A challenge-response endoscopic sinus surgery specific checklist as an add-on to standard surgical checklist: an evaluation of potential safety and quality improvement issues.

PubMed

Sommer, Doron D; Arbab-Tafti, Sadaf; Farrokhyar, Forough; Tewfik, Marc; Vescan, Allan; Witterick, Ian J; Rotenberg, Brian; Chandra, Rakesh; Weitzel, Erik K; Wright, Erin; Ramakrishna, Jayant

2018-02-27

The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery-specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery. This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method. Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%). The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting. © 2018 ARS-AAOA, LLC.

Qualitative Future Safety Risk Identification an Update

NASA Technical Reports Server (NTRS)

Barr, Lawrence C.

2017-01-01

The purpose of this report is to document the results of a high-level qualitative study that was conducted to identify future aviation safety risks and to assess the potential impacts to the National Airspace System (NAS) of NASA Aviation Safety research on these risks. Multiple external sources (for example, the National Transportation Safety Board, the Flight Safety Foundation, the National Research Council, and the Joint Planning and Development Office) were used to develop a compilation of future safety issues risks, also referred to as future tall poles. The primary criterion used to identify the most critical future safety risk issues was that the issue must be cited in several of these sources as a safety area of concern. The tall poles in future safety risk, in no particular order of importance, are as follows: Runway Safety, Loss of Control In Flight, Icing Ice Detection, Loss of Separation, Near Midair Collision Human Fatigue, Increasing Complexity and Reliance on Automation, Vulnerability Discovery, Data Sharing and Dissemination, and Enhanced Survivability in the Event of an Accident.

U.S. Food System Working Conditions as an Issue of Food Safety.

PubMed

Clayton, Megan L; Smith, Katherine C; Pollack, Keshia M; Neff, Roni A; Rutkow, Lainie

2017-02-01

Food workers' health and hygiene are common pathways to foodborne disease outbreaks. Improving food system jobs is important to food safety because working conditions impact workers' health, hygiene, and safe food handling. Stakeholders from key industries have advanced working conditions as an issue of public safety in the United States. Yet, for the food industry, stakeholder engagement with this topic is seemingly limited. To understand this lack of action, we interviewed key informants from organizations recognized for their agenda-setting role on food-worker issues. Findings suggest that participants recognize the work standards/food safety connection, yet perceived barriers limit adoption of a food safety frame, including more pressing priorities (e.g., occupational safety); poor fit with organizational strategies and mission; and questionable utility, including potential negative consequences. Using these findings, we consider how public health advocates may connect food working conditions to food and public safety and elevate it to the public policy agenda.

Road safety issues for bus transport management.

PubMed

Cafiso, Salvatore; Di Graziano, Alessandro; Pappalardo, Giuseppina

2013-11-01

Because of the low percentage of crashes involving buses and the assumption that public transport improves road safety by reducing vehicular traffic, public interest in bus safety is not as great as that in the safety of other types of vehicles. It is possible that less attention is paid to the significance of crashes involving buses because the safety level of bus systems is considered to be adequate. The purpose of this study was to evaluate the knowledge and perceptions of bus managers with respect to safety issues and the potential effectiveness of various technologies in achieving higher safety standards. Bus managers were asked to give their opinions on safety issues related to drivers (training, skills, performance evaluation and behaviour), vehicles (maintenance and advanced devices) and roads (road and traffic safety issues) in response to a research survey. Kendall's algorithm was used to evaluate the level of concordance. The results showed that the majority of the proposed items were considered to have great potential for improving bus safety. The data indicated that in the experience of the participants, passenger unloading and pedestrians crossing near bus stops are the most dangerous actions with respect to vulnerable users. The final results of the investigation showed that start inhibition, automatic door opening, and the materials and internal architecture of buses were considered the items most strongly related to bus passenger safety. Brake assistance and vehicle monitoring systems were also considered to be very effective. With the exception of driver assistance systems for passenger and pedestrian safety, the perceptions of the importance of other driver assistance systems for vehicle monitoring and bus safety were not unanimous among the bus company managers who participated in this survey. The study results showed that the introduction of new technologies is perceived as an important factor in improving bus safety, but a better understanding of their actual effectiveness and related risk factor avoidance must be developed to permit their useful implementation in bus fleets. Copyright © 2013 Elsevier Ltd. All rights reserved.

Assessment of environmental health and safety issues associated with the commercialization of unconventional gas recovery: methane from coal seams

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

Ethridge, L.J.; Cowan, C.E.; Riedel, E.F.

1980-07-01

Potential public health and safety problems and the potential environmental impacts from the recovery of gas from coalbeds are identified and examined. The technology of methane recovery is described and economic and legal barriers to production are discussed. (ACR)

Safety Issues in Agricultural Education Laboratories: A Synthesis of Research.

ERIC Educational Resources Information Center

Dyer, James E.; Andreasen, Randall J.

1999-01-01

Synthesis of research on safety in agricultural education laboratories found most research focused on agricultural mechanics. Labs appeared to be potentially hazardous places, and teachers have inadequate knowledge of safety laws and ways to provide a safe working environment. (SK)

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation challenges and user experiences of telecare with the help of a human factors systems approach to patient safety.

A safety assessment of biological therapies targeting the IL-23/IL-17 axis in inflammatory bowel diseases.

PubMed

Verstockt, Bram; Deleenheer, Barbara; Van Assche, Gert; Vermeire, Séverine; Ferrante, Marc

2017-07-01

Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab. Firstly, the authors discuss briefly how genetics can inform about potential safety issues. Secondly, they extensively describe safety issues (common adverse events, infections, malignancies…), immunogenicity, exposure to ustekinumab in specific populations and provide advice for vaccination. Finally, they address safety profiles of secukinumab and other biological targeting the IL-23/17 axis in IBD. Expert opinion: Current evidence suggests that ustekinumab therapy overweigh the potential drug-related risks. Additional safety data beyond randomized-controlled trials, derived from statistically powered, large prospective studies with long-term follow-up are urgently needed to assess the real-life ustekinumab-related risks and to establish the correct position of these novel class of biologicals in IBD treatment. Combining immunomodulators with ustekinumab seems to be safe, though prospective data specifically addressing this topic are currently missing. Similarly, the combination of different biological therapies still has to be studied.

Evaluation of work zone safety operations and issues.

DOT National Transportation Integrated Search

2006-03-01

Work zone activities are one of the areas with a high potential for compromised safety for workers and road users. Various measures have been taken to increase the level of safety in work zones; including the use of double fines for speeding and the ...

Non-Use of Motor Vehicle Safety Belts as an Issue in Civil Litigation

DOT National Transportation Integrated Search

1983-08-01

The current and potential role of the "safety belt defense" in civil litigation is studied. The paper presents an overview of the safety belt defense, including an evaluation of current precedent. Based on interviews with leading motor vehicle civil ...

Sociotechnical approaches to workplace safety: Research needs and opportunities.

PubMed

Robertson, Michelle M; Hettinger, Lawrence J; Waterson, Patrick E; Noy, Y Ian; Dainoff, Marvin J; Leveson, Nancy G; Carayon, Pascale; Courtney, Theodore K

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety.

Student and Faculty Issues in Distance Education.

ERIC Educational Resources Information Center

Fender, David L.

Occupational safety and health faculty and occupational safety and health professionals (i.e., the potential audience for graduate level distance education programs) were surveyed to determine the considerations for a distance education-based graduate occupational safety and health program. Findings are reported related to the demand for distance…

Ethical and Safety Issues of Stem Cell-Based Therapy.

PubMed

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

Ethical and Safety Issues of Stem Cell-Based Therapy

PubMed Central

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells. PMID:29333086

Contribution of ITS to rural safety : a look at crashes in Washington state

DOT National Transportation Integrated Search

1999-01-01

Increasingly, transportation professionals are using technology, known as Intelligent Transportation Systems (ITS), to address transportation problems. This paper investigates the potential applications of ITS to safety issues on rural roadways in Wa...

NATIONAL RESPONSE TEAM TECHNICAL ASSISTANCE ...

EPA Pesticide Factsheets

This document provides technical information on a wide range of activities to aid in response to intentional release of anthrax in urban environments. It includes initial actions when a potential release is discovered, health and safety issues for responders, sampling and analysis methods, decontamination technologies, decontamination waste disposal, and communication with public. This document provides technical information on a wide range of activities to aid in response to intentional release of anthrax in urban environments. It includes initial actions when a potential release is discovered, health and safety issues for responders, sampling and analysis methods, decontamination technologies, decontamination waste disposal, and communication with public.

Post-approval safety issues with innovative drugs: a European cohort study.

PubMed

Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M

2013-11-01

At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having a first serious safety issue was statistically significant, log-rank (Mantel-Cox) p = 0.036. In the final adjusted Cox proportional hazard model there was no statistically significant difference in occurrence of a first serious safety issue for important, moderate and modest innovations versus non-innovative drugs; hazard ratios 1.76 (95 % CI 0.82-3.77), 1.61 (95 % CI 0.76-3.41)], and 1.25 (95 % CI 0.51-3.06), respectively. A higher level of innovation was not clearly related to an increased risk of serious safety issues identified after approval.

Support from Afar: Using Chemical Safety Information on the Internet.

ERIC Educational Resources Information Center

Stuart, Ralph

One of the major challenges facing people committed to Teaching Safety in High Schools, Colleges, and Universities is keeping up with both the wide range of relevant technical information about potential hazards (ranging from fire protection to chemical hazards to biological issues) and the ever-changing world of safety regulations and standards.…

Analysis of safety reports involving area navigation and required navigation performance procedures.

DOT National Transportation Integrated Search

2010-11-03

In order to achieve potential operational and safety benefits enabled by Area Navigation (RNAV) and Required Navigation Performance (RNP) procedures it is important to monitor emerging issues in their initial implementation. Reports from the Aviation...

Signal phase and timing (SPaT) applications, communications requirements, communications technology potential solutions, issues and recommendations.

DOT National Transportation Integrated Search

2012-04-01

This report addresses communications to support safety applications specifically aimed at improving safety for mobile entities (vehicles, pedestrians, bicycles etc.) at signalized intersections. Collectively these applications are referred to as Sign...

The Environmental Health/Home Safety Education Project: a successful and practical U.S.-Mexico border initiative.

PubMed

Forster-Cox, Susan C; Mangadu, Thenral; Jacquez, Benjamín; Fullerton, Lynne

2010-05-01

The Environmental Health/Home Safety Education Project (Proyecto de Salud Ambiental y Seguridad en el Hogar) has been developed in response to a wide array of severe and often preventable environmental health issues occurring in and around homes on the U.S.-Mexico border. Utilizing well-trained community members, called promotoras , homes are visited and assessed for potential environmental hazards, including home fire and food safety issues. Data analyzed from project years 2002 to 2005 shows a significant impact in knowledge levels and initial behavior change among targeted participants as it relates to fire and food safety issues. Since the initiation of the project in 1999, hundreds of participants have improved their quality of life by making their homes safer. The project has proven to be sustainable, replicable, flexible, and attractive to funders.

Sociotechnical approaches to workplace safety: Research needs and opportunities

PubMed Central

Robertson, Michelle M.; Hettinger, Lawrence J.; Waterson, Patrick E.; Ian Noy, Y.; Dainoff, Marvin J.; Leveson, Nancy G.; Carayon, Pascale; Courtney, Theodore K.

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Practitioner Summary: Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety. PMID:25728246

Environmental, health, and safety issues of sodium-sulfur batteries for electric and hybrid vehicles. Volume 1, Cell and battery safety

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

Ohi, J M

1992-09-01

This report is the first of four volumes that identify and assess the environmental, health, and safety issues involved in using sodium-sulfur (Na/S) battery technology as the energy source in electric and hybrid vehicles that may affect the commercialization of Na/S batteries. This and the other reports on recycling, shipping, and vehicle safety are intended to help the Electric and Hybrid Propulsion Division of the Office of Transportation Technologies in the US Department of Energy (DOE/EHP) determine the direction of its research, development, and demonstration (RD&D) program for Na/S battery technology. The reports review the status of Na/S battery RD&Dmore » and identify potential hazards and risks that may require additional research or that may affect the design and use of Na/S batteries. This volume covers cell design and engineering as the basis of safety for Na/S batteries and describes and assesses the potential chemical, electrical, and thermal hazards and risks of Na/S cells and batteries as well as the RD&D performed, under way, or to address these hazards and risks. The report is based on a review of the literature and on discussions with experts at DOE, national laboratories and agencies, universities, and private industry. Subsequent volumes will address environmental, health, and safety issues involved in shipping cells and batteries, using batteries to propel electric vehicles, and recycling and disposing of spent batteries. The remainder of this volume is divided into two major sections on safety at the cell and battery levels. The section on Na/S cells describes major component and potential failure modes, design, life testing and failure testing, thermal cycling, and the safety status of Na/S cells. The section on batteries describes battery design, testing, and safety status. Additional EH&S information on Na/S batteries is provided in the appendices.« less

Identification of priorities for medication safety in neonatal intensive care.

PubMed

Kunac, Desireé L; Reith, David M

2005-01-01

Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.

Structured inspection of medications carried and stored by emergency medical services agencies identifies practices that may lead to medication errors.

PubMed

Kupas, Douglas F; Shayhorn, Meghan A; Green, Paul; Payton, Thomas F

2012-01-01

Medications are essential to emergency medical services (EMS) agencies when providing lifesaving care, but the EMS environment has challenges related to safe medication storage when compared with a hospital setting. We developed a structured process, based on common pharmacy practices, to review medications carried by EMS agencies to identify situations that may lead to medication error and to determine some best practices that may reduce potential errors and the risk of patient harm. To provide a descriptive account of EMS practices related to carrying and storing medications that have the potential for causing a medication administration error or patient harm. Using a structured process for inspection, an emergency medicine pharmacist and emergency physician(s) reviewed the medication carrying and storage practices of all nine advanced life support ambulance agencies within a five-county EMS region. Each medication carried and stored by the EMS agency was inspected for predetermined and spontaneously observed issues that could lead to medication error. These issues were documented and photographed. Two EMS medical directors reviewed each potential error for the risk of producing patient harm and assigned each to a category of high, moderate, or low risk. Because issues of temperature on EMS medications have been addressed elsewhere, this study concentrated on potential for EMS medication administration errors exclusive of storage temperatures. When reviewing medications carried by the nine EMS agencies, 38 medication safety issues were identified (range 1 to 8 per EMS agency). Of these, 16 were considered to be high risk, 14 moderate risk, and eight low risk for patient harm. Examples of potential issues included carrying expired medications, container-labeling issues, different medications stored in look-alike vials or prefilled syringes in the same compartment, and carrying crystalloid solutions next to solutions premixed with a medication. When reviewing medications stored at the EMS agency stations, eight safety issues were identified (range from 0 to 4 per station), including five moderate-risk and three low-risk issues. No agency had any high-risk medication issues related to storage of medication stock in the station. We observed potential medication safety issues related to how medications are carried and stored at all nine EMS agencies in a five-county region. Understanding these issues may assist EMS agencies in reducing the potential for a medication error and risk of patient harm. More research is needed to determine whether following these suggested best practices for carrying medications on EMS vehicles actually reduces errors in medication administration by EMS providers or decreases patient harm.

Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

PubMed

Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

2013-12-01

In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is recommended.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

Bridging the Divide between Safety and Risk Management for your Project or Program

NASA Technical Reports Server (NTRS)

Lutomski, Mike

2005-01-01

This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

Safety Precautions in Fiber Arts.

ERIC Educational Resources Information Center

Hamilton, Marcia

1979-01-01

The author discusses the potential hazards of working with fibers, dyes, and wax in textile art projects: bacteria, dust, poisons, allergies, and fumes. Safety precautions for working with dyes are listed. This article is one of seven in this issue on fiber arts. (SJL)

77 FR 39408 - Safety Zone; Buffalo July 4th Fireworks, Lake Erie, Buffalo, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities The... the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies...

77 FR 39406 - Safety Zone; Tom Graves Memorial Fireworks, Port Bay, Wolcott, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities The... the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies...

The Use of Safety Plans with Children and Adolescents Living in Violent Families

ERIC Educational Resources Information Center

Kress, Victoria E.; Adamson, Nicole A.; Paylo, Matthew J.; DeMarco, Carrie; Bradley, Nicole

2012-01-01

Counselors are regularly confronted with children and adolescents who reside in violent or potentially violent living environments. In this article, safety plans are presented as a tool that counselors can use to promote the safety of children living in unsafe family situations. Ethics-related counseling issues that should be considered when…

The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety

PubMed Central

Ekor, Martins

2014-01-01

The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety. PMID:24454289

Gender differences and demographic influences in perceived concern for driver safety and support for impaired driving countermeasures.

PubMed

Butters, Jennifer; Mann, Robert E; Wickens, Christine M; Boase, Paul

2012-12-01

Driving safety, impaired driving, and legislation to address these concerns remain important issues. It is imperative countermeasures be targeted toward the most appropriate groups. This paper explores the potential relationship between gender and driving attitudes toward safety issues and impaired-driving countermeasures. The data are from the 2007 Impaired Driving Survey commissioned by Transport Canada and Mothers Against Drunk Driving (MADD) Canada. The survey is a, stratified by region, telephone survey of 1,514 Canadian drivers 18years of age and older with a valid driver's license who had driven within the past 30days. The findings illustrate a consistent impact of gender on these issues. Other variables were also identified as relevant factors although less consistently. Current findings suggest that strategies for building support for interventions, or for changing risk perception/concern for risky driving behaviors should be tailored by gender to maximize the potential for behavior change. This information may assist program and policy developers through the identification of more or less receptive target groups. Future research directions are also presented. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-01-01

Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

46 CFR 162.060-24 - Test Plan requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (including the test facility's standard operating procedures for achieving such conditions). (9) Sampling.... Test Plans must include an examination of all the manufacturer's stated requirements and procedures for... potential environmental, health, and safety issues; unusual operating requirements; and any issues related...

46 CFR 162.060-24 - Test Plan requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (including the test facility's standard operating procedures for achieving such conditions). (9) Sampling.... Test Plans must include an examination of all the manufacturer's stated requirements and procedures for... potential environmental, health, and safety issues; unusual operating requirements; and any issues related...

46 CFR 162.060-24 - Test Plan requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (including the test facility's standard operating procedures for achieving such conditions). (9) Sampling.... Test Plans must include an examination of all the manufacturer's stated requirements and procedures for... potential environmental, health, and safety issues; unusual operating requirements; and any issues related...

Potential safety issues and other factors that may affect the introduction and uptake of rotavirus vaccines

PubMed Central

Aliabadi, N.; Tate, J.E.; Parashar, U.D.

2018-01-01

Rotavirus vaccines have demonstrated significant impact in reducing the burden of morbidity and mortality from childhood diarrhoea in countries that have implemented routine vaccination to date. Despite this success, in many countries, rotavirus vaccine coverage remains lower than that of other routine childhood vaccines. Several issues may potentially affect vaccine uptake, namely safety concerns related to intussusception with consequent age restrictions on rotavirus vaccination, contamination with porcine circovirus, vaccine-derived reassortant strains and hospitalization in newborn nurseries at time of administration of live oral rotavirus vaccine. In addition to these safety concerns, other factors may also affect uptake, including lower vaccine efficacy in the developing world, potential emergence of strains escaping from vaccine protection resulting in lower overall impact of a vaccination programme and sustainable vaccine financing. Although further work is needed to address some of these concerns, global policy bodies have reaffirmed that the benefits of rotavirus vaccination outweigh the risks, and vaccine use is recommended globally. PMID:27129416

Potential safety issues and other factors that may affect the introduction and uptake of rotavirus vaccines.

PubMed

Aliabadi, N; Tate, J E; Parashar, U D

2016-12-01

Rotavirus vaccines have demonstrated significant impact in reducing the burden of morbidity and mortality from childhood diarrhoea in countries that have implemented routine vaccination to date. Despite this success, in many countries, rotavirus vaccine coverage remains lower than that of other routine childhood vaccines. Several issues may potentially affect vaccine uptake, namely safety concerns related to intussusception with consequent age restrictions on rotavirus vaccination, contamination with porcine circovirus, vaccine-derived reassortant strains and hospitalization in newborn nurseries at time of administration of live oral rotavirus vaccine. In addition to these safety concerns, other factors may also affect uptake, including lower vaccine efficacy in the developing world, potential emergence of strains escaping from vaccine protection resulting in lower overall impact of a vaccination programme and sustainable vaccine financing. Although further work is needed to address some of these concerns, global policy bodies have reaffirmed that the benefits of rotavirus vaccination outweigh the risks, and vaccine use is recommended globally. Published by Elsevier Ltd.

EFFECTIVENESS AND SAFETY OF STRATEGIES FOR OIL SPILL BIOREMEDIATION: POTENTIAL AND LIMITATION, LABORATORY TO FIELD (RESEARCH BRIEF)

EPA Science Inventory

Several important additional research efforts were identified during the development of test systems and protocols for assessing the effectiveness and environmental safety of oil spill commercial bioremediation agents (CBAs). Research that examined CBA efficacy issues included: (...

48 CFR 252.246-7003 - Notification of Potential Safety Issues.

Code of Federal Regulations, 2013 CFR

2013-10-01

.... Critical safety item means a part, subassembly, assembly, subsystem, installation equipment, or support... impact for systems, or subsystems, assemblies, subassemblies, or parts integral to a system, acquired by... the extent known at the time of notification; (iv) A point of contact to coordinate problem analysis...

48 CFR 252.246-7003 - Notification of Potential Safety Issues.

Code of Federal Regulations, 2010 CFR

2010-10-01

.... Critical safety item means a part, subassembly, assembly, subsystem, installation equipment, or support... impact for systems, or subsystems, assemblies, subassemblies, or parts integral to a system, acquired by... the extent known at the time of notification; (iv) A point of contact to coordinate problem analysis...

48 CFR 252.246-7003 - Notification of Potential Safety Issues.

Code of Federal Regulations, 2011 CFR

2011-10-01

.... Critical safety item means a part, subassembly, assembly, subsystem, installation equipment, or support... impact for systems, or subsystems, assemblies, subassemblies, or parts integral to a system, acquired by... the extent known at the time of notification; (iv) A point of contact to coordinate problem analysis...

48 CFR 252.246-7003 - Notification of Potential Safety Issues.

Code of Federal Regulations, 2012 CFR

2012-10-01

.... Critical safety item means a part, subassembly, assembly, subsystem, installation equipment, or support... impact for systems, or subsystems, assemblies, subassemblies, or parts integral to a system, acquired by... the extent known at the time of notification; (iv) A point of contact to coordinate problem analysis...

48 CFR 252.246-7003 - Notification of Potential Safety Issues.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... Critical safety item means a part, subassembly, assembly, subsystem, installation equipment, or support... impact for systems, or subsystems, assemblies, subassemblies, or parts integral to a system, acquired by... the extent known at the time of notification; (iv) A point of contact to coordinate problem analysis...

The Impact of Terrorism on School Safety Planning.

ERIC Educational Resources Information Center

Trump, Kenneth S.

2002-01-01

Discusses why history and "thinking outside of the box" should encourage schools to acknowledge that they are potentially vulnerable targets of terrorism. Presents new safety and security issues raised by the threat of terrorism, including anthrax scares, cell phone use, and field trips. Describes "heightened security"…

[Topics from "Overseas Drug Safety Information" in the past five years].

PubMed

Amanuma, Kimiko

2013-01-01

The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

COLD-SAT feasibility study safety analysis

NASA Technical Reports Server (NTRS)

Mchenry, Steven T.; Yost, James M.

1991-01-01

The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

Experimental Study and Computational Simulations of Key Pebble Bed Thermo-mechanics Issues for Design and Safety

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

Tokuhiro, Akira; Potirniche, Gabriel; Cogliati, Joshua

2014-07-08

An experimental and computational study, consisting of modeling and simulation (M&S), of key thermal-mechanical issues affecting the design and safety of pebble-bed (PB) reactors was conducted. The objective was to broaden understanding and experimentally validate thermal-mechanic phenomena of nuclear grade graphite, specifically, spheres in frictional contact as anticipated in the bed under reactor relevant pressures and temperatures. The contact generates graphite dust particulates that can subsequently be transported into the flowing gaseous coolent. Under postulated depressurization transients and with the potential for leaked fission products to be adsorbed onto graphite 'dust', there is the potential for fission products to escapemore » from the primary volume. This is a design safety concern. Furthermore, earlier safety assessment identified the distinct possibility for the dispersed dust to combust in contact with air if sufficient conditions are met. Both of these phenomena were noted as important to design review and containing uncertainty to warrant study. The team designed and conducted two separate effects tests to study and benchmark the potential dust-generation rate, as well as study the conditions under which a dust explosion may occure in a standardized, instrumented explosion chamber.« less

Point-of-Care Detection Devices for Food Safety Monitoring: Proactive Disease Prevention.

PubMed

Wu, Marie Yung-Chen; Hsu, Min-Yen; Chen, Shih-Jen; Hwang, De-Kuang; Yen, Tzung-Hai; Cheng, Chao-Min

2017-04-01

Food safety has become an increasingly significant public concern in both developed and under-developed nations around the world; it increases morbidity, mortality, human suffering, and economic burden. This Opinion focuses on (i) examining the influence of pathogens and chemicals (e.g., food additives and pesticide residue) on food-borne illnesses, (ii) summarizing food hazards that are present in Asia, and (iii) summarizing the array of current point-of-care (POC) detection devices that have potential applications in food safety monitoring. In addition, we provide insight into global healthcare issues in both developing and under-developed nations with a focus on bridging the gap between food safety issues in the public sector (associated with relevant clinical cases) and the use of POC detection devices for food safety monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

Applying Human Factors Principles to Mitigate Usability Issues Related to Embedded Assumptions in Health Information Technology Design

PubMed Central

Lowry, Svetlana Z; Patterson, Emily S

2014-01-01

Background There is growing recognition that design flaws in health information technology (HIT) lead to increased cognitive work, impact workflows, and produce other undesirable user experiences that contribute to usability issues and, in some cases, patient harm. These usability issues may in turn contribute to HIT utilization disparities and patient safety concerns, particularly among “non-typical” HIT users and their health care providers. Health care disparities are associated with poor health outcomes, premature death, and increased health care costs. HIT has the potential to reduce these disparate outcomes. In the computer science field, it has long been recognized that embedded cultural assumptions can reduce the usability, usefulness, and safety of HIT systems for populations whose characteristics differ from “stereotypical” users. Among these non-typical users, inappropriate embedded design assumptions may contribute to health care disparities. It is unclear how to address potentially inappropriate embedded HIT design assumptions once detected. Objective The objective of this paper is to explain HIT universal design principles derived from the human factors engineering literature that can help to overcome potential usability and/or patient safety issues that are associated with unrecognized, embedded assumptions about cultural groups when designing HIT systems. Methods Existing best practices, guidance, and standards in software usability and accessibility were subjected to a 5-step expert review process to identify and summarize those best practices, guidance, and standards that could help identify and/or address embedded design assumptions in HIT that could negatively impact patient safety, particularly for non-majority HIT user populations. An iterative consensus-based process was then used to derive evidence-based design principles from the data to address potentially inappropriate embedded cultural assumptions. Results Design principles that may help identify and address embedded HIT design assumptions are available in the existing literature. Conclusions Evidence-based HIT design principles derived from existing human factors and informatics literature can help HIT developers identify and address embedded cultural assumptions that may underlie HIT-associated usability and patient safety concerns as well as health care disparities. PMID:27025349

Applying Human Factors Principles to Mitigate Usability Issues Related to Embedded Assumptions in Health Information Technology Design.

PubMed

Gibbons, Michael C; Lowry, Svetlana Z; Patterson, Emily S

2014-12-18

There is growing recognition that design flaws in health information technology (HIT) lead to increased cognitive work, impact workflows, and produce other undesirable user experiences that contribute to usability issues and, in some cases, patient harm. These usability issues may in turn contribute to HIT utilization disparities and patient safety concerns, particularly among "non-typical" HIT users and their health care providers. Health care disparities are associated with poor health outcomes, premature death, and increased health care costs. HIT has the potential to reduce these disparate outcomes. In the computer science field, it has long been recognized that embedded cultural assumptions can reduce the usability, usefulness, and safety of HIT systems for populations whose characteristics differ from "stereotypical" users. Among these non-typical users, inappropriate embedded design assumptions may contribute to health care disparities. It is unclear how to address potentially inappropriate embedded HIT design assumptions once detected. The objective of this paper is to explain HIT universal design principles derived from the human factors engineering literature that can help to overcome potential usability and/or patient safety issues that are associated with unrecognized, embedded assumptions about cultural groups when designing HIT systems. Existing best practices, guidance, and standards in software usability and accessibility were subjected to a 5-step expert review process to identify and summarize those best practices, guidance, and standards that could help identify and/or address embedded design assumptions in HIT that could negatively impact patient safety, particularly for non-majority HIT user populations. An iterative consensus-based process was then used to derive evidence-based design principles from the data to address potentially inappropriate embedded cultural assumptions. Design principles that may help identify and address embedded HIT design assumptions are available in the existing literature. Evidence-based HIT design principles derived from existing human factors and informatics literature can help HIT developers identify and address embedded cultural assumptions that may underlie HIT-associated usability and patient safety concerns as well as health care disparities.

Keeping nurse researchers safe: workplace health and safety issues.

PubMed

Barr, Jennieffer; Welch, Anthony

2012-07-01

This article is a report of a qualitative study of workplace health and safety issues in nursing research. Researcher health and safety have become increasing concerns as there is an increased amount of research undertaken in the community and yet there is a lack of appropriate guidelines on how to keep researchers safe when undertaking fieldwork. This study employed a descriptive qualitative approach, using different sources of data to find any references to researcher health and safety issues. A simple descriptive approach to inquiry was used for this study. Three approaches to data collection were used: interviews with 15 researchers, audits of 18 ethics applications, and exploration of the literature between 1992 and 2010 for examples of researcher safety issues. Data analysis from the three approaches identified participant comments, narrative descriptions or statements focused on researcher health and safety. Nurse researchers' health and safety may be at risk when conducting research in the community. Particular concern involves conducting sensitive research where researchers are physically at risk of being harmed, or being exposed to the development of somatic symptoms. Nurse researchers may perceive the level of risk of harm as lower than the actual or potential harm present in research. Nurse researchers do not consistently implement risk assessment before and during research. Researcher health and safety should be carefully considered at all stages of the research process. Research focusing on sensitive data and vulnerable populations need to consider risk minimization through strategies such as appropriate researcher preparation, safety during data collection, and debriefing if required. © 2012 Blackwell Publishing Ltd.

Workplace exposure to engineered nanomaterials: the Italian path for the definition of occupational health and safety policies.

PubMed

Mirabile, Marco; Boccuni, Fabio; Gagliardi, Diana; Rondinone, Bruna Maria; Iavicoli, Sergio

2014-07-01

This study explores the way the publication of a National White Book on health and safety risks that affect workers in jobs involving Nanotechnologies and Nanomaterials influenced the key Italian stakeholders attitude toward this issue and identifies the standpoints and priorities shared among researchers and stakeholders to develop a policy framework to address this issue. The study not only highlights some important assumptions (i.e. the acknowledgment by the key stakeholders of the need for actions and the identification of objectives which can gain a wide consensus) for the establishment of a policy community that sustains the development of a policymaking process on the issue but, through the interaction between stakeholders and OSH researchers, it also identifies some in nuce proposals that represent the starting point for policy interventions aimed at meeting the needs of both stakeholders and scientific community. Results obtained in terms of clarification of interests at stake, identification of potential areas of consensus and level of key national actors' engagement achieved, show the potentialities of adopting a knowledge based and inclusive approach to policy-making to address the issue of prevention and management of health and safety risks related to technological innovation within a framework of scientific uncertainty. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

GammaKnife surgery: safety and the identity of users.

PubMed

Dinka, David; Nyce, James M; Timpka, Toomas

2005-01-01

In this study we investigated safety-related usability issues of an advanced medical technology, a radiosurgery system. We were interested in which criteria are important for users when a system's usability and safety is to be improved. The data collection was based on interviews and observations at three different sites where the Leksell GammaKnife is used. The analysis was qualitative. The main finding was that the user's identity or professional background has a significant impact both on how he or she views his or her role in the clinical setting, and on how he or she defines what improvements are necessary and general safety issues. In fact, the opinion even of users experienced in safety-related problems was highly influenced by how they related to the technology and its development. None of the users actually considered Leksell GammaKnife as lacking in safety, instead, their assessment was directed towards potential future system improvements. Our findings suggest that the importance of user identity or professional background cannot be neglected during the development of advanced technology. They also suggest that the user feedback should always be related to user background and identity in order to understand how important different issues are for particular users.

Occupational health and safety among commercial sex workers.

PubMed

Ross, Michael W; Crisp, Beth R; Månsson, Sven-Axel; Hawkes, Sarah

2012-03-01

The concept of occupational health and safety (OHS) for commercial sex workers has rarely been investigated, perhaps because of the often informal nature of the workplace, the associated stigma, and the frequently illegal nature of the activity. We reviewed the literature on health, occupational risks, and safety among commercial sex workers. Cultural and local variations and commonalities were identified. Dimensions of OHS that emerged included legal and policing risks, risks associated with particular business settings such as streets and brothels, violence from clients, mental health risks and protective factors, alcohol and drug use, repetitive strain injuries, sexually transmissible infections, risks associated with particular classes of clients, issues associated with male and transgender commercial sex workers, and issues of risk reduction that in many cases are associated with lack of agency or control, stigma, and legal barriers. We further discuss the impact and potential of OHS interventions for commercial sex workers. The OHS of commercial sex workers covers a range of domains, some potentially modifiable by OHS programs and workplace safety interventions targeted at this population. We argue that commercial sex work should be considered as an occupation overdue for interventions to reduce workplace risks and enhance worker safety.

Too much information? A document analysis of sport safety resources from key organisations.

PubMed

Bekker, Sheree; Finch, Caroline F

2016-05-06

The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport safety behaviour change. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Too much information? A document analysis of sport safety resources from key organisations

PubMed Central

Finch, Caroline F

2016-01-01

Objectives The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Design Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. Setting This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. Participants The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. Results The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. Conclusions People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport safety behaviour change. PMID:27154480

76 FR 37258 - Airworthiness Directives; Bombardier, Inc. Model DHC-8-400 Series Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-27

... Aerospace has completed a system safety review of the aeroplanes fuel system against fuel tank safety... the fuel system are required to mitigate unsafe conditions that could result in potential ignition source within the fuel system. We are issuing this AD to require actions to correct the unsafe condition...

75 FR 9232 - Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... for assessing progress in food safety and associated methodological issues and to discuss potential.... The FoodNet also conducts special studies to determine risk factors for acquiring those illnesses... production, studies on the prevalence of specific pathogens in specific classes of food, and studies of...

77 FR 67012 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

... a range of policy issues to include: innovations in blood and tissue products and their potential... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office...

Recent patents on biosafety strategies of selectable marker genes in genetically modified crops.

PubMed

Jiang, Yiming; Hu, Xiaoning; Huang, Haiying

2014-01-01

Genetically modified crops (GMCs) have been planted world wide since 1990s, but the potential insecurity of selectable marker genes raises the questions about GMC safety. Therefore, several researches have been conducted on marker gene safety issues and recently several patents have been issued on this subject. There are two main approaches to achieve this goal: seeking the biosafety selectable marker and eliminating these insecure marker genes after transformation. Results show that these two systems are quite effective. Recent patents on the two ways are discussed in this review.

Nanotechnology in cosmetics.

PubMed

Katz, Linda M; Dewan, Kapal; Bronaugh, Robert L

2015-11-01

Nanomaterials are being used in cosmetic products for various effects. However, their use also raises potential safety concerns. Some of these concerns can be addressed by determining the type of nanomaterials used, as well as stability, potential for skin absorption, route of exposure, and how they are formulated in cosmetic products. There has been considerable effort internationally to harmonize approaches in order to address definitional issues and safety concerns related to the use of nanomaterials in cosmetic products. Published by Elsevier Ltd.

Economic analysis requirements in support of orbital debris regulatory policy

NASA Astrophysics Data System (ADS)

Greenberg, Joel S.

1996-10-01

As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads

PubMed Central

Thompson, Kirrilly; Matthews, Chelsea

2015-01-01

Simple Summary Riding horses on roads can be dangerous, but little is known about accidents and near misses. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey, mostly attributed to speed. Whilst our findings confirmed factors identified overseas, we also identified issues around road rules, hand signals and road rage. This paper suggests strategies for improving the safety of horses, riders and other road users. Abstract Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles; (2) harmonising laws regarding passing horses; (3) mandating personal protective equipment; (4) improving road signage; (5) comprehensive data collection; (6) developing mutual understanding amongst road-users; (7) safer road design and alternative riding spaces; and (8) increasing investment in horse-related safety initiatives. PMID:26479376

Laboratory safety and the WHO World Alliance for Patient Safety.

PubMed

McCay, Layla; Lemer, Claire; Wu, Albert W

2009-06-01

Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.

Health and safety: Preliminary comparative assessment of the Satellite Power System (SPS) and other energy alternatives

NASA Technical Reports Server (NTRS)

Habegger, L. J.; Gasper, J. R.; Brown, C.

1980-01-01

Data readily available from the literature were used to make an initial comparison of the health and safety risks of a fission power system with fuel reprocessing; a combined-cycle coal power system with a low-Btu gasifier and open-cycle gas turbine; a central-station, terrestrial, solar photovoltaic power system; the satellite power system; and a first-generation fusion system. The assessment approach consists of the identification of health and safety issues in each phase of the energy cycle from raw material extraction through electrical generation, waste disposal, and system deactivation; quantitative or qualitative evaluation of impact severity; and the rating of each issue with regard to known or potential impact level and level of uncertainty.

The use of in-situ simulation to improve safety in the plastic surgery office: a feasibility study.

PubMed

Shapiro, Fred E; Pawlowski, John B; Rosenberg, Noah M; Liu, Xiaoxia; Feinstein, David M; Urman, Richard D

2014-01-01

Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors.

The Use of In-Situ Simulation to Improve Safety in the Plastic Surgery Office: A Feasibility Study

PubMed Central

Shapiro, Fred E.; Pawlowski, John B.; Rosenberg, Noah M.; Liu, Xiaoxia; Feinstein, David M.; Urman, Richard D.

2014-01-01

Objective: Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. Methods: A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. Results: The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Conclusions: Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors. PMID:24501616

Introduction to Preharvest Food Safety.

PubMed

Torrence, Mary E

2016-10-01

This introductory article provides an overview of preharvest food safety activities and initiatives for the past 15 years. The section on traditional areas of preharvest food safety focuses on significant scientific advancements that are a culmination of collaborative efforts (both public health and agriculture) and significant research results. The highlighted advancements provide the foundation for exploring future preharvest areas and for improving and focusing on more specific intervention/control/prevention strategies. Examples include Escherichia coli and cattle, Salmonella and Campylobacter in poultry, and interventions and prevention and control programs. The section on "nontraditional" preharvest food safety areas brings attention to potential emerging food safety issues and to future food safety research directions. These include organic production, the FDA's Produce Rule (water and manure), genomic sequencing, antimicrobial resistance, and performance metrics. The concluding section emphasizes important themes such as strategic planning, coordination, epidemiology, and the need for understanding food safety production as a continuum. Food safety research, whether at the pre- or postharvest level, will continue to be a fascinating complex web of foodborne pathogens, risk factors, and scientific and policy interactions. Food safety priorities and research must continue to evolve with emerging global issues, emerging technologies, and methods but remain grounded in a multidisciplinary, collaborative, and systematic approach.

OSHA safety requirements for hazardous chemicals in the workplace.

PubMed

Dohms, J

1992-01-01

This article outlines the Occupational Safety and Health Administration (OSHA) requirements set forth by the Hazard Communication Standard, which has been in effect for the healthcare industry since 1987. Administrators who have not taken concrete steps to address employee health and safety issues relating to hazardous chemicals are encouraged to do so to avoid the potential of large fines for cited violations. While some states administer their own occupational safety and health programs, they must adopt standards and enforce requirements that are at least as effective as federal requirements.

Driving safety in elderly individuals.

PubMed

Marottoli, R A

1993-05-01

Driving safety in elderly individuals is becoming an increasingly important issue in geriatrics and in medical practice. The number of elderly drivers is increasing as the population ages, and especially as current generations of female drivers age. Concern is raised about their safe operation of motor vehicles because of the increasing likelihood with advancing age of developing conditions that may adversely affect the visual, cognitive, and motor abilities integral to driving. But this issue is not only a medical one, since there are social and political components as well. This discussion will describe the background of this issue, focus on the changes that may occur with aging and their potential relationship to driving ability, and, finally, will outline an approach that physicians may employ in their practice.

Climate change and food safety: an emerging issue with special focus on Europe.

PubMed

Miraglia, M; Marvin, H J P; Kleter, G A; Battilani, P; Brera, C; Coni, E; Cubadda, F; Croci, L; De Santis, B; Dekkers, S; Filippi, L; Hutjes, R W A; Noordam, M Y; Pisante, M; Piva, G; Prandini, A; Toti, L; van den Born, G J; Vespermann, A

2009-05-01

According to general consensus, the global climate is changing, which may also affect agricultural and livestock production. The potential impact of climate change on food security is a widely debated and investigated issue. Nonetheless, the specific impact on safety of food and feed for consumers has remained a less studied topic. This review therefore identifies the various food safety issues that are likely to be affected by changes in climate, particularly in Europe. Amongst the issues identified are mycotoxins formed on plant products in the field or during storage; residues of pesticides in plant products affected by changes in pest pressure; trace elements and/or heavy metals in plant products depending on changes in their abundance and availability in soils; polycyclic aromatic hydrocarbons in foods following changes in long-range atmospheric transport and deposition into the environment; marine biotoxins in seafood following production of phycotoxins by harmful algal blooms; and the presence of pathogenic bacteria in foods following more frequent extreme weather conditions, such as flooding and heat waves. Research topics that are amenable to further research are highlighted.

Blame the Patient, Blame the Doctor or Blame the System? A Meta-Synthesis of Qualitative Studies of Patient Safety in Primary Care

PubMed Central

Daker-White, Gavin; Hays, Rebecca; McSharry, Jennifer; Giles, Sally; Cheraghi-Sohi, Sudeh; Rhodes, Penny; Sanders, Caroline

2015-01-01

Objective Studies of patient safety in health care have traditionally focused on hospital medicine. However, recent years have seen more research located in primary care settings which have different features compared to secondary care. This study set out to synthesize published qualitative research concerning patient safety in primary care in order to build a conceptual model. Method Meta-ethnography, an interpretive synthesis method whereby third order interpretations are produced that best describe the groups of findings contained in the reports of primary studies. Results Forty-eight studies were included as 5 discrete subsets where the findings were translated into one another: patients’ perspectives of safety, staff perspectives of safety, medication safety, systems or organisational issues and the primary/secondary care interface. The studies were focused predominantly on issues seen to either improve or compromise patient safety. These issues related to the characteristics or behaviour of patients, staff or clinical systems and interactions between staff, patients and staff, or people and systems. Electronic health records, protocols and guidelines could be seen to both degrade and improve patient safety in different circumstances. A conceptual reading of the studies pointed to patient safety as a subjective feeling or judgement grounded in moral views and with potentially hidden psychological consequences affecting care processes and relationships. The main threats to safety appeared to derive from ‘grand’ systems issues, for example involving service accessibility, resources or working hours which may not be amenable to effective intervention by individual practices or health workers, especially in the context of a public health system. Conclusion Overall, the findings underline the human elements in patient safety primary health care. The key to patient safety lies in effective face-to-face communication between patients and health care staff or between the different staff involved in the care of an individual patient. Electronic systems can compromise safety when they override the opportunities for face-to-face communication. The circumstances under which guidelines or protocols are seen to either compromise or improve patient safety needs further investigation. PMID:26244494

Dual mode vehicle and infrastructure alternatives analysis

DOT National Transportation Integrated Search

2008-04-01

The United States has a transportation challenge that requires addressing four issues simultaneously: traffic congestion, environmental pollution, safety, and energy security. A potential solution to these transportation challenges is the concept of ...

The use of biomarkers in occupational health research, practice, and policy.

