. The WMDs of the IOPR between the AGV implant and the Baerveldt implant were 1.58 [95 % confidence interval (CI): -2.99 to 6.15] at 6 months, -1.01 (95 % CI: -3.40 to 1.98) at 12 months, -0.54 (95 % CI: -4.89 to 3.82) at 24 months, and -0.47 (95 % CI: -3.29 to 2.35) at 36 months. No significant difference was detected between the two groups at any point in time. The pooled ORs comparing the AGV implant with the Baerveldt implant were 0.51 (95 % CI: 0.33 to 0.80) for the complete success rate and 0.67 (95 % CI: 0.50 to 0.91) for qualified success rate. The Baerveldt implant was associated with a reduction in glaucoma medication at -0.51 (95 % CI: -0.90 to -0.12). There were no significant differences between the AGV implant and the Baerveldt implant on the rates of adverse events. The Baerveldt implant is more effective in both its surgical success rate and reducing glaucoma medication, but it is comparable to the AGV implant in lowering IOP. Both implants may have comparable incidences of adverse events.

Hybrid nanocomposite coatings from metal (Mg alloy)-drug deposited onto medical implant by laser adaptive ablation deposition technique

NASA Astrophysics Data System (ADS)

Serbezov, Valery; Sotirov, Sotir; Serbezov, Svetlin

2013-03-01

Drug-eluting medical implants are active implants whose function is to create healing effects. The current requirements for active medical coatings for Drug-eluting medical implants are to be biocompatible, biodegradable, polymer free, mechanically stable and enable a controlled release of one or more drugs and defined degradation. This brings hybrid nanocomposite coatings into focus especially in the field of cardiovascular implants. We studied the properties of Metal (Mg alloy)-Paclitaxel coatings obtained by novel Laser Adaptive Ablation Deposition Technique (LAAD) onto cardiovascular stents from 316 LVM stainless steel material. The morphology and topology of coatings were studied by Bright field / Fluorescence optical microscope and Scanning Electron Microscope (SEM). Comparative measurements were made of the morphology and topology of hybrid, polymer free nanocomposite coatings deposited by LAAD and polymerdrug coatings deposited by classical spray technique. The coatings obtained by LAAD are homogeneous without damages and cracks. Metal nanoparticles with sizes from 40 nm to 230 nm were obtained in drug matrixes. Energy Dispersive X-ray Spectroscopy (EDX) was used for identification of metal nanoparticles presence in hybrid nanocomposites coatings. The new technology opens up possibilities to obtain new hybrid nanocomposite coatings with applications in medicine, pharmacy and biochemistry.

Impact of imaging landmark on the risk of MRI-related heating near implanted medical devices like cardiac pacemaker leads.

PubMed

Nordbeck, Peter; Ritter, Oliver; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Burkard, Natalie; Herold, Volker; Jakob, Peter M; Ertl, Georg; Ladd, Mark E; Quick, Harald H; Bauer, Wolfgang R

2011-01-01

Implanted medical devices such as cardiac pacemakers pose a potential hazard in magnetic resonance imaging. Electromagnetic fields have been shown to cause severe radio frequency-induced tissue heating in some cases. Imaging exclusion zones have been proposed as an instrument to reduce patient risk. The purpose of this study was to further assess the impact of the imaging landmark on the risk for unintended implant heating by measuring the radio frequency-induced electric fields in a body phantom under several imaging conditions at 1.5T. The results show that global radio frequency-induced coupling is highest with the torso centered along the superior-inferior direction of the transmit coil. The induced E-fields inside the body shift when changing body positioning, reducing both global and local radio frequency coupling if body and/or conductive implant are moved out from the transmit coil center along the z-direction. Adequate selection of magnetic resonance imaging landmark can significantly reduce potential hazards in patients with implanted medical devices. © 2010 Wiley-Liss, Inc.

Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands.

PubMed

Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

2016-06-21

The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich's flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands

NASA Astrophysics Data System (ADS)

Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

2016-06-01

The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich’s flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

Tetanus in adult males, Bugando Medical Centre, United Republic of Tanzania.

PubMed

Aziz, Riaz; Peck, Robert N; Kalluvya, Samuel; Kenemo, Bernard; Chandika, Alphonce; Downs, Jennifer A

2017-11-01

In the United Republic of Tanzania, the incidence of non-neonatal circumcision-related tetanus is probably underreported. We analysed charts and extracted information on outcome and wound location for non-neonatal cases of tetanus admitted to the intensive care unit of Bugando Medical Centre between 2001 and 2016. Bugando Medical Centre, which is one of four teaching referral hospitals in the United Republic of Tanzania, has a 13-bed intensive care unit that manages all admitted patients with tetanus. Within the United Republic of Tanzania, formal programmes of tetanus immunization are targeted at infants or women. From our inpatient logs, we identified six patients with non-neonatal tetanus among male patients with a recent history of circumcision. Only one of these patients had been circumcised within a subnational programme of voluntary medical male circumcision. The other five had been circumcised outside of the programme - e.g. at small rural dispensaries or by a traditional provider with no formal medical training. The six patients were aged 11-55 years and five (83%) of them died in hospital - all of overwhelming sepsis. Within the Tanzanian programme of voluntary medical male circumcision, education on wound hygiene probably helps to reduce the incidence of non-neonatal circumcision-related tetanus. The corresponding incidence among the boys and men who are circumcised beyond this subnational programme is probably higher. The training of all circumcision providers in wound care and a vaccination programme to ensure that male Tanzanians receive tetanus immunization post-infancy are recommended.

Critical review: medical students' motivation after failure.

PubMed

Holland, Chris

2016-08-01

About 10 % of students in each years' entrants to medical school will encounter academic failure at some stage in their programme. The usual approach to supporting these students is to offer them short term remedial study programmes that often enhance approaches to study that are orientated towards avoiding failure. In this critical review I will summarise the current theories about student motivation that are most relevant to this group of students and describe how they are enhanced or not by various contextual factors that medical students experience during their programme. I will conclude by suggesting ways in which support programmes for students who have encountered academic failure might be better designed and researched in the future.

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES State... 34 Education 2 2010-07-01 2010-07-01 false Routine checking of hearing aids and external components of surgically implanted medical devices. 300.113 Section 300.113 Education Regulations of the...

Novel Biomaterials Used in Medical 3D Printing Techniques

PubMed Central

Tappa, Karthik; Jammalamadaka, Udayabhanu

2018-01-01

The success of an implant depends on the type of biomaterial used for its fabrication. An ideal implant material should be biocompatible, inert, mechanically durable, and easily moldable. The ability to build patient specific implants incorporated with bioactive drugs, cells, and proteins has made 3D printing technology revolutionary in medical and pharmaceutical fields. A vast variety of biomaterials are currently being used in medical 3D printing, including metals, ceramics, polymers, and composites. With continuous research and progress in biomaterials used in 3D printing, there has been a rapid growth in applications of 3D printing in manufacturing customized implants, prostheses, drug delivery devices, and 3D scaffolds for tissue engineering and regenerative medicine. The current review focuses on the novel biomaterials used in variety of 3D printing technologies for clinical applications. Most common types of medical 3D printing technologies, including fused deposition modeling, extrusion based bioprinting, inkjet, and polyjet printing techniques, their clinical applications, different types of biomaterials currently used by researchers, and key limitations are discussed in detail. PMID:29414913

Combined Glaucoma Tube Shunt (Ahmed) and Fluocinolone Acetonide (Retisert™) Implantation Compared to Ahmed Alone in Uveitic Glaucoma.

PubMed

Zivney, Mark; Lin, Phoebe; Edmunds, Beth; Parikh, Mansi; Takusagawa, Hana; Tehrani, Shandiz

2016-12-01

Glaucoma is a known complication of uveitis, and may require glaucoma tube shunt implantation for intraocular pressure (IOP) control. The success of glaucoma tube shunt implantation in the setting of a local ocular steroid depot in uveitic glaucoma remains unknown. The purpose of this study was to determine whether patients who underwent combined glaucoma tube shunt (Ahmed) and fluocinolone acetonide (Retisert™, Bausch + Lomb, Bridgewater, NJ, USA) implantation have superior outcomes compared to patients with Ahmed implants only in the setting of uveitic glaucoma. All participants were studied retrospectively and underwent Ahmed implantation alone or with existing/concurrent Retisert implantation (combined group) at a single academic institution. The main outcome measures were IOP, visual acuity (VA), number of IOP-lowering medications, and adverse events at 6 months after Ahmed implantation. Secondary outcome measures included adverse events and surgical success at 6 months after Ahmed implantation. Mean IOP at 6 months after Ahmed implantation was 15.3 ± 4.8 and 15.1 ± 4.9 mm Hg in the Ahmed only group (n = 17) and the combined group (n = 17), respectively (p = 0.89). The mean number of IOP-lowering medications at 6 months after Ahmed implantation was 1.7 ± 1.0 and 1.8 ± 1.0 in the Ahmed only group and the combined group, respectively (p = 0.86). Mean VA at 6 months after Ahmed implantation was 0.35 ± 0.29 and 0.42 ± 0.33 log mean angle of resolution in the Ahmed only group and the combined group, respectively (p = 0.50). No significant differences in surgical success or adverse events were noted between the two groups. At 6 months, no significant differences in mean IOP, mean number of IOP-lowering medications, VA, surgical success, or adverse events were noted between Ahmed implantation alone or combined Ahmed and Retisert implantation in patients with uveitic glaucoma.

Programmable shunt valves for the treatment of hydrocephalus: a systematic review.

PubMed

Xu, H; Wang, Z X; Liu, F; Tan, G W; Zhu, H W; Chen, D H

2013-09-01

To evaluate the clinical effectiveness of programmable valves compared with non-programmable valves of hydrocephalus. In this paper, the authors report a systematic review and meta-analysis of complications and revision rate for programmable valves and non-programmable implantation. Randomized or non-randomized controlled trials of hydrocephalus treated by programmable and non-programmable valves were considered for inclusion. Seven published reports of eligible studies involving 1702 participants meet the inclusion criteria. Compared with non-programmable, programmable valves had no significant difference in catheter-related complications [RR = 0.88, 95%CI (0.66,1.19), p = 0.10] and infection rate [RR = 1.25, 95%CI (0.92,1.69), p = 1.00]. There were significant differences in overall complications [RR = 0.80, 95%CI (0.67,0.96), p < 0.01], over-drainage or under-drainage complications [RR = 0.44, 95%CI (0.31,0.63), p < 0.01] and revision rate [RR = 0.56, 95%CI (0.45,0.69), p < 0.01] in favor of programmable valves. Although the studies seem to demonstrate a small advantage for the programmable shunts, the probable bias and the difficulties in patient selection are too important to make a general conclusion. Copyright © 2013. Published by Elsevier Ltd.

Method for making a bio-compatible scaffold

DOEpatents

Cesarano, III, Joseph; Stuecker, John N [Albuquerque, NM; Dellinger, Jennifer G [Champaigne, IL; Jamison, Russell D [Urbana, IL

2006-01-31

A method for forming a three-dimensional, biocompatible, porous scaffold structure using a solid freeform fabrication technique (referred to herein as robocasting) that can be used as a medical implant into a living organism, such as a human or other mammal. Imaging technology and analysis is first used to determine the three-dimensional design required for the medical implant, such as a bone implant or graft, fashioned as a three-dimensional, biocompatible scaffold structure. The robocasting technique is used to either directly produce the three-dimensional, porous scaffold structure or to produce an over-sized three-dimensional, porous scaffold lattice which can be machined to produce the designed three-dimensional, porous scaffold structure for implantation.

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

PubMed

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

PubMed Central

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

Microfluidic Power Generation

DTIC Science & Technology

2008-03-28

It is designed to help patients with retinitus pigmentosa . The eye glasses and photoprocessor worn on the waist are used to train the retinal ...patient [5]. ............................................................. 3 Figure 1.3: The Learning Retinal Implant from Intelligent Medical Systems...implantable biosensors [4]. Examples of such advances include the AbioCor implantable replacement heart (Figure 1.2), Learning Retinal Implant (Figure 1.3

Medical care of type 2 diabetes in German disease management programmes: a population-based evaluation.

PubMed

Stark, Reneé G; Schunk, Michaela V; Meisinger, Christine; Rathmann, Wolfgang; Leidl, Reiner; Holle, Rolf

2011-05-01

Type 2 diabetes disease management programmes (DDMPs) are offered by German social health insurance to promote healthcare consistent with evidence-based medical guidelines. The aim of this study was to compare healthcare quality and medical endpoints between diabetes management programme participants and patients receiving usual care designated as controls. All patients with type 2 diabetes (age range: 36-81) in a cross-sectional survey of a cohort study, performed by the Cooperative Health Research in the Region of Augsburg, received a self-administered questionnaire regarding their diabetes care. Physical examination and laboratory tests were also performed. The analysis only included patients with social health insurance and whose participation status in a diabetes disease management program was validated by the primary physician (n = 166). Regression analyses, adjusting for age, sex, education, diabetes duration, baseline waist circumference and clustering regarding primary physician were conducted. Evaluation of healthcare processes showed that those in diabetes disease management programmes (n = 89) reported medical examination of eyes and feet and medical advice regarding diet [odds ratio (OR): 2.39] and physical activity (OR: 2.87) more frequently, received anti-diabetic medications (OR: 3.77) and diabetes education more often (OR: 2.66) than controls. Both groups had satisfactory HbA(1c) control but poor low-density lipoprotein cholesterol control. Blood pressure goals (<140/90 mmHg) were achieved more frequently by patients in diabetes disease management programmes (OR: 2.21). German diabetes disease management programmes are associated with improved healthcare processes and blood pressure control. Low-density lipoprotein cholesterol control must be improved for all patients with diabetes. Further research will be required to assess the long-term effects of this diabetes disease management programme. Copyright © 2011 John Wiley & Sons, Ltd.

Telemetry and Telestimulation via Implanted Devices Necessary in Long-Term Experiments Using Conscious Untethered Animals for the Development of New Medical Treatments

NASA Astrophysics Data System (ADS)

Sugimachi, Masaru; Kawada, Toru; Uemura, Kazunori

Effective countermeasures against explosive increase in healthcare expenditures are urgently needed. A paradigm shift in healthcare is called for, and academics and governments worldwide are working hard on the application of information and communication technologies (ICT) as a feasible and effective measure for reducing medical cost. The more prevalent the disease and the easier disease outcome can be improved, the more efficient is medical ICT in reducing healthcare cost. Hypertension and diabetes mellitus are such examples. Chronic heart failure is another disease in which patients may benefit from ICT-based medical practice. It is conceivable that daily monitoring of hemodynamics together with appropriate treatments may obviate the expensive hospitalization. ICT potentially permit continuous monitoring with wearable or implantable medical devices. ICT may also help accelerate the development of new therapeutic devices. Traditionally effectiveness of treatments is sequentially examined by sacrificing a number of animals at a given time point. These inefficient and inaccurate methods can be replaced by applying ICT to the devices used in chronic animal experiments. These devices allow researchers to obtain biosignals and images from live animals without killing them. They include implantable telemetric devices, implantable telestimulation devices, and imaging devices. Implanted rather than wired monitoring and stimulation devices permit experiments to be conducted under even more physiological conditions, i.e., untethered, free-moving states. Wireless communication and ICT are indispensible technologies for the development of such telemetric and telestimulation devices.

Shared decision-making for psychiatric medication: A mixed-methods evaluation of a UK training programme for service users and clinicians.

PubMed

Ramon, Shulamit; Morant, Nicola; Stead, Ute; Perry, Ben

2017-12-01

Shared decision making (SDM) is recognised as a promising strategy to enhance good collaboration between clinicians and service users, yet it is not practised regularly in mental health. Develop and evaluate a novel training programme to enhance SDM in psychiatric medication management for service users, psychiatrists and care co-ordinators. The training programme design was informed by existing literature and local stakeholders consultations. Parallel group-based training programmes on SDM process were delivered to community mental health service users and providers. Evaluation consisted of quantitative measures at baseline and 12-month follow-up, post-programme participant feedback and qualitative interviews. Training was provided to 47 service users, 35 care-coordinators and 12 psychiatrists. Participant feedback was generally positive. Statistically significant changes in service users' decisional conflict and perceptions of practitioners' interactional style in promoting SDM occurred at the follow-up. Qualitative data suggested positive impacts on service users' and care co-ordinators confidence to explore medication experience, and group-based training was valued. The programme was generally acceptable to service users and practitioners. This indicates the value of conducting a larger study and exploring application for non-medical decisions.

A Fully-Implantable Cochlear Implant SoC with Piezoelectric Middle-Ear Sensor and Arbitrary Waveform Neural Stimulation.

PubMed

Yip, Marcus; Jin, Rui; Nakajima, Hideko Heidi; Stankovic, Konstantina M; Chandrakasan, Anantha P

2015-01-01

A system-on-chip for an invisible, fully-implantable cochlear implant is presented. Implantable acoustic sensing is achieved by interfacing the SoC to a piezoelectric sensor that detects the sound-induced motion of the middle ear. Measurements from human cadaveric ears demonstrate that the sensor can detect sounds between 40 and 90 dB SPL over the speech bandwidth. A highly-reconfigurable digital sound processor enables system power scalability by reconfiguring the number of channels, and provides programmable features to enable a patient-specific fit. A mixed-signal arbitrary waveform neural stimulator enables energy-optimal stimulation pulses to be delivered to the auditory nerve. The energy-optimal waveform is validated with in-vivo measurements from four human subjects which show a 15% to 35% energy saving over the conventional rectangular waveform. Prototyped in a 0.18 μ m high-voltage CMOS technology, the SoC in 8-channel mode consumes 572 μ W of power including stimulation. The SoC integrates implantable acoustic sensing, sound processing, and neural stimulation on one chip to minimize the implant size, and proof-of-concept is demonstrated with measurements from a human cadaver ear.

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant

PubMed Central

Ali, Moazzam; Akin, Ayse; Bahamondes, Luis; Brache, Vivian; Habib, Ndema; Landoulsi, Sihem; Hubacher, David

2016-01-01

STUDY QUESTION Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. STUDY DESIGN SIZE, DURATION For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan–Meier (K–M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. PARTICIPANTS/MATERIALS, SETTING, METHODS The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. MAIN RESULTS AND THE ROLE OF CHANCE Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K–M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2–1.8] and 0.8 per 100 W-Y [95% CI: 0.2–2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5–6.5]. LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. WIDER IMPLICATIONS OF THE FINDINGS The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. TRIAL REGISTRATION The trial was registered as ISRCTN33378571. STUDY FUNDING/COMPETING INTEREST(S) The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work. PMID:27671673

[The National Programme for Disease Management Guidelines. Goals, contents, patient involvement].

PubMed

Ollenschläger, G; Kopp, I; Lelgemann, M; Sänger, S; Klakow-Franck, R; Gibis, B; Gramsch, E; Jonitz, G

2007-03-01

The Programme for National Disease Management Guidelines (German DM-CPG Programme) aims at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. The programme, focussing on high priority healthcare topics, has been sponsored since 2003 by the German Medical Association (BAEK), the Association of the Scientific Medical Societies (AWMF), and by the National Association of Statutory Health Insurance Physicians (KBV). It is organised by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the programme is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health care provision and facilitating the coordination of care for the individual patient through time and across disciplines. Within this framework experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes goals, topics and selected contents of the DM-CPG programme - using asthma as an example.

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2012 CFR

2012-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2013 CFR

2013-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2014 CFR

2014-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

Long-term outcomes of oral rehabilitation with dental implants in HIV-positive patients: A retrospective case series

PubMed Central

Gay-Escoda, Cosme; Pérez-Álvarez, Débora; Camps-Font, Octavi

2016-01-01

Background The existing information on oral rehabilitations with dental implants in VIH-positive patients is scarce and of poor quality. Moreover, no long-term follow-up studies are available. Hence, the aims of this study were to describe the long-term survival and success rates of dental implants in a group of HIV-positive patients and to identify the most common postoperative complications, including peri-implant diseases. Material and Methods A retrospective case series of HIV-positive subjects treated with dental implants at the School of Dentistry of the University of Barcelona (Spain) was studied. Several clinical parameters were registered, including CD4 cell count, viral load and surgical complications. Additionally, the patients were assessed for implant survival and success rates and for the prevalence of peri-implant diseases. A descriptive statistical analysis of the data was performed. Results Nine participants (57 implants) were included. The patients’ median age was 42 years (IQR=13.5 years). The implant survival and success rates were 98.3% and 68.4%, respectively, with a mean follow-up of 77.5 months (SD=16.1 months). The patient-based prevalence of peri-implant mucositis and peri-implantitis were 22.2% and 44.4% respectively at the last appointment. Patients that attended regular periodontal maintenance visits had significantly less mean bone loss than non-compliant patients (1.3 mm and 3.9 mm respectively). Conclusions Oral rehabilitation with dental implants in HIV-positive patients seems to provide satisfactory results. In order to reduce the considerably high prevalence of peri-implant diseases, strict maintenance programmes must be implemented. Key words:HIV infection, dental implants, oral implantology, complications, peri-implantitis, peri-implant diseases. PMID:26946205

Strengthening medical education in haematology and blood transfusion: postgraduate programmes in Tanzania

PubMed Central

Makani, Julie; Lyimo, Magdalena; Magesa, Pius; Roberts, David J.

2017-01-01

Summary Haematology and blood transfusion, as a clinical and laboratory discipline, has a far-reaching impact on healthcare both through direct patient care as well as provision of laboratory and transfusion services. Improvement of haematology and blood transfusion may therefore be significant in achieving advances in health in Africa. In 2005, Tanzania had one of the lowest distributions of doctors in the world, estimated at 2·3 doctors per 100 000 of population, with only one haematologist, a medical doctor with postgraduate medical education in haematology and blood transfusion. Here, we describe the establishment and impact of a postgraduate programme centred on Master of Medicine and Master of Science programmes to build the capacity of postgraduate training in haematology and blood transfusion. The programme was delivered through Muhimbili University of Health and Allied Sciences (MUHAS) with partnership from visiting medical and laboratory staff from the UK and complemented by short-term visits of trainees from Tanzania to Haematology Departments in the UK. The programme had a significant impact on the development of human resources in haematology and blood transfusion, successfully training 17 specialists with a significant influence on delivery of health services and research. This experience shows how a self-sustaining, specialist medical education programme can be developed at low cost within Lower and Middle Income Countries (LMICs) to rapidly enhance delivery of capacity to provide specialist services. PMID:28369755

Strengthening medical education in haematology and blood transfusion: postgraduate programmes in Tanzania.

PubMed

Makani, Julie; Lyimo, Magdalena; Magesa, Pius; Roberts, David J

2017-06-01

Haematology and blood transfusion, as a clinical and laboratory discipline, has a far-reaching impact on healthcare both through direct patient care as well as provision of laboratory and transfusion services. Improvement of haematology and blood transfusion may therefore be significant in achieving advances in health in Africa. In 2005, Tanzania had one of the lowest distributions of doctors in the world, estimated at 2·3 doctors per 100 000 of population, with only one haematologist, a medical doctor with postgraduate medical education in haematology and blood transfusion. Here, we describe the establishment and impact of a postgraduate programme centred on Master of Medicine and Master of Science programmes to build the capacity of postgraduate training in haematology and blood transfusion. The programme was delivered through Muhimbili University of Health and Allied Sciences (MUHAS) with partnership from visiting medical and laboratory staff from the UK and complemented by short-term visits of trainees from Tanzania to Haematology Departments in the UK. The programme had a significant impact on the development of human resources in haematology and blood transfusion, successfully training 17 specialists with a significant influence on delivery of health services and research. This experience shows how a self-sustaining, specialist medical education programme can be developed at low cost within Lower and Middle Income Countries (LMICs) to rapidly enhance delivery of capacity to provide specialist services. © 2017 John Wiley & Sons Ltd.

Undergraduate training in palliative medicine: is more necessarily better?

PubMed

Mason, Stephen R; Ellershaw, John E

2010-04-01

The General Medical Council's call to modernize medical education prompted the University of Liverpool Medical School to develop a new undergraduate programme, integrating palliative medicine as 'core' curricula. Following successful piloting, the palliative medicine training programme was further developed and expanded. This paper examines whether the additional investment produces improved outcomes. In 1999, fourth year undergraduate medical students (Cohort 1, n = 217) undertook a 2-week pilot education programme in palliative medicine. Subsequently, the training programme was refined and extended, incorporating advanced communication skills training, an ethics project and individual case presentations (Cohort 2, n = 443). Congruent with the study's theoretical driver of self-efficacy, both cohorts were surveyed pre- and post-programme with validated measures of: (i) self-efficacy in palliative care scale; (ii) thanatophobia scale. No significant differences between cohorts' pre-programme scores were identified. Within each cohort, statistically and educationally significant post-education improvements were recorded in both scales. Further post-education analysis indicated that the extended programme produces significantly greater improvements in all domains of the self-efficacy in palliative care scale (communication, t =-7.28, patient management, t =-5.96, multidisciplinary team-working t =-3.77 at p < 0.000), but not thanatophobia. Although improvements were recorded in both cohorts, participation in the extended education programme resulted in further statistically significant gains. Interpreted through the theoretical model employed, improved self-efficacy and outcome expectancies will result in behavioural change that leads to improved practice and better patient care.

Participatory design of a music aural rehabilitation programme.

PubMed

van Besouw, Rachel M; Oliver, Benjamin R; Hodkinson, Sarah M; Polfreman, Richard; Grasmeder, Mary L

2015-09-01

Many cochlear implant (CI) users wish to enjoy music but are dissatisfied by its quality as perceived through their implant. Although there is evidence to suggest that training can improve CI users' perception and appraisal of music, availability of interactive music-based aural rehabilitation for adults is limited. In response to this need, an 'Interactive Music Awareness Programme' (IMAP) was developed with and for adult CI users. An iterative design and evaluation approach was used. The process began with identification of user needs through consultations, followed by use of mock-up applications in workshops. Feedback from these were used to develop the prototype IMAP; a programme of 24 interactive sessions, enabling users to create and manipulate music. The prototype IMAP was subsequently evaluated in a home trial with 16 adult CI users over a period of 12 weeks. Overall ratings for the prototype IMAP were positive and indicated that it met users' needs. Quantitative and qualitative feedback on the sessions and software in the prototype IMAP were used to identify aspects of the programme that worked well and aspects that required improvement. The IMAP was further developed in response to users' feedback and is freely available online. The participatory design approach used in developing the IMAP was fundamental in ensuring its relevance, and regular feedback from end users in each phase of development proved valuable for early identification of issues. Observations and feedback from end users supported a holistic approach to music aural rehabilitation.

MasterOnline Periodontology and Implant Therapy-revisited after seven years: A case study of the structures and outcomes in a blended learning CPD.

PubMed

Ratka-Krüger, P; Wölber, J P; Blank, J; Holst, K; Hörmeyer, I; Vögele, E

2018-02-01

There is a great need for postgraduate training and continuing professional development (CPD), specifically in the field of periodontology. Despite the plenty of periodontal CPDs, there is a lack of information about the performance of CPDs in a blended learning setting. This study is a case study of the structures and outcomes in a blended learning CPD programme in periodontology, the MasterOnline Periodontology and Implant Therapy hosted by the University of Freiburg's Dental School. The structures of the blended learning CPD were analysed with the aims to (i) make explicit how various innovative educational methods and ICT tools can be successfully applied to a Web-supported postgraduate periodontology training programme, (ii) identify the programme's impact on learning transfer in students' dental practices and (iii) identify other outcomes, synergies and any changes required during the existence. Using qualitative interviewing, the various types of learning transfer and elements of the study programme that foster transfer could be exemplified. A period of 7 years was analysed. In this duration, 50 students successfully graduated to a master of science. Qualitative interviews were performed with six students and four teachers affirming the learning transfer in a blended learning setting. This case study shows that blended learning can be a successful approach for CPD in dentistry. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The District Nursing Clinical Error Reduction Programme.

PubMed

McGraw, Caroline; Topping, Claire

2011-01-01

The District Nursing Clinical Error Reduction (DANCER) Programme was initiated in NHS Islington following an increase in the number of reported medication errors. The objectives were to reduce the actual degree of harm and the potential risk of harm associated with medication errors and to maintain the existing positive reporting culture, while robustly addressing performance issues. One hundred medication errors reported in 2007/08 were analysed using a framework that specifies the factors that predispose to adverse medication events in domiciliary care. Various contributory factors were identified and interventions were subsequently developed to address poor drug calculation and medication problem-solving skills and incorrectly transcribed medication administration record charts. Follow up data were obtained at 12 months and two years. The evaluation has shown that although medication errors do still occur, the programme has resulted in a marked shift towards a reduction in the associated actual degree of harm and the potential risk of harm.

Left ventricular assist device: exercise capacity evolution and rehabilitation added value.

PubMed

Lamotte, Michel X; Chimenti, Sara; Deboeck, Gael; Gillet, Alexis; Kacelenenbogen, Raymond; Strapart, Jonathan; Vandeneynde, Frédéric; Van Nooten, Guido; Antoine, Martine

2018-06-01

With more than 15,000 implanted patients worldwide and a survival rate of 80% at 1-year and 59% at 5-years, left ventricular assist device (LVAD) implantation has become an interesting strategy in the management of heart failure patients who are resistant to other kinds of treatment. There are limited data in the literature on the change over time of exercise capacity in LVAD patients, as well as limited knowledge about the beneficial effects that rehabilitation might have on these patients. Therefore, the aim of our study was to evaluate the evolution of exercise capacity on a cohort of patients implanted with the same device (HeartWare © ) and to analyse the potential impact of rehabilitation. Sixty-two patients implanted with a LVAD between June 2011 and June 2015 were screened. Exercise capacity was evaluated by cardiopulmonary exercise testing at 6 weeks, 6 and 12 months after implantation. We have observed significant differences in the exercise capacity and evolution between the trained and non-trained patients. Some of the trained patients nearly normalised their exercise capacity at the end of the rehabilitation programme. Exercise capacity of patient implanted with a HeartWare © LVAD increased in the early period after implantation. Rehabilitation allowed implanted patients to have a significantly better evolution compared to non-rehabilitated patients.

Long-term outcomes of oral rehabilitation with dental implants in HIV-positive patients: A retrospective case series.

PubMed

Gay-Escoda, C; Pérez-Álvarez, D; Camps-Font, O; Figueiredo, R

2016-05-01

The existing information on oral rehabilitations with dental implants in VIH-positive patients is scarce and of poor quality. Moreover, no long-term follow-up studies are available. Hence, the aims of this study were to describe the long-term survival and success rates of dental implants in a group of HIV-positive patients and to identify the most common postoperative complications, including peri-implant diseases. A retrospective case series of HIV-positive subjects treated with dental implants at the School of Dentistry of the University of Barcelona (Spain) was studied. Several clinical parameters were registered, including CD4 cell count, viral load and surgical complications. Additionally, the patients were assessed for implant survival and success rates and for the prevalence of peri-implant diseases. A descriptive statistical analysis of the data was performed. Nine participants (57 implants) were included. The patients' median age was 42 years (IQR=13.5 years). The implant survival and success rates were 98.3% and 68.4%, respectively, with a mean follow-up of 77.5 months (SD=16.1 months). The patient-based prevalence of peri-implant mucositis and peri-implantitis were 22.2% and 44.4% respectively at the last appointment. Patients that attended regular periodontal maintenance visits had significantly less mean bone loss than non-compliant patients (1.3 mm and 3.9 mm respectively). Oral rehabilitation with dental implants in HIV-positive patients seems to provide satisfactory results. In order to reduce the considerably high prevalence of peri-implant diseases, strict maintenance programmes must be implemented.

The art of medicine: arts-based training in observation and mindfulness for fostering the empathic response in medical residents.

PubMed

Zazulak, Joyce; Sanaee, May; Frolic, Andrea; Knibb, Nicole; Tesluk, Eve; Hughes, Edward; Grierson, Lawrence E M

2017-09-01

Empathy is an essential attribute for medical professionals. Yet, evidence indicates that medical learners' empathy levels decline dramatically during medical school. Training in evidence-based observation and mindfulness has the potential to bolster the acquisition and demonstration of empathic behaviours for medical learners. In this prospective cohort study, we explore the impact of a course in arts-based visual literacy and mindfulness practice ( Art of Seeing ) on the empathic response of medical residents engaged in obstetrics and gynaecology and family medicine training. Following this multifaceted arts-based programme that integrates the facilitated viewing of art and dance, art-making, and mindfulness-based practices into a practitioner-patient context, 15 resident trainees completed the previously validated Interpersonal Reactivity Index, Compassion, and Mindfulness Scales. Fourteen participants also participated in semistructured interviews that probed their perceived impacts of the programme on their empathic clinical practice. The results indicated that programme participants improved in the Mindfulness Scale domains related to self-confidence and communication relative to a group of control participants following the arts-based programme. However, the majority of the psychometric measures did not reveal differences between groups over the duration of the programme. Importantly, thematic qualitative analysis of the interview data revealed that the programme had a positive impact on the participants' perceived empathy towards colleagues and patients and on the perception of personal and professional well-being. The study concludes that a multifaceted arts-based curriculum focusing on evidence-based observation and mindfulness is a useful tool in bolstering the empathic response, improving communication, and fostering professional well-being among medical residents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES State... 34 Education 2 2011-07-01 2010-07-01 true Routine checking of hearing aids and external components of surgically implanted medical devices. 300.113 Section 300.113 Education Regulations of the Offices...

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Routine checking of hearing aids and external... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids worn...

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Routine checking of hearing aids and external components... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids worn...

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Routine checking of hearing aids and external... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids worn...

The Challenges of Balancing Safety and Security in Implantable Medical Devices.

PubMed

Katzis, Konstantinos; Jones, Richard W; Despotou, George

2016-01-01

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

Image-guided tissue engineering

PubMed Central

Ballyns, Jeffrey J; Bonassar, Lawrence J

2009-01-01

Replication of anatomic shape is a significant challenge in developing implants for regenerative medicine. This has lead to significant interest in using medical imaging techniques such as magnetic resonance imaging and computed tomography to design tissue engineered constructs. Implementation of medical imaging and computer aided design in combination with technologies for rapid prototyping of living implants enables the generation of highly reproducible constructs with spatial resolution up to 25 μm. In this paper, we review the medical imaging modalities available and a paradigm for choosing a particular imaging technique. We also present fabrication techniques and methodologies for producing cellular engineered constructs. Finally, we comment on future challenges involved with image guided tissue engineering and efforts to generate engineered constructs ready for implantation. PMID:19583811

Preliminary Analysis of the Social and Scientific Impact of the UAEM-ININ M.Sc. and D.Sc. Graduate Programme in Medical Physics

NASA Astrophysics Data System (ADS)

Mitsoura, Eleni; Isaac-Olive, Keila; Torres-Garcia, Eugenio; Camacho-Lopez, Miguel Angel; Hardy-Perez, Alberto

2010-12-01

Sponsored by the International Atomic Energy Agency (IAEA) in 1994, the Instituto Nacional de Investigaciones Nucleares (ININ) started in Mexico a teaching and training programme (Diplomado) in Radiotherapy Medical Physics. Based on this experience, the Universidad Autónoma del Estado de México (UAEM) and the Instituto Nacional de Investigaciones Nucleares (ININ) launched two years later, the first Graduate Programme in Science (M.Sc. and D.Sc.), specialised in Medical Physics in Mexico. A preliminary analysis of the social and scientific impact of the UAEM-ININ Programme is presented in this work based on the achievements attained, regarding the number of graduated Medical Physicists, their geographic and academic origin, their current professional activities and the number of scientific publications produced as a result of the thesis, as well as their citations.

Potential of Wake-Up Radio-Based MAC Protocols for Implantable Body Sensor Networks (IBSN)—A Survey

PubMed Central

Karuppiah Ramachandran, Vignesh Raja; Ayele, Eyuel D.; Meratnia, Nirvana; Havinga, Paul J. M.

2016-01-01

With the advent of nano-technology, medical sensors and devices are becoming highly miniaturized. Consequently, the number of sensors and medical devices being implanted to accurately monitor and diagnose a disease is increasing. By measuring the symptoms and controlling a medical device as close as possible to the source, these implantable devices are able to save lives. A wireless link between medical sensors and implantable medical devices is essential in the case of closed-loop medical devices, in which symptoms of the diseases are monitored by sensors that are not placed in close proximity of the therapeutic device. Medium Access Control (MAC) is crucial to make it possible for several medical devices to communicate using a shared wireless medium in such a way that minimum delay, maximum throughput, and increased network life-time are guaranteed. To guarantee this Quality of Service (QoS), the MAC protocols control the main sources of limited resource wastage, namely the idle-listening, packet collisions, over-hearing, and packet loss. Traditional MAC protocols designed for body sensor networks are not directly applicable to Implantable Body Sensor Networks (IBSN) because of the dynamic nature of the radio channel within the human body and the strict QoS requirements of IBSN applications. Although numerous MAC protocols are available in the literature, the majority of them are designed for Body Sensor Network (BSN) and Wireless Sensor Network (WSN). To the best of our knowledge, there is so far no research paper that explores the impact of these MAC protocols specifically for IBSN. MAC protocols designed for implantable devices are still in their infancy and one of their most challenging objectives is to be ultra-low-power. One of the technological solutions to achieve this objective so is to integrate the concept of Wake-up radio (WuR) into the MAC design. In this survey, we present a taxonomy of MAC protocols based on their use of WuR technology and identify their bottlenecks to be used in IBSN applications. Furthermore, we present a number of open research challenges and requirements for designing an energy-efficient and reliable wireless communication protocol for IBSN. PMID:27916822

Potential of Wake-Up Radio-Based MAC Protocols for Implantable Body Sensor Networks (IBSN)-A Survey.

PubMed

Karuppiah Ramachandran, Vignesh Raja; Ayele, Eyuel D; Meratnia, Nirvana; Havinga, Paul J M

2016-11-29

With the advent of nano-technology, medical sensors and devices are becoming highly miniaturized. Consequently, the number of sensors and medical devices being implanted to accurately monitor and diagnose a disease is increasing. By measuring the symptoms and controlling a medical device as close as possible to the source, these implantable devices are able to save lives. A wireless link between medical sensors and implantable medical devices is essential in the case of closed-loop medical devices, in which symptoms of the diseases are monitored by sensors that are not placed in close proximity of the therapeutic device. Medium Access Control (MAC) is crucial to make it possible for several medical devices to communicate using a shared wireless medium in such a way that minimum delay, maximum throughput, and increased network life-time are guaranteed. To guarantee this Quality of Service (QoS), the MAC protocols control the main sources of limited resource wastage, namely the idle-listening, packet collisions, over-hearing, and packet loss. Traditional MAC protocols designed for body sensor networks are not directly applicable to Implantable Body Sensor Networks (IBSN) because of the dynamic nature of the radio channel within the human body and the strict QoS requirements of IBSN applications. Although numerous MAC protocols are available in the literature, the majority of them are designed for Body Sensor Network (BSN) and Wireless Sensor Network (WSN). To the best of our knowledge, there is so far no research paper that explores the impact of these MAC protocols specifically for IBSN. MAC protocols designed for implantable devices are still in their infancy and one of their most challenging objectives is to be ultra-low-power. One of the technological solutions to achieve this objective so is to integrate the concept of Wake-up radio (WuR) into the MAC design. In this survey, we present a taxonomy of MAC protocols based on their use of WuR technology and identify their bottlenecks to be used in IBSN applications. Furthermore, we present a number of open research challenges and requirements for designing an energy-efficient and reliable wireless communication protocol for IBSN.

