Wildfires

MedlinePlus

... motels Expand sub-navigation Hotel fire safety tips Marijuana grow & extraction facilities Nightclubs and other assembly occupancies ... Fire behavior research Fire loss and injury research Benefits of home fire sprinklers Expand sub-navigation Environmental ...

76 FR 21253 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending and expanding the emergency safety zone established on... January 28, 2011. The safety zone is necessary to help ensure the safety of the response workers and...

Teaching Health and Safety: Preparing Staff for the Unexpected.

ERIC Educational Resources Information Center

Cronin, Greg

1999-01-01

Discusses methods for training camp counselors in safety standards. Safety awareness and camp wellness should be introduced during staff interviews. During precamp training, staff should complete a test in OSHA requirements, followed by role playing to expand staff's knowledge in each OSHA safety and health area. First aid training, fire safety,…

Medication Safety During Pregnancy: Improving Evidence-Based Practice.

PubMed

Sinclair, Susan M; Miller, Richard K; Chambers, Christina; Cooper, Elizabeth M

2016-01-01

Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy. © 2016 by the American College of Nurse-Midwives.

Characterization of nanomaterial test solutions for terrestrial plant dose-response studies: A comparative study of DLS and SAXS

EPA Science Inventory

Industrial applications of nanomaterials have expanded at an increasing rate in recent years, accompanied by the need for comprehensive toxicological assessments to establish environmental health and safety standards. Relatively few studies have examined the effects of nanoparti...

Implementation of GIS-based highway safety analyses : bridging the gap

DOT National Transportation Integrated Search

2001-01-01

In recent years, efforts have been made to expand the analytical features of the Highway Safety Information System (HSIS) by integrating Geographic Information System (GIS) capabilities. The original version of the GIS Safety Analysis Tools was relea...

Factors associated with the enactment of safety belt and motorcycle helmet laws.

PubMed

Law, Teik Hua; Noland, Robert B; Evans, Andrew W

2013-07-01

It has been shown that road safety laws, such as motorcycle helmet and safety belt laws, have a significant effect in reducing road fatalities. Although an expanding body of literature has documented the effects of these laws on road safety, it remains unclear which factors influence the likelihood that these laws are enacted. This study attempts to identify the factors that influence the decision to enact safety belt and motorcycle helmet laws. Using panel data from 31 countries between 1963 and 2002, our results reveal that increased democracy, education level, per capita income, political stability, and more equitable income distribution within a country are associated with the enactment of road safety laws. © 2012 Society for Risk Analysis.

Supra-plasma expanders: the future of treating blood loss and anemia without red cell transfusions?

PubMed

Tsai, Amy G; Vázquez, Beatriz Y Salazar; Hofmann, Axel; Acharya, Seetharama A; Intaglietta, Marcos

2015-01-01

Oxygen delivery capacity during profoundly anemic conditions depends on blood's oxygen-carrying capacity and cardiac output. Oxygen-carrying blood substitutes and blood transfusion augment oxygen-carrying capacity, but both have given rise to safety concerns, and their efficacy remains unresolved. Anemia decreases oxygen-carrying capacity and blood viscosity. Present studies show that correcting the decrease of blood viscosity by increasing plasma viscosity with newly developed plasma expanders significantly improves tissue perfusion. These new plasma expanders promote tissue perfusion, increasing oxygen delivery capacity without increasing blood oxygen-carrying capacity, thus treating the effects of anemia while avoiding the transfusion of blood.

Safety of endoscopic removal of self-expandable stents after treatment of benign esophageal diseases.

PubMed

van Halsema, Emo E; Wong Kee Song, Louis M; Baron, Todd H; Siersema, Peter D; Vleggaar, Frank P; Ginsberg, Gregory G; Shah, Pari M; Fleischer, David E; Ratuapli, Shiva K; Fockens, Paul; Dijkgraaf, Marcel G W; Rando, Giacomo; Repici, Alessandro; van Hooft, Jeanin E

2013-01-01

Temporary placement of self-expandable stents has been increasingly used for the management of benign esophageal diseases. To evaluate the safety of endoscopic removal of esophageal self-expandable stents placed for the treatment of benign esophageal diseases. Multicenter retrospective study. Six tertiary care centers in the United States and Europe. A total of 214 patients with benign esophageal diseases undergoing endoscopic stent removal. Endoscopic stent removal. Endoscopic techniques for stent removal, time to stent removal, and adverse events related to stent removal. A total of 214 patients underwent a total of 329 stent extractions. Stents were mainly placed for refractory strictures (49.2%) and fistulae (49.8%). Of the removed stents, 52% were fully covered self-expandable metal stents (FCSEMSs), 28.6% were partially covered self-expandable metal stents (PCSEMSs), and 19.5% were self-expandable plastic stents. A total of 35 (10.6%) procedure-related adverse events were reported, including 7 (2.1%) major adverse events. Multivariate analysis revealed that use of PCSEMSs (P < .001) was a risk factor for adverse events during stent removal. Favorable factors for successful stent removal were FCSEMSs (P ≤ .012) and stent migration (P = .010). No significant associations were found for stent indwelling time (P = .145) and stent embedding (P = .194). Retrospective analysis, only tertiary care centers. With an acceptable major adverse event rate of 2.1%, esophageal stent removal in the setting of benign disease was found to be a safe and feasible procedure. FCSEMSs were more successfully removed than self-expandable plastic stents and PCSEMSs. Adverse events caused by stent removal were not time dependent. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

77 FR 14007 - Sunshine Act Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Sunshine Act Meeting Notice Federal Register CITATION OF... THE MEETING: The Defense Nuclear Facilities Safety Board (Board) is expanding the matters to be.../ resolution of safety and technical issues across the defense nuclear facilities complex. Since this panel...

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.

PubMed

Fernández, Oscar; Izquierdo, Guillermo; Fernández, Victoria; Leyva, Laura; Reyes, Virginia; Guerrero, Miguel; León, Antonio; Arnaiz, Carlos; Navarro, Guillermo; Páramo, Maria Dolores; Cuesta, Antonio De la; Soria, Bernat; Hmadcha, Abdelkrim; Pozo, David; Fernandez-Montesinos, Rafael; Leal, Maria; Ochotorena, Itziar; Gálvez, Patricia; Geniz, Maria Angeles; Barón, Francisco Javier; Mata, Rosario; Medina, Cristina; Caparrós-Escudero, Carlos; Cardesa, Ana; Cuende, Natividad

2018-01-01

Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded. Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

The Association Between Professional Burnout and Engagement With Patient Safety Culture and Outcomes: A Systematic Review.

PubMed

Mossburg, Sarah E; Dennison Himmelfarb, Cheryl

2018-06-25

In the last 20 years, there have been numerous successful efforts to improve patient safety, although recent research still shows a significant gap. Researchers have begun exploring the impact of individual level factors on patient safety culture and safety outcomes. This review examines the state of the science exploring the impact of professional burnout and engagement on patient safety culture and safety outcomes. A systematic search was conducted in CINAHL, PubMed, and Embase. Studies included reported on the relationships among burnout or engagement and safety culture or safety outcomes. Twenty-two studies met inclusion criteria. Ten studies showed a relationship between both safety culture and clinical errors with burnout. Two of 3 studies reported an association between burnout and patient outcomes. Fewer studies focused on engagement. Most studies exploring engagement and safety culture found a moderately strong positive association. The limited evidence on the relationship between engagement and errors depicts inconsistent findings. Only one study explored engagement and patient outcomes, which failed to find a relationship. The burnout/safety literature should be expanded to a multidisciplinary focus. Mixed results of the relationship between burnout and errors could be due to a disparate relationship with perceived versus observed errors. The engagement/safety literature is immature, although high engagement seems to be associated with high safety culture. Extending this science into safety outcomes would be meaningful, especially in light of the recent focus on an abundance-based approach to safety.

Smoke Alarms for People Who Are Deaf or Hard-of-Hearing

MedlinePlus

... motels Expand sub-navigation Hotel fire safety tips Marijuana grow & extraction facilities Nightclubs and other assembly occupancies ... Fire behavior research Fire loss and injury research Benefits of home fire sprinklers Expand sub-navigation Environmental ...

Multiphysics Object-Oriented Simulation Environment (MOOSE)

ScienceCinema

None

2017-12-09

Nuclear reactor operators can expand safety margins with more precise information about how materials behave inside operating reactors. INL's new simulation platform makes such studies easier & more informative by letting researchers "plug-n-play" their mathematical models, skipping years of computer code development.

Optical sensing technologies for rapid food safety and quality inspection

USDA-ARS?s Scientific Manuscript database

Public concerns for food safety and foodborne illness have risen in recent years. There is a need to expand efforts to prevent and mitigate any food contamination that can potentially be harmful to human health. Researchers at the Environmental Microbial and Food Safety Laboratory, ARS, USDA is one...

78 FR 48907 - Intertek Testing Services NA, Inc.: Grant of Expansion of Recognition and Request To Remove a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-12

... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2007-0039... Recognition AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice. SUMMARY: This notice announces the Occupational Safety and Health Administration's final decision expanding the scope...

Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

PubMed

Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

2017-05-03

Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

A pilot study about the oncologic safety of colonic self-expandable metal stents (SEMS) in obstructive colon cancer: is occlusion always better than "silent" perforation?

PubMed

Zanghì, A; Piccolo, G; Cavallaro, A; Pulvirenti, E; Lo Menzo, E; Cardì, F; Di Vita, M; Cappellani, A

2016-12-01

To evaluate the oncologic safety of colonic self-expandable metal stents (SEMS) in obstructive colon cancer. We retrospectively reviewed all the patients who were treated with endoscopic placement of a self-expandable metallic stent (SEMS) at our institution. A total of 26 patients were identified during the study period, of which 24 patients (92.30%) were treated with SEMS as a bridge-to-surgery and 2 (7.69%) as palliation. In 22 cases (80.76%), the stenosis was localized to the left side. Clinical success with resolution of bowel obstructions was achieved in 22 (84.61%) patients within a short period of time. Among patients treated successfully with SEMS insertion as bridge to surgery (n = 22), 20 (90.9%) underwent one-stage surgery with primary anastomosis while 2 patients (9.09%) underwent colostomy due to intraoperative evidence of a covered perforation by cancer tissue in the pelvis. Patients with subclinical perforation developed an early peritoneal carcinomatosis, 10 patients treated with curative intent subsequently developed liver metastasis after 24 months. We reported an overall poor outcome among patients treated with the insertion of SEMS. This led us to think that, in some cases, occlusion may be better than a "silent" perforation.

Aviation Safety Program Atmospheric Environment Safety Technologies (AEST) Project

NASA Technical Reports Server (NTRS)

Colantonio, Ron

2011-01-01

Engine Icing: Characterization and Simulation Capability: Develop knowledge bases, analysis methods, and simulation tools needed to address the problem of engine icing; in particular, ice-crystal icing Airframe Icing Simulation and Engineering Tool Capability: Develop and demonstrate 3-D capability to simulate and model airframe ice accretion and related aerodynamic performance degradation for current and future aircraft configurations in an expanded icing environment that includes freezing drizzle/rain Atmospheric Hazard Sensing and Mitigation Technology Capability: Improve and expand remote sensing and mitigation of hazardous atmospheric environments and phenomena

Innovative Advances in Connectivity and Community Pharmacist Patient Care Services: Implications for Patient Safety.

PubMed

Bacci, Jennifer L; Berenbrok, Lucas A

2018-06-07

The scope of community pharmacy practice has expanded beyond the provision of drug product to include the provision of patient care services. Likewise, the community pharmacist's approach to patient safety must also expand beyond prevention of errors during medication dispensing to include optimization of medications and prevention of adverse events throughout the entire medication use process. Connectivity to patient data and other healthcare providers has been a longstanding challenge in community pharmacy with implications for the delivery and safety of patient care. Here, we describe three innovative advances in connectivity in community pharmacy practice that enhance patient safety in the provision of community pharmacist patient care services across the entire medication use process. Specifically, we discuss the growing use of immunization information systems, quality improvement platforms, and health information exchanges in community pharmacy practice and their implications for patient safety. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Fatality reduction by safety belts for front-seat occupants of cars and light trucks : updated and expanded estimates based on 1986-99 FARS data

DOT National Transportation Integrated Search

2000-12-01

The National Highway Traffic Safety Administration estimated in 1984 that manual 3-point safety belts : reduce the fatality risk of front-seat occupants of passenger cars by 45 percent relative to the unrestrained : occupant. The agency still relies ...

HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights.

PubMed

Evans, Barbara J

2018-01-04

In 2014, the United States granted individuals a right of access to their own laboratory test results, including genomic data. Many observers feel that this right is in tension with regulatory and bioethical standards designed to protect the safety of people who undergo genomic testing. This commentary attributes this tension to growing pains within an expanding federal regulatory program for genetic and genomic testing. The Genetic Information Nondiscrimination Act of 2008 expanded the regulatory agenda to encompass civil rights and consumer safety. The individual access right, as it applies to genomic data, is best understood as a civil-rights regulation. Competing regulatory objectives-safety and civil rights-were not successfully integrated during the initial rollout of genomic civil-rights regulations after 2008. Federal law clarifies how to prioritize safety and civil rights when the two come into conflict, although with careful policy design, the two need not collide. This commentary opens a dialog about possible solutions to advance safety and civil rights together. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Carbon Monoxide Poisoning - Multiple Languages

MedlinePlus

... Prevention Guidelines: You Can Prevent Carbon Monoxide Exposure - English PDF Prevention Guidelines: You Can Prevent Carbon Monoxide ... Expand Section Carbon Monoxide - Furnace Safety Fact Sheet - English PDF Carbon Monoxide - Furnace Safety Fact Sheet - العربية ( ...

PRB rail loadings shatter record

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

Buchsbaum, L.

Rail transport of coal in the Powder River Basin has expanded, with a record 2,197 trains loaded in a month. Arch Coal's Thunder basin mining complex has expanded by literally bridging the joint line railway. The dry fork mine has also celebrated its safety achievements. 4 photos.

Comparing the Affordable Care Act's Financial Impact on Safety-Net Hospitals in States That Expanded Medicaid and Those That Did Not.

PubMed

Dobson, Allen; DaVanzo, Joan E; Haught, Randy; Phap-Hoa, Luu

2017-11-01

Safety-net hospitals play a vital role in delivering health care to Medicaid enrollees, the uninsured, and other vulnerable patients. By reducing the number of uninsured Americans, the Affordable Care Act (ACA) was also expected to lower these hospitals’ significant uncompensated care costs and shore up their financial stability. To examine how the ACA’s Medicaid expansion affected the financial status of safety-net hospitals in states that expanded Medicaid and in states that did not. Using Medicare hospital cost reports for federal fiscal years 2012 and 2015, the authors compared changes in Medicaid inpatient days as a percentage of total inpatient days, Medicaid revenues as a percentage of total net patient revenues, uncompensated care costs as a percentage of total operating costs, and hospital operating margins. Medicaid expansion had a significant, favorable financial impact on safety-net hospitals. From 2012 to 2015, safety-net hospitals in expansion states, compared to those in nonexpansion states, experienced larger increases in Medicaid inpatient days and Medicaid revenues as well as reduced uncompensated care costs. These changes improved operating margins for safety-net hospitals in expansion states. Margins for safety-net hospitals in nonexpansion states, meanwhile, declined.

A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog.

PubMed

Wang, Yong; Guo, Jin-He; Zhu, Guang-Yu; Zhu, Hai-Dong; Chen, Li; Lu, Jian; Wang, Chao; Teng, Gao-Jun

2017-07-01

Airway stent placement is an effective treatment for the immediate palliation of malignant airway obstruction. However, restenosis caused by tumor ingrowth and/or overgrowth after stenting is common. The purpose of this study was to investigate the feasibility and safety of a novel self-expandable stent loaded with 125 I seeds in healthy beagle dog. Under fluoroscopic guidance, forty-eight self-expandable airway stents loaded with 125 I seeds were perorally placed in the main trachea of 48 healthy beagle dogs, who were randomly divided into four groups (Group A: 0.3 mCi; Group B: 0.6 mCi; Group C: 0.9 mCi; Control group: 0 mCi). The estimated radiation dose was calculated using the isotropic point source approximation. Radiological follow-up examinations and histopathological examinations of stented tracheal segments and their adjacent organs and tissues were performed at 2, 4, 8, and 16 weeks following the stenting. All stents were successfully deployed in the targeted tracheal segment in the beagle dogs without procedure-related complications. Tracheal stenosis became severe gradually in all the four groups, which was not associated with the radioactivity of 125 I seeds (p > 0.05). The tracheal injury scores increased along with the higher dose of radioactive seeds which reached peak at 8 weeks and then turned back slightly at 16 weeks. The adjacent tissue did not show pathohistological changes under microscope, while mild and reversible ultrastructure changes were showed under electronic microscope. This study demonstrates that it is feasible and safe to insert this novel self-expandable airway stent loaded with 125 I seeds in healthy beagle dog.

Revised fire safety system cuts emergency response time.

PubMed

Keir, D C

1979-03-01

As Margaret R. Pardee Memorial Hospital, Hendersonville, NC. expanded, fire safety plans had to be reevaluated. With each new addition, fire safety responsibilities for hospital personnel multiplied and overlapped. Confusion resulted, and a revised, simplified, and coordinated fire safety system was devised. Seventeen false alarms within one year, caused by a faulty sprinkler system, gave hospital personnel ample opportunity to test the system and iron out unexpected problems.

Development and Testing of a Nutrition, Food Safety, and Physical Activity Checklist for EFNEP and FSNE Adult Programs

ERIC Educational Resources Information Center

Bradford, Traliece; Serrano, Elena L.; Cox, Ruby H.; Lambur, Michael

2010-01-01

Objective: To develop and assess reliability and validity of the Nutrition, Food Safety, and Physical Activity Checklist to measure nutrition, food safety, and physical activity practices among adult Expanded Food and Nutrition Education Program (EFNEP) and Food Stamp Nutrition Education program (FSNE) participants. Methods: Test-retest…

Changes to Puerto Rico's motorcycle rider law.

DOT National Transportation Integrated Search

2017-04-01

In 2007 Puerto Rico enacted Law 107, a motorcycle safety law that introduced or expanded previous safety-related statutes : such as requiring motorcycle riders and passengers to wear (1) reflective vests at night and protective gear at all times of d...

Student Work Safety Guidelines in Roadside Applications and Work Zones : Safety Guidelines for Transportation Researchers

DOT National Transportation Integrated Search

2018-01-01

The Smart City Demonstration Program is intended to improve access through expanded mobility options in major job centers, enhance visitor experience by better connecting visitors to transportation options, stimulate regional economic prosperity and ...

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

PubMed

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

Obey the Rules Governing Chemical Hazards in Schools.

ERIC Educational Resources Information Center

Christiansen, Carl L.

1988-01-01

Describes how the largest school district in Utah complied with the regulations for school safety--the Occupational Safety and Health Administration expanded chemical hazard communication standard and the Environmental Protection Agency Emergency Planning and Community Right-to-Know Act of 1986. (MLF)

78 FR 77554 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... information described is the ``Consolidated Child Restraint System Registration, Labeling and Defect...: National Highway Traffic Safety Administration Title: Consolidated Child Restraint System Registration... the Federal motor vehicle safety standard for child restraint systems (CRSs) to expand its...

Food Safety - Multiple Languages

MedlinePlus

... dialect)) PDF Centers for Disease Control and Prevention French (français) Expand Section Keep Food and Water Safe After a Disaster or Emergency - ... Water Safe After a Disaster or Emergency - français (French) HTML ... Centers for Disease Control and Prevention Haitian Creole (Kreyol ayisyen) Expand Section Keep Food and Water Safe After a Disaster or Emergency - ...

Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America.

PubMed

Stadler, Walter M; Figlin, Robert A; McDermott, David F; Dutcher, Janice P; Knox, Jennifer J; Miller, Wilson H; Hainsworth, John D; Henderson, Charles A; George, Jeffrey R; Hajdenberg, Julio; Kindwall-Keller, Tamila L; Ernstoff, Marc S; Drabkin, Harry A; Curti, Brendan D; Chu, Luis; Ryan, Christopher W; Hotte, Sebastien J; Xia, Chenghua; Cupit, Lisa; Bukowski, Ronald M

2010-03-01

The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program made sorafenib available to patients with advanced renal cell carcinoma (RCC) before regulatory approval. In this nonrandomized, open-label expanded access program, 2504 patients from the United States and Canada were treated with oral sorafenib 400 mg twice daily. Safety and efficacy were explored overall and in subgroups of patients including those with no prior therapy, nonclear cell (nonclear cell) RCC, brain metastases, prior bevacizumab treatment, and elderly patients. Sorafenib was approved for RCC 6 months after study initiation, at which time patients with no prior therapy or with nonclear cell RCC could enroll in an extension protocol for continued assessment for a period of 6 months. The most common grade > or =2 drug-related adverse events were hand-foot skin reaction (18%), rash (14%), hypertension (12%), and fatigue (11%). In the 1891 patients evaluable for response, complete response was observed in 1 patient, partial response in 67 patients (4%), and stable disease for at least 8 weeks in 1511 patients (80%). Median progression-free survival in the extension population was 36 weeks (95% confidence interval [CI], 33-45 weeks; censorship rate, 56%); median overall survival in the entire population was 50 weeks (95% CI, 46-52 weeks; censorship rate, 63%). The efficacy and safety results were similar across the subgroups. Sorafenib 400 mg twice daily demonstrated activity and a clinically acceptable toxicity profile in all patient subsets enrolled in the ARCCS expanded access program (clinicaltrials.gov identifier: NCT00111020).

Expanding the specialty of occupational and environmental medicine: the role of the chief health officer. The Sappington Lecture.

PubMed

Baker, E L

1997-09-01

Passage of the Occupational Safety and Health Act in 1971 represented a major milestone for occupational and environmental medicine. Creation of the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) flowed directly from the legislation, and the specialty of occupational medicine entered a new era. As the 25th anniversaries of OSHA and NIOSH are celebrated, consideration of the future of the specialty of occupational and environmental medicine seems timely. In this lecture, an expanded role for the specialty is proposed, based on an analysis of the forces shaping the practice of public health and the opportunities that these forces present. This analysis suggests considering the concept of a "Chief Health Officer" serving the broad health needs of the workplace.

Avation Safety Reporting System (ASRS) 40th Anniversary

NASA Image and Video Library

2016-09-28

Avation Safety Reporting System (ASRS) 40th Anniversary lunch and open house at the Sunnyvale office. Thomas A Edwards, Deputy Center Director NASA Ames (Left), presents a plaque On the anniversary of the aviation safety reporting system, this award is in recognition of 18 years of outstanding leadership as Program Director, resulting in strong program growth, expanded partnership and a widely recognized impact on National and Global transportation safety. Presented to Linda J. Connell, ASRS Program Director (Right)

76 FR 31853 - Safety Zone; Commencement Bay, Tacoma, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West..., to include rescue simulations performed by low-flying helicopters. This rule expands the safety zone... 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and...

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Status of Occupational Health and Safety and Related Challenges in Expanding Economy of Tanzania.

PubMed

Mrema, Ezra J; Ngowi, Aiwerasia V; Mamuya, Simon H D

2015-01-01

Occupational health and safety is related with economic activities undertaken in the country. As the economic activities grow and expand, occupational injuries and diseases are more likely to increase among workers in different sectors of economy such as agriculture, mining, transport, and manufacture. This may result in high occupational health and safety services demand, which might be difficult to meet by developing countries that are prioritizing economic expansion without regard to their impact on occupational health and safety. To describe the status of occupational health and safety in Tanzania and outline the challenges in provision of occupational health services under the state of an expanding economy. Tanzania's economy is growing steadily, with growth being driven by communications, transport, financial intermediation, construction, mining, agriculture, and manufacturing. Along with this growth, hazards emanating from work in all sectors of the economy have increased and varied. The workers exposed to these hazards suffer from illness and injuries and yet they are not provided with adequate occupational health services. Services are scanty and limited to a few enterprises that can afford it. Existing laws and regulations are not comprehensive enough to cover the entire population. Implementation of legislation is weak and does not protect the workers. Most Tanzanians are not covered by the occupational health and safety law and do not access occupational health services. Thus an occupational health and safety services strategy, backed by legislations and provided with the necessary resources (competent experts, financial and technological resources), is a necessity in Tanzania. The existing legal provisions require major modifications to meet international requirements and standards. OHS regulations and legislations need refocusing, revision, and strengthening to cover all working population. Capacities should be improved through training and research to enable enforcement. Finally the facilities and resources should be made available for OHS services to match with the growing economy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Recent advances in the treatment of rheumatoid arthritis.

PubMed

Mahajan, Tina D; Mikuls, Ted R

2018-05-01

Therapies for rheumatoid arthritis (RA) continue to expand rapidly. The purpose of this review is to discuss novel treatment options, including biosimilars, that are available, as well as to highlight promising agents in development. The purpose is also to discuss new emerging safety signals associated with these drugs and to discuss strategies in tapering therapy. There are several novel RA therapies. These include the interleukin-6 (IL-6) receptor blocker sarilumab, which was approved in 2017. In aggregate, the sarilumab studies show that it is effective in RA, including patients with incomplete responses to methotrexate and anti-tumor necrosis factor inhibitor, and showing superior efficacy when used in higher dose (200 mg every 2 weeks) to standard-dose adalilumab. Other drugs that are currently being studied include the IL-6 cytokine blocker sarikumab, the small targeted molecule filgotinib, and many new biosimilars. Baracitinib failed to achieve approval by the Food and Drug Administration primarily over perceived safety concerns. The two biosimilar drugs currently approved are CT-P13 and SB2, which are based on the reference product infliximab. Although this review summarizes trials examining biologic tapering, additional data are needed to guide clinicians in regards to treatment de-escalation in RA. With the greatly expanded armamentarium of RA treatment options available, it is important for clinicians to understand the data regarding drug efficacy and safety. With remission increasingly attainable, effective drug tapering strategies are needed. Although tapering trials do exist, more studies will be needed to help guide clinical practice.

Virtual Road Safety Audits: Recommended Procedures for Using Driving Simulation and Technology to Expand Existing Practices

DOT National Transportation Integrated Search

2018-02-02

One approach that has been proposed to address the limitations of the current reactive safetymonitoring approaches is the use of road safety audits (RSAs). As part of an RSA, the existing or expected characteristics and traffic conditions of a locati...

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

78 FR 35976 - Petitions for Modification of Application of Existing Mandatory Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

.... (4) Training will be provided for operators to lower the grader blade to provide additional stopping... surface: (1) The operator will pump expanding cement slurry down the well to form a plug which runs from... operator will pump expanding cement slurry down the well to form a plug which runs from at least 200 feet...

76 FR 72666 - Pipeline Safety: Expanding the Use of Excess Flow Valves in Gas Distribution Systems to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... technical feasibility and cost of the installation of such valves; (D) The public safety benefits of the... public comment regarding the technical challenges, and the potential costs and the potential benefits of... a cost-benefit perspective. DATES: Persons interested in submitting written comments on this ANPRM...

Child Safety - Multiple Languages

MedlinePlus

... Cantonese dialect) (繁體中文) French (français) Hindi (हिन्दी) Japanese (日本語) Karen (S’gaw Karen) Korean (한국어) Nepali (नेपा ... हिन्दी (Hindi) Bilingual PDF Health Information Translations Japanese (日本語) Expand Section Child Safety Checklist - 日本語 (Japanese) ...

Responding to the Unthinkable: School Crisis Response and Recovery

ERIC Educational Resources Information Center

Cowan, Katherine C.; Rossen, Eric

2014-01-01

The mental health implications of crisis exposure have emerged as a critical and challenging facet of school safety and crisis response, expanding our focus to encompass both psychological and physical safety, as well as prevention and recovery. Best practice reflects this evolution in our understanding and encompasses the continuum of crisis and…

78 FR 4354 - Proposed Establishment of Area Navigation (RNAV) Routes; OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... would enhance safety and efficiency, expand the use of RNAV in the National Airspace System, and provide.... The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2012...

Role of champions in the implementation of patient safety practice change.

PubMed

Soo, Stephanie; Berta, Whitney; Baker, G Ross

2009-01-01

Practitioners of patient safety practice change agree that champions are central to the success of implementation. The clinical champion role is a concept that has been widely promoted yet empirically underdeveloped in health services literature. Questions remain as to who these champions are, what roles they play in patient safety practice change and what contexts serve to facilitate their efforts. This investigation used a multiple-case study design to critically examine the role of champions in the implementation of rapid response teams (RRTs), an innovative complex patient safety intervention, in two large urban acute care facilities. An analysis of interviews with key individuals involved in the RRT implementation process revealed a typology of the patient safety practice champion that extended beyond clinical personnel to include managerial and executive staff. Champions engaged to a varying extent in a number of core activities, including education, advocacy, relationship building and boundary spanning. Individuals became champions both through informal emergence and a combination of formal appointment and informal emergence. By identifying and elaborating upon specific features of the champion role, this study aims to expand the dialogue about champions for patient safety practice change.

How five leading safety-net hospitals are preparing for the challenges and opportunities of health care reform.

PubMed

Coughlin, Teresa A; Long, Sharon K; Sheen, Edward; Tolbert, Jennifer

2012-08-01

Safety-net hospitals will continue to play a critical role in the US health care system, as they will need to care for the more than twenty-three million people who are estimated to remain uninsured after the Affordable Care Act is implemented. Yet such hospitals will probably have less federal and state support for uncompensated care. At the same time, safety-net hospitals will need to reposition themselves in the marketplace to compete effectively for newly insured people who will have a choice of providers. We examine how five leading safety-net hospitals have begun preparing for reform. Building upon strong organizational attributes such as health information technology and system integration, the study hospitals' preparations include improving the efficiency and quality of care delivery, retaining current and attracting new patients, and expanding the medical home model.

The Pioneering Role of the Vaccine Safety Datalink Project (VSD) to Advance Collaborative Research and Distributed Data Networks

PubMed Central

Fahey, Kevin R.

2015-01-01

Introduction: Large-scale distributed data networks consisting of diverse stakeholders including providers, patients, and payers are changing health research in terms of methods, speed and efficiency. The Vaccine Safety Datalink (VSD) set the stage for expanded involvement of health plans in collaborative research. Expanding Surveillance Capacity and Progress Toward a Learning Health System: From an initial collaboration of four integrated health systems with fewer than 10 million covered lives to 16 diverse health plans with nearly 100 million lives now in the FDA Sentinel, the expanded engagement of health plan researchers has been essential to increase the value and impact of these efforts. The collaborative structure of the VSD established a pathway toward research efforts that successfully engage all stakeholders in a cohesive rather than competitive manner. The scientific expertise and methodology developed through the VSD such as rapid cycle analysis (RCA) to conduct near real-time safety surveillance allowed for the development of the expanded surveillance systems that now exist. Building on Success and Lessons Learned: These networks have learned from and built on the knowledge base and infrastructure created by the VSD investigators. This shared technical knowledge and experience expedited the development of systems like the FDA’s Mini-Sentinel and the Patient Centered Outcomes Research Institute (PCORI)’s PCORnet Conclusion: This narrative reviews the evolution of the VSD, its contribution to other collaborative research networks, longer-term sustainability of this type of distributed research, and how knowledge gained from the earlier efforts can contribute to a continually learning health system. PMID:26793736

The Victim-Offender Overlap and Fear of In-School Victimization: A Longitudinal Examination of Risk Assessment Models

ERIC Educational Resources Information Center

Melde, Chris; Esbensen, Finn-Aage

2009-01-01

Reports of serious violence in schools have raised general awareness and concern about safety in America's schools. In this article, the authors examine the extent to which in-school victimization is associated with students' perceived risk and fear of victimization. By expanding on Ferraro's risk assessment framework, the current study explores…

Science and technology issues in spacecraft fire safety

NASA Technical Reports Server (NTRS)

Friedman, Robert; Sacksteder, Kurt R.

1987-01-01

The space station, a permanently-inhabited orbiting laboratory, places new demands on spacecraft fire safety. Long-duration missions may call for more-constrained fire controls, but the accessibility of the space station to a variety of users may call for less-restrictive measures. This paper discusses fire safety issues through a review of the state of the art and a presentation of key findings from a recent NASA Lewis Research Center Workshop. The subjects covered are the fundamental science of low-gravity combustion and the technology advances in fire detection, extinguishment, materials assessment, and atmosphere selection. Key concerns are for the adoption of a fire-safe atmosphere and the substitution for the effective but toxic extinguishant, halon 1301. The fire safety studies and reviews provide several recommendations for further action. One is the expanded research in combustion, sensors, and materials in the low-gravity environment of space. Another is the development of generalized fire-safety standards for spacecraft through cooperative endeavors with aerospace and outside Government and industry sources.

Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

PubMed Central

Farley, Donna O; Damberg, Cheryl L

2009-01-01

Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

Expanded Learning (Afterschool) Leaders' Perceptions Regarding Most Important Elements for Program Quality and Use of Self-Assessment Tools for Continuous Improvement

ERIC Educational Resources Information Center

Boesch, Julie Anne

2014-01-01

California allocates $550 million to expanded learning through After School Education and Safety (ASES) state grants, and $140 million of federal money in 21st Century Community Learning Center grants each year; more than all other states combined. Much variability exists in program quality, and research has identified mixed results as to the…

Increasing the number of trained health and safety professionals in agricultural medicine: evaluation of the "building capacity" program, 2007-2013.

PubMed

Rudolphi, Josie M; Donham, Kelley J

2015-01-01

ABSTRACT The University of Iowa began training health care professionals to care for farmers' occupational health needs since 1974. In order to geographically expand this training to practicing health and safety professionals, the "Building Capacity: A National Resource of Agricultural Medicine Professionals" program was developed and launched in 2006. The model began in 1987 as a program of Iowa's Center for Agricultural Safety and Health. In 2006, with funding from the National Institute for Occupational Safety and Health (NIOSH), Great Plains Center for Agricultural Health (GPCAH), the program was expanded beyond the Iowa borders. The principal component of the program, the 40-hour course, Agricultural Medicine: Occupational and Environmental Health for Rural Health Professionals-the Core Course (AMCC) is now being offered to health and safety professionals in nine states in the United States, in Australia, and a modified version presented in Turkey. An initial paper evaluated the first phase of the program, years 2007-2010. This paper compares the first phase (2007-2010) with the second phase (2011-2013), which has involved over 500 health and safety professionals. This paper also describes evaluation of the course and changes resulting from the evaluation. Finally, this paper describes best practices for operating this program and makes recommendations for future courses, as well as other trainings within the field.

Researchers' Roles in Patient Safety Improvement.

PubMed

Pietikäinen, Elina; Reiman, Teemu; Heikkilä, Jouko; Macchi, Luigi

2016-03-01

In this article, we explore how researchers can contribute to patient safety improvement. We aim to expand the instrumental role researchers have often occupied in relation to patient safety improvement. We reflect on our own improvement model and experiences as patient safety researchers in an ongoing Finnish multi-actor innovation project through self-reflective narration. Our own patient safety improvement model can be described as systemic. Based on the purpose of the innovation project, our improvement model, and the improvement models of the other actors in the project, we have carried out a wide range of activities. Our activities can be summarized in 8 overlapping patient safety improvement roles: modeler, influencer, supplier, producer, ideator, reflector, facilitator, and negotiator. When working side by side with "practice," researchers are offered and engage in several different activities. The way researchers contribute to patient safety improvement and balance between different roles depends on the purpose of the study, as well as on the underlying patient safety improvement models. Different patient safety research paradigms seem to emphasize different improvement roles, and thus, they also face different challenges. Open reflection on the underlying improvement models and roles can help researchers with different backgrounds-as well as other actors involved in patient safety improvement-in structuring their work and collaborating productively.

Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

PubMed

Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

2015-01-01

The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Time series modeling in traffic safety research.

PubMed

Lavrenz, Steven M; Vlahogianni, Eleni I; Gkritza, Konstantina; Ke, Yue

2018-08-01

The use of statistical models for analyzing traffic safety (crash) data has been well-established. However, time series techniques have traditionally been underrepresented in the corresponding literature, due to challenges in data collection, along with a limited knowledge of proper methodology. In recent years, new types of high-resolution traffic safety data, especially in measuring driver behavior, have made time series modeling techniques an increasingly salient topic of study. Yet there remains a dearth of information to guide analysts in their use. This paper provides an overview of the state of the art in using time series models in traffic safety research, and discusses some of the fundamental techniques and considerations in classic time series modeling. It also presents ongoing and future opportunities for expanding the use of time series models, and explores newer modeling techniques, including computational intelligence models, which hold promise in effectively handling ever-larger data sets. The information contained herein is meant to guide safety researchers in understanding this broad area of transportation data analysis, and provide a framework for understanding safety trends that can influence policy-making. Copyright © 2017 Elsevier Ltd. All rights reserved.

Umbilical cord blood expansion with nicotinamide provides long-term multilineage engraftment.

PubMed

Horwitz, Mitchell E; Chao, Nelson J; Rizzieri, David A; Long, Gwynn D; Sullivan, Keith M; Gasparetto, Cristina; Chute, John P; Morris, Ashley; McDonald, Carolyn; Waters-Pick, Barbara; Stiff, Patrick; Wease, Steven; Peled, Amnon; Snyder, David; Cohen, Einat Galamidi; Shoham, Hadas; Landau, Efrat; Friend, Etty; Peleg, Iddo; Aschengrau, Dorit; Yackoubov, Dima; Kurtzberg, Joanne; Peled, Tony

2014-07-01

Delayed hematopoietic recovery is a major drawback of umbilical cord blood (UCB) transplantation. Transplantation of ex vivo-expanded UCB shortens time to hematopoietic recovery, but long-term, robust engraftment by the expanded unit has yet to be demonstrated. We tested the hypothesis that a UCB-derived cell product consisting of stem cells expanded for 21 days in the presence of nicotinamide and a noncultured T cell fraction (NiCord) can accelerate hematopoietic recovery and provide long-term engraftment. In a phase I trial, 11 adults with hematologic malignancies received myeloablative bone marrow conditioning followed by transplantation with NiCord and a second unmanipulated UCB unit. Safety, hematopoietic recovery, and donor engraftment were assessed and compared with historical controls. No adverse events were attributable to the infusion of NiCord. Complete or partial neutrophil and T cell engraftment derived from NiCord was observed in 8 patients, and NiCord engraftment remained stable in all patients, with a median follow-up of 21 months. Two patients achieved long-term engraftment with the unmanipulated unit. Patients transplanted with NiCord achieved earlier median neutrophil recovery (13 vs. 25 days, P < 0.001) compared with that seen in historical controls. The 1-year overall and progression-free survival rates were 82% and 73%, respectively. UCB-derived hematopoietic stem and progenitor cells expanded in the presence of nicotinamide and transplanted with a T cell-containing fraction contain both short-term and long-term repopulating cells. The results justify further study of NiCord transplantation as a single UCB graft. If long-term safety is confirmed, NiCord has the potential to broaden accessibility and reduce the toxicity of UCB transplantation. Clinicaltrials.gov NCT01221857. Gamida Cell Ltd.

External Port Tissue Expansion in the Pediatric Population: Confirming Its Safety and Efficacy.

PubMed

Azadgoli, Beina; Fahradyan, Artur; Wolfswinkel, Erik M; Tsuha, Michaela; Magee, William; Hammoudeh, Jeffrey A; Urata, Mark M; Howell, Lori K

2018-06-01

External filling ports in tissue expander-based reconstruction have the advantages of being associated with less pain and emotional distress. However, among practicing surgeons using tissue expansion, a theoretical concern remains regarding higher risk of infection. The authors' goal was to evaluate external port safety in the pediatric population by looking at the complications and overall success rate of reconstruction. A retrospective review of all patients undergoing tissue expansion using external ports at Children's Hospital Los Angeles between January of 2008 and June of 2016 was conducted. Patient demographic and perioperative data were collected and analyzed. Two hundred forty-one expanders were placed in 100 pediatric patients, resulting in 123 procedures for congenital and acquired conditions, with an average age at the time of surgery of 7.1 years (range, 1 month to 19.9 years) and average follow-up length of 2.5 years (range, 2.8 months to 8.8 years). The overall complication rate was 29.9 percent, and the infection rate was 17 percent. The majority of these cases were treated conservatively without additional need for surgery. Of 123 cases, 25 required premature expander removal because of complications. Despite early intervention, 21 of these cases underwent successful completion of their reconstruction according to the preoperative plan, resulting in an overall 96.7 percent success rate of tissue expander reconstruction. In children, who are often less tolerant of the pain and distress associated with internal port expansion, the authors encourage the use of external ports. This study found a high success rate in terms of successful reconstruction, with the majority of complications being treated conservatively. Therapeutic, IV.

Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China.

PubMed

Miao, Zhongrong; Zhang, Yong; Shuai, Jie; Jiang, Changchun; Zhu, Qiyi; Chen, Kangning; Liu, Li; Li, Baomin; Shi, Xiangqun; Gao, Lianbo; Liu, Yajie; Wang, Feng; Li, Yongli; Liu, Tieyan; Zheng, Hongbo; Wang, Yilong; Wang, Yongjun

2015-10-01

Although recent trials have suggested that stenting is worse than medical therapy for patients with severe symptomatic intracranial atherosclerotic stenosis, it is not clear whether this conclusion applies to a subset of patients with hypoperfusion symptoms. To justify for a new trial in China, we performed a multicenter prospective registry study to evaluate the safety and efficacy of endovascular stenting within 30 days for patients with severe symptomatic intracranial atherosclerotic stenosis. Patients with symptomatic intracranial atherosclerotic stenosis caused by 70% to 99% stenosis combined with poor collaterals were enrolled. The patients were treated either with balloon-mounted stent or with balloon predilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome within 30 days is stroke, transient ischemic attack, and death after stenting. The secondary outcome is successful revascularization. The baseline characteristics and outcomes of the 2 treatment groups were compared. From September 2013 to January 2015, among 354 consecutive patients, 300 patients (aged 58.3±9.78 years) were recruited, including 159 patients treated with balloon-mounted stent and 141 patients with balloon plus self-expanding stent. The 30-day rate of stroke, transient ischemic attack, and death was 4.3%. Successful revascularization was 97.3%. Patients treated with balloon-mounted stent were older, less likely to have middle cerebral artery lesions, more likely to have vertebral artery lesions, more likely to have Mori A lesions, less likely to have Mori C lesions, and likely to have lower degree of residual stenosis than patients treated with balloon plus self-expanding stent. The short-term safety and efficacy of endovascular stenting for patients with severe symptomatic intracranial atherosclerotic stenosis in China is acceptable. Balloon-mounted stent may have lower degree of residual stenosis than self-expanding stent. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01968122. © 2015 American Heart Association, Inc.

Traveler Trustworthy Autonomy

NASA Technical Reports Server (NTRS)

Skoog, Mark A.

2016-01-01

NASAs Armstrong Flight Research Center has been engaged in the development of highly automatic safety systems for aviation since the mid 80s. For the past three years under Seedling and Center Innovation funding this work has moved toward the development of a software architecture applicable to autonomous safety. This work is now broadening and accelerating to address the airworthiness issues surrounding making a case for trustworthy autonomy. This software architecture is called the expandable variable-autonomy architecture (EVAA) and utilizes a run-time assurance approach to safety assurance.

Expanding Eligibility for the Ross Procedure: A Reasonable Proposition?

PubMed

Ghoneim, Aly; Bouhout, Ismail; Losenno, Katie; Poirier, Nancy; Cartier, Raymond; Demers, Philippe; Tousch, Michael; Guo, Linruo; Chu, Michael W A; El-Hamamsy, Ismail

2018-06-01

Although the Ross procedure offers potential benefits in young adults, technical complexity represents a significant limitation. Therefore, the safety of expanding its use in more complex settings is uncertain. The aim of this study was to compare early outcomes of standard isolated Ross procedures vs expanding elgibility to higher-risk clinical settings. From 2011 to 2016, 261 patients (46 ± 12 years) underwent Ross procedures in 2 centres. Patients were divided into 2 groups: standard Ross (n = 166) and expanded eligibility Ross (n = 95). Inclusion criteria for the expanded eligibility group were previous cardiac surgery, acute aortic valve endocarditis, severely impaired left ventricular (LV) function and patients undergoing concomitant procedures. All data were prospectively collected and are 100% complete. Hospital mortality was 0% in the standard group (0/166) vs 2% in the expanded eligibility group (2/95) (P = 0.13). Sixteen patients (10%) developed acute renal injury in the standard group vs 13 (14%) patients in the expanded eligibility group (P = 0.31). There were no postoperative myocardial infarctions, no neurological events, and no infectious complications. Median intensive care unit (ICU) stay in the standard group was 2 vs 3 days in the expanded eligibility group (P = 0.004), whereas median hospital stay was 6 vs 7 days, respectively (range: 3-19 days) (P < 0.001). Aside from longer ICU and hospital lengths of stay after the Ross procedure in higher-risk clinical scenarios, perioperative mortality and morbidity is similar to standard Ross procedures. Expanding the use of the Ross operation in young adults is a safe alternative in centres of expertise. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Pediatric emergency and essential surgical care in Zambian hospitals: a nationwide study.

PubMed

Bowman, Kendra G; Jovic, Goran; Rangel, Shawn; Berry, William R; Gawande, Atul A

2013-06-01

Pediatric surgical care in developing countries is not well studied. We sought to identify the range of pediatric surgery available, the barriers to provision, and level of safety of surgery performed for the entire pediatric population in Zambia. In cooperation with the Ministry of Health, we validated and adapted a World Health Organization instrument. During onsite visits, the availability of 32 emergency and essential surgical procedures relevant to children was surveyed. The availability of basic World Health Organization surgical safety criteria was determined. A single interviewer visited 103 (95%) of 108 surgical hospitals in Zambia and carried out 495 interviews. An average of 68% of the 32 emergency and essential surgical procedures was available (range 32%-100%). Lack of surgical skill was the primary reason for referral in 72% of procedure types, compared with 24%, 2% and 3% due to lack of equipment, supplies and anesthesia skills, respectively (p<0.001). Minimum pediatric surgical safety criteria were met by 14% of hospitals. The primary limitation to providing pediatric surgical care in Zambia is lack of surgical skills. Minimum safety standards were met by 14% of hospitals. Efforts to improve pediatric surgery should prioritize teaching surgical skills to expand access and providing safety training, equipment and supplies to increase safety. Copyright © 2013 Elsevier Inc. All rights reserved.

Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma.

PubMed

Chang, Anne Lynn S; Lewis, Karl D; Arron, Sarah T; Migden, Michael R; Solomon, James A; Yoo, Simon; Day, Bann-Mo; McKenna, Edward F; Sekulic, Aleksandar

2016-11-15

Because many patients with unresectable basal cell carcinoma (BCC) are aged ≥65 years, this study explores the efficacy and safety of vismodegib in these patients with locally advanced (la) or metastatic (m) basal cell carcinoma (BCC) in the ERIVANCE BCC trial and the expanded access study (EAS).We compared patients aged ≥65 years to patients aged <65 years taking vismodegib 150 mg/day, using descriptive statistics for response and safety. Patients aged ≥65 years (laBCC/mBCC) were enrolled in ERIVANCE BCC (33/14) and EAS (27/26). Investigator-assessed best overall response rate in patients ≥65 and <65 years was 46.7%/35.7% and 72.7%/52.6% (laBCC/mBCC), respectively, in ERIVANCE BCC and 45.8%/33.3% and 46.9%/28.6%, respectively, in EAS. These differences were not clinically meaningful. Safety was similar in both groups, although those aged ≥65 years had a higher percentage of grade 3-5 adverse events than those aged <65 years. Vismodegib demonstrated similar clinical activity and adverse events regardless of age.

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach.

PubMed

Haase, Rocco; Wunderlich, Maria; Dillenseger, Anja; Kern, Raimar; Akgün, Katja; Ziemssen, Tjalf

2018-04-01

For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex documentation becomes apparent. The collection of high-quality data sets in clinical practice requires the use of special documentation software as the quality of data in RWE studies can be an issue in contrast to the data obtained from RCTs. The MSDS3D software combines documentation of patient data with patient management of patients with multiple sclerosis. Following a continuous development over several treatment-specific modules, we improved and expanded the realization of safety management in MSDS3D with regard to the characteristics of different treatments and populations. Expert opinion: eHealth-enhanced post-authorisation safety study may complete the fundamental quest of RWE for individually improved treatment decisions and balanced therapeutic risk assessment. MSDS3D is carefully designed to contribute to every single objective in this process.

7 CFR 1217.60 - Programs, plans, and projects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... and advertising designed to: (1) Maintain, develop, expand and grow markets for softwood lumber; (2... strength, safety, environmental and sustainable benefits and technical applications of softwood lumber; and...

7 CFR 1217.60 - Programs, plans, and projects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... and advertising designed to: (1) Maintain, develop, expand and grow markets for softwood lumber; (2... strength, safety, environmental and sustainable benefits and technical applications of softwood lumber; and...

7 CFR 1217.60 - Programs, plans, and projects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... and advertising designed to: (1) Maintain, develop, expand and grow markets for softwood lumber; (2... strength, safety, environmental and sustainable benefits and technical applications of softwood lumber; and...

Expanding the Envelope of UAS Certification: What it Takes to Type Certify a UAS for Precision Agricultural Spraying

NASA Technical Reports Server (NTRS)

Maddalon, J. M.; Hayhurst, K. J.; Neogi, N. A.; Verstynen, H. A.; Clothier, R. A.

2016-01-01

One of the key challenges to the development of a commercial Unmanned Air-craft System (UAS) market is the lack of explicit consideration of UAS in the current regulatory framework. Despite recent progress, additional steps are needed to enable broad UAS types and operational models. This paper discusses recent research that examines how a risk-based approach for safety might change the process and substance of airworthiness requirements for UAS. The project proposed risk-centric airworthiness requirements for a midsize un-manned rotorcraft used for agricultural spraying and also identified factors that may contribute to distinguishing safety risk among different UAS types and operational concepts. Lessons learned regarding how a risk-based approach can expand the envelope of UAS certification are discussed.

Review article: practical current issues in perioperative patient safety.

PubMed

Eichhorn, John H

2013-02-01

This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.

Assessing the Safety of Expanded Polytetrafluoroethylene Synthetic Grafts in Living Donor Liver Transplantation: Graft Migration Into Hollow Viscous Organs - Diagnosis and Treatment Options.

PubMed

Hsu, Shih-Chao; Thorat, Ashok; Yang, Horng-Ren; Poon, Kin-Shing; Li, Ping-Chun; Yeh, Chun-Chieh; Chen, Te-Hung; Jeng, Long-Bin

2017-07-06

BACKGROUND Our recent studies have highlighted the importance and safety of backtable venoplasty for middle hepatic vein (MHV) and inferior right hepatic veins (IRHV) reconstruction using expanded polytetrafluoroethylene (ePTFE) vascular grafts. In this study, we aim to analyze the complications associated with ePTFE graft use and discuss the management of the rare, but, potentially life threatening complications directly related to ePTFE conduits. MATERIAL AND METHODS From January 2012 to October 2015 a total of 397 patients underwent living donor liver transplantation (LDLT). The ePTFE vascular grafts were used during the backtable venoplasty for outflow reconstruction in 262 of the liver allografts. Recipients who developed ePTFE-related complications were analyzed. RESULTS ePTFE-related complications developed in 1.52% (4/262) of the patients. One patient (0.38%) developed complete thrombosis with sepsis at 24 months post-transplantation and died due to multiorgan failure. Three patients (1.1%) developed graft migration into the second portion of the duodenum, without overt peritonitis. Surgical exploration and ePTFE graft removal was done in all the patients. One patient died due to overwhelming sepsis. CONCLUSIONS ePTFE graft migration into the duodenum causing perforation is a new set of complications that has been recently described in LDLT and can be treated effectively by surgical removal of the infected vascular graft and duodenal perforation closure. Despite of such complications, in our experience, ePTFE use in LDLT continues to have wide safety margin, with a complication rate of only 1.52%.

The use of retrievable fully covered self-expanding metal stent in refractory postoperative restenosis of benign esophageal stricture in children.

PubMed

Zhang, Jie; Ren, Lixin; Huo, Jirong; Zhu, Zhiyuan; Liu, Deliang

2013-11-01

This study analyzes the efficacy and safety of a retrievable, fully covered self-expanding metal stent (cSEMS) in the treatment of refractory benign esophageal restenosis in children. This is a retrospective analysis of the application of a newly designed cSEMS in treating refractory benign postoperative restenosis in five children with ages ranging from 16 months to 8 years. Efficacy and safety were evaluated during the follow-up period. cSEMS with or without an antireflux valve at the distal end were successfully placed and removed in five children. These five patients were followed up for 4-12 months after stent removal. Among the five patients, ulcerative stricture was observed in two patients because of reflux esophagitis, while three patients showed no signs of stricture recurrence. Stent migration was observed in three patients, two of which required the stent to be reset. The narrow esophagus was successfully expended to a diameter of 12-13 mm. Besides the observation of mild granulation tissue growth in one case, no severe complications were observed during surgery and after stent placement. Our study suggests that a retrievable, fully covered SEMS is safe and partially effective for treating refractory benign postoperative esophageal restenosis in children during short-term observation. © 2013.

Reuse prevention syringes for reconstitution of lyophilized vaccines: Operational study and UNICEF plans for expanding introduction.

PubMed

Fleming, Jessica A; Hoekstra, Edward John; Moniaga, Vanda; Widjaya, Anton; Soepardi, Jane; Supartha, Nyoman; Salovaara, Annika; Khamassi, Selma; Nelson, Carib

2009-01-01

Since the 1990s, the United Nation's Children's Fund has encouraged injection safety for immunizations through bundling vaccines with appropriate amounts of supporting equipment and by supplying autodisable (AD) syringes for injections. However, poor vaccine reconstitution practices continue to be reported worldwide. By 2009, UNICEF will begin to phase out the distribution of standard disposable syringes for vaccine reconstitution and replace them with reuse prevention (RUP) syringes, with a full transition expected by the end of 2010. A field evaluation in Indonesia was conducted to identify introduction requirements, issues with healthcare worker training and acceptance, and RUP syringe performance and safety. Managers and health workers felt that RUP syringes improved injection safety and fit easily into country logistical systems. Healthcare workers felt they were intuitive to use, but recommended special training. The integration of RUP reconstitution syringes by UNICEF could increase injection safety by preventing the reuse of syringes and reducing vaccine contamination.

Preventing Harm in the ICU-Building a Culture of Safety and Engaging Patients and Families.

PubMed

Thornton, Kevin C; Schwarz, Jennifer J; Gross, A Kendall; Anderson, Wendy G; Liu, Kathleen D; Romig, Mark C; Schell-Chaple, Hildy; Pronovost, Peter J; Sapirstein, Adam; Gropper, Michael A; Lipshutz, Angela K M

2017-09-01

Preventing harm remains a persistent challenge in the ICU despite evidence-based practices known to reduce the prevalence of adverse events. This review seeks to describe the critical role of safety culture and patient and family engagement in successful quality improvement initiatives in the ICU. We review the evidence supporting the impact of safety culture and provide practical guidance for those wishing to implement initiatives aimed at improving safety culture and more effectively integrate patients and families in such efforts. Literature review using PubMed including evaluation of key studies assessing large-scale quality improvement efforts in the ICU, impact of safety culture on patient outcomes, methodologies for quality improvement commonly used in healthcare, and patient and family engagement. Print and web-based resources from leading patient safety organizations were also searched. Our group completed a review of original studies, review articles, book chapters, and recommendations from leading patient safety organizations. Our group determined by consensus which resources would best inform this review. A strong safety culture is associated with reduced adverse events, lower mortality rates, and lower costs. Quality improvement efforts have been shown to be more effective and sustainable when paired with a strong safety culture. Different methodologies exist for quality improvement in the ICU; a thoughtful approach to implementation that engages frontline providers and administrative leadership is essential for success. Efforts to substantively include patients and families in the processes of quality improvement work in the ICU should be expanded. Efforts to establish a culture of safety and meaningfully engage patients and families should form the foundation for all safety interventions in the ICU. This review describes an approach that integrates components of several proven quality improvement methodologies to enhance safety culture in the ICU and highlights opportunities to include patients and families.

Review of Occupational Health and Safety Organization in Expanding Economies: The Case of Southern Africa.

PubMed

Moyo, Dingani; Zungu, Muzimkhulu; Kgalamono, Spoponki; Mwila, Chimba D

2015-01-01

Globally, access to occupational health and safety (OHS) by workers has remained at very low levels. The organization and implementation of OHS in South Africa, Zimbabwe, Zambia, and Botswana has remained at suboptimal levels. Inadequacy of human resource capital, training, and education in the field of OHS has had a major negative impact on the improvement of worker access to such services in expanding economies. South Africa, Zimbabwe, Zambia, and Botswana have expanding economies with active mining and agricultural activities that pose health and safety risks to the working population. A literature review and country systems inquiry on the organization of OHS services in the 4 countries was carried out. Because of the infancy and underdevelopment of OHS in southern Africa, literature on the status of this topic is limited. In the 4 countries under review, OHS services are a function shared either wholly or partially by 3 ministries, namely Health, Labor, and Mining. Other ministries, such as Environment and Agriculture, carry small fragments of OHS function. The 4 countries are at different stages of OHS legislative frameworks that guide the practice of health and safety in the workplace. Inadequacies in human resource capital and expertise in occupational health and safety are noted major constraints in the implementation and compliance to health and safety initiatives in the work place. South Africa has a more mature system than Zimbabwe, Zambia, and Botswana. Lack of specialized training in occupational health services, such as occupational medicine specialization for physicians, has been a major drawback in Zimbabwe, Zambia, and Botswana. The full adoption and success of OHS systems in Southern Africa remains constrained. Training and education in OHS, especially in occupational medicine, will enhance the development and maturation of occupational health in southern Africa. Capacitating primary health services with basic occupational health knowledge would be invaluable in bridging the current skills deficit. Introducing short courses and foundational tracks in occupational medicine for general medical practitioners would be invaluable. Copyright © 2015 Icahn School of Medicine at Mount Sinai. Published by Elsevier Inc. All rights reserved.

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US

PubMed Central

Cunningham, Thomas R.; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries’ planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator–intermediary–small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system. PMID:26300585

The relationship between employees' perceptions of safety and organizational culture.