PubMed

Schulte, P A; Hauser, J E

2012-08-13

Biomarkers are potentially useful tools for occupational health and safety research, practice, and policy. However, the full realization of this potential has not been achieved. In this paper, the progress made in these three usage areas is reviewed to identify what efforts can be taken to realize the full promise of biomarkers. Biomarker uses are described by a diverse taxonomy that builds on the categories of exposure, effect and susceptibility, and the continuum between exposure and disease prognosis. The most significant uses of biomarkers in occupational health have been in biological monitoring of workers. Other important uses have been in enhancing research and assessing mechanisms of action of occupational toxicants at low exposures. Seven critical areas will influence the extent to which the potential of biomarkers in occupational health and safety is realized. These include: (1) adequate investment in validation; (2) obtaining international agreement on exposure guidelines; (3) exploring the utility of biomarkers in regulation; (4) applying biomarkers to critical occupational safety and health questions; (5) developing the exposome; (6) utilizing biomarkers to address emerging occupational health issues; and (7) continuing to address the ethical and social justice issues related to biomarkers. Overall, if biomarkers are to make a major contribution to occupational health and safety then a more holistic approach to bringing them from the laboratory to practice will be needed. Published by Elsevier Ireland Ltd.

The Fukushima Dai-ichi Accident and its implications for the safety of nuclear power

NASA Astrophysics Data System (ADS)

Barletta, William

2016-05-01

Five years ago the dramatic events in Fukushima that followed the massive earthquake and subsequent tsunami that struck Japan on March 11, 2011 sharpened the focus of scientists, engineers and general public on the broad range of technical, environmental and societal issues involved in assuring the safety of the world's nuclear power complex. They also called into question the potential of nuclear power to provide a growing, sustainable resource of CO2-free energy. The issues raised by Fukushima Dai-ichi have provoked urgent concern, not only because of the potential harm that could result from severe accidents or from intentional damage to nuclear reactors or to facilities involved in the nuclear fuel cycle, but also because of the extensive economic impact of those accidents and of the measures taken to avoid them.

Staying silent about safety issues: Conceptualizing and measuring safety silence motives.

PubMed

Manapragada, Archana; Bruk-Lee, Valentina

2016-06-01

Communication between employees and supervisors about safety-related issues is an important component of a safe workplace. When supervisors receive information from employees about safety issues, they may gain otherwise-missed opportunities to correct these issues and/or prevent negative safety outcomes. A series of three studies were conducted to identify various safety silence motives, which describe the reasons that employees do not speak up to supervisors about safety-related issues witnessed in the workplace, and to develop a tool to assess these motives. Results suggest that employees stay silent about safety issues based on perceptions of altering relationships with others (relationship-based), perceptions of the organizational climate (climate-based), the assessment of the safety issue (issue-based), or characteristics of the job (job-based). We developed a 17-item measure to assess these four motives, and initial evidence was found for the construct and incremental validity of the safety silence motives measure in a sample of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

PubMed Central

Russo, Ethan B.

2016-01-01

This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

The development and psychometric evaluation of a safety climate measure for primary care.

PubMed

de Wet, C; Spence, W; Mash, R; Johnson, P; Bowie, P

2010-12-01

Building a safety culture is an important part of improving patient care. Measuring perceptions of safety climate among healthcare teams and organisations is a key element of this process. Existing measurement instruments are largely developed for secondary care settings in North America and many lack adequate psychometric testing. Our aim was to develop and test an instrument to measure perceptions of safety climate among primary care teams in National Health Service for Scotland. Questionnaire development was facilitated through a steering group, literature review, semistructured interviews with primary care team members, a modified Delphi and completion of a content validity index by experts. A cross-sectional postal survey utilising the questionnaire was undertaken in a random sample of west of Scotland general practices to facilitate psychometric evaluation. Statistical methods, including exploratory and confirmatory factor analysis, and Cronbach and Raykov reliability coefficients were conducted. Of the 667 primary care team members based in 49 general practices surveyed, 563 returned completed questionnaires (84.4%). Psychometric evaluation resulted in the development of a 30-item questionnaire with five safety climate factors: leadership, teamwork, communication, workload and safety systems. Retained items have strong factor loadings to only one factor. Reliability coefficients was satisfactory (α = 0.94 and ρ = 0.93). This study is the first stage in the development of an appropriately valid and reliable safety climate measure for primary care. Measuring safety climate perceptions has the potential to help primary care organisations and teams focus attention on safety-related issues and target improvement through educational interventions. Further research is required to explore acceptability and feasibility issues for primary care teams and the potential for organisational benchmarking.

Technical Note: Some Issues Related to the Selection of Polymers for Aerospace Oxygen Systems

NASA Technical Reports Server (NTRS)

Hirsch, David; Beeson, Harold

2004-01-01

Materials intended for use in aerospace oxygen systems are commonly screened for oxygen compatibility following NASA STD 6001. This standard allows qualification of materials based on results provided by only one test method. Potential issues related to this practice are reviewed and recommendations are proposed that would lead to improved aerospace oxygen systems safety.

RFID-Based Asset Management for Space Habitats

NASA Technical Reports Server (NTRS)

Fink, Patrick W.

2013-01-01

Remote habitats are often densely packed - items necessary to sustain life - items necessary to conduct work center dot Inhabitant's time is often quite valuable, if not priceless. Resupply shipments can be infrequent and expensive. Inaccurate inventory knowledge can lead to unnecessary overstocking, which can lead to insufficient work and/or living volume. Not being able to find items when they are needed can present: - safety issues - morale issues. RFID technology has the potential solve a lot of these issues.

Overview of NORM and activities by a NORM licensed permanent decontamination and waste processing facility

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

Mirro, G.A.

1997-02-01

This paper presents an overview of issues related to handling NORM materials, and provides a description of a facility designed for the processing of NORM contaminated equipment. With regard to handling NORM materials the author discusses sources of NORM, problems, regulations and disposal options, potential hazards, safety equipment, and issues related to personnel protection. For the facility, the author discusses: description of the permanent facility; the operations of the facility; the license it has for handling specific radioactive material; operating and safety procedures; decontamination facilities on site; NORM waste processing capabilities; and offsite NORM services which are available.

Ergonomic Training for Tomorrow's Office.

ERIC Educational Resources Information Center

Gross, Clifford M.; Chapnik, Elissa Beth

1987-01-01

The authors focus on issues related to the continual use of video display terminals in the office, including safety and health regulations, potential health problems, and the role of training in minimizing work-related health problems. (CH)

Food safety regulations in Australia and New Zealand Food Standards.

PubMed

Ghosh, Dilip

2014-08-01

Citizens of Australia and New Zealand recognise that food security is a major global issue. Food security also affects Australia and New Zealand's status as premier food exporting nations and the health and wellbeing of the Australasian population. Australia is uniquely positioned to help build a resilient food value chain and support programs aimed at addressing existing and emerging food security challenges. The Australian food governance system is fragmented and less transparent, being largely in the hands of government and semi-governmental regulatory authorities. The high level of consumer trust in Australian food governance suggests that this may be habitual and taken for granted, arising from a lack of negative experiences of food safety. In New Zealand the Ministry of Primary Industries regulates food safety issues. To improve trade and food safety, New Zealand and Australia work together through Food Standards Australia New Zealand (FSANZ) and other co-operative agreements. Although the potential risks to the food supply are dynamic and constantly changing, the demand, requirement and supply for providing safe food remains firm. The Australasian food industry will need to continually develop its system that supports the food safety program with the help of scientific investigations that underpin the assurance of what is and is not safe. The incorporation of a comprehensive and validated food safety program is one of the total quality management systems that will ensure that all areas of potential problems are being addressed by industry. © 2014 Society of Chemical Industry.

Imaginable Technologies for Human Missions to Mars

NASA Technical Reports Server (NTRS)

Bushnell, Dennis M.

2007-01-01

The thesis of the present discussion is that the simultaneous cost and inherent safety issues of human on-site exploration of Mars will require advanced-to-revolutionary technologies. The major crew safety issues as currently identified include reduced gravity, radiation, potentially extremely toxic dust and the requisite reliability for years-long missions. Additionally, this discussion examines various technological areas which could significantly impact Human-Mars cost and safety. Cost reductions for space access is a major metric, including approaches to significantly reduce the overall up-mass. Besides fuel, propulsion and power systems, the up-mass consists of the infrastructure and supplies required to keep humans healthy and the equipment for executing exploration mission tasks. Hence, the major technological areas of interest for potential cost reductions include propulsion, in-space and on-planet power, life support systems, materials and overall architecture, systems, and systems-of-systems approaches. This discussion is specifically offered in response to and as a contribution to goal 3 of the Presidential Exploration Vision: "Develop the Innovative Technologies Knowledge and Infrastructures both to explore and to support decisions about the destinations for human exploration".

Toxicants exposures as novel zoonoses: reflections on sustainable development, food safety and veterinary public health.

PubMed

Frazzoli, C; Mantovani, A

2010-12-01

The modern concept of zoonosis considers any detriment to the health and/or quality of human life resulting from relationships with (other) vertebrate or edible or toxic invertebrate animals. Whereas exposure to toxicants through foods of animal origin (a.o.) is a well-established issue, hereby we discuss it as novel zoonoses, from the standpoints of health implications as well as similarities and differences with classical zoonoses caused by biological agents. Novel toxicant-related zoonoses are linked with new issues in food safety, such as the environment-feed-food chain. In fact, the potential effect of the combined and repeated exposure to dietary toxicants is generally long-term and not readily discernible. Endocrine disrupting chemicals in staple foods of a.o. are discussed as a telling example of a food safety issue summing up critical points covered by the definition of sustainable development, also implicating health risks for generations to come. We suggest some critical points to implement the veterinary public health action in sustainable food safety, such as enhancement of Hazard Analysis and Critical Control Points systems for toxicological risk management. © 2010 Blackwell Verlag GmbH.

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Identification of crew-systems interactions and decision related trends

DOT National Transportation Integrated Search

2013-05-01

National Aeronautics and Space Administration (NASA) Vehicle System Safety Technology (VSST) project management uses systems analysis to identify key issues and maintain a portfolio of research leading to potential solutions to its three identified t...

Timing issues for traffic signals interconnected with highway-railroad grade crossings.

DOT National Transportation Integrated Search

2013-02-01

The coordination of highway-railroad grade crossing warning signals with nearby traffic signals is of vital : importance due to potential safety consequences. Interconnections between traffic signals in close : proximity to railroad crossings provide...

INDUSTRIAL/MILITARY ACTIVITY-INITIATED ACCIDENT SCREENING ANALYSIS

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

D.A. Kalinich

1999-09-27

Impacts due to nearby installations and operations were determined in the Preliminary MGDS Hazards Analysis (CRWMS M&O 1996) to be potentially applicable to the proposed repository at Yucca Mountain. This determination was conservatively based on limited knowledge of the potential activities ongoing on or off the Nevada Test Site (NTS). It is intended that the Industrial/Military Activity-Initiated Accident Screening Analysis provided herein will meet the requirements of the ''Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants'' (NRC 1987) in establishing whether this external event can be screened from further consideration or must be includedmore » as a design basis event (DBE) in the development of accident scenarios for the Monitored Geologic Repository (MGR). This analysis only considers issues related to preclosure radiological safety. Issues important to waste isolation as related to impact from nearby installations will be covered in the MGR performance assessment.« less

Patient safety is not elective: a debate at the NPSF Patient Safety Congress.

PubMed

McTiernan, Patricia; Wachter, Robert M; Meyer, Gregg S; Gandhi, Tejal K

2015-02-01

The opening keynote session of the 16th Annual National Patient Safety Foundation Patient Safety Congress, held 14-16 May 2014, featured a debate addressing the merits and challenges of accountability with respect to key issues in patient safety. The specific resolution debated was: Certain safety practices should be inviolable, and transgressions should result in penalties, potentially including fines, suspensions, and firing. The themes discussed in the debate are issues that healthcare professionals and leaders commonly struggle with in their day-to-day work. How do we draw a line between systems problems and personal failings? When should clinicians and staff be penalised for failing to follow a known safety protocol? The majority of those who listened to the live debate agreed that it is time to begin holding health professionals accountable when they wilfully or repeatedly violate policies or protocols put in place by their institutions to protect the safety of patients. This article summarises the debate as well as the questions and discussion generated by each side. A video of the original debate can be found at http://bit.ly/Npsf_debate. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads.

PubMed

Thompson, Kirrilly; Matthews, Chelsea

2015-07-22

Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles (2) harmonising laws regarding passing horses, (3) mandating personal protective equipment, (4) improving road signage, (5) comprehensive data collection, (6) developing mutual understanding amongst road-users, (7) safer road design and alternative riding spaces; and (8) increasing investment in horse-related safety initiatives.

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

PubMed Central

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

Safety Issues at the DOE Test and Research Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

This report provides an assessment of safety issues at the Department of Energy (DOE) test and research reactors. Part A identifies six safety issues of the reactors. These issues include the safety design philosophy, the conduct of safety reviews, the performance of probabilistic risk assessments, the reliance on reactor operators, the fragmented…

Biosimilar safety considerations in clinical practice.

PubMed

Choy, Edwin; Jacobs, Ira Allen

2014-02-01

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed. © 2014 Elsevier Inc. All rights reserved.

Improving Patient Safety in Hospitals through Usage of Cloud Supported Video Surveillance.

PubMed

Dašić, Predrag; Dašić, Jovan; Crvenković, Bojan

2017-04-15

Patient safety in hospitals is of equal importance as providing treatments and urgent healthcare. With the development of Cloud technologies and Big Data analytics, it is possible to employ VSaaS technology virtually anywhere, for any given security purpose. For the listed benefits, in this paper, we give an overview of the existing cloud surveillance technologies which can be implemented for improving patient safety. Modern VSaaS systems provide higher elasticity and project scalability in dealing with real-time information processing. Modern surveillance technologies can prove to be an effective tool for prevention of patient falls, undesired movement and tempering with attached life supporting devices. Given a large number of patients who require constant supervision, a cloud-based monitoring system can dramatically reduce the occurring costs. It provides continuous real-time monitoring, increased overall security and safety, improved staff productivity, prevention of dishonest claims and long-term digital archiving. Patient safety is a growing issue which can be improved with the usage of high-end centralised surveillance systems allowing the staff to focus more on treating health issues rather that keeping a watchful eye on potential incidents.

Swedish dairy farmers' perceptions of animal-related injuries.

PubMed

Lindahl, Cecilia; Lundqvist, Peter; Norberg, Annika Lindahl

2012-01-01

Animal-related injuries are among the most common occupational injuries in agriculture. Despite the large number of documented animal-related injuries in dairy farming, the issue has received relatively limited attention in the scientific literature. The farmers' own perspectives and views on risks and safety during livestock handling and what they think are effective ways of preventing injuries are valuable for the future design of effective interventions. This paper presents results from a qualitative study with the aim to investigate Swedish dairy farmers' own experience of animal-related occupational injuries, as well as their perceptions of and attitudes towards them, including risk and safety issues, and prevention measures. A total of 12 dairy farmers with loose housing systems participated in the study. Data collection was conducted by means of semistructured in-depth interviews. Three main themes with an impact on risks and safety when handling cattle were identified: the handler, the cattle, and the facilities. They all interact with each other, influencing the potential risks of any work task. Most of the farmers believed that a majority of the injuries can be prevented, but there are always some incidents that are impossible to foresee. In conclusion, this study indicates that Swedish dairy farmers are aware of the dangers from working with cattle. However, even though safety is acknowledged by the farmers as an important and relevant issue, in the end safety is often forgotten or not prioritized. One concern is that farmers are willing to take calculated risks to save money or time. In situations where they work alone with high stress levels and under economic distress, safety issues are easily given low priority.

Climate change and the health impact of aflatoxins exposure in Portugal - an overview.

PubMed

Assunção, Ricardo; Martins, Carla; Viegas, Susana; Viegas, Carla; Jakobsen, Lea S; Pires, Sara; Alvito, Paula

2018-03-08

Climate change has been indicated as a driver for food safety issues worldwide, mainly due to the impact on the occurrence of food safety hazards at various stages of food chain. Mycotoxins, natural contaminants produced by fungi, are among the most important of such hazards. Aflatoxins, which have the highest acute and chronic toxicity of all mycotoxins, assume particular importance. A recent study predicted aflatoxin contamination in maize and wheat crops in Europe within the next 100 years and aflatoxin B1 is predicted to become a food safety issue in Europe, especially in the most probable scenario of climate change (+2°C). This review discusses the potential influence of climate change on the health risk associated to aflatoxins dietary exposure of Portuguese population. We estimated the burden of disease associated to the current aflatoxin exposure for Portuguese population in terms of Disability Adjusted Life Years (DALYs). It is expected that in the future the number of DALYs and the associated cases of hepatocellular carcinoma due to aflatoxins exposure will increase due to climate change. The topics highlighted through this review, including the potential impact on health of the Portuguese population through the dietary exposure to aflatoxins, should represent an alert for the potential consequences of an incompletely explored perspective of climate change. Politics and decision-makers should be involved and committed to implement effective measures to deal with climate change issues and to reduce its possible consequences. This review constitutes a contribution for the prioritisation of strategies to face the unequal burden of effects of weather-related hazards in Portugal and across Europe.

Recent Progresses in Nanobiosensing for Food Safety Analysis

PubMed Central

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-01-01

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014–present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly. PMID:27447636

Recent Progresses in Nanobiosensing for Food Safety Analysis.

PubMed

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-07-19

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014-present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly.

Prospectus on Multi-Modal Aspects of Human Factors in Transportation

DOT National Transportation Integrated Search

1991-02-01

This prospectus identifies and discusses a series of human factors : issues which are critical to transportation safety and productivity, and : examines the potential benefits that can accrue from taking a multi-modal : approach to human factors rese...

Non-Nuclear Testing of Space Nuclear Systems at NASA MSFC

NASA Technical Reports Server (NTRS)

Houts, Michael G.; Pearson, Boise J.; Aschenbrenner, Kenneth C.; Bradley, David E.; Dickens, Ricky; Emrich, William J.; Garber, Anne; Godfroy, Thomas J.; Harper, Roger T.; Martin, Jim J.;

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Fertility and pregnancy issues in BRCA-mutated breast cancer patients.

PubMed

Lambertini, Matteo; Goldrat, Oranite; Toss, Angela; Azim, Hatem A; Peccatori, Fedro A; Ignatiadis, Michail; Del Mastro, Lucia; Demeestere, Isabelle

2017-09-01

Fertility and pregnancy-related issues represent one of the main areas of concerns for young women with breast cancer. Carrying a germline deleterious BRCA mutation adds additional burden on this regard due to the specific issues that should be considered during the oncofertility counseling of this special patient group. Despite the availability of a growing amount of data in the general breast cancer population on the feasibility and safety of fertility preservation and pregnancy after diagnosis, numerous challenges remain for BRCA-mutated breast cancer patients in whom very limited studies have been performed so far. Therefore, studies aiming to address the specific issues of these patients, including the impact of the mutation on their fertility potential, the safety and efficacy of the different strategies for fertility preservation, and the feasibility of having a pregnancy after diagnosis, should be considered a research priority. The aim of the present manuscript is to perform an in depth overview on the role of BRCA mutations in breast cancer with a specific focus on their impact on reproductive potential, and to discuss the fertility and pregnancy issues faced by BRCA-mutated breast cancer patients. The final goal of this manuscript is to highlight current and upcoming knowledge in this field for trying to help physicians dealing with these patients during oncofertility counseling. Copyright © 2017 Elsevier Ltd. All rights reserved.

Contemporary issues: The pre-licensure nursing student and medication errors.

PubMed

Green, Cheryl

2018-06-01

In Modern health care, the creation of cultures of safety for patients is of the upmost importance. Impacting the institutional stabilization of health care facilities safety initiatives, is the preparation of pre-licensure nursing students to safely administer medications to patients. Therefore, preparation of the pre-licensure nursing student must be evidence-based practice focused and incorporate innovative ways to reduce the potential for medication errors. Copyright © 2018. Published by Elsevier Ltd.

40 Years of Safer Aviation Through Reporting

NASA Image and Video Library

2016-09-28

NASA’s Aviation Safety Reporting System (ASRS) is one of the tools used to make aviation in the United States as safe as it is. Celebrating its 40th anniversary this year, NASA’s confidential ASRS is widely used by pilots and other airline employees to identify potential hazards. Over the past 40 years, the ASRS has issued more than 6,200 safety alerts to the FAA and other decision makers in the aviation community.

Cultural safety, diversity and the servicer user and carer movement in mental health research.

PubMed

Cox, Leonie G; Simpson, Alan

2015-12-01

This study will be of interest to anyone concerned with a critical appraisal of mental health service users' and carers' participation in research collaboration and with the potential of the postcolonial paradigm of cultural safety to contribute to the service user research (SUR) movement. The history and nature of the mental health field and its relationship to colonial processes provokes a consideration of whether cultural safety could focus attention on diversity, power imbalance, cultural dominance and structural inequality, identified as barriers and tensions in SUR. We consider these issues in the context of state-driven approaches towards SUR in planning and evaluation and the concurrent rise of the SUR movement in the UK and Australia, societies with an intimate involvement in processes of colonisation. We consider the principles and motivations underlying cultural safety and SUR in the context of the policy agenda informing SUR. We conclude that while both cultural safety and SUR are underpinned by social constructionism constituting similarities in principles and intent, cultural safety has additional dimensions. Hence, we call on researchers to use the explicitly political and self-reflective process of cultural safety to think about and address issues of diversity, power and social justice in research collaboration. © 2015 John Wiley & Sons Ltd.

Multiple Intravenous Infusions Phase 1b

PubMed Central

Cassano-Piché, A; Fan, M; Sabovitch, S; Masino, C; Easty, AC

2012-01-01

Background Minimal research has been conducted into the potential patient safety issues related to administering multiple intravenous (IV) infusions to a single patient. Previous research has highlighted that there are a number of related safety risks. In Phase 1a of this study, an analysis of 2 national incident-reporting databases (Institute for Safe Medical Practices Canada and United States Food and Drug Administration MAUDE) found that a high percentage of incidents associated with the administration of multiple IV infusions resulted in patient harm. Objectives The primary objectives of Phase 1b of this study were to identify safety issues with the potential to cause patient harm stemming from the administration of multiple IV infusions; and to identify how nurses are being educated on key principles required to safely administer multiple IV infusions. Data Sources and Review Methods A field study was conducted at 12 hospital clinical units (sites) across Ontario, and telephone interviews were conducted with program coordinators or instructors from both the Ontario baccalaureate nursing degree programs and the Ontario postgraduate Critical Care Nursing Certificate programs. Data were analyzed using Rasmussen’s 1997 Risk Management Framework and a Health Care Failure Modes and Effects Analysis. Results Twenty-two primary patient safety issues were identified with the potential to directly cause patient harm. Seventeen of these (critical issues) were categorized into 6 themes. A cause-consequence tree was established to outline all possible contributing factors for each critical issue. Clinical recommendations were identified for immediate distribution to, and implementation by, Ontario hospitals. Future investigation efforts were planned for Phase 2 of the study. Limitations This exploratory field study identifies the potential for errors, but does not describe the direct observation of such errors, except in a few cases where errors were observed. Not all issues are known in advance, and the frequency of errors is too low to be observed in the time allotted and with the limited sample of observations. Conclusions The administration of multiple IV infusions to a single patient is a complex task with many potential associated patient safety risks. Improvements to infusion and infusion-related technology, education standards, clinical best practice guidelines, hospital policies, and unit work practices are required to reduce the risk potential. This report makes several recommendations to Ontario hospitals so that they can develop an awareness of the issues highlighted in this report and minimize some of the risks. Further investigation of mitigating strategies is required and will be undertaken in Phase 2 of this research. Plain Language Summary Patients, particularly in critical care environments, often require multiple intravenous (IV) medications via large volumetric or syringe infusion pumps. The infusion of multiple IV medications is not without risk; unintended errors during these complex procedures have resulted in patient harm. However, the range of associated risks and the factors contributing to these risks are not well understood. Health Quality Ontario’s Ontario Health Technology Advisory Committee commissioned the Health Technology Safety Research Team at the University Health Network to conduct a multi-phase study to identify and mitigate the risks associated with multiple IV infusions. Some of the questions addressed by the team were as follows: What is needed to reduce the risk of errors for individuals who are receiving a lot of medications? What strategies work best? The initial report, Multiple Intravenous Infusions Phase 1a: Situation Scan Summary Report, summarizes the interim findings based on a literature review, an incident database review, and a technology scan. The Health Technology Safety Research Team worked in close collaboration with the Institute for Safe Medication Practices Canada on an exploratory study to understand the risks associated with multiple IV infusions and the degree to which nurses are educated to help mitigate them. The current report, Multiple Intravenous Infusions Phase 1b: Practice and Training Scan, presents the findings of a field study of 12 hospital clinical units across Ontario, as well as 13 interviews with educators from baccalaureate-level nursing degree programs and postgraduate Critical Care Nursing Certificate programs. It makes 9 recommendations that emphasize best practices for the administration of multiple IV infusions and pertain to secondary infusions, line identification, line set-up and removal, and administering IV bolus medications. The Health Technology Safety Research Team has also produced an associated report for hospitals entitled Mitigating the Risks Associated With Multiple IV Infusions: Recommendations Based on a Field Study of Twelve Ontario Hospitals, which highlights the 9 interim recommendations and provides a brief rationale for each one. PMID:23074426

Cyber safety for adolescent girls: bullying, harassment, sexting, pornography, and solicitation.

PubMed

Smith, Peter K; Thompson, Fran; Davidson, Julia

2014-10-01

To examine cyber safety for adolescent girls, specifically issues around the definition, measurement, prevalence, and impact of cyberbullying, harassment, sexting, pornography, and solicitation. Despite some continuing disagreements about definition, especially around cyberbullying and cyber harassment, and about measurement, it is clear that a significant minority of adolescents have potentially or actually harmful experiences on the Internet. There are important sex differences, and those exploited by pornography are mainly women. On some measures, these dangers have increased in recent years, although the extent can be exaggerated. The nature of Internet grooming appears to be changing. Negative effects are well documented in a range of domains, although more longitudinal studies are needed. Individual coping strategies, family and school-based support, and legal actions, all have a role to play in minimizing these dangers. Cyber safety is an important issue. More research and action is needed, and interventions need to be evaluated for their effectiveness.

The "Goldilocks model" of overtime in construction: not too much, not too little, but just right.

PubMed

Goldenhar, Linda M; Hecker, Steven; Moir, Susan; Rosecrance, John

2003-01-01

Little research exists on the relationship between working overtime and possible adverse health and safety outcomes for construction workers. Five focus-group discussions were conducted with construction workers from around the United States. From the analyzed transcripts, a model of overtime was developed. The model includes three dominant themes: (1) work organization issues [(a) definitions of overtime, (b) scheduling, and (c) economic conditions], (2) why workers choose to work overtime [(a) management expectations, (b) career, and (c) money], and (3) the effects of working overtime [(a) health and safety, including sleep deprivation, injury, fatigue, and stress, and (b) productivity]. Health and safety is only one of the adverse outcomes related to working too much overtime. A list of worker-inspired recommendations for addressing overtime issues is provided. Both employers and workers need to better understand the potential adverse effects of working too much overtime.

Promoting public health messages: Should we move beyond fear-evoking appeals in road safety?

PubMed

Lewis, Ioni M; Watson, Barry; White, Katherine M; Tay, Richard

2007-01-01

Road traffic injury is one of the most significant global public health issues of the 21st century. The extent to which negative, fear-evoking messages represent effective persuasive strategies remains a contentious public and empirical issue. Nevertheless, negative, fear-based appeals represent a frequently used approach in Australasian road safety advertising. The authors conducted a series of focus groups with 16 licensed drivers to explore the potential utility of appeals to emotions other than fear. More specifically, they sought to explore the utility of positive emotional appeals, such as those incorporating humor. The themes emerging from the qualitative analysis suggested that both emotion and the provision of strategies are key components contributing to the overall persuasiveness of a road safety advertisement. Overall, it appears there is support for researchers and health advertising practitioners to provide further attention to the role that positive emotional appeals might play in future campaigns.

A novel approach to enhance food safety: industry-academia-government partnership for applied research.

PubMed

Osterholm, Michael T; Ostrowsky, Julie; Farrar, Jeff A; Gravani, Robert B; Tauxe, Robert V; Buchanan, Robert L; Hedberg, Craig W

2009-07-01

An independent collaborative approach was developed for stimulating research on high-priority food safety issues. The Fresh Express Produce Safety Research Initiative was launched in 2007 with $2 million in unrestricted funds from industry and independent direction and oversight from a scientific advisory panel consisting of nationally recognized food safety experts from academia and government agencies. The program had two main objectives: (i) to fund rigorous, innovative, and multidisciplinary research addressing the safety of lettuce, spinach, and other leafy greens and (ii) to share research findings as widely and quickly as possible to support the development of advanced safeguards within the fresh-cut produce industry. Sixty-five proposals were submitted in response to a publicly announced request for proposals and were competitively evaluated. Nine research projects were funded to examine underlying factors involved in Escherichia coli O157:H7 contamination of lettuce, spinach, and other leafy greens and potential strategies for preventing the spread of foodborne pathogens. Results of the studies, published in the Journal of Food Protection, help to identify promising directions for future research into potential sources and entry points of contamination and specific factors associated with harvesting, processing, transporting, and storing produce that allow contaminants to persist and proliferate. The program provides a model for leveraging the strengths of industry, academia, and government to address high-priority issues quickly and directly through applied research. This model can be productively extended to other pathogens and other leafy and nonleafy produce.

14 CFR 414.9 - Pre-application consultation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... application process and the potential issues relevant to the FAA's safety approval decision. ...

14 CFR 414.9 - Pre-application consultation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... application process and the potential issues relevant to the FAA's safety approval decision. ...

14 CFR 414.9 - Pre-application consultation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... application process and the potential issues relevant to the FAA's safety approval decision. ...

14 CFR 414.9 - Pre-application consultation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Pre-application consultation. 414.9 Section 414.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... application process and the potential issues relevant to the FAA's safety approval decision. ...

76 FR 44985 - Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-27

... Bulletin. SUMMARY: PHMSA is issuing this advisory bulletin to all owners and operators of gas and hazardous..., Nevada, Oregon, Utah, Washington, and Wyoming, call 720-963-3160. Intrastate pipeline operators should... failure near [[Page 44986

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

PubMed

de Vries, Sieta T; van der Sar, Maartje J M; Coleman, Anna Marie; Escudero, Yvette; Rodríguez Pascual, Alfonso; Maciá Martínez, Miguel-Ángel; Cupelli, Amelia; Baldelli, Ilaria; Šipić, Ivana; Andrić, Adriana; Michan, Line; Denig, Petra; Mol, Peter G M

2018-07-01

National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ 2  test per country and post hoc Pearson χ 2  tests in the case of statistically significant differences. Of the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs' awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91% aware of the diclofenac issue to 66% of the ivabradine issue). Cardiologists' awareness ranged from 91% for the ivabradine issue to 34% for the valproate issue. Overall, DHPCs were a common source through which GPs (range: 45% of those aware of the contraceptives issue to 60% of those aware of the valproate issue), cardiologists (range: 33% for the contraceptives issue to 61% for the valproate issue), and pharmacists (range: 41% for the contraceptives issue to 51% for the ivabradine issue) had become aware of the specific safety issues, followed by information on websites or in newsletters. GPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic area but with risks related to their field of specialisation. DHPCs were an important source for the different professions to become aware of specific safety issues, but other sources were also often used. NCAs should consider the use of a range of sources when communicating important safety issues to HCPs.

Capability maturity models for offshore organisational management.

PubMed

Strutt, J E; Sharp, J V; Terry, E; Miles, R

2006-12-01

The goal setting regime imposed by the UK safety regulator has important implications for an organisation's ability to manage health and safety related risks. Existing approaches to safety assurance based on risk analysis and formal safety assessments are increasingly considered unlikely to create the step change improvement in safety to which the offshore industry aspires and alternative approaches are being considered. One approach, which addresses the important issue of organisational behaviour and which can be applied at a very early stage of design, is the capability maturity model (CMM). The paper describes the development of a design safety capability maturity model, outlining the key processes considered necessary to safety achievement, definition of maturity levels and scoring methods. The paper discusses how CMM is related to regulatory mechanisms and risk based decision making together with the potential of CMM to environmental risk management.

Aviation Safety Issues Database

NASA Technical Reports Server (NTRS)

Morello, Samuel A.; Ricks, Wendell R.

2009-01-01

The aviation safety issues database was instrumental in the refinement and substantiation of the National Aviation Safety Strategic Plan (NASSP). The issues database is a comprehensive set of issues from an extremely broad base of aviation functions, personnel, and vehicle categories, both nationally and internationally. Several aviation safety stakeholders such as the Commercial Aviation Safety Team (CAST) have already used the database. This broader interest was the genesis to making the database publically accessible and writing this report.

Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

PubMed

Morgan, Sherry J; Couch, Jessica; Guzzie-Peck, Peggy; Keller, Douglas A; Kemper, Ray; Otieno, Monicah A; Schulingkamp, Robert J; Jones, Thomas W

2017-04-01

An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities.

Non-Nuclear Testing of Fission Technologies at NASA MSFC

NASA Technical Reports Server (NTRS)

Houts, Robert G.; Pearson, J. Boise; Aschenbrenner, Kenneth C.; Bradley, David E.; Dickens, Ricky E.; Emrich, William J.; Garber, Anne E.; Godfroy, Thomas J.; Harper, Roger T.; Martin, Jim J.;

Defining a Road Safety Audits Program for Enhancing Safety and Reducing Tort Liability

DOT National Transportation Integrated Search

2000-07-01

Table of Contents: (1) Introduction; (2) Review of Safety Issues; (3) Review of Legal Liability Issues; (4) Summary of Safety and Legal Liability Issues. Prepared in cooperation with Wyoming Univ., Laramie. Dept. of Civil and Architectural Engineerin...

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Consensus-based Recommendations for Research Priorities Related to Interventions to Safeguard Patient Safety in the Crowded Emergency Department

PubMed Central

Fee, Christopher; Hall, Kendall; Morrison, J. Bradley; Stephens, Robert; Cosby, Karen; Fairbanks, Rollin (Terry) J.; Youngberg, Barbara; Lenehan, Gail; Abualenain, Jameel; O’Connor, Kevin; Wears, Robert

2012-01-01

This article describes the results of the Interventions to Safeguard Safety breakout session of the 2011 Academic Emergency Medicine (AEM) consensus conference entitled “Interventions to Assure Quality in the Crowded Emergency Department.” Using a multistep nominal group technique, experts in emergency department (ED) crowding, patient safety, and systems engineering defined knowledge gaps and priority research questions related to the maintenance of safety in the crowded ED. Consensus was reached for seven research priorities related to interventions to maintain safety in the setting of a crowded ED. Included among these are: 1) How do routine corrective processes and compensating mechanism change during crowding? 2) What metrics should be used to determine ED safety? 3) How can checklists ensure safer care and what factors contribute to their success or failure? 4) What constitutes safe staffing levels / ratios? 5) How can we align emergency medicine (EM)-specific patient safety issues with national patient safety issues? 6) How can we develop metrics and skills to recognize when an ED is getting close to catastrophic overload conditions? and 7) What can EM learn from experts and modeling from fields outside of medicine to develop innovative solutions? These priorities have the potential to inform future clinical and human factors research and extramural funding decisions related to this important topic. PMID:22168192

[Case Study] CityCenter and Cosmopolitan Construction Projects, Las Vegas, Nevada: lessons learned from the use of multiple sources and mixed methods in a safety needs assessment.

PubMed

Gittleman, Janie L; Gardner, Paige C; Haile, Elizabeth; Sampson, Julie M; Cigularov, Konstantin P; Ermann, Erica D; Stafford, Pete; Chen, Peter Y

2010-06-01

The present study describes a response to eight tragic deaths over an eighteen month times span on a fast track construction project on the largest commercial development project in U.S. history. Four versions of a survey were distributed to workers, foremen, superintendents, and senior management. In addition to standard Likert-scale safety climate scale items, an open-ended item was included at the end of the survey. Safety climate perceptions differed by job level. Specifically, management perceived a more positive safety climate as compared to workers. Content analysis of the open-ended item was used to identify important safety and health concerns which might have been overlooked with the qualitative portion of the survey. The surveys were conducted to understand workforce issues of concern with the aim of improving site safety conditions. Such efforts can require minimal investment of resources and time and result in critical feedback for developing interventions affecting organizational structure, management processes, and communication. The most important lesson learned was that gauging differences in perception about site safety can provide critical feedback at all levels of a construction organization. Implementation of multi-level organizational perception surveys can identify major safety issues of concern. Feedback, if acted upon, can potentially result in fewer injuries and fatal events. (c) 2010 Elsevier Ltd. All rights reserved.

Specific issues, exact locations: case study of a community mapping project to improve safety in a disadvantaged community.

PubMed

Qummouh, Rana; Rose, Vanessa; Hall, Pat

2012-12-01

Safety is a health issue and a significant concern in disadvantaged communities. This paper describes an example of community-initiated action to address perceptions of fear and safety in a suburb in south-west Sydney which led to the development of a local, community-driven research project. As a first step in developing community capacity to take action on issues of safety, a joint resident-agency group implemented a community safety mapping project to identify the extent of safety issues in the community and their exact geographical location. Two aerial maps of the suburb, measuring one metre by two metres, were placed on display at different locations for four months. Residents used coloured stickers to identify specific issues and exact locations where crime and safety were a concern. Residents identified 294 specific safety issues in the suburb, 41.9% (n=123) associated with public infrastructure, such as poor lighting and pathways, and 31.9% (n=94) associated with drug-related issues such as drug activity and discarded syringes. Good health promotion practice reflects community need. In a very practical sense, this project responded to community calls for action by mapping resident knowledge on specific safety issues and exact locations and presenting these maps to local decision makers for further action.

Role of the independent donor advocacy team in ethical decision making.

PubMed

Rudow, Dianne LaPointe; Brown, Robert S

2005-09-01

Adult living donor liver transplantation has developed as a direct result of the critical shortage of deceased donors. Recent regulations passed by New York State require transplant programs to appoint an Independent Donor Advocacy Team to evaluate, educate, and consent to all potential living liver donors. Ethical issues surround the composition of the team, who appoints them, and the role the team plays in the process. Critics of living liver donation have questioned issues surrounding motivation and the ability of donors to provide true informed consent during a time of family crisis. This article will address issues surrounding the controversies and discuss how using the team can effectively evaluate and educate potential living liver donors and improve practice to ensure safety of living donors.

Parametric Modeling of the Safety Effects of NextGen Terminal Maneuvering Area Conflict Scenarios

NASA Technical Reports Server (NTRS)

Rogers, William H.; Waldron, Timothy P.; Stroiney, Steven R.

2011-01-01

The goal of this work was to analytically identify and quantify the issues, challenges, technical hurdles, and pilot-vehicle interface issues associated with conflict detection and resolution (CD&R)in emerging operational concepts for a NextGen terminal aneuvering area, including surface operations. To this end, the work entailed analytical and trade studies focused on modeling the achievable safety benefits of different CD&R strategies and concepts in the current and future airport environment. In addition, crew-vehicle interface and pilot performance enhancements and potential issues were analyzed based on review of envisioned NextGen operations, expected equipage advances, and human factors expertise. The results of perturbation analysis, which quantify the high-level performance impact of changes to key parameters such as median response time and surveillance position error, show that the analytical model developed could be useful in making technology investment decisions.

Safety and Environment aspects of Tokamak- type Fusion Power Reactor- An Overview

NASA Astrophysics Data System (ADS)

Doshi, Bharat; Reddy, D. Chenna

2017-04-01

Naturally occurring thermonuclear fusion reaction (of light atoms to form a heavier nucleus) in the sun and every star in the universe, releases incredible amounts of energy. Demonstrating the controlled and sustained reaction of deuterium-tritium plasma should enable the development of fusion as an energy source here on Earth. The promising fusion power reactors could be operated on the deuterium-tritium fuel cycle with fuel self-sufficiency. The potential impact of fusion power on the environment and the possible risks associated with operating large-scale fusion power plants is being studied by different countries. The results show that fusion can be a very safe and sustainable energy source. A fusion power plant possesses not only intrinsic advantages with respect to safety compared to other sources of energy, but also a negligible long term impact on the environment provided certain precautions are taken in its design. One of the important considerations is in the selection of low activation structural materials for reactor vessel. Selection of the materials for first wall and breeding blanket components is also important from safety issues. It is possible to fully benefit from the advantages of fusion energy if safety and environmental concerns are taken into account when considering the conceptual studies of a reactor design. The significant safety hazards are due to the tritium inventory and energetic neutron fluence induced activity in the reactor vessel, first wall components, blanket system etc. The potential of release of radioactivity under operational and accident conditions needs attention while designing the fusion reactor. Appropriate safety analysis for the quantification of the risk shall be done following different methods such as FFMEA (Functional Failure Modes and Effects Analysis) and HAZOP (Hazards and operability). Level of safety and safety classification such as nuclear safety and non-nuclear safety is very important for the FPR (Fusion Power Reactor). This paper describes an overview of safety and environmental merits of fusion power reactor, issues and design considerations and need for R&D on safety and environmental aspects of Tokamak type fusion reactor.

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

Aderhold, J. R.; Gordon, G.; Scott, G. W.

1976-01-01

The economic, technical, and environmental implications of remotely piloted vehicles (RVP) are examined. The time frame is 1980-85. Representative uses are selected; detailed functional and performance requirements are derived for RPV systems; and conceptual system designs are devised. Total system cost comparisons are made with non-RPV alternatives. The potential market demand for RPV systems is estimated. Environmental and safety requirements are examined, and legal and regulatory concerns are identified. A potential demand for 2,000-11,000 RVP systems is estimated. Typical cost savings of 25 to 35% compared to non-RPV alternatives are determined. There appear to be no environmental problems, and the safety issue appears manageable.

Potential contaminants in the food chain: identification, prevention and issue management.

PubMed

Scanlan, Francis P

2007-01-01

Contaminants are a vast subject area of food safety and quality. They are generally divided into chemical, microbiological and physical classes and are present in our food chain from raw materials to finished products. They are the subject of international and national legislation that has widened to cover more and more contaminant classes and food categories. In addition, consumers have become increasingly aware of and alarmed by their risks, whether rightly or not. What is the food industry doing to ensure the safety and quality of the products we feed our children? This is a valid question which this article attempts to address from an industrial viewpoint. Chemical food safety is considered a complex field where the risk perception of consumers is often the highest. The effects of chronic or acute exposure to chemical carcinogens may cause disease conditions long after exposure that can be permanently debilitating or even fatal. It is also a moving target, as knowledge about the toxicity and occurrence data of new chemical contaminants continues to be generated. Their identification, prevention and management are challenges to the food industry as a whole. A reminder of the known chemical hazards in the food chain will be presented with an emphasis on the use of early warning to identify potential new contaminants. Early warning is also a means of prevention, anticipating food safety concerns before they become issues to manage. Current best management practices including Hazard Analysis and Critical Control Points relating to the supply chain of baby foods and infant formulae will be developed. Finally, key lessons from a case study on recent contamination issues in baby food products will be presented.

Exploring the concept of medication discrepancy within the context of patient safety to improve population health.

PubMed

Murphy, Catherine R; Corbett, Cynthia L; Setter, Stephen M; Dupler, Alice

2009-01-01

Medication discrepancy is a concept often used in discussions about medication safety but has neither been fully explained nor clearly defined in the literature. This article explores medication discrepancy as it relates to patient safety and population health in the management of medications. Literature review reveals 2 main aspects of discrepancies in medication management; prescribing issues and patient adherence to regimens. Further development of the concept of medication discrepancy can be beneficial to the theorist, researcher, or clinician. Conceptual clarity about the various aspects of medication discrepancy in the context of patient safety has the potential to enhance quality improvement efforts and patient outcomes to improve population health.

Quality and strength of patient safety climate on medical-surgical units.