21 CFR 882.5820 - Implanted cerebellar stimulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted...

21 CFR 882.5820 - Implanted cerebellar stimulator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted...

Brainjacking: Implant Security Issues in Invasive Neuromodulation.

PubMed

Pycroft, Laurie; Boccard, Sandra G; Owen, Sarah L F; Stein, John F; Fitzgerald, James J; Green, Alexander L; Aziz, Tipu Z

2016-08-01

The security of medical devices is critical to good patient care, especially when the devices are implanted. In light of recent developments in information security, there is reason to be concerned that medical implants are vulnerable to attack. The ability of attackers to exert malicious control over brain implants ("brainjacking") has unique challenges that we address in this review, with particular focus on deep brain stimulation implants. To illustrate the potential severity of this risk, we identify several mechanisms through which attackers could manipulate patients if unauthorized access to an implant can be achieved. These include blind attacks in which the attacker requires no patient-specific knowledge and targeted attacks that require patient-specific information. Blind attacks include cessation of stimulation, draining implant batteries, inducing tissue damage, and information theft. Targeted attacks include impairment of motor function, alteration of impulse control, modification of emotions or affect, induction of pain, and modulation of the reward system. We also discuss the limitations inherent in designing implants and the trade-offs that must be made to balance device security with battery life and practicality. We conclude that researchers, clinicians, manufacturers, and regulatory bodies should cooperate to minimize the risk posed by brainjacking. Copyright © 2016 Elsevier Inc. All rights reserved.

Orbital Wall Reconstruction with Two-Piece Puzzle 3D Printed Implants: Technical Note

PubMed Central

Mommaerts, Maurice Y.; Büttner, Michael; Vercruysse, Herman; Wauters, Lauri; Beerens, Maikel

2015-01-01

The purpose of this article is to describe a technique for secondary reconstruction of traumatic orbital wall defects using titanium implants that act as three-dimensional (3D) puzzle pieces. We present three cases of large defect reconstruction using implants produced by Xilloc Medical B.V. (Maastricht, the Netherlands) with a 3D printer manufactured by LayerWise (3D Systems; Heverlee, Belgium), and designed using the biomedical engineering software programs ProPlan and 3-Matic (Materialise, Heverlee, Belgium). The smaller size of the implants allowed sequential implantation for the reconstruction of extensive two-wall defects via a limited transconjunctival incision. The precise fit of the implants with regard to the surrounding ledges and each other was confirmed by intraoperative 3D imaging (Mobile C-arm Systems B.V. Pulsera, Philips Medical Systems, Eindhoven, the Netherlands). The patients showed near-complete restoration of orbital volume and ocular motility. However, challenges remain, including traumatic fat atrophy and fibrosis. PMID:26889349

Evolution and acceptability of medical applications of RFID implants among early users of technology.

PubMed

Smith, Alan D

2007-01-01

RFID as a wireless identification technology that may be combined with microchip implants have tremendous potential in today's market. Although these implants have their advantages and disadvantages, recent improvements how allowed for implants designed for humans. Focus was given to the use of RFID tags and its effects on technology and CRM through a case study on VeriChip, the only corporation to hold the rights and the patent to the implantable chip for humans, and an empirically based study on working professionals to measure perceptions by early adopters of such technology. Through hypotheses-testing procedures, it was found that although some resistance to accept microchip implants was found in several applications, especially among gender, it was totally expected that healthcare and medical record keeping activities would be universally treated in a positive light and the use of authorities (namely governmental agencies) would be equally treated in a negative light by both sexes. Future trends and recommendations are presented along with statistical results collected through personal interviews.

Modular adaptive implant based on smart materials.

PubMed

Bîzdoacă, N; Tarniţă, Daniela; Tarniţă, D N

2008-01-01

Applications of biological methods and systems found in nature to the study and design of engineering systems and modern technology are defined as Bionics. The present paper describes a bionics application of shape memory alloy in construction of orthopedic implant. The main idea of this paper is related to design modular adaptive implants for fractured bones. In order to target the efficiency of medical treatment, the implant has to protect the fractured bone, for the healing period, undertaking much as is possible from the daily usual load of the healthy bones. After a particular stage of healing period is passed, using implant modularity, the load is gradually transferred to bone, assuring in this manner a gradually recover of bone function. The adaptability of this design is related to medical possibility of the physician to made the implant to correspond to patient specifically anatomy. Using a CT realistic numerical bone models, the mechanical simulation of different types of loading of the fractured bones treated with conventional method are presented. The results are commented and conclusions are formulated.

Computer-based auditory phoneme discrimination training improves speech recognition in noise in experienced adult cochlear implant listeners.

PubMed

Schumann, Annette; Serman, Maja; Gefeller, Olaf; Hoppe, Ulrich

2015-03-01

Specific computer-based auditory training may be a useful completion in the rehabilitation process for cochlear implant (CI) listeners to achieve sufficient speech intelligibility. This study evaluated the effectiveness of a computerized, phoneme-discrimination training programme. The study employed a pretest-post-test design; participants were randomly assigned to the training or control group. Over a period of three weeks, the training group was instructed to train in phoneme discrimination via computer, twice a week. Sentence recognition in different noise conditions (moderate to difficult) was tested pre- and post-training, and six months after the training was completed. The control group was tested and retested within one month. Twenty-seven adult CI listeners who had been using cochlear implants for more than two years participated in the programme; 15 adults in the training group, 12 adults in the control group. Besides significant improvements for the trained phoneme-identification task, a generalized training effect was noted via significantly improved sentence recognition in moderate noise. No significant changes were noted in the difficult noise conditions. Improved performance was maintained over an extended period. Phoneme-discrimination training improves experienced CI listeners' speech perception in noise. Additional research is needed to optimize auditory training for individual benefit.

[Regional networking of medical and vocational rehabilitation-- the bad Krozingen model].

PubMed

Kinne, G; Elsässer, D; Best, S; Jost, S; Zschache, R

2002-10-01

Regional networking facilitates flexible and individual integration of vocational programmes in medical rehabilitation. We present a pilot project of Theresienklinik II in cooperation with the Education centre for occupation and health (Bildungszentrum Beruf und Gesundheit) in Bad Krozingen. Orthopaedic and cardiac patients who are in danger to lose their capacity to work, participate in an integrated vocational reorientation programme during extended medical rehabilitation. The aim of the pilot project is an early assessment of motivation, work hardening, aptitude and interest, in order to accelerate vocational retraining and reintegration. Within one year 30 patients participated in the programme. Presented are the contents and course of the pilot project. First results show a high patient satisfaction with the programme.

Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland.

PubMed

Gibson, Irene; Flaherty, Gerard; Cormican, Sarah; Jones, Jennifer; Kerins, Claire; Walsh, Anne Marie; Costello, Caroline; Windle, Jane; Connolly, Susan; Crowley, James

2014-03-01

The aim of this observational, descriptive study is to evaluate the impact of an intensive, evidence-based preventive cardiology programme on medical and lifestyle risk factors in patients at high risk of developing cardiovascular disease (CVD). Increased CVD risk patients and their family members/partners were invited to attend a 16-week programme consisting of a professional multidisciplinary lifestyle intervention, with appropriate risk factor and therapeutic management in a community setting. Smoking, dietary habits, physical activity levels, waist circumference and body mass index, and medical risk factors were measured at initial assessment, at end of programme, and at 1-year follow up. Adherence to the programme was high, with 375 (87.2%) participants and 181 (84.6%) partners having completed the programme, with 1-year data being obtained from 235 (93.6%) patients and 107 (90.7%) partners. There were statistically significant improvements in both lifestyle (body mass index, waist circumference, physical activity, Mediterranean diet score, fish, fruit, and vegetable consumption, smoking cessation rates), psychosocial (anxiety and depression scales and quality of life indices), and medical risk factors (blood pressure, lipid and glycaemic targets) between baseline and end of programme, with these improvements being sustained at 1-year follow up. These findings demonstrate how a holistic model of CVD prevention can improve cardiovascular risk factors by achieving healthier lifestyles and optimal medical management.

Medical monitoring of asbestos-exposed workers: experience from Poland

PubMed Central

Szeszenia-Dąbrowska, Neonila; Wilczyńska, Urszula

2016-01-01

Abstract In Poland, the use of asbestos was banned in 1997 and asbestos plants have been closed since then. Despite their closure, cases of asbestos-related occupational diseases among former asbestos workers are still being recorded in the Central Register of Occupational Diseases. Between 2001 and 2014, there were 2726 asbestos-related illnesses, classified and reported as diseases associated with occupational exposure to asbestos. In 2000, Poland introduced a programme called Amiantus, targeted at former asbestos-processing plant workers. The programme provided periodic medical examinations to workers and free access to medications for treatment of asbestos-related illnesses. Introduction of the programme provided additional data to generate a reliable estimation of the number of asbestos-related occupational diseases, including cancer. The average latency period for asbestosis, lung cancer and mesothelioma is about 40 years so there may still be some health impact to former workers necessitating follow-up. We present the Polish experience of implementing a medical examination programme for asbestos-exposed workers and provide a list of activities to consider when planning for such a programme. PMID:27516637

Medical monitoring of asbestos-exposed workers: experience from Poland.

PubMed

Świątkowska, Beata; Szeszenia-Dąbrowska, Neonila; Wilczyńska, Urszula

2016-08-01

In Poland, the use of asbestos was banned in 1997 and asbestos plants have been closed since then. Despite their closure, cases of asbestos-related occupational diseases among former asbestos workers are still being recorded in the Central Register of Occupational Diseases. Between 2001 and 2014, there were 2726 asbestos-related illnesses, classified and reported as diseases associated with occupational exposure to asbestos. In 2000, Poland introduced a programme called Amiantus, targeted at former asbestos-processing plant workers. The programme provided periodic medical examinations to workers and free access to medications for treatment of asbestos-related illnesses. Introduction of the programme provided additional data to generate a reliable estimation of the number of asbestos-related occupational diseases, including cancer. The average latency period for asbestosis, lung cancer and mesothelioma is about 40 years so there may still be some health impact to former workers necessitating follow-up. We present the Polish experience of implementing a medical examination programme for asbestos-exposed workers and provide a list of activities to consider when planning for such a programme.

An Implantable Wireless Neural Interface System for Simultaneous Recording and Stimulation of Peripheral Nerve with a Single Cuff Electrode.

PubMed

Shon, Ahnsei; Chu, Jun-Uk; Jung, Jiuk; Kim, Hyungmin; Youn, Inchan

2017-12-21

Recently, implantable devices have become widely used in neural prostheses because they eliminate endemic drawbacks of conventional percutaneous neural interface systems. However, there are still several issues to be considered: low-efficiency wireless power transmission; wireless data communication over restricted operating distance with high power consumption; and limited functionality, working either as a neural signal recorder or as a stimulator. To overcome these issues, we suggest a novel implantable wireless neural interface system for simultaneous neural signal recording and stimulation using a single cuff electrode. By using widely available commercial off-the-shelf (COTS) components, an easily reconfigurable implantable wireless neural interface system was implemented into one compact module. The implantable device includes a wireless power consortium (WPC)-compliant power transmission circuit, a medical implant communication service (MICS)-band-based radio link and a cuff-electrode path controller for simultaneous neural signal recording and stimulation. During in vivo experiments with rabbit models, the implantable device successfully recorded and stimulated the tibial and peroneal nerves while communicating with the external device. The proposed system can be modified for various implantable medical devices, especially such as closed-loop control based implantable neural prostheses requiring neural signal recording and stimulation at the same time.

An Implantable Wireless Neural Interface System for Simultaneous Recording and Stimulation of Peripheral Nerve with a Single Cuff Electrode

PubMed Central

Shon, Ahnsei; Chu, Jun-Uk; Jung, Jiuk; Youn, Inchan

2017-01-01

Recently, implantable devices have become widely used in neural prostheses because they eliminate endemic drawbacks of conventional percutaneous neural interface systems. However, there are still several issues to be considered: low-efficiency wireless power transmission; wireless data communication over restricted operating distance with high power consumption; and limited functionality, working either as a neural signal recorder or as a stimulator. To overcome these issues, we suggest a novel implantable wireless neural interface system for simultaneous neural signal recording and stimulation using a single cuff electrode. By using widely available commercial off-the-shelf (COTS) components, an easily reconfigurable implantable wireless neural interface system was implemented into one compact module. The implantable device includes a wireless power consortium (WPC)-compliant power transmission circuit, a medical implant communication service (MICS)-band-based radio link and a cuff-electrode path controller for simultaneous neural signal recording and stimulation. During in vivo experiments with rabbit models, the implantable device successfully recorded and stimulated the tibial and peroneal nerves while communicating with the external device. The proposed system can be modified for various implantable medical devices, especially such as closed-loop control based implantable neural prostheses requiring neural signal recording and stimulation at the same time. PMID:29267230

Medical Textiles as Vascular Implants and Their Success to Mimic Natural Arteries

PubMed Central

Singh, Charanpreet; Wong, Cynthia S.; Wang, Xungai

2015-01-01

Vascular implants belong to a specialised class of medical textiles. The basic purpose of a vascular implant (graft and stent) is to act as an artificial conduit or substitute for a diseased artery. However, the long-term healing function depends on its ability to mimic the mechanical and biological behaviour of the artery. This requires a thorough understanding of the structure and function of an artery, which can then be translated into a synthetic structure based on the capabilities of the manufacturing method utilised. Common textile manufacturing techniques, such as weaving, knitting, braiding, and electrospinning, are frequently used to design vascular implants for research and commercial purposes for the past decades. However, the ability to match attributes of a vascular substitute to those of a native artery still remains a challenge. The synthetic implants have been found to cause disturbance in biological, biomechanical, and hemodynamic parameters at the implant site, which has been widely attributed to their structural design. In this work, we reviewed the design aspect of textile vascular implants and compared them to the structure of a natural artery as a basis for assessing the level of success as an implant. The outcome of this work is expected to encourage future design strategies for developing improved long lasting vascular implants. PMID:26133386

Developing a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens (MEMORABLE)--a realist synthesis.

PubMed

Maidment, Ian; Booth, Andrew; Mullan, Judy; McKeown, Jane; Bailey, Sylvia; Wong, Geoffrey

2017-07-03

Medication-related adverse events have been estimated to be responsible for 5700 deaths and cost the UK £750 million annually. This burden falls disproportionately on older people. Outcomes from interventions to optimise medication management are caused by multiple context-sensitive mechanisms. The MEdication Management in Older people: REalist Approaches BAsed on Literature and Evaluation (MEMORABLE) project uses realist synthesis to understand how, why, for whom and in what context interventions, to improve medication management in older people on complex medication regimes residing in the community, work. This realist synthesis uses secondary data and primary data from interviews to develop the programme theory. A realist logic of analysis will synthesise data both within and across the two data sources to inform the design of a complex intervention(s) to help improve medication management in older people. 1. Literature review The review (using realist synthesis) contains five stages to develop an initial programme theory to understand why processes are more or less successful and under which situations: focussing of the research question; developing the initial programme theory; developing the search strategy; selection and appraisal based on relevance and rigour; and data analysis/synthesis to develop and refine the programme theory and context, intervention and mechanism configurations. 2. Realist interviews Realist interviews will explore and refine our understanding of the programme theory developed from the realist synthesis. Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff will be interviewed. 3. Developing framework for the intervention(s) Data from the realist synthesis and interviews will be used to refine the programme theory for the intervention(s) to identify: the mechanisms that need to be 'triggered', and the contexts related to these mechanisms. Intervention strategies that change the contexts so the mechanisms are triggered to produce desired outcomes will be developed. Feedback on these strategies will be obtained. This realist synthesis aims to develop a framework (underpinned by our programme theory) for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens. PROSPERO CRD42016043506.

An Irish Experience in Establishing and Evaluating an Intern Led Teaching Programme.

PubMed

Jenkinson, A; Kelleher, E; Moneley, D; Offiah, G

2017-03-10

Near-Peer Teaching is a relatively new and expanding area of medical education. The benefit to medical students has been demonstrated in numerous contexts around the world. Our aim was to establish a structured Intern-Led Teaching (ILT) programme in the context of an Irish Intern Training Network affiliated to an Irish Medical School. We then sought to evaluate the success of this programme. Seventy interns were enrolled in the ILT programme and completed a Train the Trainer course involving teaching methods and skills of effective feedback. Following this, the intern tutors delivered several one-hour teaching sessions in small groups to final year medical students on a weekly basis. At the end of each teaching block, a feedback questionnaire was distributed to participating students to evaluate their experiences of this new teaching modality. Tutorial topics were varied. They included clinical examination, history taking, prescribing, and emergencies. Eighty-one percent of students found the intern-led tutorials to be beneficial compared to tutorials run by more senior doctors. Additionally, students felt that with intern led tutorials they could ask questions they otherwise would not. There was a more comfortable environment, and information taught was considered more relevant. A significant number of students felt less nervous about the final medical examinations after the intern-led tutorials. The establishment of a structured intern-led teaching programme was well received by final year medical students. This project shows that interns are a valuable teaching resource in the medical school and should be included in medical schools' curricula.

In Vivo Self-Powered Wireless Cardiac Monitoring via Implantable Triboelectric Nanogenerator.

PubMed

Zheng, Qiang; Zhang, Hao; Shi, Bojing; Xue, Xiang; Liu, Zhuo; Jin, Yiming; Ma, Ye; Zou, Yang; Wang, Xinxin; An, Zhao; Tang, Wei; Zhang, Wei; Yang, Fan; Liu, Yang; Lang, Xilong; Xu, Zhiyun; Li, Zhou; Wang, Zhong Lin

2016-07-26

Harvesting biomechanical energy in vivo is an important route in obtaining sustainable electric energy for powering implantable medical devices. Here, we demonstrate an innovative implantable triboelectric nanogenerator (iTENG) for in vivo biomechanical energy harvesting. Driven by the heartbeat of adult swine, the output voltage and the corresponding current were improved by factors of 3.5 and 25, respectively, compared with the reported in vivo output performance of biomechanical energy conversion devices. In addition, the in vivo evaluation of the iTENG was demonstrated for over 72 h of implantation, during which the iTENG generated electricity continuously in the active animal. Due to its excellent in vivo performance, a self-powered wireless transmission system was fabricated for real-time wireless cardiac monitoring. Given its outstanding in vivo output and stability, iTENG can be applied not only to power implantable medical devices but also possibly to fabricate a self-powered, wireless healthcare monitoring system.

Fluocinolone acetonide implant (Retisert) for chronic cystoid macular edema in two patients with AIDS and a history of cytomegalovirus retinitis.

PubMed

Hu, Jianmin; Coassin, Marco; Stewart, Jay M

2011-06-01

To report the authors' experience using fluocinolone acetonide (Retisert) to treat cystoid macular edema (CME) resulting from immune recovery uveitis (IRU) in 2 acquired immunodeficiency syndrome (AIDS) patients with a history of cytomegalovirus (CMV) retinitis. Interventional case series. Medical records were reviewed of 2 patients who received Retisert implantation in 3 eyes for IRU-associated inflammation and CME. Suppression of CMV disease was achieved with oral medication in one patient and with simultaneous implantation of a ganciclovir implant in the other patient. After Retisert implantation in 3 eyes in AIDS patients on HAART, improvement in CME was seen in 2 eyes. No CMV reactivation was detected during the several-month follow-up period. Retisert may be an effective treatment for CME in AIDS patients with IRU reactivation and a history of CMV retinitis.

Surgically Induced Scleral Necrosis in a Patient With Rheumatoid Arthritis After AGV Implantation.

PubMed

Kumar, Suresh; Ichhpujani, Parul; Thakur, Sahil

2018-03-01

Surgically induced scleral necrosis (SINS) is a rare entity that has till date not been reported in a patient of glaucoma undergoing Ahmed glaucoma valve (AGV) implantation. We present a case of primary open-angle glaucoma who underwent AGV implantation followed by development of scleral necrosis, involving both the scleral patch graft and host sclera. After failure of surgical and medical management, AGV had to be explanted. The patient was diagnosed with rheumatoid arthritis and had to be treated with steroids and azathioprine for the same. SINS is a potentially disastrous complication of ocular surgery that can occur in patients with systemic diseases like rheumatoid arthritis and requires aggressive management to salvage the eye. SINS can occur with AGV implantation. Treatment may require aggressive medical and surgical intervention. It is imperative to evaluate patients for systemic illness before planning an AGV implant.

21 CFR 882.5225 - Implanted malleable clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted malleable clip. 882.5225 Section 882.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip...

21 CFR 882.5225 - Implanted malleable clip.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted malleable clip. 882.5225 Section 882.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip...

21 CFR 876.3630 - Penile rigidity implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a...

21 CFR 878.4750 - Implantable staple.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple. (a...

21 CFR 878.4750 - Implantable staple.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple. (a...

21 CFR 878.4750 - Implantable staple.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple. (a...

21 CFR 878.4300 - Implantable clip.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip. (a...

21 CFR 878.4300 - Implantable clip.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip. (a...

21 CFR 878.4300 - Implantable clip.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip. (a...

21 CFR 878.4300 - Implantable clip.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip. (a...

21 CFR 878.4300 - Implantable clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip. (a...

21 CFR 878.4750 - Implantable staple.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple. (a...

21 CFR 878.4750 - Implantable staple.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple. (a...

Numb chin syndrome as a manifestation of possible breast cancer metastasis around dental implants.

PubMed

Orhan, Kaan; Bayndr, Hakan; Aksoy, Seçil; Seker, Basak Kusakci; Berberoğlu, Atilla; Ozan, Oğuz

2011-05-01

Numb chin syndrome, sometimes called numb lip syndrome, is an uncommon but well-recognized symptom in medical oncology. It may be a metastatic neurologic manifestation of malignancy, often with no clinically visible pathologic finding. The authors report a numb chin syndrome as a manifestation possible breast cancer metastasis around dental implants in a 69-year-old woman. The patient was presented with complaint of numbness in the lower jaw. Medical anamnesis revealed a metastatic breast carcinoma (CA). Radiographic imaging with conventional panoramic radiography and cone beam computed tomographic examination, revealed a moth-eaten shape, radiolucent, and radiopaque mixed appearance around the dental implants that was related with possible metastasis of the breast cancer. Numb chin syndrome is almost unknown within the dental and oral and maxillofacial community, despite being well reported in the medical literature. General dentists, oral medicine specialists, and oral and maxillofacial surgeons must be aware of this condition to consider metastatic cancer in patients with unexplained facial hypoesthesia. Moreover, although the development of metastatic lesions around implants is an uncommon pathologic finding, the examination of peri-implant lesion should be performed carefully considering the entire pathologic situations.

Contribution of medical colleges to tuberculosis control in India under the Revised National Tuberculosis Control Programme (RNTCP): Lessons learnt & challenges ahead

PubMed Central

Sharma, Surendra K.; Mohan, Alladi; Chauhan, L.S.; Narain, J.P.; Kumar, P.; Behera, D.; Sachdeva, K.S.; Kumar, Ashok

2013-01-01

Medical college faculty, who are academicians are seldom directly involved in the implementation of national public health programmes. More than a decade ago for the first time in the global history of tuberculosis (TB) control, medical colleges of India were involved in the Revised National TB Control Programme (RNTCP) of Government of India (GOI). This report documents the unique and extraordinary course of events that led to the involvement of medical colleges in the RNTCP of GOI. It also reports the contributions made by the medical colleges to TB control in India. For more than a decade, medical colleges have been providing diagnostic services (Designated Microscopy Centres), treatment [Directly Observed Treatment (DOT) Centres] referral for treatment, recording and reporting data, carrying out advocacy for RNTCP and conducting operational research relevant to RNTCP. Medical colleges are contributing to diagnosis and treatment of human immunodeficiency virus (HIV)-TB co-infection and development of laboratory infrastructure for early diagnosis of multidrug-resistant and/or extensively drug-resistant TB (M/XDR-TB) and DOTS-Plus sites for treatment of MDR-TB cases. Overall, at a national level, medical colleges have contributed to 25 per cent of TB suspects referred for diagnosis; 23 per cent of ‘new smear-positives’ diagnosed; 7 per cent of DOT provision within medical college; and 86 per cent treatment success rate among new smear-positive patients. As the Programme widens its scope, future challenges include sustenance of this contribution and facilitating universal access to quality TB care; greater involvement in operational research relevant to the Programme needs; and better co-ordination mechanisms between district, state, zonal and national level to encourage their involvement. PMID:23563371

A hydrogel actuator with flexible folding deformation and shape programming via using sodium carboxymethyl cellulose and acrylic acid.

PubMed

Wu, Shuiping; Yu, Feng; Dong, Hua; Cao, Xiaodong

2017-10-01

Hydrogel actuator is an intelligent material, which can work as artificial muscle. However, most present hydrogel actuators, due to the inferior mechanical property and uncontrolled folding property, have always resulted in slipping off or the failure of grasping an object with specific shape and required weight. In order to solve this problem, here a tough hydrogel actuator with programmable folding deformation has been prepared by combining the "selective implanting method" and "ionic coordination". The shape and folding angle (from 0 to 180 o ) of hydrogel actuator can be precisely controlled by altering the location and size of the implanting parts that seems like the joints of finger. The ionic coordination is not only the force to trigger the folding of hydrogel, but also utilized to reinforce the mechanical property. We believed the superior mechanical and shape-programmable property can endow the hydrogel actuator with great application prospect in soft machine. Copyright © 2017 Elsevier Ltd. All rights reserved.

iStent as a Solo Procedure for Glaucoma Patients: A Systematic Review and Meta-Analysis.

PubMed

Malvankar-Mehta, Monali S; Chen, Yufeng Nancy; Iordanous, Yiannis; Wang, Wan Wendy; Costella, John; Hutnik, Cindy M L

2015-01-01

Glaucoma is a leading cause of irreversible blindness. It is firmly entrenched in the traditional treatment paradigm to start with pharmacotherapy. However, pharmacotherapy is not benign and has been well documented to have a number of significant challenges. Minimally invasive glaucoma surgery (MIGS) that targets the outflow pathway with minimal to no scleral dissection has resulted in the need to reconsider the glaucoma treatment paradigm. To perform a systematic review and meta-analysis to evaluate and quantify the effect on post-operative intraocular pressure (IOP) and number of topical glaucoma medications, in patients receiving the iStent MIGS device as the solo procedure without concurrent cataract surgery. A systematic review was conducted by searching various databases between January 1, 2000, and June 30, 2014. Studies reporting up to a maximum follow-up period of 24 months were retrieved and screened using the EPPI-Reviewer 4 gateway. Percentage reduction in IOP (IOPR%), and mean reduction in topical glaucoma medications after surgery were computed. Meta-analysis was performed using STATA v. 13.0. The standardized mean difference (SMD) was calculated as the effect size for continuous scale outcomes. Heterogeneity was determined using the I2 statistics, Z-value, and χ2 statistics. Fixed-effect and random-effect models were developed based on heterogeneity. Sub-group analysis was performed based on the number of iStents implanted and the follow-up period. The outcome measures were changes in the IOP and number of glaucoma medications. The search strategy identified 105 records from published literature and 9 records from the grey literature. Five studies with 248 subjects were included for quantitative synthesis. A 22% IOP reduction (IOPR%) from baseline occurred at 18-months after one iStent implant, 30% at 6-months after two iStents implantations, and 40% at 6-months after implantation of three iStents. A mean reduction of 1.2 bottles per patient of topical glaucoma medications occurred at 18-months after one iStent implant, 1.45 bottles per patient at 6-months after two iStents, and one bottle of medication per patient was reduced at 6-months following placement of three iStents implants. Meta-analysis results showed a significant reduction in the IOP after one iStent (SMD = -1.68, 95% CI: [-2.7, -0.61]), two iStents (SMD = -1.88, 95% CI: [-2.2, -1.56]), and three iStents (SMD = -2, 95% CI: [-2.62, -1.38]) implantation. Results showed a significant drop in the topical glaucoma medications after one iStent (SMD = -2.11, CI: [-3.95, -0.27]), two iStent (SMD = -1.88, CI: [-2.20, -1.56]), and three iStents (SMD = -2.00, CI: [-2.62, -1.38]) implantation. The maximum reduction in IOP occurred at 12-months (SMD = -2.21, CI: [-2.53, -1.88]) and a significant reduction in post-operative topical glaucoma medications occurred even after 18-months of iStent implantation (SMD = -0.71, CI: [-1.15, -0.26]). iStent implantation as a solo procedure without concurrent cataract extraction does lower IOP, and reduces the dependency on glaucoma medications. This effect seems to last at least 18 months.

Preventing deaths and injuries from house fires: a cost–benefit analysis of a community-based smoke alarm installation programme

PubMed Central

Yellman, Merissa A; Peterson, Cora; McCoy, Mary A; Stephens-Stidham, Shelli; Caton, Emily; Barnard, Jeffrey J; Padgett, Ted O; Florence, Curtis; Istre, Gregory R

2017-01-01

Background Operation Installation (OI), a community-based smoke alarm installation programme in Dallas, Texas, targets houses in high-risk urban census tracts. Residents of houses that received OI installation (or programme houses) had 68% fewer medically treated house fire injuries (non-fatal and fatal) compared with residents of non-programme houses over an average of 5.2 years of follow-up during an effectiveness evaluation conducted from 2001 to 2011. Objective To estimate the cost–benefit of OI. Methods A mathematical model incorporated programme cost and effectiveness data as directly observed in OI. The estimated cost per smoke alarm installed was based on a retrospective analysis of OI expenditures from administrative records, 2006–2011. Injury incidence assumptions for a population that had the OI programme compared with the same population without the OI programme was based on the previous OI effectiveness study, 2001–2011. Unit costs for medical care and lost productivity associated with fire injuries were from a national public database. Results From a combined payers’ perspective limited to direct programme and medical costs, the estimated incremental cost per fire injury averted through the OI installation programme was $128,800 (2013 US$). When a conservative estimate of lost productivity among victims was included, the incremental cost per fire injury averted was negative, suggesting long-term cost savings from the programme. The OI programme from 2001 to 2011 resulted in an estimated net savings of $3.8 million, or a $3.21 return on investment for every dollar spent on the programme using a societal cost perspective. Conclusions Community smoke alarm installation programmes could be cost-beneficial in high-fire-risk neighbourhoods. PMID:28183740

Ultrafine-grained titanium for medical implants

DOEpatents

Zhu, Yuntian T.; Lowe, Terry C.; Valiev, Ruslan Z.; Stolyarov, Vladimir V.; Latysh, Vladimir V.; Raab, Georgy J.

2002-01-01

We disclose ultrafine-grained titanium. A coarse-grained titanium billet is subjected to multiple extrusions through a preheated equal channel angular extrusion (ECAE) die, with billet rotation between subsequent extrusions. The resulting billet is cold processed by cold rolling and/or cold extrusion, with optional annealing. The resulting ultrafine-grained titanium has greatly improved mechanical properties and is used to make medical implants.

Graphite Oxide to Graphene. Biomaterials to Bionics.

PubMed

Thompson, Brianna C; Murray, Eoin; Wallace, Gordon G

2015-12-09

The advent of implantable biomaterials has revolutionized medical treatment, allowing the development of the fields of tissue engineering and medical bionic devices (e.g., cochlea implants to restore hearing, vagus nerve stimulators to control Parkinson's disease, and cardiac pace makers). Similarly, future materials developments are likely to continue to drive development in treatment of disease and disability, or even enhancing human potential. The material requirements for implantable devices are stringent. In all cases they must be nontoxic and provide appropriate mechanical integrity for the application at hand. In the case of scaffolds for tissue regeneration, biodegradability in an appropriate time frame may be required, and for medical bionics electronic conductivity is essential. The emergence of graphene and graphene-family composites has resulted in materials and structures highly relevant to the expansion of the biomaterials inventory available for implantable medical devices. The rich chemistries available are able to ensure properties uncovered in the nanodomain are conveyed into the world of macroscopic devices. Here, the inherent properties of graphene, along with how graphene or structures containing it interface with living cells and the effect of electrical stimulation on nerves and cells, are reviewed. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Optimization of Vertical Double-Diffused Metal-Oxide Semiconductor (VDMOS) Power Transistor Structure for Use in High Frequencies and Medical Devices

PubMed Central

Farhadi, Rozita; Farhadi, Bita

2014-01-01

Power transistors, such as the vertical, double-diffused, metal-oxide semiconductor (VDMOS), are used extensively in the amplifier circuits of medical devices. The aim of this research was to construct a VDMOS power transistor with an optimized structure to enhance the operation of medical devices. First, boron was implanted in silicon by implanting unclamped inductive switching (UIS) and a Faraday shield. The Faraday shield was implanted in order to replace the gate-field parasitic capacitor on the entry part of the device. Also, implanting the UIS was used in order to decrease the effect of parasitic bipolar junction transistor (BJT) of the VDMOS power transistor. The research tool used in this study was Silvaco software. By decreasing the transistor entry resistance in the optimized VDMOS structure, power losses and noise at the entry of the transistor were decreased, and, by increasing the breakdown voltage, the lifetime of the VDMOS transistor lifetime was increased, which resulted in increasing drain flow and decreasing Ron. This consequently resulted in enhancing the operation of high-frequency medical devices that use transistors, such as Radio Frequency (RF) and electrocardiograph machines. PMID:25763152

Optimization of Vertical Double-Diffused Metal-Oxide Semiconductor (VDMOS) Power Transistor Structure for Use in High Frequencies and Medical Devices.

PubMed

Farhadi, Rozita; Farhadi, Bita

2014-01-01

Power transistors, such as the vertical, double-diffused, metal-oxide semiconductor (VDMOS), are used extensively in the amplifier circuits of medical devices. The aim of this research was to construct a VDMOS power transistor with an optimized structure to enhance the operation of medical devices. First, boron was implanted in silicon by implanting unclamped inductive switching (UIS) and a Faraday shield. The Faraday shield was implanted in order to replace the gate-field parasitic capacitor on the entry part of the device. Also, implanting the UIS was used in order to decrease the effect of parasitic bipolar junction transistor (BJT) of the VDMOS power transistor. The research tool used in this study was Silvaco software. By decreasing the transistor entry resistance in the optimized VDMOS structure, power losses and noise at the entry of the transistor were decreased, and, by increasing the breakdown voltage, the lifetime of the VDMOS transistor lifetime was increased, which resulted in increasing drain flow and decreasing Ron. This consequently resulted in enhancing the operation of high-frequency medical devices that use transistors, such as Radio Frequency (RF) and electrocardiograph machines.

Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

PubMed Central

Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

2011-01-01

Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5

Training a medical workforce to meet the needs of diverse minority communities.

PubMed

Sopoaga, Faafetai; Zaharic, Tony; Kokaua, Jesse; Covello, Sahra

2017-01-21

The growing demand for a competent health workforce to meet the needs of increasingly diverse societies has been widely acknowledged. One medical school in New Zealand explored the integration of the commonly used patient-centred model approach, with an intersectional framework in the development of a cultural competency training programme. In the Pacific Immersion Programme, medical students in their fourth year of training are given the opportunity to learn about different factors that influence the health and health care of a minority community through immersion in that community. The programme objectives include enabling students to learn through experience living within the local community context, and supporting them to re-evaluate their own personal beliefs, assumptions and/or prior prejudices. This study evaluates the usefulness of this programme in the training of medical students to work in diverse communities. Two analytical approaches were used for evaluation. Deductive and inductive analyses were conducted on 235 reflective essays completed by three cohorts of students from 2011 to 2013 to ascertain the value of the programme for student learning. In addition, one cohort was invited to complete a pre and post-programme questionnaire. Overall, the students found the programme to be a valued learning environment. They found living within a Pacific family environment to be an eye opening experience. It increased students comfort level in cross cultural engagement and emphasised the importance of patient's perspectives in health care provision. Students' self-reported knowledge about Pacific cultural values, protocols, traditional beliefs and the main health challenges increased significantly after the programme. They appreciated learning directly from community members, and through observations about how culture, beliefs and the socio-economic environment influence peoples' health and wellbeing. Medical schools are required to train a competent health workforce to meet the needs of diverse communities. The Pacific Immersion Programme provides a unique learning environment which can improve the training of doctors to work in diverse communities. The key to its success is enabling students to be engaged learners from "the inside" rather than an "outsider looking in". The Programme enables experiential learning in a sensitive and meaningful way and can be useful for training in other institutions.

Progestin-based contraceptive on the same day as medical abortion.

PubMed

Park, Jeanna; Robinson, Nuriya; Wessels, Ursula; Turner, James; Geller, Stacie

2016-05-01

To determine the success rate of medical abortion when a progestin-based contraceptive-either an etonogestrel implant or depot medroxyprogesterone acetate (DMPA) injection-is given on the same day as mifepristone for medical abortion. In a retrospective chart review, data were assessed for women aged 15-49years who underwent medical abortion (≤63days of pregnancy) at two hospitals in KwaZulu Natal, South Africa, between August 2013 and July 2014. The women were given oral mifepristone (200mg) and buccal misoprostol (800μg), and received an etonogestrel implant or DMPA injection on the same day as mifepristone. The primary outcome was the success rate of medical abortion. Comparative data were obtained through a PubMed search. A total of 89 women were included. Complete termination was achieved in 87 (98%, 95% confidence interval 95%-100%) women. This success rate is similar to that reported in a previous systematic review of the rate of medical abortion success without progestin contraceptive administration (94.8%). Administration of a progestin-based contraceptive such as an etonogestrel implant or DMPA injection on the same day as mifepristone for medical abortion did not alter the success rates. Published by Elsevier Ireland Ltd.

Fitness to practice of medical graduates: one programme's approach.

