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.

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.

Energy, climate, food and health.

PubMed

Erwin, Patricia J

2008-01-01

On June 3-5, 2008, international organizations and heads of state met in Rome to discuss the critical situation in global food supplies and prices during the World Food Crisis Summit. The intent of this column is to provide approaches to identifying the complex issues that impact public health, public safety, and nutrition on a global basis. The Web sites selected provide a background for the complex issues involved (energy, climate and environment, agriculture, and politics) and reveal controversial and competing agendas with many far-reaching implications.

Between demarcation and discretion: The medical-administrative boundary as a locus of safety in high-volume organisational routines.

PubMed

Grant, Suzanne; Guthrie, Bruce

2018-04-01

Patient safety is an increasing concern for health systems internationally. The majority of administrative work in UK general practice takes place in the context of organisational routines such as repeat prescribing and test results handling, where high workloads and increased clinician dependency on administrative staff have been identified as an emerging safety issue. Despite this trend, most research to date has focused on the redistribution of the clinical workload between doctors, nurses and allied health professionals within individual care settings. Drawing on Strauss's negotiated order perspective, we examine ethnographically the achievement of safety across the medical-administrative boundary in key high-volume routines in UK general practice. We focus on two main issues. First, GPs engaged in strategies of demarcation by defining receptionist work as routine, unspecialised and dependent upon GP clinical knowledge and oversight as the safety net to deal with complexity and risk. Receptionists consented to this 'social closure' when describing their role, thus reinforcing the underlying inter-occupational relationship of medical domination. Second, in everyday practice, GPs and receptionists engaged in informal boundary-blurring to safely accommodate the complexity of everyday high-volume routine work. This comprised additional informal discretionary spaces for receptionist decision-making and action that went beyond the routine safety work formally assigned to them. New restratified intra-occupational hierarchies were also being created between receptionists based on the complexity of the safety work that they were authorised to do at practice level, with specialised roles constituting a new form of administrative 'professional project'. The article advances negotiated order theory by providing an in-depth examination of the ways in which medical-administrative boundary-making and boundary-blurring constitute distinct modes of safety in high-volume routines. It also provides the basis for further research and safety improvement to maximise team-level understandings of the pivotal role of medical-administrative negotiations in achieving safety and mitigating risk. Copyright © 2018 Elsevier Ltd. All rights reserved.

Focus on Balance, Not Black Swans

ERIC Educational Resources Information Center

Williams, Rodnie; Peterson, Josh

2012-01-01

The speed and access of information today has increased the scrutiny level facing risk managers in higher education. It is true that a more complex, more connected world has created new risks and new issues for university leadership. However, a lot of the same issues have remained constant for campuses: (1) emergency management; (2) campus safety;…

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.

Accidents in Malaysian construction industry: statistical data and court cases.

PubMed

Chong, Heap Yih; Low, Thuan Siang

2014-01-01

Safety and health issues remain critical to the construction industry due to its working environment and the complexity of working practises. This research attempts to adopt 2 research approaches using statistical data and court cases to address and identify the causes and behavior underlying construction safety and health issues in Malaysia. Factual data on the period of 2000-2009 were retrieved to identify the causes and agents that contributed to health issues. Moreover, court cases were tabulated and analyzed to identify legal patterns of parties involved in construction site accidents. Approaches of this research produced consistent results and highlighted a significant reduction in the rate of accidents per construction project in Malaysia.

Patient safety: Needs and initiatives.

PubMed

Bion, Julian

2008-04-01

Patient safety has become a major defining issue for healthcare at the beginning of the 21(st) century. Viewed from the perspective of reliability of delivery of best practice, healthcare systems demonstrate a degree of imperfection which would not be tolerated in industry. In part, this is because of uncertainty about what constitutes best practice, combined with complex interventions in complex systems. The acutely ill patient is particularly challenging, and as the majority of admissions to hospitals are emergencies, it makes sense to focus on this group as a coherent entity. Changing clinical behavior is central to improving safety, and this requires a systems-wide approach integrating care throughout patient journey, combined with incorporating reliability training in life-long learning.

Operational Issues: What Science in Available?

NASA Technical Reports Server (NTRS)

Rosekind, Mark R.; Neri, David F.

1997-01-01

Flight/duty/rest considerations involve two highly complex factors: the diverse demands of aviation operations and human physiology (especially sleep and circadian rhythms). Several core operational issues related to fatigue have been identified, such as minimum rest requirements, duty length, flight time considerations, crossing multiple time zones, and night flying. Operations also can involve on-call reserve status and callout, delays due to unforeseen circumstances (e.g., weather, mechanical), and on-demand flights. Over 40 years of scientific research is now available to apply to these complex issues of flight/duty/rest requirements. This research involves controlled 'laboratory studies, simulations, and data collected during regular flight operations. When flight/duty/rest requirements are determined they are typically based on a variety of considerations, such as operational demand, safety, economic, etc. Rarely has the available, state-of-the-art science been a consideration along with these other factors when determining flight/duty/rest requirements. While the complexity of the operational demand and human physiology precludes an absolute solution, there is an opportunity to take full advantage of the current scientific data. Incorporating these data in a rational operational manner into flight/duty/rest requirements can improve flight crew performance, alertness, and ultimately, aviation safety.

Medical innovation versus stem cell tourism.

PubMed

Lindvall, Olle; Hyun, Insoo

2009-06-26

Stem cell tourism is criticized on grounds of consumer fraud, blatant lack of scientific justification, and patient safety. However, the issues are complex because they invoke questions concerning the limits of acceptable medical innovation and medical travel. Here we discuss these issues and articulate conditions under which "unproven" therapies may be offered to patients outside of regular clinical trials.

Investigating Safely: A Guide for High School Teachers

ERIC Educational Resources Information Center

Texley, Juliana; Kwan, Terry; Summers, John

2004-01-01

Just as high school science is more complex than it is at lower grade levels, so are the safety issues teachers face in their classes and labs. Reduce the risks to people and place with Investigating Safely, the third and most advanced and detailed volume in NSTA's unique series of safety guidebooks for science teachers. Some of the guides 11…

Ecological policy in oil-gas complexes, HSE MS implementation in oil and gas company

NASA Astrophysics Data System (ADS)

Kochetkova, O. P.; Glyzina, T. S.; Vazim, A. A.; Tugutova, S. S.

2016-09-01

The paper considers the following issues: HSE MS international standard implementation in oil and gas industry, taking into account international practices; implementation of standards in oil and gas companies; policy in the field of environmental protection and occupational health and safety; achievement of planned indicators and targets in environmental protection and occupational health and safety.

System Driven Workarounds

NASA Technical Reports Server (NTRS)

Connell, Linda; Wichner, David; Jakey, Abegael Marie

2013-01-01

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 system driven workarounds for the aviation community highlight the human workaround for the complex aviation system.

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.

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

Training and qualification of health and safety technicians at a national laboratory

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

Egbert, W.F.; Trinoskey, P.A.

1994-10-01

Over the last 30 years, Lawrence Livermore National Laboratory (LLNL) has successfully implemented the concept of a multi-disciplined technician. LLNL Health and Safety Technicians have responsibilities in industrial hygiene, industrial safety, health physics, as well as fire, explosive, and criticality safety. One of the major benefits to this approach is the cost-effective use of workers who display an ownership of health and safety issues which is sometimes lacking when responsibilities are divided. Although LLNL has always promoted the concept of a multi-discipline technician, this concept is gaining interest within the Department of Energy (DOE) community. In November 1992, individuals frommore » Oak Ridge Institute of Science and Education (ORISE) and RUST Geotech, joined by LLNL established a committee to address the issues of Health and Safety Technicians. In 1993, the DOE Office of Environmental, Safety and Health, in response to the Defense Nuclear Facility Safety Board Recommendation 91-6, stated DOE projects, particularly environmental restoration, typically present hazards other than radiation such as chemicals, explosives, complex construction activities, etc., which require additional expertise by Radiological Control Technicians. They followed with a commitment that a training guide would be issued. The trend in the last two decades has been toward greater specialization in the areas of health and safety. In contrast, the LLNL has moved toward a generalist approach integrating the once separate functions of the industrial hygiene and health physics technician into one function.« less

Patient Safety Movement: History and Future Directions.

PubMed

Lark, Meghan E; Kirkpatrick, Kay; Chung, Kevin C

2018-02-01

Despite progress within the past 15 years, improving patient safety in health care remains an important public health issue. The history of safety policies, research, and development has revealed that this issue is more complex than initially perceived and is pertinent to all health care settings. Solutions, therefore, must be approached at the systems level and supplemented with a change in safety culture, especially in higher risk fields such as surgery. To do so, health care agents at all levels have started to prioritize the improvement of nontechnical skills such as teamwork, communication, and accountability, as reflected by the development of various checklists and safety campaigns. This progress may be sustained by adopting teamwork training programs that have proven successful in other high-risk industries, such as crew resource management in aviation. These techniques can be readily implemented among surgical teams; however, successful application depends heavily on the strong leadership and vigilance of individual surgeons. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

75 FR 31800 - Substances Generally Recognized as Safe Added to Food for Animals; Notice of Pilot Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-04

... certain food safety issues for complex substances (e.g., macroingredients or biological polymers, such as proteins, carbohydrates, and fats and oils). Finally, FDA tentatively concluded that the reduction in...

Japan-U.S. Relations: Issues for Congress

DTIC Science & Technology

2013-02-15

million Japanese were displaced. Damage to several reactors at the Fukushima Dai-ichi nuclear power plant complex led the government to declare a state of...the March 11, 2011, natural disasters and meltdowns at the Fukushima Daiichi nuclear power plant. Public trust in the safety of nuclear power...aircraft’s safety record may be connected to widespread distrust of the government stemming from the nuclear disaster at the Fukushima Daichi

Operating safely in surgery and critical care with perioperative automation.

PubMed

Grover, Christopher; Barney, Kate

2004-01-01

A study by the Institute of Medicine (IOM) found that as many as 98,000 Americans die each year from preventable medical errors. These findings, combined with a growing spate of negative publicity, have brought patient safety to its rightful place at the healthcare forefront. Nowhere are patient safety issues more critical than in the anesthesia, surgery and critical care environments. These high-acuity settings--with their fast pace, complex and rapidly changing care regimens and mountains of diverse clinical data-arguably pose the greatest patient safety risk in the hospital.

Projected Impact of Compositional Verification on Current and Future Aviation Safety Risk

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Withrow, Colleen A.; Leone, Karen M.; Jones, Sharon M.

2014-01-01

The projected impact of compositional verification research conducted by the National Aeronautic and Space Administration System-Wide Safety and Assurance Technologies on aviation safety risk was assessed. Software and compositional verification was described. Traditional verification techniques have two major problems: testing at the prototype stage where error discovery can be quite costly and the inability to test for all potential interactions leaving some errors undetected until used by the end user. Increasingly complex and nondeterministic aviation systems are becoming too large for these tools to check and verify. Compositional verification is a "divide and conquer" solution to addressing increasingly larger and more complex systems. A review of compositional verification research being conducted by academia, industry, and Government agencies is provided. Forty-four aviation safety risks in the Biennial NextGen Safety Issues Survey were identified that could be impacted by compositional verification and grouped into five categories: automation design; system complexity; software, flight control, or equipment failure or malfunction; new technology or operations; and verification and validation. One capability, 1 research action, 5 operational improvements, and 13 enablers within the Federal Aviation Administration Joint Planning and Development Office Integrated Work Plan that could be addressed by compositional verification were identified.

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.

Use of NGS in Commercial Broiler Production

USDA-ARS?s Scientific Manuscript database

With the development and evolution of next generation sequencing technologies, these powerful tools can be applied to a variety of aspect of commercial broiler production, especially in respect to food safety issues. NGS technologies allow for a deeper understanding of the complex microbiota inhere...

Critical issues in sensor science to aid food and water safety.

PubMed

Farahi, R H; Passian, A; Tetard, L; Thundat, T

2012-06-26

The stability of food and water supplies is widely recognized as a global issue of fundamental importance. Sensor development for food and water safety by nonconventional assays continues to overcome technological challenges. The delicate balance between attaining adequate limits of detection, chemical fingerprinting of the target species, dealing with the complex food matrix, and operating in difficult environments are still the focus of current efforts. While the traditional pursuit of robust recognition methods remains important, emerging engineered nanomaterials and nanotechnology promise better sensor performance but also bring about new challenges. Both advanced receptor-based sensors and emerging non-receptor-based physical sensors are evaluated for their critical challenges toward out-of-laboratory applications.

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.

Effects of health and safety problem recognition on small business facility investment

PubMed Central

2013-01-01

Objectives This study involved a survey of the facility investment experiences, which was designed to recognize the importance of health and safety problems, and industrial accident prevention. Ultimately, we hope that small scale industries will create effective industrial accident prevention programs and facility investments. Methods An individual survey of businesses’ present physical conditions, recognition of the importance of the health and safety problems, and facility investment experiences for preventing industrial accidents was conducted. The survey involved 1,145 business operators or management workers in small business places with fewer than 50 workers in six industrial complexes. Results Regarding the importance of occupational health and safety problems (OHS), 54.1% said it was “very important”. Received technical and financial support, and industrial accidents that occurred during the past three years were recognized as highly important for OHS. In an investigation regarding facility investment experiences for industrial accident prevention, the largest factors were business size, greater numbers of industrial accidents, greater technical and financial support received, and greater recognition of the importance of the OHS. The related variables that decided facility investment for industry accident prevention in a logistic regression analysis were the experiences of business facilities where industrial accidents occurred during the past three years, received technical and financial support, and recognition of the OHS. Those considered very important were shown to be highly significant. Conclusions Recognition of health and safety issues was higher when small businesses had experienced industrial accidents or received financial support. The investment in industrial accidents was greater when health and safety issues were recognized as important. Therefore, the goal of small business health and safety projects is to prioritize health and safety issues in terms of business management and recognition of importance. Therefore, currently various support projects are being conducted. However, there are issues regarding the limitations of the target businesses and inadequacies in maintenance and follow-up. Overall, it is necessary to provide various incentives for onsite participation that can lead to increased recognition of health and safety issues and practical investments, while perfecting maintenance and follow up measures by thoroughly revising existing operating systems. PMID:24472180

Effects of health and safety problem recognition on small business facility investment.

PubMed

Park, Jisu; Jeong, Harin; Hong, Sujin; Park, Jong-Tae; Kim, Dae-Sung; Kim, Jongseo; Kim, Hae-Joon

2013-10-23

This study involved a survey of the facility investment experiences, which was designed to recognize the importance of health and safety problems, and industrial accident prevention. Ultimately, we hope that small scale industries will create effective industrial accident prevention programs and facility investments. An individual survey of businesses' present physical conditions, recognition of the importance of the health and safety problems, and facility investment experiences for preventing industrial accidents was conducted. The survey involved 1,145 business operators or management workers in small business places with fewer than 50 workers in six industrial complexes. Regarding the importance of occupational health and safety problems (OHS), 54.1% said it was "very important". Received technical and financial support, and industrial accidents that occurred during the past three years were recognized as highly important for OHS. In an investigation regarding facility investment experiences for industrial accident prevention, the largest factors were business size, greater numbers of industrial accidents, greater technical and financial support received, and greater recognition of the importance of the OHS. The related variables that decided facility investment for industry accident prevention in a logistic regression analysis were the experiences of business facilities where industrial accidents occurred during the past three years, received technical and financial support, and recognition of the OHS. Those considered very important were shown to be highly significant. Recognition of health and safety issues was higher when small businesses had experienced industrial accidents or received financial support. The investment in industrial accidents was greater when health and safety issues were recognized as important. Therefore, the goal of small business health and safety projects is to prioritize health and safety issues in terms of business management and recognition of importance. Therefore, currently various support projects are being conducted. However, there are issues regarding the limitations of the target businesses and inadequacies in maintenance and follow-up. Overall, it is necessary to provide various incentives for onsite participation that can lead to increased recognition of health and safety issues and practical investments, while perfecting maintenance and follow up measures by thoroughly revising existing operating systems.

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.

Using an Ethical Decision-Making Model to Address Ethical Dilemmas in School Counseling

ERIC Educational Resources Information Center

Brown, Timothy; Armstrong, Stephen A.; Bore, Samuel; Simpson, Chris

2017-01-01

School counselors frequently face ethical dilemmas. These dilemmas often involve relationships with principals, parents, and other stakeholders. School counselors may confront complex ethical issues involving confidentiality, student safety, parental rights,and social media. The American School Counselor Association recommends following an ethical…

Sustainable Transport Systems: Linkages Between Environmental Issues, Public Transport, Non-Motorized Transport And Safety

DOT National Transportation Integrated Search

2000-10-01

A sustainable transport system must provide mobility and accessibility to all urban residents in a safe and end environmentally friendly mode of transport. This is a complex and difficult task when the needs and demands of people belonging to differe...

Fire safety concerns in space operations

NASA Technical Reports Server (NTRS)

Friedman, Robert

1987-01-01

This paper reviews the state-of-the-art in fire control techniques and identifies important issues for continuing research, technology, and standards. For the future permanent orbiting facility, the space station, fire prevention and control calls for not only more stringent fire safety due to the long-term and complex missions, but also for simplified and flexible safety rules to accommodate the variety of users. Future research must address a better understanding of the microgravity space environment as it influences fire propagation and extinction and the application of the technology of fire detection, extinguishment, and material assessment. Spacecraft fire safety should also consider the adaptation of methods and concepts derived from aircraft and undersea experience.

Design strategies from sexual exploitation and sex work studies among women and girls: Methodological considerations in a hidden and vulnerable population.

PubMed

Gerassi, Lara; Edmond, Tonya; Nichols, Andrea

2017-06-01

The study of sex trafficking, prostitution, sex work, and sexual exploitation is associated with many methodological issues and challenges. Researchers' study designs must consider the many safety issues related to this vulnerable and hidden population. Community advisory boards and key stakeholder involvement are essential to study design to increase safety of participants, usefulness of study aims, and meaningfulness of conclusions. Nonrandomized sampling strategies are most often utilized when studying exploited women and girls, which have the capacity to provide rich data and require complex sampling and recruitment methods. This article reviews the current methodological issues when studying this marginalized population as well as strategies to address challenges while working with the community in order to bring about social change. The authors also discuss their own experiences in collaborating with community organizations to conduct research in this field.

Design strategies from sexual exploitation and sex work studies among women and girls: Methodological considerations in a hidden and vulnerable population

PubMed Central

Gerassi, Lara; Edmond, Tonya; Nichols, Andrea

2016-01-01

The study of sex trafficking, prostitution, sex work, and sexual exploitation is associated with many methodological issues and challenges. Researchers’ study designs must consider the many safety issues related to this vulnerable and hidden population. Community advisory boards and key stakeholder involvement are essential to study design to increase safety of participants, usefulness of study aims, and meaningfulness of conclusions. Nonrandomized sampling strategies are most often utilized when studying exploited women and girls, which have the capacity to provide rich data and require complex sampling and recruitment methods. This article reviews the current methodological issues when studying this marginalized population as well as strategies to address challenges while working with the community in order to bring about social change. The authors also discuss their own experiences in collaborating with community organizations to conduct research in this field. PMID:28824337

Software for occupational health and safety risk analysis based on a fuzzy model.

PubMed

Stefanovic, Miladin; Tadic, Danijela; Djapan, Marko; Macuzic, Ivan

2012-01-01

Risk and safety management are very important issues in healthcare systems. Those are complex systems with many entities, hazards and uncertainties. In such an environment, it is very hard to introduce a system for evaluating and simulating significant hazards. In this paper, we analyzed different types of hazards in healthcare systems and we introduced a new fuzzy model for evaluating and ranking hazards. Finally, we presented a developed software solution, based on the suggested fuzzy model for evaluating and monitoring risk.

Badging people not on your payroll.

PubMed

Hogan, Mary Alice

2009-01-01

A complex badging process to create a culture of safety in a medical center is described by the author. Badging is not only used to control access by employees, but non-employees--medical students, vendors, contractors, volunteers, etc.--are subjected to similar processing procedures before they can be issued badges.

CDS Re Mix

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

None

CDS (Change Detection Systems) is a mechanism for rapid visual analysis using complex image alignment algorithms. CDS is controlled with a simple interface that has been designed for use for anyone that can operate a digital camera. A challenge of complex industrial systems like nuclear power plants is to accurately identify changes in systems, structures and components that may critically impact the operation of the facility. CDS can provide a means of early intervention before the issues evolve into safety and production challenges.

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

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.

Natural areas and urban populations: communication and environmental education challenges and actions in outdoor recreation

Treesearch

Deborah J. Chavez

2005-01-01

Challenges, opportunities, and actions exist in areas where large urban populations interface with natural areas, such as outdoor recreation sites in southern California. Challenges in the interface include intense recreation use, public safety issues, and complex information strategies. Research results on communications and environmental education offer opportunities...

Issues Concerning The Development Of A Mobile Platform For Health Care Applications

NASA Astrophysics Data System (ADS)

Korba, Larry W.; Liscano, Ramiro; Green, David; Durie, Nelson

1989-03-01

There are a number of problems that must yet be overcome before robotic technology can be applied in a hospital or a home care setting. The four basic problems are: cost, safety, finding appropriate applications and developing application specific solutions. Advanced robotics technology is now costly because of the complexity associated with autonomous systems. In any application, it is most important that the safety of the individuals using or exposed to the vehicle is ensured. Often in the health care field, innovative and useful new devices require an inordinate amount of time before they are accepted. The technical and ergonomic problems associated with any application must be solved so that cost containment, safety, ease of use, and quality of life are ensured. This paper discusses these issues in relation to our own development of an autonomous vehicle for health care applications. In this advancement, a commercially available platform is being equipped with an on-board, multiprocessor computer system and a variety of sensor systems. In order to develop pertinent solutions to the technical problems, there must be a framework wherein there is a focus upon the practical issues associated with the end application.

Socio-Technical Considerations for the Use of Blockchain Technology in Healthcare.

PubMed

Wong, Ming Chao; Yee, Kwang Chien; Nøhr, Christian

2018-01-01

Blockchain technology is often considered as the fourth industrial revolution that will change the world. The enthusiasm of the transformative nature of blockchain technology has infiltrated healthcare. Blockchain is often seen as the much needed and perfect technology for healthcare, addressing the difficult and complex issues of security and inter-operability. More importantly, the "value" and trust-based system can deliver automated action and response via its smart contract mechanism. Healthcare, however, is a complex system. Health information technology (HIT) so far, has not delivered its promise of transforming healthcare due to its complex socio-technical and context sensitive interaction. The introduction of blockchain technology will need to consider a whole range of socio-technical issues in order to improve the quality and safety of patient care. This paper presents a discussion on these socio-technical issues. More importantly, this paper argues that in order to achieve the best outcome from blockchain technology, there is a need to consider a clinical transformation from "information" to "value " and trust. This paper argues that urgent research is needed to address these socio-technical issues in order to facilitate best outcomes for blockchain in healthcare. These socio-technical issues must then be further evaluated by means of working prototypes in the medical domain in coming years.

Cultural safety and the challenges of translating critically oriented knowledge in practice.

PubMed

Browne, Annette J; Varcoe, Colleen; Smye, Victoria; Reimer-Kirkham, Sheryl; Lynam, M Judith; Wong, Sabrina

2009-07-01

Cultural safety is a relatively new concept that has emerged in the New Zealand nursing context and is being taken up in various ways in Canadian health care discourses. Our research team has been exploring the relevance of cultural safety in the Canadian context, most recently in relation to a knowledge-translation study conducted with nurses practising in a large tertiary hospital. We were drawn to using cultural safety because we conceptualized it as being compatible with critical theoretical perspectives that foster a focus on power imbalances and inequitable social relationships in health care; the interrelated problems of culturalism and racialization; and a commitment to social justice as central to the social mandate of nursing. Engaging in this knowledge-translation study has provided new perspectives on the complexities, ambiguities and tensions that need to be considered when using the concept of cultural safety to draw attention to racialization, culturalism, and health and health care inequities. The philosophic analysis discussed in this paper represents an epistemological grounding for the concept of cultural safety that links directly to particular moral ends with social justice implications. Although cultural safety is a concept that we have firmly positioned within the paradigm of critical inquiry, ambiguities associated with the notions of 'culture', 'safety', and 'cultural safety' need to be anticipated and addressed if they are to be effectively used to draw attention to critical social justice issues in practice settings. Using cultural safety in practice settings to draw attention to and prompt critical reflection on politicized knowledge, therefore, brings an added layer of complexity. To address these complexities, we propose that what may be required to effectively use cultural safety in the knowledge-translation process is a 'social justice curriculum for practice' that would foster a philosophical stance of critical inquiry at both the individual and institutional levels.

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.

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.

Meeting the global demand of sports safety: the intersection of science and policy in sports safety.

PubMed

Timpka, Toomas; Finch, Caroline F; Goulet, Claude; Noakes, Tim; Yammine, Kaissar

2008-01-01

Sports and physical activity are transforming, and being transformed by, the societies in which they are practised. From the perspectives of both competitive and non-competitive sports, the complexity of their integration into today's society has led to neither sports federations nor governments being able to manage the safety problem alone. In other words, these agencies, whilst promoting sport and physical activity, deliver policy and practices in an uncoordinated way that largely ignores the need for a concurrent overall policy for sports safety. This article reviews and analyses the possibility of developing an overall sports safety policy from a global viewpoint. Firstly, we describe the role of sports in today's societies and the context within which much sport is delivered. We then discuss global issues related to injury prevention and safety in sports, with practical relevance to this important sector, including an analysis of critical policy issues necessary for the future development of the area and significant safety gains for all. We argue that there is a need to establish the sports injury problem as a critical component of general global health policy agendas, and to introduce sports safety as a mandatory component of all sustainable sports organizations. We conclude that the establishment of an explicit intersection between science and policy making is necessary for the future development of sports and the necessary safety gains required for all participants around the world. The Safe Sports International safety promotion programme is outlined as an example of an international organization active within this arena.

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.

ASAS Centennial Paper: Developments and future outlook for preharvest food safety.

PubMed

Oliver, S P; Patel, D A; Callaway, T R; Torrence, M E

2009-01-01

The last century of food animal agriculture is a remarkable triumph of scientific research. Knowledge derived through research has resulted in the development and use of new technologies that have increased the efficiency of food production and created a huge animal production and food manufacturing industry capable of feeding the US population while also providing significant quantities of high-quality food for export to other countries. Although the US food supply is among the safest in the world, the US Center for Disease Prevention and Control estimates that 76 million people get sick, more than 300,000 are hospitalized, and 5,000 die each year from foodborne illness. Consequently, preventing foodborne illness and death remains a major public health concern. Challenges to providing a safe, abundant, and nutritious food supply are complex because all aspects of food production, from farm to fork, must be considered. Given the national and international demand and expectations for food safety as well as the formidable challenges of producing and maintaining a safe food supply, food safety research and educational programs have taken on a new urgency. Remarkable progress has been made during the last century. Wisdom from a century of animal agriculture research now includes the realization that on-farm pathogens are intricately associated with animal health and well-being, the production of high-quality food, and profitability. In this review, some of the developments that have occurred over the last few decades are summarized, including types, sources, and concentrations of disease-causing pathogens encountered in food-producing animal environments and their association with food safety; current and future methods to control or reduce foodborne pathogens on the farm; and present and future preharvest food safety research directions. Future scientific breakthroughs will no doubt have a profound impact on animal agriculture and the production of high-quality food, but we will also be faced with moral, ethical, and societal dilemmas that must be reconciled. A strong, science-based approach that addresses all the complex issues involved in continuing to improve food safety and public health is necessary to prevent foodborne illnesses. Not only must research be conducted to solve complex food safety issues, but results of that research must also be communicated effectively to producers and consumers.

Video Analysis and Remote Digital Ethnography: Approaches to understanding user perspectives and processes involving healthcare information technology.

PubMed

Kushniruk, Andre W; Borycki, Elizabeth M

2015-01-01

Innovations in healthcare information systems promise to revolutionize and streamline healthcare processes worldwide. However, the complexity of these systems and the need to better understand issues related to human-computer interaction have slowed progress in this area. In this chapter the authors describe their work in using methods adapted from usability engineering, video ethnography and analysis of digital log files for improving our understanding of complex real-world healthcare interactions between humans and technology. The approaches taken are cost-effective and practical and can provide detailed ethnographic data on issues health professionals and consumers encounter while using systems as well as potential safety problems. The work is important in that it can be used in techno-anthropology to characterize complex user interactions with technologies and also to provide feedback into redesign and optimization of improved healthcare information systems.

Evaluation of fleet management techniques for timber highway bridges

Treesearch

Brent M. Phares; Travis K. Hosteng; Justin Dahlberg; Michael A. Ritter

2011-01-01

The general condition of the nation's bridges presents a complex management issue when considering cost, safety, and time. Consequently, the management of those bridges can become an overwhelming task. The need for a management system that is specific to rural systems may help to improve the management of this significant number of bridges. Although individual...