PubMed

Hughes, Linda C; Chang, Yunkyung; Mark, Barbara A

2009-01-01

Describing the safety climate in hospitals is an important first step in creating work environments where safety is a priority. Yet, little is known about the patient safety climate on medical-surgical units. Study purposes were to describe quality and strength of the patient safety climate on medical-surgical units and explore hospital and unit characteristics associated with this climate. Data came from a larger organizational study to investigate hospital and unit characteristics associated with organizational, nurse, and patient outcomes. The sample for this study was 3,689 RNs on 286 medical-surgical units in 146 hospitals. Nursing workgroup and managerial commitment to safety were the two most strongly positive attributes of the patient safety climate. However, issues surrounding the balance between job duties and safety compliance and nurses' reluctance to reveal errors continue to be problematic. Nurses in Magnet hospitals were more likely to communicate about errors and participate in error-related problem solving. Nurses on smaller units and units with lower work complexity reported greater safety compliance and were more likely to communicate about and reveal errors. Nurses on smaller units also reported greater commitment to patient safety and participation in error-related problem solving. Nursing workgroup commitment to safety is a valuable resource that can be leveraged to promote a sense of personal responsibility for and shared ownership of patient safety. Managers can capitalize on this commitment by promoting a work environment in which control over nursing practice and active participation in unit decisions are encouraged and by developing channels of communication that increase staff nurse involvement in identifying patient safety issues, prioritizing unit-level safety goals, and resolving day-to-day operational problems the have the potential to jeopardize patient safety.

Food safety issues affecting the dairy beef industry.

PubMed

Stefan, G

1997-12-01

The ability of dairy farmers to market cull cows and veal calves may be affected by the final rule on Pathogen Reduction and HACCP (Hazard Analysis Critical Control Points) Systems, a sweeping reform of USDA food safety regulations that was published on July 25, 1996. Although the regulations apply only to slaughter and processing plants handling meat and poultry, the rule will have an impact on food animal producers, including dairy farmers. Under this regulation, plant operators are required to evaluate potential hazards and to devise and implement controls that are appropriate for each product and plant to prevent or reduce those hazards. Processing plants may need to consider the potential hazards associated with incoming animals, such as illegal drug residues, which may result in marked changes in the relationships among some producers, livestock markets, and slaughter plants. Such information may actually improve the marketability of some animal classes because documentation will help the packer ensure the safety of products for sale to domestic and foreign markets. Dairy scientists are in an excellent position to explain the food safety issues to dairy farmers and to help develop the appropriate strategies that are necessary to guide the changes needed. These scientists can be conduits for information, the research leaders for practical solutions to reduce public health risks, and valuable resources to help farmers adjust to the impact of these new in-plant regulatory systems.

Ethical Issues in Transnational Eye Banking.

PubMed

Martin, Dominique E; Kelly, Richard; Jones, Gary L A; Machin, Heather; Pollock, Graeme A

2017-02-01

To review ethical issues that may arise in the setting of transnational eye banking activities, such as when exporting or importing corneal tissue for transplantation. A principle-based normative analysis of potential common dilemmas in transnational eye banking activities was performed. Transnational activities in eye banking, like those in other fields involving procurement and use of medical products of human origin, may present a number of ethical issues for policy makers and professionals. Key ethical concerns include the potential impact of export or import activities on self-sufficiency of corneal tissue supply within exporting and importing countries; potential disclosure requirements when obtaining consent or authorization for ocular tissue donation when donations may be exported; and difficulties inherent in assuring equity in the allocation of tissues available for export and in establishing and respecting standards of safety and quality across different jurisdictions. Further analysis of specific ethical issues in eye banking is necessary to inform development of guidelines and other governance tools that will assist policy makers and professionals to support ethical practice.

Communicating with the public about risk

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

Wade, C R; Molony, S T; Durbin, M E

1992-01-01

Risk communication is a growing specialty field in communication that draws from well-established principles of sociology and psychology. It is a new way to communicate with potentially hostile audiences about sensitive environmental, safety, and health issues they face. This paper explains the most important principles of risk communication and discusses audience analyses, perceptions of risk (outrage factors), and risk comparisons. These principles are applied to a risk communication issue in Malhuevo, a fictitious Arizona community.

Cabin Safety Issues Related to Pre-Departure and Inflight Issues

NASA Technical Reports Server (NTRS)

Connell, Linda

2014-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline. Safety reports highlighting the human element in cabin safety issues and concerns.

Return of the psychedelics: Psilocybin for treatment resistant depression.

PubMed

Patra, Suravi

2016-12-01

Psilocybin, the clinically most researched classic psychedelic has recently been tested for its safety and efficacy in a clinical population of treatment resistant depression. The efficacy of psilocybin in clinical depression previously demonstrated in the elecrophysiologic and neuroimaging findings as also in neuropsychological assessments is further validated by the findings of this rigorously conducted randomized trial. Mechanism of action of psilocybin and efficacy in treatment resistant depression are discussed in this paper. Ethical issues of conducting clinical trials with psychedelics are also discussed with particular emphasis on their relative safety and absence of addiction potential. Implications of these issues for conduct of larger trials for establishing risk benefit ratio in treatment resistant depression are further suggested. Copyright © 2016 Elsevier B.V. All rights reserved.

Project Artemis

NASA Technical Reports Server (NTRS)

Birchenough, Shawn; Kato, Denise; Kennedy, Fred; Akin, David

1990-01-01

The goals of Project Artemis are designed to meet the challege of President Bush to return to the Moon, this time to stay. The first goal of the project is to establish a permanent manned base on the Moon for the purposes of scientific research and technological development. The knowledge gained from the establishment and operations of the lunar base will then be used to achieve the second goal of Project Artemis, the establishment of a manned base on the Martian surface. Throughout both phases of the program, crew safety will be the number one priority. There are four main issues that have governed the entire program: crew safety and mission success, commonality, growth potential, and costing and scheduling. These issues are discussed in more detail.

Improving Patient Safety in Hospitals through Usage of Cloud Supported Video Surveillance

PubMed Central

Dašić, Predrag; Dašić, Jovan; Crvenković, Bojan

2017-01-01

BACKGROUND: Patient safety in hospitals is of equal importance as providing treatments and urgent healthcare. With the development of Cloud technologies and Big Data analytics, it is possible to employ VSaaS technology virtually anywhere, for any given security purpose. AIM: For the listed benefits, in this paper, we give an overview of the existing cloud surveillance technologies which can be implemented for improving patient safety. MATERIAL AND METHODS: Modern VSaaS systems provide higher elasticity and project scalability in dealing with real-time information processing. Modern surveillance technologies can prove to be an effective tool for prevention of patient falls, undesired movement and tempering with attached life supporting devices. Given a large number of patients who require constant supervision, a cloud-based monitoring system can dramatically reduce the occurring costs. It provides continuous real-time monitoring, increased overall security and safety, improved staff productivity, prevention of dishonest claims and long-term digital archiving. CONCLUSION: Patient safety is a growing issue which can be improved with the usage of high-end centralised surveillance systems allowing the staff to focus more on treating health issues rather that keeping a watchful eye on potential incidents. PMID:28507610

Response to issues on GM agriculture in Africa: Are transgenic crops safe?

PubMed

Adenle, Ademola A

2011-10-08

The controversies surrounding transgenic crops, often called Genetically Modified Organisms (GMOs), call for a need to raise the level of public awareness of Genetic Modification (GM) technology in Africa. This should be accomplished by educating the public about the potential benefits and risks that may be associated with this new technology. In the last 15 years, GM crop producing countries have benefited from adoption of this new technology in the form of improved crop productivity, food security, and quality of life. The increased income to resource-poor farmers is a key benefit at the individual level especially as most countries using this technology are in the developing world, including three African countries (South Africa, Burkina Faso and Egypt). Despite clear benefits to countries and farmers who grow GMOs, many people are concerned about suspected potential risks associated with GMOs. This sparks debate as to whether GM technology should be adopted or not. Given the concerns regarding the safety of GMO products, thorough scientific investigation of safe application of GMOs is required. The objective of this paper is to respond to the issues of GM agriculture in Africa and some of the issues surrounding the adoption of GM crops between developed and developing countries. In this article, I analyse relevant papers relating to the adoption of GM technology particularly in developing countries including the few African countries that have adopted GM crops. The issues discussed span a wide range including: safety; potential benefits and risks; disputes between the United States of America (USA) and the European Union (EU) over adoption of GM crops with a focus on Africa continent. This article is concluded by summarising the issues raised and how GM technology can be adopted for agricultural development in Africa.

Response to issues on GM agriculture in Africa: Are transgenic crops safe?

PubMed Central

2011-01-01

The controversies surrounding transgenic crops, often called Genetically Modified Organisms (GMOs), call for a need to raise the level of public awareness of Genetic Modification (GM) technology in Africa. This should be accomplished by educating the public about the potential benefits and risks that may be associated with this new technology. In the last 15 years, GM crop producing countries have benefited from adoption of this new technology in the form of improved crop productivity, food security, and quality of life. The increased income to resource-poor farmers is a key benefit at the individual level especially as most countries using this technology are in the developing world, including three African countries (South Africa, Burkina Faso and Egypt). Despite clear benefits to countries and farmers who grow GMOs, many people are concerned about suspected potential risks associated with GMOs. This sparks debate as to whether GM technology should be adopted or not. Given the concerns regarding the safety of GMO products, thorough scientific investigation of safe application of GMOs is required. The objective of this paper is to respond to the issues of GM agriculture in Africa and some of the issues surrounding the adoption of GM crops between developed and developing countries. In this article, I analyse relevant papers relating to the adoption of GM technology particularly in developing countries including the few African countries that have adopted GM crops. The issues discussed span a wide range including: safety; potential benefits and risks; disputes between the United States of America (USA) and the European Union (EU) over adoption of GM crops with a focus on Africa continent. This article is concluded by summarising the issues raised and how GM technology can be adopted for agricultural development in Africa. PMID:21981823

An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

NASA Technical Reports Server (NTRS)

Marshall, A. C.; Sawyer, J. C., Jr.

1991-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

Safety Tips from the Expert Witness.

ERIC Educational Resources Information Center

Gray, Gary R.

1995-01-01

Many physical educators and coaches use the potential for liability to guide their decisions about conducting activities. By understanding expert witnesses' roles in negligence actions, surer planning, teaching, and coaching are possible. The paper describes issues that expert witnesses examine in negligence actions against physical educators,…

77 FR 15961 - Revision of Organization and Conforming Changes to Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No... (including potential economic, environmental, public health and safety, and other advantages; distributive... Relations. Communications Staff. Office of Public Affairs. Office of Special Health Issues. Office of...

NASA S and MA at the Crossroads; The Role of NASA Quality Insight/Oversight for Commercial Crewed Launch Vehicles

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.

2010-01-01

The presentation slides examine: The Journey, Current Safety and Mission Assurance (S and MA) Oversight/Insight, The Change, The Issue, Potential NASA relationship with Commercial Partners, and Commercial "X" FRR - Are you Go.

Evaluation of the patient safety Leadership Walkabout programme of a hospital in Singapore.

PubMed

Lim, Raymond Boon Tar; Ng, Benjamin Boon Lui; Ng, Kok Mun

2014-02-01

The Patient Safety Leadership Walkabout (PSLWA) programme is a commonly employed tool in the West, in which senior leaders visit sites within the hospital that are involved in patient care to talk to healthcare staff about patient safety issues. As there is a lack of perspective regarding PSLWA in Asia, we carried out an evaluation of its effectiveness in improving the patient safety culture in Tan Tock Seng Hospital, Singapore. A mixed methods analysis approach was used to review and evaluate all documents, protocols, meeting minutes, post-walkabout surveys, action plans and verbal feedback pertaining to the walkabouts conducted from January 2005 to October 2012. A total of 321 patient safety issues were identified during the study period. Of these, 308 (96.0%) issues were resolved as of November 2012. Among the various categories of issues raised, issues related to work environment were the most common (45.2%). Of all the issues raised during the walkabouts, 72.9% were not identified through other conventional methods of error detection. With respect to the hospital's patient safety culture, 94.8% of the participants reported an increased awareness in patient safety and 90.2% expressed comfort in openly and honestly discussing patient safety issues. PSLWA serves as a good tool to uncover latent errors before actual harm reaches the patient. If properly implemented, it is an effective method for engaging leadership, identifying patient safety issues, and supporting a culture of patient safety in the hospital setting.

Radiological protection, safety and security issues in the industrial and medical applications of radiation sources

NASA Astrophysics Data System (ADS)

Vaz, Pedro

2015-11-01

The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.

Collegiate Aviation Research and Education Solutions to Critical Safety Issues. UNO Aviation Monograph Series. UNOAI Report.

ERIC Educational Resources Information Center

Bowen, Brent, Ed.

This document contains four papers concerning collegiate aviation research and education solutions to critical safety issues. "Panel Proposal Titled Collegiate Aviation Research and Education Solutions to Critical Safety Issues for the Tim Forte Collegiate Aviation Safety Symposium" (Brent Bowen) presents proposals for panels on the…

Hearing on the Reauthorization of the Higher Education Act of 1965; Sallie Mae--Safety and Soundness. Hearing before the Subcommittee on Postsecondary Education of the Committee on Education and Labor. House of Representatives, One Hundred Second Congress, First Session.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Subcommittee on Postsecondary Education.

As part of a series of hearings on the reauthorization of the Higher Education Act of 1965, testimony was heard on the safety and soundness of the Student Loan Marketing Association (Sallie Mae). Witnesses discussed many issues surrounding financial oversight of federal agencies and financial risk to the taxpayer through the potential failure of…

Safety issues in the exotic pet practice.

PubMed

Johnson-Delaney, Cathy A

2005-09-01

Small animal practitioners are well versed in the potential zoonoses from dogs and cats. Although these account for the vast majority of documented cases of zoonotic disease in humans, there are documented as well as potential zoonotic diseases that the nontraditional companion animal is capable of transmitting. This article is a compilation of potential disease risks to veterinarians, staff, and owners of nontraditional companion animals. In addition, the article may serve as a training tool for veterinary practices.

Five major NASA health and safety issues

NASA Astrophysics Data System (ADS)

Gavert, Raymond B.

2000-01-01

The goal has been set to establish NASA as number one in safety in the nation. This includes Systems and Mission Safety as well as Occupational Safety for all NASA employees and contractors on and off the job. There are five major health and safety issues important in the pursuit of being number one and they are: (1) Radiation (2) Hearing (3) Habitability/Toxicology (4) Extravehicular Activity (EVA) (5) Stress. The issues have features of accumulated injury since NASA's future missions involve long time human presence in space i.e., International Space Station operations and Mars missions. The objective of this paper is to discuss these five issues in terms of controlling risks and enhancing health and safety. Safety metrics are discussed in terms of the overall goal of NASA to be number one in safety. .

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

Ethical and medical dilemmas of space tourism

NASA Astrophysics Data System (ADS)

Marsh, Melinda

Space tourism is an important new venture, however it raises several issues that must be addressed; namely, the medical implications associated with space flight and potential for ethical problems surrounding the safety of such travel. It seems highly likely that businesses involved in space tourism could find themselves liable for any passenger deaths or injuries, if they are found to have been negligent. This paper, therefore, discusses such issues as the medical facilities that need to be made available on board a space facility, and the companies' duty to disclose to potential passengers the risks associated with microgravity and the likelihood of space sickness, loss of bone density, disease, and pregnancy.

78 FR 37675 - Federal Acquisition Regulation; Contracting Officer's Representative

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... it has either a significant effect beyond the internal operation procedures of the agency issuing the... responsibilities. This rule does not have a significant effect beyond the internal operation procedures of the... potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O...

Life in a Regulated Environment: Do You Comply with Environmental Laws?

ERIC Educational Resources Information Center

McKeague, Kevin J.

1994-01-01

Discusses the following issues: (1) implications of the Americans with Disabilities Act; (2) Asbestos Hazard Emergency Response Act regulations; (3) new lead guidelines; (4) requirements regarding underground storage tanks; (5) potential indoor air quality requirements; and (6) Occupational Safety and Health Administration guidelines. (MLF)

Positioning continuing education: boundaries and intersections between the domains continuing education, knowledge translation, patient safety and quality improvement.

PubMed

Kitto, Simon; Bell, Mary; Peller, Jennifer; Sargeant, Joan; Etchells, Edward; Reeves, Scott; Silver, Ivan

2013-03-01

Public and professional concern about health care quality, safety and efficiency is growing. Continuing education, knowledge translation, patient safety and quality improvement have made concerted efforts to address these issues. However, a coordinated and integrated effort across these domains is lacking. This article explores and discusses the similarities and differences amongst the four domains in relation to their missions, stakeholders, methods, and limitations. This paper highlights the potential for a more integrated and collaborative partnership to promote networking and information sharing amongst the four domains. This potential rests on the premise that an integrated approach may result in the development and implementation of more holistic and effective interdisciplinary interventions. In conclusion, an outline of current research that is informed by the preliminary findings in this paper is also briefly discussed. The research concerns a comprehensive mapping of the relationships between the domains to gain an understanding of potential dissonances between how the domains represent themselves, their work and the work of their 'partner' domains.

Impacts of soil and water pollution on food safety and health risks in China.

PubMed

Lu, Yonglong; Song, Shuai; Wang, Ruoshi; Liu, Zhaoyang; Meng, Jing; Sweetman, Andrew J; Jenkins, Alan; Ferrier, Robert C; Li, Hong; Luo, Wei; Wang, Tieyu

2015-04-01

Environmental pollution and food safety are two of the most important issues of our time. Soil and water pollution, in particular, have historically impacted on food safety which represents an important threat to human health. Nowhere has that situation been more complex and challenging than in China, where a combination of pollution and an increasing food safety risk have affected a large part of the population. Water scarcity, pesticide over-application, and chemical pollutants are considered to be the most important factors impacting on food safety in China. Inadequate quantity and quality of surface water resources in China have led to the long-term use of waste-water irrigation to fulfill the water requirements for agricultural production. In some regions this has caused serious agricultural land and food pollution, especially for heavy metals. It is important, therefore, that issues threatening food safety such as combined pesticide residues and heavy metal pollution are addressed to reduce risks to human health. The increasing negative effects on food safety from water and soil pollution have put more people at risk of carcinogenic diseases, potentially contributing to 'cancer villages' which appear to correlate strongly with the main food producing areas. Currently in China, food safety policies are not integrated with soil and water pollution management policies. Here, a comprehensive map of both soil and water pollution threats to food safety in China is presented and integrated policies addressing soil and water pollution for achieving food safety are suggested to provide a holistic approach. Copyright © 2014 Elsevier Ltd. All rights reserved.

Australian fly-in, fly-out operations: Impacts on communities, safety, workers and their families.

PubMed

Langdon, Rebecca R; Biggs, Herbert C; Rowland, Bevan

2016-10-17

Australia's mineral, resource and infrastructure sectors continues to expand as operations in rural and remote locations increasingly rely on fly-in, fly-out or drive-in, drive-out workforces in order to become economically competitive. The issues in effectively managing these workforces are becoming more apparent with reported high amounts of turnover and concerns for safety and performance. The issues presented include a range of physical, mental, psychosocial, safety and community challenges. This review aims to consolidate a range of research conducted to communicate potential challenges for industry in relation to a wide variety of issues when engaging and using FIFO/DIDO workforces which includes compressed working schedule design (work schedules), working hours, fatigue, safety performance, employee wellbeing, turnover, psychosocial relationships and community concerns. A comprehensive literature review was performed using EBSCOhost, PubMed and google scholar, with a focus on FIFO or DIDO workforces engaged within the resources sector. Search terms were kept broad in order to capture all national and international research conducted and included: "fly-in, fly-out" "FIFO" "DIDO" "drive-in, drive-out" "mining". There was no date restriction included in the search. Many of the studies were focused on sleep quality, fatigue and the influence of lowered safety performance while at work, presenting an increased risk for health and safety. These issues may be exacerbated for the FIFO workforce when linked to additional research surrounding the extended periods of absence from families influencing workers personal relationships, psychological wellbeing, job satisfaction and the reported high amounts of turnover within the industry. Taken together, this presents a unique implication for the management and continued use of FIFO workforces when considering balancing safety and performance with economic viability of production and operations. The issues of long working hours, fatigue, turnover and job satisfaction are not new to the management of workers. However, FIFO workforces appear to be at an increased risk physically and mentally due to a culmination of other influences, such as extended and frequent periods of absence from friends and families which contribute to feelings of isolation and lowered psychological wellbeing. FIFO workers and their families, engage in a unique lifestyle, rarely are other workers subjected to long hours and compressed work weeks while separated or isolated from their families for extended periods of time. Recently, FIFO interest has shifted to understanding the influences on employee engagement, satisfaction, retention and safety. Considering the management of FIFO workforces from a holistic perspective incorporating all of the issues impacting on these workers may assist to ensure the challenges associated with FIFO employment are understood, addressed and communicated to workers and their families is crucial for safety and health.

Microbiological Safety and Food Handling Practices of Seed Sprout Products in the Australian State of Victoria.

PubMed

Symes, Sally; Goldsmith, Paul; Haines, Heather

2015-07-01

Seed sprouts have been implicated as vehicles for numerous foodborne outbreaks worldwide. Seed sprouts pose a unique food safety concern because of the ease of microbiological seed contamination, the inherent ability of the sprouting process to support microbial growth, and their consumption either raw or lightly cooked. To examine seed sprout safety in the Australian state of Victoria, a survey was conducted to detect specific microbes in seed sprout samples and to investigate food handling practices relating to seed sprouts. A total of 298 seed sprout samples were collected from across 33 local council areas. Escherichia coli was detected in 14.8%, Listeria spp. in 12.3%, and Listeria monocytogenes in 1.3% of samples analyzed. Salmonella spp. were not detected in any of the samples. A range of seed sprout handling practices were identified as potential food safety issues in some food businesses, including temperature control, washing practices, length of storage, and storage in proximity to unpackaged ready-to-eat potentially hazardous foods.

Establishing the value of occupational health nurses' contributions to worker health and safety: a pilot test of a user-friendly estimation tool.

PubMed

Graeve, Catherine; McGovern, Patricia; Nachreiner, Nancy M; Ayers, Lynn

2014-01-01

Occupational health nurses use their knowledge and skills to improve the health and safety of the working population; however, companies increasingly face budget constraints and may eliminate health and safety programs. Occupational health nurses must be prepared to document their services and outcomes, and use quantitative tools to demonstrate their value to employers. The aim of this project was to create and pilot test a quantitative tool for occupational health nurses to track their activities and potential cost savings for on-site occupational health nursing services. Tool developments included a pilot test in which semi-structured interviews with occupational health and safety leaders were conducted to identify currents issues and products used for estimating the value of occupational health nursing services. The outcome was the creation of a tool that estimates the economic value of occupational health nursing services. The feasibility and potential value of this tool is described.

An investigation into online videos as a source of safety hazard reports.

PubMed

Nasri, Leila; Baghersad, Milad; Gruss, Richard; Marucchi, Nico Sung Won; Abrahams, Alan S; Ehsani, Johnathon P

2018-06-01

Despite the advantages of video-based product reviews relative to text-based reviews in detecting possible safety hazard issues, video-based product reviews have received no attention in prior literature. This study focuses on online video-based product reviews as possible sources to detect safety hazards. We use two common text mining methods - sentiment and smoke words - to detect safety issues mentioned in videos on the world's most popular video sharing platform, YouTube. 15,402 product review videos from YouTube were identified as containing either negative sentiment or smoke words, and were carefully manually viewed to verify whether hazards were indeed mentioned. 496 true safety issues (3.2%) were found. Out of 9,453 videos that contained smoke words, 322 (3.4%) mentioned safety issues, vs. only 174 (2.9%) of the 5,949 videos with negative sentiment words. Only 1% of randomly-selected videos mentioned safety hazards. Comparing the number of videos with true safety issues that contain sentiment words vs. smoke words in their title or description, we show that smoke words are a more accurate predictor of safety hazards in video-based product reviews than sentiment words. This research also discovers words that are indicative of true hazards versus false positives in online video-based product reviews. Practical applications: The smoke words lists and word sub-groups generated in this paper can be used by manufacturers and consumer product safety organizations to more efficiently identify product safety issues from online videos. This project also provides realistic baselines for resource estimates for future projects that aim to discover safety issues from online videos or reviews. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

PubMed

Goh, Yang Miang; Askar Ali, Mohamed Jawad

2016-08-01

One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Risk Management Plans: are they a tool for improving drug safety?

PubMed

Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

2010-08-01

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

Recent Accomplishments and Future Directions in US Fusion Safety & Environmental Program

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

David A. Petti; Brad J. Merrill; Phillip Sharpe

2006-07-01

The US fusion program has long recognized that the safety and environmental (S&E) potential of fusion can be attained by prudent materials selection, judicious design choices, and integration of safety requirements into the design of the facility. To achieve this goal, S&E research is focused on understanding the behavior of the largest sources of radioactive and hazardous materials in a fusion facility, understanding how energy sources in a fusion facility could mobilize those materials, developing integrated state of the art S&E computer codes and risk tools for safety assessment, and evaluating S&E issues associated with current fusion designs. In thismore » paper, recent accomplishments are reviewed and future directions outlined.« less

Patient safety in the care of mentally ill people in Switzerland: Action plan 2016

PubMed

Richard, Aline; Mascherek, Anna C; Schwappach, David L B

2017-01-01

Background: Patient safety in mental healthcare has not attracted great attention yet, although the burden and the prevalence of mental diseases are high. The risk of errors with potential for harm of patients, such as aggression against self and others or non-drug treatment errors is particularly high in this vulnerable group. Aim: To develop priority topics and strategies for action to foster patient safety in mental healthcare. Method: The Swiss patient safety foundation together with experts conducted round table discussions and a Delphi questionnaire to define topics along the treatment pathway, and to prioritise these topics. Finally, fields of action were developed. Results: An action plan was developed including the definition and prioritization of 9 topics where errors may occur. A global rating task revealed errors concerning diagnostics and structural errors as most important. This led to the development of 4 fields of action (awareness raising, research, implementation, and education and training) including practice-oriented potential starting points to enhance patient safety. Conclusions: The action plan highlights issues of high concern for patient safety in mental healthcare. It serves as a starting point for the development of strategies for action as well as of concrete activities.

Identification of potentially emerging food safety issues by analysis of reports published by the European Community's Rapid Alert System for Food and Feed (RASFF) during a four-year period.

PubMed

Kleter, G A; Prandini, A; Filippi, L; Marvin, H J P

2009-05-01

The SAFE FOODS project undertakes to design a new approach towards the early identification of emerging food safety hazards. This study explored the utility of notifications filed through RASFF, the European Commission's Rapid Alert System for Food and Feed, to identify emerging trends in food safety issues. RASFF information and alert notifications published in the four-year period of July 2003-June 2007 were assigned to categories of products and hazards. For chronological trend analysis, a basic time unit of three months was chosen. Data within each hazard category were analyzed for chronological trends, relationships between product and hazard categories, regions of origin, and countries filing the notifications. Conspicuous trends that were observed included a rise in the incidence of food contact substances, particularly 2-isopropyl-thioxanthone, as well as of chemical substances migrating from utensils and fraud-related issues. Temporary increases were noted in the incidences of the unauthorized dye Para Red, genetically modified organisms, the pesticide isophenfos-methyl, and herring worm, Anisakis simplex. National and European authorities themselves have signaled these conspicuous trends and taken measures. It is recommended to add complementary data to RASFF data, including safety assessments, risk management measures, background data on hazards and surveillance patterns, for a holistic approach towards early identification of emerging hazards.

Current status of environmental, health, and safety issues of nickel metal-hydride batteries for electric vehicles

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

Corbus, D; Hammel, C J; Mark, J

1993-08-01

This report identifies important environment, health, and safety issues associated with nickel metal-hydride (Ni-MH) batteries and assesses the need for further testing and analysis. Among the issues discussed are cell and battery safety, workplace health and safety, shipping requirements, and in-vehicle safety. The manufacture and recycling of Ni-MH batteries are also examined. This report also overviews the ``FH&S`` issues associated with other nickel-based electric vehicle batteries; it examines venting characteristics, toxicity of battery materials, and the status of spent batteries as a hazardous waste.

Safer Science

ERIC Educational Resources Information Center

Roy, Ken

2011-01-01

This column provides best safety practices for the science classroom and laboratory. In this month's issue, pregnancy policy in the laboratory is discussed. One can't ignore the fact that student and faculty pregnancies--and the resulting potential hazards in the science laboratory--exist at the high school level. Science teachers need to be…

Orienting apples for imaging using their inertial properties and random apple loading

USDA-ARS?s Scientific Manuscript database

The inability to control apple orientation during imaging has hindered development of automated systems for sorting apples for defects such as bruises and for safety issues such as fecal contamination. Recently, a potential method for orienting apples based on their inertial properties was discovere...

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

Hazard Identification and Risk Assessment in Water Treatment Plant considering Environmental Health and Safety Practice

NASA Astrophysics Data System (ADS)

Falakh, Fajrul; Setiani, Onny

2018-02-01

Water Treatment Plant (WTP) is an important infrastructure to ensure human health and the environment. In its development, aspects of environmental safety and health are of concern. This paper case study was conducted at the Water Treatment Plant Company in Semarang, Central Java, Indonesia. Hazard identification and risk assessment is one part of the occupational safety and health program at the risk management stage. The purpose of this study was to identify potential hazards using hazard identification methods and risk assessment methods. Risk assessment is done using criteria of severity and probability of accident. The results obtained from this risk assessment are 22 potential hazards present in the water purification process. Extreme categories that exist in the risk assessment are leakage of chlorine and industrial fires. Chlorine and fire leakage gets the highest value because its impact threatens many things, such as industrial disasters that could endanger human life and the environment. Control measures undertaken to avoid potential hazards are to apply the use of personal protective equipment, but management will also be better managed in accordance with hazard control hazards, occupational safety and health programs such as issuing work permits, emergency response training is required, Very useful in overcoming potential hazards that have been determined.

International Approaches for Nuclear Waste Disposal in Geological Formations: Report on Fifth Worldwide Review

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

Faybishenko, Boris; Birkholzer, Jens; Persoff, Peter

2016-09-01

The goal of the Fifth Worldwide Review is to document evolution in the state-of-the-art of approaches for nuclear waste disposal in geological formations since the Fourth Worldwide Review that was released in 2006. The last ten years since the previous Worldwide Review has seen major developments in a number of nations throughout the world pursuing geological disposal programs, both in preparing and reviewing safety cases for the operational and long-term safety of proposed and operating repositories. The countries that are approaching implementation of geological disposal will increasingly focus on the feasibility of safely constructing and operating their repositories in short-more » and long terms on the basis existing regulations. The WWR-5 will also address a number of specific technical issues in safety case development along with the interplay among stakeholder concerns, technical feasibility, engineering design issues, and operational and post-closure safety. Preparation and publication of the Fifth Worldwide Review on nuclear waste disposal facilitates assessing the lessons learned and developing future cooperation between the countries. The Report provides scientific and technical experiences on preparing for and developing scientific and technical bases for nuclear waste disposal in deep geologic repositories in terms of requirements, societal expectations and the adequacy of cases for long-term repository safety. The Chapters include potential issues that may arise as repository programs mature, and identify techniques that demonstrate the safety cases and aid in promoting and gaining societal confidence. The report will also be used to exchange experience with other fields of industry and technology, in which concepts similar to the design and safety cases are applied, as well to facilitate the public perception and understanding of the safety of the disposal approaches relative to risks that may increase over long times frames in the absence of a successful implementation of final dispositioning.« less

49 CFR 385.407 - What conditions must a motor carrier satisfy for FMCSA to issue a safety permit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety performance. (1) The motor carrier: (i) Must be in compliance with any remedial directive issued under subpart J of this part, and (ii) Must have a “Satisfactory” safety rating assigned by either FMCSA... FMCSA to issue a safety permit? 385.407 Section 385.407 Transportation Other Regulations Relating to...

49 CFR 385.407 - What conditions must a motor carrier satisfy for FMCSA to issue a safety permit?

Code of Federal Regulations, 2011 CFR

2011-10-01

... safety performance. (1) The motor carrier: (i) Must be in compliance with any remedial directive issued under subpart J of this part, and (ii) Must have a “Satisfactory” safety rating assigned by either FMCSA... FMCSA to issue a safety permit? 385.407 Section 385.407 Transportation Other Regulations Relating to...

Lost in hospital: a qualitative interview study that explores the perceptions of NHS inpatients who spent time on clinically inappropriate hospital wards.

PubMed

Goulding, Lucy; Adamson, Joy; Watt, Ian; Wright, John

2015-10-01

Prior research suggests that the placement of patients on clinically inappropriate hospital wards may increase the risk of experiencing patient safety issues. To explore patients' perspectives of the quality and safety of the care received during their inpatient stay on a clinically inappropriate hospital ward. Qualitative study using semi-structured interviews. Nineteen patients who had spent time on at least one clinically inappropriate ward during their hospital stay at a large NHS teaching hospital in England. Patients would prefer to be treated on the correct specialty ward, but it is generally accepted that this may not be possible. When patients are placed on inappropriate wards, they may lack a sense of belonging. Participants commented on potential failings in communication, medical staff availability, nurses' knowledge and the resources available, each of which may contribute to unsafe care. Patients generally acknowledge the need for placement on inappropriate wards due to demand for inpatient beds, but may report dissatisfaction in terms of preference and belonging. Importantly, patients recount issues resulting from this placement that may compromise their safety. Hospital managers should be encouraged to appreciate this insight and potential threat to safe practice and where possible avoid inappropriate ward transfers and admissions. Where such admissions are unavoidable, staff should take action to address the gaps in safety of care that have been identified. © 2013 John Wiley & Sons Ltd.

Eighteen years of recommendations to prevent industrial chemical incidents: results and lessons learned of the US Chemical Safety Board.

PubMed

Tinney, V A; Anenberg, S C; Kaszniak, M; Robinson, B

2016-10-01

The US Chemical Safety Board (CSB), a federal agency that investigates significant chemical incidents and hazards, is interested in determining the impact of the recommendations resulting from its investigations, and how to better more effective recommendations to prevent chemical incidents. This is a descriptive study of the US Chemical Safety Board's safety recommendations. The CSB coded and analysed its safety recommendations according to potential impact on reducing incidents, implementation status, purpose and recipient type. As of March 31, 2015, the CSB has issued 733 recommendations, 75% (548) of which are closed and 25% (185) of which remain open. For recommendations categorised as having high, medium, and low impact, 38% (78), 76% (160), and 78% (245) were implemented, respectively. CSB recommendations have led to important and lasting safety changes through regulations, industry guidance and voluntary consensus standards, and individual companies; however, coding recommendations by potential impact do not fully capture the influence of CSB recommendations. While this methodology serves as a preliminary way to determine the effect of recommendations, further data are needed to determine the extent to which these safety changes have reduced the frequency or severity of industrial accidents. Copyright © 2016 The Royal Society for Public Health. All rights reserved.

[Patient safety culture in Family practice residents of Galicia].

PubMed

Portela Romero, Manuel; Bugarín González, Rosendo; Rodríguez Calvo, María Sol

To determine the views held by Family practice (FP) residents on the different dimensions of patient safety, in order to identify potential areas for improvement. A cross-sectional study. Seven FP of Galicia teaching units. 182 FP residents who completed the Medical Office Survey on Patient Safety Culture questionnaire. The Medical Office Survey on Patient Safety Culture questionnaire was chosen because it is translated, validated, and adapted to the Spanish model of Primary Care. The results were grouped into 12 composites assessed by the mentioned questionnaire. The study variables were the socio-demographic dimensions of the questionnaire, as well as occupational/professional variables: age, gender, year of residence, and teaching unit of FP of Galicia. The "Organisational learning" and "Teamwork" items were considered strong areas. However, the "Patient safety and quality issues", "Information exchange with other settings", and "Work pressure and pace" items were considered areas with significant potential for improvement. First-year residents obtained the best results and the fourth-year ones the worst. The results may indicate the need to include basic knowledge on patient safety in the teaching process of FP residents in order to increase and consolidate the fragile patient safety culture described in this study. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues,"…

Aeromedical decision making in attention-deficit/hyperactivity disorder.

PubMed

Fitzgerald, David J P; Navathe, Pooshan D; Drane, A Michael

2011-05-01

Attention-deficit/hyperactivity disorder is a problematic diagnosis in the context of aeromedical certification. Certain characteristics of the disorder such as impaired attention potentially affect the safe conduct of flying. Pharmacological treatment with stimulants also has issues surrounding short half-lives and effects on the recognition of fatigue. This article gives a broad overview of the issues involved and provides certification guidelines as adopted in the Australian Civil Aviation Safety Authority which may be helpful if adopted by other certification bodies.

And now, from the company that brought you the seven-eyed trout: Risk communication in action

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

Durbin, M.E.; Klein, S.H.; Molony, S.T.

1992-01-01

Risk communication is a growing specialty field in communication that draws from well-established principles of sociology and psychology. It is a way to communicate with potentially hostile audiences about sensitive environmental, safety, and health issues they face. This paper explains the most important principles of risk communication and discusses audience analyses, perceptions of risk (outrage factors), and risk comparisons. These principles are applied to a risk communication issue in a fictitious community.

DELIVERY OF THERAPEUTIC PROTEINS

PubMed Central

Pisal, Dipak S.; Kosloski, Matthew P.; Balu-Iyer, Sathy V.

2009-01-01

The safety and efficacy of protein therapeutics are limited by three interrelated pharmaceutical issues, in vitro and in vivo instability, immunogenicity and shorter half-lives. Novel drug modifications for overcoming these issues are under investigation and include covalent attachment of poly(ethylene glycol) (PEG), polysialic acid, or glycolic acid, as well as developing new formulations containing nanoparticulate or colloidal systems (e.g. liposomes, polymeric microspheres, polymeric nanoparticles). Such strategies have the potential to develop as next generation protein therapeutics. This review includes a general discussion on these delivery approaches. PMID:20049941

A novel briefing checklist at shift handoff in an emergency department improves situational awareness and safety event identification.

PubMed

Mullan, Paul C; Macias, Charles G; Hsu, Deborah; Alam, Sartaj; Patel, Binita

2015-04-01

Emergency department (ED) shift handoffs are sources of potential medical error, delays in care, and medicolegal liabilities. Few handoff studies exist in the ED literature. We aimed to describe the implementation of a standardized checklist for improving situational awareness during physician handoffs in a pediatric ED. This is a descriptive observational study in a large academic pediatric ED. Checklists were evaluated for rates of use, completion, and identification of potential safety events. We defined a complete checklist as 80% or more of items checked.  A user perception survey was used. After 1 year, all checklist users (residents, fellows, faculty, and charge nurses with ED experience before and after checklist implementation) were anonymously surveyed to assess the checklist's usability, perceived contributions to Institute of Medicine quality domains, and situational awareness. The electronically administered survey used Likert frequency scales. Of 732 handoffs, 98% used the checklist, and 89% were complete. A mean of 1.7 potential safety events were identified per handoff. The most frequent potential safety events were identification of intensive care unit-level patients in the ED (48%), equipment problems (46%), staffing issues (21%), and intensive care unit-level patients in transport (16%). Eighty-one subjects (88%) responded to the survey. The users agreed that the checklist promoted better communication, safety, efficiency, effective care, and situational awareness. The Physician Active Shift Signout in the Emergency Department briefing checklist was used often and at a high completion rate, frequently identifying potential safety events. The users found that it improved the quality of care and team communication. Future studies on outcomes and processes are needed.

Alaska Humans Factors Safety Study: The Southern Coastal Area

NASA Technical Reports Server (NTRS)

Chappell, Sheryl L.; Reynard, William (Technical Monitor)

1995-01-01

At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASA-ASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the southern coastal areas, specifically: Anchorage, Dillingham, King Salmon, Kodiak, Cold Bay, Juneau, and Ketchikan. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

Comprehensive in vitro Proarrhythmia Assay (CiPA): Pending issues for successful validation and implementation.

PubMed

Cavero, Icilio; Guillon, Jean-Michel; Ballet, Veronique; Clements, Mike; Gerbeau, Jean-Frédéric; Holzgrefe, Henry

2016-01-01

The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a nonclinical Safety Pharmacology paradigm for discovering electrophysiological mechanisms that are likely to confer proarrhythmic liability to drug candidates intended for human use. Key talks delivered at the 'CiPA on my mind' session, held during the 2015 Annual Meeting of the Safety Pharmacology Society (SPS), are summarized. Issues and potential solutions relating to crucial constituents [e.g., biological materials (ion channels and pluripotent stem cell-derived cardiomyocytes), study platforms, drug solutions, and data analysis] of CiPA core assays are critically examined. In order to advance the CiPA paradigm from the current testing and validation stages to a research and regulatory drug development strategy, systematic guidance by CiPA stakeholders is necessary to expedite solutions to pending and newly arising issues. Once a study protocol is proved to yield robust and reproducible results within and across laboratories, it can be implemented as qualified regulatory procedure. Copyright © 2016 Elsevier Inc. All rights reserved.

Aviation safety data accessibility study index: a report on the issues related to public interest in aviation safety data

DOT National Transportation Integrated Search

1997-01-20

This paper reviews aviation safety data and measurement issues relevant to the determination of the best means of providing safety information to the public while ensuring the integrity of the aviation safety system. In addition , the paper examines ...

29 CFR 1902.1 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... State law over any occupational safety or health issue with respect to which a Federal standard has been... occupational safety or health issue covered by the plan. Notwithstanding plan approval and a determination... safety and health issues as possible. To these ends, the Assistant Secretary intends to cooperate with...

New Automated System Available for Reporting Safety Concerns | Poster

Cancer.gov

A new system has been developed for reporting safety issues in the workplace. The Environment, Health, and Safety’s (EHS’) Safety Inspection and Issue Management System (SIIMS) is an online resource where any employee can report a problem or issue, said Siobhan Tierney, program manager at EHS.

Development of safe infrared gas lasers

NASA Astrophysics Data System (ADS)

Mainuddin; Singhal, Gaurav; Tyagi, R. K.; Maini, A. K.

2013-04-01

Infrared gas lasers find application in numerous civil and military areas. Such lasers are therefore being developed at different institutions around the world. However, the development of chemical infrared gas lasers such as chemical oxygen iodine lasers (COIL) involves the use of several hazardous chemicals. In order to exploit full potential of these lasers, one must take diligent care of the safety issues associated with the handling of these chemicals and the involved processes. The present paper discusses the safety aspects to be taken into account in the development of these infrared gas lasers including various detection sensors working in conjunction with a customized data acquisition system loaded with safety interlocks for safe operation. The developed safety schemes may also be implemented for CO2 gas dynamic laser (GDL) and hydrogen fluoride-deuterium fluoride (HF-DF) Laser.

What has change management in industry got to do with improving patient safety?

PubMed

Noble, Douglas J; Lemer, Claire; Stanton, Emma

2011-05-01

Healthcare is often in a constant state of change - for political, technological, patient related, and scientific reasons. Yet, for a business where change is the norm, too little time is spent thinking theoretically about how change occurs. One area where change is still needed is in patient safety. Presented is an analysis of the literature on change to suggest how this may inform patient safety. No one change approach guarantees success in patient safety. Success very much depends on selecting the best fit change framework and adapting it to local context. Well regarded change models, like that of Kotter, are not well tested within a healthcare context. Those that are, such as Pettigrew, do not specifically address all the issues associated with patient safety. Kotter's phases of change may be applied in a healthcare context to enhance patient safety. Kotter's model is well studied in non-healthcare contexts and has potential to be adapted for improving patient safety.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-09-01

There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-01-01

ABSTRACT Background: There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. Objective: To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Methods: Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. Results: The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Conclusion: Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care. PMID:26339832

49 CFR 385.413 - What happens if a motor carrier receives a proposed safety rating that is less than Satisfactory?

Code of Federal Regulations, 2010 CFR

2010-10-01

... proposed safety rating that is less than Satisfactory? 385.413 Section 385.413 Transportation Other... Satisfactory? (a) If a motor carrier does not already have a safety permit, it will not be issued a safety permit (including a temporary safety permit) unless and until a Satisfactory safety rating is issued to...

Assessment and management of the violent patient.

PubMed Central

Bell, C. C.

2000-01-01

This article provides guidance on how to manage the unavoidable challenge of aggression in psychiatric relationships. Accordingly, this article addresses issues of personal safety and how to manage potentially violent patients, defuse situations that threaten imminent violence, and manage emergent violence. In addition, a useful chart is highlighted that differentiates different types of violence. PMID:10881474

Nuclear Powerplant Safety: Source Terms. Nuclear Energy.

ERIC Educational Resources Information Center

Department of Energy, Washington, DC. Nuclear Energy Office.

There has been increased public interest in the potential effects of nuclear powerplant accidents since the Soviet reactor accident at Chernobyl. People have begun to look for more information about the amount of radioactivity that might be released into the environment as a result of such an accident. When this issue is discussed by people…

What Are College Students' Perceptions about Campus Safety?