PubMed

Braatvedt, Claire; Poole, Phillippa; Merry, Alan; Gorman, Des; Reid, Papaarangi; Bagg, Warwick

2014-11-07

Doctors must ensure they are fit to practise medicine. There is a relationship between unprofessional behaviour at medical school and in subsequent medical practice. This study describes one programme's Fitness to Practice (FtP) policy and outcomes since inception in 2005. FtP notifications were classified into: health or personal; professional attitudes, or external issues. Seriousness was classified as non-critical, critical or extraordinarily critical. Anonymous data were extracted and analysed from a confidential FtP database. There were 157 FtP notifications involving 132 (5.5%) students. 87.2% were for issues with professional attitudes and 80.3% were non-critical. 17 students received more than one FtP notification. Students in clinical years were over-represented (p<0.0001) as were males (57% vs. 43%: p=0.0286). 96% of students continued the programme after remedial action. Two students were excluded from the programme on FtP grounds. The national regulatory body was notified of nine individual students with the potential for on- going FtP concerns. Over 9 years, 5.5% of medical students received a FtP notification, with most of these isolated non-critical incidents of a professional nature. A small subset of students had repeated or serious concerns, underscoring the need for a FtP policy in any medical programme.

Generic learning skills in academically-at-risk medical students: a development programme bridges the gap.

PubMed

Burch, Vanessa C; Sikakana, Cynthia N T; Gunston, Geney D; Shamley, Delva R; Murdoch-Eaton, Deborah

2013-08-01

Widening access to medical students from diverse educational backgrounds is a global educational mandate. The impact, on students' generic learning skills profiles, of development programmes designed for students at risk of attrition is unknown. This study investigated the impact of a 12-month Intervention Programme (IP) on the generic learning skills profile of academically-at-risk students who, after failing at the end of the first semester, completed the IP before entering the second semester of a conventional medical training programme. This prospective study surveyed medical students admitted in 2009 and 2010, on entry and on completion of first year, on their reported practice and confidence in information handling, managing own learning, technical and numeracy, computer, organisational and presentation skills. Of 414 first year students, 80 (19%) entered the IP. Levels of practice and confidence for five of the six skills categories were significantly poorer at entry for IP students compared to conventional stream students. In four categories these differences were no longer statistically significant after students had completed the IP; 62 IP students (77.5%) progressed to second year. A 12-month development programme, the IP, effectively addressed generic learning skills deficiencies present in academically-at-risk students entering medical school.

Stakeholder views of rural community-based medical education: a narrative review of the international literature.

PubMed

Somporn, Praphun; Ash, Julie; Walters, Lucie

2018-03-30

Rural community-based medical education (RCBME), in which medical student learning activities take place within a rural community, requires students, clinical teachers, patients, community members and representatives of health and government sectors to actively contribute to the educational process. Therefore, academics seeking to develop RCBME need to understand the rural context, and the views and needs of local stakeholders. The aim of this review is to examine stakeholder experiences of RCBME programmes internationally. This narrative literature review of original research articles published after 1970 utilises Worley's symbiosis model of medical education as an analysis framework. This model proposes that students experience RCBME through their intersection with multiple clinical, social and institutional relationships. This model seeks to provide a framework for considering the intersecting relationships in which RCBME programmes are situated. Thirty RCBME programmes are described in 52 articles, representing a wide range of rural clinical placements. One-year longitudinal integrated clerkships for penultimate-year students in Anglosphere countries were most common. Such RCBME enables students to engage in work-integrated learning in a feasible manner that is acceptable to many rural clinicians and patients. Academic results are not compromised, and a few papers demonstrate quality improvement for rural health services engaged in RCBME. These programmes have delivered some rural medical workforce outcomes to communities and governments. Medical students also provide social capital to rural communities. However, these programmes have significant financial cost and risk student social and educational isolation. Rural community-based medical education programmes are seen as academically acceptable and can facilitate symbiotic relationships among students, rural clinicians, patients and community stakeholders. These relationships can influence students' clinical competency and professional identity, increase graduates' interest in rural careers, and potentially improve rural health service stability. Formal prospective stakeholder consultations should be published in the literature. © 2018 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Cochlear Implants

MedlinePlus

... learn or relearn the sense of hearing. Not everyone performs at the same level with this device. The decision to receive an implant should involve discussions with medical specialists, including an experienced ...

21 CFR 886.3320 - Eye sphere implant.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An eye...

21 CFR 886.3320 - Eye sphere implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An eye...

Advanced Biomimetic Implants Based on Nanostructured Coatings Synthesized by Pulsed Laser Technologies

NASA Astrophysics Data System (ADS)

Mihailescu, Ion N.; Ristoscu, Carmen; Bigi, Adriana; Mayer, Isaac

Calcium phosphates (CaPs) are alternative substitutes for human bones and so primary candidates for the manufacture of medical implants. Unfortunately, they do not withstand stress in bulk. To overcome this obstacle, a solution was developed to cover metallic implants with functional biomimetic layers.

Fostering research skills in undergraduate medical students through mentored students projects: example from an Indian medical school.

PubMed

Devi, V; Abraham, R R; Adiga, A; Ramnarayan, K; Kamath, A

2010-01-01

Healthcare decision-making is largely reliant on evidence-based medicine; building skills in scientific reasoning and thinking among medical students becomes an important part of medical education. Medical students in India have no formal path to becoming physicians, scientists or academicians. This study examines students' perceptions regarding research skills improvement after participating in the Mentored Student Project programme at Melaka Manipal Medical College, Manipal Campus, India. Additionally, this paper describes the initiatives taken for the continual improvement of the Mentored Student Project programme based on faculty and student perspectives. At Melaka Manipal Medical College, Mentored Student Project was implemented in the curriculum during second year of Bachelor of Medicine and Bachelor of Surgery programme with the intention of developing research skills essential to the career development of medical students. The study design was cross-sectional. To inculcate the spirit of team work students were grouped (n=3 to 5) and each group was asked to select a research project. The students' research projects were guided by their mentors. A questionnaire (Likert's five point scale) on students' perceptions regarding improvement in research skills after undertaking projects and guidance received from the mentor was administered to medical students after they had completed their Mentored Student Project. The responses of students were summarised using percentages. The median grade with inter-quartile range was reported for each item in the questionnaire. The median grade for all the items related to perceptions regarding improvement in research skills was 4 which reflected that the majority of the students felt that Mentored Student Project had improved their research skills. The problems encountered by the students during Mentored Student Project were related to time management for the Mentored Student Project and mentors. This study shows that students acknowledged that their research skills were improved after participating in the Mentored Student Project programme. The Mentored Student Project programme was successful in fostering positive attitudes among medical students towards scientific research. The present study also provides scope for further improvement of the Mentored Student Project programme based on students' and faculty perspectives.

Breaking the sound barrier: exploring parents' decision-making process of cochlear implants for their children.

PubMed

Chang, Pamara F

2017-08-01

To understand the dynamic experiences of parents undergoing the decision-making process regarding cochlear implants for their child(ren). Thirty-three parents of d/Deaf children participated in semi-structured interviews. Interviews were digitally recorded, transcribed, and coded using iterative and thematic coding. The results from this study reveal four salient topics related to parents' decision-making process regarding cochlear implantation: 1) factors parents considered when making the decision to get the cochlear implant for their child (e.g., desire to acculturate child into one community), 2) the extent to which parents' communities influence their decision-making (e.g., norms), 3) information sources parents seek and value when decision-making (e.g., parents value other parent's experiences the most compared to medical or online sources), and 4) personal experiences with stigma affecting their decision to not get the cochlear implant for their child. This study provides insights into values and perspectives that can be utilized to improve informed decision-making, when making risky medical decisions with long-term implications. With thorough information provisions, delineation of addressing parents' concerns and encompassing all aspects of the decision (i.e., medical, social and cultural), health professional teams could reduce the uncertainty and anxiety for parents in this decision-making process for cochlear implantation. Copyright © 2017 Elsevier B.V. All rights reserved.

Description and student self-evaluation of a pilot integrated small group learning and simulation programme for medical students in the first clinical year.

PubMed

Levinson, Michele; Kelly, Diane; Zahariou, Krisoula; Johnson, Matthew; Jackman, Christine; Mackenzie, Sara

2017-02-01

Contemporary education for medical students should be student-centred, integrated and contextualised. Small group learning promotes clinical reasoning and skills for lifelong learning. Simulation can provide experiential learning in a safe and controlled environment. We developed a weekly integrated problem-based learning and simulation programme (IPS) over two semesters in the first clinical year to augment clinical placement experience and contextualise theory into work-relevant practice. To evaluate the new programme at Kirkpatrick level 1. An anonymous survey of participating students. The programme was well liked. Students found the programme relevant and that they had a better understanding of patient safety and the assessment of the deteriorating patient. They felt it contributed to integration of theory and practice, clinical reasoning and the acquisition of non-technical skills, particularly affective and communication elements. This IPS programme in the first clinical year can deliver a student-centred curriculum to complement clinical placement that delivers the important requirements of contemporary medical student education. © 2016 Royal Australasian College of Physicians.

The medical physics specialization system in Poland.

PubMed

Bulski, Wojciech; Kukołowicz, Paweł; Skrzyński, Witold

2016-07-01

This paper presents the situation of the profession of medical physicists in Poland. The official recognition of the profession of medical physicist in Polish legislation was in 2002. In recent years, more and more Universities which have Physics Faculties introduce a medical physics specialty. At present, there are about 15 Universities which offer such programmes. These Universities are able to graduate about 150 medical physicists per year. In 2002, the Ministry of Health introduced a programme of postgraduate specialization in medical physics along the same rules employed in the specialization of physicians in various branches of medicine. Five institutions, mostly large oncology centres, were selected as teaching institutions, based on their experience, the quality of the medical physics professionals, staffing levels, equipment availability, lecture halls, etc. The first cycle of the specialization programme started in 2006, and the first candidates completed their training at the end of 2008, and passed their official state exams in May 2009. As of January 2016, there are 196 specialized medical physicists in Poland. Another about 120 medical physicists are undergoing specialization. The system of training of medical physics professionals in Poland is well established. The principles of postgraduate training and specialization are well defined and the curriculum of the training is very demanding. The programme of specialization was revised in 2011 and is in accordance with EC and EFOMP recommendations. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Food service programme for promoting healthy nutrition among medical cadets of Phramongkutklao College of Medicine: a preliminary study.

PubMed

Viravathana, Nantaporn

2005-11-01

To evaluate the patterns of food services and to determine the kinds and frequencies of food items served to the medical cadets. Menu records of the meals served to the medical cadets at a mess hall of Phramongkutklao College of Medicine were retrospectively reviewed, covering the period of one month of the academic year 2004. The menus were analysed using descriptive statistics. Sixty-five medical cadets participated in the food service programme by setting their own menus. The programme provided three main meals a day. In August, the studied month, it was found that some selected menus were not suitable. Only two types of foods of carbohydrate sources were used. The predominant one was milled rice (87 meals or 93.5%). At least 5 meals (5.4%) did not serve vegetables at all. As for fresh fruits, up to 16 days (51.6%) they were not served. The food service programme is a strength point for promoting healthy nutrition to medical cadets in this setting. Involvement of medical cadets by setting up their own menus can reflect very clearly undesirable eating habits. Thus, appropriate involvement of medical cadets can be a good means to help them acquire knowledge and skills in healthy nutrition practices.

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification

PubMed Central

2013-01-01

Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Methods Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medical devices in an RFID environment. The methods presented in this paper are time-consuming and burdensome and suggest the need for standard test methods for assessing the immunity of medical devices to RFID systems. PMID:23845013

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.

PubMed

Seidman, Seth J; Guag, Joshua W

2013-07-11

The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125-134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medical devices in an RFID environment. The methods presented in this paper are time-consuming and burdensome and suggest the need for standard test methods for assessing the immunity of medical devices to RFID systems.

La création et l’implantation réussie d’un outil de remédiation en résidence de médecine familiale

PubMed Central

Sanche, Gilbert; Béland, Normand; Audétat, Marie-Claude

2011-01-01

Résumé Problème à l’étude Comme dans la majorité des programmes de formation médicale post-graduée, environ 10% des résidents du programme de résidence en médecine familiale de l’Université de Montréal éprouvent des difficultés considérables dans la construction de leurs compétences. Objectif du programme Afin de mieux soutenir les enseignants du programme dans le diagnostic de ces difficultés ainsi que dans la conception, la planification et le suivi d’une stratégie de remédiation, le Comité d’évaluation du programme de résidence a conçu un outil constitué d’un plan type de remédiation et d’un guide de rédaction de ce plan. Description du programme L’outil de remédiation est constitué de 2 documents. Le premier est un plan type de remédiation constitué d’une partie contractuelle suivie de 4 sections: diagnostic pédagogique, intentions de remédiation, moyens de remédiation et évaluation de la remédiation, avec un bilan intermédiaire et un bilan final. Le deuxième est un guide de rédaction et de systématisation d’un plan de remédiation. Conclusion L’accueil favorable qu’a reçu l’outil et l’utilisation qui en a été faite durant l’année de son implantation témoignent du succès des processus que nous avions adoptés. L’appui de la faculté, le mécanisme de «co-construction» de l’outil, de même que la formation et le soutien aux utilisateurs sont des facteurs qui expliquent ce succès. Un projet de recherche est en route pour documenter l’impact qu’aura l’utilisation de cet outil dans notre programme de résidence. PMID:22170208

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

Online patient safety education programme for junior doctors: is it worthwhile?

PubMed

McCarthy, S E; O'Boyle, C A; O'Shaughnessy, A; Walsh, G

2016-02-01

Increasing demand exists for blended approaches to the development of professionalism. Trainees of the Royal College of Physicians of Ireland participated in an online patient safety programme. Study aims were: (1) to determine whether the programme improved junior doctors' knowledge, attitudes and skills relating to error reporting, open communication and care for the second victim and (2) to establish whether the methodology facilitated participants' learning. 208 junior doctors who completed the programme completed a pre-online questionnaire. Measures were "patient safety knowledge and attitudes", "medical safety climate" and "experience of learning". Sixty-two completed the post-questionnaire, representing a 30 % matched response rate. Participating in the programme resulted in immediate (p < 0.01) improvement in skills such as knowing when and how to complete incident forms and disclosing errors to patients, in self-rated knowledge (p < 0.01) and attitudes towards error reporting (p < 0.01). Sixty-three per cent disagreed that doctors routinely report medical errors and 42 % disagreed that doctors routinely share information about medical errors and what caused them. Participants rated interactive features as the most positive elements of the programme. An online training programme on medical error improved self-rated knowledge, attitudes and skills in junior doctors and was deemed an effective learning tool. Perceptions of work issues such as a poor culture of error reporting among doctors may prevent improved attitudes being realised in practice. Online patient safety education has a role in practice-based initiatives aimed at developing professionalism and improving safety.

Teaching basic life support to school children using medical students and teachers in a 'peer-training' model--results of the 'ABC for life' programme.

PubMed

Toner, P; Connolly, M; Laverty, L; McGrath, P; Connolly, D; McCluskey, D R

2007-10-01

The 'ABC for life' programme was designed to facilitate the wider dissemination of basic life support (BLS) skills and knowledge in the population. A previous study demonstrated that using this programme 10-12-year olds are capable of performing and retaining these vital skills when taught by medical students. There are approximately 25,000 year 7 school children in 900 primary schools in Northern Ireland. By using a pyramidal teaching approach involving medical students and teachers, there is the potential to train BLS to all of these children each year. To assess the effectiveness of a programme of CPR instruction using a three-tier training model in which medical students instruct primary school teachers who then teach school children. School children and teachers in the Western Education and Library Board in Northern Ireland. A course of instruction in cardiopulmonary resuscitation (CPR)--the 'ABC for life' programme--specifically designed to teach 10-12-year-old children basic life support skills. Medical students taught teachers from the Western Education and Library Board area of Northern Ireland how to teach basic life support skills to year 7 pupils in their schools. Pupils were given a 22-point questionnaire to assess knowledge of basic life support immediately before and after a teacher led training session. Children instructed in cardiopulmonary resuscitation using this three-tier training had a significantly improved score following training (57.2% and 77.7%, respectively, p<0.001). This study demonstrates that primary school teachers, previously trained by medical students, can teach BLS effectively to 10-12-year-old children using the 'ABC for life' programme.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

PubMed

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Interest in dental implantology and preferences for implant therapy: a survey of Victorian dentists.

PubMed

Cheung, M C; Kao, Plh; Lee, N; Sivathasan, D; Vong, C W; Zhu, J; Polster, A; Darby, I

2016-12-01

The purpose of this study was to gauge dentists' interest, knowledge and training in implantology, and to compare their treatment preferences with current literature. Subsequently, this information may be used to evaluate implantology education pathways. A cross-sectional postal survey of 600 randomly selected dentists registered with the Dental Practice Board of Victoria was conducted. Respondents were asked about background, interest and training in implantology, and implant treatment preferences. Results were analysed according to primary practice location, decade of graduation and attendance at continuing professional development (CPD) programmes. One hundred and seventy-six questionnaires were included for analysis. In general, dentists rate their implant knowledge, interest and enjoyment in restoring implants favourably. No differences were found between city and country practitioners, and different graduation decades. The level of CPD significantly influenced treatment preferences. Practitioners were generally unwilling to treat patients taking bisphosphonates, or to perform grafting procedures. Most dentists provide common services to treat peri-implant conditions. Direct-to-fixture is the most popular fixture-abutment connection. Overall, there is a high level of implant knowledge corresponding to current evidence in the literature. Level of CPD attendance is the most important factor in dentists' willingness to provide more implant therapy options. © 2016 Australian Dental Association.

Metastatic Breast Cancer in Medication-Related Osteonecrosis Around Mandibular Implants.

PubMed

Favia, Gianfranco; Tempesta, Angela; Limongelli, Luisa; Crincoli, Vito; Piattelli, Adriano; Maiorano, Eugenio

2015-09-15

Many authors have considered dental implants to be unrelated to increased risk of medication-related osteonecrosis of the jaw (MRONJ). Nevertheless, more recently, more cases of peri-implant MRONJ (PI-MRONJ) have been described, thus becoming a challenging health problem. Also, metastatic cancer deposits are not infrequently found at peri-implant sites and this may represent an additional complication for such treatments. We present the case of a breast cancer patient with PI-MRONJ, presenting a clinically and radiologically undetected metastasis within the necrotic bone, and highlight the necessity of an accurate histopathological analysis. A 66-year-old female patient, who had received intravenous bisphosphonates for bone breast cancer metastases, came to our attention for a non-implant surgery-triggered PI-MRONJ. After surgical resection of the necrotic bone, conventional and immunohistochemical examinations were performed, which showed breast cancer deposits within the necrotic bone. Cancer patients with metastatic disease, who are undergoing bisphosphonate treatment, may develop unusual complications, including MRONJ, which is a site at risk for hosting additional metastatic deposits that may be clinically and radiologically overlooked. Such risk is increased by previous or concomitant implant procedures. Consequently, clinicians should be prudent when performing implant surgery in cancer patients with advanced-stage disease and consider the possible occurrence of peri-implant metastases while planning adequate treatments in such patients.

Recent refinements to cranial implants for rhesus macaques (Macaca mulatta)

PubMed Central

Johnston, Jessica M.; Cohen, Yale E.; Shirley, Harry; Tsunada, Joji; Bennur, Sharath; Christison-Lagay, Kate; Veeder, Christin L.

2017-01-01

The advent of cranial implants revolutionized primate neurophysiological research because they allow researchers to stably record neural activity from monkeys during active behavior. Cranial implants have improved over the years since their introduction, but chronic implants still increase the risk for medical complications including bacterial contamination and resultant infection, chronic inflammation, bone and tissue loss and complications related to the use of dental acrylic. These complications can lead to implant failure and early termination of study protocols. In an effort to reduce complications, we describe several refinements that have helped us improve cranial implants and the wellbeing of implanted primates. PMID:27096188

Public health implications of differences in U.S. and European Union regulatory policies for breast implants.

PubMed

Zuckerman, Diana; Booker, Nyedra; Nagda, Sonia

2012-12-01

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (U.S.) and European Union (EU). In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the U.S. than in the EU, a decision U.S. government health agencies can point to with pride. Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Undergraduate medical education programme renewal: a longitudinal context, input, process and product evaluation study.

PubMed

Mirzazadeh, Azim; Gandomkar, Roghayeh; Hejri, Sara Mortaz; Hassanzadeh, Gholamreza; Koochak, Hamid Emadi; Golestani, Abolfazl; Jafarian, Ali; Jalili, Mohammad; Nayeri, Fatemeh; Saleh, Narges; Shahi, Farhad; Razavi, Seyed Hasan Emami

2016-02-01

The purpose of this study was to utilize the Context, Input, Process and Product (CIPP) evaluation model as a comprehensive framework to guide initiating, planning, implementing and evaluating a revised undergraduate medical education programme. The eight-year longitudinal evaluation study consisted of four phases compatible with the four components of the CIPP model. In the first phase, we explored the strengths and weaknesses of the traditional programme as well as contextual needs, assets, and resources. For the second phase, we proposed a model for the programme considering contextual features. During the process phase, we provided formative information for revisions and adjustments. Finally, in the fourth phase, we evaluated the outcomes of the new undergraduate medical education programme in the basic sciences phase. Information was collected from different sources such as medical students, faculty members, administrators, and graduates, using various qualitative and quantitative methods including focus groups, questionnaires, and performance measures. The CIPP model has the potential to guide policy makers to systematically collect evaluation data and to manage stakeholders' reactions at each stage of the reform in order to make informed decisions. However, the model may result in evaluation burden and fail to address some unplanned evaluation questions.

21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882... the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class...

Personal medical electronic devices and walk-through metal detector security systems: assessing electromagnetic interference effects.

PubMed

Guag, Joshua; Addissie, Bisrat; Witters, Donald

2017-03-20

There have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators. Incidents of EMI between WTMDs and active medical devices also known as personal medical electronic devices (PMED) continue to be reported. This paper reports on emission measurements of sample WTMDs and testing of 20 PMEDs in a WTMD simulation system. Magnetic fields from sample WTMD systems were characterized for emissions and exposure of certain PMEDs. A WTMD simulator system designed and evaluated by FDA in previous studies was used to mimic the PMED exposures to the waveform from sample WTMDs. The simulation system allows for controlled PMED exposure enabling careful study with adjustable magnetic field strengths and exposure duration, and provides flexibility for PMED exposure at elevated levels in order to study EMI effects on the PMED. The PMED samples consisted of six implantable cardiac pacemakers, six implantable cardioverter defibrillators (ICD), five implantable neurostimulators, and three insulin pumps. Each PMED was exposed in the simulator to the sample WTMD waveforms using methods based on appropriate consensus test standards for each of the device type. Testing the sample PMEDs using the WTMD simulator revealed EMI effects on two implantable pacemakers and one implantable neurostimulator for exposure field strength comparable to actual WTMD field strength. The observed effects were transient and the PMEDs returned to pre-exposure operation within a few seconds after removal from the simulated WTMD exposure fields. No EMI was observed for the sample ICDs or insulin pumps. The findings are consistent with earlier studies where certain sample PMEDs exhibited EMI effects. Clinical implications were not addressed in this study. Additional studies are needed to evaluate potential PMED EMI susceptibilities over a broader range of security systems.

The effect of intravitreal bevacizumab injection before Ahmed valve implantation in patients with neovascular glaucoma.

PubMed

Kang, Jung Youb; Nam, Ki Yup; Lee, Sang Joon; Lee, Seung Uk

2014-08-01

To evaluate the effect of intravitreal bevacizumab (IVB) before Ahmed valve implantation for treatment of neovascular glaucoma (NVG). This study is a retrospective, comparative, consecutive case series. The study group consisted of 27 eyes of 26 patients with NVG who underwent an Ahmed valve implantation. Thirteen eyes were treated with Ahmed valve implantation alone (control group), and 14 eyes were treated with a combination of preoperative IVB injection and Ahmed valve implantation (IVB group). Visual acuity, intraocular pressure (IOP), number of anti-glaucoma medications, surgical complications, and success rate were compared between the two groups. There were no significant differences in preoperative characteristics between the two groups. Visual acuity at 1, 2 weeks, and 1 month after surgery were significantly better in the IVB group (p = 0.038, 0.034, and 0.032, respectively). Hyphema associated with Ahmed valve implantation occurred significantly less in the IVB group (p = 0.016). On the other hand, the mean IOP and number of anti-glaucoma medications at all follow-up periods were similar between the two groups. Kaplan-Meier survival analysis showed the probability of success 6 months after surgery as 71.4 % in the IVB group and 84.6 % in the control group. No significant difference in success rate was found between the groups (p = 0.422). IVB before Ahmed valve implantation for treatment of NVG reduced the incidence of hyphema. In this retrospective study, IVB provided better visual outcome in the early postoperative periods but did not significantly improve mean IOP, number of anti-glaucoma medications, or success rate.

Beam Profile Disturbances from Implantable Pacemakers or Implantable Cardioverter-Defibrillator Interactions

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

Gossman, Michael S., E-mail: mgossman@tsrcc.com; Comprehensive Heart and Vascular Associates, Heart and Vascular Center, Ashland, KY; Medtronic, Inc., External Research Program, Mounds View, MN

2011-01-01

The medical community is advocating for progressive improvement in the design of implantable cardioverter-defibrillators and implantable pacemakers to accommodate elevations in dose limitation criteria. With advancement already made for magnetic resonance imaging compatibility in some, a greater need is present to inform the radiation oncologist and medical physicist regarding treatment planning beam profile changes when such devices are in the field of a therapeutic radiation beam. Treatment plan modeling was conducted to simulate effects induced by Medtronic, Inc.-manufactured devices on therapeutic radiation beams. As a continuation of grant-supported research, we show that radial and transverse open beam profiles of amore » medical accelerator were altered when compared with profiles resulting when implantable pacemakers and cardioverter-defibrillators are placed directly in the beam. Results are markedly different between the 2 devices in the axial plane and the sagittal planes. Vast differences are also presented for the therapeutic beams at 6-MV and 18-MV x-ray energies. Maximum changes in percentage depth dose are observed for the implantable cardioverter-defibrillator as 9.3% at 6 MV and 10.1% at 18 MV, with worst distance to agreement of isodose lines at 2.3 cm and 1.3 cm, respectively. For the implantable pacemaker, the maximum changes in percentage depth dose were observed as 10.7% at 6 MV and 6.9% at 18 MV, with worst distance to agreement of isodose lines at 2.5 cm and 1.9 cm, respectively. No differences were discernible for the defibrillation leads and the pacing lead.« less

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

Applications of patient-specific 3D printing in medicine.

PubMed

Heller, Martin; Bauer, Heide-Katharina; Goetze, Elisabeth; Gielisch, Matthias; Roth, Klaus E; Drees, Philipp; Maier, Gerrit S; Dorweiler, Bernhard; Ghazy, Ahmed; Neufurth, Meik; Müller, Werner E G; Schröder, Heinz C; Wang, Xiaohong; Vahl, Christian-Friedrich; Al-Nawas, Bilal

Already three decades ago, the potential of medical 3D printing (3DP) or rapid prototyping for improved patient treatment began to be recognized. Since then, more and more medical indications in different surgical disciplines have been improved by using this new technique. Numerous examples have demonstrated the enormous benefit of 3DP in the medical care of patients by, for example, planning complex surgical interventions preoperatively, reducing implantation steps and anesthesia times, and helping with intraoperative orientation. At the beginning of every individual 3D model, patient-specific data on the basis of computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound data is generated, which is then digitalized and processed using computer-aided design/computer-aided manufacturing (CAD/CAM) software. Finally, the resulting data sets are used to generate 3D-printed models or even implants. There are a variety of different application areas in the various medical fields, eg, drill or positioning templates, or surgical guides in maxillofacial surgery, or patient-specific implants in orthopedics. Furthermore, in vascular surgery it is possible to visualize pathologies such as aortic aneurysms so as to improve the planning of surgical treatment. Although rapid prototyping of individual models and implants is already applied very successfully in regenerative medicine, most of the materials used for 3DP are not yet suitable for implantation in the body. Therefore, it will be necessary in future to develop novel therapy approaches and design new materials in order to completely reconstruct natural tissue.

Biomechanical analysis on stent materials used as cardiovascular implants

NASA Astrophysics Data System (ADS)

Kumar, Vasantha; Ramesha, C. M.; Sajjan, Sudheer S.

2018-04-01

Atherosclerosis is the most common cause of death in the world, accounting for 48% of all deaths in the world. Atherosclerosis, also known as coronary artery disease occurs when excess cholesterol attaches itself to the walls of blood vessels. Coronary stent implantation is one of the most important procedures to treating coronary artery disease such atherosclerosis. Due to its efficiency, flexibility and simplicity, the use of coronary stents procedures has increased rapidly. In order to have better output of stent implantation, it is needed to study and analyze the biomechanical behavior of this device before manufacturing and put into use. Biomaterials are commonly used for medical application in cardiovascular stent implantation. A biomaterial is a non-viable material used as medical implant, so it is intended to interact with biological system. In this paper, an explicit dynamic analysis is used for analyzing the biomechanical behavior of cardiovascular stent by using finite element analysis tool, ABAQUS 6.10. Results showed that a best suitable biomaterial for cardiovascular stent implants, which exhibits an outstanding biocompatibility and biomechanical characteristics will be aimed at which will be quite useful to the human beings worldwide.

Plasma Concentrations of Itraconazole, Voriconazole, and Terbinafine When Delivered by an Impregnated, Subcutaneous Implant in Japanese Quail ( Coturnix japonica ).

PubMed

Souza, Marcy J; Redig, Patrick; Cox, Sherry K

2017-06-01

Aspergillosis is a common fungal infection in both wild and pet birds. Although effective antifungal medications are available, treatment of aspergillosis can require months of medication administration, which entails stressful handling one or more times per day. This study examined the delivery of the antifungal drugs itraconazole, voriconazole, and terbinafine to Japanese quail ( Coturnix japonica ) via an impregnated implant. Implants contained 0.5, 3, 8, or 24 mg of itraconazole, voriconazole, or terbinafine. The implants were administered subcutaneously over the dorsum and between the scapulae. Blood was collected from birds before and 2, 7, 21, 42, and 56 days after implant placement. Plasma was analyzed by high-performance liquid chromatography for concentrations of itraconazole, voriconazole, or terbinafine, as appropriate. During the course of the study, targeted terbinafine concentrations were achieved in some birds at various time points, but concentrations were inconsistent. Itraconazole and voriconazole concentrations were also inconsistent and did not reach targeted concentrations. Currently, the implant examined in this study cannot be recommended for treatment of aspergillosis in avian species.

Mechanical stability of custom-made implants: Numerical study of anatomical device and low elastic Young's modulus alloy.

PubMed

Didier, P; Piotrowski, B; Fischer, M; Laheurte, P

2017-05-01

The advent of new manufacturing technologies such as additive manufacturing deeply impacts the approach for the design of medical devices. It is now possible to design custom-made implants based on medical imaging, with complex anatomic shape, and to manufacture them. In this study, two geometrical configurations of implant devices are studied, standard and anatomical. The comparison highlights the drawbacks of the standard configuration, which requires specific forming by plastic strain in order to be adapted to the patient's morphology and induces stress field in bones without mechanical load in the implant. The influence of low elastic modulus of the materials on stress distribution is investigated. Two biocompatible alloys having the ability to be used with SLM additive manufacturing are considered, commercial Ti-6Al-4V and Ti-26Nb. It is shown that beyond the geometrical aspect, mechanical compatibility between implants and bones can be significantly improved with the modulus of Ti-26Nb implants compared with the Ti-6Al-4V. Copyright © 2016 Elsevier B.V. All rights reserved.

Organization and startup of The Gambia's new community-based medical programme.

PubMed

Chávez, José A; Suárez, Lázaro V; Del Rosario, Odalis; Hechavarría, Suiberto; Quiñones, Judith

2012-01-01

The shortage of health professionals in developing countries and especially in their poorest regions imperils the vision of health for all. New training policies and strategies are needed urgently to address these shortages. The Gambia's new Community-Based Medical Programme is one such strategy. KEYWORDS Medical education, access to health care, healthcare disparities, health manpower, rural health, developing countries, The Gambia.

Incidence and clinical implication of nosocomial infections associated with implantable biomaterials – catheters, ventilator-associated pneumonia, urinary tract infections

PubMed Central

Guggenbichler, Josef Peter; Assadian, Ojan; Boeswald, Michael; Kramer, Axel

2012-01-01

Health care associated infections, the fourth leading cause of disease in industrialised countries, are a major health issue. One part of this condition is based on the increasing insertion and implantation of prosthetic medical devices, since presence of a foreign body significantly reduces the number of bacteria required to produce infection. The most significant hospital-acquired infections, based on frequency and potential severity, are those related to procedures e.g. surgical site infections and medical devices, including urinary tract infection in catheterized patients, pneumonia in patients intubated on a ventilator and bacteraemia related to intravascular catheter use. At least half of all cases of nosocomial infections are associated with medical devices. Modern medical and surgical practices have increasingly utilized implantable medical devices of various kinds. Such devices may be utilized only short-time or intermittently, for months, years or permanently. They improve the therapeutic outcome, save human lives and greatly enhance the quality of life of these patients. However, plastic devices are easily colonized with bacteria and fungi, able to be colonized by microorganisms at a rate of up to 0.5 cm per hour. A thick biofilm is formed within 24 hours on the entire surface of these plastic devices once inoculated even with a small initial number of bacteria. The aim of the present work is to review the current literature on causes, frequency and preventive measures against infections associated with intravascular devices, catheter-related urinary tract infection, ventilator-associated infection, and infections of other implantable medical devices. Raising awareness for infection associated with implanted medical devices, teaching and training skills of staff, and establishment of surveillance systems monitoring device-related infection seem to be the principal strategies used to achieve reduction and prevention of such infections. The intelligent use of suitable antiseptics in combination with medical devices may further support reduction and prevention of such infections. In addition to reducing the adverse clinical outcomes related with these infections, such reduction may substantially decrease the economic burden caused by device-related infection for health care systems. PMID:22242099

Computer Aided Lip Reading Training Tool

ERIC Educational Resources Information Center

Sarmasik, Gamze; Dalkilic, Gokhan; Kut, Alp; Cebi, Yalcin; Serbetcioglu, Bulent

2007-01-01

Worldwide auditory-verbal education is becoming widespread for deaf children. But many prelingually, late-diagnosed deaf children and adults may utilize neither hearing aids nor cochlear implants and needed the support of lip-reading. Therefore, lip-reading skill remains to be important for oral education programmes of hearing impaired. The…

Research on Hearing and Balance--Current and Future Developments.

ERIC Educational Resources Information Center

Snow, James B., Jr.

1997-01-01

This article reviews current research that has located disease genes causing hearing impairments, discovered the ability of sensory cells of the inner ear to regenerate, developed vaccines to prevent otitis media, developed programmable hearing aids, improved cochlear implants, and demonstrated the positive effects of physical therapy with balance…

Simulation Analysis of Wireless Power Transmission System for Biomedical Applications

NASA Astrophysics Data System (ADS)

Yang, Zhao; Wei, Zhiqiang; Chi, Haokun; Yin, Bo; Cong, Yanping

2018-03-01

In recent years, more and more implantable medical devices have been used in the medical field. Some of these devices, such as brain pacemakers, require long-term power support. The WPT(wireless power transmission) technology which is more convenient and economical than replacing the battery by surgery, has become the first choice of many patients. In this paper, we design a WPT system that can be used in implantable medical devices, simulate the transmission efficiency of the system in the air and in the head model, and simulate the SAR value when the system working in the head model. The results show that when implantation depth of the secondary coil is 3 mm, the efficiency of the system can reach 45%, and the maximum average SAR value is 2.19 W / kg, slightly higher than the standard of IEEE.

New risks inadequately managed: the case of smart implants and medical device regulation

PubMed Central

Haddow, Gill; Gilman, Leah

2016-01-01

Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance. PMID:28058060

Extracurricular leadership development programme to prepare future Saudi physicians as leaders.

PubMed

Ayuob, Nasra Naeim; Al Sayes, Faten Mohamed; El Deek, Basem Salama

2016-06-01

To describe and evaluate an innovative approach for developing leadership skills in a cohort of medical students through an extracurricular programme. The study was conducted at King Abdulaziz University, Jeddah, Saudi Arabia, from April to June of the academic year 2014-15, and comprised medical students from all batches. Mixed-method design was used to evaluate the leadership development programme. Pre- and post-tests were conducted to assess students' learning and their satisfaction was evaluated at the end of the programme. Focus groups were conducted to assess the programme's impact on participants' behaviour. Data analysis was done using SPSS 16. Of the 55 participants, 45(82%) responded to the evaluation survey. Of them, 29(65%) reported intended changes in their leadership practices immediately after the programme, with 8(28%) of them reporting more than one change. The mean students' satisfaction with the overall performance of the speakers and programme organisation was high at 4.12±0.91 and 4.54±0.89, respectively. Early experience of the leadership development programme produced positive results. An intense programme analysis is required to fully understand this significant organisational need.

Implantable and ingestible medical devices with wireless telemetry functionalities: a review of current status and challenges.

PubMed

Kiourti, Asimina; Psathas, Konstantinos A; Nikita, Konstantina S

2014-01-01

Wireless medical telemetry permits the measurement of physiological signals at a distance through wireless technologies. One of the latest applications is in the field of implantable and ingestible medical devices (IIMDs) with integrated antennas for wireless radiofrequency (RF) communication (telemetry) with exterior monitoring/control equipment. Implantable medical devices (MDs) perform an expanding variety of diagnostic and therapeutic functions, while ingestible MDs receive significant attention in gastrointestinal endoscopy. Design of such wireless IIMD telemetry systems is highly intriguing and deals with issues related to: operation frequency selection, electronics and powering, antenna design and performance, and modeling of the wireless channel. In this paper, we attempt to comparatively review the current status and challenges of IIMDs with wireless telemetry functionalities. Full solutions of commercial IIMDs are also recorded. The objective is to provide a comprehensive reference for scientists and developers in the field, while indicating directions for future research. © 2013 Wiley Periodicals, Inc.

Single-Stage Ear Reconstruction and Hearing Restoration Using Polyethylene Implant and Implantable Hearing Devices.

PubMed

Hempel, John Martin

2015-12-01

The use of porous polyethylene in reconstructive surgery of the auricle is becoming increasingly accepted. This is a single-stage procedure providing pleasing cosmetic rehabilitation. Further advantages are the possibility of early implantation and the lack of complications caused by harvesting costal cartilage. Additional hearing restoration using middle ear implants allows functional rehabilitation at an early stage. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Allergic Reaction to Polyether Ether Ketone Following Cross-Reactivity to Epoxy Resin.