PubMed

O'Toole, Michael

2002-01-01

With limited resources to help reduce occupational injuries, companies struggle with how to best focus these resources to achieve the greatest reduction in injuries for the optimal cost. Safety culture has been identified as a critical factor that sets the tone for importance of safety within an organization. An employee safety perception survey was conducted, and injury data were collected over a 45-month period from a large ready-mix concrete producer located in the southwest region of the United States. The results of this preliminary study suggest that the reductions in injuries experienced at the company locations was strongly impacted by the positive employee perceptions on several key factors. Management's commitment to safety was the factor with the greatest positive perception by employees taking the survey. This study was set up as a pilot project and did not unitize an experimental design. That weakness reduces the strength of these findings but adds to the importance of expanding the pilot project with an appropriate experimental design. Management leadership has been identified, along with several other factors, to influence employee perceptions of the safety management system. Those perceptions, in turn, appear to influence employee decisions that relate to at-risk behaviors and decisions on the job. The results suggest that employee perceptions of the safety system are related to management's commitment to safety, which, in turn, appear to be related to injury rates. Management should focus on how to best leverage these key factors to more positively impact injury rates within their companies.

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US.

PubMed

Cunningham, Thomas R; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries' planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator-intermediary-small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system.

[Chemical safety, health, and environment: prospects for governance in the Brazilian context].

PubMed

Freitas, Carlos Machado de; Porto, Marcelo Firpo S; Moreira, Josino Costa; Pivetta, Fatima; Machado, Jorge M Huet; Freitas, Nilton B B de; Arcuri, Arline S

2002-01-01

Chemical safety is acknowledged by Agenda 21 as one of the most serious problems worldwide, involving governance at the national and international levels. In Brazil, chemical safety problems have increased in intensity and extent, far beyond the capacity to deal with them. The problems are all the more serious in Brazil because issues of democracy, security, sustainability, and equity, all fundamental to governance, are still incipient and still far from being solved. New societal arrangements and a new, contextualized and more participatory science form the basis for developing and expanding strategies for governance to deal with the problem of chemical safety.

EFFECTS: an expanded access program of everolimus for patients with subependymal giant cell astrocytoma associated with tuberous sclerosis complex.

PubMed

Fogarasi, Andras; De Waele, Liesbeth; Bartalini, Gabriella; Jozwiak, Sergiusz; Laforgia, Nicola; Verhelst, Helene; Petrak, Borivoj; Pedespan, Jean-Michel; Witt, Olaf; Castellana, Ramon; Crippa, Stefania; Gislimberti, Gabriella; Gyorsok, Zsuzsanna

2016-08-08

Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been shown to be effective and safe in the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC). The Everolimus For Fast Expanded aCcess in TSC SEGA (EFFECTS) study was designed to provide everolimus access to patients with SEGA associated with TSC and to mainly assess the safety and also efficacy of everolimus in a real-world setting. EFFECTS was a phase 3b, open-label, noncomparative, multicenter, expanded access study. Eligible patients were ≥ 3 years of age, with a definite diagnosis of TSC, and with at least one SEGA lesion identified by MRI or CT scan. Patients received once daily everolimus (dose adjusted to attain a trough level of 5-15 ng/mL). Safety evaluation was the primary objective and included collection of adverse events (AEs) and serious AEs, with their severity and relationship to everolimus. Efficacy evaluation, which was the secondary objective, was based on the best overall response as per medical judgment. Of the 120 patients enrolled, 100 (83.3%) completed the study. Median age of patients was 11 years (range, 1-47). Median daily dose of everolimus was 5.82 mg (range, 2.0-11.8). Median duration of exposure was 56.5 weeks (range, 0.3-130). The overall incidence of AEs was 74.2%. Aphthous stomatitis (18 [15.0%]), pyrexia (18 [15.0%]), bronchitis (11 [9.2%]), and stomatitis (10 [8.3%]) were the most common AEs reported. Overall, 25 patients had grade 3 AEs; most frequent was stomatitis (4 [3.3%]). Grade 4 AEs were reported in three (2.5%) patients. A total of 62 (51.7%) patients had suspected drug-related AEs, of which 15 (12.5%) were of grade 3 or 4. In eight (6.7%) patients, AEs led to drug discontinuation. With regard to efficacy, 81 (67.5%) patients had a partial response, 35 (29.2%) had a stable disease, and one (0.8%) had progressive disease. The response was unknown in three (2.5%) patients. This study confirms the acceptable safety profile of everolimus in patients with SEGA associated with TSC in a real-world setting. The results further support the efficacy of everolimus in the treatment of SEGA associated with TSC. (EudraCT: 2010-022583-13).

Pilot trial of intravenous autologous culture-expanded mesenchymal stem cell transplantation in multiple sclerosis.

PubMed

Cohen, Jeffrey A; Imrey, Peter B; Planchon, Sarah M; Bermel, Robert A; Fisher, Elizabeth; Fox, Robert J; Bar-Or, Amit; Sharp, Susan L; Skaramagas, Thomai T; Jagodnik, Patricia; Karafa, Matt; Morrison, Shannon; Reese Koc, Jane; Gerson, Stanton L; Lazarus, Hillard M

2018-04-01

Mesenchymal stem cells (MSCs) exhibit immunomodulatory, tissue-protective, and repair-promoting properties in vitro and in animals. Clinical trials in several human conditions support the safety and efficacy of MSC transplantation. Published experience in multiple sclerosis (MS) is modest. To assess feasibility, safety, and tolerability and explore efficacy of autologous MSC transplantation in MS. Participants with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), Expanded Disability Status Scale score 3.0-6.5, disease activity or progression in the prior 2 years, and optic nerve involvement were enrolled. Bone-marrow-derived MSCs were culture-expanded and then cryopreserved. After confirming fulfillment of release criteria, 1-2 × 10 6 MSCs/kg were thawed and administered IV. In all, 24 of 26 screened patients were infused: 16 women and 8 men, 10 RRMS and 14 SPMS, mean age 46.5, mean Expanded Disability Status Scale score 5.2, 25% with gadolinium-enhancing magnetic resonance imaging (MRI) lesions. Mean cell dosage (requiring 1-3 passages) was 1.9 × 10 6 MSCs/kg (range, 1.5-2.0) with post-thaw viability uniformly ⩾95%. Cell infusion was tolerated well without treatment-related severe or serious adverse events, or evidence of disease activation. Autologous MSC transplantation in MS appears feasible, safe, and well tolerated. Future trials to assess efficacy more definitively are warranted.

Assessment of safety and efficacy of an indigenous self-expandable fully covered esophageal metal stent for palliation of esophageal cancer.

PubMed

Padhan, R K; Nongthombam, S K; Venuthurimilli, A; Dhingra, R; Sahni, P; Garg, P K

2016-01-01

Patients with unresectable esophageal cancer require palliation for dysphagia. Placement of a self-expandable metal stent (SEMS) is the procedure of choice for palliation of dysphagia. To evaluate the safety and efficacy of an indigenous fully-covered SEMS in patients with esophageal cancer. Eligible patients with unresectable esophageal cancer requiring palliation for dysphagia were included in the study. An indigenous fully covered SEMS of appropriate length was placed under endoscopic and fluoroscopic guidance. Outcome measures assessed were adverse events and improvement in dysphagia. Twenty one patients (mean age 57.71±13.14 years; 17 males) were included. After stenting, dysphagia score decreased from 3.2+0.4 to 0.35+0.74 at 4 weeks. Adverse events included retrosternal pain, respiratory distress and aspiration pneumonia in 12, 2 and 1 patients respectively. Five patients required repeat stenting due to stent migration in 4 (following radiotherapy in 3) and tumour ingrowth in 1. There was primary stent malfunction in one patient. The median survival of patients was 140 (76-199) days, which was higher in those who received radiotherapy. The stent was reasonably safe and effective to relieve dysphagia due to unresectable esophageal cancer.

Body dirt or liquid gold? How the 'safety' of donated breastmilk is constructed for use in neonatal intensive care.

PubMed

Carroll, Katherine

2014-06-01

When mothers of preterm infants are unable to produce sufficient volumes of breastmilk, neonatologists in many Western countries prescribe pasteurized donor breastmilk. Breastmilk has a paradoxical presence in the neonatal intensive care unit while it has therapeutic properties, it also has the potential to transmit disease. National health authorities and local neonatal intensive care unit policies each delimit the safety of donor milk by focusing on the presence or absence of pathogens. It is in this light that breastmilk from the human milk bank is both sought and legitimated to minimize safety concerns. This research uses data arising from an ethnographic study of two human milk banks and two neonatal intensive care units in the United States, and 73 interviews with milk donors, neonatal intensive care unit parents and clinicians. The primary research question framing the study was 'What are the underlying processes and practices that have enabled donor milk to be endorsed as a safe and legitimate feeding option in neonatal intensive care units?' This study is framed using three key principles of Latour's 'new critique', namely, adding to reality rather than debunking it, getting closer to data rather than turning away from fact and creating arenas in which to assemble. As a result, conceptions of donor milk's safety are expanded. This case study of donor milk demonstrates how Latour's new critique can inform science and technology studies approaches to the study of safety in health care.

Relief, restoration and reform: economic upturn yields modest and uneven health returns.

PubMed

Hurley, Robert; Katz, Aaron; Felland, Laurie

2008-01-01

The sensitivity of state budgets to economic cycles contributes to fluctuations in health coverage, eligibility, benefits and provider payment levels in public programs, as well as support for safety net hospitals and community health centers (CHCs). The aftershocks of the 2001 recession on state budgets were felt well into 2004. More recently, the economic recovery allowed many states to restore cuts and, in some cases, expand health services for low-income people, according to findings from the Center for Studying Health System Change's (HSC) 2007 site visits to 12 nationally representative metropolitan communities. Along with bolstering support of safety net providers and raising Medicaid payments for private physicians, some states advanced even more ambitious health reform proposals. Yet across communities, safety net systems face mounting challenges of caring for more uninsured patients, and these pressures will likely increase given the current economic downturn.

An analysis of US fertility centre educational materials suggests that informed consent for preimplantation genetic diagnosis may be inadequate.

PubMed

LaBonte, Michelle Lynne

2012-08-01

The use of preimplantation genetic diagnosis (PGD) has expanded both in number and scope over the past 2 decades. Initially carried out to avoid the birth of children with severe genetic disease, PGD is now used for a variety of medical and non-medical purposes. While some human studies have concluded that PGD is safe, animal studies and a recent human study suggest that the embryo biopsy procedure may result in neurological problems for the offspring. Given that the long-term safety of PGD has not been clearly established in humans, this study sought to determine how PGD safety is presented to prospective patients by means of a detailed website analysis. The websites of 262 US fertility centres performing PGD were analysed and comments about safety and risk were catalogued. Results of the analysis demonstrated that 78.2% of centre websites did not mention safety or risk of PGD at all. Of the 21.8% of centres that did contain safety or risk information about PGD, 28.1% included statements highlighting the potential risks, 38.6% presented information touting the procedure as safe and 33.3% included statements highlighting potential risks and the overall safety of the procedure. Thus, 86.6% of PGD-performing centres state that PGD is safe and/or fail to disclose any risks on their websites despite the fact that the impact of the procedure on the long-term health of offspring is unproven. This lack of disclosure suggests that informed consent is inadequate; this study examines numerous factors that are likely to inhibit comprehensive discussions of safety.

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

PubMed

Kahaleh, Michel; Brijbassie, Alan; Sethi, Amrita; Degaetani, Marisa; Poneros, John M; Loren, David E; Kowalski, Thomas E; Sejpal, Divyesh V; Patel, Sandeep; Rosenkranz, Laura; McNamara, Kevin N; Raijman, Isaac; Talreja, Jayant P; Gaidhane, Monica; Sauer, Bryan G; Stevens, Peter D

2013-09-01

Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS. : To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS. Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study.Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications. A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)]. FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease.

PubMed

Faries, Peter; Jaff, Michael; Peeters, Patrick; Khatib, Yazan; Roberts, David; Bosiers, Marc; Malik, Rajesh; Ravin, Reid; Rundback, John

2018-04-17

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of two nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10 cm in length and >50% stenosis in subjects with Rutherford Classification peripheral arterial disease stages 2-4. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30 days, 9 months, and 1, 2, and 3 years post procedure. The primary outcome measured was the major adverse event rate (MAE) at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically-driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9 months post-procedure. Secondary outcomes included primary patency rate at 9 months, clinically-driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30 days and 9 months. Device success was defined as the ability to deploy the stent as intended at the treatment site. The MAE rate at 9 months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, myocardial infarctions, or amputations were reported. Primacy patency at 9 months was 95.8%. Freedom from CD-TVR was 98.6% at 9 months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries. Copyright © 2018. Published by Elsevier Inc.

Safety Studies for Use of Adipose Tissue‐Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial

PubMed Central

Riester, Scott M.; Denbeigh, Janet M.; Lin, Yang; Jones, Dakota L.; de Mooij, Tristan; Lewallen, Eric A.; Nie, Hai; Paradise, Christopher R.; Radel, Darcie J.; Dudakovic, Amel; Camilleri, Emily T.; Larson, Dirk R.; Qu, Wenchun; Krych, Aaron J.; Frick, Matthew A.; Im, Hee‐Jeong; Dietz, Allan B.; Smith, Jay

2016-01-01

Abstract Adipose‐derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra‐articular joint space. Culture‐expanded human AMSCs grown in human platelet‐lysate were delivered via intra‐articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x‐ray, magnetic resonance imaging, and histopathology. Intra‐articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra‐articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910–922 PMID:28297568

Rare Esophageal Migration of AXIOS Stent Used for Walled-off Pancreatic Necrosis Drainage

PubMed Central

Renno, Anas; Hammad, Tariq; Nawras, Ali

2017-01-01

The AXIOS stent (Boston Scientific, Marlborough, MA) is a novel lumen-apposing self-expandable metallic stent designed for enteric drainage of nonadherent lumens. Efficacy and safety of using the AXIOS stent for pancreatic fluid drainage have been consistently shown in several studies. Although it is less common with this novel stent, stent migration still may happen. We present a case of AXIOS stent migration into the esophagus. PMID:28584846

Safety regulations, firm size, and the risk of accidents in E&P operations on the Gulf of Mexico outer continental shelf

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

Iledare, O.O.; Pulsipher, A.G.; Baumann, R.H.

1996-12-31

The current expanded role of smaller independent oil producers in the OCS has led to concern about the possibility of increased risk of accidents in E&P operations on the Gulf of Mexico OCS. In addition, questions have been posed concerning the effects of the Minerals Management Service`s (MMS) safety regulations and inspection program, firm size, and industry practices on the risk of accidents in E&P operations on the Gulf of Mexico OCS. The specific purposes of the study reported in this paper were to ascertain (1) whether any empirical justification exists for the widespread concern that an increase in independentsmore » relative share of E&P operations in the Gulf OCS region will be detrimental to safety, and (2) whether MMS policies and safety programs have reduced the frequency or severity of accidents on the OCS. Our statistical and descriptive analyses of data on accidents from MMS provide no statistical evidence to support the apprehension that an expanded role for independents in E&P activity constitutes any major threat to safety on the OCS. Further, the results of our econometrics analysis confirm the expectation that the more effective MMS inspectors are at detecting incidents of noncompliance the lower the rate of accidents on the OCS is, ceteris paribus. In addition the results indicate that the variability in platform exposure years--cumulative age of operating platform--in comparison to other factors explains a significant portion of the variation in accidents per operating platform. That is, the platform aging process provides more opportunity for accidents than any other contributing factors. Our econometrics analysis also suggests that, if the other factors contributing to offshore accidents are held constant, the responsiveness of accident rate to drilling activity is inelastic while the response of accident rate to production activity levels is elastic.« less

Participant and Household Characteristics Associated With Graduation From the Expanded Food and Nutrition Education Program.

PubMed

Cooper, Brittany Rhoades; Barale, Karen; Funaiole, Angie; Power, Thomas G; Combe, Angela

2016-01-01

To examine empirically participant and household characteristics associated with Expanded Food and Nutrition Education Program (EFNEP) graduation and to determine whether they differ across 2 counties. Survey of EFNEP participants from 2011 to 2012. Expanded Food and Nutrition Education Program sites serving limited-resource families in 1 rural and 1 urban/suburban county in Washington State. Expanded Food and Nutrition Education Program participants (urban/suburban: n = 647; rural: n = 569). Expanded Food and Nutrition Education Program completion/graduation. Multivariate logistic regression was used to examine associations of participant (ethnicity, race, age, education, pregnancy status, and nutrition knowledge/behavior at baseline) and household (number of people in the house, place of residence, and public assistance services) characteristics with EFNEP graduation. Associations were moderated by county. For the urban/suburban county, participants living with more people (after controlling for the total number of adults) were more likely to graduate. For the rural county, participants living with fewer total adults (after controlling for the total number in the house) and those with better food safety practices at baseline were more likely to graduate. This study aids in understanding which participants are more or less likely to complete EFNEP successfully, and therefore can inform strategies aimed at increasing graduation rates. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Intramyocardial injection of autologous bone marrow-derived ex vivo expanded mesenchymal stem cells in acute myocardial infarction patients is feasible and safe up to 5 years of follow-up.

PubMed

Rodrigo, Sander F; van Ramshorst, Jan; Hoogslag, Georgette E; Boden, Helèn; Velders, Matthijs A; Cannegieter, Suzanne C; Roelofs, Helene; Al Younis, Imad; Dibbets-Schneider, Petra; Fibbe, Willem E; Zwaginga, Jaap Jan; Bax, Jeroen J; Schalij, Martin J; Beeres, Saskia L; Atsma, Douwe E

2013-10-01

In experimental studies, mesenchymal stem cell (MSC) transplantation in acute myocardial infarction (AMI) models has been associated with enhanced neovascularization and myogenesis. Clinical data however, are scarce. Therefore, the present study evaluates the safety and feasibility of intramyocardial MSC injection in nine patients, shortly after AMI during short-term and 5-year follow-up. Periprocedural safety analysis demonstrated one transient ischemic attack. No other adverse events related to MSC treatment were observed during 5-year follow-up. Clinical events were compared to a nonrandomized control group comprising 45 matched controls. A 5-year event-free survival after MSC-treatment was comparable to controls (89 vs. 91 %, P = 0.87). Echocardiographic imaging for evaluation of left ventricular function demonstrated improvements up to 5 years after MSC treatment. These findings were not significantly different when compared to controls. The present safety and feasibility study suggest that intramyocardial injection of MSC in patients shortly after AMI is feasible and safe up to 5-year follow-up.

Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

PubMed

Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

2010-11-01

The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. 2010 Elsevier Ltd. All rights reserved.

Farmworkers at the border: a bilingual initiative for occupational health and safety.

PubMed

Acosta, Martha Soledad Vela; Sechrest, Lee; Chen, Mei-Kuang

2009-01-01

Bilingual and bicultural occupational health and safety interventions for Hispanic farmworkers are extremely rare and, because of language barriers and cultural differences, issues important to their health and safety on the job remain unaddressed. We designed, conducted, and assessed the first bilingual occupational health and safety education program for farmworkers attending High School Equivalency Programs (HEPs). We took an interdisciplinary participatory approach by integrating educators and researchers with a community advisory board to guide development, evaluation, and implementation of Work Safely-Trabaje con Cuidado Curriculum (Curriculum), a bilingual occupational health and safety curriculum. We created a quasi-experimental design using mixed-method evaluation (quantitative and qualitative elements) via pre- and posttest comparisons, follow-up surveys, and focus groups assessing the Curriculum effect on knowledge, safety risk perception (SRP), and safety behavior. Focus groups and follow-up surveys reflected success and acceptance of the Curriculum among participating farmworkers under the study's logic model. Completion of the Curriculum resulted in statistically significant improvements in the combined score of knowledge and SRP at the posttest (p = 0.001) and follow-up survey (p = 0.02) in the intervention group. After completing this study, the Curriculum was permanently adopted by the two high school equivalency sites involved. The participatory approach resulted in integration of community and applied research partnership. The potential to expand use of this Curriculum by other HEP sites can further assess effectiveness and external validity among underserved minority groups.

Final Environmental Assessment: For the M270 Multiple Launch Rocket System (MLRS) Expanded Training Use Areas at Avon Park Air Force Range, Florida

DTIC Science & Technology

2005-11-10

Florida Final Environmental Assessment VOC Volatile Organic Compound WSF Weapon Safety Footprint WWII World War II Executive Summary 11/10/05 M270...Air Force, 2003b). World War I brought military training camps and flying schools to Florida, and stimulated shipbuilding, agriculture, and...turpentine operations. Increased defense spending for World War II expanded industry and agriculture further. Avon Park Army Air Field was built from

Incentivizing primary care providers to innovate: building medical homes in the post-Katrina New Orleans safety net.

PubMed

Rittenhouse, Diane R; Schmidt, Laura A; Wu, Kevin J; Wiley, James

2014-02-01

To evaluate safety-net clinics' responses to a novel community-wide Patient-Centered Medical Home (PCMH) financial incentive program in post-Katrina New Orleans. Between June 2008 and June 2010, we studied 50 primary care clinics in New Orleans receiving federal funds to expand services and improve care delivery. Multiwave, longitudinal, observational study of a local safety-net primary care system. Clinic-level data from a semiannual survey of clinic leaders (89.3 percent response rate), augmented by administrative records. Overall, 62 percent of the clinics responded to financial incentives by achieving PCMH recognition from the National Committee on Quality Assurance (NCQA). Higher patient volume, higher baseline PCMH scores, and type of ownership were significant predictors of achieving NCQA recognition. The steepest increase in adoption of PCMH processes occurred among clinics achieving the highest, Level 3, NCQA recognition. Following NCQA recognition, 88.9 percent stabilized or increased their use of PCMH processes, although several specific PCMH processes had very low rates of adoption overall. Findings demonstrate that widespread PCMH implementation is possible in a safety-net environment when external financial incentives are aligned with the goal of practice innovation. © Health Research and Educational Trust.

Hennepin Health: a safety-net accountable care organization for the expanded Medicaid population.

PubMed

Sandberg, Shana F; Erikson, Clese; Owen, Ross; Vickery, Katherine D; Shimotsu, Scott T; Linzer, Mark; Garrett, Nancy A; Johnsrud, Kimry A; Soderlund, Dana M; DeCubellis, Jennifer

2014-11-01

Health care payment and delivery models that challenge providers to be accountable for outcomes have fueled interest in community-level partnerships that address the behavioral, social, and economic determinants of health. We describe how Hennepin Health--a county-based safety-net accountable care organization in Minnesota--has forged such a partnership to redesign the health care workforce and improve the coordination of the physical, behavioral, social, and economic dimensions of care for an expanded community of Medicaid beneficiaries. Early outcomes suggest that the program has had an impact in shifting care from hospitals to outpatient settings. For example, emergency department visits decreased 9.1 percent between 2012 and 2013, while outpatient visits increased 3.3 percent. An increasing percentage of patients have received diabetes, vascular, and asthma care at optimal levels. At the same time, Hennepin Health has realized savings and reinvested them in future improvements. Hennepin Health offers lessons for counties, states, and public hospitals grappling with the problem of how to make the best use of public funds in serving expanded Medicaid populations and other communities with high needs. Project HOPE—The People-to-People Health Foundation, Inc.

Platelet lysate supports the in vitro expansion of human periodontal ligament stem cells for cytotherapeutic use.

PubMed

Wu, Rui-Xin; Yu, Yang; Yin, Yuan; Zhang, Xi-Yu; Gao, Li-Na; Chen, Fa-Ming

2017-08-01

Human platelet lysate (PL) produced under optimal conditions of standardization and safety has been increasingly suggested as the future 'gold standard' supplement to replace fetal bovine serum (FBS) for the ex vivo propagation of mesenchymal stem cells for translational medicine and cell therapy applications. However, the multifaceted effects of PL on tissue-specific stem cells remain largely unexplored. In the present study, we investigated the stem cell behaviours of human periodontal ligament stem cells (PDLSCs) in media with or without PL. Our data indicate that human PL, either as an adjuvant for culture media or as a substitute for FBS, supports the proliferation and expansion of human PDLSCs derived from either 'young' or 'old' donors to the same extent as FBS, without interfering with their immunomodulatory capacities. Although PL appears to inhibit the in vitro differentiation of 'young' or 'old' PDLSCs, their decreased osteogenic potential may be restored to similar or higher levels compared with FBS-expanded cells. PL- and FBS-expanded PDLSCs exhibited a similar potential to form mineralized nodules and expressed similar levels of osteogenic genes. Our data indicate that large clinically relevant quantities of PDLSCs may be yielded by the use of human PL; however, further analysis of its precise composition and function will pave the way for determining optimized, defined culture conditions. In addition to the potential increase in patient safety, our findings highlight the need for further research to develop the potential of PL-expanded PDLSCs for clinical use. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Primary Self-Expandable Nitinol Stent Placement in Focal Lesions of Infrarenal Abdominal Aorta: Long Term Results

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

Lastovickova, Jarmila, E-mail: jala@medicon.cz; Peregrin, Jan H.

Purpose. To evaluate the technical and clinical success, safety and long term results of percutaneous transluminal angioplasty/self-expandable nitinol stent placement of infrarenal abdominal aorta focal lesions. Materials and Methods. Eighteen patients underwent PTA of focal atherosclerotic occlusive disease of distal abdominal aorta. Two symptomatic occlusions and 16 stenoses in 10 male and 8 female patients (mean age 68.2 years) were treated with primary self-expandable nitinol stent placement. Results. Primary self-expandable nitinol stent placement was technically successful in all 18 procedures; clinical success was achieved in 100% of patients. No complications associated with the procedure occurred. During the 49.4 months ofmore » mean follow up (range 3-96, 4 months) all treated aortic segments remained patent. Conclusions. Endovascular treatment (primary self-expandable nitinol stent placement) of focal atherosclerotic lesions of distal abdominal aorta is a safe method with excellent primary technical and clinical success rates and favourable Long term results.« less

Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Clinical Experience from an Expanded Access Study in the United States.

PubMed

Pal, Sumanta Kumar; Hoffman-Censits, Jean; Zheng, Hanzhe; Kaiser, Constanze; Tayama, Darren; Bellmunt, Joaquim

2018-05-01

Atezolizumab (anti-programmed death-ligand 1) was approved in the USA, Europe, and elsewhere for treatment-naive and platinum-treated locally advanced/metastatic urothelial carcinoma (mUC). To report efficacy and safety from an atezolizumab expanded access study. This single-arm, open-label study enrolled 218 patients at 36 US sites. Key eligibility criteria included progression during/following ≥1 platinum-based chemotherapy for mUC or in perioperative setting (progression within 12 mo) and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. Patients received atezolizumab1200mg intravenously every 3 wk until loss of clinical benefit, unacceptable toxicity, consent withdrawal, decision to discontinue, death, atezolizumab commercial availability, or study closure. Key end points reported herein included Response Evaluation Criteria in Solid Tumors v1.1 objective response rate and duration, disease control rate (DCR; response or stable disease), and safety. All patients received prior systemic therapy (68% mUC; 27% adjuvant; and 26% neoadjuvant). At baseline, 57% of 214 treated patients had ECOG PS ≥1, 19% had hemoglobin <10g/dl, and 25% had liver metastases. Median treatment duration was 9 wk (interquartile range [IQR], 6-12 wk). Median follow-up duration was 2.3 mo (IQR, 1.6-3.4 mo) overall and 2.7 mo (IQR, 2.0-3.5 mo) in patients not known to have died. Seventeen of 114 evaluable patients (15%) had objective responses (16 ongoing at study termination). DCR was 49%. Treatment-related adverse events (mostly fatigue) occurred in 98 of 214 treated patients. The benefit/risk profile of atezolizumab was consistent with that observed in previous studies, despite pretreatment and poor prognostic factors. These results suggest a potential role for atezolizumab in a broader patient range than typically eligible for phase 1-3 studies. In this expanded access study, atezolizumab was active and tolerable in a range of patients with platinum-treated metastatic urothelial carcinoma. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves.

PubMed

Husser, Oliver; Kim, Won-Keun; Pellegrini, Costanza; Holzamer, Andreas; Walther, Thomas; Mayr, Patrick N; Joner, Michael; Kasel, Albert M; Trenkwalder, Teresa; Michel, Jonathan; Rheude, Tobias; Kastrati, Adnan; Schunkert, Heribert; Burgdorf, Christof; Hilker, Michael; Möllmann, Helge; Hengstenberg, Christian

2017-10-23

This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days. Deployment of these THV showed promising initial clinical results. However, no comparative data are available. Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311). In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3. Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Determining animal drug combinations based on efficacy and safety.

PubMed

Kratzer, D D; Geng, S

1986-08-01

A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

Dose-ranging phase 1 study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers.

PubMed

Jespers, Vicky A; Van Roey, Jens M; Beets, Greet I; Buvé, Anne M

2007-02-01

To evaluate the short-term safety, tolerability, and systemic exposure of a vaginal microbicide gel containing the nonnucleoside reverse transcriptase inhibitor TMC120. Randomized, controlled, double-blind, phase 1 trial of a gel containing 3 different concentrations of TMC120 versus placebo. Of the 48 HIV-negative and 16 HIV-positive women enrolled, 52 women received active product. Participants applied the gel twice daily for 7 days and were assessed on 6 occasions. Colposcopic evaluation was performed before and after first gel application and on day 8. Laboratory safety assessments were carried out on all visits except day 7. Plasma levels of TMC120 were measured on days 1 and 7. All TMC120 concentrations were well tolerated, and there were no apparent differences in safety parameters. Four women (6%) had treatment-emergent mild cervical findings (petechiae in 3 women and erythema in 1 woman) of <5 mm. Plasma levels of TMC120 were quantifiable on day 1 in 7 (13%) participants and on day 7 in 39 (75%) participants using TMC120 gel. The TMC120 vaginal gel was well-tolerated in this short study by HIV-negative and HIV-positive women. The implications of the absorption of TMC120 should be studied further in expanded safety and effectiveness trials.

Hydrogen flammability limits and implications on fire safety of transportation vehicles

DOT National Transportation Integrated Search

2008-01-01

The recent establishment of the National University Transportation Center at MST under the "Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users," expands the research and education activities to include alternative tr...

Clinician's guide to assessing and counseling older drivers, 3rd Edition.

DOT National Transportation Integrated Search

2015-01-01

The American Geriatrics Society (AGS) entered into a cooperative agreement with the U. S . : Department of Transportations National Highway Traffic Safety Administration (NHTSA) to : update and expand the Physicians Guide to Assessing and Couns...

Safety huddles to proactively identify and address electronic health record safety

PubMed Central

Menon, Shailaja; Singh, Hardeep; Giardina, Traber D; Rayburn, William L; Davis, Brenda P; Russo, Elise M

2017-01-01

Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety. PMID:28031286

Balloon-Expandable Stent Graft for Treating Uretero-Iliac Artery Fistula

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

Guntau, Moritz, E-mail: guntau@med.uni-marburg.de; Hegele, Axel; Rheinheimer, Stephan

PurposeTo evaluate the safety, efficacy and outcome of percutaneous balloon-expandable covered stent graft placement for uretero-iliac artery fistula (UAF) treatment.MethodsThis retrospective study evaluated the single-center experience of percutaneous balloon-expandable covered stent graft placement (ADVANTA™, Atrium Hudson, NH, USA) in UAF. Data were obtained from a prospective institutional database. Patient follow-up included complications, symptoms recurrence and mortality rate.ResultsTen UAFs in eight patients (3 males; 5 females) with a mean age of 64.5 (35–77) years were identified. All patients had a history pelvic malignancy, extirpative surgery (n = 6), long-term ureteral stenting (n = 7) and pelvic radiation (n = 5). All procedures were completed successfully without complications.more » Thirty-day mortality rate was zero. At a median follow-up of 6 (1–60) months, one patient suffered recurrent hematuria requiring a secondary stent graft placement 26 months after the initial treatment. During follow-up, five patients died of the underlying disease (43, 66, 105, and 183 and 274 days after the last procedure).ConclusionPercutaneous balloon-expandable stent graft placement in UAF is a safe and effective treatment option. Implantation of stent grafts should be considered as treatment of choice in UAF.« less

Characterization and Application of a Disposable Rotating Bed Bioreactor for Mesenchymal Stem Cell Expansion.

PubMed

Neumann, Anne; Lavrentieva, Antonina; Heilkenbrinker, Alexandra; Loenne, Maren; Kasper, Cornelia

2014-11-27

Recruitment of mesenchymal stromal cells (MSC) into the field of tissue engineering is a promising development since these cells can be expanded vivo to clinically relevant numbers and, after expansion, retain their ability to differentiate into various cell lineages. Safety requirements and the necessity to obtain high cell numbers without frequent subcultivation of cells raised the question of the possibility of expanding MSC in one-way (single-use) disposable bioreactors. In this study, umbilical cord-derived MSC (UC-MSC) were expanded in a disposable Z 2000 H bioreactor under dynamic conditions. Z was characterized regarding residence time and mixing in order to evaluate the optimal bioreactor settings, enabling optimal mass transfer in the absence of shear stress, allowing an reproducible expansion of MSC, while maintaining their stemness properties. Culture of the UC-MSC in disposable Z 2000 H bioreactor resulted in a reproducible 8-fold increase of cell numbers after 5 days. Cells were shown to maintain specific MSC surface marker expression as well as trilineage differentiation potential and lack stress-induced premature senescence.

Health Topics: MedlinePlus

MedlinePlus

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Evaluation of Education and Outreach Programs

DOT National Transportation Integrated Search

2011-12-01

Education and outreach are acknowledged, if only anecdotally, for contributing to an overall safer rail environment. The use of education and outreach programs as a means to improve highway-rail safety has expanded over the years since 1970 and the i...

Development of a portable weigh-in-motion system.

DOT National Transportation Integrated Search

2013-03-01

Weigh-In-Motion (WIM) data is used for a variety of roadway design and safety purposes. In compliance with Federal Highway Administration (FHWA) mandates, many states have installed permanent WIM sites to measure vehicle weight. Expanding current sit...

Clinical Outcomes of Self-Expandable Metal Stents for Malignant Rectal Obstruction.

PubMed

Lee, Hyun Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho; Park, Soo Jung

2018-01-01

Self-expandable metal stents are widely used to treat malignant colorectal obstruction. However, data on clinical outcomes of stent placement for rectal obstruction specifically are lacking. We aimed to investigate the clinical outcomes of self-expandable metal stents in malignant rectal obstruction in comparison with those in left colonic obstruction and to identify factors associated with clinical failure and complication. This was a retrospective study. The study was conducted at a tertiary care center. Between January 2005 and December 2013, medical charts of patients who underwent stent placement for malignant rectal or left colonic obstruction were reviewed retrospectively. Study intervention included self-expandable metal stent placement. Technical success, clinical success, and complications were measured. Technical success rates for the 2 study groups (rectum vs left colon, 93.5% vs 93.1%; p = 0.86) did not differ significantly; however, the clinical success rate was lower in patients with rectal obstruction (85.4% vs 92.1%; p = 0.02). In addition, the complication rate was higher in patients with rectal obstruction (37.4% vs 25.1%; p = 0.01). Patients with rectal obstruction showed higher rates of obstruction because of extracolonic malignancy (33.8% vs 15.8%; p < 0.001) and stent use for palliation (78.6% vs 56.3%; p < 0.001). Multivariate analysis indicated obstruction attributed to extracolonic malignancy and covered stent usage to be independent risk factors for clinical failure. Factors predictive of complications in the palliative group were total obstruction, obstruction because of extracolonic malignancy, and covered stent usage. This was a retrospective, single-center study. The efficacy and safety of stent placement for malignant rectal obstruction were comparable with those for left colonic obstruction. However, obstruction attributed to extracolonic malignancy, use of covered stents, and total obstruction negatively impacted clinical outcomes of self-expandable metal stent placement and must be considered by endoscopists. See Video Abstract at http://links.lww.com/DCR/A417.

Childhood lead poisoning associated with lead dust contamination of family vehicles and child safety seats - Maine, 2008.

PubMed

2009-08-21

Persons employed in high-risk lead-related occupations can transport lead dust home from a worksite through clothing, shoes, tools, or vehicles. During 2008, the Maine Childhood Lead Poisoning Prevention Program (MCLPPP) identified 55 new cases of elevated (>or=15 microg/dL) venous blood lead levels (BLLs) among children aged <6 years through mandated routine screening. Although 90% of childhood lead poisoning cases in Maine during 2003-2007 had been linked to lead hazards in the child's home, no lead-based paint or dust or water with elevated lead levels were found inside the homes associated with six of the 2008 cases (i.e., five families, including one family with two affected siblings). An expanded environmental investigation determined that these six children were exposed to lead dust in the family vehicles and in child safety seats. The sources of the lead dust were likely household contacts who worked in high-risk lead exposure occupations. Current recommendations for identifying and reducing risk from take-home lead poisoning include 1) ensuring that children with elevated BLLs are identified through targeted blood lead testing, 2) directing prevention activities to at-risk workers and employers, and 3) improving employer safety protocols. State and federal prevention programs also should consider, when appropriate, expanded environmental lead dust testing to include vehicles and child safety seats.

The Safety and efficacy of a new self-expandable intratracheal nitinol stent for the tracheal collapse in dogs

PubMed Central

Kim, Joon-young; Han, Hyun-jung; Yun, Hun-young; Lee, Bora; Jang, Ha-young; Eom, Ki-dong; Park, Hee-myung

2008-01-01

To evaluate the potential utility of a self-expandable intratracheal nitinol stent with flared ends for the treatment of tracheal collapse in dogs, endotracheal stenting therapy was performed under fluoroscopic guidance in four dogs with severe tracheal collapse. During the 4 to 7 month follow-up, after stent implantation, clinical signs, including dyspnea and respiratory distress, dramatically improved in all dogs. The radiographs showed that the implanted stents improved the tracheal collapse, and there were no side effects such as collapse, shortening or migration of the stents. In conclusion, the self-expandable intratracheal nitinol stents provided adequate stability to the trachea and were effective for attenuating the clinical signs associated with severe tracheal collapse. PMID:18296893

Harnessing hospital purchase power to design safe care delivery.

PubMed

Ebben, Steven F; Gieras, Izabella A; Gosbee, Laura Lin

2008-01-01

Since the Institute of Medicine's well-publicized 1999 report To Err is Human, the healthcare patient safety movement has grown at an exponential pace. However, much more can be done to advance patient safety from a care process design vantage point-improving safety through effective care processes and technology integration. While progress is being made, the chasm between technology developers and caregivers remains a profound void. Why hasn't more been done to expand our view of patient safety to include technology design? Healthcare organizations have not consolidated their purchasing power to expect improved designs. This article will (1) provide an assessment of the present state of healthcare technology management and (2) provide recommendations for collaborative design of safe healthcare delivery systems.

Modified fully covered self-expandable metal stents with antimigration features for benign pancreatic-duct strictures in advanced chronic pancreatitis, with a focus on the safety profile and reducing migration.

PubMed

Moon, Sung-Hoon; Kim, Myung-Hwan; Park, Do Hyun; Song, Tae Joon; Eum, Junbum; Lee, Sang Soo; Seo, Dong Wan; Lee, Sung Koo

2010-07-01

Fully covered self-expandable metal stent (FCSEMS) placement has recently been tried in the management of refractory pancreatic-duct strictures associated with advanced chronic pancreatitis. The major limitation of FCSEMSs was frequent migration. To assess the safety, migration rate, and removability of modified FCSEMSs with antimigration features used for the treatment of benign pancreatic-duct strictures. Prospective study. Tertiary academic center. Thirty-two patients with chronic painful pancreatitis and dominant ductal stricture. Transpapillary endoscopic placement of FCSEMSs in the pancreatic duct with removal after 3 months. Technical and functional success and adverse events associated with the placement of metal stents. FCSEMSs were successfully placed in all patients through the major (n = 27) or minor (n = 5) duodenal papilla. All patients achieved pain relief from stent placement. There was no occurrence of stent-induced pancreatitis or pancreatic sepsis. No stent migrated, and all stents were easily removed. Follow-up ERCP 3 months after stent placement showed resolution of duct strictures in all patients. Pancreatograms obtained at FCSEMS removal displayed de novo focal pancreatic duct strictures in 5 patients, but all were asymptomatic. No long-term follow-up. Temporary 3-month placement of FCSEMSs was effective in resolving pancreatic-duct strictures in chronic pancreatitis, with an acceptable morbidity profile. Modified FCSEMSs can prevent stent migration, but may be associated with de novo duct strictures. Further trials are needed to assess long-term safety and efficacy. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

E-cigarettes: facts, perceptions, and marketing messages.

PubMed

Carr, Ellen R

2014-02-01

Electronic cigarettes (e-cigarettes) are perceived as an alternative to standard tobacco cigarette smoking, primarily because of the e-cigarette industry's marketing messages. However, scientific studies about e-cigarette safety and efficacy remain limited. This column presents some of the issues associated with e-cigarette use, such as potential components of regulation, perceptions that e-cigarettes can help users quit smoking, and free-wheeling marketing strategies that include expanding e-cigarette use to young people. Nurses can be a reliable source of information about e-cigarettes.

Evaluation of education and outreach programs : research results.

DOT National Transportation Integrated Search

2011-12-01

"Education and outreach are acknowledged, if only anecdotally, for contributing to an overall safer rail environment. The use of education and outreach programs as a means to improve highway-rail safety has expanded over the years since 1970 and the ...

METHOD AND APPARATUS FOR REACTOR SAFETY CONTROL

DOEpatents

Huston, N.E.

1961-06-01

A self-contained nuclear reactor fuse controlled device tron absorbing material, normally in a compact form but which can be expanded into an extended form presenting a large surface for neutron absorption when triggered by an increase in neutron flux, is described.

Drug Safety - Multiple Languages

MedlinePlus

... Expand Section Guide to Over the Counter Medications - English PDF Guide to Over the Counter Medications - Amarɨñña / ... Information Translations Guide to Over the Counter Medications - English PDF Guide to Over the Counter Medications - العربية ( ...

Pet Food Safety A Shared Concern

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

Buchanan, Robert L; Baker, Robert C; Charlton, Adrian J

2011-01-01

The safety of the food supply is a subject of intense interest to consumers, particularly as a result of large scale outbreaks that involve hundreds and sometimes thousands of consumers. During the last decade this concern about food safety has expanded to include the diets of companion animals as a result of several incidences of chemical toxicities and infectious disease transmission. This has led to increased research into the causes and controls for these hazards for both companion animals and their owners. The following summary provides an introduction to the issues, challenges, and new tools being developed to ensure thatmore » commercial pet foods are both nutritious and safe.« less

Examination of the safety of pediatric vaccine schedules in a non-human primate model: assessments of neurodevelopment, learning, and social behavior.

PubMed

Curtis, Britni; Liberato, Noelle; Rulien, Megan; Morrisroe, Kelly; Kenney, Caroline; Yutuc, Vernon; Ferrier, Clayton; Marti, C Nathan; Mandell, Dorothy; Burbacher, Thomas M; Sackett, Gene P; Hewitson, Laura

2015-06-01

In the 1990s, the mercury-based preservative thimerosal was used in most pediatric vaccines. Although there are currently only two thimerosal-containing vaccines (TCVs) recommended for pediatric use, parental perceptions that vaccines pose safety concerns are affecting vaccination rates, particularly in light of the much expanded and more complex schedule in place today. The objective of this study was to examine the safety of pediatric vaccine schedules in a non-human primate model. We administered vaccines to six groups of infant male rhesus macaques (n = 12-16/group) using a standardized thimerosal dose where appropriate. Study groups included the recommended 1990s Pediatric vaccine schedule, an accelerated 1990s Primate schedule with or without the measles-mumps-rubella (MMR) vaccine, the MMR vaccine only, and the expanded 2008 schedule. We administered saline injections to age-matched control animals (n = 16). Infant development was assessed from birth to 12 months of age by examining the acquisition of neonatal reflexes, the development of object concept permanence (OCP), computerized tests of discrimination learning, and infant social behavior. Data were analyzed using analysis of variance, multilevel modeling, and survival analyses, where appropriate. We observed no group differences in the acquisition of OCP. During discrimination learning, animals receiving TCVs had improved performance on reversal testing, although some of these same animals showed poorer performance in subsequent learning-set testing. Analysis of social and nonsocial behaviors identified few instances of negative behaviors across the entire infancy period. Although some group differences in specific behaviors were reported at 2 months of age, by 12 months all infants, irrespective of vaccination status, had developed the typical repertoire of macaque behaviors. This comprehensive 5-year case-control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.

Phase I Study of RO4929097, a Gamma Secretase Inhibitor of Notch Signaling, in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

PubMed Central

Tolcher, Anthony W.; Messersmith, Wells A.; Mikulski, Stanislaw M.; Papadopoulos, Kyriakos P.; Kwak, Eunice L.; Gibbon, Darlene G.; Patnaik, Amita; Falchook, Gerald S.; Dasari, Arvind; Shapiro, Geoffrey I.; Boylan, John F.; Xu, Zhi-Xin; Wang, Ka; Koehler, Astrid; Song, James; Middleton, Steven A.; Deutsch, Jonathan; DeMario, Mark; Kurzrock, Razelle; Wheler, Jennifer J.

2012-01-01

Purpose To determine the maximum-tolerated dose (MTD) and assess safety, pharmacokinetics, pharmacodynamics, and evidence of antitumor activity of RO4929097, a gamma secretase inhibitor of Notch signaling in patients with advanced solid malignancies. Patients and Methods Patients received escalating doses of RO4929097 orally on two schedules: (A) 3 consecutive days per week for 2 weeks every 3 weeks; (B) 7 consecutive days every 3 weeks. To assess reversible CYP3A4 autoinduction, the expanded part of the study tested three dosing schedules: (B) as above; modified A, 3 consecutive d/wk for 3 weeks; and (C) continuous daily dosing. Positron emission tomography scans with [18F]fluorodeoxyglucose (FDG-PET) were used to assess tumor metabolic effects. Results Patients on schedule A (n = 58), B (n = 47), and C (n = 5; expanded cohort) received 302 cycles of RO4929097. Common grade 1 to 2 toxicities were fatigue, thrombocytopenia, fever, rash, chills, and anorexia. Transient grade 3 hypophosphatemia (dose-limiting toxicity, one patient) and grade 3 pruritus (two patients) were observed at 27 mg and 60 mg, respectively; transient grade 3 asthenia was observed on schedule A at 80 mg (one patient). Tumor responses included one partial response in a patient with colorectal adenocarcinoma with neuroendocrine features, one mixed response (stable disease) in a patient with sarcoma, and one nearly complete FDG-PET response in a patient with melanoma. Effect on CYP3A4 induction was observed. Conclusion RO4929097 was well tolerated at 270 mg on schedule A and at 135 mg on schedule B; the safety of schedule C has not been fully evaluated. Further studies are warranted on the basis of a favorable safety profile and preliminary evidence of clinical antitumor activity. PMID:22529266

Long-term in-vivo tumorigenic assessment of human culture-expanded adipose stromal/stem cells

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

MacIsaac, Zoe Marie, E-mail: zmm4a@virgina.edu; Shang, Hulan, E-mail: shanghulan@gmail.com; Agrawal, Hitesh, E-mail: hiteshdos@hotmail.com

2012-02-15

After more than a decade of extensive experimentation, the promise of stem cells to revolutionize the field of medicine has negotiated their entry into clinical trial. Adipose tissue specifically holds potential as an attainable and abundant source of stem cells. Currently undergoing investigation are adipose stem cell (ASC) therapies for diabetes and critical limb ischemia, among others. In the enthusiastic pursuit of regenerative therapies, however, questions remain regarding ASC persistence and migration, and, importantly, their safety and potential for neoplasia. To date, assays of in vivo ASC activity have been limited by early end points. We hypothesized that with time,more » ASCs injected subcutaneously undergo removal by normal tissue turnover and homeostasis, and by the host's immune system. In this study, a high dose of culture expanded ASCs was formulated and implanted as multicellular aggregates into immunocompromised mice, which were maintained for over one year. Animals were monitored for toxicity, and surviving cells quantified at study endpoint. No difference in growth/weight or lifespan was found between cell-treated and vehicle treated animals, and no malignancies were detected in treated animals. Moreover, real-time PCR for a human specific sequence, ERV-3, detected no persistent ASCs. With the advent of clinical application, clarification of currently enigmatic stem cell properties has become imperative. Our study represents the longest duration determination of stem cell activity in vivo, and contributes strong evidence in support of the safety of adipose derived stem cell applications. -- Highlights: Black-Right-Pointing-Pointer Adipose stem cells promise novel clinical therapies. Black-Right-Pointing-Pointer Before clinical translation, safety profiles must be further elucidated. Black-Right-Pointing-Pointer Subcutaneously injected non-autologous adipose stem cells do not form tumors. Black-Right-Pointing-Pointer Subcutaneously injected non-autologous adipose stem cells undergo complete removal by one year.« less

Food traceability systems in China: The current status of and future perspectives on food supply chain databases, legal support, and technological research and support for food safety regulation.

PubMed

Tang, Qi; Li, Jiajia; Sun, Mei; Lv, Jun; Gai, Ruoyan; Mei, Lin; Xu, Lingzhong

2015-02-01

Over the past few decades, the field of food security has witnessed numerous problems and incidents that have garnered public attention. Given this serious situation, the food traceability system (FTS) has become part of the expanding food safety continuum to reduce the risk of food safety problems. This article reviews a great deal of the related literature and results from previous studies of FTS to corroborate this contention. This article describes the development and benefits of FTS in developed countries like the United States of America (USA), Japan, and some European countries. Problems with existing FTS in China are noted, including a lack of a complete database, inadequate laws and regulations, and lagging technological research into FTS. This article puts forward several suggestions for the future, including improvement of information websites, clarification of regulatory responsibilities, and promotion of technological research.

Safety Grooving

NASA Technical Reports Server (NTRS)

1985-01-01

Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association (IG&GA), the industry expanded into highway and pedestrian applications. The technique originated at Langley, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle's cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots and other potentially slippery surfaces.

High-dose irradiated food: Current progress, applications, and prospects

NASA Astrophysics Data System (ADS)

Feliciano, Chitho P.

2018-03-01

Food irradiation as an established and mature technology has gained more attention in the food industry for ensuring food safety and quality. Primarily used for phytosanitary applications, its use has been expanded for developing various food products for varied purposes (e.g. ready-to-eat & ready-to-cook foods, hospital diets, etc.). This paper summarized and analyzed the recent progress and application of high-dose irradiation and discussed its prospects in the field of food product development, its safety and quality.

The Path to NGATS

NASA Technical Reports Server (NTRS)

Scardina, John

2006-01-01

NGATS operational Improvements and benefits include: 1) Broad area and precision navigation to access and capacity; 2) Airspace access and management to capacity; 3) 4D trajectory based ATM to capacity and efficiency; 4) Reduced separation between aircraft to capacity; 5) Flight deck situational awareness and delegation to capacity and safety; 6) ATM decision support to capacity; 7) Improved weather data and dissemination to capacity and safety; 8) Reduced cost to deliver ATM services to cost; 9) Greatly expanded airport network and improved terminals to capacity.

Clinician perceptions of personal safety and confidence to manage inpatient aggression in a forensic psychiatric setting.

PubMed

Martin, T; Daffern, M

2006-02-01

Inpatient mental health clinicians need to feel safe in the workplace. They also require confidence in their ability to work with aggressive patients, allowing the provision of therapeutic care while protecting themselves and other patients from psychological and physical harm. The authors initiated this study with the predetermined belief that a comprehensive and integrated organizational approach to inpatient aggression was required to support clinicians and that this approach increased confidence and staff perceptions of personal safety. To assess perceptions of personal safety and confidence, clinicians in a forensic psychiatric hospital were surveyed using an adapted version of the Confidence in Coping With Patient Aggression Instrument. In this study clinicians reported the hospital as safe. They reported confidence in their work with aggressive patients. The factors that most impacted on clinicians' confidence to manage aggression were colleagues' knowledge, experience and skill, management of aggression training, use of prevention and intervention strategies, teamwork and the staff profile. These results are considered with reference to an expanding literature on inpatient aggression. It is concluded that organizational resources, policies and frameworks support clinician perceptions of safety and confidence to manage inpatient aggression. However, how these are valued by clinicians and translated into practice at unit level needs ongoing attention.

Site selection plan and installation guidelines for a nationwide differential GPS service

DOT National Transportation Integrated Search

1997-08-05

The Global Positioning System (GPS), in its current form, is used within the transportation industry for vehicle tracking and navigation. With the advent of a nationwide differential GPS (DGPS) service, this role will expand to include public safety,...

77 FR 21777 - Expanded Charge for Peer Review of the NIOSH document Titled: “Criteria for a Recommended...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

....html for Docket number NIOSH-245. After consultation with the Occupational Safety and Health... consideration which are posted here: http://www.cdc.gov/niosh/review/peer/HISA/diacetyl-pr.html . This entry...

Closure of a Recurrent Bronchopleural Fistula Using a Matrix Seeded With Patient-Derived Mesenchymal Stem Cells.

PubMed

Aho, Johnathon M; Dietz, Allan B; Radel, Darcie J; Butler, Greg W; Thomas, Mathew; Nelson, Timothy J; Carlsen, Brian T; Cassivi, Stephen D; Resch, Zachary T; Faubion, William A; Wigle, Dennis A

2016-10-01

: Management of recurrent bronchopleural fistula (BPF) after pneumonectomy remains a challenge. Although a variety of devices and techniques have been described, definitive management usually involves closure of the fistula tract through surgical intervention. Standard surgical approaches for BPF incur significant morbidity and mortality and are not reliably or uniformly successful. We describe the first-in-human application of an autologous mesenchymal stem cell (MSC)-seeded matrix graft to repair a multiply recurrent postpneumonectomy BPF. Adipose-derived MSCs were isolated from patient abdominal adipose tissue, expanded, and seeded onto bio-absorbable mesh, which was surgically implanted at the site of BPF. Clinical follow-up and postprocedural radiological and bronchoscopic imaging were performed to ensure BPF closure, and in vitro stemness characterization of patient-specific MSCs was performed. The patient remained clinically asymptomatic without evidence of recurrence on bronchoscopy at 3 months, computed tomographic imaging at 16 months, and clinical follow-up of 1.5 years. There is no evidence of malignant degeneration of MSC populations in situ, and the patient-derived MSCs were capable of differentiating into adipocytes, chondrocytes, and osteocytes using established protocols. Isolation and expansion of autologous MSCs derived from patients in a malnourished, deconditioned state is possible. Successful closure and safety data for this approach suggest the potential for an expanded study of the role of autologous MSCs in regenerative surgical applications for BPF. Bronchopleural fistula is a severe complication of pulmonary resection. Current management is not reliably successful. This work describes the first-in-human application of an autologous mesenchymal stem cell (MSC)-seeded matrix graft to the repair of a large, multiply recurrent postpneumonectomy BPF. Clinical follow-up of 1.5 years without recurrence suggests initial safety and feasibility of this approach. Further assessment of MSC grafts in these difficult clinical scenarios requires expanded study. ©AlphaMed Press.

Health impact assessment: assessing opportunities and barriers to intersectoral health improvement in an expanded European Union

PubMed Central

Lock, K.; McKee, M.

2005-01-01

On 1 May 2004 the European Union (EU) underwent unprecedented enlargement, from 15 to 25 countries, increasing its population by 20% to over 450 million. Although EU law has limited specific competence in the area of health, its influence on other policy sectors such as agriculture, trade, and employment has wide ranging implications for health. Yet with the exception of provisions on communicable disease control and food safety, public health considerations have played little part in negotiations on EU accession. This paper argues for an intersectoral public health approach in the expanded EU. It reviews the legal basis for assessing the health impacts of policy in the EU and, using health impact assessment as a case study, it examines how well the new member states may be prepared to tackle intersectoral public health action within the constraints imposed by EU policy. PMID:15831682

Listening to a conversation with aggressive content expands the interpersonal space

PubMed Central

Vagnoni, Eleonora; Lewis, Jessica; Tajadura-Jiménez, Ana

2018-01-01

The distance individuals maintain between themselves and others can be defined as ‘interpersonal space’. This distance can be modulated both by situational factors and individual characteristics. Here we investigated the influence that the interpretation of other people interaction, in which one is not directly involved, may have on a person’s interpersonal space. In the current study we measured, for the first time, whether the size of interpersonal space changes after listening to other people conversations with neutral or aggressive content. The results showed that the interpersonal space expands after listening to a conversation with aggressive content relative to a conversation with a neutral content. This finding suggests that participants tend to distance themselves from an aggressive confrontation even if they are not involved in it. These results are in line with the view of the interpersonal space as a safety zone surrounding one’s body. PMID:29590110

Drug development and nonclinical to clinical translational databases: past and current efforts.

PubMed

Monticello, Thomas M

2015-01-01

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

A Synthetic Vision Preliminary Integrated Safety Analysis

NASA Technical Reports Server (NTRS)

Hemm, Robert; Houser, Scott

2001-01-01

This report documents efforts to analyze a sample of aviation safety programs, using the LMI-developed integrated safety analysis tool to determine the change in system risk resulting from Aviation Safety Program (AvSP) technology implementation. Specifically, we have worked to modify existing system safety tools to address the safety impact of synthetic vision (SV) technology. Safety metrics include reliability, availability, and resultant hazard. This analysis of SV technology is intended to be part of a larger effort to develop a model that is capable of "providing further support to the product design and development team as additional information becomes available". The reliability analysis portion of the effort is complete and is fully documented in this report. The simulation analysis is still underway; it will be documented in a subsequent report. The specific goal of this effort is to apply the integrated safety analysis to SV technology. This report also contains a brief discussion of data necessary to expand the human performance capability of the model, as well as a discussion of human behavior and its implications for system risk assessment in this modeling environment.

Cultural safety as an ethic of care: a praxiological process.

PubMed

McEldowney, Rose; Connor, Margaret J

2011-10-01

New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.

Economic approaches to measuring the significance of food safety in international trade.

PubMed

Caswell, J A

2000-12-20

International trade in food products has expanded rapidly in recent years. This paper presents economic approaches for analyzing the effects on trade in food products of the food safety requirements of governments and private buyers. Important economic incentives for companies to provide improved food safety arise from (1) public incentives such as ex ante requirements for sale of a product with sufficient quality and ex post penalties (liability) for sale of products with deficient quality, and (2) private incentives for producing quality such as internal performance goals (self-regulation) and the external (certification) requirements of buyers. The World Trade Organization's Sanitary Phytosanitary Agreement facilitates scrutiny of the benefits and costs of country-level regulatory programs and encourages regulatory rapprochement on food safety issues. Economists can help guide risk management decisions by providing estimates of the benefits and costs of programs to improve food safety and by analyzing their effect on trade in food products.

A data-driven model for estimating industry average numbers of hospital security staff.

PubMed

Vellani, Karim H; Emery, Robert J; Reingle Gonzalez, Jennifer M

2015-01-01

In this article the authors report the results of an expanded survey, financed by the International Healthcare Security and Safety Foundation (IHSSF), applied to the development of a model for determining the number of security officers required by a hospital.