Emerging Environmental Justice Issues in Nuclear Power and Radioactive Contamination.

PubMed

Kyne, Dean; Bolin, Bob

2016-07-12

Nuclear hazards, linked to both U.S. weapons programs and civilian nuclear power, pose substantial environment justice issues. Nuclear power plant (NPP) reactors produce low-level ionizing radiation, high level nuclear waste, and are subject to catastrophic contamination events. Justice concerns include plant locations and the large potentially exposed populations, as well as issues in siting, nuclear safety, and barriers to public participation. Other justice issues relate to extensive contamination in the U.S. nuclear weapons complex, and the mining and processing industries that have supported it. To approach the topic, first we discuss distributional justice issues of NPP sites in the U.S. and related procedural injustices in siting, operation, and emergency preparedness. Then we discuss justice concerns involving the U.S. nuclear weapons complex and the ways that uranium mining, processing, and weapons development have affected those living downwind, including a substantial American Indian population. Next we examine the problem of high-level nuclear waste and the risk implications of the lack of secure long-term storage. The handling and deposition of toxic nuclear wastes pose new transgenerational justice issues of unprecedented duration, in comparison to any other industry. Finally, we discuss the persistent risks of nuclear technologies and renewable energy alternatives.

Safety I-II, resilience and antifragility engineering: a debate explained through an accident occurring on a mobile elevating work platform.

PubMed

Martinetti, Alberto; Chatzimichailidou, Maria Mikela; Maida, Luisa; van Dongen, Leo

2018-04-24

Occupational health and safety (OHS) represents an important field of exploration for the research community: in spite of the growth of technological innovations, the increasing complexity of systems involves critical issues in terms of degradation of the safety levels. In such a situation, new safety management approaches are now mandatory in order to face the safety implications of the current technological evolutions. Along these lines, performing risk-based analysis alone seems not to be enough anymore. The evaluation of robustness, antifragility and resilience of a socio-technical system is now indispensable in order to face unforeseen events. This article will briefly introduce the topics of Safety I and Safety II, resilience engineering and antifragility engineering, explaining correlations, overlapping aspects and synergies. Secondly, the article will discuss the applications of those paradigms to a real accident, highlighting how they can challenge, stimulate and inspire research for improving OHS conditions.

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.

Occupational Safety and Related Impacts on Health  and the Environment.

PubMed

Watterson, Andrew

2016-10-05

The inter-relationship between safety, health and the 'environment' is a complex and at times a relatively neglected topic. In this issue, 'safety' is often viewed by contributors as 'health and safety' and includes occupationally-related ill health as well as injury or harm to employees and the wider public. 'Environment' is also interpreted in the widest sense covering both physical and work environments with upstream work hazards presenting risks to downstream communities. The focus is very much on exploring and where possible addressing the challenges, some old and some facing workers in a range of public and private settings and also at times their nearby communities. The 19 papers in the issue cover public and private sectors, global and very local populations, macro-theoretical perspectives, large epidemiological and some single factory or hospital site small case studies. A number of the papers are just beginning to explore and draw out for the first time the risks from hazards in their part of the world. The methodologies adopted also range from lab-based studies through ergonomic assessments and interventions to therapeutic approaches.

Researching safety culture: deliberative dialogue with a restorative lens.

PubMed

Lorenzini, Elisiane; Oelke, Nelly D; Marck, Patricia Beryl; Dall'agnol, Clarice Maria

2017-10-01

Safety culture is a key component of patient safety. Many patient safety strategies in health care have been adapted from high-reliability organizations (HRO) such as aviation. However, to date, attempts to transform the cultures of health care settings through HRO approaches have had mixed results. We propose a methodological approach for safety culture research, which integrates the theory and practice of restoration science with the principles and methods of deliberative dialogue to support active engagement in critical reflection and collective debate. Our aim is to describe how these two innovative approaches in health services research can be used together to provide a comprehensive effective method to study and implement change in safety culture. Restorative research in health care integrates socio-ecological theory of complex adaptive systems concepts with collaborative, place-sensitive study of local practice contexts. Deliberative dialogue brings together all stakeholders to collectively develop solutions on an issue to facilitate change. Together these approaches can be used to actively engage people in the study of safety culture to gain a better understanding of its elements. More importantly, we argue that the synergistic use of these approaches offers enhanced potential to move health care professionals towards actionable strategies to improve patient safety within today's complex health care systems. © The Author 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.

The Daily Readiness Huddle: a process to rapidly identify issues and foster improvement through problem-solving accountability.

PubMed

Donnelly, Lane F; Cherian, Shirley S; Chua, Kimberly B; Thankachan, Sam; Millecker, Laura A; Koroll, Alex G; Bisset, George S

2017-01-01

Because of the increasing complexities of providing imaging for pediatric health care services, a more reliable process to manage the daily delivery of care is necessary. Objective We describe our Daily Readiness Huddle and the effects of the process on problem identification and improvement. Our Daily Readiness Huddle has four elements: metrics review, clinical volume review, daily readiness assessment, and problem accountability. It is attended by radiologists, directors, managers, front-line staff with concerns, representatives from support services (information technology [IT] and biomedical engineering [biomed]), and representatives who join the meeting in a virtual format from off-site locations. Data are visually displayed on erasable whiteboards. The daily readiness assessment uses queues to determine whether anyone has concerns or outlier data in regard to S-MESA (Safety, Methods, Equipment, Supplies or Associates). Through this assessment, problems are identified and categorized as quick hits (will be resolved in 24-48 h, not requiring project management) and complex issues. Complex issues are assigned an owner, quality coach and report-back date. Additionally, projects are defined as improvements that are often strategic, are anticipated to take more than 60 days, and do not necessarily arise out of identified issues during the Daily Readiness Huddle. We tracked and calculated the mean, median and range of days to resolution and completion for complex issues and for projects during the first full year of implementing this process. During the first 12 months, 91 complex issues were identified and resolved, 11 projects were in progress and 33 completed, with 23 other projects active or in planning. Time to resolution of complex issues (in days) was mean 37.5, median 34.0, and range 1-105. For projects, time to completion (in days) was mean 86.0, median 84.0, and range 5-280. The Daily Readiness Huddle process has given us a framework to rapidly identify issues, bring accountability to problem-solving, and foster improvement. It has also had a positive effect on team-building and coordination.

Challenges in global ballast water management.

PubMed

Endresen, Øyvind; Lee Behrens, Hanna; Brynestad, Sigrid; Bjørn Andersen, Aage; Skjong, Rolf

2004-04-01

Ballast water management is a complex issue raising the challenge of merging international regulations, ship's specific configurations along with ecological conservation. This complexity is illustrated in this paper by considering ballast water volume, discharge frequency, ship safety and operational issues aligned with regional characteristics to address ecological risk for selected routes. A re-estimation of ballast water volumes gives a global annual level of 3500 Mton. Global ballast water volume discharged into open sea originating from ballast water exchange operations is estimated to approximately 2800 Mton. Risk based decision support systems coupled to databases for different ports and invasive species characteristics and distributions can allow for differentiated treatment levels while maintaining low risk levels. On certain routes, the risk is estimated to be unacceptable and some kind of ballast water treatment or management should be applied.

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…

Verification and Validation for Flight-Critical Systems (VVFCS)

NASA Technical Reports Server (NTRS)

Graves, Sharon S.; Jacobsen, Robert A.

2010-01-01

On March 31, 2009 a Request for Information (RFI) was issued by NASA s Aviation Safety Program to gather input on the subject of Verification and Validation (V & V) of Flight-Critical Systems. The responses were provided to NASA on or before April 24, 2009. The RFI asked for comments in three topic areas: Modeling and Validation of New Concepts for Vehicles and Operations; Verification of Complex Integrated and Distributed Systems; and Software Safety Assurance. There were a total of 34 responses to the RFI, representing a cross-section of academic (26%), small & large industry (47%) and government agency (27%).

Integrated Safety Analysis Tiers

NASA Technical Reports Server (NTRS)

Shackelford, Carla; McNairy, Lisa; Wetherholt, Jon

2009-01-01

Commercial partnerships and organizational constraints, combined with complex systems, may lead to division of hazard analysis across organizations. This division could cause important hazards to be overlooked, causes to be missed, controls for a hazard to be incomplete, or verifications to be inefficient. Each organization s team must understand at least one level beyond the interface sufficiently enough to comprehend integrated hazards. This paper will discuss various ways to properly divide analysis among organizations. The Ares I launch vehicle integrated safety analyses effort will be utilized to illustrate an approach that addresses the key issues and concerns arising from multiple analysis responsibilities.

Regulatory Compliance in Multi-Tier Supplier Networks

NASA Technical Reports Server (NTRS)

Goossen, Emray R.; Buster, Duke A.

2014-01-01

Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

Evaluation of aviation-based safety team training in a hospital in The Netherlands.

PubMed

De Korne, Dirk F; Van Wijngaarden, Jeroen D H; Van Dyck, Cathy; Hiddema, U Francis; Klazinga, Niek S

2014-01-01

The purpose of this paper is to evaluate the implementation of a broad-scale team resource management (TRM) program on safety culture in a Dutch eye hospital, detailing the program's content and procedures. Aviation-based TRM training is recognized as a useful approach to increase patient safety, but little is known about how it affects safety culture. Pre- and post-assessments of the hospitals' safety culture was based on interviews with ophthalmologists, anesthesiologists, residents, nurses, and support staff. Interim observations were made at training sessions and in daily hospital practice. The program consisted of safety audits of processes and (team) activities, interactive classroom training sessions by aviation experts, a flight simulator session, and video recording of team activities with subsequent feedback. Medical professionals considered aviation experts inspiring role models and respected their non-hierarchical external perspective and focus on medical-technical issues. The post-assessment showed that ophthalmologists and other hospital staff had become increasingly aware of safety issues. The multidisciplinary approach promoted social (team) orientation that replaced the former functionally-oriented culture. The number of reported near-incidents greatly increased; the number of wrong-side surgeries stabilized to a minimum after an initial substantial reduction. The study was observational and the hospital's variety of efforts to improve safety culture prevented us from establishing a causal relation between improvement and any one specific intervention. Aviation-based TRM training can be a useful to stimulate safety culture in hospitals. Safety and quality improvements are not single treatment interventions but complex socio-technical interventions. A multidisciplinary system approach and focus on "team" instead of "profession" seems both necessary and difficult in hospital care.

Working safely with robot workers: Recommendations for the new workplace.

PubMed

Murashov, Vladimir; Hearl, Frank; Howard, John

2016-01-01

The increasing use of robots in performing tasks alongside or together with human co-workers raises novel occupational safety and health issues. The new 21st century workplace will be one in which occupational robotics plays an increasing role. This article describes the increasing complexity of robots and proposes a number of recommendations for the practice of safe occupational robotics.

Cultures of Silence and Cultures of Voice: The Role of Whistleblowing in Healthcare Organisations

PubMed Central

Mannion, Russell; Davies, Huw TO

2015-01-01

‘Whistleblowing’ has come to increased prominence in many health systems as a means of identifying and addressing quality and safety issues. But whistleblowing – and the reactions to it – have many complex and ambiguous aspects that need to be considered as part of the broader (organisational) cultural dynamics of healthcare institutions. PMID:26340388

Working Safely with Robot Workers: Recommendations for the New Workplace

PubMed Central

Murashov, Vladimir; Hearl, Frank; Howard, John

2016-01-01

The increasing use of robots in performing tasks alongside or together with human coworkers raises novel occupational safety and health issues. The new 21st century workplace will be one in which occupational robotics plays an increasing role. This paper describes the increasing complexity of robots and proposes a number of recommendations for the practice of safe occupational robotics. PMID:26554511

Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem

PubMed Central

Williams, Patricia AH; Woodward, Andrew J

2015-01-01

The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. PMID:26229513

Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem.

PubMed

Williams, Patricia Ah; Woodward, Andrew J

2015-01-01

The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat.

Advanced spacecraft fire safety: Proposed projects and program plan

NASA Technical Reports Server (NTRS)

Youngblood, Wallace W.; Vedha-Nayagam, M.

1989-01-01

A detailed review identifies spacecraft fire safety issues and the efforts for their resolution, particularly for the threats posed by the increased on-orbit duration, size, and complexity of the Space Station Freedom. Suggestions provided by a survey of Wyle consultants and outside fire safety experts were combined into 30 research and engineering projects. The projects were then prioritized with respect to urgency to meet Freedom design goals, status of enabling technology, cost, and so on, to yield 14 highest priority projects, described in terms of background, work breakdown structure, and schedule. These highest priority projects can be grouped into the thematic areas of fire detection, fire extinguishment, risk assessment, toxicology and human effects, and ground based testing. Recommendations for overall program management stress the need for NASA Headquarters and field center coordination, with information exchange through spacecraft fire safety oversight committees.

Workplace Bullying, Job Stress, Intent to Leave, and Nurses' Perceptions of Patient Safety in South Korean Hospitals.

PubMed

Oh, Hyunjin; Uhm, Dong-Choon; Yoon, Young Joo

2016-01-01

Negative work environments influence the ability of nurses to provide optimal patient care in a safe environment. The purpose of the study was to test a model linking workplace bullying (WPB) and lateral violence (LV) with job stress, intent to leave, and, subsequently, nurse-assessed patient adverse outcomes (safety issues). This descriptive-correlational study examined the relationships between study variables and used a structural equation model to test the validity of the proposed theoretical framework. A convenience sample of 508 clinical nurses working in eight general hospitals in Daejeon, South Korea, completed a questionnaire on measures of WPB, LV, job stress, intent to leave, and nurse-assessed patient safety. Analysis of moment structures was used to estimate a set of three models with competing measurement structures for WPB and LV and the same structural model. Akaike Information Criterion was used for model selection. Among the three proposed models, the model with complex factor loadings was selected (WPB and LV were both associated with verbal abuse and physical threat). WPB directly and indirectly influenced nurse-assessed patient safety. Job stress directly influenced intent to leave, and intent to leave directly influenced nurse-assessed patient safety. The results of the study support the proposition that WPB, job stress, and intent to leave may be associated with nurse-perceived adverse outcomes (patient safety issues) in hospitals. Nurse perceptions of WPB were associated with nurse-assessed patient safety outcomes (adverse events) directly and through mediating job stress and intent to leave. LV was not associated with the mediators or nurse-assessed adverse outcomes (safety).

[Post-marketing drug safety measures for the attainment of safer and more effective use of drug].

PubMed

Kurokawa, Tatsuo

2011-01-01

In contrast with the 20th century's dramatic improvements in the direct and/or hazardous toxicity of drugs, indirect toxicity and/or long-term safety concerns such as relation of cancer risk and TNF-alpha receptor blockers have caused significant complexity in post-marketing surveillance (PMS) scenery. The post-marketing phase of drugs and their safety measures now appear to be much more complicated and heavier than decades ago. The spontaneous adverse drug reaction (ADR) reporting system which has been one of the main pillars of PMS measures for almost 50 years may have to be reviewed in terms of its effectiveness, and may need augmentation from medical data bases. Only a pharmaco-epidemiological analysis and integration of the output with a conventional spontaneous reporting approach offers a chance to satisfy the current complex safety issues. Today's tendency toward practical saturation at medical/pharmaceutical frontiers, by regulatory authorities and safety divisions of pharmaceutical companies with ever-increasing day-to-day safety information can also be pointed out. Such phenomena may actually reduce the productivity of safety measures and also jeopardize the maintenance of an acceptable risk/benefit drug ratio. To alleviate these potential negative implications, establishment of a consortium to act as a sentinel that would gather up-to-date and essential safety information, including epidemiological data, from all sources and provide it plus recommendations to all stakeholders can be suggested. Through such activities, we could expect significant improvement of drug safety measures in post-marketing phase which would effectively cover not only new drugs but also generic and bio-simulated drugs.

Optimal multi-floor plant layout based on the mathematical programming and particle swarm optimization.

PubMed

Lee, Chang Jun

2015-01-01

In the fields of researches associated with plant layout optimization, the main goal is to minimize the costs of pipelines and pumping between connecting equipment under various constraints. However, what is the lacking of considerations in previous researches is to transform various heuristics or safety regulations into mathematical equations. For example, proper safety distances between equipments have to be complied for preventing dangerous accidents on a complex plant. Moreover, most researches have handled single-floor plant. However, many multi-floor plants have been constructed for the last decade. Therefore, the proper algorithm handling various regulations and multi-floor plant should be developed. In this study, the Mixed Integer Non-Linear Programming (MINLP) problem including safety distances, maintenance spaces, etc. is suggested based on mathematical equations. The objective function is a summation of pipeline and pumping costs. Also, various safety and maintenance issues are transformed into inequality or equality constraints. However, it is really hard to solve this problem due to complex nonlinear constraints. Thus, it is impossible to use conventional MINLP solvers using derivatives of equations. In this study, the Particle Swarm Optimization (PSO) technique is employed. The ethylene oxide plant is illustrated to verify the efficacy of this study.

Global ship accidents and ocean swell-related sea states

NASA Astrophysics Data System (ADS)

Zhang, Zhiwei; Li, Xiao-Ming

2017-11-01

With the increased frequency of shipping activities, navigation safety has become a major concern, especially when economic losses, human casualties and environmental issues are considered. As a contributing factor, the sea state plays a significant role in shipping safety. However, the types of dangerous sea states that trigger serious shipping accidents are not well understood. To address this issue, we analyzed the sea state characteristics during ship accidents that occurred in poor weather or heavy seas based on a 10-year ship accident dataset. Sea state parameters of a numerical wave model, i.e., significant wave height, mean wave period and mean wave direction, were analyzed for the selected ship accident cases. The results indicated that complex sea states with the co-occurrence of wind sea and swell conditions represent threats to sailing vessels, especially when these conditions include similar wave periods and oblique wave directions.

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.

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.

Emerging Environmental Justice Issues in Nuclear Power and Radioactive Contamination

PubMed Central

Kyne, Dean; Bolin, Bob

2016-01-01

Nuclear hazards, linked to both U.S. weapons programs and civilian nuclear power, pose substantial environment justice issues. Nuclear power plant (NPP) reactors produce low-level ionizing radiation, high level nuclear waste, and are subject to catastrophic contamination events. Justice concerns include plant locations and the large potentially exposed populations, as well as issues in siting, nuclear safety, and barriers to public participation. Other justice issues relate to extensive contamination in the U.S. nuclear weapons complex, and the mining and processing industries that have supported it. To approach the topic, first we discuss distributional justice issues of NPP sites in the U.S. and related procedural injustices in siting, operation, and emergency preparedness. Then we discuss justice concerns involving the U.S. nuclear weapons complex and the ways that uranium mining, processing, and weapons development have affected those living downwind, including a substantial American Indian population. Next we examine the problem of high-level nuclear waste and the risk implications of the lack of secure long-term storage. The handling and deposition of toxic nuclear wastes pose new transgenerational justice issues of unprecedented duration, in comparison to any other industry. Finally, we discuss the persistent risks of nuclear technologies and renewable energy alternatives. PMID:27420080

A data-driven approach to quality risk management.

PubMed

Alemayehu, Demissie; Alvir, Jose; Levenstein, Marcia; Nickerson, David

2013-10-01

An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. ONLY A SUBSET OF THE RISK FACTORS HAD A SIGNIFICANT ASSOCIATION WITH QUALITY ISSUES, AND INCLUDED: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety.

Cultures of Silence and Cultures of Voice: The Role of Whistleblowing in Healthcare Organisations.

PubMed

Mannion, Russell; Davies, Huw To

2015-06-24

'Whistleblowing' has come to increased prominence in many health systems as a means of identifying and addressing quality and safety issues. But whistleblowing - and the reactions to it - have many complex and ambiguous aspects that need to be considered as part of the broader (organisational) cultural dynamics of healthcare institutions. © 2015 by Kerman University of Medical Sciences.

Injury prevention in Australian Indigenous communities.

PubMed

Ivers, Rebecca; Clapham, Kathleen; Senserrick, Teresa; Lyford, Marilyn; Stevenson, Mark

2008-12-01

Injury prevention in Indigenous communities in Australia is a continuing national challenge, with Indigenous fatality rates due to injury three times higher than the general population. Suicide and transport are the leading causes of injury mortality, and assault, transport and falls the primary causes of injury morbidity. Addressing the complex range of injury problems in disadvantaged Indigenous communities requires considerable work in building or enhancing existing capacity of communities to address local safety issues. Poor data, lack of funding and absence of targeted programs are some of the issues that impede injury prevention activities. Traditional approaches to injury prevention can be used to highlight key areas of need, however adaptations are needed in keeping with Indigenous peoples' holistic approach to health, linked to land and linked to community in order to address the complex spiritual, emotional and social determinants of Indigenous injury.

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...

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.

Implementing person-environment approaches to prevent falls: a qualitative inquiry in applying the Westmead approach to occupational therapy home visits.

PubMed

Clemson, Lindy; Donaldson, Alex; Hill, Keith; Day, Lesley

2014-10-01

Despite evidence of the effectiveness of home safety interventions for preventing falls, there is limited uptake of such interventions within community services. Therefore, as part of a broader translational project, we explored issues underlying the implementation of an evidence-based home safety fall prevention intervention. We conducted in-depth interviews with eight occupational therapists and two programme coordinators engaged to deliver a home safety fall prevention intervention. Six community health centres within two metropolitan regions of Melbourne, Australia participated. The RE-AIM framework and Diffusion of Innovations theory underpinned the interviews which examine the enablers and barriers to implementing a home safety fall prevention intervention and integrating it into routine community preventive practice. Analysis involved thematic and content analysis. Investment in the home safety for fall prevention intervention was supported and valued by coordinators and therapists alike, and a number of themes emerged which influenced implementation of this intervention. These included issues of: compatibility with organisational processes, individual practitioner practices and skills, a prevention approach, and client expectations; relative advantage in terms of flexibility of the process, client engagement and regional capacity building; complexity of implementing the intervention; and observability related to the invisible nature of fall prevention outcomes. Implementation of this home safety fall prevention intervention was influenced by a range of interrelated organisational, practitioner and client related factors. The findings from this project provide insights into, and opportunities to increase the sustainable implementation of the home safety fall prevention intervention into practice. © 2014 Occupational Therapy Australia.

Student internships with unions and workers: building the occupational health and safety movement.

PubMed

Bateson, Gail

2013-01-01

One of the most successful programs to recruit young professionals to the occupational safety and health field was launched more than 35 years ago, in 1976. Created by the Montefiore Medical Center's Department of Social Medicine collaborating with Tony Mazzocchi of the Oil, Chemical and Atomic Workers International Union (OCAW), it placed medical, nursing, and public health students in summer internships with local unions to identify and solve health and safety problems in the workplace. The experience of working with and learning from workers about the complex interactions of political, economic, and scientific-technological issues surrounding workplace conditions inspired many students to enter and stay in our field. Many former interns went on to make important medical and scientific contributions directly linked to their union-based projects. Former interns are now among the leaders within the occupational health and safety community, holding key positions in leading academic institutions and governmental agencies.

EPSRC Principles of Robotics: commentary on safety, robots as products, and responsibility

NASA Astrophysics Data System (ADS)

Boddington, Paula

2017-04-01

The EPSRC Principles of Robotics refer to safety. How safety is understood is relative to how tasks are characterised and identified. But the exact task(s) a robot plays within a complex system of agency may be hard to identify. If robots are seen as products, it is nonetheless vital that the safety and other implications of their use in situ must also be considered carefully, and they must be fit for purpose. The Principles identify humans as responsible, rather than robots. We must thus understand how the replacement of human agency by robotic agency may impact upon attributions of responsibility. The Principles seek to fit into existing systems of law and ethics. But these may need development, and in certain context, attention to more local regulations is also needed. A distinction between ethical issues related to the design of robotics, and to their use, may be needed in the Principles.

Systemic Analysis Approaches for Air Transportation

NASA Technical Reports Server (NTRS)

Conway, Sheila

2005-01-01

Air transportation system designers have had only limited success using traditional operations research and parametric modeling approaches in their analyses of innovations. They need a systemic methodology for modeling of safety-critical infrastructure that is comprehensive, objective, and sufficiently concrete, yet simple enough to be used with reasonable investment. The methodology must also be amenable to quantitative analysis so issues of system safety and stability can be rigorously addressed. However, air transportation has proven itself an extensive, complex system whose behavior is difficult to describe, no less predict. There is a wide range of system analysis techniques available, but some are more appropriate for certain applications than others. Specifically in the area of complex system analysis, the literature suggests that both agent-based models and network analysis techniques may be useful. This paper discusses the theoretical basis for each approach in these applications, and explores their historic and potential further use for air transportation analysis.

48 CFR 246.371 - Notification of potential safety issues.

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety issues. 246.371 Section 246.371 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Clauses 246.371 Notification of potential safety issues. (a) Use the clause at 252.246-7003, Notification of Potential Safety...

Design considerations to improve cognitive ergonomic issues of unmanned vehicle interfaces utilizing video game controllers.

PubMed

Oppold, P; Rupp, M; Mouloua, M; Hancock, P A; Martin, J

2012-01-01

Unmanned (UAVs, UCAVs, and UGVs) systems still have major human factors and ergonomic challenges related to the effective design of their control interface systems, crucial to their efficient operation, maintenance, and safety. Unmanned system interfaces with a human centered approach promote intuitive interfaces that are easier to learn, and reduce human errors and other cognitive ergonomic issues with interface design. Automation has shifted workload from physical to cognitive, thus control interfaces for unmanned systems need to reduce mental workload on the operators and facilitate the interaction between vehicle and operator. Two-handed video game controllers provide wide usability within the overall population, prior exposure for new operators, and a variety of interface complexity levels to match the complexity level of the task and reduce cognitive load. This paper categorizes and provides taxonomy for 121 haptic interfaces from the entertainment industry that can be utilized as control interfaces for unmanned systems. Five categories of controllers were based on the complexity of the buttons, control pads, joysticks, and switches on the controller. This allows the selection of the level of complexity needed for a specific task without creating an entirely new design or utilizing an overly complex design.

Random safety auditing, root cause analysis, failure mode and effects analysis.

PubMed

Ursprung, Robert; Gray, James

2010-03-01

Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

USMC Ground Surveillance Robot (GSR): Lessons Learned

NASA Astrophysics Data System (ADS)

Harmon, S. Y.

1987-02-01

This paper describes the design of an autonomous vehicle and the lessons learned during the implementation of that complex robot. The major problems encountered to which solutions were found include sensor processing bandwidth limitations, coordination of the interactions between major subsystems, sensor data fusion and system knowledge representation. Those problems remaining unresolved include system complexity management, the lack of powerful system monitoring and debugging tools, exploratory implementation of a complex system and safety and testing issues. Many of these problems arose from working with underdeveloped and continuously evolving technology and will probably be resolved as the technological resources mature and stabilize. Unfortunately, other problems will continue to plague developers throughout the evolution of autonomous system technology.

Driving safety and adolescent behavior.

PubMed

Brown, R C; Sanders, J M; Schonberg, S K

1986-04-01

Accidents, and mainly automotive accidents, are currently the leading cause of mortality and morbidity among young people. Understanding and addressing the issue of automotive accident prevention requires an awareness of the multiple psychodynamic, familial, and societal influences that affect the development and behavior of adolescents. Risk-taking behavior is the product of complex personal and environmental factors. As pediatricians, we have the obligation and the opportunity to improve the safety of our youth who drive and ride. This opportunity is available to us not only in our roles as counselors to youth and families, but also as we serve as role models, educators, and agents for change within our communities.

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.

Into the void: Regulating pesticide use in Colorado's commercial cannabis markets.

PubMed

Subritzky, Todd; Pettigrew, Simone; Lenton, Simon

2017-04-01

In 2014, Colorado implemented the world's first seed-to-sale recreational cannabis market under a commercial model. This paper aims to provide a thick descriptive account that gives insight into the issues and complexities of Colorado's pioneering and evolving attempt to regulate the use of pesticides on commercial cannabis plantations. The paper examines multiple data sets including: (i) Colorado State Government documents; (ii) recreational cannabis regulations; (iii) mass and niche media publications (n=175); (iv) face-to-face interviews with key stakeholders, including seniors, regulators and industry executives (n=8); and (v) field notes from relevant conferences and cultivation facility tours in Denver in October, 2016. Two key issues are identified. First, a public safety threat has arisen relating to application of pesticides on cannabis with intensified toxicity in concentrated products of particular concern. Second, as a pioneering jurisdiction, Colorado faces a considerable knowledge gap. To expand collective learning on this issue, for which no regulatory template and little research exists, state regulators tapped industry and other stakeholder expertise while attempting to ensure public safety goals were achieved and regulatory capture by industry was limited. Four years since the recreational cannabis market in Colorado was legalised, the State continues to grapple with the pesticide issue as testing regulations and cultivation standards are yet to be finalised. While more work is needed, Colorado has made significant progress in developing regulations relating to this complex matter. As governments of countries such as Canada and US states, including California, contemplate changes to recreational cannabis laws, Colorado's experience can assist regulators in other jurisdictions considering policy change. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

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.