PubMed

Kofler, Lukas; Wambacher, Markus; Schweinzer, Katrin; Scherl, Maritta; Kofler, Heinz

Polyether ether ketone (PEEK) is a thermoplastic polymer frequently used in engineering but also in medical devices. Only 1 case of allergic reaction to PEEK used as an implanted medical device has been reported so far; however, the route of sensitization remained unclear. Here we report on a 62-year-old male patient with a preknown, severe type IV allergy to epoxy resin. He reported strong pain in his shoulder after implantation of a PEEK-containing device after a rotator cuff injury. For testing, the device was implanted in a small pouch subcutaneously on the abdomen. The patient reported massive pain starting 8 hours after the implantation, strictly limited to the procedural area and showing perifocal erythema. A possible explanation of the sensitization mode is the source material for PEEK and epoxy resin, as both are mainly based on bisphenols. An allergic reaction to PEEK with preknown epoxy resin sensitization has not been reported so far. As epoxy resins are a frequent cause of occupational contact dermatitis and PEEK is widely used for medical and nonmedical devices, we believe that this is of great clinical relevance.

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

Slabodchikov, Vladimir A., E-mail: dipis1991@mail.ru; Borisov, Dmitry P., E-mail: borengin@mail.ru; Kuznetsov, Vladimir M., E-mail: kuznetsov@rec.tsu.ru

The paper reports on a new method of plasma immersion ion implantation for the surface modification of medical materials using the example of nickel-titanium (NiTi) alloys much used for manufacturing medical implants. The chemical composition and surface properties of NiTi alloys doped with silicon by conventional ion implantation and by the proposed plasma immersion method are compared. It is shown that the new plasma immersion method is more efficient than conventional ion beam treatment and provides Si implantation into NiTi surface layers through a depth of a hundred nanometers at low bias voltages (400 V) and temperatures (≤150°C) of the substrate.more » The research results suggest that the chemical composition and surface properties of materials required for medicine, e.g., NiTi alloys, can be successfully attained through modification by the proposed method of plasma immersion ion implantation and by other methods based on the proposed vacuum equipment without using any conventional ion beam treatment.« less

Biodegradable Magnesium (Mg) Implantation Does Not Impose Related Metabolic Disorders in Rats with Chronic Renal Failure

PubMed Central

Wang, Jiali; Xu, Jiankun; Liu, Waiching; Li, Yangde; Qin, Ling

2016-01-01

Mg and its alloys have been considered as one of the most promising biodegradable medical devices, but it was still unclear whether hypermagnesemia involved health risks would occur in persons with kidney disease due to their deteriorated kidney function for Mg ions excretion from their body. In this study, we established a chronic renal failure (CRF) model in rats induced by adenine administration prior to Mg implantation, aiming to predict if CRF patients are suitable for the use of Mg implants. The results showed that Mg levels in serum, urine, feces and internal organs had no significant changes after Mg implantation for both normal and CRF rats. Biochemical indices detection and histopathological analysis in kidney, liver and heart tissue confirmed that Mg implants did not induce any extra damage in animals even with renal failure. Our study indicates that Mg based orthopaedic medical device may be considered for use in CRF patients without biosafety concerns. PMID:27210744

Biodegradable Magnesium (Mg) Implantation Does Not Impose Related Metabolic Disorders in Rats with Chronic Renal Failure

NASA Astrophysics Data System (ADS)

Wang, Jiali; Xu, Jiankun; Liu, Waiching; Li, Yangde; Qin, Ling

2016-05-01

Mg and its alloys have been considered as one of the most promising biodegradable medical devices, but it was still unclear whether hypermagnesemia involved health risks would occur in persons with kidney disease due to their deteriorated kidney function for Mg ions excretion from their body. In this study, we established a chronic renal failure (CRF) model in rats induced by adenine administration prior to Mg implantation, aiming to predict if CRF patients are suitable for the use of Mg implants. The results showed that Mg levels in serum, urine, feces and internal organs had no significant changes after Mg implantation for both normal and CRF rats. Biochemical indices detection and histopathological analysis in kidney, liver and heart tissue confirmed that Mg implants did not induce any extra damage in animals even with renal failure. Our study indicates that Mg based orthopaedic medical device may be considered for use in CRF patients without biosafety concerns.

Electromagnetic interference in cardiac rhythm management devices.

PubMed

Sweesy, Mark W; Holland, James L; Smith, Kerry W

2004-01-01

Clinicians caring for cardiac device patients with implanted pacemakers or cardioverter defibrillators (ICDs) are frequently asked questions by their patients concerning electromagnetic interference (EMI) sources and the devices. EMI may be radiated or conducted and may be present in many different forms including (but not limited to) radiofrequency waves, microwaves, ionizing radiation, acoustic radiation, static and pulsed magnetic fields, and electric currents. Manufacturers have done an exemplary job of interference protection with device features such as titanium casing, signal filtering, interference rejection circuits, feedthrough capacitors, noise reversion function, and programmable parameters. Nevertheless, EMI remains a real concern and a potential danger. Many factors influence EMI including those which the patient can regulate (eg, distance from and duration of exposure) and some the patient cannot control (eg, intensity of the EMI field, signal frequency). Potential device responses are many and range from simple temporary oversensing to permanent device damage Several of the more common EMI-generating devices and their likely effects on cardiac devices are considered in the medical, home, and daily living and work environments.

The socially constructed breast: breast implants and the medical construction of need.

PubMed Central

Jacobson, N

1998-01-01

When silicone gel breast implants became the subject of a public health controversy in the early 1990s, the most pressing concern was safety. This paper looks at another, less publicized issue: the need for implants. Using a symbolic interactionist approach, the author explores the social construction of the need for implants by tracing the history of the 3 surgical procedures for which implants were used. Stakeholders in this history constructed need as legitimized individual desire, the form of which shifted with changes in the technological and social context. PMID:9702166

Basic concepts and techniques of dental implants.

PubMed

Tagliareni, Jonathan M; Clarkson, Earl

2015-04-01

Dental implants provide completely edentulous and partial edentulous patients the function and esthetics they had with natural dentition. It is critical to understand and apply predictable surgical principles when treatment planning and surgically restoring edentulous spaces with implants. This article defines basic implant concepts that should be meticulously followed for predictable results when treating patients and restoring dental implants. Topics include biological and functional considerations, biomechanical considerations, preoperative assessments, medical history and risk assessments, oral examinations, radiographic examinations, contraindications, and general treatment planning options. Copyright © 2015 Elsevier Inc. All rights reserved.

Process factors explaining the ineffectiveness of a multidisciplinary fall prevention programme: A process evaluation

PubMed Central

Bleijlevens, Michel HC; Hendriks, Marike RC; van Haastregt, Jolanda CM; van Rossum, Erik; Kempen, Gertrudis IJM; Diederiks, Joseph PM; Crebolder, Harry FJM; van Eijk, Jacques ThM

2008-01-01

Background Falls are a major health threat to older community-living people, and initiatives to prevent falls should be a public health priority. We evaluated a Dutch version of a successful British fall prevention programme. Results of this Dutch study showed no effects on falls or daily functioning. In parallel to the effect evaluation, we carried out a detailed process evaluation to assess the feasibility of our multidisciplinary fall prevention programme. The present study reports on the results of this process evaluation. Methods Our fall prevention programme comprised a medical and occupational-therapy assessment, resulting in recommendations and/or referrals to other services if indicated. We used self-administered questionnaires, structured telephone interviews, structured recording forms, structured face-to-face interviews and a plenary group discussion to collect data from participants allocated to the intervention group (n = 166) and from all practitioners who performed the assessments (n = 8). The following outcomes were assessed: the extent to which the multidisciplinary fall prevention programme was performed according to protocol, the nature of the recommendations and referrals provided to the participants, participants' self-reported compliance and participants' and practitioners' opinions about the programme. Results Both participants and practitioners judged the programme to be feasible. The programme was largely performed according to protocol. The number of referrals and recommendations ensuing from the medical assessment was relatively small. Participants' self-reported compliance as regards contacting their GP to be informed of the recommendations and/or referrals was low to moderate. However, self-reported compliance with such referrals and recommendations was reasonable to good. A large majority of participants reported they had benefited from the programme. Conclusion The results of the present study show that the programme was feasible for both practitioners and participants. Main factors that seem to be responsible for the lack of effectiveness are the relatively low number of referrals and recommendations ensuing from the medical assessments and participants' low compliance as regards contacting their GP about the results of the medical assessment. We do not recommend implementing the programme in its present form in regular care. Trial registration ISRCTN64716113 PMID:18816381

Journal of Astonishment--A Tool to Increase Satisfaction with Exchange Programmes

ERIC Educational Resources Information Center

Reinhardt, Claus H.; Rosen, Evelyne N.

2012-01-01

Many medical students use exchange programmes to enrich their portfolio. However, such a confrontation with reality can be challenging because custom and practice sometimes differ radically between countries. Exchange students post specific peculiarities, as encountered by them abroad, onto the medical exchange website. They can ask for the…

Certified ion implantation fluence by high accuracy RBS.

PubMed

Colaux, Julien L; Jeynes, Chris; Heasman, Keith C; Gwilliam, Russell M

2015-05-07

From measurements over the last two years we have demonstrated that the charge collection system based on Faraday cups can robustly give near-1% absolute implantation fluence accuracy for our electrostatically scanned 200 kV Danfysik ion implanter, using four-point-probe mapping with a demonstrated accuracy of 2%, and accurate Rutherford backscattering spectrometry (RBS) of test implants from our quality assurance programme. The RBS is traceable to the certified reference material IRMM-ERM-EG001/BAM-L001, and involves convenient calibrations both of the electronic gain of the spectrometry system (at about 0.1% accuracy) and of the RBS beam energy (at 0.06% accuracy). We demonstrate that accurate RBS is a definitive method to determine quantity of material. It is therefore useful for certifying high quality reference standards, and is also extensible to other kinds of samples such as thin self-supporting films of pure elements. The more powerful technique of Total-IBA may inherit the accuracy of RBS.

Combined Ahmed Glaucoma Valve Placement, Intravitreal Fluocinolone Acetonide Implantation and Cataract Extraction for Chronic Uveitis.

PubMed

Chang, Ingrid T; Gupta, Divakar; Slabaugh, Mark A; Vemulakonda, Gurunadh A; Chen, Philip P

2016-10-01

To report the outcomes of combined Ahmed glaucoma valve (AGV) placement, intravitreal fluocinolone acetonide implant, and cataract extraction procedure in the treatment of chronic noninfectious uveitis. Retrospective case series of patients with chronic noninfectious uveitis who underwent AGV placement, intravitreal fluocinolone acetonide implantation, and cataract extraction in a single surgical session performed at 1 institution from January 2009 to November 2014. Outcome measures included intraocular pressure (IOP) and glaucoma medication use. Secondary outcome measures included visual acuity, systemic anti-inflammatory medications, number of uveitis flares, and complications. Fifteen eyes of 10 patients were studied, with a mean age of 40.3±15.7 and mean follow-up duration of 26 months (range, 13 to 39 mo). Before surgery, the IOP was 18.5±7.3 mm Hg and patients were using 1.5±1.5 topical glaucoma medications. At the 12-month follow-up, IOP was 12.8±3.2 mm Hg (P=0.01) and patients were using 0.5±0.8 (P=0.03) topical glaucoma medications. At 36 months of follow-up, late, nonsustained hypotony had occurred in 3 eyes (20%), and 1 eye (6%) had received a second AGV for IOP control. Before treatment, patients had 2.7±1.5 uveitis flares in the year before surgery while on an average of 2.1±0.6 systemic anti-inflammatory medications, which decreased to an average of 0.1±0.3 (P<0.01) flares the year after surgery while on an average of 0.4±1.1 (P<0.01) systemic medications. Combined AGV, intravitreal fluocinolone acetonide implant, and cataract extraction is effective in controlling IOP and reducing the number of glaucoma medications at 12 months after treatment in patients with chronic uveitis.

Educational Progress Profiles of Cochlear Implant Children.

ERIC Educational Resources Information Center

Dawson, Sarah A.

This study examined the educational development of 22 children (ages 2 to 10), under the supervision of the Cochlear Implant Team of the Medical College of Virginia, who had received implants as a result of deafness (in most cases prelingual and congenital) from 6 months to 3 years prior to the study. Data included a review of the children's case…

Preventing deaths and injuries from house fires: a cost-benefit analysis of a community-based smoke alarm installation programme.

PubMed

Yellman, Merissa A; Peterson, Cora; McCoy, Mary A; Stephens-Stidham, Shelli; Caton, Emily; Barnard, Jeffrey J; Padgett, Ted O; Florence, Curtis; Istre, Gregory R

2018-02-01

Operation Installation (OI), a community-based smoke alarm installation programme in Dallas, Texas, targets houses in high-risk urban census tracts. Residents of houses that received OI installation (or programme houses) had 68% fewer medically treated house fire injuries (non-fatal and fatal) compared with residents of non-programme houses over an average of 5.2 years of follow-up during an effectiveness evaluation conducted from 2001 to 2011. To estimate the cost-benefit of OI. A mathematical model incorporated programme cost and effectiveness data as directly observed in OI. The estimated cost per smoke alarm installed was based on a retrospective analysis of OI expenditures from administrative records, 2006-2011. Injury incidence assumptions for a population that had the OI programme compared with the same population without the OI programme was based on the previous OI effectiveness study, 2001-2011. Unit costs for medical care and lost productivity associated with fire injuries were from a national public database. From a combined payers' perspective limited to direct programme and medical costs, the estimated incremental cost per fire injury averted through the OI installation programme was $128,800 (2013 US$). When a conservative estimate of lost productivity among victims was included, the incremental cost per fire injury averted was negative, suggesting long-term cost savings from the programme. The OI programme from 2001 to 2011 resulted in an estimated net savings of $3.8 million, or a $3.21 return on investment for every dollar spent on the programme using a societal cost perspective. Community smoke alarm installation programmes could be cost-beneficial in high-fire-risk neighbourhoods. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Introduction of an interdisciplinary heart team-based transcatheter aortic valve implantation programme: short and mid-term outcomes.

PubMed

Martínez, G J; Seco, M; Jaijee, S K; Adams, M R; Cartwright, B L; Forrest, P; Celermajer, D S; Vallely, M P; Wilson, M K; Ng, M K C

2014-09-01

Transcatheter aortic valve implantation (TAVI) has been developed to treat symptomatic aortic stenosis in patients deemed too high risk for open-heart surgery. To address this complex population, an interdisciplinary heart team approach was proposed. Present the short- and mid-term outcomes of the first 100 patients in the Royal Prince Alfred Hospital multidisciplinary TAVI programme. Single-centre registry. Baseline and procedural data were prospectively recorded. Outcomes were recorded according to Valve Academic Research Consortium - version 2 guidelines. All patients underwent a comprehensive interdisciplinary pre-procedural evaluation. Sixty-eight transfemoral and 32 transapical implantations were performed. Mean age was 82 (±8.9) years old with an average logistic EuroSCORE of 33. Although 13 procedures had major complications, there was no intraprocedural mortality. During the first month, 9% of patients were re-admitted due to heart failure and 13% had a permanent pacemaker implanted. A 3% 30-day and 8% follow-up (mean 17 months) mortalities were recorded. While no significant differences in the rate of complications were found between the first and second half of the experience, all cases of mortality within 30 days (n = 3) occurred in the initial half. Sustained haemodynamic results were obtained with TAVI (immediate mean aortic valve gradient reduction from 47 to 9 mmHg; 1-year echocardiographic gradient 9.9 mmHg, with no moderate or severe aortic regurgitation). Excellent results can be achieved with TAVI in very high-risk patients at an Australian institution. A comprehensive evaluation based on a heart team can overcome most of the difficulties imposed by this challenging population. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

The Effect of Titanium Surface Roughness on Growth, Differentiation, and Protein Synthesis of Cartilage and Bone Cells

DTIC Science & Technology

1996-05-01

at San Antonio Supervising Professors: Barbara D. Boyan, Ph.D. David L. Cochran, D.D.S., Ph.D. Placement of endosseous dental implants requires the...titanium substratum was chosen for these studies since most medical and dental implants are fabricated from titanium The titanium was cut into uniform...electron microscopy to evaluate the histomorphometry of the implant-bone interface of various titanium and ceramic dental implants placed in dog mandibles

Helping doctors in training to STEP-UP: A leadership and quality improvement programme in the Belfast Health and Social Care Trust.

PubMed

Donaghy, Grainne; McKeever, Kris; Flanagan, Catherine; O'Kane, Donal; McQuillan, Bernie; Cash, Johnny; Jack, Cathy; Lundy, Claire

2018-05-01

Medical engagement in healthcare organisations can improve service development and patient experience. Doctors in training have limited opportunities to engage in service improvement work and develop leadership skills. We describe the Specialist Trainees Engaged in Leadership Programme (STEP) , a programme developed to introduce concepts of medical leadership and quality improvement skills in the Belfast Trust. STEP started in 2013 and over 140 trainees have now participated in the programme. Over 42 quality improvement projects have been completed with the support of the programme. Evaluation of STEP has demonstrated an improvement across all domains explored throughout the duration of the programme, with benefits for the individual trainee and the wider organisation. We describe the programme in detail. The STEP curriculum can easily be adapted to meet the needs of NHS trainees, allowing them to understand the objectives and strategy of their employers and improve their ability to plan and deliver safe, effective, patient-centred care.

Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast.

PubMed

de Boer, Mintsje; van Leeuwen, Flora E; Hauptmann, Michael; Overbeek, Lucy I H; de Boer, Jan Paul; Hijmering, Nathalie J; Sernee, Arthur; Klazen, Caroline A H; Lobbes, Marc B I; van der Hulst, René R W J; Rakhorst, Hinne A; de Jong, Daphne

2018-03-01

Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants. To determine relative and absolute risks of breast-ALCL in women with breast implants. Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales. Relative and absolute risks of breast-ALCL in women with breast implants. Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920. Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.

Silver nanoparticle-enriched diamond-like carbon implant modification as a mammalian cell compatible surface with antimicrobial properties

PubMed Central

Gorzelanny, Christian; Kmeth, Ralf; Obermeier, Andreas; Bauer, Alexander T.; Halter, Natalia; Kümpel, Katharina; Schneider, Matthias F.; Wixforth, Achim; Gollwitzer, Hans; Burgkart, Rainer; Stritzker, Bernd; Schneider, Stefan W.

2016-01-01

The implant-bone interface is the scene of competition between microorganisms and distinct types of tissue cells. In the past, various strategies have been followed to support bony integration and to prevent bacterial implant-associated infections. In the present study we investigated the biological properties of diamond-like carbon (DLC) surfaces containing silver nanoparticles. DLC is a promising material for the modification of medical implants providing high mechanical and chemical stability and a high degree of biocompatibility. DLC surface modifications with varying silver concentrations were generated on medical-grade titanium discs, using plasma immersion ion implantation-induced densification of silver nanoparticle-containing polyvinylpyrrolidone polymer solutions. Immersion of implants in aqueous liquids resulted in a rapid silver release reducing the growth of surface-bound and planktonic Staphylococcus aureus and Staphylococcus epidermidis. Due to the fast and transient release of silver ions from the modified implants, the surfaces became biocompatible, ensuring growth of mammalian cells. Human endothelial cells retained their cellular differentiation as indicated by the intracellular formation of Weibel-Palade bodies and a high responsiveness towards histamine. Our findings indicate that the integration of silver nanoparticles into DLC prevents bacterial colonization due to a fast initial release of silver ions, facilitating the growth of silver susceptible mammalian cells subsequently. PMID:26955791

[Postoperative Follow-Up of Glaucoma Drainage Devices].

PubMed

Dietlein, T S; Neugebauer, A; Fricke, J; Lappas, A; Rosentreter, A

2016-05-01

There is an increasing trend towards using glaucoma drainage implants. The postoperative management of such devices depends on their technical characteristics and specific complications. The Baerveldt glaucoma implant with its larger surface area has been shown to lower mean intraocular pressure more effectively than the Ahmed-FP7 implant. As a non-valve implant, however, it has been associated with a higher rate of severe complications, particularly ocular hypotension. Moreover, glaucoma implants may induce diplopia if they interfere with extraocular muscles. Topical treatment with antibiotics and steroids is necessary in cases of intraocular inflammation. In refractory cases, the tube may even have to be removed. Surgical reposition of the tube may be indicated when it is severely dislocated. Increased intraocular pressure is primarily treated by pressure-lowering medications during postoperative follow-up. If topical glaucoma medication is insufficient to control increases in intraocular pressure due to encapsulation, a second implant may be considered or the capsule surrounding the implant may be excised to reduce outflow resistance or additional cyclodestructive procedures can be performed. Chronic hypotension may be treated with tube ligation or occlusion. Severe corneal oedema may require lamellar keratoplasty. Conjunctival erosions with tube exposure or tube retractions also require surgical correction. Georg Thieme Verlag KG Stuttgart · New York.

Introducing a Semi-Coated Model to Investigate Antibacterial Effects of Biocompatible Polymers on Titanium Surfaces

PubMed Central

Winkel, Andreas; Dempwolf, Wibke; Gellermann, Eva; Sluszniak, Magdalena; Grade, Sebastian; Heuer, Wieland; Eisenburger, Michael; Menzel, Henning; Stiesch, Meike

2015-01-01

Peri-implant infections from bacterial biofilms on artificial surfaces are a common threat to all medical implants. They are a handicap for the patient and can lead to implant failure or even life-threatening complications. New implant surfaces have to be developed to reduce biofilm formation and to improve the long-term prognosis of medical implants. The aim of this study was (1) to develop a new method to test the antibacterial efficacy of implant surfaces by direct surface contact and (2) to elucidate whether an innovative antimicrobial copolymer coating of 4-vinyl-N-hexylpyridinium bromide and dimethyl(2-methacryloyloxyethyl) phosphonate (VP:DMMEP 30:70) on titanium is able to reduce the attachment of bacteria prevalent in peri-implant infections. With a new in vitro model with semi-coated titanium discs, we were able to show a dramatic reduction in the adhesion of various pathogenic bacteria (Streptococcus sanguinis, Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis), completely independently of effects caused by soluble materials. In contrast, soft tissue cells (human gingival or dermis fibroblasts) were less affected by the same coating, despite a moderate reduction in initial adhesion of gingival fibroblasts. These data confirm the hypothesis that VP:DMMEP 30:70 is a promising antibacterial copolymer that may be of use in several clinical applications. PMID:25690041

Silver nanoparticle-enriched diamond-like carbon implant modification as a mammalian cell compatible surface with antimicrobial properties

NASA Astrophysics Data System (ADS)

Gorzelanny, Christian; Kmeth, Ralf; Obermeier, Andreas; Bauer, Alexander T.; Halter, Natalia; Kümpel, Katharina; Schneider, Matthias F.; Wixforth, Achim; Gollwitzer, Hans; Burgkart, Rainer; Stritzker, Bernd; Schneider, Stefan W.

2016-03-01

The implant-bone interface is the scene of competition between microorganisms and distinct types of tissue cells. In the past, various strategies have been followed to support bony integration and to prevent bacterial implant-associated infections. In the present study we investigated the biological properties of diamond-like carbon (DLC) surfaces containing silver nanoparticles. DLC is a promising material for the modification of medical implants providing high mechanical and chemical stability and a high degree of biocompatibility. DLC surface modifications with varying silver concentrations were generated on medical-grade titanium discs, using plasma immersion ion implantation-induced densification of silver nanoparticle-containing polyvinylpyrrolidone polymer solutions. Immersion of implants in aqueous liquids resulted in a rapid silver release reducing the growth of surface-bound and planktonic Staphylococcus aureus and Staphylococcus epidermidis. Due to the fast and transient release of silver ions from the modified implants, the surfaces became biocompatible, ensuring growth of mammalian cells. Human endothelial cells retained their cellular differentiation as indicated by the intracellular formation of Weibel-Palade bodies and a high responsiveness towards histamine. Our findings indicate that the integration of silver nanoparticles into DLC prevents bacterial colonization due to a fast initial release of silver ions, facilitating the growth of silver susceptible mammalian cells subsequently.

Silver nanoparticle-enriched diamond-like carbon implant modification as a mammalian cell compatible surface with antimicrobial properties.

PubMed

Gorzelanny, Christian; Kmeth, Ralf; Obermeier, Andreas; Bauer, Alexander T; Halter, Natalia; Kümpel, Katharina; Schneider, Matthias F; Wixforth, Achim; Gollwitzer, Hans; Burgkart, Rainer; Stritzker, Bernd; Schneider, Stefan W

2016-03-09

The implant-bone interface is the scene of competition between microorganisms and distinct types of tissue cells. In the past, various strategies have been followed to support bony integration and to prevent bacterial implant-associated infections. In the present study we investigated the biological properties of diamond-like carbon (DLC) surfaces containing silver nanoparticles. DLC is a promising material for the modification of medical implants providing high mechanical and chemical stability and a high degree of biocompatibility. DLC surface modifications with varying silver concentrations were generated on medical-grade titanium discs, using plasma immersion ion implantation-induced densification of silver nanoparticle-containing polyvinylpyrrolidone polymer solutions. Immersion of implants in aqueous liquids resulted in a rapid silver release reducing the growth of surface-bound and planktonic Staphylococcus aureus and Staphylococcus epidermidis. Due to the fast and transient release of silver ions from the modified implants, the surfaces became biocompatible, ensuring growth of mammalian cells. Human endothelial cells retained their cellular differentiation as indicated by the intracellular formation of Weibel-Palade bodies and a high responsiveness towards histamine. Our findings indicate that the integration of silver nanoparticles into DLC prevents bacterial colonization due to a fast initial release of silver ions, facilitating the growth of silver susceptible mammalian cells subsequently.

Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

NASA Astrophysics Data System (ADS)

Anastasiou, Alexandros; Saatsakis, George

2015-09-01

Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

[Survey on the use and behaviour of metal-metal hip replacements in Spain].

PubMed

Calcerrada, N; Fernández-Vega, A; Valls-León, C; Garcia-Cimbrelo, E

2016-01-01

Following medical device alerts published in different countries of problems with metal-on-metal total hip replacements, the Spanish Agency of Medicines and Medical Devices (AEMPS) in collaboration with the Spanish Hip Society Surgery designed a national survey to gather information on the use and behaviour of these hip implants. The survey consisted of a questionnaire sent by e-mail to 283 clinical centre recipients of metal-on-metal hips to be filled in by surgeons with expertise in the field. A total of 257 questionnaires were completed. The response rate of the clinical centres was 36.7%. A total of 97.7% of the responses reported that clinical and radiological follow-ups are carried out, and 79.6% undertook metal ion analyses (chromium and cobalt). A large majority (83.6%) of the responders who had who used surface implants, and 70% of those with large-head implants reported peri-operative complications. The most common complication was pain (25% with surface implants and 30.8% with large-head implants). Currently 80.8% of those responding were considering abandoning implanting of these hip replacements. Despite the many limitations to this study, the survey has allowed us to obtain in a quick first view of the implant scenario of Metal on Metal hip implants in Spain, and to determine the type of patient implanted, the time of implantation, and the experience/expertise of the surgeons, and the type of follow-up carried out. Copyright © 2015 SECOT. Published by Elsevier Espana. All rights reserved.

Ability and willingness to pay for voluntary medical male circumcision: a cross-sectional survey in Kisumu County, Kenya.

PubMed

Wandei, Stephen; Nangami, Mabel; Egesa, Omar

2016-01-01

Voluntary medical male circumcision is one of the most effective measures in preventing male acquisition of HIV during heterosexual intercourse. In Kenya, the voluntary medical male circumcision programme was launched in the year 2008 as part of a comprehensive national HIV prevention strategy. With the global challenge of funding HIV intervention programs, the sustainability of the programme beyond the donor periods need to be assessed. The purpose of this study was to determine the household ability and willingness to pay for voluntary medical male circumcision as an alternative method of funding the programme. The findings show that 62.2% of the households were "able" to pay for medical circumcision. However, 60.4% of them were not "willing" to pay for the service regardless of the cost. The findings indicate that ability to pay is not a significant predictor of willingness to pay for voluntary medical male circumcision within Kisumu County. Knowledge on the role of medical circumcision is a more important factor in determining willingness to pay for the service.

Oral Effects and Early Implant Survival Results After Imatinib Discontinuation Therapy for Chronic Myelogenous Leukemia: A Case Report.

PubMed

Dixon, Douglas R; Yassin, Alaa

2017-08-01

Little is known regarding the success, failure, or complication rates of advanced implant procedures in patients after discontinuation therapy of long-term medications for the treatment of chronic myelogenous leukemia (CML). This case report presents initial results of a case involving implant placement in the mandible and maxilla as well as reduction of palatal oral pigmentation in a patient discontinuing long-term tyrosine kinase inhibitor (TKI) therapy for CML. A 57-year-old male was referred to the Department of Periodontics, University of Washington, Seattle, Washington, for an assessment of edentulous areas (tooth sites #3 and #14) and failing tooth #19. Previous medical treatment included oral administration (>10 years) of TKI for the treatment of CML. Systemic complications arising from long-term TKI therapy were treated with discontinuation of this medication. Concurrently, after multispecialty dental and medical consultation, extraction of tooth #19 with immediate implant placement and bilateral sinus augmentation with simultaneous implant placement were successfully performed during three separate surgical appointments. Additionally, marked reduction of oral palatal pigmentation was observed during the surgical and restorative phases after TKI discontinuation. Patients with a history of long-term TKIs for CML are at risk for developing complications that result in discontinuation of therapy. Long-term benefits of therapy may allow these patients to enjoy remission with an extended and improved quality of life. Patients undergoing discontinuation therapy may seek dental care. Therefore, dental providers need to understand these systemic interactions and, with multispecialty consultation, may help effectively treat these individuals.

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes.

PubMed

Erçalık, Nimet Yeşim; İmamoğlu, Serhat

2018-01-01

To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. The mean follow-up duration was 11.7 ± 5.5 (range, 6-23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg ( p =0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 ( p =0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation.

Cultural competence in medical education: A questionnaire study of Danish medical teachers' perceptions of and preparedness to teach cultural competence.

PubMed

Sorensen, Janne; Jervelund, Signe Smith; Norredam, Marie; Kristiansen, Maria; Krasnik, Allan

2017-03-01

The cultural competence training of healthcare professionals is a key element in ensuring the quality of both the access and delivery of healthcare to increasingly ethnically diverse populations. The aim of this study is to investigate Danish medical teachers' opinions about cultural competence, their willingness to receive training and preparedness to teach cultural competence topics. The survey was sent to medical teachers, clinical teachers and external lecturers who teach in the medical programme at the University of Copenhagen. A total of 1400 medical teachers received the survey, and 199 responded. The response rate is 14%. Data were analysed through descriptive calculations, and answers to open-ended questions were coded using content analysis. Results showed that 82.4% of the informants agreed or strongly agreed that the medical education programme should include training on cultural issues, and 60.3% agreed or strongly agreed that students should be assessed on their cultural competence skills. Regarding preparedness to teach a diverse classroom, 88.4% felt somewhat or very prepared to engage and motivate all students. About 70% were interested in receiving training on cultural competence. Generally, there is interest in and acknowledgement of the importance of cultural competence in Danish medical education among teachers at the University of Copenhagen. This creates an opportunity to implement cultural competence in the medical curriculum, training of teachers and strengthening the diversity sensitivity of the organisation. However, support for this programme by management and the allocation of an appropriate level of resources is a prerequisite to the success of the programme.

Clinical outcomes after combined Ahmed glaucoma valve implantation and penetrating keratoplasty or pars plana vitrectomy.

PubMed

Lee, Jin Young; Sung, Kyung Rim; Tchah, Hung Won; Yoon, Young Hee; Kim, June Gone; Kim, Myoung Joon; Kim, Jae Yong; Yun, Sung-Cheol; Lee, Joo Yong

2012-12-01

To evaluate whether a combination of penetrating keratoplasty (PKP) or pars plana vitrectomy (PPV) and Ahmed glaucoma valve (AGV) implantation affords a level of success similar to that of AGV implantation alone. Eighteen eyes underwent simultaneous PPV and AGV, 14 eyes with PKP and AGV and 30 eyes with AGV implantation alone were evaluated. Success was defined as attainment of an intraocular pressure (IOP) >5 and <22 mmHg, with or without use of anti-glaucoma medication. Kaplan-Meier survival analysis was performed to compare cumulative survival between the combined surgery groups and the AGV implantation-alone group. Cox proportional hazard regression analysis was conducted to identify factors predictive of success in each of the three groups. Mean (±standard deviation) preoperative IOP was 30.2 ± 10.2 mmHg in the PKP + AGV, 35.2 ± 9.8 mmHg in the PPV + AGV, and 36.2 ± 10.1 mmHg in the AGV implantation-alone group. The cumulative success rate at 18 months was 66.9%, 73.2%, and 70.8% in the three groups, respectively. Neither combined surgery group differed significantly in terms of cumulative success rate compared with the AGV implantation-alone group (p = 0.556, p = 0.487, respectively). The mean number of preoperative anti-glaucoma medications prescribed was significantly associated with success in the PKP + AGV implantation group (hazard ratio, 2.942; p = 0.024). Either PKP or PPV performed in conjunction with AGV implantation afforded similar success rates compared to patients treated with AGV implantation alone. Therefore, in patients with refractory glaucoma who have underlying corneal or retinal pathology requiring treatment with PKP or PPV, AGV implantation can be performed simultaneously.

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips.

PubMed

Gill, Amreeta; Shellock, Frank G

2012-01-09

Metallic skin closure staples and vessel ligation clips should be tested at 3-Tesla to characterize MRI issues in order to ensure patient safety. Therefore, metallic surgical implants were assessed at 3-Tesla for magnetic field interactions, MRI-related heating, and artifacts. A skin closure staple (Visistat Skin Stapler, staple, Polytetrafluoroethylene, PTFE, coated 316L/316LVM stainless steel; Teleflex Medical, Durham, NC) and a vessel ligation clip (Hemoclip Traditional, stainless steel; Teleflex Medical, Durham, NC) that represented the largest metallic sizes made from materials with the highest magnetic susceptibilities (i.e., based on material information) among 61 other surgical implants (52 metallic implants, 9 nonmetallic implants) underwent evaluation for magnetic field interactions, MRI-related heating, and artifacts using standardized techniques. MRI-related heating was assessed by placing each implant in a gelled-saline-filled phantom with MRI performed using a transmit/receive RF body coil at an MR system reported, whole body averaged SAR of 2.9-W/kg for 15-min. Artifacts were characterized using T1-weighted, SE and GRE pulse sequences. Each surgical implant showed minor magnetic field interactions (20- and 27-degrees, which is acceptable from a safety consideration). Heating was not substantial (highest temperature change, ≤ 1.6°C). Artifacts may create issues if the area of interest is in the same area or close to the respective surgical implant. The results demonstrated that it would be acceptable for patients with these metallic surgical implants to undergo MRI at 3-Tesla or less. Because of the materials and dimensions of the surgical implants that underwent testing, these findings pertain to 61 additional similar implants.

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips

PubMed Central

2012-01-01

Purpose Metallic skin closure staples and vessel ligation clips should be tested at 3-Tesla to characterize MRI issues in order to ensure patient safety. Therefore, metallic surgical implants were assessed at 3-Tesla for magnetic field interactions, MRI-related heating, and artifacts. Methods A skin closure staple (Visistat Skin Stapler, staple, Polytetrafluoroethylene, PTFE, coated 316L/316LVM stainless steel; Teleflex Medical, Durham, NC) and a vessel ligation clip (Hemoclip Traditional, stainless steel; Teleflex Medical, Durham, NC) that represented the largest metallic sizes made from materials with the highest magnetic susceptibilities (i.e., based on material information) among 61 other surgical implants (52 metallic implants, 9 nonmetallic implants) underwent evaluation for magnetic field interactions, MRI-related heating, and artifacts using standardized techniques. MRI-related heating was assessed by placing each implant in a gelled-saline-filled phantom with MRI performed using a transmit/receive RF body coil at an MR system reported, whole body averaged SAR of 2.9-W/kg for 15-min. Artifacts were characterized using T1-weighted, SE and GRE pulse sequences. Results Each surgical implant showed minor magnetic field interactions (20- and 27-degrees, which is acceptable from a safety consideration). Heating was not substantial (highest temperature change, ≤ 1.6°C). Artifacts may create issues if the area of interest is in the same area or close to the respective surgical implant. Conclusions The results demonstrated that it would be acceptable for patients with these metallic surgical implants to undergo MRI at 3-Tesla or less. Because of the materials and dimensions of the surgical implants that underwent testing, these findings pertain to 61 additional similar implants. PMID:22230200

Two-way communication for programming and measurement in a miniature implantable stimulator.

PubMed

Thil, M A; Gérard, B; Jarvis, J C; Delbeke, J

2005-07-01

Implantable stimulators are needed for chronic electrical stimulation of nerves and muscles in experimental studies. The device described exploits the versatility of current microcontrollers for stimulation and communication in a miniature implant. Their standard outputs can provide the required selectable constant-current sources. In this device, pre-programmed stimulation paradigms were selected by transcutaneous light pulses. The potential of a programmable integrated circuit (PIC) was thus exploited. Implantable devices must be biocompatible. A novel encapsulation method that require no specialised equipment and that used two classical encapsulants, silicone and Teflon was developed. It was tested for implantation periods of up to four weeks. A novel way to estimate electrode impedance in awake animals is also presented. It was thus possible to follow the evolution of the nerve-electrode interface and, if necessary, to adjust the stimulation parameters. In practice, the electrode voltage at the end of a known constant-current pulse was measured by the PIC. The binary coded value was then indicated to the user as a series of muscle twitches that represented the binary value of the impedance measurement. This neurostimulator has been successfully tested in vitro and in vivo. Thresholds and impedance values were chronically monitored following implantation of a self-sizing spiral cuff electrode. Impedance variations in the first weeks could reflect morphological changes usually observed after the implantation of such electrodes.

Pacemakers and implantable cardioverter defibrillators--general and anesthetic considerations.

PubMed

Rapsang, Amy G; Bhattacharyya, Prithwis

2014-01-01

A pacemaking system consists of an impulse generator and lead or leads to carry the electrical impulse to the patient's heart. Pacemaker and implantable cardioverter defibrillator codes were made to describe the type of pacemaker or implantable cardioverter defibrillator implanted. Indications for pacing and implantable cardioverter defibrillator implantation were given by the American College of Cardiologists. Certain pacemakers have magnet-operated reed switches incorporated; however, magnet application can have serious adverse effects; hence, devices should be considered programmable unless known otherwise. When a device patient undergoes any procedure (with or without anesthesia), special precautions have to be observed including a focused history/physical examination, interrogation of pacemaker before and after the procedure, emergency drugs/temporary pacing and defibrillation, reprogramming of pacemaker and disabling certain pacemaker functions if required, monitoring of electrolyte and metabolic disturbance and avoiding certain drugs and equipments that can interfere with pacemaker function. If unanticipated device interactions are found, consider discontinuation of the procedure until the source of interference can be eliminated or managed and all corrective measures should be taken to ensure proper pacemaker function should be done. Post procedure, the cardiac rate and rhythm should be monitored continuously and emergency drugs and equipments should be kept ready and consultation with a cardiologist or a pacemaker-implantable cardioverter defibrillator service may be necessary. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

Students' perception of the learning environment in a distributed medical programme.