ERIC Educational Resources Information Center

Chekwa, Charles; Thomas, Eugene, Jr.; Jones, Valerie James

2013-01-01

Crime and violence on college and university campuses have found their way into the media spotlight. As a result, criminal and violent acts have become issues that warrant research. We discuss literature focused on the potential contributing factors that may lead to violent behavior. Additionally, we review legislation intended to protect students…

Cellular Radio Telecommunication for Health Care: Benefits and Risks

PubMed Central

Sneiderman, Charles A.; Ackerman, Michael J.

2004-01-01

Cellular radio telecommunication has increased exponentially with many applications to health care reported. The authors attempt to summarize published applications with demonstrated effect on health care, review briefly the rapid evolution of hardware and software standards, explain current limitations and future potential of data quality and security, and discuss issues of safety. PMID:15298996

Risk Management for Study Abroad Programs: Issues and Resources to Inform Program Development, Administration, and Training

ERIC Educational Resources Information Center

Rhodes, Gary

2014-01-01

This chapter provides a practical background to the health and safety risks and challenges for U.S. colleges and universities and other program providers. Potential risks, field-based guidelines, good practices, and resources to support the management of risks by study abroad offices will be covered.

Safety issues and new rapid detection methods in traditional Chinese medicinal materials

PubMed Central

Wang, Lili; Kong, Weijun; Yang, Meihua; Han, Jianping; Chen, Shilin

2015-01-01

The safety of traditional Chinese medicine (TCM) is a major strategic issue that involves human health. With the continuous improvement in disease prevention and treatment, the export of TCM and its related products has increased dramatically in China. However, the frequent safety issues of Chinese medicine have become the ‘bottleneck’ impeding the modernization of TCM. It was proved that mycotoxins seriously affect TCM safety; the pesticide residues of TCM are a key problem in TCM international trade; adulterants have also been detected, which is related to market circulation. These three factors have greatly affected TCM safety. In this study, fast, highly effective, economically-feasible and accurate detection methods concerning TCM safety issues were reviewed, especially on the authenticity, mycotoxins and pesticide residues of medicinal materials. PMID:26579423

75 FR 34520 - The Future of Aviation Advisory Committee (FAAC) Aviation Safety Subcommittee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... of the global economy. The Aviation Safety Subcommittee will develop a list of priority safety issues...-- 1. Develop a list of priority safety issues to be referred to the full committee for deliberation. 2...

Incorporating organisational safety culture within ergonomics practice.

PubMed

Bentley, Tim; Tappin, David

2010-10-01

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

Maximising harm reduction in early specialty training for general practice: validation of a safety checklist

PubMed Central

2012-01-01

Background Making health care safer is a key policy priority worldwide. In specialty training, medical educators may unintentionally impact on patient safety e.g. through failures of supervision; providing limited feedback on performance; and letting poorly developed behaviours continue unchecked. Doctors-in-training are also known to be susceptible to medical error. Ensuring that all essential educational issues are addressed during training is problematic given the scale of the tasks to be undertaken. Human error and the reliability of local systems may increase the risk of safety-critical topics being inadequately covered. However adherence to a checklist reminder may improve the reliability of task delivery and maximise harm reduction. We aimed to prioritise the most safety-critical issues to be addressed in the first 12-weeks of specialty training in the general practice environment and validate a related checklist reminder. Methods We used mixed methods with different groups of GP educators (n = 127) and specialty trainees (n = 9) in two Scottish regions to prioritise, develop and validate checklist content. Generation and refinement of checklist themes and items were undertaken on an iterative basis using a range of methods including small group work in dedicated workshops; a modified-Delphi process; and telephone interviews. The relevance of potential checklist items was rated using a 4-point scale content validity index to inform final inclusion. Results 14 themes (e.g. prescribing safely; dealing with medical emergency; implications of poor record keeping; and effective & safe communication) and 47 related items (e.g. how to safety-net face-to-face or over the telephone; knowledge of practice systems for results handling; recognition of harm in children) were judged to be essential safety-critical educational issues to be covered. The mean content validity index ratio was 0.98. Conclusion A checklist was developed and validated for educational supervisors to assist in the reliable delivery of safety-critical educational issues in the opening 12-week period of training, and aligned with national curriculum competencies. The tool can also be adapted for use as a self-assessment instrument by trainees to guide patient safety-related learning needs. Dissemination and implementation of the checklist and self-rating scale are proceeding on a national, voluntary basis with plans to evaluate its feasibility and educational impact. PMID:22721273

Maximising harm reduction in early specialty training for general practice: validation of a safety checklist.

PubMed

Bowie, Paul; McKay, John; Kelly, Moya

2012-06-21

Making health care safer is a key policy priority worldwide. In specialty training, medical educators may unintentionally impact on patient safety e.g. through failures of supervision; providing limited feedback on performance; and letting poorly developed behaviours continue unchecked. Doctors-in-training are also known to be susceptible to medical error. Ensuring that all essential educational issues are addressed during training is problematic given the scale of the tasks to be undertaken. Human error and the reliability of local systems may increase the risk of safety-critical topics being inadequately covered. However adherence to a checklist reminder may improve the reliability of task delivery and maximise harm reduction. We aimed to prioritise the most safety-critical issues to be addressed in the first 12-weeks of specialty training in the general practice environment and validate a related checklist reminder. We used mixed methods with different groups of GP educators (n=127) and specialty trainees (n=9) in two Scottish regions to prioritise, develop and validate checklist content. Generation and refinement of checklist themes and items were undertaken on an iterative basis using a range of methods including small group work in dedicated workshops; a modified-Delphi process; and telephone interviews. The relevance of potential checklist items was rated using a 4-point scale content validity index to inform final inclusion. 14 themes (e.g. prescribing safely; dealing with medical emergency; implications of poor record keeping; and effective & safe communication) and 47 related items (e.g. how to safety-net face-to-face or over the telephone; knowledge of practice systems for results handling; recognition of harm in children) were judged to be essential safety-critical educational issues to be covered. The mean content validity index ratio was 0.98. A checklist was developed and validated for educational supervisors to assist in the reliable delivery of safety-critical educational issues in the opening 12-week period of training, and aligned with national curriculum competencies. The tool can also be adapted for use as a self-assessment instrument by trainees to guide patient safety-related learning needs. Dissemination and implementation of the checklist and self-rating scale are proceeding on a national, voluntary basis with plans to evaluate its feasibility and educational impact.

The impact of biotechnology on agricultural worker safety and health.

PubMed

Shutske, J M; Jenkins, S M

2002-08-01

Biotechnology applications such as the use and production of genetically modified organisms (GMOs) have been widely promoted, adopted, and employed by agricultural producers throughout the world. Yet, little research exists that examines the implications of agricultural biotechnology on the health and safety of workers involved in agricultural production and processing. Regulatory frameworks do exist to examine key issues related to food safety and environmental protection in GMO applications. However, based on the lack of research and regulatory oversight, it would appear that the potential impact on the safety and health of workers is of limited interest. This article examines some of the known worker health and safety implications related to the use and production of GMOs using the host, agent, and environment framework. The characteristics of employers, workers, inputs, production practices, and socio-economic environments in which future agricultural workers perform various tasks is likely to change based on the research summarized here.

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

PubMed

Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

2011-11-01

Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our analysis (DHPCs related to contamination/medication error). Six 'index' drugs were paired, each with one to six 'follow-on' drugs. Three concerned drug-drug interactions (DDIs); the other three were intracranial haemorrhage, neuromuscular weakness and severe skin/hepatic reactions. All but one 'follow-on' drug had information in the EPAR on that specific ADR (i.e. attention was paid to the ADR). The DDIs were addressed in pre-marketing studies and/or the SmPC. Two of the other ADRs were addressed by postmarketing surveillance commitments; intracranial haemorrhage was not addressed. Three safety issues for two 'index' drugs could not be paired with a 'follow-on' drug as no drug in the same class was approved after the corresponding DHPCs were issued. Five of the nine safety issues were added to at least one of the current SmPCs for the 'older' drugs already on the market at the time of DHPC issue. Two safety issues were already in the SmPC of the 'older' drugs at time of market approval and two were not introduced into the SmPC of 'older' drugs. Population size to assess short-term safety complied with the guidelines for four 'index', seven 'follow-on' and three 'older' drugs; population size to assess long-term safety complied for one, three and two drugs, respectively. For five drugs, EPARs did not provide adequate information on population size. No statistically significant difference in development time between 'index' and 'follow-on' drugs was found. Generally, safety issues were taken into account in the approval process of other drugs in the class. The approaches were different and determined by the nature of the ADR. Taking safety issues into account in the approval process did not seem to impact on the time taken to perform the pre-approval clinical programme.

Security Implications of Physical Design Attributes in the Emergency Department.

PubMed

Pati, Debajyoti; Pati, Sipra; Harvey, Thomas E

2016-07-01

Security, a subset of safety, is equally important in the efficient delivery of patient care. The emergency department (ED) is susceptible to violence creating concerns for the safety and security of patients, staff, and visitors and for the safe and efficient delivery of care. Although there is an implicit and growing recognition of the role of the physical environment, interventions typically have been at the microlevel. The objective of this study was to identify physical design attributes that potentially influence safety and efficiency of ED operations. An exploratory, qualitative research design was adopted to examine the efficiency and safety correlates of ED physical design attributes. The study comprised a multimeasure approach involving multidisciplinary gaming, semistructured interviews, and touring interviews of frontline staff in four EDs at three hospital systems across three states. Five macro physical design attributes (issues that need to be addressed at the design stage and expensive to rectify once built) emerged from the data as factors substantially associated with security issues. They are design issues pertaining to (a) the entry zone, (b) traffic management, (c) patient room clustering, (d) centralization versus decentralization, and (e) provisions for special populations. Data from this study suggest that ED security concerns are generally associated with three sources: (a) gang-related violence, (b) dissatisfied patients, and (c) behavioral health patients. Study data show that physical design has an important role in addressing the above-mentioned concerns. Implications for ED design are outlined in the article. © The Author(s) 2016.

Assessing the Biological Safety Profession's Evaluation and Control of Risks Associated with the Field Collection of Potentially Infectious Specimens.

PubMed

Patlovich, Scott J; Emery, Robert J; Whitehead, Lawrence W; Brown, Eric L; Flores, Rene

2015-03-01

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting field collection activities) indicated that training on field research safety issues would be helpful, and even more (71% overall; 93% from institutions conducting field collection activities) would consider participation in such a training course. Results obtained from this study can be used to develop a field research safety toolkit and associated training curricula specifically targeted to biological safety professionals.

Signal treatments to reduce heavy vehicle crash-risk at metropolitan highway intersections.

PubMed

Archer, Jeffery; Young, William

2009-05-01

Heavy vehicle red-light running at intersections is a common safety problem that has severe consequences. This paper investigates alternative signal treatments that address this issue. A micro-simulation analysis approach was adopted as a precursor to a field trial. The simulation model emulated traffic conditions at a known problem intersection and provided a baseline measure to compare the effects of: an extension of amber time; an extension of green for heavy vehicles detected in the dilemma zone at the onset of amber; an extension of the all-red safety-clearance time based on the detection of vehicles considered likely to run the red light at two detector locations during amber; an extension of the all-red safety-clearance time based on the detection of potential red-light runners during amber or red; and a combination of the second and fourth alternatives. Results suggested safety improvements for all treatments. An extension of amber provided the best safety effect but is known to be prone to behavioural adaptation effects and wastes traffic movement time unnecessarily. A green extension for heavy vehicles detected in the dilemma zone and an all-red extension for potential red-light runners were deemed to provide a sustainable safety improvement and operational efficiency.

Safety in numbers? Tackling domestic abuse in couples and network therapies.

PubMed

Galvani, Sarah A

2007-03-01

Family, network or couples-based therapies have been helping to support people with substance problems for decades. Their value in supporting a person to change their alcohol or drug use is clear. However, as links between substance use and domestic abuse are increasingly recognised, these approaches need to reflect on the potential safety risks they present to people taking part. The prevalence of domestic abuse among people receiving drug and alcohol services is considerably higher than general population estimates, yet this does not appear to have been adequately addressed in network therapies. This article suggests that this needs to change and that safety of service users needs to be at least as important as the intervention itself. It offers for debate a number of potential safety issues raised by network therapies where there is evidence of domestic abuse; it provides examples of three approaches used to marshal social and network support in substance interventions; and offers a number of suggestions for how network therapies can ensure their use remains safe and supportive where there is domestic abuse.

Safety assessment of personal care products/cosmetics and their ingredients.

PubMed

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.

Safety assessment of personal care products/cosmetics and their ingredients

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

Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.« less

One-Day Conference on School Safety & Security and Fair Dismissals Issues (Dayton, Ohio, June 24, 1999).

ERIC Educational Resources Information Center

Education Law Association, Dayton, OH.

This booklet contains five chapters relating to issues in school safety and security, and fair dismissals: (1) "Ohio Legislation and Federal and State Decisions" (Richard J. Dickinson). Items of deliberation include financial matters, school safety issues, administrator and teacher contract matters, Title IX liability, school prayer, drug testing…

Health and Safety Issues of Telecommuters: A Macroergonomic Perspective

DTIC Science & Technology

2004-06-01

Issues of Telecommuters : A Macroergonomic Perspective Michelle M. Robertson Liberty Mutual Research Institute for Safety, Hopkinton...Massachussetts, USA. Abstract. With the rising number of telecommuters who are working in non-traditional work locations, health and safety issues are...even more critical. While telecommuting programs offer attractive alternatives to traditional work locations, it is not without challenges for

The effect of governance mechanisms on food safety in the supply chain: Evidence from the Lebanese dairy sector.

PubMed

Abebe, Gumataw K; Chalak, Ali; Abiad, Mohamad G

2017-07-01

Food safety is a key public health issue worldwide. This study aims to characterise existing governance mechanisms - governance structures (GSs) and food safety management systems (FSMSs) - and analyse the alignment thereof in detecting food safety hazards, based on empirical evidence from Lebanon. Firm-to-firm and public baseline are the dominant FSMSs applied in a large-scale, while chain-wide FSMSs are observed only in a small-scale. Most transactions involving farmers are relational and market-based in contrast to (large-scale) processors, which opt for hierarchical GSs. Large-scale processors use a combination of FSMSs and GSs to minimise food safety hazards albeit potential increase in coordination costs; this is an important feature of modern food supply chains. The econometric analysis reveals contract period, on-farm inspection and experience having significant effects in minimising food safety hazards. However, the potential to implement farm-level FSMS is influenced by formality of the contract, herd size, trading partner choice, and experience. Public baseline FSMSs appear effective in controlling food safety hazards; however, this may not be viable due to the scarcity of public resources. We suggest public policies to focus on long-lasting governance mechanisms by introducing incentive schemes and farm-level FSMSs by providing loans and education to farmers. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Criteria for risk acceptance: a health physicist's view. [Cost benefits of nuclear power

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

Hull, A P

1977-01-01

A controversy over the safety of nuclear energy has grown in the U.S. since about 1970 and has now spread to near worldwide proportions. This controversy has been fueled by a variety of issues. Initially in the U.S. the most prominent issue concerned the degree of hazard of low-level radiation, in particular that associated with the nuclear fuel cycle. Since then, attention has shifted successively to the reliability of emergency core cooling systems, the longevity of nuclear wastes, the possible misuse of radioactivity by terrorists and the potential for diversion of nuclear-power-produced plutonium to weapons fabrication. Underlying each of thesemore » issues has been the implication that the employment of nuclear power will entail an unacceptable risk to the public. A reasonable perspective in this regard is a yearly risk of 1 x 10/sup -6/ compared to the level of natural hazards such as earthquakes, floods, hurricanes, and tornados. Following a satisfactory demonstration of the safety of nuclear energy, hopefully the nuclear argument could be terminated. Society could then move on to the real issues affecting energy, population and quality of life.« less

Public Health, Ethics, and Autonomous Vehicles

PubMed Central

2017-01-01

With the potential to save nearly 30 000 lives per year in the United States, autonomous vehicles portend the most significant advance in auto safety history by shifting the focus from minimization of postcrash injury to collision prevention. I have delineated the important public health implications of autonomous vehicles and provided a brief analysis of a critically important ethical issue inherent in autonomous vehicle design. The broad expertise, ethical principles, and values of public health should be brought to bear on a wide range of issues pertaining to autonomous vehicles. PMID:28207327

Public Health, Ethics, and Autonomous Vehicles.

PubMed

Fleetwood, Janet

2017-04-01

With the potential to save nearly 30 000 lives per year in the United States, autonomous vehicles portend the most significant advance in auto safety history by shifting the focus from minimization of postcrash injury to collision prevention. I have delineated the important public health implications of autonomous vehicles and provided a brief analysis of a critically important ethical issue inherent in autonomous vehicle design. The broad expertise, ethical principles, and values of public health should be brought to bear on a wide range of issues pertaining to autonomous vehicles.

Tank 241-C-112 vapor sampling and analysis tank characterization report. Revision 1

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

Huckaby, J.L.

1995-05-31

Tank 241-C-112 headspace gas and vapor samples were collected and analyzed to help determine the potential risks to tank farm workers due to fugitive emissions from the tank. The drivers and objectives of waste tank headspace sampling and analysis are discussed in {open_quotes}Program Plan for the Resolution of Tank Vapor Issues.{close_quotes} Tank 241-C-112 was vapor sampled in accordance with {open_quotes}Data Quality Objectives for Generic In-Tank Health and Safety Issue Resolution.{close_quotes}

What about the dentist-patient relationship in dental tourism?

PubMed

Conti, Adelaide; Delbon, Paola; Laffranchi, Laura; Paganelli, Corrado

2014-03-01

Dental tourism is patients travelling across international borders with the intention of receiving dental care. It is a growing phenomenon that raises many ethical issues, particularly regarding the dentist-patient relationship. We discuss various issues related to this phenomenon, including patient autonomy over practitioner choice, patient safety, continuity of care, informed consent and doctor-patient communication, among other factors. In particular, patients partaking in medical tourism should be informed of its potential problems and the importance of proper planning and post-treatment care to guarantee high-quality treatment outcomes.

Safety Issues with Hydrogen as a Vehicle Fuel

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

Cadwallader, Lee Charles; Herring, James Stephen

1999-10-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This reportmore » serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.« less

Safety Issues with Hydrogen as a Vehicle Fuel

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

L. C. Cadwallader; J. S. Herring

1999-09-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This reportmore » serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.« less

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

PubMed

Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

2013-04-18

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

Novel approaches to improving the chemical safety of the meat chain towards toxicants.

PubMed

Engel, E; Ratel, J; Bouhlel, J; Planche, C; Meurillon, M

2015-11-01

In addition to microbiological issues, meat chemical safety is a growing concern for the public authorities, chain stakeholders and consumers. Meat may be contaminated by various chemical toxicants originating from the environment, treatments of agricultural production or food processing. Generally found at trace levels in meat, these toxicants may harm human health during chronic exposure. This paper overviews the key issues to be considered to ensure better control of their occurrence in meat and assessment of the related health risk. We first describe potential contaminants of meat products. Strategies to move towards a more efficient and systematic control of meat chemical safety are then presented in a second part, with a focus on emerging approaches based on toxicogenomics. The third part presents mitigation strategies to limit the impact of process-induced toxicants in meat. Finally, the last part introduces methodological advances to refine chemical risk assessment related to the occurrence of toxicants in meat by quantifying the influence of digestion on the fraction of food contaminants that may be assimilated by the human body. Copyright © 2015 Elsevier Ltd. All rights reserved.

Administrative and research policies required to bring cellular therapies from the research laboratory to the patient's bedside.

PubMed

Yim, Robyn

2005-10-01

The research process is a balance between the inherent risks of new discoveries and the risks of research participant safety. Conflicts of interest, inherent to the research process, as well as those introduced by emerging cellular therapies, have the potential to compromise safety. The relationship of trust between the researcher and the clinical trial participant facilitates objective decision making, in the best interest of both parties. In the setup of each clinical trial, investigators incorporate ethical, political, legal, financial, and regulatory considerations as protocols are established. Responsibility to abide by these decisions ensures a systematic process and safeguards participants in this process. The integrity of the research process is strengthened by identifying potential conflicting issues with the guiding principles established in the protocols, which may threaten the objectivity of involved parties and jeopardize safety of the participants. The rapid pace and changing paradigms of new discoveries in cellular therapies exaggerate existing conflicts and introduce new ones. Ethical issues raised by emerging cellular therapies include the division of opinions regarding the use of embryonic and fetal tissue to develop stem cell lines for research, the individual versus professional conscience of a researcher, overselling of outcomes as a result of the researcher's desire to be the first to discover a cellular therapy, and therapeutic misconception resulting from a participant's desire for a miracle cure. The basic ethical issue of whether stem cells should be utilized as a cellular therapy raises heated debates because some believe that it is not acceptable to use fetal material as a source of research material for future cures and others feel equally as strong that inaction is unethical because it results in needless suffering and death owing to the absence of this research. Political issues include the divergent position statements of presidential administrations on cellular therapy, variations in individual state laws, and states becoming involved in research funding, such as California's Proposition 71. Legal concerns include expanding private litigation with diversity of lawsuits, expanding lists of defendants, and the use of class-action lawsuits in research cases. Ownership issues also arise in terms of intellectual property, patents, and ownership of stem cells collected from minors, as in umbilical cord blood donations. Situations that challenge the regulatory processes established to ensure participant safety include differences in reporting requirements for private- and public-funded research and the lack of adequate funding and resources to implement and support the institutional review board (IRB) process. Financial considerations influence the development of clinical protocols, because funding is often limited. Financial incentives, personal investment in companies funding research activities, and fundraising pressures may present potential conflicts. In addition, the increasing role of emerging biotechnology start-up companies and pharmaceutical companies in clinical research introduces additional financial considerations. Administrative policies are needed to address these possible conflicts and ensure research participant safety as cellular therapies progress from the research laboratories to the patient's bedside. Administrative policies to ensure minimum standards of quality for emerging products before human clinical trials, policies to enforce consistent reporting requirements for private and public cellular research, policies to minimize financial conflicts of interest, policies to strengthen implementation of the existing IRB process and to structure into the process a consistent, systematic review of these identified conflicts, and policies to limit private litigation will help to preserve the objectivity of the review process and ultimately increase participant safety.

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

Aderhold, J. R.; Gordon, G.; Scott, G. W.

1976-01-01

The technology effort is identified and assessed that is required to bring the civil uses of RPVs to fruition and to determine whether or not the potential market is real and economically practical, the technologies are within reach, the operational problems are manageable, and the benefits are worth the cost. To do so, the economic, technical, and environmental implications are examined. The time frame is 1980-85. Representative uses are selected; detailed functional and performance requirements are derived for RPV systems; and conceptual system designs are devised. Total system cost comparisons are made with non-RPV alternatives. The potential market demand for RPV systems is estimated. Environmental and safety requirements are examined, and legal and regulatory concerns are identified. A potential demand for 2,000-11,000 RPV systems is estimated. Typical cost savings of 25-35% compared to non-RPV alternatives are determined. There appear to be no environmental problems, and the safety issue appears manageable.

Integrating Public Relations and Legal Responses during a Crisis: The Case of Odwalla, Inc.

ERIC Educational Resources Information Center

Martinelli, Kathleen A.; Briggs, William

1998-01-01

Examines the crisis-communication strategies employed by Odwalla, Inc. during its juice contamination crisis, a crisis whose impact on public health and safety gave it the potential for developing into an issue that required public policy relief. Finds that public-relations response strategies dominated legal response strategies, followed by mixed…

Occupational health and safety issues in military field hospitals.

PubMed

Bricknell, M C

2001-10-01

This paper considers the occupational health and safety issues that apply within a military field hospital. It considers NHS occupational health and safety activities and examines how these might be applied within an Army Medical Services unit. Areas that are unique to field hospitals are highlighted in comparison with a static NHS hospital. Some issues for future work are also considered.

Compressed Natural Gas Safety in Transit Operations

DOT National Transportation Integrated Search

1995-09-14

This report examines the safety issues relating to the use of Compressed Natural Gas (CNG) in transit service. The safety issues were determined by on-site surveys performed by Battelle of Columbus, Ohio and Science Applications International Corpora...

Anthropology in Agricultural Health and Safety Research and Intervention.

PubMed

Arcury, Thomas

2017-01-01

Agriculture remains a dangerous industry, even as agricultural science and technology continue to advance. Research that goes beyond technological changes to address safety culture and policy are needed to improve health and safety in agriculture. In this commentary, I consider the potential for anthropology to contribute to agricultural health and safety research by addressing three aims: (1) I briefly consider what the articles in this issue of the Journal of Agromedicine say about anthropologists in agricultural health and safety; (2) I discuss what anthropologists can add to agricultural health and safety research; and (3) I examine ways in which anthropologists can participate in agricultural health and safety research. In using their traditions of rigorous field research to understand how those working in agriculture perceive and interpret factors affecting occupational health and safety (their "emic" perspective), and translating this perspective to improve the understanding of occupational health professionals and policy makers (an "etic" perspective), anthropologists can expose myths that limit improvements in agricultural health and safety. Addressing significant questions, working with the most vulnerable agricultural communities, and being outside establishment agriculture provide anthropologists with the opportunity to improve health and safety policy and regulation in agriculture.

Patients' Perspectives of Engagement as a Safety Strategy.

PubMed

Burrows Walters, Chasity; Duthie, Elizabeth A

2017-11-01

To describe patient engagement as a safety strategy from the perspective of hospitalized surgical patients with cancer.
. Qualitative, descriptive approach using grounded theory.
. Memorial Sloan Kettering Cancer Center in New York, New York.
. 13 hospitalized surgical patients with cancer.
. Grounded theory with maximum variation sampling.
. Participants' perceptions regarding their engagement as a patient safety strategy were expressed through three overarching themes. Using direct messaging, such as "your safety" as opposed to "patient safety," and teaching patients specific behaviors to maintain their safety appeared to facilitate patient engagement and increase awareness of safety issues. Patients may be willing to accept some responsibility for ensuring their safety by engaging in behaviors that are intuitive or that they are clearly instructed to do; however, they described their involvement in their safety as a right, not an obligation.
. Clear, inviting, multimodal communication appears to have the greatest potential to enhance patients' engagement in their safety. Nurses' ongoing assessment of patients' ability to engage is critical insofar as it provides the opportunity to encourage engagement without placing undue burden on them. By employing communication techniques that consider patients' perspectives, nurses can support patient engagement.

Annual Report To Congress. Department of Energy Activities Relating to the Defense Nuclear Facilities Safety Board, Calendar Year 2003

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

None, None

2004-02-28

The Department of Energy (Department) submits an Annual Report to Congress each year detailing the Department’s activities relating to the Defense Nuclear Facilities Safety Board (Board), which provides advice and recommendations to the Secretary of Energy (Secretary) regarding public health and safety issues at the Department’s defense nuclear facilities. In 2003, the Department continued ongoing activities to resolve issues identified by the Board in formal recommendations and correspondence, staff issue reports pertaining to Department facilities, and public meetings and briefings. Additionally, the Department is implementing several key safety initiatives to address and prevent safety issues: safety culture and review ofmore » the Columbia accident investigation; risk reduction through stabilization of excess nuclear materials; the Facility Representative Program; independent oversight and performance assurance; the Federal Technical Capability Program (FTCP); executive safety initiatives; and quality assurance activities. The following summarizes the key activities addressed in this Annual Report.« less

NNI Public Webinars | Nano

Science.gov Websites

Communities Environmental, Health, and Safety Issues Ethical, Legal, and Societal Issues Federal Legislation Environmental, Health, and Safety Issues Ethical, Legal, and Societal Issues Federal Legislation & Infrastructure (NNCI) Nodes and Environmental Research: Examples from the Field - Slides and Transcript An

Metabonomics approaches and the potential application in foodsafety evaluation.

PubMed

Kuang, Hua; Li, Zhe; Peng, Chifang; Liu, Liqiang; Xu, Liguang; Zhu, Yingyue; Wang, Libing; Xu, Chuanlai

2012-01-01

It is essential that the novel biomarkers discovered by means of advanced detection tools based on metabonomics could be used for long-term monitoring in food safety. By summarizing the common biomarkers discovery flowsheet based on metabonomics, this review evaluates the possible application of metabonomics in new biomarker discovery, especially in relation to food safety issues. Metabonomics have the advantages of decreasing detection limits and constant monitoring. Although metabonomics is still in the developmental stage, we believe that, based on its properties, such as noninvasiveness, sensitivity, and persistence, together with rigorous experimental designs, new and novel technologies, as well as increasingly accurate chemometrics and a relational database, metabonomics can demonstrate extensive application in food safety in the postgenome period.

Role of telephone triage in obstetrics.

PubMed

Manning, Nirvana Afsordeh; Magann, Everett F; Rhoads, Sarah J; Ivey, Tesa L; Williams, Donna J

2012-12-01

The telephone has become an indispensable method of communication in the practice of obstetrics. The telephone is one of the primary methods by which the patient makes her appointments and contacts her health care provider for advice, reassurance, and referrals. Current methods of telephone triage include personal at the physicians' office, telephone answering services, labor and delivery nurses, and a dedicated telephone triage system using algorithms. Limitations of telephone triage include the inability of the provider to see the patient and receive visual clues from the interaction and the challenges of obtaining a complete history over the telephone. In addition, there are potential safety and legal issues with telephone triage. To date, there is insufficient evidence to either validate or refute the use of a dedicated telephone triage system compared with a traditional system using an answering service or nurses on labor and delivery. Obstetricians and gynecologists, family physicians. After completing this CME activity, physicians should be better able to analyze the scope of variation in telephone triage across health care providers and categorize the components that go into a successful triage system, assess the current scope of research in telephone triage in obstetrics, evaluate potential safety and legal issues with telephone triage in obstetrics, and identify issues that should be addressed in any institution that is using or implementing a system of telephone triage in obstetrics.

Ethical issues in the use of genetic information in the workplace: a review of recent developments.

PubMed

Geppert, Cynthia M A; Roberts, Laura Weiss

2005-09-01

In the wake of the Human Genome Project, the pace of genetic discovery has quickened. New genetic tests and other molecular technology have had immediate and wide relevance to American and European workers. These tests have the potential to provide improved workplace safety and protect workers' health, but they also carry the risk of genetic discrimination including loss of employment, promotion, insurance and health care. Ethical safeguards are necessary if the benefits are to outweigh the adverse consequences of genetics in the workplace. This review examines the major policy statements issued in Europe and the USA from 2000 to 2005 pertaining to genetic issues in occupational health. Recent findings stress that genetic testing can only be utilized with worker consent and that the workers should control access to genetic information. Such testing is only justified when the information is required to protect the safety of the worker or a third party. The progress of occupational genetic technology should not be permitted to shift the responsibility for a safe working environment from the employer to the employee. Genetic discrimination in all forms is neither supported scientifically nor warranted ethically. Increasingly, occupational physicians and clinicians treating workers will be faced with potentially stigmatizing genetic information and there is an urgent need for education and research to expand and implement the recommendations of major governmental and professional policy statements.

Translational plant proteomics: a perspective.

PubMed

Agrawal, Ganesh Kumar; Pedreschi, Romina; Barkla, Bronwyn J; Bindschedler, Laurence Veronique; Cramer, Rainer; Sarkar, Abhijit; Renaut, Jenny; Job, Dominique; Rakwal, Randeep

2012-08-03

Translational proteomics is an emerging sub-discipline of the proteomics field in the biological sciences. Translational plant proteomics aims to integrate knowledge from basic sciences to translate it into field applications to solve issues related but not limited to the recreational and economic values of plants, food security and safety, and energy sustainability. In this review, we highlight the substantial progress reached in plant proteomics during the past decade which has paved the way for translational plant proteomics. Increasing proteomics knowledge in plants is not limited to model and non-model plants, proteogenomics, crop improvement, and food analysis, safety, and nutrition but to many more potential applications. Given the wealth of information generated and to some extent applied, there is the need for more efficient and broader channels to freely disseminate the information to the scientific community. This article is part of a Special Issue entitled: Translational Proteomics. Copyright © 2012 Elsevier B.V. All rights reserved.

The potential of smart homes for injury prevention among the elderly.

PubMed

Eriksson, Henrik; Timpka, Toomas

2002-06-01

Smart homes promise to make the lives of elderly people more comfortable and safe. Today, there is a significant interest from industry and policy makers in developing these technologies. In theory, the emerging technologies make it possible to provide a new range of services. So far, however, the goal has often been to develop new services for young people rather than assisting old people to improve their quality of life. Especially important is the potential for using these technologies to promote safety and prevent injury among old people because this group is at home more than the other age groups. Networked devices can collect data from sensors and aid decision-making on intervention and other measures. Furthermore, these devices can instruct and remind individuals about safety-related issues.

29 CFR 1902.2 - General policies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... health program with respect to covered issues that in his judgment meets or will meet the criteria set... State plan may cover any occupational safety and health issue with respect to which a Federal standard... State plan shall describe the occupational safety and health issue or issues and the State standard or...

29 CFR 1902.2 - General policies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... health program with respect to covered issues that in his judgment meets or will meet the criteria set... State plan may cover any occupational safety and health issue with respect to which a Federal standard... State plan shall describe the occupational safety and health issue or issues and the State standard or...

Current issues and actions in radiation protection of patients.

PubMed

Holmberg, Ola; Malone, Jim; Rehani, Madan; McLean, Donald; Czarwinski, Renate

2010-10-01

Medical application of ionizing radiation is a massive and increasing activity globally. While the use of ionizing radiation in medicine brings tremendous benefits to the global population, the associated risks due to stochastic and deterministic effects make it necessary to protect patients from potential harm. Current issues in radiation protection of patients include not only the rapidly increasing collective dose to the global population from medical exposure, but also that a substantial percentage of diagnostic imaging examinations are unnecessary, and the cumulative dose to individuals from medical exposure is growing. In addition to this, continued reports on deterministic injuries from safety related events in the medical use of ionizing radiation are raising awareness on the necessity for accident prevention measures. The International Atomic Energy Agency is engaged in several activities to reverse the negative trends of these current issues, including improvement of the justification process, the tracking of radiation history of individual patients, shared learning of safety significant events, and the use of comprehensive quality audits in the clinical environment. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

[Cell therapy for Parkinson's disease: IV. Risks and future trends].

PubMed

Anisimov, S V

2009-01-01

Motor dysfunctions in Parkinson's disease are believed to be primarily due to the degeneration of dopaminergic neurons located in the substantia nigra pars compacta. Numerous cell replacement therapy approaches have been developed and tested, including these based on donor cell transplantation (embryonic and adult tissue-derived), adult mesenchymal stem cells (hMSCs)-, neural stem cells (hNSCs)- and finally human embryonic stem cells (hESCs)-based. Despite the progress achieved, numerous difficulties prevent wider practical application of stem cell-based therapy approaches for the treatment of Parkinson's disease. Among the latter, ethical, safety and technical issues stand out. Current series of reviews (Cell therapy for Parkinson's disease: I. Embryonic and adult donor tissue-based applications; II. Adult stem cell-based applications; III. Neonatal, fetal and embryonic stem cell-based applications; IV. Risks and future trends) aims providing a balanced and updated view on various issues associated with cell types (including stem cells) in regards to their potential in the treatment of Parkinson's disease. Essential features of the individual cell subtypes, principles of available cell handling protocols, transplantation, and safety issues are discussed extensively.

[Cell therapy for Parkinson's disease: III. Neonatal, fetal and embryonic stem cell-based applications].

PubMed

Anisimov, S V

2009-01-01

Motor dysfunctions in Parkinson's disease are believed to be primarily due to the degeneration of dopaminergic neurons located in the substantia nigra pars compacta. Numerous cell replacement therapy approaches have been developed and tested, including these based on donor cell transplantation (embryonic and adult tissue-derived), adult mesenchymal stem cells (hMSCs)-, neural stem cells (hNSCs)- and finally human embryonic stem cells (hESCs)-based. Despite the progress achieved, numerous difficulties prevent wider practical application of stem cell-based therapy approaches for the treatment of Parkinson's disease. Among the latter, ethical, safety and technical issues stand out. Current series of reviews (Cell therapy for Parkinson's disease: I. Embryonic and adult donor tissue-based applications; II. Adult stem cell-based applications; III. Neonatal, fetal and embryonic stem cell-based applications; IV. Risks and future trends) aims providing a balanced and updated view on various issues associated with cell types (including stem cells) in regards to their potential in the treatment of Parkinson's disease. Essential features of the individual cell subtypes, principles of available cell handling protocols, transplantation, and safety issues are discussed extensively.

Regaining Lost Separation in a Piloted Simulation of Autonomous Aircraft Operations

NASA Technical Reports Server (NTRS)

Barhydt, Richard; Eischeid, Todd M.; Palmer, Michael T.; Wing, David J.

2002-01-01

NASA is currently investigating a new concept of operations for the National Airspace System, designed to improve capacity while maintaining or improving current levels of safety. This concept, known as Distributed Air/Ground Traffic Management (DAG-TM), allows appropriately equipped autonomous aircraft to maneuver freely for flight optimization while resolving conflicts with other traffic and staying out of special use airspace and hazardous weather. While Airborne Separation Assurance System (ASAS) tools would normally allow pilots to resolve conflicts before they become hazardous, evaluation of system performance in sudden, near-term conflicts is needed in order to determine concept feasibility. If an acceptable safety level can be demonstrated in these situations, then operations may be conducted with lower separation minimums. An experiment was conducted in NASA Langley s Air Traffic Operations Lab to address issues associated with resolving near-term conflicts and the potential use of lower separation minimums. Sixteen commercial airline pilots flew a total of 32 traffic scenarios that required them to use prototype ASAS tools to resolve close range pop-up conflicts. Required separation standards were set at either 3 or 5 NM lateral spacing, with 1000 ft vertical separation being used for both cases. Reducing the lateral separation from 5 to 3 NM did not appear to increase operational risk, as indicated by the proximity to the intruder aircraft. Pilots performed better when they followed tactical guidance cues provided by ASAS than when they didn't follow the guidance. As air-air separation concepts are evolved, further studies will consider integration issues between ASAS and existing Airborne Collision Avoidance Systems (ACAS).These types of non-normal events will require the ASAS to provide effective alerts and resolutions prior to the time that an Airborne Collision Avoidance System (ACAS) would give a Resolution Advisory (RA). When an RA is issued, a pilot must take immediate action in order to avoid a potential near miss. The Traffic Alert and Collision Avoidance System (TCAS) II currently functions as an ACAS aboard commercial aircraft. Depending on the own aircraft s altitude, TCAS only issues RA s 15-35 seconds prior to the Closest Point of Approach (CPA). Prior to an RA, DAG-TM pilots operating autonomous aircraft must rely solely on ASAS for resolution guidance. An additional area of DAG-TM concept feasibility relates to a potential reduction in separation standards. Lower separation standards are likely needed in order to improve NAS efficiency and capacity. Current separation minimums are based in large part on the capabilities of older radar systems. Safety assessments are needed to determine the feasibility of reduced separation minimums. They will give strong consideration to surveillance system performance, including accuracy, integrity, and availability. Candidate surveillance systems include Automatic Dependent Surveillance-Broadcast (ADS-B) and multi-lateration systems. Considering studies done for Reduced Vertical Separation Minimums (RVSM) operations, it is likely that flight technical errors will also be considered. In addition to a thorough evaluation of surveillance system performance, a potential decision to lower the separation standards should also take operational considerations into account. An ASAS Safety Assessment study identified improper maneuvering in response to a conflict (due to ambiguous or improper resolution commands or a pilot s failure to comply with the resolution) as a potential safety risk. If near-term conflicts with lower separation minimums were determined to be more challenging for pilots, the severity of these risks could be even greater.

Implementing new technologies for public safety communication: competing frequency demands and standardization issues

NASA Astrophysics Data System (ADS)

Stevens, Kathryn J.

1997-01-01

Attempting to incorporate new technology into an existing environment is often very difficult. The problems are lengthy to resolve, wrought with confusion and seldom turn out like anyone expected. This document represents an overview of one such attempt. It outlines the general areas of concern which could be affected by a transition, and potential problems that may be encountered as a result of the effort. Over the past several decades, many local, state and federal agencies are pressing for more efficient use of frequency spectrums. The urgency of this issue has grown due to the demands of several groups wanting access to these channels for commercial use. Pager systems, cellular telephones, radio systems for private businesses all demand more space. Public safety agencies are starting to fear their needs will diminish in importance as the available channel spectrums are consumed by commercial ventures. How to share these channels, purchase appropriate equipment to meet your needs, and stay within a reasonable budget are not easy tasks. Public safety agencies who rely on communication networks in the performance of their jobs also know why encryption is important. Protecting the rights of citizens as police exchange information over the air, maintaining the integrity of an investigation and officer safety are all concerns police must address each time they use a radio.

Review of Issues Associated with Safe Operation and Management of the Space Shuttle Program

NASA Technical Reports Server (NTRS)

Johnstone, Paul M.; Blomberg, Richard D.; Gleghorn, George J.; Krone, Norris J.; Voltz, Richard A.; Dunn, Robert F.; Donlan, Charles J.; Kauderer, Bernard M.; Brill, Yvonne C.; Englar, Kenneth G.;

Ethical Considerations Regarding the Use of Smart Home Technologies for Older Adults: An Integrative Review.

PubMed

Chung, Jane; Demiris, George; Thompson, Hilaire J

2016-01-01

With the wide adoption and use of smart home applications, there is a need for examining ethical issues regarding smart home use at the intersection of aging, technology, and home environment. The purpose of this review is to provide an overview of ethical considerations and the evidence on these ethical issues based on an integrative literature review with regard to the utilization of smart home technologies by older adults and their family members. REVIEW DESIGN AND METHODS: We conducted an integrative literature review of the scientific literature from indexed databases (e. g., MEDLINE, CINAHL, and PsycINFO). The framework guiding this review is derived from previous work on ethical considerations related to telehealth use for older adults and smart homes for palliative care. Key ethical issues of the framework include privacy, informed consent, autonomy, obtrusiveness, equal access, reduction in human touch, and usability. Six hundred and thirty-five candidate articles were identified between the years 1990 and 2014. Sixteen articles were included in the review. Privacy and obtrusiveness issues appear to be the most important factors that can affect smart home technology adoption. In addition, this article recommends that stigmatization and reliability and maintenance of the system are additional factors to consider. When smart home technology is used appropriately, it has the potential to improve quality of life and maintain safety among older adults, ultimately supporting the desire of older adults for aging in place. The ability to respond to potential ethical concerns will be critical to the future development and application of smart home technologies that aim to enhance safety and independence.

Investigation of a supplementary tool to assist in the prioritization of emphasis areas in North American strategic highway safety plans.

PubMed

Park, Peter Y; Young, Jason

2012-03-01

An important potential benefit of a jurisdiction developing an upper-level traffic safety policy statement, such as a strategic highway safety plan (SHSP) or a traffic safety action plan, is the creation of a manageable number of focus areas, known as emphasis areas. The responsible agencies in the jurisdiction can then direct their finite resources in a systematic and strategic way designed to maximize the effort to reduce the number and severity of roadway collisions. In the United States, the federal government through AASHTO has suggested 22 potential emphasis areas. In Canada, CCMTA's 10 potential emphasis areas have been listed for consideration. This study reviewed the SHSP and traffic safety action plan of 53 jurisdictions in North America, and conducted descriptive data analyses to clarify the issues that currently affect the selection and prioritization process of jurisdiction-specific emphasis areas. We found that the current process relies heavily on high-level collision data analysis and communication among the SHSP stakeholders, but may not be the most efficient and effective way of selecting and prioritizing the emphasis areas and allocating safety improvement resources. This study then formulated a formal collision diagnosis test, known as the beta-binomial test, to clarify and illuminate the selection and the prioritization of jurisdiction-specific emphasis areas. We developed numerical examples to demonstrate how engineers can apply the proposed diagnosis test to improve the selection and prioritization of individual jurisdictions' emphasis areas. Copyright © 2011 Elsevier Ltd. All rights reserved.

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety and health in the petrochemical industry in Map Ta Phut, Thailand.

PubMed

Langkulsen, Uma; Vichit-Vadakan, Nuntavarn; Taptagaporn, Sasitorn

2011-01-01

Petrochemical industries are known as sources of many toxic chemicals. Safety and health risks of the petrochemical workers employed at Map Ta Phut Industrial Estate, located in Rayong, Thailand, are potentially high. The research materials consisted of documents emanating from statutory reports on safety in working with toxic chemicals and the results of interviews by questionnaire among 457 petrochemical workers regarding occupational health and safety issues. Most of workers who were working with toxic chemicals had knowledge and awareness of health risks and chemical hazards at work. We found that safe behavior at work through read the safety information among operational workers less than non-operational workers around 10%. Most of workers had perceived occupational health and safety management in their companies. Some companies revealed that they had not been performing biological monitoring of blood or urine for their health examination reports and that workplace exposure monitoring had not correlated well with health examination of workers. Our study suggested that occupational health and safety for petrochemical industries requires standards and guidelines for workers' health surveillance aimed at protection of workers.