Issues of Food Chain Security and Case Studies in the Czech Army

NASA Astrophysics Data System (ADS)

Komar, Ales; Vasicka, Pavlina

Food supply system is fundamental extremely open complex. Global challenge is acknowledged and must be considered because food is important source of existence and can be used as a desirable terrorist vehicle. Raw material and food featured intentional versus accidental contamination. Manifestation of global challenges, aspiration for sustainable development and appearance of terrorism create the new paradigm for threats to food safety and defence management.

The perception of the patient safety climate by professionals of the emergency department.

PubMed

Rigobello, Mayara Carvalho Godinho; Carvalho, Rhanna Emanuela Fontenele Lima de; Guerreiro, Juliana Magalhães; Motta, Ana Paula Gobbo; Atila, Elizabeth; Gimenes, Fernanda Raphael Escobar

2017-07-01

The aim of this study was to assess the patient safety climate from the perspective of healthcare professionals working in the emergency department of a hospital in Brazil. Emergency departments are complex and dynamic environments. They are prone to adverse events that compromise the quality of care provided and reveal the importance of patient safety culture and climate. This was a quantitative, descriptive, cross-sectional study. The Safety Attitudes Questionnaire (SAQ) - Short Form 2006 was used for data collection, validated and adapted into Portuguese. The study sample consisted of 125 participants. Most of the participants were female (57.6%) and had worked in emergency department for more than 10years (56.8%). Sixty-two participants (49.6%) were nursing professionals. The participants demonstrated satisfaction with their jobs and dissatisfaction with the actions of management with regard to safety issues. Participants' perceptions about the patient safety climate were found to be negative. Knowledge of professionals' perceptions of patient safety climate in the context of emergency care helps with assessments of the safety culture, contributes to improvement of health care, reduces adverse events, and can focus efforts to improve the quality of care provided to patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

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…

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. .

Accidental versus operational oil spills from shipping in the Baltic Sea: risk governance and management strategies.

PubMed

Hassler, Björn

2011-03-01

Marine governance of oil transportation is complex. Due to difficulties in effectively monitoring procedures on vessels en voyage, incentives to save costs by not following established regulations on issues such as cleaning of tanks, crew size, and safe navigation may be substantial. The issue of problem structure is placed in focus, that is, to what degree the specific characteristics and complexity of intentional versus accidental oil spill risks affect institutional responses. It is shown that whereas the risk of accidental oil spills primarily has been met by technical requirements on the vessels in combination with Port State control, attempts have been made to curb intentional pollution by for example increased surveillance and smart governance mechanisms such as the No-Special-Fee system. It is suggested that environmental safety could be improved by increased use of smart governance mechanisms tightly adapted to key actors' incentives to alter behavior in preferable directions.

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.

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... or potential safety hazards over the life cycle of the equipment; (3) Identify safety issues during... issues, reducing hazards, and meeting safety requirements; (6) Develop a program of testing or analysis...

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... or potential safety hazards over the life cycle of the equipment; (3) Identify safety issues during... issues, reducing hazards, and meeting safety requirements; (6) Develop a program of testing or analysis...

Quality of herbal medicines: challenges and solutions.

PubMed

Zhang, Junhua; Wider, Barbara; Shang, Hongcai; Li, Xuemei; Ernst, Edzard

2012-01-01

The popularity of herbal medicines has risen worldwide. This increase in usage renders safety issues important. Many adverse events of herbal medicines can be attributed to the poor quality of the raw materials or the finished products. Different types of herbal medicines are associated with different problems. Quality issues of herbal medicines can be classified into two categories: external and internal. In this review, external issues including contamination (e.g. toxic metals, pesticides residues and microbes), adulteration and misidentification are detailed. Complexity and non-uniformity of the ingredients in herbal medicines are the internal issues affecting the quality of herbal medicines. Solutions to the raised problems are discussed. The rigorous implementation of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) would undoubtedly reduce the risk of external issues. Through the use of modern analytical methods and pharmaceutical techniques, previously unsolved internal issues have become solvable. Standard herbal products can be manufactured from the standard herbal extracts. Copyright © 2011 Elsevier Ltd. All rights reserved.

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

PubMed

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

Total safety management: An approach to improving safety culture

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

Blush, S.M.

A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobylmore » nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair.« less

Mathematical modelling of active safety system functions as tools for development of driverless vehicles

NASA Astrophysics Data System (ADS)

Ryazantsev, V.; Mezentsev, N.; Zakharov, A.

2018-02-01

This paper is dedicated to a solution of the issue of synthesis of the vehicle longitudinal dynamics control functions (acceleration and deceleration control) based on the element base of the vehicle active safety system (ESP) - driverless vehicle development tool. This strategy helps to reduce time and complexity of integration of autonomous motion control systems (AMCS) into the vehicle architecture and allows direct control of actuators ensuring the longitudinal dynamics control, as well as reduction of time for calibration works. The “vehicle+wheel+road” longitudinal dynamics control is complicated due to the absence of the required prior information about the control object. Therefore, the control loop becomes an adaptive system, i.e. a self-adjusting monitoring system. Another difficulty is the driver’s perception of the longitudinal dynamics control process in terms of comfort. Traditionally, one doesn’t pay a lot of attention to this issue within active safety systems, and retention of vehicle steerability, controllability and stability in emergency situations are considered to be the quality criteria. This is mainly connected to its operational limits, since it is activated only in critical situations. However, implementation of the longitudinal dynamics control in the AMCS poses another challenge for the developers - providing the driver with comfortable vehicle movement during acceleration and deceleration - while the possible highest safety level in terms of the road grip is provided by the active safety system (ESP). The results of this research are: universal active safety system - AMCS interaction interface; block diagram for the vehicle longitudinal acceleration and deceleration control as one of the active safety system’s integrated functions; ideology of adaptive longitudinal dynamics control, which enables to realize the deceleration and acceleration requested by the AMCS; algorithms synthesised; analytical experiments proving the efficiency and practicability of the chosen concept.

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.

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

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.

Impact of climate change and anthropogenic pressure on the water resources of India: challenges in management

NASA Astrophysics Data System (ADS)

Shadananan Nair, K.

2016-10-01

Freshwater resources of India are getting fast degraded and depleted from the changing climate and pressure of fast rising population. Changing intensity and seasonality of rainfall affect quantity and quality of water. Most of the rivers are polluted far above safety limits from the untreated domestic, industrial and agricultural effluents. Changes in the intensity, frequency and tracks of storms salinate coastal aquifers. Aquifers are also under the threat from rising sea level. Groundwater in urban limits and industrial zones are far beyond safety limits. Large-scale destruction of wetlands for industries and residential complexes has affected the quality of surface and groundwater resources in most parts of India. Measures to maintain food security and the new developments schemes such as river linking will further deteriorate the water resources. Falling water availability leads to serious health issues and various socio-economic issues. India needs urgent and appropriate adaptation strategies in the water sector.

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.

Achieving the Proper Balance Between Crew and Public Safety

NASA Technical Reports Server (NTRS)

Gowan, John; Rosati, Paul; Silvestri, Ray; Stahl, Ben; Wilde, Paul

2011-01-01

A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. Historical examples and lessons learned from both the Space Shuttle and Constellation Programs will be presented. Using these examples as context, the paper will discuss some operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the FAA and Air Force organizations that oversee public safety will also be summarized. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

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...

Identification of Crew-Systems Interactions and Decision Related Trends

NASA Technical Reports Server (NTRS)

Jones, Sharon Monica; Evans, Joni K.; Reveley, Mary S.; Withrow, Colleen A.; Ancel, Ersin; Barr, Lawrence

2013-01-01

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 technical challenges. Statistical data and published safety priority lists from academic, industry and other government agencies were reviewed and analyzed by NASA Aviation Safety Program (AvSP) systems analysis personnel to identify issues and future research needs related to one of VSST's technical challenges, Crew Decision Making (CDM). The data examined in the study were obtained from the National Transportation Safety Board (NTSB) Aviation Accident and Incident Data System, Federal Aviation Administration (FAA) Accident/Incident Data System and the NASA Aviation Safety Reporting System (ASRS). In addition, this report contains the results of a review of safety priority lists, information databases and other documented references pertaining to aviation crew systems issues and future research needs. The specific sources examined were: Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementation (SERFIs), Flight Deck Automation Issues (FDAI) and NTSB Most Wanted List and Open Recommendations. Various automation issues taxonomies and priority lists pertaining to human factors, automation and flight design were combined to create a list of automation issues related to CDM.

Creating patient safety capacity in a nation's health system: A comparison between Israel and Canada

PubMed Central

2012-01-01

Injuries to patients by the healthcare system (i.e., adverse events) are common and their impact on individuals and systems is considerable. Over the last decade, extensive efforts have been made worldwide to improve patient safety. Given the complexity and extent of the activities required to address the issue, coordinating and organizing them at a national level is likely beneficial. Whereas some capacity and expertise already exist in Israel, there is a considerable gap that needs to be filled. In this paper two countries, Canada and Israel, are examined and some of the essential steps for any country are considered. Possible immediate next steps for Israel are suggested. PMID:22913865

Development of pediatric vaccine recommendations and policies.

PubMed

Pickering, Larry K; Orenstein, Walter A

2002-07-01

A significant decrease in each vaccine-preventable disease has occurred since the introduction of the respective immunizations now included in the recommended childhood immunization schedule. The process through which a vaccine must travel from development to approval and implementation is complex. Hurdles include receiving approval from several advisory committees, government agencies, and professional organizations. At each step in the process, data regarding safety, immunogenicity, and efficacy are evaluated continuously and rigorously. Once a vaccine is approved by the Food and Drug Administration (FDA) and incorporated into the recommended childhood immunization schedule, continuing issues include those that deal with supply, safety, effectiveness, and financing. The logistics of development and implementation of pediatric vaccine recommendations and policies are reviewed.

Japan-U.S. Relations: Issues for Congress

DTIC Science & Technology

2014-09-24

disasters and meltdowns at the Fukushima Daiichi nuclear power plant. Public trust in the safety of nuclear power collapsed, and a vocal anti- nuclear ...to half a million Japanese were displaced. Damage to several reactors at the Fukushima Dai-ichi nuclear power plant complex led the government to...of Japan’s power generation capacity, and the 2006 “New National Energy Strategy” had set out a goal of significantly increasing Japan’s nuclear power

The evolving role of biosimilars in haematology–oncology: a practical perspective

PubMed Central

Gascon, Pere

2015-01-01

The loss of patents covering many biopharmaceutical/biological agents in the mid 1990s led to the introduction of a new generation of drugs: biosimilars. These new agents, produced by living cells just as the originator drugs, are chemically highly similar to endogenous human proteins; characterized by three-dimensionally complex, high molecular weight compounds. Among the first biosimilars used in haematology–oncology were erythropoietin and granulocyte colony-stimulating factor. After five years of use in clinical practice, the efficacy and safety profile of biosimilars approved by the European Medicines Agency is excellent. Over the next year or two, biosimilar monoclonal antibodies (MoAbs) will become available; the first will be rituximab and trastuzumab. Not only are MoAbs more complex in terms of molecular weight and number of amino acids than the first biosimilars, but they are also anticancer drugs, not merely supportive treatments like their predecessors. This opens up important questions. How are regulatory agencies to assess their clinical efficacy, immunogenicity and safety? Is the neoadjuvant clinical setting the best to evaluate them? What will regulatory agencies decide in terms of switching an originator molecule for a biosimilar or extrapolating efficacy results from one pathology to another? Once biosimilars of rituximab and trastuzumab are approved, several challenging issues will need to be addressed such as how to maintain appropriate pharmacovigilance, how to extrapolate across indications, and issues concerning automatic substitution. There is currently no consensus in any of these areas. This review addresses all these issues: new challenges that the oncology community will face in the near future. PMID:26622996

A data-driven approach to quality risk management

PubMed Central

Alemayehu, Demissie; Alvir, Jose; Levenstein, Marcia; Nickerson, David

2013-01-01

Aim: An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Materials and Methods: Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. Results: Only a subset of the risk factors had a significant association with quality issues, and included: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Conclusion: Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety. PMID:24312890

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,"…

[Current ideas of a complex relationship between atrial fibrillation and ischemic heart disease and of optimum tactics for anticoagulant therapy to prevent embolism in systemic circulation].

PubMed

Golshmid, M V; Gilyarevskiy, S R; Kuzmina, I M; Sinitsina, I I

The article discusses the issue of searching for optimum oral anticoagulants to prevent thrombosis and embolism induced by heart disease both in patients with atrial fibrillation and sinus rhythm. A complex bidirectional relationship between atrial fibrillation and coronary atherosclerosis is considered along with possible mechanisms for development of myocardial infarction in patients with atrial fibrillation. The authors provided evidence-based data which can be used in selecting an anticoagulant for prevention of heart disease induced thrombosis and embolism taking into account both the efficacy and safety established in randomized clinical studies.

Virtual reality simulator: demonstrated use in neurosurgical oncology.

PubMed

Clarke, David B; D'Arcy, Ryan C N; Delorme, Sebastien; Laroche, Denis; Godin, Guy; Hajra, Sujoy Ghosh; Brooks, Rupert; DiRaddo, Robert

2013-04-01

The overriding importance of patient safety, the complexity of surgical techniques, and the challenges associated with teaching surgical trainees in the operating room are all factors driving the need for innovative surgical simulation technologies. Despite these issues, widespread use of virtual reality simulation technology in surgery has not been fully implemented, largely because of the technical complexities in developing clinically relevant and useful models. This article describes the successful use of the NeuroTouch neurosurgical simulator in the resection of a left frontal meningioma. The widespread application of surgical simulation technology has the potential to decrease surgical risk, improve operating room efficiency, and fundamentally change surgical training.

A Possible Approach for Addressing Neglected Human Factors Issues of Systems Engineering

NASA Technical Reports Server (NTRS)

Johnson, Christopher W.; Holloway, C. Michael

2011-01-01

The increasing complexity of safety-critical applications has led to the introduction of decision support tools in the transportation and process industries. Automation has also been introduced to support operator intervention in safety-critical applications. These innovations help reduce overall operator workload, and filter application data to maximize the finite cognitive and perceptual resources of system operators. However, these benefits do not come without a cost. Increased computational support for the end-users of safety-critical applications leads to increased reliance on engineers to monitor and maintain automated systems and decision support tools. This paper argues that by focussing on the end-users of complex applications, previous research has tended to neglect the demands that are being placed on systems engineers. The argument is illustrated through discussing three recent accidents. The paper concludes by presenting a possible strategy for building and using highly automated systems based on increased attention by management and regulators, improvements in competency and training for technical staff, sustained support for engineering team resource management, and the development of incident reporting systems for infrastructure failures. This paper represents preliminary work, about which we seek comments and suggestions.

The Public Health Impact of Herbs and Nutritional Supplements.

PubMed

Cassileth, Barrie R; Heitzer, Marjet; Wesa, Kathleen

2009-08-01

Dietary supplement use has increased exponentially in recent years despite the lack of regulatory oversight and in the face of growing safety concerns. This paper provides an overview of the public health implications and safety concerns associated with dietary supplement use, especially by cancer patients. Botanical research is actively pursued at the Memorial Sloan-Kettering Cancer Center (MSKCC) Integrative Medicine department. Work of the MSKCC Center for the Study of Botanical Immunomodulators is described, and guidelines for cancer patients' use of dietary supplements outlined. Herbs and other botanicals are complex, physiologically active agents, but little is known about most of the popular, widely available dietary supplements. Herb-drug interactions, a major concern, are exacerbated in the cancer setting. Biologically active agents may interfere with chemotherapy and other prescription medications. They may exert anti-coagulant activity at rather inconvenient times such as during surgery, and create other serious problems. Research on the bioavailability, effective dosage, safety and benefits of these complex agents is sorely needed. Oncology professionals and other healthcare providers should educate themselves and their patients about these issues. Probably the largest, continuously-updated free information resource is MSKCC's AboutHerbs website (www.mskcc.org/AboutHerbs).

Investigating the experiences of New Zealand MRI technologists: Exploring intra-orbital metallic foreign body safety practices

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

Jacobs, Philippa K; Henwood, Suzanne; River Radiology, Victoria Clinic, 750 Victoria Street, Hamilton, Waikato

2013-12-15

Qualitative research is lacking regarding the experiences of magnetic resonance imaging (MRI) technologists and their involvement in workplace safety practices. This article provides a gateway to explore, describe and document experiences of MRI technologists in New Zealand (NZ) pertaining to intra-orbital metallic foreign body (IMFB) safety practices. This phenomenological study describes the experiences of seven MRI technologists all with a minimum of 5 years' NZ work experience in MRI. The MRI technologists were interviewed face-to-face regarding their professional IMFB workplace experiences in order to explore historical, current and potential issues. Findings demonstrated that aspects of organization and administration are fundamentallymore » important to MRI technologists. Varying levels of education and knowledge, as well as experience and skills gained, have significantly impacted on MRI technologists’ level of confidence and control in IMFB practices. Participants’ descriptions of their experiences in practice regarding decision-making capabilities further highlight the complexity of these themes. A model was developed to demonstrate the interrelated nature of the themes and the complexity of the situation in totality. Findings of this study have provided insight into the experiences of MRI technologists pertaining to IMFB safety practices and highlighted inconsistencies. It is hoped that these findings will contribute to and improve the level of understanding of MRI technologists and the practices and protocols involved in IMFB safety screening. The scarcity of available literature regarding IMFB safety practices highlights that more research is required to investigate additional aspects that could improve MRI technologists’ experiences.« less

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

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

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

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.

Putting the ‘patient’ in patient safety: a qualitative study of consumer experiences

PubMed Central

Rathert, Cheryl; Brandt, Julie; Williams, Eric S.

2011-01-01

Abstract Background  Although patient safety has been studied extensively, little research has directly examined patient and family (consumer) perceptions. Evidence suggests that clinicians define safety differently from consumers, e.g. clinicians focus more on outcomes, whereas consumers may focus more on processes. Consumer perceptions of patient safety are important for several reasons. First, health‐care policy leaders have been encouraging patients and families to take a proactive role in ensuring patient safety; therefore, an understanding of how patients define safety is needed. Second, consumer perceptions of safety could influence outcomes such as trust and satisfaction or compliance with treatment protocols. Finally, consumer perspectives could be an additional lens for viewing complex systems and processes for quality improvement efforts. Objectives  To qualitatively explore acute care consumer perceptions of patient safety. Design and methods  Thirty‐nine individuals with a recent overnight hospital visit participated in one of four group interviews. Analysis followed an interpretive analytical approach. Results  Three basic themes were identified: Communication, staffing issues and medication administration. Consumers associated care process problems, such as delays or lack of information, with safety rather than as service quality problems. Participants agreed that patients need family caregivers as advocates. Conclusions  Consumers seem acutely aware of care processes they believe pose risks to safety. Perceptual measures of patient safety and quality may help to identify areas where there are higher risks of preventable adverse events. PMID:21624026

Correlated Topics in a Scalable Multidimensional Text Cube: Algorithms and Aviation Safety Case Study

NASA Technical Reports Server (NTRS)

Zhao, Bo; Lin, Cindy X.; Srivastava, Ashok N.; Oza, Nikunj C.; Han, Jiawei

2010-01-01

As world-wide air traffic continues to grow even at a modest pace, the overall complexity of the system will increase significantly. This increased complexity can lead to a larger number of fatalities per year even if the extremely low fatality rate that we currently enjoy is maintained. One important source of information about the safety of the aviation system is in Aviation Safety Text Reports which are written by members of the flight crew, air traffic controllers, and other parties involved with the aviation system. These anonymized narrative reports contain fixed-field contextual information about the flight but also contain free-form narratives that describe, in the author s own words, the nature of the safety incident and, in many cases, the contributing factors that led to the safety incident. Several thousand such reports are filed each month, each of which is read and analyzed by highly trained experts. However, it is possible that there are emerging safety issues due to the fact that they may be reported very infrequently and in different contexts with different descriptions. The goal of this research paper is to develop correlated topic models which uncover correlations in the subspaces defined by the intersection of numerous fixed fields and discovered correlated topics. This task requires the discovery of latent topics in the text reports and the creation of a topic cube. Furthermore, because the number of potential cells in the topic cube is very large, we discuss novel methods of pruning the search space in the topic cells, thereby making the analysis feasible. We demonstrate the new algorithms on an analysis of pilot fatigue and its contributing factors, as well as the safety incidents that are correlated with this phenomenon.

Status of occupational health and safety in Iran.

PubMed

Vigeh, Mohsen; Mazaheri, Maria; Seyedaghamiri, Zahrabigom

2011-12-01

In recent decades, Iran has had a steadily growing economy with an annual rate of 6% on average. The country's economy is dominantly influenced by oil and natural gas production and related industries like petrochemicals and fertilizers. There are two million job units and sixteen million employees. The occupational health and safety (OHS) system is mainly regulated by two bodies: the Ministry of Health and Medical Education, responsible for occupational health services and legislations; and the Ministry of Labour and Social Affairs, which undertakes the enactment and enforcement of occupational safety legal issues. Inspectorates in each ministry carry out regular health and safety monitoring according to the OHS legislations. The most common occupational health disorders are musculoskeletal problems, respiratory diseases, noise induced hearing loss, and occupational injuries. Because the OHS is a complex system with overlapping responsibilities among the co-responders, its improvement needs well-organized collaboration among Iranian universities, industries, and governmental agencies, and reliable basic data. The present study takes a glance at the situation and activities of the Iranian OHS system.

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 guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes and exposure for a subset of roadway network. These SPFs, specific to a region and the analysis period are often unavailable. Calibration of already existing default national SPFs to the state's data could be a feasible solution, but, how well the state's data is represented is a legitimate question. With this background, SPFs were generated for various classifications of segments in Georgia and compared against the national default SPFs used in SafetyAnalyst calibrated to Georgia data. Dwelling deeper into the development of SPFs, the influence of actual and estimated traffic data on the fit of the equations is also studied questioning the accuracy and reliability of traffic estimations. In addition to SafetyAnalyst, HSM aims at performing quantitative safety analysis. Applying HSM methodology to two-way two-lane rural roads, the effect of using multiple CMFs (Crash Modification Factors) is studied. Lastly, data requirements, methodology, constraints, and results are compared between SafetyAnalyst and HSM.

Identifying the science and technology dimensions of emerging public policy issues through horizon scanning.

PubMed

Parker, Miles; Acland, Andrew; Armstrong, Harry J; Bellingham, Jim R; Bland, Jessica; Bodmer, Helen C; Burall, Simon; Castell, Sarah; Chilvers, Jason; Cleevely, David D; Cope, David; Costanzo, Lucia; Dolan, James A; Doubleday, Robert; Feng, Wai Yi; Godfray, H Charles J; Good, David A; Grant, Jonathan; Green, Nick; Groen, Arnoud J; Guilliams, Tim T; Gupta, Sunjai; Hall, Amanda C; Heathfield, Adam; Hotopp, Ulrike; Kass, Gary; Leeder, Tim; Lickorish, Fiona A; Lueshi, Leila M; Magee, Chris; Mata, Tiago; McBride, Tony; McCarthy, Natasha; Mercer, Alan; Neilson, Ross; Ouchikh, Jackie; Oughton, Edward J; Oxenham, David; Pallett, Helen; Palmer, James; Patmore, Jeff; Petts, Judith; Pinkerton, Jan; Ploszek, Richard; Pratt, Alan; Rocks, Sophie A; Stansfield, Neil; Surkovic, Elizabeth; Tyler, Christopher P; Watkinson, Andrew R; Wentworth, Jonny; Willis, Rebecca; Wollner, Patrick K A; Worts, Kim; Sutherland, William J

2014-01-01

Public policy requires public support, which in turn implies a need to enable the public not just to understand policy but also to be engaged in its development. Where complex science and technology issues are involved in policy making, this takes time, so it is important to identify emerging issues of this type and prepare engagement plans. In our horizon scanning exercise, we used a modified Delphi technique. A wide group of people with interests in the science and policy interface (drawn from policy makers, policy adviser, practitioners, the private sector and academics) elicited a long list of emergent policy issues in which science and technology would feature strongly and which would also necessitate public engagement as policies are developed. This was then refined to a short list of top priorities for policy makers. Thirty issues were identified within broad areas of business and technology; energy and environment; government, politics and education; health, healthcare, population and aging; information, communication, infrastructure and transport; and public safety and national security.

Electrochemical performance and thermal stability analysis of LiNixCoyMnzO2 cathode based on a composite safety electrolyte.

PubMed

Jiang, Lihua; Wang, Qingsong; Sun, Jinhua

2018-06-05

LiNi x Co y Mn z O 2 (NCM) cathode material with high energy density is one of the best choices for power batteries. But the safety issue also becomes more prominent with higher nickel content. The improvement of thermal stability by material modification is often complex and limited. In this study, a composite safety electrolyte additive consisting of perfluoro-2-methyl-3-pentanone, N, N-Dimethylacetamide (and fluorocarbon surfactant is proved to be effective and simple in improving the thermal stability of NCM materials. Electrochemical compatibility of composite safety electrolyte with various NCM materials is investigated. Uniform interface film, lower impedance and polarization for NCM (622) cycled in composite safety electrolyte are proved to be the main reasons to ensure good cycle performance. Homemade pouch cells (NCM (622)/C) are used to verify the effectiveness for practical application, accelerating rate calorimeter and nail penetration test shows a slower temperature rise and delay of thermal runaway. For heating experiment, no fire appears for pouch cell with composite safety electrolyte. Thus, this composite safety electrolyte is effective to improve the safety of lithium ion batteries with NCM materials.(. Copyright © 2018 Elsevier B.V. All rights reserved.

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...

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

Planning 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; Packer, Douglas L; Ellenbogen, Kenneth A; Hammill, Stephen C; Natale, Andrea; Page, Richard L; Prystowsky, Eric; Jackman, Warren M; Stevenson, William G; Waldo, Albert L; Wilber, David; Kowey, Peter; Yaross, Marcia S; Mark, Daniel B; Reiffel, James; Finkle, John K; Marinac-Dabic, Danica; Pinnow, Ellen; Sager, Phillip; Sedrakyan, Art; Canos, Daniel; Gross, Thomas; Berliner, Elise; Krucoff, Mitchell W

2010-01-01

Atrial fibrillation (AF) is a major public health problem in the United States that is associated with increased mortality and morbidity. Of the therapeutic modalities available to treat AF, the use of percutaneous catheter ablation of AF is expanding rapidly. Randomized clinical trials examining the efficacy and safety of AF ablation are currently underway; however, such trials can only partially determine the safety and durability of the effect of the procedure in routine clinical practice, in more complex patients, and over a broader range of techniques and operator experience. These limitations of randomized trials of AF ablation, particularly with regard to safety issues, could be addressed using a synergistically structured national registry, which is the intention of the SAFARI. To facilitate discussions about objectives, challenges, and steps for such a registry, the Cardiac Safety Research Consortium and the Duke Clinical Research Institute, Durham, NC, in collaboration with the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, organized a Think Tank meeting of experts in the field. 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 Society of Thoracic Surgeons, the AdvaMed AF working group, and additional industry representatives. The meeting took place on April 27 to 28, 2009, at the US Food and Drug Administration headquarters in Silver Spring, MD. This article summarizes the issues and directions presented and discussed at the meeting. Copyright 2010 Mosby, Inc. All rights reserved.

SAFETY: an integrated clinical reasoning and reflection framework for undergraduate nursing students.

PubMed

Hicks Russell, Bedelia; Geist, Melissa J; House Maffett, Jenny

2013-01-01

Nurse educators can no longer focus on imparting to students knowledge that is merely factual and content specific. Activities that provide students with opportunities to apply concepts in real-world scenarios can be powerful tools. Nurse educators should take advantage of student-patient interactions to model clinical reasoning and allow students to practice complex decision making throughout the entire curriculum. In response to this change in nursing education, faculty in a pediatric course designed a reflective clinical reasoning activity based on the SAFETY template, which is derived from the National Council of State Boards of Nursing RN practice analysis. Students were able to prioritize key components of nursing care, as well as integrate practice issues such as delegation, Health Insurance Portability and Accountability Act violations, and questioning the accuracy of orders. SAFETY is proposed as a framework for integration of content knowledge, clinical reasoning, and reflection on authentic professional nursing concerns. Copyright 2012, SLACK Incorporated.

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.

Hanford Site Environmental Safety and Health Fiscal Year 2001 Budget-Risk management summary

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

REEP, I.E.