PubMed

Veerapen, Kiran; McAleer, Sean

2010-09-24

The learning environment of a medical school has a significant impact on students' achievements and learning outcomes. The importance of equitable learning environments across programme sites is implicit in distributed undergraduate medical programmes being developed and implemented. To study the learning environment and its equity across two classes and three geographically separate sites of a distributed medical programme at the University of British Columbia Medical School that commenced in 2004. The validated Dundee Ready Educational Environment Survey was sent to all students in their 2nd and 3rd year (classes graduating in 2009 and 2008) of the programme. The domains of the learning environment surveyed were: students' perceptions of learning, students' perceptions of teachers, students' academic self-perceptions, students' perceptions of the atmosphere, and students' social self-perceptions. Mean scores, frequency distribution of responses, and inter- and intrasite differences were calculated. The perception of the global learning environment at all sites was more positive than negative. It was characterised by a strongly positive perception of teachers. The work load and emphasis on factual learning were perceived negatively. Intersite differences within domains of the learning environment were more evident in the pioneer class (2008) of the programme. Intersite differences consistent across classes were largely related to on-site support for students. Shared strengths and weaknesses in the learning environment at UBC sites were evident in areas that were managed by the parent institution, such as the attributes of shared faculty and curriculum. A greater divergence in the perception of the learning environment was found in domains dependent on local arrangements and social factors that are less amenable to central regulation. This study underlines the need for ongoing comparative evaluation of the learning environment at the distributed sites and interaction between leaders of these sites.

The Dexamethasone Intravitreal Implant for Noninfectious Uveitis: Practice Patterns Among Uveitis Specialists.

PubMed

Burkholder, Bryn M; Moradi, Ahmadreza; Thorne, Jennifer E; Dunn, James P

2015-01-01

To describe the practice patterns and perceptions of uveitis specialists regarding the use of the intravitreal dexamethasone (DEX) implant for the treatment of noninfectious uveitis. We invited uveitis specialists to participate in an anonymous online survey. Among the 45 respondents, 76.5% identified uveitic macular edema as the most common clinical finding for which they use the DEX implant. The most common contraindications to DEX implantation were aphakia and glaucoma requiring >2 medications. Nearly two-thirds (64.3%) felt that the advent of the DEX implant did not change the frequency with which they used the fluocinolone acetonide (FA) implant, and about one-third (32.3%) preferred to use at least one DEX implant, before committing a patient to an FA implant. Uveitis physicians use the DEX implant for a wide range of clinical findings and uveitic diagnoses. There was no clear consensus on preferences regarding the use of DEX versus FA implants.

PIP breast implant removal: a study of 828 cases.

PubMed

Oulharj, S; Pauchot, J; Tropet, Y

2014-03-01

In March, 2010, the French Health Products Safety Agency suspended the sale of prefilled silicone breast implants manufactured by Poly Implants Prosthèse Prothese (PIP) because of a high failure rate and the use of an inappropriate silicone gel that did not comply with CE marking. These findings led to an international medical crisis. In France, 30,000 female patients had PIP implants. In our Department, 1150 PIP breast implants had been implanted in 630 patients since 2001. A retrospective study was conducted to define the rupture rate of these implants and the complications that arise. The women included in the study underwent implant removal from May 2010 to September 2012 for preventive or curative reasons. Data were collected from medical records that included: results of clinical examination, breast ultrasound before removal, rates of implant rupture, results of biopsy of periprosthetic capsule and pericapsule tissue and postoperative complications. A total of 828 PIP breast implants were removed in 455 patients. The rate of ruptured implants was 7.73% (64/828), corresponding to 11.6% of patients. A periprosthetic effusion was associated with rupture in 44% of cases. Breast ultrasound indicated a rupture for 87 implants; 32% were true positives and 3% were false negatives. Periprosthetic capsule biopsy demonstrated the presence of a foreign body, which seemed to be silicone, in 26% of cases and the presence of inflammation in 13% of cases. No siliconoma-type lesion was identified in the pericapsular tissue at biopsy. A total of 14 implants presented perspiration at removal. A statistically significant difference was found between the rates of rupture for texturised implants as compared to the smooth-surfaced implants. There were eight post-revisional-surgery complications (1%) and three cases of breast adenocarcinoma. The preventive explantation of PIP breast implants is justified given the high failure rate (7.73%) and given patients' exposure to silicone gel that did not comply with CE standards in the absence of rupture, through the early perspiration of implants. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

[Career preferences among medical students].

PubMed

Soethout, Marc B M; ten Cate, Olle Th J

2014-01-01

Research on the preference of medical specialty among medical students in the Netherlands and the attractiveness of aspects of the medical profession during the period 2009-2013. Retrospective, descriptive research. Data from medical students in the Netherlands who participated in the computer programme Inventory Medical Professionals Choice (IMBK) were analyzed with respect to their preference of medical specialty and the attractiveness of various aspects of the medical profession. The IMBK programme was available free of charge through the Royal Dutch Medical Association (KNMG) website 'Arts in Spe' (Future Physician) during the period 2009-2013. The content of the IMBK programme was based on the questionnaire from the medical profile book developed by the pharmaceutical company GlaxoSmithKline (GSK). General practice was the most popular specialty, particularly among female medical students, with interest increasing during the undergraduate medical curriculum. Hardly any students were interested in insurance medicine, occupational medicine and elderly medicine. Direct patient care was the most attractive professional aspect for medical students. Female students were more attracted to direct and prolonged patient contact than their male counterparts. The number of hours students wished to work in future declined during the course of the undergraduate curriculum, and women were more inclined to prefer regular working hours with adequate leisure time than men. During the course of the undergraduate medical curriculum, medical students changed their preference for medical specialty. Major differences exist between male and female students in terms of preference of medical specialty and attractiveness of aspects of the medical profession.

Implementation of PBL Curriculum Involving Multiple Disciplines in Undergraduate Medical Education Programme

ERIC Educational Resources Information Center

Chakravarthi, Srikumar; Haleagrahara, Nagaraja

2010-01-01

This article describes how a multidisciplinary problem-based learning (PBL) curriculum was established at the International Medical University in Malaysia for preclinical education in a 5-semester phase 1 programme. Based on positive feedback from a modified PBL program implemented in one discipline, a multidisciplinary PBL curriculum was…

Critical Review: Medical Students' Motivation after Failure

ERIC Educational Resources Information Center

Holland, Chris

2016-01-01

About 10% of students in each years' entrants to medical school will encounter academic failure at some stage in their programme. The usual approach to supporting these students is to offer them short term remedial study programmes that often enhance approaches to study that are orientated towards avoiding failure. In this critical review I will…

The ties that bind: a network approach to creating a programme in faculty development.

PubMed

Baker, Lindsay; Reeves, Scott; Egan-Lee, Eileen; Leslie, Karen; Silver, Ivan

2010-02-01

Current trends in medical education reflect the changing health care environment. An increasingly large and diverse student population, a move to more distributed models of education, greater community involvement and an emphasis on social accountability, interprofessional education and student-centred approaches to learning necessitate new approaches to faculty development to help faculty members respond effectively to this rapidly changing landscape. Drawing upon the tenets of network theory and the broader organisational literature, we propose a 'fishhook' model of faculty development programme formation. The model is based on seven key factors which supported the successful formation of a centralised programme for faculty development that addressed many of the contemporary issues in medical education. These factors include: environmental readiness; commitment and vision of a mobiliser; recruitment of key stakeholders and leaders to committees; formation of a collaborative network structure; accumulation of networking capital; legitimacy, and flexibility. Our aim in creating this model is to provide a guide for other medical schools to consider when developing similar programmes. The model can be adapted to reflect the local goals, settings and cultures of other medical education contexts.

Public engagement in Malawi through a health-talk radio programme ' Umoyo nkukambirana': A mixed-methods evaluation.

PubMed

Nyirenda, Deborah; Makawa, Tamara Chipasula; Chapita, Greyson; Mdalla, Chisomo; Nkolokosa, Mzati; O'byrne, Thomasena; Heyderman, Robert; Desmond, Nicola

2018-02-01

Radio is an effective source of health information in many resource poor countries. In Malawi, 53% of households own radios however few radio programmes in Malawi focus on health issues in the context of medical research. An interactive health-talk radio programme ' Umoyo nkukambirana' was introduced by Malawi-Liverpool-Wellcome Trust Clinical Research Programme on a national radio station. The aim was to increase awareness of health and medical research, and improve engagement between researchers, healthcare workers and the public. The content and presentation were developed through participatory community consultations. Focus Group Discussions were conducted with established Radio Listening Clubs whilst quantitative data was collected using toll free FrontlineSMS to explore national response. A total of 277 to 695 SMS (Median: 477) were received per theme. The majority of SMS were received from men (64%) and mainly from rural areas (54%). The programme improved knowledge of medical research, health and dispelled misconceptions. This study suggests that the radio may be an effective means of increasing the exposure of men to health information in resource poor settings.

Public engagement in Malawi through a health-talk radio programme ‘Umoyo nkukambirana’: A mixed-methods evaluation

PubMed Central

Nyirenda, Deborah; Makawa, Tamara Chipasula; Chapita, Greyson; Mdalla, Chisomo; Nkolokosa, Mzati; O’byrne, Thomasena; Heyderman, Robert; Desmond, Nicola

2016-01-01

Radio is an effective source of health information in many resource poor countries. In Malawi, 53% of households own radios however few radio programmes in Malawi focus on health issues in the context of medical research. An interactive health-talk radio programme ‘Umoyo nkukambirana’ was introduced by Malawi-Liverpool-Wellcome Trust Clinical Research Programme on a national radio station. The aim was to increase awareness of health and medical research, and improve engagement between researchers, healthcare workers and the public. The content and presentation were developed through participatory community consultations. Focus Group Discussions were conducted with established Radio Listening Clubs whilst quantitative data was collected using toll free FrontlineSMS to explore national response. A total of 277 to 695 SMS (Median: 477) were received per theme. The majority of SMS were received from men (64%) and mainly from rural areas (54%). The programme improved knowledge of medical research, health and dispelled misconceptions. This study suggests that the radio may be an effective means of increasing the exposure of men to health information in resource poor settings. PMID:27365364

La gestion sanitaire des élevages de rongeurs utilisés en recherche biomédicale: II. Les facteurs pouvant influencer I'implantation d'un programme de gestion sanitaire.

PubMed

1986-02-01

FACTORS INFLUENCING THE IMPLEMENTATION OF A MONITORING PROGRAM: This article outlines the principal factors that should be taken into account in a quality assurance program for rodents used in biomedical research.

Clinical guideline on bone conduction implants.

PubMed

Lavilla Martín de Valmaseda, María José; Cavalle Garrido, Laura; Huarte Irujo, Alicia; Núñez Batalla, Faustino; Manrique Rodriguez, Manuel; Ramos Macías, Ángel; de Paula Vernetta, Carlos; Gil-Carcedo Sañudo, Elisa; Lassaleta, Luis; Sánchez-Cuadrado, Isabel; Espinosa Sánchez, Juan Manuel; Batuecas Caletrio, Ángel; Cenjor Español, Carlos

2018-04-13

During the last decade there have been multiple and relevant advances in conduction and mixed hearing loss treatment. These advances and the appearance of new devices have extended the indications for bone-conduction implants. The Scientific Committee of Audiology of the Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello SEORL-CCC (Spanish Society of Otolaryngology and Head and Neck Surgery), together with the Otology and Otoneurology Committees, have undertaken a review of the current state of bone-conduction devices with updated information, to provide a clinical guideline on bone-conduction implants for otorhinolaryngology specialists, health professionals, health authorities and society in general. This clinical guideline on bone-conduction implants contains information on the following: 1) Definition and description of bone-conduction devices; 2) Current and upcoming indications for bone conduction devices: Magnetic resonance compatibility; 3) Organization requirements for a bone-conduction implant programme. The purpose of this guideline is to describe the different bone-conduction implants, their characteristics and their indications, and to provide coordinated instructions for all the above-mentioned agents for decision making within their specific work areas. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

Mix-and-match nanobiosensor design: Logical and spatial programming of biosensors using self-assembled DNA nanostructures.

PubMed

Liu, Ying; Kumar, Sriram; Taylor, Rebecca E

2018-04-06

The evergrowing need to understand and engineer biological and biochemical mechanisms has led to the emergence of the field of nanobiosensing. Structural DNA nanotechnology, encompassing methods such as DNA origami and single-stranded tiles, involves the base pairing-driven knitting of DNA into discrete one-, two-, and three-dimensional shapes at nanoscale. Such nanostructures enable a versatile design and fabrication of nanobiosensors. These systems benefit from DNA's programmability, inherent biocompatibility, and the ability to incorporate and organize functional materials such as proteins and metallic nanoparticles. In this review, we present a mix-and-match taxonomy and approach to designing nanobiosensors in which the choices of bioanalyte and transduction mechanism are fully independent of each other. We also highlight opportunities for greater complexity and programmability of these systems that are built using structural DNA nanotechnology. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Diagnostic Tools > Biosensing Biology-Inspired Nanomaterials > Nucleic Acid-Based Structures Nanotechnology Approaches to Biology > Nanoscale Systems in Biology. © 2018 Wiley Periodicals, Inc.

In vivo biocompatibility of boron doped and nitrogen included conductive-diamond for use in medical implants.

PubMed

Garrett, David J; Saunders, Alexia L; McGowan, Ceara; Specks, Joscha; Ganesan, Kumaravelu; Meffin, Hamish; Williams, Richard A; Nayagam, David A X

2016-01-01

Recently, there has been interest in investigating diamond as a material for use in biomedical implants. Diamond can be rendered electrically conducting by doping with boron or nitrogen. This has led to inclusion of boron doped and nitrogen included diamond elements as electrodes and/or feedthroughs for medical implants. As these conductive device elements are not encapsulated, there is a need to establish their clinical safety for use in implants. This article compares the biocompatibility of electrically conducting boron doped diamond (BDD) and nitrogen included diamond films and electrically insulating poly crystalline diamond films against a silicone negative control and a BDD sample treated with stannous octoate as a positive control. Samples were surgically implanted into the back muscle of a guinea pig for a period of 4-15 weeks, excised and the implant site sectioned and submitted for histological analysis. All forms of diamond exhibited a similar or lower thickness of fibrotic tissue encapsulating compared to the silicone negative control samples. All forms of diamond exhibited similar or lower levels of acute, chronic inflammatory, and foreign body responses compared to the silicone negative control indicating that the materials are well tolerated in vivo. © 2015 Wiley Periodicals, Inc.

REVIEW ARTICLE: Medical implants based on microsystems

NASA Astrophysics Data System (ADS)

Mokwa, W.

2007-05-01

The fast development of CMOS technologies to smaller dimensions led to very high integration densities with complex circuitry on very small chip areas. In 2006 Intel fabricated the first products in a 65 nm technology. The cointegration of microsensors or actuators together with the very low power consumption of the CMOS circuitry is very well suited for use in implanted systems. Applications like intracranial or intraocular pressure measurements have become possible. This review presents an overview over actual applications and developments of sensor/actuator-based microsystems for medical implants. It concentrates on the technical part of these investigations. It will mainly review work on systems measuring pressure in blood vessels and on systems for ophthalmic applications.

"Bionic Man" Showcases Medical Research | NIH MedlinePlus the Magazine

MedlinePlus

... Wisconsin Implantable Sensors for Prosthesis Control Implantable myoelectric (electrical properties of muscle) sensors detect nerve signals above ... treatments reach the brain. Spinal Stimulation for Paralysis Electrical stimulation of the spinal cord is being used ...

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

Comparing polymethylmethacrylate implant with collagen implant in deep sclerectomy: a randomized controlled trial.

PubMed

Mansouri, Kaweh; Shaarawy, Tarek; Wedrich, Andreas; Mermoud, André

2006-06-01

To compare the intraocular pressure (IOP) lowering effect and safety of a new rigid, nonabsorbable polymethylmethacrylate implant (PMMA) with the commercially available cylindrical collagen implant used in deep sclerectomy procedure. Nonpenetrating deep sclerectomy was performed on all patients. Patients were randomly assigned to receive either a PMMA implant or a collagen implant. The trial involved 60 patients (60 eyes) with medically uncontrolled primary and secondary open-angle glaucoma who were randomized to receive either a PMMA implant (30 eyes) or the collagen implant (30 eyes). The patients were examined before and after the operation 1 day before surgery and at day 1; weeks 1, 2 and 3; and months 1, 2, 3, 6, 9, 12, 18, 24, and 30. At each visit, the following examinations were performed: slit lamp examination, tonometry, visual acuity, and fundoscopy. The mean follow-up period was 20.4 (SD 12.4) months (PMMA) and 15.1 (SD 7.7) months (collagen) (P=NS). The mean preoperative IOP was 21.4 (SD 7.1) mm Hg (PMMA) and 21.0 mm Hg (SD 5.4) (collagen). The mean postoperative IOP was 7.4 (SD 4.5) mm Hg (PMMA) and 5.4 (SD 4.4) mm Hg (collagen) at day 1 (P=NS), 15.7 (SD 5.0) mm Hg (PMMA) and 14.7 (SD 5.0) mm Hg (collagen) at month 1 (P=NS), and 13.8 (SD 4.8) mm Hg (PMMA) and 13.3 (SD 2.4) mm Hg (collagen) at month 12 (P=NS). Seven patients had perforations of the trabeculo-Descemet membrane and were excluded from the analysis. At the last follow-up visit, 42% of PMMA patients and 44% of collagen patients achieved an IOP of 21 mm Hg or less without medication (P=NS). The number of medications was reduced from 2.4 (SD 1.0) to 0.6 (SD 0.6) (P<0.001) in the PMMA group, and from 2.4 (SD 1.1) to 0.7 (SD 0.8) (P<0.001) in the collagen group. There were no significant differences between the 2 groups in postoperative and transient complications. The new PMMA implant offered success and complication rates equal to those of the collagen implant. The new PMMA implant could serve as a low-cost alternative to the collagen implant and render the use of deep sclerectomy with an implant affordable for settings with limited financial resources.

Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

PubMed

Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

2014-02-01

Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

Photodynamic therapy in peri-implantitis

NASA Astrophysics Data System (ADS)

Leretter, Marius; Cândea, Adrian; Topala, Florin

2014-01-01

Peri-implantitis is like Damocles sword, threatening over our final results as is the most common cause of implant failure. It is, was and will be one of the most challenging tasks for the practitioner to deal with. The rough implant surface offers the ideal conditions for the pathogenic bacteria to stick and multiply. Even more, the growing mature biofilm is harder to eliminate. Mechanical cleaning and rinsing is not capable to destroy it entirely. Most treatment protocols include strong antibiotics, disregarding their side effects and interactions with other medications.

Using peer mentoring for people with spinal cord injury to enhance self-efficacy beliefs and prevent medical complications.

PubMed

Ljungberg, Inger; Kroll, Thilo; Libin, Alexander; Gordon, Samuel

2011-02-01

Individuals with spinal cord injury/disease are faced with a myriad of psychosocial adjustment challenges. This article describes the implementation of a peer-mentoring programme designed to support this adjustment process for people with SCI/disease and the programme's believed impact on self-efficacy and prevention of medical complications. With shorter length of stay in acute inpatient rehabilitation after spinal cord injury/disease, peer mentor programmes are becoming an important component to assist with education and community re-integration. Quasi-experimental non-controlled pretest/post-test. Patients with newly acquired spinal cord injury/disease participated in a one-year spinal cord injury peer-mentoring programme. Peer mentors met with their assigned participants regularly during inpatient care and on discharge to track medical complications and assist with adjusting to life after spinal cord injury/disease. In all, of 37 mentees enrolled, 24 successfully completed the programme. Sixty-seven per cent showed improved self-efficacy score between the two time points. Medical complications and doctor visits all decreased significantly between 0-6 months and 7-12 months. Our findings indicate that the older an individual is, the lower the likelihood of having a urinary tract infection (p = 0.006). The programme was well received by all mentees who felt they could connect well with their peer mentor. Peer mentoring in a rehabilitation setting enhances the understanding of challenges that patients and medical staff deal with on a day-to-day basis. Our findings suggest it is important to monitor and educate individuals with spinal cord injury/disease at the acute stage to improve medical outcomes. Caution is advised in the interpretation of these results as they were obtained in a small non-random sample using self-report data. Peer mentors play an increasingly important role in nurse-delivered education in the spinal cord injury/disease population. © 2011 Blackwell Publishing Ltd.

[Orthodontic treatment of patients medicated with bisphosphonates-a clinical case report].

PubMed

Krieger, Elena; d'Hoedt, Bernd; Scheller, Herbert; Jacobs, Collin; Walter, Christian; Wehrbein, Heinrich

2013-01-01

Bisphosphonates (BP) are an established medication, e.g., for the prevention/therapy of osteoporosis. The effects of the changed bone metabolism for orthodontic treatments are unknown. A 66-year-old woman underwent a total oral rehabilitation. The therapy included (1) tooth extractions, (2) periodontal treatment, (3) insertion of dental implants, (4) provisional implant restorations, (5) orthodontic treatment, and (6) definite implant restorations. The orthodontic tooth movements were in- and retrusion of the upper frontal teeth, intrusion of the lower front teeth, using the dental implants as skeletal anchorage. After implant insertion and one month before beginning the orthodontic treatment, osteoporosis was diagnosed in this patient and, without notification to our facility, BP treatment was initiated by her general practitioner (alendronate oral, 70 mg/week), with an overall duration of intake of 7 months. After 13 months, the orthodontic treatment was successfully accomplished; however enlarged periodontal gaps, sclerotic bone areas, and mild apical root resorptions of the upper frontal teeth were found in this patient. Currently, there are no recommendations for orthodontic patients undergoing BP therapy. Orthodontic tooth movement in this low-risk patient with a short duration of intake and a low-dose BP medication was possible. Because of the reduced bone metabolism and the higher amount of side effects, the treatment should be performed with extremely light forces and frequent monitoring.

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.

The appearance and effects of metallic implants in CT images.

PubMed

Kairn, T; Crowe, S B; Fogg, P; Trapp, J V

2013-06-01

The computed tomography (CT) imaging artefacts that metallic medical implants produce in surrounding tissues are usually contoured and over-ridden during radiotherapy treatment planning. In cases where radiotherapy treatment beams unavoidably pass though implants, it is especially important to understand the imaging artefacts that may occur within the implants themselves. This study examines CT images of a set of simple metallic objects, immersed in water, in order to evaluate reliability and variability of CT numbers (Hounsfield units, HUs) within medical implants. Model implants with a range of sizes (heights from 2.2 to 49.6 mm), electron densities (from 2.3 to 7.7 times the electron density of water) and effective atomic numbers (from 3.9 to 9.0 times the effective atomic number of water in a CT X-ray beam) were created by stacking metal coins from several currencies. These 'implants' were CT scanned within a large (31.0 cm across) and a small (12.8 cm across) water phantom. Resulting HU values are as much as 50 % lower than the result of extrapolating standard electron density calibration data (obtained for tissue and bone densities) up to the metal densities and there is a 6 % difference between the results obtained by scanning with 120 and 140 kVp tube potentials. Profiles through the implants show localised cupping artefacts, within the implants, as well as a gradual decline in HU outside the implants that can cause the implants' sizes to be over estimated by 1.3-9.0 mm. These effects are exacerbated when the implants are scanned in the small phantom or at the side of the large phantom, due to reduced pre-hardening of the X-ray beam in these configurations. These results demonstrate the necessity of over-riding the densities of metallic implants, as well as their artefacts in tissue, in order to obtain accurate radiotherapy dose calculations.

Electronic design of a multichannel programmable implant for neuromuscular electrical stimulation.

PubMed

Arabi, K; Sawan, M A

1999-06-01

An advanced stimulator for neuromuscular stimulation of spinal cord injured patients has been developed. The stimulator is externally controlled and powered by a single encoded radio frequency carrier and has four independently controlled bipolar stimulation channels. It offers a wide range of reprogrammability and flexibility, and can be used in many neuromuscular electrical stimulation applications. The implant system is adaptable to patient's needs and to future developments in stimulation algorithms by reprogramming the stimulator. The stimulator is capable of generating a wide range of stimulation waveforms and stimulation patterns and therefore is very suitable for selective nerve stimulation techniques. The reliability of the implant has been increased by using a forward error detection and correction communication protocol and by designing the chip for structural testability based on scan test approach. Implemented testability scheme makes it possible to verify the complete functionality of the implant before and after implantation. The stimulators architecture is designed to be modular and therefore its different blocks can be reused as standard building blocks in the design and implementation of other neuromuscular prostheses. Design for low-power techniques have also been employed to reduce power consumption of the electronic circuitry.

Trabeculectomy With Mitomycin C or Ahmed Valve Implantation in Eyes With Uveitic Glaucoma.

PubMed

Bettis, Daniel I; Morshedi, Richard G; Chaya, Craig; Goldsmith, Jason; Crandall, Alan; Zabriskie, Norm

2015-01-01

To report and compare the results of trabeculectomy with mitomycin C (MMC) and Ahmed valve implantation in the management of uveitic glaucoma. The records of 41 eyes of 29 patients who underwent trabeculectomy with MMC or Ahmed valve implantation for uveitic glaucoma were retrospectively reviewed. Seventeen eyes underwent trabeculectomy with MMC, and 24 eyes underwent Ahmed valve implantation. Outcomes included postoperative intraocular pressure (IOP), percent reduction from preoperative IOP, postoperative number of medications, time to failure, and complications. Mean follow-up was 21.2 months in the trabeculectomy group and 23.8 months in the valve group (P=0.06). Mean IOP was reduced from 29.2 to 18.4 mm Hg in the trabeculectomy group (31.3%), compared with a reduction from 33.4 to 15.5 mm Hg in the Ahmed valve group (42.7%, P=0.53). Postoperatively, 1.76 medications were used in the trabeculectomy group, compared with 1.83 medications in the Ahmed valve group (P=0.89). Cumulative success at 1 year was 66.7% in the trabeculectomy group, compared with 100% in the Ahmed valve group (P=0.02). Mean time to failure was 8.36 months with trabeculectomy, and 21.8 months with Ahmed valve (P=0.02). Complications in both groups were typically rare and self-limited, with recurrent inflammation being most common. Although both trabeculectomy with MMC and Ahmed valve implantation are reasonable surgical options in the management of uncontrolled uveitic glaucoma, Ahmed valve implantation was associated with higher cumulative success rate at 1 year and a longer mean time to failure.

Doctor pharmaceutical utilization behaviour changed by the global budget programme strategies on hypertensive outpatient prescription.

PubMed

Wei, Ching-Kuo; Wang, Shun-Mu; Yeh, Ming-Kung

2012-04-01

This study was to examine changes in doctor pharmaceutical utilization behaviour in response to Taiwan's newly implemented National Health Insurance individual hospital global budget (GB) programme and the changes in health care costs and prescription trends for hypertensive (HT) patients. We analysed hospital outpatient prescription utilization with a pre-post individual hospital GB group and comparison group (the hospitals who did not join the programme) to evaluate the impact of GB strategies on hypertensive expenditure. Descriptive analyses were performed based on the average daily medication expenditure for each prescription, and average number of items per prescription. This study reviewed 16,770,057 outpatient records and prescription records of 213,568 hypertensive patients. The average total medication expense (+17.6%), HT medication expense (+8.8%), daily medication expense (+16.3%), and daily HT medication expense (+6.3%) significantly increased after the action. After the individual hospital GB action, hospital doctors participating in action switched their patients' prescription drugs to other less expensive drugs such as rennin-angiotensin-aldosterone system inhibitors (-1.1%). The increase in volume of medications prescribed for control group were significantly larger for both alfa- and beta-adrenergic blocking agents (1.5%), and calcium channel blocking agents (3.9%). The individual hospital GB programme slowed down the trend of prescription drug cost increasing rate and reduced the prescription drug volume in hospitals. © 2010 Blackwell Publishing Ltd.

The contribution of short-term memory capacity to reading ability in adolescents with cochlear implants.

PubMed

Edwards, Lindsey; Aitkenhead, Lynne; Langdon, Dawn

2016-11-01

This study aimed to establish the relationship between short-term memory capacity and reading skills in adolescents with cochlear implants. A between-groups design compared a group of young people with cochlear implants with a group of hearing peers on measures of reading, and auditory and visual short-term memory capacity. The groups were matched for non-verbal IQ and age. The adolescents with cochlear implants were recruited from the Cochlear Implant Programme at a specialist children's hospital. The hearing participants were recruited from the same schools as those attended by the implanted adolescents. Participants were 18 cochlear implant users and 14 hearing controls, aged between 12 and 18 years. All used English as their main language and had no significant learning disability or neuro-developmental disorder. Short-term memory capacity was assessed in the auditory modality using Forward and Reverse Digit Span from the WISC IV UK, and visually using Forward and Reverse Memory from the Leiter-R. Individual word reading, reading comprehension and pseudoword decoding were assessed using the WIAT II UK. A series of ANOVAs revealed that the adolescents with cochlear implants had significantly poorer auditory short-term memory capacity and reading skills (on all measures) compared with their hearing peers. However, when Forward Digit Span was entered into the analyses as a covariate, none of the differences remained statistically significant. Deficits in immediate auditory memory persist into adolescence in deaf children with cochlear implants. Short-term auditory memory capacity is an important neurocognitive process in the development of reading skills after cochlear implantation in childhood that remains evident in later adolescence. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The breast implant controversy.

PubMed

Cook, R R; Harrison, M C; LeVier, R R

1994-02-01

The breast implant issue is a "bad news/good news" story. For many women with implants, the controversy has caused a fair degree of anxiety which may or may not be resolved as further information becomes available. It has also taken its toll on Dow Corning. Whole lines of medical products have been eliminated or are being phase out. The development of new medical applications has been terminated. As a consequence, employees have lost their jobs. What the effect will be on the biomedical industry as a whole remains to be seen (11). While silicones have been an important component in various medical devices, it is likely that other materials can be used as replacements. However, suppliers of non-silicone materials are also reevaluating their role in this market. For example, Du Pont, the nation's largest chemical company, has determined that the unpredictable and excessive costs of doing business with manufacturers of implantable medical devices no longer justifies the unrestricted sale of standard raw materials into this industry. Other companies are quietly following suit. On the up side, it is possible that the research being driven by this controversy will result in a greater understanding of the immunologic implications of xenobiotics, of the importance of nonbiased observations, of the need for ready access to valid data sets, and of the opportunity for valid scientific information to guide legal decisions. Only time will tell.

77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System sponsored by Cameron Health, Inc. The S-ICD is the first implantable defibrillator that...

Experiences with the implementation of a national teaching qualification in university medical centres and veterinary medicine in the Netherlands.

PubMed

Molenaar, Willemina M Ineke; Zanting, Anneke

2015-02-01

In 2008, a compulsory national basic teaching qualification was introduced for all university teachers in the Netherlands. At that time all eight University Medical Centres (UMCs) and the only Faculty of Veterinary Medicine had adopted or were setting up teacher development programmes. This study explores how these programmes relate to each other and to the basic teaching qualification. To gather information on teacher development programmes in the UMCs and the Veterinary Medicine Faculty an online survey was filled out by teacher development representatives from each of them. The programmes had main features in common (e.g. competency based and portfolio assessment), but differed somewhat in contents according to the local situation. Importantly, they had all been formally accepted as equivalent to the basic teaching qualification. We consider the freedom to tailor the qualifications to the medical context as well as to the local situation of the UMCs and the Veterinary Medicine Faculty one of the major success factors and the well-established collaboration between teacher development representatives of the UMCs and the Faculty of Veterinary Medicine as another. Challenges for the future include embedding the teacher development programmes in the institutional organizations and maintaining and further developing the programmes and the competencies of the qualified teachers, e.g. in a senior qualification.

[Indication guidelines for medical rehabilitation in the context of disease management programmes].

PubMed

Raspe, Heiner

2005-02-01

In current and upcoming disease management programmes in Germany, the provision of medical services is strongly oriented on ICD diagnoses and on services traditionally provided by the statutory health insurance. Multidisciplinary services, such as medical rehabilitation, mostly covered by other payers (e.g. pension funds) are not taken into account. On the other hand, many chronically-ill patients have complex and multifocal health complaints that are best addressed by multidisciplinary interventions. Considering this inherent deficit, in 2002 the German Society of Rehabilitation Sciences has initiated the research project "Indication Guidelines" aimed at developing indication criteria for rehabilitation in the context of disease management programmes. The concept presented in this paper relies on three basic requirements: 1. Impaired participation (according to ICF) caused by multifocal deficits leads to the definition of goals for rehabilitation, taking into account clinical and legal aspects as well as the patients preferences. 2. Multifocal health problems are best addressed by a multidisciplinary rehabilitation programme as it is currently provided by the German pension funds. 3. Scientific evidence has to demonstrate that these programmes are very likely to be effective (positive rehabilitation prognosis, evidence-based rehabilitation). Further requirements include adequate instruction of patients, as well as intensive and prolonged after-care. Both could be very well integrated into comprehensive disease management programmes.

Implementing economic evaluation in simulation-based medical education: challenges and opportunities.

PubMed

Lin, Yiqun; Cheng, Adam; Hecker, Kent; Grant, Vincent; Currie, Gillian R

2018-02-01

Simulation-based medical education (SBME) is now ubiquitous at all levels of medical training. Given the substantial resources needed for SBME, economic evaluation of simulation-based programmes or curricula is required to demonstrate whether improvement in trainee performance (knowledge, skills and attitudes) and health outcomes justifies the cost of investment. Current literature evaluating SBME fails to provide consistent and interpretable information on the relative costs and benefits of alternatives. Economic evaluation is widely applied in health care, but is relatively scarce in medical education. Therefore, in this paper, using a focus on SBME, we define economic evaluation, describe the key components, and discuss the challenges associated with conducting an economic evaluation of medical education interventions. As a way forward to the rigorous and state of the art application of economic evaluation in medical education, we outline the steps to gather the necessary information to conduct an economic evaluation of simulation-based education programmes and curricula, and describe the main approaches to conducting an economic evaluation. A properly conducted economic evaluation can help stakeholders (i.e., programme directors, policy makers and curriculum designers) to determine the optimal use of resources in selecting the modality or method of assessment in simulation. It also helps inform broader decision making about allocation of scarce resources within an educational programme, as well as between education and clinical care. Economic evaluation in medical education research is still in its infancy, and there is significant potential for state-of-the-art application of these methods in this area. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Reducing RF-related heating of cardiac pacemaker leads in MRI: implementation and experimental verification of practical design changes.

PubMed

Nordbeck, Peter; Fidler, Florian; Friedrich, Michael T; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Herold, Volker; Geistert, Wolfgang; Jakob, Peter M; Ertl, Georg; Ritter, Oliver; Ladd, Mark E; Bauer, Wolfgang R; Quick, Harald H

2012-12-01

There are serious concerns regarding safety when performing magnetic resonance imaging in patients with implanted conductive medical devices, such as cardiac pacemakers, and associated leads, as severe incidents have occurred in the past. In this study, several approaches for altering an implant's lead design were systematically developed and evaluated to enhance the safety of implanted medical devices in a magnetic resonance imaging environment. The individual impact of each design change on radiofrequency heating was then systematically investigated in functional lead prototypes at 1.5 T. Radiofrequency-induced heating could be successfully reduced by three basic changes in conventional pacemaker lead design: (1) increasing the lead tip area, (2) increasing the lead conductor resistance, and (3) increasing outer lead insulation conductivity. The findings show that radiofrequency energy pickup in magnetic resonance imaging can be reduced and, therefore, patient safety can be improved with dedicated construction changes according to a "safe by design" strategy. Incorporation of the described alterations into implantable medical devices such as pacemaker leads can be used to help achieve favorable risk-benefit-ratios when performing magnetic resonance imaging in the respective patient group. Copyright © 2012 Wiley Periodicals, Inc.

The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.

PubMed

Greco, Cinzia

2015-12-01

This article examines the 2010 scandal surrounding the use and subsequent recall of adulterated Poly Implant Prothèse (PIP) silicone breast prostheses in France. It uses a mixed method approach that includes 12 interviews with French PIP prosthesis recipients, analyses of medical literature, policy documents of French and EU regulatory agencies, and an online forum for PIP recipients. These data are used to explain how the definition of "acceptable risk" in the silicone implants controversy of the 1990s in the US influenced the PIP scandal later on in France. Additionally, PIP recipients had an embodied experience of risk that clashed with the definition of risk used by authorities and some surgeons. The coverage of re-implantation was also defined at different policy levels, leading to variation in patients' suffering. The combination of fraud and lack of recognition from part of the medical system constitutes an example of social suffering for the patients involved. The PIP scandal is a useful case for analyzing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship. Copyright © 2015 Elsevier Ltd. All rights reserved.

Successful implementation of the European Resuscitation Council basic life support course as mandatory peer-led training for medical students.

PubMed

Grove, Erik L; Løfgren, Bo

2014-04-01

We aimed to implement the European Resuscitation Council (ERC) basic life support (BLS) and automated external defibrillator (AED) course as a mandatory peer-led training programme for medical students and to evaluate the satisfaction with this course. Medical students certified as ERC BLS/AED instructors were recruited as student trainers and organizers of the course, which was included as a mandatory part of the curriculum for second-year medical students before first clinical rotation. After each course, questionnaires were distributed to evaluate the peer-led training programme. In total, 146 students were trained and assessed. The quality of the course was rated as 9.4±0.8 (10-point scale, 10 being best), and the majority (95%) felt better prepared for their clinical rotation. Implementation of the ERC BLS/AED course as a mandatory peer-led training programme for medical students is feasible. The course has been very well accepted and the students feel better prepared for their first clinical rotation.

Recognition Organisations That Evaluate Agencies Accrediting Medical Education Programmes: "Quis Custodiet Ipsos Custodes?"

ERIC Educational Resources Information Center

van Zanten, Marta

2017-01-01

The goals of agencies that accredit medical education programmes or institutions are to ensure high quality student experiences and to certify the readiness of graduates to further their training or begin practice as physicians. While accreditation provides a level of legitimacy, the agencies conducting the reviews vary in their organisation,…

Medical implications of employee assistance programmes.

PubMed

Lloyd, G G; Doyle, Y; Grange, C

1999-04-01

The development of employee assistance programmes (EAPs) has significant implications for doctors, especially general practitioners and psychiatrists. This paper discusses the importance of training counsellors to detect serious psychological disorders among people who use an EAP service and the need for clinicians to accept referrals of those users who are identified as being in need of further medical treatment.