Passenger vehicle driver cell phone use : results from the fall 2000 National Occupant Protection Use Survey

DOT National Transportation Integrated Search

2001-07-01

The National Highway Traffic Safety Administration's National Occupant Protection Use Survey (NOPUS) expanded its data collection protocols during October and November 2000 to obtain national estimates of driver cell phone use. The results of NOPUS f...

Prevention of Child Abuse: Possibilities for Educational Systems.

ERIC Educational Resources Information Center

Holmes, Christine P.

1987-01-01

Educators' roles in identification of abused/neglected children, subsequent reporting, and techniques for interviewing suspected abused children are discussed. Educators' expanded role in abuse prevention, involving such activities as offering courses in parenting, child safety/protection, and human sexuality, is examined, followed by a…

A humanized system to expand in vitro amniotic fluid-derived stem cells intended for clinical application.

PubMed

Martinelli, Daniela; Pereira, Rui Cruz; Mogni, Massimo; Benelli, Roberto; Mastrogiacomo, Maddalena; Coviello, Domenico; Cancedda, Ranieri; Gentili, Chiara

2016-03-01

The amniotic fluid is a new source of multipotent stem cells with therapeutic potential for human diseases. In agreement with the regulatory requirement to reduce and possibly to avoid animal-derived reagents in the culture of cells intended for cell therapy, bovine serum, the most common supplement in the culture medium, was replaced by human platelet-derived growth factors. We tested a new culture medium to expand monolayers of human amniotic fluid stem cells (hAFSC) for clinical use. The AFSC were isolated by c-Kit selection and expanded in media supplemented with either bovine serum or a human platelet lysate (Lyset). We compared proliferation kinetics, colony-forming unit percentage, multilineage differentiation, immunophenotypic characterization and inhibition of peripheral blood mononuclear cell proliferation of the two AFSC cell cultures and we found no significant differences. Moreover, the karyotype analysis of the cells expanded in the presence of the platelet lysate did not present cytogenetic abnormalities and in vitro and in vivo studies revealed no cell tumorigenicity. Platelet derivatives represent a rich source of growth factors that can play a safety role in the homeostasis, proliferation and remodeling of tissue healing. We propose human platelet extracts as a preferential alternative to animal serum for the expansion of stem cells for clinical applications. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Tracheal stricture and fistula: management with a barbed silicone-covered retrievable expandable nitinol stent.

PubMed

Kim, Yong Hee; Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung

2010-02-01

The purpose of this study was to evaluate the safety and effectiveness of a barbed silicone-covered retrievable expandable nitinol stent in preventing stent migration in patients with tracheal strictures or fistulas. Under fluoroscopic guidance, barbed silicone-covered retrievable expandable nitinol stents were placed in 15 patients with tracheal strictures, two patients with fistulas, two patients with combined strictures and fistulas, and one patient with variable extrathoracic airway obstruction. The three pairs of barbs were attached to the external stent surface at the middle of the stent at equal intervals. Technical success, improvement in respiratory status, complications, and related interventions were evaluated. The technical success rate was 100%, and respiratory status improved or the fistula closed in all 20 patients. Complications included sputum retention (three patients), tumor overgrowth (three patients), pain (one patient), and granulation tissue formation (one patient). No stent migration occurred, even in the three patients without fixed strictures. Four stents subsequently were removed because of complications, and one stent was removed because the patient's condition improved. Stent removal was not difficult and was uneventful. The silicone membranes and barbs of the removed stents were intact. Use of a barbed silicone-covered retrievable expandable nitinol stent relieves dyspnea and facilitates fistula closure in patients with benign or malignant tracheal strictures or fistulas. The barbed design of the stent is important in preventing migration.

Cell-Based Therapies for Joint Disease in Veterinary Medicine: What We Have Learned and What We Need to Know

PubMed Central

Bogers, Sophie Helen

2018-01-01

Biological cell-based therapies for the treatment of joint disease in veterinary patients include autologous-conditioned serum, platelet-rich plasma, and expanded or non-expanded mesenchymal stem cell products. This narrative review outlines the processing and known mechanism of action of these therapies and reviews current preclinical and clinical efficacy in joint disease in the context of the processing type and study design. The significance of variation for biological activity and consequently regulatory approval is also discussed. There is significant variation in study outcomes for canine and equine cell-based products derived from whole blood or stem cell sources such as adipose and bone marrow. Variation can be attributed to altering bio-composition due to factors including preparation technique and source. In addition, study design factors like selection of cases with early vs. late stage osteoarthritis (OA), or with intra-articular soft tissue injury, influence outcome variation. In this under-regulated field, variation raises concerns for product safety, consistency, and efficacy. Cell-based therapies used for OA meet the Food and Drug Administration’s (FDA’s) definition of a drug; however, researchers must consider their approach to veterinary cell-based research to meet future regulatory demands. This review explains the USA’s FDA guidelines as an example pathway for cell-based therapies to demonstrate safety, effectiveness, and manufacturing consistency. An understanding of the variation in production consistency, effectiveness, and regulatory concerns is essential for practitioners and researchers to determine what products are indicated for the treatment of joint disease and tactics to improve the quality of future research. PMID:29713634

Buprenorphine – an attractive opioid with underutilized potential in treatment of chronic pain

PubMed Central

Khanna, Ish K; Pillarisetti, Sivaram

2015-01-01

Despite proven clinical utility, buprenorphine has not been used widely for the treatment of chronic pain. Questions about “ceiling effect” or bell-shaped curve observed for analgesia in preclinical studies and potential withdrawal issues on combining with marketed μ-agonists continue to hinder progress in expanding full potential of buprenorphine in the treatment of cancer and noncancer pain. Mounting evidence from clinical studies and conclusions drawn by a panel of experts strongly support superior safety and efficacy profile of buprenorphine vs marketed opioids. No ceiling on analgesic effect has been reported in clinical studies. The receptor pharmacology and pharmacokinetics profile of buprenorphine is complex but unique and contributes to its distinct safety and efficacy. The buprenorphine pharmacology also allows it to be combined with other μ-receptor opioids for additivity in efficacy. Transdermal delivery products of buprenorphine have been preferred choices for the management of pain but new delivery options are under investigation for the treatment of both opioid dependence and chronic pain. PMID:26672499

A review of health and safety leadership and managerial practices on modern dairy farms.

PubMed

Hagevoort, G Robert; Douphrate, David I; Reynolds, Stephen J

2013-01-01

As modern dairy operations around the world expand, farmers are increasingly reliant on greater automation and larger numbers of hired labor to milk cows and perform other essential farm tasks. Dairy farming is among the most dangerous occupations, with high rates of injury, illness, and employee turnover. Lower education levels, illiteracy, and limited language proficiency increase the possibility of injury or death associated with higher risk occupations such as dairy. Sustaining a healthy, productive workforce is a critical component of risk management; however, many owners and managers have not received formal training in employee management or occupational health and safety. Optimal dairy farming management should address milk production that is sustainable and responsible from the animal welfare, social, economic, and environmental perspectives. Each of these aspects is interdependent with each other and with a sustainable, healthy, productive workforce. Very few studies address the effectiveness of risk management in the dairy industry. Studies suggest that labor management practices are a potential competitive advantage for dairy farms, but the connection with efficiency, productivity, and profitability has not been clearly demonstrated. Transformational leadership has been associated with improved safety climate and reduced incidence of injury, whereas passive leadership styles have opposite effects. There is a need to develop and evaluate the effectiveness of safety-specific transformational leadership among dairy owners and managers. A systematic approach to risk management should address worker health and safety as an integral component of production, food safety, and animal welfare. A successful program must address the cultural and linguistic barriers associated with immigrant workers.

An overview of the safety pharmacology society strategic plan.

PubMed

Pugsley, M K; Authier, S; Koerner, J E; Redfern, W S; Markgraf, C G; Brabham, T; Correll, K; Soloviev, M V; Botchway, A; Engwall, M; Traebert, M; Valentin, J-P; Mow, T J; Greiter-Wilke, A; Leishman, D J; Vargas, H M

2018-01-09

Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology. Education remains a primary emphasis for the society through content derived from regional and annual meetings, webinars and publication of its works it seeks to inform the general scientific and regulatory community. In considering the future of safety pharmacology the society has developed a strategy to successfully navigate forward and not be mired in stagnation of the discipline. Strategy can be defined in numerous ways but generally involves establishing and setting goals, determining what actions are needed to achieve those goals, and mobilizing resources within the society to accomplish the actions. The discipline remains in rapid evolution and its coverage is certain to expand to provide better guidance for more systems in the next few years. This overview from the Safety Pharmacology Society will outline the strategic plan from 2016 to 2018 and beyond and provide insight into the future of the discipline which builds upon a previous strategic plan established in 2009. Copyright © 2018 Elsevier Inc. All rights reserved.

Quality and Safety Education for Nurses (QSEN): The Key is Systems Thinking.

PubMed

Dolansky, Mary A; Moore, Shirley M

2013-09-30

Over a decade has passed since the Institute of Medicine's reports on the need to improve the American healthcare system, and yet only slight improvement in quality and safety has been reported. The Quality and Safety Education for Nurses (QSEN) initiative was developed to integrate quality and safety competencies into nursing education. The current challenge is for nurses to move beyond the application of QSEN competencies to individual patients and families and incorporate systems thinking in quality and safety education and healthcare delivery. This article provides a history of QSEN and proposes a framework in which systems thinking is a critical aspect in the application of the QSEN competencies. We provide examples of how using this framework expands nursing focus from individual care to care of the system and propose ways to teach and measure systems thinking. The conclusion calls for movement from personal effort and individual care to a focus on care of the system that will accelerate improvement of healthcare quality and safety.

Reserve Li/SOC12 Battery Safety Testing

NASA Technical Reports Server (NTRS)

Dils, C. T.; Garoutte, K. F.

1984-01-01

A reserve Lithium/Thionyl Chloride Battery concept is developed and undergoing feasibility testing in terms of performance, safety and abusive conditions. The feasibility of employing a battery of this type to replace thermal batteries in certain applications is demonstrated. Excellent performance of a Li/SOCl2 reserve battery is obtained across the temperature range from 0 C to +44 C. Performance improvement over the thermal battery usage is greater by a factor of 3 when discharge time and energy density are compared. Performance over an expanded temperature range is also possible. Safety and abusive testing is accomplished successfully on a series of five units. Further performance improvements can be achieved with regard to battery weight and volume reductions.

Safety Behaviors in Adults With Social Anxiety: Review and Future Directions.

PubMed

Piccirillo, Marilyn L; Taylor Dryman, M; Heimberg, Richard G

2016-09-01

Safety behaviors are considered an important factor in the maintenance of social anxiety disorder (SAD). Safety behaviors are typically employed by socially anxious individuals to reduce anxiety in feared social situations. However, by preventing individuals with social anxiety from gathering evidence that would disconfirm their maladaptive beliefs about social situations, the use of safety behaviors ultimately maintains social anxiety over time. Twenty years ago, Wells and colleagues (1995) demonstrated that use of safety behaviors diminishes the efficacy of exposure treatment for SAD, suggesting that reduction in the use of safety behaviors during exposure can enhance treatment response. Research on safety behaviors has expanded considerably since Wells et al.'s seminal publication, and our understanding of the role safety behaviors may play in the maintenance of social anxiety has grown in breadth and depth. In this paper, we present a detailed review of the published research on safety behaviors relevant to social anxiety and social-anxiety-related processes. Finally, we evaluate the impact of safety behaviors on the outcome of treatment for SAD, and we look to the literature on safety behaviors in other anxiety disorders to inform our understanding of use of safety behaviors during exposure and to facilitate future research in SAD. Copyright © 2015. Published by Elsevier Ltd.

Determinants of debit cards acceptance: An empirical investigation

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

Ismail, Shafinar; Adnan, Azimah; Azizi, Amsyar

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300more » respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.« less

Determinants of debit cards acceptance: An empirical investigation

NASA Astrophysics Data System (ADS)

Ismail, Shafinar; Bakri, Mohamed Hariri; Zulkepli, Jafri; Adnan, Azimah; Azizi, Amsyar

2014-12-01

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300 respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.

Mesenchymal Stem Cell Transplantation in Multiple Sclerosis

PubMed Central

Cohen, Jeffrey A.

2013-01-01

Mesenchymal stem cells (MSCs) are a pluripotent non-hematopoietic precursor cells that can be isolated from bone marrow and numerous other tissues, culture-expanded to purity, and induced to differentiate in vitro and in vivo into mesodermal derivatives. MSCs exhibit many phenotypic and functional similarities to pericytes. The immunomodulatory, tissue protective, and repair-promoting properties of MSCs demonstrated both in vitro and in animal models make them an attractive potential therapy for MS and other conditions characterized by inflammation and/or tissue injury. Other potential advantages of MSCs as a therapeutic include the relative ease of culture expansion, relative immunoprivilege allowing allogeneic transplantation, and their ability to traffic from blood to areas of tissue allowing intravascular administration. The overall published experience with MSC transplantation in MS is modest, but several small case series and preliminary studies yielded promising results. Several groups, including us, recently initiated formal studies of autologous, culture-expanded, bone-marrow-derived MSC transplantation in MS. Although there are several potential safety concerns, to date, the procedure has been well tolerated. Future studies that more definitively assess efficacy also will need to address several technical issues. PMID:23294498

Construction managers' perceptions of construction safety practices in small and large firms: a qualitative investigation.

PubMed

Gillen, Marion; Kools, Susan; McCall, Cade; Sum, Juliann; Moulden, Kelli

2004-01-01

Despite the institution of explicit safety practices in construction, there continue to be exceedingly high rates of morbidity and mortality from work-related injury. This study's purpose was to identify, compare and contrast views of construction managers from large and small firms regarding construction safety practices. A complementary analysis was conducted with construction workers. A semi-structured interview guide was used to elicit information from construction managers (n = 22) in a series of focus groups. Questions were designed to obtain information on direct safety practices and indirect practices such as communication style, attitude, expectations, and unspoken messages. Data were analyzed using thematic content analysis. Managers identified a broad commitment to safety, worker training, a changing workplace culture, and uniform enforcement as key constructs in maintaining safe worksites. Findings indicate that successful managers need to be involved, principled, flexible, and innovative. Best practices, as well as unsuccessful injury prevention programs, were discussed in detail. Obstacles to consistent safety practice include poor training, production schedules and financial constraints. Construction managers play a pivotal role in the definition and implementation of safety practices in the workplace. In order to succeed in this role, they require a wide variety of management skills, upper management support, and tools that will help them instill and maintain a positive safety culture. Developing and expanding management skills of construction managers may assist them in dealing with the complexity of the construction work environment, as well as providing them with the tools necessary to decrease work-related injuries.

Threats to patient safety in telenursing as revealed in Swedish telenurses' reflections on their dialogues.

PubMed

Röing, Marta; Rosenqvist, Urban; Holmström, Inger K

2013-12-01

Telenursing is a rapidly expanding actor in the Swedish healthcare system, as in other Western nations. Although rare, tragic events occur within this context, and are reminders of the importance of giving patient safety the highest priority. As telenurses' main sources of information are their dialogues with the callers, the provision of safe care can depend on the quality of this dialogue. The aim of this study was to identify issues that could threaten patient safety in telenurses' dialogues with callers. As part of an educational intervention, a researcher visited a sample of six telenurses five to six times at their workplace to listen to and discuss, together with the telenurses, their dialogues with callers in stimulated recall sessions. Each call and the following discussion between researcher and telenurse was tape-recorded and transcribed as text, resulting in a total of 121 calls. Qualitative content analysis of the reflections and following discussions revealed that threats to patient safety could be related to the surrounding society, to the organisation of telenursing, to the telenurse and to the caller. This study gives insight into significant problem areas that can affect patient safety in telenursing in Sweden. Issues that need to be focused on in telenursing educational programmes and future research are suggested, as well as the need for organisational development. © 2012 The Authors Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

Safety of human papillomavirus vaccines: a review.

PubMed

Macartney, Kristine K; Chiu, Clayton; Georgousakis, Melina; Brotherton, Julia M L

2013-06-01

Vaccination to prevent human papillomavirus (HPV)-related infection leading to cancer, particularly cervical cancer, is a major public health breakthrough. There are currently two licensed HPV vaccines, both of which contain recombinant virus-like particles of HPV types 16 and 18 (which account for approximately 70 % of cervical cancer). One vaccine also protects against HPV types 6 and 11, which cause genital warts. The safety profile of both vaccines was assessed extensively in randomised controlled clinical trials conducted prior to licensure and has been further elucidated following licensure from surveillance and specific studies in large populations. This review aims to examine current evidence regarding the safety of HPV vaccines. In summary, both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions. Whilst this reassuring safety profile affirms the positive risk benefit of vaccination, as HPV vaccine use expands into more diverse populations, including males, ongoing safety assessment using well-conducted studies is appropriate.

Identifying countermeasure strategies to increase safety of older pedestrians : traffic tech.

DOT National Transportation Integrated Search

2013-07-01

Pedestrian deaths accounted for 13% of all traffic fatalities : in 2010. While adults 65 and older made up 13% of the U.S. : population, they accounted for 19% of all pedestrian fatalities : in 2010. This age group is rapidly expanding in size : and ...

Developing a sustainable freight transportation framework with the consideration of improving safety and minimizing carbon emissions.

DOT National Transportation Integrated Search

2011-09-01

Despite the difficulties of the American economy in recent years the transportation sector continues to expand. Freight transportation alone has been projected to increase enormously even if the economy as a whole only manages a very moderate growth....

Highway Safety Information System guidebook for the Utah state data files. Volume 1 : SAS file formats

DOT National Transportation Integrated Search

1996-06-01

This volume expands on the presentations in the main manual by presenting further discussions and examples. Contents: Appendix A: The Costs of Travel Surveys; Appendix B: Census Data for Travel Surveys; Appendix C: An Example of the Systems Capabilit...

Analysis of roadside safety devices for use on very high-speed roadways.

DOT National Transportation Integrated Search

2009-09-01

The Texas Department of Transportation (TxDOT) is embarking on a multi-decade effort to expand : the states transportation system. TxDOT has expressed an interest in using very high design speeds (above : 80 mph) for some of these facilities to pr...

Tracing the foundations of a conceptual framework for a patient safety ontology.

PubMed

Runciman, William B; Baker, G Ross; Michel, Philippe; Dovey, Susan; Lilford, Richard J; Jensen, Natasja; Flin, Rhona; Weeks, William B; Lewalle, Pierre; Larizgoitia, Itziar; Bates, David

2010-12-01

In work for the World Alliance for Patient Safety on research methods and measures and on defining key concepts for an International Patient Safety Classification (ICPS), it became apparent that there was a need to try to understand how the meaning of patient safety and underlying concepts relate to the existing safety and quality frameworks commonly used in healthcare. To unfold the concept of patient safety and how it relates to safety and quality frameworks commonly used in healthcare and to trace the evolution of the ICPS framework as a basis of the electronic capture of the component elements of patient safety. The ICPS conceptual framework for patient safety has its origins in existing frameworks and an international consultation process. Although its 10 classes and their semantic relationships may be used as a reference model for different disciplines, it must remain dynamic in the ever-changing world of healthcare. By expanding the ICPS by examining data from all available sources, and ensuring rigorous compliance with the latest principles of informatics, a deeper interdisciplinary approach will progressively be developed to address the complex, refractory problem of reducing healthcare-associated harm.

The Expanding Context of European and Mediterranean Security: A Joint Project Between the Center for Naval Analyses (CNA) and Centro Militare di Studi Strategici (CeMiSS)

DTIC Science & Technology

2007-04-01

has deployed several police-type assistance missions. The UN’s Food and Agriculture Organization (FAO), has, in the broadest of senses, a "security...34 mandate, inasmuch as food shortages in the world ineluctably are a direct cause of insecurity, which, in turn, is likely to require response by...failure of international institutions, like the International Maritime Organization, to address the environmental and safety impacts of shipping on coastal

The Expanding Context of European and Mediterranean Security: A Joint Project Between the Center for Naval Analyses (CNA) and Centro Militare di Studi Strategici (CeMiSS)

DTIC Science & Technology

2007-07-01

deployed several police-type assistance missions. The UN’s Food and Agriculture Organization (FAO), has, in the broadest of senses, a "security" mandate...inasmuch as food shortages in the world ineluctably are a direct cause of insecurity, which, in turn, is likely to require response by "security... safety impacts of shipping on coastal states 5. Yale University Press (1962) 57 6.3 Modern challenges preventing achievement of desired end states * Flag

77 FR 45558 - 4.9 GHz Band

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

...The Commission allocated the 4940-4990 MHz (4.9 GHz) band in 2002 for fixed and mobile use and dedicated the band for public safety broadband communications. In the ten years since, the band has gone underutilized. The purpose of these proposed rules is to invigorate and maximize use of the 4.9 GHz band and attract more users while improving spectrum efficiency. The Commission seeks comment on formal coordination requirements, expanded eligibility, how the band can complement the 700 MHz public safety broadband network, technical rule changes, aeronautical mobile operations, interoperability standards, and deployment reporting.

Results from a phase 1 study of nusinersen (ISIS-SMN(Rx)) in children with spinal muscular atrophy.

PubMed

Chiriboga, Claudia A; Swoboda, Kathryn J; Darras, Basil T; Iannaccone, Susan T; Montes, Jacqueline; De Vivo, Darryl C; Norris, Daniel A; Bennett, C Frank; Bishop, Kathie M

2016-03-08

To examine safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of intrathecal nusinersen (previously ISIS-SMNRx), an antisense oligonucleotide designed to alter splicing of SMN2 mRNA, in patients with childhood spinal muscular atrophy (SMA). Nusinersen was delivered by intrathecal injection to medically stable patients with type 2 and type 3 SMA aged 2-14 years in an open-label phase 1 study and its long-term extension. Four ascending single-dose levels (1, 3, 6, and 9 mg) were examined in cohorts of 6-10 participants. Participants were monitored for safety and tolerability, and CSF and plasma pharmacokinetics were measured. Exploratory efficacy endpoints included the Hammersmith Functional Motor Scale Expanded (HFMSE) and Pediatric Quality of Life Inventory. A total of 28 participants enrolled in the study (n = 6 in first 3 dose cohorts; n = 10 in the 9-mg cohort). Intrathecal nusinersen was well-tolerated with no safety/tolerability concerns identified. Plasma and CSF drug levels were dose-dependent, consistent with preclinical data. Extended pharmacokinetics indicated a prolonged CSF drug half-life of 4-6 months after initial clearance. A significant increase in HFMSE scores was observed at the 9-mg dose at 3 months postdose (3.1 points; p = 0.016), which was further increased 9-14 months postdose (5.8 points; p = 0.008) during the extension study. Results from this study support continued development of nusinersen for treatment of SMA. This study provides Class IV evidence that in children with SMA, intrathecal nusinersen is not associated with safety or tolerability concerns. © 2016 American Academy of Neurology.

Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior

PubMed Central

Curtis, Britni; Liberato, Noelle; Rulien, Megan; Morrisroe, Kelly; Kenney, Caroline; Yutuc, Vernon; Ferrier, Clayton; Marti, C. Nathan; Mandell, Dorothy; Burbacher, Thomas M.; Sackett, Gene P.

2015-01-01

Background In the 1990s, the mercury-based preservative thimerosal was used in most pediatric vaccines. Although there are currently only two thimerosal-containing vaccines (TCVs) recommended for pediatric use, parental perceptions that vaccines pose safety concerns are affecting vaccination rates, particularly in light of the much expanded and more complex schedule in place today. Objectives The objective of this study was to examine the safety of pediatric vaccine schedules in a non-human primate model. Methods We administered vaccines to six groups of infant male rhesus macaques (n = 12–16/group) using a standardized thimerosal dose where appropriate. Study groups included the recommended 1990s Pediatric vaccine schedule, an accelerated 1990s Primate schedule with or without the measles–mumps–rubella (MMR) vaccine, the MMR vaccine only, and the expanded 2008 schedule. We administered saline injections to age-matched control animals (n = 16). Infant development was assessed from birth to 12 months of age by examining the acquisition of neonatal reflexes, the development of object concept permanence (OCP), computerized tests of discrimination learning, and infant social behavior. Data were analyzed using analysis of variance, multilevel modeling, and survival analyses, where appropriate. Results We observed no group differences in the acquisition of OCP. During discrimination learning, animals receiving TCVs had improved performance on reversal testing, although some of these same animals showed poorer performance in subsequent learning-set testing. Analysis of social and nonsocial behaviors identified few instances of negative behaviors across the entire infancy period. Although some group differences in specific behaviors were reported at 2 months of age, by 12 months all infants, irrespective of vaccination status, had developed the typical repertoire of macaque behaviors. Conclusions This comprehensive 5-year case–control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals. Citation Curtis B, Liberato N, Rulien M, Morrisroe K, Kenney C, Yutuc V, Ferrier C, Marti CN, Mandell D, Burbacher TM, Sackett GP, Hewitson L. 2015. Examination of the safety of pediatric vaccine schedules in a non-human primate model: assessments of neurodevelopment, learning, and social behavior. Environ Health Perspect 123:579–589; http://dx.doi.org/10.1289/ehp.1408257 PMID:25690930

Understanding adolescent development: implications for driving safety.

PubMed

Keating, Daniel P

2007-01-01

The implementation of Graduated Driver Licensing (GDL) programs has significantly improved the crash and fatality rates of novice teen drivers, but these rates remain unacceptably high. A review of adolescent development research was undertaken to identify potential areas of improvement. Research support for GDL was found to be strong, particularly regarding early acquisition of expertise in driving safety (beyond driving skill), and to limitations that reduce opportunities for distraction. GDL regimes are highly variable, and no US jurisdictions have implemented optimal regimes. Expanding and improving GDL to enhance acquisition of expertise and self-regulation are indicated for implementation and for applied research. Driver training that effectively incorporates safety goals along with driving skill is another target. The insurance industry will benefit from further GDL enhancements. Benefits may accrue to improved driver training, improved simulation devices during training, and automated safety feedback instrumentation.

Enhanced Time Out: An Improved Communication Process.

PubMed

Nelson, Patricia E

2017-06-01

An enhanced time out is an improved communication process initiated to prevent such surgical errors as wrong-site, wrong-procedure, or wrong-patient surgery. The enhanced time out at my facility mandates participation from all members of the surgical team and requires designated members to respond to specified time out elements on the surgical safety checklist. The enhanced time out incorporated at my facility expands upon the safety measures from the World Health Organization's surgical safety checklist and ensures that all personnel involved in a surgical intervention perform a final check of relevant information. Initiating the enhanced time out at my facility was intended to improve communication and teamwork among surgical team members and provide a highly reliable safety process to prevent wrong-site, wrong-procedure, and wrong-patient surgery. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Safety Considerations in the Use of Ketorolac for Postoperative Pain.

PubMed

Maslin, Benjamin; Lipana, Lawrence; Roth, Brandon; Kodumudi, Gopal; Vadivelu, Nalini

2017-01-01

Ketorolac use has significantly expanded for postoperative pain management since it first became available in the United States, primarily due to well established effects on patient pain scores and its ability to reduce perioperative opioid requirements. As an inhibitor of cyclooxygenase, ketorolac use has raised clinical concern including particular controversy regarding its potential effects on bone healing, postoperative kidney function and perioperative bleeding. To review the supporting data from clinical studies addressing the safety of ketorolac use for postoperative pain. This review highlights the most up-to-date research from clinical trials as well as from retrospective studies and meta-analyses regarding the effects of perioperative use of ketorolac on bone healing, kidney function and blood loss. Based on the most up-to-date literature, ketorolac in normal doses has been demonstrated to be safe with respect to bone healing. In patients with normal kidney function, numerous studies have established the safety of Ketorolac; however other studies have raised safety concerns in patients with comorbid kidney, heart and liver disease. While there is evidence that ketorolac may cause prolonged bleeding time and may be associated with increased postoperative blood loss after tonsillectomy, large scale prospective randomized controlled trials and subsequent meta-analyses have failed to establish an association of ketorolac use and perioperative blood loss. Perioperative administration of ketorolac has been demonstrated to be safe and effective in healthy patients and is particularly beneficial as an opioid-sparing agent in vulnerable patient groups. However, in certain surgical and medical contexts, proper patient selection based on the multidisciplinary collaboration between perioperative clinician specialists will optimize patient safety and pain management outcomes. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A longitudinal study of clinical peer review's impact on quality and safety in U.S. hospitals.

PubMed

Edwards, Marc T

2013-01-01

Clinical peer review is the dominant method of event analysis in U.S. hospitals. It is pivotal to medical staff efforts to improve quality and safety, yet the quality assurance process model that has prevailed for the past 30 years evokes fear and is fundamentally antithetical to a culture of safety. Two prior national studies characterized a quality improvement model that corrects this dysfunction but failed to demonstrate progress toward its adoption despite a high rate of program change between 2007 and 2009. This study's online survey of 470 organizations participating in either of the prior studies further assessed relationships between clinical peer review program factors, including the degree of conformance to the quality improvement model (the QI model score), and subjectively measured program impact variables. Among the 300 hospitals (64%) that responded, the median QI model score was only 60 on a 100-point scale. Scores increased somewhat for the 2007 cohort (mean pair-wise difference of 5.9 [2-10]), but not for the 2009 cohort. The QI model is expanded as the result of the finding that self-reporting of adverse events, near misses, and hazardous conditions--an essential practice in high-reliability organizations--is no longer rare in hospitals. Self-reporting and the quality of case review are additional multivariate predictors of the perceived ongoing impact of clinical peer review on quality and safety, medical staff perceptions of the program, and medical staff engagement in quality and safety initiatives. Hospital leaders and trustees who seek to improve patient outcomes should facilitate the adoption of this best practice model for clinical peer review.

Whole Life Living Skills Curriculum.

ERIC Educational Resources Information Center

Roelofs, Alice R.; And Others

This manual provides ideas to enable Whole Life Program staff and friends to begin expanding on ways to reach and teach survival skills to adults. A list of suggestions for use of the curriculum activities and process appears first. Activities are provided for 11 curriculum areas: emergency procedures; apartment safety; apartment upkeep; food…

Tort liability : a handbook for employees of the Virginia Department of Transportation and Virginia municipal corporations, May 2003.

DOT National Transportation Integrated Search

2003-01-01

Transportation agencies and their employees have always been concerned with providing safe roadways for the public. In recent years, the concern for safety has expanded to include concerns about the high cost of suits brought by those who have suffer...

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

DTIC Science & Technology

2016-10-01

above for publication in a peer-reviewed journal 4. Expand the release of the Clinical Scenario Repository (CSR), also known as “Good Ideas for...the Clinical Scenario Repository (CSR). The CSR pilot with the American Society of Anesthesiologists (ASA) Committee on Patient Safety and Education

The AOP framework and causality: Meeting chemical risk assessment challenges in the 21st century

EPA Science Inventory

Chemical safety assessments are expanding from a focus on a few chemicals (or chemical mixtures) to the broader “universe” of thousands, if not hundreds of thousands of substances that potentially could impact humans or the environment. This is exemplified in ...

How to Reduce the Threat of Terrorism.

ERIC Educational Resources Information Center

Beres, Louis Rene

1986-01-01

Maintains that the answer to terrorism lies not in higher fences, laser weapons, or expanded commando forces, but in improved understanding of the linkages between U.S. foreign policy and anti-American terrorism. Reviews geopolitical developments, including international law, and concludes that U.S. safety from terrorism will depend upon our…

National model for the statewide application of data collection and management technology to improve highway safety

DOT National Transportation Integrated Search

2005-01-01

The project involves the enhancement of the statewide crash data reporting with automated collection and data capture tools. To that end the project provided funding for computer hardware and peripherals to expand the use of the national model to mor...

Washington State Survey of Adolescent Health Behaviors.

ERIC Educational Resources Information Center

Washington State Dept. of Social and Health Services, Olympia.

The 1992 Washington State Survey of Adolescent Health Behaviors (WSSAHB) was created to collect information regarding a variety of adolescent health behaviors among students in the state of Washington. It expands on two previous administrations of a student tobacco, alcohol, and other drug survey and includes questions about medical care, safety,…

Cold plasma processing to improve food safety

USDA-ARS?s Scientific Manuscript database

Cold plasma is an antimicrobial process being developed for application as a food processing technology. This novel intervention is the subject of an expanding research effort by groups around the world. A variety of devices can be used to generate cold plasma and apply it to the food commodity bein...

Certified Nurse Aide scope of practice: state-by-state differences in allowable delegated activities.

PubMed

McMullen, Tara L; Resnick, Barbara; Chin-Hansen, Jennie; Geiger-Brown, Jeanne M; Miller, Nancy; Rubenstein, Robert

2015-01-01

To gain a better understanding of the state-by-state differences in allowable delegated activities for Certified Nurse Aides (CNAs) working in long-term care settings, this exploratory descriptive study assessed what are the allowable tasks for CNAs based on findings from each state board of nursing. Specifically, findings from each state determined whether the care tasks allowed were consistent with those delineated by the 42 CFR § 483. This descriptive study included data drawn from all 50 states' regulatory offices or health care services agencies. Data were obtained from the regulations listed on each state's board of nursing, department of health, department of aging, department of health professions, department of commerce, and office of long-term care, among like agencies. The Code of Federal regulations (42 CFR § 483) listed 9 tasks that are allowable by each state. These tasks are identified as items 1 to 9: (1) personal care skills, (2) safety/emergency procedures, (3) basic nursing skills, (4) infection control, (5) communication and interpersonal skills, (6) care of cognitively impaired residents, (7) basic restorative care, (8) mental health and social service needs, and (9) residents' rights. Nine tasks delineated in the 42 CFR § 483 were identified as allowable in each state. On data analysis, it was found that 11 states noted that CNAs were able to perform workplace tasks that could be considered "expanded" care tasks, tasks beyond the basic care tasks listed in the 42 CFR § 483. Findings from this exploratory study aid in limiting the confusion around the application of workplace duties across states, providing a useful description of the care tasks CNAs are allowed to perform in an attempt to find uniformity state-by-state. Overall, states reported considering expanding the scope of practice or authorized duties for CNAs to strengthen patient care and safety. States may choose to expand CNA authorized duties so as to equip CNAs with specific training so that the CNA is able to provide a certain level of care when or if he or she is needed to do so. Without uniformity of CNA authorized duties, it is difficult to interpret whether expanding the scope of the CNA can result in outcomes such as improved patient care. State regulations vary and there were state boards of nursing that were not sure about the true extent of CNA workplace responsibilities. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Utilization of the Seniors Falls Investigation Methodology to identify system-wide causes of falls in community-dwelling seniors.

PubMed

Zecevic, Aleksandra A; Salmoni, Alan W; Lewko, John H; Vandervoort, Anthoney A; Speechley, Mark

2009-10-01

As a highly heterogeneous group, seniors live in complex environments influenced by multiple physical and social structures that affect their safety. Until now, the major approach to falls research has been person centered. However, in industrial settings, the individuals involved in an accident are seen as the inheritors of system defects. The objective of the present study was to investigate safety deficiencies that contributed to falls in community-dwelling seniors using a systems approach. The investigations were conducted using the Seniors Falls Investigation Methodology (SFIM), an adapted version of a method used to examine transportation accidents, such as airplane crashes. Fifteen seniors, who experienced a fall or near fall, participated in multiple case studies. A cross-case synthesis was used to summarize findings and identify common patterns of causes and safety deficiencies. Falls and near falls are a result of latent unsafe conditions, and unsafe acts and decisions combined in a diverse set of circumstances. If not identified and removed, these unsafe conditions can cause falls for other seniors. This study provided compelling evidence that causes of falling are systemic and develop over time. It demonstrated that the systems approach is needed to expand the focus from the individual to multilayered organizational and supervisory causes. The SFIM demonstrated capability to identify causes of falls that will allow better prevention and management programs, hence advancing seniors' safety. SFIM shows great potential for implementation in organized settings, such as hospitals and long-term care homes.

Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.

PubMed

Ascherman, Jeffrey A; Zeidler, Kamakshi; Morrison, Kerry A; Appel, James Z; Berkowitz, R L; Castle, John; Colwell, Amy; Chun, Yoon; Johnson, Debra; Mohebali, Khashayar

2016-12-01

AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders. Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed. One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent). The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion. Therapeutic, I.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

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

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

Identification of serious and reportable events in home care: a Delphi survey to develop consensus.

PubMed

Doran, Diane M; Baker, G Ross; Szabo, Cathy; McShane, Julie; Carryer, Jennifer

2014-04-01

To assess which client events should be considered reportable and preventable in home care (HC) settings in the opinion of HC safety experts. Patient safety in acute care settings has been well documented; however, there are limited data about this issue in HC. While many organizations collect information about 'incidents', there are no standards for reporting and it is challenging to compare incident rates among organizations. A 29-item electronic survey that included potential HC safety issues was used in a two-round Delphi study. Twenty-four pan-Canadian HC safety experts participated in an electronic survey. Perceived reportability and preventability of patient safety events, HC. The events that were perceived as being most reportable and preventable included the following: a serious injury related to inappropriate client service plan (e.g. incomplete/inaccurate assessments, poor care plan design, flawed implementation); an adverse reaction requiring emergency room visit or hospitalization related to a medication-related event; a catheter-site infection (e.g. a new peritoneal dialysis infection or peritonitis); any serious event related to care or services that are contrary to current professional or other practice standards (e.g. incorrect treatment regimen, theft, retention of a foreign object in a wound, individual practicing outside scope or competence). These data represent an important step in the development and validation of standard metrics about client safety in HC. The results address an expanding area of health services where there is a need to improve standardization and reporting.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Anomaly Analysis: NASA's Engineering and Safety Center Checks Recurring Shuttle Glitches

NASA Technical Reports Server (NTRS)

Morring, Frank, Jr.

2004-01-01

The NASA Engineering and Safety Center (NESC), set up in the wake of the Columbia accident to backstop engineers in the space shuttle program, is reviewing hundreds of recurring anomalies that the program had determined don't affect flight safety to see if in fact they might. The NESC is expanding its support to other programs across the agency, as well. The effort, which will later extend to the International Space Station (ISS), is a principal part of the attempt to overcome the normalization of deviance--a situation in which organizations proceeded as if nothing was wrong in the face of evidence that something was wrong--cited by sociologist Diane Vaughn as contributing to both space shuttle disasters.

Development of a check sheet for collecting information necessary for occupational safety and health activities and building relevant systems in overseas business places.

PubMed

Kajiki, Shigeyuki; Kobayashi, Yuichi; Uehara, Masamichi; Nakanishi, Shigemoto; Mori, Koji

2016-06-07

This study aimed to develop an information gathering check sheet to efficiently collect information necessary for Japanese companies to build global occupational safety and health management systems in overseas business places. The study group consisted of 2 researchers with occupational physician careers in a foreign-affiliated company in Japan and 3 supervising occupational physicians who were engaged in occupational safety and health activities in overseas business places. After investigating information and sources of information necessary for implementing occupational safety and health activities and building relevant systems, we conducted information acquisition using an information gathering check sheet in the field, by visiting 10 regions in 5 countries (first phase). The accuracy of the information acquired and the appropriateness of the information sources were then verified in study group meetings to improve the information gathering check sheet. Next, the improved information gathering check sheet was used in another setting (3 regions in 1 country) to confirm its efficacy (second phase), and the information gathering check sheet was thereby completed. The information gathering check sheet was composed of 9 major items (basic information on the local business place, safety and health overview, safety and health systems, safety and health staff, planning/implementation/evaluation/improvement, safety and health activities, laws and administrative organs, local medical care systems and public health, and medical support for resident personnel) and 61 medium items. We relied on the following eight information sources: the internet, company (local business place and head office in Japan), embassy/consulate, ISO certification body, university or other educational institutions, and medical institutions (aimed at Japanese people or at local workers). Through multiple study group meetings and a two-phased field survey (13 regions in 6 countries), an information gathering check sheet was completed. We confirmed the possibility that this check sheet would enable the user to obtain necessary information when expanding safety and health activities in a country or region that is new to the user. It is necessary in the future to evaluate safety and health systems and activities using this information gathering check sheet in a local business place in any country in which a Japanese business will be established, and to verify the efficacy of the check sheet by conducting model programs to test specific approaches.

Predictors of Cell Phone Use in Distracted Driving: Extending the Theory of Planned Behavior.

PubMed

Tian, Yan; Robinson, James D

2017-09-01

This study examines the predictors of six distracted driving behaviors, and the survey data partially support Ajzen's (1991) Theory of Planned Behavior (TPB). The data suggest that the attitude variable predicted intention to engage in all six distracted driving behaviors (reading and sending text messages, making and answering cell phone calls, reading/viewing social media, and posting on social media while driving). Extending the model to include past experience and the variable perceived safety of technology yielded an improvement in the prediction of the distraction variables. Specifically, past experience predicted all six distracted driving behaviors, and the variable perceived safety of technology predicted intentions to read/view social media and intention to post on social media while driving. The study provides evidence for the importance of incorporating expanded variables into the original TPB model to predict cell phone use behaviors while driving, and it suggests that it is essential to tailor campaign materials for each specific cell phone use behavior to reduce distracted driving.

Using advanced mobile devices in nursing practice--the views of nurses and nursing students.

PubMed

Johansson, Pauline; Petersson, Göran; Saveman, Britt-Inger; Nilsson, Gunilla

2014-09-01

Advanced mobile devices allow registered nurses and nursing students to keep up-to-date with expanding health-related knowledge but are rarely used in nursing in Sweden. This study aims at describing registered nurses' and nursing students' views regarding the use of advanced mobile devices in nursing practice. A cross-sectional study was completed in 2012; a total of 398 participants replied to a questionnaire, and descriptive statistics were applied. Results showed that the majority of the participants regarded an advanced mobile device to be useful, giving access to necessary information and also being useful in making notes, planning their work and saving time. Furthermore, the advanced mobile device was regarded to improve patient safety and the quality of care and to increase confidence. In order to continuously improve the safety and quality of health care, advanced mobile devices adjusted for nursing practice should be further developed, implemented and evaluated in research. © The Author(s) 2013.

iStent trabecular micro-bypass stent for open-angle glaucoma

PubMed Central

Le, Kim; Saheb, Hady

2014-01-01

Trabecular micro-bypass stents, commonly known as iStents, are micro-invasive glaucoma surgery (MIGS) devices used to treat open-angle glaucoma. Like other MIGS procedures that enhance trabecular outflow, the iStent lowers intraocular pressure (IOP) by creating a direct channel between the anterior chamber and Schlemm’s canal. iStents are typically implanted at the time of phacoemulsification for patients with open-angle glaucoma and visually significant cataracts. This review summarizes the published data regarding the efficacy, safety, and cost considerations of trabecular micro-bypass stents. Most studies found statistically significant reductions in mean IOP and ocular medication use after combined phacoemulsification with single or double iStent implantation. The devices were found to be very safe, with a safety profile similar to that of cataract surgery. Complications were infrequent, with the most common complications being temporary stent obstruction or malposition, which resolved with observation or secondary procedures. Future studies are needed to evaluate long-term outcomes, patient satisfaction, cost effectiveness, and expanded indications. PMID:25284980

The NHLBI Retrovirus Epidemiology Donor Studies (REDS and REDS-II): Twenty years of research to advance blood product safety and availability

PubMed Central

Kleinman, Steven; King, Melissa R; Busch, Michael P; Murphy, Edward L; Glynn, Simone A.

2012-01-01

The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989–2001, and the Retrovirus Epidemiology Donor Study-II (REDS-II), conducted from 2004–2012, were National Heart Lung and Blood Institute (NHLBI) funded multicenter programs focused on improving blood safety and availability in the United States. REDS-II also included international study sites in Brazil and China. The three major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as XMRV. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of HIV, HTLV I/II, HCV, HBV, WNV, CMV, HHV-8, B19V, malaria, CJD, influenza, and T. cruzi infections. Other analyses have characterized: blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors’ perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, two large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these two REDS programs. In 2011, a new seven year program, the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III), was launched. REDS-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting, and adds a third country, South Africa, to the international program. PMID:22633182

A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures.

PubMed

Saxena, Payal; Diehl, David L; Kumbhari, Vivek; Shieh, Frederick; Buscaglia, Jonathan M; Sze, Wilson; Kapoor, Sumit; Komanduri, Srinadh; Nasr, John; Shin, Eun Ji; Singh, Vikesh; Lennon, Anne Marie; Kalloo, Anthony N; Khashab, Mouen A

2015-11-01

Endoscopic therapy is considered first line for management of benign biliary strictures (BBSs). Placement of plastic stents has been effective but limited by their short-term patency and need for repeated procedures. Fully covered self-expandable metallic stents (FCSEMSs) offer longer-lasting biliary drainage without the need for frequent exchanges. The aim of this study was to assess the efficacy and safety of FCSEMS in patients with BBS. A retrospective review of all patients who underwent ERCP and FCSEMS placement at five tertiary referral US hospitals was performed. Stricture resolution and adverse events related to ERCP and/or stenting were recorded. A total of 123 patients underwent FCSEMS placement for BBS and 112 underwent a subsequent follow-up ERCP. The mean age was 62 years (±15.6), and 57% were males. Stricture resolution occurred in 81% of patients after a mean of 1.2 stenting procedures (mean stent dwell time 24.4 ± 2.3 weeks), with a mean follow-up of 18.5 months. Stricture recurrence occurred in 5 patients, and 3 patients required surgery for treatment of refractory strictures. Stent migration (9.7%) was the most common complication, followed by stent occlusion (4.9%), cholangitis (4.1%), and pancreatitis (3.3%). There was one case of stent fracture during removal, and one stent could not be removed. There was one death due to cholangitis. Majority of BBS can be successfully managed with 1-2 consecutive FCSEMS with stent dwell time of 6 months.

The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

PubMed

Morrato, Elaine H; Ling, Sarah B

2012-11-01

The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making. We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods. DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA. Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.

Innovation in the safety net: integrating community health centers through accountable care.

PubMed

Lewis, Valerie A; Colla, Carrie H; Schoenherr, Karen E; Shortell, Stephen M; Fisher, Elliott S

2014-11-01

Safety net primary care providers, including as community health centers, have long been isolated from mainstream health care providers. Current delivery system reforms such as Accountable Care Organizations (ACOs) may either reinforce the isolation of these providers or may spur new integration of safety net providers. This study examines the extent of community health center involvement in ACOs, as well as how and why ACOs are partnering with these safety net primary care providers. Mixed methods study pairing the cross-sectional National Survey of ACOs (conducted 2012 to 2013), followed by in-depth, qualitative interviews with a subset of ACOs that include community health centers (conducted 2013). One hundred and seventy-three ACOs completed the National Survey of ACOs. Executives from 18 ACOs that include health centers participated in in-depth interviews, along with leadership at eight community health centers participating in ACOs. Key survey measures include ACO organizational characteristics, care management and quality improvement capabilities. Qualitative interviews used a semi-structured interview guide. Interviews were recorded and transcribed, then coded for thematic content using NVivo software. Overall, 28% of ACOs include a community health center (CHC). ACOs with CHCs are similar to those without CHCs in organizational structure, care management and quality improvement capabilities. Qualitative results showed two major themes. First, ACOs with CHCs typically represent new relationships or formal partnerships between CHCs and other local health care providers. Second, CHCs are considered valued partners brought into ACOs to expand primary care capacity and expertise. A substantial number of ACOs include CHCs. These results suggest that rather than reinforcing segmentation of safety net providers from the broader delivery system, the ACO model may lead to the integration of safety net primary care providers.

The Use of Crow-AMSAA Plots to Assess Mishap Trends

NASA Technical Reports Server (NTRS)

Dawson, Jeffrey W.

2011-01-01

Crow-AMSAA (CA) plots are used to model reliability growth. Use of CA plots has expanded into other areas, such as tracking events of interest to management, maintenance problems, and safety mishaps. Safety mishaps can often be successfully modeled using a Poisson probability distribution. CA plots show a Poisson process in log-log space. If the safety mishaps are a stable homogenous Poisson process, a linear fit to the points in a CA plot will have a slope of one. Slopes of greater than one indicate a nonhomogenous Poisson process, with increasing occurrence. Slopes of less than one indicate a nonhomogenous Poisson process, with decreasing occurrence. Changes in slope, known as "cusps," indicate a change in process, which could be an improvement or a degradation. After presenting the CA conceptual framework, examples are given of trending slips, trips and falls, and ergonomic incidents at NASA (from Agency-level data). Crow-AMSAA plotting is a robust tool for trending safety mishaps that can provide insight into safety performance over time.

Organized labor and the origins of the Occupational Safety and Health Act.

PubMed

Asher, Robert

2014-11-01

New Solutions is republishing this 1991 article by Robert Asher, which reviews the history of organized labor's efforts in the United States to secure health and safety protections for workers. The 1877 passage of the Massachusetts factory inspection law and the implementation of primitive industrial safety inspection systems in many states paralleled labor action for improved measures to protect workers' health and safety. In the early 1900s labor was focusing on workers' compensation laws. The New Deal expanded the federal government's role in worker protection, supported at least by the Congress of Industrial Organizations (CIO), but challenged by industry and many members of the U.S. Congress. The American Federation of Labor (AFL) and the CIO backed opposing legal and inspection strategies in the late 1940s and through the 1950s. Still, by the late 1960s, several unions were able to help craft the Occupational Safety and Health Act of 1970 and secure new federal protections for U.S. workers.

Control Oriented Modeling and Validation of Aeroservoelastic Systems

NASA Technical Reports Server (NTRS)

Crowder, Marianne; deCallafon, Raymond (Principal Investigator)

2002-01-01

Lightweight aircraft design emphasizes the reduction of structural weight to maximize aircraft efficiency and agility at the cost of increasing the likelihood of structural dynamic instabilities. To ensure flight safety, extensive flight testing and active structural servo control strategies are required to explore and expand the boundary of the flight envelope. Aeroservoelastic (ASE) models can provide online flight monitoring of dynamic instabilities to reduce flight time testing and increase flight safety. The success of ASE models is determined by the ability to take into account varying flight conditions and the possibility to perform flight monitoring under the presence of active structural servo control strategies. In this continued study, these aspects are addressed by developing specific methodologies and algorithms for control relevant robust identification and model validation of aeroservoelastic structures. The closed-loop model robust identification and model validation are based on a fractional model approach where the model uncertainties are characterized in a closed-loop relevant way.

Beyond engagement in working with children in eight Nairobi slums to address safety, security, and housing: Digital tools for policy and community dialogue.

PubMed

Mitchell, Claudia; Chege, Fatuma; Maina, Lucy; Rothman, Margot

2016-01-01

This article studies the ways in which researchers working in the area of health and social research and using participatory visual methods might extend the reach of participant-generated creations such as photos and drawings to engage community leaders and policy-makers. Framed as going 'beyond engagement', the article explores the idea of the production of researcher-led digital dialogue tools, focusing on one example, based on a series of visual arts-based workshops with children from eight slums in Nairobi addressing issues of safety, security, and well-being in relation to housing. The authors conclude that there is a need for researchers to embark upon the use of visual tools to expand the life and use of visual productions, and in particular to ensure meaningful participation of communities in social change.

Use of contrast media in computed tomography and magnetic resonance imaging in horses: Techniques, adverse events and opportunities.

PubMed

Nelson, B B; Goodrich, L R; Barrett, M F; Grinstaff, M W; Kawcak, C E

2017-07-01

The use of contrast media in computed tomography (CT) and magnetic resonance imaging (MRI) is increasing in horses. These contrast-enhanced imaging techniques provide improved tissue delineation and evaluation, thereby expanding diagnostic capabilities. While generally considered safe, not all contrast media exhibit the same safety profiles. The safety of contrast media use and descriptions of adverse events occurring in horses are sparsely reported. This review summarises the reported evidence of contrast media use and adverse events that occur in horses, with added contribution from other veterinary species and studies in man for comparison. This comprehensive data set empowers equine clinicians to develop use and monitoring strategies when working with contrast media. Finally, it summarises the current state-of-the-art and highlights the potential applications of contrast-enhanced CT and MRI for assessment of diseased or injured equine tissues, as well as (patho)physiological processes. © 2017 EVJ Ltd.

Efficacy and safety of a new fully covered self-expandable non-foreshortening metal esophageal stent.

PubMed

Dua, Kulwinder S; Latif, Sahibzada U; Yang, Juliana F; Fang, Tom C; Khan, Abdul; Oh, Young

2014-10-01

Fully covered esophageal self-expandable metal stents (SEMSs) are potentially removable but can be associated with high migration rates. For precise positioning, non-foreshortening SEMSs are preferred. Recently, a new fully covered non-foreshortening SEMS with anti-migration features was introduced. To evaluate the efficacy and safety of this new esophageal SEMS. Retrospective study. Single, tertiary-care center. Consecutive patients with malignant and benign strictures with dysphagia grade of ≥3 and patients with fistulas/leaks were studied. Stent placement and removal. Technical success in stent deployment/removal, efficacy in relieving dysphagia and sealing fistulas/leaks, and adverse events. Forty-three stents were placed in 35 patients (mean [± standard deviation] age 65 ± 11 years; 31 male), 24 for malignant and 11 for benign (5 strictures, 6 leaks) indications. Technical success in precise SEMS placement was 100%. The after-stent dysphagia grade improved significantly (at 1 week: 1.5 ± 0.7; at 4 weeks: 1.2 ± 0.4; baseline: 3.8 ± 0.4; P < .0001). Twenty stents were removed for clinical indications, with technical success of 100%. All leaks sealed after SEMS placement and did not recur after stent removal. All benign strictures recurred after stent removal. Adverse events included migration (14%), chest pain (11%), and dysphagia from tissue hyperplasia (6%). There was no stent-related mortality. Nonrandomized, single-center study. The new esophageal SEMS was effective in relieving malignant dysphagia, allowed for precise placement, and was easily removable. It was effective in treating benign esophageal fistulas and leaks. Stent-related adverse events were acceptable. Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Disclosure and Fit Capability of the Filtering Facepiece Respirator.

PubMed

Lofgren, Don J

2018-05-01

The filtering facepiece air-purifying respirator is annually purchased in the tens of millions and widely used for worker protection from harmful airborne particulates. The workplace consumers of this safety product, i.e., employers, workers, and safety and health professionals, have assurances of its effectiveness through the respirator certification and disclosure requirements of the National Institute for Occupational Safety and Health. However, the certification of a critical performance requirement has been missing for the approved filtering facepiece respirator since 1995: fit capability. Without this certification, consumers continue to be at risk of purchasing a respirator model that may fit a small percentage of the intended users. This commentary updates and expands an earlier one by this author, addresses the consequences of poorly fitting certified models on the market and lack of disclosure, and calls for further action by National Institute for Occupational Safety and Health to meet the needs and expectations of the consumer.

Safety in Acute Pain Medicine-Pharmacologic Considerations and the Impact of Systems-Based Gaps.

PubMed

Weingarten, Toby N; Taenzer, Andreas H; Elkassabany, Nabil M; Le Wendling, Linda; Nin, Olga; Kent, Michael L

2018-05-02

In the setting of an expanding prevalence of acute pain medicine services and the aggressive use of multimodal analgesia, an overview of systems-based safety gaps and safety concerns in the setting of aggressive multimodal analgesia is provided below. Expert commentary. Recent evidence focused on systems-based gaps in acute pain medicine is discussed. A focused literature review was conducted to assess safety concerns related to commonly used multimodal pharmacologic agents (opioids, nonsteroidal anti-inflammatory drugs, gabapentanoids, ketamine, acetaminophen) in the setting of inpatient acute pain management. Optimization of systems-based gaps will increase the probability of accurate pain assessment, improve the application of uniform evidence-based multimodal analgesia, and ensure a continuum of pain care. While acute pain medicine strategies should be aggressively applied, multimodal regimens must be strategically utilized to minimize risk to patients and in a comorbidity-specific fashion.

An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

PubMed

Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

2016-01-01

As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

Orbital transfer vehicle concept definition and systems analysis study. Volume 11: Study extension 2 results

NASA Technical Reports Server (NTRS)

Willcockson, W. H.

1988-01-01

Work conducted in the second extension of the Phase A Orbit Transfer Vehicle Concept Definition and Systems Analysis Study is summarized. Four major tasks were identified: (1) define an initial OTV program consistent with near term Civil Space Leadership Initiative missions; (2) develop program evolution to long term advanced missions; (3) investigate the implications of current STS safety policy on an Aft Cargo Carrier based OTV; and (4) expand the analysis of high entry velocity aeroassist. An increased emphasis on the breath of OTV applications was undertaken to show the need for the program on the basis of the expansion of the nation's capabilities in space.

Telemedicine to promote patient safety: Use of phone-based interactive voice response system (IVRS) to reduce adverse safety events in predialysis CKD

PubMed Central

Weiner, Shoshana; Fink, Jeffery C.

2017-01-01

Chronic kidney disease (CKD) patients have several features conferring upon them a high risk of adverse safety events, which are defined as incidents with unintended harm related to processes of care or medications. These characteristics include impaired renal function, polypharmacy, and frequent health system encounters. The consequences of such events in CKD can include new or prolonged hospitalization, accelerated renal function loss, acute kidney injury, end-stage renal disease and death. Health information technology administered via telemedicine presents opportunities for CKD patients to remotely communicate safety-related findings to providers for the purpose of improving their care. However, many CKD patients have limitations which hinder their use of telemedicine and access to the broad capabilities of health information technology. In this review we summarize previous assessments of the pre-dialysis CKD populations’ proficiency in using telemedicine modalities and describe the use of interactive voice-response system (IVRS) to gauge the safety phenotype of the CKD patient. We discuss the potential for expanded IVRS use in CKD to address the safety threats inherent to this population. PMID:28224940

How do we keep our residents safe? An educational intervention.

PubMed

Wasser, Tobias D

2015-02-01

Recent evidence suggests that 25-64 % of psychiatry residents are the victims of assault by patients; only a minority, however, feel they receive adequate safety and violence training during residency. To address this disparity, the author designed, implemented, and assessed the effectiveness of a brief educational intervention focused on improving the residents' ability to recognize violence risk and increase attention to safety in the psychiatric interview. The subjects were 13 second-year psychiatry residents. Effectiveness was evaluated via the assessment of the residents' written responses describing their first clinical intervention after hearing a case vignette of a potentially violent patient (before and 1 month following the intervention). Responses were evaluated for any evidence of concerns for safety. The number of residents citing safety concerns increased (38 to 92 %), as did the level of sophistication in their proposed interventions. A brief educational intervention focused on violence risk and interview safety may be effective in increasing residents' attention to safety concerns in their clinical care, and further work will be beneficial to confirm and expand upon these findings.

[Application of supply chain integration management of medical consumables].

PubMed

Zhang, Jian

2013-07-01

This paper introduces the background, the content, the information management system of material supply chain integration management and the consumables management process. The system helps to expand the selection of hospital supplies varieties, to reduce consumables management costs, to improve the efficiency of supplies, to ensure supplies safety, reliability and traceability.

78 FR 54775 - Bulk Packaging To Allow for Transfer of Hazardous Liquid Cargoes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... the selection and use of packaging in the transportation of hazardous materials. This rule will... Pipeline and Hazardous Materials Safety Administration SBA Small Business Administration U.S.C. United... materials to and from bulk packaging on vessels. The Coast Guard is expanding the list of bulk packaging...

A review of the current state-of-the-art methodology for handling bias and uncertainty in performing criticality safety evaluations. Final report

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

Disney, R.K.

1994-10-01

The methodology for handling bias and uncertainty when calculational methods are used in criticality safety evaluations (CSE`s) is a rapidly evolving technology. The changes in the methodology are driven by a number of factors. One factor responsible for changes in the methodology for handling bias and uncertainty in CSE`s within the overview of the US Department of Energy (DOE) is a shift in the overview function from a ``site`` perception to a more uniform or ``national`` perception. Other causes for change or improvement in the methodology for handling calculational bias and uncertainty are; (1) an increased demand for benchmark criticalsmore » data to expand the area (range) of applicability of existing data, (2) a demand for new data to supplement existing benchmark criticals data, (3) the increased reliance on (or need for) computational benchmarks which supplement (or replace) experimental measurements in critical assemblies, and (4) an increased demand for benchmark data applicable to the expanded range of conditions and configurations encountered in DOE site restoration and remediation.« less

Exploring Science Applications for Unmanned Aircraft Systems Aboard UNOLS Ships

NASA Astrophysics Data System (ADS)

Bailey, R.; Lachenmeier, T.; Hatfield, M. C.

2014-12-01

The University of Alaska Fairbanks has been expanding the use of small Unmanned Aircraft Systems (UAS) for science support from a variety of ships for several years. The ease and safety of flying from research vessels offers the science community lower cost access to overhead surveys of marine mammals without impact on sensitive populations, monitoring of AUV operations and collection of transmitted data, extensive surveys of sea ice during formation, melt, and sea temperatures through multiple seasons. As FAA expands access to the Arctic airspace over the Chukchi, Beaufort, and Bering Seas, the opportunities to employ UAS in science applications will become easier to exploit. This presentation describes the changes coming through new FAA rules, through the Alaska FAA Test Site, the Pan-Pacific UAS Test Range Complex which includes Oregon and Hawaii, and even Iceland. Airspace access advances associated with recent operations including the NASA-sponsored MIZOPEX, whale detection, and forming sea ice work in October will be presented, as well as a glider UAS connected to very high altitude balloons collecting atmospheric data. Development of safety procedures for use of UAS on UNOLS ships will be discussed.

No-fault compensation in New Zealand: harmonizing injury compensation, provider accountability, and patient safety.

PubMed

Bismark, Marie; Paterson, Ron

2006-01-01

In 1974 New Zealand jettisoned a tort-based system for compensating medical injuries in favor of a government-funded compensation system. Although the system retained some residual fault elements, it essentially barred medical malpractice litigation. Reforms in 2005 expanded eligibility for compensation to all "treatment injuries," creating a true no-fault compensation system. Compared with a medical malpractice system, the New Zealand system offers more-timely compensation to a greater number of injured patients and more-effective processes for complaint resolution and provider accountability. The unfinished business lies in realizing its full potential for improving patient safety.

An Updated Examination of Aviation Accidents Associated with Turbulence, Wind Shear and Thunderstorm

NASA Technical Reports Server (NTRS)

Evans, Joni K.

2014-01-01

One of the technical challenges within the Atmospheric Environment Safety Technologies (AEST) Project of the Aviation Safety Program was to "improve and expand remote sensing and mitigation of hazardous atmospheric environments and phenomena"1. In 2012, the author performed an analysis comparing various characteristics of accidents associated with different types of atmospheric hazard environments2. This document reports an update to that analysis which was done in preparation for presenting these findings at the 2015 annual meeting of the Transportation Research Board. Specifically, an additional three years of data were available, and a time-trend analysis was added.

Fast kinetics of magnesium monochloride cations in interlayer-expanded titanium disulfide for magnesium rechargeable batteries

DOE PAGES

Yoo, Hyun Deog; Liang, Yanliang; Dong, Hui; ...

2017-08-24

Magnesium rechargeable batteries potentially offer high-energy density, safety, and low cost due to the ability to employ divalent, dendrite-free, and earth-abundant magnesium metal anode. Despite recent progress, further development remains stagnated mainly due to the sluggish scission of magnesium-chloride bond and slow diffusion of divalent magnesium cations in cathodes. Here in this paper we report a battery chemistry that utilizes magnesium monochloride cations in expanded titanium disulfide. Combined theoretical modeling, spectroscopic analysis, and electrochemical study reveal fast diffusion kinetics of magnesium monochloride cations without scission of magnesium-chloride bond. The battery demonstrates the reversible intercalation of 1 and 1.7 magnesium monochloridemore » cations per titanium at 25 and 60 °C, respectively, corresponding to up to 400 mAh g -1 capacity based on the mass of titanium disulfide. The large capacity accompanies with excellent rate and cycling performances even at room temperature, opening up possibilities for a variety of effective intercalation hosts for multivalent-ion batteries.« less

Assessing causality in drug policy analyses: How useful are the Bradford Hill criteria in analysing take-home naloxone programs?

PubMed

Olsen, Anna; McDonald, David; Lenton, Simon; Dietze, Paul M

2018-05-01

The Bradford Hill criteria for assessing causality are useful in assembling evidence, including within complex policy analyses. In this paper, we argue that the implementation of take-home naloxone (THN) programs in Australia and elsewhere reflects sensible, evidence-based public health policy, despite the absence of randomised controlled trials. However, we also acknowledge that the debate around expanding access to THN would benefit from a careful consideration of causal inference and health policy impact of THN program implementation. Given the continued debate around expanding access to THN, and the relatively recent access to new data from implementation studies, two research groups independently conducted Bradford Hill analyses in order to carefully consider causal inference and health policy impact. Hill's criteria offer a useful analytical tool for interpreting current evidence on THN programs and making decisions about the (un)certainty of THN program safety and effectiveness. © 2017 Australasian Professional Society on Alcohol and other Drugs.

Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

PubMed

Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

2018-01-01

The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

Study of knowledge and attitudes on medical abortion among Chinese health providers.

PubMed

Cheng, Yimin; Zhou, You; Zhang, Ying; Jiang, Xiaomei; Xi, Maomao; Gan, Kang; Ren, Shanshan

2012-09-01

To investigate providers' knowledge and attitudes about medical abortion (MA) and their views regarding the main challenges to expanding the use of MA in urban and rural areas in China. A total of 658 abortion providers were surveyed from November 7, 2009, to May 29, 2010. The providers' knowledge about MA was relatively poor, and most thought the risks of severe complications of MA were much higher than they are. Urban nonphysician providers were the least informed about MA. Most providers thought that the main challenges to an expanded use of MA were its lesser effectiveness in comparison to surgical abortion and women's lack of knowledge about it. In rural areas many providers thought that deficiencies of clinics, such as limited bed space and inadequate toilets and washing facilities, also posed serious obstacles to expanding MA use. Abortion providers, especially urban nonphysician providers, need refresher training to strengthen their knowledge of the approved protocol for providing MA in China, and also of the indications, contraindications, and safety and efficacy of the method. Deficiencies at abortion facilities should be addressed as well, and they are more numerous in rural areas. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

The growth of partnerships to support patient safety practice adoption.

PubMed

Mendel, Peter; Damberg, Cheryl L; Sorbero, Melony E S; Varda, Danielle M; Farley, Donna O

2009-04-01

To document the numbers and types of interorganizational partnerships within the national patient safety domain, changes over time in these networks, and their potential for disseminating patient safety knowledge and practices. Self-reported information gathered from representatives of national-level organizations active in promoting patient safety. Social network analysis was used to examine the structure and composition of partnership networks and changes between 2004 and 2006. Two rounds of structured telephone interviews (n=35 organizations in 2004 and 55 in 2006). Patient safety partnerships expanded between 2004 and 2006. The average number of partnerships per interviewed organization increased 40 percent and activities per reported partnership increased over 50 percent. Partnerships increased in all activity domains, particularly dissemination and tools development. Fragmentation of the overall partnership network decreased and potential for information flow increased. Yet network centralization increased, suggesting vulnerability to partnership failure if key participants disengage. Growth in partnerships signifies growing strength in the capacity to disseminate and implement patient safety advancements in the U.S. health care system. The centrality of AHRQ in these networks of partnerships bodes well for its leadership role in disseminating information, tools, and practices generated by patient safety research projects.

Stability of the anterior arm of three different Hyrax hybrid expanders: an in vitro study

PubMed Central

de la Iglesia, Gonzalo; Walter, André; de la Iglesia, Fernando; Winsauer, Heinz; Puigdollers, Andreu

2018-01-01

ABSTRACT Introduction: The force applied to the teeth by fixed orthopaedic expanders has previously been studied, but not the force applied to the orthodontic mini-implant (OMI) used to expand the maxilla with Hyrax hybrid expanders (HHE). Objective: The aim of this article was to evaluate the clinical safety of the components (OMI, abutment and double wire arms) of three different force-transmitting systems (FTS) for conducting orthopaedic maxillary expansion: Jeil Medical & Tiger Dental™, Microdent™ and Ortholox™. Methods: For the realization of this in vitro study of the resistance to mechanical load, three different abutment types (bonded, screwed on, and coupling) and three different OMIs’ diameters (Jeil™ 2.5 mm, Microdent™ 1.6 mm and Ortholox™ 2.2 mm) were used. Ten tests for each of these three FTS were carried out in a static lateral load in artificial bone blocks (Sawbones™) by a Galdabini universal testing machine, then comparing its performance. Comparisons of loads, deformations and fractures were carried out by means of radiographs of FTS components in each case. Results: At 1- mm load and within the elastic deformation, FTS values ranged from 67 ± 13 N to 183 ± 48 N. Under great deformations, Jeil & Tiger™ was the one who withstood the greatest loads, with an average 378 ± 22 N; followed by Microdent™, with 201 ± 18 N, and Ortholox™, with 103 ± 10 N. At 3 mm load, the OMIs shaft bends and deforms when the diameter is smaller than 2.5 mm. The abutment fixation is crucial to transmit forces and moments. Conclusions: The present study shows the importance of a rigid design of the different components of HHEs, and also that HHEs would be suitable for maxillary expansion in adolescents and young adults, since its mean expansion forces exceed 120N. Furthermore, early abutment detachment or smaller mini-implants diameter would only be appropriate for children. PMID:29791684

Are signalized intersections with cycle tracks safer? A case-control study based on automated surrogate safety analysis using video data.

PubMed

Zangenehpour, Sohail; Strauss, Jillian; Miranda-Moreno, Luis F; Saunier, Nicolas

2016-01-01

Cities in North America have been building bicycle infrastructure, in particular cycle tracks, with the intention of promoting urban cycling and improving cyclist safety. These facilities have been built and expanded but very little research has been done to investigate the safety impacts of cycle tracks, in particular at intersections, where cyclists interact with turning motor-vehicles. Some safety research has looked at injury data and most have reached the conclusion that cycle tracks have positive effects of cyclist safety. The objective of this work is to investigate the safety effects of cycle tracks at signalized intersections using a case-control study. For this purpose, a video-based method is proposed for analyzing the post-encroachment time as a surrogate measure of the severity of the interactions between cyclists and turning vehicles travelling in the same direction. Using the city of Montreal as the case study, a sample of intersections with and without cycle tracks on the right and left sides of the road were carefully selected accounting for intersection geometry and traffic volumes. More than 90h of video were collected from 23 intersections and processed to obtain cyclist and motor-vehicle trajectories and interactions. After cyclist and motor-vehicle interactions were defined, ordered logit models with random effects were developed to evaluate the safety effects of cycle tracks at intersections. Based on the extracted data from the recorded videos, it was found that intersection approaches with cycle tracks on the right are safer than intersection approaches with no cycle track. However, intersections with cycle tracks on the left compared to no cycle tracks seem to be significantly safer. Results also identify that the likelihood of a cyclist being involved in a dangerous interaction increases with increasing turning vehicle flow and decreases as the size of the cyclist group arriving at the intersection increases. The results highlight the important role of cycle tracks and the factors that increase or decrease cyclist safety. Results need however to be confirmed using longer periods of video data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Human Adipose‐Derived Stem Cells Expanded Under Ambient Oxygen Concentration Accumulate Oxidative DNA Lesions and Experience Procarcinogenic DNA Replication Stress

PubMed Central

Renoud, Marie‐Laure; Hoede, Claire; Gonzalez, Ignacio; Jones, Natalie; Longy, Michel; Sensebé, Luc; Cazaux, Christophe

2016-01-01

Abstract Adipose‐derived stem cells (ADSCs) have led to growing interest in cell‐based therapy because they can be easily harvested from an abundant tissue. ADSCs must be expanded in vitro before transplantation. This essential step causes concerns about the safety of adult stem cells in terms of potential transformation. Tumorigenesis is driven in its earliest step by DNA replication stress, which is characterized by the accumulation of stalled DNA replication forks and activation of the DNA damage response. Thus, to evaluate the safety of ADSCs during ex vivo expansion, we monitored DNA replication under atmospheric (21%) or physiologic (1%) oxygen concentration. Here, by combining immunofluorescence and DNA combing, we show that ADSCs cultured under 21% oxygen accumulate endogenous oxidative DNA lesions, which interfere with DNA replication by increasing fork stalling events, thereby leading to incomplete DNA replication and fork collapse. Moreover, we found by RNA sequencing (RNA‐seq) that culture of ADSCs under atmospheric oxygen concentration leads to misexpression of cell cycle and DNA replication genes, which could contribute to DNA replication stress. Finally, analysis of acquired small nucleotide polymorphism shows that expansion of ADSCs under 21% oxygen induces a mutational bias toward deleterious transversions. Overall, our results suggest that expanding ADSCs at a low oxygen concentration could reduce the risk for DNA replication stress‐associated transformation, as occurs in neoplastic tissues. Stem Cells Translational Medicine 2017;6:68–76 PMID:28170194

Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma.

PubMed

Gore, M E; Szczylik, C; Porta, C; Bracarda, S; Bjarnason, G A; Oudard, S; Lee, S-H; Haanen, J; Castellano, D; Vrdoljak, E; Schöffski, P; Mainwaring, P; Hawkins, R E; Crinò, L; Kim, T M; Carteni, G; Eberhardt, W E E; Zhang, K; Fly, K; Matczak, E; Lechuga, M J; Hariharan, S; Bukowski, R

2015-06-30

We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%). Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.

Expansion of the visual angle of a car rear-view image via an image mosaic algorithm

NASA Astrophysics Data System (ADS)

Wu, Zhuangwen; Zhu, Liangrong; Sun, Xincheng

2015-05-01

The rear-view image system is one of the active safety devices in cars and is widely applied in all types of vehicles and traffic safety areas. However, studies made by both domestic and foreign researchers were based on a single image capture device while reversing, so a blind area still remained to drivers. Even if multiple cameras were used to expand the visual angle of the car's rear-view image in some studies, the blind area remained because different source images were not mosaicked together. To acquire an expanded visual angle of a car rear-view image, two charge-coupled device cameras with optical axes angled at 30 deg were mounted below the left and right fenders of a car in three light conditions-sunny outdoors, cloudy outdoors, and an underground garage-to capture rear-view heterologous images of the car. Then these rear-view heterologous images were rapidly registered through the scale invariant feature transform algorithm. Combined with the random sample consensus algorithm, the two heterologous images were finally mosaicked using the linear weighted gradated in-and-out fusion algorithm, and a seamless and visual-angle-expanded rear-view image was acquired. The four-index test results showed that the algorithms can mosaic rear-view images well in the underground garage condition, where the average rate of correct matching was the lowest among the three conditions. The rear-view image mosaic algorithm presented had the best information preservation, the shortest computation time and the most complete preservation of the image detail features compared to the mean value method (MVM) and segmental fusion method (SFM), and it was also able to perform better in real time and provided more comprehensive image details than MVM and SFM. In addition, it had the most complete image preservation from source images among the three algorithms. The method introduced by this paper provided the basis for researching the expansion of the visual angle of a car rear-view image in all-weather conditions.

Carotid Artery Stenting Using a Novel Self-Expanding Braided Nickel-Titanium Stent: Feasibility and Safety Porcine Trial

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

Ahlhelm, Frank, E-mail: frah1@gmx.de; Kaufmann, Ralf, E-mail: ralf.kaufmann@vascomed.d; Ahlhelm, Dirk, E-mail: ahlhelmd@gmx.de

We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular interventionmore » as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted.« less

Marginal lung donors: A diminishing margin of safety?

PubMed

Botha, Phil; Fisher, Andrew J; Dark, John H

2006-11-27

Lung donor shortages have resulted in the critical appraisal of cadaveric donor acceptability criteria and the gradual relaxation of once strict guidelines. Many centers have reported their results with these "extended criteria" donors and an increasing number of multicenter registry studies have also been published. The results have been contradictory and leave many questions unanswered. Important new data has however come to light since the last review of the subject by the International Society for Heart and Lung Transplantation Pulmonary Council. We review the current literature focusing on recent developments in the pursuit of an expanded lung donor pool with acceptable outcomes.

The SCALE Verified, Archived Library of Inputs and Data - VALID

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

Marshall, William BJ J; Rearden, Bradley T

The Verified, Archived Library of Inputs and Data (VALID) at ORNL contains high quality, independently reviewed models and results that improve confidence in analysis. VALID is developed and maintained according to a procedure of the SCALE quality assurance (QA) plan. This paper reviews the origins of the procedure and its intended purpose, the philosophy of the procedure, some highlights of its implementation, and the future of the procedure and associated VALID library. The original focus of the procedure was the generation of high-quality models that could be archived at ORNL and applied to many studies. The review process associated withmore » model generation minimized the chances of errors in these archived models. Subsequently, the scope of the library and procedure was expanded to provide high quality, reviewed sensitivity data files for deployment through the International Handbook of Evaluated Criticality Safety Benchmark Experiments (IHECSBE). Sensitivity data files for approximately 400 such models are currently available. The VALID procedure and library continue fulfilling these multiple roles. The VALID procedure is based on the quality assurance principles of ISO 9001 and nuclear safety analysis. Some of these key concepts include: independent generation and review of information, generation and review by qualified individuals, use of appropriate references for design data and documentation, and retrievability of the models, results, and documentation associated with entries in the library. Some highlights of the detailed procedure are discussed to provide background on its implementation and to indicate limitations of data extracted from VALID for use by the broader community. Specifically, external users of data generated within VALID must take responsibility for ensuring that the files are used within the QA framework of their organization and that use is appropriate. The future plans for the VALID library include expansion to include additional experiments from the IHECSBE, to include experiments from areas beyond criticality safety, such as reactor physics and shielding, and to include application models. In the future, external SCALE users may also obtain qualification under the VALID procedure and be involved in expanding the library. The VALID library provides a pathway for the criticality safety community to leverage modeling and analysis expertise at ORNL.« less

Preoperative biliary drainage using a fully covered self-expandable metallic stent for pancreatic head cancer: A prospective feasibility study.

PubMed

Togawa, Osamu; Isayama, Hiroyuki; Kawakami, Hiroshi; Nakai, Yousuke; Mohri, Dai; Hamada, Tsuyoshi; Kogure, Hirofumi; Kawakubo, Kazumichi; Sakamoto, Naoya; Koike, Kazuhiko; Kita, Hiroto

2018-01-01

The role of endoscopic preoperative biliary drainage (PBD) for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. This study was performed to evaluate the feasibility and safety of PBD using a fully covered self-expandable metallic stent (FCSEMS). This multicenter prospective study involved 26 patients treated for pancreatic head cancer with distal bile duct obstruction from April 2011 to March 2013. An FCSEMS was endoscopically placed in 24 patients. Among these, 7 patients were diagnosed with unresectable cancer, and 17 underwent surgery at a median of 18 days after FCSEMS placement. The main outcome measure was preoperative and postoperative adverse events. Two adverse events (cholecystitis and insufficient resolution of jaundice) occurred between FCSEMS placement and surgery (12%). Postoperative adverse events occurred in eight patients (47%). The cumulative incidence of stent-related adverse events 4 and 8 weeks after FCSEMS placement among the 24 patients who underwent this procedure were 19%. PBD using an FCSEMS is feasible in patients with resectable pancreatic head cancer. Placement of an FCSEMS can be an alternative PBD technique when surgery without delay is impossible. A larger randomized controlled trial is warranted.

Taking Psychedelics Seriously.

PubMed

Byock, Ira

2018-04-01

Psychiatric research in the 1950s and 1960s showed potential for psychedelic medications to markedly alleviate depression and suffering associated with terminal illness. More recent published studies have demonstrated the safety and efficacy of psilocybin, MDMA, and ketamine when administered in a medically supervised and monitored approach. A single or brief series of sessions often results in substantial and sustained improvement among people with treatment-resistant depression and anxiety, including those with serious medical conditions. Need and Clinical Considerations: Palliative care clinicians occasionally encounter patients with emotional, existential, or spiritual suffering, which persists despite optimal existing treatments. Such suffering may rob people of a sense that life is worth living. Data from Oregon show that most terminally people who obtain prescriptions to intentionally end their lives are motivated by non-physical suffering. This paper overviews the history of this class of drugs and their therapeutic potential. Clinical cautions, adverse reactions, and important steps related to safe administration of psychedelics are presented, emphasizing careful patient screening, preparation, setting and supervision. Even with an expanding evidence base confirming safety and benefits, political, regulatory, and industry issues impose challenges to the legitimate use of psychedelics. The federal expanded access program and right-to-try laws in multiple states provide precendents for giving terminally ill patients access to medications that have not yet earned FDA approval. Given the prevalence of persistent suffering and growing acceptance of physician-hastened death as a medical response, it is time to revisit the legitimate therapeutic use of psychedelics.

Leadership and Funding: Changes Ahead for Agricultural Safety and Health.

PubMed

Murphy, Dennis J; Lee, Barbara C

2018-01-01

For the last several decades, financial support for agricultural safety and health programs and professionals has primarily been covered by public dollars through federal and state government grant programs and appropriations. This federal and state funding provided a tremendous boost to farm safety and health professionals and program efforts for 30+ years and has provided the foundation and structure for current agricultural safety and health efforts and activities. However, there is reason to question long-term sustainability of a sufficient level of federal and state dollars for agricultural safety and health. Public funding for agricultural safety and health has never quite kept up to inflation, but even more ominous is that the entire agricultural safety and health program has been proposed for elimination each year by the White House budget beginning with the fiscal year 2012. It seems prudent, perhaps even imperative, for the agricultural safety and health community to find alternative support mechanisms. We suggest that now is a great time for agricultural businesses, services, and organizations to step up their financial support. Fortunately, several positive examples have recently surfaced within the agricultural community. As the agricultural industry continues to be a dominant enterprise in the United States, the integration of significant funding and the role of leadership from within the industry must continue to expand.

Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

PubMed

Roth, Eva; Rosenthal, Harald

2006-01-01

Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

.... ENDURANT STENT GRAFT SYSTEM. FDA-2011-M-0040 P100010 Medtronic Cryocath, ARCTIC FRONT December 17, 2010. LP.... Vascular. LX VASCULAR STENT SYSTEMS. FDA-2011-M-0039 P070026 Depuy, Inc......... CERAMAX CERAMIC HIP.... EXPANDABLE RENAL STENT SYSTEM. FDA-2011-M-0056 P090013 Medtronic, Inc..... REVO MRI SURESCAN IPG February 8...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

...] Fenestrated April 4, 2012. AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). P110029, FDA...\\ plus CoCr April 12, 2012. Coronary Stent on RX System. P110035, FDA-2012-M-0373 Boston Scientific Epic\\TM\\ Vascular Self- April 13, 2012. Corp. Expanding Stent System. P090015, FDA-2012-M-0390 Leica...

77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... 26, 2011. iliac balloon- expandable stent system. P100042, FDA-2011-M-0792 Gen-Probe APTIMA HPV assay..., 2011. XIENCE PRIME LL EVEROLIMUS-eluting coronary stent system. P100041, FDA-2011-M-0837 Edwards.... EVEROLIMUS-eluting platinum chromium coronary stent system. P100024, FDA-2011-M-0866 Dako Denmark A/S...

Professional Commitment, Ethical Reasoning, and the Belief in Regulatory Compliance as Perceived by Safety Professionals

ERIC Educational Resources Information Center

Wells, John W., Jr.

2012-01-01

The awareness of ethical business practices is becoming a focal point in both the business world and academia. As cross-cultural growth expands due to globalization, the perception of ethical behavior invites increasing scrutiny as society witnesses the changing global community. This ever-changing environment of demographics and globalization of…

The peanut genome consortium and peanut genome sequence: Creating a better future through global food security

USDA-ARS?s Scientific Manuscript database

The competitiveness of peanuts in domestic and global markets has been threatened by losses in productivity and quality that are attributed to diseases, pests, environmental stresses and allergy or food safety issues. The U.S. Peanut Genome Initiative (PGI) was launched in 2004, and expanded to a gl...

Consumer Product Category Database

EPA Pesticide Factsheets

The Chemical and Product Categories database (CPCat) catalogs the use of over 40,000 chemicals and their presence in different consumer products. The chemical use information is compiled from multiple sources while product information is gathered from publicly available Material Safety Data Sheets (MSDS). EPA researchers are evaluating the possibility of expanding the database with additional product and use information.

Demonstration Advanced Avionics System (DAAS). Phase 1 report

NASA Technical Reports Server (NTRS)

1981-01-01

An integrated avionics system which provides expanded functional capabilities that significantly enhance the utility and safety of general aviation at a cost commensurate with the general aviation market is discussed. Displays and control were designed so that the pilot can use the system after minimum training. Functional and hardware descriptions, operational evaluation and failure modes effects analysis are included.

Food safety intervention research at the Eastern Regional Research Center: innovative sanitizers, natural antimicrobials and nonthermal processing technologies

USDA-ARS?s Scientific Manuscript database

Foodborne pathogens such as Salmonella, Listeria monocytogenes and Escherichia coli O157:H7cause millions of illnesses every year. A variety of technologies have been advanced in recent years to expand on the suite of tools available to food processors. At the US Department of Agriculture’s Eastern ...

Patient Safety - Multiple Languages

MedlinePlus

... Cantonese dialect) (繁體中文) French (français) Hindi (हिन्दी) Japanese (日本語) Korean (한국어) Russian (Русский) Somali (Af-Soomaali ) ... हिन्दी (Hindi) Bilingual PDF Health Information Translations Japanese (日本語) Expand Section Appointment Reminder - 日本語 (Japanese) Bilingual ...

Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies.

PubMed

Mukai, Tsuyoshi; Yasuda, Ichiro; Isayama, Hiroyuki; Iwashita, Takuji; Itoi, Takao; Kawakami, Hiroshi; Kogure, Hirofumi; Nakai, Yousuke

2016-09-01

In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. © 2016 Japan Gastroenterological Endoscopy Society.

Covered Balloon-Expanding Stents in Airway Stenosis.

PubMed

Majid, Adnan; Kheir, Fayez; Chung, Jey; Alape, Daniel; Husta, Bryan; Oh, Scott; Folch, Erik

2017-04-01

The balloon-expanding stents are widely available but rarely described for use within the tracheobronchial tree. This report describes our experience with these stents in airway stenosis particularly as a lobar salvage therapy. This was a retrospective review of all records in which the balloon-expanding stents were used at a tertiary medical center. Ages, sex, location of stenosis, etiology of stenosis, stent size, duration of stent placement and associated interventions for airway stenosis were recorded. Patient's self-reported respiratory symptoms, dyspnea scale, and radiographic imaging at baseline and after stent placement were also reported. Twenty-one Atrium iCAST stents were inserted in 18 patients with malignant and benign airway disease. The median age was 69.5 years (interquartile range, 53.5 to 74). Most stents (n=20, 95%) were deployed in the lobar airways. There was a significant improvement in the modified Medical Research Council dyspnea scale from median of 3 to 2 (P<0.05). Self-reported respiratory symptoms improved in 14 patients (78%, P<0.05). Radiographic improvement post Atrium iCAST stent placement was achieved in 15 patients (83%). No deaths were related to airway stenting complications. Adverse events related to stents included migration (n=2, 9.5%), granulation tissue formation (n=2, 9.5%) and mucus plugging (n=1, 4.8%). Lobar stenting with balloon-expanding metallic stents appears feasible, safe and improves symptoms as well as radiographic atelectasis in patients with lobar airway stenosis in this small case series. Larger studies are needed to confirm this observation and to address long-term safety.

Analysis of the safety profile of treatment with a large number of shock waves per session in extracorporeal lithotripsy.

PubMed

Budía Alba, A; López Acón, J D; Polo-Rodrigo, A; Bahílo-Mateu, P; Trassierra-Villa, M; Boronat-Tormo, F

2015-06-01

To assess the safety of increasing the number of waves per session in the treatment of urolithiasis using extracorporeal lithotripsy. Prospective, comparative, nonrandomized parallel study of patients with renoureteral lithiasis and an indication for extracorporeal lithotripsy who were consecutively enrolled between 2009 and 2010. We compared group I (160 patients) treated on schedule with a standard number of waves/session (mean 2858,3±302,8) using a Dornier lithotripter U/15/50 against group II (172 patients) treated with an expanded number of waves/session (mean, 6728,9±889,6) using a Siemens Modularis lithotripter. The study variables were age, sex, location, stone size, number of waves/session and total number of waves to resolution, stone-free rate (SFR) and rate of complications (Clavien-Dindo classification). Student's t-test and the chi-squared test were employed for the statistical analysis. The total rate of complications was 11.9% and 10.46% for groups I and II, respectively (P=.39). All complications were minor (Clavien-Dindo grade I). The most common complications were colic pain and hematuria in groups I and II, respectively, with a similar treatment intolerance rate (P>.05). The total number of waves necessary was lower in group II than in group I (P=.001), with SFRs of 96.5% and 71.5%, respectively (P=.001). Treatment with an expanded number of waves per session in extracorporeal lithotripsy does not increase the rate of complications or their severity. However, it could increase the overall effectiveness of the treatment. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Functional safety for the Advanced Technology Solar Telescope

NASA Astrophysics Data System (ADS)

Bulau, Scott; Williams, Timothy R.

2012-09-01

Since inception, the Advanced Technology Solar Telescope (ATST) has planned to implement a facility-wide functional safety system to protect personnel from harm and prevent damage to the facility or environment. The ATST will deploy an integrated safety-related control system (SRCS) to achieve functional safety throughout the facility rather than relying on individual facility subsystems to provide safety functions on an ad hoc basis. The Global Interlock System (GIS) is an independent, distributed, facility-wide, safety-related control system, comprised of commercial off-the-shelf (COTS) programmable controllers that monitor, evaluate, and control hazardous energy and conditions throughout the facility that arise during operation and maintenance. The GIS has been designed to utilize recent advances in technology for functional safety plus revised national and international standards that allow for a distributed architecture using programmable controllers over a local area network instead of traditional hard-wired safety functions, while providing an equivalent or even greater level of safety. Programmable controllers provide an ideal platform for controlling the often complex interrelationships between subsystems in a modern astronomical facility, such as the ATST. A large, complex hard-wired relay control system is no longer needed. This type of system also offers greater flexibility during development and integration in addition to providing for expanded capability into the future. The GIS features fault detection, self-diagnostics, and redundant communications that will lead to decreased maintenance time and increased availability of the facility.

Novel expandable short dental implants in situations with reduced vertical bone height-technical note and first results.

PubMed

Reich, Waldemar; Schweyen, Ramona; Heinzelmann, Christian; Hey, Jeremias; Al-Nawas, Bilal; Eckert, Alexander Walter

2017-10-30

Short implants often have the disadvantage of reduced primary stability. The present study was conducted to evaluate the feasibility and safety of a new expandable short dental implant system intended to increase primary stability. As a "proof of concept", a prospective clinical cohort study was designed to investigate intraoperative handling, primary and secondary implant stability (resonance frequency analysis), crestal bone changes, implant survival and implant success, of an innovative short expandable screw implant. From 2014 until 2015, 9 patients (7-9-mm vertical bone height) with 30 implants (length 5-7 mm, diameter 3.75-4.1 mm) were recruited consecutively. All 30 implants in the 9 patients (age 44 to 80 years) could be inserted and expanded without intraoperative problems. Over the 3-year follow-up period, the implant success rate was 28/30 (93.3%). The mean implant stability quotients (ISQ) were as follows: primary stability, 69.7 ± 10.3 ISQ units, and secondary stability, 69.8 ± 10.2 ISQ units (p = 0.780), both without significant differences between the maxilla and mandible (p ≥ 0.780). The mean crestal bone changes after loading were (each measured from the baseline) as follows: in the first year, 1.0 ± 0.9 mm in the maxilla and 0.7 ± 0.4 mm in the mandible, and in the second year, 1.3 ± 0.8 mm and 1.0 ± 0.7 mm, respectively. Compared to other prospective studies, in this indication, the success rate is acceptable. Implant stability shows high initial and secondary stability values. The system might present an extension of functional rehabilitation to the group of elderly patients with limited vertical bone height. Further long-term investigations should directly compare this compressive implant with standard short implants.

Development of a new generation of high-resolution anatomical models for medical device evaluation: the Virtual Population 3.0

NASA Astrophysics Data System (ADS)

Gosselin, Marie-Christine; Neufeld, Esra; Moser, Heidi; Huber, Eveline; Farcito, Silvia; Gerber, Livia; Jedensjö, Maria; Hilber, Isabel; Di Gennaro, Fabienne; Lloyd, Bryn; Cherubini, Emilio; Szczerba, Dominik; Kainz, Wolfgang; Kuster, Niels

2014-09-01

The Virtual Family computational whole-body anatomical human models were originally developed for electromagnetic (EM) exposure evaluations, in particular to study how absorption of radiofrequency radiation from external sources depends on anatomy. However, the models immediately garnered much broader interest and are now applied by over 300 research groups, many from medical applications research fields. In a first step, the Virtual Family was expanded to the Virtual Population to provide considerably broader population coverage with the inclusion of models of both sexes ranging in age from 5 to 84 years old. Although these models have proven to be invaluable for EM dosimetry, it became evident that significantly enhanced models are needed for reliable effectiveness and safety evaluations of diagnostic and therapeutic applications, including medical implants safety. This paper describes the research and development performed to obtain anatomical models that meet the requirements necessary for medical implant safety assessment applications. These include implementation of quality control procedures, re-segmentation at higher resolution, more-consistent tissue assignments, enhanced surface processing and numerous anatomical refinements. Several tools were developed to enhance the functionality of the models, including discretization tools, posing tools to expand the posture space covered, and multiple morphing tools, e.g., to develop pathological models or variations of existing ones. A comprehensive tissue properties database was compiled to complement the library of models. The results are a set of anatomically independent, accurate, and detailed models with smooth, yet feature-rich and topologically conforming surfaces. The models are therefore suited for the creation of unstructured meshes, and the possible applications of the models are extended to a wider range of solvers and physics. The impact of these improvements is shown for the MRI exposure of an adult woman with an orthopedic spinal implant. Future developments include the functionalization of the models for specific physical and physiological modeling tasks.

Would Socrates Have Actually Used the "Socratic Method" for Clinical Teaching?

PubMed

Stoddard, Hugh A; O'Dell, David V

2016-09-01

Medical students and residents are familiar with clinical teaching methods in which a faculty member poses a series of questions to them. This technique is often called the "Socratic method," but it is frequently perceived by learners as an attempt to demean them, a practice that is colloquially known as "pimping." The distinction between Socratic teaching and pimping lies in the perception of "psychological safety." Psychological safety allows learners to answer questions or ask for help without threats to their dignity or worthiness. In a psychologically safe clinical teaching context, learners recognize that questions posed by attending physicians probe their current understanding and guide them to expand their knowledge. In pimping, questions are posed to embarrass the learner and to reinforce the teacher's position of power over them. Absent a threat of disparagement or condemnation, learners are able to focus on building schema for knowledge, skills, and attitudes, rather than worrying about shielding their self-worth. This article presents the proper Socratic method, as intended by Socrates, and contrasts it with pimping. This perspective defines psychological safety as the pivotal factor distinguishing Socratic teaching from pimping, and establishes the foundation for empirical studies of these common practices in medical education.

Participatory support to farmers in improving safety and health at work: building WIND farmer volunteer networks in Viet Nam.

PubMed

Kawakami, Tsuyoshi; Van, Vhu Nhu; Theu, Nguyen Van; Khai, Ton That; Kogi, Kazutaka

2008-10-01

The government of Viet Nam places a high priority on upgrading the quality of farmers' lives. Providing adequate occupational safety and health (OSH) protection for all farmers is an important challenge. The Ministry of Labour, Invalids and Social Affairs (MOLISA) of Viet Nam trained WIND (Work Improvement in Neighbourhood Development) farmer volunteers. From 2004-2007, MOLISA in cooperation with ministries of health and agriculture trained 480 WIND farmer volunteers in selected 14 provinces. Trained farmer volunteers trained their neighbouring farmers and expanded their networks. The WIND training programme produced in Cantho, Viet Nam in 1996, was used as the core training methodology. The WIND action-checklist, good example photo-sheets, and other participatory training materials were designed for WIND farmer volunteers as practical training tools. The volunteers trained 7,922 farmers. The trained farmers implemented 28,508 improvements in materials handling, work posture, machine and electrical safety, working environments and control of hazardous chemicals, and welfare facilities. The provincial support committees organized follow-up workshops and strengthen the WIND farmer volunteer networks. The system of WIND farmer volunteers proved effective in extending practical OSH protection measures to farmers at grassroots level. The system of WIND farmer volunteers was adopted in the First National Programme on Labour Protection and OSH of Viet Nam as a practical means in OSH and is now further expanding within the framework of the National Programme.

Verteporfin therapy in age-related macular degeneration (VAM): an open-label multicenter photodynamic therapy study of 4,435 patients.

PubMed

Bessler, Neil M

2004-08-01

To provide broad clinical experience and to gather safety data on photodynamic therapy with verteporfin (Visudyne, Novartis AG, Basel, Switzerland), also termed verteporfin therapy, in patients with predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The Verteporfin in Age-related Macular Degeneration (VAM) Study was designed to provide expanded access to verteporfin therapy after beneficial results for these cases were reported but before regulatory approval in North America. This open-label multicenter study from September 1999 through June 2000 enrolled among 222 centers patients 50 years or older in the United States, or 40 years or older in Canada, with age-related macular degeneration and subfoveal CNV with a lesion composition that was predominantly classic CNV on fluorescein angiography. Corrected visual acuity with habitual eyewear in the office setting was 20/40 to 20/200, inclusive. All patients received verteporfin therapy and returned for follow-up every 3 months. At those follow-up examinations, additional courses of treatment were recommended if any fluorescein leakage from CNV was identified. Safety information was collected from patient self-reporting, questioning (in person and by telephone), and physician evaluation. Safety was assessed by evaluating the effect of treatment on corrected distance visual acuity and by evaluating adverse events. A total of 4,435 patients were enrolled of whom 4,051 (91%) completed the study after receiving 6,701 treatments. Most patients received only one treatment in VAM before regulatory approval of verteporfin in the United States and Canada. Three hundred patients (6.8%) experienced an adverse event considered by the treating ophthalmologist to be associated with treatment, including 115 (2.6%) with abnormal or decreased vision, of whom 25 (0.6%) experienced acute severe visual acuity decrease, and 14 (0.3%) with transient infusion-related back pain. Patients were advised to avoid exposure to direct sunlight for 24 hours; however, after verteporfin administration only 2 (0.05%) reported a photosensitivity reaction. An additional course of verteporfin therapy was administered to 1,739 of 2,314 patients (75.2%) who had a month 3 examination that was not their close-out visit and 177 of 266 (66.5%) who had a month 6 examination that was not their close-out visit. Verteporfin therapy exhibited no additional or new safety concerns. The therapy associated with a low incidence of adverse events when expanded access was provided in a large, open-label, multicenter study, including a low incidence (0.05%) of reported photosensitivity reactions despite a short photosensitivity protection period (24 hours) following verteporfin administration.

Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video).

PubMed

Park, Do Hyun; Kim, Myung-Hwan; Moon, Sung-Hoon; Lee, Sang Soo; Seo, Dong-Wan; Lee, Sung-Koo

2008-12-01

Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia. We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures. A prospective pilot and feasibility study. A tertiary academic center. Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology. ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. End points were feasibility, safety, and morbidity. Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent migration. Small patient populations without long-term follow-up. Two-month placement of FCSEMSs in patients with refractory benign pancreatic ductal strictures may be feasible and relatively safe. However, stent migration was not uncommon. A further investigation with ideal stent design may therefore be needed before recommending FCSEMSs as a therapeutic option for refractory benign pancreatic ductal strictures.

Posttest analysis of the FFTF inherent safety tests

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

Padilla, A. Jr.; Claybrook, S.W.

Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactormore » and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code.« less

Unmanned aerial vehicles in construction and worker safety.

PubMed

Howard, John; Murashov, Vladimir; Branche, Christine M

2018-01-01

Applications of unmanned aerial vehicles (UAVs) for military, recreational, public, and commercial uses have expanded significantly in recent years. In the construction industry, UAVs are used primarily for monitoring of construction workflow and job site logistics, inspecting construction sites to assess structural integrity, and for maintenance assessments. As is the case with other emerging technologies, occupational safety assessments of UAVs lag behind technological advancements. UAVs may create new workplace hazards that need to be evaluated and managed to ensure their safe operation around human workers. At the same time, UAVs can perform dangerous tasks, thereby improving workplace safety. This paper describes the four major uses of UAVs, including their use in construction, the potential risks of their use to workers, approaches for risk mitigation, and the important role that safety and health professionals can play in ensuring safe approaches to the their use in the workplace. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Teamwork and communication: an effective approach to patient safety.

PubMed

Mujumdar, Sandhya; Santos, Diana

2014-01-01

Teamwork and communication failures are leading causes of patient safety incidents in health care. Though health care providers must work in teams, they are not well-trained in teamwork and communication skills. Health care faces the problems of differences in communication styles, communication failures and poor teamwork. There is enough evidence in the literature to show that communication failure is detrimental to patient safety. It is estimated that 80% of serious medical errors worldwide take place because of miscommunication between medical providers. NUH recognizes that effective communication and teamwork are essential in the delivery of high quality safe patient care, especially in a complex organization. NUH is a good example, where there is a rich mix of nationalities and races, in staff and in patients, and there is a rapidly expanding care environment. NUH had to overcome these challenges by adopting a multi-pronged approach. The trials and tribulations of NUH in this journey were worthwhile as the patient safety climate survey scores improved over the years.

Efficacy of stent angioplasty for symptomatic stenoses of the proximal vertebral artery.

PubMed

Weber, W; Mayer, T E; Henkes, H; Kis, B; Hamann, G F; Holtmannspoetter, M; Brueckmann, H; Kuehne, D

2005-11-01

To evaluate the safety and efficacy of stent angioplasty in the treatment of symptomatic arteriosclerotic stenoses of the proximal vertebral artery (VA). Thirty-eight symptomatic stenoses of the vertebral origin were treated with flexible balloon-expandable coronary stents. Angiographic and clinical follow-up examinations were obtained in 26 patients at a mean of 11 months. The immediate post-procedural angiographic results showed no residual stenosis in 33 vessels and mild residual stenoses in five vessels. Periprocedurally, there were two asymptomatic technical complications and one TIA. During follow-up re-stenosis could be detected in 10 cases (36%), and vessel occlusions in two patients. Two stents were broken. One of the restenosis caused a TIA within the follow-up period. Flexible balloon-expandable coronary stents proved to be save and effective in preventing vertebrobasilar stroke but were incapable to preserve the proximal vertebral artery lumen. For the VA origine an adequate stent, self-expanding, bioresorbable, or drug-eluting has to be found.

Advancing the framework for considering the effects of climate change on worker safety and health.

PubMed

Schulte, P A; Bhattacharya, A; Butler, C R; Chun, H K; Jacklitsch, B; Jacobs, T; Kiefer, M; Lincoln, J; Pendergrass, S; Shire, J; Watson, J; Wagner, G R

2016-11-01

In 2009, a preliminary framework for how climate change could affect worker safety and health was described. That framework was based on a literature search from 1988-2008 that supported seven categories of climate-related occupational hazards: (1) increased ambient temperature; (2) air pollution; (3) ultraviolet radiation exposure; (4) extreme weather; (5) vector-borne diseases and expanded habitats; (6) industrial transitions and emerging industries; and (7) changes in the built environment. This article reviews the published literature from 2008-2014 in each of the seven categories. Additionally, three new topics related to occupational safety and health are considered: mental health effects, economic burden, and potential worker safety and health impacts associated with the nascent field of climate intervention (geoengineering). Beyond updating the literature, this article also identifies key priorities for action to better characterize and understand how occupational safety and health may be associated with climate change events and ensure that worker health and safety issues are anticipated, recognized, evaluated, and mitigated. These key priorities include research, surveillance, risk assessment, risk management, and policy development. Strong evidence indicates that climate change will continue to present occupational safety and health hazards, and this framework may be a useful tool for preventing adverse effects to workers.

Advancing the framework for considering the effects of climate change on worker safety and health

PubMed Central

Schulte, P.A.; Bhattacharya, A.; Butler, C.R.; Chun, H.K.; Jacklitsch, B.; Jacobs, T.; Kiefer, M.; Lincoln, J.; Pendergrass, S.; Shire, J.; Watson, J.; Wagner, G.R.

2016-01-01

ABSTRACT In 2009, a preliminary framework for how climate change could affect worker safety and health was described. That framework was based on a literature search from 1988–2008 that supported seven categories of climate-related occupational hazards: (1) increased ambient temperature; (2) air pollution; (3) ultraviolet radiation exposure; (4) extreme weather; (5) vector-borne diseases and expanded habitats; (6) industrial transitions and emerging industries; and (7) changes in the built environment. This article reviews the published literature from 2008–2014 in each of the seven categories. Additionally, three new topics related to occupational safety and health are considered: mental health effects, economic burden, and potential worker safety and health impacts associated with the nascent field of climate intervention (geoengineering). Beyond updating the literature, this article also identifies key priorities for action to better characterize and understand how occupational safety and health may be associated with climate change events and ensure that worker health and safety issues are anticipated, recognized, evaluated, and mitigated. These key priorities include research, surveillance, risk assessment, risk management, and policy development. Strong evidence indicates that climate change will continue to present occupational safety and health hazards, and this framework may be a useful tool for preventing adverse effects to workers. PMID:27115294

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

The National Heart, Lung, and Blood Institute retrovirus epidemiology donor studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): twenty years of research to advance blood product safety and availability.

PubMed

Kleinman, Steven; King, Melissa R; Busch, Michael P; Murphy, Edward L; Glynn, Simone A

2012-10-01

The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute-funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as xenotropic murine leukemia virus-related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma cruzi infections. Other analyses have characterized blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors' perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, 2 large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting and adds a third country, South Africa, to the international program. Copyright © 2012 Elsevier Inc. All rights reserved.

Back Injuries - Multiple Languages

MedlinePlus

... Cantonese dialect) (繁體中文) French (français) Hindi (हिन्दी) Japanese (日本語) Korean (한국어) Nepali (नेपाली) Russian (Русский) ... हिन्दी (Hindi) Bilingual PDF Health Information Translations Japanese (日本語) Expand Section Back Health and Safety - 日本語 ( ...

77 FR 50166 - Petitions for Modification of Application of Existing Mandatory Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-20

... less than one shot per 10 feet to permit expanding cement to infiltrate the annulus between the casing... mineable coal seam will be perforated with one shot at the elevation of each coal seam above the lowest... detected. The record will be retained at the mine for one year. The petitioner asserts that the proposed...

Using American Community Survey Data to Expand Access to the School Meals Program

ERIC Educational Resources Information Center

Schirm, Allen, Ed.; Kirkendall, Nancy, Ed.

2012-01-01

The National School Lunch and School Breakfast Programs, administered by the Food and Nutrition Service (FNS) of the U.S. Department of Agriculture (USDA), are key components of the nation's food security safety net, providing free or low-cost meals to millions of schoolchildren each day. To qualify their children each year for free or…

In vitro assessment of MRI issues at 3-Tesla for a breast tissue expander with a remote port.

PubMed

Linnemeyer, Hannah; Shellock, Frank G; Ahn, Christina Y

2014-04-01

A patient with a breast tissue expander may require a diagnostic assessment using magnetic resonance imaging (MRI). To ensure patient safety, this type of implant must undergo in vitro MRI testing using proper techniques. Therefore, this investigation evaluated MRI issues (i.e., magnetic field interactions, heating, and artifacts) at 3-Tesla for a breast tissue expander with a remote port. A breast tissue expander with a remote port (Integra Breast Tissue Expander, Model 3612-06 with Standard Remote Port, PMT Corporation, Chanhassen, MN) underwent evaluation for magnetic field interactions (translational attraction and torque), MRI-related heating, and artifacts using standardized techniques. Heating was evaluated by placing the implant in a gelled-saline-filled phantom and MRI was performed using a transmit/receive RF body coil at an MR system reported, whole body averaged specific absorption rate of 2.9-W/kg. Artifacts were characterized using T1-weighted and GRE pulse sequences. Magnetic field interactions were not substantial and, thus, will not pose a hazard to a patient in a 3-Tesla or less MRI environment. The highest temperature rise was 1.7°C, which is physiologically inconsequential. Artifacts were large in relation to the remote port and metal connector of the implant but will only present problems if the MR imaging area of interest is where these components are located. A patient with this breast tissue expander with a remote port may safely undergo MRI at 3-Tesla or less under the conditions used for this investigation. These findings are the first reported at 3-Tesla for a tissue expander. Copyright © 2014 Elsevier Inc. All rights reserved.

A business planning model to identify new safety net clinic locations.

PubMed

Langabeer, James; Helton, Jeffrey; DelliFraine, Jami; Dotson, Ebbin; Watts, Carolyn; Love, Karen

2014-01-01

Community health clinics serving the poor and underserved are geographically expanding due to changes in U.S. health care policy. This paper describes the experience of a collaborative alliance of health care providers in a large metropolitan area who develop a conceptual and mathematical decision model to guide decisions on expanding its network of community health clinics. Community stakeholders participated in a collaborative process that defined constructs they deemed important in guiding decisions on the location of community health clinics. This collaboration also defined key variables within each construct. Scores for variables within each construct were then totaled and weighted into a community-specific optimal space planning equation. This analysis relied entirely on secondary data available from published sources. The model built from this collaboration revolved around the constructs of demand, sustainability, and competition. It used publicly available data defining variables within each construct to arrive at an optimal location that maximized demand and sustainability and minimized competition. This is a model that safety net clinic planners and community stakeholders can use to analyze demographic and utilization data to optimize capacity expansion to serve uninsured and Medicaid populations. Communities can use this innovative model to develop a locally relevant clinic location-planning framework.

Expanding Role of Third Space Endoscopy in the Management of Esophageal Diseases.

PubMed

Yang, Dennis; Draganov, Peter V

2018-03-01

OPINION STATEMENT: "Third space" endoscopy, also commonly referred as submucosal endoscopy, is founded on the principle that the deeper layers of the gastrointestinal (GI) tract can be accessed by tunneling in the submucosal space without compromising the integrity of the overlying mucosa. Peroral endoscopic myotomy (POEM), endoscopic submucosal dissection (ESD), and submucosal tunneling endoscopic resection (STER) are innovative techniques within the field of third space endoscopy in the management of esophageal disorders. POEM has become an accepted minimally invasive therapy for achalasia and related motility disorders with excellent short-term results, with early studies yielding similar efficacy to surgical myotomy and increased durability when compared to pneumatic balloon dilation (PBD). Data are needed to establish long-term outcomes with POEM, with particular interest on the incidence of gastroesophageal reflux, which appears to be higher than initially anticipated. ESD, a mature endoscopic resection technique in Asia, has recently gained traction in the West as a viable option for the management of early Barrett's esophagus (BE) neoplasia. Compared to standard endoscopic mucosal resection (EMR), ESD allows the en bloc resection of lesions irrespective of size, which may facilitate histological interpretation and reduce recurrence rates. Large prospective randomized controlled trials are needed to validate the efficacy and safety of this technique and to further define its role in the endoscopic armamentarium in early BE neoplasia. STER is an attractive technique that theoretically permits the resection of subepithelial esophageal tumors (SETs) arising from the deeper GI layers. Initial studies from highly experienced endoscopic centers support its technical feasibility and safety, although these results should be interpreted with caution due to variability arising from small numbers and heterogeneity among studies. Overall, third space endoscopy is an expanding field within endoscopic therapeutics for the treatment of esophageal diseases. While initial results have been very promising, large prospective studies, long-term data, and structured training programs with the establishment of competency parameters are needed before third space endoscopy can be advocated outside of highly specialized centers.

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

PubMed

Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

2016-09-01

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

Effort-reward imbalance and organisational injustice among aged nurses: a moderated mediation model.

PubMed

Topa, Gabriela; Guglielmi, Dina; Depolo, Marco

2016-09-01

To test the effort-reward imbalance model among older nurses, expanding it to include the moderation of overcommitment and age in the stress-health complaints relationship, mediated by organisational injustice. The theoretical framework included the effort-reward imbalance, the uncertainty management and the socio-emotional selectivity models. Employing a two-wave design, the participants were 255 nurses aged 45 years and over, recruited from four large hospitals in Spain (Madrid and Basque Country). The direct effect of imbalance on health complaints was supported: it was significant when overcommitment was low but not when it was high. Organisational injustice mediated the influence of effort-reward imbalance on health complaints. The conditional effect of the mediation of organisational injustice was significant in three of the overcommitment/age conditions but it weakened, becoming non-significant, when the level of overcommitment was low and age was high. The study tested the model in nursing populations and expanded it to the settings of occupational health and safety at work. The results of this study highlight the importance of effort-reward imbalance and organisational justice for creating healthy work environments. © 2016 John Wiley & Sons Ltd.

A framework for reporting on human factor/usability studies of health information technologies.

PubMed

Peute, Linda W; Driest, Keiko F; Marcilly, Romaric; Bras Da Costa, Sabrina; Beuscart-Zephir, Marie-Catherine; Jaspers, Monique W M

2013-01-01

Increasingly, studies are being published on the potential negative effect of introducing poor designed Health Information Technology (HIT) into clinical settings, relating to technology-induced errors and adverse events. Academic research on HIT design and evaluation is an extremely important source of information in providing new insights into factors contributing to successful system (re)design efforts, system user-friendliness and usability issues and safety critical aspects of HIT design. However, these studies have been inconsistent and incomprehensive in their reporting, complicating the appraisal of outcomes, generalizability of study findings, meta-analysis and harmonization of the available evidence. To improve identification of type of use errors and safety related issues regarding design and implementation of HIT, consensus on issues to be reported on in scientific publications is a necessary step forward. This study presents the first approach to a framework providing a set of principles to follow for comprehensive and unambiguous reporting of HIT design and usability evaluation studies with the objective to reduce variation, improve on the publication reporting quality and proper indexation of these studies. This framework may be helpful in expanding the knowledge base not only concerning the application of Human Factors (HF)/Usability studies of HIT but also improve the knowledge base of how to (re)design and implement effective, efficient and safe HIT.

Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine.

PubMed

Bologa, Monica; Kamtchoua, Thierry; Hopfer, Robert; Sheng, Xiaohua; Hicks, Bryony; Bixler, Garvin; Hou, Victor; Pehlic, Vildana; Yuan, Tao; Gurunathan, Sanjay

2012-12-14

Pneumococcal vaccines based on protein antigens may provide expanded protection against Streptococcus pneumoniae. To evaluate safety and immunogenicity in adults of pneumococcal vaccine candidates comprising S. pneumoniae pneumococcal histidine triad protein D (PhtD) and pneumococcal choline-binding protein A (PcpA) in monovalent and bivalent formulations. This was a phase I, randomized, observer-blinded, placebo-controlled, step-wise dose-escalation study. Following a pilot safety study in which participants received one intramuscular injection of either aluminum hydroxide (AH)-adjuvanted PcpA (25 μg) or PhtD-PcpA (10 μg each), participants in the main study received AH-adjuvanted PcpA (25 μg), AH-adjuvanted PhtD-PcpA (10, 25, or 50 μg each), unadjuvanted PhtD-PcpA (25 μg each), or placebo as 2 injections 30 days apart. Assignment of successive dose cohorts was made after blinded safety reviews after each dose level. Safety endpoints included rates of solicited injection site and systemic reactions, unsolicited adverse events (AEs), serious AEs (SAEs), and safety laboratory tests. Immunogenicity endpoints included levels of anti-PhtD and anti-PcpA antibodies (ELISA). Six adults 18-50 years of age were included in the pilot study and 125 in the main study. No obvious increases in solicited reactions or unsolicited AEs were reported with escalating doses (adjuvanted vaccine) after either injection, or with repeated administration. Adjuvanted vaccine candidates were associated with a higher incidence of solicited reactions (particularly injection site reactions) than unadjuvanted vaccine candidates. However, no SAE or discontinuation due to an AE occurred. Geometric mean concentrations of anti-PhtD IgG and anti-PcpA IgG increased significantly after injection 2 compared with injection 1 at each dose level. No enhancement of immune responses was shown with adjuvanted vaccine candidates compared with the unadjuvanted vaccine candidate. In the dose-escalating comparison, a plateau effect at the 25 μg dose was observed as measured by geometric mean concentrations and by fold increases. Promising safety profiles and immunogenicity of these monovalent and bivalent protein vaccine candidates were demonstrated in an adult population (ClinicalTrials.gov registry no. NCT01444339). Copyright © 2012 Elsevier Ltd. All rights reserved.

[Acupuncture with Point Location-a mandatory examination for American NCCAOM certification of acupuncture and oriental medicine].

PubMed

Tian, Kaiyu; Rao, Hong; Lin, Yongqing; He, Yang; Zhao, Junqing; Chen, Qiang

2017-03-12

Acupuncture with Point Location is one of the mandatory examinations for the Diplomate of Oriental Medicine (Dipl.OM.) or Acupuncture (Dipl. Ac.) by American National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). In reference to NCCAOM Certification Handbook, Acupuncture with Point Location Expanded Content Outline , and Study Guide for Diplomates in Acupuncture Certification , the authors introduced the examination pattern and examination-related contents including such aspects as safety and professional responsibilities, treatment plan, and point location and discussed additionally the enlightening effects on acupuncture practice and examination in universities and international associations of Chinese medicine in our country.