1999-05-12

The Hanford Site Environment, Safety and Health (ES&H) Budget-Risk Management Summary report is prepared to support the annual request to sites in the U.S. Department of Energy (DOE) Complex by DOE, Headquarters. The request requires sites to provide supplementary crosscutting information related to ES&H activities and the ES&H resources that support these activities. The report includes the following: (1) A summary status of fiscal year (FY) 1999 ES&H performance and ES&H execution commitments; (2)Status and plans of Hanford Site Office of Environmental Management (EM) cleanup activities; (3) Safety and health (S&H) risk management issues and compliance vulnerabilities of FY 2001more » Target Case and Below Target Case funding of EM cleanup activities; (4) S&H resource planning and crosscutting information for FY 1999 to 2001; and (5) Description of indirect-funded S&H activities.« less

Unconventional oil and gas extraction and animal health.

PubMed

Bamberger, M; Oswald, R E

2014-08-01

The extraction of hydrocarbons from shale formations using horizontal drilling with high volume hydraulic fracturing (unconventional shale gas and tight oil extraction), while derived from methods that have been used for decades, is a relatively new innovation that was introduced first in the United States and has more recently spread worldwide. Although this has led to the availability of new sources of fossil fuels for domestic consumption and export, important issues have been raised concerning the safety of the process relative to public health, animal health, and our food supply. Because of the multiple toxicants used and generated, and because of the complexity of the drilling, hydraulic fracturing, and completion processes including associated infrastructure such as pipelines, compressor stations and processing plants, impacts on the health of humans and animals are difficult to assess definitively. We discuss here findings concerning the safety of unconventional oil and gas extraction from the perspectives of public health, veterinary medicine, and food safety.

What Would Pascal Think About Space Safety?

NASA Astrophysics Data System (ADS)

Pfitzer, Tom

2013-09-01

Blaise Pascal was a true Renaissance man being well versed in science, physics, religion, philosophy, and especially mathematics. He had a knack for simplifying complex problems into mathematical formulae. He had well-formed opinions about the scientific issues of his day, in particular about risk. There is little doubt that were he alive today, he would have opinions useful to this society. This paper addresses what he thought then as a foundation for what he would have thought now.

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...

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

PubMed

Asturias, Edwin J; Wharton, Melinda; Pless, Robert; MacDonald, Noni E; Chen, Robert T; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N; Hartigan-Go, Kenneth; Zuber, Patrick L F

2016-06-17

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

Optimization-based decision support to assist in logistics planning for hospital evacuations.

PubMed

Glick, Roger; Bish, Douglas R; Agca, Esra

2013-01-01

The evacuation of the hospital is a very complex process and evacuation planning is an important part of a hospital's emergency management plan. There are numerous factors that affect the evacuation plan including the nature of threat, availability of resources and staff the characteristics of the evacuee population, and risk to patients and staff. The safety and health of patients is of fundamental importance, but safely moving patients to alternative care facilities while under threat is a very challenging task. This article describes the logistical issues and complexities involved in planning and execution of hospital evacuations. Furthermore, this article provides examples of how optimization-based decision support tools can help evacuation planners to better plan for complex evacuations by providing real-world solutions to various evacuation scenarios.

Nuclear safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Dix, Terry E.

1991-01-01

The results of a study to identify potential hazards arising from nuclear reactor power systems for use on the lunar and Martian surfaces, related safety issues, and resolutions of such issues by system design changes, operating procedures, and other means are presented. All safety aspects of nuclear reactor power systems from prelaunch ground handling to eventual disposal were examined consistent with the level of detail for SP-100 reactor design at the 1988 System Design Review and for launch vehicle and space transport vehicle designs and mission descriptions as defined in the 90-day Space Exploration Initiative (SEI) study. Information from previous aerospace nuclear safety studies was used where appropriate. Safety requirements for the SP-100 space nuclear reactor system were compiled. Mission profiles were defined with emphasis on activities after low earth orbit insertion. Accident scenarios were then qualitatively defined for each mission phase. Safety issues were identified for all mission phases with the aid of simplified event trees. Safety issue resolution approaches of the SP-100 program were compiled. Resolution approaches for those safety issues not covered by the SP-100 program were identified. Additionally, the resolution approaches of the SP-100 program were examined in light of the moon and Mars missions.

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.

Multiple sclerosis - New treatment modalities

PubMed Central

Totaro, Rocco; Di Carmine, Caterina; Marini, Carmine; Carolei, Antonio

2015-01-01

Ever since the introduction of the first disease modifying therapies, the concept of multiple sclerosis treatment algorithms developed ceaselessly. The increasing number of available drugs is paralleled by impelling issue of ensuring the most appropriate treatment to the right patient at the right time. The purpose of this review is to describe novel agents recently approved for multiple sclerosis treatment, namely teriflunomide, alemtuzumab and dimethylfumarate, focusing on mechanism of action, efficacy data in experimental setting, safety and tolerability. The place in therapy of newer treatment implies careful balancing of risk-benefit profile as well as accurate patient selection. Hence the widening of therapeutic arsenal provides greater opportunity for personalized therapy but also entails a complex trade-off between efficacy, tolerability, safety and eventually patient preference. PMID:26831413

Risks and issues in fire safety on the Space Station

NASA Technical Reports Server (NTRS)

Friedman, Robert

1993-01-01

A fire in the inhabited portion of a spacecraft is a greatly feared hazard, but fire protection in space operations is complicated by two factors. First, the spacecraft cabin is an enclosed volume, which limits the resources for fire fighting and the options for crew escape. Second, an orbiting spacecraft experiences a balance of forces, creating a near-zero-gravity (microgravity) environment that profoundly affects the characteristics of fire initiation, spread, and suppression. The current Shuttle Orbiter is protected by a fire-detection and suppression system whose requirements are derived of necessity from accepted terrestrial and aircraft standards. While experience has shown that Shuttle fire safety is adequate, designers recognize that improved systems to respond specifically to microgravity fire characteristics are highly desirable. Innovative technology is particularly advisable for the Space Station, a forthcoming space community with a complex configuration and long-duration orbital missions, in which the effectiveness of current fire-protection systems is unpredictable. The development of risk assessments to evaluate the probabilities and consequences of fire incidents in spacecraft are briefly reviewed. It further discusses the important unresolved issues and needs for improved fire safety in the Space Station, including those of material selection, spacecraft atmospheres, fire detection, fire suppression, and post-fire restoration.

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

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

Why do patients engage in medical tourism?

PubMed

Runnels, Vivien; Carrera, P M

2012-12-01

Medical tourism is commonly perceived and popularly depicted as an economic issue, both at the system and individual levels. The decision to engage in medical tourism, however, is more complex, driven by patients' unmet need, the nature of services sought and the manner by which treatment is accessed. In order to beneficially employ the opportunities medical tourism offers, and address and contain possible threats and harms, an informed decision is crucial. This paper aims to enhance the current knowledge on medical tourism by isolating the focal content of the decisions that patients make. Based on the existing literature, it proposes a sequential decision-making process in opting for or against medical care abroad, and engaging in medical tourism, including considerations of the required treatments, location of treatment, and quality and safety issues attendant to seeking care. Accordingly, it comments on the imperative of access to health information and the current regulatory environment which impact on this increasingly popular and complex form of accessing and providing medical care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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.

International Space Station Materials: Selected Lessons Learned

NASA Technical Reports Server (NTRS)

Golden, Johnny L.

2007-01-01

The International Space Station (ISS) program is of such complexity and scale that there have been numerous issues addressed regarding safety of materials: from design to manufacturing, test, launch, assembly on-orbit, and operations. A selection of lessons learned from the ISS materials perspective will be provided. Topics of discussion are: flammability evaluation of materials with connection to on-orbit operations; toxicity findings for foams; compatibility testing for materials in fluid systems; and contamination control in precision clean systems and critical space vehicle surfaces.

`You caught me off guard': Probing the futures of complex engineered nanomaterials

NASA Astrophysics Data System (ADS)

Sadowski, Jathan; Guston, David H.

2016-07-01

This paper applies principles and methods from the framework of anticipatory governance to the case of what the National Research Council calls "complex engineered nanomaterials" (CENM). This framework does not aim to generate crystal ball visions or definitive answers, but rather provides guidance for uncovering, understanding, and addressing social, ethical, environmental, and policy issues that stem from emerging technologies. Thus, in anticipation of increased CENM research, CENM products, and their different governance challenges, we aim to lay the groundwork for the anticipatory governance of CENMs by mapping out what—according to the engineers and scientists, we interviewed who are working at the research level of these CENMs—will be the main issues and themes that we need to pay attention to in the near future. The structured interviews focused on three groups of questions: (1) potential and/or actual applications and/or products from the participant's research; (2) environmental health and safety issues pertaining to both the participant's research and CENMs generally; and (3) the future of CENMs. Without a foundational understanding to build on, social scientists, policymakers, and regulatory agencies will be at a loss about how to govern CENMs before they are widely implemented in society.

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...

Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

PubMed Central

Small, Will; Maher, Lisa; Kerr, Thomas

2014-01-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. PMID:24581074

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

Occupational Safety and Related Impacts on Health and the Environment

PubMed Central

Watterson, Andrew

2016-01-01

The inter-relationship between safety, health and the ‘environment’ is a complex and at times a relatively neglected topic. In this issue, ‘safety’ is often viewed by contributors as ‘health and safety’ and includes occupationally-related ill health as well as injury or harm to employees and the wider public. ‘Environment’ is also interpreted in the widest sense covering both physical and work environments with upstream work hazards presenting risks to downstream communities. The focus is very much on exploring and where possible addressing the challenges, some old and some facing workers in a range of public and private settings and also at times their nearby communities. The 19 papers in the issue cover public and private sectors, global and very local populations, macro-theoretical perspectives, large epidemiological and some single factory or hospital site small case studies. A number of the papers are just beginning to explore and draw out for the first time the risks from hazards in their part of the world. The methodologies adopted also range from lab-based studies through ergonomic assessments and interventions to therapeutic approaches. PMID:27782047

Modeling Increased Complexity and the Reliance on Automation: FLightdeck Automation Problems (FLAP) Model

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

This paper highlights the development of a model that is focused on the safety issue of increasing complexity and reliance on automation systems in transport category aircraft. Recent statistics show an increase in mishaps related to manual handling and automation errors due to pilot complacency and over-reliance on automation, loss of situational awareness, automation system failures and/or pilot deficiencies. Consequently, the aircraft can enter a state outside the flight envelope and/or air traffic safety margins which potentially can lead to loss-of-control (LOC), controlled-flight-into-terrain (CFIT), or runway excursion/confusion accidents, etc. The goal of this modeling effort is to provide NASA's Aviation Safety Program (AvSP) with a platform capable of assessing the impacts of AvSP technologies and products towards reducing the relative risk of automation related accidents and incidents. In order to do so, a generic framework, capable of mapping both latent and active causal factors leading to automation errors, is developed. Next, the framework is converted into a Bayesian Belief Network model and populated with data gathered from Subject Matter Experts (SMEs). With the insertion of technologies and products, the model provides individual and collective risk reduction acquired by technologies and methodologies developed within AvSP.

Biosimilars--global issues, national solutions.

PubMed

Knezevic, Ivana; Griffiths, Elwyn

2011-09-01

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of "biosimilars", to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherapeutic products. Copyright © 2011. Published by Elsevier Ltd.

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...

Effects of efforts to optimise morbidity and mortality rounds to serve contemporary quality improvement and educational goals: a systematic review.

PubMed

Smaggus, Andrew; Mrkobrada, Marko; Marson, Alanna; Appleton, Andrew

2018-01-01

The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Global Perspective on Vaccine Safety and Public Health: The Global Advisory Committee on Vaccine Safety

PubMed Central

Folb, Peter I.; Bernatowska, Ewa; Chen, Robert; Clemens, John; Dodoo, Alex N. O.; Ellenberg, Susan S.; Farrington, C. Patrick; John, T. Jacob; Lambert, Paul-Henri; MacDonald, Noni E.; Miller, Elizabeth; Salisbury, David; Schmitt, Heinz-J.; Siegrist, Claire-Anne; Wimalaratne, Omala

2004-01-01

Established in 1999, the Global Advisory Committee on Vaccine Safety advises the World Health Organization (WHO) on vaccine-related safety issues and enables WHO to respond promptly, efficiently, and with scientific rigor to issues of vaccine safety with potential global importance. The committee also assesses the implications of vaccine safety for practice worldwide and for WHO policies. We describe the principles on which the committee was established, its modus operandi, and the scope of the work undertaken, both present and future. We highlight its recent recommendations on major issues, including the purported link between the measles–mumps–rubella vaccine and autism and the safety of the mumps, influenza, yellow fever, BCG, and smallpox vaccines as well as that of thiomersal-containing vaccines. PMID:15514229

Toward an Application Guide for Safety Integrity Level Allocation in Railway Systems.

PubMed

Ouedraogo, Kiswendsida Abel; Beugin, Julie; El-Koursi, El-Miloudi; Clarhaut, Joffrey; Renaux, Dominique; Lisiecki, Frederic

2018-02-02

The work in the article presents the development of an application guide based on feedback and comments stemming from various railway actors on their practices of SIL allocation to railway safety-related functions. The initial generic methodology for SIL allocation has been updated to be applied to railway rolling stock safety-related functions in order to solve the SIL concept application issues. Various actors dealing with railway SIL allocation problems are the intended target of the methodology; its principles will be summarized in this article with a focus on modifications and precisions made in order to establish a practical guide for railway safety authorities. The methodology is based on the flowchart formalism used in CSM (common safety method) European regulation. It starts with the use of quantitative safety requirements, particularly tolerable hazard rates (THR). THR apportioning rules are applied. On the one hand, the rules are related to classical logical combinations of safety-related functions preventing hazard occurrence. On the other hand, to take into account technical conditions (last safety weak link, functional dependencies, technological complexity, etc.), specific rules implicitly used in existing practices are defined for readjusting some THR values. SIL allocation process based on apportioned and validated THR values is finally illustrated through the example of "emergency brake" subsystems. Some specific SIL allocation rules are also defined and illustrated. © 2018 Society for Risk Analysis.

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...

Protection from Induced Space Environments Effects on the International Space Station

NASA Technical Reports Server (NTRS)

Soares, Carlos; Mikatarian, Ron; Stegall, Courtney; Schmidl, Danny; Huang, Alvin; Olsen, Randy; Koontz, Steven

2010-01-01

The International Space Station (ISS) is one of the largest, most complex multinational scientific projects in history and protection from induced space environments effects is critical to its long duration mission as well as to the health of the vehicle and safety of on-orbit operations. This paper discusses some of the unique challenges that were encountered during the design, assembly and operation of the ISS and how they were resolved. Examples are provided to illustrate the issues and the risk mitigation strategies that were developed to resolve these issues. Of particular importance are issues related with the interaction of multiple spacecraft as in the case of ISS and Visiting Vehicles transporting crew, hardware elements, cargo and scientific payloads. These strategies are applicable to the development of future long duration space systems, not only during design, but also during assembly and operation of these systems.

Current Demands for Food-Approved Liposome Nanoparticles in Food and Safety Sector

PubMed Central

Shukla, Shruti; Haldorai, Yuvaraj; Hwang, Seung Kyu; Bajpai, Vivek K.; Huh, Yun Suk; Han, Young-Kyu

2017-01-01

Safety of food is a noteworthy issue for consumers and the food industry. A number of complex challenges associated with food engineering and food industries, including quality food production and safety of the food through effective and feasible means can be explained by nanotechnology. However, nanoparticles have unique physicochemical properties compared to normal macroparticles of the same composition and thus could interact with living system in surprising ways to induce toxicity. Further, few toxicological/safety assessments have been performed on nanoparticles, thereby necessitating further research on oral exposure risk prior to their application to food. Liposome nanoparticles are viewed as attractive novel materials by the food and medical industries. For example, nanoencapsulation of bioactive food compounds is an emerging application of nanotechnology. In several food industrial practices, liposome nanoparticles have been utilized to improve flavoring and nutritional properties of food, and they have been examined for their capacity to encapsulate natural metabolites that may help to protect the food from spoilage and degradation. This review focuses on ongoing advancements in the application of liposomes for food and pharma sector. PMID:29259595

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study

PubMed Central

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-01

Introduction Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. Methods This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. Ethics and dissemination This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. PMID:28132001

Defining drug response for stratified medicine.

PubMed

Lonergan, Mike; Senn, Stephen J; McNamee, Christine; Daly, Ann K; Sutton, Robert; Hattersley, Andrew; Pearson, Ewan; Pirmohamed, Munir

2017-01-01

The premise for stratified medicine is that drug efficacy, drug safety, or both, vary between groups of patients, and biomarkers can be used to facilitate more targeted prescribing, with the aim of improving the benefit:risk ratio of treatment. However, many factors can contribute to the variability in response to drug treatment. Inadequate characterisation of the nature and degree of variability can lead to the identification of biomarkers that have limited utility in clinical settings. Here, we discuss the complexities associated with the investigation of variability in drug efficacy and drug safety, and how consideration of these issues a priori, together with standardisation of phenotypes, can increase both the efficiency of stratification procedures and identification of biomarkers with the potential for clinical impact. Copyright © 2016 Elsevier Ltd. All rights reserved.

An in vivo strategy to counteract post-administration anticoagulant activity of azido-Warfarin

NASA Astrophysics Data System (ADS)

Ursuegui, Sylvain; Recher, Marion; Krężel, Wojciech; Wagner, Alain

2017-05-01

Drugs, usually long acting and metabolically stable molecules, might be the source of adverse effects triggered by complex drug interactions, anaphylaxis and drug-induced coagulopathy. To circumvent this growing drug safety issue, we herein investigate the opportunity offered by bio-orthogonal chemistry for in vivo drug neutralization. We design a small-molecule anticoagulant drug (Warfarin) containing an azide group that acts as a safety pin. It allows drug deactivation and restoration of physiological coagulation via in vivo click reaction with a suitable cyclooctyne-based neutralizing agent. In this strategy, the new molecule formed by reaction of the drug and the antidote is deprived of biological activity and prone to fast renal clearance. This `Click & Clear' approach lays ground for new strategies in designing drugs with switchable biophysical properties.

Software Reliability Issues Concerning Large and Safety Critical Software Systems

NASA Technical Reports Server (NTRS)

Kamel, Khaled; Brown, Barbara

1996-01-01

This research was undertaken to provide NASA with a survey of state-of-the-art techniques using in industrial and academia to provide safe, reliable, and maintainable software to drive large systems. Such systems must match the complexity and strict safety requirements of NASA's shuttle system. In particular, the Launch Processing System (LPS) is being considered for replacement. The LPS is responsible for monitoring and commanding the shuttle during test, repair, and launch phases. NASA built this system in the 1970's using mostly hardware techniques to provide for increased reliability, but it did so often using custom-built equipment, which has not been able to keep up with current technologies. This report surveys the major techniques used in industry and academia to ensure reliability in large and critical computer systems.

How SEIPS can be used as a model for macroergonomic approach in subunit healthcare (Case study: The nurse perception of fatigue in surgery ward unit)

NASA Astrophysics Data System (ADS)

Iftadi, Irwan; Astuti, Rahmaniyah Dwi; Pristiyana, Ardian Ade

2017-11-01

Occupational fatigue in healthcare nurses, which has multifaceted issues, is associated with decreased patient safety and the quality of nursing care. The aim of this study was to investigate the nurses fatigue problem in sub-unit healthcare based on their perceptual experience. Interviews were conducted and analyzed utilizing a direct qualitative content analysis approach using NVivo Software and guided by Model of System Engineering Initiative for Patient Safety (SEIPS). The findings of this research were a steering on what nurses perceive as contributing and preventing to fatigue which are likewise arranged in SEIPS model. It was shown that a macro ergonomic approach is valuable for understanding complexities of work systems, even though it is a small unit organization.

Identifying the Science and Technology Dimensions of Emerging Public Policy Issues through Horizon Scanning

PubMed Central

Parker, Miles; Acland, Andrew; Armstrong, Harry J.; Bellingham, Jim R.; Bland, Jessica; Bodmer, Helen C.; Burall, Simon; Castell, Sarah; Chilvers, Jason; Cleevely, David D.; Cope, David; Costanzo, Lucia; Dolan, James A.; Doubleday, Robert; Feng, Wai Yi; Godfray, H. Charles J.; Good, David A.; Grant, Jonathan; Green, Nick; Groen, Arnoud J.; Guilliams, Tim T.; Gupta, Sunjai; Hall, Amanda C.; Heathfield, Adam; Hotopp, Ulrike; Kass, Gary; Leeder, Tim; Lickorish, Fiona A.; Lueshi, Leila M.; Magee, Chris; Mata, Tiago; McBride, Tony; McCarthy, Natasha; Mercer, Alan; Neilson, Ross; Ouchikh, Jackie; Oughton, Edward J.; Oxenham, David; Pallett, Helen; Palmer, James; Patmore, Jeff; Petts, Judith; Pinkerton, Jan; Ploszek, Richard; Pratt, Alan; Rocks, Sophie A.; Stansfield, Neil; Surkovic, Elizabeth; Tyler, Christopher P.; Watkinson, Andrew R.; Wentworth, Jonny; Willis, Rebecca; Wollner, Patrick K. A.; Worts, Kim; Sutherland, William J.

2014-01-01

Public policy requires public support, which in turn implies a need to enable the public not just to understand policy but also to be engaged in its development. Where complex science and technology issues are involved in policy making, this takes time, so it is important to identify emerging issues of this type and prepare engagement plans. In our horizon scanning exercise, we used a modified Delphi technique [1]. A wide group of people with interests in the science and policy interface (drawn from policy makers, policy adviser, practitioners, the private sector and academics) elicited a long list of emergent policy issues in which science and technology would feature strongly and which would also necessitate public engagement as policies are developed. This was then refined to a short list of top priorities for policy makers. Thirty issues were identified within broad areas of business and technology; energy and environment; government, politics and education; health, healthcare, population and aging; information, communication, infrastructure and transport; and public safety and national security. PMID:24879444

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.

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...

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.

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

Health Informatics in Developing Countries: A Review of Unintended Consequences of IT Implementations, as They Affect Patient Safety and Recommendations on How to Address Them.

PubMed

Park, Hyeoun-Ae

2016-11-10

Patient safety concerns every healthcare organization. Adoption of Health information technology (HIT) appears to have the potential to address this issue, however unanticipated and undesirable consequences from implementing HIT could lead to new and more complex hazards. This could be particularly problematic in developing countries, where regulations, policies and implementations are few, less standandarized and in some cases almost non-existing. Based on the available information and our own experience, we conducted a review of unintended consequences of HIT implementations, as they affect patient safety in developing countries. We found that user dependency on the system, alert fatigue, less communications among healthcare actors and workarounds topics should be prioritize. Institution should consider existing knowledge, learn from other experiences and model their implementations to avoid known consequences. We also recommend that they monitor and communicate their own efforts to expand knowledge in the region.

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 ...

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

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.

Launching the dialogue: Safety and innovation as partners for success in advanced manufacturing.

PubMed

Geraci, C L; Tinkle, S S; Brenner, S A; Hodson, L L; Pomeroy-Carter, C A; Neu-Baker, N

2018-06-01

Emerging and novel technologies, materials, and information integrated into increasingly automated and networked manufacturing processes or into traditional manufacturing settings are enhancing the efficiency and productivity of manufacturing. Globally, there is a move toward a new era in manufacturing that is characterized by: (1) the ability to create and deliver more complex designs of products; (2) the creation and use of materials with new properties that meet a design need; (3) the employment of new technologies, such as additive and digital techniques that improve on conventional manufacturing processes; and (4) a compression of the time from initial design concept to the creation of a final product. Globally, this movement has many names, but "advanced manufacturing" has become the shorthand for this complex integration of material and technology elements that enable new ways to manufacture existing products, as well as new products emerging from new technologies and new design methods. As the breadth of activities associated with advanced manufacturing suggests, there is no single advanced manufacturing industry. Instead, aspects of advanced manufacturing can be identified across a diverse set of business sectors that use manufacturing technologies, ranging from the semiconductors and electronics to the automotive and pharmaceutical industries. The breadth and diversity of advanced manufacturing may change the occupational and environmental risk profile, challenge the basic elements of comprehensive health and safety (material, process, worker, environment, product, and general public health and safety), and provide an opportunity for development and dissemination of occupational and environmental health and safety (OEHS) guidance and best practices. It is unknown how much the risk profile of different elements of OEHS will change, thus requiring an evolution of health and safety practices. These changes may be accomplished most effectively through multi-disciplinary, multi-sector, public-private dialogue that identifies issues and offers solutions.

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.

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.

Socio-Technical Systems Analysis in Health Care: A Research Agenda

PubMed Central

Bass, Ellen; Bellandi, Tommaso; Gurses, Ayse; Hallbeck, Susan; Mollo, Vanina

2012-01-01

Given the complexity of health care and the ‘people’ nature of healthcare work and delivery, STSA (Sociotechnical Systems Analysis) research is needed to address the numerous quality of care problems observed across the world. This paper describes open STSA research areas, including workload management, physical, cognitive and macroergonomic issues of medical devices and health information technologies, STSA in transitions of care, STSA of patient-centered care, risk management and patient safety management, resilience, and feedback loops between event detection, reporting and analysis and system redesign. PMID:22611480

The Hours: between safety and servitude.

PubMed

Charles, Marilyn

2004-09-01

This paper explores the issue of how character is created and re-created in the context of relationships. This theme, salient in the recent film The Hours, has been particularly problematic for creative women, who are often caught in tensions between self-development and relationship. Two case examples are given, in counterpoint to the film and to illustrations from Woolf's life and work. Through these various lenses, we can consider the complex interplays between our conjectures as to the expected price of relationship, and the actual price exacted as our various dramas unfold.

RICIS research

NASA Technical Reports Server (NTRS)

Mckay, Charles W.; Feagin, Terry; Bishop, Peter C.; Hallum, Cecil R.; Freedman, Glenn B.

1987-01-01

The principle focus of one of the RICIS (Research Institute for Computing and Information Systems) components is computer systems and software engineering in-the-large of the lifecycle of large, complex, distributed systems which: (1) evolve incrementally over a long time; (2) contain non-stop components; and (3) must simultaneously satisfy a prioritized balance of mission and safety critical requirements at run time. This focus is extremely important because of the contribution of the scaling direction problem to the current software crisis. The Computer Systems and Software Engineering (CSSE) component addresses the lifestyle issues of three environments: host, integration, and target.

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.

Achieving the Proper Balance Between Crew and Public Safety

NASA Technical Reports Server (NTRS)

Gowan, John; Silvestri, Ray; Stahl, Ben; Rosati, Paul; Wilde, Paul

2011-01-01

A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the Federal Aviation Administration (FAA) and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

Achieving the Proper Balance between Crew & Public Safety

NASA Astrophysics Data System (ADS)

Wilde, P.; Gowan, J.; Silvestri, R.; Stahl, B.; Rosati, P.

2012-01-01

A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Crewed vehicle perspectives from the Federal Aviation Administration and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

76 FR 29335 - Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

...On January 12, 2009, the FAA published a notice of proposed rulemaking on qualification, service, and use of crewmembers and aircraft dispatchers. Because of the complexity of the issues and the concerns raised by commenters, the FAA is issuing this supplemental notice of proposed rulemaking. The FAA proposes to amend the regulations for crewmember and aircraft dispatcher training programs in domestic, flag, and supplemental operations. The proposed regulations enhance traditional training programs by requiring the use of flight simulation training devices for flightcrew members and including additional training and evaluation requirements for all crewmembers and aircraft dispatchers in areas that are critical to safety. The proposal also reorganizes and revises the qualification, training, and evaluation requirements. The proposed changes are intended to contribute significantly to reducing aviation accidents.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Corporate and program objectives focus on desired performance and results. ?Management decisions that affect how to meet these objectives now involve a complex mix of: technology, safety issues, operations, process considerations, employee considerations, regulatory requirements, financial concerns and legal issues. ?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. Using a risk assessment methodology is only a starting point. ?A risk assessment program provides management with important input in the decision making process. ?A pro-active organization looks to the future to avoid problems, a reactive organization can be blindsided by risks that could have been avoided. ?You get out what you put in, how useful your program is will be up to the individual organization.

Institutional ethical review and ethnographic research involving injection drug users: a case study.

PubMed

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Evolution of Process Safety: Current Status and Future Direction.

PubMed

Mannan, M Sam; Reyes-Valdes, Olga; Jain, Prerna; Tamim, Nafiz; Ahammad, Monir

2016-06-07

The advent of the industrial revolution in the nineteenth century increased the volume and variety of manufactured goods and enriched the quality of life for society as a whole. However, industrialization was also accompanied by new manufacturing and complex processes that brought about the use of hazardous chemicals and difficult-to-control operating conditions. Moreover, human-process-equipment interaction plus on-the-job learning resulted in further undesirable outcomes and associated consequences. These problems gave rise to many catastrophic process safety incidents that resulted in thousands of fatalities and injuries, losses of property, and environmental damages. These events led eventually to the necessity for a gradual development of a new multidisciplinary field, referred to as process safety. From its inception in the early 1970s to the current state of the art, process safety has come to represent a wide array of issues, including safety culture, process safety management systems, process safety engineering, loss prevention, risk assessment, risk management, and inherently safer technology. Governments and academic/research organizations have kept pace with regulatory programs and research initiatives, respectively. Understanding how major incidents impact regulations and contribute to industrial and academic technology development provides a firm foundation to address new challenges, and to continue applying science and engineering to develop and implement programs to keep hazardous materials within containment. Here the most significant incidents in terms of their impact on regulations and the overall development of the field of process safety are described.