Student teacher training: participant motivation.

PubMed

Burgess, Annette; van Diggele, Christie; Mellis, Craig

2016-08-01

Teaching, assessment and feedback skills are documented globally as required graduate attributes for medical students. By integrating teacher training into curricula, the importance of teaching and educational scholarship is highlighted. In this study, we used self-determination theory (SDT) to consider medical students' motivation to voluntarily participate in a short teacher training programme. Thirty-eight senior medical students were invited to attend a teacher training programme at a major tertiary teaching hospital. Participating students were asked to respond to one question: 'Why did you volunteer to take part in the teacher training course?' Self-determination theory was used as a conceptual framework to identify and code recurrent themes in the data. In total, 23/38 (61%) of invited students chose to participate in the programme, and 21/23 (91%) of the students responded to the survey. Students' motivation to participate in the teacher training programme were related to: (1) autonomy - their enjoyment of their current voluntary involvement in teaching; (2) competence - a recognition of the need for formal training and certification in teaching, and as an essential part of their future career in medicine; (3) relatedness - the joint recognition of the importance of quality in teaching, as emphasised by their own learning experiences in the medical programme. Students reported being motivated to take part in teacher training because of their enjoyment of teaching, their desire to increase the quality of teaching within medical education, their desire for formal recognition of teaching as a learned skill, plus their recognition of teaching as a requirement within the medical profession. By integrating teacher training into curricula, the importance of teaching and educational scholarship is highlighted. © 2015 John Wiley & Sons Ltd.

Profound hearing loss associated with hydrocodone/acetaminophen abuse.

PubMed

Friedman, R A; House, J W; Luxford, W M; Gherini, S; Mills, D

2000-03-01

To describe profound hearing loss associated with hydrocodone overuse and the successful rehabilitation of these patients with cochlear implantation. Retrospective review. A tertiary otologic referral center. Twelve patients with rapidly progressive hearing loss and a concurrent history of hydrocodone overuse. Comprehensive medical histories, physical findings, audiometric tests, and, in those patients undergoing cochlear implantation, postimplantation performance data were reviewed. Clinical characteristics of hydrocodone-related hearing loss and open set word and sentence performance in those patients undergoing cochlear implantation. Hydrocodone overuse was associated with rapidly progressive sensorineural hearing loss in 12 patients. In four patients the initial presentation was unilateral, and two of the patients experienced vestibular symptoms. None of the 12 patients experienced improved thresholds after high-dose prednisone. Seven of the eight patients undergoing cochlear implantation have demonstrated early success with their devices. Hydrocodone is frequently prescribed in combination with acetaminophen for the relief of pain and has a side effects profile similar to other medications in its class. Although not described previously, overuse or abuse can be associated with a rapidly progressive sensorineural hearing loss. These patients can be successfully rehabilitated with cochlear implantation.

Pathological mandibular fracture: A severe complication of periimplantitis

PubMed Central

Rodriguez-Campo, Francisco; Naval-Parra, Beatriz; Sastre-Pérez, Jesús

2015-01-01

Nowadays, dental implant treatment is a very common option for patients even in medical compromised conditons. Some complications related to them have been described. Periimplantitis (PI) is one of the biggest concerns complications of these kind of treatments, probably has a multifactorial aethiology. Usually the consequences of PI are the loss of the implants and prostheses, expenses of money and time for dentists and patients. Very often PI implies the necesity of repeating the treatment . Pathological mandibular fracture due to PI is a severe but infrequent complication after dental implant treatment, especially after PI. In this study we present three cases of mandibular pathologic fractures among patients with different medical and dental records but similar management: two of them had been treated years ago of oral squamous cell carcinoma with surgery and radiotherapy, the other patient received oral bisphosphonates for osteoporosis some years after implantation. We analized the causes, consequences and posible prevention of these fractures as well as the special features of this kind of mandibular fractures and the different existing treatments. Key words:Periimplantitis, pathological mandibular fracture, mandibular atrophy, bicortical implants. PMID:26155355

Pathological mandibular fracture: A severe complication of periimplantitis.

PubMed

Naval-Gías, Luis; Rodriguez-Campo, Francisco; Naval-Parra, Beatriz; Sastre-Pérez, Jesús

2015-04-01

Nowadays, dental implant treatment is a very common option for patients even in medical compromised conditons. Some complications related to them have been described. Periimplantitis (PI) is one of the biggest concerns complications of these kind of treatments, probably has a multifactorial aethiology. Usually the consequences of PI are the loss of the implants and prostheses, expenses of money and time for dentists and patients. Very often PI implies the necesity of repeating the treatment . Pathological mandibular fracture due to PI is a severe but infrequent complication after dental implant treatment, especially after PI. In this study we present three cases of mandibular pathologic fractures among patients with different medical and dental records but similar management: two of them had been treated years ago of oral squamous cell carcinoma with surgery and radiotherapy, the other patient received oral bisphosphonates for osteoporosis some years after implantation. We analized the causes, consequences and posible prevention of these fractures as well as the special features of this kind of mandibular fractures and the different existing treatments. Key words:Periimplantitis, pathological mandibular fracture, mandibular atrophy, bicortical implants.

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker programmers. 870.3700 Section 870.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers...

Implants for elderly patients.

PubMed

Schimmel, Martin; Müller, Frauke; Suter, Valérie; Buser, Daniel

2017-02-01

In the developed world, the large birth cohorts of the so-called baby boomer generation have arrived in medical and dental practices. Often, elderly patients are 'young-old' baby boomers in whom partial edentulism is the predominant indication for implant therapy. However, the generation 85+ years of age represents a new challenge for the dental profession, as their lives are frequently dominated by dependency, multimorbidity and frailty. In geriatric implant dentistry, treatment planning is highly individualized, as interindividual differences become more pronounced with age. Nevertheless, there are four typical indications for implant therapy: (i) avoidance of removable partial prostheses; (ii) preservation of existing removable partial prostheses; (iii) stabilization of Kennedy Class I removable partial prostheses; and (iv) stabilization of complete prostheses. From a surgical point of view, two very important aspects must be considered when planning implant surgery in elderly patients: first, the consistent strive to minimize morbidity; and, second, the fact that coexisting medical risk factors are significantly more common in elderly patients. Modern three-dimensional cone beam computed tomography imaging is often indicated in order to plan minimally invasive implant surgery. Computer-assisted implant surgery might allow flapless implant surgery, which offers a low level of postoperative morbidity and a minimal risk of postsurgical bleeding. Short and reduced-diameter implants are now utilized much more often than a decade ago. Two-stage surgical procedures should be avoided in elderly patients. Implant restorations for elderly patients should be designed so that they can be modified to become low-maintenance prostheses, or even be removed, as a strategy to facilitate oral hygiene and comfort in the final stage of life. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Temporary Piggyback Intraocular Lens Implantation Versus Single Intraocular Lens Implantation in Congenital Cataracts: Long-Term Clinical Outcomes.

PubMed

Hwang, Sungsoon; Lim, Dong Hui; Lee, Soomin; Choi, Daye Diana; Chung, Eui-Sang; Chung, Tae-Young

2018-04-01

To report the long-term results of temporary piggyback IOL implantation in congenital cataract and to compare the clinical outcomes of temporary piggyback IOL with those of single IOL implantation. This is a retrospective, comparative, interventional study. The medical records of all consecutive patients who underwent cataract extraction and single or temporary piggyback IOL implantation within the first 3 years of life from 1999 to 2013 at Samsung Medical Center were reviewed. Twenty-eight eyes from 18 patients underwent single IOL implantation (monopseudophakia group), and 32 eyes of 20 patients underwent temporary piggyback IOL implantation in congenital cataract surgery (polypseudophakia group). The mean age at initial cataract surgery was 15.8 months in the monopseudophakia group and 11.1 months in the polypseudophakia group (P = 0.144). The average follow-up duration was 133 months in the monopseudophakia group and 120 months in the polypseudophakia group (P = 0.391). The best-corrected visual acuity at the last visit was 0.36 logMAR in the monopseudophakia group and 0.55 logMAR in the polypseudophakia group (P = 0.044). Four (14%) and 14 (44%) reoperations for complications within the anterior segment were performed in the monopseudophakia group and polypseudophakia group, respectively (P = 0.042). Four cases (14.3%) in the monopseudophakia group and 13 cases (40.6%) in the polypseudophakia group had a glaucoma-related adverse event (P = 0.086). Compared with primary single IOL implantation in congenital cataract, temporary piggyback IOL implantation produced worse visual acuity, higher reoperation rate, and higher risk of secondary glaucoma. Temporary piggyback IOL implantation does not have benefit in congenital cataract.

Surface characterization and biodegradation behavior of magnesium implanted poly(L-lactide/caprolactone) films

NASA Astrophysics Data System (ADS)

Sokullu, Emel; Ersoy, Fulya; Yalçın, Eyyup; Öztarhan, Ahmet

2017-11-01

Biopolymers are great source for medical applications such as drug delivery, wound patch, artificial tissue studies etc., food packaging, cosmetic applications etc. due to their biocompatibility and biodegradability. Particularly, the biodegradation ability of a biomaterial makes it even advantageous for the applications. The more tunable the biodegradation rate the more desired the biopolymers. There are many ways to tune degradation rate including surface modification. In this study ion implantation method applied to biopolymer surface to determine its effect on biodegradation rate. In this study, surface modification of poly(L-lactide/caprolactone) copolymer film is practiced via Mg-ion-implantation using a MEVVA ion source. Mg ions were implanted at a fluence of 1 × 1015 ions/cm2 and ion energy of 30 keV. Surface characterization of Mg-ion-implanted samples is examined using Atomic Force Microscopy, Raman spectroscopy, contact angle measurement and FT-IR Spectroscopy. These analyses showed that the surface become more hydrophilic and rougher after the ion implantation process which is advantageous for cell attachment on medical studies. The in vitro enzymatic degradation of Mg-implanted samples was investigated in Lipase PS containing enzyme solution. Enzymatic degradation rate was examined by mass loss calculation and it is shown that Mg-implanted samples lost more than 30% of their weight while control samples lost around 20% of their weight at the end of the 16 weeks. The evaluation of the results confirmed that Mg-ion-implantation on poly(L-lactide/caprolactone) films make the surface rougher and more hydrophilic and changes the organic structure on the surface. On the other hand, ion implantation has increased the biodegradation rate.

Preliminary fabrication and characterization of electron beam melted Ti-6Al-4V customized dental implant.

PubMed

Ramakrishnaiah, Ravikumar; Al Kheraif, Abdulaziz Abdullah; Mohammad, Ashfaq; Divakar, Darshan Devang; Kotha, Sunil Babu; Celur, Sree Lalita; Hashem, Mohamed I; Vallittu, Pekka K; Rehman, Ihtesham Ur

2017-05-01

The current study was aimed to fabricate customized root form dental implant using additive manufacturing technique for the replacement of missing teeth. The root form dental implant was designed using Geomagic™ and Magics™, the designed implant was directly manufactured by layering technique using ARCAM A2™ electron beam melting system by employing medical grade Ti-6Al-4V alloy powder. Furthermore, the fabricated implant was characterized in terms of certain clinically important parameters such as surface microstructure, surface topography, chemical purity and internal porosity. Results confirmed that, fabrication of customized dental implants using additive rapid manufacturing technology offers an attractive method to produce extremely pure form of customized titanium dental implants, the rough and porous surface texture obtained is expected to provide better initial implant stabilization and superior osseointegration.

[Impact of the Core Training Law on preventive medicine and public health training and other common medical specialties].

PubMed

Latasa, Pello; Gil-Borrelli, Christian; Aguilera, José Antonio; Reques, Laura; Barreales, Saúl; Ojeda, Elena; Alemán, Guadalupe; Iniesta, Carlos; Gullón, Pedro

2016-01-01

The purpose of the Core Training Law (CTL) is to amend specialised medical training to include 24 months of common training. The aim of this study is to assess its potential impact on the Preventive Medicine and Public Health (PM&PH) training programme and other medical specialties. The programmes of the 21 common medical specialties were analysed and the recommended training periods for each specialty collected, before the information was agreed upon by three observers. The training impact was calculated as the percentage of months that should be amended per specialty to adapt to the common training schedule. The Preventive Medicine and Public Health training programme is the specialty most affected by the Core Training Law (100%, 24 months). Intensive medicine (0%, 0 months) and medical oncology (17%, 4 months) is the least affected. The CTL affects the common medical specialties in different ways and requires a complete reorganisation of the activities and competencies of PM&PH professionals. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

The use of tungsten as a chronically implanted material.

PubMed

Shah Idil, A; Donaldson, N

2018-04-01

This review paper shows that tungsten should not generally be used as a chronically implanted material. The metal has a long implant history, from neuroscience, vascular medicine, radiography, orthopaedics, prosthodontics, and various other fields, primarily as a result of its high density, radiopacity, tensile strength, and yield point. However, a crucial material criterion for chronically implanted metals is their long-term resistance to corrosion in body fluids, either by inherently noble metallic surfaces, or by protective passivation layers of metal oxide. The latter is often assumed for elemental tungsten, with references to its 'inertness' and 'stability' common in the literature. This review argues that in the body, metallic tungsten fails this criterion, and will eventually dissolve into the soluble hexavalent form W 6+ , typically represented by the orthotungstate [Formula: see text] (monomeric tungstate) anion. This paper outlines the metal's unfavourable corrosion thermodynamics in the human physiological environment, the chemical pathways to either metallic or metal oxide dissolution, the rate-limiting steps, and the corrosion-accelerating effects of reactive oxidising species that the immune system produces post-implantation. Multiple examples of implant corrosion have been reported, with failure by dissolution to varying extents up to total loss, with associated emission of tungstate ions and elevated blood serum levels measured. The possible toxicity of these corrosion products has also been explored. As the field of medical implants grows and designers explore novel solutions to medical implant problems, the authors recommend the use of alternative materials.

The use of tungsten as a chronically implanted material

NASA Astrophysics Data System (ADS)

Shah Idil, A.; Donaldson, N.

2018-04-01

This review paper shows that tungsten should not generally be used as a chronically implanted material. The metal has a long implant history, from neuroscience, vascular medicine, radiography, orthopaedics, prosthodontics, and various other fields, primarily as a result of its high density, radiopacity, tensile strength, and yield point. However, a crucial material criterion for chronically implanted metals is their long-term resistance to corrosion in body fluids, either by inherently noble metallic surfaces, or by protective passivation layers of metal oxide. The latter is often assumed for elemental tungsten, with references to its ‘inertness’ and ‘stability’ common in the literature. This review argues that in the body, metallic tungsten fails this criterion, and will eventually dissolve into the soluble hexavalent form W6+, typically represented by the orthotungstate WO42- (monomeric tungstate) anion. This paper outlines the metal’s unfavourable corrosion thermodynamics in the human physiological environment, the chemical pathways to either metallic or metal oxide dissolution, the rate-limiting steps, and the corrosion-accelerating effects of reactive oxidising species that the immune system produces post-implantation. Multiple examples of implant corrosion have been reported, with failure by dissolution to varying extents up to total loss, with associated emission of tungstate ions and elevated blood serum levels measured. The possible toxicity of these corrosion products has also been explored. As the field of medical implants grows and designers explore novel solutions to medical implant problems, the authors recommend the use of alternative materials.

The use of cluster sampling to determine aid needs in Grozny, Chechnya in 1995.

PubMed

Drysdale, S; Howarth, J; Powell, V; Healing, T

2000-09-01

War broke out in Chechnya in November 1994 following a three-year economic blockade. It caused widespread destruction in the capital Grozny. In April 1995 Medical Relief International--or Merlin, a British medical non-governmental organisation (NGO)--began a programme to provide medical supplies, support health centres, control communicable disease and promote preventive health-care in Grozny. In July 1995 the agency undertook a city-wide needs assessment using a modification of the cluster sampling technique developed by the Expanded Programme on Immunisation. This showed that most people had enough drinking-water, food and fuel but that provision of medical care was inadequate. The survey allowed Merlin to redirect resources earmarked for a clean water programme towards health education and improving primary health-care services. It also showed that rapid assessment by a statistically satisfactory method is both possible and useful in such a situation.

Employees' perceptions of the Aid-for-AIDS disease-management programme, South Africa.

PubMed

Rothberg, Alan; Van Huyssteen, Karen

2008-11-01

It is estimated that 18-20% of South Africa's more than 5 million HIV-positive individuals are formally employed. Disease management programmes for these employees vary in scope and sophistication, with services provided by the employer, or third-party specialist disease managers, or through medical aid schemes. This study surveyed 215 HIV-positive employees in two organisations contracted to the Aid for AIDS (AfA) disease management programme through their in-house medical aid schemes. The two organisations differed in their overall approach to HIV and AIDS: one mainly relies on on-site access to voluntary counselling and testing (VCT) and AfA's management of registered HIV-positive employees, while the other has invested in and actively developed a comprehensive programme that also extends to families and the community as well as links employees to the AfA programme. Responses received from 28 of the 215 employees surveyed indicate that fear of disclosure of one's HIV status and of stigmatisation are reasons for late registration with the AfA programme or non-utilisation of other available support programmes. Respondents mentioned that confidence in the employer's ability to maintain confidentiality was also an issue. Respondents' important suggestions for change included: a) on-site educational and awareness programmes for management personnel and staff in order to reduce HIV discrimination and stigmatisation; b) information directed at HIV-positive employees publicising the benefits and effectiveness of medical treatment; c) support groups for HIV-positive employees; and d) management personnel to engage with HIV-infected employees who are willing to take an active role in staff education and the development of workplace policies and programmes.

Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial.

PubMed

Hognert, Helena; Kopp Kallner, Helena; Cameron, Sharon; Nyrelli, Christina; Jawad, Izabella; Heller, Rebecca; Aronsson, Annette; Lindh, Ingela; Benson, Lina; Gemzell-Danielsson, Kristina

2016-11-01

Does a progestin releasing subdermal contraceptive implant affect the efficacy of medical abortion if inserted at the same visit as the progesterone receptor modulator, mifepristone, at medical abortion? A etonogestrel releasing subdermal implant inserted on the day of mifepristone did not impair the efficacy of the medical abortion compared with routine insertion at 2-4 weeks after the abortion. The etonogestrel releasing subdermal implant is one of the most effective long acting reversible contraceptive methods. The effect of timing of placement on the efficacy of mifepristone and impact on prevention of subsequent unintended pregnancy is not known. This multicentre, randomized controlled, equivalence trial with recruitment between 13 October 2013 and 17 October 2015 included a total of 551 women with pregnancies below 64 days gestation opting for the etonogestrel releasing subdermal implant as postabortion contraception. Women were randomized to either insertion at 1 hour after mifepristone intake (immediate) or at follow-up 2-4 weeks later (delayed insertion). An equivalence design was used due to advantages for women such as fewer visits to the clinic with immediate insertion. The primary outcome was the percentage of women with complete abortion not requiring surgical intervention within 1 month. Secondary outcomes included insertion rates, pregnancy and repeat abortion rates during 6 months follow-up. Analysis was per protocol and by intention to treat. Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation and opted for an etonogestrel releasing contraceptive implant were recruited in outpatient family planning clinics in six hospitals in Sweden and Scotland. Efficacy of medical abortion was 259/275 (94.2%) in the immediate insertion group and 239/249 (96%) in the routine insertion group with a risk difference of 1.8% (95% CI -0.4 to 4.1%), which was within the ±5% margin of equivalence. The insertion rate was 275/277 (98.9%) in the immediate group compared to 187/261 (71.6%) women in the routine group (P < 0.001). At 6 months of follow-up significantly fewer women in the immediate group had become pregnant again (2/277, 0.8%) compared to the routine group (10/261, 3.8%) P = 0.018. For the main outcome loss to follow-up data was minimized through access to patient records. Efforts were made to reduce loss to follow-up also for secondary outcomes. The results of the sensitivity analysis did not differ from the intention to treat or per protocol analysis. Guidelines on postabortion contraception should be amended to include insertion of the etonogestrel releasing implant at the time of mifepristone intake for medical abortion up to and including a gestation of 63 days. This study was funded by the Swedish Research Council (2012-2844), Stockholm City County and Karolinska Institutet (ALF). The contraceptive implants were provided by Merck and supplied by MSD Sweden. HKK and KGD have received honorariums for giving lectures for MSD/Merck and have participated in the national (HKK and KGD) and international (KGD) medical advisory boards for MSD/Merck. The other authors have nothing to declare. ClinicalTrials number NCT01920022. 06 August 2013. 13 October 2013. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A questionnaire-based study on patients' experiences with rechargeable implanted programmable generators for spinal cord stimulation to treat chronic lumbar spondylosis pain.

PubMed

McAuley, John; Farah, Nima; van Gröningen, Richard; Green, Christopher

2013-01-01

The latest generation of rechargeable implantable programmable generators (IPGs) for spinal cord stimulation may greatly extend IPG lifespan compared with previous nonrechargeable devices. This study explores patients' experiences with these devices. Twenty-five patients attending the Department of Neurostimulation, Royal London Hospital, who were implanted with a rechargeable IPG (SC-1110; Boston Scientific, Minneapolis, MN, USA) to provide pain relief from post-surgical lumbosacral spondylosis were surveyed using a questionnaire. Patients reported a mean (SD) benefit from stimulation of 43.7% (32.6%). On a 1 (worst) to 5 (best) scale, the median score was 5 for ease of recharging. Eight patients who had previously had nonrechargeable IPGs felt the rechargeable system was better (p= 0.0143). A particular issue with nonrechargeable batteries was that, while patients considered 5 years an acceptable interval for battery replacements and the procedure itself not too inconvenient, they felt an acceptable wait for replacement after failure to be only 1 week, much shorter than actual waiting times. Patients found the rechargeable IPG easy to recharge and those who had had previous experience with nonrechargeable devices preferred using the rechargeable device. Its benefits in terms of pain relief fell within the range expected from previous studies using nonrechargeable batteries. The main disadvantage of nonrechargeable devices as reported by the patients in this study was concern over the length of time they would have to wait without pain relief between battery replacements. © 2012 International Neuromodulation Society.

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes

PubMed Central

İmamoğlu, Serhat

2018-01-01

Purpose To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. Materials and Methods The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. Results The mean follow-up duration was 11.7 ± 5.5 (range, 6–23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg (p=0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 (p=0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Conclusions Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation. PMID:29862068

Short-term to Long-term Results of Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

PubMed

Yakin, Mehmet; Eksioglu, Umit; Sungur, Gulten; Satana, Banu; Demirok, Gulizar; Ornek, Firdevs

2017-01-01

To evaluate short-term to long-term outcomes of Ahmed glaucoma valve (AGV) implantation in the management of uveitic glaucoma (UG) secondary to Behçet disease (BD). A retrospective chart review of 47 eyes of 35 patients with UG secondary to BD who underwent AGV implantation was conducted. Success was defined as having an intraocular pressure (IOP) between 6 and 21 mm Hg with (qualified success) or without (complete success) antiglaucomatous medications and without need for further glaucoma surgery. Mean postoperative follow-up was 57.72±26.13 months. Mean preoperative IOP was 35.40±8.33 mm Hg versus 12.28±2.90 mm Hg at the last follow-up visit (P<0.001). Mean number of preoperative topical antiglaucomatous medications was 2.96±0.29 versus 0.68±1.12 at the last follow-up visit (P<0.001). In all eyes, IOP could be maintained between 6 and 21 mm Hg with or without antiglaucomatous medications during follow-up. The cumulative probability of complete success was 46.8% at 6 months, 40.4% at 12 months, and 35.9% at 36 months, and the cumulative probability of eyes without complication was 53.2% at 6 months, 46.5% at 12 months, and 39.6% at 24 months postoperatively based on Kaplan-Meier survival analysis. No persistent or irreparable complications were observed. This study includes one of the largest series of AGV implantation in the management of UG with the longest follow-up reported. AGV implantation can be considered as a primary surgical option in the management of UG secondary to BD with 100% total success rate (with or without medications).

Outcomes of Ahmed Valve Implant Following a Failed Initial Trabeculotomy and Trabeculectomy in Refractory Primary Congenital Glaucoma

PubMed Central

Dave, Paaraj; Senthil, Sirisha; Choudhari, Nikhil; Sekhar, Garudadri Chandra

2015-01-01

Purpose: The aim was to report the outcome of Ahmed glaucoma valve (AGV) (New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation as a surgical intervention following an initial failed combined trabeculotomy + trabeculectomy (trab + trab) in refractory primary congenital glaucoma (RPCG). Materials and Methods: Retrospective chart review of 11 eyes of 8 patients who underwent implantation of AGV (model FP8) for RPCG between 2009 and 2011. Prior trab + trab had failed in all the eyes. Success was defined as an intraocular pressure (IOP) >5 and ≤ 18 mmHg during examination under anesthesia with or without medications and without serious complications or additional glaucoma surgery. Results: The mean age at AGV implantation was 15.4 ± 4.9 months. The mean preoperative IOP was 28 ± 5.7 mmHg which reduced to 13.6 ± 3.4 mmHg postoperatively at the last follow-up (P < 0.0001). The number of topical antiglaucoma medications reduced from a mean of 2.6 ± 0.5 to 1.6 ± 0.9 postoperatively (P = 0.009). The definition of qualified success was met in 10 (90%) eyes. One eye developed a shallow anterior chamber with choroidal detachment at 1-week, which resolved spontaneously with medications. None of the eyes developed a hypertensive phase. One eye had a long tube resulting in tube corneal touch that required trimming of the tube. One eye developed tube retraction, which was treated with a tube extender. The mean follow-up was 17.9 ± 9.3 (6.2-35.4) months. Conclusion: Managing RPCG remains a challenge. AGV implant was successful in a significant proportion of cases. PMID:25624676

ATTITUDES OF ORTHOPEDIC SPECIALISTS TOWARD EFFECTS OF MEDICAL DEVICE PURCHASING.

PubMed

Lingg, Myriam; Merida-Herrera, Everth; Wyss, Kaspar; Durán-Arenas, Luis

2017-01-01

The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes. We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico. We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments. To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

Clinical experience with a chronic pain management programme in Hong Kong Chinese patients.

PubMed

Man, Alice K Y; Chu, M C; Chen, P P; Ma, M; Gin, Tony

2007-10-01

To describe experience with a chronic pain management programme in Hong Kong Chinese patients. Prospective study. Regional hospital, Hong Kong. Patients with chronic pain who participated in the first six Comprehensive Out-patient Pain Engagement programmes between 2002 and 2005. Comprehensive Out-patient Pain Engagement is a 14-day structured, multidisciplinary out-patient programme conducted over 6 weeks. It includes pain education, cognitive re-conceptualisation, training in communication skills and coping strategies, graded physical exercises and functional activities training. It aims to improve patient function and quality of life, despite persistent pain. Changes in scores from baseline values after joining the programme, with respect to several assessment tools. These included the following: visual analogue pain scale, Pain Catastrophizing Scale, Patient Self-efficacy Questionnaire, Canadian Occupational Performance Measure, Medical Outcome Survey-Short Form 36 Questionnaire, and duration of physical tolerances, medication utilisation, and work status records. Forty-five patients were available for analysis. After the Comprehensive Out-patient Pain Engagement programme, improvements in Medical Outcome Survey-Short Form 36 Questionnaire (role physical and vitality), Pain Catastrophizing Scale, Patient Self-efficacy Questionnaire, and Canadian Occupational Performance Measure were demonstrated (P<0.05). The duration of standing and sitting tolerances increased (P<0.05). An improvement in employment rate was also evident (P=0.01). The initial results of our management programme in Chinese patients with chronic pain are encouraging. This type of programme should be promoted more widely in this group of patients, as it appears to improve physical function, psychological well-being, and productivity.

An end to "See one, do one and teach one" residency training programme - impact of the training, education, surgical accreditation and assessment (TESA) programme on medical care and patients' safety.

PubMed

Tan, Thiam-Chye; Tan, Kim-Teng; Tee, John Cs

2007-09-01

The delivery of optimal and safe medical care is critical in healthcare. The traditional practice of "See one, do one and teach one" residency training programme is no longer acceptable. In the past, there was no structured residency training programme in our hospital. There were several cases of organ injuries from surgeries performed by the residents. In 2005, we conducted a pilot study to organise a structured teaching, education, surgical accreditation and assessment (TESA) residency programme for 15 residents in the Division of Obstetrics and Gynaecology, KK Women's and Children's Hospital. We performed a written questionnaire survey of the residents on the new programme and patients' expectation (n = 2926) as subjective outcomes in the 1-year follow-up. We also studied the complication rates of all minor and major surgeries performed by the residents in 2004 and 2005 as an objective outcome. All the residents (n = 15) surveyed supported the TESA programme. Patients' expectation improved significantly from 71% in 2004 (n = 1559) to 83% in 2005 (n = 1367) (P = 0.03). There were 10,755 surgeries in 2004 and 10,558 surgeries in 2005 performed by our residents, with 6 cases (5.6%) of organ injuries in 2004 compared to 3 cases (2.8%) in 2005. This reduction was not statistically significant. The TESA residency programme in our hospital has an impact on the delivery of optimal and safe medical care while ensuring the training of residents to be competent specialists.

Biocompatible materials developments for new medical implants.

PubMed

Hodgins, Diana; Wasikiewicz, J M; Grahn, M F; Paul, D; Roohpour, N; Vadgama, P; Silmon, Angela M; Cousins, Bernard; Verdon, Brian

2007-10-01

Recent work on modifying silicone rubber to improve water permeability and biocompatibility is described. In addition, modifications to the interface between an active implanted device and the body are reported, which have led to reduced power consumption and improved device performance.

42 CFR 419.2 - Basis of payment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... prospective payment system establishes a national payment rate, standardized for geographic wage differences...) Capital-related costs; (9) Implantable items used in connection with diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests; (10) Durable medical equipment that is implantable; (11...

Barriers and enablers to academic health leadership.

PubMed

Bharwani, Aleem; Kline, Theresa; Patterson, Margaret; Craighead, Peter

2017-02-06

Purpose This study sought to identify the barriers and enablers to leadership enactment in academic health-care settings. Design/methodology/approach Semi-structured interviews ( n = 77) with programme stakeholders (medical school trainees, university leaders, clinical leaders, medical scientists and directors external to the medical school) were conducted, and the responses content-analysed. Findings Both contextual and individual factors were identified as playing a role in affecting academic health leadership enactment that has an impact on programme development, success and maintenance. Contextual factors included sufficient resources allocated to the programme, opportunities for learners to practise leadership skills, a competent team around the leader once that person is in place, clear expectations for the leader and a culture that fosters open communication. Contextual barriers included highly bureaucratic structures, fear-of-failure and non-trusting cultures and inappropriate performance systems. Programmes were advised to select participants based on self-awareness, strong communication skills and an innovative thinking style. Filling specific knowledge and skill gaps, particularly for those not trained in medical school, was viewed as essential. Ineffective decision-making styles and tendencies to get involved in day-to-day activities were barriers to the development of academic health leaders. Originality/value Programmes designed to develop academic health-care leaders will be most effective if they develop leadership at all levels; ensure that the organisation's culture, structure and processes reinforce positive leadership practices; and recognise the critical role of teams in supporting its leaders.

Perceptions of medical students and their mentors in a specialised programme designed to provide insight into non-traditional career paths

PubMed Central

Josephson, Anna; Stenfors-Hayes, Terese

2011-01-01

Objectives This pilot study explores the perceptions of medical students and their individual mentors who advised them in a specialised programme where students gained insight into non-tradition career paths. Methods Twelve medical students in years 3-6 at Karolinska Institutet, Sweden were recruited to the Prominentia mentor programme where they were individually paired with mentors who met with them to discuss and advise them on non-traditional career paths. Application letters of students to join the programme as well as electronically distributed questionnaires and semi-structured interviews were used to assess the perceptions of mentors and students to the programme. Both the questionnaire and the interview transcripts were thematised using content analysis. Results In terms of expectations and requests, the application letters showed that all students specified their career goals and the type of mentor they desired. Whereas mentors in general had fewer requests and some had no specific demands. In light of perceived effects, all mentors felt they discussed future careers with their students and the majority of students responded the same way, with some interesting deviations. Most discussed topics during meetings were: future career, medical education, combinations of private life and work, and work environment. Conclusions This pilot study revealed that students appreciated receiving inspiration and seeing career path opportunities outside academic medicine as well as receiving support in personal and professional development and guidance about the students’ role as a doctor. However, discrepancies were found regarding how mentors and students respectively perceived the mentor programme.

Teenagers with diabetes: self-management education and training on a big schooner.

PubMed

Viklund, Gunnel E; Rudberg, Susanne; Wikblad, K F

2007-12-01

The aims of this study are to evaluate whether diabetic teenagers participating in a group educational programme, 'the schooner programme', differ from non-participants in attitudes towards diabetes and self-care, and to evaluate the impact on the attitudes, HbA1c and treatment of the programme. Ninety teenagers aged 14-18 years attended the programme. Attitudes towards diabetes and self-care were measured with a validated questionnaire. Medical data were collected from the medical records. The participants reported more positive attitudes towards diabetes and self-care and more frequent contacts with others with diabetes monitored blood glucose more often and felt less disturbed by diabetes than non-participants. The programme had positive impact on attitudes towards diabetes. There was no change in HbA1c, but the use of insulin pumps was more frequent among participants after the programme. To get teenagers attracted to group education, the diabetes care team needs to influence them towards more positive attitudes.

Effect of interprofessional clinical education programme length on students' attitudes towards teamwork.

PubMed

Renschler, Lauren; Rhodes, Darson; Cox, Carol

2016-05-01

This article reports on a study involving a range of health professions students who participated in similar one-semester (short) or two-semester (long) interprofessional clinical education programmes that focused on clinical assessment of senior citizens living independently in the community. Students' attitudes towards teamwork skills and perceptions of their own teamwork skills both before and after the programmes were assessed using two validated scales. Osteopathic medical student participants reported no significant changes in attitudes towards interprofessional healthcare teamwork skills or their perceptions of their own interprofessional teamwork skills after either the one- or two-semester programmes. For athletic training, speech-language pathology, exercise sciences, public health, and nursing students, though, attitudes towards teamwork skills significantly improved (p < .05) after the one-semester programme; and perceptions of their own team skills significantly improved (p < .05) after both the one- and two-semester programmes. Overall, this study provides some support for interprofessional teamwork attitude change, but with a significant difference between medical as compared to nursing, allied health, and public health students.

Production of yarns composed of oriented nanofibers for ophthalmological implants

NASA Astrophysics Data System (ADS)

Shynkarenko, A.; Klapstova, A.; Krotov, A.; Moucka, M.; Lukas, D.

2017-10-01

Parallelized nanofibrous structures are commonly used in medical sector, especially for the ophthalmological implants. In this research self-fabricated device is tested for improved collection and twisting of the parallel nanofibers. Previously manual techniques are used to collect the nanofibers and then twist is given, where as in our device different parameters can be optimized to obtained parallel nanofibers and further twisting can be given. The device is used to bring automation to the technique of achieving parallel fibrous structures for medical applications.

Computer Simulation of the Elastic Properties of Titanium Alloys for Medical Applications

NASA Astrophysics Data System (ADS)

Estevez, Elsa Paz; Burganova, R. M.; Lysogorskii, Yu. V.

2016-09-01

Results of a computer simulation of the elastic properties of α+β- and β-titanium alloys, used for medical purposes, within the framework of the molecular-dynamics method are presented. It is shown that β-titanium alloys are best suited for the use as bone implants because of their small moduli of elasticity. The advisability of the use of the molecular-dynamics method for the study of the elastic properties of titanium alloys, serving as bone implants, is demonstrated.

[Pedagogical Professional Development of Medical Teachers: The Experience of NOVA Medical School / Universidade Nova de Lisboa].

PubMed

Marques, Joana; Rosado-Pinto, Patrícia

2017-03-31

To be a college teacher requires a permanent effort in developing specific competencies, namely in the pedagogical domain. This paper aims both to describe the pedagogical professional development program offered by the Medical Education Office of NOVA Medical School of Universidade Nova de Lisboa and to analyse its role in the enhancement of reflection around curriculum and teaching practice. Description of the pedagogical programme offered between 2010 and 2016. We focused the analysis on different kinds of data - opinions of the participants in the training programme (questionnaire before and after the training); pedagogical products elaborated by the participants in the programme - design of lessons, modules or curricular units; questionnaire sent in 2016 to NOVA Medical School teachers responsible for the curricular units, about the contribution of their disciplines to the accomplishment of the core learning outcomes of the NOVA Medical School medical graduates. The pedagogical training needs identified by the teachers focused mainly on improving practice, critically analysing the curriculum and sharing experiences. Globally the training programme was deeply appreciated and considered very good by 97% of the participants. The lesson plans delivered showed that the teachers were able to integrate and apply the concepts developed during the training. The answers from the 46 faculty responsible for the curricular units (the majority of them had attended the Medical Education Office training programme) highlighted their capacity to critically approach content and pedagogical strategies within their disciplines as well as their contribution to the main goals of the medical curriculum. The results underlined the importance of a pedagogical training focused on the critical analysis of curriculum and pedagogical practice. On the other hand, the pedagogical products analyzed revealed great mastery by teachers of the content and pedagogical strategies present in the curricula of their respective curricular units, as well as their alignment with the general objectives of the Mestrado Integrado em Medicina. In line with the literature of the specialty, pedagogical training in Higher Education, rather than aiming at the mere acquisition of techniques, should, above all, give priority to spaces for joint reflection on the curriculum and on the pedagogical options of teachers.

The influence of the Product Liability Act, governmental regulation, and medical economics on medical devices and their clinical applications.

PubMed

Hirose, T T

1996-12-01

The advancement of medical technology constantly demands the introduction of safer and more efficient medical instruments and devices. Recent litigation and rulings against the manufacturers of breast implants and the subsequent refusal of major plastic companies to supply materials to them are seriously threatening the production and development of other permanent implants such as ventricular assist devices and even disposable catheters. In addition, government overregulation also discourages and hinders production and clinical applications of new instruments. Current trends such as cost effectiveness measures and economic restraints imposed by government agencies and managed care systems are endangering investments from the medical and industrial communities to exploit more expensive and sophisticated instrument technologies. The resultant lack of grant money and pressure from animal rights advocates also suppress experimentation on primates and domestic laboratory animals.

Get SET: aligning anatomy demonstrator programmes with Surgical Education and Training selection criteria.