Aviation occupant survival factors: an empirical study of the SQ006 accident.

PubMed

Chang, Yu-Hern; Yang, Hui-Hua

2010-03-01

We present an empirical study of Singapore Airline (SIA) flight SQ006 to illustrate the critical factors that influence airplane occupant survivability. The Fuzzy Delphi Method was used to identify and rank the survival factors that may reduce injury and fatality in potentially survivable accidents. This is the first attempt by a group from both the public and private sectors in Taiwan to focus on cabin-safety issues related to survival factors. We designed a comprehensive survey based on our discussions with aviation safety experts. We next designed an array of important cabin-safety dimensions and then investigated and selected the critical survival factors for each dimension. Our findings reveal important cabin safety and survivability information that should provide a valuable reference for developing and evaluating aviation safety programs. We also believe that the results will be practical for designing cabin-safety education material for air travelers. Finally, the major contribution of this research is that it has identified 47 critical factors that influence accident survivability; therefore, it may encourage improvements that will promote more successful cabin-safety management. Copyright 2009 Elsevier Ltd. All rights reserved.

Clean air program : liquefied natural gas safety in transit operations

DOT National Transportation Integrated Search

1996-03-31

The report examines the safety issues relating to the use of Liquefied Natural Gas (LNG) in transit service. The safety issues were determined by on-site surveys performed by Battelle of Columbus, Ohio, and Science Applications International Corp. (S...

Physical design correlates of efficiency and safety in emergency departments: a qualitative examination.

PubMed

Pati, Debajyoti; Harvey, Thomas E; Pati, Sipra

2014-01-01

The objective of this study was to explore and identify physical design correlates of safety and efficiency in emergency department (ED) operations. This study adopted an exploratory, multimeasure approach to (1) examine the interactions between ED operations and physical design at 4 sites and (2) identify domains of physical design decision-making that potentially influence efficiency and safety. Multidisciplinary gaming and semistructured interviews were conducted with stakeholders at each site. Study data suggest that 16 domains of physical design decisions influence safety, efficiency, or both. These include (1) entrance and patient waiting, (2) traffic management, (3) subwaiting or internal waiting areas, (4) triage, (5) examination/treatment area configuration, (6) examination/treatment area centralization versus decentralization, (7) examination/treatment room standardization, (8) adequate space, (9) nurse work space, (10) physician work space, (11) adjacencies and access, (12) equipment room, (13) psych room, (14) staff de-stressing room, (15) hallway width, and (16) results waiting area. Safety and efficiency from a physical environment perspective in ED design are mutually reinforcing concepts--enhancing efficiency bears positive implications for safety. Furthermore, safety and security emerged as correlated concepts, with security issues bearing implications for safety, thereby suggesting important associations between safety, security, and efficiency.

Use of New Communication Technologies to Change NASA Safety Culture: Incorporating the Use of Blogs as a Fundamental Communications Tool

NASA Technical Reports Server (NTRS)

Huls, Dale thomas

2005-01-01

The purpose of this paper is to explore an innovative approach to culture change at NASA that goes beyond reorganizations, management training, and a renewed emphasis on safety. Over the last five years, a technological social revolution has been emerging from the internet. Blogs (aka web logs) are transforming traditional communication and information sharing outlets away from established information sources such as the media. The Blogosphere has grown from zero blogs in 1999 to approximately 4.5 million as of November 2004 and is expected to double in 2005. Blogs have demonstrated incredible effectiveness and efficiency with regards to affecting major military and political events. Consequently, NASA should embrace the new information paradigm presented by blogging. NASA can derive exceptional benefits from the new technology as follows: 1) Personal blogs can overcome the silent safety culture by giving voice to concerns or questions that are not well understood or seemingly inconsequential to the NASA community at-large without the pressure of formally raising a potential false alarm. Since blogs can be open to Agency-wide participation, an incredible amount of resources from an extensive pool of experience can focus on a single issue, concern, or problem and quickly vetted, discussed and assessed for feasibility, significance, and criticality. The speed for which this could be obtained cannot be matched through any other process or procedure currently in use. 2) Through official NASA established blogs, lessons learned can be a real-time two way process that is formed and implemented from the ground level. Data mining of official NASA blogs and personal blogs of NASA personnel can identify hot button issues and concerns to senior management. 3) NASA blogs could function as a natural ombudsman for the NASA community. Through the recognition of issues being voiced by the community and taking a proactive stance on those issues, credibility within NASA Management can be restored. For NASA to harness the capabilities of blogs, NASA must develop an Agency-wide policy on blogging to encourage use and provide guidance. This policy should describe basic rules of conduct and content as well as a policy of non-retribution and/or anonymity. The Agency must provide sever space within their firewalls, provide appropriate software tools, and promote blogs in newsletters and official websites. By embracing the use of blogs, a potential pool of 19,000 experts could be available to address each posted safety issue, concern, problem, or question. Blogs could result in real NASA culture change.

Sexual assault consultations - from high risk to high reliability.

PubMed

Cunningham, Nicola

2012-02-01

The sexual assault consultation is a high-risk procedure with the potential for errors resulting in harm to both patients and staff. As such, it can be likened to practices in highrisk industries such as aviation and surgery. In contrast to these domains however, the focus on performance safety and Threat and Error Management has not been widely adopted. This is despite a growing recognition of the vulnerabilities of the investigative and prosecutorial stages of alleged sexual assaults. In the context of “high risk” sexual assault consultations, the notion of safety refers not only to the risk of patient morbidity and mortality, but also to physical, psychological and judicial outcomes that affect patients, staff, and the wider community. This article identifies the latent threats present in sexual assault consultations and suggests a conceptual framework for application of Threat and Error Management in this specialised area of medicine. This will enable practitioners to be better equipped to recognise the risks and improve the performance and safety of sexual assault consultation processes. In an era of growing medicolegal concerns regarding issues such as environmental safety and the potential for contamination of cases, focussing on education and safety culture components within the investigative systems will allow sexual assault consultation processes to progress towards a new level of organisational reliability.

Autonomy Software: V&V Challenges and Characteristics

NASA Technical Reports Server (NTRS)

Schumann, Johann; Visser, Willem

2006-01-01

The successful operation of unmanned air vehicles requires software with a high degree of autonomy. Only if high level functions can be carried out without human control and intervention, complex missions in a changing and potentially unknown environment can be carried out successfully. Autonomy software is highly mission and safety critical: failures, caused by flaws in the software cannot only jeopardize the mission, but could also endanger human life (e.g., a crash of an UAV in a densely populated area). Due to its large size, high complexity, and use of specialized algorithms (planner, constraint-solver, etc.), autonomy software poses specific challenges for its verification, validation, and certification. -- - we have carried out a survey among researchers aid scientists at NASA to study these issues. In this paper, we will present major results of this study, discussing the broad spectrum. of notions and characteristics of autonomy software and its challenges for design and development. A main focus of this survey was to evaluate verification and validation (V&V) issues and challenges, compared to the development of "traditional" safety-critical software. We will discuss important issues in V&V of autonomous software and advanced V&V tools which can help to mitigate software risks. Results of this survey will help to identify and understand safety concerns in autonomy software and will lead to improved strategies for mitigation of these risks.

Trends in technology, trade and consumption likely to impact on microbial food safety.

PubMed

Quested, T E; Cook, P E; Gorris, L G M; Cole, M B

2010-05-30

Current and potential future trends in technology, consumption and trade of food that may impact on food-borne disease are analysed and the key driving factors identified focusing on the European Union and, to a lesser extent, accounting for the United States and global issues. Understanding of factors is developed using system-based methods and their impact is discussed in relation to current events and predictions of future trends. These factors come from a wide range of spheres relevant to food and include political, economic, social, technological, regulatory and environmental drivers. The degree of certainty in assessing the impact of important driving factors is considered in relation to food-borne disease. The most important factors driving an increase in the burden of food-borne disease in the next few decades were found to be the anticipated doubling of the global demand for food and of the international trade in food next to a significantly increased consumption of certain high-value food commodities such as meat and poultry and fresh produce. A less important factor potentially increasing the food-borne disease burden would be the increased demand for convenience foods. Factors that may contribute to a reduction in the food-borne disease burden were identified as the ability of governments around the world to take effective regulatory measures as well as the development and use of new food safety technologies and detection methods. The most important factor in reducing the burden of food-borne disease was identified as our ability to first detect and investigate a food safety issue and then to develop effective control measures. Given the global scale of impact on food safety that current and potentially future trends have, either by potentially increasing or decreasing the food-borne disease burden, it is concluded that a key role is fulfilled by intergovernmental organisations and by international standard setting bodies in coordinating the establishment and rolling-out of effective measures that, on balance, help ensure long-term consumer protection and fair international trade. Copyright 2010 Elsevier B.V. All rights reserved.

Growing trend of identity theft poses safety and billing loss threats.

PubMed

2010-08-01

Identity theft is more than just a legal issue. Patients with improper identification are at risk for receiving potentially harmful treatment. Have registration department require photo identification from all patients. Ask additional questions, such as the patient's date of birth. Ask staff members to be the "eyes and ears" of registration and security, and ask them to report anything suspicious.

Don't Forget to Pack My EpiPen[R] Please: What Issues Does Food Allergy Present for Children's Starting School?

ERIC Educational Resources Information Center

Sanagavarapu, Prathyusha

2012-01-01

Food allergy impairs the health-related quality of life of both the affected children and their families. In particular, parents and children become anxious about the potential risks and consequences of food allergy, including disruptions in families' and children's social activities, the need for constant vigilance, children's safety, and the…

Health System Implications of Direct-to-Consumer Personal Genome Testing

PubMed Central

McGuire, Amy L.; Burke, Wylie

2010-01-01

Direct-to-consumer personal genome testing is now widely available to consumers. Proponents argue that knowledge is power but critics worry about consumer safety and potential harms resulting from misinterpretation of test information. In this article, we consider the health system implications of direct-to-consumer personal genome testing, focusing on issues of accountability, both corporate and professional. PMID:21071927

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.

Working with cognitively impaired drivers: legal issues for mental health professionals to consider.

PubMed

Love, Christopher M; Welsh, Robert K; Knabb, Joshua J; Scott, Sheryn T; Brokaw, David W

2008-01-01

Mental health professionals are gatekeepers of patient confidentiality. Yet, confidentiality held too strictly, by allowing a potentially dangerous driver to assume control of a car, endangers society. Recent court cases have mandated that mental health professionals must warn those who may be potentially harmed by patients. In spite of this, disagreements linger as to whether it is the responsibility of governmental agencies or mental health professionals to decide who is unfit to operate a vehicle because of cognitive impairment. This article addresses the legally relevant considerations when working with cognitively compromised individuals who operate a motor vehicle. Legal issues surrounding confidentiality, patient rights, foreseeable risk, and the duty to warn and protect are presented in order to understand their relationship to recent court rulings. The impact on the mental health care industry includes not only concerns about increased insurance premiums or costs due to alleged negligence or litigation expenses secondary to failure to ensure the safety of an impaired client under their care. Mental health care providers are aware that the welfare of clients with impairment to cognitive decision making ability may require unique considerations for safety such as ensuring safe and appropriate transportation.

Regenerative Chemical Biology: Current Challenges and Future Potential

PubMed Central

Ao, Ada; Hao, Jijun; Hong, Charles C.

2011-01-01

The enthusiasm surrounding the clinical potential of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) is tempered by the fact that key issues regarding their safety, efficacy, and long-term benefits have thus far been suboptimal. Small molecules can potentially relieve these problems at major junctions of stem cell biology and regenerative therapy. In this review, we will introduce recent advances in these important areas and the first-generation of small molecules used in the regenerative context. Current chemical biology studies will provide the archetype for future interdisciplinary collaborations, and improve clinical benefits of cell-based therapies. PMID:21513877

Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

PubMed

Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

2010-12-01

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

Active drug safety surveillance: a tool to improve public health.

PubMed

Platt, Richard; Madre, Leanne; Reynolds, Robert; Tilson, Hugh

2008-12-01

Ensuring that drugs have an acceptable safety profile and are used safely is a major public health priority. The Centers for Education and Research on Therapeutics (CERTs) convened experts from academia, government, and industry to assess strategies to increase the speed and predictive value of generating and evaluating safety signals, and to identify next steps to improve the US system for identifying and evaluating potential safety signals. The CERTs convened a think tank comprising representatives of the groups noted above to address these goals. Participants observed that, with the increasing availability of electronic health data, opportunities have emerged to more accurately characterize and confirm potential safety issues. The gain for public health from a highly coordinated network of population-based databases for active surveillance is great and within reach, although operational questions remain. A collaborative network must create a working definition of a safety signal, screening algorithms, and criteria and strategies to confirm or refute a signal once identified through screening. Guidelines are needed for when and how to communicate a signal exists and is being evaluated, as well as the outcome of that evaluation. A public-private partnership to create a network of government and private databases to routinely evaluate and prioritize safety questions is in the public interest. Better methods are needed, and a knowledgeable workforce is required to conduct the surveillance and understand how to interpret the results. The international community will benefit from the availability of better methods and more experts. Copyright (c) 2008 John Wiley & Sons, Ltd.

Predictors of Likelihood of Speaking Up about Safety Concerns in Labour and Delivery

PubMed Central

Lyndon, Audrey; Sexton, J. Bryan; Simpson, Kathleen Rice; Rosenstein, Alan; Lee, Kathryn A.; Wachter, Robert M.

2011-01-01

Background Despite widespread emphasis on promoting “assertive communication” by caregivers as essential to patient safety improvement efforts, fairly little is known about when and how clinicians speak up to address safety concerns. In this cross-sectional study we use a new measure of speaking up to begin exploring this issue in maternity care. Methods We developed a scenario-based measure of clinician’s assessment of potential harm and likelihood of speaking up in response to perceived harm. We embedded this scale in a survey with measures of safety climate, teamwork climate, disruptive behaviour, work stress, and personality traits of bravery and assertiveness. The survey was distributed to all registered nurses and obstetricians practicing in two US Labour & Delivery units. Results The response rate was 54% (125 of 230 potential respondents). Respondents were experienced clinicians (13.7 ± 11 years in specialty). Higher perception of harm, respondent role, specialty experience, and site predicted likelihood of speaking up when controlling for bravery and assertiveness. Physicians rated potential harm in common clinical scenarios lower than nurses did (7.5 vs. 8.4 on 2–10 scale; p<0.001). Some participants (12%) indicated they were unlikely to speak up despite perceiving high potential for harm in certain situations. Discussion This exploratory study found nurses and physicians differed in their harm ratings, and harm rating was a predictor of speaking up. This may partially explain persistent discrepancies between physicians and nurses in teamwork climate scores. Differing assessments of potential harms inherent in everyday practice may be a target for teamwork intervention in maternity care. PMID:22927492

Professional and interprofessional differences in electronic health records use and recognition of safety issues in critically ill patients

PubMed Central

Sakata, Knewton K.; Stephenson, Laurel S.; Mulanax, Ashley; Bierman, Jesse; Mcgrath, Karess; Scholl, Gretchen; McDougal, Adrienne; Bearden, David T.; Mohan, Vishnu; Gold, Jeffrey A.

2018-01-01

During interprofessional intensive care unit (ICU) rounds each member of the interprofessional team is responsible for gathering and interpreting information from the electronic health records (EHR) to facilitate effective team decision-making. This study was conducted to determine how each professional group reviews EHR data in preparation for rounds and their ability to identify patient safety issues. Twenty-five physicians, 29 nurses, and 20 pharmacists participated. Individual participants were given verbal and written sign-out and then asked to review a simulated record in our institution’s EHR, which contained 14 patient safety items. After reviewing the chart, subjects presented the patient and the number of safety items recognised was recorded. About 40%, 30%, and 26% of safety issues were recognised by physicians, nurses, and pharmacists, respectively (p = 0.0006) and no item recognised 100% of the time. There was little overlap between the three groups with only 50% of items predicted to be recognised 100% of the time by the team. Differential recognition was associated with marked differences in EHR use, with only 3/152 EHR screens utilised by all three groups and the majority of screens used exclusively only by one group. There were significant and non-overlapping differences in individual profession recognition of patient safety issues in the EHR. Preferential identification of safety issues by certain professional groups may be attributed to differences in EHR use. Future studies will be needed to determine if shared decision-making during rounds can improve recognition of safety issues. PMID:27341177

29 CFR 1952.325 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Indiana plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under section 6 of the Act do not apply with...

29 CFR 1952.375 - Level of Federal Enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Virginia plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under section 6 of the Act do not apply with...

77 FR 53164 - Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

...-0059, Notice No. 6] RIN 2130-AC37 Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway... complex issues raised in both the petitions for reconsideration of the final rule published November 30... issues. One of the Petitions included a request for a delay in the effective date of the final rule until...

The incidence of coring with blunt versus sharp needles.

PubMed

Wani, Tariq; Wadhwa, Anupama; Tobias, Joseph D

2014-03-01

With the advent of safety needles to prevent inadvertent needle sticks in the operating room (OR), a potentially new issue has arisen. These needles may result in coring, or the shaving off of fragments of the rubber stopper, when the needle is pierced through the rubber stopper of the medication vial. These fragments may be left in the vial and then drawn up with the medication and possibly injected into patients. The current study prospectively evaluated the incidence of coring when blunt and sharp needles were used to pierce rubber topped vials. We also evaluated the incidence of coring in empty medication vials with rubber tops. The rubber caps were then pierced with either an18-gauge sharp hypodermic needle or a blunt plastic (safety) needle. Coring occurred in 102 of 250 (40.8%) vials when a blunt needle was used versus 9 of 215 (4.2%) vials with a sharp needle (P < 0.0001). A significant incidence of coring was demonstrated when a blunt plastic safety needle was used. This situation is potentially a patient safety hazard and methods to eliminate this problem are needed. Copyright © 2014 Elsevier Inc. All rights reserved.

Morinda citrifolia (Noni) fruit--phytochemistry, pharmacology, safety.

PubMed

Potterat, Olivier; Hamburger, Matthias

2007-03-01

Products derived from Noni fruit (Morinda citrifolia) have been commercialised in the USA since the 1990s and are increasingly distributed all over the world. A large number of beneficial effects have been claimed for Noni. Fruit juice of Noni has been approved as a Novel Food by the European Commission in 2003. This article reviews current knowledge on the phytochemistry, pharmacology, safety aspects of Noni fruit and Noni-derived products, and health-related claims and benefits. The knowledge on the chemical composition of Noni fruit has considerably increased over recent years. A number of in vitro and, to a certain extent, in vivo studies demonstrate a range of potentially beneficial effects. However, clinical data are essentially lacking. To what extent the findings from experimental pharmacological studies are of potential clinical relevance is not clear at present. Based on a toxicological assessment, Noni juice was considered as safe. Due to recent reports of cases of hepatotoxicity, the safety issue has been re-examined in Europe. While the European Food Safety Authority sees no link between adverse effects on liver and consumption of Noni juice, a continuing monitoring of the situation is desirable and some vigilance advised.

Cardiovascular Safety Pharmacology of Sibutramine.

PubMed

Yun, Jaesuk; Chung, Eunyong; Choi, Ki Hwan; Cho, Dae Hyun; Song, Yun Jeong; Han, Kyoung Moon; Cha, Hey Jin; Shin, Ji Soon; Seong, Won-Keun; Kim, Young-Hoon; Kim, Hyung Soo

2015-07-01

Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an IC50 of 3.92 μM in patch clamp assay and increased the heart rate and blood pressure (76 Δbpm in heart rate and 51 ΔmmHg in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at 10 μM and 30 μM, resulted in 15% and 29% decreases in APD50, and 9% and 17% decreases in APD90, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.

PubMed

Lu, Ellen; Wang, Bing Wei; Guimond, Colleen; Synnes, Anne; Sadovnick, A Dessa; Dahlgren, Leanne; Traboulsee, Anthony; Tremlett, Helen

2013-03-01

When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures.

DOT's Budget: Safety, Management, and Other Issues Facing the Department in Fiscal Year 1998 and Beyond

DOT National Transportation Integrated Search

1997-03-06

This testimony discusses key resource management issues and performance challenges facing the Department of Transportation in 1998 and beyond. 1. Increased safety and security concerns prompted by accidents and maintenance issues. 2. Important manage...

Hospital safety climate surveys: measurement issues.

PubMed

Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

2010-12-01

Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

Development of an Integrative Program of Nanosafety: Promote the Coordination Between Industries and Risk Assessor

NASA Astrophysics Data System (ADS)

Emond, Claude; Kouassi, Serge; Schuster, Frédéric

2013-04-01

Nanomaterials are widely present in many industrial sectors (e.g., chemical, biomedical, environment), and their application is expected to significantly expand in the coming years. However, nanomaterial use raises many questions about the potential risks to human health and the environment and, more specifically, to occupational health. The available literature supports the ability of the lung, gastrointestinal tract, and skin to act as significant barriers against systemic exposure to many nanomaterials. However, because a potential risk issue exists about the toxicity of nanomaterials to the biological material, tools need to be developed for improving the risk management of the regulators. The goal is to develop a tool that examines the current knowledge base regarding the health risks posed by engineered nanoparticles to improve nanotechnology safety prior to the marketing phase. The approach proposed during this work was to establish a safety assessment constructed on a decision-control pathway regarding nanomaterial production and consumer's product to integrate different aspects. These aspects include: (1) primarily research and identification of the nanomaterial base of physicochemical properties, toxicity, and application; (2) the occupational exposure risk during the manufacturing process; (3) and the engineered nanomaterial upon the consumer product. This approach provides important parameters to reduce the uncertainty related to the production of nanomaterials prior their commercialization, reduce the reluctance from the industry, and provide a certification tool of sanitary control for the regulators. This work provides a better understanding of a critical issue of nanomaterials and consumer safety.

Pharmacist recognition of and adherence to medication-use policies and safety practices.

PubMed

Saad, Aline H; Sweet, Burgunda V; Stumpf, Janice L; Gruppen, Larry; Oh, Mary; Stevenson, James G

2007-10-01

Pharmacist recognition of and adherence to medication-use policies and safety practices were assessed. Simulation testing was used to assess the performance of pharmacists in hypothetical scenarios simulating real-life situations. Fifty test case medication orders were developed, some requiring specific intervention and some requiring no special action. Orders were classified into four categories: those posing safety concerns n ( = 16), those with formulary and product standardization issues (n = 4), those with pharmacy and therapeutics (P&T) committee restrictions (n = 4), and those requiring no special action (n = 26). Potential barriers to compliance were identified by the project team and the orders categorized accordingly. The orders were processed by 25 pharmacists using a simulation testing procedure. Data were analyzed by pharmacists' demographics, order category, and perceived barriers to compliance. Pharmacists were correctly able to recognize 77.3% of test orders: 67.3% with safety concerns, 98.9% with formulary issues, and 98.5% with restrictions. Appropriate action was taken with 74.2% of test orders: 64.5% of safety orders, 96.6% of formulary orders, and 92.4% of restriction orders. There was no correlation between pharmacists' performance and demographic characteristics. The two barriers to correct response identified most often were ambiguous responsibility and low perceived level of importance. Pharmacists generally recognized and took appropriate action with simulated medication orders that contained problems related to formulary or P&T committee restrictions. They were less able to recognize and act appropriately on orders with safety-related problems. Ambiguous responsibility and low perceived importance were the most significant factors contributing to noncompliance with P&T committee policies and guidelines.

Veterinary infection control in Australia: is there control?

PubMed

Attard, K; Burrows, E; Kotiranta-Harris, K; Hedlefs, R; Ketheesan, N; Govan, B

2012-11-01

There is little information relating to infection control procedures in Australian veterinary practices. This review summarises the findings of international studies in the area of zoonoses and infection control, and discusses potential reasons for the apparent complacency about these issues in veterinary practice. It is the authors' opinion that legislative changes governing veterinary practice in Australia should be implemented. The curricula in veterinary schools should also emphasise infection control. These measures would significantly improve safety issues associated with the control of zoonoses in veterinary practice. © 2012 The Authors. Australian Veterinary Journal © 2012 Australian Veterinary Association.

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.

29 CFR 1952.95 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... safety and health issues covered by the South Carolina plan. OSHA retains full authority over issues... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Carolina plan under section 18(e) of the Act, effective December 15, 1987, occupational safety and health...

49 CFR 192.933 - What actions must be taken to address integrity issues?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Gas Transmission Pipeline Integrity Management § 192.933 What actions must be taken to address integrity issues? (a...

29 CFR 1952.165 - Level of Federal enforcement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... occupational safety and health issues covered by the Iowa plan. OSHA retains full authority over issues which... approval of the Iowa plan under section 18(e) of the Act, effective July 2, 1985, occupational safety and...

29 CFR 1952.165 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... occupational safety and health issues covered by the Iowa plan. OSHA retains full authority over issues which... approval of the Iowa plan under section 18(e) of the Act, effective July 2, 1985, occupational safety and...

Development of a large truck safety data needs study plan. Vol. 1, Summary

DOT National Transportation Integrated Search

1986-02-01

This report discusses the results of a study to determine the data needs necessary to address truck safety issues and to develop a data collection and analysis plan. Priority truck safety issues that are amenable to truck accident data analyses were ...

Comparative health and safety assessment of the SPS and alternative electrical generation systems

NASA Astrophysics Data System (ADS)

Habegger, L. J.; Gasper, J. R.; Brown, C. D.

1980-07-01

A comparative analysis of health and safety risks is presented for the Satellite Power System and five alternative baseload electrical generation systems: a low-Btu coal gasification system with an open-cycle gas turbine combined with a steam topping cycle; a light water fission reactor system without fuel reprocessing; a liquid metal fast breeder fission reactor system; a central station terrestrial photovoltaic system; and a first generation fusion system with magnetic confinement. For comparison, risk from a decentralized roof-top photovoltaic system with battery storage is also evaluated. Quantified estimates of public and occupational risks within ranges of uncertainty were developed for each phase of the energy system. The potential significance of related major health and safety issues that remain unquantitied are also discussed.

Laser-based firing systems for prompt initiation of secondary explosives

NASA Technical Reports Server (NTRS)

Meeks, Kent D.; Setchell, Robert E.

1993-01-01

Motivated by issues of weapon safety and security, laser based firing systems for promptly initiating secondary explosives have been under active development at Sandia National Laboratories for more than four years. Such a firing system consists of miniaturized, Q-switched, solid-state laser, optical detonators, optical safety switches, and elements for splitting, coupling, and transmitting the laser output. Potential system applications pose significant challenges in terms of server mechanical and thermal environments and packaging constraints, while requiring clear demonstration of safety enhancements. The Direct Optical Initiation (DOI) Program at Sandia is addressing these challenges through progress development phases during which the design, fabrication, and testing of prototype hardware is aimed at more difficult application requirements. A brief history of the development program, and a summary of current and planned activities, will be presented.

Comparative health and safety assessment of the SPS and alternative electrical generation systems

NASA Technical Reports Server (NTRS)

Habegger, L. J.; Gasper, J. R.; Brown, C. D.

1980-01-01

A comparative analysis of health and safety risks is presented for the Satellite Power System and five alternative baseload electrical generation systems: a low-Btu coal gasification system with an open-cycle gas turbine combined with a steam topping cycle; a light water fission reactor system without fuel reprocessing; a liquid metal fast breeder fission reactor system; a central station terrestrial photovoltaic system; and a first generation fusion system with magnetic confinement. For comparison, risk from a decentralized roof-top photovoltaic system with battery storage is also evaluated. Quantified estimates of public and occupational risks within ranges of uncertainty were developed for each phase of the energy system. The potential significance of related major health and safety issues that remain unquantitied are also discussed.

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.

PubMed

Al-Khatib, Sana M; Calkins, Hugh; Eloff, Benjamin C; Kowey, Peter; Hammill, Stephen C; Ellenbogen, Kenneth A; Marinac-Dabic, Danica; Waldo, Albert L; Brindis, Ralph G; Wilbur, David J; Jackman, Warren M; Yaross, Marcia S; Russo, Andrea M; Prystowsky, Eric; Varosy, Paul D; Gross, Thomas; Pinnow, Ellen; Turakhia, Mintu P; Krucoff, Mitchell W

2010-10-01

Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry. Copyright © 2010 Mosby, Inc. All rights reserved.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

NASA Astrophysics Data System (ADS)

Green, M. A.

2006-04-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, "How is hydrogen different from flammable gasses that are commonly being used all over the world?" This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

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

Green, Michael A.

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standardsmore » for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.« less

Regulations as Prevention Strategies for Shiftwork Problems.

PubMed

Jeppesen; Bøggild; Larsen

1997-07-01

The study examines how the Danish system of regulations stemming from collective agreements and legislation and its associated participatory structures operate at the local level in relation to shiftwork and health and safety issues in a regional hospital system consisting of seven hospitals. The study analyzed ward reports of each employee's employment and working hours, local agreements about working time for deviations from legislation, and accounts from meetings in Co-operation Committees and Health and Safety Committees with respect to shiftwork issues from 1980 to 1994. The results showed that part-time employment, especially for those working on fixed evening and night shifts, was a dominant feature in the shiftwork arrangements. A majority of wards were found to have mixtures of employees working rotating or fixed shifts. Each hospital had local agreements that extended the number of work days between periods with days off and reduced the daily resting period to its minimum. None of the meetings of the Health and Safety Committees dealt with shiftwork, and when shiftwork and working time were on the agendas of the Co-operation Committees, health and safety aspects did not feature in the conclusions. The absence of consideration of health and safety aspects is discussed in relation to the uncertainty of the general regulatory principles for work organization and scheduling. The paper concludes that in order to utilize the potential af the participatory structures in developing prevention strategies for shiftwork problems, it is important to clarify responsibilities and cooperation between the two participatory committees.

Tank waste remediation system nuclear criticality safety program management review

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

BRADY RAAP, M.C.

1999-06-24

This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

75 FR 45697 - Safety Advisory Notice: Personal Electronic Device Related Distractions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... the Federal safety authority for the transportation of hazardous materials by air, rail, highway, and... transportation of hazardous materials. In light of PHMSA's vital safety mission, we issue this advisory bulletin... hazardous materials transportation. Issued in Washington, DC, on July 27, 2010. Magdy El-Sibaie, Associate...

Workplace Health and Safety.

ERIC Educational Resources Information Center

Massachusetts Career Development Inst., Springfield.

This booklet is one of six texts from a workplace literacy curriculum designed to assist learners in facing the increased demands of the workplace. It is a short guide to workplace health and safety issues, laws, and regulations, especially in Massachusetts. Topics covered include the following: (1) safety issues--workplace ergonomics, the…

Safety issues with herbal products.

PubMed

Marrone, C M

1999-12-01

To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

Quality and safety aspects in histopathology laboratory

PubMed Central

Adyanthaya, Soniya; Jose, Maji

2013-01-01

Histopathology is an art of analyzing and interpreting the shapes, sizes and architectural patterns of cells and tissues within a given specific clinical background and a science by which the image is placed in the context of knowledge of pathobiology, to arrive at an accurate diagnosis. To function effectively and safely, all the procedures and activities of histopathology laboratory should be evaluated and monitored accurately. In histopathology laboratory, the concept of quality control is applicable to pre-analytical, analytical and post-analytical activities. Ensuring safety of working personnel as well as environment is also highly important. Safety issues that may come up in a histopathology lab are primarily those related to potentially hazardous chemicals, biohazardous materials, accidents linked to the equipment and instrumentation employed and general risks from electrical and fire hazards. This article discusses quality management system which can ensure quality performance in histopathology laboratory. The hazards in pathology laboratories and practical safety measures aimed at controlling the dangers are also discussed with the objective of promoting safety consciousness and the practice of laboratory safety. PMID:24574660

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Securing Safety - Spaceflight Standards for the Mass Market

NASA Astrophysics Data System (ADS)

Goh, G.

The projected total revenue of the space tourism industry is expected to exceed USD $1 billion by 2021. The vast economic potential of space tourism has fuelled ambitious plans for commercial orbital and suborbital flights, in addition to longer- duration spaceflights on board the International Space Station (ISS) and other planned orbiting habitats. International and national legal frameworks are challenged to provide regulations to ensure minimum standards of spaceflight safety for a high risk activity that aims to enter the mainstream tourism market. Thrown into the mix are various considerations of the number of spaceflight participants per flight, the economic viability of stringent safety standards, the plethora of possible flight vehicles and the compensation mechanism in case of violations of safety regulations. This paper surveys the legal challenges in the regulation of safety in commercial manned spaceflight, including issues of jurisdiction, authorization, licensing and liability. Drawing on analogous developments in other fields of law related to international carriage, a safety regulation framework with minimum international standards is proposed. This proposed framework considers both accident avoidance and emergency response in light of international legal, policy and economic perspectives.

International perspectives on food safety and regulations - a need for harmonized regulations: perspectives in China.

PubMed

Liu, Xiumei

2014-08-01

Food safety is a major livelihood issue and a priority concern in China. Since the Food Safety Law of the People's Republic of China was issued in 2009, the food safety control system has been strengthened through, inter alia, the Food Safety Risk Surveillance System, the Food Safety Risk Assessment System and the Food Safety Standards System. In accordance with the Food Safety Law and regulations for implementation, the Ministry of Health released the 'Twelfth Five-year Plan' of Food Safety Standards. The existing 5000 food-related standards will be integrated. Notwithstanding, the supervision system in China needs to be further improved and strengthened. © 2014 Society of Chemical Industry.

Polymer optical fiber sensors in human life safety

NASA Astrophysics Data System (ADS)

Marques, C. A. F.; Webb, D. J.; Andre, P.

2017-07-01

The current state of research into polymer optical fiber (POF) sensors linked to safety in human life is summarized in this paper. This topic is directly related with new solutions for civil aircraft, structural health monitoring, healthcare and biomedicine fields. In the last years, the properties of polymers have been explored to identify situations offering potential advantages over conventional silica fiber sensing technology, replacing, in some cases, problematic electronic technology used in these mentioned fields, where there are some issues to overcome. POFs could preferably replace their silica counterparts, with improved performance and biocompatibility. Finally, new developments are reported which use the unique properties of POF.

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

Multilevel models in the explanation of the relationship between safety climate and safe behavior.

PubMed

Cheyne, Alistair; Tomás, José M; Oliver, Amparo

2013-01-01

This study examines the relationships between components of organizational safety climate, including employee attitudes to organizational safety issues; perceptions of the physical working environment, and evaluations of worker engagement with safety issues; and relates these to self-reported levels of safety behavior. It attempts to explore the relationships between these variables in 1189 workers across 78 work groups in a large transportation organization. Evaluations of safety climate, the working environment and worker engagement, as well as safe behaviors, were collected using a self report questionnaire. The multilevel analysis showed that both levels of evaluation (the work group and the individual), and some cross-level interactions, were significant in explaining safe behaviors. Analyses revealed that a number of variables, at both levels, were associated with worker engagement and safe behaviors. The results suggest that, while individual evaluations of safety issues are important, there is also a role for the fostering of collective safety climates in encouraging safe behaviors and therefore reducing accidents.

Statistical issues in the design, conduct and analysis of two large safety studies.

PubMed

Gaffney, Michael

2016-10-01

The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

Can stress in farm animals increase food safety risk?

PubMed

Rostagno, Marcos H

2009-09-01

All farm animals will experience some level of stress during their lives. Stress reduces the fitness of an animal, which can be expressed through failure to achieve production performance standards, or through disease and death. Stress in farm animals can also have detrimental effects on the quality of food products. However, although a common assumption of a potential effect of stress on food safety exists, little is actually known about how this interaction may occur. The aim of this review was to examine the current knowledge of the potential impact of stress in farm animals on food safety risk. Colonization of farm animals by enteric pathogens such as Escherichia coli O157:H7, Salmonella, and Campylobacter, and their subsequent dissemination into the human food chain are a major public health and economic concern for the food industries. This review shows that there is increasing evidence to demonstrate that stress can have a significant deleterious effect on food safety through a variety of potential mechanisms. However, as the impact of stress is difficult to precisely determine, it is imperative that the issue receives more research attention in the interests of optimizing animal welfare and minimizing losses in product yield and quality, as well as to food safety risks to consumers. While there is some evidence linking stress with pathogen carriage and shedding in farm animals, the mechanisms underlying this effect have not been fully elucidated. Understanding when pathogen loads on the farm are the highest or when animals are most susceptible to infection will help identifying times when intervention strategies for pathogen control may be most effective, and consequently, increase the safety of food of animal origin.

Evaluation of a BCMA’s Electronic Medication Administration Record

PubMed Central

Staggers, Nancy; Iribarren, Sarah; Guo, Jia-Wen; Weir, Charlene

2015-01-01

Barcode medication administration (BCMA) systems can reduce medication errors, but sociotechnical issues are quite common. Although crucial to nurses’ work, few usability evaluations are available for electronic medication administration record screens (eMARs). The purpose of this research was to identify current usability problems in the VA’s eMAR/BCMA system and explore how these might impact nurses’ situation awareness. Three expert evaluators used 10 tasks/elements, heuristic evaluation techniques and explored potential impacts using a situation awareness perspective. The results yielded 99 usability problems categorized into 440 heuristic violations with the largest volume in the category of Match with the Real World. Fifteen usability issues were rated as catastrophic with the Administer/Chart medications task having the most. Situational awareness was impacted at all levels, especially at Level 2, Comprehension. Usability problems point to important areas for improvement because these issues have the potential to impact nurses’ situation awareness, “at a glance” information, nurse productivity and patient safety. PMID:25601936

A Safety Case Approach for Deep Geologic Disposal of DOE HLW and DOE SNF in Bedded Salt - 13350

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

Sevougian, S. David; MacKinnon, Robert J.; Leigh, Christi D.

2013-07-01

The primary objective of this study is to investigate the feasibility and utility of developing a defensible safety case for disposal of United States Department of Energy (U.S. DOE) high-level waste (HLW) and DOE spent nuclear fuel (SNF) in a conceptual deep geologic repository that is assumed to be located in a bedded salt formation of the Delaware Basin [1]. A safety case is a formal compilation of evidence, analyses, and arguments that substantiate and demonstrate the safety of a proposed or conceptual repository. We conclude that a strong initial safety case for potential licensing can be readily compiled bymore » capitalizing on the extensive technical basis that exists from prior work on the Waste Isolation Pilot Plant (WIPP), other U.S. repository development programs, and the work published through international efforts in salt repository programs such as in Germany. The potential benefits of developing a safety case include leveraging previous investments in WIPP to reduce future new repository costs, enhancing the ability to effectively plan for a repository and its licensing, and possibly expediting a schedule for a repository. A safety case will provide the necessary structure for organizing and synthesizing existing salt repository science and identifying any issues and gaps pertaining to safe disposal of DOE HLW and DOE SNF in bedded salt. The safety case synthesis will help DOE to plan its future R and D activities for investigating salt disposal using a risk-informed approach that prioritizes test activities that include laboratory, field, and underground investigations. It should be emphasized that the DOE has not made any decisions regarding the disposition of DOE HLW and DOE SNF. Furthermore, the safety case discussed herein is not intended to either site a repository in the Delaware Basin or preclude siting in other media at other locations. Rather, this study simply presents an approach for accelerated development of a safety case for a potential DOE HLW and DOE SNF repository using the currently available technical basis for bedded salt. This approach includes a summary of the regulatory environment relevant to disposal of DOE HLW and DOE SNF in a deep geologic repository, the key elements of a safety case, the evolution of the safety case through the successive phases of repository development and licensing, and the existing technical basis that could be used to substantiate the safety of a geologic repository if it were to be sited in the Delaware Basin. We also discuss the potential role of an underground research laboratory (URL). (authors)« less

EDITORIAL: Safety aspects of fusion power plants

NASA Astrophysics Data System (ADS)

Kolbasov, B. N.

2007-07-01

This special issue of Nuclear Fusion contains 13 informative papers that were initially presented at the 8th IAEA Technical Meeting on Fusion Power Plant Safety held in Vienna, Austria, 10-13 July 2006. Following recommendation from the International Fusion Research Council, the IAEA organizes Technical Meetings on Fusion Safety with the aim to bring together experts to discuss the ongoing work, share new ideas and outline general guidance and recommendations on different issues related to safety and environmental (S&E) aspects of fusion research and power facilities. Previous meetings in this series were held in Vienna, Austria (1980), Ispra, Italy (1983), Culham, UK (1986), Jackson Hole, USA (1989), Toronto, Canada (1993), Naka, Japan (1996) and Cannes, France (2000). The recognized progress in fusion research and technology over the last quarter of a century has boosted the awareness of the potential of fusion to be a practically inexhaustible and clean source of energy. The decision to construct the International Thermonuclear Experimental Reactor (ITER) represents a landmark in the path to fusion power engineering. Ongoing activities to license ITER in France look for an adequate balance between technological and scientific deliverables and complying with safety requirements. Actually, this is the first instance of licensing a representative fusion machine, and it will very likely shape the way in which a more common basis for establishing safety standards and policies for licensing future fusion power plants will be developed. Now that ITER licensing activities are underway, it is becoming clear that the international fusion community should strengthen its efforts in the area of designing the next generations of fusion power plants—demonstrational and commercial. Therefore, the 8th IAEA Technical Meeting on Fusion Safety focused on the safety aspects of power facilities. Some ITER-related safety issues were reported and discussed owing to their potential importance for the fusion power plant research programmes. The objective of this Technical Meeting was to examine in an integrated way all the safety aspects anticipated to be relevant to the first fusion power plant prototype expected to become operational by the middle of the century, leading to the first generation of economically viable fusion power plants with attractive S&E features. After screening by guest editors and consideration by referees, 13 (out of 28) papers were accepted for publication. They are devoted to the following safety topics: power plant safety; fusion specific operational safety approaches; test blanket modules; accident analysis; tritium safety and inventories; decommissioning and waste. The paper `Main safety issues at the transition from ITER to fusion power plants' by W. Gulden et al (EU) highlights the differences between ITER and future fusion power plants with magnetic confinement (off-site dose acceptance criteria, consequences of accidents inside and outside the design basis, occupational radiation exposure, and waste management, including recycling and/or final disposal in repositories) on the basis of the most recent European fusion power plant conceptual study. Ongoing S&E studies within the US inertial fusion energy (IFE) community are focusing on two design concepts. These are the high average power laser (HAPL) programme for development of a dry-wall, laser-driven IFE power plant, and the Z-pinch IFE programme for the production of an economically-attractive power plant using high-yield Z-pinch-driven targets. The main safety issues related to these programmes are reviewed in the paper `Status of IFE safety and environmental activities in the US' by S. Reyes et al (USA). The authors propose future directions of research in the IFE S&E area. In the paper `Recent accomplishments and future directions in the US Fusion Safety & Environmental Program' D. Petti et al (USA) state that the US fusion programme has long recognized that the S&E potential of fusion can be attained by prudent materials selection, judicious design choices, and integration of safety requirements into the design of the facility. To achieve this goal, S&E research is focused on understanding the behaviour of the largest sources of radioactive and hazardous materials in a fusion facility, understanding how energy sources in a fusion facility could mobilize those materials, developing integrated state-of-the-art S&E computer codes and risk tools for safety assessment, and evaluating and improving fusion facility design in terms of accident safety, worker safety, and waste disposal. There are three papers considering safety issues of the test blanket modules (TBM) producing tritium to be installed in ITER. These modules represent different concepts of demonstration fusion power facilities (DEMO). L. Boccaccini et al (Germany) analyses the possibility of jeopardizing the ITER safety under specific accidents in the European helium-cooled pebble-bed TBM, e.g. pressurization of the vacuum vessel (VV), hydrogen production from the Be-steam reaction, the possible interconnection between the port cell and VV causing air ingress. Safety analysis is also presented for Chinese TBM with a helium-cooled solid breeder to be tested in ITER by Z. Chen et al (China). Radiological inventories, afterheat, waste disposal ratings, electromagnetic characteristics, LOCA and tritium safety management are considered. An overview of a preliminary safety analysis performed for a US proposed TBM is presented by B. Merrill et al (USA). This DEMO relevant dual coolant liquid lead-lithium TBM has been explored both in the USA and EU. T. Pinna et al (Italy) summarize the six-year development of a failure rate database for fusion specific components on the basis of data coming from operating experience gained in various fusion laboratories. The activity began in 2001 with the study of the Joint European Torus vacuum and active gas handling systems. Two years later the neutral beam injectors and the power supply systems were considered. This year the ion cyclotron resonant heating system is under evaluation. I. Cristescu et al (Germany) present the paper `Tritium inventories and tritium safety design principles for the fuel cycle of ITER'. She and her colleagues developed the dynamic mathematical model (TRIMO) for tritium inventory evaluation within each system of the ITER fuel cycle in various operational scenarios. TRIMO is used as a tool for trade-off studies within the fuel cycle systems with the final goal of global tritium inventory minimization. M. Matsuyama et al (Japan) describes a new technique for in situ quantitative measurements of high-level tritium inventory and its distribution in the VV and tritium systems of ITER and future fusion reactors. This technique is based on utilization of x-rays induced by beta-rays emitting from tritium species. It was applied to three physical states of high-level tritium: to gaseous, aqueous and solid tritium retained on/in various materials. Finally, there are four papers devoted to safety issues in fusion reactor decommissioning and waste management. A paper by R. Pampin et al (UK) provides the revised radioactive waste analysis of two models in the PPCS. Another paper by M. Zucchetti (Italy), S.A. Bartenev (Russia) et al describes a radiochemical extraction technology for purification of V-Cr-Ti alloy components from activation products to the dose rate of 10 µSv/h allowing their clearance or hands-on recycling which has been developed and tested in laboratory stationary conditions. L. El-Guebaly (USA) and her colleagues submitted two papers. In the first paper she optimistically considers the possibility of replacing the disposal of fusion power reactor waste with recycling and clearance. Her second paper considers the implications of new clearance guidelines for nuclear applications, particularly for slightly irradiated fusion materials.