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

A Total Management Measurement Model for the Naval Weapons Center

DTIC Science & Technology

1991-02-01

Efficiency Productivity Public safety Employee safety Safety’Sccurity Customer safety Product security _ Quality of worklife Corporate Concern for...3 Corporate-ievel measures should represent a balance of in-house expertise; types of customers; and issues that surpass the customers’ I expertise...consideration. Examining the balance of distribution of these resources is also important. Addressing these issues would link the best potential to the most

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.

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.

Non-English Speaking Background Workers' Literacies--a Health and Safety Issue.

ERIC Educational Resources Information Center

Wyatt-Smith, Claire; Castleton, Geraldine

1995-01-01

Summarizes the experiences of workers from non-English-speaking backgrounds (NESB) in accessing safety information. The article examines the issue through the workers' eyes and focuses on the potential relationships between language and literacy and workplace health and safety and a concern for the reasons why some NESB workers are losers in…

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...

Space station crew safety: Human factors interaction model

NASA Technical Reports Server (NTRS)

Cohen, M. M.; Junge, M. K.

1985-01-01

A model of the various human factors issues and interactions that might affect crew safety is developed. The first step addressed systematically the central question: How is this space station different from all other spacecraft? A wide range of possible issue was identified and researched. Five major topics of human factors issues that interacted with crew safety resulted: Protocols, Critical Habitability, Work Related Issues, Crew Incapacitation and Personal Choice. Second, an interaction model was developed that would show some degree of cause and effect between objective environmental or operational conditions and the creation of potential safety hazards. The intermediary steps between these two extremes of causality were the effects on human performance and the results of degraded performance. The model contains three milestones: stressor, human performance (degraded) and safety hazard threshold. Between these milestones are two countermeasure intervention points. The first opportunity for intervention is the countermeasure against stress. If this countermeasure fails, performance degrades. The second opportunity for intervention is the countermeasure against error. If this second countermeasure fails, the threshold of a potential safety hazard may be crossed.

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

Diabetes Drugs and Cardiovascular Safety

PubMed Central

2016-01-01

Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration. PMID:27302713

Cross-border healthcare: Directive 2011/24 and the Greek law.

PubMed

Vidalis, Takis; Kyriakaki, Irini

2014-03-01

The Greek legal framework on healthcare is characterized by the complexity of an immense number of laws and regulatory acts, particularly regarding the national health system. In the face front of that problem, the Directive stands as an effort (and an opportunity) to achieve a regulatory rationalization. The Law 3918/2011 established the National Organisation for Healthcare (EOPYY). EOPYY is the unique national contact point in the country for the purposes of the Directive, having a responsibility to ensure that the services provided by its affiliated healthcare providers meet certain quality and safety standards. Furthermore, the Greek legal system encompasses an integrated body of legislation on informed consent, privacy, and data protection, as well as an explicit reference to the 'quality, safety and efficiency' of medical services, and provisions related to reimbursement issues that need further regulatory specification.

The reemergence of the trampoline as a recreational activity and competitive sport.

PubMed

Esposito, Paul W; Esposito, Lisa M

2009-01-01

The recreational use of trampolines is widespread and growing rapidly around the world. The reported incidence of significant injuries continues to increase despite more than three decades of attempts to educate the public on the inherent dangers of trampolines and appropriate safety rules for their use. Competitive trampolining also is growing, although there is scant medical literature related to training issues and injuries to assist the physician in guiding and treating these athletes. It is anticipated that with the increased use of trampolines and with the evolution of ever more complex competitive techniques and routines, the potential for catastrophic injuries in competition will increase. This article discusses awareness of the risks and attempts to mitigate injuries. It remains unclear, from an injury risk standpoint, whether trampolines can be used with an acceptable degree of safety.

Nurses' Perceptions and Practices Toward Clinical Alarms in a Transplant Cardiac Intensive Care Unit: Exploring Key Issues Leading to Alarm Fatigue

PubMed Central

Tarriela, Albert Fajardo; Gomez, Tiffany Michelle; Reed, Charles Calhoun; Rapp, Kami Marie

2015-01-01

Background Intensive care units (ICUs) are complex work environments where false alarms occur more frequently than on non-critical care units. The Joint Commission National Patient Safety Goal .06.01.01 targeted improving the safety of clinical alarm systems and required health care facilities to establish alarm systems safety as a hospital priority by July 2014. An important initial step toward this requirement is identifying ICU nurses’ perceptions and common clinical practices toward clinical alarms, where little information is available. Objective Our aim was to determine perceptions and practices of transplant/cardiac ICU (TCICU) nurses toward clinical alarms and benchmark the results against the 2011 Healthcare Technology Foundation’s (HTF) Clinical Alarms Committee Survey. Methods A quality improvement project was conducted on a 20-bed TCICU with 39 full- and part-time nurses. Nurses were surveyed about their perceptions and attitudes toward and practices on clinical alarms using an adapted HTF clinical alarms survey. Results were compared to the 2011 HTF data. Correlations among variables were examined. Results All TCICU nurses provided usable responses (N=39, 100%). Almost all nurses (95%-98%) believed that false alarms are frequent, disrupt care, and reduce trust in alarm systems, causing nurses to inappropriately disable them. Unlike the 2011 HTF clinical alarms survey results, a significantly higher percentage of our TCICU nurses believed that existing devices are complex, questioned the ability and adequacy of the new monitoring systems to solve alarm management issues, pointed to the lack of prompt response to alarms, and indicated the lack of clinical policy on alarm management (P<.01). Major themes in the narrative data focused on nurses’ frustration related to the excessive number of alarms and poor usability of the cardiac monitors. A lack of standardized approaches exists in changing patients’ electrodes and individualizing parameters. Around 60% of nurses indicated they received insufficient training on bedside and central cardiac monitors. A correlation also showed the need for training on cardiac monitors, specifically for older nurses (P=.01). Conclusions False and non-actionable alarms continue to desensitize TCICU nurses, perhaps resulting in missing fatal alarms. Nurses’ attitudes and practices related to clinical alarms are key elements for designing contextually sensitive quality initiatives to fight alarm fatigue. Alarm management in ICUs is a multidimensional complex process involving usability of monitoring devices, and unit, clinicians, training, and policy-related factors. This indicates the need for a multi-method approach to decrease alarm fatigue and improve alarm systems safety. PMID:27025940

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study.

PubMed

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-27

Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. 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/.

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.

Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.

PubMed

Dothel, Giovanni; Raschi, Emanuel; Rimondini, Roberto; De Ponti, Fabrizio

2016-11-07

The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodent vs human MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves ( e.g ., supernatants).

An innovative approach to interdisciplinary occupational safety and health education.

PubMed

Rosen, Mitchel A; Caravanos, Jack; Milek, Debra; Udasin, Iris

2011-07-01

The New York and New Jersey Education and Research Center (ERC) provides a range of graduate continuing education for occupational safety and health (OSH) professionals in training. A key element of the education is to provide interdisciplinary training to industrial hygienists, ergonomists, occupational medicine physicians and other health and safety trainees to prepare them for the collaboration required to solve the complex occupational health and safety problems they will face in their careers. This center has developed an innovative interdisciplinary training approach that provides an historical aspect, while allowing the graduate students to identify solutions to occupational issues from a multi-disciplinary approach. The ERC developed a tour that brings students to sites of historical and/or contemporary significance in the occupational safety and health and environmental fields. The ERC has conducted five tours, and has included 85 students and residents as participants. 80% of participants rated the tour as providing a high amount of OSH knowledge gained. 98% of the participants felt the goal of providing interdisciplinary education was achieved. This tour has been successful in bridging the OSH fields to better understand how occupational and environmental exposures have occurred, in order to prevent future exposures so that workplace conditions and health can be improved. Copyright © 2011 Wiley-Liss, Inc.

Using Space Syntax to Assess Safety in Public Areas - Case Study of Tarbiat Pedestrian Area, Tabriz-Iran

NASA Astrophysics Data System (ADS)

Cihangir Çamur, Kübra; Roshani, Mehdi; Pirouzi, Sania

2017-10-01

In studying the urban complex issues, simulation and modelling of public space use considerably helps in determining and measuring factors such as urban safety. Depth map software for determining parameters of the spatial layout techniques; and Statistical Package for Social Sciences (SPSS) software for analysing and evaluating the views of the pedestrians on public safety were used in this study. Connectivity, integration, and depth of the area in the Tarbiat city blocks were measured using the Space Syntax Method, and these parameters are presented as graphical and mathematical data. The combination of the results obtained from the questionnaire and statistical analysis with the results of spatial arrangement technique represents the appropriate and inappropriate spaces for pedestrians. This method provides a useful and effective instrument for decision makers, planners, urban designers and programmers in order to evaluate public spaces in the city. Prior to physical modification of urban public spaces, space syntax simulates the pedestrian safety to be used as an analytical tool by the city management. Finally, regarding the modelled parameters and identification of different characteristics of the case, this study represents the strategies and policies in order to increase the safety of the pedestrians of Tarbiat in Tabriz.

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

PubMed

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

2018-04-01

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

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.

Seniors managing multiple medications: using mixed methods to view the home care safety lens.

PubMed

Lang, Ariella; Macdonald, Marilyn; Marck, Patricia; Toon, Lynn; Griffin, Melissa; Easty, Tony; Fraser, Kimberly; MacKinnon, Neil; Mitchell, Jonathan; Lang, Eddy; Goodwin, Sharon

2015-12-12

Patient safety is a national and international priority with medication safety earmarked as both a prevalent and high-risk area of concern. To date, medication safety research has focused overwhelmingly on institutional based care provided by paid healthcare professionals, which often has little applicability to the home care setting. This critical gap in our current understanding of medication safety in the home care sector is particularly evident with the elderly who often manage more than one chronic illness and a complex palette of medications, along with other care needs. This study addresses the medication management issues faced by seniors with chronic illnesses, their family, caregivers, and paid providers within Canadian publicly funded home care programs in Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS). Informed by a socio-ecological perspective, this study utilized Interpretive Description (ID) methodology and participatory photographic methods to capture and analyze a range of visual and textual data. Three successive phases of data collection and analysis were conducted in a concurrent, iterative fashion in eight urban and/or rural households in each province. A total of 94 participants (i.e., seniors receiving home care services, their family/caregivers, and paid providers) were interviewed individually. In addition, 69 providers took part in focus groups. Analysis was iterative and concurrent with data collection in that each interview was compared with subsequent interviews for converging as well as diverging patterns. Six patterns were identified that provide a rich portrayal of the complexity of medication management safety in home care: vulnerabilities that impact the safe management and storage of medication, sustaining adequate supports, degrees of shared accountability for care, systems of variable effectiveness, poly-literacy required to navigate the system, and systemic challenges to maintaining medication safety in the home. There is a need for policy makers, health system leaders, care providers, researchers, and educators to work with home care clients and caregivers on three key messages for improvement: adapt care delivery models to the home care landscape; develop a palette of user-centered tools to support medication safety in the home; and strengthen health systems integration.

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.

Addressing the human factors issues associated with control room modifications

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

O`Hara, J.; Stubler, W.; Kramer, J.

1998-03-01

Advanced human-system interface (HSI) technology is being integrated into existing nuclear plants as part of plant modifications and upgrades. The result of this trend is that hybrid HSIs are created, i.e., HSIs containing a mixture of conventional (analog) and advanced (digital) technology. The purpose of the present research is to define the potential effects of hybrid HSIs on personnel performance and plant safety and to develop human factors guidance for safety reviews of them where necessary. In support of this objective, human factors issues associated with hybrid HSIs were identified. The issues were evaluated for their potential significance to plantmore » safety, i.e., their human performance concerns have the potential to compromise plant safety. The issues were then prioritized and a subset was selected for design review guidance development.« less

Lightning Impacts on Airports - Challenges of Balancing Safety & Efficiency

NASA Astrophysics Data System (ADS)

Steiner, Matthias; Deierling, Wiebke; Nelson, Eric; Stone, Ken

2013-04-01

Thunderstorms and lightning pose a safety risk to personnel working outdoors, such as people maintaining airport grounds (e.g., mowing grass or repairing runway lighting) or servicing aircraft on ramps (handling baggage, food service, refueling, tugging and guiding aircraft from/to gates, etc.). Since lightning strikes can cause serious injuries or death, it is important to provide timely alerts to airport personnel so that they can get to safety when lightning is imminent. This presentation discusses the challenges and uncertainties involved in using lightning information and stakeholder procedures to ensure safety of outdoor personnel while keeping ramp operations as efficient as possible considering thunderstorm impacts. The findings presented are based on extensive observations of airline operators under thunderstorm impacts. These observations reveal a complex picture with substantial uncertainties related to the (1) source of lightning information (e.g., sensor type, network, data processing) used to base ramp closure decisions on, (2) uncertainties involved in the safety procedures employed by various stakeholders across the aviation industry (yielding notably different rules being applied by multiple airlines even at a single airport), and (3) human factors issues related to the use of decision support tools and the implementation of safety procedures. This research is supported by the United States Federal Aviation Administration (FAA). The views expressed are those of the authors and do not necessarily represent the official policy or position of the FAA.

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...

[Developing traditional Chinese medicine injection is the need for curing sickness to save patients].

PubMed

He, Ping; Li, Feng-Jie; Li, Lian-da; Li, Yi-Kui

2017-03-01

Safety issues of traditional Chinese medicine injections has been heated debate. There are two diametrically opposed views: it should be used reasonable and developed healthily or be forbidden to use. Some people have many misunderstandings and prejudices about the safety of traditional Chinese medicine injections. Compared with western medicine,traditional Chinese medicine has its own particularity. Traditional Chinese medicine has complex components. Its research and clinical application is different from western medicine. Adverse reactions of traditional Chinese medicine injections are related to many factors,such as a large number of irrational use,blind use of traditional Chinese medicine injections and western medicine injections,counterfeit and substandard drugs,incorrect methods of intravenous infusion,toxicity of supplementary materials,drug ingredients. Developing traditional Chinese medicine injection is the need for curing sickness to save patients. The purposeful, targeted, organized and planned systematic research of traditional Chinese medicine injections should be strengthened,especially the safety of traditional Chinese medicine. Strengthen supervision and control of rational drug use.Strengthen the examination and approval,supervision and management of all aspects to ensure the safety of patients. Copyright© by the Chinese Pharmaceutical Association.

The second “time-out”: a surgical safety checklist for lengthy robotic surgeries

PubMed Central

2013-01-01

Robotic surgeries of long duration are associated with both increased risks to patients as well as distinct challenges for care providers. We propose a surgical checklist, to be completed during a second “time-out”, aimed at reducing peri-operative complications and addressing obstacles presented by lengthy robotic surgeries. A review of the literature was performed to identify the most common complications of robotic surgeries with extended operative times. A surgical checklist was developed with the goal of addressing these issues and maximizing patient safety. Extended operative times during robotic surgery increase patient risk for position-related complications and other adverse events. These cases also raise concerns for surgical, anesthesia, and nursing staff which are less common in shorter, non-robotic operations. Key elements of the checklist were designed to coordinate operative staff in verifying patient safety while addressing the unique concerns within each specialty. As robotic surgery is increasingly utilized, operations with long surgical times may become more common due to increased case complexity and surgeons overcoming the learning curve. A standardized surgical checklist, conducted three to four hours after the start of surgery, may enhance perioperative patient safety and quality of care. PMID:23731776

Food Crises and Food Safety Incidents in European Union, United States, and Maghreb Area: Current Risk Communication Strategies and New Approaches.

PubMed

Chammem, Nadia; Issaoui, Manel; De Almeida, Ana Isabel Dâmaso; Delgado, Amélia Martins

2018-03-22

Globalization has created a dynamic market, which has dramatically intensified interchanges of goods and information as well as the flow of people among nations. This international phenomenon offers the consumer a choice between a wide variety of foods from diverse locations. However, there are challenges to improving food security and safety on a global scale; the major question is how food safety can be guaranteed while increasing the complexity of food supply chains. A food produced in a certain location usually contains ingredients, additives, and preservatives from different and distant origins. Although countries take several food control measures, their institutional and regulatory frameworks diverge widely, as do the definitions of food crisis, food incidents, and risk management approaches. The present review discusses some past food safety issues and lessons learned. Convergences and differences in the regulatory framework of food control agencies in different regions of the world are herein revealed. Emerging risks are also discussed, particularly the spread of antibiotic resistance in the food chain and the environment, as well as the rise of new antibiotic-resistant pathogenic strains with broader tolerance to environmental factors.

Biosimilar therapeutics-what do we need to consider?

PubMed

Schellekens, Huub

2009-01-01

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as 'biosimilars' (European Union) or 'follow-on protein products' (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.

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.

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.

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

GunderKids: Design of a Clinical Care Management Program for Parents With Substance Abuse and Their Newborn Children with a Focus on Preventing Child Abuse.

PubMed

Budzak-Garza, Ann E; Allmon Dixson, Allison L; Holzer, Renee A; Lillard-Pierce, Kaitlin E; Devine, Carolynn J

2018-03-01

In response to an increased need to care for babies born to mothers with substance abuse issues, we developed GunderKids, a care management program that provides integrated medical care beyond standard-of-care, well-child appointments for these socially complex families. The program incorporates frequent visits to the pediatrician and the care team, which includes pediatric nurses, a pediatric social worker, and a child psychologist. Enrollment is voluntary. Each visit addresses parenting challenges, home environment, basic needs, safety issues, and maintenance of sobriety, as well as child development and health issues. We found that mothers and fathers (or parents) welcome intense support following delivery, appreciate the relationship that is built with the care team, and prefer frequent visits at the medical center over in-home visits, which they perceive as potentially intrusive. We describe here the planning and implementation of the program, as well as insights gained in our first year. Copyright© Wisconsin Medical Society.

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.

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…

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

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.

Hybrid optical security system using photonic crystals and MEMS devices

NASA Astrophysics Data System (ADS)

Ciosek, Jerzy; Ostrowski, Roman

2017-10-01

An important issue in security systems is that of selection of the appropriate detectors or sensors, whose sensitivity guarantees functional reliability whilst avoiding false alarms. Modern technology enables the optimization of sensor systems, tailored to specific risk factors. In optical security systems, one of the safety parameters considered is the spectral range in which the excitation signal is associated with a risk factor. Advanced safety systems should be designed taking into consideration the possible occurrence of, often multiple, complex risk factors, which can be identified individually. The hazards of concern in this work are chemical warfare agents and toxic industrial compounds present in the forms of gases and aerosols. The proposed sensor solution is a hybrid optical system consisting of a multi-spectral structure of photonic crystals associated with a MEMS (Micro Electro-Mechanical System) resonator. The crystallographic structures of carbon present in graphene rings and graphenecarbon nanotube nanocomposites have properties which make them desirable for use in detectors. The advantage of this system is a multi-spectral sensitivity at the same time as narrow-band selectivity for the identification of risk factors. It is possible to design a system optimized for detecting specified types of risk factor from very complex signals.

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.

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.

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...

Donor motivations, associated risks and ethical considerations of oocyte donation.

PubMed

Boutelle, Amy L

2014-01-01

Three decades after the first reported successful cases, oocyte donation continues to grow in popularity and regard as an established method to aid women in achieving their reproductive goals. As a result of the increased demand for donated oocytes, many young women in the U.S. volunteer to undergo complex medical procedures to donate their oocytes in return for financial compensation. To best care for these women before, during and after donation, it is important to explore donor characteristics and motivations, discuss the safety of the donation procedure and examine the ethical issues related to this process. © 2014 AWHONN.

Women's experiences of participation in a feminist group for women with complex mental health issues.

PubMed

Clements Eaton, Emma Catherine; Cox, Rachel

2015-01-01

A sample of women (n = 5) participated in a qualitative service evaluation concerning an open-ended, therapeutic group for women only. Data analysis followed suggestions by Halcomb and Davidson (2006). Main themes derived from the evaluation included: 'Groups are different from individual work', 'Belonging/ not being alone', 'Performance in the group', 'The group as a safety net', 'Life improvements and hope for the future' and 'The extent of emotional despair felt'. In this paper, several sub-themes within the main themes and relevant theories and implications for theory and service provision are discussed.

Transcranial Electrical Stimulation to Enhance Cognitive Performance of Healthy Minors: A Complex Governance Challenge

PubMed Central

Schuijer, Jantien W.; de Jong, Irja M.; Kupper, Frank; van Atteveldt, Nienke M.

2017-01-01

An increasing number of healthy adolescents are consuming products that can enhance their cognitive performance in educational settings. Currently, the use of pharmaceuticals is the most widely discussed enhancement method in the literature, but new evidence suggests that other methods based on Transcranial Electrical Stimulation (tES) also have potential as cognitive enhancer. Just like pharmaceutical enhancers, the availability and education-related use of tES-devices raise a broad range of ethical, legal, and societal issues that need to be addressed by policy-makers. Few studies, however, have specifically explored these issues in relation to child wellbeing. In this narrative review with systematic search, we describe the issues for child wellbeing that could arise from the availability and education-related use of tES-based enhancers by healthy minors. We demonstrate that the issues form a complex web of uncertainties and concerns, which are mainly incited by two factors. First is the high level of factual uncertainty due to gaps in empirical evidence about the exact working mechanisms and efficacy of tES. Moreover, a lack of insight into the technique’s (long-term) effects on healthy developing brains, and uncertainties about potential cognitive trade-offs have fueled concerns about the technique’s safety and impact. The second factor that contributes to the complexity of issues is the presence of moral diversity in our society. Different opinions exist on whether a certain enhancement effect would be desirable and whether potential risks would be acceptable. These opinions depend on one’s moral perspective, and the way one interprets and weights values such as the child’s autonomy and authenticity. The challenge for proper governance resides in the design of an appropriate framework that is capable of balancing the different moral perspectives in society, while recognizing the uncertainties that still exist. We therefore argue for a responsible innovation approach, which encourages an adaptive attitude toward emerging knowledge and dynamic societal values, to deal with the identified issues regarding tES-based enhancement appropriately. PMID:28396631

Adapting Dialectical Behavior Therapy for the Treatment of Dissociative Identity Disorder.

PubMed

Foote, Brad; Van Orden, Kim

2016-12-31

Dialectical Behavior Therapy (DBT), created by Marsha Linehan, has been shown to be an effective therapy for the treatment of borderline personality disorder (BPD) and for suicidal and self-harming behavior. Dissociative identity disorder (DID) is a complex post-traumatic disorder which is highly comorbid with BPD, shares a number of clinical features with BPD, and which like BPD features a high degree of suicidality. The DID treatment literature emphasizes the importance of a staged approach, beginning with the creation of a safe therapeutic frame prior to addressing traumatic material; DBT is also a staged treatment, in which behavioral and safety issues are addressed in Stage 1, and trauma work reserved for Stage 2. The authors describe adapting DBT, and especially its techniques for Stage 1 safety work, for work with DID patients. Basic theoretical principles are described and illustrated with a case example.

Adapting Dialectical Behavior Therapy for the Treatment of Dissociative Identity Disorder

PubMed Central

Foote, Brad; Van Orden, Kim

2017-01-01

Dialectical Behavior Therapy, created by Marsha Linehan, has been shown to be an effective therapy for the treatment of borderline personality disorder (BPD) and for suicidal and self-harming behavior. Dissociative identity disorder (DID) is a complex post-traumatic disorder which is highly comorbid with BPD, shares a number of clinical features with BPD, and which like BPD features a high degree of suicidality. The DID treatment literature emphasizes the importance of a staged approach, beginning with the creation of a safe therapeutic frame prior to addressing traumatic material; DBT is also a staged treatment, where behavioral and safety issues are addressed in Stage 1 and trauma work reserved for Stage 2. The authors describe adapting DBT, and especially its techniques for Stage 1 safety work, for work with DID patients. Basic theoretical principles are described and illustrated with a case example. PMID:28068498

A new approach of active compliance control via fuzzy logic control for multifingered robot hand

NASA Astrophysics Data System (ADS)

Jamil, M. F. A.; Jalani, J.; Ahmad, A.

2016-07-01

Safety is a vital issue in Human-Robot Interaction (HRI). In order to guarantee safety in HRI, a model reference impedance control can be a very useful approach introducing a compliant control. In particular, this paper establishes a fuzzy logic compliance control (i.e. active compliance control) to reduce impact and forces during physical interaction between humans/objects and robots. Exploiting a virtual mass-spring-damper system allows us to determine a desired compliant level by understanding the behavior of the model reference impedance control. The performance of fuzzy logic compliant control is tested in simulation for a robotic hand known as the RED Hand. The results show that the fuzzy logic is a feasible control approach, particularly to control position and to provide compliant control. In addition, the fuzzy logic control allows us to simplify the controller design process (i.e. avoid complex computation) when dealing with nonlinearities and uncertainties.

Reducing Falls After Electroconvulsive Therapy: A Quality Improvement Project.

PubMed

Brown, Allana Marie

2017-07-01

Falls after electroconvulsive therapy (ECT) in patients 60 and older have been long recognized as a major clinical care issue across many mental health care settings. The evidence base for fall prevention strategies after receiving ECT is sparse. The risk factors for falls after ECT are vast and complex in nature, especially considering existing comorbid medical conditions. The dearth of research in guiding practitioners on fall reduction interventions for this patient population illuminates a gap in mental health care quality and safety. The purpose of the current nurse-led quality improvement project was to reduce falls in patients undergoing ECT by enhancing safety measures through education and a post-ECT treatment protocol. The project did not prove to be as efficacious as anticipated as measured by fall rate outcomes. Several factors that may account for the project's findings are discussed. [Journal of Psychosocial Nursing and Mental Health Services, 55(7), 20-29.]. Copyright 2017, SLACK Incorporated.

Developing a proactive research agenda to advance nail salon worker health, safety, and rights.

PubMed

Quach, Thu; Liou, Julia; Fu, Lisa; Mendiratta, Anuja; Tong, My; Reynolds, Peggy

2012-01-01

Nail salons represent a burgeoning industry with Vietnamese immigrant workers making up the majority. Workers routinely handle cosmetic products containing hazardous compounds, with implications for their health. This paper describes how a collaborative of multiple organizations and community members collectively developed a proactive research agenda for salon worker health, safety, and rights during a pivotal multistakeholder convening, and advanced on such recommendations, including creating groundbreaking policy changes. Key recommendations included (1) creating a multidisciplinary research advisory committee, (2) conducting research on workplace exposures and long-term health impacts, (3) advocating for better governmental oversight of product manufacturers, and (4) identifying safer product alternatives via green chemistry, albeit with cost considerations to salon businesses. The participation of diverse stakeholders in the discussions allowed for cross-dialogue on a complex issue, helped to align different stakeholders as allies, and identified critical resources to addressing research gaps.

Considerations for management of patients with diabetic macular edema: Optimizing treatment outcomes and minimizing safety concerns through interdisciplinary collaboration.

PubMed

Strain, W David; Cos, Xavier; Prünte, Christian

2017-04-01

Diabetes is a growing worldwide epidemic and a leading cause of blindness in working-age people around the world. Diabetic retinopathy (DR) and diabetic macular edema (DME) are common causes of visual impairment in people with diabetes and often indicate the presence of diabetes-associated preclinical micro- and macrovascular complications. As such, patients with DR and DME often display complex, highly comorbid profiles. Several treatments are currently available for the treatment of DME, including anti-vascular endothelial growth factor (VEGF) agents, which are administered via intravitreal injection. While the safety profiles of approved ocular anti-VEGF therapies have been reassuring, the high-risk nature of the DME patient population means that treatment must be carefully considered and a holistic approach to disease management should be taken. This requires multidisciplinary, collaborative care involving all relevant specialties to ensure that patients not only receive prompt treatment for DME but also appropriate consideration is taken of any systemic comorbidities to evaluate and minimize potentially serious safety issues. Copyright © 2017. Published by Elsevier B.V.

Comparative study between single core model and detail core model of CFD modelling on reactor core cooling behaviour

NASA Astrophysics Data System (ADS)

Darmawan, R.

2018-01-01

Nuclear power industry is facing uncertainties since the occurrence of the unfortunate accident at Fukushima Daiichi Nuclear Power Plant. The issue of nuclear power plant safety becomes the major hindrance in the planning of nuclear power program for new build countries. Thus, the understanding of the behaviour of reactor system is very important to ensure the continuous development and improvement on reactor safety. Throughout the development of nuclear reactor technology, investigation and analysis on reactor safety have gone through several phases. In the early days, analytical and experimental methods were employed. For the last four decades 1D system level codes were widely used. The continuous development of nuclear reactor technology has brought about more complex system and processes of nuclear reactor operation. More detailed dimensional simulation codes are needed to assess these new reactors. Recently, 2D and 3D system level codes such as CFD are being explored. This paper discusses a comparative study on two different approaches of CFD modelling on reactor core cooling behaviour.

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

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.

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.

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 ...

[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.

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 ...

Juggling confidentiality and safety: a qualitative study of how general practice clinicians document domestic violence in families with children.

PubMed

Drinkwater, Jessica; Stanley, Nicky; Szilassy, Eszter; Larkins, Cath; Hester, Marianne; Feder, Gene

2017-06-01

Domestic violence and abuse (DVA) and child safeguarding are interlinked problems, impacting on all family members. Documenting in electronic patient records (EPRs) is an important part of managing these families. Current evidence and guidance, however, treats DVA and child safeguarding separately. This does not reflect the complexity clinicians face when documenting both issues in one family. To explore how and why general practice clinicians document DVA in families with children. A qualitative interview study using vignettes with GPs and practice nurses (PNs) in England. Semi-structured telephone interviews with 54 clinicians (42 GPs and 12 PNs) were conducted across six sites in England. Data were analysed thematically using a coding frame incorporating concepts from the literature and emerging themes. Most clinicians recognised DVA and its impact on child safeguarding, but struggled to work out the best way to document it. They described tensions among the different roles of the EPR: a legal document; providing continuity of care; information sharing to improve safety; and a patient-owned record. This led to strategies to hide information, so that it was only available to other clinicians. Managing DVA in families with children is complex and challenging for general practice clinicians. National integrated guidance is urgently needed regarding how clinicians should manage the competing roles of the EPR, while maintaining safety of the whole family, especially in the context of online EPRs and patient access. © British Journal of General Practice 2017.

Juggling confidentiality and safety: a qualitative study of how general practice clinicians document domestic violence in families with children

PubMed Central

Drinkwater, Jessica; Stanley, Nicky; Szilassy, Eszter; Larkins, Cath; Hester, Marianne; Feder, Gene

2017-01-01

Background Domestic violence and abuse (DVA) and child safeguarding are interlinked problems, impacting on all family members. Documenting in electronic patient records (EPRs) is an important part of managing these families. Current evidence and guidance, however, treats DVA and child safeguarding separately. This does not reflect the complexity clinicians face when documenting both issues in one family. Aim To explore how and why general practice clinicians document DVA in families with children. Design and setting A qualitative interview study using vignettes with GPs and practice nurses (PNs) in England. Method Semi-structured telephone interviews with 54 clinicians (42 GPs and 12 PNs) were conducted across six sites in England. Data were analysed thematically using a coding frame incorporating concepts from the literature and emerging themes. Results Most clinicians recognised DVA and its impact on child safeguarding, but struggled to work out the best way to document it. They described tensions among the different roles of the EPR: a legal document; providing continuity of care; information sharing to improve safety; and a patient-owned record. This led to strategies to hide information, so that it was only available to other clinicians. Conclusion Managing DVA in families with children is complex and challenging for general practice clinicians. National integrated guidance is urgently needed regarding how clinicians should manage the competing roles of the EPR, while maintaining safety of the whole family, especially in the context of online EPRs and patient access. PMID:28137783

Critical Incident Stress Management (CISM) in complex systems: cultural adaptation and safety impacts in healthcare.

PubMed

Müller-Leonhardt, Alice; Mitchell, Shannon G; Vogt, Joachim; Schürmann, Tim

2014-07-01

In complex systems, such as hospitals or air traffic control operations, critical incidents (CIs) are unavoidable. These incidents can not only become critical for victims but also for professionals working at the "sharp end" who may have to deal with critical incident stress (CIS) reactions that may be severe and impede emotional, physical, cognitive and social functioning. These CIS reactions may occur not only under exceptional conditions but also during every-day work and become an important safety issue. In contrast to air traffic management (ATM) operations in Europe, which have readily adopted critical incident stress management (CISM), most hospitals have not yet implemented comprehensive peer support programs. This survey was conducted in 2010 at the only European general hospital setting which implemented CISM program since 2004. The aim of the article is to describe possible contribution of CISM in hospital settings framed from the perspective of organizational safety and individual health for healthcare professionals. Findings affirm that daily work related incidents also can become critical for healthcare professionals. Program efficiency appears to be influenced by the professional culture, as well as organizational structure and policies. Overall, findings demonstrate that the adaptation of the CISM program in general hospitals takes time but, once established, it may serve as a mechanism for changing professional culture, thereby permitting the framing of even small incidents or near misses as an opportunity to provide valuable feedback to the system. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

Capacity planning in a transitional economy: What issues? Which models?

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

Mubayi, V.; Leigh, R.W.; Bright, R.N.

1996-03-01

This paper is devoted to an exploration of the important issues facing the Russian power generation system and its evolution in the foreseeable future and the kinds of modeling approaches that capture those issues. These issues include, for example, (1) trade-offs between investments in upgrading and refurbishment of existing thermal (fossil-fired) capacity and safety enhancements in existing nuclear capacity versus investment in new capacity, (2) trade-offs between investment in completing unfinished (under construction) projects based on their original design versus investment in new capacity with improved design, (3) incorporation of demand-side management options (investments in enhancing end-use efficiency, for example)more » within the planning framework, (4) consideration of the spatial dimensions of system planning including investments in upgrading electric transmission networks or fuel shipment networks and incorporating hydroelectric generation, (5) incorporation of environmental constraints and (6) assessment of uncertainty and evaluation of downside risk. Models for exploring these issues include low power shutdown (LPS) which are computationally very efficient, though approximate, and can be used to perform extensive sensitivity analyses to more complex models which can provide more detailed answers but are computationally cumbersome and can only deal with limited issues. The paper discusses which models can usefully treat a wide range of issues within the priorities facing decision makers in the Russian power sector and integrate the results with investment decisions in the wider economy.« less

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...

The complexity of patient safety reporting systems in UK dentistry.

PubMed

Renton, T; Master, S

2016-10-21

Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.

Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation.

PubMed

Pai, Amy Barton

2017-11-01

Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting. © 2017 New York Academy of Sciences.

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.

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.

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 ...

The impact of assay technology as applied to safety assessment in reducing compound attrition in drug discovery.

PubMed

Thomas, Craig E; Will, Yvonne

2012-02-01

Attrition in the drug industry due to safety findings remains high and requires a shift in the current safety testing paradigm. Many companies are now positioning safety assessment at each stage of the drug development process, including discovery, where an early perspective on potential safety issues is sought, often at chemical scaffold level, using a variety of emerging technologies. Given the lengthy development time frames of drugs in the pharmaceutical industry, the authors believe that the impact of new technologies on attrition is best measured as a function of the quality and timeliness of candidate compounds entering development. The authors provide an overview of in silico and in vitro models, as well as more complex approaches such as 'omics,' and where they are best positioned within the drug discovery process. It is important to take away that not all technologies should be applied to all projects. Technologies vary widely in their validation state, throughput and cost. A thoughtful combination of validated and emerging technologies is crucial in identifying the most promising candidates to move to proof-of-concept testing in humans. In spite of the challenges inherent in applying new technologies to drug discovery, the successes and recognition that we cannot continue to rely on safety assessment practices used for decades have led to rather dramatic strategy shifts and fostered partnerships across government agencies and industry. We are optimistic that these efforts will ultimately benefit patients by delivering effective and safe medications in a timely fashion.

System for decision analysis support on complex waste management issues

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

Shropshire, D.E.

1997-10-01

A software system called the Waste Flow Analysis has been developed and applied to complex environmental management processes for the United States Department of Energy (US DOE). The system can evaluate proposed methods of waste retrieval, treatment, storage, transportation, and disposal. Analysts can evaluate various scenarios to see the impacts to waste slows and schedules, costs, and health and safety risks. Decision analysis capabilities have been integrated into the system to help identify preferred alternatives based on a specific objectives may be to maximize the waste moved to final disposition during a given time period, minimize health risks, minimize costs,more » or combinations of objectives. The decision analysis capabilities can support evaluation of large and complex problems rapidly, and under conditions of variable uncertainty. The system is being used to evaluate environmental management strategies to safely disposition wastes in the next ten years and reduce the environmental legacy resulting from nuclear material production over the past forty years.« less

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.

Which sources of flavonoids: complex diets or dietary supplements?

PubMed

Egert, Sarah; Rimbach, Gerald

2011-01-01

There is increasing interest in the potential health benefits of dietary flavonoids. Fruits and vegetables, tea, and cocoa are rich natural sources of flavonoids. Epidemiological studies have indicated that consumption of these foods is likely to be associated with a reduced risk of cardiovascular disease, but the etiology of this benefit is not yet clearly defined. Furthermore, in some acute interventions, a positive effect of tea and cocoa on vascular function has been reported. An alternative source of flavonoids is dietary supplements, which have become increasingly popular in the recent past. In this context, it needs to be critically evaluated whether vascular health-promoting and other positive properties of flavonoid-rich diets can be replaced by purified flavonoids as dietary supplements. Plant sources of flavonoids contain a complex mixture of secondary plant metabolites and not only flavonoids per se. This complex mixture of secondary plant metabolites cannot be simply exchanged by single purified compounds as dietary supplements. If flavonoids are given as dietary supplements, toxicity issues as well as nutrient drug interactions need to be taken into account. Purified flavonoids given in high doses as dietary supplements may affect trace element, folate, and vitamin C status. Furthermore, they may exhibit antithyroid and goitrogenic activities. In this review article, the available literature on the safety issues surrounding high dose supplemental flavonoid consumption has been summarized.

Which Sources of Flavonoids: Complex Diets or Dietary Supplements?1

PubMed Central

Egert, Sarah; Rimbach, Gerald

2011-01-01

There is increasing interest in the potential health benefits of dietary flavonoids. Fruits and vegetables, tea, and cocoa are rich natural sources of flavonoids. Epidemiological studies have indicated that consumption of these foods is likely to be associated with a reduced risk of cardiovascular disease, but the etiology of this benefit is not yet clearly defined. Furthermore, in some acute interventions, a positive effect of tea and cocoa on vascular function has been reported. An alternative source of flavonoids is dietary supplements, which have become increasingly popular in the recent past. In this context, it needs to be critically evaluated whether vascular health-promoting and other positive properties of flavonoid-rich diets can be replaced by purified flavonoids as dietary supplements. Plant sources of flavonoids contain a complex mixture of secondary plant metabolites and not only flavonoids per se. This complex mixture of secondary plant metabolites cannot be simply exchanged by single purified compounds as dietary supplements. If flavonoids are given as dietary supplements, toxicity issues as well as nutrient drug interactions need to be taken into account. Purified flavonoids given in high doses as dietary supplements may affect trace element, folate, and vitamin C status. Furthermore, they may exhibit antithyroid and goitrogenic activities. In this review article, the available literature on the safety issues surrounding high dose supplemental flavonoid consumption has been summarized. PMID:22211185

A conceptual framework contributing to nursing administration and research.

PubMed

Biron, Alain D; Richer, Marie-Claire; Ezer, Hélène

2007-03-01

The health care system has undergone major changes in the last decade. With greater acuity and complexity of illness, the adoption of innovative technologies and the shortage of health care personnel, the coordination and integration of health care services has become increasingly demanding for administrators. Growing dissatisfaction and concerns about safety issues are being expressed by the users of care who need to navigate through an increasingly complex system and by health care personnel who feel less efficient within the organization. Nursing administrators have a responsibility to address these issues but there is little scientific evidence to guide their actions. There are also few comprehensive models highlighting the main components of nursing administration - models that could guide nursing administration research. This paper presents a conceptual framework for nursing administration and research that links patient health care needs, nursing resources and the nursing care processes to the context of the health care system, and the social, political and cultural environments of care. A selected review of the oncology and cancer care literature is presented to demonstrate how this framework can organize existing knowledge about these concepts in the context of cancer care.

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.

PubMed

Boudreaux, Edwin D; Miller, Ivan; Goldstein, Amy B; Sullivan, Ashley F; Allen, Michael H; Manton, Anne P; Arias, Sarah A; Camargo, Carlos A

2013-09-01

Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes. This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment. While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

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.…

Biosimilar therapeutics—what do we need to consider?

PubMed Central

Schellekens, Huub

2009-01-01

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions. The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance. Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data. PMID:19461855

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.

[Guidelines for wise utilization of knee imaging].

PubMed

Finestone, Aharon S; Eshed, Iris; Freedman, Yehuda; Beer, Yiftah; Bar-Sever, Zvi; Kots, Yavvgeni; Adar, Eliyahu; Mann, Gideon

2012-02-01

The knee is a complex structure afflicted with diverse pathologies. Correct management of knee complaints demands wise utilization of imaging modalities, considering their accuracy in the specific clinical situation, the patient's safety and availability and financial issues. Some of these considerations are universal, while others are local, depending on medical and insurance systems. There is controversy and unclearness regarding the best imaging modality in different clinical situations. To develop clinical guidelines for utilizing knee imaging. Leading physicians in specialties associated with knee disease and imaging were invited to participate in a panel on the guidelines. Controversies were settled in the main panel or in sub-panels. The panel agreed on the principles in choosing from the various modalities, primarily medical accuracy, followed by patient safety, availability and cost. There was agreement that the physician is responsible to choose the most appropriate diagnostic tool, consulting, when necessary, on the advantages, limitations and risks of the various imaging modalities. A comprehensive table was compiled with the importance of the different imaging modalities in various clinical situations. For the first time, Israeli guidelines on wise utilization of knee imaging are presented. They take into consideration the clinical situations and also availability and financial issues specific to Israel. These guidelines will serve physicians of several disciplines and medical insurers to improve patient management efficiently.

The carrier safety measurement system (CSMS) effectiveness test by behavior analysis and safety improvement categories (BASICs)

DOT National Transportation Integrated Search

2014-01-24

The Carrier Safety Measurement System (CSMS) is the Federal Motor Carrier Safety Administrations (FMCSA's) workload prioritization tool. This tool is used to identify carriers with potential safety issues so that they are subject to interventions ...

An RFID solution for enhancing inpatient medication safety with real-time verifiable grouping-proof.

PubMed

Chen, Yu-Yi; Tsai, Meng-Lin

2014-01-01

The occurrence of a medication error can threaten patient safety. The medication administration process is complex and cumbersome, and nursing staffs are prone to error when they are tired. Proper Information Technology (IT) can assist the nurse in correct medication administration. We review a recent proposal regarding a leading-edge solution to enhance inpatient medication safety by using RFID technology. The proof mechanism is the kernel concept in their design and worth studying to develop a well-designed grouping-proof scheme. Other RFID grouping-proof protocols could be similarly applied in administering physician orders. We improve on the weaknesses of previous works and develop a reading-order independent RFID grouping-proof scheme in this paper. In our scheme, tags are queried and verified under the direct control of the authorized reader without connecting to the back-end database server. Immediate verification in our design makes this application more portable and efficient and critical security issues have been analyzed by the threat model. Our scheme is suitable for the safe drug administration scenario and the drug package scenario in a hospital environment to enhance inpatient medication safety. It automatically checks for correct drug unit-dose and appropriate inpatient treatments. Copyright © 2013. Published by Elsevier Ireland Ltd.

Integrated Approaches to Occupational Health and Safety: A Systematic Review.

PubMed

Cooklin, A; Joss, N; Husser, E; Oldenburg, B

2017-09-01

The study objective was to conduct a systematic review of the effectiveness of integrated workplace interventions that combine health promotion with occupational health and safety. Electronic databases (n = 8), including PsychInfo and MEDLINE, were systematically searched. Studies included were those that reported on workplace interventions that met the consensus definition of an "integrated approach," published in English, in the scientific literature since 1990. Data extracted were occupation, worksite, country, sample size, intervention targets, follow-up period, and results reported. Quality was assessed according to American College of Occupational and Environmental Medicine Practice Guidelines. Heterogeneity precluded formal meta-analyses. Results were classified according to the outcome(s) assessed into five categories (health promotion, injury prevention, occupational health and safety management, psychosocial, and return-on-investment). Narrative synthesis of outcomes was performed. A total of 31 eligible studies were identified; 23 (74%) were (quasi-)experimental trials. Effective interventions were most of those aimed at improving employee physical or mental health. Less consistent results were reported from integrated interventions targeting occupational health and safety management, injury prevention, or organizational cost savings. Integrated approaches have been posed as comprehensive solutions to complex issues. Empirical evidence, while still emerging, provides some support for this. Continuing investment in, and evaluation of, integrated approaches are worthwhile.

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

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

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

Determinants of business sustainability: an ergonomics perspective.

PubMed

Genaidy, Ash M; Sequeira, Reynold; Rinder, Magda M; A-Rehim, Amal D

2009-03-01

There is a need to integrate both macro- and micro-ergonomic approaches for the effective implementation of interventions designed to improve the root causes of problems such as work safety, quality and productivity in the enterprise system. The objective of this study was to explore from an ergonomics perspective the concept of business sustainability through optimising the worker-work environment interface. The specific aims were: (a) to assess the working conditions of a production department work process with the goal to jointly optimise work safety, quality and quantity; (b) to evaluate the enterprise-wide work process at the system level as a social entity in an attempt to trace the root causes of ergonomic issues impacting employees throughout the work process. The Work Compatibility Model was deployed to examine the experiences of workers (that is, effort, perceived risk/benefit, performance and satisfaction/dissatisfaction or psychological impact) and their associations with the complex domains of the work environment (task content, physical and non-physical work environment and conditions for learning/growth/development). This was followed by assessment of the enterprise system through detailed interviews with department managers and lead workers. A system diagnostic instrument was also constructed from information derived from the published literature to evaluate the enterprise system performance. The investigation of the production department indicated that the stress and musculoskeletal pain experienced by workers (particularly on the day shift) were derived from sources elsewhere in the work process. The enterprise system evaluation and detailed interviews allowed the research team to chart the feed-forward and feedback stress propagation loops in the work system. System improvement strategies were extracted on the basis of tacit/explicit knowledge obtained from department managers and lead workers. In certain situations concerning workplace human performance issues, a combined macro-micro ergonomic methodology is essential to solve the productivity, quality and safety issues impacting employees along the trajectory or path of the enterprise-wide work process. In this study, the symptoms associated with human performance issues in one production department work process had root causes originating in the customer service department work process. In fact, the issues found in the customer service department caused performance problems elsewhere in the enterprise-wide work process such as the traffic department. Sustainable enterprise solutions for workplace human performance require the integration of macro- and micro-ergonomic approaches.

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.

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...

'Failure to fail' in nursing - A catch phrase or a real issue? A systematic integrative literature review.

PubMed

Hughes, Lynda J; Mitchell, Marion; Johnston, Amy N B

2016-09-01

'Failure to fail' is the allocation of pass grades to nursing students who do not display satisfactory clinical performance. This issue can have significant implications for individual students and assessors involved, as well as for nursing professionalism and patient safety. The aim of this systematic integrative literature review was to determine what is currently known about the issue of 'failure to fail' within undergraduate nursing programs. A literature search of five databases up to May 2015 was conducted to identify primary research papers. The search yielded 169 papers of which 24 met the inclusion criteria. The majority of papers had moderate or good methodological rigour, with most of the literature originating from the Northern Hemisphere. Five main themes emerged: failing a student is difficult; an emotional experience; confidence is required; unsafe student characteristics; and university support is required to fail students. The results suggest that 'failure to fail' is a real issue in tertiary facilities, with many complex facets. Given the costs of nurse education and the potential social and professional costs of poor quality nursing graduates, further rigorous research is required in this area. Copyright © 2016 Elsevier Ltd. All rights reserved.

Facing the challenges and building solutions in clinical psychiatric nursing in Iran: a qualitative study.

PubMed

Zarea, Kourosh; Nikbakht-Nasrabadi, Alireza; Abbaszadeh, Abbas; Mohammadpour, Ali

2012-10-01

Psychiatric nurses play an important role in the process of caring for mentally ill patients and are continually faced with the numerous challenges and complex issues related to this field. This study aimed to understand the perspectives of psychiatric nurses regarding the issues they face while providing care and examine the possible solutions for improvement of inpatient care in clinical settings. The study adopted a qualitative approach that utilized a content analysis of audio taped, semi-structured interviews that had been conducted with 24 nurses. Two main themes emerged from the data. The first, Challenges in Providing Care within Psychiatric Wards, had the following subthemes: Politics and Rules of Organization, Safety and Security Issues, Uncertainty about the Role, Lack of Trained Staff, and Sociocultural Issues. The second theme, Solutions for Improving Psychiatric Care, had the subthemes of Empowerment across four domains: Psychiatric Nurses, Mentally Ill Patients and their Families, The Psychiatric Mental Health System, and the Cultural Context. The results indicated that if nurses are expected to provide optimal nursing care within a psychiatric ward, then there is a need for a stable and responsible organizational structure, skilled psychiatric nurses, and community-based care along with an anti-stigma program.

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.

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

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.

Potential of near-infrared hyperspectral reflectance imaging for screening of farm feed contamination

NASA Astrophysics Data System (ADS)

Wang, Wenbo; Paliwal, Jitendra

2005-09-01

With the outbreak of Bovine Spongiform Encephalopathy (BSE) (commonly known as mad cow disease) in 1987 in the United Kingdom and a recent case discovered in Alberta, more and more emphasis is placed on food and farm feed quality and safety issues internationally. The disease is believed to be spread through farm feed contamination by animal byproducts in the form of meat-and-bone-meal (MBM). The paper reviewed the available techniques necessary to the enforcement of legislation concerning the feed safety issues. The standard microscopy method, although highly sensitive, is laborious and costly. A method to routinely screen farm feed contamination certainly helps to reduce the complexity of safety inspection. A hyperspectral imaging system working in the near-infrared wavelength region of 1100-1600 nm was used to study the possibility of detection of ground broiler feed contamination by ground pork. Hyperspectral images of raw broiler feed, ground broiler feed, ground pork, and contaminated feed samples were acquired. Raw broiler feed samples were found to possess comparatively large spectral variations due to light scattering effect. Ground feed adulterated with 1%, 3%, 5%, and 10% of ground pork was tested to identify feed contamination. Discriminant analysis using Mahalanobis distance showed that the model trained using pure ground feed samples and pure ground pork samples resulted in 100% false negative errors for all test replicates of contaminated samples. A discriminant model trained with pure ground feed samples and 10% contamination level samples resulted in 12.5% false positive error and 0% false negative error.

Non destructive testing of soft body armor

NASA Astrophysics Data System (ADS)

Bhise, Karan

Pristine bullet proof vests are extremely effective at halting pre-determined projectile threats and have saved over 3000 lives. However, the effectiveness of these vests to halt a bullet is seen to decrease over time.Owing to the importance of bullet proof vests over a period of time, tests to determine their effectiveness have been carried out on every batch of vests at the time of inception and at certain time intervals by shooting a bullet through them. A few vests from every batch are picked up and shot at to check for bullet penetration during this process while these results are extrapolated onto the other vests from the batch.One of the main issues with this method is the fact that testing a few jackets among a large set of jackets does not guarantee the safety of every jacket in the entire batch.Further the jackets that are shot-at have the possibility of undergoing substantial damage during the process thus compromising its safety rendering them unsafe for future use.As the vest penetration phenomenon is extremely complex too, there arose a need for a better testing procedure that could not only help ensure more safety, but also save time and money.The new testing procedure proposed a non-destructive evaluation of the jackets that would solve the issues previous faced in testing the vests. This would lead to the building of a portable set up which could be carried to any location to test jackets in a matter of minutes thus saving time and money.

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.

Abusive behavior is barrier to high-reliability health care systems, culture of patient safety.

PubMed

Cassirer, C; Anderson, D; Hanson, S; Fraser, H

2000-11-01

Addressing abusive behavior in the medical workplace presents an important opportunity to deliver on the national commitment to improve patient safety. Fundamentally, the issue of patient safety and the issue of abusive behavior in the workplace are both about harm. Undiagnosed and untreated, abusive behavior is a barrier to creating high reliability service delivery systems that ensure patient safety. Health care managers and clinicians need to improve their awareness, knowledge, and understanding of the issue of workplace abuse. The available research suggests there is a high prevalence of workplace abuse in medicine. Both administrators at the blunt end and clinicians at the sharp end should consider learning new approaches to defining and treating the problem of workplace abuse. Eliminating abusive behavior has positive implications for preventing and controlling medical injury and improving organizational performance.

75 FR 56549 - National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS...-1403. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate... pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH...

Effects of metric change on safety in the workplace for selected occupations

NASA Astrophysics Data System (ADS)

Lefande, J. M.; Pokorney, J. L.

1982-04-01

The study assesses the potential safety issues of metric conversion in the workplace. A purposive sample of 35 occupations based on injury and illnesses indexes were assessed. After an analysis of workforce population, hazard analysis and measurement sensitivity of the occupations, jobs were analyzed to identify potential safety hazards by industrial hygienists, safety engineers and academia. The study's major findings were as follows: No metric hazard experience was identified. An increased exposure might occur when particular jobs and their job tasks are going the transition from customary measurement to metric measurement. Well planned metric change programs reduce hazard potential. Metric safety issues are unresolved in the aviation industry.

LGBTQ-Inclusive Curricula: Why Supportive Curricula Matter

ERIC Educational Resources Information Center

Snapp, Shannon D.; McGuire, Jenifer K.; Sinclair, Katarina O.; Gabrion, Karlee; Russell, Stephen T.

2015-01-01

There is growing attention to lesbian, gay, bisexual, transgender, queer and questioning (LGBTQ) issues in schools, including efforts to address such issues through the curriculum. This study examines whether students' perceptions of personal safety and school climate safety are stronger when curricula that include LGBTQ people are present and…

Realized Benefits for First-Year Student Peer Educators

ERIC Educational Resources Information Center

Wawrzynski, Matthew R.; Beverly, Andrew M.

2012-01-01

This study investigated student-learning outcomes of college peer educators whose primary responsibility or interest was to address health and safety topics on campus, such as alcohol and illicit drug use, tobacco issues, sexual health and safety issues, nutrition, and violence prevention. Participants included 69 first-year college students who…

29 CFR 1902.42 - Effect of affirmative 18(e) determination.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., 13 and 17 of the Act shall not apply with respect to those occupational safety and health issues... 1902.42 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Secretary shall retain his authority under the above sections for those issues covered in the plan which...

29 CFR 1902.42 - Effect of affirmative 18(e) determination.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 13 and 17 of the Act shall not apply with respect to those occupational safety and health issues... 1902.42 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Secretary shall retain his authority under the above sections for those issues covered in the plan which...

Ukraine: Current Issues and U.S. Policy

DTIC Science & Technology

2014-02-26

The United States also pledged to continue to cooperate with Ukraine on nuclear safety issues, including the cleanup of the Chernobyl nuclear...Congressional Research Service 13 A significant portion of U.S. aid to Ukraine in the ESF account is dedicated to improving the safety of the Chernobyl nuclear

Improving Safety of the Surface Transportation System by Addressing the Issues of Vulnerable Road Users : Case of the Motorcyclists

DOT National Transportation Integrated Search

2012-07-01

Over the past few years, motorcycle fatalities have increased at an alarming rate in the United States. Motorcycle safety issues in Kansas : are no different from the national scenario. Accordingly, this study examines motorcycle crashes in Kansas in...

Internet Safety Issues for Adolescents and Adults with Intellectual Disabilities

ERIC Educational Resources Information Center

Buijs, Petra C. M.; Boot, Erik; Shugar, Andrea; Fung, Wai Lun Alan; Bassett, Anne S.

2017-01-01

Background: Research on Internet safety for adolescents has identified several important issues including unwanted exposure to sexual material and sexual solicitation. Methods: Although individuals with intellectual disabilities often have poor insight and judgment, and may therefore be at risk for Internet dangers, there is surprisingly little…

A review of technology and safety aspects of erbium lasers in dentistry.

PubMed

Clarkson, D M

2001-01-01

This article reviews aspects of the probable mechanisms used by erbium dental lasers for cutting dentine and enamel, describes key issues of the risk of temperature elevation and speed of cutting relative to conventional techniques and looks at issues concerned with the safety of lasers.

Child Care Health Connections, 2002.

ERIC Educational Resources Information Center

Guralnick, Eva, Ed.; Zamani, Rahman, Ed.; Evinger, Sara, Ed.; Dailey, Lyn, Ed.; Sherman, Marsha, Ed.; Oku, Cheryl, Ed.; Kunitz, Judith, Ed.

2002-01-01

This document is comprised of the six 2002 issues of a bimonthly newsletter on children's health for California's child care professionals. The newsletter provides information on current and emerging health and safety issues relevant to child care providers and links the health, safety, and child care communities. Regular features include columns…

75 FR 3941 - Notice of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

... collection and analysis of worldwide safety issues. II. Method of Collection Aviation stakeholders will be... option of printing it and filling it out manually and then returning it via traditional mail, filling it.... III. Data Title: Biennial NextGen Safety Issue Survey. OMB Number: 2700-XXXX. Type of Review: New...

Ecological Issues Related to Children's Health and Safety

ERIC Educational Resources Information Center

Aldridge, Jerry; Kohler, Maxie

2009-01-01

Issues concerning the health and safety of children and youth occur at multiple levels. Bronfenbrenner (1995) proposed an ecological systems approach in which multiple systems interact to enhance or diminish children's development. The same systems are at work in health promotion. The authors present and review articles that reflect the multiple…

Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.

PubMed

Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

2016-05-01

In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related to the purpose of the database and the source of the reports, resulting in significant differences in reported event categories across the 3 systems, and (3) a public-private collaboration for investigating ventilator-related adverse events under the P5S model is feasible. Copyright © 2016 by Daedalus Enterprises.

Sharing the responsibility for driver distraction across road transport systems: a systems approach to the management of distracted driving.

PubMed

Young, Kristie L; Salmon, Paul M

2015-01-01

Distracted driving is acknowledged universally as a large and growing road safety problem. Compounding the problem is that distracted driving is a complex, multifaceted issue influenced by a multitude of factors, organisations and individuals. As such, management of the problem is not straightforward. Numerous countermeasures have been developed and implemented across the globe. The vast majority of these measures have derived from the traditional reductionist, driver-centric approach to distraction and have failed to fully reflect the complex mix of actors and components that give rise to drivers becoming distracted. An alternative approach that is gaining momentum in road safety is the systems approach, which considers all components of the system and their interactions as an integrated whole. In this paper, we review the current knowledge base on driver distraction and argue that the systems approach is not currently being realised in practice. Adopting a more holistic, systems approach to distracted driving will not only improve existing knowledge and interventions from the traditional approach, but will enhance our understanding and management of distraction by considering the complex relationships and interactions of the multiple actors and the myriad sources, enablers and interventions that make up the distracted driving system. It is only by recognising and understanding how all of the system components work together to enable distraction to occur, that we can start to work on solutions to help mitigate the occurrence and consequences of distracted driving. Copyright © 2014 Elsevier Ltd. All rights reserved.

Chasing the silver bullet: measuring driver fatigue using simple and complex tasks.

PubMed

Baulk, S D; Biggs, S N; Reid, K J; van den Heuvel, C J; Dawson, D

2008-01-01

Driver fatigue remains a significant cause of motor-vehicle accidents worldwide. New technologies are increasingly utilised to improve road safety, but there are no effective on-road measures for fatigue. While simulated driving tasks are sensitive, and simple performance tasks have been used in industrial fatigue management systems (FMS) to quantify risk, little is known about the relationship between such measures. Establishing a simple, on-road measure of fatigue, as a fitness-to-drive tool, is an important issue for road safety and accident prevention, particularly as many fatigue related accidents are preventable. This study aimed to measure fatigue-related performance decrements using a simple task (reaction time - RT) and a complex task (driving simulation), and to determine the potential for a link between such measures, thus improving FMS success. Fifteen volunteer participants (7 m, 8 f) aged 22-56 years (mean 33.6 years), underwent 26 h of supervised wakefulness before an 8h recovery sleep opportunity. Participants were tested using a 30-min interactive driving simulation test, bracketed by a 10-min psychomotor vigilance task (PVT) at 4, 8, 18 and 24h of wakefulness, and following recovery sleep. Extended wakefulness caused significant decrements in PVT and driving performance. Although these measures are clearly linked, our analyses suggest that driving simulation cannot be replaced by a simple PVT. Further research is needed to closely examine links between performance measures, and to facilitate accurate management of fitness to drive, which requires more complex assessments of performance than RT alone.

White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

PubMed

Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

2016-02-15

While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety management of complex research operators

NASA Technical Reports Server (NTRS)

Brown, W. J.

1981-01-01

Complex research and technology operations present varied potential hazards which are addressed in a disciplined, independent safety review and approval process. Potential hazards vary from high energy fuels to hydrocarbon fuels, high pressure systems to high voltage systems, toxic chemicals to radioactive materials and high speed rotating machinery to high powered lasers. A Safety Permit System presently covers about 600 potentially hazardous operations. The Safety Management Program described is believed to be a major factor in maintaining an excellent safety record.

Health and the life course: why safety nets matter.

PubMed Central

Bartley, M.; Blane, D.; Montgomery, S.

1997-01-01

This article argues that a life course approach is necessary to understand social variations in health. This is needed in order to take into account the complex ways in which biological risk interacts with economic, social, and psychological factors in the development of chronic disease. Such an approach reveals biological and social "critical periods" during which social policies that will defend individuals against an accumulation of risk are particularly important. In many ways, the authors of modern welfare states were implicitly addressing these issues, and the contribution of these policies to present day high standards of health in developed countries should not be ignored. PMID:9146402

Smart home technology for safety and functional independence: the UK experience.

PubMed

Dewsbury, Guy; Linskell, Jeremy

2011-01-01

This paper proposes that people with neurological conditions can be successfully supported by smart homes only when their needs and aspirations of the technological interventions are fully understood and integrated in the design. A neurological condition can and does provide a clue to the finished technological design but this alone fails to personalise the system and stands to be rejected by the person who requires the technology. This paper explores the underlying issues of the complexity of this design process when designing for people with neurological conditions, and advances a matrix to facilitate the assessment process to maintain a person-centred design of any system.

49 CFR 350.319 - What are permissible uses of High Priority Activity Funds?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Implement, promote, and maintain national programs to improve CMV safety. (2) Increase compliance with CMV safety regulations. (3) Increase public awareness about CMV safety. (4) Provide education on CMV safety and related issues. (5) Demonstrate new safety related technologies. (b) These funds will be allocated...

2007 motor vehicle occupant safety survey. Volume 5, Child safety seat report

DOT National Transportation Integrated Search

2009-04-01

The 2007 Motor Vehicle Occupant Safety Survey (MVOSS) was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conduct...

2000 motor vehicle occupant safety survey. Volume 5, Child safety seat report

DOT National Transportation Integrated Search

2002-06-01

The 2000 Motor Vehicle Occupant Safety Survey was the fourth in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by S...

2003 motor vehicle occupant safety survey. Volume 2, Safety belt report

DOT National Transportation Integrated Search

2003-09-01

The 2003 Motor Vehicle Occupant Safety Survey was the fifth in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

1998 Motor Vehicle Occupant Safety Survey. Volume 3, Child safety seat report

DOT National Transportation Integrated Search

2000-07-01

The 1998 Motor Vehicle Occupant Safety Survey was the third in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by th...

Scheduling Software for Complex Scenarios

NASA Technical Reports Server (NTRS)

2006-01-01

Preparing a vehicle and its payload for a single launch is a complex process that involves thousands of operations. Because the equipment and facilities required to carry out these operations are extremely expensive and limited in number, optimal assignment and efficient use are critically important. Overlapping missions that compete for the same resources, ground rules, safety requirements, and the unique needs of processing vehicles and payloads destined for space impose numerous constraints that, when combined, require advanced scheduling. Traditional scheduling systems use simple algorithms and criteria when selecting activities and assigning resources and times to each activity. Schedules generated by these simple decision rules are, however, frequently far from optimal. To resolve mission-critical scheduling issues and predict possible problem areas, NASA historically relied upon expert human schedulers who used their judgment and experience to determine where things should happen, whether they will happen on time, and whether the requested resources are truly necessary.

Sodium-based hydrides for thermal energy applications

NASA Astrophysics Data System (ADS)

Sheppard, D. A.; Humphries, T. D.; Buckley, C. E.

2016-04-01

Concentrating solar-thermal power (CSP) with thermal energy storage (TES) represents an attractive alternative to conventional fossil fuels for base-load power generation. Sodium alanate (NaAlH4) is a well-known sodium-based complex metal hydride but, more recently, high-temperature sodium-based complex metal hydrides have been considered for TES. This review considers the current state of the art for NaH, NaMgH3- x F x , Na-based transition metal hydrides, NaBH4 and Na3AlH6 for TES and heat pumping applications. These metal hydrides have a number of advantages over other classes of heat storage materials such as high thermal energy storage capacity, low volume, relatively low cost and a wide range of operating temperatures (100 °C to more than 650 °C). Potential safety issues associated with the use of high-temperature sodium-based hydrides are also addressed.

Noise propagation issues in Belle II pixel detector power cable

NASA Astrophysics Data System (ADS)

Iglesias, M.; Arteche, F.; Echeverria, I.; Pradas, A.; Rivetta, C.; Moser, H.-G.; Kiesling, C.; Rummel, S.; Arcega, F. J.

2018-04-01

The vertex detector used in the upgrade of High-Energy physics experiment Belle II includes DEPFET pixel detector (PXD) technology. In this complex topology the power supply units and the front-end electronics are connected through a PXD power cable bundle which may propagate the output noise from the power supplies to the vertex area. This paper presents a study of the propagation of noise caused by power converters in the PXD cable bundle based on Multi-conductor Transmission Line (MTL) theory. The work exposes the effect of the complex cable topology and shield connections on the noise propagation, which has an impact on the requirements of the power supplies. This analysis is part of the electromagnetic compatibility based design focused on functional safety to define the shield connections and power supply specifications required to ensure the successful integration of the detector and, specifically, to achieve the designed performance of the front-end electronics.

Safety management of a complex R and D ground operating system

NASA Technical Reports Server (NTRS)

Connors, J. F.; Maurer, R. A.

1975-01-01

A perspective on safety program management was developed for a complex R&D operating system, such as the NASA-Lewis Research Center. Using a systems approach, hazardous operations are subjected to third-party reviews by designated-area safety committees and are maintained under safety permit controls. To insure personnel alertness, emergency containment forces and employees are trained in dry-run emergency simulation exercises. The keys to real safety effectiveness are top management support and visibility of residual risks.

Safety management of a complex R&D ground operating system

NASA Technical Reports Server (NTRS)

Connors, J. F.; Maurer, R. A.

1975-01-01

A perspective on safety program management has been developed for a complex R&D operating system, such as the NASA-Lewis Research Center. Using a systems approach, hazardous operations are subjected to third-party reviews by designated area safety committees and are maintained under safety permit controls. To insure personnel alertness, emergency containment forces and employees are trained in dry-run emergency simulation exercises. The keys to real safety effectiveness are top management support and visibility of residual risks.

Seniors' perceptions of vehicle safety risks and needs.

PubMed

Shaw, Lynn; Polgar, Jan Miller; Vrkljan, Brenda; Jacobson, Jill

2010-01-01

The investigation of vehicle safety needs for older drivers and passengers is integral for their safe transportation. A program of research on safe transportation for seniors was launched through AUTO21, a Canadian Network of Centres of Excellence. This national research network focuses on a wide range of automotive issues, from materials and design to safety and societal issues. An inductive qualitative inquiry of seniors' driving experiences, safety feature use, and strategies to prevent injury and manage risks was a first step in this program. We conducted interviews and focus groups with 58 seniors without disabilities and 9 seniors with disabilities. We identified a lack of congruity between the vehicle and safety feature design and seniors' needs. Seniors described strategies to manage their safety and that of others. Specific aspects of vehicle design, safety features, and action strategies that support safer use and operation of a vehicle by seniors are outlined.

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

Campus Safety and Student Privacy Issues in Higher Education

ERIC Educational Resources Information Center

Burnett, Kristen Slater

2010-01-01

The purpose of this study is to delve into, and further understand, the perceptions of higher education administrators when they experience having to simultaneously balance the issues of campus safety and student privacy. The research surveyed approximately 900 (with 147 returns) administrators who self-identified as having a role in incidents of…

78 FR 27198 - Privacy Act of 1974; System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Officer, Department of Defense. Deletion: N05100-3 Safety Equipment Needs, Issues, Authorizations (May 9... Management Systems (ESAMS) (March 25, 2011, 76 FR 16739); therefore, N05100-3, Safety Equipment Needs, Issues... Management System Office, 4800 Mark Center Drive, East Tower, 2nd Floor, Suite 02G09, Alexandria, VA 22350...

Food Safety. Nourishing News. Volume 3, Issue 10

ERIC Educational Resources Information Center

Idaho State Department of Education, 2009

2009-01-01

Serving safe food is a critical responsibility for maintaining quality foodservice programs and healthy environments at schools and child care facilities. Child Nutrition Programs hopes you find this newsletter of assistance when reviewing the food safety program you have at each serving site. The articles contained in this issue are: (1) A…

Wheelchair transportation safety on school buses: stakeholder recommendations for priority issues and actions.

PubMed

Buning, Mary Ellen; Karg, Patricia E

2011-01-01

This paper presents results from and provides discussion of a state-of-the-science workshop in which highly informed stakeholders in wheelchair transportation safety for students on school buses were participants. The Nominal Group Technique was used to create a process in which the main issues preventing safe transportation of wheelchair-seated students and key strategies to overcome these issues were identified and ranked. These results, along with a synthesis of group discussion and recommendations for action, are presented along with consideration of current policies, regulations, and political realities. Critical safety shortcomings exist in this highly specialized enterprise that varies from state to state. Recommended strategies include implementing wheelchair requirements in federal transportation safety standards, creation of a clearinghouse for wheelchair transportation best practices and education, creation of national standards for training, practices, and monitoring, and increased "buy-in" to voluntary wheelchair standards by wheelchair manufacturers.

78 FR 19507 - National Boating Safety Advisory Council

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-0164] National Boating Safety Advisory... Associated Equipment Subcommittee of the National Boating Safety Advisory Council (NBSAC) will meet via teleconference and online webinar to discuss safety issues related to boats and associated equipment. This...

78 FR 19506 - National Boating Safety Advisory Council

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-0164] National Boating Safety Advisory... Through People Subcommittee of the National Boating Safety Advisory Council (NBSAC) will meet via teleconference and online webinar to discuss issues related to improving safety of recreational boating through...

16 CFR 1210.11 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.11 General. Section 14(a) of the Consumer Product... product that is subject to a consumer product safety standard and that is distributed in commerce to issue...

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

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

Flaws found in Los Alamos safety procedures

NASA Astrophysics Data System (ADS)

Gwynne, Peter

2017-12-01

A US government panel on nuclear safety has discovered a series of safety issues at the Los Alamos National Laboratory, concluding that government oversight of the lab's emergency preparation has been ineffective.

Safety recommendation : operator fatigue

DOT National Transportation Integrated Search

1999-06-01

During the 1980s, the National Transportation Safety Board investigated several accindets that involved operator fatigue. Following completion of these accident investigations, the Safety Board in 1989 issues three recommendation to the U.S. Departme...

Office of River Protection Integrated Safety Management System Description

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

CLARK, D.L.

Revision O was never issued. Finding safe and environmentally sound methods of storage and disposal of 54 million gallons of highly radioactive waste contained in 177 underground tanks is the largest challenge of Hanford cleanup. TWRS was established in 1991 and continues to integrate all aspects of the treatment and management of the high-level radioactive waste tanks. In fiscal Year 1997, program objectives were advanced in a number of areas. RL TWRS refocused the program toward retrieving, treating, and immobilizing the tank wastes, while maintaining safety as first priority. Moving from a mode of storing the wastes to getting themore » waste out of the tanks will provide the greatest cleanup return on the investment and eliminate costly mortgage continuance. There were a number of safety-related achievements in FY1997. The first high priority safety issue was resolved with the removal of 16 tanks from the ''Wyden Watch List''. The list, brought forward by Senator Ron Wyden of Oregon, identified various Hanford safety issues needing attention. One of these issues was ferrocyanide, a chemical present in 24 tanks. Although ferrocyanide can ignite at high temperature, analysis found that the chemical has decomposed into harmless compounds and is no longer a concern.« less

Verification and Validation of Flight-Critical Systems

NASA Technical Reports Server (NTRS)

Brat, Guillaume

2010-01-01

For the first time in many years, the NASA budget presented to congress calls for a focused effort on the verification and validation (V&V) of complex systems. This is mostly motivated by the results of the VVFCS (V&V of Flight-Critical Systems) study, which should materialize as a a concrete effort under the Aviation Safety program. This talk will present the results of the study, from requirements coming out of discussions with the FAA and the Joint Planning and Development Office (JPDO) to technical plan addressing the issue, and its proposed current and future V&V research agenda, which will be addressed by NASA Ames, Langley, and Dryden as well as external partners through NASA Research Announcements (NRA) calls. This agenda calls for pushing V&V earlier in the life cycle and take advantage of formal methods to increase safety and reduce cost of V&V. I will present the on-going research work (especially the four main technical areas: Safety Assurance, Distributed Systems, Authority and Autonomy, and Software-Intensive Systems), possible extensions, and how VVFCS plans on grounding the research in realistic examples, including an intended V&V test-bench based on an Integrated Modular Avionics (IMA) architecture and hosted by Dryden.

Mixtures of Chemical Pollutants at European Legislation Safety Concentrations: How Safe Are They?

PubMed Central

Carvalho, Raquel N.; Arukwe, Augustine; Ait-Aissa, Selim; Bado-Nilles, Anne; Balzamo, Stefania; Baun, Anders; Belkin, Shimshon; Blaha, Ludek; Brion, François; Conti, Daniela; Creusot, Nicolas; Essig, Yona; Ferrero, Valentina E. V.; Flander-Putrle, Vesna; Fürhacker, Maria; Grillari-Voglauer, Regina; Hogstrand, Christer; Jonáš, Adam; Kharlyngdoh, Joubert B.; Loos, Robert; Lundebye, Anne-Katrine; Modig, Carina; Olsson, Per-Erik; Pillai, Smitha; Polak, Natasa; Potalivo, Monica; Sanchez, Wilfried; Schifferli, Andrea; Schirmer, Kristin; Sforzini, Susanna; Stürzenbaum, Stephen R.; Søfteland, Liv; Turk, Valentina; Viarengo, Aldo; Werner, Inge; Yagur-Kroll, Sharon; Zounková, Radka; Lettieri, Teresa

2014-01-01

The risk posed by complex chemical mixtures in the environment to wildlife and humans is increasingly debated, but has been rarely tested under environmentally relevant scenarios. To address this issue, two mixtures of 14 or 19 substances of concern (pesticides, pharmaceuticals, heavy metals, polyaromatic hydrocarbons, a surfactant, and a plasticizer), each present at its safety limit concentration imposed by the European legislation, were prepared and tested for their toxic effects. The effects of the mixtures were assessed in 35 bioassays, based on 11 organisms representing different trophic levels. A consortium of 16 laboratories was involved in performing the bioassays. The mixtures elicited quantifiable toxic effects on some of the test systems employed, including i) changes in marine microbial composition, ii) microalgae toxicity, iii) immobilization in the crustacean Daphnia magna, iv) fish embryo toxicity, v) impaired frog embryo development, and vi) increased expression on oxidative stress-linked reporter genes. Estrogenic activity close to regulatory safety limit concentrations was uncovered by receptor-binding assays. The results highlight the need of precautionary actions on the assessment of chemical mixtures even in cases where individual toxicants are present at seemingly harmless concentrations. PMID:24958932

Gene therapy for cancer: regulatory considerations for approval.

PubMed

Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

2015-12-01

The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

New Challenges for Intervertebral Disc Treatment Using Regenerative Medicine

PubMed Central

Masuda, Koichi

2010-01-01

The development of tissue engineering therapies for the intervertebral disc is challenging due to ambiguities of disease and pain mechanisms in patients, and lack of consensus on preclinical models for safety and efficacy testing. Although the issues associated with model selection for studying orthopedic diseases or treatments have been discussed often, the multifaceted challenges associated with developing intervertebral disc tissue engineering therapies require special discussion. This review covers topics relevant to the clinical translation of tissue-engineered technologies: (1) the unmet clinical need, (2) appropriate models for safety and efficacy testing, (3) the need for standardized model systems, and (4) the translational pathways leading to a clinical trial. For preclinical evaluation of new therapies, we recommend establishing biologic plausibility of efficacy and safety using models of increasing complexity, starting with cell culture, small animals (rats and rabbits), and then large animals (goat and minipig) that more closely mimic nutritional, biomechanical, and surgical realities of human application. The use of standardized and reproducible experimental procedures and outcome measures is critical for judging relative efficacy. Finally, success will hinge on carefully designed clinical trials with well-defined patient selection criteria, gold-standard controls, and objective outcome metrics to assess performance in the early postoperative period. PMID:19903086

Gene therapy for cancer: regulatory considerations for approval

PubMed Central

Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

2015-01-01

The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA. PMID:26584531

The electromagnetic environment of Magnetic Resonance Imaging systems. Occupational exposure assessment reveals RF harmonics

NASA Astrophysics Data System (ADS)

Gourzoulidis, G.; Karabetsos, E.; Skamnakis, N.; Kappas, C.; Theodorou, K.; Tsougos, I.; Maris, T. G.

2015-09-01

Magnetic Resonance Imaging (MRI) systems played a crucial role in the postponement of the former occupational electromagnetic fields (EMF) European Directive (2004/40/EC) and in the formation of the latest exposure limits adopted in the new one (2013/35/EU). Moreover, the complex MRI environment will be finally excluded from the implementation of the new occupational limits, leading to an increased demand for Occupational Health and Safety (OHS) surveillance. The gradient function of MRI systems and the application of the RF excitation frequency result in low and high frequency exposures, respectively. This electromagnetic field exposure, in combination with the increased static magnetic field exposure, makes the MRI environment a unique case of combined EMF exposure. The electromagnetic field levels in close proximity of different MRI systems have been assessed at various frequencies. Quality Assurance (QA) & safety issues were also faced. Preliminary results show initial compliance with the forthcoming limits in each different frequency band, but also revealed peculiar RF harmonic components, of no safety concern, to the whole range detected (20-1000MHz). Further work is needed in order to clarify their origin and characteristics.

Safety management of an underground-based gravitational wave telescope: KAGRA

NASA Astrophysics Data System (ADS)

Ohishi, Naoko; Miyoki, Shinji; Uchiyama, Takashi; Miyakawa, Osamu; Ohashi, Masatake

2014-08-01

KAGRA is a unique gravitational wave telescope with its location underground and use of cryogenic mirrors. Safety management plays an important role for secure development and operation of such a unique and large facility. Based on relevant law in Japan, Labor Standard Act and Industrial Safety and Health Law, various countermeasures are mandated to avoid foreseeable accidents and diseases. In addition to the usual safety management of hazardous materials, such as cranes, organic solvents, lasers, there are specific safety issues in the tunnel. Prevention of collapse, flood, and fire accidents are the most critical issues for the underground facility. Ventilation is also important for prevention of air pollution by carbon monoxide, carbon dioxide, organic solvents and radon. Oxygen deficiency should also be prevented.

WE-B-BRC-01: Current Methodologies in Risk Assessment

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

Rath, F.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-03: Risk in the Context of Medical Imaging

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

Samei, E.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-00: Concepts in Risk-Based Assessment

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

NONE

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-02: Risk Analysis and Incident Learning

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

Fraass, B.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

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

Sygitowicz, L S

2008-03-20

A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiationmore » Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a site wide ALARA Committee and administrative control levels would focus attention on improved processes. Currently LLNL issues dosimeters to a large number of employees and visitors that do not enter areas requiring dosimetry. This includes 25,000 visitor TLDs per year. Dosimeters should be issued to only those personnel who enter areas where dosimetry is required.« less

Watch Out! A Teacher's Guide to Traffic Safety.

ERIC Educational Resources Information Center

New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

This guide provides teachers with activities that can initiate an awareness of the New York city-wide traffic safety campaign and reinforce safety education. It contains the following: (1) background information on safety rules for teachers; (2) curriculum topics that can include traffic safety issues; (3) class- and school-wide activities for…

Current Sports: Medicine Issues. Annual Safety Education Review--1973.

ERIC Educational Resources Information Center

Craig, Timothy T., Ed.

This document is a collection of papers whose theme is sports safety. Section one, "Government Interest in Sports Safety," includes an article on Washington, D.C.'s focus on sports safety. Section two, "Medical Aspects of Safety in Sports," includes articles regarding the medical basis of restriction from athletics, orthopaedic restrictions, and…

77 FR 26280 - Patient Safety Organizations: Voluntary Relinquishment From CareRise LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

... Organizations: Voluntary Relinquishment From CareRise LLC AGENCY: Agency for Healthcare Research and Quality... relinquishment from CareRise LLC of its status as a Patient Safety Organization (PSO). The Patient Safety and... safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement...

77 FR 75633 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...) Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... improvements in the delivery of occupational safety and health services, and the prevention of work-related... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or... issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broad...

77 FR 33777 - General Aviation Safety Forum: Climbing to the Next Level

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-07

... NATIONAL TRANSPORTATION SAFETY BOARD General Aviation Safety Forum: Climbing to the Next Level The National Transportation Safety Board (NTSB) will convene a 2- day forum focused on safety issues related to... the Next Level,'' will be chaired by NTSB Chairman Deborah A. P. Hersman and all five Board Members...

A Geospatial Mixed Methods Approach to Assessing Campus Safety

ERIC Educational Resources Information Center

Hites, Lisle S.; Fifolt, Matthew; Beck, Heidi; Su, Wei; Kerbawy, Shatomi; Wakelee, Jessica; Nassel, Ariann

2013-01-01

Background: While there is no panacea for alleviating campus safety concerns, safety experts agree that one of the key components to an effective campus security plan is monitoring the environment. Despite previous attempts to measure campus safety, quantifying perceptions of fear, safety, and risk remains a challenging issue. Since perceptions of…

Effects of the Smartphone Application "Safe Patients" on Knowledge of Patient Safety Issues Among Surgical Patients.

PubMed

Cho, Sumi; Lee, Eunjoo

2017-12-01

Recently, the patient's role in preventing adverse events has been emphasized. Patients who are more knowledgeable about safety issues are more likely to engage in safety initiatives. Therefore, nurses need to develop techniques and tools that increase patients' knowledge in preventing adverse events. For this reason, an educational smartphone application for patient safety called "Safe Patients" was developed through an iterative process involving a literature review, expert consultations, and pilot testing of the application. To determine the effect of "Safe Patients," it was implemented for patients in surgical units in a tertiary hospital in South Korea. The change in patients' knowledge about patient safety was measured using seven true/false questions developed in this study. A one-group pretest and posttest design was used, and a total of 123 of 190 possible participants were tested. The percentage of correct answers significantly increased from 64.5% to 75.8% (P < .001) after implementation of the "Safe Patients" application. This study demonstrated that the application "Safe Patients" could effectively improve patients' knowledge of safety issues. This will ultimately empower patients to engage in safe practices and prevent adverse events related to surgery.

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.

Probiotics: Safety and Side Effects

MedlinePlus

... of this page please turn JavaScript on. Feature: Probiotics Safety and Side Effects Past Issues / Winter 2016 ... Says About the Safety and Side Effects of Probiotics Whether probiotics are likely to be safe for ...

Materials for lithium-ion battery safety.

PubMed

Liu, Kai; Liu, Yayuan; Lin, Dingchang; Pei, Allen; Cui, Yi

2018-06-01

Lithium-ion batteries (LIBs) are considered to be one of the most important energy storage technologies. As the energy density of batteries increases, battery safety becomes even more critical if the energy is released unintentionally. Accidents related to fires and explosions of LIBs occur frequently worldwide. Some have caused serious threats to human life and health and have led to numerous product recalls by manufacturers. These incidents are reminders that safety is a prerequisite for batteries, and serious issues need to be resolved before the future application of high-energy battery systems. This Review aims to summarize the fundamentals of the origins of LIB safety issues and highlight recent key progress in materials design to improve LIB safety. We anticipate that this Review will inspire further improvement in battery safety, especially for emerging LIBs with high-energy density.

Materials for lithium-ion battery safety

PubMed Central

Liu, Kai

2018-01-01

Lithium-ion batteries (LIBs) are considered to be one of the most important energy storage technologies. As the energy density of batteries increases, battery safety becomes even more critical if the energy is released unintentionally. Accidents related to fires and explosions of LIBs occur frequently worldwide. Some have caused serious threats to human life and health and have led to numerous product recalls by manufacturers. These incidents are reminders that safety is a prerequisite for batteries, and serious issues need to be resolved before the future application of high-energy battery systems. This Review aims to summarize the fundamentals of the origins of LIB safety issues and highlight recent key progress in materials design to improve LIB safety. We anticipate that this Review will inspire further improvement in battery safety, especially for emerging LIBs with high-energy density. PMID:29942858

Evaluation and review of the safety management system implementation in the Royal Thai Air Force

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

Safety of railroad passenger vehicle dynamics : final summary report

DOT National Transportation Integrated Search

2002-07-01

This report is a summary of all the work done by Foster-Miller on the passenger rail vehicle dynamic safety under the contract awarded by the FRA. The report presents key issues and findings in the safety assessments and a safety assessment methodolo...

A benefit/cost analysis of the National Transportation Safety Board's safety recommendation P-01-2

DOT National Transportation Integrated Search

2003-09-01

On June 22, 2001, the National Transportation Safety Board (NTSB) issued Safety : Recommendation P-0 1-2, which recommended that the U.S. Department of Transportations : (U.S. DOTS) Research and Special Programs Administration (RSPA) require th...

78 FR 69433 - Executive Order 13650 Improving Chemical Facility Safety and Security Listening Sessions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... Chemical Facility Safety and Security Listening Sessions AGENCY: National Protection and Programs... from stakeholders on issues pertaining to Improving Chemical Facility Safety and Security (Executive... regulations, guidance, and policies; and identifying best practices in chemical facility safety and security...

77 FR 61422 - National Boating Safety Advisory Council

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2010-0164] National Boating Safety...: The National Boating Safety Advisory Council (NBSAC) and three of its subcommittees will meet on November 9-11, 2012, in Watsonville, CA, to discuss issues relating to recreational boating safety. The...

Automotive HUDs: the overlooked safety issues.

PubMed

Tufano, D R

1997-06-01

The transfer of tactical aviation technology into automobiles is creating information display requirements that are likely to be met by use of the head-up display (HUD). These developments are based largely on conclusions that the HUD-related safety issues raised in the aviation HUD literature can be dismissed and that the benefits of using HUDs are certain. Such conclusions either neglect relevant research or are supported by a very small amount of evidence, much of which is either irrelevant or generated within a flawed methodological paradigm. This critical review covers the issues of (a) HUD focal distance and its effect on the perception of outside objects and (b) the effects of HUD imagery on visual attention. The issues of focal distance, cognitive capture, and the inherent connection between the two may have a greater impact on safety in the automotive context than they do in aviation.

Is Model-Based Development a Favorable Approach for Complex and Safety-Critical Computer Systems on Commercial Aircraft?

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

A system is safety-critical if its failure can endanger human life or cause significant damage to property or the environment. State-of-the-art computer systems on commercial aircraft are highly complex, software-intensive, functionally integrated, and network-centric systems of systems. Ensuring that such systems are safe and comply with existing safety regulations is costly and time-consuming as the level of rigor in the development process, especially the validation and verification activities, is determined by considerations of system complexity and safety criticality. A significant degree of care and deep insight into the operational principles of these systems is required to ensure adequate coverage of all design implications relevant to system safety. Model-based development methodologies, methods, tools, and techniques facilitate collaboration and enable the use of common design artifacts among groups dealing with different aspects of the development of a system. This paper examines the application of model-based development to complex and safety-critical aircraft computer systems. Benefits and detriments are identified and an overall assessment of the approach is given.

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

PubMed Central

Chahal, Harinder S; Sigelman, Daniel W; Stacy, Sylvie; Sclar, Joshua; Ddamulira, Barbara

2015-01-01

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study. Data sources All applications for which FDA’s Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. Results 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters. PMID:26063327

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.

[Process design in high-reliability organizations].

PubMed

Sommer, K-J; Kranz, J; Steffens, J

2014-05-01

Modern medicine is a highly complex service industry in which individual care providers are linked in a complicated network. The complexity and interlinkedness is associated with risks concerning patient safety. Other highly complex industries like commercial aviation have succeeded in maintaining or even increasing its safety levels despite rapidly increasing passenger figures. Standard operating procedures (SOPs), crew resource management (CRM), as well as operational risk evaluation (ORE) are historically developed and trusted parts of a comprehensive and systemic safety program. If medicine wants to follow this quantum leap towards increased patient safety, it must intensively evaluate the results of other high-reliability industries and seek step-by-step implementation after a critical assessment.

Critical Design Issues of Tokamak Cooling Water System of ITER's Fusion Reactor

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

Kim, Seokho H; Berry, Jan

U.S. ITER is responsible for the design, engineering, and procurement of the Tokamak Cooling Water System (TCWS). The TCWS transfers heat generated in the Tokamak to cooling water during nominal pulsed operation 850 MW at up to 150 C and 4.2 MPa water pressure. This water contains radionuclides because impurities (e.g., tritium) diffuse from in-vessel components and the vacuum vessel by water baking at 200 240 C at up to 4.4MPa, and corrosion products become activated by neutron bombardment. The system is designated as safety important class (SIC) and will be fabricated to comply with the French Order concerning nuclearmore » pressure equipment (December 2005) and the EU Pressure Equipment Directive using ASME Section VIII, Div 2 design codes. The complexity of the TCWS design and fabrication presents unique challenges. Conceptual design of this one-of-a-kind cooling system has been completed with several issues that need to be resolved to move to next stage of the design. Those issues include flow balancing between over hundreds of branch pipelines in parallel to supply cooling water to blankets, determination of optimum flow velocity while minimizing the potential for cavitation damage, design for freezing protection for cooling water flowing through cryostat (freezing) environment, requirements for high-energy piping design, and electromagnetic impact to piping and components. Although the TCWS consists of standard commercial components such as piping with valves and fittings, heat exchangers, and pumps, complex requirements present interesting design challenges. This paper presents a brief description of TCWS conceptual design and critical design issues that need to be resolved.« less

Sounding the warning bells: the need for a systems approach to understanding behaviour at rail level crossings.

PubMed

Read, Gemma J M; Salmon, Paul M; Lenné, Michael G

2013-09-01

Collisions at rail level crossings are an international safety concern and have been the subject of considerable research effort. Modern human factors practice advocates a systems approach to investigating safety issues in complex systems. This paper describes the results of a structured review of the level crossing literature to determine the extent to which a systems approach has been applied. The measures used to determine if previous research was underpinned by a systems approach were: the type of analysis method utilised, the number of component relationships considered, the number of user groups considered, the number of system levels considered and the type of model described in the research. None of research reviewed was found to be consistent with a systems approach. It is recommended that further research utilise a systems approach to the study of the level crossing system to enable the identification of effective design improvements. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Promoting the wellbeing of lesbian, gay, bisexual and transgender forced migrants in Canada: providers' perspectives.

PubMed

Kahn, Sarilee; Alessi, Edward; Woolner, Leah; Kim, Hanna; Olivieri, Christina

2017-10-01

Researchers are beginning to document the experiences of lesbian, gay, bisexual and transgender (LGBT) forced migrants in settlement. However, studies exploring the perceptions of service providers working with this vulnerable population are limited. These may shed light on the challenges of meeting the needs of LGBT forced migrants, especially mental health issues and problems. This qualitative study elicited the views of 22 Canadian service providers, including advocates, lawyers and mental health practitioners, who serve LGBT forced migrants. Grounded theory analysis revealed the following four themes: facilitating safety, buffering rejection; tracking avoidance patterns; interpreting mental health; and negotiating identity paradigms. Participants' accounts suggest that LGBT forced migrants may be best served by providers who understand the exigencies of establishing trust and safety for their clients; recognise their clients' nuanced social support needs; facilitate the refugee claims process; grasp the complexity of their clients' mental health challenges; and interrogate their own cultural biases regarding sexual orientations and gender identities.

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

PubMed Central

Khanna, Ish K; Pillarisetti, Sivaram

2015-01-01

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

A Framework for Reliability and Safety Analysis of Complex Space Missions

NASA Technical Reports Server (NTRS)

Evans, John W.; Groen, Frank; Wang, Lui; Austin, Rebekah; Witulski, Art; Mahadevan, Nagabhushan; Cornford, Steven L.; Feather, Martin S.; Lindsey, Nancy

2017-01-01

Long duration and complex mission scenarios are characteristics of NASA's human exploration of Mars, and will provide unprecedented challenges. Systems reliability and safety will become increasingly demanding and management of uncertainty will be increasingly important. NASA's current pioneering strategy recognizes and relies upon assurance of crew and asset safety. In this regard, flexibility to develop and innovate in the emergence of new design environments and methodologies, encompassing modeling of complex systems, is essential to meet the challenges.

Using NASA Using Remote Sensing in Public Health Applications

NASA Technical Reports Server (NTRS)

Estes, Sue; Haynes, John

2011-01-01

The Public Health application area focuses on Earth science applications to public health and safety, particularly regarding infectious disease, emergency preparedness and response, and environmental health issues. The application explores issues of toxic and pathogenic exposure, as well as natural and man-made hazards and their effects, for risk characterization/mitigation and improvements to health and safety.

State Legislative Developments on Campus Sexual Violence: Issues in the Context of Safety

ERIC Educational Resources Information Center

Morse, Andrew; Sponsler, Brian A.; Fulton, Mary

2015-01-01

NASPA--Student Affairs Administrators in Higher Education and Education Commission of the States (ECS) have partnered to address legislative developments and offer considerations for leaders in higher education and policy on two top-level safety issues facing the higher education community: campus sexual violence and guns on campus. The first in a…

An Analysis of the Safety Issues Involving Local School Children as Pedestrians. Revised.

ERIC Educational Resources Information Center

Ducote, Kenneth J.

The New Orleans Public Schools' Department of Planning has been concerned with school children as pedestrians for the past five years. The safety issues include the streets, the drivers, and the children. First, the streets contribute to the hazard because many major streets traverse residential areas; many streets serve as major commuter…

Child Care Health Connections, 1999: A Health and Safety Newsletter for California Child Care Professionals.

ERIC Educational Resources Information Center

Walery, Nancy, Ed.; Evinger, Sara, Ed.; Dailey, Lyn, Ed.; Sherman, Marsha, Ed.; Zamani, Rahman, Ed.

1999-01-01

This document is comprised of the six 1999 issues of a bimonthly newsletter providing information on young children's health and safety for California's child care professionals. Regular features include a column on infant/toddler concerns, a question-answer column regarding medical and health issues, a nutrition column, and resources for child…

76 FR 24925 - Solicitation for Public Comment on Potential Alternatives To Resolve Generic Safety Issue 191...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... comment on potential alternatives for risk informing the path forward to resolve Generic Safety Issue (GSI... Notation Vote Paper (SECY-10-0113) which presented to the Commission the regulatory path forward options... the staff, in part, to explore alternative paths forward for resolving GSI-191. Discussion While GSI...

29 CFR 1903.18 - Failure to correct a violation for which a citation has been issued.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES... Compliance Safety and Health Officer of such failure and of the additional penalty proposed under section 17... citation has been issued shall not begin to run until the entry of a final order of the Review Commission...

29 CFR 1903.18 - Failure to correct a violation for which a citation has been issued.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES... Compliance Safety and Health Officer of such failure and of the additional penalty proposed under section 17... citation has been issued shall not begin to run until the entry of a final order of the Review Commission...

Safety issues involving marine containers on chassis.

DOT National Transportation Integrated Search

2009-01-01

This study performed by The University of Tennessee investigated safety related problems involving chassis used for transporting marine containers on US highways. In recent years, much concern has arisen regarding the safety implications of allegedly...

Commercial wireless technologies for public safety users

DOT National Transportation Integrated Search

2000-07-01

This report on commercial wireless for public safety addresses the issues associated with the use of commercial services for public safety. It then reviews available wireless services for wide area data services: cellular, personal communication and ...

Cerebrospinal fluid protein and glucose examinations and tuberculosis:
Will laboratory safety regulations force a change of practice?

PubMed

Tormey, William P; O'Hagan, Christopher

2015-01-01

Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.

Using the Framework for Health Promotion Action to address staff perceptions of occupational health and safety at a fly-in/fly-out mine in north-west Queensland.

PubMed

Devine, Susan G; Muller, Reinhold; Carter, Anthony

2008-12-01

An exploratory descriptive study was undertaken to identify staff perceptions of the types and sources of occupational health and safety hazards at a remote fly-in-fly-out minerals extraction and processing plant in northwest Queensland. Ongoing focus groups with all sectors of the operation were conducted concurrently with quantitative research studies from 2001 to 2005. Action research processes were used with management and staff to develop responses to identified issues. Staff identified and generated solutions to the core themes of: health and safety policies and procedures; chemical exposures; hydration and fatigue. The Framework for Health Promotion Action was applied to ensure a comprehensive and holistic response to identified issues. Participatory processes using an action research framework enabled a deep understanding of staff perceptions of occupational health and safety hazards in this setting. The Framework for Health Promotion provided a relevant and useful tool to engage with staff and develop solutions to perceived occupational health and safety issues in the workplace.

77 FR 17084 - National Boating Safety Advisory Council

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2010-0164] National Boating Safety...: The National Boating Safety Advisory Council (NBSAC) will meet on April 13-14, 2012, in Arlington, Virginia, to discuss issues relating to recreational boating safety. The meetings will be open to the...

77 FR 62248 - Commercial Fishing Safety Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-0936] Commercial Fishing Safety.... SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Washington, DC to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the...

76 FR 65205 - Commercial Fishing Safety Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0979] Commercial Fishing Safety.... SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Seattle, Washington to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to...

76 FR 8372 - Commercial Fishing Safety Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-14

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0070] Commercial Fishing Safety... Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Portsmouth, Virginia to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the public...

75 FR 59658 - Airworthiness Directives; SOCATA Model TBM 700 Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... drive assemblies. The European Aviation Safety Agency (EASA), which is the Technical Agent for the... United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section... Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Proposed...

Revitalizing Nuclear Safety Research.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC.

This report covers the general issues involved in nuclear safety research and points out the areas needing detailed consideration. Topics included are: (1) "Principles of Nuclear Safety Research" (examining who should fund, who should conduct, and who should set the agenda for nuclear safety research); (2) "Elements of a Future…

Safety and operational performance evaluation of four types of exit ramps on Florida's freeways (final report).

DOT National Transportation Integrated Search

2010-12-01

This project mainly focuses on exit ramp performance analysis of safety and operations. In addition, issues of advance guide sign for exit ramp are also mentioned. : Safety analysis evaluates safety performances of different exit ramps used in Florid...

Analysis of Eye-Tracking Data with Regards to the Complexity of Flight Deck Information Automation and Management - Inattentional Blindness, System State Awareness, and EFB Usage

NASA Technical Reports Server (NTRS)

Dill, Evan T.; Young, Steven D.

2015-01-01

In the constant drive to further the safety and efficiency of air travel, the complexity of avionics-related systems, and the procedures for interacting with these systems, appear to be on an ever-increasing trend. While this growing complexity often yields productive results with respect to system capabilities and flight efficiency, it can place a larger burden on pilots to manage increasing amounts of information and to understand intricate system designs. Evidence supporting this observation is becoming widespread, yet has been largely anecdotal or the result of subjective analysis. One way to gain more insight into this issue is through experimentation using more objective measures or indicators. This study utilizes and analyzes eye-tracking data obtained during a high-fidelity flight simulation study wherein many of the complexities of current flight decks, as well as those planned for the next generation air transportation system (NextGen), were emulated. The following paper presents the findings of this study with a focus on electronic flight bag (EFB) usage, system state awareness (SSA) and events involving suspected inattentional blindness (IB).

A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

ERIC Educational Resources Information Center

Ellis, Jason D.; Henroid, Daniel H., Jr.

2005-01-01

Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

Promoting individual learning for trainees with perceived high helplessness: experiences of a safety training program.

PubMed

Kiani, Fariba; Khodabakhsh, Mohamad Reza

2014-01-01

The article arises from a research project investigating the effectiveness of safety training on changing attitudes toward safety issues. Followed by the training intervention was observed that employees' helplessness decreased. The researchers have come to the idea of investigating how safety training can reduce perceived helplessness. Thus, this research examined the effectiveness of safety training on reducing employees' helplessness with attention to the mediating role of attitude toward safety issues. The current study was an experimental study with the control group. A total of 204 (101 experimental group and 103 control group) completed safety attitude questionnaire and perceived helplessness before a safety training course including four 90-min sessions over 4 consecutive days in Esfahan Steel Company in 2012 between October and December. Only members of the experimental group participated in this course. These questionnaires, approximately 30 days later, again were run on members of both groups. Data were analyzed using descriptive indexes, t-, and F-test. RESULTS by comparing the two groups showed that safety training was effective only on individuals with perceived low helplessness (p = 0.02). In individuals with perceived high helplessness, safety training only with changing safety attitudes can reduce the perceived helplessness.

Napping during breaks on night shift: critical care nurse managers' perceptions.

PubMed

Edwards, Marie P; McMillan, Diana E; Fallis, Wendy M

2013-01-01

Fatigue associated with shiftwork can threaten the safety and health of nurses and the patients in their care. Napping during night shift breaks has been shown to be an effective strategy to decrease fatigue and enhance performance in a variety of work environments, but appears to have mixed support within health care. The purpose of this study was to explore critical care unit managers'perceptions of and experiences with their nursing staff's napping practices on night shift, including their perceptions of the benefits and barriers to napping/not napping in terms of patient safety and nurses'personal health and safety. A survey design was used. Forty-seven Canadian critical care unit managers who were members of the Canadian Association of Critical Care Nurses responded to the web-based survey. Data analysis involved calculation of frequencies and percentages for demographic data, use of the Friedman rank test for comparison of managers' perceptions, and content analysis for responses to open-ended questions. The findings of this study offer valuable insights into the complexities and conflicts perceived by managers with respect to napping on night shift breaks by nursing staff Staff and patient health and safety issues, work and break expectations and experiences, and strengths and deficits related to organizational napping resources and policy are considerations that will be instrumental in the development of effective napping strategies and guidelines.

Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials.

PubMed

Clark, Catharine H; Aird, Edwin G A; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia A D; Thomas, Russell A S; Venables, Karen; Thwaites, David I

2015-01-01

Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed.

Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials

PubMed Central

Aird, Edwin GA; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia AD; Thomas, Russell AS; Venables, Karen; Thwaites, David I

2015-01-01

Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed. PMID:26329469

Legal and ethical issues in robotic surgery.

PubMed

Mavroforou, A; Michalodimitrakis, E; Hatzitheo-Filou, C; Giannoukas, A

2010-02-01

With the rapid introduction of revolutionary technologies in surgical practice, such as computer-enhanced robotic surgery, the complexity in various aspects, including medical, legal and ethical, will increase exponentially. Our aim was to highlight important legal and ethical implications emerged from the application of robotic surgery. Search of the pertinent medical and legal literature. Robotic surgery may open new avenues in the near future in surgical practice. However, in robotic surgery, special training and experience along with high quality assessment are required in order to provide normal conscientious care and state-of-the-art treatment. While the legal basis for professional liability remains exactly the same, litigation with the use of robotic surgery may be complex. In case of an undesirable outcome, in addition to physician and hospital, the manufacturer of the robotic system may be sued. In respect to ethical issues in robotic surgery, equipment safety and reliability, provision of adequate information, and maintenance of confidentiality are all of paramount importance. Also, the cost of robotic surgery and the lack of such systems in most of the public hospitals may restrict the majority from the benefits offered by the new technology. While surgical robotics will have a significant impact on surgical practice, it presents challenges so much in the realm of law and ethics as of medicine and health care.

Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper

PubMed Central

Safran, Charles; Bloomrosen, Meryl; Hammond, W. Edward; Labkoff, Steven; Markel-Fox, Suzanne; Tang, Paul C.; Detmer, Don E.

2007-01-01

Secondary use of health data applies personal health information (PHI) for uses outside of direct health care delivery. It includes such activities as analysis, research, quality and safety measurement, public health, payment, provider certification or accreditation, marketing, and other business applications, including strictly commercial activities. Secondary use of health data can enhance health care experiences for individuals, expand knowledge about disease and appropriate treatments, strengthen understanding about effectiveness and efficiency of health care systems, support public health and security goals, and aid businesses in meeting customers’ needs. Yet, complex ethical, political, technical, and social issues surround the secondary use of health data. While not new, these issues play increasingly critical and complex roles given current public and private sector activities not only expanding health data volume, but also improving access to data. Lack of coherent policies and standard “good practices” for secondary use of health data impedes efforts to strengthen the U.S. health care system. The nation requires a framework for the secondary use of health data with a robust infrastructure of policies, standards, and best practices. Such a framework can guide and facilitate widespread collection, storage, aggregation, linkage, and transmission of health data. The framework will provide appropriate protections for legitimate secondary use. PMID:17077452

Advanced Compatibility Characterization Of AF-M315E With Spacecraft Propulsion System Materials Project

NASA Technical Reports Server (NTRS)

McClure, Mark B.; Greene, Benjamin

2014-01-01

All spacecraft require propulsion systems for thrust and maneuvering. Propulsion systems can be chemical, nuclear, electrical, cold gas or combinations thereof. Chemical propulsion has proven to be the most reliable technology since the deployment of launch vehicles. Performance, storability, and handling are three important aspects of liquid chemical propulsion. Bipropellant systems require a fuel and an oxidizer for propulsion, but monopropellants only require a fuel and a catalyst for propulsion and are therefore simpler and lighter. Hydrazine is the state of the art propellant for monopropellant systems, but has drawbacks because it is highly hazardous to human health, which requires extensive care in handling, complex ground ops due to safety and environmental considerations, and lengthy turnaround times for reusable spacecraft. All users of hydrazine monopropellant must contend with these issues and their associated costs. The development of a new monopropellant, intended to replace hydrazine, has been in progress for years. This project will apply advanced techniques to characterize the engineering properties of materials used in AF-M315E propulsion systems after propellant exposure. AF-M315E monopropellant has been selected HQ's Green Propellant Infusion Mission (GPIM) to replace toxic hydrazine for improved performance and reduce safety and health issues that will shorten reusable spacecraft turn-around time. In addition, this project will fundamentally strengthen JSC's core competency to evaluate, use and infuse liquid propellant systems.

Video recording of neonatal resuscitation: A feasibility study to inform widespread adoption

PubMed Central

Shivananda, Sandesh; Twiss, Jennifer; el-Gouhary, Enas; el-Helou, Salhab; Williams, Connie; Murthy, Prashanth; Suresh, Gautham

2017-01-01

AIM To determine the feasibility of introducing video recording (VR) of neonatal resuscitation (NR) in a perinatal centre. METHODS This was a prospective cohort quality improvement study on preterm infants and their caregivers. Based on evidence and experience of other centers using VR intervention, a contextually relevant implementation and evaluation strategy was designed in the planning phase. The components of intervention were pre-resuscitation team huddle, VR of NR and video debriefing (VD), all occurring on the same day. Various domains of feasibility and sustainability as well as feasibility criteria were predefined. Data for analysis was collected using quantitative and qualitative methods. RESULTS Seventy-one caregivers participated in VD of 14 NRs facilitated by six trained instructors. Ninety-one percent of caregivers perceived enhanced learning and patient safety and, 48 issues were identified related to policy, caregiver roles, and latent safety threats. Ninety percent of caregivers expressed their willingness to participate in VD activity and supported the idea of integrating it into a resuscitation team routine. Eighty-three percent and 50% of instructors expressed satisfaction with video review software and quality of audio VR. No issues about maintenance of infant or caregivers’ confidentiality and erasure of videos were reported. Criteria for feasibility were met (refusal rate of < 10%, VR performed on > 50% of occasions, and < 20% caregivers’ perceiving a negative impact on team performance). Necessary adaptations to enhance sustainability were identified. CONCLUSION VR of NR as a standard of care quality assurance activity to enhance caregivers’ learning and create opportunities that improve patient safety is feasible. Despite its complexity with inherent challenges in implementation, the intervention was acceptable, implementable, and potentially sustainable with adaptations. PMID:28224098

Health Topics: MedlinePlus

MedlinePlus

... Groups Seniors Women Health and Wellness Expand Section Disasters Fitness and Exercise Food and Nutrition Health System Personal Health Issues Safety Issues Sexual Health Issues Social/Family Issues Wellness and Lifestyle About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe ...

Railroad safety statistics annual report 2006

DOT National Transportation Integrated Search

2008-04-01

It is hoped that the information provided in this publication will provide insight into the most : significant safety issues facing the rail industry and, in turn, lead to continued rail safety : improvements. Only by continuing our understanding abo...

Railroad safety statistics annual report 2002

DOT National Transportation Integrated Search

2004-03-01

It is hoped that the information provided in this publication will provide insight into the most significant safety issues facing the rail industry and, in turn, lead to continued rail safety improvements. Only by continuing our understanding about h...

Railroad safety statistics annual report 2001

DOT National Transportation Integrated Search

2003-07-01

It is hoped that the information provided in this publication will provide insight into the most significant safety issues facing the rail industry and, in turn, lead to continued rail safety improvements. Only by continuing our understanding about h...

Rural expressway intersection safety toolbox : desktop reference.

DOT National Transportation Integrated Search

2011-06-01

This document is intended to be a guide for planning-level decisions concerning safety : issues and subsequent potential improvements at rural expressway intersections. It is : NOT a design guide. It simply presents the gamut of safety treatment opti...

Worker Health and Safety: An Area of Conflicts

ERIC Educational Resources Information Center

Ashford, Nicholas A.

1975-01-01

The article outlines four basic conflicts concerning occupational health and safety, discusses the nature and dimensions of health and safety problems, examines the generation of information and its diffusion, and deals briefly with some economic issues. (Author)

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

School Bus Safety Advisory Committee: 1999 Annual Report.

ERIC Educational Resources Information Center

Lazenberry, Dennis; Anderson, Barbara

This report summarizes the deliberations and recommendations of Minnesota's School Bus Safety Advisory Committee (SBSAC). The committee, which operates under the auspices of the Minnesota Department of Public Safety, is charged to study issues affecting the safety of students on school buses, arrive at consensus on ways to improve student safety…

49 CFR 350.319 - What are permissible uses of High Priority Activity Funds?

Code of Federal Regulations, 2011 CFR

2011-10-01

..., except that approved public information and education activities may be reimbursed up to 100 percent of... safety regulations. (3) Increase public awareness about CMV safety. (4) Provide education on CMV safety and related issues. (5) Demonstrate new safety related technologies. (b) These funds will be allocated...

49 CFR 350.319 - What are permissible uses of High Priority Activity Funds?

Code of Federal Regulations, 2014 CFR

2014-10-01

..., except that approved public information and education activities may be reimbursed up to 100 percent of... safety regulations. (3) Increase public awareness about CMV safety. (4) Provide education on CMV safety and related issues. (5) Demonstrate new safety related technologies. (b) These funds will be allocated...

49 CFR 350.319 - What are permissible uses of High Priority Activity Funds?

Code of Federal Regulations, 2013 CFR

2013-10-01

..., except that approved public information and education activities may be reimbursed up to 100 percent of... safety regulations. (3) Increase public awareness about CMV safety. (4) Provide education on CMV safety and related issues. (5) Demonstrate new safety related technologies. (b) These funds will be allocated...

49 CFR 350.319 - What are permissible uses of High Priority Activity Funds?

Code of Federal Regulations, 2012 CFR

2012-10-01

..., except that approved public information and education activities may be reimbursed up to 100 percent of... safety regulations. (3) Increase public awareness about CMV safety. (4) Provide education on CMV safety and related issues. (5) Demonstrate new safety related technologies. (b) These funds will be allocated...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant issues the original SOLAS...

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

76 FR 52231 - Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Standards Service Aviation Safety Inspectors AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... responsible for the oversight of, a Flight Standards Service Aviation Safety Inspector, and had direct... . SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA's authority to issue rules on aviation safety...

Overview of Federal Motor Carrier Safety Administration safety training research for new entrant motor carriers : [research brief].

DOT National Transportation Integrated Search

2015-07-01

In 2002, the Federal Motor Carrier Safety Administration (FMCSA) issued the New Entrant Program Interim Final Rule in response to the requirement in the Motor Carrier Safety Improvement Act of 1999. The requirement in the Act was based on research fi...

Vaccines Stop Illness

MedlinePlus

Skip Navigation Bar Home Current Issue Past Issues Vaccines Stop Illness Past Issues / Spring 2008 Table of ... meningitis won't infect, cripple, or kill children. Vaccine Safety In light of recent questions about vaccine ...

Simulation-Based Testing of Pager Interruptions During Laparoscopic Cholecystectomy.

PubMed

Sujka, Joseph A; Safcsak, Karen; Bhullar, Indermeet S; Havron, William S

2018-01-30

To determine if pager interruptions affect operative time, safety, or complications and management of pager issues during a simulated laparoscopic cholecystectomy. Twelve surgery resident volunteers were tested on a Simbionix Lap Mentor II simulator. Each resident performed 6 randomized simulated laparoscopic cholecystectomies; 3 with pager interruptions (INT) and 3 without pager interruptions (NO-INT). The pager interruptions were sent in the form of standardized patient vignettes and timed to distract the resident during dissection of the critical view of safety and clipping of the cystic duct. The residents were graded on a pass/fail scale for eliciting appropriate patient history and management of the pager issue. Data was extracted from the simulator for the following endpoints: operative time, safety metrics, and incidence of operative complications. The Mann-Whitney U test and contingency table analysis were used to compare the 2 groups (INT vs. NO-INT). Level I trauma center; Simulation laboratory. Twelve general surgery residents. There was no significant difference between the 2 groups in any of the operative endpoints as measured by the simulator. However, in the INT group, only 25% of the time did the surgery residents both adequately address the issue and provide effective patient management in response to the pager interruption. Pager interruptions did not affect operative time, safety, or complications during the simulated procedure. However, there were significant failures in the appropriate evaluations and management of pager issues. Consideration for diversion of patient care issues to fellow residents not operating to improve quality and safety of patient care outside the operating room requires further study. Copyright © 2018. Published by Elsevier Inc.

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.