Study on comprehensive planning of rocky desertification in karst area of Chongqing

NASA Astrophysics Data System (ADS)

Zang, Yajun

2017-11-01

Chongqing is a key area for comprehensive treatment of rocky desertification in karst areas of china. Strengthening the comprehensive management of karst rocky desertification area, for the maintenance of ecological safety of Three Gorges Reservoir area, expanding the karst rocky desertification area people survival and development space, and improving the regional ecological conditions, have important practical significance to the construction of ecological civilization and building a harmonious society. Based on the investigation, analysis and arrangement of the data in the rocky desertification area, the paper puts forward the corresponding measures and phased targets for the treatment of the Rocky Desertification in the karst areas of Chongqing.

An Advanced One-Dimensional Finite Element Model for Incompressible Thermally Expandable Flow

DOE PAGES

Hu, Rui

2017-03-27

Here, this paper provides an overview of a new one-dimensional finite element flow model for incompressible but thermally expandable flow. The flow model was developed for use in system analysis tools for whole-plant safety analysis of sodium fast reactors. Although the pressure-based formulation was implemented, the use of integral equations in the conservative form ensured the conservation laws of the fluid. A stabilization scheme based on streamline-upwind/Petrov-Galerkin and pressure-stabilizing/Petrov-Galerkin formulations is also introduced. The flow model and its implementation have been verified by many test problems, including density wave propagation, steep gradient problems, discharging between tanks, and the conjugate heatmore » transfer in a heat exchanger.« less

An Advanced One-Dimensional Finite Element Model for Incompressible Thermally Expandable Flow

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

Hu, Rui

Here, this paper provides an overview of a new one-dimensional finite element flow model for incompressible but thermally expandable flow. The flow model was developed for use in system analysis tools for whole-plant safety analysis of sodium fast reactors. Although the pressure-based formulation was implemented, the use of integral equations in the conservative form ensured the conservation laws of the fluid. A stabilization scheme based on streamline-upwind/Petrov-Galerkin and pressure-stabilizing/Petrov-Galerkin formulations is also introduced. The flow model and its implementation have been verified by many test problems, including density wave propagation, steep gradient problems, discharging between tanks, and the conjugate heatmore » transfer in a heat exchanger.« less

FDA Expands List of "Do Not Compound" Drug Products.

PubMed

2017-03-01

EDITOR'S ABSTRACT On October 3, 2016, the U.S. Food and Drug Administration published in the Federal Register an expanded list of drug products that are not to be used in compounding extemporaneous dosage forms. This list contains numerous analgesic or anti-inflammatory agents and other chemicals sometimes used to manage pain and related symptoms. Because pharmacies are licensed by the states and other jurisdictions (districts, territories) as opposed to the federal government, regulation of extemporaneous compounding is inconsistent across the nation and minimal to nonexistent is some jurisdictions. Clinicians are urged to assure that pharmacies they and their patients use adhere to this list and compound only dosage forms for which there is good evidence of both safety and efficacy.

Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

PubMed

Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

2017-12-01

Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

Safety and Efficacy of a Fully Covered Self-Expandable Metallic Stent in Benign Airway Stenosis.

PubMed

Fortin, Marc; Lacasse, Yves; Elharrar, Xavier; Tazi-Mezalek, Rachid; Laroumagne, Sophie; Guinde, Julien; Astoul, Philippe; Dutau, Hervé

2017-01-01

The use of self-expandable metallic stents (SEMS) in benign airway disease was the object of a boxed warning from the United States Food and Drug Administration in 2005 due to the risk of stent-related complications and difficulties associated with their removal. Third-generation fully covered SEMS have been commercialized since this warning and theoretically should not present the same difficulties associated with removal as they cannot become embedded in the airway mucosa. We aimed to examine the safety and efficacy of a specific third-generation SEMS, the Silmet stent. We reviewed the records of all patients treated for benign airway stenosis with third-generation Silmet SEMS from January 2011 to December 2015 at the North Hospital of Marseilles, France. Forty SEMS were inserted in 30 patients over this period. Twenty (50.0%) stents were removed because of stent-related complications after a median of 77.0 ± 96.6 days (migration 32.5%, granulation tissue formation 7.5%, subjective intolerance 5.0%, mucus plugging 2.5%, laryngeal edema 2.5%). There were no cases of stent-related mortality. All complications were managed successfully endoscopically. Thirty-six stents (90.0%) were removed successfully after a median of 122.0 ± 113.2 days without any complications. The clinical success rate of stent treatment was 40.7%. Third-generation SEMS are a safe treatment option for complex benign airway stenosis, but complications requiring stent removal are frequent. Further studies are needed to compare the performance of third-generation SEMS and silicone stents in benign airway stenosis. © 2017 S. Karger AG, Basel.

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

Vajda, Zsolt, E-mail: Z.Vajda@klinikum-stuttgart.de; Guethe, Thomas, E-mail: T.Guethe@klinikum-stuttgart.de; Perez, Marta Aguilar, E-mail: M.Aguilar@klinikum-stuttgart.de

Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followedmore » by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.« less

Use of autologous human mesenchymal stromal cell/fibrin clot constructs in upper limb non-unions: long-term assessment.

PubMed

Giannotti, Stefano; Trombi, Luisa; Bottai, Vanna; Ghilardi, Marco; D'Alessandro, Delfo; Danti, Serena; Dell'Osso, Giacomo; Guido, Giulio; Petrini, Mario

2013-01-01

Tissue engineering appears to be an attractive alternative to the traditional approach in the treatment of fracture non-unions. Mesenchymal stromal cells (MSCs) are considered an appealing cell source for clinical intervention. However, ex vivo cell expansion and differentiation towards the osteogenic lineage, together with the design of a suitable scaffold have yet to be optimized. Major concerns exist about the safety of MSC-based therapies, including possible abnormal overgrowth and potential cancer evolution. We examined the long-term efficacy and safety of ex vivo expanded bone marrow MSCs, embedded in autologous fibrin clots, for the healing of atrophic pseudarthrosis of the upper limb. Our research work relied on three main issues: use of an entirely autologous context (cells, serum for ex vivo cell culture, scaffold components), reduced ex vivo cell expansion, and short-term MSC osteoinduction before implantation. Bone marrow MSCs isolated from 8 patients were expanded ex vivo until passage 1 and short-term osteo-differentiated in autologous-based culture conditions. Tissue-engineered constructs designed to embed MSCs in autologous fibrin clots were locally implanted with bone grafts, calibrating their number on the extension of bone damage. Radiographic healing was evaluated with short- and long-term follow-ups (range averages: 6.7 and 76.0 months, respectively). All patients recovered limb function, with no evidence of tissue overgrowth or tumor formation. Our study indicates that highly autologous treatment can be effective and safe in the long-term healing of bone non-unions. This tissue engineering approach resulted in successful clinical and functional outcomes for all patients.

A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

PubMed

Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

2011-10-26

although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the sociology of improvement in equal measure to the science and technique of improvement, or at least expand the discipline of improvement to include these critical organisational and cultural processes. We define the 'organisational and cultural characteristics associated with better quality of care' in a broad sense that encompasses all the features of a hospital that might be hypothesised to impact upon clinical effectiveness, patient safety and/or patient experience.

Efficacy and Safety of Probiotics and Synbiotics in Liver Transplantation.

PubMed

Jorgenson, Margaret R; Descourouez, Jillian L; Siodlak, Magdalena; Tjugum, Shelby; Rice, John P; Fernandez, Luis A

2018-05-26

This article summarizes available literature regarding the utilization of probiotic and synbiotics in liver transplant (LTX) recipients, reviewing efficacy in both decreasing infectious complications and immunomodulation, as well as exploring safety concerns. Data suggest that the use of probiotics containing Lactobacillus species, either alone or in combination with prebiotics (referred to as synbiotics), may be effective in reducing infectious complications after LTX, a major contributor to graft loss, hospital length of stay, and mortality. Literature evaluating the use of probiotics to induce tolerance, reduce rejection, and prevent damage associated with ischemic reperfusion injury is limited to animal models, but compelling, as it suggests the use of probiotics may augment deleterious immune-mediated processes in this population. While the benefits of probiotics should be weighed against potential risks, these concerns are largely theoretically in the LTX recipient, with the majority of evidence extrapolated from case reports in other immunosuppressed populations. Based on available literature, it may be prudent to avoid products containing Saccharomyces sp, as these were not used in the efficacy studies, and the majority of the adverse event reporting stems from the use of products containing this organism. Further evaluation of the safety and efficacy of probiotic therapy is warranted. Studies specifically designed to elucidate the optimal product and initiation scenario and delineate safety in this population are needed to allow expanded use of this inexpensive, relatively non-toxic, and potentially beneficial therapeutic option after LTX. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Increasing Patient Safety by Closing the Sterile Production Gap-Part 1. Introduction.

PubMed

Agalloco, James P

2017-01-01

Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required. The origin of this misconception is unclear, but it has resulted in sterilization conditions that are extremely harsh (15 min at 121 °C, of F 0 > 8 min), which limit the use of terminal sterilization to extremely heat-stable formulations. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-destruction of the bioburden present in the container prior to sterilization. Recognition that the true intention is bioburden destruction in routine products allows for the use of reduced conditions (lower temperatures, shorter process dwell, or both) without added patient risk. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background and describes the benefits to patient, producer, and regulator. The second article includes validation and operational advice that can be used in the implementation. LAY ABSTRACT: Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-destruction of the bioburden present in the container prior to sterilization. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background, and describes the benefits to patient, producer, and regulator. The second article includes validation and operational advice that can be used in the implementation. © PDA, Inc. 2017.

The hybrid reactor project based on the straight field line mirror concept

NASA Astrophysics Data System (ADS)

Ågren, O.; Noack, K.; Moiseenko, V. E.; Hagnestâl, A.; Källne, J.; Anglart, H.

2012-06-01

The straight field line mirror (SFLM) concept is aiming towards a steady-state compact fusion neutron source. Besides the possibility for steady state operation for a year or more, the geometry is chosen to avoid high loads on materials and plasma facing components. A comparatively small fusion hybrid device with "semi-poor" plasma confinement (with a low fusion Q factor) may be developed for industrial transmutation and energy production from spent nuclear fuel. This opportunity arises from a large fission to fusion energy multiplication ratio, Qr = Pfis/Pfus>>1. The upper bound on Qr is primarily determined by geometry and reactor safety. For the SFLM, the upper bound is Qr≈150, corresponding to a neutron multiplicity of keff=0.97. Power production in a mirror hybrid is predicted for a substantially lower electron temperature than the requirement Te≈10 keV for a fusion reactor. Power production in the SFLM seems possible with Q≈0.15, which is 10 times lower than typically anticipated for hybrids (and 100 times smaller than required for a fusion reactor). This relaxes plasma confinement demands, and broadens the range for use of plasmas with supra-thermal ions in hybrid reactors. The SFLM concept is based on a mirror machine stabilized by qudrupolar magnetic fields and large expander tanks beyond the confinement region. The purpose of the expander tanks is to distribute axial plasma loss flow over a sufficiently large area so that the receiving plates can withstand the heat. Plasma stability is not relying on a plasma flow into the expander regions. With a suppressed plasma flow into the expander tanks, a possibility arise for higher electron temperature. A brief presentation will be given on basic theory for the SFLM with plasma stability and electron temperature issues, RF heating computations with sloshing ion formation, neutron transport computations with reactor safety margins and material load estimates, magnetic coil designs as well as a discussion on the implications of the geometry for possible diagnostics. Reactor safety issues are addressed and a vertical orientation of the device could assist passive coolant circulation. Specific attention is put to a device with a 25 m long confinement region and 40 cm plasma radius in the mid-plane. In an optimal case (keff = 0.97) with a fusion power of only 10 MW, such a device may be capable of producing a power of 1.5 GWth.

Infusion of a non-HLA-matched ex-vivo expanded cord blood progenitor cell product after intensive acute myeloid leukaemia chemotherapy: a phase 1 trial.

PubMed

Delaney, Colleen; Milano, Filippo; Cicconi, Laura; Othus, Megan; Becker, Pamela S; Sandhu, Vicky; Nicoud, Ian; Dahlberg, Ann; Bernstein, Irwin D; Appelbaum, Frederick R; Estey, Elihu H

2016-07-01

The intensive chemotherapy regimens used to treat acute myeloid leukaemia routinely result in serious infections, largely due to prolonged neutropenia. We investigated the use of non-HLA-matched ex-vivo expanded cord blood progenitor cells to accelerate haemopoietic recovery and reduce infections after chemotherapy. We enrolled patients with a diagnosis of acute myeloid leukaemia by WHO criteria and aged 18-70 years inclusive at our institution (Fred Hutchinson Cancer Research Center) into this phase 1 trial. The primary endpoint of the study was safety of infusion of non-HLA-matched expanded cord blood progenitor cells after administration of clofarabine, cytarabine, and granulocyte-colony stimulating factor priming. The protocol is closed to accrual and analysis was performed per protocol. The trial is registered with ClinicalTrials.gov, NCT01031368. Between June 29, 2010, and June 26, 2012, 29 patients with acute myeloid leukaemia (19 newly diagnosed, ten relapsed or refractory) were enrolled. The most common adverse events were fever (27 [93%] of 29 patients) and infections (25 [86%] of 29 patients). We observed one case of acute infusional toxicity (attributed to an allergic reaction to dimethyl sulfoxide) in the 29 patients enrolled, who received 42 infusions of expanded progenitor cells. The following additional serious but expected adverse events were observed (each in one patient): grade 4 atrial fibrillation, grade 4 febrile neutropenia, lung infection with grade 4 absolute neutrophil count, colon infection with grade 4 absolute neutrophil count, grade 4 changed mental status, and one death from liver failure. No unexpected toxicity or graft-versus-host disease was observed. There was no evidence of in-vivo persistence of the expanded progenitor cell product in any patient beyond 14 days or induced alloimmunisation. Infusion of the expanded progenitor cell product seemed safe and might provide a promising treatment method for patients with acute myeloid leukaemia. Biomedical Advanced Research and Development Authority in the US Department of Health and Human Services and Genzyme (Sanofi). Copyright © 2016 Elsevier Ltd. All rights reserved.

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma.

PubMed

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-09-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans.

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma

PubMed Central

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-01-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans. PMID:27401141

Overview of experimental support for fission-product transport analyses at Oak Ridge National Laboratory

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

Wichner, R.P.

The program was designed to determine fission product and aerosol release rates from irradiated fuel under accident conditions, to identify the chemical forms of the released material, and to correlate the results with experimental and specimen conditions with the data from related experiments. These tests of PWR fuel were conducted and fuel specimen and test operating data are presented. The nature and rate of fission product vapor interaction with aerosols were studied. Aerosol deposition rates and transport in the reactor vessel during LWR core-melt accidents were studied. The Nuclear Safety Pilot Plant is dedicated to developing an expanded data basemore » on the behavior of aerosols generated during a severe accident.« less

The COMmunity of Practice And Safety Support (COMPASS) Total Worker Health™ study among home care workers: study protocol for a randomized controlled trial.

PubMed

Olson, Ryan; Elliot, Diane; Hess, Jennifer; Thompson, Sharon; Luther, Kristy; Wipfli, Brad; Wright, Robert; Buckmaster, Annie Mancini

2014-10-27

Home care workers are a high-risk group for injury and illness. Their unique work structure presents challenges to delivering a program to enhance their health and safety. No randomized controlled trials have assessed the impact of a Total Worker Health™ program designed for their needs. The COMPASS (COMmunity of Practice And Safety Support) study is a cluster randomized trial being implemented among Oregon's unionized home care workers. Partnering with the Oregon Home Care Commission allowed recruiting 10 pairs of home care worker groups with 8 participants per group (n = 160) for balanced randomization of groups to intervention and control conditions. Physiologic and survey evaluation of all participants will be at enrollment, 6 months and 12 months. Primary outcomes are to increase health promoting (for example, healthy nutrition and regular physical activity) and health protecting (that is, safety) behaviors. In addition to assessing outcomes adjusted for the hierarchical design, mediation analyses will be used to deconstruct and confirm the program's theoretical underpinnings and intervention processes. Intervention groups will participate in a series of monthly 2-hour meetings designed as ritualized, scripted peer-led sessions to increase knowledge, practice skills and build support for healthy actions. Self-monitoring and individual and team level goals are included to augment change. Because generalizability, reach and achieving dissemination are priorities, following initial wave findings, a second wave of COMPASS groups will be recruited and enrolled with tailoring of the program to align with existing Home Care Commission educational offerings. Outcomes, process and mediation of those tailored groups will be compared with the original wave's findings. The COMPASS trial will assess a novel program to enhance the safety and health of a vulnerable, rapidly expanding group of isolated caregivers, whose critical work allows independent living of frail seniors and the disabled. ClinicalTrials.gov identifier: NCT02113371, first registered 11 March 2014.

Overview of Therapeutic Ultrasound Applications and Safety Considerations

PubMed Central

Miller, Douglas; Smith, Nadine; Bailey, Michael; Czarnota, Gregory; Hynynen, Kullervo; Makin, Inder

2013-01-01

Summary Applications of ultrasound in medicine for therapeutic purposes have been an accepted and beneficial use of ultrasonic biological effects for many years. Low power ultrasound of about 1 MHz frequency has been widely applied since the 1950s for physical therapy in conditions such as tendinitis or bursitis. In the 1980s, high pressure-amplitude shockwaves came into use for mechanically resolving kidney stones, and “lithotripsy” rapidly replaced surgery as the most frequent treatment choice. The use of ultrasonic energy for therapy continues to expand, and approved applications now include uterine fibroid ablation, cataract removal (phacoemulsification), surgical tissue cutting and hemostasis, transdermal drug delivery, and bone fracture healing, among others. Undesirable bioeffects can occur including burns for thermal-based therapies and significant hemorrhage for mechanical-based therapies (e. g. lithotripsy). In all these therapeutic applications for bioeffects of ultrasound, standardization, ultrasound dosimetry, benefits assurance and side-effects risk minimization must be carefully considered in order to insure an optimal benefit to risk ratio for the patient. Therapeutic ultrasound typically has well-defined benefits and risks, and therefore presents a tractable safety problem to the clinician. However, safety information can be scattered, confusing or subject to commercial conflict of interest. Of paramount importance for managing this problem is the communication of practical safety information by authoritative groups, such as the AIUM, to the medical ultrasound community. In this overview, the Bioeffects Committee outlines the wide range of therapeutic ultrasound methods, which are in clinical use or under study, and provides general guidance for assuring therapeutic ultrasound safety. PMID:22441920

An Economic Evaluation of Food Safety Education Interventions: Estimates and Critical Data Gaps.

PubMed

Zan, Hua; Lambea, Maria; McDowell, Joyce; Scharff, Robert L

2017-08-01

The economic evaluation of food safety interventions is an important tool that practitioners and policy makers use to assess the efficacy of their efforts. These evaluations are built on models that are dependent on accurate estimation of numerous input variables. In many cases, however, there is no data available to determine input values and expert opinion is used to generate estimates. This study uses a benefit-cost analysis of the food safety component of the adult Expanded Food and Nutrition Education Program (EFNEP) in Ohio as a vehicle for demonstrating how results based on variable values that are not objectively determined may be sensitive to alternative assumptions. In particular, the focus here is on how reported behavioral change is translated into economic benefits. Current gaps in the literature make it impossible to know with certainty how many people are protected by the education (what are the spillover effects?), the length of time education remains effective, and the level of risk reduction from change in behavior. Based on EFNEP survey data, food safety education led 37.4% of participants to improve their food safety behaviors. Under reasonable default assumptions, benefits from this improvement significantly outweigh costs, yielding a benefit-cost ratio of between 6.2 and 10.0. Incorporation of a sensitivity analysis using alternative estimates yields a greater range of estimates (0.2 to 56.3), which highlights the importance of future research aimed at filling these research gaps. Nevertheless, most reasonable assumptions lead to estimates of benefits that justify their costs.

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure.

PubMed

McGuire, Michael K; Scheyer, E Todd

2007-01-01

The aim of this study was to assess the efficacy and safety of using autologous fibroblast injections following a minimally invasive papilla priming procedure to augment open interproximal spaces. Twenty-one patients with open interproximal spaces were enrolled in this study, with 20 patients retained to study completion. Two primary sites were selected and randomized to receive autologous fibroblast injections or placebo injections beginning 1 week following the papilla priming procedure; two additional injections were performed 7 to 14 days following the initial injections. Up to seven additional sites could be treated per patient, and the analyses were conducted for the primary and secondary sites. The primary efficacy parameter was the percentage change in papillary height of the primary treatment areas from baseline to the 4-month visit, as measured by a periodontal probe from the base of the contact area to the tip of the interproximal papilla. Digital image analysis and diagnostic models were used to confirm clinical measurements. A visual analog scale (VAS) was used by the examiner and subject to assess the defect change from baseline to 2, 3, and 4 months. Tissue texture also was assessed by the examiner. The primary efficacy analysis failed to show a significant treatment effect at 4 months, but the treatment areas showed a statistically significant mean percentage increase from baseline in papillary height (P = 0.0067; signed-rank test) at 2 months. The difference between test and placebo sites in papillary height at 2 months approached statistical significance (P = 0.0730), suggesting that the test treatment was superior to the placebo treatment. The examiner and subject VASs were statistically significantly different from baseline for both treatment groups, and the VAS was superior for the test sites over the placebo. Based on safety data, the test treatment was deemed safe. This early-phase study using cell transplantation of autologous cultured and expanded fibroblasts following a papilla priming procedure suggests that the treatment is safe and may be efficacious for treating papillary insufficiency, especially in the early phases (2 months) of healing. The analysis of the investigator and subject VAS assessments indicates that the test treatment was superior to the placebo treatment. The finite measurement required to detect a change creates a problem that needs to be addressed in future studies.

New Equipment for Mine Safety

NASA Technical Reports Server (NTRS)

1983-01-01

While planning for the space shuttle, Bendix Corporation with the help of Johnson Space Center expanded the anthropometric data base for aerospace and nonaerospace use in clothing, workplace, etc. The result was the Anthropometric Source Book which was later utilized by the U.S. Bureau of Mines in designing advanced mining systems. The book was particularly valuable in the design of a remote cab used in mining.

The Federal Aviation Administration Plan for Research, Engineering and Development, 1994

DTIC Science & Technology

1994-05-01

Aeronautical Data Link Communications and (COTS) runway incursion system software will Applications, and 051-130 Airport Safety be demonstrated as a... airport departure and ar- efforts rival scheduling plans that optimize daily traffic flows for long-range flights between major city- * OTFP System to...Expanded HARS planning capabilities to in- aviation dispatchers to develop optimized high clude enhanced communications software for altitude flight

Nonlethal Munitions (NLM) Expand Warfighter Capabilities

DTIC Science & Technology

2008-03-01

regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Washington...the Office of the Project Manager Close Combat Systems (PM CCS), part of Program Executive Office Ammuni- tion (PEO Ammo), deployed the Army’s first...provide com- manders the flexibility to influence the situation favorably with increased safety to U.S. Forces while reducing risk of both noncombatant

V/STOL Concepts and Developed Aircraft. Volume 1. A Historical Report (1940-1986)

DTIC Science & Technology

1986-06-26

in this - direction. Generally, the propellants considered for use create logistic, safety and operational cost problems. Further, the very high...been expanded into multiplace transpcrt devices. The operational use of the individual lift systems creates an important distinction between them in...two separate, alternate thrust vectoring means tc control horizontal translational flight with attitude stabilization being created by the flier’s

A Uniform Framework of Global Nuclear Materials Management

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

Dupree, S.A.; Mangan, D.L.; Sanders, T.L

1999-04-20

Global Nuclear Materials Management (GNMM) anticipates and supports a growing international recognition of the importance of uniform, effective management of civilian, excess defense, and nuclear weapons materials. We expect thereto be a continuing increase in both the number of international agreements and conventions on safety, security, and transparency of nuclear materials, and the number of U.S.-Russian agreements for the safety, protection, and transparency of weapons and excess defense materials. This inventory of agreements and conventions may soon expand into broad, mandatory, international programs that will include provisions for inspection, verification, and transparency, To meet such demand the community must buildmore » on the resources we have, including State agencies, the IAEA and regional organizations. By these measures we will meet the future expectations for monitoring and inspection of materials, maintenance of safety and security, and implementation of transparency measures.« less

Advances in antivirals for non-influenza respiratory virus infections.

PubMed

Hayden, Frederick G

2013-11-01

Progress in the development of antivirals for non-influenza respiratory viruses has been slow with the result that many unmet medical needs and few approved agents currently exist. This commentary selectively reviews examples of where specific agents have provided promising clinical benefits in selected target populations and also considers potential therapeutics for emerging threats like the SARS and Middle East respiratory syndrome coronaviruses. Recent studies have provided encouraging results in treating respiratory syncytial virus infections in lung transplant recipients, serious parainfluenza virus and adenovirus infections in immunocompromised hosts, and rhinovirus colds in outpatient asthmatics. While additional studies are needed to confirm the efficacy and safety of the specific agents tested, these observations offer the opportunity to expand therapeutic studies to other patient populations. © 2013 Blackwell Publishing Ltd.

Stimulation with lysates of Aspergillus terreus, Candida krusei and Rhizopus oryzae maximizes cross-reactivity of anti-fungal T cells.

PubMed

Deo, Shivashni S; Virassamy, Balaji; Halliday, Catriona; Clancy, Leighton; Chen, Sharon; Meyer, Wieland; Sorrell, Tania C; Gottlieb, David J

2016-01-01

Invasive fungal diseases caused by filamentous fungi and yeasts are significant causes of morbidity and mortality in immunosuppressed hematology patients. We previously published a method to expand Aspergillus fumigatus-specific T cells for clinical cell therapy. In the present study, we investigated expansion of T cells specific for other fungal pathogens and creation of a broadly reactive panfungal T-cell product. Fungal strains selected were those frequently observed in the clinical hematology setting and included Aspergillus, Candida, Fusarium, Rhizopus and Lomentospora/Scedosporium. Four T-cell cultures specific to each fungus were established. We selected lysates of Aspergillus terreus, Candida krusei and Rhizopus oryzae to expand panfungal T cells. Allelic restriction of anti-fungal activity was determined through the use of specific major histocompatibility complex class II-blocking antibodies. Individual T-cell cultures specific to each fungus could be expanded in vitro, generating predominantly CD4(+) T cells of which 8% to 20% were fungus-specific. We successfully expanded panfungal T cells from the peripheral blood (n = 8) and granulocyte-colony-stimulating factor-primed stem cell products (n = 3) of normal donors by using a combination of lysates from Aspergillus terreus, Candida krusei and Rhizopus oryzae. Anti-fungal activity was mediated through human leukocyte antigen (HLA)-DR alleles and was maintained when antigen-presenting cells from partially HLA-DRB1-matched donors were used to stimulate T cells. We demonstrate a method to manufacture panfungal T-cell products with specificity against a range of clinical fungal pathogens by use of the blood and stem cells of healthy donors as the starting material. The safety and efficacy of these products will need to be tested clinically. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

The impact of the consumer on healthcare delivery.

PubMed

Scott, Cheryl M

2003-01-01

The authors of the lead articles are correct that the customer experience should be at the forefront of our attention and work in healthcare delivery. Expanding our current definitions of customer satisfaction and patient safety to include the important intangibles of "experience" will be key. However, a singular focus on patient or consumer experience is not enough in the long run. A solid business model and an understanding of the healthcare market dynamics are also required. The promises we make in support of our business strategy are at the core of how we interact with our patients, how we ensure their safety, and how we build their loyalty. Our work as healthcare leaders should be to keep those promises.

Design of 3D simulation engine for oilfield safety training

NASA Astrophysics Data System (ADS)

Li, Hua-Ming; Kang, Bao-Sheng

2015-03-01

Aiming at the demand for rapid custom development of 3D simulation system for oilfield safety training, this paper designs and implements a 3D simulation engine based on script-driven method, multi-layer structure, pre-defined entity objects and high-level tools such as scene editor, script editor, program loader. A scripting language been defined to control the system's progress, events and operating results. Training teacher can use this engine to edit 3D virtual scenes, set the properties of entity objects, define the logic script of task, and produce a 3D simulation training system without any skills of programming. Through expanding entity class, this engine can be quickly applied to other virtual training areas.

Trauma caused by falling objects at construction sites.

PubMed

Atique, Sajid; Zarour, Ahmad; Siddiqui, Tariq; El-Menyar, Ayman; Maull, Kimball; Al Thani, Hassan; Latifi, Rifat

2012-09-01

Workplace-related injuries carry a significant health care challenge. The state of Qatar is developing rapidly, with much construction and an expanding industrial work force. This study aimed to assess the incidence and social impact of work-related injuries requiring hospitalization caused by falling objects at the construction sites. We performed a prospective study for all admissions, which resulted from falling objects between January 2008 and June 2010 at the only trauma center in the state of Qatar. Data were analyzed, and outcomes were described (mortality, length of hospital stay, and safety measures). Of the total injured patients (N = 4,302) admitted between January 2008 and June 2010, 185 (4%) had injuries caused purely by falling objects. Patients' mean age was 29 years, and 97% of the patients were men. All injuries occurred at construction sites. Most patients (86%) were brought by ambulance, and the reminder was brought by private vehicles. After initial evaluation and resuscitation, 120 patients (65%) were found to have a single-system injury, and 65 (35%) had multisystem injury. Operative interventions were required in 50% of the patients. Mean length of hospital stay varied from 6.5 days for single-system injuries to 19 days for multisystem injuries. Safety devices were used in 32 patients (17.3%). All of the 16 mortality cases (8.6%) were reported in multiple injuries. Traumatic injury caused by falling object represents a significant problem in a rapidly developing country. Many of these injuries could be prevented by following established safety guidelines. Epidemiologic study, level III.

Phenotypical and functional characteristics of mesenchymal stem cells from bone marrow: comparison of culture using different media supplemented with human platelet lysate or fetal bovine serum

PubMed Central

2012-01-01

Introduction Mesenchymal stem cells (MSCs) are multipotent cells able to differentiate into several mesenchymal lineages, classically derived from bone marrow (BM) but potentially from umbilical cord blood (UCB). Although they are becoming a good tool for regenerative medicine, they usually need to be expanded in fetal bovine serum (FBS)-supplemented media. Human platelet lysate (HPL) has recently been proposed as substitute for safety reasons, but it is not yet clear how this supplement influences the properties of expanded MSCs. Methods In the present study, we compared the effect of various media combining autologous HPL with or without FBS on phenotypic, proliferative and functional (differentiation, cytokine secretion profile) characteristics of human BM-derived MSCs. Results Despite less expression of adipogenic and osteogenic markers, MSCs cultured in HPL-supplemented media fully differentiated along osteoblastic, adipogenic, chondrogenic and vascular smooth muscle lineages. The analyses of particular specific proteins expressed during osteogenic differentiation (calcium-sensing receptor (CaSR) and parathormone receptor (PTHR)) showed their decrease at D0 before any induction for MSC cultured with HPL mostly at high percentage (10%HPL). The cytokine dosage showed a clear increase of proliferation capacity and interleukin (IL)-6 and IL-8 secretion. Conclusions This study shows that MSCs can be expanded in media supplemented with HPL that can totally replace FBS. HPL-supplemented media not only preserves their phenotype as well as their differentiation capacity, but also shortens culture time by increasing their growth rate. PMID:22333342

A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS.

PubMed

Freedman, M S; Bar-Or, A; Oger, J; Traboulsee, A; Patry, D; Young, C; Olsson, T; Li, D; Hartung, H-P; Krantz, M; Ferenczi, L; Verco, T

2011-10-18

To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)). This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life. There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified. In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).

Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients.

PubMed

Meisner, Søren; González-Huix, Ferran; Vandervoort, Jo G; Goldberg, Paul; Casellas, Juan A; Roncero, Oscar; Grund, Karl E; Alvarez, Alberto; García-Cano, Jesús; Vázquez-Astray, Enrique; Jiménez-Pérez, Javier

2011-10-01

The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS). Prospective clinical cohort study. Two global registries with 39 academic and community centers. This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified). Colorectal through-the-scope SEMS placement. The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications. The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding. No control group. No primary endpoint analysis data for 25% of patients. This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Self-Expanding Nitinol Renal Artery Stents: Comparison of Safety and Efficacy of Bare Versus Polyzene-F Nanocoated Stents in a Porcine Model

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

Kurz, P.; Stampfl, U.; Christoph, P.

2011-02-15

Objective: To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries. Materials and Methods: Ten bare nitinol stents (BNS) and 10 stents coated with a 50 nm-thin Polyzene-F coating were randomly implanted into renal arteries of 10 minipigs (4- and 12-week follow-up, 5 animals/group). Thrombogenicity, on-stent surface endothelialization, vessel wall injury, late in-stent stenosis, and peristrut vessel wall inflammation were determined by quantitative angiography and postmortem histomorphometry. Results: In 6 of 10 BNS, >50% stenosis was found, but no stenosis was found in stents with a nanothin Polyzene-F coating. Histomorphometrymore » showed a statistically significant (p < 0.05) different average maximum luminal loss of 55.16% {+-} 8.43% at 12 weeks in BNS versus 39.77% {+-} 7.41% in stents with a nanothin Polyzene-F coating. Stents with a nanothin Polyzene-F coating had a significantly (p < 0.05) lower inflammation score after 12 weeks, 1.31 {+-} 1.17 versus 2.17 {+-} 0.85 in BNS. The results for vessel wall injury (0.6 {+-} 0.58 for Polyzene-F-coated stents; 0.72 {+-} 0.98 for BNS) and re-endothelialization, (1.16 {+-} 0.43 and 1.23 {+-} 0.54, respectively) were not statistically significant at 12-week follow-up. No thrombus deposition was observed on the stents at either follow-up time point. Conclusion: Nitinol stents with a nanothin Polyzene-F coating successfully decreased in-stent stenosis and vessel wall inflammation compared with BNS. Endothelialization and vessel wall injury were found to be equal. These studies warrant long-term pig studies ({>=}120 days) because 12 weeks may not be sufficient time for complete healing; thereafter, human studies may be warranted.« less

Annual report to Congress: Department of Energy activities relating to the Defense Nuclear Facilities Safety Board, Calendar Year 1999

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

None

2000-02-01

This is the tenth Annual Report to the Congress describing Department of Energy activities in response to formal recommendations and other interactions with the Defense Nuclear Facilities Safety Board (Board). The Board, an independent executive-branch agency established in 1988, provides advice and recommendations to the Secretary of Energy regarding public health and safety issues at the Department's defense nuclear facilities. The Board also reviews and evaluates the content and implementation of health and safety standards, as well as other requirements, relating to the design, construction, operation, and decommissioning of the Department's defense nuclear facilities. During 1999, Departmental activities resulted inmore » the closure of nine Board recommendations. In addition, the Department has completed all implementation plan milestones associated with three Board recommendations. One new Board recommendation was received and accepted by the Department in 1999, and a new implementation plan is being developed to address this recommendation. The Department has also made significant progress with a number of broad-based initiatives to improve safety. These include expanded implementation of integrated safety management at field sites, opening of a repository for long-term storage of transuranic wastes, and continued progress on stabilizing excess nuclear materials to achieve significant risk reduction.« less

An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

PubMed

Komparic, Ana; Smith, Maxwell J; Thompson, Alison

2016-04-01

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

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

Hopper, Calvin Mitchell

In May 1973 the University of New Mexico conducted the first nationwide criticality safety training and education week-long short course for nuclear criticality safety engineers. Subsequent to that course, the Los Alamos Critical Experiments Facility (LACEF) developed very successful 'hands-on' subcritical and critical training programs for operators, supervisors, and engineering staff. Since the inception of the US Department of Energy (DOE) Nuclear Criticality Technology and Safety Project (NCT&SP) in 1983, the DOE has stimulated contractor facilities and laboratories to collaborate in the furthering of nuclear criticality as a discipline. That effort included the education and training of nuclear criticality safetymore » engineers (NCSEs). In 1985 a textbook was written that established a path toward formalizing education and training for NCSEs. Though the NCT&SP went through a brief hiatus from 1990 to 1992, other DOE-supported programs were evolving to the benefit of NCSE training and education. In 1993 the DOE established a Nuclear Criticality Safety Program (NCSP) and undertook a comprehensive development effort to expand the extant LACEF 'hands-on' course specifically for the education and training of NCSEs. That successful education and training was interrupted in 2006 for the closing of the LACEF and the accompanying movement of materials and critical experiment machines to the Nevada Test Site. Prior to that closing, the Lawrence Livermore National Laboratory (LLNL) was commissioned by the US DOE NCSP to establish an independent hands-on NCSE subcritical education and training course. The course provided an interim transition for the establishment of a reinvigorated and expanded two-week NCSE education and training program in 2011. The 2011 piloted two-week course was coordinated by the Oak Ridge National Laboratory (ORNL) and jointly conducted by the Los Alamos National Laboratory (LANL) classroom education and facility training, the Sandia National Laboratory (SNL) hands-on criticality experiments training, and the US DOE National Criticality Experiment Research Center (NCERC) hands-on criticality experiments training that is jointly supported by LLNL and LANL and located at the Nevada National Security Site (NNSS) This paper provides the description of the bases, content, and conduct of the piloted, and future US DOE NCSP Criticality Safety Engineer Training and Education Project.« less

Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States: An Expanded Access Program.

PubMed

Gangadhar, Tara C; Hwu, Wen-Jen; Postow, Michael A; Hamid, Omid; Daud, Adil; Dronca, Roxana; Joseph, Richard; O'Day, Steven J; Hodi, F S; Pavlick, Anna C; Kluger, Harriet; Oxborough, Romina P; Yang, Aiming; Gazdoiu, Mihaela; Kush, Debra A; Ebbinghaus, Scot; Salama, April K S

KEYNOTE-030 (ClinicalTrials.gov ID, NCT02083484) was a global expanded access program that allowed access to pembrolizumab, an antiprogrammed death 1 antibody, for patients with advanced melanoma before its regulatory approval. Patients with unresectable stage III/IV melanoma that progressed after standard-of-care therapy, including ipilimumab and, if BRAF mutant, a BRAF inhibitor, were eligible to receive pembrolizumab 2 mg/kg every 3 weeks. Response was assessed by immune-related response criteria by investigator review. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. In the United States, 979 patients enrolled between April and September 2014. Of the 947 evaluable patients, 621 (65.6%) remained on treatment and transitioned to receive commercial pembrolizumab following approval by the Food and Drug Administration, whereas 326 (34.4%) discontinued, most commonly for disease progression (39.6%) or death (26.4%). Objective response rate was 14.5% (95% confidence interval, 12.2%-16.8%) in the treated population (n=947) and 22.1% (95% confidence interval, 18.8%-25.5%) in patients who had ≥1 response assessment reported (n=619). Twelve patients achieved complete response. One hundred eighty-one (19.1%) patients experienced ≥1 treatment-related AE, most commonly general disorders (8.0%), skin/subcutaneous tissue disorders (7.3%), and gastrointestinal disorders (6.4%); 29 (3.1%) patients experienced ≥1 grade 3/4 treatment-related AE. Immune-mediated AEs were also reported. There were no treatment-related deaths. The safety and efficacy observed in this expanded access program were consistent with those previously reported for similar populations and support the use of pembrolizumab for patients with advanced melanoma.

Water for Agriculture: the Convergence of Sustainability and Safety.

PubMed

Markland, Sarah M; Ingram, David; Kniel, Kalmia E; Sharma, Manan

2017-05-01

Agricultural water is a precious and limited resource. Increasingly more water types and sources are being explored for use in irrigation within the United States and across the globe. As outlined in this chapter, the Produce Safety Rule (PSR) in the Food Safety and Modernization Act (FSMA) provide irrigation water standards for application of water to fruits and vegetables consumed raw. These rules for production and use of water will continue to develop and be required as the world experiences aspects of a changing climate including flooding as well as drought conditions. Research continues to assess the use of agricultural water types. The increased use of reclaimed water in the United States as well as for selected irrigation water needs for specific crops may provide increased water availability. The use of surface water can be used in irrigation as well, but several studies have shown the presence of some enteric bacterial pathogens (enterohemorrhagic E. coli , Salmonella spp. and Listeria monocytogenes ) in these waters that may contaminate fruits and vegetables. There have been outbreaks of foodborne illness in the U.S., South America, Europe, and Australia related to the use of contaminated water in fruit and vegetable irrigation or washing. Unreliable water supplies, more stringent microbial water standards, mitigation technologies and expanded uses of reclaimed waters have all increased interest in agricultural water.

Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.

PubMed

Ulrich, Peter; Blaich, Guenter; Baumann, Andreas; Fagg, Rajni; Hey, Adam; Kiessling, Andrea; Kronenberg, Sven; Lindecrona, Rikke Hvid; Mohl, Silke; Richter, Wolfgang F; Tibbitts, Jay; Crameri, Flavio; Weir, Lucinda

2018-04-01

Biological drugs comprise a wide field of different modalities with respect to structure, pharmacokinetics and pharmacological function. Considerable non-clinical experience in the development of proteins (e.g. insulin) and antibodies has been accumulated over the past thirty years. In order to improve the efficacy and the safety of these biotherapeutics, Fc modifications (e.g. Fc silent antibody versions), combinations (antibody-drug conjugates, protein-nanoparticle combinations), and new constructs (darpins, fynomers) have been introduced. In the last decade, advanced therapy medicinal products (ATMPs) in research and development have become a considerable and strongly growing part of the biotherapeutic portfolio. ATMPs consisting of gene and cell therapy modalities or even combinations of them, further expand the level of complexity, which already exists in non-clinical development strategies for biological drugs and has thereby led to a further diversification of expertise in safety and PKPD assessment of biological drugs. It is the fundamental rationale of the BioSafe meetings, held yearly in the EU and in the US, to convene experts on a regular basis and foster knowledge exchange and mutual understanding in this fast growing area. In order to reflect at least partially the variety of the biotherapeutics field, the 2016 EU BioSafe meeting addressed the following topics in six sessions: (i) In vitro Meets in vivo to Leverage Biologics Development (ii) New developments and regulatory considerations in the cell and gene therapy field (iii) CMC Challenges with Biologics development (iv) Minipigs in non-clinical safety assessment (v) Opportunities of PKPD Assessment in Less Common Administration Routes In the breakout sessions the following questions were discussed: (i) Cynomolgus monkey as a reprotoxicology Species: Impact of Immunomodulators on Early Pregnancy Maintenance (ii) Safety Risk of Inflammation and Autoimmunity Induced by Immunomodulators (iii) Experience with non-GMP Material in Pivotal Non-clinical Safety Studies to Support First in Man (FiM) Trials (iv) Safety Assessment of Combination Products for Non-oncology. Copyright © 2018 Elsevier Inc. All rights reserved.

Recent antiseizure medications in the Intensive Care Unit.

PubMed

Orinx, Cindy; Legros, Benjamin; Gaspard, Nicolas

2017-08-01

Seizures and status epilepticus (SE), both clinical and subclinical, are frequent in critically ill patients. The list of available antiseizure medications (ASMs) is expanding and now includes older and widely used drugs as well as more recent medications with a better safety and pharmacokinetics profile. We review a selection of recent publications about the indications and administration of ASMs in critical care for the prophylaxis and treatment of seizures and SE, focusing on recent ASMs available as intravenous formulation and emphasizing pharmacokinetics and safety issues in relation to several aspects of critical illness. Levetiracetam, lacosamide and more recently brivaracetam, represent interesting alternatives to older ASMs, mostly due to a more favorable safety and pharmacokinetic profile. Low-quality studies suggest that this profile results in better tolerability in treated patients. Ketamine might represent a useful addition in our anesthetic armamentarium for refractory SE, due to its different mechanism of action and cardiovascular properties. Little evidence is available however to support the prophylactic use of ASMs in critically ill patients, except in specific settings (traumatic brain injury and subarachnoid hemorrhage). Head-to-head studies comparing recent and older ASMs in the treatment of acute seizures and SE are ongoing or awaiting publication. Administration of ASMs to critically ill patients needs to be adapted to organ dysfunction, and especially to renal dysfunction for recent drugs. Recent ASMs and could represent better treatment choices in critically ill patients than older ones but this needs to be confirmed in randomized controlled studies. In general, further studies are required to clarify the indications and optimal use of ASMs in the critical care setting.

Expertise in physiological breech birth: A mixed-methods study.

PubMed

Walker, Shawn; Parker, Pam; Scamell, Mandie

2018-06-01

The safety of vaginal breech birth depends on the expertise of birth attendants, yet the meaning of "expertise" remains unclear and subjectively defined. The objective of this study was to define expertise and the roles experts may play in expanding access to this service. We performed an integrative analysis of two strands of data concerning expertise in physiological breech birth, including the following: survey data from a Delphi study involving 26 very experienced clinicians (mean experience = 135 breech births) and 2 service user representatives, and interviews from a grounded theory study of 14 clinicians more moderately experienced with physiological methods (5-30 upright breech births). Data were pooled and analyzed using constant comparative methods. Expertise is defined by its ongoing function, the generation of comparatively good outcomes, and confidence and competence among colleagues. Although clinical experience is important, expertise is developed and expressed in social clinical roles, which expand as experience grows: clinician, mentor, specialist, and expert. To develop expertise within a service, clinicians who have an interest in breech birth should be supported to perform these roles within specialist teams. Specialist breech teams may facilitate the development of expertise within maternity care settings. Evaluation of expertise based on enablement of women and colleagues, as well as outcomes, will potentially avoid the pitfalls of alienation produced by some forms of specialist authority. © 2017 Wiley Periodicals, Inc.

Simulation-based medical education: an ethical imperative.

PubMed

Ziv, Amitai; Wolpe, Paul Root; Small, Stephen D; Glick, Shimon

2006-01-01

Medical training must at some point use live patients to hone the skills of health professionals. But there is also an obligation to provide optimal treatment and to ensure patients' safety and well-being. Balancing these 2 needs represents a fundamental ethical tension in medical education. Simulation-based learning can help mitigate this tension by developing health professionals' knowledge, skills, and attitudes while protecting patients from unnecessary risk. Simulation-based training has been institutionalized in other high-hazard professions, such as aviation, nuclear power, and the military, to maximize training safety and minimize risk. Health care has lagged behind in simulation applications for a number of reasons, including cost, lack of rigorous proof of effect, and resistance to change. Recently, the international patient safety movement and the U.S. federal policy agenda have created a receptive atmosphere for expanding the use of simulators in medical training, stressing the ethical imperative to "first do no harm" in the face of validated, large epidemiological studies describing unacceptable preventable injuries to patients as a result of medical management. Four themes provide a framework for an ethical analysis of simulation-based medical education: best standards of care and training, error management and patient safety, patient autonomy, and social justice and resource allocation. These themes are examined from the perspectives of patients, learners, educators, and society. The use of simulation wherever feasible conveys a critical educational and ethical message to all: patients are to be protected whenever possible and they are not commodities to be used as conveniences of training.

Simulation-based medical education: an ethical imperative.

PubMed

Ziv, Amitai; Wolpe, Paul Root; Small, Stephen D; Glick, Shimon

2003-08-01

Medical training must at some point use live patients to hone the skills of health professionals. But there is also an obligation to provide optimal treatment and to ensure patients' safety and well-being. Balancing these two needs represents a fundamental ethical tension in medical education. Simulation-based learning can help mitigate this tension by developing health professionals' knowledge, skills, and attitudes while protecting patients from unnecessary risk. Simulation-based training has been institutionalized in other high-hazard professions, such as aviation, nuclear power, and the military, to maximize training safety and minimize risk. Health care has lagged behind in simulation applications for a number of reasons, including cost, lack of rigorous proof of effect, and resistance to change. Recently, the international patient safety movement and the U.S. federal policy agenda have created a receptive atmosphere for expanding the use of simulators in medical training, stressing the ethical imperative to "first do no harm" in the face of validated, large epidemiological studies describing unacceptable preventable injuries to patients as a result of medical management. Four themes provide a framework for an ethical analysis of simulation-based medical education: best standards of care and training, error management and patient safety, patient autonomy, and social justice and resource allocation. These themes are examined from the perspectives of patients, learners, educators, and society. The use of simulation wherever feasible conveys a critical educational and ethical message to all: patients are to be protected whenever possible and they are not commodities to be used as conveniences of training.

A multidisciplinary protocol for planned skin-preserving delayed breast reconstruction for patients with locally advanced breast cancer requiring postmastectomy radiation therapy: 3-year follow-up.

PubMed

Kronowitz, Steven J; Lam, Candace; Terefe, Welela; Hunt, Kelly K; Kuerer, Henry M; Valero, Vicente; Lance, Samuel; Robb, Geoffrey L; Feng, Lei; Buchholz, Thomas A

2011-06-01

The authors examined the safety of a protocol for planned skin-preserving delayed breast reconstruction after postmastectomy radiotherapy with placement of a tissue expander for patients with locally advanced breast cancer (stages IIB and III). The authors compared 47 patients treated according to the protocol between December 2003 and May 2008 with 47 disease-stage-matched control patients who underwent standard delayed reconstruction after postmastectomy radiotherapy (no skin preservation or tissue expander) during the same period. Protocol-group complication rates were 21 percent for skin-preserving mastectomy and placement of the expander (stage 1), 5 percent for postmastectomy radiotherapy, 25 percent for expander reinflation after radiotherapy, and 24 percent for skin-preserving delayed reconstruction. The complication rate for standard delayed reconstruction was 38 percent. Tissue-expander loss rates were 32 percent overall, 9 percent for stage 1, 5 percent for postmastectomy radiotherapy, and 22 percent for reinflation. Wound-healing complications after reconstruction occurred in 3 percent of protocol-group and 10 percent of control-group patients. The median follow-up time for patients still alive at last follow-up was 40 months (range, 8.5 to 85.3 months). Three-year recurrence-free survival rates were 92 percent (95 percent CI, 83 to 100 percent) and 86 percent (95 percent CI, 76 to 98 percent) for the protocol and control groups, respectively (p = 0.87). In patients with locally advanced breast cancer, skin-preserving mastectomy with a deflated tissue expander on the chest wall during postmastectomy radiotherapy does not increase locoregional recurrence risk and is associated with lower complication rates of definitive reconstruction.

Human factors in modern traffic systems.

PubMed

Noy, Y I

1997-10-01

Traffic systems are undergoing enormous change with the advent of Intelligent Transport Systems (ITS). Although productivity and quality of mobility are emerging interests, safety remains the predominant preoccupation of ITS human factors. It should be evident that while intelligent technologies may have the potential to improve traffic safety, they also have the potential to adversely affect it. Ultimately, the effect on safety depends on the specific technologies that are invoked and the manner in which they are incorporated within the vehicle as well as within the larger road transportation system. Current automotive developments can be characterized as technology-centred solutions rather than user-centred solutions. Greater effort must be directed at understanding and accommodating the human element in the road transportation system in order that future transportation objectives can be achieved. There is a need to expand the scope of traditional human factors to include macro-level effects as well as to place greater emphasis on understanding human interactions with other elements of the system. There is also increasing recognition of the urgent need for systematic procedures and criteria for testing the safety of ITS prior to large-scale market penetration.

Overview of the National Aeronautics and Space Administration's Nondestructive Evaluation (NDE) Program

NASA Technical Reports Server (NTRS)

Generazio, Edward R.

2002-01-01

NASA's Office of Safety and Mission Assurance sponsors an Agency-wide NDE Program that supports Aeronautics and Space Transportation Technology, Human Exploration and Development of Space, Earth Science, and Space Science Enterprises. For each of these Enterprises, safety is the number one priority. Development of the next generation aero-space launch and transportation vehicles, satellites, and deep space probes have highlighted the enabling role that NDE plays in these advanced technology systems. Specific areas of advanced component development, component integrity, and structural heath management are critically supported by NDE technologies. The simultaneous goals of assuring safety, maintaining overall operational efficiency, and developing and utilizing revolutionary technologies to expand human activity and space-based commerce in the frontiers of air and space places increasing demands on the Agencies NDE infrastructure and resources. In this presentation, an overview of NASA's NDE Program will be presented, that includes a background and status of current Enterprise NDE issues, and the NDE investment areas being developed to meet Enterprise safety and mission assurance needs through the year 2009 and beyond.

Fundamentals of Aeronautical and Aerospace Medical Science,

DTIC Science & Technology

1981-07-17

internal air bubbles and gas embol - isms can appear; over 18 kilometers it is necessary to use a pressure suit to maintain life safety. 10. Airtight...examinations have expanded this to fractures , muscle and skin injuries, blood spots, muscle tension and weakness, heart and intracranial hemorrhaging...vertebra inclines forward and when the front edge of the vertebra is subjected to a concentration of negative overweightness, fractures occur. If the

The evolving role of radiologists within the health care system.

PubMed

Knechtges, Paul Martin; Carlos, Ruth C

2007-09-01

The traditional view of radiologists as physicians who add value to the health care system solely by generating and interpreting diagnostic images is outdated. Radiologists' roles have expanded to encompass economic gatekeeping, political advocacy, public health delivery, patient safety, quality-of-care improvement, and information technology. It is through these roles that radiologists will continue to find new ways to add value to the health care system.

Civil Forensic Psychiatry - part 3: practical aspects of managing a medico-legal practice.

PubMed

Samuels, Anthony H

2018-06-01

This is the third in a series of papers on Civil Forensic Psychiatry and provides practical advice for forensic psychiatrists, general psychiatrists and trainees who are expanding or contemplating a medico-legal aspect to their practice. Attention to the practice setting, office layout, recording of information, management of documentation, screening of briefs and proper timetabling can improve safety, quality, reliability and workload manageability.

Everolimus Plus Exemestane in Advanced Breast Cancer: Safety Results of the BALLET Study on Patients Previously Treated Without and with Chemotherapy in the Metastatic Setting.

PubMed

Generali, Daniele; Montemurro, Filippo; Bordonaro, Roberto; Mafodda, Antonino; Romito, Sante; Michelotti, Andrea; Piovano, Pierluigi; Ionta, Maria Teresa; Bighin, Claudia; Sartori, Donata; Frassoldati, Antonio; Cazzaniga, Marina Elena; Riccardi, Ferdinando; Testore, Franco; Vici, Patrizia; Barone, Carlo Antonio; Schirone, Alessio; Piacentini, Federico; Nolè, Franco; Molino, Annamaria; Latini, Luciano; Simoncini, Edda Lucia; Roila, Fausto; Cognetti, Francesco; Nuzzo, Francesco; Foglietta, Jennifer; Minisini, Alessandro Marco; Goffredo, Francesca; Portera, Giuseppe; Ascione, Gilda; Mariani, Gabriella

2017-06-01

The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). One thousand one hundred and fifty-one Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. With the advent of new targeted agents for advanced or metastatic breast cancer, multiple lines of therapy may be possible, and components of the combined regimens can overlap from one line to another. Thus, it is important to assess even the potential of cumulative and additive toxic effects among the drugs. Previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The continuous monitoring of the safety signals of this drug combination from general clinical practice is important, in particular for stomatitis. © AlphaMed Press 2017.

Proposal for Certifying Expandable Planetary Surface Habitation Structures

NASA Technical Reports Server (NTRS)

Dorsey, John T.

2011-01-01

A factor-of-safety (FS) of 4.0 is currently used to design habitation structures made from structural soft goods. This approach is inconsistent with using a FS of 2.0 for metallic and polymeric composite pressure vessels as well as soft good structures such as space suits and parachutes. This inconsistency arises by using the FS to improperly account for the unknown effects of a variety of environmental and loading uncertainties. Using a 4.0 FS not only results in additional structural mass, it also makes it difficult to gain insight into the limitations of the material and/or product form and thus, it becomes difficult to make improvements. In order to bring consistency to the design and certification of expandable habitat structures, the approach used by the Federal Aviation Administration (FAA) to certify polymeric composite aircraft structures is used as a model and point of departure. A draft certification plan for Expandable Habitat Structures is developed in this paper and offered as an option for placing habitats made from soft goods on an equal footing with other structural implementations.

Analysis of time in establishing synchronization radio communication system with expanded spectrum conditions for communication with mobile robots

NASA Astrophysics Data System (ADS)

Latinovic, T. S.; Kalabic, S. B.; Barz, C. R.; Petrica, P. Paul; Pop-Vădean, A.

2018-01-01

This paper analyzes the influence of the Doppler Effect on the length of time to establish synchronization pseudorandom sequences in radio communications systems with an expanded spectrum. Also, this paper explores the possibility of using secure wireless communication for modular robots. Wireless communication could be used for local and global communication. We analyzed a radio communication system integrator, including the two effects of the Doppler signal on the duration of establishing synchronization of the received and locally generated pseudorandom sequence. The effects of the impact of the variability of the phase were analyzed between the said sequences and correspondence of the phases of these signals with the interval of time of acquisition of received sequences. An analysis of these impacts is essential in the transmission of signal and protection of the transfer of information in the communication systems with an expanded range (telecommunications, mobile telephony, Global Navigation Satellite System GNSS, and wireless communication). Results show that wireless communication can provide a safety approach for communication with mobile robots.

Use of N-Acetylcysteine in Psychiatric Conditions among Children and Adolescents: A Scoping Review.

PubMed

Naveed, Sadiq; Amray, Afshan; Waqas, Ahmed; Chaudhary, Amna M; Azeem, Muhammad W

2017-11-29

N-acetylcysteine (NAC) is a well-known antidote for acetaminophen toxicity and is easily available over the counter. It has antioxidant and anti-inflammatory properties and an established tolerance and safety profile. Owing to its neuroprotective effects, its clinical use has recently expanded to include the treatment of different psychiatric and non-psychiatric disorders. Although a number of randomized controlled trials have documented the clinical evidence for NAC, there are no reviews that summarize the evidence. The present scoping review summarizes the study designs, the patient characteristics, the evidence and the limitations in randomized controlled trials designed to explore the efficacy of NAC for psychiatric conditions in the pediatric population.

Surgical center: challenges and strategies for nurses in managerial activities.

PubMed

Martins, Fabiana Zerbieri; Dall'Agnoll, Clarice Maria

2017-02-23

Analyze the challenges and strategies of nurses performing managerial activities in a surgical center. Exploratory, descriptive study with a qualitative approach, involving six nurses by means of the Focus Group Technique, between April and August 2013. Data were submitted to thematic content analysis. The main challenges noted were deficiency of material resources, communication noise, adequacy of personnel downsizing, and relationships with the multidisciplinary team. Key strategies include construction of co-management spaces to promote integration among professionals, conflict resolution and exchange of knowledge. Managerial activities involve the promotion of dialogic moments to coordinate the different processes in the surgical center to provide inputs to expand safety and quality of services provided.

Adoptive cell transfer in autoimmune hepatitis.

PubMed

Czaja, Albert J

2015-06-01

Adoptive cell transfer is an intervention in which autologous immune cells that have been expanded ex vivo are re-introduced to mitigate a pathological process. Tregs, mesenchymal stromal cells, dendritic cells, macrophages and myeloid-derived suppressor cells have been transferred in diverse immune-mediated diseases, and Tregs have been the focus of investigations in autoimmune hepatitis. Transferred Tregs have improved histological findings in animal models of autoimmune hepatitis and autoimmune cholangitis. Key challenges relate to discrepant findings among studies, phenotypic instability of the transferred population, uncertain side effects and possible need for staged therapy involving anti-inflammatory drugs. Future investigations must resolve issues about the purification, durability and safety of these cells and consider alternative populations if necessary.

The German Long-Term Care Insurance Program: Evolution and Recent Developments.

PubMed

Nadash, Pamela; Doty, Pamela; von Schwanenflügel, Matthias

2018-05-08

Since 1995, Germany has operated one of the longest-running public programs providing universal support for the cost of long term services and supports (LTSS). Its self-funding, social insurance approach provides basic supports to nearly all Germans. We discuss its design and development, including recent reforms expanding the program and ensuring its ongoing sustainability. The study reviews legislative and programmatic changes, using program data, as well as legislative documents and program reports. The program is widely accepted among citizens and has achieved many of its original goals: ensuring access to LTSS and reducing reliance on the locally-funded safety-net social assistance program, which can be used to cover nursing home costs. It also strengthened the LTSS provider infrastructure and expanded access to home care. Recent reforms have addressed some of the program's key issues: the benefit's decreasing value, the eligibility and benefit structure that largely excluded cognitive impairment, and the program's longer-term financial sustainability-particularly its ability to sustain newly expanded benefits, which provide stronger protections to caregivers, index-link benefits, and more systematically incorporate cognitive impairment via a new assessment system. It has addressed financing issues by increasing premiums, introducing subsidies for the purchase of private insurance, and creating a "demographic reserve fund." The reforms constitute a significant strengthening of the program, remarkable in an era of retrenchment. Overall, the program provides evidence for the financial viability of a social insurance model, although longer-term challenges may yet arise.

Expanding protection motivation theory: investigating an application to animal owners and emergency responders in bushfire emergencies.

PubMed

Westcott, Rachel; Ronan, Kevin; Bambrick, Hilary; Taylor, Melanie

2017-04-26

Protection Motivation Theory (PMT) was developed by Rogers in 1975, to describe how individuals are motivated to react in a self-protective way towards a perceived health threat. Rogers expected the use of PMT to diversify over time, which has proved true over four decades. The purpose of this paper is to explore how PMT can be used and expanded to inform and improve public safety strategies in natural hazards. As global climate change impacts on the Australian environment, natural hazards seem to be increasing in scale and frequency, and Emergency Services' public education campaigns have necessarily escalated to keep pace with perceived public threat. Of concern, is that the awareness-preparedness gap in residents' survival plans is narrowing disproportionately slowly compared to the magnitude of resources applied to rectify this trend. Practical applications of adaptable social theory could be used to help resolve this dilemma. PMT has been used to describe human behaviour in individuals, families, and the parent-child unit. It has been applied to floods in Europe and wildfire and earthquake in the United States. This paper seeks to determine if an application of PMT can be useful for achieving other-directed human protection across a novel demographic spectrum in natural hazards, specifically, animal owners and emergency responders in bushfire emergencies. These groups could benefit from such an approach: owners to build and fortify their response- and self-efficacy, and to help translate knowledge into safer behaviour, and responders to gain a better understanding of a diverse demographic with animal ownership as its common denominator, and with whom they will be likely to engage in contemporary natural hazard management. Mutual collaboration between these groups could lead to a synergy of reciprocated response efficacy, and safer, less traumatic outcomes. Emergency services' community education programs have made significant progress over the last decade, but public safety remains suboptimal while the magnitude of the awareness-preparedness gap persists. This paper examines an expanded, other-directed application of PMT to expand and enhance safer mitigation and response behaviour strategies for communities threatened by bushfire, which may ultimately help save human life.

A mass vaccination campaign targeting adults and children to prevent typhoid fever in Hechi; Expanding the use of Vi polysaccharide vaccine in Southeast China: A cluster-randomized trial

PubMed Central

Yang, Jin; Acosta, Camilo J; Si, Guo-ai; Zeng, Jun; Li, Cui-yun; Liang, Da-bin; Ochiai, R Leon; Page, Anne-Laure; Danovaro-Holliday, M Carolina; Zhang, Jie; Zhou, Bao-de; Liao, He-zhuang; Wang, Ming-liu; Tan, Dong-mei; Tang, Zhen-zhu; Gong, Jian; Park, Jin-Kyung; Ali, Mohammad; Ivanoff, Bernard; Liang, Gui-chen; Yang, Hong-hui; Pang, Tikki; Xu, Zhi-yi; Donner, Allan; Galindo, Claudia M; Dong, Bai-qing; Clemens, John D

2005-01-01

Background One of the goals of this study was to learn the coverage, safety and logistics of a mass vaccination campaign against typhoid fever in children and adults using locally produced typhoid Vi polysaccharide (PS) and group A meningococcal PS vaccines in southern China. Methods The vaccination campaign targeted 118,588 persons in Hechi, Guangxi Province, aged between 5 to 60 years, in 2003. The study area was divided into 107 geographic clusters, which were randomly allocated to receive one of the single-dose parenteral vaccines. All aspects regarding vaccination logistics, feasibility and safety were documented and systematically recorded. Results of the logistics, feasibility and safety are reported. Results The campaign lasted 5 weeks and the overall vaccination coverage was 78%. On average, the 30 vaccine teams gave immunizations on 23 days. Vaccine rates were higher in those aged ≤ 15 years (90%) than in adolescents and young adults (70%). Planned mop-up activities increased the coverage by 17%. The overall vaccine wastage was 11%. The cold chain was maintained and documented. 66 individuals reported of adverse events out of all vaccinees, where fever (21%), malaise (19%) and local redness (19%) were the major symptoms; no life-threatening event occurred. Three needle-sharp events were reported. Conclusion The mass immunization proved feasible and safe, and vaccine coverage was high. Emphasis should be placed on: injection safety measures, community involvement and incorporation of mop-up strategies into any vaccination campaign. School-based and all-age Vi mass immunizations programs are potentially important public health strategies for prevention of typhoid fever in high-risk populations in southern China. PMID:15904514

The private funding of public research. New directions in the administration of occupational and environmental health research.

PubMed

Cullen, M R; Upton, A; Buffler, P; Robins, T; Schenker, M; Fine, L; Wiencek, R; Widess, E; Chiazze, L

1994-12-01

Dr. Cullen: The experience with the new research models, starting with the prototypic experience of the rubber industry studies of the 1970s and expanding to diverse sectors of American industry in the 1980s, has yielded some important lessons for the future. In closing this symposium I shall try to summarize these briefly. Certain strengths of the evolving process seem common to each of the models. Alone and collectively, the new research arrangements have quite apparently served to increase substantially the pool of funds available to the academic sector for the study of occupational health and safety problems. As a consequence, a larger pool of investigators has participated in the research process, greatly strengthening the future academic capability and experience of our fragilely supported teaching centers. Combined with the involvement of the academic centers in the review process, there has been an undeniable broadening and deepening of the nation's research output and long-term capability in occupational health. On the side of the private sector, the new relationships have led to marked progress in the knowledge base about health and safety problems, with a heavily directed focus on those of greatest relevance to the industries involved. The credibility of the knowledge acquired has been enhanced, an important achievement in a society in which perception of truth is often as important as the truth itself! Because of the requirements of the process for broad involvement by the organizations which undertake these activities, health and safety have achieved far greater visibility and attention by corporate and union leaders who may have previously had no involvement in issues of health and safety.(ABSTRACT TRUNCATED AT 250 WORDS)

First Responders and Prehospital Care for Road Traffic Injuries in Malawi.

PubMed

Chokotho, Linda; Mulwafu, Wakisa; Singini, Isaac; Njalale, Yasin; Maliwichi-Senganimalunje, Limbika; Jacobsen, Kathryn H

2017-02-01

Introduction Road traffic collisions are a common cause of injuries and injury-related deaths in sub-Saharan Africa (SSA). Basic prehospital care can be the difference between life and death for injured drivers, passengers, and pedestrians. Problem This study examined the challenges associated with current first response practices in Malawi. In April 2014, focus groups were conducted in two areas of Malawi: Karonga (in the Northern Region) and Blantyre (in the Southern Region; both are along the M1 highway), and a qualitative synthesis approach was used to identify themes. All governmental and nongovernmental first response organizations identified by key informants were contacted, and a checklist was used to identify the services they offer. Access to professional prehospital care in Malawi is almost nonexistent, aside from a few city fire departments and private ambulance services. Rapid transportation to a hospital is usually the primary goal of roadside care because of limited first aid knowledge and a lack of access to basic safety equipment. The key informants recommended: expanding community-based first aid training; emphasizing umunthu (shared humanity) to inspire bystander involvement in roadside care; empowering local leaders to coordinate on-site responses; improving emergency communication systems; equipping traffic police with road safety gear; and expanding access to ambulance services. Prehospital care in Malawi would be improved by the creation of a formal network of community leaders, police, commercial drivers, and other lay volunteers who are trained in basic first aid and are equipped to respond to crash sites to provide roadside care to trauma patients and prepare them for safe transport to hospitals. Chokotho L , Mulwafu W , Singini I , Njalale Y , Maliwichi-Senganimalunje L , Jacobsen KH . First responders and prehospital care for road traffic injuries in Malawi. Prehosp Disaster Med. 2017;32(1):14-19.

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

PubMed Central

Nam, Hyeong Seok; Kang, Dae Hwan; Kim, Hyung Wook; Choi, Cheol Woong; Park, Su Bum; Kim, Su Jin; Ryu, Dae Gon

2017-01-01

AIM To evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of self-expandable metal stent (SEMS). METHODS This was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. RESULTS Among the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, pancreatic cancer in 79, and non-pancreatic or non-biliary malignancies in the remaining 47 patients. Early post-ERCP complications occurred in 9 patients (3.7%), with PEP in 7 patients (2.9%; mild, 6; moderate, 1) and mild bleeding in 2 patients (0.8%). There was no significant association between the incidence of post-ERCP complications and the type of malignancy (cholangiocarcinoma vs pancreatic cancer vs others, P = 0.696) or the type of SEMS used (uncovered vs covered, P = 1.000). Patients who had more than one SEMS placed at the first instance were at a significantly higher risk of post-ERCP complications (one SEMS vs two SEMS, P = 0.031). No other factors were predictive of post-ERCP complications. CONCLUSION Limited ES is feasible and safe, and effectively facilitates the placement of SEMS, without any significant risk of PEP or severe bleeding. PMID:28321164

Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.

PubMed

Vazquez-Sequeiros, Enrique; Baron, Todd H; Pérez-Miranda, Manuel; Sánchez-Yagüe, Andres; Gornals, Joan; Gonzalez-Huix, Ferran; de la Serna, Carlos; Gonzalez Martin, Juan Angel; Gimeno-Garcia, Antonio Z; Marra-Lopez, Carlos; Castellot, Ana; Alberca, Fernando; Fernandez-Urien, Ignacio; Aparicio, Jose Ramon; Legaz, Maria Luisa; Sendino, Oriol; Loras, Carmen; Subtil, Jose Carlos; Nerin, Juan; Perez-Carreras, Mercedes; Diaz-Tasende, Jose; Perez, Gustavo; Repiso, Alejandro; Vilella, Angels; Dolz, Carlos; Alvarez, Alberto; Rodriguez, Santiago; Esteban, Jose Miguel; Juzgado, Diego; Albillos, Agustin

2016-09-01

Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome. Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction.

PubMed

Nam, Hyeong Seok; Kang, Dae Hwan; Kim, Hyung Wook; Choi, Cheol Woong; Park, Su Bum; Kim, Su Jin; Ryu, Dae Gon

2017-03-07

To evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of self-expandable metal stent (SEMS). This was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. Among the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, pancreatic cancer in 79, and non-pancreatic or non-biliary malignancies in the remaining 47 patients. Early post-ERCP complications occurred in 9 patients (3.7%), with PEP in 7 patients (2.9%; mild, 6; moderate, 1) and mild bleeding in 2 patients (0.8%). There was no significant association between the incidence of post-ERCP complications and the type of malignancy (cholangiocarcinoma vs pancreatic cancer vs others, P = 0.696) or the type of SEMS used (uncovered vs covered, P = 1.000). Patients who had more than one SEMS placed at the first instance were at a significantly higher risk of post-ERCP complications (one SEMS vs two SEMS, P = 0.031). No other factors were predictive of post-ERCP complications. Limited ES is feasible and safe, and effectively facilitates the placement of SEMS, without any significant risk of PEP or severe bleeding.

Health Safety of Soft Drinks: Contents, Containers, and Microorganisms

PubMed Central

2015-01-01

Soft drinks consumption is still a controversial issue for public health and public policy. Over the years, numerous studies have been conducted into the possible links between soft drink intake and medical problems, the results of which, however, remain highly contested. Nevertheless, as a result, increasing emphasis is being placed on the health properties of soft drinks, by both the industry and the consumers, for example, in the expanding area of functional drinks. Extensive legislation has been put in place to ensure that soft drinks manufacturers conform to established national and international standards. Consumers trust that the soft drinks they buy are safe and their quality is guaranteed. They also expect to be provided with information that can help them to make informed decisions about the purchase of products and that the information on product labels is not false or misleading. This paper provides a broad overview of available scientific knowledge and cites numerous studies on various aspects of soft drinks and their implications for health safety. Particular attention is given to ingredients, including artificial flavorings, colorings, and preservatives and to the lesser known risks of microbiological and chemical contamination during processing and storage. PMID:25695045

Health safety of soft drinks: contents, containers, and microorganisms.

PubMed

Kregiel, Dorota

2015-01-01

Soft drinks consumption is still a controversial issue for public health and public policy. Over the years, numerous studies have been conducted into the possible links between soft drink intake and medical problems, the results of which, however, remain highly contested. Nevertheless, as a result, increasing emphasis is being placed on the health properties of soft drinks, by both the industry and the consumers, for example, in the expanding area of functional drinks. Extensive legislation has been put in place to ensure that soft drinks manufacturers conform to established national and international standards. Consumers trust that the soft drinks they buy are safe and their quality is guaranteed. They also expect to be provided with information that can help them to make informed decisions about the purchase of products and that the information on product labels is not false or misleading. This paper provides a broad overview of available scientific knowledge and cites numerous studies on various aspects of soft drinks and their implications for health safety. Particular attention is given to ingredients, including artificial flavorings, colorings, and preservatives and to the lesser known risks of microbiological and chemical contamination during processing and storage.

Roles of Social Movement Organizations for Securing Workers' Safety in Korea: A Case Study of Abolition of the 30-Minute Delivery Guarantee Program in Pizza Delivery Service.

PubMed

Park, Ji-Eun; Kim, Myoung-Hee

2016-07-01

Many restaurants in Korea maintain quick-delivery service programs to satisfy customers. This service allows delivery workers limited time to deliver, which frequently put them in danger. Most of the workers are young, work part-time, and are rarely organized into trade unions. In this article, through a case study of the social movement to abolish the 30-minute delivery guarantee program of pizza companies in Korea, we argue that social movements involving social movement organizations (SMOs) and individual citizens could serve as a means to rectify this problem. We show how the SMOs developed and expanded the movement using a framing perspective and how the general public became involved through social media. Data was collected via online searching. Interview scripts from key players of SMOs and unofficial documents they provided were also reviewed. Three SMOs primarily led the movement, successfully forming a frame that emphasized social responsibility. SMOs also utilized social media to link their standing frame with unmobilized citizens and to expand the movement. We identified contributing factors and limitations of the movement and drew lessons that could be applied to other sectors where workers are in vulnerable positions. © The Author(s) 2016.

Oxygen and Fuel Jet Diffusion Flame Studies in Microgravity Motivated by Spacecraft Oxygen Storage Fire Safety

NASA Technical Reports Server (NTRS)

Sunderland, P. B.; Yuan, Z.-G.; Krishnan, S. S.; Abshire, J. M.; Gore, J. P.

2003-01-01

Owing to the absence of past work involving flames similar to the Mir fire namely oxygen-enhanced, inverse gas-jet diffusion flames in microgravity the objectives of this work are as follows: 1. Observe the effects of enhanced oxygen conditions on laminar jet diffusion flames with ethane fuel. 2. Consider both earth gravity and microgravity. 3. Examine both normal and inverse flames. 4. Compare the measured flame lengths and widths with calibrated predictions of several flame shape models. This study expands on the work of Hwang and Gore which emphasized radiative emissions from oxygen-enhanced inverse flames in earth gravity, and Sunderland et al. which emphasized the shapes of normal and inverse oxygen-enhanced gas-jet diffusion flames in microgravity.

Fire safety practices in the Shuttle and the Space Station Freedom

NASA Technical Reports Server (NTRS)

Friedman, Robert

1993-01-01

The Shuttle reinforces its policy of fire-preventive measures with onboard smoke detectors and Halon 1301 fire extinguishers. The forthcoming Space Station Freedom will have expanded fire protection with photoelectric smoke detectors, radiation flame detectors, and both fixed and portable carbon dioxide fire extinguishers. Many design and operational issues remain to be resolved for Freedom. In particular, the fire-suppression designs must consider the problems of gas leakage in toxic concentrations, alternative systems for single-failure redundancy, and commonality with the corresponding systems of the Freedom international partners. While physical and engineering requirements remain the primary driving forces for spacecraft fire-safety technology, there are, nevertheless, needs and opportunities for the application of microgravity combustion knowledge to improve and optimize the fire-protective systems.

Spent nuclear fuel project cold vacuum drying facility operations manual

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

IRWIN, J.J.

This document provides the Operations Manual for the Cold Vacuum Drying Facility (CVDF). The Manual was developed in conjunction with HNF-SD-SNF-SAR-002, Safety Analysis Report for the Cold Vacuum Drying Facility, Phase 2, Supporting Installation of Processing Systems (Garvin 1998) and, the HNF-SD-SNF-DRD-002, 1997, Cold Vacuum Drying Facility Design Requirements, Rev. 3a. The Operations Manual contains general descriptions of all the process, safety and facility systems in the CVDF, a general CVD operations sequence, and has been developed for the SNFP Operations Organization and shall be updated, expanded, and revised in accordance with future design, construction and startup phases of themore » CVDF until the CVDF final ORR is approved.« less

Advanced propulsion engine assessment based on a cermet reactor

NASA Technical Reports Server (NTRS)

Parsley, Randy C.

1993-01-01

A preferred Pratt & Whitney conceptual Nuclear Thermal Rocket Engine (NTRE) has been designed based on the fundamental NASA priorities of safety, reliability, cost, and performance. The basic philosophy underlying the design of the XNR2000 is the utilization of the most reliable form of ultrahigh temperature nuclear fuel and development of a core configuration which is optimized for uniform power distribution, operational flexibility, power maneuverability, weight, and robustness. The P&W NTRE system employs a fast spectrum, cermet fueled reactor configured in an expander cycle to ensure maximum operational safety. The cermet fuel form provides retention of fuel and fission products as well as high strength. A high level of confidence is provided by benchmark analysis and independent evaluations.

Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study

PubMed Central

Goldberg, Andrew J; Zaidi, Razi; Brooking, Deirdre; Kim, Louise; Korda, Michelle; Masci, Lorenzo; Green, Ruth; O’Donnell, Paul; Smith, Roger

2018-01-01

Introduction Achilles tendinopathy (AT) is a cause of pain and disability affecting both athletes and sedentary individuals. More than 150 000 people in the UK every year suffer from AT. While there is much preclinical work on the use of stem cells in tendon pathology, there is a scarcity of clinical data looking at the use of mesenchymal stem cells to treat tendon disease and there does not appear to be any studies of the use of autologous cultured mesenchymal stem cells (MSCs) for AT. Our hypothesis is that autologous culture expanded MSCs implanted into an area of mid-portion AT will lead to improved pain-free mechanical function. The current paper presents the protocol for a phase IIa clinical study. Methods and analysis The presented protocol is for a non-commercial, single-arm, open-label, phase IIa proof-of-concept study. The study will recruit 10 participants and will follow them up for 6 months. Included will be patients aged 18–70 years with chronic mid-portion AT who have failed at least 6 months of non-operative management. Participants will have a bone marrow aspirate collected from the posterior iliac crest under either local or general anaesthetic. MSCs will be isolated and expanded from the bone marrow. Four to 6 weeks after the harvest, participants will undergo implantation of the culture expanded MSCs under local anaesthetic and ultrasound guidance. The primary outcome will be safety as defined by the incidence rate of serious adverse reaction. The secondary outcomes will be efficacy as measured by patient-reported outcome measures and radiological outcome using ultrasound techniques. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Harrow; reference 13/LO/1670). Trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02064062. PMID:29764889

Planning a study abroad clinical experience.

PubMed

Wright, Dolores J

2010-05-01

Not only is globalization expanding areas of human activity, it is also influencing the variety of educational offerings in universities. Therefore, globalization must be considered by nurse educators as they reevaluate ways of preparing nursing students to meet the health care needs of populations they currently serve and will care for in the future. Study abroad programs have been encouraged to be part of the college experience in the United States for more than 30 years; however, these programs have been relatively lacking in nursing education. Most of the study abroad programs described in the nursing literature are research-based or first-person accounts of an experience and provide little information about planning a study abroad program. This article describes a study abroad learning experience for senior nursing students and discusses the issues such as student selection, student safety, and available clinical experiences that need to be considered before undertaking such an endeavor.

Botulinum Toxin Use in Pediatric Plastic Surgery.

PubMed

Fu, Katherine J; Teichgraeber, John F; Greives, Matthew R

2016-11-01

Botulinum toxin has increasingly become a prevalent treatment option for a wide range of conditions, many of which have their roots in plastic surgery and have been well studied. In adults, chronic headache, hyperhidrosis, and facial muscular hypertrophy have been effectively treated with botulinum toxin, and emerging studies have begun looking at its efficacy in children, as well. Successful treatment of spasticity and muscular contraction has allowed for the creation of safety profiles and dosage guidelines for botulinum toxin usage in children. The expanded indications for its use have since flourished in all arenas of pediatric care, including plastic surgery. Recent studies have described the use of botulinum toxin as an adjunct to the treatment of congenital torticollis and cleft lip. This review discusses the various applications of botulinum toxin for pediatric patients in the field of plastic surgery.

Identifying nontechnical skills associated with safety in the emergency department: a scoping review of the literature.

PubMed

Flowerdew, Lynsey; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

2012-05-01

Understanding the nontechnical skills specifically applicable to the emergency department (ED) is essential to facilitate training and more broadly consider interventions to reduce error. The aim of this scoping review is to first identify and then explore in depth the nontechnical skills linked to safety in the ED. The review was conducted in 2 stages. In stage 1, online databases were searched for published empirical studies linking nontechnical skills to safety and performance in the ED. Articles were analyzed to identify key ED nontechnical skills. In stage 2, these key skills were used to generate additional key words, which enabled a second search of the literature to be undertaken and expand on the evidence available for review. In stage 1, 11 articles were retrieved for data analysis and 9 core emergency medicine nontechnical skills were identified. These were communicating, managing workload, anticipating, situational awareness, supervising and providing feedback, leadership, maintaining standards, using assertiveness, and decisionmaking. In stage 2, a secondary search, using these 9 skills and related terms, uncovered a further 21 relevant articles. Therefore, 32 articles were used to describe the main nontechnical skills linked to safety in the ED. This article highlights the challenges of reviewing a topic for which the terms are not clearly defined in the literature. A novel methodological approach is described that provides a structured and transparent process for reviewing the literature in emerging areas of interest. A series of literature reviews focusing on individual nontechnical skills will provide a clearer understanding of how the skills identified contribute to safety in the ED. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin's lymphoma: results of a phase I study.

PubMed

Advani, Anjali; Coiffier, Bertrand; Czuczman, Myron S; Dreyling, Martin; Foran, James; Gine, Eva; Gisselbrecht, Christian; Ketterer, Nicolas; Nasta, Sunita; Rohatiner, Ama; Schmidt-Wolf, Ingo G H; Schuler, Martin; Sierra, Jorge; Smith, Mitchell R; Verhoef, Gregor; Winter, Jane N; Boni, Joseph; Vandendries, Erik; Shapiro, Mark; Fayad, Luis

2010-04-20

PURPOSE Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent. This was a phase I study to determine the maximum-tolerated dose (MTD), safety, and preliminary efficacy of inotuzumab ozogamicin in an expanded MTD cohort of patients with relapsed or refractory CD22(+) B-cell non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS Inotuzumab ozogamicin was administered intravenously as a single agent once every 3 or 4 weeks at doses ranging from 0.4 to 2.4 mg/m(2). Outcomes included MTD, safety, pharmacokinetics, response, progression-free survival (PFS), and overall survival. Results Seventy-nine patients were enrolled. The MTD was determined to be 1.8 mg/m(2). Common adverse events at the MTD were thrombocytopenia (90%), asthenia (67%), and nausea and neutropenia (51% each). The objective response rate at the end of treatment was 39% for the 79 enrolled patients, 68% for all patients with follicular NHL treated at the MTD, and 15% for all patients with diffuse large B-cell lymphoma treated at the MTD. Median PFS was 317 days (approximately 10.4 months) and 49 days for patients with follicular NHL and diffuse large B-cell lymphoma, respectively. CONCLUSION Inotuzumab ozogamicin has demonstrated efficacy against CD22(+) B-cell NHL, with reversible thrombocytopenia as the main toxicity.

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

PubMed

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

Safety and Effectiveness of Fingolimod in Real-World Multiple Sclerosis Portuguese Patients.

PubMed

Ribeiro de Barros, Ariana Helena; Fiadeiro Sequeira, João Paulo; Lopes de Sousa, Ary Severino; Cheganças Capela, Carlos Miguel; Gomes Pedrosa, Rui Manuel; Dos Santos Manita, Manuel Alexandre

2018-06-20

The aim of this study was to evaluate postmarketing fingolimod safety and effectiveness in a real-world clinical population. This was a retrospective, single-center study with active multiple sclerosis patients treated with fingolimod with at least 12 months of follow-up. Demographic and clinical and imaging characteristics, including annualized relapse rate (ARR), Expanded Disability Status Score, previous treatment, adverse events, treatment duration, and reason for discontinuation, were analyzed. Sixty-three patients were included; 61.9% were females. Mean age and mean disease duration were 30.9 ± 9.3 years and 11.4 ± 6.9 years, respectively. Fifty-one patients received prior first-line disease-modifying therapies, 11 patients were previously treated with natalizumab, and 1 was treatment naive. The ARR decreased by 75.3% for the total population at the end of the first year of treatment (P < 0.0001). The proportion of relapse-free patients improved significantly. All patients previously treated with natalizumab switched because of safety concerns, although the ARR kept low after treatment initiation. Only 3 patients (4.8%) discontinued treatment because of adverse drug reactions, and 2 (3.2%) because of lack of effectiveness. In this real-world audit, fingolimod appeared to be effective after first-line treatment failure in reducing disease activity and progression of disability throughout the observational period and may be an effective option after natalizumab. Fingolimod was well tolerated with low rates of discontinuation and adverse events.

Contribution of the Retrovirus Epidemiology Donor Study (REDS) to research on blood transfusion safety in Brazil.

PubMed

Loureiro, Paula; de Almeida-Neto, Cesar; Proietti, Anna Bárbara Carneiro; Capuani, Ligia; Gonçalez, Thelma Terezinha; de Oliveira, Claudia Di Lorenzo; Leão, Silvana Carneiro; Lopes, Maria Inês; Sampaio, Divaldo; Patavino, Giuseppina Maria; Ferreira, João Eduardo; Blatyta, Paula Fraiman; Lopes, Maria Esther Duarte; Mendrone-Junior, Alfredo; Salles, Nanci Alves; King, Melissa; Murphy, Edward; Busch, Michael; Custer, Brian; Sabino, Ester Cerdeira

2014-03-01

The Retrovirus Epidemiology Donor Study (REDS) program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

Seafloor in the Expanded Malaysia Airlines Flight MH370 Search Area

NASA Astrophysics Data System (ADS)

Smith, W. H. F.; Marks, K. M.; Beaman, R. J.

2014-12-01

Smith and Marks (Eos Trans. AGU, 95(21), 27 May 2014) illustrated a map of the seafloor in the Malaysia Airlines Flight MH370 search area. This map showed a bathymetric model that is constructed from a combination of available ship soundings and depths estimated from satellite altimetry. They noted that available depth measurements covered only 5% of their study region, and that very few of these measurements were collected using modern multibeam and navigation systems. Recently the MH370 search has been expanded along the "7th Arc" to encompass newly prioritized underwater search areas identified in an Australian Transport Safety Bureau report (AE-2014-054, 26 June 2014). While the new "Priority" search area is within the Eos article Fig. 1, the new "Wide" search area extends beyond the region evaluated in Eos. Additionally, multibeam data that were not incorporated in the bathymetric model have been made available to us after the Eos article was published. This presentation will update and extend the study published in Eos. We will present illustrations of the expanded region, sounding coverage, and tectonic features that are associated with steep topographic slopes. Our results include comparisons of multibeam survey depths and bathymetric model depths. The standard deviation of the differences is 182 m, with the greatest differences (exceeding 1000 m) over steep topographic slopes, and the smallest over low-relief ocean floor. This is consistent with differences found by Smith and Sandwell (JGR, 99(B11), 1994) between soundings and bathymetric predictions from altimetry. Such depth differences are common where bathymetric model constraints are sparse, which is typical of many of the world's oceans.

Removal process of prion and parvovirus from human platelet lysates used as clinical-grade supplement for ex vivo cell expansion.

PubMed

Kao, Yu-Chun; Bailey, Andy; Samminger, Bernhard; Tanimoto, Junji; Burnouf, Thierry

2016-07-01

Pooled human platelet lysate (HPL) is becoming the new gold standard as supplement for ex vivo cell culture for clinical protocols. However, the risk of pathogen contamination of HPL increases with the platelet pool size. We hypothesized that hollow fiber anion exchange membrane chromatography using QyuSpeed D (QSD) could remove resistant and untested bloodborne pathogens, such as parvoviruses and prions, from HPL-supplemented growth media without substantially affecting their capacity to support ex vivo cell expansion. Frozen or thawed platelet concentrates were serum-converted and centrifuged for obtaining HPL that was added to various growth media (ca. 100 mL), filtered through a 0.6-mL QSD membrane and characterized for proteins, growth factors and chemical composition. Capacity to expand Chinese hamster ovary, periodontal ligament, gingival fibroblast cells and Wharton's jelly mesenchymal stromal cells was studied. Removal of porcine parvovirus (PPV) and of the 263K prion strain of hamster-adapted scrapie was studied by spiking experiments following international guidelines. QSD had minimal impact on HPL-supplemented medium composition in proteins, growth factors and chemical content, nor capacity to expand and differentiate cells. In addition, QSD could remove ≥5.58 log10 [TCID50/mL] and ≥3.72 log10 of PPV and the 263K prion, respectively. QSD hollow fiber chromatography can be used to improve the virus and prion safety of HPL-supplemented media to safely expand cells for clinical protocols. These data bring new perspectives for increasingly safer use of pooled HPL in cell therapy and regenerative medicine applications. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Polyflex self-expanding, removable plastic stents: assessment of treatment efficacy and safety in a variety of benign and malignant conditions of the esophagus.

PubMed

Karbowski, M; Schembre, D; Kozarek, R; Ayub, K; Low, D

2008-05-01

Historically, esophageal fistulas, perforations, and benign and malignant strictures have been managed surgically or with the placement of permanent endoprostheses or metallic stents. Recently, a removable, self-expanding, plastic stent has become available. The authors investigated the use of this new stent at their institution. The study reviewed all the patients who received a Polyflex stent for an esophageal indication at the authors' institution between January 2004 and October 2006. Duration of placement, complications, and treatment efficacy were recorded. A total of 37 stents were placed in 30 patients (14 women and 16 men) with a mean age of 68 years (range, 28-92 years). Stent placement included 7 for fistulas, 3 for perforations, 1 for an anastomotic leak, 7 for malignant strictures, and 19 for benign strictures (8 anastomotic, 1 caustic, 5 reflux, 2 radiation, and 2 autoimmune esophagitis strictures, and 1 post-Nissen gas bloat stricture). The mean follow-up period was 6 months. Stent deployment was successful for all the patients, and no complications resulted from stent placement or removal. Nine stents migrated spontaneously. Three of three perforations and three of five fistulas sealed. Only one stent was removed because of patient discomfort. One patient with a radiation stricture experienced tracheoesophageal fistulas secondary to pressure necrosis. Of 20 patients with stricture, 18 experienced improvement in their dysphagia. Self-expanding, removable plastic stents are easily and safely placed and removed from the esophagus. This has facilitated their use in the authors' institution for an increasing number of esophageal conditions. Further studies to help define their ultimate role in benign and malignant esophageal pathology are warranted.

The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand.

PubMed

Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R

2006-04-03

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines.

Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal.

PubMed

Rocca, Corinne H; Puri, Mahesh; Shrestha, Prabhakar; Blum, Maya; Maharjan, Dev; Grossman, Daniel; Regmi, Kiran; Darney, Philip D; Harper, Cynthia C

2018-01-01

Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal. Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16-45, and had no medical contraindications. Between 2014-2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 μg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14-21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression. Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]). Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care.

Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal

PubMed Central

Puri, Mahesh; Shrestha, Prabhakar; Blum, Maya; Maharjan, Dev; Grossman, Daniel; Regmi, Kiran; Darney, Philip D.; Harper, Cynthia C.

2018-01-01

Background Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal. Methods Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16–45, and had no medical contraindications. Between 2014–2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 μg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14–21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression. Results Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]). Conclusions Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care. PMID:29351313

Annual report to Congress: Department of Energy activities relating to the Defense Nuclear Facilities Safety Board, calendar year 1998

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

NONE

1999-02-01

This is the ninth Annual Report to the Congress describing Department of Energy (Department) activities in response to formal recommendations and other interactions with the Defense Nuclear Facilities Safety Board (Board). The Board, an independent executive-branch agency established in 1988, provides advice and recommendations to the Secretary of energy regarding public health and safety issues at the Department`s defense nuclear facilities. The Board also reviews and evaluates the content and implementation of health and safety standards, as well as other requirements, relating to the design, construction, operation, and decommissioning of the Department`s defense nuclear facilities. The locations of the majormore » Department facilities are provided. During 1998, Departmental activities resulted in the proposed closure of one Board recommendation. In addition, the Department has completed all implementation plan milestones associated with four other Board recommendations. Two new Board recommendations were received and accepted by the Department in 1998, and two new implementation plans are being developed to address these recommendations. The Department has also made significant progress with a number of broad-based initiatives to improve safety. These include expanded implementation of integrated safety management at field sites, a renewed effort to increase the technical capabilities of the federal workforce, and a revised plan for stabilizing excess nuclear materials to achieve significant risk reduction.« less

Increasing Patient Safety by Closing the Sterile Production Gap-Part 2. Implementation.

PubMed

Agalloco, James P

2017-01-01

Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high concentration of a resistant biological indicator is required. The origin of this misconception is unclear, but it has resulted in sterilization conditions that are extremely harsh (15 min at 121 °C, of F 0 >8 min), which limit the use of terminal sterilization to extremely heat-stable formulations. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-the destruction of the bioburden present in the container prior to sterilization. Recognition that the true intention is bioburden destruction in routine products allows for the use of reduced conditions (lower temperatures, shorter process dwell, or both) without added patient risk. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background, and describes the benefits to patient, producer, and regulator. The second article includes validation and operational advice that can be used in the implementation. LAY ABSTRACT: Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-the destruction of the bioburden present in the container prior to sterilization. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background, and describes the benefits to patient, producer, and regulator. The article manuscript includes validation and operational advice that can be used in the implementation. © PDA, Inc. 2017.

Impact of Pharmacy Practice Model Expansion on Pharmacokinetic Services: Optimization of Vancomycin Dosing and Improved Patient Safety.

PubMed

Han, Zhe; Pettit, Natasha N; Landon, Emily M; Brielmaier, Benjamin D

2017-04-01

Background: The impact of pharmacy interventions on optimizing vancomycin therapy has been described, however interventions vary among studies and the most optimal pharmacy practice model (PPM) for pharmacokinetic (PK) services has not been established. Objective: The purpose of this study is to demonstrate the value of 24 hours a day, 7 days a week (24/7) PK services. Methods: New PK services were implemented in 2 phases with institutional PPM expansion. Phase 1 included universal monitoring by pharmacists with recommendations made to prescribers during business hours. Phase 2 expanded clinical pharmacists' coverage to 24/7 and provided an optional 24/7 pharmacist-managed PK consult service. We compared vancomycin therapeutic trough attainment, dosing, and clinical and safety outcomes between phases 1 and 2 in adult inpatients receiving therapeutic intravenous vancomycin. Results. One hundred and fifty patients were included in each phase. Phase 2 had a greater proportion of vancomycin courses with therapeutic initial trough concentrations (27.5% vs 46.1%; p = 0.002), higher initial trough concentrations (10.9 mcg/mL vs 16.4 mcg/mL; p < 0.001), and optimized initial vancomycin dosing (13.5 mg/kg vs 16.2 mg/kg; p < 0.001). Phase 2 also saw significant reduction in the incidence of vancomycin-associated nephrotoxicity (21.1% vs 11.7%; p = 0.038). Dose optimization and improvement in initial target trough attainment were most notable among intensive care unit (ICU) patients. Conclusions. Our study demonstrated that 24/7 PK services implemented with institutional PPM expansion optimized vancomycin target trough attainment and improved patient safety.

Expanding leadership capacity: educational levels for nurse leaders.

PubMed

Yoder-Wise, Patricia S; Scott, Elaine S; Sullivan, Dori Taylor

2013-06-01

A master's degree in nursing administration prepares the nurse to lead nursing and interprofessional teams, to create new and innovative approaches to improve care processes and outcomes, as well as traditional management responsibilities related to budgets, human resources, quality and safety, and a healthy work environment. Are we not at a critical juncture in our profession when we should challenge the profession to require a master's degree education for all levels of nursing administration?

Port and Waterways Safety Assessment Workshop Report, New York

DTIC Science & Technology

2008-09-01

conduct Operation Clear Channel (14) • Increase the number of small craft fueling stations outside the port area (2) • Expand VTS AOR to include the...Island (6) • Increase the number of fueling stations outside of the port area (5) • Encourage less aggressive timetables for commuter ferries (5...data available through Stevens Institute of Technology, sponsored by the State of New York • Ambrose Light being replaced with a NOAA weather

Medical Area Body Network. Final rule.

PubMed

2012-09-11

This document expands the Commission's Medical Device Radiocommunications Service (MedRadio) rules to permit the development of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. This platform will enhance patient safety, care and comfort by reducing the need to physically connect sensors to essential monitoring equipment by cables and wires. This decision is the latest in a series of actions to expand the spectrum available for wireless medical use. The Commission finds that the risk of increased interference is minimal and is greatly outweighed by the benefits of the MBAN rules.

Targeting adequate thermal stability and fire safety in selecting ionic liquid-based electrolytes for energy storage.

PubMed

Chancelier, L; Diallo, A O; Santini, C C; Marlair, G; Gutel, T; Mailley, S; Len, C

2014-02-07

The energy storage market relating to lithium based systems regularly grows in size and expands in terms of a portfolio of energy and power demanding applications. Thus safety focused research must more than ever accompany related technological breakthroughs regarding performance of cells, resulting in intensive research on the chemistry and materials science to design more reliable batteries. Formulating electrolyte solutions with nonvolatile and hardly flammable ionic liquids instead of actual carbonate mixtures could be safer. However, few definitions of thermal stability of electrolytes based on ionic liquids have been reported in the case of abuse conditions (fire, shortcut, overcharge or overdischarge). This work investigates thermal stability up to combustion of 1-butyl-3-methylimidazolium bis(trifluoromethanesulfonyl)imide ([C1C4Im][NTf2]) and 1-butyl-1-methylpyrrolidinium bis(trifluoromethanesulfonyl)imide ([PYR14][NTf2]) ionic liquids, and their corresponding electrolytes containing lithium bis(trifluoromethanesulfonyl)imide LiNTf2. Their possible routes of degradation during thermal abuse testings were investigated by thermodynamic studies under several experimental conditions. Their behaviours under fire were also tested, including the analysis of emitted compounds.

Problems with health information technology and their effects on care delivery and patient outcomes: a systematic review.

PubMed

Kim, Mi Ok; Coiera, Enrico; Magrabi, Farah

2017-03-01

To systematically review studies reporting problems with information technology (IT) in health care and their effects on care delivery and patient outcomes. We searched bibliographic databases including Scopus, PubMed, and Science Citation Index Expanded from January 2004 to December 2015 for studies reporting problems with IT and their effects. A framework called the information value chain, which connects technology use to final outcome, was used to assess how IT problems affect user interaction, information receipt, decision-making, care processes, and patient outcomes. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Of the 34 studies identified, the majority ( n  = 14, 41%) were analyses of incidents reported from 6 countries. There were 7 descriptive studies, 9 ethnographic studies, and 4 case reports. The types of IT problems were similar to those described in earlier classifications of safety problems associated with health IT. The frequency, scale, and severity of IT problems were not adequately captured within these studies. Use errors and poor user interfaces interfered with the receipt of information and led to errors of commission when making decisions. Clinical errors involving medications were well characterized. Issues with system functionality, including poor user interfaces and fragmented displays, delayed care delivery. Issues with system access, system configuration, and software updates also delayed care. In 18 studies (53%), IT problems were linked to patient harm and death. Near-miss events were reported in 10 studies (29%). The research evidence describing problems with health IT remains largely qualitative, and many opportunities remain to systematically study and quantify risks and benefits with regard to patient safety. The information value chain, when used in conjunction with existing classifications for health IT safety problems, can enhance measurement and should facilitate identification of the most significant risks to patient safety. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Self-Determination Theory and Risk Behavior in a Collectivistic Society: Preventing Reckless Driving in Urban Nepal.

PubMed

Ranjit, Yerina S; Snyder, Leslie B; Hamilton, Mark A; Rimal, Rajiv N

2017-08-01

Traffic road accidents are one of the leading causes of mortality in Nepal and around the world. Drivers in Nepal are not adequately educated about road safety rules. Road conditions are chaotic as traffic regulations are also not strictly enforced. Public safety campaigns may be able to alter drivers' attitudes and behaviors; however, little is known about which persuasive strategies may be most effective. Drawing on self-determination theory and the Health Belief Model, the current study used a post-only experimental design to test the impact of a short video message. The video included collective vs. individual appeals, and messages emphasizing one's ability to make the right choice (autonomy support) vs. directive language. Participants were Nepali college students (mean age 20, N = 199). Using structural equation modeling, the study found that directive messages rather than autonomy support influenced an individual seeing value in the recommended behavior (identified regulation), which in turn influenced perceived susceptibility, perceived severity, and behavioral intention. The study also proposed a behavior change model by incorporating the stage of identification with the message upon exposure. This model aims to expand the model proposed by the Health Belief Model, to include a stage of value identification before cues to action influence perception of threat. Further implications are discussed.

Measuring mobile patient safety information system success: an empirical study.

PubMed

Jen, Wen-Yuan; Chao, Chia-Cheng

2008-10-01

The Health Risk Reminders and Surveillance (HRRS) system was designed to deliver critical abnormal test results of severely ill patients from Laboratory, Radiology, and Pathology departments to physicians within 5 min using cell phone text messages. This paper explores the success of the HRRS system. This study employed an augmented version of the DeLone and McLean IS success model. Seven variables (system quality, information quality, system use, user satisfaction, mobile healthcare anxiety, impact on the individual and impact on the organization) were used to evaluate the success of the HRRS system. The interrelationships between the seven variables were hypothesized and the hypotheses were empirically tested. The results indicate that the information quality of the HRRS system is positively associated with both system use and user satisfaction. In addition, system use is positively associated with user satisfaction, which is also positively associated with mobile healthcare anxiety. Moreover, results indicate that impact on the individual is positively associated with both user satisfaction and mobile healthcare anxiety. Finally, the impact of the organization is positively associated with impact on the individual. The results of the study provide an expanded understanding of the factors that contribute to mobile patient safety information system (IS) success. Implications of the relationship between system use and physician mobile healthcare anxiety are discussed.

Will Catheter Interventions Replace Surgery for Valve Abnormalities?

PubMed Central

O’Byrne, Michael L; Gillespie, Matthew J

2015-01-01

Purpose of Review Catheter-based valve technologies have evolved rapidly over the last decade. Transcatheter aortic valve replacement (TAVR) has become a routine procedure in high-risk adult patients with calcific aortic stenosis. In patients with congenital heart disease (CHD), transcatheter pulmonary valve replacement represents a transformative technology for right ventricular outflow tract dysfunction with the potential to expand to other indications. This review aims to summarize 1) the current state of the art for transcatheter valve replacement (TVR) in CHD, 2) the expanding indications for TVR, and 3) the technological obstacles to optimizing TVR. Recent findings Multiple case series have demonstrated that TVR with the Melody transcatheter pulmonary valve in properly selected patients is safe, effective, and durable in short-term follow-up. The Sapien transcatheter heart valve represents an alternative device with similar safety and efficacy in limited studies. Innovative use of current valves has demonstrated the flexibility of TVR, while highlighting the need for devices to address the broad range of post-operative anatomies either with a single device or strategies to prepare the outflow tract for subsequent device deployment. Summary The potential of TVR has not been fully realized, but holds promise in treatment of CHD. PMID:24281347

Fatalism and its implications for risky road use and receptiveness to safety messages: a qualitative investigation in Pakistan.

PubMed

Kayani, A; King, M J; Fleiter, J J

2012-12-01

Given the increasing vehicle numbers and expanding road construction in developing countries, the importance of safe road user behaviour is critical. Road traffic crashes (RTCs) are a significant problem in Pakistan; however, the factors that contribute to RTCs in Pakistan are not well researched. Fatalistic beliefs are a potential barrier to the enhancement of road safety, especially participation in health-promoting and injury prevention behaviours, and also contribute to risk taking. Fatalistic beliefs relating to road safety have been found in some developing countries, although research is scarce and indicates that the nature and extent of fatalism differs in each country. Qualitative research was undertaken with a range of drivers, religious orators, police and policy makers to explore associations between fatalism, risky road use and associated issues. Findings indicate that fatalistic beliefs are pervasive in Pakistan, are strongly linked with religion, present a likely barrier to road safety messages and contribute to risky road use. Fatalism appears to be a default attribution of RTC and the intensity of belief in fate surpasses the kinds of fatalism noted in the limited existing literature. These findings have importance to developing road safety countermeasures in countries where fatalistic beliefs are strong.

A Safety Evaluation of Empagliflozin for the Treatment of Type 2 Diabetes

PubMed Central

Neeland, Ian J.; Salahuddin, Usman; McGuire, Darren K.

2016-01-01

Introduction Empagliflozin is a sodium glucose co-transporter 2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) by enhancing urinary glucose excretion. Empagliflozin is effective at lowering glycosylated hemoglobin and was recently proven superior to placebo for reduction of cardiovascular disease (CVD) risk. As with any new drug, there are safety considerations that inform its potential use in patients with T2DM. Areas Covered Here, we evaluate the safety of empagliflozin and provide an expert opinion as to its current and future role in the treatment of patients with T2DM. A search of the English language literature was performed using PubMed search terms: “empagliflozin”, “sodium glucose cotransporter 2 inhibitors”, and “drug safety”. Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included. Expert Opinion The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD. Ongoing trials will continue to address the safety and efficacy of empagliflozin and expand our clinical knowledge of this medication. PMID:26695551

Building on the Past- Looking to the Future: Part 2: A Focus on Expanding Horizons

NASA Astrophysics Data System (ADS)

Nash, Sally K.; Rehm, Raymond B.; Wong, Teresa K.; Guidry, Richard W.; Wolf, Scott L.

2010-09-01

The history of space endeavors stretches far from the first liquid-fueled rocket created by the father of modern rocketry, Robert Goddard, in 1926 and will certainly extend far beyond the construction of the International Space Station(ISS) scheduled to be complete with the addition of the Permanent Multipurpose Module on STS-133/ULF5. National Aeronautics and Space Administration(NASA) and the ISS International Partners(IPs) will be the unrelenting venue used to satisfy the curiosities of man as we seek an understanding of space through various experiments(also referred to as payloads) conducted in microgravity. The NASA Payload Safety Review Panel(PSRP) continues to serve as the lead for the review and assessment of payload hardware to assure facility and crew safety. This is the second in a series of papers and presentations that illustrate challenges and lessons learned in the areas of communication, safety requirements, and processes which have been vital to the PSRP.

Building on the Past - Looking to the Future. Part 2: A Focus on Expanding Horizons

NASA Technical Reports Server (NTRS)

Nash, Sally K.; Rehm, Raymond; Wong, Teresa K.; Guidry, Richard; Wolf, Scott L.

2010-01-01

The history of space endeavors stretches far from the first liquid-fueled rocket created by the father of modern rocketry, Robert Goddard, in 1926 and will certainly extend far beyond the construction of the International Space Station (ISS) scheduled to be complete with the addition of the Permanent Multipurpose Module on STS-133/ULF5. National Aeronautics and Space Administration (NASA) and the ISS International Partners (IPs) will be the unrelenting venue used to satisfy the curiosities of man as we seek an understanding of space through various experiments (also referred to as payloads) conducted in microgravity. The NASA Payload Safety Review Panel (PSRP) continues to serve as the lead for the review and assessment of payload hardware to assure facility and crew safety. This is the second in a series of papers and presentations that illustrate challenges and lessons learned in the areas of communication, safety requirements, and processes which have been vital to the PSRP.

Standards Development Activities at White Sands Test Facility

NASA Technical Reports Server (NTRS)

Baker, D. L.; Beeson, H. D.; Saulsberry, R. L.; Julien, H. L.; Woods, S. S.

2003-01-01

The development of standards and standard activities at the JSC White Sands Test Facility (WSTF) has been expanded to include the transfer of technology and standards to voluntary consensus organizations in five technical areas of importance to NASA. This effort is in direct response to the National Technology Transfer Act designed to accelerate transfer of technology to industry and promote government-industry partnerships. Technology transfer is especially important for WSTF, whose longterm mission has been to develop and provide vital propellant safety and hazards information to aerospace designers, operations personnel, and safety personnel. Meeting this mission is being accomplished through the preparation of consensus guidelines and standards, propellant hazards analysis protocols, and safety courses for the propellant use of hydrogen, oxygen, and hypergols, as well as the design and inspection of spacecraft pressure vessels and the use of pyrovalves in spacecraft propulsion systems. The overall WSTF technology transfer program is described and the current status of technology transfer activities are summarized.

Health Informatics in Developing Countries: A Review of Unintended Consequences of IT Implementations, as They Affect Patient Safety and Recommendations on How to Address Them.

PubMed

Park, Hyeoun-Ae

2016-11-10

Patient safety concerns every healthcare organization. Adoption of Health information technology (HIT) appears to have the potential to address this issue, however unanticipated and undesirable consequences from implementing HIT could lead to new and more complex hazards. This could be particularly problematic in developing countries, where regulations, policies and implementations are few, less standandarized and in some cases almost non-existing. Based on the available information and our own experience, we conducted a review of unintended consequences of HIT implementations, as they affect patient safety in developing countries. We found that user dependency on the system, alert fatigue, less communications among healthcare actors and workarounds topics should be prioritize. Institution should consider existing knowledge, learn from other experiences and model their implementations to avoid known consequences. We also recommend that they monitor and communicate their own efforts to expand knowledge in the region.

A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

PubMed Central

Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

2013-01-01

Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty followed by stent placement is feasible. The immediate procedural outcomes with primary angioplasty are comparable to stent placement and warrant further studies. PMID:24358415

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study

PubMed Central

Gerckens, Ulrich; Tamburino, Corrado; Bleiziffer, Sabine; Bosmans, Johan; Wenaweser, Peter; Brecker, Stephen; Guo, Jia; Linke, Axel

2017-01-01

Abstract Aims The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. Methods and results Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days. Conclusion Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction. Trial registration ClinicalTrials.gov, NCT01074658. PMID:28633375

Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

Locomotor loading mechanics in the hindlimbs of tegu lizards (Tupinambis merianae): comparative and evolutionary implications.

PubMed

Sheffield, K Megan; Butcher, Michael T; Shugart, S Katherine; Gander, Jennifer C; Blob, Richard W

2011-08-01

Skeletal elements are usually able to withstand several times their usual load before they yield, and this ratio is known as the bone's safety factor. Limited studies on amphibians and non-avian reptiles have shown that they have much higher limb bone safety factors than birds and mammals. It has been hypothesized that this difference is related to the difference in posture between upright birds and mammals and sprawling ectotherms; however, limb bone loading data from a wider range of sprawling species are needed in order to determine whether the higher safety factors seen in amphibians and non-avian reptiles are ancestral or derived conditions. Tegus (family Teiidae) are an ideal lineage with which to expand sampling of limb bone loading mechanics for sprawling taxa, particularly for lizards, because they are from a different clade than previously sampled iguanas and exhibit different foraging and locomotor habits (actively foraging carnivore versus burst-activity herbivore). We evaluated the mechanics of locomotor loading for the femur of the Argentine black and white tegu (Tupinambus merianae) using three-dimensional measurements of the ground reaction force and hindlimb kinematics, in vivo bone strains and femoral mechanical properties. Peak bending stresses experienced by the femur were low (tensile: 10.4 ± 1.1 MPa; compressive: -17.4 ± 0.9 MPa) and comparable to those in other reptiles, with moderate shear stresses and strains also present. Analyses of peak femoral stresses and strains led to estimated safety factor ranges of 8.8-18.6 in bending and 7.8-17.5 in torsion, both substantially higher than typical for birds and mammals but similar to other sprawling tetrapods. These results broaden the range of reptilian and amphibian taxa in which high femoral safety factors have been evaluated and further indicate a trend for the independent evolution of lower limb bone safety factors in endothermic taxa.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Community health centers tackle rising demands and expectations.

PubMed

Hurley, Robert; Felland, Laurie; Lauer, Johanna

2007-12-01

As key providers of preventive and primary care for underserved people, including the uninsured, community health centers (CHCs) are the backbone of the U.S. health care safety net. Despite significant federal funding increases, community health centers are struggling to meet rising demand for care, particularly for specialty medical, dental and mental health services, according to findings from the Center for Studying Health System Change's (HSC) 2007 site visits to 12 nationally representative metropolitan communities. Health centers are responding to these pressures by expanding capacity and adding services but confront staffing, resource and other constraints. At the same time, CHCs are facing other demands, including increased quality reporting expectations, addressing racial and ethnic disparities, developing electronic medical records, and preparing for public health emergencies.

The role of technology in clinician-to-clinician communication.

PubMed

McElroy, Lisa M; Ladner, Daniela P; Holl, Jane L

2013-12-01

Incomplete, fragmented and poorly organised communications contribute to more than half the errors that lead to adverse and sentinel events. Meanwhile, communication software and devices with expanding capabilities are rapidly proliferating and being introduced into the healthcare setting. Clinicians face a large communication burden, which has been exacerbated by the additional challenge of selecting a mode of communication. In addition to specific communication devices, some hospitals have implemented advanced technological systems to assist with communication. However, few studies have provided empirical evidence of the specific advantages and disadvantages of the different devices used for communication. Given the increasing quantities of information transmitted to and by clinicians, evaluations of how communication methods and devices can improve the quality, safety and outcomes of healthcare are needed.

Microgravity Combustion Research: 1999 Program and Results

NASA Technical Reports Server (NTRS)

Friedman, Robert (Editor); Gokoglu, Suleyman A. (Editor); Urban, David L. (Editor)

1999-01-01

The use of the microgravity environment of space to expand scientific knowledge and to enable the commercial development of space for enhancing the quality of life on Earth is particularly suitable to the field of combustion. This document reviews the current status of microgravity combustion research and derived information. It is the fourth in a series of timely surveys, all published as NASA Technical Memoranda, and it covers largely the period from 1995 to early 1999. The scope of the review covers three program areas: fundamental studies, applications to fire safety and other fields. and general measurements and diagnostics. The document also describes the opportunities for Principal Investigator participation through the NASA Research Announcement program and the NASA Glenn Research Center low-gravity facilities available to researchers.

UTSG-2; A theoretical model describing the transient behavior of a pressurized water reactor natural circulation U-tube steam generator

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

Hold, A.

An advanced nonlinear transient model for calculating steady-state and dynamic behaviors of characteristic parameters of a Kraftwerk Union-type vertical natural-circulation U-tube steam generator and its main steam system is presented. This model has been expanded due to the increasing need for safety-related accident research studies. It now takes into consideration the possibilities of dryout and superheating along the secondary side of the steam generator. The resulting theoretical model is the basis of the digital code UTSG-2, which can be used both by itself and in combination with other pressurized water reactor transient codes, such as ALMOD-3.4, AMOD-4, and ATHLET.

Vulnerability Analysis and Evaluation of Urban Road System in Tianjin

NASA Astrophysics Data System (ADS)

Liu, Y. Q.; Wu, X.

In recent years, with the development of economy, the road construction of our country has entered into a period of rapid growth. The road transportation network has been expanding and the risk of disasters is increasing. In this paper we study the vulnerability of urban road system in Tianjin. After analyzed many risk factors of the urban road system security, including road construction, road traffic and the natural environment, we proposed an evaluation index of vulnerability of urban road system and established the corresponding evaluation index system. Based on the results of analysis and comprehensive evaluation, appropriate improvement measures and suggestions which may reduce the vulnerability of the road system and improve the safety and reliability of the road system are proposed.

Evaluation of the National Throughput Benefits of the Civil Tilt Rotor

NASA Technical Reports Server (NTRS)

Johnson, Jesse; Stouffer, Virginia; Long, Dou; Gribko, Joana; Yackovetsky, Robert (Technical Monitor)

2001-01-01

The air transportation system is a key part of the U.S. and global economic infrastructure. In recent years, this system, by any measure of usage - operations, enplanements, or revenue passenger miles (RPMs) - has grown rapidly. The rapid growth in demand has not been matched; however, by commensurate increases in the ability of airports and the airspace system to handle the additional traffic. As a result, the air transportation system is approaching capacity and airlines will face excessive delays or significant constraints on service unless capacity is expanded. To expand capacity, the air traffic management system must be improved. To improve the air traffic management system, the National Aeronautics and Space Administration (NASA) Aerospace Technology Enterprise developed the strategic goal of tripling air traffic throughput over the next 10 years, in all weather conditions, while at least maintaining current safety standards. As the first step in meeting that goal, the NASA Intercenter Systems Analysis Team (ISAT) is evaluating the contribution of existing programs to meet that goal. A major part of the study is an examination of the ability of the National Airspace System (NAS) to meet the predicted growth in travel demand and the potential benefits of technology infusion to expand NAS capacity. We previously analyzed the effects of the addition of two technology elements - Terminal Area Productivity (TAP) and Advanced Air Transportation Technologies (AATT). The next program we must analyze is not specific to airspace or aircraft technology. The program incorporates a fundamentally different vehicle to improve throughput: the civil tilt rotor (CTR). The CTR has the unique operating characteristic of being able to take off and land like a rotorcraft (vertical take off and landing, or VTOL, capability) but cruises like a traditional fixed-wing aircraft. The CTR also can operate in a short take off and landing (STOL) mode; generally, with a greater payload capacity (i.e., more passengers) than when operating in the VTOL mode. CTR could expand access to major airports without interfering with fixed-wing aircraft operating on congested runways and it could add service to new markets without the infrastructure support needed for fixed-wing aircraft. During FY 1999, we preliminarily assessed the feasibility of operating CTRs at two major U.S. airports as part of the annual review of NASA aerospace goals by the ISAT. This current study expands the analysis and concepts of that study to the complete NAS to quantify the national throughput effects of the CTR.

Engineering and public health at CDC.

PubMed

Earnest, G Scott; Reed, Laurence D; Conover, D; Estill, C; Gjessing, C; Gressel, M; Hall, R; Hudock, S; Hudson, H; Kardous, C; Sheehy, J; Topmiller, J; Trout, D; Woebkenberg, M; Amendola, A; Hsiao, H; Keane, P; Weissman, D; Finfinger, G; Tadolini, S; Thimons, E; Cullen, E; Jenkins, M; McKibbin, R; Conway, G; Husberg, B; Lincoln, J; Rodenbeck, S; Lantagne, D; Cardarelli, J

2006-12-22

Engineering is the application of scientific and technical knowledge to solve human problems. Using imagination, judgment, and reasoning to apply science, technology, mathematics, and practical experience, engineers develop the design, production, and operation of useful objects or processes. During the 1940s, engineers dominated the ranks of CDC scientists. In fact, the first CDC director, Assistant Surgeon General Mark Hollis, was an engineer. CDC engineers were involved in malaria control through the elimination of standing water. Eventually the CDC mission expanded to include prevention and control of dengue, typhus, and other communicable diseases. The development of chlorination, water filtration, and sewage treatment were crucial to preventing waterborne illness. Beginning in the 1950s, CDC engineers began their work to improve public health while developing the fields of environmental health, industrial hygiene, and control of air pollution. Engineering disciplines represented at CDC today include biomedical, civil, chemical, electrical, industrial, mechanical, mining, and safety engineering. Most CDC engineers are located in the National Institute for Occupational Safety and Health (NIOSH) and the Agency for Toxic Substances and Disease Registry (ATSDR). Engineering research at CDC has a broad stakeholder base. With the cooperation of industry, labor, trade associations, and other stakeholders and partners, current work includes studies of air contaminants, mining, safety, physical agents, ergonomics, and environmental hazards. Engineering solutions remain a cornerstone of the traditional "hierarchy of controls" approach to reducing public health hazards.

Flow Diverter Stents for the Treatment of Anterior Cerebral Artery Aneurysms: Safety and Effectiveness.

PubMed

Clarençon, F; Di Maria, F; Gabrieli, J; Shotar, E; Zeghal, C; Nouet, A; Chiras, J; Sourour, N-A

2017-03-01

Flow diverter stents (FDSs) are increasingly used for the treatment of intracranial aneurysms. Initially developed for the management of giant and large aneurysms, their indications have progressively expanded. The purpose of our study was to evaluate the safety and effectiveness of FDSs for the treatment of anterior cerebral artery (ACA) aneurysms. Among the 94 consecutive patients treated for 100 intracranial aneurysms by means of FDSs in our institution from October 2010 to January 2015, eight aneurysms (8 %) in seven patients were located on the ACA. Three aneurysms were located on the A1 segment, three aneurysms on the anterior communicating artery (ACom) and two on the A2-A3 junction. In three cases, FDS was used for angiographic recurrence after coiling. Five patients were treated with a Pipeline embolization device, one with a NeuroEndograft and the last one with a Silk FDS. Treatment was feasible in all cases. No technical difficulty was reported. No acute or delayed clinical complication was recorded. Modified Rankin Scale was 0 for six patients and one for one patient. Mean angiographic follow-up was 9.7 ± 3.9 months (range 6-15). Total exclusion was observed in five aneurysms (71.4 %) and neck remnant in two (28.6 %) cases. One patient refused the control DSA. Our series shows the safety and effectiveness of FDSs for the treatment of ACA aneurysms.

From clinical integration to accountable care.

PubMed

Shields, Mark

2011-01-01

Four key challenges to reforming health care organizations can be addressed by a clinical integration model patterned after Advocate Physician Partners (APP). These challenges are: predominance of small group practices, dominant fee-for-service reimbursement methods, weaknesses of the traditional hospital medical staff structure and a need to partner with commercial insurance companies. APP has demonstrated teamwork between 3800 physicians and hospitals to improve quality, patient safety and cost-effectiveness. Building on this model, an innovative contract with Blue Cross Blue Shield of Illinois serves as a prototype for a commercial Accountable Care Organization. For this contract to succeed, APP must outperform the market competition. To accomplish this, APP has implemented strategies to reduce readmissions, avoid unnecessary admissions and emergency room visits, expand primary care access, and enhance quality and patient safety.

Framework for Considering Productive Aging and Work.

PubMed

Schulte, Paul A; Grosch, James; Scholl, Juliann C; Tamers, Sara L

2018-05-01

The U.S. population is experiencing a demographic transition resulting in an aging workforce. The objective of this article is to elucidate and expand an approach to keep that workforce safe, healthy, and productive. This article elucidates the framework for the National Center for Productive Aging at Work of the National Institute for Occupational Safety and Health. Subject matter experts used a snowball method to review published literature to substantiate elements in the framework. Evidence-based literature supports a productive aging framework for the workforce involving the following elements: 1) life span perspective; 2) comprehensive and integrated approaches to occupational safety and health; 3) emphasis on positive outcomes for both workers and organizations; and 4) supportive work culture for multigenerational issues. The productive aging framework provides a foundational and comprehensive approach for addressing the aging workforce.

Shuttle: forever young?

PubMed

Sietzen, Frank

2002-01-01

NASA has started a 4-phase program of upgrades designed to increase safety and extend use of the space shuttles through the year 2020. Phase I is aimed at improving vehicle safety and supporting the space station. Phase II is aimed at combating obsolescence and includes a checkout launch and control system and protection from micrometeoroids and orbital debris. Phase III is designed to expand or enhance the capabilities of the shuttle and includes development of an auxiliary power unit, avionics, a channel-wall nozzle, extended nose landing gear, long-life fuel cells, a nontoxic orbital maneuvering system/reaction control system, and a water membrane evaporator. Phase IV is aimed at design of system changes that would alter the shuttle mold line and configuration; projects include a five-segment solid rocket booster, liquid flyback boosters, and a crew escape module.

Linking live animals and products: traceability.

PubMed

Britt, A G; Bell, C M; Evers, K; Paskin, R

2013-08-01

It is rarely possible to successfully contain an outbreak of an infectious animal disease, or to respond effectively to a chemical residue incident, without the use of a system for identifying and tracking animals. The linking of animals at the time they are slaughtered--through the use of identification devices or marks and accompanying movement documentation--with the meat produced from their carcasses, adds further value from the perspective of consumer safety. Over the past decade, animal identification technology has become more sophisticated and affordable. The development of the Internet and mobile communication tools, complemented bythe expanded capacity of computers and associated data management applications, has added a new dimension to the ability of Competent Authorities and industry to track animals and the food they produce for disease control, food safety and commercial purposes.

GROWTH OF THE INTERNATIONAL CRITICALITY SAFETY AND REACTOR PHYSICS EXPERIMENT EVALUATION PROJECTS

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

J. Blair Briggs; John D. Bess; Jim Gulliford

2011-09-01

Since the International Conference on Nuclear Criticality Safety (ICNC) 2007, the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and the International Reactor Physics Experiment Evaluation Project (IRPhEP) have continued to expand their efforts and broaden their scope. Eighteen countries participated on the ICSBEP in 2007. Now, there are 20, with recent contributions from Sweden and Argentina. The IRPhEP has also expanded from eight contributing countries in 2007 to 16 in 2011. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Criticality Safety Benchmark Experiments1' have increased from 442 evaluations (38000 pages), containing benchmark specifications for 3955 critical ormore » subcritical configurations to 516 evaluations (nearly 55000 pages), containing benchmark specifications for 4405 critical or subcritical configurations in the 2010 Edition of the ICSBEP Handbook. The contents of the Handbook have also increased from 21 to 24 criticality-alarm-placement/shielding configurations with multiple dose points for each, and from 20 to 200 configurations categorized as fundamental physics measurements relevant to criticality safety applications. Approximately 25 new evaluations and 150 additional configurations are expected to be added to the 2011 edition of the Handbook. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Reactor Physics Benchmark Experiments2' have increased from 16 different experimental series that were performed at 12 different reactor facilities to 53 experimental series that were performed at 30 different reactor facilities in the 2011 edition of the Handbook. Considerable effort has also been made to improve the functionality of the searchable database, DICE (Database for the International Criticality Benchmark Evaluation Project) and verify the accuracy of the data contained therein. DICE will be discussed in separate papers at ICNC 2011. The status of the ICSBEP and the IRPhEP will be discussed in the full paper, selected benchmarks that have been added to the ICSBEP Handbook will be highlighted, and a preview of the new benchmarks that will appear in the September 2011 edition of the Handbook will be provided. Accomplishments of the IRPhEP will also be highlighted and the future of both projects will be discussed. REFERENCES (1) International Handbook of Evaluated Criticality Safety Benchmark Experiments, NEA/NSC/DOC(95)03/I-IX, Organisation for Economic Co-operation and Development-Nuclear Energy Agency (OECD-NEA), September 2010 Edition, ISBN 978-92-64-99140-8. (2) International Handbook of Evaluated Reactor Physics Benchmark Experiments, NEA/NSC/DOC(2006)1, Organisation for Economic Co-operation and Development-Nuclear Energy Agency (OECD-NEA), March 2011 Edition, ISBN 978-92-64-99141-5.« less

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women.

PubMed

Ruiz-Sternberg, Ángela María; Moreira, Edson D; Restrepo, Jaime A; Lazcano-Ponce, Eduardo; Cabello, Robinson; Silva, Arnaldo; Andrade, Rosires; Revollo, Francisco; Uscanga, Santos; Victoria, Alejandro; Guevara, Ana María; Luna, Joaquín; Plata, Manuel; Dominguez, Claudia Nossa; Fedrizzi, Edison; Suarez, Eugenio; Reina, Julio C; Ellison, Misoo C; Moeller, Erin; Ritter, Michael; Shields, Christine; Cashat, Miguel; Perez, Gonzalo; Luxembourg, Alain

2018-06-01

A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16-26 years, and an immunogenicity and safety study in girls and boys aged 9-15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants. The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity. The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden. Copyright © 2018 Merck Sharp & Dohme Corp., and The Authors. Published by Elsevier B.V. All rights reserved.

Are metals emitted from electronic cigarettes a reason for health concern? A risk-assessment analysis of currently available literature.

PubMed

Farsalinos, Konstantinos E; Voudris, Vassilis; Poulas, Konstantinos

2015-05-15

Studies have found that metals are emitted to the electronic cigarette (EC) aerosol. However, the potential health impact of exposure to such metals has not been adequately defined. The purpose of this study was to perform a risk assessment analysis, evaluating the exposure of electronic cigarette (EC) users to metal emissions based on findings from the published literature. Two studies were found in the literature, measuring metals emitted to the aerosol from 13 EC products. We estimated that users take on average 600 EC puffs per day, but we evaluated the daily exposure from 1200 puffs. Estimates of exposure were compared with the chronic Permissible Daily Exposure (PDE) from inhalational medications defined by the U.S. Pharmacopeia (cadmium, chromium, copper, lead and nickel), the Minimal Risk Level (MRL) defined by the Agency for Toxic Substances and Disease Registry (manganese) and the Recommended Exposure Limit (REL) defined by the National Institute of Occupational Safety and Health (aluminum, barium, iron, tin, titanium, zinc and zirconium). The average daily exposure from 13 EC products was 2.6 to 387 times lower than the safety cut-off point of PDEs, 325 times lower than the safety limit of MRL and 665 to 77,514 times lower than the safety cut-off point of RELs. Only one of the 13 products was found to result in exposure 10% higher than PDE for one metal (cadmium) at the extreme daily use of 1200 puffs. Significant differences in emissions between products were observed. Based on currently available data, overall exposure to metals from EC use is not expected to be of significant health concern for smokers switching to EC use, but is an unnecessary source of exposure for never-smokers. Metal analysis should be expanded to more products and exposure can be further reduced through improvements in product quality and appropriate choice of materials.

Advanced Range Safety System for High Energy Vehicles

NASA Technical Reports Server (NTRS)

Claxton, Jeffrey S.; Linton, Donald F.

2002-01-01

The advanced range safety system project is a collaboration between the National Aeronautics and Space Administration and the United States Air Force to develop systems that would reduce costs and schedule for safety approval for new classes of unmanned high-energy vehicles. The mission-planning feature for this system would yield flight profiles that satisfy the mission requirements for the user while providing an increased quality of risk assessment, enhancing public safety. By improving the speed and accuracy of predicting risks to the public, mission planners would be able to expand flight envelopes significantly. Once in place, this system is expected to offer the flexibility of handling real-time risk management for the high-energy capabilities of hypersonic vehicles including autonomous return-from-orbit vehicles and extended flight profiles over land. Users of this system would include mission planners of Space Launch Initiative vehicles, space planes, and other high-energy vehicles. The real-time features of the system could make extended flight of a malfunctioning vehicle possible, in lieu of an immediate terminate decision. With this improved capability, the user would have more time for anomaly resolution and potential recovery of a malfunctioning vehicle.

[The application of laser in endodontics].

PubMed

He, W X; Liu, N N; Wang, X L; He, X Y

2016-08-01

Since laser was introduced in the field of medicine in 1970's, its application range has continuously expanded. The application of laser in endodontics also increased due to its safety and effectiveness in dental treatments. The majority of the laser application researches in dentistry focused on dentin hypersensitivity, removal of carious tissues, tooth preparations, pulp capping or pulpotomy, and root canal treatment. In this article, we reviewed literature on the effects of laser in the treatments of dental and pulp diseases.

Programmable Infusion Pumps in ICUs: An Analysis of Corresponding Adverse Drug Events

PubMed Central

Bower, Anthony G.; Paddock, Susan M.; Hilborne, Lee H.; Wallace, Peggy; Rothschild, Jeffrey M.; Griffin, Anne; Fairbanks, Rollin J.; Carlson, Beverly; Panzer, Robert J.; Brook, Robert H.

2007-01-01

Background Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. Objectives To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software (“smart pump”) and to suggest potential improvements in smart-pump design. Design Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 hospitals replaced conventional pumps with smart pumps. The smart pumps alerted users when programmed to deliver duplicate infusions or continuous-infusion doses outside hospital-defined ranges. Participants 4,604 critically ill adults at 1 academic and 1 nonacademic hospital. Measurements Preventable IV-ADEs matching smart-pump features and errors involved in preventable IV-ADEs. Results Of 100 preventable IV-ADEs identified, 4 involved errors matching smart-pump features. Two occurred before and 2 after smart-pump implementation. Overall, 29% of preventable IV-ADEs involved overdoses; 37%, failures to monitor for potential problems; and 45%, failures to intervene when problems appeared. Error descriptions suggested that expanding smart pumps’ capabilities might enable them to prevent more IV-ADEs. Conclusion The smart pumps we evaluated are unlikely to reduce preventable IV-ADEs in ICUs because they address only 4% of them. Expanding smart-pump capabilities might prevent more IV-ADEs. PMID:18095043

A Study of the Economic Benefit Potential of Intermodal Transports

NASA Technical Reports Server (NTRS)

Nelson, J. M.; Kawai, R. T.; Gregg, R. D.; McKinley, Robert E., Jr. (Technical Monitor)

2001-01-01

A conceptual study was conducted to determine the benefit potential of an Intermodal Transport in which quick change payload modules are used to reduce the cost of air travel by increasing daily utilization. Three basic concepts varying the degree of modularity were investigated for a 122,000 pounds payload 3,000 NM range regional wide body transport. The profit potential for operating as a passenger transport during the day and as a freighter at night was assessed. Assuming current levels of profitability, Intermodal operations could offer an operating cost reduction potential up to 20%. Enabling technology needs are identified as very quiet aircraft for expanded night operations, distributed load carrying quick disconnect latching, and configuration dependent safety issues. Recommendations are made to explore if additional benefits are possible from alternative mission and usage modules.

Ex-vivo expansion of red blood cells: How real for transfusion in humans?

PubMed Central

Migliaccio, Anna Rita; Masselli, Elena; Varricchio, Lilian; Whitsett, Carolyn

2013-01-01

Blood transfusion is indispensable for modern medicine. In developed countries, the blood supply is adequate and safe but blood for alloimmunized patients is often unavailable. Concerns are increasing that donations may become inadequate in the future as the population ages prompting a search for alternative transfusion products. Improvements in culture conditions and proof-of-principle studies in animal models have suggested that ex-vivo expanded red cells may represent such a product. Compared to other cell therapies transfusion poses the unique challenge of requiring great cell doses (2.5 × 1012 cells vs 107 cells). Although production of such cell numbers is theoretically possible, current technologies generate red cells in numbers sufficient only for safety studies. It is conceived that by the time these studies will be completed, technical barriers to mass cell production will have been eliminated making transfusion with ex-vivo generated red cells a reality. PMID:22177597

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.

PubMed

Curro, Frederick; Thompson, Van P; Naftolin, Frederick; Grill, Ashley; Vena, Don; Terracio, Louis; Hashimoto, Mariko; Buchholz, Matthew; McKinstry, Andrea; Cannon, Diane; Alfano, Vincent; Gooden, Thalia; Vernillo, Anthony; Czeisler, Elan

2013-01-01

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Platelet-lysate-expanded mesenchymal stromal cells as a salvage therapy for severe resistant graft-versus-host disease in a pediatric population.

PubMed

Lucchini, Giovanna; Introna, Martino; Dander, Erica; Rovelli, Attilio; Balduzzi, Adriana; Bonanomi, Sonia; Salvadè, Agnese; Capelli, Chiara; Belotti, Daniela; Gaipa, Giuseppe; Perseghin, Paolo; Vinci, Paola; Lanino, Edoardo; Chiusolo, Patrizia; Orofino, Maria Grazia; Marktel, Sarah; Golay, Jose; Rambaldi, Alessandro; Biondi, Andrea; D'Amico, Giovanna; Biagi, Ettore

2010-09-01

Despite advances in graft-versus-host-disease (GVHD) treatment, it is estimated that overall survival (OS) at 2 years for hematopoietic cell transplantation (HCT) recipients who experience steroid-resistant GVHD is 10%. Among recent therapeutic approaches for GVHD treatment, mesenchymal stromal cells (MSCs) hold a key position. We describe a multicenter experience of 11 pediatric patients diagnosed with acute or chronic GVHD (aGVHD, cGVHD) treated for compassionate use with GMP-grade unrelated HLA-disparate donors' bone marrow-derived MSCs, expanded in platelet-lysate (PL)-containing medium. Eleven patients (aged 4-15 years) received intravenous (i.v.) MSCs for aGVHD or cGVHD, which was resistant to multiple lines of immunosuppression. The median dose was 1.2 x 10(6)/kg (range: 0.7-3.7 x 10(6)/kg). No acute side effects were observed, and no late side effects were reported at a median follow-up of 8 months (range: 4-18 months). Overall response was obtained in 71.4% of patients, with complete response in 23.8% of cases. None of our patients presented GVHD progression upon MSC administration, but 4 patients presented GVHD recurrence 2 to 5 months after infusion. Two patients developed chronic limited GVHD. This study underlines the safety of PL-expanded MSC use in children. MSC efficacy seems to be greater in aGVHD than in cGVHD, even after failure of multiple lines of immunosuppression. Copyright (c) 2010 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Biological Features of Human Bone Marrow Stromal Cells (hBMSC) Cultured with Animal Protein-Free Medium-Safety and Efficacy of Clinical Use for Neurotransplantation.

PubMed

Shichinohe, Hideo; Kuroda, Satoshi; Sugiyama, Taku; Ito, Masaki; Kawabori, Masahito; Nishio, Mitsufumi; Takeda, Yukari; Koike, Takao; Houkin, Kiyohiro

2011-09-01

The donor cell culture in animal serum-free medium is quite important for the clinical application of cell transplantation therapy. This study was aimed to test the hypothesis that the human bone marrow stromal cells (hBMSC) expanded with fetal calf serum (FCS)-free, platelet lysate (PL)-containing medium retain their biological features favoring central nervous system regeneration. The hBMSC were cultured with 5% PL or 10% FCS. Their phenotypes were analyzed with flow cytometry, and their production of growth factors was quantified with enzyme-linked immunosorbent assay. Their capacity of neural differentiation was verified by immunocytochemistry. There was no significant difference in morphology and cell surface marker between the hBMSC-FCS and hBMSC-PL. Both of them were positive for CD44, CD90, CD105, and CD166 and were negative for CD34, CD45, and CD271. The production of human brain-derived neurotrophic factor, human hepatocyte growth factor, human β-nerve growth factor, and human platelet-derived growth factor-BB did not differ between the two groups, although the hBMSC-PL produced significantly more amount of TGF-β1 than the hBMSC-FCS. There was no significant difference in their in vitro differentiation into the neurons and astrocytes between the two groups. The hBMSC expanded with PL-containing medium retain their biological capacity of neural differentiation and neuroprotection. The PL may be a clinically valuable and safe substitute for FCS in expanding the hBMSC for cell therapy.

Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS).

PubMed

Aryaie, Amir H; Singer, Jordan L; Fayezizadeh, Mojtaba; Lash, Jon; Marks, Jeffrey M

2017-02-01

Anastomotic or staple-line leak after foregut surgery presents a formidable management challenge. In recent years, with advancement of endoscopy, self-expanding covered stents have been gaining popularity. In this study, we aimed to determine the safety and effectiveness of self-expanding covered stents in management of leak after foregut surgery. Consecutive patients who received a fully covered self-expandable metal stent (SEMS) due to an anastomotic leak after upper gastrointestinal surgery between 2009 and 2014 were retrospectively reviewed. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were collected. Predictive factors for clinical success rate were assessed. A total of 20 consecutive patients underwent placement of fully covered SEMS for anastomotic leak, following esophagectomy (n = 5), esophageal diverticulectomy (n = 1), gastric sleeve (n = 4), gastric bypass (n = 3), partial gastrectomy (n = 4), and total gastrectomy (n = 3). All the stents were removed successfully, and clinical resolution was achieved in 18 patients (90 %) after a median of two (range 1-3) procedures and a mean of 6.2 weeks (range 0.4-14). Complications presented in 12 patients (60 %), including stent migration (n = 8), mucosal friability (n = 4), tissue integration (n = 2), and bleeding (n = 2). Two (10 %) patients' treatment was complicated by aorto-esophageal fistula formation resulting in one death. Demographic factors, comorbidities, and type of surgery were not predictive of clinical success rate or time to resolution. SEMS are effective tools for the management of leaks after foregut surgery. The biggest challenge with this approach is stent migration. Caution is warranted due to the risk of fatal complications such as aorto-esophageal fistula formation. No type of surgery or particular patient factor, including age, sex, BMI, albumin, history of radiation, malignancy, and comorbid diabetes or coronary artery disease, appeared to be correlated with success rate. Larger studies are needed to determine factors predictive of clinical success.

Long-acting rilpivirine for HIV prevention.

PubMed

Jackson, Akil; McGowan, Ian

2015-07-01

Long-acting injectable antiretroviral (ARV) formulations are being developed for the treatment and prevention of HIV infection. The purpose of this review is to summarize recent preclinical and clinical data on TMC278 (rilpivirine), a nonnucleoside reverse transcriptase inhibitor (NNRTI), that is being developed for both a treatment and prevention indication. Long-acting rilpivirine has demonstrated efficacy in preventing HIV acquisition in a humanized mouse model and has been found to be well tolerated and acceptable in several Phase I clinical trials. Pharmacokinetic data from Phase I studies suggest that 1200 mg of long-acting rilpivirine administered every 8 weeks would be associated with plasma and tissue levels of rilpivirine anticipated to be necessary for preventing HIV infection. This regimen is being evaluated in the HPTN-076 Phase II expanded safety study that will enroll women in South Africa, Zimbabwe, and the USA. The HPTN-076 study requires a 4-week run in with oral rilpivirine (25 mg capsules) before receiving 1200 mg of rilpivirine. It is not yet certain whether oral dosing will remain a prerequisite in future trials or post licensure. Long-acting rilpivirine shows promise as a candidate agent for HIV prevention. Preclinical efficacy has been demonstrated in a murine model. Phase I studies have shown good safety and efficacy, but breakthrough infection and resistance have been documented with lower doses of long-acting rilpivirine. Phase II development for a prevention indication is ongoing.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

PubMed

Krankenberg, Hans; Zeller, Thomas; Ingwersen, Maja; Schmalstieg, Josefin; Gissler, Hans Martin; Nikol, Sigrid; Baumgartner, Iris; Diehm, Nicolas; Nickling, Estell; Müller-Hülsbeck, Stefan; Schmiedel, Rainer; Torsello, Giovanni; Hochholzer, Willibald; Stelzner, Christian; Brechtel, Klaus; Ito, Wulf; Kickuth, Ralph; Blessing, Erwin; Thieme, Marcus; Nakonieczny, Jaroslaw; Nolte, Thomas; Gareis, Ragnar; Boden, Harald; Sixt, Sebastian

2017-08-28

Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Efficacy and complications in the use of self-expanding colonic stents: an analysis of 15 years' experience.

PubMed

Samper Wamba, J D; Fernández Martínez, A; González Pastrana, L; López González, L; Balboa Arregui, Ó

2015-01-01

To analyze the efficacy and safety of the procedure for placing self-expanding stents in the colon. To evaluate the factors associated with complications. To analyze the dose of radiation delivered in the procedure. This was a retrospective descriptive study of 478 procedures done at a single center to place self-expanding metallic stents in the colon. A total of 423 nitinol stents and 79 stainless steel stents were placed. We included all colonic obstructions, of which 446 had malignant causes and 8 had benign causes. We excluded patients with intestinal perforation, severe colonic bleeding, short life expectancy, or lesions located less than 5 cm from the anus. We collected the dosimetric data and analyzed the technical success, clinical success, and complications during follow-up. The procedure was a technical success in 92.26% of cases (n=441) and a clinical success in 78.45% (n=375); complications occurred during follow-up in 18.5% of cases. Complications occurred more frequently with the stainless steel stents than with the nitinol stents (OR: 3.2; 95% CI: 1.8-5.7). The mean value of the dose area product was 35 Gy*cm(2). When instead of being done by the interventional radiologist working together with an endoscopist the procedure was done exclusively by the interventional radiologist, the time under fluoroscopy (p=0.001), dose area product (p=0.029), and kinetic energy released per unit mass (p=0.001) were greater. The procedure for placing self-expanding colonic stents is efficacious and safe with an acceptable rate of complications. The doses of radiation delivered were low, and the radiation doses and time under fluoroscopy were lower when the procedure was done together with an endoscopist. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

PubMed

Wallace, Taylor C

2015-08-01

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. © 2015 American Society for Nutrition.

Testing HyDE on ADAPT

NASA Technical Reports Server (NTRS)

Sweet, Adam

2008-01-01

The IVHM Project in the Aviation Safety Program has funded research in electrical power system (EPS) health management. This problem domain contains both discrete and continuous behavior, and thus is directly relevant for the hybrid diagnostic tool HyDE. In FY2007 work was performed to expand the HyDE diagnosis model of the ADAPT system. The work completed resulted in a HyDE model with the capability to diagnose five times the number of ADAPT components previously tested. The expanded diagnosis model passed a corresponding set of new ADAPT fault injection scenario tests with no incorrect faults reported. The time required for the HyDE diagnostic system to isolate the fault varied widely between tests; this variance was reduced by tuning HyDE input parameters. These results and other diagnostic design trade-offs are discussed. Finally, possible future improvements for both the HyDE diagnostic model and HyDE itself are presented.

Characterisation of an Exploding Foil Initiator (EFI) system

NASA Astrophysics Data System (ADS)

Davies, H. R.; Chapman, D. J.; Vine, T. A.; Proud, W. G.

2009-06-01

Exploding Foil Initiators (EFIs) provide a safe and reliable means of detonation of explosives. They are highly insensitive to mechanical shock and electrical interference, requiring a specific high current pulse for initiation. The use of only insensitive secondary explosives and not more sensitive primary explosives further improves safety. When a high current is passed through the metal bridge, a plasma is formed as the metal can not expand beyond the polymer film layer above. This causes the film to expand forming a bubble or shearing off to form a flyer. These flyers can then be used to initiate secondary explosives. Due to the very high speed at which these systems operate, high speed streak photography was used to characterise the behaviour of the polymer film flyers produced. This paper will report the preliminary findings on the mechanical, electrical and velocity changes seen in some proprietary systems.

Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

PubMed

Moore, Thomas J; Furberg, Curt D

2014-01-01

The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.

Midterm to long-term safety and efficacy of self-expandable nitinol stent implantation for coarctation of aorta in adults.

PubMed

Haji Zeinali, Ali Mohammad; Sadeghian, Mohammad; Qureshi, Shakeel A; Ghazi, Payam

2017-09-01

Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome. © 2017 Wiley Periodicals, Inc.

Nurses', physicians' and radiographers' perceptions of the safety of a nurse prescribing of ionising radiation initiative: A cross-sectional survey.

PubMed

Hyde, Abbey; Coughlan, Barbara; Naughton, Corina; Hegarty, Josephine; Savage, Eileen; Grehan, Jennifer; Kavanagh, Eoin; Moughty, Adrian; Drennan, Jonathan

2016-06-01

A new initiative was introduced in Ireland following legislative changes that allowed nurses with special training to prescribe ionising radiation (X-ray) for the first time. A small number of studies on nurse prescribing of ionising radiation in other contexts have found it to be broadly as safe as ionising radiation prescribing by physicians. Sociological literature on perceptions of safety indicates that these tend to be shaped by the ideological position of the professional rather than based on objective evidence. To describe, compare and analyse perceptions of the safety of a nurse prescribing of ionising radiation initiative across three occupational groups: nursing, radiography and medicine. A cross-sectional survey design. Participants were drawn from a range of clinical settings in Ireland. Respondents were 167 health professionals comprised of 49 nurses, 91 radiographers, and 27 physicians out of a total of 300 who were invited to participate. Non-probability sampling was employed and the survey was targeted specifically at health professionals with a specific interest in, or involvement with, the development of the nurse prescribing of ionising radiation initiative in Ireland. Comparisons of perspectives on the safety of nurse prescribing of ionising radiation across the three occupational groups captured by questionnaire were analysed using the Kruskal-Wallis H test. Pairwise post hoc tests were conducted using the Mann-Whitney U test. While the majority of respondents from all three groups perceived nurse prescribing of ionising radiation to be safe, the extent to which this view was held varied. A higher proportion of nurses was found to display confidence in the safety of nurse prescribing of ionising radiation compared to physicians and radiographers with differences between nurses' perceptions and those of the other two groups being statistically significant. That an occupational patterning emerged suggests that perceptions about safety and risk of nurse prescribing of ionising radiation are socially constructed according to the vantage point of the professional and may not reflect objective measures of safety. These findings need to be considered more broadly in the context of ideological barriers to expanding the role of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

Orion MPCV Touchdown Detection Threshold Development and Testing

NASA Technical Reports Server (NTRS)

Daum, Jared; Gay, Robert

2013-01-01

A robust method of detecting Orion Multi ]Purpose Crew Vehicle (MPCV) splashdown is necessary to ensure crew and hardware safety during descent and after touchdown. The proposed method uses a triple redundant system to inhibit Reaction Control System (RCS) thruster firings, detach parachute risers from the vehicle, and transition to the post ]landing segment of the Flight Software (FSW). The vehicle crew is the prime input for touchdown detection, followed by an autonomous FSW algorithm, and finally a strictly time based backup timer. RCS thrusters must be inhibited before submersion in water to protect against possible damage due to firing these jets under water. In addition, neglecting to declare touchdown will not allow the vehicle to transition to post ]landing activities such as activating the Crew Module Up ]righting System (CMUS), resulting in possible loss of communication and difficult recovery. A previous AIAA paper gAssessment of an Automated Touchdown Detection Algorithm for the Orion Crew Module h concluded that a strictly Inertial Measurement Unit (IMU) based detection method using an acceleration spike algorithm had the highest safety margins and shortest detection times of other methods considered. That study utilized finite element simulations of vehicle splashdown, generated by LS ]DYNA, which were expanded to a larger set of results using a Kriging surface fit. The study also used the Decelerator Systems Simulation (DSS) to generate flight dynamics during vehicle descent under parachutes. Proto ]type IMU and FSW MATLAB models provided the basis for initial algorithm development and testing. This paper documents an in ]depth trade study, using the same dynamics data and MATLAB simulations as the earlier work, to further develop the acceleration detection method. By studying the combined effects of data rate, filtering on the rotational acceleration correction, data persistence limits and values of acceleration thresholds, an optimal configuration was determined. The lever arm calculation, which removes the centripetal acceleration caused by vehicle rotation, requires that the vehicle angular acceleration be derived from vehicle body rates, necessitating the addition of a 2nd order filter to smooth the data. It was determined that using 200 Hz data directly from the vehicle IMU outperforms the 40 Hz FSW data rate. Data persistence counter values and acceleration thresholds were balanced in order to meet desired safety and performance. The algorithm proved to exhibit ample safety margin against early detection while under parachutes, and adequate performance upon vehicle splashdown. Fall times from algorithm initiation were also studied, and a backup timer length was chosen to provide a large safety margin, yet still trigger detection before CMUS inflation. This timer serves as a backup to the primary acceleration detection method. Additionally, these parameters were tested for safety on actual flight test data, demonstrating expected safety margins.

Rotavirus vaccination within the South African Expanded Programme on Immunisation.

PubMed

Seheri, L Mapaseka; Page, Nicola A; Mawela, Mothahadini P B; Mphahlele, M Jeffrey; Steele, A Duncan

2012-09-07

Diarrhoeal diseases are ranked the third major cause of childhood mortality in South African children less than 5 years, where the majority of deaths are among black children. Acute severe dehydrating rotavirus diarrhoea remains an important contributor towards childhood mortality and morbidity and has been well documented in South Africa. As the preventive strategy to control rotavirus diarrhoea, South Africa became the first country in the WHO African Region to adopt the rotavirus vaccine in the national childhood immunisation programme in August 2009. The rotavirus vaccine in use, Rotarix, GSK Biologicals, is given at 6 and 14 weeks of age, along with other vaccines as part of Expanded Programme on Immunisation (EPI). Studies which facilitated the introduction of rotavirus vaccine in South Africa included the burden of rotavirus disease and strain surveillance, economic burden of rotavirus infection and clinical trials to assess the safety and efficacy of vaccine candidates. This paper reviews the epidemiology of rotavirus in South Africa, outlines some of the steps followed to introduce rotavirus vaccine in the EPI, and highlights the early positive impact of vaccination in reducing the rotavirus burden of disease based on the post-marketing surveillance studies at Dr George Mukhari hospital, a sentinel site at University of Limpopo teaching hospital in Pretoria, South Africa, which has conducted rotavirus surveillance for >20 years. Copyright © 2012 Elsevier Ltd. All rights reserved.

The use of double lasso, fully covered self-expandable metal stents with new "anchoring flap" system in the treatment of benign biliary diseases.

PubMed

Mangiavillano, B; Manes, G; Baron, T H; Frego, R; Dinelli, M; Radaelli, F; Teruzzi, V; Amato, A; Pallotta, S; Santoro, T; Masci, E

2014-09-01

Many benign biliary diseases (BBD) can be treated with fully covered, self-expandable metal stents (FCSEMS) but stent migration occurs in up to 35.7 %. The aim of this study was to prospectively assess the rate of, safety and effectiveness and stent migration of a new biliary FCSEMS with an anti-migration flap (FCSEMS-AF) in patients with BBD. This was a prospective study from four Italian referral endoscopy centers of 32 consecutive patients (10 females and 22 males; mean age: 60.1 ± 14.8 years; range: 32-84 years) with BBD who were offered endoscopic placement of a FCSEMS-AF as first-line therapy. Were 24 strictures and 8 leaks. Stent placement was technically successful in 32/32 patients (100 %). Immediate clinical improvement was seen in all 32 patients (100 %). One late stent migration occurred (3.3 %). FCSEMS-AF were removed from 30 of the 32 patients (93.7 %) at a mean (± SD) of 124.4 ± 84.2 days (range: 10-386 days) after placement. All patients remained clinically and biochemically well at 1- and 3-month follow-up. One patient (3.3 %) with a post-laparoscopic cholecystectomy stricture developed distal stent migration at 125 days. This new FCSEMS with anti-migration flap seems to be a safe and effective first-line treatment option for patients with BBD.

An image-based method to measure all-terrain vehicle dimensions for engineering safety purposes.

PubMed

Jennissen, Charles A; Miller, Nathan S; Tang, Kaiyang; Denning, Gerene M

2014-04-01

All-terrain vehicle (ATV) crashes are a serious public health and safety concern. Engineering approaches that address ATV injury prevention are critically needed. Avenues to pursue include evidence-based seat design that decreases risky behaviours, such as carrying passengers and operation of adult-size vehicles by children. The goal of this study was to create and validate an image-based method to measure ATV seat length and placement. Publicly available ATV images were downloaded. Adobe Photoshop was then used to generate a vertical grid through the centre of the vehicle, to define the grid scale using the manufacturer's reported wheelbase, and to determine seat length and placement relative to the front and rear axles using this scale. Images that yielded a difference greater than 5% between the calculated and the manufacturer's reported ATV lengths were excluded from further analysis. For the 77 images that met inclusion criteria, the mean±SD for the difference in calculated versus reported vehicle length was 1.8%±1.2%. The Pearson correlation coefficient for comparing image-based seat lengths determined by two independent measurers (20 models) and image-based lengths versus lengths measured at dealerships (12 models) were 0.95 and 0.96, respectively. The image-based method provides accurate and reproducible results for determining ATV measurements, including seat length and placement. This method greatly expands the number of ATV models that can be studied, and may be generalisable to other motor vehicle types. These measurements can be used to guide engineering approaches that improve ATV safety design.

Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report.

PubMed

Gsell, Pierre-Stéphane; Camacho, Anton; Kucharski, Adam J; Watson, Conall H; Bagayoko, Aminata; Nadlaou, Séverine Danmadji; Dean, Natalie E; Diallo, Abdourahamane; Diallo, Abdourahmane; Honora, Djidonou A; Doumbia, Moussa; Enwere, Godwin; Higgs, Elizabeth S; Mauget, Thomas; Mory, Diakite; Riveros, Ximena; Oumar, Fofana Thierno; Fallah, Mosoka; Toure, Alhassane; Vicari, Andrea S; Longini, Ira M; Edmunds, W J; Henao-Restrepo, Ana Maria; Kieny, Marie Paule; Kéïta, Sakoba

2017-12-01

In March, 2016, a flare-up of Ebola virus disease was reported in Guinea, and in response ring vaccination with the unlicensed rVSV-ZEBOV vaccine was introduced under expanded access, the first time that an Ebola vaccine has been used in an outbreak setting outside a clinical trial. Here we describe the safety of rVSV-ZEBOV candidate vaccine and operational feasibility of ring vaccination as a reactive strategy in a resource-limited rural setting. Approval for expanded access and compassionate use was rapidly sought and obtained from relevant authorities. Vaccination teams and frozen vaccine were flown to the outbreak settings. Rings of contacts and contacts of contacts were defined and eligible individuals, who had given informed consent, were vaccinated and followed up for 21 days under good clinical practice conditions. Between March 17 and April 21, 2016, 1510 individuals were vaccinated in four rings in Guinea, including 303 individuals aged between 6 years and 17 years and 307 front-line workers. It took 10 days to vaccinate the first participant following the confirmation of the first case of Ebola virus disease. No secondary cases of Ebola virus disease occurred among the vaccinees. Adverse events following vaccination were reported in 47 (17%) 6-17 year olds (all mild) and 412 (36%) adults (individuals older than 18 years; 98% were mild). Children reported fewer arthralgia events than adults (one [<1%] of 303 children vs 81 [7%] of 1207 adults). No severe vaccine-related adverse events were reported. The results show that a ring vaccination strategy can be rapidly and safely implemented at scale in response to Ebola virus disease outbreaks in rural settings. WHO, Gavi, and the World Food Programme. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Initial perceptions of key stakeholders in Ontario regarding independent prescriptive authority for pharmacists.

PubMed

Pojskic, Nedzad; MacKeigan, Linda; Boon, Heather; Austin, Zubin

2014-01-01

A number of jurisdictions, both in Canada and internationally, have recently expanded pharmacists' scope of practice to allow prescriptive authority. To ascertain the initial perceptions of the Ontario government and health professional stakeholder groups regarding the prospect of prescriptive authority for pharmacists. Qualitative research methods were used; data sources were policy documents and semi-structured interviews with key informants from the Ontario government and pharmacy and medical professional organizations. Purposive and snowball sampling strategies were used to identify 17 key informants. Fifty-one relevant policy documents were retrieved through searches of organizational websites and interviewee suggestions. Interview transcripts and documents were content analyzed independently by 2 researchers; and once consensus was achieved on key themes, the primary investigator analyzed the remainder. Pharmacy organizations and Ontario government representatives both expressed support for pharmacist prescriptive authority, suggesting that it would enhance patient access to primary care. Medical organizations were opposed to this expanded pharmacist role, arguing that pharmacists' lack of training and experience in diagnosis and prescribing would endanger patient safety. Other concerns were fragmentation of care and pharmacists' lack of access to patient clinical information. Some government and pharmacy informants felt that pharmacist prescribing would decrease health system costs through substitution of cheaper health professionals for physicians, while others felt that costs would increase due to increased utilization of services. Medical organizations preferred delegated medical authority as the policy alternative to pharmacist prescribing. Widely different views were expressed by the Ontario government and pharmacy organizations on the one hand and medical professional organizations on the other hand, regarding the potential impact of pharmacist prescribing on patient safety and access to primary care. This is likely due, at least in part, to the lack of evidence on the expected impact of this expanded pharmacist role. More research is needed to help inform discussions regarding this issue. Copyright © 2014 Elsevier Inc. All rights reserved.

Construction and Organization of a BSL-3 Cryo-Electron Microscopy Laboratory at UTMB

PubMed Central

Sherman, Michael B.; Trujillo, Juan; Leahy, Ian; Razmus, Dennis; DeHate, Robert; Lorcheim, Paul; Czarneski, Mark A.; Zimmerman, Domenica; Newton, Je T’Aime M.; Haddow, Andrew D.; Weaver, Scott C.

2013-01-01

A unique cryo-electron microscopy facility has been designed and constructed at the University of Texas Medical Branch (UTMB) to study the three-dimensional organization of viruses and bacteria classified as select agents at biological safety level (BSL)-3, and their interactions with host cells. A 200 keV high-end cryo-electron microscope was installed inside a BSL-3 containment laboratory and standard operating procedures were developed and implemented to ensure its safe and efficient operation. We also developed a new microscope decontamination protocol based on chlorine dioxide gas with a continuous flow system, which allowed us to expand the facility capabilities to study bacterial agents including spore-forming species. The new unified protocol does not require agent-specific treatment in contrast to the previously used heat decontamination. To optimize the use of the cryo-electron microscope and to improve safety conditions, it can be remotely controlled from a room outside of containment, or through a computer network world-wide. Automated data collection is provided by using JADAS (single particle imaging) and SerialEM (tomography). The facility has successfully operated for more than a year without an incident and was certified as a select agent facility by the Centers for Disease Control. PMID:23274136

The Cardiac Safety Research Consortium ECG database.

PubMed

Kligfield, Paul; Green, Cynthia L

2012-01-01

The Cardiac Safety Research Consortium (CSRC) ECG database was initiated to foster research using anonymized, XML-formatted, digitized ECGs with corresponding descriptive variables from placebo- and positive-control arms of thorough QT studies submitted to the US Food and Drug Administration (FDA) by pharmaceutical sponsors. The database can be expanded to other data that are submitted directly to CSRC from other sources, and currently includes digitized ECGs from patients with genotyped varieties of congenital long-QT syndrome; this congenital long-QT database is also linked to ambulatory electrocardiograms stored in the Telemetric and Holter ECG Warehouse (THEW). Thorough QT data sets are available from CSRC for unblinded development of algorithms for analysis of repolarization and for blinded comparative testing of algorithms developed for the identification of moxifloxacin, as used as a positive control in thorough QT studies. Policies and procedures for access to these data sets are available from CSRC, which has developed tools for statistical analysis of blinded new algorithm performance. A recently approved CSRC project will create a data set for blinded analysis of automated ECG interval measurements, whose initial focus will include comparison of four of the major manufacturers of automated electrocardiographs in the United States. CSRC welcomes application for use of the ECG database for clinical investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

Construction and organization of a BSL-3 cryo-electron microscopy laboratory at UTMB.

PubMed

Sherman, Michael B; Trujillo, Juan; Leahy, Ian; Razmus, Dennis; Dehate, Robert; Lorcheim, Paul; Czarneski, Mark A; Zimmerman, Domenica; Newton, Je T'aime M; Haddow, Andrew D; Weaver, Scott C

2013-03-01

A unique cryo-electron microscopy facility has been designed and constructed at the University of Texas Medical Branch (UTMB) to study the three-dimensional organization of viruses and bacteria classified as select agents at biological safety level (BSL)-3, and their interactions with host cells. A 200keV high-end cryo-electron microscope was installed inside a BSL-3 containment laboratory and standard operating procedures were developed and implemented to ensure its safe and efficient operation. We also developed a new microscope decontamination protocol based on chlorine dioxide gas with a continuous flow system, which allowed us to expand the facility capabilities to study bacterial agents including spore-forming species. The new unified protocol does not require agent-specific treatment in contrast to the previously used heat decontamination. To optimize the use of the cryo-electron microscope and to improve safety conditions, it can be remotely controlled from a room outside of containment, or through a computer network world-wide. Automated data collection is provided by using JADAS (single particle imaging) and SerialEM (tomography). The facility has successfully operated for more than a year without an incident and was certified as a select agent facility by the Centers for Disease Control. Copyright © 2012 Elsevier Inc. All rights reserved.

Solid-liquid staged combustion space boosters

NASA Technical Reports Server (NTRS)

Culver, D. W.

1990-01-01

NASA has begun to evaluate solid-liquid hybrid propulsion for launch vehicle booster. A three-phase program was outlined to identify, acquire, and demonstrate technology needed to approximate solid and liquid propulsion state of the art. Aerojet has completed a Phase 1 study and recommends a solid-liquid staged combustion concept in which turbopump fed LO2 is burned with fuel-rich solid propellant effluent in aft-mounted thrust chambers.These reasonably sized thrust chambers are LO2 regeneratively cooled, supplemented with fuel-rich barrier cooling. Turbopumps are driven by the resulting GO2 coolant in an expander-bleed-burnoff cycle. Turbine exhaust pressurizes the LO2 tankage directly, and the excess is bled into supersonic nozzle splitlines, where it combusts with the fuel rich boundary layer. Thrust vector control is enhanced by supersonic nozzle movement on flexseal mounts. Every hybrid solid-liquid concept examined improves booster energy management and launch propellant safety compared to current solid boosters. Solid-liquid staged combustion improves hybrid performance by improving both combustion efficiency and combustion stability, especially important for large boosters. These improvements result from careful fluid management and use of smaller combustors. The study shows NASA safety, reliability, cost, and performance criteria are best met with this concept, wherein simple hardware relies on several separate emerging technologies, all of which have been demonstrated successfully.

Use of Self-Expanding Metallic Ureteral Stents in the Secondary Treatment of Ureteral Stenosis Following Kidney Transplantation.

PubMed

Xu, Guibin; Li, Xun; He, Yongzhong; Zhao, Haibo; Yang, Weiqing; Xie, Qingling

2015-10-01

To evaluate the safety and efficacy of self-expanding metal stents in the treatment of ureteral stenosis following kidney transplantation. Seven patients who developed benign stenosis after kidney transplantation were treated by a self-expanding metallic stent implantation from June 2007 to March 2014. All patients had undergone at least one open surgical procedure and one endourologic procedure for treatment of the stenosis. The extent of stenosis varied from 1.2 to 3.7 cm. Ultrasonography, urography, diuretic renography, and urine culture were performed every 3 months after stent insertion. Ureteroscopic examination was performed when needed. Stent placement was technically effective in all cases. The mean operative time was 37 minutes (range, 26-59 minutes). Lower urinary-tract symptoms and the ipsilateral flank pain were common early-stage complications and were greatly relieved after an average of 3 months. The mean follow-up duration was 38 months (range, 13-86 months), and no stent migration or fragmentation was observed. Urothelial hyperplasia occurred in only one patient and was effectively managed with a Double-J stent. Five patients had normal stable renal function; the remaining two had impaired renal function, including one patient with a preoperative renal failure who required dialysis at the end of the follow-up period (36 months). As an alternative to open surgery, implantation of a self-expanding metal stent is a safe and effective treatment for ureteral stenosis in patients who have undergone kidney transplantation.

On a Slow Roll

NASA Technical Reports Server (NTRS)

Hughes, David

2005-01-01

Satellite navigation and surveillance products and services can cut costs, improve accuracy, expand coverage and enhance safety. But the global transformation of air traffic management (ATM) that satellites and ground augmentation systems have promised is being realized much more slowly than expected. "There are still a lot of nations that could benefit [from satellite navigation and surveillance] that haven't invested dime in new equipment." says Tim Katanik, manager of business development for navigation and landing systems Raytheon. But then things usually move slowly in this industry, he adds.

Numerical Simulation of HIWC Conditions with the Terminal Area Simulation System

NASA Technical Reports Server (NTRS)

Proctor, Fred H.; Switzer, George F.

2016-01-01

Three-dimensional, numerical simulation of a mesoconvective system is conducted in order to better understand conditions associated with High Ice Water Content (HIWC) and its threat to aviation safety. Although peak local values of ice water content may occur early in the storm lifetime, large areas of high concentrations expand with time and persist even when the storm tops begin to warm. The storm canopy which contains HIWC, has low radar reflectivity factor and is fed by an ensemble of regenerating thermal pulses.

Southeast Asia Report No. 1323, Vietnam Tap Chi Cong San No. 6, June 1983

DTIC Science & Technology

1983-08-10

safety in every situation, implement the mechanism "the party leads, the people exercise ownership and the state manages" well and have an intense...scientific-technological research and training cadres. The outskirts of the city have been expanded. The majority of the people of Hanoi are urban cadres...economy and the standard of living, the party organization and people of Hanoi have made many efforts to implement the lines, positions and policies of

Programmatic Life Cycle Environmental Assessment for Smoke/Obscurants. Volume 5. Dye/Colored Smokes

DTIC Science & Technology

1983-07-01

mostly of test or training debtls, i.e., expanded rounds and/or packaging materials or munition duds. SOP’s and test 0 plans which are required for each...This procedure I; especially applicable to test sites, If a safety (handling) hazard exists with colored smoke munitions and for excess mix, the material ...Countermeasures and Test Division Roger L. Schultz, DRCPM-SMK-M, Material Development and Technology ".• ,.Division Sq 52 I.,.’. S%" 2. Chemical Research and

[Expertise level of occupational health physician, implementation of occupational safety and health management system (OSHMS) and occupational safety and health activity level in Japan in the companies listed on Tokyo Stock Exchange first section].

PubMed

Ikeda, Yukiko; Kameda, Takashi; Shirakawa, Chie; Nagata, Tomohisa; Zama, Satoko; Kayashima, Koutarou; Kobayashi, Yuuichi; Mori, Koji

2007-12-01

By enforcement of the revised Japanese Industrial Safety and Health Law on April, 2006, the implementation of OSHMS seems to be expanding and encouraged. In OSHMS of Japan, however, the occupational health aspects have not been put into operated, while only occupational safety aspects have been prioritized. To clarify the issues to deploy OSHMS with occupational health aspects, we conducted a mail survey of 1,581 companies listed on the Tokyo Stock Market First Section in December, 2004. The effective responses were 267 (16.9%). The number of companies which had installed OSHMS, those that planned to install OSHMS and those had no plan for OSHMS were 62 (23.2%), 82 (30.7%) and 123 (46.1%), respectively. Only 12 companies include the complete OH activities in the installed OSHMS. A significant relationship was observed among expertise of OH physicians, actual role and responsibility of OH physicians, installation of OSHMS and OH services quality level. To deploy OSHMS well-balanced for health and safety aspects in present Japan, it was suggested that the education regarding OH operation in OSHMS was necessary to the person in charge of OSHMS in each company, and the participation by OH physicians to operate OSHMS, especially OH physicians with expertise, was essential.

Study on a model for future occupational health: proposal for an occupational health service model in Japan.

PubMed

Higashi, Toshiaki

2006-10-01

The Study Model for Future Occupational Health (funded by a research grant from the Ministry of Health, Welfare and Labor) is a joint research project involving various organizations and agencies undertaken from 2002 to 2004. Society has undergone a dramatic transformation due to technological developments and internationalization. At the same time a low birth rate and an aging population have resulted in an increase in both the percentage of workers experiencing strong anxiety and stress in relation to their jobs and the working environment and the number of suicides. As a natural consequence, occupational health services are now expected to provide EAP, consulting and other functions that were formerly considered outside the realm of occupational health. In consideration of this background, the present study propose the following issues to provide a model for future occupational health services that meet the conditions presently confronted by each worker. 1. How to provide occupational health services and occupational physicians' services: 1) a basic time of 20 minutes of occupational health services per year should be allotted to each worker and to all workers; 2) the obligatory regulations should be revised to expand the obligation from businesses each with 50 or more employees under the present laws to businesses each with 30 or more employees. 2. Providers of occupational health services and occupational physicians' services: (1) reinforcement of outside occupational health agencies; (2) fostering occupational health consultant firms; (3) development of an institute of occupational safety and health; (4) support of activities by authorized occupational physicians in the field; (5) expanding of joint selection of occupational physicians including subsidy increase and the extension of a period of subsidy to five hears; (6) licensing of new entry into occupational health undertaking. 3. Introduction of new report system: (1) establishment of the obligation to submit reports on risk evaluation and improvement measures; (2) establishment of the obligation to prepare a report on results of medical examinations in all sizes of businesses. 4. Introduction of a merit system into businesses in establishment of a new system: the application of the special merit system of the workers' compensation insurance shall be revised to add occupational health activities, cover business with 20 or more to 100 or less employees and expand the period of application for three years under the present laws to five years. 5. Ensuring of international coordination: harmonization of standards of individual countries for occupational health and safety; thorough (1) ensuring of international agreement on high-level specialist qualifications; (2) mutual recognition of qualifications of occupational physician, nurse, occupational hygienist, ergonomist, and counselor; (3) preparation of guidelines for occupations relating to occupational health businesses.

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience.

PubMed

Anderloni, Andrea; Genco, Chiara; Massidda, Marco; Di Leo, Milena; Fumagalli, Uberto Romario; Rosati, Riccardo; Correale, Loredana; Maselli, Roberta; Ferrara, Elisa Chiara; Jovani, Manol; Repici, Alessandro

2018-06-05

The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients). The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome. © 2018 S. Karger AG, Basel.

Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.

PubMed

Reynolds, Matthew R; Lei, Yang; Wang, Kaijun; Chinnakondepalli, Khaja; Vilain, Katherine A; Magnuson, Elizabeth A; Galper, Benjamin Z; Meduri, Christopher U; Arnold, Suzanne V; Baron, Suzanne J; Reardon, Michael J; Adams, David H; Popma, Jeffrey J; Cohen, David J

2016-01-05

Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Strategies to reduce driving under the influence of alcohol.

PubMed

DeJong, W; Hingson, R

1998-01-01

The purpose of this review is to update research on the prevention of alcohol-related traffic deaths since the 1988 Surgeon General's Workshop on Drunk Driving. Four primary areas of research are reviewed here: (a) general deterrence policies, (b) alcohol control policies, (c) mass communications campaigns, including advertising restrictions, and (d) community traffic safety programs. Modern efforts to combat drunk driving in the United States began with specific deterrence strategies to punish convicted drunk drivers, and then evolved to include general deterrence strategies that were targeted to the population as a whole. Efforts next expanded to include the alcohol side of the problem, with measures installed to decrease underage drinking and excessive alcohol consumption. In the next several years, greater efforts are needed on all these fronts. Also needed, however, are programs that integrate drunk driving prevention with other traffic safety initiatives.

Manufacturing and NDE of Large Composite Structures for Space Transportation at MSFC

NASA Technical Reports Server (NTRS)

McGill, Preston; Russell, Sam

2000-01-01

This paper presents the Marshall Space Flight Center's (MSFC's) vision to manufacture, increase safety and reduce the cost of launch vehicles. Nondestructive evaluations of large composite structures are tested for space transportation at MSFC. The topics include: 1) 6 1/2 Generations of Airplanes in a Century; 2) Shuttle Safety Upgrades; 3) Generations of Reusable Launch Vehicles; 4) RLV Technology Demonstration Path; 5) Second Generation; 6) Key NASA Requirements; 7) X-33 Elements; 8) Future-X Pathfinder Projects and Experiments; 9) Focus Area Technical Goals; 10) X-34 Expanded View; 11) X-38 Spacecraft with De-Orbit Propulsion Stage (DPS); 12) Deorbit Module (DM) Critical Design Review (CDR) Design; 13) Forward Structural Adapter (FSA) CDR Design; 14) X-38 DPS CDR Design; 15) RLV Focused Propulsion Technologies; and 16) Challenges in Technology. This paper is presented in viewgraph form.

Simulation study of traffic car accidents at a single lane roundabout

NASA Astrophysics Data System (ADS)

Echab, H.; Lakouari, N.; Ez-Zahraouy, H.; Benyoussef, A.

2016-07-01

In this paper, using the Nagel-Schreckenberg model, we numerically investigate the probability Pac of entering/circulating car accidents to occur at single-lane roundabout under the expanded open boundary. The roundabout consists of N on-ramps (respectively, off-ramps). The boundary is controlled by the injecting rates α1,α2 and the extracting rate β. The simulation results show that, depending on the injecting rates, the car accidents are more likely to happen when the capacity of the rotary is set to its maximum. Moreover, we found that the large values of rotary size L and the probability of preferential Pexit are reliable to improve safety and reduce accidents. However, the usage of indicator, the increase of β and/or N provokes an increase of car accident probability.

Health Benefits of Probiotics: A Review

PubMed Central

Dimitriadi, Dimitra; Gyftopoulou, Konstantina; Skarmoutsou, Nikoletta

2013-01-01

Probiotic bacteria have become increasingly popular during the last two decades as a result of the continuously expanding scientific evidence pointing to their beneficial effects on human health. As a result they have been applied as various products with the food industry having been very active in studying and promoting them. Within this market the probiotics have been incorporated in various products, mainly fermented dairy foods. In light of this ongoing trend and despite the strong scientific evidence associating these microorganisms to various health benefits, further research is needed in order to establish them and evaluate their safety as well as their nutritional aspects. The purpose of this paper is to review the current documentation on the concept and the possible beneficial properties of probiotic bacteria in the literature, focusing on those available in food. PMID:24959545

Power recovery from waste heat in modern turboexpander plants

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

Mafi, S.; Drake, C.

1981-01-01

The object of this study is to determine the feasibility and cost of installing a power recovery system in an existing gas processing plant. The power generated by the system is to be used to drive a residue gas compressor, a refrigeration compressor and the heat medium circulating pump, each having its own expander driver. For this purpose the heat from the exhaust of a number of gas turbines is to be combined to provide a total 75 MM Btu/hr. heat energy. Because of safety reasons, Freon 12 has been chosen for the working fluid. The condensing media is watermore » at a design temperature of 80 degrees F. The process conditions for the cycle and the duties of the major equipments are described.« less

Physical hazard safety awareness among healthcare workers in Tanta university hospitals, Egypt.

PubMed

El-Sallamy, Rania M; Kabbash, Ibrahim Ali; El-Fatah, Sanaa Abd; El-Feky, Asmaa

2017-05-17

Hospital workers are exposed to many occupational hazards that may threaten their health and safety. Physical hazards encountered in hospital working environment include temperature, illumination, noise, electrical injuries, and radiation. To assess the awareness of healthcare workers (HCWs) about physical hazards in Tanta university hospitals, this cross-sectional study included 401 HCWs (physicians, nurses, technicians, and workers) from seven departments (general surgery, orthopedics, radiology, ophthalmology, kitchen, incinerator, and laundry). Data were collected through interview questionnaire to assess six types of physical hazards (noise, electric hazards, temperature, radiation, fire, and lighting,). Most of the physicians (63.7%) were aware of the level of noise. All physicians, nurses, technicians, and majority of workers reported that hearing protective devices were not available, and all HCWs reported that periodic hearing examination was not performed. Most of the nurses (75.2%) and workers (68.5%) did not attended emergency training, and more than two thirds of all HCWs were not briefed about emergency evacuation. Most HCWs were not given appropriate radiation safety training before starting work (88% of workers, 73.7% of nurses, 65.7% of physicians, and 68.3% of technicians). The majority of physicians, nurses, and technicians (70.5, 65.4, and 53.7%) denied regular environmental monitoring for radiation level inside work place. Health education programs on health and safety issues regarding physical hazards should be mandatory to all healthcare workers to improve their awareness and protect them from undue exposures they may face due to lack of adequate awareness and knowledge. There is urgent need of expanding the occupational healthcare services in Egypt to cover all the employees as indicated by the international recommendations and the Egyptian Constitution, legislation, and community necessity.

Using Human 'Experiments of Nature' to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors.

PubMed

Jerome, Rebecca N; Pulley, Jill M; Roden, Dan M; Shirey-Rice, Jana K; Bastarache, Lisa A; R Bernard, Gordon; B Ekstrom, Leeland; Lancaster, William J; Denny, Joshua C

2018-03-01

When a new drug enters the market, its full array of side effects remains to be defined. Current surveillance approaches targeting these effects remain largely reactive. There is a need for development of methods to predict specific safety events that should be sought for a given new drug during development and postmarketing activities. We present here a safety signal identification approach applied to a new set of drug entities, inhibitors of the serine protease proprotein convertase subtilisin/kexin type 9 (PCSK9). Using phenome-wide association study (PheWAS) methods, we analyzed available genotype and clinical data from 29,722 patients, leveraging the known effects of changes in PCSK9 to identify novel phenotypes in which this protein and its inhibitors may have impact. PheWAS revealed a significantly reduced risk of hypercholesterolemia (odds ratio [OR] 0.68, p = 7.6 × 10 -4 ) in association with a known loss-of-function variant in PCSK9, R46L. Similarly, laboratory data indicated significantly reduced beta mean low-density lipoprotein cholesterol (- 14.47 mg/dL, p = 2.58 × 10 -23 ) in individuals carrying the R46L variant. The R46L variant was also associated with an increased risk of spina bifida (OR 5.90, p = 2.7 × 10 -4 ), suggesting that further investigation of potential connections between inhibition of PCSK9 and neural tube defects may be warranted. This novel methodology provides an opportunity to put in place new mechanisms to assess the safety and long-term tolerability of PCSK9 inhibitors specifically, and other new agents in general, as they move into human testing and expanded clinical use.

A randomised controlled trial using mobile advertising to promote safer sex and sun safety to young people.

PubMed

Gold, J; Aitken, C K; Dixon, H G; Lim, M S C; Gouillou, M; Spelman, T; Wakefield, M; Hellard, M E

2011-10-01

Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the use of mobile advertising for health promotion. Mobile advertising subscribers aged 16-29 years residing in Victoria, Australia (n = 7606) were randomised to the 'sex' or 'sun' group and received eight messages during the 2008-2009 summer period. Changes in sex- and sun-related knowledge and behaviour were measured by questionnaires completed on mobile phones. At follow-up, the sex group had significantly higher sexual health knowledge and fewer sexual partners than the sun group. The sun group had no change in hat-wearing frequency compared with a significant decline in hat-wearing frequency in the sex group. This is the first study of mobile advertising for health promotion, which can successfully reach most young people. Challenges experienced with project implementation and evaluation should be considered as new technological approaches to health promotion continue to be expanded.

Medical marijuana in neurology.

PubMed

Benbadis, Selim R; Sanchez-Ramos, Juan; Bozorg, Ali; Giarratano, Melissa; Kalidas, Kavita; Katzin, Lara; Robertson, Derrick; Vu, Tuan; Smith, Amanda; Zesiewicz, Theresa

2014-12-01

Constituents of the Cannabis plant, cannabinoids, may be of therapeutic value in neurologic diseases. The most abundant cannabinoids are Δ(9)-tetrahydrocannabinol, which possesses psychoactive properties, and cannabidiol, which has no intrinsic psychoactive effects, but exhibits neuroprotective properties in preclinical studies. A small number of high-quality clinical trials support the safety and efficacy of cannabinoids for treatment of spasticity of multiple sclerosis, pain refractory to opioids, glaucoma, nausea and vomiting. Lower level clinical evidence indicates that cannabinoids may be useful for dystonia, tics, tremors, epilepsy, migraine and weight loss. Data are also limited in regards to adverse events and safety. Common nonspecific adverse events are similar to those of other CNS 'depressants' and include weakness, mood changes and dizziness. Cannabinoids can have cardiovascular adverse events and, when smoked chronically, may affect pulmonary function. Fatalities are rare even with recreational use. There is a concern about psychological dependence, but physical dependence is less well documented. Cannabis preparations may presently offer an option for compassionate use in severe neurologic diseases, but at this point, only when standard-of-care therapy is ineffective. As more high-quality clinical data are gathered, the therapeutic application of cannabinoids will likely expand.

Modeling the frequency of opposing left-turn conflicts at signalized intersections using generalized linear regression models.

PubMed

Zhang, Xin; Liu, Pan; Chen, Yuguang; Bai, Lu; Wang, Wei

2014-01-01

The primary objective of this study was to identify whether the frequency of traffic conflicts at signalized intersections can be modeled. The opposing left-turn conflicts were selected for the development of conflict predictive models. Using data collected at 30 approaches at 20 signalized intersections, the underlying distributions of the conflicts under different traffic conditions were examined. Different conflict-predictive models were developed to relate the frequency of opposing left-turn conflicts to various explanatory variables. The models considered include a linear regression model, a negative binomial model, and separate models developed for four traffic scenarios. The prediction performance of different models was compared. The frequency of traffic conflicts follows a negative binominal distribution. The linear regression model is not appropriate for the conflict frequency data. In addition, drivers behaved differently under different traffic conditions. Accordingly, the effects of conflicting traffic volumes on conflict frequency vary across different traffic conditions. The occurrences of traffic conflicts at signalized intersections can be modeled using generalized linear regression models. The use of conflict predictive models has potential to expand the uses of surrogate safety measures in safety estimation and evaluation.

Nurse managers describe their practice environments.

PubMed

Warshawsky, Nora E; Lake, Sharon W; Brandford, Arica

2013-01-01

Hospital work environments that support the professional practice of nurses are critical to patient safety. Nurse managers are responsible for creating these professional practice environments for staff nurses, yet little is known about the environments needed to support nurse managers. Domains of nurse managers' practice environment have recently been defined. This is a secondary analysis of 2 cross-sectional studies of organizational characteristics that influence nurse manager practice. Content analysis of the free text comments from 127 nurse managers was used to illustrate the 8 domains of nurse managers' practice environments. Nurse managers valued time spent with their staff; therefore, workloads must permit meaningful interaction. Directors demonstrated trust when they empowered nurse managers to make decisions. Administrative leaders should build patient safety cultures on the basis of shared accountability and mutual respect among the health care team. The expectations of nurse managers have greatly expanded in the volume and complexity of direct reports, patient care areas, and job functions. The nurse managers in this analysis reported characteristics of their practice environments that limit their role effectiveness and may negatively impact organizational performance. Further research is needed to understand the effects of nurse managers' practice environments on staff and patient outcomes.

Effect of ivacaftor in patients with advanced cystic fibrosis and a G551D-CFTR mutation: Safety and efficacy in an expanded access program in the United States.

PubMed

Taylor-Cousar, Jennifer; Niknian, Minoo; Gilmartin, Geoffrey; Pilewski, Joseph M

2016-01-01

Ivacaftor is the first therapeutic agent approved for the treatment of cystic fibrosis (CF) that targets the underlying molecular defect. Patients with severe lung disease were excluded from the randomized Phase 3 trials. This open-label study was designed to provide ivacaftor to patients in critical medical need prior to commercial product availability. CF patients aged ≥6 years with a G551D-CFTR mutation and FEV1 ≤ 40% predicted or listed for lung transplant received ivacaftor 150 mg every 12 h. The primary endpoint was safety as determined by adverse events. Secondary endpoints included assessment of lung function and weight. The rate of serious adverse events was consistent with disease severity. At 24 weeks of treatment with ivacaftor, there was a mean absolute increase in percent predicted FEV1 of 5.5 percentage points and a 3.3 kg mean absolute increase in weight from baseline. In patients with severe lung disease, ivacaftor was well tolerated and was associated with improved lung function and weight gain. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Effects of the temporary placement of a self-expandable metallic stent in benign pyloric stenosis.

PubMed

Choi, Won Jae; Park, Jong-Jae; Park, Jain; Lim, Eun-Hye; Joo, Moon Kyung; Yun, Jae-Won; Noh, Hyejin; Kim, Sung Ho; Choi, Woo Seok; Lee, Beom Jae; Kim, Ji Hoon; Yeon, Jong Eun; Kim, Jae Seon; Byun, Kwan Soo; Bak, Young-Tae

2013-07-01

The use of self-expandable metallic stents (SEMS) is an established palliative treatment for malignant stenosis in the gastrointestinal tract; therefore, its application to benign stenosis is expected to be beneficial because of the more gradual and sustained dilatation in the stenotic portion. We aimed in this prospective observational study to evaluate the efficacy and safety of temporary SEMS placement in benign pyloric stenosis. Twenty-two patients with benign stenosis of the prepylorus, pylorus, and duodenal bulb were enrolled and underwent SEMS placement. We assessed symptom improvement, defined as an increase of at least 1 degree in the gastric-outlet-obstruction scoring system after stent insertion. No major complications were observed during the procedures. After stent placement, early symptom improvement was achieved in 18 of 22 patients (81.8%). During the follow-up period (mean 10.2 months), the stents remained in place successfully for 6 to 8 weeks in seven patients (31.8%). Among the 15 patients (62.5%) with stent migration, seven (46.6%) showed continued symptomatic improvement without recurrence of obstructive symptoms. Despite the symptomatic improvement, temporary SEMS placement is premature as an effective therapeutic tool for benign pyloric stenosis unless a novel stent is developed to prevent migration.

Effects of the Temporary Placement of a Self-Expandable Metallic Stent in Benign Pyloric Stenosis

PubMed Central

Choi, Won Jae; Park, Jain; Lim, Eun-Hye; Joo, Moon Kyung; Yun, Jae-Won; Noh, Hyejin; Kim, Sung Ho; Choi, Woo Seok; Lee, Beom Jae; Kim, Ji Hoon; Yeon, Jong Eun; Kim, Jae Seon; Byun, Kwan Soo; Bak, Young-Tae

2013-01-01

Background/Aims The use of self-expandable metallic stents (SEMS) is an established palliative treatment for malignant stenosis in the gastrointestinal tract; therefore, its application to benign stenosis is expected to be beneficial because of the more gradual and sustained dilatation in the stenotic portion. We aimed in this prospective observational study to evaluate the efficacy and safety of temporary SEMS placement in benign pyloric stenosis. Methods Twenty-two patients with benign stenosis of the prepylorus, pylorus, and duodenal bulb were enrolled and underwent SEMS placement. We assessed symptom improvement, defined as an increase of at least 1 degree in the gastric-outlet-obstruction scoring system after stent insertion. Results No major complications were observed during the procedures. After stent placement, early symptom improvement was achieved in 18 of 22 patients (81.8%). During the follow-up period (mean 10.2 months), the stents remained in place successfully for 6 to 8 weeks in seven patients (31.8%). Among the 15 patients (62.5%) with stent migration, seven (46.6%) showed continued symptomatic improvement without recurrence of obstructive symptoms. Conclusions Despite the symptomatic improvement, temporary SEMS placement is premature as an effective therapeutic tool for benign pyloric stenosis unless a novel stent is developed to prevent migration. PMID:23898381

In Vivo Rat T-Lymphocyte Pig-a Assay: Detection and Expansion of Cells Deficient in the GPI-Anchored CD48 Surface Marker for Analysis of Mutation in the Endogenous Pig-a Gene.

PubMed

Dobrovolsky, Vasily N; Revollo, Javier; Petibone, Dayton M; Heflich, Robert H

2017-01-01

The Pig-a assay is being developed as an in vivo gene mutation assay for regulatory safety assessments. The assay is based on detecting mutation in the endogenous Pig-a gene of treated rats by using flow cytometry to measure changes in cell surface markers of peripheral blood cells. Here we present a methodology for demonstrating that phenotypically mutant rat T-cells identified by flow cytometry contain mutations in the Pig-a gene, an important step for validating the assay. In our approach, the mutant phenotype T-cells are sorted into individual wells of 96-well plates and expanded into clones. Subsequent sequencing of genomic DNA from the expanded clones confirms that the Pig-a assay detects exactly what it claims to detect-cells with mutations in the endogenous Pig-a gene. In addition, determining the spectra of Pig-a mutations provides information for better understanding the mutational mechanism of compounds of interest. Our methodology of combining phenotypic antibody labeling, magnetic enrichment, sorting, and single-cell clonal expansion can be used in genotoxicity/mutagenicity studies and in other general immunotoxicology research requiring identification, isolation, and expansion of extremely rare subpopulations of T-cells.

Safety of dual kidney transplantation compared to single kidney transplantation from expanded criteria donors: a single center cohort study of 39 recipients.

PubMed

Mendel, Lionel; Albano, Laetitia; Bentellis, Imad; Yandza, Thierry; Bernardi, Caroline; Quintens, Herve; Tibi, Brannwel; Jourdan, Jacques; Durand, Matthieu; Amiel, Jean; Chevallier, Daniel

2018-05-17

Our objective was to compare the outcomes of dual kidney transplanataion (DKT) to single kidney transplantation (SKT) performed with grafts from expanded criteria donors (ECD) in recipients ≥65 years, focusing on surgical complications. All kidney transplantations (KT) performed between 2006 and 2014 in our institution were analysed. DKT was indicated according to the criteria of the French national Agence de la Biomedecine. Thirty-nine DKT and 155 SKT were included, with a median follow-up of 36 and 26.5 months, respectively. The rate of early surgical revisions was not significantly higher after DKT (23.1% vs 15.5% (P = 0.2593)) but more venous graft thromboses (12.8% vs 3.2% (P = 0.02)) were reported. The glomerular filtration rate (GFR) 24 months after KT was significantly higher after DKT (45.0 ± 16.3 vs 39.8 ± 13.8 ml/min/1.73m 2 ; P = 0.04) and allowed shorter waiting time without a significant increased risk of surgical revision, excepted for venous graft thrombosis, more frequent after DKT. Graft survivals were not significantly different and GFR was higher after DKT. DKT seems to remain an appropriate strategy to address the growing graft shortage in elderly patients. © 2018 Steunstichting ESOT.

Development Status of the CECE Cryogenic Deep Throttling Demonstrator Engine

NASA Technical Reports Server (NTRS)

2008-01-01

As one of the first technology development programs awarded by NASA under the U.S. Space Exploration Policy (USSEP), the Pratt & Whitney Rocketdyne (PWR) Deep Throttling, Common Extensible Cryogenic Engine (CECE) program was selected by NASA in November 2004 to begin technology development and demonstration toward a deep throttling, cryogenic engine supporting ongoing trade studies for NASA's Lunar Lander descent stage. The CECE program leverages the maturity and previous investment of a flight-proven hydrogen/oxygen expander cycle engine, the PWR RLI0, to develop and demonstrate an unprecedented combination of reliability, safety, durability, throttlability, and restart capabilities in a high-energy, cryogenic engine. The testbed selected for the deep throttling demonstration phases of this program was a minimally modified RL10 engine, allowing for maximum current production engine commonality and extensibility with minimum program cost. Two series of demonstrator engine tests, the first in April-May 2006 and the second in March-April 2007, have demonstrated in excess of 10:1 throttling of the hydrogen/oxygen expander cycle engine. Both test series have explored a combustion instability ("chug") environment at low throttled power levels. These tests have provided an early demonstration of an enabling cryogenic propulsion concept with invaluable system-level technology data acquisition toward design and development risk mitigation for future CECE Demonstrator engine tests.

Marine proteomics: a critical assessment of an emerging technology.

PubMed

Slattery, Marc; Ankisetty, Sridevi; Corrales, Jone; Marsh-Hunkin, K Erica; Gochfeld, Deborah J; Willett, Kristine L; Rimoldi, John M

2012-10-26

The application of proteomics to marine sciences has increased in recent years because the proteome represents the interface between genotypic and phenotypic variability and, thus, corresponds to the broadest possible biomarker for eco-physiological responses and adaptations. Likewise, proteomics can provide important functional information regarding biosynthetic pathways, as well as insights into mechanism of action, of novel marine natural products. The goal of this review is to (1) explore the application of proteomics methodologies to marine systems, (2) assess the technical approaches that have been used, and (3) evaluate the pros and cons of this proteomic research, with the intent of providing a critical analysis of its future roles in marine sciences. To date, proteomics techniques have been utilized to investigate marine microbe, plant, invertebrate, and vertebrate physiology, developmental biology, seafood safety, susceptibility to disease, and responses to environmental change. However, marine proteomics studies often suffer from poor experimental design, sample processing/optimization difficulties, and data analysis/interpretation issues. Moreover, a major limitation is the lack of available annotated genomes and proteomes for most marine organisms, including several "model species". Even with these challenges in mind, there is no doubt that marine proteomics is a rapidly expanding and powerful integrative molecular research tool from which our knowledge of the marine environment, and the natural products from this resource, will be significantly expanded.

A Novel Partially Covered Self-Expandable Metallic Stent with Proximal Flare in Patients with Malignant Gastric Outlet Obstruction.

PubMed

Takahara, Naminatsu; Isayama, Hiroyuki; Nakai, Yousuke; Yoshida, Shuntaro; Saito, Tomotaka; Mizuno, Suguru; Yagioka, Hiroshi; Kogure, Hirofumi; Togawa, Osamu; Matsubara, Saburo; Ito, Yukiko; Yamamoto, Natsuyo; Tada, Minoru; Koike, Kazuhiko

2017-07-15

Endoscopic placement of self-expandable metal stents (SEMSs) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although covered SEMSs can prevent tumor ingrowth, frequent migration of covered SEMSs may offset their advantages in preventing tumor ingrowth. We conducted this multicenter, single-arm, retrospective study at six tertiary referral centers to evaluate the safety and efficacy of a partially covered SEMS with an uncovered large-bore flare at the proximal end as an antimigration system in 41 patients with symptomatic malignant GOO. The primary outcome was clinical success, and the secondary outcomes were technical success, stent dysfunction, adverse events, and survival after stent placement. The technical and clinical success rates were 100% and 95%, respectively. Stent dysfunctions occurred in 17 patients (41%), including stent migration in nine (23%), tumor ingrowth in one (2%), and tumor overgrowth in four (10%). Two patients (5%) developed adverse events: one pancreatitis and one perforation. No procedure-related death was observed. A novel partially covered SEMS with a large-bore flare proximal end was safe and effective for malignant GOO but failed to prevent stent migration. Further research is warranted to develop a covered SEMS with an optimal antimigration system.

Spring-mediated distraction enterogenesis in-continuity.

PubMed

Huynh, Nhan; Rouch, Joshua D; Scott, Andrew; Chiang, Elvin; Wu, Benjamin M; Shekherdimian, Shant; Dunn, James C Y

2016-12-01

Distraction enterogenesis has been investigated as a novel treatment for patients with short bowel syndrome (SBS) but has been limited by loss of intestinal length during restoration and need for multiple bowel surgeries. The feasibility of in-continuity, spring-mediated intestinal lengthening has yet to be demonstrated. Juvenile mini-Yucatan pigs underwent in-continuity placement of polycaprolactone (PCL) degradable springs within jejunum. Methods used to anchor the spring ends to the intestine included full-thickness sutures and a high-friction surface spring. Spring constant (k) was 6-15N/m. Bowel was examined for length and presence of spring at 1 to 4weeks. Animals tolerated in-continuity lengthening without bowel obstruction for up to 29days. In-continuity jejunum with springs demonstrated intestinal lengthening by 1.47-fold ±0.11. Five springs had detached prematurely, and lengthening could not be assessed. Histologically, in-continuity jejunum showed significantly increased crypt depth and muscularis thickness in comparison to normal jejunum. Self-expanding endoluminal springs placed in continuity could lengthen intestine without obstruction in a porcine model. This is the first study showing safety and efficacy of a self-expanding endoluminal device for distraction enterogenesis. This is proof-of-concept that in-continuity spring lengthening is feasible and demonstrates its therapeutic potential in SBS. Level 3. Copyright © 2016 Elsevier Inc. All rights reserved.

Preoperative Embolization of Extra-axial Hypervascular Tumors with Onyx

PubMed Central

Fusco, Matthew R.; Salem, Mohamed M.; Reddy, Arra S.; Ogilvy, Christopher S.; Kasper, Ekkehard M.; Thomas, Ajith J.

2016-01-01

Objective Preoperative endovascular embolization of intracranial tumors is performed to mitigate anticipated intraoperative blood loss. Although the usage of a wide array of embolic agents, particularly polyvinyl alcohol (PVA), has been described for a variety of tumors, literature detailing the efficacy, safety and complication rates for the usage of Onyx is relatively sparse. Materials and Methods We reviewed our single institutional experience with pre-surgical Onyx embolization of extra-axial tumors to evaluate its efficacy and safety and highlight nuances of individualized cases. Results Five patients underwent pre-surgical Onyx embolization of large or giant extra-axial tumors within 24 hours of surgical resection. Four patients harbored falcine or convexity meningiomas (grade I in 2 patients, grade II in 1 patient and grade III in one patient), and one patient had a grade II hemangiopericytoma. Embolization proceeded uneventfully in all cases and there were no complications. Conclusion This series augments the expanding literature confirming the safety and efficacy of Onyx in the preoperative embolization of extra-axial tumors, underscoring its advantage of being able to attain extensive devascularization via only one supplying pedicle. PMID:27114961

Preoperative Embolization of Extra-axial Hypervascular Tumors with Onyx.

PubMed

Fusco, Matthew R; Salem, Mohamed M; Gross, Bradley A; Reddy, Arra S; Ogilvy, Christopher S; Kasper, Ekkehard M; Thomas, Ajith J

2016-03-01

Preoperative endovascular embolization of intracranial tumors is performed to mitigate anticipated intraoperative blood loss. Although the usage of a wide array of embolic agents, particularly polyvinyl alcohol (PVA), has been described for a variety of tumors, literature detailing the efficacy, safety and complication rates for the usage of Onyx is relatively sparse. We reviewed our single institutional experience with pre-surgical Onyx embolization of extra-axial tumors to evaluate its efficacy and safety and highlight nuances of individualized cases. Five patients underwent pre-surgical Onyx embolization of large or giant extra-axial tumors within 24 hours of surgical resection. Four patients harbored falcine or convexity meningiomas (grade I in 2 patients, grade II in 1 patient and grade III in one patient), and one patient had a grade II hemangiopericytoma. Embolization proceeded uneventfully in all cases and there were no complications. This series augments the expanding literature confirming the safety and efficacy of Onyx in the preoperative embolization of extra-axial tumors, underscoring its advantage of being able to attain extensive devascularization via only one supplying pedicle.

Safety assessment of Cracked K-joint Structure Based on Fracture Mechanics

NASA Astrophysics Data System (ADS)

Wang, Xin; Pengyu, Yan; Jianwei, Du; Fuhai, Cai

2017-05-01

The K-joint is the main bearing structure of lattice jib crane. During frequent operation of the crane, surface cracks often occur at its weld toe, and then continue to expand until failure. The safety of the weak structure K-joint of the crane jib can be evaluated by BS7910 failure assessment standard in order to improve its utilization. The finite element model of K-joint structure with cracks is established, and its mechanical properties is analyzed by ABAQUS software, the results show that the crack depth has a great influence on the bearing capacity of the structure compared with the crack length. It is assumed that the K-joint with the semi-elliptical surface crack under the action of the tension propagate stably under the condition that the c/a (ratio of short axis to long axis of ellipse) is about 0.3. The safety assessment of K-joint with different lengths crack is presented according to the 2A failure assessment diagram of BS7910, and the critical crack of K-joint under different loads can be obtained.

Novel approaches to the pharmacotherapy of obesity.

PubMed

Gouni-Berthold, Ioanna; Brüning, Jens C; Berthold, Heiner K

2013-01-01

Although the obesity epidemic is constantly expanding at very high costs for health care systems, the currently available options for the pharmacotherapy of obesity are very limited. This is not due to lack of interest or research on the subject but rather to the poor efficacy and/or safety profile of the majority of the antiobesity drugs developed up to now. Since the late fifties, various medications were brought to advanced states of clinical development but either never made it to the market or were initially approved only to be withdrawn some years later because of safety issues. However, our understanding of the pathophysiology of obesity has been steadily increasing and new, promising drugs targeting various selected obesity-associated and energy-homeostasis-related pathways are now under development. Nonetheless, obesity remains a disease mainly caused by an excess of caloric intake in relation to energy expenditure and on that basis, its treatment should be a healthy diet and physical activity. When these options alone are not sufficient, then additional pharmacotherapy with an acceptable efficacy and safety profile could provide a useful option.

Is it necessary to plan with safety margins for actively scanned proton therapy?

NASA Astrophysics Data System (ADS)

Albertini, F.; Hug, E. B.; Lomax, A. J.

2011-07-01

In radiation therapy, a plan is robust if the calculated and the delivered dose are in agreement, even in the case of different uncertainties. The current practice is to use safety margins, expanding the clinical target volume sufficiently enough to account for treatment uncertainties. This, however, might not be ideal for proton therapy and in particular when using intensity modulated proton therapy (IMPT) plans as degradation in the dose conformity could also be found in the middle of the target resulting from misalignments of highly in-field dose gradients. Single field uniform dose (SFUD) and IMPT plans have been calculated for different anatomical sites and the need for margins has been assessed by analyzing plan robustness to set-up and range uncertainties. We found that the use of safety margins is a good way to improve plan robustness for SFUD and IMPT plans with low in-field dose gradients but not necessarily for highly modulated IMPT plans for which only a marginal improvement in plan robustness could be detected through the definition of a planning target volume.

Monte Carlo capabilities of the SCALE code system

DOE PAGES

Rearden, Bradley T.; Petrie, Jr., Lester M.; Peplow, Douglas E.; ...

2014-09-12

SCALE is a broadly used suite of tools for nuclear systems modeling and simulation that provides comprehensive, verified and validated, user-friendly capabilities for criticality safety, reactor physics, radiation shielding, and sensitivity and uncertainty analysis. For more than 30 years, regulators, licensees, and research institutions around the world have used SCALE for nuclear safety analysis and design. SCALE provides a “plug-and-play” framework that includes three deterministic and three Monte Carlo radiation transport solvers that can be selected based on the desired solution, including hybrid deterministic/Monte Carlo simulations. SCALE includes the latest nuclear data libraries for continuous-energy and multigroup radiation transport asmore » well as activation, depletion, and decay calculations. SCALE’s graphical user interfaces assist with accurate system modeling, visualization, and convenient access to desired results. SCALE 6.2 will provide several new capabilities and significant improvements in many existing features, especially with expanded continuous-energy Monte Carlo capabilities for criticality safety, shielding, depletion, and sensitivity and uncertainty analysis. Finally, an overview of the Monte Carlo capabilities of SCALE is provided here, with emphasis on new features for SCALE 6.2.« less

The Tuscan Mobile Simulation Program: a description of a program for the delivery of in situ simulation training.

PubMed

Ullman, Edward; Kennedy, Maura; Di Delupis, Francesco Dojmi; Pisanelli, Paolo; Burbui, Andrea Giuliattini; Cussen, Meaghan; Galli, Laura; Pini, Riccardo; Gensini, Gian Franco

2016-09-01

Simulation has become a critical aspect of medical education. It allows health care providers the opportunity to focus on safety and high-risk situations in a protected environment. Recently, in situ simulation, which is performed in the actual clinical setting, has been used to recreate a more realistic work environment. This form of simulation allows for better team evaluation as the workers are in their traditional roles, and can reveal latent safety errors that often are not seen in typical simulation scenarios. We discuss the creation and implementation of a mobile in situ simulation program in emergency departments of three hospitals in Tuscany, Italy, including equipment, staffing, and start-up costs for this program. We also describe latent safety threats identified in the pilot in situ simulations. This novel approach has the potential to both reduce the costs of simulation compared to traditional simulation centers, and to expand medical simulation experiences to providers and healthcare organizations that do not have access to a large simulation center.

Calculation of Hazard Category 2/3 Threshold Quantities Using Contemporary Dosimetric Data

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

Walker, William C.

The purpose of this report is to describe the methodology and selection of input data utilized to calculate updated Hazard Category 2 and Hazard Category 3 Threshold Quantities (TQs) using contemporary dosimetric information. The calculation of the updated TQs will be considered for use in the revision to the Department of Energy (DOE) Technical Standard (STD-) 1027-92 Change Notice (CN)-1, “Hazard Categorization and Accident Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports.” The updated TQs documented in this report complement an effort previously undertaken by the National Nuclear Security Administration (NNSA), which in 2014 issued revisedmore » Supplemental Guidance documenting the calculation of updated TQs for approximately 100 radionuclides listed in DOE-STD-1027-92, CN-1. The calculations documented in this report complement the NNSA effort by expanding the set of radionuclides to more than 1,250 radionuclides with a published TQ. The development of this report was sponsored by the Department of Energy’s Office of Nuclear Safety (AU-30) within the Associate Under Secretary for Environment, Health, Safety, and Security organization.« less

Formal Methods Applications in Air Transportation

NASA Technical Reports Server (NTRS)

Farley, Todd

2009-01-01

The U.S. air transportation system is the most productive in the world, moving far more people and goods than any other. It is also the safest system in the world, thanks in part to its venerable air traffic control system. But as demand for air travel continues to grow, the air traffic control system s aging infrastructure and labor-intensive procedures are impinging on its ability to keep pace with demand. And that impinges on the growth of our economy. Air traffic control modernization has long held the promise of a more efficient air transportation system. Part of NASA s current mission is to develop advanced automation and operational concepts that will expand the capacity of our national airspace system while still maintaining its excellent record for safety. It is a challenging mission, as efforts to modernize have, for decades, been hamstrung by the inability to assure safety to the satisfaction of system operators, system regulators, and/or the traveling public. In this talk, we ll provide a brief history of air traffic control, focusing on the tension between efficiency and safety assurance, and the promise of formal methods going forward.

Effect of the Economic Recession on Primary Care Access for the Homeless.

PubMed

White, Brandi M; Jones, Walter J; Moran, William P; Simpson, Kit N

2016-01-01

Primary care access (PCA) for the homeless can prove challenging, especially during periods of economic distress. In the United States, the most recent recession may have presented additional barriers to accessing care. Limited safety-net resources traditionally used by the homeless may have also been used by the non-homeless, resulting in delays in seeking treatment for the homeless. Using hospitalizations for ambulatory care sensitivity (ACS) conditions as a proxy measure for PCA, this study investigated the recession's impact on PCA for the homeless and non-homeless in four states. The State Inpatient Databases were used to identify ACS admissions. Findings from this study indicate the recession was a barrier to PCA for homeless people who were uninsured. Ensuring that economically-disadvantaged populations have the ability to obtain insurance coverage is crucial to facilitating PCA. With targeted outreach efforts, the Affordable Care Act provides an opportunity for expanding coverage to the homeless.

Mobile Integrated Health Care and Community Paramedicine: An Emerging Emergency Medical Services Concept.

PubMed

Choi, Bryan Y; Blumberg, Charles; Williams, Kenneth

2016-03-01

Mobile integrated health care and community paramedicine are models of health care delivery that use emergency medical services (EMS) personnel to fill gaps in local health care infrastructure. Community paramedics may perform in an expanded role and require additional training in the management of chronic disease, communication skills, and cultural sensitivity, whereas other models use all levels of EMS personnel without additional training. Currently, there are few studies of the efficacy, safety, and cost-effectiveness of mobile integrated health care and community paramedicine programs. Observations from existing program data suggest that these systems may prevent congestive heart failure readmissions, reduce EMS frequent-user transports, and reduce emergency department visits. Additional studies are needed to support the clinical and economic benefit of mobile integrated health care and community paramedicine. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study.

PubMed

Kozlowski, Allan J; Fabian, Michelle; Lad, Dipan; Delgado, Andrew D

2017-07-01

To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS). Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. Outpatient MS clinic, tertiary care hospital. Participants (N=13; age range, 38-62y) were mostly women with Expanded Disability Status Scale scores ranging from 5.5 to 7.0. Exoskeleton-assisted walk training. Primary outcomes were accessibility (enrollment/screen pass), tolerability (completion/dropout), learnability (time to event for standing, walking, and sitting with little or no assistance), acceptability (satisfaction on the device subscale of the Quebec User Evaluation of Satisfaction with Assistive Technology version 2), and safety (event rates standardized to person-time exposure in the powered exoskeleton). Secondary outcomes were walking without the device (timed 25-foot walk test and 6-minute walk test distance), spasticity (Modified Ashworth Scale), and health-related quality of life (Patient-Reported Outcomes Measurement and Information System pain interference and Quality of Life in Neurological Conditions fatigue, sleep disturbance, depression, and positive affect and well-being). The device was accessible to 11 and tolerated by 5 participants. Learnability was moderate, with 5 to 15 sessions required to walk with minimal assistance. Safety was good; the highest adverse event rate was for skin issues at 151 per 1000 hours' exposure. Acceptability ranged from not very satisfied to very satisfied. Participants who walked routinely improved qualitatively on sitting, standing, or walking posture. Two participants improved and 2 worsened on ≥1 quality of life domain. The pattern of spasticity scores may indicate potential benefit. The device appeared feasible and safe for about a third of our sample, for whom routine exoskeleton-assisted walking may offer secondary benefits. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety.

PubMed

Seshia, Shashi S; Bryan Young, G; Makhinson, Michael; Smith, Preston A; Stobart, Kent; Croskerry, Pat

2018-02-01

Although patient safety has improved steadily, harm remains a substantial global challenge. Additionally, safety needs to be ensured not only in hospitals but also across the continuum of care. Better understanding of the complex cognitive factors influencing health care-related decisions and organizational cultures could lead to more rational approaches, and thereby to further improvement. A model integrating the concepts underlying Reason's Swiss cheese theory and the cognitive-affective biases plus cascade could advance the understanding of cognitive-affective processes that underlie decisions and organizational cultures across the continuum of care. Thematic analysis, qualitative information from several sources being used to support argumentation. Complex covert cognitive phenomena underlie decisions influencing health care. In the integrated model, the Swiss cheese slices represent dynamic cognitive-affective (mental) gates: Reason's successive layers of defence. Like firewalls and antivirus programs, cognitive-affective gates normally allow the passage of rational decisions but block or counter unsounds ones. Gates can be breached (ie, holes created) at one or more levels of organizations, teams, and individuals, by (1) any element of cognitive-affective biases plus (conflicts of interest and cognitive biases being the best studied) and (2) other potential error-provoking factors. Conversely, flawed decisions can be blocked and consequences minimized; for example, by addressing cognitive biases plus and error-provoking factors, and being constantly mindful. Informed shared decision making is a neglected but critical layer of defence (cognitive-affective gate). The integrated model can be custom tailored to specific situations, and the underlying principles applied to all methods for improving safety. The model may also provide a framework for developing and evaluating strategies to optimize organizational cultures and decisions. The concept is abstract, the model is virtual, and the best supportive evidence is qualitative and indirect. The proposed model may help enhance rational decision making across the continuum of care, thereby improving patient safety globally. © 2017 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety

PubMed Central

Bryan Young, G.; Makhinson, Michael; Smith, Preston A.; Stobart, Kent; Croskerry, Pat

2017-01-01

Abstract Introduction Although patient safety has improved steadily, harm remains a substantial global challenge. Additionally, safety needs to be ensured not only in hospitals but also across the continuum of care. Better understanding of the complex cognitive factors influencing health care–related decisions and organizational cultures could lead to more rational approaches, and thereby to further improvement. Hypothesis A model integrating the concepts underlying Reason's Swiss cheese theory and the cognitive‐affective biases plus cascade could advance the understanding of cognitive‐affective processes that underlie decisions and organizational cultures across the continuum of care. Methods Thematic analysis, qualitative information from several sources being used to support argumentation. Discussion Complex covert cognitive phenomena underlie decisions influencing health care. In the integrated model, the Swiss cheese slices represent dynamic cognitive‐affective (mental) gates: Reason's successive layers of defence. Like firewalls and antivirus programs, cognitive‐affective gates normally allow the passage of rational decisions but block or counter unsounds ones. Gates can be breached (ie, holes created) at one or more levels of organizations, teams, and individuals, by (1) any element of cognitive‐affective biases plus (conflicts of interest and cognitive biases being the best studied) and (2) other potential error‐provoking factors. Conversely, flawed decisions can be blocked and consequences minimized; for example, by addressing cognitive biases plus and error‐provoking factors, and being constantly mindful. Informed shared decision making is a neglected but critical layer of defence (cognitive‐affective gate). The integrated model can be custom tailored to specific situations, and the underlying principles applied to all methods for improving safety. The model may also provide a framework for developing and evaluating strategies to optimize organizational cultures and decisions. Limitations The concept is abstract, the model is virtual, and the best supportive evidence is qualitative and indirect. Conclusions The proposed model may help enhance rational decision making across the continuum of care, thereby improving patient safety globally. PMID:29168290

Defining Safety in the Nursing Home Setting: Implications for Future Research.

PubMed

Simmons, Sandra F; Schnelle, John F; Sathe, Nila A; Slagle, Jason M; Stevenson, David G; Carlo, Maria E; McPheeters, Melissa L

2016-06-01

Currently, the Agency for Healthcare Research and Quality (AHRQ) Common Format for nursing homes (NHs) accommodates voluntary reporting for 4 adverse events: falls with injury, pressure ulcers, medication errors, and infections. In 2015, AHRQ funded a technical brief to describe the state of the science related to safety in the NH setting to inform a research agenda. Thirty-six recent systematic reviews evaluated NH safety-related interventions to address these 4 adverse events and reported mostly mixed evidence about effective approaches to ameliorate them. Furthermore, these 4 events are likely inadequate to capture safety issues that are unique to the NH setting and encompass other domains related to residents' quality of care and quality of life. Future research needs include expanding our definition of safety in the NH setting, which differs considerably from that of hospitals, to include contributing factors to adverse events as well as more resident-centered care measures. Second, future research should reflect more rigorous implementation science to include objective measures of care processes related to adverse events, intervention fidelity, and staffing resources for intervention implementation to inform broader uptake of efficacious interventions. Weaknesses in implementation contribute to the current inconclusive and mixed evidence base as well as remaining questions about what outcomes are even achievable in the NH setting, given the complexity of most resident populations. Also related to implementation, future research should determine the effects of specific staffing models on care processes related to safety outcomes. Last, future efforts should explore the potential for safety issues in other care settings for older adults, most notably dementia care within assisted living. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.

Analysis of the medication-use process in North American hospital systems: underlining key points for adoption to improve patient safety in French hospitals.

PubMed

Brouard, Agnes; Fagon, Jean Yves; Daniels, Charles E

2011-01-01

This project was designed to underline any actions relative to medication error prevention and patient safety improvement setting up in North American hospitals which could be implemented in French Parisian hospitals. A literature research and analysis of medication-use process in the North American hospitals and a validation survey of hospital pharmacist managers in the San Diego area was performed to assess main points of hospital medication-use process. Literature analysis, survey analysis of respondents highlighted main differences between the two countries at three levels: nationwide, hospital level and pharmaceutical service level. According to this, proposal development to optimize medication-use process in the French system includes the following topics: implementation of an expanded use of information technology and robotics; increase pharmaceutical human resources allowing expansion of clinical pharmacy activities; focus on high-risk medications and high-risk patient populations; develop a collective sense of responsibility for medication error prevention in hospital settings, involving medical, pharmaceutical and administrative teams. Along with a strong emphasis that should be put on the identified topics to improve the quality and safety of hospital care in France, consideration of patient safety as a priority at a nationwide level needs to be reinforced.

Review article: the role of practice guidelines and evidence-based medicine in perioperative patient safety.

PubMed

Crosby, Edward

2013-02-01

The purpose of this narrative review is to discuss the impact of clinical practice guidelines on the outcomes of care and patient safety. The care provided to patients has a high degree of variability, including some care that is discordant with available evidence. This inconsistency has implications for patient safety as some patients receive care that is unlikely beneficial yet may be harmful, while others are denied care that would clearly be helpful. The medical literature is expanding at an alarming rate; its quality and reliability is often poor; study methodology is frequently suboptimal, and reversal is common, even among frequently cited articles. For decades, specialty societies and other agencies have been providing clinical practice guidelines to assist physicians with the integration of evidence into clinical decision-making. Implementation of guidelines has been variable, and their goals are often not achieved due to failed uptake and application. The reasons for this shortcoming are complex and some explanations are valid. Many guidelines have not been evidence-based and many have been methodologically unsound. Physician autonomy likely also plays an important role in guideline uptake; an updated concept of autonomy that embraces appropriate guidelines is long overdue. Under certain conditions, guidelines can add value to care and improve outcomes; they need to be evidence-based, methodologically sound, and appropriately applied to patients and clinical scenarios. Simply summarizing evidence in a guideline is an inadequate process. To achieve the benefit of guidelines, implementation strategies need to be robust.

Self-Expanding Metal Stents Improve Swallowing and Maintain Nutrition During Neoadjuvant Therapy for Esophageal Cancer.

PubMed

Smith, Zachary L; Gonzaga, Jason E; Haasler, George B; Gore, Elizabeth M; Dua, Kulwinder S

2017-06-01

Patients with locally advanced esophageal cancer can have significant dysphagia. Nutritional support during neoadjuvant therapy is often delivered via nasoenteric or percutaneous feeding tubes. These approaches do not allow for per-oral feeding. Evaluate the safety and efficacy of fully covered self-expanding metal esophageal stents for nutritional support during neoadjuvant therapy. This was a pilot, prospective study at a single tertiary center. From March 2012 to May 2013, consecutive patients with esophageal cancer eligible for neoadjuvant therapy were enrolled. Metal stents were placed prior to starting neoadjuvant therapy. Data were collected at baseline and predetermined intervals until an endpoint (surgery or disease progression). Outcomes included dysphagia grade, satisfaction of swallowing score, nutritional status (weight, serum albumin), impact on surgery, and adverse events. Fourteen stents were placed in 12 patients (59.1 ± 9.5 years, 11 men, 1 woman). Dysphagia grade (pre 3.4 ± 0.5 vs post 0.2 ± 0.4, p < 0.0001) and swallowing scores (20.2 ± 5.9 vs 6.3 ± 4.7, p < 0.0001) significantly improved after stent placement. Improvements were sustained throughout neoadjuvant therapy. Body weight and serum albumin levels remained stable. Adverse events included severe chest pain (2), food impaction (1), and delayed stent migration (2). Five patients underwent surgical resection. No significant chemoradiation or operative adverse events occurred due to the presence of a stent. During neoadjuvant therapy for esophageal cancer, self-expanding metal stents are safe and effective in relieving dysphagia and maintaining nutrition. They allow patients to eat orally, thereby improving patient satisfaction. The presence of an in situ stent did not interfere with surgery.

Creating a Connected Community: Lessons Learned from the Western New York Beacon Community

PubMed Central

Maloney, Nancy; Heider, Arvela R.; Rockwood, Amy; Singh, Ranjit

2014-01-01

Introduction: Secure exchange of clinical data among providers has the potential to improve quality, safety, efficiency, and reduce duplication. Many communities are experiencing challenges in building effective health information exchanges (HIEs). Previous studies have focused on financial and technical issues regarding HIE development. This paper describes the Western New York (WNY) HIE growth and lessons learned about accelerating progress to become a highly connected community. Methods: HEALTHeLINK, with funding from the Office of the National Coordinator for Health Information Technology (ONC) under the Beacon Community Program, expanded HIE usage in eight counties. The communitywide transformation process used three main drivers: (1) a communitywide Electronic Health Record (EHR) adoption program; (2) clinical transformation partners; and (3) HIE outreach and infrastructure development. Results: ONC Beacon Community funding allowed WNY to achieve a new level in the use of interoperable HIE. Electronic delivery of results into the EHR expanded from 23 practices in 2010 to 222 practices in 2013, a tenfold increase. There were more than 12.5 million results delivered electronically (HL7 messages) to 222 practices’ EHRs via the HIE in 2013. Use of a secure portal and Virtual Health Record (VHR) to access reports (those not delivered directly to the EHR) also increased significantly, from 13,344 report views in 2010 to over 600,000 in 2013. Discussion and Conclusion: The WNY Beacon successfully expanded the sharing of clinical information among different sources of data and providers, creating a highly connected community to improve the quality and continuity of care. Technical, organizational, and community lessons described in this paper should prove beneficial to others as they pursue efforts to create connected communities. PMID:25848618

Malignant esophageal-tracheobronchial strictures: parallel placement of covered retrievable expandable nitinol stents.

PubMed

Nam, D H; Shin, J H; Song, H Y; Jung, G S; Han, Y M

2006-02-01

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days). Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Trazodone for Insomnia: A Systematic Review

PubMed Central

Jaffer, Karim Yahia; Chang, Tiffany; Vanle, Brigitte; Dang, Jonathan; Steiner, Alexander J.; Loera, Natalie; Abdelmesseh, Marina; Danovitch, Itai

2017-01-01

OBJECTIVE: While trazodone is approved for the treatment of depression, the off-label use of this medication for insomnia has surpassed its usage as an antidepressant. In this systematic review, we examined the evidence for the efficacy and safety of trazodone for insomnia. METHODS: A literature search was conducted using MEDLINE/PubMed databases from the past 33 years (1983–2016) and the keywords insomnia, trazodone, sedative, treatment, and hypnotics. The results were restricted to English language and human subjects. All randomized clinical trials, meta-analyses, observational studies, and placebo-controlled trials regarding trazodone for the treatment of primary or secondary insomnia were reported, per PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The study selection process yielded a total of 45 studies. RESULTS: Evidence for the efficacy of trazodone has been repeatedly demonstrated for primary insomnia, as well as secondary insomnia, including for symptoms that are a result of depression, dementia, and being a healthy man. Earlier studies (1980–2000) focused on utilizing trazodone at high doses (≥100mg/d) for the treatment of insomnia among the depressed population; however, since the 2000s, the utility of trazodone has been expanded to treat secondary insomnia among the non-depressed population as well. The side effects are dose-dependent, and the most common is drowsiness. CONCLUSION: A review of the literature suggests that there are adequate data supporting the efficacy and general safety of the low-dose use of trazodone for the treatment of insomnia. PMID:29552421

A national portfolio of bone oncology trials—The Canadian experience in 2012

PubMed Central

Kuchuk, I.; Simos, D.; Addison, C.L.; Clemons, M.

2012-01-01

Background The impact of both cancer and its treatment on bone is an essential component of oncological practice. Bone oncology not only affects patients with both early stage and metastatic disease but also covers the entire spectrum of tumour types. We therefore decided to review and summarise bone oncology-related trials that are currently being conducted in Canada. Method We assessed ongoing and recently completed trials in Canada. We used available North American and Canadian cancer trial websites and also contacted known investigators in this field for their input. Results Twenty seven clinical trials were identified. Seven pertained to local treatment of bone metastasis from any solid tumour type. Seven were systemic treatment trials, five focused on bone biology and predictive factors, three evaluated safety of bone-targeted agents, three were adjuvant trials and two trials investigated impact of cancer therapy on bone health. The majority of trials were related to systemic treatment and bone biology in breast cancer. Most were small, single centre, grant-funded studies. Not surprisingly the larger safety and adjuvant studies were pharmaceutical company driven. Discussion Despite the widespread interest in bone-targeted therapies our survey would suggest that most studies are single centre and breast cancer focused. If major advances in bone oncology are to be made then collaborative strategies are needed to not only increase current sample sizes but to also expand these studies into non-breast cancer populations. PMID:26909263

Expanded Schools: Developing Mindsets to Support Academic Success. Research Brief

ERIC Educational Resources Information Center

ExpandED Schools, 2014

2014-01-01

The national demonstration of ExpandED Schools, The After-School Corporation's (TASC) expanded learning model, was launched in 2011-12 in New York City, Baltimore, and New Orleans. The ExpandED Schools demonstration is being evaluated by Policy Studies Associates (PSA) and is rolling out at a time when there is heightened awareness among…

Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Dossett, Michelle L; Mu, Lin; Davis, Roger B; Bell, Iris R; Lembo, Anthony J; Kaptchuk, Ted J; Yeh, Gloria Y

2015-01-01

It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD. 24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life. There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes. An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted. ClinicalTrials.gov NCT01915173.

Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study.

PubMed

Lauten, Alexander; Figulla, Hans R; Unbehaun, Axel; Fam, Neil; Schofer, Joachim; Doenst, Torsten; Hausleiter, Joerg; Franz, Marcus; Jung, Christian; Dreger, Henryk; Leistner, David; Alushi, Brunilda; Stundl, Anja; Landmesser, Ulf; Falk, Volkmar; Stangl, Karl; Laule, Michael

2018-02-01

Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days). Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach. © 2018 American Heart Association, Inc.

Safety of immunization injections in Africa: not simply a problem of logistics.

PubMed Central

Dicko, M.; Oni, A. Q.; Ganivet, S.; Kone, S.; Pierre, L.; Jacquet, B.

2000-01-01

In 1995, the WHO Regional Office for Africa launched a logistics project to address the four main areas of immunization logistics: the cold chain, transport, vaccine supply and quality, and the safety of injections in the countries of the region. The impact of this logistic approach on immunization injection safety was evaluated through surveys of injection procedures and an analysis of the injection materials (e.g. sterilizable or disposable syringes) chosen by the Expanded Programme on Immunization (EPI) and those actually seen to be used. Re-use of injection materials without sterilization, accidental needle-stick injuries among health care workers, and injection-related abscesses in patients were common in countries in the WHO African Region. Few health centres used time-steam saturation-temperature (TST) indicators to check the quality of sterilization and, in many centres, the injection equipment was boiled instead of being steam sterilized. Facilities for the proper disposal of used materials were rarely present. Although the official EPI choice was to use sterilizable equipment, use of a combination of sterilizable and disposable equipment was observed in the field. Unsafe injection practices in these countries were generally due to a failure to integrate nursing practices and public awareness with injection safety issues, and an absence of the influence of EPI managers on health care service delivery. Holistic rather than logistic approaches should be adopted to achieve safe injections in immunization, in the broader context of promoting safe vaccines and safety of all injections. PMID:10743280

The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

The extent of community and public support available to families caring for orphans in Malawi.

PubMed

Kidman, Rachel; Heymann, S Jody

2009-04-01

There are an estimated 15 million AIDS orphans worldwide. Families play an important role in safeguarding orphans, but they may be increasingly compromised by the HIV/AIDS epidemic. The international aid community has recognized the need to help families continue caring for orphaned children by strengthening their safety nets. Before we build new structures, however, we need to know the extent to which community and public safety nets already provide support to families with orphans. To address this gap, we analyzed nationally representative data from 27,495 children in the 2004-2005 Malawi Integrated Household Survey. We found that communities commonly assisted orphan households through private transfers; organized responses to the orphan crisis were far less frequent. Friends and relatives provided assistance to over 75% of orphan households through private gifts, but the value of such support was relatively low. Over 40% of orphans lived in a community with support groups for the chronically ill and approximately a third of these communities provided services specifically for orphans and other vulnerable children. Public programs, which form a final safety net for vulnerable households, were more widespread. Free/subsidized agricultural inputs and food were the most commonly used public safety nets by children's households in the past year (44 and 13%, respectively), and households with orphans were more likely to be beneficiaries. Malawi is poised to drastically expand safety nets to orphans and their families, and these findings provide an important foundation for this process.

Safety and Feasibility of a Ketamine Package to Support Emergency and Essential Surgery in Kenya when No Anesthetist is Available: An Analysis of 1216 Consecutive Operative Procedures.

PubMed

Burke, Thomas F; Suarez, Sebastian; Sessler, Daniel I; Senay, Ayla; Yusufali, Taha; Masaki, Charles; Guha, Moytrayee; Rogo, Debora; Jani, Pankaj; Nelson, Brett D; Rogo, Khama

2017-12-01

Lack of access to emergency and essential surgery is widespread in low- and middle-income countries. Scarce anesthesia services contribute to this unmet need. The aim of this study was to evaluate the safety and feasibility of the Every Second Matters for Emergency and Essential Surgery-Ketamine (ESM-Ketamine) package for emergency and essential procedures when no anesthetist was available. From November 2013 to September 2017, the ESM-Ketamine package was used for patients requiring emergency or life-improving surgeries in fifteen selected facilities across Kenya when no anesthetist was available. A mixed-methods approach was used to assess safety and feasibility of the ESM-Ketamine package, including demand, acceptability, and practicality. The primary outcome was ketamine-related adverse events. Key-informant interviews captured perceptions of providers, hospital administrators, and surgeons/proceduralists. Non-anesthetist mid-level providers used ESM-Ketamine for 1216 surgical procedures across the fifteen study facilities. The median ketamine dose was 2.1 mg/kg. Brief (<30 s) oxygen desaturations occurred in 39 patients (3%), and prolonged (>30 s) oxygen desaturations occurred in seven patients (0.6%). There were 157 (13%) reported cases of hallucinations and agitation which were treated with diazepam. All patients recovered uneventfully, and no ketamine-related deaths were reported. Twenty-seven key-informant interviews showed strong support for the program with four main themes: financial considerations, provision of services, staff impact, and scaling considerations. The ESM-Ketamine package appears safe and feasible and is capable of expanding access to emergency and essential surgeries in rural Kenya when no anesthetist is available.

Perceived medical benefit, peer/partner influence and safety and cost to access the service: client motivators for voluntary seeking of medical male circumcision in Iganga district eastern Uganda, a qualitative study.

PubMed

Muhamadi, Lubega; Ibrahim, Musenze; Wabwire-Mangen, Fred; Peterson, Stefan; Reynolds, Steven J

2013-01-01

Although voluntary medical male circumcision (VMMC) in Iganga district was launched in 2010 as part of the Uganda national strategy to prevent new HIV infections with a target of having 129,896 eligible males circumcised by 2012, only 35,000 (27%) of the anticipated target had been circumcised by mid 2012. There was paucity of information on why uptake of VMMC was low in this setting where HIV awareness is presumably high. This study sought to understand motivators for uptake of VMMC from the perspective of the clients themselves in order to advocate for feasible approaches to expanding uptake of VMMC in Iganga district and similar settings. In Iganga district, we conducted seven key informant interviews with staff who work in the VMMC clinics and twenty in-depth interviews with clients who had accepted and undergone VMMC. Ten focus-group discussions including a total of 112 participants were also conducted with clients who had undergone VMMC. Motivators for uptake of VMMC in the perspective of the circumcised clients and the health care staff included: perceived medical benefit to those circumcised such as protection against acquiring HIV and other sexually transmitted diseases, peer/partner influence, sexual satisfaction and safety and cost to access the service. Since perceived medical benefit was a motivator for seeking VMMC, it can be used to strengthen campaigns for increasing uptake of VMMC. Peer influence could also be used in advocacy campaigns for VMMC expansion, especially using peers who have already undergone VMMC. There is need to ensure that safety and cost to access the service is affordable especially to rural poor as it was mentioned as a motivator for seeking VMMC.

Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

PubMed

Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

2017-10-01

Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.