A Historical Analysis of Crane Mishaps at Kennedy Space Center

NASA Technical Reports Server (NTRS)

Wolfe, Crystal

2014-01-01

Cranes and hoists are widely used in many areas. Crane accidents and handling mishaps are responsible for injuries, costly equipment damage, and program delays. Most crane accidents are caused by preventable factors. Understanding these factors is critical when designing cranes and preparing lift plans. Analysis of previous accidents provides insight into current recommendations for crane safety. Cranes and hoists are used throughout Kennedy Space Center to lift everything from machine components to critical flight hardware. Unless they are trained crane operators, most NASA employees and contractors do not need to undergo specialized crane training and may not understand the safety issues surrounding the use of cranes and hoists. A single accident with a crane or hoist can injure or kill people, cause severe equipment damage, and delay or terminate a program. Handling mishaps can also have a significant impact on the program. Simple mistakes like bouncing or jarring a load, or moving the crane down when it should go up, can damage fragile flight hardware and cause major delays in processing. Hazardous commodities (high pressure gas, hypergolic propellants, and solid rocket motors) can cause life safety concerns for the workers performing the lifting operations. Most crane accidents are preventable with the correct training and understanding of potential hazards. Designing the crane with human factors taken into account can prevent many accidents. Engineers are also responsible for preparing lift plans where understanding the safety issues can prevent or mitigate potential accidents. Cranes are widely used across many areas of KSC. Failure of these cranes often leads to injury, high damage costs, and significant delays in program objectives. Following a basic set of principles and procedures during design, fabrication, testing, regular use, and maintenance can significantly minimize many of these failures. As the accident analysis shows, load drops are often caused or influenced by human factors. Therefore, proper training and understanding of crane safety throughout the workforce is critical. It is important that the engineers designing the cranes, lift planners preparing the lift plans, operators performing the lifts, and training officers conducting the operator training all understand the problems that can happen with cranes and how to ensure the safety of the workforce and equipment being lifted.

Radiolytic and Thermal Processes Relevant to Dry Storage of Spent Nuclear Fuels

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

Marschman, Steven C.; Madey,Theodore E.; Haustein, Peter E.

2000-06-01

The purpose of this project is to deliver pertinent information that can be used to make rational decisions about the safety and treatment issues associated with dry storage of spent nuclear fuel materials. In particular, we will establish an understanding of: (1) water interactions with failed-fuel rods and metal-oxide materials; (2) the role of thermal processes and radiolysis (solid-state and interfacial) in the generation of potentially explosive mixtures of gaseous H2 and O2; and (3) the potential role of radiation-assisted corrosion during fuel rod storage.

Striving for a good standard of maths for potential student nurses.

PubMed

Roberts, Sheila; Campbell, Anne

2017-01-12

This article explores some of the issues surrounding numerical competence for potential pre-registration children's nursing students, with examples of success and failure, at the University of Hertfordshire. With poor numerical ability causing concern in the UK, and the effect of low competence on patient safety when calculating drug dosages in healthcare, this article considers some of the literature surrounding numerical ability, confidence and anxiety, along with considering whether a 'C' grade at GCSE is a suitable marker for assessing numerical competence before starting a pre-registration nursing programme.

School Safety Concerns All Students.

ERIC Educational Resources Information Center

Henderson, Megan

1999-01-01

Suggests that school safety is an issue that concerns all students. Discusses how the staff of the Rockwood South (Missouri) "RAMpage" covered the shootings at Columbine High School in a 14-page issue and in follow-up issues. Suggests that the student newspaper covered the controversial topic in an appropriate, tasteful manner. (RS)

Principles of Safety Pharmacology

PubMed Central

Pugsley, M K; Authier, S; Curtis, M J

2008-01-01

Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.). PMID:18604233

2011 Annual Criticality Safety Program Performance Summary

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

Andrea Hoffman

The 2011 review of the INL Criticality Safety Program has determined that the program is robust and effective. The review was prepared for, and fulfills Contract Data Requirements List (CDRL) item H.20, 'Annual Criticality Safety Program performance summary that includes the status of assessments, issues, corrective actions, infractions, requirements management, training, and programmatic support.' This performance summary addresses the status of these important elements of the INL Criticality Safety Program. Assessments - Assessments in 2011 were planned and scheduled. The scheduled assessments included a Criticality Safety Program Effectiveness Review, Criticality Control Area Inspections, a Protection of Controlled Unclassified Information Inspection,more » an Assessment of Criticality Safety SQA, and this management assessment of the Criticality Safety Program. All of the assessments were completed with the exception of the 'Effectiveness Review' for SSPSF, which was delayed due to emerging work. Although minor issues were identified in the assessments, no issues or combination of issues indicated that the INL Criticality Safety Program was ineffective. The identification of issues demonstrates the importance of an assessment program to the overall health and effectiveness of the INL Criticality Safety Program. Issues and Corrective Actions - There are relatively few criticality safety related issues in the Laboratory ICAMS system. Most were identified by Criticality Safety Program assessments. No issues indicate ineffectiveness in the INL Criticality Safety Program. All of the issues are being worked and there are no imminent criticality concerns. Infractions - There was one criticality safety related violation in 2011. On January 18, 2011, it was discovered that a fuel plate bundle in the Nuclear Materials Inspection and Storage (NMIS) facility exceeded the fissionable mass limit, resulting in a technical safety requirement (TSR) violation. The TSR limits fuel plate bundles to 1085 grams U-235, which is the maximum loading of an ATR fuel element. The overloaded fuel plate bundle contained 1097 grams U-235 and was assembled under an 1100 gram U-235 limit in 1982. In 2003, the limit was reduced to 1085 grams citing a new criticality safety evaluation for ATR fuel elements. The fuel plate bundle inventories were not checked for compliance prior to implementing the reduced limit. A subsequent review of the NMIS inventory did not identify further violations. Requirements Management - The INL Criticality Safety program is organized and well documented. The source requirements for the INL Criticality Safety Program are from 10 CFR 830.204, DOE Order 420.1B, Chapter III, 'Nuclear Criticality Safety,' ANSI/ANS 8-series Industry Standards, and DOE Standards. These source requirements are documented in LRD-18001, 'INL Criticality Safety Program Requirements Manual.' The majority of the criticality safety source requirements are contained in DOE Order 420.1B because it invokes all of the ANSI/ANS 8-Series Standards. DOE Order 420.1B also invokes several DOE Standards, including DOE-STD-3007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities.' DOE Order 420.1B contains requirements for DOE 'Heads of Field Elements' to approve the criticality safety program and specific elements of the program, namely, the qualification of criticality staff and the method for preparing criticality safety evaluations. This was accomplished by the approval of SAR-400, 'INL Standardized Nuclear Safety Basis Manual,' Chapter 6, 'Prevention of Inadvertent Criticality.' Chapter 6 of SAR-400 contains sufficient detail and/or reference to the specific DOE and contractor documents that adequately describe the INL Criticality Safety Program per the elements specified in DOE Order 420.1B. The Safety Evaluation Report for SAR-400 specifically recognizes that the approval of SAR-400 approves the INL Criticality Safety Program. No new source requirements were released in 2011. A revision to LRD-18001 is planned for 2012 to clarify design requirements for criticality alarms. Training - Criticality Safety Engineering has developed training and provides training for many employee positions, including fissionable material handlers, facility managers, criticality safety officers, firefighters, and criticality safety engineers. Criticality safety training at the INL is a program strength. A revision to the training module developed in 2010 to supplement MFC certified fissionable material handlers (operators) training was prepared and presented in August of 2011. This training, 'Applied Science of Criticality Safety,' builds upon existing training and gives operators a better understanding of how their criticality controls are derived. Improvements to 00INL189, 'INL Criticality Safety Principles' are planned for 2012 to strengthen fissionable material handler training.« less

Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

PubMed

Campbell, Emma Jean; Turpin, Merrill June

2010-12-01

Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

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

Dogs in the Workplace: A Review of the Benefits and Potential Challenges.

PubMed

Foreman, Anne M; Glenn, Margaret K; Meade, B Jean; Wirth, Oliver

2017-05-08

Pet dogs, therapy dogs, and service dogs can be seen in workplaces with increasing frequency. Although dogs may provide many benefits to employees and employers, their presence may introduce additional hazards and concerns to the work environment. Therefore, decisions to accept dogs in the workplace may include many considerations including the health, safety, and well-being of employees, legal and cultural sensitivities, and animal welfare. The present paper serves to introduce the issue of dogs in the workplace and outline the potential benefits and challenges to their presence. The legal accommodations afforded to certain types of dogs in workplace settings are discussed, and the research findings pertaining to the potential benefits of dogs on human health and well-being are summarized. The paper concludes with considerations for human resource management personnel in the areas of diversity, employee relations, ethics and corporate responsibility, organizational and employee development, safety and security, and legal considerations, as well as suggested topics for future research.

Dogs in the Workplace: A Review of the Benefits and Potential Challenges

PubMed Central

Foreman, Anne M.; Glenn, Margaret K.; Meade, B. Jean; Wirth, Oliver

2017-01-01

Pet dogs, therapy dogs, and service dogs can be seen in workplaces with increasing frequency. Although dogs may provide many benefits to employees and employers, their presence may introduce additional hazards and concerns to the work environment. Therefore, decisions to accept dogs in the workplace may include many considerations including the health, safety, and well-being of employees, legal and cultural sensitivities, and animal welfare. The present paper serves to introduce the issue of dogs in the workplace and outline the potential benefits and challenges to their presence. The legal accommodations afforded to certain types of dogs in workplace settings are discussed, and the research findings pertaining to the potential benefits of dogs on human health and well-being are summarized. The paper concludes with considerations for human resource management personnel in the areas of diversity, employee relations, ethics and corporate responsibility, organizational and employee development, safety and security, and legal considerations, as well as suggested topics for future research. PMID:28481317

A web-based tool for the Comprehensive Unit-based Safety Program (CUSP).

PubMed

Pronovost, Peter J; King, Jay; Holzmueller, Christine G; Sawyer, Melinda; Bivens, Shauna; Michael, Michelle; Haig, Kathy; Paine, Lori; Moore, Dana; Miller, Marlene

2006-03-01

An organization's ability to change is driven by its culture, which in turn has a significant impact on safety. The six-step Comprehensive Unit-Based Safety Program (CUSP) is intended to improve local culture and safety. A Web-based project management tool for CUSP was developed and then pilot tested at two hospitals. HOW ECUSP WORKS: Once a patient safety concern is identified (step 3), a unit-level interdisciplinary safety committee determines issue criticality and starts up the projects (step 4), which are managed using project management tools within eCUSP (step 5). On a project's completion, the results are disseminated through a shared story (step 6). OSF St. Joseph's Medical Center-The Medical Birthing Center (Bloomington, Illinois), identified 11 safety issues, implemented 11 projects, and created 9 shared stories--including one for its Armband Project. The Johns Hopkins Hospital (Baltimore) Medical Progressive Care (MPC4) Unit identified 5 safety issues and implemented 4 ongoing projects, including the intravenous (IV) Tubing Compliance Project. The eCUSP tool's success depends on an organizational commitment to creating a culture of safety.

29 CFR 1952.240 - Description of the plan as initially approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... occupational safety and health issues as defined by the Secretary of Labor in § 1902.2(c)(1) of this chapter... standards and issue rules and regulations necessary for the implementation of the safety and health law. (d... Section 1952.240 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.240 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues as defined by the Secretary of Labor in § 1902.2(c)(1) of this chapter... standards and issue rules and regulations necessary for the implementation of the safety and health law. (d... Section 1952.240 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

75 FR 33162 - Airworthiness Directives; Microturbo Saphir 20 Model 095 Auxiliary Power Units (APUs)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-11

... information (MCAI) issued by the European Aviation Safety Agency (EASA) to identify and correct an unsafe... States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106... the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

Food Supply and Food Safety Issues in China

PubMed Central

Lam, Hon-Ming; Remais, Justin; Fung, Ming-Chiu; Xu, Liqing; Sun, Samuel Sai-Ming

2013-01-01

Food supply and food safety are major global public health issues, and are particularly important in heavily populated countries such as China. Rapid industrialisation and modernisation in China are having profound effects on food supply and food safety. In this Review, we identified important factors limiting agricultural production in China, including conversion of agricultural land to other uses, freshwater deficits, and soil quality issues. Additionally, increased demand for some agricultural products is examined, particularly those needed to satisfy the increased consumption of animal products in the Chinese diet, which threatens to drive production towards crops used as animal feed. Major sources of food poisoning in China include pathogenic microorganisms, toxic animals and plants entering the food supply, and chemical contamination. Meanwhile, two growing food safety issues are illegal additives and contamination of the food supply by toxic industrial waste. China’s connections to global agricultural markets are also having important effects on food supply and food safety within the country. Although the Chinese Government has shown determination to reform laws, establish monitoring systems, and strengthen food safety regulation, weak links in implementation remain. PMID:23746904

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

Hospital safety climate and safety behavior: A social exchange perspective.

PubMed

Ancarani, Alessandro; Di Mauro, Carmela; Giammanco, Maria D

Safety climate is considered beneficial to the improvement of hospital safety outcomes. Nevertheless, the relations between two of its key constituents, namely those stemming from leader-subordinate relations and coworker support for safety, are still to be fully ascertained. This article uses the theoretical lens of Social Exchange Theory to study the joint impact of leader-member exchange in the safety sphere and coworker support for safety on safety-related behavior at the hospital ward level. Social exchange constructs are further related to the existence of a shame-/blame-free environment, seen as a potential antecedent of safety behavior. A cross-sectional study including 166 inpatients in hospital wards belonging to 10 public hospitals in Italy was undertaken to test the hypotheses developed. Hypothesized relations have been analyzed through a fully mediated multilevel structural equation model. This methodology allows studying behavior at the individual level, while keeping into account the heterogeneity among hospital specialties. Results suggest that the linkage between leader support for safety and individual safety behavior is mediated by coworker support on safety issues and by the creation of a shame-free environment. These findings call for the creation of a safety climate in which managerial efforts should be directed not only to the provision of new safety resources and the enforcement of safety rules but also to the encouragement of teamwork and freedom to report errors as ways to foster the capacity of the staff to communicate, share, and learn from each other.

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

A PILOT SURVEY ON INJURY AND SAFETY CONCERNS IN INTERNATIONAL SLEDGE HOCKEY

PubMed Central

Finlayson, Heather; O'Connor, Russ; Anton, Hugh

2011-01-01

Objective: To describe sledge hockey injury patterns, safety issues and to develop potential injury prevention strategies. Design: Pilot survey study of international sledge hockey professionals, including trainers, physiotherapists, physicians, coaches and/or general managers. Setting: Personal encounter or online correspondence. Respondents: Sledge hockey professionals; a total of 10 respondents from the 5 top-ranked international teams recruited by personal encounter or online correspondence. Main Outcome Measurements: Descriptive Data reports on sledge athlete injury characteristics, quality of rules and enforcement, player equipment, challenges in the medical management during competition, and overall safety. Results: Muscle strains and concussions were identified as common, and injuries were reported to affect the upper body more frequently than the lower body. Overuse and body checking were predominant injury mechanisms. Safety concerns included excessive elbowing, inexperienced refereeing and inadequate equipment standards. Conclusions: This paper is the first publication primarily focused on sledge hockey injury and safety. This information provides unique opportunity for the consideration of implementation and evaluation of safety strategies. Safety interventions could include improved hand protection, cut-resistant materials in high-risk areas, increased vigilance to reduce intentional head-contact, lowered rink boards and modified bathroom floor surfacing. PMID:21904696

Food Safety Practices in the Egg Products Industry.

PubMed

Viator, Catherine L; Cates, Sheryl C; Karns, Shawn A; Muth, Mary K; Noyes, Gary

2016-07-01

We conducted a national census survey of egg product plants (n = 57) to obtain information on the technological and food safety practices of the egg products industry and to assess changes in these practices from 2004 to 2014. The questionnaire asked about operational and sanitation practices, microbiological testing practices, food safety training for employees, other food safety issues, and plant characteristics. The findings suggest that improvements were made in the industry's use of food safety technologies and practices between 2004 and 2014. The percentage of plants using advanced pasteurization technology and an integrated, computerized processing system increased by almost 30 percentage points. Over 90% of plants voluntarily use a written hazard analysis and critical control point (HACCP) plan to address food safety for at least one production step. Further, 90% of plants have management employees who are trained in a written HACCP plan. Most plants (93%) conduct voluntary microbiological testing. The percentage of plants conducting this testing on egg products before pasteurization has increased by almost 30 percentage points since 2004. The survey findings identify strengths and weaknesses in egg product plants' food safety practices and can be used to guide regulatory policymaking and to conduct required regulatory impact analysis of potential regulations.

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

DOE PAGES

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

2017-06-21

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Current and Future Technologies for Microbiological Decontamination of Cereal Grains.

PubMed

Los, Agata; Ziuzina, Dana; Bourke, Paula

2018-06-01

Cereal grains are the most important staple foods for mankind worldwide. The constantly increasing annual production and yield is matched by demand for cereals, which is expected to increase drastically along with the global population growth. A critical food safety and quality issue is to minimize the microbiological contamination of grains as it affects cereals both quantitatively and qualitatively. Microorganisms present in cereals can affect the safety, quality, and functional properties of grains. Some molds have the potential to produce harmful mycotoxins and pose a serious health risk for consumers. Therefore, it is essential to reduce cereal grain contamination to the minimum to ensure safety both for human and animal consumption. Current production of cereals relies heavily on pesticides input, however, numerous harmful effects on human health and on the environment highlight the need for more sustainable pest management and agricultural methods. This review evaluates microbiological risks, as well as currently used and potential technologies for microbiological decontamination of cereal grains. © 2018 Institute of Food Technologists®.

Occupational Safety Review of High Technology Facilities

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

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

Sex differences in principal farm operators' tractor driving safety beliefs and behaviors.

PubMed

Cole, H P; Westneat, S C; Browning, S R; Piercy, L R; Struttmann, T

2000-01-01

To examine the widely accepted hypothesis that farm women are more concerned with safety issues and behaviors than their male counterparts are. A telephone survey was administered to a random sample of Kentucky principal farm operators, 90 of whom were women. Participants were questioned about their tractor safety beliefs and practices. No significant sex differences in tractor safety perceptions and behavior were observed. Socialization of women to the role of principal farm operator may override their typically greater sensitivity to safety issues, an important consideration when designing safety campaigns for this population.

Availability and utility of crop composition data.

PubMed

Kitta, Kazumi

2013-09-04

The safety assessment of genetically modified (GM) crops is mandatory in many countries. Although the most important factor to take into account in these safety assessments is the primary effects of artificially introduced transgene-derived traits, possible unintended effects attributed to the insertion of transgenes must be carefully examined in parallel. However, foods are complex mixtures of compounds characterized by wide variations in composition and nutritional values. Food components are significantly affected by various factors such as cultivars and the cultivation environment including storage conditions after harvest, and it can thus be very difficult to detect potential adverse effects caused by the introduction of a transgene. A comparative approach focusing on the identification of differences between GM foods and their conventional counterparts has been performed to reveal potential safety issues and is considered the most appropriate strategy for the safety assessment of GM foods. This concept is widely shared by authorities in many countries. For the efficient safety assessment of GM crops, an easily accessible and wide-ranging compilation of crop composition data is required for use by researchers and regulatory agencies. Thus, we developed an Internet-accessible food composition database comprising key nutrients, antinutrients, endogenous toxicants, and physiologically active substances of staple crops such as rice and soybeans. The International Life Sciences Institute has also been addressing the same matter and has provided the public a crop composition database of soybeans, maize, and cotton.

The development of an information system and installation of an Internet web database for the purposes of the occupational health and safety management system.

PubMed

Mavrikakis, I; Mantas, J; Diomidous, M

2007-01-01

This paper is based on the research on the possible structure of an information system for the purposes of occupational health and safety management. We initiated a questionnaire in order to find the possible interest on the part of potential users in the subject of occupational health and safety. The depiction of the potential interest is vital both for the software analysis cycle and development according to previous models. The evaluation of the results tends to create pilot applications among different enterprises. Documentation and process improvements ascertained quality of services, operational support, occupational health and safety advice are the basics of the above applications. Communication and codified information among intersted parts is the other target of the survey regarding health issues. Computer networks can offer such services. The network will consist of certain nodes responsible to inform executives on Occupational Health and Safety. A web database has been installed for inserting and searching documents. The submission of files to a server and the answers to questionnaires through the web help the experts to perform their activities. Based on the requirements of enterprises we have constructed a web file server. We submit files so that users can retrieve the files which they need. The access is limited to authorized users. Digital watermarks authenticate and protect digital objects.

Quality requirements for cross-border care in Europe: a qualitative study of patients’, professionals’ and healthcare financiers’ views

PubMed Central

Groene, O; Poletti, P; Vallejo, P; Cucic, C; Klazinga, N; Suñol, R

2009-01-01

Background: In the past decade the issue of patient mobility has emerged on the European health policy agenda. Although the volume of patients crossing borders to obtain healthcare is low, it is increasing continuously and, due to its legal, financial and medical implications, has generated considerable interest among health policy and other decision makers. However, there is little information available on the safety and patient-centredness of cross-border care and neither governments nor citizens have an explicit basis for comparing healthcare delivery in Europe. Methods: This study investigated the viewpoints of patients, professionals and healthcare financiers on the safety and patient-centredness of cross-border care. Qualitative interviews were carried out during 2005 and early 2006 with 40 patients, 30 professionals (doctors, nurses and managers) and 3 healthcare-financing bodies. Results: Although cross-border care has become a common issue in many European countries, there remain uncertainties on the side of each of the parties addressed—patients, professionals and financiers—with regard to the provision of cross-border care. One of the most striking results of this project is the current lack of research on systematic knowledge on the quality of cross-border care. Conclusion: Many of the issues identified through this research may have a potential impact on the quality and safety of cross-border care and will support further investigation and help shape the health policy agenda on patients crossing borders in European Union countries. PMID:19188456

Towards patient safety in anaesthesia.

PubMed

Cooper, J B

1994-07-01

The anaesthesia specialty has focused on the safety of the patient and examination of untoward outcomes. Serious injuries are now rare in medically advanced countries. Still, anaesthesia deaths and complications are important because the anaesthetic itself has no intended therapeutic effect. Safety is a never-ending battle that requires continued effort because many forces have the potential to diminish whatever progress is made. This paper describes the modern movement in anaesthesia patient safety--the reasons it started, the major foci and explanations for why anaesthesia seems now to be safer than at any time in history. The American legal system, critical incident studies, studies of malpractice claims and large-scale studies of anaesthesia outcomes played a role in increasing the awareness of the need to enhance anaesthesia safety. Many efforts are believed to have contributed to improvements in the safety of anaesthesia: improved training of anaesthesia clinicians, new pharmaceuticals, new technologies for monitoring (especially pulse oximetry and capnography), standards for monitoring and other aspects of anaesthesia care, safety enhancements in anaesthesia equipment and the implementation of quality assurance and risk management programmes. The creation of the Anesthesia Patient Safety Foundation in the United States and a similar organization in Australia have helped to bring about awareness of safety issues and to support study of patient safety. Ultimately, the motto of the Anesthesia Patient Safety Foundation should be the goal of all anaesthesia professionals: "That no patient shall be harmed by anaesthesia".

TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.

PubMed

Weld, Lancaster R; Stringer, Matthew T; Ebertowski, James S; Baumgartner, Timothy S; Kasprenski, Matthew C; Kelley, Jeremy C; Cho, Doug S; Tieva, Erwin A; Novak, Thomas E

2016-09-01

The objective was to evaluate the effect of TeamSTEPPS on operating room efficiency and patient safety. TeamSTEPPS consisted of briefings attended by all health care personnel assigned to the specific operating room to discuss issues unique to each case scheduled for that day. The operative times, on-time start rates, and turnover times of all cases performed by the urology service during the initial year with TeamSTEPPS were compared to the prior year. Patient safety issues identified during postoperative briefings were analyzed. The mean case time was 12.7 minutes less with TeamSTEPPS (P < .001). The on-time first-start rate improved by 21% with TeamSTEPPS (P < .001). The mean room turnover time did not change. Patient safety issues declined from an initial rate of 16% to 6% at midyear and remained stable (P < 0.001). TeamSTEPPS was associated with improved operating room efficiency and diminished patient safety issues in the operating room. © The Author(s) 2015.

Consumer confidence in the safety of food and newspaper coverage of food safety issues: a longitudinal perspective.

PubMed

de Jonge, Janneke; Van Trijp, Hans; Renes, Reint Jan; Frewer, Lynn J

2010-01-01

This study develops a longitudinal perspective on consumer confidence in the safety of food to explore if, how, and why consumer confidence changes over time. In the first study, a theory-based monitoring instrument for consumer confidence in the safety of food was developed and validated. The monitoring instrument assesses consumer confidence together with its determinants. Model and measurement invariance were validated rigorously before developments in consumer confidence in the safety of food and its determinants were investigated over time. The results from the longitudinal analysis show that across four waves of annual data collection (2003-2006), the framework was stable and that the relative importance of the determinants of confidence was, generally, constant over time. Some changes were observed regarding the mean ratings on the latent constructs. The second study explored how newspaper coverage of food safety related issues affects consumer confidence in the safety of food through subjective consumer recall of food safety incidents. The results show that the newspaper coverage on food safety issues is positively associated with consumer recall of food safety incidents, both in terms of intensity and recency of media coverage.

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

PubMed

Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

2014-01-01

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

Situation analysis for automotive pre-crash systems

NASA Astrophysics Data System (ADS)

Böhning, Marcus A.; Ritter, Henning; Rohling, Herrman

2008-01-01

According to the "World Report on Road Traffic Injury Prevention" jointly issued by the World Health Organization and the World Bank about 1.2 million people are killed and up to 50 million people are injured in road traffic accidents worldwide each year. While passive safety systems like the airbag are already deployed successfully to reduce fatalities and injuries, active safety systems assist the driver by issuing a warning or by taking corrective actions to either avoid a collision completely or, if impossible, to mitigate collision consequences. Today's radar sensors have the ability to detect and track objects with a high accuracy in range and velocity, therefore a collision warning system may consist of a radar sensor, a data processing unit and a model to describe possible evasion maneuvers. This allows to analyze the probability of a collision and to calculate the danger potential of the current situation. In this paper, such a system is proposed and it is verified with synthetic as well as real sensor data.

Integrating Building Information Modeling and Health and Safety for Onsite Construction

PubMed Central

Ganah, Abdulkadir; John, Godfaurd A.

2014-01-01

Background Health and safety (H&S) on a construction site can either make or break a contractor, if not properly managed. The usage of Building Information Modeling (BIM) for H&S on construction execution has the potential to augment practitioner understanding of their sites, and by so doing reduce the probability of accidents. This research explores BIM usage within the construction industry in relation to H&S communication. Methods In addition to an extensive literature review, a questionnaire survey was conducted to gather information on the embedment of H&S planning with the BIM environment for site practitioners. Results The analysis of responses indicated that BIM will enhance the current approach of H&S planning for construction site personnel. Conclusion From the survey, toolbox talk will have to be integrated with the BIM environment, because it is the predominantly used procedure for enhancing H&S issues within construction sites. The advantage is that personnel can visually understand H&S issues as work progresses during the toolbox talk onsite. PMID:25830069

Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning system.

PubMed

Halloran, Kylene; Barash, Paul G

2010-06-01

To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study. Scientific studies report that there is no basis to issue a black-box warning for perioperative administration of droperidol for postoperative nausea and vomiting on the basis of the potential of adverse cardiac events (prolongation of the QT interval and/or development of torsades de pointes). Rather than relying on well conducted clinical investigations, the Food and Drug Administration subjectively issued a black-box warning to droperidol, which effectively removed droperidol from clinical practice for the indication of postoperative nausea and vomiting. Newer data suggest that the incidence of prolongation of the QT interval and the occurrence of torsades de pointes is similar to more expensive alternative medications used to treat postoperative nausea and vomiting.

The Wiley Protocol: an analysis of ethical issues.

PubMed

Rosenthal, M Sara

2008-01-01

: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol. : A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts. : The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring. : Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

Integrating building information modeling and health and safety for onsite construction.

PubMed

Ganah, Abdulkadir; John, Godfaurd A

2015-03-01

Health and safety (H&S) on a construction site can either make or break a contractor, if not properly managed. The usage of Building Information Modeling (BIM) for H&S on construction execution has the potential to augment practitioner understanding of their sites, and by so doing reduce the probability of accidents. This research explores BIM usage within the construction industry in relation to H&S communication. In addition to an extensive literature review, a questionnaire survey was conducted to gather information on the embedment of H&S planning with the BIM environment for site practitioners. The analysis of responses indicated that BIM will enhance the current approach of H&S planning for construction site personnel. From the survey, toolbox talk will have to be integrated with the BIM environment, because it is the predominantly used procedure for enhancing H&S issues within construction sites. The advantage is that personnel can visually understand H&S issues as work progresses during the toolbox talk onsite.

Connected cane: Tactile button input for controlling gestures of iOS voiceover embedded in a white cane.

PubMed

Batterman, Jared M; Martin, Vincent F; Yeung, Derek; Walker, Bruce N

2018-01-01

Accessibility of assistive consumer devices is an emerging research area with potential to benefit both users with and without visual impairments. In this article, we discuss the research and evaluation of using a tactile button interface to control an iOS device's native VoiceOver Gesture navigations (Apple Accessibility, 2014). This research effort identified potential safety and accessibility issues for users trying to interact and control their touchscreen mobile iOS devices while traveling independently. Furthermore, this article discusses the participatory design process in creating a solution that aims to solve issues in utilizing a tactile button interface in a novel device. The overall goal of this study is to enable visually impaired white cane users to access their mobile iOS device's capabilities navigation aids more safely and efficiently on the go.

Patient Safety Culture: A Review of the Nursing Home Literature and Recommendations for Practice

PubMed Central

Bonner, Alice F.; Castle, Nicholas G.; Perera, Subashan; Handler, Steven M.

2010-01-01

Patient safety culture (PSC) is a critical factor in creating high-reliability health-care organizations. Most PSC research studies to date have been conducted in acute care settings; however, nursing home studies have recently begun to appear in the literature. Nursing homes differ from hospitals in a number of ways, including the population they serve, the medical model of care, and having the vast majority of direct care provided by non-licensed certified nursing assistants. Research has shown that nursing home PSC differs in important ways from PSC in acute care institutions. Recent PSC studies conducted in nursing homes and related quality and safety research can guide recommendations for nursing homes wishing to evaluate their own PSC. Relationships between PSC measurement, quality improvement, and workforce issues are potentially important and may influence clinical outcomes. PMID:21701601

Fire and worker health and safety: an introduction to the special issue.

PubMed

Campbell, Richard; Levenstein, Charles

2015-02-01

One century ago, the landmark fire at the Triangle Shirtwaist Factory in New York City claimed the lives of 146 garment workers and helped spur the adoption of fire safety measures and laws targeting dangerous working conditions. Since that time, continuing advances have been made to address the threat of fire-in workplace fire safety practices and regulations, in training and safety requirements for firefighters and first responders, and in hazard communication laws that enhance disaster planning and response. Recent high profile events, including the West, Texas fertilizer plant explosion, derailments of fuel cargo trains, and garment factory fires in Bangladesh, have brought renewed attention to fire as a workplace health and safety issue and to the unevenness of safety standards and regulatory enforcement, in the United States as well as internationally. In this article, we provide an overview of fire as a workplace health and safety hazard and an introduction to the essays included in this special issue of New Solutions on fire and work. © 2015 SAGE Publications.

IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

PubMed

Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

2008-11-01

As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

77 FR 45242 - Revisions to Safety Standards for Durable Infant or Toddler Products: Infant Bath Seats and Full...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... direction in the Danny Keysar Child Product Safety Notification Act to issue standards for durable infant or... not usually subject to CPSC's standards, such as child care facilities, family child care homes, and... standard issued under the Danny Keysar Child Product Safety Notification Act was based, the revision...

Case and commentary: using simulation to address hierarchy issues during medical crises.

PubMed

Calhoun, Aaron W; Boone, Megan C; Miller, Karen H; Pian-Smith, May C M

2013-02-01

Medicine is hierarchical, and both positive and negative effects of this can be exposed and magnified during a crisis. Ideally, hierarchies function in an orderly manner, but when an inappropriate directive is given, the results can be disastrous unless team members are empowered to challenge the order. This article describes a case that uses misdirection and the possibility of simulated "death" to facilitate learning among experienced clinicians about the potentially deadly effects of an unchallenged, inappropriate order. The design of this case, however, raises additional questions regarding both ethics and psychological safety. The ethical concerns that surround the use of misdirection in simulation and the psychological ramifications of incorporating patient death in this context are explored in the commentary. We conclude with a discussion of debriefing strategies that can be used to promote psychological safety during potentially emotionally charged simulations and possible directions for future research.

A question about the potential cardiac toxicity of escitalopram.

PubMed

Howland, Robert H

2012-04-01

Previous reviews have focused on the potential cardiac toxicity of the racemic drug citalopram (Celexa(®)). Evaluating the safety of escitalopram (Lexapro(®)) is an important issue to consider, since it is the S-enantiomer of citalopram. Escitalopram has a small effect on the QTc interval. A prolonged QTc was seen in 2% to 14% of escitalopram overdose cases, without serious cardiac sequelae. The QTc prolongation effect of citalopram in beagle dogs has been attributed to the minor metabolite racemic didemethylcitalopram (DDCT). Whether the escitalopram minor metabolite S-DDCT has this effect is not known. Concentrations of S-DDCT are lower than DDCT, but for a broad range of doses of escitalopram and citalopram, the S-DDCT and DDCT concentrations are well below the QTc prolonging concentrations reported in dogs. There is no strong evidence from human and animal studies that the cardiac safety of escitalopram is significantly superior to that of citalopram. Copyright 2012, SLACK Incorporated.

Constructing a novel and safer energy storing system using a graphite cathode and a MoO 3 anode

NASA Astrophysics Data System (ADS)

Gunawardhana, Nanda; Park, Gum-Jae; Dimov, Nikolay; Thapa, Arjun Kumar; Nakamura, Hiroyoshi; Wang, Hongyu; Ishihara, Tatsumi; Yoshio, Masaki

A cell employing a graphite cathode and a molybdenum (VI) oxide (MoO 3) anode is investigated as a possible energy storage device. Graphite cathode allows raising the voltage well above the cathode materials of LIBs without causing safety issues. The bottom potential of this anode is 2.0 V vs. Li/Li +, which is well above the lithium plating potential. Pulse polarization experiment reveals that no lithium deposition occurs, which further enhances the safety of the graphite/MoO 3 full cell. Charge/discharge mechanism of this system results from intercalation and de-intercalation of the PF 6 - in the cathode (KS-6) and Li + in the anode (MoO 3). This mechanism is supported by in situ X-ray diffraction data of the graphite/MoO 3 cell recorded at various states of charge.

Data and methods for studying commercial motor vehicle driver fatigue, highway safety and long-term driver health.

PubMed

Stern, Hal S; Blower, Daniel; Cohen, Michael L; Czeisler, Charles A; Dinges, David F; Greenhouse, Joel B; Guo, Feng; Hanowski, Richard J; Hartenbaum, Natalie P; Krueger, Gerald P; Mallis, Melissa M; Pain, Richard F; Rizzo, Matthew; Sinha, Esha; Small, Dylan S; Stuart, Elizabeth A; Wegman, David H

2018-03-09

This article summarizes the recommendations on data and methodology issues for studying commercial motor vehicle driver fatigue of a National Academies of Sciences, Engineering, and Medicine study. A framework is provided that identifies the various factors affecting driver fatigue and relating driver fatigue to crash risk and long-term driver health. The relevant factors include characteristics of the driver, vehicle, carrier and environment. Limitations of existing data are considered and potential sources of additional data described. Statistical methods that can be used to improve understanding of the relevant relationships from observational data are also described. The recommendations for enhanced data collection and the use of modern statistical methods for causal inference have the potential to enhance our understanding of the relationship of fatigue to highway safety and to long-term driver health. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Usability Methods for Ensuring Health Information Technology Safety: Evidence-Based Approaches. Contribution of the IMIA Working Group Health Informatics for Patient Safety.

PubMed

Borycki, E; Kushniruk, A; Nohr, C; Takeda, H; Kuwata, S; Carvalho, C; Bainbridge, M; Kannry, J

2013-01-01

Issues related to lack of system usability and potential safety hazards continue to be reported in the health information technology (HIT) literature. Usability engineering methods are increasingly used to ensure improved system usability and they are also beginning to be applied more widely for ensuring the safety of HIT applications. These methods are being used in the design and implementation of many HIT systems. In this paper we describe evidence-based approaches to applying usability engineering methods. A multi-phased approach to ensuring system usability and safety in healthcare is described. Usability inspection methods are first described including the development of evidence-based safety heuristics for HIT. Laboratory-based usability testing is then conducted under artificial conditions to test if a system has any base level usability problems that need to be corrected. Usability problems that are detected are corrected and then a new phase is initiated where the system is tested under more realistic conditions using clinical simulations. This phase may involve testing the system with simulated patients. Finally, an additional phase may be conducted, involving a naturalistic study of system use under real-world clinical conditions. The methods described have been employed in the analysis of the usability and safety of a wide range of HIT applications, including electronic health record systems, decision support systems and consumer health applications. It has been found that at least usability inspection and usability testing should be applied prior to the widespread release of HIT. However, wherever possible, additional layers of testing involving clinical simulations and a naturalistic evaluation will likely detect usability and safety issues that may not otherwise be detected prior to widespread system release. The framework presented in the paper can be applied in order to develop more usable and safer HIT, based on multiple layers of evidence.

Pathogenic psychrotolerant sporeformers: an emerging challenge for low-temperature storage of minimally processed foods.

PubMed

Markland, Sarah M; Farkas, Daniel F; Kniel, Kalmia E; Hoover, Dallas G

2013-05-01

Sporeforming bacteria are a significant problem in the food industry as they are ubiquitous in nature and capable of resisting inactivation by heat and chemical treatments designed to inactivate them. Beyond spoilage issues, psychrotolerant sporeformers are becoming increasingly recognized as a potential hazard given the ever-expanding demand for refrigerated processed foods with extended shelf-life. In these products, the sporeforming pathogens of concern are Bacillus cereus, Bacillus weihenstephanensis, and Clostridium botulinum type E. This review article examines the foods, conditions, and organisms responsible for the food safety issue caused by the germination and outgrowth of psychrotolerant sporeforming pathogens in minimally processed refrigerated foods.

Market Access Advancements and Challenges in “Drug-Companion Diagnostic Test” Co-Development in Europe

PubMed Central

Akhmetov, Ildar; Ramaswamy, Rakshambikai; Akhmetov, Illias; Thimmaraju, Phani Kishore

2015-01-01

The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed. PMID:26075972

NASA Safety Standard: Guidelines and Assessment Procedures for Limiting Orbital Debris

NASA Technical Reports Server (NTRS)

1995-01-01

Collision with orbital debris is a hazard of growing concern as historically accepted practices and procedures have allowed man-made objects to accumulate in orbit. To limit future debris generation, NASA Management Instruction (NMI) 1700.8, 'Policy to Limit Orbital Debris Generation,' was issued in April of 1993. The NMI requires each program to conduct a formal assessment of the potential to generate orbital debris. This document serves as a companion to NMI 1700.08 and provides each NASA program with specific guidelines and assessment methods to assure compliance with the NMI. Each main debris assessment issue (e.g., Post Mission Disposal) is developed in a separate chapter.

Helium-3 blankets for tritium breeding in fusion reactors

NASA Technical Reports Server (NTRS)

Steiner, Don; Embrechts, Mark; Varsamis, Georgios; Vesey, Roger; Gierszewski, Paul

1988-01-01

It is concluded that He-3 blankets offers considerable promise for tritium breeding in fusion reactors: good breeding potential, low operational risk, and attractive safety features. The availability of He-3 resources is the key issue for this concept. There is sufficient He-3 from decay of military stockpiles to meet the International Thermonuclear Experimental Reactor needs. Extraterrestrial sources of He-3 would be required for a fusion power economy.

Patient safety in primary care: a survey of general practitioners in The Netherlands.

PubMed

Gaal, Sander; Verstappen, Wim; Wensing, Michel

2010-01-21

Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

An analysis of electronic health record-related patient safety concerns

PubMed Central

Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

2014-01-01

Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them. PMID:24951796

Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations

PubMed Central

Christiansen, Jens Sandahl; Backeljauw, Philippe F; Bidlingmaier, Martin; Biller, Beverly M K; Boguszewski, Margaret C S; Casanueva, Felipe F; Chanson, Philippe; Chatelain, Pierre; Choong, Catherine S; Clemmons, David R; Cohen, Laurie E; Cohen, Pinchas; Frystyk, Jan; Grimberg, Adda; Hasegawa, Yukihiro; Haymond, Morey W; Ho, Ken; Holly, Jeff M P; Horikawa, Reiko; Höybye, Charlotte; Jorgensen, Jens Otto L; Johannsson, Gudmundur; Juul, Anders; Katznelson, Laurence; Kopchick, John J; Lee, K O; Lee, Kuk-Wha; Luo, Xiaoping; Melmed, Shlomo; Miller, Bradley S; Misra, Madhusmita; Popovic, Vera; Rosenfeld, Ron G; Ross, Judith; Ross, Richard J; Saenger, Paul; Strasburger, Christian J; Thorner, Michael O; Werner, Haim; Yuen, Kevin

2016-01-01

Objective The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). Participants A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Evidence Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Consensus process Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. Conclusions LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations. PMID:27009113

Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations.

PubMed

Christiansen, Jens Sandahl; Backeljauw, Philippe F; Bidlingmaier, Martin; Biller, Beverly M K; Boguszewski, Margaret C S; Casanueva, Felipe F; Chanson, Philippe; Chatelain, Pierre; Choong, Catherine S; Clemmons, David R; Cohen, Laurie E; Cohen, Pinchas; Frystyk, Jan; Grimberg, Adda; Hasegawa, Yukihiro; Haymond, Morey W; Ho, Ken; Hoffman, Andrew R; Holly, Jeff M P; Horikawa, Reiko; Höybye, Charlotte; Jorgensen, Jens Otto L; Johannsson, Gudmundur; Juul, Anders; Katznelson, Laurence; Kopchick, John J; Lee, K O; Lee, Kuk-Wha; Luo, Xiaoping; Melmed, Shlomo; Miller, Bradley S; Misra, Madhusmita; Popovic, Vera; Rosenfeld, Ron G; Ross, Judith; Ross, Richard J; Saenger, Paul; Strasburger, Christian J; Thorner, Michael O; Werner, Haim; Yuen, Kevin

2016-06-01

The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations. © 2016 The authors.

Special issue : safety advancements

DOT National Transportation Integrated Search

1999-04-24

This issue of 'Status Report' focuses on some of the most recent key safety technology improvements. The crash protection in passenger vehicles is improving substantially; advanced frontal airbags will soon be available in a number of models and side...

Safety impact issues of job-associated sleep

DOT National Transportation Integrated Search

1997-09-01

This research investigated the safety impact issues of job-associated sleep in truck drivers. The research focused on the anonymous survey of professional truck drivers. Information was gathered regarding perception of driving performance and its rel...

Introduction to LNG vehicle safety

NASA Astrophysics Data System (ADS)

Bratvold, Delma; Friedman, David; Chernoff, Harry; Farkhondehpay, Dariush; Comay, Claudia

1994-03-01

Basic information on the characteristics of liquefied natural gas (LNG) is assembled to provide an overview of safety issues and practices for the use of LNG vehicles. This document is intended for those planning or considering the use of LNG vehicles, including vehicle fleet owners and operators, public transit officials and boards, local fire and safety officials, manufacturers and distributors, and gas industry officials. Safety issues and mitigation measures that should be considered for candidate LNG vehicle projects are addressed.

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

AIDS and the responsibilities of academic health science centers: a case law approach.

PubMed

McKenzie, S B

1992-01-01

The advent of AIDS and HIV infection has heightened administrator and faculty concern over providing and maintaining a safe environment for students in the health professions. Failure to provide this environment may result in litigation. Although case law on AIDS-related issues in higher education is sparse, court decisions on related issues are helpful in providing guidance on university responsibility. Case law indicates that if faculty provide appropriate supervision and give adequate instruction, including accepted safety practices, the courts will determine that the university has provided reasonable care to prevent student exposure to HIV. Other issues, related to HIV-positive students, demand that universities create carefully deliberated policies and procedures that do not discriminate against these individuals. This paper is the result of research on case law as it pertains to the potential legal issues of HIV and the university.

Major food safety episodes in Taiwan: implications for the necessity of international collaboration on safety assessment and management.

PubMed

Li, Jih-Heng; Yu, Wen-Jing; Lai, Yuan-Hui; Ko, Ying-Chin

2012-07-01

The major food safety episodes that occurred in Taiwan during the past decade are briefly reviewed in this paper. Among the nine major episodes surveyed, with the exception of a U.S. beef (associated with Creutzfeldt-Jakob disease)-related incident, all the others were associated with chemical toxicants. The general public, which has a layperson attitude of zero tolerance toward food safety, may panic over these food-safety-associated incidents. However, the health effects and impacts of most incidents, with the exception of the melamine incident, were essentially not fully evaluated. The mass media play an important role in determining whether a food safety concern becomes a major incident. A well-coordinated and harmonized system for domestic and international collaboration to set up standards and regulations is critical, as observed in the incidents of pork with ractopamine, Chinese hairy crab with nitrofuran antibiotics, and U.S. wheat with malathion. In the future, it can be anticipated that food safety issues will draw more attention from the general public. For unknown new toxicants or illicit adulteration of food, the establishment of a more proactive safety assessment system to monitor potential threats and provide real-time information exchange is imperative. Copyright © 2012. Published by Elsevier B.V.

Patient Safety Executive Walkarounds

PubMed Central

Feitelberg, Steven P

2006-01-01

The KP Patient Safety Executive Walkarounds Program in the KP San Diego Service Area was developed to provide routine opportunities for senior KP leaders, staff, and clinicians to discuss patient safety concerns proactively, working closely with our labor partners to foster a culture of safety that supports our staff and physicians. Throughout the KP San Diego Service Area, the Walkarounds program plays a major part in promoting responsible identification and reporting of patient safety issues. Because each staff member has an equal voice in discussing patient safety concerns, the program enables all employees—union and nonunion alike—to engage directly in discussions about improving patient safety. The KPSC leadership has recognized this program as a major demonstration that the leadership supports patient safety and promotes reporting of safety issues in a “just culture.” PMID:21519438

Radiation Safety in Nuclear Medicine Procedures.

PubMed

Cho, Sang-Geon; Kim, Jahae; Song, Ho-Chun

2017-03-01

Since the nuclear disaster at the Fukushima Daiichi Nuclear Power Plant in 2011, radiation safety has become an important issue in nuclear medicine. Many structured guidelines or recommendations of various academic societies or international campaigns demonstrate important issues of radiation safety in nuclear medicine procedures. There are ongoing efforts to fulfill the basic principles of radiation protection in daily nuclear medicine practice. This article reviews important principles of radiation protection in nuclear medicine procedures. Useful references, important issues, future perspectives of the optimization of nuclear medicine procedures, and diagnostic reference level are also discussed.

NSPWG-recommended safety requirements and guidelines for SEI nuclear propulsion

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Sawyer, J. C., Jr.; Bari, Robert A.; Brown, Neil W.; Cullingford, Hatice S.; Hardy, Alva C.; Lee, James H.; Mcculloch, William H.; Niederauer, George F.; Remp, Kerry

1992-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top-level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of safety functional requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. Safety requirements were developed for reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, and safeguards. Guidelines were recommended for risk/reliability, operational safety, flight trajectory and mission abort, space debris and meteoroids, and ground test safety. In this paper the specific requirements and guidelines will be discussed.

Use of New Communication Technologies to Change NASA Safety Culture: Incorporating the Use of Blogs as a Fundamental Communications Tool

NASA Astrophysics Data System (ADS)

Huls, Dale Thomas

2005-12-01

Blogs are an increasingly dominant new communication function on the internet. The power of this technology has forced media, corporations and government organizations to begin to incorporate blogging into their normal business practices. Blogs could be a key component to overcoming NASA's "silent safety culture." As a communications tool, blogs are used to establish trust primarily through the use of a personal voice style of writing. Dissenting voices can be raised and thoroughly vetted via a diversity of participation and experience without peer pressure or fear of retribution. Furthermore, the benefits of blogging as a technical resource to enhance safety are also discussed. The speed and self-vetting nature of blogging can allow managers and decision-makers to make more informed and therefore potentially better decisions with regard to technical and safety issues. Consequently, it is recommended that NASA utilize this new technology as an agent for cultural change.

Neonatal Cranial Ultrasound: Are Current Safety Guidelines Appropriate?

PubMed

Lalzad, Assema; Wong, Flora; Schneider, Michal

2017-03-01

Ultrasound can lead to thermal and mechanical effects in interrogated tissues. We reviewed the literature to explore the evidence on ultrasound heating on fetal and neonatal neural tissue. The results of animal studies have suggested that ultrasound exposure of the fetal or neonatal brain may lead to a significant temperature elevation at the bone-brain interface above current recommended safety thresholds. Temperature increases between 4.3 and 5.6°C have been recorded. Such temperature elevations can potentially affect neuronal structure and function and may also affect behavioral and cognitive function, such as memory and learning. However, the majority of these studies were carried out more than 25 y ago using non-diagnostic equipment with power outputs much lower than those of modern machines. New studies to address the safety issues of cranial ultrasound are imperative to provide current clinical guidelines and safety recommendations. Copyright © 2016 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

In Situ Monitoring of Temperature inside Lithium-Ion Batteries by Flexible Micro Temperature Sensors

PubMed Central

Lee, Chi-Yuan; Lee, Shuo-Jen; Tang, Ming-Shao; Chen, Pei-Chi

2011-01-01

Lithium-ion secondary batteries are commonly used in electric vehicles, smart phones, personal digital assistants (PDA), notebooks and electric cars. These lithium-ion secondary batteries must charge and discharge rapidly, causing the interior temperature to rise quickly, raising a safety issue. Over-charging results in an unstable voltage and current, causing potential safety problems, such as thermal runaways and explosions. Thus, a micro flexible temperature sensor for the in in-situ monitoring of temperature inside a lithium-ion secondary battery must be developed. In this work, flexible micro temperature sensors were integrated into a lithium-ion secondary battery using the micro-electro-mechanical systems (MEMS) process for monitoring temperature in situ. PMID:22163735

In situ monitoring of temperature inside lithium-ion batteries by flexible micro temperature sensors.

PubMed

Lee, Chi-Yuan; Lee, Shuo-Jen; Tang, Ming-Shao; Chen, Pei-Chi

2011-01-01

Lithium-ion secondary batteries are commonly used in electric vehicles, smart phones, personal digital assistants (PDA), notebooks and electric cars. These lithium-ion secondary batteries must charge and discharge rapidly, causing the interior temperature to rise quickly, raising a safety issue. Over-charging results in an unstable voltage and current, causing potential safety problems, such as thermal runaways and explosions. Thus, a micro flexible temperature sensor for the in in-situ monitoring of temperature inside a lithium-ion secondary battery must be developed. In this work, flexible micro temperature sensors were integrated into a lithium-ion secondary battery using the micro-electro-mechanical systems (MEMS) process for monitoring temperature in situ.

Factors Influencing Young Children's Risk of Unintentional Injury: Parenting Style and Strategies for Teaching about Home Safety

ERIC Educational Resources Information Center

Morrongiello, Barbara A.; Corbett, Michael; Lasenby, Jennifer; Johnston, Natalie; McCourt, Meghan

2006-01-01

This study examined mothers' teaching about home-safety issues to 24-30 month and 36-42 month old children, explored the relationship of teaching strategies to parenting styles, and assessed how these factors are related to children's risk of unintentional injury. A structured interview assessed home-safety issues relevant to falls, burns, cuts,…

Preliminary Examination of Safety Issues on a University Campus: Personal Safety Practices, Beliefs & Attitudes of Female Faculty & Staff

ERIC Educational Resources Information Center

Fletcher, Paula C.; Bryden, Pamela J.

2007-01-01

University and college campuses are not immune to acts of violence. Unfortunately there is limited information regarding violence in the academic setting among women employees. As such, the purpose of this exploratory research was to examine issues that female faculty and staff members have about safety on and around campus, including concerns…

Safety and capacity evaluation for interstates in Kentucky.

DOT National Transportation Integrated Search

2005-04-01

This analysis and evaluation was directed toward assessing safety and capacity issues on interstates in Kentucky and, particularly, the manner in which commercial vehicle traffic affects these issues. Analyses was undertaken to show past trends and p...

Nuclear safety policy working group recommendations on nuclear propulsion safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Lee, James H.; Mcculloch, William H.; Sawyer, J. Charles, Jr.; Bari, Robert A.; Cullingford, Hatice S.; Hardy, Alva C.; Niederauer, George F.; Remp, Kerry; Rice, John W.

1993-01-01

An interagency Nuclear Safety Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program. These recommendations, which are contained in this report, should facilitate the implementation of mission planning and conceptual design studies. The NSPWG has recommended a top-level policy to provide the guiding principles for the development and implementation of the SEI nuclear propulsion safety program. In addition, the NSPWG has reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. These recommendations should be useful for the development of the program's top-level requirements for safety functions (referred to as Safety Functional Requirements). The safety requirements and guidelines address the following topics: reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations.

SmartRoads: training Indonesian workers to become road safety ambassadors in industrial and community settings.

PubMed

Montero, Kerry; Spencer, Graham; Ariens, Bernadette

2012-06-01

This paper reports on a programme to improve road safety awareness in an industrial community in the vicinity of Jakarta, in Indonesia. Adapting the model of a successful community and school-based programme in Victoria, in Australia, and using a peer education approach, 16 employees of a major manufacturing company were trained to implement road safety education programmes amongst their peers. Specific target groups for the educators were colleagues, schools and the local community. Over 2 days the employees, from areas as diverse as production, public relations, personnel services, administration and management, learned about road safety facts, causes of traffic casualties, prevention approaches and peer education strategies. They explored and developed strategies to use with their respective target groups and practised health education skills. The newly trained workers received certificates to acknowledge them as 'SmartRoads Ambassadors' and, with follow-up support and development, became road safety educators with a commitment and responsibility to deliver education to their respective work and local communities. This paper argues that the model has potential to provide an effective and locally relevant response to road safety issues in similar communities.

Improving Employees' Safety Awareness in Healthcare Organizations Using the DMAIC Quality Improvement Approach.

PubMed

Momani, Amer; Hirzallah, Muʼath; Mumani, Ahmad

Occupational injuries and illnesses in healthcare can cause great human suffering, incur high cost, and have an adverse impact on the quality of patient care. One of the most effective solutions for addressing health and safety issues and improving decisions at the point of care rests in raising employees' safety awareness to recognize, avoid, or respond to potential problems before they arise. In this article, the DMAIC Six Sigma model (Define, Measure, Analyze, Improve, Control) is used as a systematic program to measure, improve, and sustain employees' safety awareness in healthcare organizations. We report on a case study using the model, which was implemented and validated at a local hospital. First, the occupational health and safety knowledge that each job requires was identified. Next, the degree of competence of jobholders to meet these requirements was assessed. Based on the assessment, different awareness-raising efforts were proposed and implemented. The results showed significant improvement in the overall safety awareness compliance assessed: from 74.2% to 84.4% (p < .001) after the intervention. The proposed model ensures that the organization's awareness-raising efforts serve its actual needs and produce optimized and sustained results that eventually lead to safer healthcare service.

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

"Raising the bar" in safety performance is a critical challenge for many organizations, including Kennedy Space Center. Contributing-factor taxonomies organize information about the reasons accidents occur and therefore are essential elements of accident investigations and safety reporting systems. Organizations must balance efforts to identify causes of specific accidents with efforts to evaluate systemic safety issues in order to become more proactive about improving safety. This project successfully addressed the following two problems: (1) methods and metrics to support the design of effective taxonomies are limited and (2) influence relationships among contributing factors are not explicitly modeled within a taxonomy.

Considerations for the design of safe and effective consumer health IT applications in the home.

PubMed

Zayas-Cabán, Teresa; Dixon, Brian E

2010-10-01

Consumer health IT applications have the potential to improve quality, safety and efficiency of consumers' interactions with the healthcare system. Yet little attention has been paid to human factors and ergonomics in the design of consumer health IT, potentially limiting the ability of health IT to achieve these goals. This paper presents the results of an analysis of human factors and ergonomics issues encountered by five projects during the design and implementation of home-based consumer health IT applications. Agency for Healthcare Research and Quality-funded consumer health IT research projects, where patients used the IT applications in their homes, were reviewed. Project documents and discussions with project teams were analysed to identify human factors and ergonomic issues considered or addressed by project teams. The analysis focused on system design and design processes used as well as training, implementation and use of the IT intervention. A broad range of consumer health IT applications and diverse set of human factors and ergonomics issues were identified. The design and implementation processes used resulted in poor fit with some patients' healthcare tasks and the home environment and, in some cases, resulted in lack of use. Clinician interaction with patients and the information provided through health IT applications appeared to positively influence adoption and use. Consumer health IT application design would benefit from the use of human factors and ergonomics design and evaluation methods. Considering the context in which home-based consumer health IT applications are used will likely affect the ability of these applications to positively impact the quality, safety and efficiency of patient care.

Cardiac Implantable Electronic Device Interrogation at Forensic Autopsy: An Underestimated Resource?

PubMed

Lacour, Philipp; Buschmann, Claas; Storm, Christian; Nee, Jens; Parwani, Abdul Shokor; Huemer, Martin; Attanasio, Philipp; Boldt, Leif-Hendrik; Rauch, Geraldine; Kucher, Andreas; Pieske, Burkert; Haverkamp, Wilhelm; Blaschke, Florian

2018-06-19

Postmortem interrogations of cardiac implantable electronic devices (CIEDs), recommended at autopsy in suspected cases of sudden cardiac death, are rarely performed, and data on systematic postmortem CIED analysis in the forensic pathology are missing. The aim of the study was to determine whether nonselective postmortem CIED interrogations and data analysis are useful to the forensic pathologist to determine the cause, mechanism, and time of death and to detect potential CIED-related safety issues. From February 2012 to April 2017, all autopsy subjects in the department of forensic medicine at the University Hospital Charité who had a CIED underwent device removal and interrogation. Over the study period, 5368 autopsies were performed. One hundred fifty subjects had in total 151 CIEDs, including 109 pacemakers, 35 defibrillators, and 7 implantable loop recorders. In 40 cases (26.7%) time of death and in 51 cases (34.0%) cause of death could not be determined by forensic autopsy. Of these, CIED interrogation facilitated the determination of time of death in 70.0% of the cases and clarified the cause of death in 60.8%. Device concerns were identified in 9 cases (6.0%), including 3 hardware, 4 programming, and 2 algorithm issues. One CIED was submitted to the manufacturer for a detailed technical analysis. Our data demonstrate the necessity of systematic postmortem CIED interrogation in forensic medicine to determine the cause and timing of death more accurately. In addition, CIED analysis is an important tool to detect potential CIED-related safety issues. © 2018 American Heart Association, Inc.

Commercial truck parking and other safety issues.

DOT National Transportation Integrated Search

2015-10-01

Commercial truck parking is a safety issue, since trucks are involved in approximately 10% of all fatal accidents on interstates and : parkways in Kentucky. Drivers experience schedule demands and long hours on the road, yet they cannot easily determ...

Evaluation of pedestrian safety campaigns : final report.

DOT National Transportation Integrated Search

2004-02-01

The objective of the study was to determine the efficacy and success of SHAs public service campaign : regarding pedestrian safety. Data collection issues forced a change in this focus as the project progressed. : The study contains two issues tha...

77 FR 35844 - Safety Zone; Olde Ellison Bay Days Fireworks Display, Ellison Bay, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... of Proposed Rulemaking A. Regulatory History and Information The Coast Guard is issuing this... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone...

Bus operator safety : critical issues examination and model practices.

DOT National Transportation Integrated Search

2014-01-01

In this study, researchers at the National Center for Transit Research performed a multi-topic comprehensive : examination of bus operator-related critical safety and personal security issues. The goals of this research : effort were to: : 1. Identif...

Stem Cell Therapy: A Promising Therapeutic Method for Intracerebral Hemorrhage.

PubMed

Gao, Liansheng; Xu, Weilin; Li, Tao; Chen, Jingyin; Shao, Anwen; Yan, Feng; Chen, Gao

2018-01-01

Spontaneous intracerebral hemorrhage (ICH) is one type of the most devastating cerebrovascular diseases worldwide, which causes high morbidity and mortality. However, efficient treatment is still lacking. Stem cell therapy has shown good neuroprotective and neurorestorative effect in ICH and is a promising treatment. In this study, our aim was to review the therapeutic effects, strategies, related mechanisms and safety issues of various types of stem cell for ICH treatment. Numerous studies had demonstrated the therapeutic effects of diverse stem cell types in ICH. The potential mechanisms include tissue repair and replacement, neurotrophy, promotion of neurogenesis and angiogenesis, anti-apoptosis, immunoregulation and anti-inflammation and so forth. The microenvironment of the central nervous system (CNS) can also influence the effects of stem cell therapy. The detailed therapeutic strategies for ICH treatment such as cell type, the number of cells, time window, and the routes of medication delivery, varied greatly among different studies and had not been determined. Moreover, the safety issues of stem cell therapy for ICH should not be ignored. Stem cell therapy showed good therapeutic effect in ICH, making it a promising treatment. However, safety should be carefully evaluated, and more clinical trials are required before stem cell therapy can be extensively applied to clinical use.

Biofuels and North American agriculture--implications for the health and safety of North American producers.

PubMed

Gunderson, Paul D

2008-01-01

This decade has provided North American agricultural producers with opportunity to not only produce fiber and food, but also fuel and other industrial products. The drivers incenting this development could be sustained well into the future, therefore workforce safety and health implications are likely to persist for some time. Within production agriculture, the 'feedstock growth and harvest cycle' and 'transport' sectors possess the changing exposures experienced by workers. The Conference explored the following exposures: distiller's grains and bio-processing byproducts, spent catalyst, solvent brine, microbial agents, genetically modified organisms, discharge effluent, H2O dilutes, change in cropping patterns and resultant use of different seeding and harvest technologies, pests (whether target or non-target), and rural traffic resulting from concentrated movement of massive quantities of biomass and grain. Other issues of a more general public health nature such as watershed implications, other environmental impacts, emissions, uneven economic development potential, public safety issues associated with transport of both fuel and other industrial products, and rural emergency medical service need were explored. And, agronomic impacts were noted, including tillage change, potassium buildup in soil, nutrient depletion, sedimentation and erosion of tillable soil, and local esthetics. It was concluded that rural venues for formation and exploration of public policy need to be created.

Combination use of medicines from two classes of renin-angiotensin system blocking agents: risk of hyperkalemia, hypotension, and impaired renal function.

PubMed

Esteras, Raquel; Perez-Gomez, Maria Vanessa; Rodriguez-Osorio, Laura; Ortiz, Alberto; Fernandez-Fernandez, Beatriz

2015-08-01

European and United States regulatory agencies recently issued warnings against the use of dual renin-angiotensin system (RAS) blockade therapy through the combined use of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs) or aliskiren in any patient, based on absence of benefit for most patients and increased risk of hyperkalemia, hypotension, and renal failure. Special emphasis was made not to use these combinations in patients with diabetic nephropathy. The door was left open to therapy individualization, especially for patients with heart failure, when the combined use of an ARB and ACEI is considered absolutely essential, although renal function, electrolytes and blood pressure should be closely monitored. Mineralocorticoid receptor antagonists were not affected by this warning despite increased risk of hyperkalemia. We now critically review the risks associated with dual RAS blockade and answer the following questions: What safety issues are associated with dual RAS blockade? Can the safety record of dual RAS blockade be improved? Is it worth trying to improve the safety record of dual RAS blockade based on the potential benefits of the combination? Is dual RAS blockade dead? What is the role of mineralocorticoid antagonists in combination with other RAS blocking agents: RAAS blockade?

Anesthesia Quality and Patient Safety in China: A Survey.

PubMed

Zhu, Bin; Gao, Huan; Zhou, Xiangyong; Huang, Jeffrey

There has been no nationwide investigation into anesthesia quality and patient safety in China. The authors surveyed Chinese anesthesiologists about anesthesia quality by sending a survey to all anesthesiologist members of the New Youth Anesthesia Forum via WeChat. The respondents could choose to use a mobile device or desktop to complete the survey. The overall response rate was 43%. Intraoperative monitoring: 77.9% of respondents reported that electrocardiogram monitoring was routinely applied for all patients; only 55% of the respondents reported that they routinely used end-tidal carbon dioxide monitoring for their patients under general anesthesia. 10.3% of respondents admitted that they had at least one wrong medicine administration in the past 3 months; 12.4% reported that they had at least one case of cardiac arrest in the past year. This is the first anesthesia quality survey in China. The findings revealed potential anesthesia safety issues in China.

Advancing patient safety: a framework for accountability and practical action.

PubMed

Wilson, N J; Hatlie, M J

2001-01-01

This article traces the development of the patient safety movement in healthcare from 1997 to the present. It reviews the findings and recommendations in the Institute of Medicine report on medical errors, which issued a call to action. Moving beyond the call to action requires aligning incentives, in both public and private sectors, consistent with complexity theory and the tenets of a systems approach to the reliable delivery of service in dynamic environments in which failure produces severe consequences. Because safety is a fundamental value of healthcare and has money-saving potential, it can be a powerful pathway forcultural change. Thisarticle explains a simple framework that requires alignment among stakeholder groups and communities. It recommends a practical problem-solving approach and explores the roles and responsibilities of each segment within the framework. Finally, it describes a VHA Inc. leadership initiative, based on the framework, to promote change within healthcare systems.

Neurotoxins at home and in the workplace. Hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, House of Representatives, Ninety-Ninth Congress, First Session, October 8, 9, 1985

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

Not Available

1986-01-01

Experts in neurology and toxicology, disabled workers, health and safety agencies, and labor unions were among those represented at two days of hearings on the impact of chemicals on human health and safety. The witnesses described how neurotoxins, which occur in everyday household and workplace situations, affect the human body and how it would be possible to test for these effects before exposure. Representatives of the Occupational Safety and Health Administration (OSHA) described the communication standard for letting workers know about potential hazards. At issue was whether OSHA has done as much as it should to see that employers whomore » produce or use hazardous chemicals are providing adequate information to workers and consumers. An appendix with additional material submitted for the record follows the testimony of 13 witnesses.« less

Extractables and leachables considerations for prefilled syringes.

PubMed

Jenke, Dennis R

2014-10-01

Use of pre-filled syringes as both a packaging and delivery system for pharmaceutical drug products is accelerating. Pre-filled syringes must meet the quality and suitability for use requirements for both systems, including compatibility with the drug product. Relevant incompatibilities between pre-filled syringes and drug products include the safety of syringe-based leachables that accumulate in drug products and the ability of leachables to interact with the drug product's ingredients as such interactions can affect safety, efficacy, stability and physical viability. Relevant suitability considerations for pre-filled syringes are discussed herein and specific examples of suitability for use issues for pre-filled syringes are cited, focusing on extractables associated with pre-filled syringes and leachables derived from such syringes. Aspects considered include the toxicological impact of leachables, their ability to alter the efficacy of drug products and to produce other undesirable outcomes such as aggregation and immunogenic responses. Materials used in pre-filled syringes and the conditions of use minimize the traditional safety risk associated with leachables. However, drug products that use pre-filled syringes are prone to non-traditional interactions such as disruption of protein conformation, leading to potential efficacy, safety and quality issues. In order to qualify pre-filled syringes for use, the traditional approach of measuring extractables and leachables and inferring their effect must be augmented by rigorous compatibility testing. Research into the fundamental relationship between leachables and drug substances will be necessary so the more time- and cost-efficient 'measure and infer' approach can be widely implemented.

Safety considerations in the pharmacological management of atrial fibrillation.

PubMed

Camm, A John

2008-07-21

The pharmacological management of atrial fibrillation (AF) requires careful consideration from a safety perspective. This article focuses primarily on maintenance therapy using antiarrhythmic drugs (AADs). The foremost safety issue for AADs is the propensity of class IA and III agents to cause torsade de pointes arrhythmias. Class IA drugs, particularly quinidine, can induce torsade de pointes at low or subtherapeutic doses, but higher doses are not necessarily associated with an increased incidence. 'Pure' class III drugs such as dofetilide induce torsade de pointes in a dose-related manner, but some class III agents with more complex actions such as amiodarone have a markedly lower potential to cause this arrhythmia. The risk of torsade de pointes precludes the use of class IA and 'pure' class III agents in patients with left ventricular hypertrophy and bradycardia. Class IC agents may cause sustained monomorphic ventricular tachycardias and are generally precluded in ischaemic and structural heart disease. Advanced heart failure patients may be treated with amiodarone or dofetilide, but most other AADs are unsuitable. The most important extracardiac toxicities occurring with AADs are those of amiodarone. Drug interactions are a significant safety issue in the management of AF, including pharmacokinetic interactions in which plasma levels of the AAD are raised - increasing the risk of proarrhythmia - and concomitant use of drugs that prolong the QT interval. Notwithstanding these considerations, most patients with AF can be considered for rhythm control, provided there is adequate pre-treatment assessment and protocols for initiation, dosing and monitoring are followed with care.

Priorities for reducing the burden of injuries in sport: the example of Australian football.

PubMed

Gabbe, Belinda J; Finch, Caroline F; Cameron, Peter A

2007-10-01

The promotion of safe sports participation has become a public health issue due to rising obesity rates and the potential for parental concerns about safety to inhibit sports participation. The safety of Australian football and its elite game, the Australian Football League (AFL), is often the focus of media commentary. Participation in the modified version of the game (Auskick) has been shown to be safer but by the time children reach the under-15 age group, adult rules are in place and the umbrella of safety provided by modified rules is gone. Figures released recently by the AFL suggest that injury rates at the elite-level are at an historical low, but equivalent information for the more than 400,000 non-elite participants is not available. Published literature related to preventing injuries in Australian football highlights a significant knowledge gap with respect to the aetiology of injuries in non-elite participants and only a very small evidence base for prevention of injuries in this sport. Gains in reducing the public health impact of football injuries, and injury-related barriers to Australian football participation, will only come from substantial investment in large-scale trials at the non-elite level, and a co-ordinated and multidisciplinary approach to dealing with safety and injury issues across all levels of play. Active and committed collaboration of key stakeholders such as government health agencies, peak sports bodies, sports administrators, clinicians, researchers, clubs, coaches and the participants themselves will be necessary.

Radio Frequency Radiation of Millimeter Wave Length: An Evaluation of Potential Occupational Safety Issues Relating to Surface Heating

DTIC Science & Technology

2000-02-01

aging process or are associated with several disease processes. They are also thought to result from excessive heating that accompanies microwave...ulcers, heart disease and cancer. Conversely, the possibility exists that hazards might be associated with accidental overexposure to MMWs. This...risks that might be associated with accidental overexposure to MMWs. Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting

2001 traffic safety issues opinion survey.

DOT National Transportation Integrated Search

2002-02-01

As a means of determining public opinion on specific traffic safety issues, a public opinion survey was conducted. A total of 4,500 mail surveys were sent to a stratified sample of drivers selected from the drivers license file. The state was divided...

Occupant protection issues among older drivers and passengers. Volume 2, Appendices

DOT National Transportation Integrated Search

2008-04-01

The National Highway Traffic Safety Administration is concerned about highway safety issues for older adults and is interested in understanding what contributes to seat belt use or nonuse among people 65 and older. This background report details the ...

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

Wood, Richard Thomas; Ewing, Paul D.

The U.S. Nuclear Regulatory Commission’s (NRC’s) regulations in Part 50, “Domestic Licensing of Production and Utilization Facilities,” of Title 10 of the Code of Federal Regulations (10 CFR Part 50) state that structures, systems, and components important to safety in a nuclear power plant are to be designed to accommodate the effects of environmental conditions (i.e., remain functional under all postulated service conditions) and that design control measures such as testing are to be used to check the adequacy of design. Regulatory Guide (RG) 1.180 was developed to provide guidance to licensees and applicants on methods acceptable to the NRCmore » staff for complying with the NRC’s regulations on design, installation, and testing practices for addressing the effects of electromagnetic and radio-frequency interference (EMI/RFI) and power surges on safety-related instrumentation and control (I&C) systems. The first revision of RG 1.180 was issued in January 2000 and a second revision was issued in October 2003*. The second revision differed from the first revision in endorsing Military Standard (MIL-STD)-461E and the International Electrotechnical Commission (IEC) Standard (Std) 61000 series of EMI/RFI test methods, extending the guidance to cover signal line testing, incorporating frequency ranges where portable communications devices are experiencing increasing use, and relaxing the operating envelopes (test levels) when experience and confirmatory research warranted. It also offered exemptions from specific test criteria based on technical considerations such as plant conditions and the intended location of the safety-related I&C equipment. Since the last revision, new requirements have been identified, associated RGs have been created and updated, and additional industry guidance has been developed. Additionally, the operational environment has changed with the increase in wireless communication technology for both personal (smartphone) and industrial (remote I&C) purposes. Also, specific concerns and issues with testing methods and methodologies have been identified that must be addressed. Further, most of the standards that serve as the basis for the RG have been revised. Therefore, the NRC’s Office of Regulatory Research has contracted with Oak Ridge National Laboratory (ORNL) to incorporate new information and resolve the identified issues under NRC-HQ-60-14-D-0015, “Update to RG 1.180, Revision 2, Guidelines for Evaluating Electromagnetic and Radio-Frequency Interference in Safety-Related Instrumentation and Control Systems.” The ultimate goal of this project is to provide NRC the technical basis for developing and publishing a new revision of the RG. The focus of Task 4 was for ORNL to identify and address any new or additional EMI/RFI issues that could potentially impact the EMC of I&C systems. More specifically, ORNL was to evaluate the impact of any new issue on safety equipment in their local environments and then determine whether the issues should be included and discussed in the revision to RG 1.180 that is currently under way.« less

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

A systematic review of Human Factors and Ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety

PubMed Central

Xie, Anping; Carayon, Pascale

2014-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how Human Factors and Ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified twelve projects representing 23 studies and addressing different physical, cognitive and organizational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care. Practitioner Summary Existing evidence shows that HFE-based healthcare system redesign has the potential to improve quality of care and patient safety. Healthcare organizations need to recognize the importance of HFE-based healthcare system redesign to quality of care and patient safety, and invest resources to integrate HFE in healthcare improvement activities. PMID:25323570

The Environmental Protection Agency's Safety Standards for Disposal of Spent Nuclear Fuel: Potential Path Forward in Response to the Report of the Blue Ribbon Commission on America's Nuclear Future - 13388

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

Forinash, Betsy; Schultheisz, Daniel; Peake, Tom

2013-07-01

Following the decision to withdraw the Yucca Mountain license application, the Department of Energy created a Blue Ribbon Commission (BRC) on America's Nuclear Future, tasked with recommending a national strategy to manage the back end of the nuclear fuel cycle. The BRC issued its final report in January 2012, with recommendations covering transportation, storage and disposal of spent nuclear fuel (SNF); potential reprocessing; and supporting institutional measures. The BRC recommendations on disposal of SNF and high-level waste (HLW) are relevant to the U.S. Environmental Protection Agency (EPA), which shares regulatory responsibility with the Nuclear Regulatory Commission (NRC): EPA issues 'generallymore » applicable' performance standards for disposal repositories, which are then implemented in licensing. For disposal, the BRC endorses developing one or more geological repositories, with siting based on an approach that is adaptive, staged and consent-based. The BRC recommends that EPA and NRC work cooperatively to issue generic disposal standards-applying equally to all sites-early in any siting process. EPA previously issued generic disposal standards that apply to all sites other than Yucca Mountain. However, the BRC concluded that the existing regulations should be revisited and revised. The BRC proposes a number of general principles to guide the development of future regulations. EPA continues to review the BRC report and to assess the implications for Agency action, including potential regulatory issues and considerations if EPA develops new or revised generic disposal standards. This review also involves preparatory activities to define potential process and public engagement approaches. (authors)« less

Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia.

PubMed

Stein, Evan A; Bays, Harold; O'Brien, Dennis; Pedicano, Jim; Piper, Edward; Spezzi, Andrea

2011-05-10

Lapaquistat acetate is a squalene synthase inhibitor investigated for the treatment of hypercholesterolemia. This report summarizes the phase 2 and 3 results from the lapaquistat clinical program, which was halted at an advanced stage as a result of potential hepatic safety issues. Efficacy and safety data were pooled from 12 studies (n=6151). These were 6- to 96-week randomized, double-blind, parallel, placebo- or active-controlled trials with lapaquistat monotherapy or coadministration with other lipid-altering drugs in dyslipidemic patients, including a large (n=2121) 96-week safety study. All studies included lapaquistat 100 mg daily; 5 included 50 mg; and 1 included 25 mg. The main outcome measures were the percent change in low-density lipoprotein cholesterol, secondary lipid/metabolic parameters, and overall safety. Lapaquistat 100 mg significantly decreased low-density lipoprotein cholesterol by 21.6% in monotherapy and by 18.0% in combination with a statin. It also reduced other cardiovascular risk markers, such as C-reactive protein. Total adverse events were higher for lapaquistat than placebo, although individual events were generally similar. At 100 mg, there was an increase in alanine aminotransferase value ≥3 times the upper limit of normal on ≥2 consecutive visits (2.0% versus 0.3% for placebo in the pooled efficacy studies; 2.7% versus 0.7% for low-dose atorvastatin in the long-term study). Two patients receiving lapaquistat 100 mg met the Hy Law criteria of alanine aminotransferase elevation plus increased total bilirubin. Squalene synthase inhibition with lapaquistat acetate, alone or in combination with statins, effectively lowered low-density lipoprotein cholesterol in a dose-dependent manner. Elevations in alanine aminotransferase, combined with a rare increase in bilirubin, presented potential hepatic safety issues, resulting in termination of development. The lapaquistat experience illustrates the current challenges in lipid-altering drug development. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00487994, NCT00143663, NCT00143676, NCT00864643, NCT00263081, NCT00286481, NCT00249899, NCT00249912, NCT00813527, NCT00256178, NCT00268697, and NCT00251680.

Clinically relevant safety issues associated with St. John's wort product labels.

PubMed

Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

2008-07-17

St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.

Clinically relevant safety issues associated with St. John's wort product labels

PubMed Central

Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

2008-01-01

Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements. PMID:18637192

Emotional Issues and Bathroom Problems

MedlinePlus

... Healthy Living Healthy Living Healthy Living Nutrition Fitness Sports Oral Health Emotional Wellness Growing Healthy Sleep Safety & Prevention Safety & Prevention Safety and Prevention Immunizations ...

Beryllium Health and Safety Committee Data Reporting Task Force White Paper #2 -- Uses of Uncensored Data

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

MacQueen, D H

2007-10-10

On December 8, 1999, the Department of Energy (DOE) published Title 10 CFR 850 (hereafter referred to as the Rule) to establish a chronic beryllium disease prevention program (CBDPP) to: (1) reduce the number of workers currently exposed to beryllium in the course of their work at DOE facilities managed by DOE or its contractors; (2) minimize the levels of, and potential for, exposure to beryllium; and (3) establish medical surveillance requirements to ensure early detection of the disease. On January 4, 2001, DOE issued DOE G 440.1-7A, Implementation Guide for use with 10 CFR 850, Chronic Beryllium Disease Preventionmore » Program, to assist line managers in meeting their responsibilities for implementing the CBDPP. That guide describes methods and techniques that DOE considers acceptable in complying with the Rule. In 2005 a draft DOE Technical Standard ''Management of Items and Areas Containing Low Levels of Beryllium'' (SAFT 0103; hereafter referred to as the ''TS'') was circulated for comment (http://www.hss.energy.gov/NuclearSafety/techstds/tsdrafts/saft-0103.pdf). DOE technical standards are voluntary consensus standards developed when industry standards do not exist (see http://www.hss.energy.gov/NuclearSafety/techstds/index.html for more information). DOE does not require its field elements to implement DOE technical standards, but field elements may choose to adopt these standards to meet specific needs. This beryllium TS is intended to provide best practices and lessons learned for manageing items and areas that contain low levels of beryllium, which has been a costly and technically challenging component of CBDPPs. The TS is also intended to provide guidance for determining if the Rule's housekeeping and release criteria are met. On challenge the TS addressed was the statistical interpretation of data sets with non-detected results, a topic for which no strong consensus exists. Among the many comments on the draft TS was a suggestion that certain of the statistical comparisons described in the TS could be better implemented if analytical results, even when below a reporting limit, were to be reported by analytical laboratories. See Appendix 1 for a review of terminology related to reporting limits. The Beryllium Health and Safety Committee (BHSC) formed a Sampling and Analysis Subcommittee (SAS) in 2003. The SAS established a working group on accreditation and reporting limits. By 2006 it had become evident that the issues extended to data reporting as a whole. The SAS proposed to the BHSC the formation of a Data Reporting Task Force (DRTF) to consider issues related to data reporting. The BHSC Board agreed, and requested that the DRTF generate a white paper, to be offered by the BHSC to potential interested parties such as the DOE policy office that is responsible for beryllium health and safety policy. It was noted that additional products could include detailed guidance and potentially a journal article in the future. The SAS proposed that DRTF membership represent the affected disciplines (chemists, industrial hygiene professionals and statisticians, and the DOE office that is responsible for beryllium health and safety policy). The BHSC Board decided that DRTF membership should come from DOE sites, since the focus would be on reporting in the context of the TS and the Rule. The DRTF came into existence in late 2006. The DRTF membership includes industrial hygienists, analytical chemists and laboratory managers, members of the regulatory and oversight community, and environmental statisticians. A first White Paper, ''Summary of Issues and Path Forward'', was reviewed by the BHSC in March 2007 and issued by the DRTF in June 2007. It describes the charter of the DRTF, introduces some basic terminology (reproduced here in Appendix 1), lays out the issues the DRTF is expected to address, and describes a path forward for the DRTF's work. This first White Paper is available through the BHSC web site. This White Paper presents recommendations developed by the DRTF following the process laid out in that first White Paper.« less

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

PubMed

Mol, Peter G M; Straus, Sabine M J M; Piening, Sigrid; de Vries, Jonie T N; de Graeff, Pieter A; Haaijer-Ruskamp, Flora M

2010-06-01

As pre-approval trials are inherently limited in assessing the complete benefit-risk profile of a new drug, serious safety issues may emerge once a drug gains widespread use after approval. Regulators face the dilemma of balancing timely market access with the need for complete data on risks. This challenge has led to a life-cycle approach but, so far, few data are available on post-approval safety issues requiring regulatory action. The aim of this study is to determine the frequency, timing and nature of safety issues that necessitated safety-related regulatory action in the form of a Direct Healthcare Professional Communication (DHPC) issued by pharmaceutical companies in collaboration with the Dutch Medicines Evaluation Board during the past decade. All DHPCs issued in the Netherlands from 1 January 1999 to 1 January 2009 were retrospectively collected from the national regulatory authorities. Elapsed time between the approval date and the issue of the DHPC was determined. Characteristics of the action including the nature of the safety issue (according to Medical Dictionary for Regulatory Activities [MedDRA] terminology), type of drug and procedural aspects of the regulatory action taken were reviewed. DHPC characteristics were tabulated and explorative non-parametric tests were performed to study the effect of safety issue, drug class, drug type, orphan drug and first-in-class status on elapsed time from approval to the DHPC. 157 DHPCs were issued concerning 112 different active substances, approximately 9% (112/1200) of active substances available in the Netherlands in 2007. The number of DHPCs issued increased by 2.1 (95% CI 1.2, 3.1; p < 0.001) DHPCs per year over the past decade, reaching a total of 25 in 2008. The median time between approval and DHPC was 5.3 years (range 0.13-48 years). No significant trend in elapsed time to DHPC was observed in relation to the studied years (p = 0.06). One-third of all DHPCs were issued in the first 3 years after approval, but 27% (n = 43/157) of the DHPCs were issued 10 or more years after approval. Timing of DHPCs differed depending on safety issue, drug class, drug type and orphan drug status. DHPCs mostly concerned adverse events in the system organ class of 'cardiac disorders' (15%), 'injury, poisoning and procedural complications' (13%) and 'general disorders and administration site conditions' (10%). In ten cases the drug was eventually withdrawn. Withdrawal occurred a median duration of 2.4 years after registration (range of 1.5-48 years) and was most frequently due to cardiac disorders (including QT interval prolongation; four occasions) and hepatobiliary disorders (two occasions). In the past decade, the number of DHPCs has increased over time. This is likely caused by a multitude of factors: increased risk awareness by the public, media, regulators and other stakeholders; the type of drugs approved, such as orphan drugs and biologicals; and the regulatory process, including conditional approvals. The number of DHPCs may in the future increase further with the possibility of screening large epidemiological databases proactively for adverse drug events. Nine percent of all marketed drugs required a safety-related action. Regulatory action is taken shortly (<3 years) after market approval nearly as often as after intermediate (3-10 years) and long-term (>10 years) market exposure. These findings underline the need for risk management during the whole life cycle of a drug.

Development and validation of a survey instrument for assessing prescribers' perception of computerized drug-drug interaction alerts.

PubMed

Zheng, Kai; Fear, Kathleen; Chaffee, Bruce W; Zimmerman, Christopher R; Karls, Edward M; Gatwood, Justin D; Stevenson, James G; Pearlman, Mark D

2011-12-01

To develop a theoretically informed and empirically validated survey instrument for assessing prescribers' perception of computerized drug-drug interaction (DDI) alerts. The survey is grounded in the unified theory of acceptance and use of technology and an adapted accident causation model. Development of the instrument was also informed by a review of the extant literature on prescribers' attitude toward computerized medication safety alerts and common prescriber-provided reasons for overriding. To refine and validate the survey, we conducted a two-stage empirical validation study consisting of a pretest with a panel of domain experts followed by a field test among all eligible prescribers at our institution. The resulting survey instrument contains 28 questionnaire items assessing six theoretical dimensions: performance expectancy, effort expectancy, social influence, facilitating conditions, perceived fatigue, and perceived use behavior. Satisfactory results were obtained from the field validation; however, a few potential issues were also identified. We analyzed these issues accordingly and the results led to the final survey instrument as well as usage recommendations. High override rates of computerized medication safety alerts have been a prevalent problem. They are usually caused by, or manifested in, issues of poor end user acceptance. However, standardized research tools for assessing and understanding end users' perception are currently lacking, which inhibits knowledge accumulation and consequently forgoes improvement opportunities. The survey instrument presented in this paper may help fill this methodological gap. We developed and empirically validated a survey instrument that may be useful for future research on DDI alerts and other types of computerized medication safety alerts more generally.

En route care patient safety: thoughts from the field.

PubMed

McNeill, Margaret M; Pierce, Penny; Dukes, Susan; Bridges, Elizabeth J

2014-08-01

The purpose of this study was to describe the patient safety culture of en route care in the United States Air Force aeromedical evacuation system. Almost 100,000 patients have been transported since 2001. Safety concerns in this unique environment are complex because of the extraordinary demands of multitasking, time urgency, long duty hours, complex handoffs, and multiple stressors of flight. An internet-based survey explored the perceptions and experiences of safety issues among nursing personnel involved throughout the continuum of aeromedical evacuation care. A convenience sample of 236 nurses and medical technicians from settings representing the continuum was studied. Descriptive and nonparametric statistics were used to analyze the quantitative data, and thematic analysis was applied to the qualitative data. Results indicate that over 90% of respondents agree or strongly agree safety is a priority in their unit and that their unit is responsive to patient safety initiatives. Many respondents described safety incidents or near misses, and these have been categorized as personnel physical capability limitations, environmental threats, medication and equipment issues, and care process problems. Results suggest the care of patients during transport is influenced by the safety culture, human factors, training, experience, and communication. Suggestions to address safety issues emerged from the survey data. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

Highway safety data : costs, quality, and strategies for improvement, final report.

DOT National Transportation Integrated Search

1998-01-01

The goal of this project was to analyze the collection and management of highway safety data by identifying issues and costs, and proposing means of resolving those issues and reducing the costs. Initial emphasis addressed known elements of the highw...

Highway Safety Data : costs, quality, and strategies for improvement : research report

DOT National Transportation Integrated Search

1998-01-01

The goal of this project was to analyze the collection and management of highway safety data by identifying issues and costs, and proposing means of resolving those issues and reducing the costs. Initial emphasis addressed known elements of the highw...

Occupant protection issues among older drivers and passengers. Volume 1, Final report

DOT National Transportation Integrated Search

2008-04-01

With the older adult population of the United States growing at a rapid pace, the National Highway Traffic Safety Administration (NHTSA) is concerned with highway safety issues affecting this age group. NHTSA initiated a three-stage research study in...

77 FR 38495 - Safety Zone; Village of Sodus Point Fireworks Display, Sodus Bay, Sodus Point, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-28

.... Regulatory History and Information The Coast Guard is issuing this temporary final rule without prior notice... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone...

Misinformation contributing to safety issues in vehicle restraints for children : a rural/urban comparison.

DOT National Transportation Integrated Search

2013-12-01

This study sought to determine current knowledge-levels of health care providers regarding child passenger safety issues and frequency of counseling on this topic. In addition, this study explored the differences in child restraint knowledge levels a...

Collegiate Aviation Research and Education Solutions to Critical Safety Issues

NASA Technical Reports Server (NTRS)

Bowen, Brent (Editor)

2002-01-01

This Conference Proceedings is a collection of 6 abstracts and 3 papers presented April 19-20, 2001 in Denver, CO. The conference focus was "Best Practices and Benchmarking in Collegiate and Industry Programs". Topics covered include: satellite-based aviation navigation; weather safety training; human-behavior and aircraft maintenance issues; disaster preparedness; the collegiate aviation emergency response checklist; aviation safety research; and regulatory status of maintenance resource management.

Assessing potentially dangerous medical actions with the computer-based case simulation portion of the USMLE step 3 examination.

PubMed

Harik, Polina; Cuddy, Monica M; O'Donovan, Seosaimhin; Murray, Constance T; Swanson, David B; Clauser, Brian E

2009-10-01

The 2000 Institute of Medicine report on patient safety brought renewed attention to the issue of preventable medical errors, and subsequently specialty boards and the National Board of Medical Examiners were encouraged to play a role in setting expectations around safety education. This paper examines potentially dangerous actions taken by examinees during the portion of the United States Medical Licensing Examination Step 3 that is particularly well suited to evaluating lapses in physician decision making, the Computer-based Case Simulation (CCS). Descriptive statistics and a general linear modeling approach were used to analyze dangerous actions ordered by 25,283 examinees that completed CCS for the first time between November 2006 and January 2008. More than 20% of examinees ordered at least one dangerous action with the potential to cause significant patient harm. The propensity to order dangerous actions may vary across clinical cases. The CCS format may provide a means of collecting important information about patient-care situations in which examinees may be more likely to commit dangerous actions and the propensity of examinees to order dangerous tests and treatments.

From shame to shame resilience: narratives of counselor trainees with eating issues.

PubMed

Dayal, Helena; Weaver, Kathryn; Domene, José F

2015-02-01

Using narrative analysis, the experiences of 7 Canadian counselor trainees with eating issues were explored for meanings of shame and resilience. Shame was experienced as layers of discounting and disconnection from self and others, which served as barriers to help seeking and recovery. Trainees' attempts to overcome shame were characterized by a dialectic conflict of protecting shame vs. prioritizing recovery. Finding a culture of safety and belonging, invalidating perfection, and redefining ideals emerged as elements that fostered resilience from the layers of shame. Recommendations for future research include exploring the important features of social support and examining how safe disclosure contributes to overcoming shame. Potential implications for counselor education programs include introducing self-care initiatives, discussions about counselor wellness and ethical practice, and education on eating issues. © The Author(s) 2014.

Recent Development of Inorganic Nanoparticles for Biomedical Imaging

PubMed Central

2018-01-01

Inorganic nanoparticle-based biomedical imaging probes have been studied extensively as a potential alternative to conventional molecular imaging probes. Not only can they provide better imaging performance but they can also offer greater versatility of multimodal, stimuli-responsive, and targeted imaging. However, inorganic nanoparticle-based probes are still far from practical use in clinics due to safety concerns and less-optimized efficiency. In this context, it would be valuable to look over the underlying issues. This outlook highlights the recent advances in the development of inorganic nanoparticle-based probes for MRI, CT, and anti-Stokes shift-based optical imaging. Various issues and possibilities regarding the construction of imaging probes are discussed, and future research directions are suggested. PMID:29632878

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.

An Asian perspective on GMO and biotechnology issues.

PubMed

Teng, Paul P S

2008-01-01

Of the 102 million hectares that made up the global area of biotech crops in 2006, less than 8% (7.6 million ha) were in Asia. Three biotech crops are currently planted in significant areas in four Asian countries with government regulatory approval; namely, cotton, corn (maize), and canola. However, the amount of GM crop material imported into the Asian region for processing into food and animal feed is very substantial, and almost every country imports GM food. The issues which concern Asian scientists, regulators, and the lay public resemble those of other regions - biosafety, food safety, ethics and social justice, competitiveness, and the "EU" trade question. Most Asian countries now have regulatory systems for approving the commercialization of GM crops, and for approving food safety of GM crops. In Asia, because of the varied cultures, issues concerning the use of genes derived from animals arouse much emotion for religious and diet choice reasons. Because many Asian producers and farmers are small-scale, there is also concern about technology dependency and to whom the benefits accrue. All consumers surveyed have expressed concern about potential allergenic and long-term toxic effects, neither of which is grounded on scientific facts. Because of Asia's growing demand for high volumes of quality food, it is likely that GM crops will become an increasing feature of our diet.

Improving safety on rural local and tribal roads safety toolkit.

DOT National Transportation Integrated Search

2014-08-01

Rural roadway safety is an important issue for communities throughout the country and presents a challenge for state, local, and Tribal agencies. The Improving Safety on Rural Local and Tribal Roads Safety Toolkit was created to help rural local ...

Synthetic Vision Workshop 2

NASA Technical Reports Server (NTRS)

Kramer, Lynda J. (Compiler)

1999-01-01

The second NASA sponsored Workshop on Synthetic/Enhanced Vision (S/EV) Display Systems was conducted January 27-29, 1998 at the NASA Langley Research Center. The purpose of this workshop was to provide a forum for interested parties to discuss topics in the Synthetic Vision (SV) element of the NASA Aviation Safety Program and to encourage those interested parties to participate in the development, prototyping, and implementation of S/EV systems that enhance aviation safety. The SV element addresses the potential safety benefits of synthetic/enhanced vision display systems for low-end general aviation aircraft, high-end general aviation aircraft (business jets), and commercial transports. Attendance at this workshop consisted of about 112 persons including representatives from industry, the FAA, and other government organizations (NOAA, NIMA, etc.). The workshop provided opportunities for interested individuals to give presentations on the state of the art in potentially applicable systems, as well as to discuss areas of research that might be considered for inclusion within the Synthetic Vision Element program to contribute to the reduction of the fatal aircraft accident rate. Panel discussions on topical areas such as databases, displays, certification issues, and sensors were conducted, with time allowed for audience participation.

How Can We Make PV Modules Safer?: Preprint

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

Wohlgemuth, J. H.; Kurtz, S. R.

2012-06-01

Safety is a prime concern for the photovoltaics (PV) industry. As a technology deployed on residential and commercial buildings, it is critical that PV not cause damage to the buildings nor harm the occupants. Many of the PV systems on buildings are of sufficiently high voltage (300 to 600 Volts dc) that they may present potential hazards. These PV systems must be safe in terms of mechanical damage (nothing falls on someone), shock hazard (no risk of electrical shock when touching an exposed circuit element), and fire (the modules neither cause nor promote a fire). The present safety standards (IECmore » 61730 and UL 1703) do a good job of providing for design rules and test requirements for mechanical, shock, and spread of flame dangers. However, neither standard addresses the issue of electrical arcing within a module that can cause a fire. To make PV modules, they must be designed, built, and installed with an emphasis on minimizing the potential for open circuits and ground faults. This paper provides recommendations on redundant connection designs, robust mounting methods, and changes to the safety standards to yield safer PV modules.« less

Causes, consequences and countermeasures to driver fatigue in the rail industry: The train driver perspective.

PubMed

Filtness, A J; Naweed, A

2017-04-01

Fatigue is an important workplace risk management issue. Within the rail industry, the passing of a stop signal (signal passed at danger; SPAD) is considered to be one of the most major safety breaches which can occur. Train drivers are very aware of the negative consequences associated with a SPAD. Therefore, SPADs provide a practical and applied safety relevant context within which to structure a discussion on fatigue. Focus groups discussing contributing factors to SPADs were undertaken at eight passenger rail organisations across Australia and New Zealand (n = 28 drivers). Data relating to fatigue was extracted and inductively analysed identifying three themes: causes, consequences, and countermeasures (to fatigue). Drivers experienced negative consequences of fatigue, despite existing countermeasures to mitigate it. Organisational culture was a barrier to effective fatigue management. A fatigue assessment tool consistently informed rostering, however, shift swapping was commonplace and often unregulated, reducing any potential positive impact. In discussing fatigue countermeasure strategies, drivers talked interchangeably about mitigating task related fatigue (e.g. increasing cognitive load) and sleepiness (e.g. caffeine). Ensuring the concepts of fatigue and sleepiness are properly understood has the potential to maximise safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

Status of microbial based cleaning products in statutory regulations and ecolabelling in Europe, the USA, and Canada.

PubMed

Spök, Armin; Arvanitakis, George; McClung, Gwendolyn

2018-06-01

Cleaning products containing living microorganisms as active ingredients are increasingly being used in household, professional and industrial cleaning applications. Microorganisms can degrade soiling associated with dirt, food residues, and grease by enzymatic and metabolic action and out-compete microorganisms associated with odor problems. Their potential for odor control seems to result in a competitive advantage over conventional chemically-based cleaning products. Moreover, producers of microbial-based cleaning products (MBCPs) claim that their products are less harmful to the environment. These promising prospects have triggered interest from consumer and environmental organizations, professional users, and regulators in understanding if there are also possible negative health and environmental impacts which require attention and how the safety of these products is ensured. Unfortunately, there is little information on these issues in the public domain. Moreover, regulatory oversight in Europe is essentially limited to pathogenic properties in the context of worker protection. Canada, in contrast, has a regulatory framework in place to assess risks to human health and the environment from the manufacture, import and/or use of new microorganisms contained in MBCPs. In the absence of mandatory standards, safety assessment and hygienic practices seem to vary considerably across companies. Recently developed ecolabelling standards are - for the time being - the only option for transparent compliance to minimum standards in terms of safety as well as assessments of manufacturer information by third parties. These standards highlight in particular the need for precise taxonomic information for assessing the pathogenic properties and the need to ensure the absence of potentially harmful microorganisms as contaminants. Ecolabelling standards are, however, voluntary and do not cover all relevant safety issues. In order to develop a more comprehensive set of mandatory standards for health and safety, a number of areas would benefit from further research (e.g. the role in plant pathogenicity and other environmental properties of the microorganisms used; the relevance of chronic exposure to dusts and aerosols containing vegetative cells and spores; the relevance of strains which belong to species known to include opportunistic pathogens and possible hazards for particularly sensitive risk groups). Improved knowledge in these areas will contribute to a predictable level of product safety. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

From the school of nursing quality and safety officer: nursing students' use of safety reporting tools and their perception of safety issues in clinical settings.

PubMed

Cooper, Elizabeth

2013-01-01

Improved patient safety and quality are priority goals for nurses and schools of nursing. This article describes the innovative new role of quality and safety officer (QSO) developed by one university in response to the Quality and Safety Education for Nurses challenge to increase quality and safety education for prelicensure nursing students. The article also describes the results of a study conducted by the QSO, obtaining information from prelicensure nursing students about the use of safety tools and identifying the students' perceptions of safety issues, communication, and safety reporting in the clinical setting. Responses of 145 prelicensure nursing students suggest that it is difficult to get all errors and near-miss events reported. Barriers for nursing students are similar to the barriers nurses and physicians identify in reporting errors and near-miss events. The survey reveals that safety for the patient is the primary concern of the student nurse. Copyright © 2013 Elsevier Inc. All rights reserved.

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

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

G. L. Sharp; R. T. McCracken

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR safety basis. The need for a design basis reconstitution program for the ATR has been identified along with the use of sound configuration management principles in order to support safe and efficient facility operation.« less

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research☆

PubMed Central

Rossi, Simone; Hallett, Mark; Rossini, Paolo M.; Pascual-Leone, Alvaro

2011-01-01

This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible. PMID:19833552

29 CFR 1952.215 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Maryland plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

29 CFR 1952.355 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Arizona plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

29 CFR 1952.205 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Minnesota plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

29 CFR 1952.345 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Wyoming plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

29 CFR 1952.225 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Tennessee plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

29 CFR 1952.235 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Kentucky plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... and health standards which have been promulgated under section 6 of the Act do not apply with respect...

Schoolyard Ponds: Safety and Liability.

ERIC Educational Resources Information Center

Danks, Sharon Gamson

2001-01-01

Engaging, attractive schoolyard ponds provide habitat for wildlife and hold great educational promise. Reviews water safety and liability issues including mud, stagnant pond water that serves as mosquito breeding grounds, and drowning. Offers ideas for creatively addressing those issues through site planning, shallow water depth, signage and…

School Safety: A Collaborative Effort.

ERIC Educational Resources Information Center

ERIC Review, 2000

2000-01-01

The "ERIC Review" announces research results, publications, and new programs relevant to each issue's theme topic. This issue focuses on school safety and violence prevention. An introductory section includes two articles: "How Safe Is My Child's School?" (Kevin Mitchell) and "Making America's Schools Safer" (U.S.…

Factors to consider in the introduction of huddles on clinical wards: perceptions of staff on the SAFE programme.

PubMed

Stapley, Emily; Sharples, Evelyn; Lachman, Peter; Lakhanpaul, Monica; Wolpert, Miranda; Deighton, Jessica

2018-02-01

To explore paediatric hospital staff members' perceptions of the emerging benefits and challenges of the huddle, a new safety improvement initiative, as well as the barriers and facilitators to its implementation. A qualitative study was conducted using semi-structured interviews to explore staff perspectives and experiences. Situation Awareness For Everyone (SAFE), a safety improvement programme, was implemented on a sample of National Health Service (NHS) paediatric wards from September 2014 to June 2016. Previously untested in England, the huddle was a central component of the programme. Semi-structured interviews were conducted with 76 staff members on four wards ~4 months after the start of the programme. A thematic analysis showed that staff perceived the huddle as helping to increase their awareness of important issues, improve communication, facilitate teamwork, and encourage a culture of increased efficiency, anticipation and planning on the ward. Challenges of the huddle included added pressure on staff time and workload, and the potential for junior nurses to be excluded from involvement, thus perhaps inadvertently reinforcing medical hierarchies. Staff also identified several barriers and facilitators to the huddle process, including the importance of senior nursing and medical staff leadership and managing staff time and capacity issues. The findings point towards the potential efficacy of the huddle as a way of improving hospital staff members' working environments and clinical practice, with important implications for other sites seeking to implement such safety improvement initiatives. © The Author(s) 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

PubMed

Balka, Ellen; Tolar, Marianne; Coates, Shannon; Whitehouse, Sandra

2013-12-01

Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Naturally occurring asbestos: a recurring public policy challenge.

PubMed

Lee, R J; Strohmeier, B R; Bunker, K L; Van Orden, D R

2008-05-01

The potential environmental hazards and associated public health issues related to exposure to respirable dusts from the vicinity of natural in-place asbestos deposits (commonly referred to as naturally occurring asbestos, NOA) have gained the regulatory and media spotlight in many areas around the United States, such as Libby, MT, Fairfax County, VA, and El Dorado Hills, CA, among others. NOA deposits may be present in a variety of geologic formations. It has been suggested that airborne asbestos may be released from NOA deposits, and absent appropriate engineering controls, may pose a potential health hazard if these rocks are crushed or exposed to natural weathering and erosion or to human activities that create dust. The issue that needs to be addressed at a policy level is the method of assessing exposures to elongated rock fragments ubiquitous in dust clouds in these same environments and the associated risk. Elongated rock fragments and single crystal minerals present in NOA have been construed by some as having attributes, including the health effects, of asbestos fibers. However, the Occupational Safety and Health Administration (OSHA), Mine Safety and Health Administration (MSHA), and the Consumer Products Safety Commission (CPSC) found that the scientific evidence did not support this assumption. As in many environmental fields of study, the evidence is often disputed. Regulatory policy is not uniform on the subject of rock fragments, even within single agencies. The core of the issue is whether the risk parameters associated with exposures to commercial asbestos can or should be applied to rock fragments meeting an arbitrary set of particle dimensions used for counting asbestos fibers. Inappropriate inclusion of particles or fragments results in dilution of risk and needless expenditure of resources. On the other hand, inappropriate exclusion of particles or fragments may result in increased and unnecessary risk. Some of the fastest growing counties in the United States are in areas where NOA is known to exist and therefore this issue takes on national significance. This ongoing national dilemma has raised public and business concerns. There has been continuing political and scientific debate and widespread miscommunication over perceived versus actual health risks, the validity of various analytical sampling and testing methods, the questionable necessity and escalating costs of remediation procedures, and the combined negative impact on numerous commercial and public interests. Thus, conflicting research and regulatory positions on the distinctions between and hazards of true asbestos and ordinary rock fragments is all that is presently available to the public until the differing scientific communities and government agencies arrive at a consensus on these issues. The risk assessment methodology and the analytical technology needed to support inferences drawn from existing research are available, but have not been organized and implemented in the manner needed to resolve the NOA controversy. There should exist nationally adopted and peer-reviewed NOA standards (developed jointly by the scientific community, health risk professionals, and government regulators) that establish: (1) a scientific basis for risk evaluation and assessment of NOA and rock fragments; (2) accepted analytical protocols for determining if NOA actually exists in a given area and for separating NOA from related non-asbestos rock fragments and single crystal minerals; and (3) effective public policies for managing NOA, minimizing potential hazards, and protecting public health. This article will review some of the key issues involved with the current NOA debate, propose improved analytical methodologies, describe potential solutions for dealing with NOA, and outline the benefits to be gained by creating a practical national NOA public policy.

Food Safety Legislation Regarding Of Aflatoxins Contamination

NASA Astrophysics Data System (ADS)

Ketney, Otto

2015-09-01

The main objective of the European Union (EU) is to reduce certain contaminants in foodstuffs to acceptable levels. The occurrence of aflatoxin B1 in food was considered to be one of the most important issues of global food security to protect the health of humans and animals, over 100 nations have established maximum tolerable levels for aflatoxin in food. Although EU legislation covers many aspects of food safety was not legally establish an integrated framework that could effectively combat and cover all sectors of the food chain. Monitoring and reporting levels of aflatoxins after controls are essential actions that assist to identify potential risks to human health. The review process for aflatoxin regulations is a complex activity involving many factors and stakeholders.

Establishing powder-handling workflow practices and standard operating procedures: compounding pharmacy and safety.

PubMed

Prince, Bryan; Lundevall, Jeremy

2014-01-01

This is an ongoing discussion and analysis of powder-handling safety in the compounding pharmacy laboratory that started in the November/December 2013 issue of the International Journal of Pharmaceutical Compounding. In the previous technical article, we established that most chemical powders handled during compounding procedures have an established occupational exposure limits and that powders are micronized during manipulation. All micronized powders handled on an open bench create health hazards to the technicians and create a potential for cross-contamination to the lab environment. Proper identification of the chemical hazard and established standard operating procedures in direct correlation to Good Lab Practices when working inside a powder hood will positively improve the compounding pharmacy's work environment.

Inspection of fecal contamination on strawberries using fluorescence imaging

NASA Astrophysics Data System (ADS)

Chuang, Yung-Kun; Yang, Chun-Chieh; Kim, Moon S.; Delwiche, Stephen R.; Lo, Y. Martin; Chen, Suming; Chan, Diane E.

2013-05-01

Fecal contamination of produce is a food safety issue associated with pathogens such as Escherichia coli that can easily pollute agricultural products via animal and human fecal matters. Outbreaks of foodborne illnesses associated with consuming raw fruits and vegetables have occurred more frequently in recent years in the United States. Among fruits, strawberry is one high-potential vector of fecal contamination and foodborne illnesses since the fruit is often consumed raw and with minimal processing. In the present study, line-scan LED-induced fluorescence imaging techniques were applied for inspection of fecal material on strawberries, and the spectral characteristics and specific wavebands of strawberries were determined by detection algorithms. The results would improve the safety and quality of produce consumed by the public.

Issues in Software System Safety: Polly Ann Smith Co. versus Ned I. Ludd

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2002-01-01

This paper is a work of fiction, but it is fiction with a very real purpose: to stimulate careful thought and friendly discussion about some questions for which thought is often careless and discussion is often unfriendly. To accomplish this purpose, the paper creates a fictional legal case. The most important issue in this fictional case is whether certain proffered expert testimony about software engineering for safety critical systems should be admitted. Resolving this issue requires deciding the extent to which current practices and research in software engineering, especially for safety-critical systems, can rightly be considered based on knowledge, rather than opinion.

From Here to There: Lessons from an Integrative Patient Safety Project in Rural Health Care Settings

DTIC Science & Technology

2005-05-01

errors and patient falls. The medication errors generally involved one of three issues: incorrect dose, time, or port. Although most of the health...statistics about trends; and the summary of events related to patient safety and medical errors.12 The interplay among factors These three domains...the medical staff. We explored these issues further when administering a staff-wide Patient Safety Survey. Responses mirrored the findings that

Unique Safety Issues Associated with Virus Vectored Vaccines: Potential for and Theoretical Consequences of Recombination with Wild Type Virus Strains

PubMed Central

Condit, Richard C.; Williamson, Anna-Lise; Sheets, Rebecca; Seligman, Stephen J.; Monath, Thomas P.; Excler, Jean-Louis; Gurwith, Marc; Bok, Karin; Robertson, James S.; Kim, Denny; Hendry, Michael; Singh, Vidisha; Mac, Lisa M.; Chen, Robert T.

2016-01-01

In 2003 and 2013, the World Health Organization convened informal consultations on characterization and quality aspects of vaccines based on live virus vectors. In the resulting reports, one of several issues raised for future study was the potential for recombination of virus-vectored vaccines with wild type pathogenic virus strains. This paper presents an assessment of this issue formulated by the Brighton Collaboration. To provide an appropriate context for understanding the potential for recombination of virus-vectored vaccines, we review briefly the current status of virus vectored vaccines, mechanisms of recombination between viruses, experience with recombination involving live attenuated vaccines in the field, and concerns raised previously in the literature regarding recombination of virus-vectored vaccines with wild type virus strains. We then present a discussion of the major variables that could influence recombination between a virus-vectored vaccine and circulating wild type virus and the consequences of such recombination, including intrinsic recombination properties of the parent virus used as a vector; sequence relatedness of vector and wild virus; virus host range, pathogenesis and transmission; replication competency of vector in target host; mechanism of vector attenuation; additional factors potentially affecting virulence; and circulation of multiple recombinant vectors in the same target population. Finally, we present some guiding principles for vector design and testing intended to anticipate and mitigate the potential for and consequences of recombination of virus-vectored vaccines with wild type pathogenic virus strains. PMID:27346303

A qualitative exploration of the perceptions and information needs of public health inspectors responsible for food safety

PubMed Central

2010-01-01

Background In Ontario, local public health inspectors play an important frontline role in protecting the public from foodborne illness. This study was an in-depth exploration of public health inspectors' perceptions of the key food safety issues in public health, and their opinions and needs with regards to food safety information resources. Methods Four focus group discussions were conducted with public health inspectors from the Central West region of Ontario, Canada during June and July, 2008. A questioning route was used to standardize qualitative data collection. Audio recordings of sessions were transcribed verbatim and data-driven content analysis was performed. Results A total of 23 public health inspectors participated in four focus group discussions. Five themes emerged as key food safety issues: time-temperature abuse, inadequate handwashing, cross-contamination, the lack of food safety knowledge by food handlers and food premise operators, and the lack of food safety information and knowledge about specialty foods (i.e., foods from different cultures). In general, participants reported confidence with their current knowledge of food safety issues and foodborne pathogens. Participants highlighted the need for a central source for food safety information, access to up-to-date food safety information, resources in different languages, and additional food safety information on specialty foods. Conclusions The information gathered from these focus groups can provide a basis for the development of resources that will meet the specific needs of public health inspectors involved in protecting and promoting food safety. PMID:20553592

Analysis of governmental Web sites on food safety issues: a global perspective.

PubMed

Namkung, Young; Almanza, Barbara A

2006-10-01

Despite a growing concern over food safety issues, as well as a growing dependence on the Internet as a source of information, little research has been done to examine the presence and relevance of food safety-related information on Web sites. The study reported here conducted Web site analysis in order to examine the current operational status of governmental Web sites on food safety issues. The study also evaluated Web site usability, especially information dimensionalities such as utility, currency, and relevance of content, from the perspective of the English-speaking consumer. Results showed that out of 192 World Health Organization members, 111 countries operated governmental Web sites that provide information about food safety issues. Among 171 searchable Web sites from the 111 countries, 123 Web sites (71.9 percent) were accessible, and 81 of those 123 (65.9 percent) were available in English. The majority of Web sites offered search engine tools and related links for more information, but their availability and utility was limited. In terms of content, 69.9 percent of Web sites offered information on foodborne-disease outbreaks, compared with 31.5 percent that had travel- and health-related information.

Titanium dioxide nanoparticles stimulate sea urchin immune cell phagocytic activity involving TLR/p38 MAPK-mediated signalling pathway

PubMed Central

Pinsino, Annalisa; Russo, Roberta; Bonaventura, Rosa; Brunelli, Andrea; Marcomini, Antonio; Matranga, Valeria

2015-01-01

Titanium dioxide nanoparticles (TiO2NPs) are one of the most widespread-engineered particles in use for drug delivery, cosmetics, and electronics. However, TiO2NP safety is still an open issue, even for ethical reasons. In this work, we investigated the sea urchin Paracentrotus lividus immune cell model as a proxy to humans, to elucidate a potential pathway that can be involved in the persistent TiO2NP-immune cell interaction in vivo. Morphology, phagocytic ability, changes in activation/inactivation of a few mitogen-activated protein kinases (p38 MAPK, ERK), variations of other key proteins triggering immune response (Toll-like receptor 4-like, Heat shock protein 70, Interleukin-6) and modifications in the expression of related immune response genes were investigated. Our findings indicate that TiO2NPs influence the signal transduction downstream targets of p38 MAPK without eliciting an inflammatory response or other harmful effects on biological functions. We strongly recommend sea urchin immune cells as a new powerful model for nano-safety/nano-toxicity investigations without the ethical normative issue. PMID:26412401

The in silico drug discovery toolbox: applications in lead discovery and optimization.

PubMed

Bruno, Agostino; Costantino, Gabriele; Sartori, Luca; Radi, Marco

2017-11-06

Discovery and development of a new drug is a long lasting and expensive journey that takes around 15 years from starting idea to approval and marketing of new medication. Despite the R&D expenditures have been constantly increasing in the last few years, number of new drugs introduced into market has been steadily declining. This is mainly due to preclinical and clinical safety issues, which still represent about 40% of drug discontinuation. From this point of view, it is clear that if we want to increase drug-discovery success rate and reduce costs associated with development of a new drug, a comprehensive evaluation/prediction of potential safety issues should be conducted as soon as possible during early drug discovery phase. In the present review, we will analyse the early steps of drug-discovery pipeline, describing the sequence of steps from disease selection to lead optimization and focusing on the most common in silico tools used to assess attrition risks and build a mitigation plan. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.

PubMed

Jaspan, Heather B; Cunningham, Coleen K; Tucker, Tim J P; Wright, Peter F; Self, Steve G; Sheets, Rebecca L; Rogers, Audrey S; Bekker, Linda-Gail; Wilson, Craig M; Duerr, Ann; Wasserheit, Judith N

2008-01-01

The search for a safe effective HIV vaccine has been a centerpiece of HIV research for almost 2 decades. More than 60 clinical HIV vaccine trials have been conducted to date. Several promising candidate HIV vaccines are in advanced clinical development. To date, however, no trial has included adolescents, one of the most important target groups for any preventive HIV vaccine. To license a vaccine for use in this age group, efficacy data or, at a minimum, bridging safety and immunogenicity data in this population are needed. To accomplish this, several critical issues and special challenges in the development and implementation of HIV vaccine trials in adolescents must be addressed, including regulatory considerations, potential differentials in safety and immunogenicity, alternative trial design strategies, recruitment and retention challenges, community involvement models, and approaches to informed consent/assent. This article examines these issues and proposes specific next steps to facilitate the routine inclusion of this high-priority population in preventive HIV vaccine trials as early and seamlessly as possible.

The application of carbon monoxide in meat packaging needs to be re-evaluated within the EU: An overview.

PubMed

Van Rooyen, Lauren Anne; Allen, Paul; O'Connor, David I

2017-10-01

Carbon monoxide (CO) has many value-added benefits in meat packaging due to its colour stabilising effects and enhancement of meat quality attributes. The regulation of CO within meat packaging varies worldwide and remains a topical and controversial issue. CO is prohibited in the EU for use in meat packaging mainly due to fears it may mask spoilage therefore misleading consumers. The issue of consumer acceptance of CO was not considered. This article reviews the most pertinent literature to assess if the problems associated with the prohibition have been addressed. Applying CO pretreatments prior to vacuum packaging enhances colour while allowing discolouration to occur by the use-by-date, thereby addressing concerns about safety. Recent work showing European consumer acceptance of CO in meat packaging demonstrates its future potential within the EU. The information provided may support framing future policies intended to assure consumer protection, safety, choice and interest. Re-evaluation of permitting CO as a packaging gas within the EU may be warranted. Copyright © 2017 Elsevier Ltd. All rights reserved.

Consumer Poultry Handling Behavior in the Grocery Store and In-Home Storage.

PubMed

Donelan, Amy K; Chambers, Delores H; Chambers, Edgar; Godwin, Sandria L; Cates, Sheryl C

2016-04-01

Considerable work on consumers' food safety habits has highlighted issues associated with home food preparation. However, consumer handling of foods, such as poultry, during shopping and storage has not been noted. The objective of this study was to determine consumer behaviors during purchasing and initial storage of raw poultry to determine potential cross-contamination issues. A shop-along observational study was conducted to determine actual shopping, transportation, and storage behavior of consumers who purchase raw poultry products. Neither hand sanitizer nor wipes were observed in 71% of grocery store meat sections of stores visited. Plastic bags could be found in the meat section 85% of the time, but only 25% of shoppers used the bag for their raw poultry purchases. During checkout, the poultry was bagged separately from other products 71% of the time. A majority of shoppers stored raw poultry in the original package without an additional container or overwrap. Overall, there needs to be an increase in food safety education on the handling of poultry during purchasing, transportation, and storage.

Introduction of the pill and its impact.

PubMed

Tyrer, L

1999-01-01

Introduction of the birth control pill in the United States in 1960 marked the end of a relatively short period of time (< 10 years) to intentionally produce an oral contraceptive, and the beginning of a relatively long period of controversy surrounding the use of the pill. Availability of the pill had an impact on various aspects of social life, including women's health, fertility trends, laws and policies, religion, interpersonal relationships and family roles, feminist issues, and gender relations, as well as sexual practices among both adults and adolescents. The pill proved to be highly effective from the outset. Although safety issues developed with the earlier formulations, continued evolution of pill hormones and doses has resulted in a greatly improved and safe oral contraceptive. A broad range of noncontraceptive health benefits also is associated with the pill. These health effects are significant, as they include protection against potentially fatal diseases, including ovarian and endometrial cancers, as well as against other conditions that are associated with substantial morbidity and potential hospitalization and associated costs. The popularity of the pill has remained high, with rates of use in the past 30 years in the United States ranging from one-quarter to almost one-third of women using contraception. Almost 40 years after its introduction, the pill's contraceptive efficacy is proven, its improved safety has been established, and the focus has shifted from supposed health risks to documented and real health benefits.

29 CFR 1952.115 - Level of Federal enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues covered by the Utah plan. OSHA retains full authority over issues which... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... health standards which have been promulgated under section 6 of the Act do not apply with respect to...

Safety of High-Speed Guided Ground Transportation Systems : Shared Right-of-Way Safety Issues

DOT National Transportation Integrated Search

1992-09-01

One of the most important issues in the debate over the viability in the United States of high-speed guided ground : transportation (HSGGT) systems, which include magnetic levitation (maglev) and high-speed rail (HSR), is the : feasibility of using e...

North Carolina school bush crash data and issues related to seat belts on large school buses

DOT National Transportation Integrated Search

1999-04-01

School bus transportation and safety is a very serious and sometimes controversial and : emotional issue. Although school buses have been shown to be a very safe form of : transportation, many parents and safety advocates question the absence of seat...

ERCMExpress. Volume 2, Issue 3

ERIC Educational Resources Information Center

US Department of Education, 2006

2006-01-01

This issue of the Emergency Response and Crisis Management (ERCM) Technical Assistance Center's "ERCMExpress" promotes emergency exercises as an effective way to validate school safety plans. Simulations of emergency situations, or emergency exercises, are integral to a sound school safety plan. They offer opportunities for district and schools to…

76 FR 67461 - Cosmetic Microbiological Safety Issues; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0770] Cosmetic Microbiological Safety Issues; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments and opening of a docket. SUMMARY: The Food and Drug...

Potential health and environmental issues of mercury-contaminated amalgamators.

PubMed

Roberts, H W; Leonard, D; Osborne, J

2001-01-01

Dental amalgamators may become contaminated internally with metallic mercury. This contamination may result from mercury leakage from capsules during trituration or from the long-term accrual from microscopic exterior contaminants that result from the industrial assembly process. The potential health risk to dental personnel from this contamination is unknown. The authors assessed used amalgamators from the federal service inventory for the amounts of mercury vapor levels, as well as the visual presence of mercury contamination. They evaluated these amalgamators for potential mercury vapor health risk, using established National Institute for Occupational Safety and Health methods and American Conference of Governmental Industrial Hygienists standards. Ten of the 11 amalgamators assessed had measurable mercury vapor levels. Four amalgamators were found to have internal static mercury vapor levels above Occupational Safety and Health Administration ceiling limit thresholds. During a simulated worst-case clinical use protocol, the authors found that no amalgamators produced mercury vapor in the breathing space of dental personnel that exceeded established time-weighted federal mercury vapor limits. Amalgamators may be contaminated internally with metallic mercury. Although the authors detected mercury vapor from these units during aggressive, simulated clinical use, dilution factors combined with room air exchange were found to keep health risks below established federal safety thresholds. Dental personnel should be aware that amalgamators may be contaminated with mercury and produce minute amounts of mercury vapor. These contaminated amalgamators may require disposal as environmentally hazardous waste.

State of security at US colleges and universities: a national stakeholder assessment and recommendations.

PubMed

Greenberg, Sheldon F

2007-09-01

In 2004 the US Department of Justice, Office of Community Oriented Policing Services, sponsored a National Summit on Campus Public Safety. The summit brought together various stakeholders including campus police and security officials, local police chiefs, college and university faculty and administrators, federal officials, students and parents, and community leaders to address the issues and complexities of campus safety. Delegates to the summit identified key issues in campus safety and security, which included establishing a national center on campus safety, balancing traditional open environments with the need to secure vulnerable sites, improving coordination with state and local police, reducing internal fragmentation, elevating professionalism, and increasing eligibility of campus police and security agencies to compete for federal law enforcement funds. Focus on "active shooters" on campus, resulting from the Virginia Tech incident, should not diminish attention placed on the broader, more prevalent safety and security issues facing the nation's educational campuses. Recommendations resulting from the summit called for establishing a national agenda on campus safety, formation of a national center on campus public safety, and increased opportunity for campus police and security agencies to compete for federal and state funds.

Georgia Highway Safety 1997 fact book : a report on highway safety In Georgia

DOT National Transportation Integrated Search

1997-01-01

The goal of this fact book is to present highway safety statistics and fact-based analysis that will increase public awareness on highway safety issues, and to provide information that will assist policy makers and highway safety advocates in making ...

Safety and health practice among laboratory staff in Malaysian education sector

NASA Astrophysics Data System (ADS)

Husna Che Hassan, Nurul; Rasdan Ismail, Ahmad; Kamilah Makhtar, Nor; Azwadi Sulaiman, Muhammad; Syuhadah Subki, Noor; Adilah Hamzah, Noor

2017-10-01

Safety is the most important issue in industrial sector such as construction and manufacturing. Recently, the increasing number of accident cases reported involving school environment shows the important of safety issues in education sector. Safety awareness among staff in this sector is crucial in order to find out the method to prevent the accident occurred in future. This study was conducted to analyze the knowledge of laboratory staff in term of safety and health practice in laboratory. Survey questionnaires were distributing among 255 of staff laboratory from ten District Education Offices in Kelantan. Descriptive analysis shows that the understanding of safety and health practice are low while doing some job activities in laboratory. Furthermore, some of the staff also did not implemented safety practice that may contribute to unplanned event occur in laboratory. Suggestion that the staff at laboratory need to undergo on Occupational Safety and Health training to maintain and create safe environment in workplaces.

Safety management practices in small and medium enterprises in India.

PubMed

Unnikrishnan, Seema; Iqbal, Rauf; Singh, Anju; Nimkar, Indrayani M

2015-03-01

Small and medium enterprises (SMEs) are often the main pillar of an economy. Minor accidents, ergonomics problems, old and outdated machinery, and lack of awareness have created a need for implementation of safety practices in SMEs. Implementation of healthy working conditions creates positive impacts on economic and social development. In this study, a questionnaire was developed and administered to 30 randomly chosen SMEs in and around Mumbai, Maharashtra, and other states in India to evaluate safety practices implemented in their facilities. The study also looked into the barriers and drivers for technology innovation and suggestions were also received from the respondent SMEs for best practices on safety issues. In some SMEs, risks associated with safety issues were increased whereas risks were decreased in others. Safety management practices are inadequate in most SMEs. Market competitiveness, better efficiency, less risk, and stringent laws were found to be most significant drivers; and financial constraints, lack of awareness, resistance to change, and lack of training for employees were found to be main barriers. Competition between SMEs was found to be major reason for implementation of safety practices in the SMEs. The major contribution of the study has been awareness building on safety issues in the SMEs that participated in the project.

Economic Issues on Food Safety.

PubMed

Adinolfi, Felice; Di Pasquale, Jorgelina; Capitanio, Fabian

2016-01-18

A globalised food trade, with a huge increase of the exchanged volume, extensive production and complex supply chains are contributing towards an increased number of microbiological food safety outbreaks. All of these factors are putting pressure on the stakeholders, either public or private, in terms of rule and control. In fact, this scenario could force manufacturers to be lenient towards food safety control intentionally, or unintentionally, and result in a major foodborne outbreak that causes health problems and economic loss. As a response to emerging calls for the adoption of a systemic approach to food safety, we try to identify and discuss the several related economics issue in this field. Based on an extensive analysis of academic and policy literatures on the economic effects of global environmental change at different stages of the food system, we highlight the main issues involving economists in the field of food safety. In the first part, we assessed the several approaches and problems related to the evaluation of food safety improvements, followed by an overview of drivers of food safety demand in the second part. The third section is devoted to discussing changes occurred at the institutional level in building and managing food safety policies. The last section summarises the main considerations aroused from the work.

Safety Management Practices in Small and Medium Enterprises in India

PubMed Central

Unnikrishnan, Seema; Iqbal, Rauf; Singh, Anju; Nimkar, Indrayani M.

2014-01-01

Background Small and medium enterprises (SMEs) are often the main pillar of an economy. Minor accidents, ergonomics problems, old and outdated machinery, and lack of awareness have created a need for implementation of safety practices in SMEs. Implementation of healthy working conditions creates positive impacts on economic and social development. Methods In this study, a questionnaire was developed and administered to 30 randomly chosen SMEs in and around Mumbai, Maharashtra, and other states in India to evaluate safety practices implemented in their facilities. The study also looked into the barriers and drivers for technology innovation and suggestions were also received from the respondent SMEs for best practices on safety issues. Results In some SMEs, risks associated with safety issues were increased whereas risks were decreased in others. Safety management practices are inadequate in most SMEs. Market competitiveness, better efficiency, less risk, and stringent laws were found to be most significant drivers; and financial constraints, lack of awareness, resistance to change, and lack of training for employees were found to be main barriers. Conclusion Competition between SMEs was found to be major reason for implementation of safety practices in the SMEs. The major contribution of the study has been awareness building on safety issues in the SMEs that participated in the project. PMID:25830070

The R&D PERFROI Project on Thermal Mechanical and Thermal Hydraulics Behaviors of a Fuel Rod Assembly during a Loss of Coolant Accident

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

Repetto, G.; Dominguez, C.; Durville, B.

The safety principle in case of a LOCA is to preserve the short and long term coolability of the core. The associated safety requirements are to ensure the resistance of the fuel rods upon quench and post-quench loads and to maintain a coolable geometry in the core. An R&D program has been launched by IRSN with the support of EDF, to perform both experimental and modeling activities in the frame of the LOCA transient, on technical issues such as: - flow blockage within a fuel rods bundle and its potential impact on coolability, - fuel fragment relocation in the balloonedmore » areas: its potential impact on cladding PCT (Peak Cladding Temperature) and on the maximum oxidation rate, - potential loss of cladding integrity upon quench and post-quench loads. The PERFROI project (2014-2019) focusing on the first above issue, is structured in two axes: 1. axis 1: thermal mechanical behavior of deformation and rupture of cladding taking into account the contact between fuel rods; specific research at LaMCoS laboratory focus on the hydrogen behavior in cladding alloys and its impact on the mechanical behavior of the rod; and, 2. axis 2: thermal hydraulics study of a partially blocked region of the core (ballooned area taking into account the fuel relocation with local over power), during cooling phase by water injection; More detailed activities foreseen in collaboration with LEMTA laboratory will focus on the characterization of two phase flows with heat transfer in deformed structures.« less

Health and safety in clinical laboratories in developing countries: safety considerations.

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Sustaining Vaccine Confidence in the 21st Century

PubMed Central

Hardt, Karin; Schmidt-Ott, Ruprecht; Glismann, Steffen; Adegbola, Richard A.; Meurice, François P.

2013-01-01

Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-making procedures and recommendations, controlled processes for licensing and monitoring vaccine safety and effectiveness and disease surveillance. Community engagement with appropriate communication approaches for each audience is a key factor in building trust in vaccines. Vaccine safety/quality issues should be handled rapidly and transparently by informing and involving those most affected and those concerned with public health in effective ways. Openness and transparency in the exchange of information between industry and other stakeholders is also important. To maximize the safety of vaccines, and thus sustain trust in vaccines, partnerships are needed between public health sector stakeholders. Vaccine confidence can be improved through collaborations that ensure high vaccine uptake rates and that inform the public and other stakeholders of the benefits of vaccines and how vaccine safety is constantly assessed, assured and communicated. PMID:26344109