PubMed

Rhodes, Danielle; Fogg, Quentin A; Lazarus, Michelle D

2018-05-01

Prevocational doctors aspiring to surgical careers are commonly recruited as anatomy demonstrators for undergraduate and graduate medical programmes. Entry into Surgical Education and Training (SET) is highly competitive and a unique opportunity exists to align anatomy demonstrator programmes with the selection criteria and core competencies of SET programmes. This study used a qualitative approach to (i) determine what criteria applicants for SET are assessed on and (ii) identify criteria that could be aligned with and enhanced by an anatomy demonstrator programme. The selection guidelines of all nine surgical specialties for the 2017 intake of SET trainees were analysed using qualitative content analysis methodology. The Royal Australasian College of Surgeons adopted a holistic approach to trainee selection that assessed both discipline-specific and discipline-independent skills. Qualitative content analysis identified eight categories of key selection criteria: medical expertise, scholarly activity, professional identity, interpersonal skills, integrity, self-management, insight and self-awareness and community involvement. The structured curriculum vitae was heavily weighted towards discipline-specific skills, such as medical expertise and scholarly activity. Insufficient information was available to determine the weighting of selection criteria assessed by the structured referee reports or interviews. Anatomy demonstrator programmes provide prevocational doctors with unique opportunities to develop surgical skills and competencies in a non-clinical setting. Constructively aligned anatomy demonstrator programmes may be particularly beneficial for prevocational doctors seeking to improve their anatomical knowledge, teaching skills or scholarly activity. © 2017 Royal Australasian College of Surgeons.

Physical Activity on Medical Prescription: A Qualitative Study of Factors Influencing Take-Up and Adherence in Chronically Ill Patients

ERIC Educational Resources Information Center

Gasparini, William; Knobé, Sandrine; Didierjean, Romaine

2015-01-01

Objective: This study sought to determine the effects of an innovative public health programme offering physical and sports activities on medical prescription to chronically ill patients. Method: Semi-structured interviews were conducted with programme participants at two time points: at the start of their activity (n?=?33) and 3?months after the…

Tube thoracostomy; chest tube implantation and follow up

PubMed Central

Kuhajda, Ivan; Zarogoulidis, Konstantinos; Kougioumtzi, Ioanna; Huang, Haidong; Li, Qiang; Dryllis, Georgios; Kioumis, Ioannis; Pitsiou, Georgia; Machairiotis, Nikolaos; Katsikogiannis, Nikolaos; Papaiwannou, Antonis; Lampaki, Sofia; Papaiwannou, Antonis; Zaric, Bojan; Branislav, Perin; Porpodis, Konstantinos

2014-01-01

Pneumothorax is an urgent medical situation that requires urgent treatment. We can divide this entity based on the etiology to primary and secondary. Chest tube implantation can be performed either in the upper chest wall or lower. Both thoracic surgeons and pulmonary physicians can place a chest tube with minimal invasive techniques. In our current work, we will demonstrate chest tube implantation to locations, methodology and tools. PMID:25337405

Tissue Variability and Antennas for Power Transfer to Wireless Implantable Medical Devices.

PubMed

Bocan, Kara N; Mickle, Marlin H; Sejdic, Ervin

2017-01-01

The design of effective transcutaneous systems demands the consideration of inevitable variations in tissue characteristics, which vary across body areas, among individuals, and over time. The purpose of this paper was to design and evaluate several printed antenna topologies for ultrahigh frequency (UHF) transcutaneous power transfer to implantable medical devices, and to investigate the effects of variations in tissue properties on dipole and loop topologies. Here, we show that a loop antenna topology provides the greatest achievable gain with the smallest implanted antenna, while a dipole system provides higher impedance for conjugate matching and the ability to increase gain with a larger external antenna. In comparison to the dipole system, the loop system exhibits greater sensitivity to changes in tissue structure and properties in terms of power gain, but provides higher gain when the separation is on the order of the smaller antenna dimension. The dipole system was shown to provide higher gain than the loop system at greater implant depths for the same implanted antenna area, and was less sensitive to variations in tissue properties and structure in terms of power gain at all investigated implant depths. The results show the potential of easily-fabricated, low-cost printed antenna topologies for UHF transcutaneous power, and the importance of environmental considerations in choosing the antenna topology.

Late complications in patients with Björk-Shiley and St. Jude Medical heart valve replacement.

PubMed

Horstkotte, D; Körfer, R; Seipel, L; Bircks, W; Loogen, F

1983-09-01

Valve-related complications after Björk-Shiley mitral valve implantation (n = 475), aortic valve implantation (n = 424), or mitral-aortic valve implantation (n = 119) were compared with those after St. Jude Medical mitral valve replacement (n = 173), aortic valve replacement (n = 152), or mitral-aortic valve replacement (n = 69). All patients were placed on anticoagulant therapy with phenprocoumon early after operation. All patients had a comparable follow-up time of approximately 23 months, which showed that cumulative thromboembolic rates were significantly higher after St. Jude valve implantation than after Björk-Shiley valve implantation. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2.2%), or prosthetic valve endocarditis with perivalvular regurgitation (0.46%). One Björk-Shiley mitral valve prosthesis had to be replaced because of fracture of the outlet strut. Without significant intergroup differences, hemorrhage due to anticoagulant treatment was the most frequent complication. Thromboembolic complications were significantly more frequent after Björk-Shiley mitral, aortic, and double valve replacements than after St. Jude valve implantation. This may lead to consideration of changes in the prophylaxis of thrombus formations in the St. Jude valve, especially in aortic valve replacements, in patients with sinus rhythm.

Tissue Variability and Antennas for Power Transfer to Wireless Implantable Medical Devices

PubMed Central

Bocan, Kara N.; Mickle, Marlin H.

2017-01-01

The design of effective transcutaneous systems demands the consideration of inevitable variations in tissue characteristics, which vary across body areas, among individuals, and over time. The purpose of this paper was to design and evaluate several printed antenna topologies for ultrahigh frequency (UHF) transcutaneous power transfer to implantable medical devices, and to investigate the effects of variations in tissue properties on dipole and loop topologies. Here, we show that a loop antenna topology provides the greatest achievable gain with the smallest implanted antenna, while a dipole system provides higher impedance for conjugate matching and the ability to increase gain with a larger external antenna. In comparison to the dipole system, the loop system exhibits greater sensitivity to changes in tissue structure and properties in terms of power gain, but provides higher gain when the separation is on the order of the smaller antenna dimension. The dipole system was shown to provide higher gain than the loop system at greater implant depths for the same implanted antenna area, and was less sensitive to variations in tissue properties and structure in terms of power gain at all investigated implant depths. The results show the potential of easily-fabricated, low-cost printed antenna topologies for UHF transcutaneous power, and the importance of environmental considerations in choosing the antenna topology. PMID:29018637

Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

PubMed

Vihvelin, Hugo; Leadbetter, Jeff; Bance, Manohar; Brown, Jeremy A; Adamson, Robert B A

2016-04-01

Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications.

Aviation accident risk for airmen with aphakia and artificial lens implants.

DOT National Transportation Integrated Search

1993-06-01

Airmen with aphakia and intraocular (IOL) implants who on a case-by-case basis, may obtain a waiver for a medical certificate have been previously associated with higher aviation accident rates when compared to the total civil airman population. This...

Determining the Young's modulus of a cellular titanium implant by FEM simulation

NASA Astrophysics Data System (ADS)

Loginov, Yu. N.; Golodnov, A. I.; Stepanov, S. I.; Kovalev, E. Yu.

2017-12-01

The role of additive manufacturing is noted for the construction of titanium medical implants. The purpose of the study is to determine the Young's modulus of cellular titanium implants, which is based on calculations performed by finite element analysis. A honeycomb structure from intersecting cylinder surfaces is offered for the implant made of the Ti-6Al-4V alloy. Boundary conditions are stated for the loading of the implant structure. It is demonstrated that the Young's modulus can be reduced more than three times comparing to a solid titanium alloy. Zones of strain and stress localization located near the abutment of the cylindrical surfaces. Recommendations for the further improvement of the implant architecture are generated.

Undergraduate Medical Research Programme: A Cross-Sectional Study of Students' Satisfactions, Perceived Challenges, and Attitudes.

PubMed

Althubaiti, Alaa

2015-02-24

Implementing an undergraduate Medical Research Programme (MRP) in medical colleges may not only improve the subsequent career of medical students but also benefit the health system in general. If not designed effectively, however, such a programme could have the opposite impact. Therefore, the quality of a MRP should be evaluated continuously. This study aims to evaluate the MRP from medical students' perspective. A cross-sectional survey study was conducted from March to April 2014 amongst undergraduate medical students at the College of Medicine, King Saud University for Health Sciences, Riyadh, Saudi Arabia. Satisfaction, perceived challenges, and attitudes towards the MRP were evaluated. A total of 154 responses were collected from the students; 81(52.6%) were in the 2nd year and 73 (47.4%) were in the 3rd year of the MRP, 97(63%) were males. The mean±SD age was 21.5±0.82 years. Overall, most students were satisfied with the MRP (51.3%). The majority of students were of the opinion that there was a shortage of time to complete their work (57.6%) and a lack of motivation to do research (53.3%). Significant differences were found in the satisfaction levels and perceived challenges between students in the 2nd and 3rd year of the MRP (P≤.013). Assessment of medical students' perspective towards the MRP is an important aspect of the educative process. We recommend more evaluation studies, because they ensure that programmes effectively meet their goals and continue to be improved. A solid MRP is essential and will increase the university's profile.

Comparison of the Outcome of Silicone Ahmed Glaucoma Valve Implantation with a Surface Area between 96 and 184 mm2 in Adult Eyes

PubMed Central

Koh, Kyung Min; Hwang, Young Hoon; Jung, Jong Jin; Sohn, Yong Ho

2013-01-01

Purpose To compare the success rates, complications, and visual outcomes between silicone Ahmed glaucoma valve (AGV) implantation with 96 mm2 (FP8) or 184 mm2 (FP7) surface areas. Methods This study is a retrospective review of the records from 132 adult patients (134 eyes) that underwent silicone AGV implant surgery. Among them, the outcomes of 24 eyes from 24 patients with refractory glaucoma who underwent FP8 AGV implantation were compared with 76 eyes from 76 patients who underwent FP7 AGV implantation. Preoperative and postoperative data, including intraocular pressure (IOP), visual acuity, number of medications, and complications were compared between the 2 groups. Results There were no significant differences in baseline characteristics between the 2 groups (p > 0.05). The postoperative visual acuity of the patients in the FP8 group was better than that of the patients in the FP7 group in some early postoperative periods (p < 0.05); however, after 10 postoperative months, visual acuity was not significantly different through the 3-year follow-up period (p > 0.05). Postoperative IOP was not significantly different between the 2 groups (p > 0.05) except for IOP on postoperative day 1 (11.42 mmHg for the FP7 group and 7.42 mmHg for the FP8 group; p = 0.031). There was no statistical difference in success rates, final IOP, number of medications, or complication rates between the 2 groups (p > 0.05). Conclusions The FP7 and FP8 AGV implants showed no difference in terms of vision preservation, IOP reduction, and number of glaucoma medications required. PMID:24082774

A double-helix and cross-patterned solenoid used as a wirelessly powered receiver for medical implants

NASA Astrophysics Data System (ADS)

Mao, Shitong; Wang, Hao; Mao, Zhi-Hong; Sun, Mingui

2018-05-01

Many medical implants need to be designed in the shape of a cylinder (rod), a cuboid or a capsule in order to adapt to a specific site within the human body or facilitate the implantation procedure. In order to wirelessly power these types of implants, a pair of coils, one is located inside the human body and one is outside, is often used. Since most organs such as major muscles, blood vessels, and nerve bundles are anatomically parallel to the body surface, the most desired wireless power transfer (WPT) direction is from the external power transmission pad (a planar coil) to the lateral surface of the implant. However, to obtain optimal coupling, the currently used solenoid coil requires being positioned perpendicular to the body surface, which is often medically or anatomically unacceptable. In this research, a concentric double-helix (DH) coil with an air core is presented for use in implantable devices. Two helical coils are tilted at opposite angles (±45 degrees) to form a cross pattern. The WPT system is designed using the magnetic resonance concept for wireless power transfer (MR-WPT). The power transfer efficiency (PTE) relies on the near-field magnetic coupling which is closely related to the location and orientation of the DH coil. We explain how the novel structure of the DH solenoid magnifies the mutual inductance with the widely adopted circular planner coil and how the PTE is improved in comparison to the case of the conventional solenoid coil. We also study an important case where the double-helix power reception coil is laterally and angularly misaligned with the transmitter. Finally, our computational study using the finite element method and experimental study with actually constructed prototypes are presented which have proven our new double-helix coil design.

Veggie Rx: an outcome evaluation of a healthy food incentive programme.

PubMed

Cavanagh, Michelle; Jurkowski, Janine; Bozlak, Christine; Hastings, Julia; Klein, Amy

2017-10-01

One challenge to healthy nutrition, especially among low-income individuals, is access to and consumption of fresh fruits and vegetables. To address this problem, Veggie Rx, a healthy food incentive programme, was established within a community clinic to increase access to fresh produce for low-income patients diagnosed with obesity, hypertension and/or type 2 diabetes. The current research aimed to evaluate Veggie Rx programme effectiveness. A retrospective pre/post design using medical records and programme data was used to evaluate the programme. The study was approved by the University of Albany Institutional Review Board and the Patient Interest Committee of a community clinic. The study was conducted in a low-income, urban neighbourhood in upstate New York. Medical record data and Veggie Rx programme data were analysed for fifty-four eligible participants. An equal-sized control group of patients who were not programme participants were matched on age, ethnicity and co-morbidity status. A statistically significant difference in mean BMI change (P=0·02) between the intervention and the control group was calculated. The intervention group had a mean decrease in BMI of 0·74 kg/m2. Greater improvement in BMI was found among Veggie Rx programme participants. This information will guide programme changes and inform the field on the effectiveness of healthy food incentive programmes for improving health outcomes for low-income populations.

Veggie Rx: an outcome evaluation of a healthy food incentive programme

PubMed Central

Cavanagh, Michelle; Jurkowski, Janine; Bozlak, Christine; Hastings, Julia; Klein, Amy

2017-01-01

Objective One challenge to healthy nutrition, especially among low-income individuals, is access to and consumption of fresh fruits and vegetables. To address this problem, Veggie Rx, a healthy food incentive programme, was established within a community clinic to increase access to fresh produce for low-income patients diagnosed with obesity, hypertension and/or type 2 diabetes. The current research aimed to evaluate Veggie Rx programme effectiveness. Design A retrospective pre/post design using medical records and programme data was used to evaluate the programme. The study was approved by the University of Albany Institutional Review Board and the Patient Interest Committee of a community clinic. Setting The study was conducted in a low-income, urban neighbourhood in upstate New York. Subjects Medical record data and Veggie Rx programme data were analysed for fifty-four eligible participants. An equal-sized control group of patients who were not programme participants were matched on age, ethnicity and co-morbidity status. Results: A statistically significant difference in mean BMI change (P = 0.02) between the intervention and the control group was calculated. The intervention group had a mean decrease in BMI of 0.74 kg/m2. Conclusions Greater improvement in BMI was found among Veggie Rx programme participants. This information will guide programme changes and inform the field on the effectiveness of healthy food incentive programmes for improving health outcomes for low-income populations. PMID:27539192

Cranioplasty with individual carbon fibre reinforced polymere (CFRP) medical grade implants based on CAD/CAM technique.

PubMed

Saringer, W; Nöbauer-Huhmann, I; Knosp, E

2002-11-01

The authors present a new method for the reconstruction of large or complex-formed cranial bone defects using prefabricated, computer-generated, individual CFRP (carbon fibre reinforced plastics) medical grade implants. CFRP is a composite material containing carbon fibres embedded in an epoxy resin matrix. It is radiolucent, heat-resistant, extremely strong and light (its weight is 20% that of steel), has a modulus of elasticity close to that of bone, and an established biocompatibility. The utilisation of a CAD/CAM (computer aided design/computer aided manufacture) technique based on digitised computed tomography (CT) data, with stereolithographic modelling as intermediate step, enabled the production of individual, prefabricated CFRP medical grade implants with an arithmetical maximum aberration in extension of less than +/-0.25 mm. Between 1995 and February 2002, 29 patients (15 men and 14 women; mean age, 39.9 years; range, 16 to 67 years) underwent cranioplasty with CFRP medical grade implants at the neurosurgical department of the University of Vienna. Twenty-four patients were repaired secondarily (delayed cranioplasty) while 5 were repaired immediately following craniectomy (single stage cranioplasty). All cases were assessed for the accuracy of the intra-operative fit of the implant, restoration of the natural skull contour and aesthetics and adverse symptoms. The intra-operative fit was excellent in 93.1% and good in 6.9% of the implants. In two cases minor adjustments of the bony margin of the defect were required. The operating time for insertion ranged from 16 to 38 minutes, median 21 minutes. Postoperatively, 86.2% of the patients graded the restoration of their natural skull shape and symmetry as excellent while 13.8% termed it good. In one patient a non-space occupying subdural hygroma was found at the follow-up, but required no intervention. Two patients experienced atrophy of the frontal portion of the temporal muscle while one patient had a transient palsy of the frontal branch of the facial nerve. Over the mean follow-up period of 3.3 years (range, 0.08 to 6.8 years), there were no adverse reactions and no plate had to be removed. Individual, prefabricated CFRP medical grade implants may be considered as an alternative to conventionally utilised materials for cranioplasty, in particular in the challenging group of patients with extensive cranial defects or more complex-formed defects of the fronto-orbital or temporo-zygomatic region, guaranteeing short operating times and excellent functional and aesthetic results, which justifies the expense of their production.

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

PubMed

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Comparison of 1-year outcomes after Ahmed glaucoma valve implantation with and without Ologen adjuvant.

PubMed

Kim, Tai Jun; Kang, Sohyun; Jeoung, Jin Wook; Kim, Young Kook; Park, Ki Ho

2018-02-14

Many studies have investigated the clinical benefits of Ologen for trabeculectomy. However, its benefits for Ahmed glaucoma valve (AGV) implantation have not been investigated as extensively. The aim of this study was to compare the 1-year outcomes of AGV implantation with and without Ologen adjuvant for the treatment of refractory glaucoma. This retrospective study included a total of 20 eyes of 20 glaucoma patients, who were followed for at least 1-year after undergoing AGV implantation. In 12 eyes of 12 patients, conventional AGV (CAGV) surgery was performed, while in 8 eyes of 8 patients, Ologen-augmented AGV (OAGV) implantation was performed. The outcomes were evaluated according to intraocular pressure (IOP) and the number of IOP-lowering medications. Complete success was defined as IOP ≤ 21 mmHg without medications throughout the 1-year follow-up period, and qualified success was defined as IOP ≤ 21 mmHg with or without medications throughout the 1-year follow-up period. The rate of complete success was significantly higher in the OAGV group (50.0%) than in the CAGV group (8.3%) (p = 0.035). There were no significant differences between the two groups in terms of qualified success or incidence of the early hypertensive phase. The IOP changes were similar between the groups within 1-year postoperatively, though the number of IOP-lowering medications was significantly lower in the OAGV group during the early hypertensive phase (p = 0.031, 0.031, and 0.025 at postoperative months 1, 2, and 3, respectively). When subjects were divided into groups according to the occurrence of the early hypertensive phase, the group with early hypertensive phase was more likely to use IOP-lowering medications at postoperative 6 months and 1 year (p = 0.002 and 0.005, respectively). OAGV surgery shows encouraging results for patients with refractory glaucoma, specifically with respect to the achievement of complete success and the reduction of the number of IOP-lowering medications during the early hypertensive phase. Furthermore, our results suggest that occurrence of the early hypertensive phase is predictive of which patients will require IOP-lowering medications at postoperative 6 months and 1 year.

Is the delivery of a quality improvement education programme in obstetrics and gynaecology for final year medical students feasible and still effective in a shortened time frame?

PubMed

Kool, Bridget; Wise, Michelle R; Peiris-John, Roshini; Sadler, Lynn; Mahony, Faith; Wells, Susan

2017-05-26

Teaching clinical audit skills to nascent health professionals is one strategy to improve frontline care. The undergraduate medical curriculum at the University of Auckland provides improvement science theory and skills in Year 5 teaching, and the opportunity to put this into practice during an Obstetrics and Gynaecology (O&G) clinical attachment in Year 6. In 2015, a revised medical school curriculum at the university resulted in a planned reduction of the O&G attachment from five weeks to four, necessitating revision of the Year 6 Quality Improvement (QI) project. The aim of this study was to evaluate if the revised programme provided an important experiential learning opportunity for medical students without imposing an unsustainable burden on clinical services. Based on a CIPP (Context/Input/Process/Product) evaluation model, the study was conducted in several stages to get a sense of the context as the new programme was being planned (Context evaluation), the feasibility of an alternative approach to meet the educational need (Input evaluation), the implementation of the revised programme (Process evaluation) and finally, the programme outcomes (Product evaluation). We used multiple data sources (supervisors, students, academic administrators, and hospital staff) and data collection methods (questionnaires, focus groups, individual interviews, consultative workshops, student reports and oral presentations). The context evaluation revealed the Year 6 QI programme to be valuable and contributed to O&G service improvements, however, the following concerns were identified: time to complete the project, timely topic selection and access to data, recognition of student achievement, and staff workload. The evaluation of the revised QI project indicated improvement in student perceptions of their QI knowledge and skills, and most areas previously identified as challenging, despite the concurrent reduction in the duration of the O&G attachment. Applying the CIPP model for evaluation to our revised QI programme enabled streamlining of procedures to achieve greater efficiency without compromising the quality of the learning experience, or increasing pressure on staff. A four week clinical rotation is adequate for medical educators to consider opportunities for including QI projects as part of student experiential learning.

Desire and reality--teaching and assessing communicative competencies in undergraduate medical education in German-speaking Europe--a survey.

PubMed

Härtl, Anja; Bachmann, Cadja; Blum, Katharina; Höfer, Stefan; Peters, Tim; Preusche, Ingrid; Raski, Bianca; Rüttermann, Stefan; Wagner-Menghin, Michaela; Wünsch, Alexander; Kiessling, Claudia

2015-01-01

Increasingly, communicative competencies are becoming a permanent feature of training and assessment in German-speaking medical schools (n=43; Germany, Austria, Switzerland - "D-A-CH"). In support of further curricular development of communicative competencies, the survey by the "Communicative and Social Competencies" (KusK) committee of the German Society for Medical Education (GMA) systematically appraises the scope of and form in which teaching and assessment take place. The iterative online questionnaire, developed in cooperation with KusK, comprises 70 questions regarding instruction (n=14), assessment (n=48), local conditions (n=5), with three fields for further remarks. Per location, two to three individuals who were familiar with the respective institute's curriculum were invited to take part in the survey. Thirty-nine medical schools (40 degree programmes) took part in the survey. Communicative competencies are taught in all of the programmes. Ten degree programmes have a longitudinal curriculum for communicative competencies; 25 programmes offer this in part. Sixteen of the 40 programmes use the Basler Consensus Statement for orientation. In over 80% of the degree programmes, communicative competencies are taught in the second and third year of studies. Almost all of the programmes work with simulated patients (n=38) and feedback (n=37). Exams are exclusively summative (n=11), exclusively formative (n=3), or both summative and formative (n=16) and usually take place in the fifth or sixth year of studies (n=22 and n=20). Apart from written examinations (n=15) and presentations (n=9), practical examinations are primarily administered (OSCE, n=31); WPA (n=8), usually with self-developed scales (OSCE, n=19). With regards to the examiners' training and the manner of results-reporting to the students, there is a high variance. Instruction in communicative competencies has been implemented at all 39 of the participating medical schools. For the most part, communicative competencies instruction in the D-A-C-H region takes place in small groups and is tested using the OSCE. The challenges for further curricular development lie in the expansion of feedback, the critical evaluation of appropriate assessment strategies, and in the quality assurance of exams.

Simultaneous bilateral stereotactic procedure for deep brain stimulation implants: a significant step for reducing operation time.

PubMed

Fonoff, Erich Talamoni; Azevedo, Angelo; Angelos, Jairo Silva Dos; Martinez, Raquel Chacon Ruiz; Navarro, Jessie; Reis, Paul Rodrigo; Sepulveda, Miguel Ernesto San Martin; Cury, Rubens Gisbert; Ghilardi, Maria Gabriela Dos Santos; Teixeira, Manoel Jacobsen; Lopez, William Omar Contreras

2016-07-01

OBJECT Currently, bilateral procedures involve 2 sequential implants in each of the hemispheres. The present report demonstrates the feasibility of simultaneous bilateral procedures during the implantation of deep brain stimulation (DBS) leads. METHODS Fifty-seven patients with movement disorders underwent bilateral DBS implantation in the same study period. The authors compared the time required for the surgical implantation of deep brain electrodes in 2 randomly assigned groups. One group of 28 patients underwent traditional sequential electrode implantation, and the other 29 patients underwent simultaneous bilateral implantation. Clinical outcomes of the patients with Parkinson's disease (PD) who had undergone DBS implantation of the subthalamic nucleus using either of the 2 techniques were compared. RESULTS Overall, a reduction of 38.51% in total operating time for the simultaneous bilateral group (136.4 ± 20.93 minutes) as compared with that for the traditional consecutive approach (220.3 ± 27.58 minutes) was observed. Regarding clinical outcomes in the PD patients who underwent subthalamic nucleus DBS implantation, comparing the preoperative off-medication condition with the off-medication/on-stimulation condition 1 year after the surgery in both procedure groups, there was a mean 47.8% ± 9.5% improvement in the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) score in the simultaneous group, while the sequential group experienced 47.5% ± 15.8% improvement (p = 0.96). Moreover, a marked reduction in the levodopa-equivalent dose from preoperatively to postoperatively was similar in these 2 groups. The simultaneous bilateral procedure presented major advantages over the traditional sequential approach, with a shorter total operating time. CONCLUSIONS A simultaneous stereotactic approach significantly reduces the operation time in bilateral DBS procedures, resulting in decreased microrecording time, contributing to the optimization of functional stereotactic procedures.

Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark.

PubMed

Sayers, Adrian; Crowther, Michael J; Judge, Andrew; Whitehouse, Michael R; Blom, Ashley W

2017-08-28

The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However, it is not currently clear how or how many implants should be statistically compared with a benchmark to assess whether or not that implant is superior, equivalent, non-inferior or inferior to the performance benchmark of interest.We aim to describe the methods and sample size required to conduct a one-sample non-inferiority study of a medical device for the purposes of benchmarking. Simulation study. Simulation study of a national register of medical devices. We simulated data, with and without a non-informative competing risk, to represent an arthroplasty population and describe three methods of analysis (z-test, 1-Kaplan-Meier and competing risks) commonly used in surgical research. We evaluate the performance of each method using power, bias, root-mean-square error, coverage and CI width. 1-Kaplan-Meier provides an unbiased estimate of implant net failure, which can be used to assess if a surgical device is non-inferior to an external benchmark. Small non-inferiority margins require significantly more individuals to be at risk compared with current benchmarking standards. A non-inferiority testing paradigm provides a useful framework for determining if an implant meets the required performance defined by an external benchmark. Current contemporary benchmarking standards have limited power to detect non-inferiority, and substantially larger samples sizes, in excess of 3200 procedures, are required to achieve a power greater than 60%. It is clear when benchmarking implant performance, net failure estimated using 1-KM is preferential to crude failure estimated by competing risk models. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Failure of Urological Implants in Spinal Cord Injury Patients due to Infection, Malfunction, and Implants Becoming Obsolete due to Medical Progress and Age-Related Changes in Human Body Making Implant Futile: Report of Three Cases.

PubMed

Vaidyanathan, Subramanian; Soni, Bakul; Singh, Gurpreet; Hughes, Peter; Selmi, Fahed; Mansour, Paul

2013-01-01

Any new clinical data, whether positive or negative, generated about a medical device should be published because health professionals should know which devices do not work, as well as those which do. We report three spinal cord injury patients in whom urological implants failed to work. In the first, paraplegic, patient, a sacral anterior root stimulator failed to produce erection, and a drug delivery system for intracavernosal administration of vasoactive drugs was therefore implanted; however, this implant never functioned (and, furthermore, such penile drug delivery systems to produce erection had effectively become obsolete following the advent of phosphodiesterase type 5 inhibitors). Subsequently, the sacral anterior root stimulator developed a malfunction and the patient therefore learned to perform self-catheterisation. In the second patient, also paraplegic, an artificial urinary sphincter was implanted but the patient developed a postoperative sacral pressure sore. Eight months later, a suprapubic cystostomy was performed as urethral catheterisation was very difficult. The pressure sore had not healed completely even after five years. In the third case, a sacral anterior root stimulator was implanted in a tetraplegic patient in whom, after five years, a penile sheath could not be fitted because of penile retraction. This patient was therefore established on urethral catheter drainage. Later, infection with Staphylococcus aureus around the receiver block necessitated its removal. In conclusion, spinal cord injury patients are at risk of developing pressure sores, wound infections, malfunction of implants, and the inability to use implants because of age-related changes, as well as running the risk of their implants becoming obsolete due to advances in medicine. Some surgical procedures such as dorsal rhizotomy are irreversible. Alternative treatments such as intermittent catheterisations may be less damaging than bladder stimulator in the long term.

Dental implants with fixed prosthodontics in oligodontia: A retrospective cohort study with a follow-up of up to 25 years.

PubMed

Filius, Marieke A P; Cune, Marco S; Koopmans, Petra C; Vissink, Arjan; Raghoebar, Gerry M; Visser, Anita

2018-04-24

Long-term assessments of implant survival and treatment outcome in patients with oligodontia are lacking. The purpose of this retrospective clinical study was to assess which factors determine a long-term implant survival and treatment outcome of up to 25 years in a cohort of patients with oligodontia. The medical records of all patients with oligodontia treated with fixed implant prosthodontics between January 1991 and December 2015 in the Department of Oral and Maxillofacial Surgery at the University Medical Center Groningen, the Netherlands, were assessed. Specifically, this involved the retrieval of records on the need for and mode of bone augmentation, implant survival, and survival of and adverse events associated with the prosthodontics. The Kaplan-Meier estimator was used to analyze implant and superstructure survival. Log-rank tests were used to compare the survival of subgroups. A total of 126 patients with oligodontia were treated with dental implants. Of the 777 implants in total, 56 were lost, resulting in a 5-year cumulative survival of 95.7% (95% confidence interval [CI], 94.2% to 97.2%) and a 10-year cumulative survival of 89.2% (95% CI, 86.2% to 92.2%). The survival of implants placed in regions where bone augmentation surgery had been performed was significantly lower. The 5-year cumulative superstructure survival was 90.5% (95% CI, 87.6% to 93.5%), and the 10-year cumulative superstructure survival was 80.3% (95% CI, 75.3% to 85.3%). The performance of the screw-retained and cemented superstructures was comparable, but the survival of single crowns was significantly higher than the survival of fixed partial dentures (P<.001). Implant treatment is a predictable treatment option for patients with oligodontia with a favorable long-term outcome. Survival of implants in augmented areas is lower. Copyright © 2018 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

[Fusion implants of carbon fiber reinforced plastic].

PubMed

Früh, H J; Liebetrau, A; Bertagnoli, R

2002-05-01

Carbon fiber reinforced plastics (CFRP) are used in the medical field when high mechanical strength, innovative design, and radiolucency (see spinal fusion implants) are needed. During the manufacturing process of the material CFRP carbon fibers are embedded into a resin matrix. This resin material could be thermoset (e.g., epoxy resin EPN/DDS) or thermoplastic (e.g., PEAK). CFRP is biocompatible, radiolucent, and has higher mechanical capabilities compared to other implant materials. This publication demonstrates the manufacturing process of fusion implants made of a thermoset matrix system using a fiber winding process. The material has been used clinically since 1994 for fusion implants of the cervical and lumbar spine. The results of the fusion systems CORNERSTONE-SR C (cervical) and UNION (lumbar) showed no implant-related complications. New implant systems made of this CFRP material are under investigation and are presented.

Evaluation of the Spanish Urological Association quality care indicators in a kidney transplantation programme.

PubMed

Cienfuegos-Belmonte, I R; León-Dueñas, E; Román-Martín, A A; Olmo-Ruíz, M; González-Roncero, F M; Medina-López, R A

2016-10-01

Indicators show the presence of a phenomenon and its intensity. They assess the level of quality care and identify potential situations for improvement. Our objective is to assess the 2013 and 2014 quality care indicators of our department's kidney transplantation area. For 2013 and 2014, we reviewed 88 and 106 kidney transplants and 47 and 66 extractions. We evaluated the quality care indicators developed by the Spanish Urological Association, analysing the results with the SPSS v 21.0 programme. The mean cold ischaemia time (CIT) was 14.96hours in 2013 and 18.07hours in 2014. The CIT was ≤18h in 53% and 56% of cadaveric donor kidneys in 2013 and 2014, respectively. The rate of relevant early onset urinary fistulae was 1.14% and 2.83% for each year. The rate of early transplantectomy due to a vascular complication was 3.41% and 2.83% for 2013 and 2014, respectively. Overall patient survival at 1 year was 100% for both periods, and graft survival at 1 year was 95% and 94.34% for 2013 and 2014, respectively. The rate of living-donor transplantation was 14.77% and 17.92%, and 92.31% and 68.42% of the living-donor extractions were laparoscopic for 2013 and 2014, respectively. Resident medical interns were the first surgeon in 6.67% and 12.64% of the transplantations and in 55.88% and 19.14% of the cadaveric extractions during 2013 and 2014, respectively. During the evaluated period, all quality care standards in kidney transplantation were met, except for CIT in both years and resident medical intern participation in kidney implantation in 2013. This analysis promotes improvements in quality care, highlighting weak spots that need work. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators.

PubMed

Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Flanigan, Susan; Adelstein, Evan; Jain, Sandeep; Saba, Samir

2014-02-01

Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients. All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy. There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.

Sex selection for non-medical indications: a survey of current pre-implantation genetic screening practices among U.S. ART clinics.

PubMed

Capelouto, Sarah M; Archer, Sydney R; Morris, Jerrine R; Kawwass, Jennifer F; Hipp, Heather S

2018-03-01

This study aimed to determine the current percentage of United States (U.S.) assisted reproductive technology (ART) clinics offering sex selection via pre-implantation genetic screening (PGS) for non-medical purposes. The authors conducted website review and telephone interview survey of 493 U.S. ART clinics performing in vitro fertilization (IVF) in 2017. Main outcome measures were pre-implantation genetic screening (PGS)/pre-implantation genetic diagnosis (PGD) practices and non-medical sex selection practices including family balancing. Of the 493 ART clinics in the USA, 482 clinics (97.8%) responded to our telephone interview survey. Among all U.S. ART clinics, 91.9% (n = 449) reported offering PGS and/or PGD. Furthermore, 476 clinics responded to survey questions about sex selection practices. Of those ART clinics, 72.7% (n = 346) reported offering sex selection. More specifically among those clinics offering sex selection, 93.6% (n = 324) reported performing sex selection for family balancing, and 81.2% (n = 281) reported performing for elective purposes (patient preference, regardless of rationale for the request). For couples without infertility, 83.5% (n = 289) of clinics offer sex selection for family balancing and 74.6% (n = 258) for non-specific elective reasons. The majority of U.S. ART clinics offer non-medical sex selection, a percentage that has increased substantially since last reported in 2006.

A fully integrated mixed-signal neural processor for implantable multichannel cortical recording.

PubMed

Sodagar, Amir M; Wise, Kensall D; Najafi, Khalil

2007-06-01

A 64-channel neural processor has been developed for use in an implantable neural recording microsystem. In the Scan Mode, the processor is capable of detecting neural spikes by programmable positive, negative, or window thresholding. Spikes are tagged with their associated channel addresses and formed into 18-bit data words that are sent serially to the external host. In the Monitor Mode, two channels can be selected and viewed at high resolution for studies where the entire signal is of interest. The processor runs from a 3-V supply and a 2-MHz clock, with a channel scan rate of 64 kS/s and an output bit rate of 2 Mbps.

Unusual placement of intrathecal baclofen pumps: report of two cases.

PubMed

Devine, Oliver; Harborne, Andrew; Lo, William B; Weinberg, Daniel; Ciras, Mahesh; Price, Rupert

2016-01-01

Intrathecal baclofen delivery via implantable pump represents an important modality for symptomatic relief in patients with chronic spasticity. Pumps are routinely implanted subcutaneously in the anterior abdominal wall. We describe two unusual cases where skin-related complications necessitated revision surgery in order to relocate the pump to alternative sites. The first patient was an international power canoeist, whose strenuous exercise programme interfered with his pump's original siting. The second patient was a cachectic university student with a history of cerebral palsy, who maintained low body mass despite attempted weight gain. The relocation of these two intrathecal devices to the medial compartment of the right thigh and right iliac fossa, respectively, is described.

Investigation of the medical applications of the unique biocarbons developed by NASA

NASA Technical Reports Server (NTRS)

Mooney, V.

1976-01-01

Experience with 127 percutaneous implants in 43 patients and volunteers is discussed. Pure carbon has demonstrated the highest level of success. It is indicated that prolonged success of these implants can be expected if mechanical factors are reduced to a minimum.

Security and privacy issues in implantable medical devices: A comprehensive survey.

PubMed

Camara, Carmen; Peris-Lopez, Pedro; Tapiador, Juan E

2015-06-01

Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. Copyright © 2015 Elsevier Inc. All rights reserved.

Students' perception of the learning environment in a distributed medical programme

PubMed Central

Veerapen, Kiran; McAleer, Sean

2010-01-01

Background The learning environment of a medical school has a significant impact on students' achievements and learning outcomes. The importance of equitable learning environments across programme sites is implicit in distributed undergraduate medical programmes being developed and implemented. Purpose To study the learning environment and its equity across two classes and three geographically separate sites of a distributed medical programme at the University of British Columbia Medical School that commenced in 2004. Method The validated Dundee Ready Educational Environment Survey was sent to all students in their 2nd and 3rd year (classes graduating in 2009 and 2008) of the programme. The domains of the learning environment surveyed were: students' perceptions of learning, students' perceptions of teachers, students' academic self-perceptions, students' perceptions of the atmosphere, and students' social self-perceptions. Mean scores, frequency distribution of responses, and inter- and intrasite differences were calculated. Results The perception of the global learning environment at all sites was more positive than negative. It was characterised by a strongly positive perception of teachers. The work load and emphasis on factual learning were perceived negatively. Intersite differences within domains of the learning environment were more evident in the pioneer class (2008) of the programme. Intersite differences consistent across classes were largely related to on-site support for students. Conclusions Shared strengths and weaknesses in the learning environment at UBC sites were evident in areas that were managed by the parent institution, such as the attributes of shared faculty and curriculum. A greater divergence in the perception of the learning environment was found in domains dependent on local arrangements and social factors that are less amenable to central regulation. This study underlines the need for ongoing comparative evaluation of the learning environment at the distributed sites and interaction between leaders of these sites. PMID:20922033

Enabling personalized implant and controllable biosystem development through 3D printing.

PubMed

Nagarajan, Neerajha; Dupret-Bories, Agnes; Karabulut, Erdem; Zorlutuna, Pinar; Vrana, Nihal Engin

The impact of additive manufacturing in our lives has been increasing constantly. One of the frontiers in this change is the medical devices. 3D printing technologies not only enable the personalization of implantable devices with respect to patient-specific anatomy, pathology and biomechanical properties but they also provide new opportunities in related areas such as surgical education, minimally invasive diagnosis, medical research and disease models. In this review, we cover the recent clinical applications of 3D printing with a particular focus on implantable devices. The current technical bottlenecks in 3D printing in view of the needs in clinical applications are explained and recent advances to overcome these challenges are presented. 3D printing with cells (bioprinting); an exciting subfield of 3D printing, is covered in the context of tissue engineering and regenerative medicine and current developments in bioinks are discussed. Also emerging applications of bioprinting beyond health, such as biorobotics and soft robotics, are introduced. As the technical challenges related to printing rate, precision and cost are steadily being solved, it can be envisioned that 3D printers will become common on-site instruments in medical practice with the possibility of custom-made, on-demand implants and, eventually, tissue engineered organs with active parts developed with biorobotics techniques. Copyright © 2018 Elsevier Inc. All rights reserved.

The value of programmable shunt valves for the management of subdural collections in patients with hydrocephalus.

PubMed

Pachatouridis, Dimitrios; Alexiou, George A; Mihos, Evaggelos; Fotakopoulos, George; Voulgaris, Spyridon

2013-01-01

The aim of the present study was to assess the value of electromagnetic programmable shunt valves for the treatment of subdural collections. Adult patients with hydrocephalus of various causes that were treated with programmable shunt valves during the last ten years were retrospectively studied. In 127 patients, 139 electromagnetic programmable shunt valves were implanted. A nontraumatic subdural fluid collection was detected in 12 patients. The treatment of these patients consisted of reprogramming of the valve's opening pressure. In 5 patients small subdural hematomas were detected; 4 of these patients were treated by raising the opening pressure alone and one patient required surgical drainage and change of the pressure setting. Traumatic chronic subdural hematomas were detected in 6 patients. These patients were treated by surgical drainage and readjustment of the valve's opening pressure. The ability to treat a shunt-related complication, such as a subdural fluid collection, by reprogramming the valve's opening pressure to a higher setting is an advantage over nonprogrammable valves, and it enables the opening pressure to be slowly lowered once the fluid collection is reabsorbed. Based on our results, we believe that programmable shunt valves should be preferred.

The Value of Programmable Shunt Valves for the Management of Subdural Collections in Patients with Hydrocephalus

PubMed Central

Alexiou, George A.; Mihos, Evaggelos; Fotakopoulos, George; Voulgaris, Spyridon

2013-01-01

Background. The aim of the present study was to assess the value of electromagnetic programmable shunt valves for the treatment of subdural collections. Methods. Adult patients with hydrocephalus of various causes that were treated with programmable shunt valves during the last ten years were retrospectively studied. In 127 patients, 139 electromagnetic programmable shunt valves were implanted. Results. A nontraumatic subdural fluid collection was detected in 12 patients. The treatment of these patients consisted of reprogramming of the valve's opening pressure. In 5 patients small subdural hematomas were detected; 4 of these patients were treated by raising the opening pressure alone and one patient required surgical drainage and change of the pressure setting. Traumatic chronic subdural hematomas were detected in 6 patients. These patients were treated by surgical drainage and readjustment of the valve's opening pressure. Conclusion. The ability to treat a shunt-related complication, such as a subdural fluid collection, by reprogramming the valve's opening pressure to a higher setting is an advantage over nonprogrammable valves, and it enables the opening pressure to be slowly lowered once the fluid collection is reabsorbed. Based on our results, we believe that programmable shunt valves should be preferred. PMID:24453855

Intracranial Hypertension: Medication and Surgery

MedlinePlus

... the atrium (heart). Many shunts used today have programmable valves, which means that the valves are externally adjustable. The advantage of a programmable valve is that after surgery, a physician can ...

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.

Effect of growth solution, membrane size and array connection on microbial fuel cell power supply for medical devices.

PubMed

Roxby, Daniel N; Nham Tran; Pak-Lam Yu; Nguyen, Hung T

2016-08-01

Implanted biomedical devices typically last a number of years before their batteries are depleted and a surgery is required to replace them. A Microbial Fuel Cell (MFC) is a device which by using bacteria, directly breaks down sugars to generate electricity. Conceptually there is potential to continually power implanted medical devices for the lifetime of a patient. To investigate the practical potential of this technology, H-Cell Dual Chamber MFCs were evaluated with two different growth solutions and measurements recorded for maximum power output both of individual MFCs and connected MFCs. Using Luria-Bertani media and connecting MFCs in a hybrid series and parallel arrangement with larger membrane sizes showed the highest power output and the greatest potential for replacing implanted batteries.

Innovative health systems projects.

PubMed

Green, Michael; Amad, Mansoor; Woodland, Mark

2015-02-01

Residency programmes struggle with the systems-based practice and improvement competency promoted by the Accreditation Council for Graduate Medical Education. The development of Innovative Health Systems Projects (IHelP) was driven by the need for better systems-based initiatives at an institutional level. Our objective was to develop a novel approach that successfully incorporates systems-based practice in our Graduate Medical Education (GME) programmes, while tracking our impact on health care delivery as an academic medical centre. We started the IHelP programme as a 'volunteer initiative' in 2010. A detailed description of the definition, development and implementation of the IHelP programme, along with our experience of the first year, is described. Residents, fellows and faculty mentors all played an important role in establishing the foundation of this initiative. Following the positive response, we have now incorporated IHelP into all curricula as a graduating requirement. IHelP has promoted scholarly activity and faculty mentorship, [and] has improved aspects of patient care and safety A total of 123 residents and fellows, representing 26 specialties, participated. We reviewed 145 projects that addressed topics ranging from administrative and departmental improvements to clinical care algorithms. The projects by area of focus were: patient care - clinical care, 38 per cent; patient care - quality, 27 per cent; resident education, 21 per cent; and a cumulative 16 per cent among pharmacy, department activities, patient education, medical records and clinical facility. We are pleased with the results of our first year of incorporating a systems-based improvement programme into the GME programmes. This initiative has promoted scholarly activity and faculty mentorship, has improved aspects of patient care and safety, and has led to the development of many practical innovations. © 2015 John Wiley & Sons Ltd.

Knowledge of and concerns about long-acting reversible contraception among women in medication-assisted treatment for opioid use disorder.

PubMed

Matusiewicz, Alexis K; Melbostad, Heidi S; Heil, Sarah H

2017-11-01

To assess interest in, concerns about and knowledge of long-acting reversible contraceptives (LARC) among women in medication-assisted treatment (MAT) for opioid use disorder who were at risk for unintended pregnancy. Women in MAT completed a survey on contraceptive use, attitudes and knowledge, including LARC methods, as part of eligibility screening for an ongoing trial evaluating family planning interventions for this population. Eighty-three women at risk for unintended pregnancy completed the survey, and a subset of 51 completed supplemental questions about implants. All participants had heard of IUDs and 75/83 (90%) had heard of implants, but only 34/83 (41%) and 14/51 (27%) reported being likely to use IUDs and implants, respectively. Thirty-five women reported they were unlikely to use IUDs, with 29/35 (83%) citing unspecified "other reasons" for this position and 24/35 (69%) endorsing concerns about side effects. Seventeen women reported they were unlikely to use implants, with 8/17 (47%) citing "other reasons" and 9/17 (53%) and 10/17 (59%) reporting concerns about insertion and removal, respectively. Participants reported they knew "a little" about LARCs, but only their knowledge of implants was limited. Only 50/83 (60%) participants were aware of the superior effectiveness of IUDs and 26/51 (51%) were aware of the superior effectiveness of implants relative to other reversible methods. Participants reported relatively low interest in LARCs. Many women had unspecified reasons for not using LARCs. Participants also lacked information about LARC safety and effectiveness, especially with regard to implants. Women in medication-assisted treatment for opioid use disorder are at high risk of unintended pregnancy, yet contraceptive use is low and use of less effective methods is common. Women in MAT may benefit from efforts to increase knowledge about implants and assuage concerns about their insertion and removal as well as more general efforts to improve knowledge about the relative efficacy of LARCs. Many women in MAT endorsed unspecified "other reasons" for not using LARCs, which should be explored further. Copyright © 2017 Elsevier Inc. All rights reserved.

An international virtual medical school (IVIMEDS): the future for medical education?

PubMed

Harden, R M; Hart, I R

2002-05-01

The introduction of new learning technologies, the exponential growth of Internet usage and the advent of the World Wide Web have the potential of changing the face of higher education. There are also demands in medical education for greater globalization, for the development of a common core curriculum, for improving access to training, for more flexible and student-centred training programmes including programmes with multi-professional elements and for maintaining quality while increasing student numbers and working within financial constraints. An international virtual medical school (IVIMEDS) with a high-quality education programme embodying a hybrid model of a blended curriculum of innovative e-learning approaches and the best of traditional face-to-face teaching is one response to these challenges. Fifty leading international medical schools and institutions are participating in a feasibility study. This is exploring: innovative thinking and approaches to the new learning technologies including e-learning and virtual reality; new approaches to curriculum planning and mapping and advanced instructional design based on the use of 'reusable learning objects'; an international perspective on medical education which takes into account the trend to globalization; a flexible curriculum which meets the needs of different students and has the potential of increasing access to medicine.

A study of patient satisfaction after cataract surgery with implantation of different types of intraocular lenses

PubMed Central

2012-01-01

Background The implementation of capitated payment has driven medical institutions through developing balance billing for medical services. By exploring the patients’ decision-making factors on different self-pay items, a reference for the pricing and sales strategy for the related products can be formed. The major purposes of this study were to analyze the determinants of preoperative selection and postoperative satisfaction with implantation of different types of intraocular lenses in cataract surgery. Methods This cross-sectional study consisted of 127 patients that were 50 years of age and older, and who had phacoemulsification with intraocular lens implantation in both eyes. Data were collected by using a structured questionnaire. The following parameters were measured: access to medical care, attitude towards receiving medical products at one’s own expense, overall patient satisfaction and postoperative visual clarity. Results The results showed that the patient’s gender, educational level and economic status influenced the type of intraocular lens chosen. Patients in the insurance group cared about access to medical care, and patients in the balance billing group cared about product differentiation. ANOVA results showed no statistically significant differences in the overall satisfaction of the patients among the groups with different types of intraocular lenses. Patients that received cataract surgery with implantation of multifocal intraocular lenses had better vision when trying to view smaller objects and when looking at objects under strong light. Conclusions Manufacturers should increase the number of differences between their products, and health care providers can then recommend the appropriate intraocular lens in accordance with the needs or demands of their patients, and also by keeping in mind the financial constraints of their patients. PMID:23107001

A study of patient satisfaction after cataract surgery with implantation of different types of intraocular lenses.

PubMed

Wei, Ching-Kuo; Wang, Shun-Mu; Lin, Jen-Chieh

2012-10-29

The implementation of capitated payment has driven medical institutions through developing balance billing for medical services. By exploring the patients' decision-making factors on different self-pay items, a reference for the pricing and sales strategy for the related products can be formed. The major purposes of this study were to analyze the determinants of preoperative selection and postoperative satisfaction with implantation of different types of intraocular lenses in cataract surgery. This cross-sectional study consisted of 127 patients that were 50 years of age and older, and who had phacoemulsification with intraocular lens implantation in both eyes. Data were collected by using a structured questionnaire. The following parameters were measured: access to medical care, attitude towards receiving medical products at one's own expense, overall patient satisfaction and postoperative visual clarity. The results showed that the patient's gender, educational level and economic status influenced the type of intraocular lens chosen. Patients in the insurance group cared about access to medical care, and patients in the balance billing group cared about product differentiation. ANOVA results showed no statistically significant differences in the overall satisfaction of the patients among the groups with different types of intraocular lenses. Patients that received cataract surgery with implantation of multifocal intraocular lenses had better vision when trying to view smaller objects and when looking at objects under strong light. Manufacturers should increase the number of differences between their products, and health care providers can then recommend the appropriate intraocular lens in accordance with the needs or demands of their patients, and also by keeping in mind the financial constraints of their patients.

Utility of Intraoperative Neuromonitoring during Minimally Invasive Fusion of the Sacroiliac Joint.

PubMed

Woods, Michael; Birkholz, Denise; MacBarb, Regina; Capobianco, Robyn; Woods, Adam

2014-01-01

Study Design. Retrospective case series. Objective. To document the clinical utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion for patients diagnosed with sacroiliac joint dysfunction (as a direct result of sacroiliac joint disruptions or degenerative sacroiliitis) and determine stimulated electromyography thresholds reflective of favorable implant position. Summary of Background Data. Intraoperative neuromonitoring is a well-accepted adjunct to minimally invasive pedicle screw placement. The utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion using a series of triangular, titanium porous plasma coated implants has not been evaluated. Methods. A medical chart review of consecutive patients treated with minimally invasive surgical sacroiliac joint fusion was undertaken at a single center. Baseline patient demographics and medical history, intraoperative electromyography thresholds, and perioperative adverse events were collected after obtaining IRB approval. Results. 111 implants were placed in 37 patients. Sensitivity of EMG was 80% and specificity was 97%. Intraoperative neuromonitoring potentially avoided neurologic sequelae as a result of improper positioning in 7% of implants. Conclusions. The results of this study suggest that intraoperative neuromonitoring may be a useful adjunct to minimally invasive surgical sacroiliac joint fusion in avoiding nerve injury during implant placement.

Antibacterial poly(D,L-lactic acid) coating of medical implants using a biodegradable drug delivery technology.

PubMed

Gollwitzer, Hans; Ibrahim, Karim; Meyer, Henriette; Mittelmeier, Wolfram; Busch, Raymonde; Stemberger, Axel

2003-03-01

Biomaterial-associated bacterial infections present common and challenging complications with medical implants. The purpose of this study was to determine the antibacterial properties of a low molecular weight biodegradable poly(D,L-lactic acid) coating with integrated antibiotics gentamicin and teicoplanin. Coating of Kirschner-wires was carried out by a solvent casting technique under aseptic conditions with and without incorporated antibiotics. Release kinetics of gentamicin and teicoplanin were studied in phosphate-buffered saline. Initial bacterial adhesion of Staphylococcus epidermidis on coated and bare implants was determined by radiolabelling and counts of detached viable organisms. The incorporated antibiotics showed a continuous release over a period of at least 96 h with an initial peak of release in the first 6 h. Attachment of non-viable microorganisms, detected by radiolabelled bacteria, was increased significantly by the polymer coatings (P < 0.05). In contrast, the number of viable bacteria was reduced by the pure polymer (P < 0.01) and further by the polymer-antibiotic combinations (P < 0.05). Poly(D,L-lactic acid) coating of implants could offer new perspectives in preventing biomaterial-associated infections. Combinations with other drugs to formulate custom-tailored implant surfaces are feasible.

Potential release of in vivo trace metals from metallic medical implants in the human body: from ions to nanoparticles--a systematic analytical review.

PubMed

Matusiewicz, Henryk

2014-06-01

Metal ion release from metallic materials, e.g. metallic alloys and pure metals, implanted into the human body in dental and orthopedic surgery is becoming a major cause for concern. This review briefly provides an overview of both metallic alloys and pure metals used in implant materials in dental and orthopedic surgery. Additionally, a short section is dedicated to important biomaterials and their corrosive behavior in both real solutions and various types of media that model human biological fluids and tissues. The present review gives an overview of analytical methods, techniques and different approaches applied to the measurement of in vivo trace metals released into body fluids and tissues from patients carrying metal-on-metal prostheses and metal dental implants. Reference levels of ion concentrations in body fluids and tissues that have been determined by a host of studies are compiled, reviewed and presented in this paper. Finally, a collection of published clinical data on in vivo released trace metals from metallic medical implants is included. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Antarctica: a review of recent medical research.

PubMed

Olson, James J

2002-10-01

This article reviews recent developments and areas of research in Antarctic medical science. Nineteen nations are part of the Antarctic treaty and undertake research programmes in Antarctica. Medical science is a small but important part of these programmes. Areas that have been studied include aspects of cold physiology, ultraviolet light effects, endocrine changes (including polar T3 syndrome), alterations in immune function, chronobiology, psychology, microbiology, epidemiology and telemedicine. Antarctica has been recognized as the closest thing on Earth to a testing ground for aspects of space exploration and as such has been termed a space analogue.

Comparison of Results of Measurement of Dimensions of the Placed Dental Implants on Cone Beam Computed Tomography with Dimensions of the Producers of the Implants.

PubMed

Repesa, Merisa; Sofic, Amela; Jakupovic, Selma; Tosum, Selma; Kazazic, Lejla; Dervisevic, Almir

2017-06-01

One of the most frequently used method for scanning patients with indication for dental implantation in dentistry is cone beam computed tomography. Implantation, CBCT imaging and implant programme are inevitable when planning a successful replacement of lost teeth. CBCT offers exact information about available bone and its density, adjacent tooth roots, the place of mandibular canal and maxillary sinus and adjacent anatomical structure. The goal of this study is to estimate accuracy of measurements on CBCT images ofpatients who have implants of different producers and determine if there is any statistically significant correlation between four test groups regardless of the alloy of which implants are made. The study was a prospective-comparative, and included fifteen patients with hundred dental implants divided in four groups depending on the producer. Over dimensioning in the gained measurements of the whole sample on CBCT images in relation to dimensions of producers is between 0.1006mm and 0.368mm. Even though over dimensioning is measured in millimetres, it has to be taken into consideration in clinical practice when planning an implant placement, and we can recommend safety zone of 0.5mm. There have been no statistically significant differences in the gained results in over dimensioning of implants of different alloys for horizontal and vertical measurements on CBCT images of Astra Tech, Brendet titanium implants and Straumann titanium-zirconium implants. Based on the goals of the study there have been confirmed statistically significant correlations of great value (from 0.841 to 0.936) of high level of importance between manufactured value of dimensions and average dimensions values gained through CBCT imaging in four types of implants (four test groups). The total exactness of measurements on CBCT scan in this research is 96.66% for horizontal measuring and 96.92% for vertical measuring. Therefore, we can conclude that CBCT as radiological method has an unavoidable importance in planning and successful realisation of dental implant procedure. Cone Beam Computed Tomography provides exact measurements of dimensions of placed dental implant in relation to dimensions of the producers of the implant because the material from which dental implants have been made does not significantly affect the precision of the measurement.

Privacy Challenges for Wireless Medical Devices

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

Lagesse, Brent J

2010-01-01

Implantable medical devices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, wemore » examine existing privacy enhancing algorithms and discuss their applicability to implantable medical devices.« less

A typology of longitudinal integrated clerkships.

PubMed

Worley, Paul; Couper, Ian; Strasser, Roger; Graves, Lisa; Cummings, Beth-Ann; Woodman, Richard; Stagg, Pamela; Hirsh, David

2016-09-01

Longitudinal integrated clerkships (LICs) represent a model of the structural redesign of clinical education that is growing in the USA, Canada, Australia and South Africa. By contrast with time-limited traditional block rotations, medical students in LICs provide comprehensive care of patients and populations in continuing learning relationships over time and across disciplines and venues. The evidence base for LICs reveals transformational professional and workforce outcomes derived from a number of small institution-specific studies. This study is the first from an international collaborative formed to study the processes and outcomes of LICs across multiple institutions in different countries. It aims to establish a baseline reference typology to inform further research in this field. Data on all LIC and LIC-like programmes known to the members of the international Consortium of Longitudinal Integrated Clerkships were collected using a survey tool developed through a Delphi process and subsequently analysed. Data were collected from 54 programmes, 44 medical schools, seven countries and over 15 000 student-years of LIC-like curricula. Wide variation in programme length, student numbers, health care settings and principal supervision was found. Three distinct typological programme clusters were identified and named according to programme length and discipline coverage: Comprehensive LICs; Blended LICs, and LIC-like Amalgamative Clerkships. Two major approaches emerged in terms of the sizes of communities and types of clinical supervision. These referred to programmes based in smaller communities with mainly family physicians or general practitioners as clinical supervisors, and those in more urban settings in which subspecialists were more prevalent. Three distinct LIC clusters are classified. These provide a foundational reference point for future studies on the processes and outcomes of LICs. The study also exemplifies a collaborative approach to medical education research that focuses on typology rather than on individual programme or context. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Does individual learning styles influence the choice to use a web-based ECG learning programme in a blended learning setting?

PubMed Central

2012-01-01

Background The compressed curriculum in modern knowledge-intensive medicine demands useful tools to achieve approved learning aims in a limited space of time. Web-based learning can be used in different ways to enhance learning. Little is however known regarding its optimal utilisation. Our aim was to investigate if the individual learning styles of medical students influence the choice to use a web-based ECG learning programme in a blended learning setting. Methods The programme, with three types of modules (learning content, self-assessment questions and interactive ECG interpretation training), was offered on a voluntary basis during a face to face ECG learning course for undergraduate medical students. The Index of Learning Styles (ILS) and a general questionnaire including questions about computer and Internet usage, preferred future speciality and prior experience of E-learning were used to explore different factors related to the choice of using the programme or not. Results 93 (76%) out of 123 students answered the ILS instrument and 91 the general questionnaire. 55 students (59%) were defined as users of the web-based ECG-interpretation programme. Cronbach's alpha was analysed with coefficients above 0.7 in all of the four dimensions of ILS. There were no significant differences with regard to learning styles, as assessed by ILS, between the user and non-user groups; Active/Reflective; Visual/Verbal; Sensing/Intuitive; and Sequential/Global (p = 0.56-0.96). Neither did gender, prior experience of E-learning or preference for future speciality differ between groups. Conclusion Among medical students, neither learning styles according to ILS, nor a number of other characteristics seem to influence the choice to use a web-based ECG programme. This finding was consistent also when the usage of the different modules in the programme were considered. Thus, the findings suggest that web-based learning may attract a broad variety of medical students. PMID:22248183

Does individual learning styles influence the choice to use a web-based ECG learning programme in a blended learning setting?

PubMed

Nilsson, Mikael; Östergren, Jan; Fors, Uno; Rickenlund, Anette; Jorfeldt, Lennart; Caidahl, Kenneth; Bolinder, Gunilla

2012-01-16

The compressed curriculum in modern knowledge-intensive medicine demands useful tools to achieve approved learning aims in a limited space of time. Web-based learning can be used in different ways to enhance learning. Little is however known regarding its optimal utilisation. Our aim was to investigate if the individual learning styles of medical students influence the choice to use a web-based ECG learning programme in a blended learning setting. The programme, with three types of modules (learning content, self-assessment questions and interactive ECG interpretation training), was offered on a voluntary basis during a face to face ECG learning course for undergraduate medical students. The Index of Learning Styles (ILS) and a general questionnaire including questions about computer and Internet usage, preferred future speciality and prior experience of E-learning were used to explore different factors related to the choice of using the programme or not. 93 (76%) out of 123 students answered the ILS instrument and 91 the general questionnaire. 55 students (59%) were defined as users of the web-based ECG-interpretation programme. Cronbach's alpha was analysed with coefficients above 0.7 in all of the four dimensions of ILS. There were no significant differences with regard to learning styles, as assessed by ILS, between the user and non-user groups; Active/Reflective; Visual/Verbal; Sensing/Intuitive; and Sequential/Global (p = 0.56-0.96). Neither did gender, prior experience of E-learning or preference for future speciality differ between groups. Among medical students, neither learning styles according to ILS, nor a number of other characteristics seem to influence the choice to use a web-based ECG programme. This finding was consistent also when the usage of the different modules in the programme were considered. Thus, the findings suggest that web-based learning may attract a broad variety of medical students.

Mini-Med School: promoting awareness of medicine as a career for suburban and rural high-school students.

PubMed

Shaikh, Faisal M; Babar, Mahwash; Cross, K Simon

2013-06-01

There is a global shortage of medical manpower. One approach to resolve such deficiencies is to effectively promote health careers to high-school students. Summer programmes held by medical faculties provide ideal opportunities for pre-medical students to examine the possible career opportunities in medicine. The Royal College of Surgeons in Ireland has recently launched a 'Mini-Medical School' (MMS) programme for suburban and rural high-school students in the South Eastern Region of Ireland. This paper illustrates the MMS project and describes the participants' reaction and evaluation of the programme and the factors influencing their desire to practise medicine in future. A total of 90 students completed the online survey (response rate 75%). Eighty-two per cent of the students indicated definitive and strong desire to study medicine after secondary school. There was no difference in interest between male and female students (P-value 0.665). The main factors influencing this interest were personal. Forty-four per cent of participants attributed this to the opportunity to help others while 30% to the intellectual challenge, whereas family, friends and other factors accounted for the rest of influential factors to study medicine. The majority agreed (60%) that the programme was quite accessible and easy to have a place. Opinions about the content of the programme focussed mainly on the interactive sessions. Forty-seven per cent liked the live patient-doctor interaction session the most, and 43% found the live video session very informative. The MMS is a highly effective platform for both the medical specialties and the high-school students. © 2012 The Authors. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons.

21 CFR 882.4545 - Shunt system implantation instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shunt system implantation instrument. 882.4545 Section 882.4545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4545 Shunt system...

21 CFR 882.4545 - Shunt system implantation instrument.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shunt system implantation instrument. 882.4545 Section 882.4545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4545 Shunt system...

21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5830...

21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5830...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable Intra-aneurysm Pressure Measurement System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable Intra-aneurysm Pressure Measurement System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Interarticular disc prosthesis (interpositional implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3970 Interarticular...

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.

PubMed

Christakis, Panos G; Kalenak, Jeffrey W; Tsai, James C; Zurakowski, David; Kammer, Jeffrey A; Harasymowycz, Paul J; Mura, Juan J; Cantor, Louis B; Ahmed, Iqbal I K

2016-10-01

To compare 2 frequently used aqueous shunts for the treatment of glaucoma. International, multicenter, randomized trial. Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Levetiracetam-loaded biodegradable polymer implants in the tetanus toxin model of temporal lobe epilepsy in rats.

PubMed

Halliday, Amy J; Campbell, Toni E; Nelson, Timothy S; McLean, Karen J; Wallace, Gordon G; Cook, Mark J

2013-01-01

Approximately one-third of people with epilepsy receive insufficient benefit from currently available anticonvulsant medication, and some evidence suggests that this may be due to a lack of effective penetration into brain parenchyma. The current study investigated the ability of biodegradable polymer implants loaded with levetiracetam to ameliorate seizures following implantation above the motor cortex in the tetanus toxin model of temporal lobe epilepsy in rats. The implants led to significantly shorter seizures and a trend towards fewer seizures for up to 1 week. The results of this study indicate that drug-eluting polymer implants represent a promising evolving treatment option for intractable epilepsy. Future research is warranted to investigate issues of device longevity and implantation site. Copyright © 2012 Elsevier Ltd. All rights reserved.

Medical team training and coaching in the Veterans Health Administration; assessment and impact on the first 32 facilities in the programme.

PubMed

Neily, Julia; Mills, Peter D; Lee, Pamela; Carney, Brian; West, Priscilla; Percarpio, Katherine; Mazzia, Lisa; Paull, Douglas E; Bagian, James P

2010-08-01

Communication is problematic in healthcare. The Veterans Health Administration is implementing Medical Team Training. The authors describe results of the first 32 of 130 sites to undergo the programme. This report is unique; it provides aggregate results of a crew resource-management programme for numerous facilities. Facilities were taught medical team training and implemented briefings, debriefings and other projects. The authors coached teams through consultative phone interviews over a year. Implementation teams self-reported implementation and rated programme impact: 1='no impact' and 5='significant impact.' We used logistic regression to examine implementation of briefing/debriefing. Ninety-seven per cent of facilities implemented briefings and debriefings, and all implemented an additional project. As of the final interview, 73% of OR and 67% of ICU implementation teams self-reported and rated staff impact 4-5. Eighty-six per cent of OR and 82% of ICU implementation teams self-reported and rated patient impact 4-5. Improved teamwork was reported by 84% of OR and 75% of ICU implementation teams. Efficiency improvements were reported by 94% of OR implementation teams. Almost all facilities (97%) reported a success story or avoiding an undesirable event. Sites with lower volume were more likely to conduct briefings/debriefings in all cases for all surgical services (p=0.03). Sites are implementing the programme with a positive impact on patients and staff, and improving teamwork, efficiency and safety. A unique feature of the programme is that implementation was facilitated through follow-up support. This may have contributed to the early success of the programme.

The preparation of students of medical faculties and other public colleges for educative activities within the national programme of health support.

PubMed

Kukurova, E; Bernadic, M; Kralova, E; Bernadicova, H; Traubner, P

2005-01-01

The tradition of education of physicians at the Medical Faculty of Comenius University (MFCU) has been developing for more than 85 years. Currently, the education has been widened by non-medical fields of study (nursing, obstetrical assistance, rehabilitation, public health care and laboratory and examination methods). After joining EU, the accreditation study programmes have been subject to transformation in compliance with current world trends in education. In accord with the transformation of content and forms of medical physics training, the authors demonstrate the main objectives and goals of this process. The goal is to prepare the graduates on high theoretical and practical levels, to teach them to work in team, and to prepare them for whole-life education. Practical skills in pre-clinical and clinical disciplines are being strengthened. One of the important outputs of pre-graduate education is the readiness of graduates for educative activities in favour of the National Programme of Health Support. (Tab. 1, Fig. 1, Ref. 7.)

Effect of diabetic case management intervention on health service utilization in Korea.

PubMed

Shin, Soon Ae; Kim, Hyeongsu; Lee, Kunsei; Lin, Vivian; Liu, George

2015-12-01

This study is to estimate the effectiveness of a diabetic case management programme on health-care service utilization. The study population included 6007 as the intervention group and 956,766 as the control group. As the indicators of health-care service utilization, numbers of medical ambulatory consultations, days of medication prescribed and medical expenses for one year were used, and we analysed the claim data of the health insurance from 2005 to 2007. The study population was classified into three subgroups based on the number of medical ambulatory consultations per year before this intervention. In the under-serviced subgroup, the intervention group showed a significant increase in the number of consultations (3.2), days of prescribed medication (66.4) and medical expenses (287,900 KRW) compared with the control group. Conversely, in the over-serviced subgroup, the intervention group showed a less decrease days of prescribed medication (1.6) compared with the control group. This showed that the case management programme led the intervention group to optimize their utilization of health-care services by subgroups. It is necessary to evaluate the appropriateness of health-care usage and clinical outcome to show the direct effectiveness of the case management programme by subgroups. © 2014 Wiley Publishing Asia Pty Ltd.

Adhesive bone bonding prospects for lithium disilicate ceramic implants

NASA Astrophysics Data System (ADS)

Vennila Thirugnanam, Sakthi Kumar

Temporomandibular Joint (TMJ) implants articulating mandible with temporal bone in humans have a very high failure rate. Metallic TMJ implants available in the medical market are not osseointegrated, but bond only by mechanical interlocking using screws which may fail, mandating a second surgery for removal. Stress concentration around fixture screws leads to aseptic loosening or fracture of the bone. It has been proposed that this problem can be overcome by using an all-ceramic TMJ implant bonded to bone with dental adhesives. Structural ceramics are promising materials with an excellent track record in the field of dentis.

[A Roman orbital implant?].

PubMed

Rohrbach, J M; Harbeck, M; Holzhauser, P; Tekeva-Rohrbach, C I; Mach, M; Codreanu-Windauer, S

2012-11-01

During an excavation in Regensburg/Germany the skeleton of an approximately 20-year-old Roman man was found who was buried in the 3rd/4th century after Christ. A "stone" was found which fitted into the left orbit precisely. After a thorough investigation of the "stone" and with the ophthalmohistorical literature in mind an orbital "implant" as well as a petrified medical paste ("Kollyrium") could be ruled out almost with certainty. Possibly the "stone" served another medical purpose or was used for protection of the eye. Georg Thieme Verlag KG Stuttgart · New York.

Profitability of Qualified-Labour-Power Production

ERIC Educational Resources Information Center

Baldino, Roberto Ribeiro; Cabral, Tânia Cristina Baptista

2015-01-01

In Baldino and Cabral (2013) we introduced the concept of qualified labour-power as the commodity produced by the school system. In the present article we outline a quantitative model to evaluate the profit rate of educational programmes. We compare a medical school programme with a teacher education programme at a public university in Brazil,…

A Tutorial Programme to Enhance Psychiatry Learning Processes within a PBL-Based Course

ERIC Educational Resources Information Center

Hood, Sean; Chapman, Elaine

2011-01-01

This paper describes a tutorial programme developed at the University of Western Australia (UWA) to enhance medical students' learning processes within problem-based learning contexts. The programme encourages students to use more effective learning approaches by scaffolding the development of effective problem-solving strategies, and by reducing…

Mentoring portfolio use in undergraduate and postgraduate medical education.

PubMed

Dekker, Hanke; Driessen, Erik; Ter Braak, Edith; Scheele, Fedde; Slaets, Joris; Van Der Molen, Thys; Cohen-Schotanus, Janke

2009-10-01

Mentoring is widely acknowledged as being crucial for portfolio learning. The aim of this study is to examine how mentoring portfolio use has been implemented in undergraduate and postgraduate settings. The results of interviews with six key persons involved in setting up portfolio use in medical education programmes were used to develop a questionnaire, which was administered to 30 coordinators of undergraduate and postgraduate portfolio programmes in the Netherlands and Flanders. The interviews yielded four main aspects of the portfolio mentoring process--educational aims, individual meetings, small group sessions and mentor characteristics. Based on the questionnaire data, 16 undergraduate and 14 postgraduate programmes were described. Providing feedback and stimulating reflection were the main objectives of the mentoring process. Individual meetings were the favourite method for mentoring (26 programmes). Small group sessions to support the use of portfolios were held in 16 programmes, mostly in the undergraduate setting. In general, portfolio mentors were clinically qualified academic staff trained for their mentoring tasks. This study provides a variety of practical insights into implementing mentoring processes in portfolio programmes.

Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results.

PubMed

Neuhann, Tobias H

2015-12-01

To evaluate long-term safety and efficacy of iStent trabecular micro-bypass stent implantation during cataract surgery in patients with primary open-angle, pseudo-exfoliation glaucoma, ocular hypertension, or secondary or post-traumatic glaucoma. AaM Augenklinik am Marienplatz, Munich, Germany. Prospective, open-label, non-randomized study. Preoperative and postoperative evaluations included intra-ocular pressure (IOP), topical ocular hypotensive medication use, cup/disc ratio, corrected-distance visual acuity (CDVA), complications, and adverse events. A single trabecular micro-bypass stent was implanted through the same temporal, limbal incision used for cataract surgery via phacoemulsification in a consecutive series of 62 eyes of 43 patients. To date, a total of 41 eyes have been followed for 3 years postoperatively, whereas long-term postoperative follow-up on the remaining patients is ongoing. Mean preoperative IOP was 24.1 ± 6.9 mm Hg on a mean of 1.8 medications (±0.9). Analyses of eyes with no secondary surgical intervention showed mean IOP reduction to 14.8 ± 4.2 mm Hg at 12 months (n = 61), 14.5 ± 2.2 mm Hg at 24 months (n = 42), and 14.9 ± 2.3 mm Hg at 36 months (n = 39). Medications were eliminated in 74% of eyes at 36 months. Five eyes, 4 with previous glaucoma surgeries and 1 with pseudo-exfoliation syndrome, required additional glaucoma surgery after stent implantation. No intra-operative or postoperative complications typically seen with conventional glaucoma surgeries occurred after stent implantation. At 36 months, CDVA was 20/40 or better in 38 eyes (93%). Trabecular micro-bypass stent implantation during cataract surgery was safe and effective in patients with ocular hypertension or glaucoma as measured by a sustained reduction in IOP and medication use and an excellent safety profile through 3 years after surgery. Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial assistance in the preparation of the manuscript. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Undergraduate Medical Research Programme: A Cross-Sectional Study of Students’ Satisfactions, Perceived Challenges, and Attitudes

PubMed Central

Althubaiti, Alaa

2015-01-01

Background: Implementing an undergraduate Medical Research Programme (MRP) in medical colleges may not only improve the subsequent career of medical students but also benefit the health system in general. If not designed effectively, however, such a programme could have the opposite impact. Therefore, the quality of a MRP should be evaluated continuously. This study aims to evaluate the MRP from medical students’ perspective. Methods: A cross-sectional survey study was conducted from March to April 2014 amongst undergraduate medical students at the College of Medicine, King Saud University for Health Sciences, Riyadh, Saudi Arabia. Satisfaction, perceived challenges, and attitudes towards the MRP were evaluated. Results: A total of 154 responses were collected from the students; 81(52.6%) were in the 2nd year and 73 (47.4%) were in the 3rd year of the MRP, 97(63%) were males. The mean ± SD age was 21.5 ± 0.82 years. Overall, most students were satisfied with the MRP (51.3%). The majority of students were of the opinion that there was a shortage of time to complete their work (57.6%) and a lack of motivation to do research (53.3%). Significant differences were found in the satisfaction levels and perceived challenges between students in the 2nd and 3rd year of the MRP (P≤ .013). Discussion: Assessment of medical students’ perspective towards the MRP is an important aspect of the educative process. We recommend more evaluation studies, because they ensure that programmes effectively meet their goals and continue to be improved. A solid MRP is essential and will increase the university’s profile. PMID:26156916

[Big differences in leadership and management training within health care services. Leadership and issues concerning cooperation should be more emphasized in basic medical education].

PubMed

Hauptig, S; Collste, L; Hammar, M; Calltorp, J; Frischer, J; Haase, H; Lindquist, I; Andersson, C

1999-12-08

A recent survey of medical management programmes at universities across the country showed manifest national differences to exist, both quantitative and qualitative. Using a questionnaire, the Swedish Society of Medical Management examined the programmes for physiotherapists, occupational therapists, social workers, nurses and physicians, with respect to such issues as leadership, self-awareness and communication, health economics, and administration. It was concluded that knowledge acquired differs between fields; that physiotherapy programmes tend to have a very didactic approach; that nurses are taught the importance of participation in developmental processes; that doctors are exposed to somewhat the same approach but to a large extent on a voluntary basis; and that social workers obtain good insight into the administrative skills necessary to their work. In the article it is concluded that students would benefit from orientation in the diverse approaches used in the other fields than their own, and that pooling of resources among different programmes might be a more economic alternative to current practice.

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Percutaneous, implanted, long-term intravascular catheter. 880.5970 Section 880.5970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital...

21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Percutaneous, implanted, long-term intravascular catheter. 880.5970 Section 880.5970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital...