Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

PubMed

Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

2017-07-01

Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

49 CFR 192.171 - Compressor stations: Additional safety equipment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Compressor stations: Additional safety equipment... Pipeline Components § 192.171 Compressor stations: Additional safety equipment. (a) Each compressor station must have adequate fire protection facilities. If fire pumps are a part of these facilities, their...

Practice-specific risk perceptions and self-reported food safety practices.

PubMed

Levy, Alan S; Choinière, Conrad J; Fein, Sara B

2008-06-01

The relationship between risk perception and risk avoidance is typically analyzed using self-reported measures. However, in domains such as driving or food handling, the validity of responses about usual behavior is threatened because people think about the situations in which they are self-aware, such as when they encounter a hazard. Indeed, researchers have often noted a divergence between what people say about their behavior and how they actually behave. Thus, in order to draw conclusions about risk perceptions and risk avoidance from survey data, it is important to identify particular cognitive elements, such as those measured by questions about risk and safety knowledge, risk perceptions, or information search behavior, which may be effective antecedents of self-reported safety behavior. It is also important to identify and correct for potential sources of bias that may exist in the data. The authors analyze the Food and Drug Administration's 1998 Food Safety Survey to determine whether there are consistent cognitive antecedents for three types of safe food practices: preparation, eating, and cooling of foods. An assessment of measurement biases shows that endogeneity of food choices affects reports of food preparation. In addition, response bias affects reports of cooling practices as evidenced by its relation to knowledge and information search, a pattern of cognitive effects unique to cooling practices. After correcting for these biases, results show that practice-specific risk perceptions are the primary cognitive antecedents of safe food behavior, which has implications for the design of effective education messages about food safety.

Dams and Levees: Safety Risks

NASA Astrophysics Data System (ADS)

Carter, N. T.

2017-12-01

The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the

Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

NASA Astrophysics Data System (ADS)

Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

2015-05-01

Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

Governance implications of nanomaterials companies' inconsistent risk perceptions and safety practices

NASA Astrophysics Data System (ADS)

Engeman, Cassandra D.; Baumgartner, Lynn; Carr, Benjamin M.; Fish, Allison M.; Meyerhofer, John D.; Satterfield, Terre A.; Holden, Patricia A.; Harthorn, Barbara Herr

2012-03-01

Current research on the nanotechnology industry indicates its downstream expansion at a rapid pace, while toxicological research and best practices for environmental health and safety are still being developed. Companies that use and/or produce engineered nanomaterials (ENMs) have enormous potential to influence safe-handling practices for ENMs across the product life cycle. Knowledge of both industry practices and leaders' perceptions of risk is vital for understanding how companies will act to control potential environmental and health risks. This article reports results from a new international survey of nanomaterials companies in 14 countries. In this survey, company participants reported relatively high levels of uncertainty and/or perceived risk with regard to ENMs. However, these perspectives were not accompanied by expected risk-avoidant practices or preferences for regulatory oversight. A majority of companies indicated "lack of information" as a significant impediment to implementing nano-specific safety practices, but they also reported practices that were inconsistent with widely available guidance. Additionally, in the absence of safe-handling regulations, companies reported nano-specific health and safety programs that were narrow in scope. Taken together, these findings indicate that health and safety guidance is not reaching industry. While industry leaders' reluctance toward regulation might be expected, their own reported unsafe practices and recognition of possible risks suggest a more top-down approach from regulators is needed to protect workers and the environment.

Risk-based Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

1992-01-01

Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

Safety analysis, risk assessment, and risk acceptance criteria

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

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

[Safety of food additives in Japan].

PubMed

Ito, Sumio

2011-01-01

Recently, many accidents relating to food happened in Japan. The consumer's distrust for food, food companies, and the administration is increasing. The consumer especially has an extreme refusal feeling for chemicals such as food additives and agricultural chemicals, and begins to request agricultural chemical-free vegetables and food additive-free food. Food companies also state no agricultural chemicals and no food additives to correspond with consumers' request and aim at differentiating. The food additive is that the Ministry of Health, Labour and Welfare specifies the one that person's health might not be ruined by providing for Food Sanitation Law Article 10 in our country. The standard for food additives and standard for use of food additives are provided according to regulations of Food Sanitation Law Article 11. Therefore, it is thought that the food additive used is safe now. Then, it reports on the procedure and the safety examination, etc. in our country for designation for food additive this time.

Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

PubMed

Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

2015-01-01

The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research.

Behavior-Based Safety and Occupational Risk Management

ERIC Educational Resources Information Center

Geller, E. Scott

2005-01-01

The behavior-based approach to managing occupational risk and preventing workplace injuries is reviewed. Unlike the typical top-down control approach to industrial safety, behavior-based safety (BBS) provides tools and procedures workers can use to take personal control of occupational risks. Strategies the author and his colleagues have been…

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

L-Band Digital Aeronautical Communications System Engineering - Initial Safety and Security Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

PubMed

DeTora, Lisa M

2017-07-01

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work. © 2017 John Wiley

Bacterial-based additives for the production of artificial snow: what are the risks to human health?

PubMed

Lagriffoul, A; Boudenne, J L; Absi, R; Ballet, J J; Berjeaud, J M; Chevalier, S; Creppy, E E; Gilli, E; Gadonna, J P; Gadonna-Widehem, P; Morris, C E; Zini, S

2010-03-01

For around two decades, artificial snow has been used by numerous winter sports resorts to ensure good snow cover at low altitude areas or more generally, to lengthen the skiing season. Biological additives derived from certain bacteria are regularly used to make artificial snow. However, the use of these additives has raised doubts concerning the potential impact on human health and the environment. In this context, the French health authorities have requested the French Agency for Environmental and Occupational Health Safety (Afsset) to assess the health risks resulting from the use of such additives. The health risk assessment was based on a review of the scientific literature, supplemented by professional consultations and expertise. Biological or chemical hazards from additives derived from the ice nucleation active bacterium Pseudomonas syringae were characterised. Potential health hazards to humans were considered in terms of infectious, toxic and allergenic capacities with respect to human populations liable to be exposed and the means of possible exposure. Taking into account these data, a qualitative risk assessment was carried out, according to four exposure scenarios, involving the different populations exposed, and the conditions and routes of exposure. It was concluded that certain health risks can exist for specific categories of professional workers (mainly snowmakers during additive mixing and dilution tank cleaning steps, with risks estimated to be negligible to low if workers comply with safety precautions). P. syringae does not present any pathogenic capacity to humans and that the level of its endotoxins found in artificial snow do not represent a danger beyond that of exposure to P. syringae endotoxins naturally present in snow. However, the risk of possible allergy in some particularly sensitive individuals cannot be excluded. Another important conclusion of this study concerns use of poor microbiological water quality to make artificial snow.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Prevention and control of food safety risks: the role of governments, food producers, marketers, and academia.

PubMed

Lupien, John R

2007-01-01

Food systems are rapidly changing as world population grows, increasing urbanization occurs, consumer tastes and preferences change and differ in various countries and cultures, large scale food production increases, and food imports and exports grow in volume and value. Consumers in all countries have become more insistent that foods available in the marketplace are of good quality and safe, and do not pose risks to them and their families. Publicity about food risk problems and related risks, including chemical and microbiological contamination of foods, mad-cow disease, avian flu, industrial chemical contamination all have made consumers and policy makers more aware of the need of the control of food safety risk factors in all countries. To discuss changes in food systems, and in consumer expectations, that have placed additional stress on the need for better control of food safety risks. Food producers, processors, and marketers have additional food law and regulations to meet; government agencies must increase monitoring and enforcement of adequate food quality and safety legislation and coordinate efforts between agriculture, health, trade, justice and customs agencies; and academia must take action to strengthen the education of competent food legislation administrators, inspectorate, and laboratory personnel for work in government and industry, including related food and food safety research . Both Government and the food industry must assure that adequate control programs are in place to control the quality and safety of all foods, raw or processed, throughout the food chain from production to final consumption. This includes appropriate laboratory facilities to perform necessary analysis of foods for risk and quality factors, and to carry out a wide range of food science, toxicological and related research.

Bus operator perceptions of safety risks.

DOT National Transportation Integrated Search

2013-07-01

This paper presents the results of a survey of TriMet bus operators addressing safety risks in their assigned work. Surveyed risk factors : were organized into five categories: vehicle design and condition; route layout; operating conditions; fatigue...

University building safety index measurement using risk and implementation matrix

NASA Astrophysics Data System (ADS)

Rahman, A.; Arumsari, F.; Maryani, A.

2018-04-01

Many high rise building constructed in several universities in Indonesia. The high-rise building management must provide the safety planning and proper safety equipment in each part of the building. Unfortunately, most of the university in Indonesia have not been applying safety policy yet and less awareness on treating safety facilities. Several fire accidents in university showed that some significant risk should be managed by the building management. This research developed a framework for measuring the high rise building safety index in university The framework is not only assessed the risk magnitude but also designed modular building safety checklist for measuring the safety implementation level. The safety checklist has been developed for 8 types of the university rooms, i.e.: office, classroom, 4 type of laboratories, canteen, and library. University building safety index determined using risk-implementation matrix by measuring the risk magnitude and assessing the safety implementation level. Building Safety Index measurement has been applied in 4 high rise buildings in ITS Campus. The building assessment showed that the rectorate building in secure condition and chemical department building in beware condition. While the library and administration center building was in less secure condition.

21 CFR 70.42 - Criteria for evaluating the safety of color additives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of color additives. (a) In deciding whether a petition is complete and suitable for filing and in reaching a decision...

Perceived safety and controllability of events: Markers of risk for marijuana use in young adults?

PubMed

Sartor, Carolyn E; Ecker, Anthony H; Kraus, Shane W; Leeman, Robert F; Dukes, Kristin N; Foster, Dawn W

2017-03-01

Drawing on constructs from the trauma literature, the current study evaluated perceptions of safety and controllability of events as potential markers of risk for marijuana use. In addition, we characterized these perceptions in relation to individual level substance abuse risk factors (marijuana expectancies, impulsivity, depression, and anxiety), gender, and race. Data were collected via web survey from college students at two northeastern universities (n=228, 82.0% female). Controllability of events (CE) was rated significantly higher by Blacks than Whites. Safety/vulnerability (SV) and CE were associated with impulsivity, depression, and anxiety. CE was also associated with marijuana expectancies. Logistic regression analyses revealed a modest but significant association between SV and lifetime use even after adjusting for race, gender, age, and individual level substance abuse risk factors (odds ratio=1.10, 95% confidence intervals:1.02-1.18). No association between SV and past 3month frequency of use or between CE and either marijuana outcome was found. Findings support a link between perceptions of safety and ever using marijuana. They further demonstrate overlap of both perceived safety and controllability of events with substance use related risk factors, and suggest that they differ by race. Additional studies that assess substance use more broadly and query trauma history, using larger, more diverse samples, are needed to more fully grasp the relevance of these constructs to substance use, including their potential as targets for substance abuse prevention efforts. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 570.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 570.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 570.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

[Post-marketing drug safety-risk management plan(RMP)].

PubMed

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

Science and Safety: 'Acceptable' Risk

ERIC Educational Resources Information Center

Science News, 1976

1976-01-01

Stresses ways to answer questions related to widespread publicity - are nuclear reactors safe, will dangerous research in genetic manipulation be banned? - with emphasis on true meaning of safety as related to risks. (EB)

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a decision on any petition filed under section 409...

Understanding children's injury-risk behavior: wearing safety gear can lead to increased risk taking.

PubMed

Morrongiello, Barbara A; Walpole, Beverly; Lasenby, Jennifer

2007-05-01

The present study examined whether school-age children show risk compensation and engage in greater risk taking when wearing safety gear compared to when not doing so when running an obstacle course containing hazards that could lead to physical injury. Because sensation seeking has been shown to influence risk taking, this child attribute was also assessed and related to risk compensation. Children 7-12 years of age were videotaped navigating the obstacle course twice, once wearing safety gear and once without safety gear, with reverse directions used to minimize possible practice effects. The time it took the child to run through the course and the number of reckless behaviors (e.g., falls, trips, bumping into things) that the child made while running the course were compared for the gear and no-gear conditions. Results indicated that children went more quickly and behaved more recklessly when wearing safety gear than when not wearing gear, providing evidence of risk compensation. Moreover, those high in sensation seeking showed greater risk compensation compared with other children. Implications for childhood injury prevention are discussed.

Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

Additional nuclear criticality safety calculations for small-diameter containers

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

Hone, M.J.

This report documents additional criticality safety analysis calculations for small diameter containers, which were originally documented in Reference 1. The results in Reference 1 indicated that some of the small diameter containers did not meet the criteria established for criticality safety at the Portsmouth facility (K{sub eff} +2{sigma}<.95) when modeled under various contingency assumptions of reflection and moderation. The calculations performed in this report reexamine those cases which did not meet the criticality safety criteria. In some cases, unnecessary conservatism is removed, and in other cases mass or assay limits are established for use with the respective containers.

Measuring mining safety with injury statistics: lost workdays as indicators of risk.

PubMed

Coleman, Patrick J; Kerkering, John C

2007-01-01

Mining in the United States remains one of the most hazardous industries, despite significant reductions in fatal injury rates over the last century. Coal mine fatality rates, for example, have dropped almost a thousand-fold since their peak in 1908. While incidence rates are very important indicators, lost worktime measures offer an alternative metric for evaluating job safety and health performance. The first objective of this study examined the distributions and summary statistics of all injuries reported to the Mine Safety and Health Administration from 1983 through 2004. Over the period studied (1983-2004), there were 31,515,368 lost workdays associated with mining injuries, for an equivalent of 5,700 person-years lost annually. The second objective addressed the problem of comparing safety program performance in mines for situations where denominator data were lacking. By examining the consequences of injuries, comparisons can be made between disparate operations without the need for denominators. Total risk in the form of lost workday sums can help to distinguish between lower- and higher-risk operations or time periods. Our method was to use a beta distribution to model the losses and to compare underground coal mining to underground metal/nonmetal mining from 2000 to 2004. Our results showed the probability of an injury having 10 or more lost workdays was 0.52 for coal mine cases versus 0.35 for metal/nonmetal mine cases. In addition, a comparison of injuries involving continuous mining machines over 2001-2002 versus 2003-2004 showed that the ratio of average losses in the later period to those in the earlier period was approximately 1.08, suggesting increasing risks for such operations. This denominator-free safety measure will help the mining industry more effectively identify higher-risk operations and more realistically evaluate their safety improvement programs. Attention to a variety of metrics concerning the performance of a job safety and health

Preventing necrotizing enterocolitis by food additives in neonates: A network meta-analysis revealing the efficacy and safety.

PubMed

Yu, Wentao; Sui, Wu; Mu, Linsong; Yi, Wenying; Li, Haijuan; Wei, Liqin; Yin, Weihong

2017-05-01

Necrotizing enterocolitis (NEC) is a serious multifactorial gastrointestinal disease which is often discovered in premature infants. Various additives have been used to prevent NEC; yet, their relative efficacy and safety remain disputed. This study aims to compare the efficacy and safety of 5 food additives, namely, probiotics, probiotics + fructo-oligosaccharides, pentoxifylline, arginine, and lactoferrin in preventing NEC in neonates. Embase, PubMed, and Cochrane Library had been searched for all eligible randomized control trials. Odds ratios (ORs) were estimated for dichotomous data and mean differences with 95% credible intervals (CrIs) were estimated for continuous data. Surface under the cumulative ranking curve was used to rank efficacy and safety of the prevention methods on each endpoint. A total of 27 eligible studies with 4649 preterm infants were included in this network meta-analysis (NMA), and the efficacy and safety of 5 food additives were evaluated. Probiotic and arginine exhibited better preventive efficacy compared with placebo (OR = 0.50, 95% CrIs: 0.32-0.73; OR = 0.30, 95% CrIs: 0.12-0.73, respectively). Only probiotic achieved a considerable decrease in the risk of mortality compared to placebo (OR = 0.68, 95% CrIs: 0.46-0.98). NEC patients with lactoferrin appeared to have lower incidence of sepsis than those of placebo (OR = 0.13, 95% CrIs: 0.03-0.61) or probiotic (OR = 0.18, 95% CrIs: 0.03-0.83). Based on this NMA, probiotics had the potential to be the most preferable additive, since it exhibited a significant superiority for NEC and mortality as well as a relatively balanced performance in safety.

A risk-based decision support framework for selection of appropriate safety measure system for underground coal mines.

PubMed

Samantra, Chitrasen; Datta, Saurav; Mahapatra, Siba Sankar

2017-03-01

In the context of underground coal mining industry, the increased economic issues regarding implementation of additional safety measure systems, along with growing public awareness to ensure high level of workers safety, have put great pressure on the managers towards finding the best solution to ensure safe as well as economically viable alternative selection. Risk-based decision support system plays an important role in finding such solutions amongst candidate alternatives with respect to multiple decision criteria. Therefore, in this paper, a unified risk-based decision-making methodology has been proposed for selecting an appropriate safety measure system in relation to an underground coal mining industry with respect to multiple risk criteria such as financial risk, operating risk, and maintenance risk. The proposed methodology uses interval-valued fuzzy set theory for modelling vagueness and subjectivity in the estimates of fuzzy risk ratings for making appropriate decision. The methodology is based on the aggregative fuzzy risk analysis and multi-criteria decision making. The selection decisions are made within the context of understanding the total integrated risk that is likely to incur while adapting the particular safety system alternative. Effectiveness of the proposed methodology has been validated through a real-time case study. The result in the context of final priority ranking is seemed fairly consistent.

Risk-Based Explosive Safety Analysis

DTIC Science & Technology

2016-11-30

safety siting of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed...liquids or propellants . 15. SUBJECT TERMS N/A 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed personnel and the

Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

PubMed

Baron, Patrick; Frattaroli, Shannon

2016-01-01

The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain.

Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

PubMed Central

Baron, Patrick; Frattaroli, Shannon

2016-01-01

The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

Sensemaking of patient safety risks and hazards.

PubMed

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-08-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced.

Sensemaking of Patient Safety Risks and Hazards

PubMed Central

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-01-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced. PMID:16898979

[Endorsement of risk management and patient safety by certification of conformity in health care quality assessment].

PubMed

Waßmuth, Ralf

2015-01-01

Certification of conformity in health care should provide assurance of compliance with quality standards. This also includes risk management and patient safety. Based on a comprehensive definition of quality, beneficial effects on the management of risks and the enhancement of patient safety can be expected from certification of conformity. While these effects have strong face validity, they are currently not sufficiently supported by evidence from health care research. Whether this relates to a lack of evidence or a lack of investigation remains open. Advancing safety culture and "climate", as well as learning from adverse events rely in part on quality management and are at least in part reflected in the certification of healthcare quality. However, again, evidence of the effectiveness of such measures is limited. Moreover, additional factors related to personality, attitude and proactive action of healthcare professionals are crucial factors in advancing risk management and patient safety which are currently not adequately reflected in certification of conformity programs.

Quantifying Safety Margin Using the Risk-Informed Safety Margin Characterization (RISMC)

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

Grabaskas, David; Bucknor, Matthew; Brunett, Acacia

2015-04-26

The Risk-Informed Safety Margin Characterization (RISMC), developed by Idaho National Laboratory as part of the Light-Water Reactor Sustainability Project, utilizes a probabilistic safety margin comparison between a load and capacity distribution, rather than a deterministic comparison between two values, as is usually done in best-estimate plus uncertainty analyses. The goal is to determine the failure probability, or in other words, the probability of the system load equaling or exceeding the system capacity. While this method has been used in pilot studies, there has been little work conducted investigating the statistical significance of the resulting failure probability. In particular, it ismore » difficult to determine how many simulations are necessary to properly characterize the failure probability. This work uses classical (frequentist) statistics and confidence intervals to examine the impact in statistical accuracy when the number of simulations is varied. Two methods are proposed to establish confidence intervals related to the failure probability established using a RISMC analysis. The confidence interval provides information about the statistical accuracy of the method utilized to explore the uncertainty space, and offers a quantitative method to gauge the increase in statistical accuracy due to performing additional simulations.« less

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

Critical factors and paths influencing construction workers' safety risk tolerances.

PubMed

Wang, Jiayuan; Zou, Patrick X W; Li, Penny P

2016-08-01

While workers' safety risk tolerances have been regarded as a main reason for their unsafe behaviors, little is known about why different people have different risk tolerances even when confronting the same situation. The aim of this research is to identify the critical factors and paths that influence workers' safety risk tolerance and to explore how they contribute to accident causal model from a system thinking perceptive. A number of methods were carried out to analyze the data collected through interviews and questionnaire surveys. In the first and second steps of the research, factor identification, factor ranking and factor analysis were carried out, and the results show that workers' safety risk tolerance can be influenced by four groups of factors, namely: (1) personal subjective perception; (2) work knowledge and experiences; (3) work characteristics; and (4) safety management. In the third step of the research, hypothetical influencing path model was developed and tested by using structural equation modeling (SEM). It is found that the effects of external factors (safety management and work characteristics) on risk tolerance are larger than that of internal factors (personal subjective perception and work knowledge & experiences). Specifically, safety management contributes the most to workers' safety risk tolerance through its direct effect and indirect effect; while personal subjective perception comes the second and can act as an intermedia for work characteristics. This research provides an in-depth insight of workers' unsafe behaviors by depicting the contributing factors as shown in the accident causal model developed in this research. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Weighing use and safety of therapeutic agents and feed additives (author's transl)].

PubMed

van der Wal, P

1982-02-01

(1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable.

RiskSOAP: Introducing and applying a methodology of risk self-awareness in road tunnel safety.

PubMed

Chatzimichailidou, Maria Mikela; Dokas, Ioannis M

2016-05-01

Complex socio-technical systems, such as road tunnels, can be designed and developed with more or less elements that can either positively or negatively affect the capability of their agents to recognise imminent threats or vulnerabilities that possibly lead to accidents. This capability is called risk Situation Awareness (SA) provision. Having as a motive the introduction of better tools for designing and developing systems that are self-aware of their vulnerabilities and react to prevent accidents and losses, this paper introduces the Risk Situation Awareness Provision (RiskSOAP) methodology to the field of road tunnel safety, as a means to measure this capability in this kind of systems. The main objective is to test the soundness and the applicability of RiskSOAP to infrastructure, which is advanced in terms of technology, human integration, and minimum number of safety requirements imposed by international bodies. RiskSOAP is applied to a specific road tunnel in Greece and the accompanying indicator is calculated twice, once for the tunnel design as defined by updated European safety standards and once for the 'as-is' tunnel composition, which complies with the necessary safety requirements, but calls for enhancing safety according to what EU and PIARC further suggest. The derived values indicate the extent to which each tunnel version is capable of comprehending its threats and vulnerabilities based on its elements. The former tunnel version seems to be more enhanced both in terms of it risk awareness capability and safety as well. Another interesting finding is that despite the advanced tunnel safety specifications, there is still room for enriching the safe design and maintenance of the road tunnel. Copyright © 2016 Elsevier Ltd. All rights reserved.

Hazards, risks and safety of diagnostic ultrasound.

PubMed

Duck, Francis A

2008-12-01

The safety of exposure to diagnostic ultrasound is evaluated using a structured approach to risk assessment, based on the acoustic output of present ultrasound scanners. Thermal hazard is described, the magnitude and probability of temperature rise is reviewed, and the severity of harm from any outcome is reviewed. Similar assessments are made separately for acoustic cavitation and gas-body effects, which have previously been considered together. Finally, radiation pressure is considered in a similar manner. In each case, means to minimize the risk are suggested where appropriate. The highest risks are associated with the use of gas-bubble contrast agents. It is concluded that there is a medium risk associated with trans-cranial Doppler use, and that this use of ultrasound deserves more detailed safety review. The risks associated with the current practice of obstetric ultrasound are low. Whilst the severity of radiation pressure as a hazard is low, it is always present. Little is known about any associated cell responses and so the associated risk cannot be evaluated.

46 CFR 308.104 - Additional war risk insurance.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 8 2012-10-01 2012-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers may...

46 CFR 308.104 - Additional war risk insurance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers may...

46 CFR 308.104 - Additional war risk insurance.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 8 2014-10-01 2014-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers may...

46 CFR 308.104 - Additional war risk insurance.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 8 2011-10-01 2011-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers may...

46 CFR 308.104 - Additional war risk insurance.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 8 2013-10-01 2013-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers may...

Food additives: an ethical evaluation.

PubMed

Mepham, Ben

2011-01-01

Food additives are an integral part of the modern food system, but opinion polls showing most Europeans have worries about them imply an urgent need for ethical analysis of their use. The existing literature on food ethics, safety assessment and animal testing. Food additives provide certain advantages in terms of many people's lifestyles. There are disagreements about the appropriate application of the precautionary principle and of the value and ethical validity of animal tests in assessing human safety. Most consumers have a poor understanding of the relative benefits and risks of additives, but concerns over food safety and animal testing remain high. Examining the impacts of food additives on consumer sovereignty, consumer health and on animals used in safety testing should allow a more informed debate about their appropriate uses.

Evaluating life-safety risk of fieldwork at New Zealand's active volcanoes

NASA Astrophysics Data System (ADS)

Deligne, Natalia; Jolly, Gill; Taig, Tony; Webb, Terry

2014-05-01

Volcano observatories monitor active or potentially active volcanoes. Although the number and scope of remote monitoring instruments and methods continues to grow, in-person field data collection is still required for comprehensive monitoring. Fieldwork anywhere, and especially in mountainous areas, contains an element of risk. However, on volcanoes with signs of unrest, there is an additional risk of volcanic activity escalating while on site, with potentially lethal consequences. As an employer, a volcano observatory is morally and sometimes legally obligated to take reasonable measures to ensure staff safety and to minimise occupational risk. Here we present how GNS Science evaluates life-safety risk for volcanologists engaged in fieldwork on New Zealand volcanoes with signs of volcanic unrest. Our method includes several key elements: (1) an expert elicitation for how likely an eruption is within a given time frame, (2) quantification of, based on historical data when possible, given a small, moderate, or large eruption, the likelihood of exposure to near-vent processes, ballistics, or surge at various distances from the vent, and (3) estimate of fatality rate given exposure to these volcanic hazards. The final product quantifies hourly fatality risk at various distances from a volcanic vent; various thresholds of risk (for example, zones with more than 10-5 hourly fatality risk) trigger different levels of required approval to undertake work. Although an element of risk will always be present when conducting fieldwork on potentially active volcanoes, this is a first step towards providing objective guidance for go/no go decisions for volcanic monitoring.

Compressed natural gas bus safety: a quantitative risk assessment.

PubMed

Chamberlain, Samuel; Modarres, Mohammad

2005-04-01

This study assesses the fire safety risks associated with compressed natural gas (CNG) vehicle systems, comprising primarily a typical school bus and supporting fuel infrastructure. The study determines the sensitivity of the results to variations in component failure rates and consequences of fire events. The components and subsystems that contribute most to fire safety risk are determined. Finally, the results are compared to fire risks of the present generation of diesel-fueled school buses. Direct computation of the safety risks associated with diesel-powered vehicles is possible because these are mature technologies for which historical performance data are available. Because of limited experience, fatal accident data for CNG bus fleets are minimal. Therefore, this study uses the probabilistic risk assessment (PRA) approach to model and predict fire safety risk of CNG buses. Generic failure data, engineering judgments, and assumptions are used in this study. This study predicts the mean fire fatality risk for typical CNG buses as approximately 0.23 fatalities per 100-million miles for all people involved, including bus passengers. The study estimates mean values of 0.16 fatalities per 100-million miles for bus passengers only. Based on historical data, diesel school bus mean fire fatality risk is 0.091 and 0.0007 per 100-million miles for all people and bus passengers, respectively. One can therefore conclude that CNG buses are more prone to fire fatality risk by 2.5 times that of diesel buses, with the bus passengers being more at risk by over two orders of magnitude. The study estimates a mean fire risk frequency of 2.2 x 10(-5) fatalities/bus per year. The 5% and 95% uncertainty bounds are 9.1 x 10(-6) and 4.0 x 10(-5), respectively. The risk result was found to be affected most by failure rates of pressure relief valves, CNG cylinders, and fuel piping.

Risk and Safety of Probiotics

PubMed Central

Doron, Shira; Snydman, David R.

2015-01-01

Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, “the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence.” Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics. PMID:25922398

Understanding Risk Tolerance and Building an Effective Safety Culture

NASA Technical Reports Server (NTRS)

Loyd, David

2018-01-01

Estimates range from 65-90 percent of catastrophic mishaps are due to human error. NASA's human factors-related mishaps causes are estimated at approximately 75 percent. As much as we'd like to error-proof our work environment, even the most automated and complex technical endeavors require human interaction... and are vulnerable to human frailty. Industry and government are focusing not only on human factors integration into hazardous work environments, but also looking for practical approaches to cultivating a strong Safety Culture that diminishes risk. Industry and government organizations have recognized the value of monitoring leading indicators to identify potential risk vulnerabilities. NASA has adapted this approach to assess risk controls associated with hazardous, critical, and complex facilities. NASA's facility risk assessments integrate commercial loss control, OSHA (Occupational Safety and Health Administration) Process Safety, API (American Petroleum Institute) Performance Indicator Standard, and NASA Operational Readiness Inspection concepts to identify risk control vulnerabilities.

Data-driven risk models could help target pipeline safety inspections

DOT National Transportation Integrated Search

2008-07-01

Federal safety agencies share a common problemthe : need to target resources effectively to reduce risk. One : way this targeting is commonly done is with a risk model : that uses safety data along with expert judgment to identify : and weight ris...

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

PubMed

Parker, Dianne

2009-03-01

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

Theories of risk and safety: what is their relevance to nursing?

PubMed

Cooke, Hannah

2009-03-01

The aim of this paper is to review key theories of risk and safety and their implications for nursing. The concept of of patient safety has only recently risen to prominence as an organising principle in healthcare. The paper considers the wider social context in which contemporary concepts of risk and safety have developed. In particular it looks at sociological debates about the rise of risk culture and the risk society and their influence on the patient safety movement. The paper discusses three bodies of theory which have attempted to explain the management of risk and safety in organisations: normal accident theory, high reliability theory, and grid-group cultural theory. It examine debates between these theories and their implications for healthcare. It discusses reasons for the dominance of high reliability theory in healthcare and its strengths and limitations. The paper suggest that high reliability theory has particular difficulties in explaining some aspects of organisational culture. It also suggest that the implementation of high reliability theory in healthcare has involved over reliance on numerical indicators. It suggests that patient safety could be improved by openness to a wider range of theoretical perspectives.

Do we see how they perceive risk? An integrated analysis of risk perception and its effect on workplace safety behavior.

PubMed

Xia, Nini; Wang, Xueqing; Griffin, Mark A; Wu, Chunlin; Liu, Bingsheng

2017-09-01

While risk perception is a key factor influencing safety behavior, the academia lacks specific attention to the ways that workers perceive risk, and thus little is known about the mechanisms through which different risk perceptions influence safety behavior. Most previous research in the workplace safety domain argues that people tend to perceive risk based on rational formulations of risk criticality. However, individuals' emotions can be also useful in understanding their perceptions. Therefore, this research employs an integrated analysis concerning the rational and emotional perspectives. Specifically, it was expected that the identified three rational ways of perceiving risk, i.e., perceived probability, severity, and negative utility, would influence the direct emotional risk perception. Furthermore, these four risk perceptions were all expected to positively but differently influence safety behavior. The hypotheses were tested using a sample of 120 construction workers. It was found that all the three rational risk perceptions significantly influenced workers' direct perception of risk that is mainly based on emotions. Furthermore, safety behavior among workers relied mainly on emotional perception but not rational calculations of risk. This research contributes to workplace safety research by highlighting the importance of integrating the emotional assessment of risk, especially when workers' risk perception and behavior are concerned. Suggested avenues for improving safety behavior through improvement in risk perception include being aware of the possibility of different ways of perceiving risk, promoting experience sharing and accident simulation, and uncovering risk information. Copyright © 2017 Elsevier Ltd. All rights reserved.

The spread model of food safety risk under the supply-demand disturbance.

PubMed

Wang, Jining; Chen, Tingqiang

2016-01-01

In this paper, based on the imbalance of the supply-demand relationship of food, we design a spreading model of food safety risk, which is about from food producers to consumers in the food supply chain. We use theoretical analysis and numerical simulation to describe the supply-demand relationship and government supervision behaviors' influence on the risk spread of food safety and the behaviors of the food producers and the food retailers. We also analyze the influence of the awareness of consumer rights protection and the level of legal protection of consumer rights on the risk spread of food safety. This model contributes to the explicit investigation of the influence relationship among supply-demand factors, the regulation behavioral choice of government, the behavioral choice of food supply chain members and food safety risk spread. And this paper provides a new viewpoint for considering food safety risk spread in the food supply chain, which has a great reference for food safety management.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines.

PubMed

Zhou, Lu-Jie; Cao, Qing-Gui; Yu, Kai; Wang, Lin-Lin; Wang, Hai-Bin

2018-04-26

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines

PubMed Central

Zhou, Lu-jie; Cao, Qing-gui; Yu, Kai; Wang, Lin-lin; Wang, Hai-bin

2018-01-01

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines. PMID:29701715

For Our Own Safety: Examining the Safety of High-Risk Interventions for Children and Young People

ERIC Educational Resources Information Center

Nunno, Michael A., Ed.; Day, David M., Ed.; Bullard, Lloyd B., Ed.

2008-01-01

"For Our Own Safety" is devoted entirely to the subject of, and risks associated with, restraint and seclusion of children. This book is a collection of the diverse viewpoints presented at the international symposium, "Examining the Safety of High-Risk Interventions for Children and Young People" (Ithaca, New York, June 1-4, 2005). It presents…

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

EPA Pesticide Factsheets

President William Jefferson Clinton's Executive Order that each Federal agency assess safety risks to children; and ensure that policies, programs, activities, and standards address disproportionate risks. Also established the Task Force.

[Adolescents, risk situations and road safety].

PubMed

Meneses Falcón, Carmen; Gil García, Eugenia; Romo Avilés, Nuria

2010-09-01

Describe the risk behaviour relationships with road safety in adolescents. Cross-sectional descriptive study. Madrid and Andalusia Regions, representative samples. The sample included 3,612 in secondary school pupils from Madrid (n=1708) and Andalusia (n=1904). The survey was carried out during May and June 2007. The data collected included sociodemographic areas (age, sex, grade, father's profession, birth place, etc.) and risk situation and behaviour (risk behaviour as driver or passenger). 16.2% of the adolescents have been involved in a dangerous situation with motorcycles during the last year. 16.7% never use a helmet when riding a motorcycle and 62% do not wear one when riding a bicycle on the road; 17.4% frequently ride a motorcycle over the speed limit and 24.5% when driving a car. There are significant differences regarding sex, grade and region (Madrid or Andalusia). There are four factors which explain 62% of the variance: drug factor, speed factor, security factor and passenger factor. Two of these have twice the probability of having a dangerous situation when riding a motorcycle: drug factor (OR=1.96; 95% CI, 1.77-2.18) and the speed factor ((OR=2.13; 95% CI, 1.92-2.36). Adolescents in higher grades and living in Andalusia were less road safety conscious. This pattern should be taken into account when designing preventive actions in Road Safety Education. 2009 Elsevier España, S.L. All rights reserved.

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

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

NASA Technical Reports Server (NTRS)

Lutomski, Mike

2005-01-01

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

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes

PubMed Central

Hammer, Leslie B.; Truxillo, Donald M.; Bodner, Todd; Rineer, Jennifer; Pytlovany, Amy C.; Richman, Amy

2015-01-01

The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based), followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety. PMID:26557703

Aviation Safety Risk Modeling: Lessons Learned From Multiple Knowledge Elicitation Sessions

NASA Technical Reports Server (NTRS)

Luxhoj, J. T.; Ancel, E.; Green, L. L.; Shih, A. T.; Jones, S. M.; Reveley, M. S.

2014-01-01

Aviation safety risk modeling has elements of both art and science. In a complex domain, such as the National Airspace System (NAS), it is essential that knowledge elicitation (KE) sessions with domain experts be performed to facilitate the making of plausible inferences about the possible impacts of future technologies and procedures. This study discusses lessons learned throughout the multiple KE sessions held with domain experts to construct probabilistic safety risk models for a Loss of Control Accident Framework (LOCAF), FLightdeck Automation Problems (FLAP), and Runway Incursion (RI) mishap scenarios. The intent of these safety risk models is to support a portfolio analysis of NASA's Aviation Safety Program (AvSP). These models use the flexible, probabilistic approach of Bayesian Belief Networks (BBNs) and influence diagrams to model the complex interactions of aviation system risk factors. Each KE session had a different set of experts with diverse expertise, such as pilot, air traffic controller, certification, and/or human factors knowledge that was elicited to construct a composite, systems-level risk model. There were numerous "lessons learned" from these KE sessions that deal with behavioral aggregation, conditional probability modeling, object-oriented construction, interpretation of the safety risk results, and model verification/validation that are presented in this paper.

Fundamentals of health risk assessment. Use, derivation, validity and limitations of safety indices.

PubMed

Putzrath, R M; Wilson, J D

1999-04-01

We investigated the way results of human health risk assessments are used, and the theory used to describe those methods, sometimes called the "NAS paradigm." Contrary to a key tenet of that theory, current methods have strictly limited utility. The characterizations now considered standard, Safety Indices such as "Acceptable Daily Intake," "Reference Dose," and so on, usefully inform only decisions that require a choice between two policy alternatives (e.g., approve a food additive or not), decided solely on the basis of a finding of safety. Risk is characterized as the quotient of one of these Safety Indices divided by an estimate of exposure: a quotient greater than one implies that the situation may be considered safe. Such decisions are very widespread, both in the U.S. federal government and elsewhere. No current method is universal; different policies lead to different practices, for example, in California's "Proposition 65," where statutory provisions specify some practices. Further, an important kind of human health risk assessment is not recognized by this theory: this kind characterizes risk as likelihood of harm, given estimates of exposure consequent to various decision choices. Likelihood estimates are necessary whenever decision makers have many possible decision choices and must weigh more than two societal values, such as in EPA's implementation of "conventional air pollutants." These estimates can not be derived using current methods; different methods are needed. Our analysis suggests changes needed in both the theory and practice of human health risk assessment, and how what is done is depicted.

Perception of risk from automobile safety defects.

PubMed

Slovic, P; MacGregor, D; Kraus, N N

1987-10-01

Descriptions of safety engineering defects of the kind that compel automobile manufacturers to initiate a recall campaign were evaluated by individuals on a set of risk characteristic scales that included overall vehicle riskiness, manufacturer's ability to anticipate the defect, importance for vehicle operation, severity of consequences and likelihood of compliance with a recall notice. A factor analysis of the risk characteristics indicated that judgments could be summarized in terms of two composite scales, one representing the uncontrollability of the damage the safety defect might cause and the other representing the foreseeability of the defect by the manufacturer. Motor vehicle defects were found to be highly diverse in terms of the perceived qualities of their risks. Location of individual defects within the factor space was closely associated with perceived riskiness, perceived likelihood of purchasing another car from the same manufacturer, perceived likelihood of compliance with a recall notice, and actual compliance rates.

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

Documentary analysis of risk-assessment and safety-planning policies and tools in a mental health context.

PubMed

Higgins, Agnes; Doyle, Louise; Morrissey, Jean; Downes, Carmel; Gill, Ailish; Bailey, Sive

2016-08-01

Despite the articulated need for policies and processes to guide risk assessment and safety planning, limited guidance exists on the processes or procedures to be used to develop such policies, and there is no body of research that examines the quality or content of the risk-management policies developed. The aim of the present study was to analyse the policies of risk and safety management used to guide mental health nursing practice in Ireland. A documentary analysis was performed on 123 documents received from 22 of the 23 directors of nursing contacted. Findings from the analysis revealed a wide variation in how risk, risk assessment, and risk management were defined. Emphasis within the risk documentation submitted was on risk related to self and others, with minimal attention paid to other types of risks. In addition, there was limited evidence of recovery-focused approaches to positive risk taking that involved service users and their families within the risk-related documentation. Many of the risk-assessment tools had not been validated, and lacked consistency or guidance in relation to how they were to be used or applied. The tick-box approach and absence of space for commentary within documentation have the potential to impact severely on the quality of information collected and documented, and subsequent clinical decision-making. Managers, and those tasked with ensuring safety and quality, need to ensure that policies and processes are, where possible, informed by best evidence and are in line with national mental health policy on recovery. © 2016 Australian College of Mental Health Nurses Inc.

9. BUILDING 65 ADDITION. LASER SAFETY TEAM. FLOOR PLAN, ELEVATIONS, ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

9. BUILDING 65 ADDITION. LASER SAFETY TEAM. FLOOR PLAN, ELEVATIONS, ETC. March 21, 1973 - Frankford Arsenal, Building No. 65, South of Tacony Street between Bridge Street & tracks of former Pennsylvania Railroad, Philadelphia, Philadelphia County, PA

Perceived safety and teen risk taking in online chat sites.

PubMed

McCarty, Cheryl; Prawitz, Aimee D; Derscheid, Linda E; Montgomery, Bette

2011-03-01

Framed by theories of adolescent development, this study explored relationships among adolescents' perceptions of chat-site safety, time spent chatting, and risky online behaviors. Tenth graders (N = 139) in rural Midwestern U.S. schools completed surveys. Factor analysis produced three factors each for perception of safety and risk-taking behaviors. Regression analyses revealed that perception of safety factors were useful in predicting online risk-taking behaviors. Teens with more social discomfort and those who thought it was safe to reveal personal information and trust chat-site "friends" were more likely to take risks. As time spent in chat sites increased, so did risk-taking behaviors. Implications for educators and parents are discussed, such as initiation of conversations about safe Internet use, parental participation in chat sites as teens' invited "friends," and school programs to teach safe online practices.

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

PubMed

Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

2016-12-20

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright �

Safety risk assessment for vertical concrete formwork activities in civil engineering construction.

PubMed

López-Arquillos, Antonio; Rubio-Romero, Juan Carlos; Gibb, Alistair G F; Gambatese, John A

2014-01-01

The construction sector has one of the worst occupational health and safety records in Europe. Of all construction tasks, formwork activities are associated with a high frequency of accidents and injuries. This paper presents an investigation of the activities and related safety risks present in vertical formwork for in-situ concrete construction in the civil engineering sector. Using the methodology of staticized groups, twelve activities and ten safety risks were identified and validated by experts. Every safety risk identified in this manner was quantified for each activity using binary methodology according to the frequency and severity scales developed in prior research. A panel of experts was selected according to the relevant literature on staticized groups. The results obtained show that the activities with the highest risk in vertical formwork tasks are: Plumbing and leveling of forms, cutting of material, handling materials with cranes, and climbing or descending ladders. The most dangerous health and safety risks detected were falls from height, cutting and overexertion. The research findings provide construction practitioners with further evidence of the hazardous activities associated with concrete formwork construction and a starting point for targeting worker health and safety programmes.

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

PubMed

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

2010-08-01

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

Discounting the value of safety: effects of perceived risk and effort.

PubMed

Sigurdsson, Sigurdur O; Taylor, Matthew A; Wirth, Oliver

2013-09-01

Although falls from heights remain the most prevalent cause of fatalities in the construction industry, factors impacting safety-related choices associated with work at heights are not completely understood. Better tools are needed to identify and study the factors influencing safety-related choices and decision making. Using a computer-based task within a behavioral economics paradigm, college students were presented a choice between two hypothetical scenarios that differed in working height and effort associated with retrieving and donning a safety harness. Participants were instructed to choose the scenario in which they were more likely to wear the safety harness. Based on choice patterns, switch points were identified, indicating when the perceived risk in both scenarios was equivalent. Switch points were a systematic function of working height and effort, and the quantified relation between perceived risk and effort was described well by a hyperbolic equation. Choice patterns revealed that the perceived risk of working at heights decreased as the effort to retrieve and don a safety harness increased. Results contribute to the development of computer-based procedure for assessing risk discounting within a behavioral economics framework. Such a procedure can be used as a research tool to study factors that influence safety-related decision making with a goal of informing more effective prevention and intervention strategies. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

NASA Technical Reports Server (NTRS)

Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

2015-01-01

Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

[Safety of food additives from a German and European point of view].

PubMed

Gürtler, R

2010-06-01

There are about 300 food additives permitted in the EU for which a re-evaluation program was initiated recently. Occasionally, it is speculated that the use of single food additives might be of safety concern. First results of the re-evaluation could give an impression on how such concerns were taken into account by responsible authorities, such as the European Food Safety Authority (EFSA). For some of the food additives, the lowest dose resulting in adverse effects was lower in recent studies compared to previous studies. Thus, the acceptable daily intake (ADI) derived applying the common uncertainty factor was lower than the ADI derived using data from previous studies. Therefore, it has to be considered whether the conditions of use need to be modified for these food additives.

Managing Risk in Safety Critical Operations - Lessons Learned from Space Operations

NASA Technical Reports Server (NTRS)

Gonzalez, Steven A.

2002-01-01

The Mission Control Center (MCC) at Johnson Space Center (JSC) has a rich legacy of supporting Human Space Flight operations throughout the Apollo, Shuttle and International Space Station eras. Through the evolution of ground operations and the Mission Control Center facility, NASA has gained a wealth of experience of what it takes to manage the risk in Safety Critical Operations, especially when human life is at risk. The focus of the presentation will be on the processes (training, operational rigor, team dynamics) that enable the JSC/MCC team to be so successful. The presentation will also share the evolution of the Mission Control Center architecture and how the evolution was introduced while managing the risk to the programs supported by the team. The details of the MCC architecture (e.g., the specific software, hardware or tools used in the facility) will not be shared at the conference since it would not give any additional insight as to how risk is managed in Space Operations.

Using a quantitative risk register to promote learning from a patient safety reporting system.

PubMed

Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie

2015-02-01

Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

Toward a Safety Risk-Based Classification of Unmanned Aircraft

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2016-01-01

There is a trend of growing interest and demand for greater access of unmanned aircraft (UA) to the National Airspace System (NAS) as the ongoing development of UA technology has created the potential for significant economic benefits. However, the lack of a comprehensive and efficient UA regulatory framework has constrained the number and kinds of UA operations that can be performed. This report presents initial results of a study aimed at defining a safety-risk-based UA classification as a plausible basis for a regulatory framework for UA operating in the NAS. Much of the study up to this point has been at a conceptual high level. The report includes a survey of contextual topics, analysis of safety risk considerations, and initial recommendations for a risk-based approach to safe UA operations in the NAS. The next phase of the study will develop and leverage deeper clarity and insight into practical engineering and regulatory considerations for ensuring that UA operations have an acceptable level of safety.

Risk perception, risk management and safety assessment: what can governments do to increase public confidence in their vaccine system?

PubMed

MacDonald, Noni E; Smith, Jennifer; Appleton, Mary

2012-09-01

For decades vaccine program managers and governments have devoted many resources to addressing public vaccine concerns, vaccine risk perception, risk management and safety assessment. Despite ever growing evidence that vaccines are safe and effective, public concerns continue. Education and evidence based scientific messages have not ended concerns. How can governments and programs more effectively address the public's vaccine concerns and increase confidence in the vaccine safety system? Vaccination hesitation has been attributed to concerns about vaccine safety, perceptions of high vaccine risks and low disease risk and consequences. Even when the public believes vaccines are important for protection many still have concerns about vaccine safety. This overview explores how heuristics affect public perception of vaccines and vaccine safety, how the public finds and uses vaccine information, and then proposes strategies for changes in the approach to vaccine safety communications. Facts and evidence confirming the safety of vaccines are not enough. Vaccine beliefs and behaviours must be shaped. This will require a shift in the what, when, how and why of vaccine risk and benefit communication content and practice. A change to a behavioural change strategy such as the WHO COMBI program that has been applied to disease eradication efforts is suggested. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

Developing safety performance functions incorporating reliability-based risk measures.

PubMed

Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

2011-11-01

Current geometric design guides provide deterministic standards where the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from these standards. Several studies have advocated probabilistic geometric design where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a risk measure of the implication of deviation from design standards. However, there is currently no link between measures of design reliability and the quantification of safety using collision frequency. The analysis presented in this paper attempts to bridge this gap by incorporating a reliability-based quantitative risk measure such as the probability of non-compliance (P(nc)) in safety performance functions (SPFs). Establishing this link will allow admitting reliability-based design into traditional benefit-cost analysis and should lead to a wider application of the reliability technique in road design. The present application is concerned with the design of horizontal curves, where the limit state function is defined in terms of the available (supply) and stopping (demand) sight distances. A comprehensive collision and geometric design database of two-lane rural highways is used to investigate the effect of the probability of non-compliance on safety. The reliability analysis was carried out using the First Order Reliability Method (FORM). Two Negative Binomial (NB) SPFs were developed to compare models with and without the reliability-based risk measures. It was found that models incorporating the P(nc) provided a better fit to the data set than the traditional (without risk) NB SPFs for total, injury and fatality (I+F) and property damage only (PDO) collisions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Integrated risk reduction framework to improve railway hazardous materials transportation safety.

PubMed

Liu, Xiang; Saat, M Rapik; Barkan, Christopher P L

2013-09-15

Rail transportation plays a critical role to safely and efficiently transport hazardous materials. A number of strategies have been implemented or are being developed to reduce the risk of hazardous materials release from train accidents. Each of these risk reduction strategies has its safety benefit and corresponding implementation cost. However, the cost effectiveness of the integration of different risk reduction strategies is not well understood. Meanwhile, there has been growing interest in the U.S. rail industry and government to best allocate resources for improving hazardous materials transportation safety. This paper presents an optimization model that considers the combination of two types of risk reduction strategies, broken rail prevention and tank car safety design enhancement. A Pareto-optimality technique is used to maximize risk reduction at a given level of investment. The framework presented in this paper can be adapted to address a broader set of risk reduction strategies and is intended to assist decision makers for local, regional and system-wide risk management of rail hazardous materials transportation. Copyright © 2013 Elsevier B.V. All rights reserved.

Understanding safety and production risks in rail engineering planning and protection.

PubMed

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Why the Eurocontrol Safety Regulation Commission Policy on Safety Nets and Risk Assessment is Wrong

NASA Astrophysics Data System (ADS)

Brooker, Peter

2004-05-01

Current Eurocontrol Safety Regulation Commission (SRC) policy says that the Air Traffic Management (ATM) system (including safety minima) must be demonstrated through risk assessments to meet the Target Level of Safety (TLS) without needing to take safety nets (such as Short Term Conflict Alert) into account. This policy is wrong. The policy is invalid because it does not build rationally and consistently from ATM's firm foundations of TLS and hazard analysis. The policy is bad because it would tend to retard safety improvements. Safety net policy must rest on a clear and rational treatment of integrated ATM system safety defences. A new safety net policy, appropriate to safe ATM system improvements, is needed, which recognizes that safety nets are an integrated part of ATM system defences. The effects of safety nets in reducing deaths from mid-air collisions should be fully included in hazard analysis and safety audits in the context of the TLS for total system design.

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

A Qualitative Comparison of Susceptibility and Behavior in Recreational and Occupational Risk Environments: Implications for Promoting Health and Safety.

PubMed

Haas, Emily Joy; Mattson, Marifran

2016-06-01

Although internal factors that influence risk are frequently studied to understand human behavior, external factors, including social, cultural, and institutional factors, should be better utilized to inform ways to efficiently target, tailor, and promote safety messaging to at-risk populations. Semi-structured interviews obtained data from 37 motorcyclists and 18 mineworkers about their risk perceptions and behaviors within their respective dynamic environments. A comparative thematic analysis revealed information about external factors that influence risk perceptions and behaviors. Results support the importance of qualitative approaches for assessing and targeting individuals' risk perceptions and behaviors. In addition, segmenting at-risk subgroups within target populations and tailoring messages for these at-risk groups is critical for safety behavior modification. Practitioners should utilize strategic, culture-centric risk communication that takes into account external factors when determining when, who, and what to communicate via health promotion activities to more accurately disseminate valid, empathetic, and engaging communication with a higher level of fidelity.

Health risk appraisal and safety belt use

DOT National Transportation Integrated Search

1987-05-01

The primary objective of this study was to determine the effectiveness of health risk appraisal (HRA) programs for increasing claimed and observed safety belt use. HRA programs were field tested with and without supplemental educational materials on ...

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

ERIC Educational Resources Information Center

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Acceptability of text messages for safety netting patients with low-risk cancer symptoms: a qualitative study.

PubMed

Hirst, Yasemin; Lim, Anita Wey Wey

2018-05-01

Safety netting is an important diagnostic strategy for patients presenting to primary care with potential (low-risk) cancer symptoms. Typically, this involves asking patients to return if symptoms persist. However, this relies on patients re-appraising their symptoms and making follow-up appointments, which could contribute to delays in diagnosis. Text messaging is increasingly used in primary care to communicate with patients, and could be used to improve safety netting. To explore the acceptability and feasibility of using text messages to safety net patients presenting with low-risk cancer symptoms in GP primary care (txt-netting). Qualitative focus group and interview study with London-based GPs. Participants were identified using convenience sampling methods. Five focus groups and two interviews were conducted with 22 GPs between August and December 2016. Sessions were audiorecorded, transcribed verbatim, and analysed using thematic analysis. GPs were amenable to the concept of using text messages in cancer safety netting, identifying it as an additional tool that could help manage patients and promote symptom awareness. There was wide variation in GP preferences for text message content, and a number of important potential barriers to txt-netting were identified. Concerns were raised about the difficulties of conveying complex safety netting advice within the constraints of a text message, and about confidentiality, widening inequalities, and workload implications. Text messages were perceived to be an acceptable potential strategy for safety netting patients with low-risk cancer symptoms. Further work is needed to ensure it is cost-effective, user friendly, confidential, and acceptable to patients. © British Journal of General Practice 2018.

Exploiting Science: Enhancing the Safety Training of Pilots to Reduce the Risk of Bird Strikes

NASA Astrophysics Data System (ADS)

Mendonca, Flavio A. C.

Analysis of bird strikes to aviation in the U.S. from 1990 to 2015 indicate that the successful mitigation efforts at airports, which must be sustained, have reduced incidents with damage and a negative effect-on-flight since 2000. However, such efforts have done little to reduce strikes outside the airport jurisdiction, such as occurred with US Airways Flight 1549 in 2009. There are basically three strategies to mitigate the risk of bird strikes: standards set by aviation authorities, technology, and actions by crewmembers. Pilots play an important role as stakeholders in the prevention of bird strikes, especially outside the airport environment. Thus, safety efforts require enhanced risk management and aeronautical decision-making training for flight crews. The purpose of this study was to determine if a safety training protocol could effectively enhance CFR Part 141 general aviation pilots' knowledge and skills to reduce the risk of bird strikes to aviation. Participants were recruited from the Purdue University professional flight program and from Purdue Aviation. The researcher of this study used a pretest posttest experimental design. Additionally, qualitative data were collected through open-ended questions in the pretest, posttest, and a follow-up survey questionnaire. The participants' pretest and posttest scores were analyzed using parametric and nonparametric tests. Results indicated a significant increase in the posttest scores of the experimental group. An investigation of qualitative data showed that the topic "safety management of bird hazards by pilots" is barely covered during the ground and flight training of pilots. Furthermore, qualitative data suggest a misperception of the safety culture tenets and a poor familiarity with the safety risk management process regarding bird hazards. Finally, the researcher presented recommendations for practice and future research.

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.

A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

2013-08-30

In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd.

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

Risk Assessment in the UK Health and Safety System: Theory and Practice.

PubMed

Russ, Karen

2010-09-01

In the UK, a person or organisation that creates risk is required to manage and control that risk so that it is reduced 'So Far As Is Reasonably Practicable' (SFAIRP). How the risk is managed is to be determined by those who create the risk. They have a duty to demonstrate that they have taken action to ensure all risk is reduced SFAIRP and must have documentary evidence, for example a risk assessment or safety case, to prove that they manage the risks their activities create. The UK Health and Safety Executive (HSE) does not tell organisations how to manage the risks they create but does inspect the quality of risk identification and management. This paper gives a brief overview of where responsibility for occupational health and safety lies in the UK, and how risk should be managed through risk assessment. The focus of the paper is three recent major UK incidents, all involving fatalities, and all of which were wholly avoidable if risks had been properly assessed and managed. The paper concludes with an analysis of the common failings of risk assessments and key actions for improvement.

Risk management modeling and its application in maritime safety

NASA Astrophysics Data System (ADS)

Qin, Ting-Rong; Chen, Wei-Jiong; Zeng, Xiang-Kun

2008-12-01

Quantified risk assessment (QRA) needs mathematicization of risk theory. However, attention has been paid almost exclusively to applications of assessment methods, which has led to neglect of research into fundamental theories, such as the relationships among risk, safety, danger, and so on. In order to solve this problem, as a first step, fundamental theoretical relationships about risk and risk management were analyzed for this paper in the light of mathematics, and then illustrated with some charts. Second, man-machine-environment-management (MMEM) theory was introduced into risk theory to analyze some properties of risk. On the basis of this, a three-dimensional model of risk management was established that includes: a goal dimension; a management dimension; an operation dimension. This goal management operation (GMO) model was explained and then emphasis was laid on the discussion of the risk flowchart (operation dimension), which lays the groundwork for further study of risk management and qualitative and quantitative assessment. Next, the relationship between Formal Safety Assessment (FSA) and Risk Management was researched. This revealed that the FSA method, which the international maritime organization (IMO) is actively spreading, comes from Risk Management theory. Finally, conclusion were made about how to apply this risk management method to concrete fields efficiently and conveniently, as well as areas where further research is required.

75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a...

Managing health and safety risks: Implications for tailoring health and safety management system practices.

PubMed

Willmer, D R; Haas, E J

2016-01-01

As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.

Risk Classification and Risk-based Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Leitner, Jesse A.

2014-01-01

Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

Biomarkers: Dynamic "Tools" for Health and Safety Risk Assessment

EPA Science Inventory

Today informational flow from biomarkers contributes importantly to various types of health effects research, risk assessment and risk management decisions that impact, or have the potential to impact, public health and safety. Therefore, dependent upon the nature of the health r...

[Food additives and healthiness].

PubMed

Heinonen, Marina

2014-01-01

Additives are used for improving food structure or preventing its spoilage, for example. Many substances used as additives are also naturally present in food. The safety of additives is evaluated according to commonly agreed principles. If high concentrations of an additive cause adverse health effects for humans, a limit of acceptable daily intake (ADI) is set for it. An additive is a risk only when ADI is exceeded. The healthiness of food is measured on the basis of nutrient density and scientifically proven effects.

5 CFR 5201.105 - Additional rules for Mine Safety and Health Administration employees.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Health Administration employees. 5201.105 Section 5201.105 Administrative Personnel DEPARTMENT OF LABOR... for Mine Safety and Health Administration employees. The rules in this section apply to employees of the Mine Safety and Health Administration (MSHA) and are in addition to §§ 5201.101, 5201.102, and...

Safety Risks Among Home Infusion Nurses and Other Home Health Care Providers

PubMed Central

Galligan, Catherine; Quinn, Margaret

2017-01-01

In the United States, home health care (HHC) is a rapidly growing industry and home infusion therapy is a rapidly growing market. HHC can present substantial occupational safety and health (OSH) risks. This article summarizes major OSH risks relevant to home infusion therapy by illustrating them through real-life scenarios collected systematically using qualitative research methods by the National Institute for Occupational Safety and Health-funded research projects at the University of Massachusetts Lowell. The need for home infusion therapy will continue to grow in the future, and safety interventions to prevent or minimize OSH risks are essential. PMID:28683000

Effects of organizational safety on employees' proactivity safety behaviors and occupational health and safety management systems in Chinese high-risk small-scale enterprises.

PubMed

Mei, Qiang; Wang, Qiwei; Liu, Suxia; Zhou, Qiaomei; Zhang, Jingjing

2018-06-07

Based on the characteristics of small-scale enterprises, the improvement of occupational health and safety management systems (OHS MS) needs an effective intervention. This study proposed a structural equation model and examined the relationships of perceived organization support for safety (POSS), person-organization safety fit (POSF) and proactivity safety behaviors with safety management, safety procedures and safety hazards identification. Data were collected from 503 employees of 105 Chinese high-risk small-scale enterprises over 6 months. The results showed that both POSS and POSF were positively related to improvement in safety management, safety procedures and safety hazards identification through proactivity safety behaviors. Our findings provide a new perspective on organizational safety for improving OHS MS for small-scale enterprises and extend the application of proactivity safety behaviors.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Why consumers behave as they do with respect to food safety and risk information.

PubMed

Verbeke, Wim; Frewer, Lynn J; Scholderer, Joachim; De Brabander, Hubert F

2007-03-14

In recent years, it seems that consumers are generally uncertain about the safety and quality of their food and their risk perception differs substantially from that of experts. Hormone and veterinary drug residues in meat persist to occupy a high position in European consumers' food concern rankings. The aim of this contribution is to provide a better understanding to food risk analysts of why consumers behave as they do with respect to food safety and risk information. This paper presents some cases of seemingly irrational and inconsistent consumer behaviour with respect to food safety and risk information and provides explanations for these behaviours based on the nature of the risk and individual psychological processes. Potential solutions for rebuilding consumer confidence in food safety and bridging between lay and expert opinions towards food risks are reviewed. These include traceability and labelling, segmented communication approaches and public involvement in risk management decision-making.

Using in vitro/in silico data for consumer safety assessment of feed flavoring additives--A feasibility study using piperine.

PubMed

Thiel, A; Etheve, S; Fabian, E; Leeman, W R; Plautz, J R

2015-10-01

Consumer health risk assessment for feed additives is based on the estimated human exposure to the additive that may occur in livestock edible tissues compared to its hazard. We present an approach using alternative methods for consumer health risk assessment. The aim was to use the fewest possible number of animals to estimate its hazard and human exposure without jeopardizing the safety upon use. As an example we selected the feed flavoring substance piperine and applied in silico modeling for residue estimation, results from literature surveys, and Read-Across to assess metabolism in different species. Results were compared to experimental in vitro metabolism data in rat and chicken, and to quantitative analysis of residues' levels from the in vivo situation in livestock. In silico residue modeling showed to be a worst case: the modeled residual levels were considerably higher than the measured residual levels. The in vitro evaluation of livestock versus rodent metabolism revealed no major differences in metabolism between the species. We successfully performed a consumer health risk assessment without performing additional animal experiments. As shown, the use and combination of different alternative methods supports animal welfare consideration and provides future perspective to reducing the number of animals. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

21 CFR 570.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false General principles for evaluating the safety of food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive...

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Motorcyclists' perceptions and experiences of riding and risk and their advice for safety.

PubMed

Simpson, Jean C; Wilson, Suzanne; Currey, Nandika

2015-01-01

To examine the knowledge, observations, and perceptions of motorcycle riders on the risks of on-road motorcycling and potential safety measures to give insight and guidance in developing policies, programs, and legislation to improve the safety of motorcyclists. Individual and focus group interviews were conducted with dealers and a cross section of motorcyclists from selected regions across New Zealand. The interviews were analyzed and coded to identify common themes and diverse perspectives on why people rode motorcycles, riders' perceptions on risk, and possible safety strategies for on-road motorcycling. Motorcycling has major benefits for riders, although most riders perceived that the risks could be severe and they were susceptible to injury. Their observations on the threats and barriers to safety focused on 3 components: the rider, the motorcycle, and the environment. Risks included inexperience, not riding to the conditions, choice of motorcycle, protective clothing and conspicuity, and speed. The underlying risk of being on 2 wheels was accentuated by the availability of high-power motorcycles. The threats perceived in the environment included the behavior of other road users, especially car drivers, and the poor road conditions and surrounds encountered. Riders identified risks that have been recognized in the road safety literature as well as risks for which there are no engineering or scientific solutions. To effectively increase motorcyclist safety, recognition of the commonalities and the differences between motorcyclists' perspectives and proposed strategies is needed. This approach is more likely to engage riders and thus support positive behavior change among riders and drivers.

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.; Moses, Kelly

2004-01-01

This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

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

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe themore » RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.« less

Establishing a proactive safety and health risk management system in the fire service.

PubMed

Poplin, Gerald S; Pollack, Keshia M; Griffin, Stephanie; Day-Nash, Virginia; Peate, Wayne F; Nied, Ed; Gulotta, John; Burgess, Jefferey L

2015-04-19

Formalized risk management (RM) is an internationally accepted process for reducing hazards in the workplace, with defined steps including hazard scoping, risk assessment, and implementation of controls, all within an iterative process. While required for all industry in the European Union and widely used elsewhere, the United States maintains a compliance-based regulatory structure, rather than one based on systematic, risk-based methodologies. Firefighting is a hazardous profession, with high injury, illness, and fatality rates compared with other occupations, and implementation of RM programs has the potential to greatly improve firefighter safety and health; however, no descriptions of RM implementation are in the peer-reviewed literature for the North American fire service. In this paper we describe the steps used to design and implement the RM process in a moderately-sized fire department, with particular focus on prioritizing and managing injury hazards during patient transport, fireground, and physical exercise procedures. Hazard scoping and formalized risk assessments are described, in addition to the identification of participatory-led injury control strategies. Process evaluation methods were conducted to primarily assess the feasibility of voluntarily instituting the RM approach within the fire service setting. The RM process was well accepted by the fire department and led to development of 45 hazard specific-interventions. Qualitative data documenting the implementation of the RM process revealed that participants emphasized the: value of the RM process, especially the participatory bottom-up approach; usefulness of the RM process for breaking down tasks to identify potential risks; and potential of RM for reducing firefighter injury. As implemented, this risk-based approach used to identify and manage occupational hazards and risks was successful and is deemed feasible for U.S. (and other) fire services. While several barriers and challenges do exist

Reduced risk of sudden death from chest wall blows (commotio cordis) with safety baseballs.

PubMed

Link, Mark S; Maron, Barry J; Wang, Paul J; Pandian, Natesa G; VanderBrink, Brian A; Estes, N A Mark

2002-05-01

In an experimental model of sudden death from baseball chest wall impact (commotio cordis), we sought to determine if sudden death by baseball impact could be reduced with safety baseballs. Sudden cardiac death can occur after chest wall impact with a baseball (commotio cordis). Whether softer-than-standard (safety) baseballs reduce the risk of sudden death is unresolved from the available human data. In a juvenile swine model, ventricular fibrillation (VF) has been shown to be induced reproducibly by precordial impact with a 30-mph baseball 10 to 30 ms before the T-wave peak, and this likelihood was reduced with the softest safety baseballs (T-balls). To further test whether safety baseballs would reduce the risk of sudden death at velocities more relevant to youth sports competition, we used our swine model of commotio cordis to test baseballs propelled at the 40-mph velocity commonly attained in that sport. Forty animals received up to 3 chest wall impacts at 40 mph during the vulnerable period of repolarization for VF with 1 of 3 different safety baseballs of varying hardness, and also by a standard baseball. Safety baseballs propelled at 40 mph significantly reduced the risk for VF. The softest safety baseballs triggered VF in only 11% of impacts, compared with 19% and 22% with safety baseballs of intermediate hardness, and 69% with standard baseballs. In this experimental model of low-energy chest wall impact, safety baseballs reduced (but did not abolish) the risk of sudden cardiac death. More universal use of these safety baseballs may decrease the risk of sudden death on the playing field for young athletes.

77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA...

A holistic approach to food safety risks: Food fraud as an example.

PubMed

Marvin, Hans J P; Bouzembrak, Yamine; Janssen, Esmée M; van der Fels-Klerx, H J; van Asselt, Esther D; Kleter, Gijs A

2016-11-01

Production of sufficient, safe and nutritious food is a global challenge faced by the actors operating in the food production chain. The performance of food-producing systems from farm to fork is directly and indirectly influenced by major changes in, for example, climate, demographics, and the economy. Many of these major trends will also drive the development of food safety risks and thus will have an effect on human health, local societies and economies. It is advocated that a holistic or system approach taking into account the influence of multiple "drivers" on food safety is followed to predict the increased likelihood of occurrence of safety incidents so as to be better prepared to prevent, mitigate and manage associated risks. The value of using a Bayesian Network (BN) modelling approach for this purpose is demonstrated in this paper using food fraud as an example. Possible links between food fraud cases retrieved from the RASFF (EU) and EMA (USA) databases and features of these cases provided by both the records themselves and additional data obtained from other sources are demonstrated. The BN model was developed from 1393 food fraud cases and 15 different data sources. With this model applied to these collected data on food fraud cases, the product categories that thus showed the highest probabilities of being fraudulent were "fish and seafood" (20.6%), "meat" (13.4%) and "fruits and vegetables" (10.4%). Features of the country of origin appeared to be important factors in identifying the possible hazards associated with a product. The model had a predictive accuracy of 91.5% for the fraud type and demonstrates how expert knowledge and data can be combined within a model to assist risk managers to better understand the factors and their interrelationships. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 70.42 - Criteria for evaluating the safety of color additives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Criteria for evaluating the safety of color... listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics...

21 CFR 70.42 - Criteria for evaluating the safety of color additives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Criteria for evaluating the safety of color... listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics...

21 CFR 70.42 - Criteria for evaluating the safety of color additives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Criteria for evaluating the safety of color... listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics...

21 CFR 70.42 - Criteria for evaluating the safety of color additives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Criteria for evaluating the safety of color... listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics...

[Organisational responsibility versus individual responsibility: safety culture? About the relationship between patient safety and medical malpractice law].

PubMed

Hart, Dieter

2009-01-01

The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.

Increasing the safety of children's vehicle travel: from effective risk communication to behavior change.

PubMed

Will, Kelli England; Geller, E Scott

2004-01-01

When installed and used correctly, child safety seats reduce the risk of fatal injury by 71% for infants and 54% for toddlers. However, four out of five safety seats are unintentionally misused. Yet, parents fail to participate in safety-seat checks and other child seat interventions aimed at correcting misuse. Such lack of participation is the focus of this article, which argues that most caregivers are naïve to their own vulnerability for misusing their child's seat. Research on risk perception is discussed as a guide to understanding both the high misuse rate and the lack of participation in interventions designed to correct this public safety problem. A comprehensive intervention plan that incorporates risk communication techniques for maximum parental participation is proposed that includes three essential components: (a) establishing community locations for parents to turn for safety seat advice, (b) making these locations well known to the public, and (c) increasing caregivers' perceptions of risk of misusing their children's seats.

Payload Safety: Risk and Characteristic-Based Control of Engineered Nanomaterials

NASA Astrophysics Data System (ADS)

Abou, Seraphin Chally; Saad, Maarouf

2013-09-01

In the last decade progress has been made to assist organizations that are developing payloads intended for flight on the International Space Station (ISS) and/or Space Shuttle. Collaboration programs for comprehensive risk assessment have been initiated between the U.S. and the European Union to generate requirements and data needed to comply with payloads safety and to perform risk assessment and controls guidance. Yet, substantial research gaps remain, as do challenges in the translation of these research findings to control for exposure to nanoscale material payloads, and the health effects. Since nanomaterial structures are different from traditional molecules, some standard material properties can change at size of 50nm or less. Changes in material properties at this scale challenge our understanding of hazards posed by nanomaterial payloads in the ISS realistic exposure conditions, and our ability to anticipate, evaluate, and control potential health issues, and safety. The research question addressed in this framework is: what kind of descriptors can be developed for nanomaterial payloads risks assessment? Methods proposed incorporate elements of characteristic- based risk an alysis: (1) to enable characterization of anthropogenic nanomaterials which can result in incidental from natural nanoparticles; and (2) to better understand safety attributes in terms of human health impacts from exposure to varying types of engineered nanomaterials.

46 CFR 308.204 - Additional war risk protection and indemnity insurance.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 8 2013-10-01 2013-10-01 false Additional war risk protection and indemnity insurance. 308.204 Section 308.204 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk...

46 CFR 308.204 - Additional war risk protection and indemnity insurance.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 8 2011-10-01 2011-10-01 false Additional war risk protection and indemnity insurance. 308.204 Section 308.204 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk...

46 CFR 308.204 - Additional war risk protection and indemnity insurance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Additional war risk protection and indemnity insurance. 308.204 Section 308.204 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk...

46 CFR 308.204 - Additional war risk protection and indemnity insurance.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 8 2014-10-01 2014-10-01 false Additional war risk protection and indemnity insurance. 308.204 Section 308.204 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk...

46 CFR 308.204 - Additional war risk protection and indemnity insurance.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 8 2012-10-01 2012-10-01 false Additional war risk protection and indemnity insurance. 308.204 Section 308.204 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk...

Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This guidance document provides OPP's current thinking on application of the provision in FFDCA about an additional safety factor for the protection of infants and children in the context of cumulative risk assessments.

A red-flag-based approach to risk management of EHR-related safety concerns.

PubMed

Sittig, Dean F; Singh, Hardeep

2013-01-01

Although electronic health records (EHRs) have a significant potential to improve patient safety, EHR-related safety concerns have begun to emerge. Based on 369 responses to a survey sent to the memberships of the American Society for Healthcare Risk Management and the American Health Lawyers Association and supplemented by our previous work in EHR-related patient safety, we identified the following common EHR-related safety concerns: (1) incorrect patient identification; (2) extended EHR unavailability (either planned or unplanned); (3) failure to heed a computer-generated warning or alert; (4) system-to-system interface errors; (5) failure to identify, find, or use the most recent patient data; (6) misunderstandings about time; (7) incorrect item selected from a list of items; and (8) open or incomplete orders. In this article, we present a "red-flag"-based approach that can be used by risk managers to identify potential EHR safety concerns in their institutions. An organization that routinely conducts EHR-related surveillance activities, such as the ones proposed here, can significantly reduce risks associated with EHR implementation and use. © 2013 American Society for Healthcare Risk Management of the American Hospital Association.

Relationship among food-safety knowledge, beliefs, and risk-reduction behavior in university students in Japan.

PubMed

Takeda, Sayaka; Akamatsu, Rie; Horiguchi, Itsuko; Marui, Eiji

2011-01-01

To identify whether university students who have both food-safety knowledge and beliefs perform risk-reduction behaviors. Cross-sectional research using a questionnaire that included food-safety knowledge, perceptions, risk-reduction behavior, stages for the selection of safer food based on the Transtheoretical Model, and demographic characteristics. Four universities in eastern Japan and 2 universities in western Japan. University students (n = 799). Food-safety knowledge, beliefs, and risk-reduction behaviors. Answers on measures assessing risk perception and food-safety knowledge were combined to form 4 groups of participants. Relationships among demographic characteristics, the 4 groups, risk-reduction behaviors, stage of change, and severity and susceptibility were assessed. The proportion of students who had more knowledge of food safety and a belief that "there are no 100% safe food items" was high in the group that frequently performed risk-reduction behaviors, as it was in the group who had taken a basic class about food or health care and who had, or were working toward, a food or nutrition qualification. University students who thought that there were no 100% safe food items and who had more knowledge about food safety were more likely to confirm food-safety information when selecting food. Copyright © 2011 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

[Occupational risks among public safety and security forces].

PubMed

Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V

2006-01-01

The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational

Road Risk Modeling and Cloud-Aided Safety-Based Route Planning.

PubMed

Li, Zhaojian; Kolmanovsky, Ilya; Atkins, Ella; Lu, Jianbo; Filev, Dimitar P; Michelini, John

2016-11-01

This paper presents a safety-based route planner that exploits vehicle-to-cloud-to-vehicle (V2C2V) connectivity. Time and road risk index (RRI) are considered as metrics to be balanced based on user preference. To evaluate road segment risk, a road and accident database from the highway safety information system is mined with a hybrid neural network model to predict RRI. Real-time factors such as time of day, day of the week, and weather are included as correction factors to the static RRI prediction. With real-time RRI and expected travel time, route planning is formulated as a multiobjective network flow problem and further reduced to a mixed-integer programming problem. A V2C2V implementation of our safety-based route planning approach is proposed to facilitate access to real-time information and computing resources. A real-world case study, route planning through the city of Columbus, Ohio, is presented. Several scenarios illustrate how the "best" route can be adjusted to favor time versus safety metrics.

Apollo experience report: Safety activities

NASA Technical Reports Server (NTRS)

Rice, C. N.

1975-01-01

A description is given of the flight safety experiences gained during the Apollo Program and safety, from the viewpoint of program management, engineering, mission planning, and ground test operations was discussed. Emphasis is placed on the methods used to identify the risks involved in flight and in certain ground test operations. In addition, there are discussions on the management and engineering activities used to eliminate or reduce these risks.

Clinical risk management and patient safety education for nurses: a critique.

PubMed

Johnstone, Megan-Jane; Kanitsaki, Olga

2007-04-01

Nurses have a pivotal role to play in clinical risk management (CRM) and promoting patient safety in health care domains. Accordingly, nurses need to be prepared educationally to manage clinical risk effectively when delivering patient care. Just what form the CRM and safety education of nurses should take, however, remains an open question. A recent search of the literature has revealed a surprising lack of evidence substantiating models of effective CRM and safety education for nurses. In this paper, a critical discussion is advanced on the question of CRM and safety education for nurses and the need for nurse education in this area to be reviewed and systematically researched as a strategic priority, nationally and internationally. It is a key contention of this paper that without 'good' safety education research it will not be possible to ensure that the educational programs that are being offered to nurses in this area are evidence-based and designed in a manner that will enable nurses to develop the capabilities they need to respond effectively to the multifaceted and complex demands that are inherent in their ethical and professional responsibilities to promote and protect patient safety and quality care in health care domains.

Chemical Mixture Risk Assessment Additivity-Based Approaches

EPA Science Inventory

Powerpoint presentation includes additivity-based chemical mixture risk assessment methods. Basic concepts, theory and example calculations are included. Several slides discuss the use of "common adverse outcomes" in analyzing phthalate mixtures.

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

Analysis of occupational accidents: prevention through the use of additional technical safety measures for machinery.

PubMed

Dźwiarek, Marek; Latała, Agata

2016-01-01

This article presents an analysis of results of 1035 serious and 341 minor accidents recorded by Poland's National Labour Inspectorate (PIP) in 2005-2011, in view of their prevention by means of additional safety measures applied by machinery users. Since the analysis aimed at formulating principles for the application of technical safety measures, the analysed accidents should bear additional attributes: the type of machine operation, technical safety measures and the type of events causing injuries. The analysis proved that the executed tasks and injury-causing events were closely connected and there was a relation between casualty events and technical safety measures. In the case of tasks consisting of manual feeding and collecting materials, the injuries usually occur because of the rotating motion of tools or crushing due to a closing motion. Numerous accidents also happened in the course of supporting actions, like removing pollutants, correcting material position, cleaning, etc.

Workplace road safety risk management: An investigation into Australian practices.

PubMed

Warmerdam, Amanda; Newnam, Sharon; Sheppard, Dianne; Griffin, Mark; Stevenson, Mark

2017-01-01

In Australia, more than 30% of the traffic volume can be attributed to work-related vehicles. Although work-related driver safety has been given increasing attention in the scientific literature, it is uncertain how well this knowledge has been translated into practice in industry. It is also unclear how current practice in industry can inform scientific knowledge. The aim of the research was to use a benchmarking tool developed by the National Road Safety Partnership Program to assess industry maturity in relation to risk management practices. A total of 83 managers from a range of small, medium and large organisations were recruited through the Victorian Work Authority. Semi-structured interviews aimed at eliciting information on current organisational practices, as well as policy and procedures around work-related driving were conducted and the data mapped onto the benchmarking tool. Overall, the results demonstrated varying levels of maturity of risk management practices across organisations, highlighting the need to build accountability within organisations, improve communication practices, improve journey management, reduce vehicle-related risk, improve driver competency through an effective workplace road safety management program and review organisational incident and infringement management. The findings of the study have important implications for industry and highlight the need to review current risk management practices. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

Improved Safety Margin Characterization of Risk from Loss of Offsite Power

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

Nelson, Paul

Original intent: The original intent of this task was “support of the Risk-Informed Safety Margin Characteristic (RISMC) methodology in order” “to address … efficiency of computation so that more accurate and cost-effective techniques can be used to address safety margin characterizations” (S. M. Hess et al., “Risk-Informed Safety Margin Characterization,” Procs. ICONE17, Brussels, July 2009, CD format). It was intended that “in Task 1 itself this improvement will be directed toward upon the very important issue of Loss of Offsite Power (LOOP) events,” more specifically toward the challenge of efficient computation of the multidimensional nonrecovery integral that has been discussedmore » by many previous contributors to the theory of nuclear safety. It was further envisioned that “three different computational approaches will be explored,” corresponding to the three subtasks listed below; deliverables were tied to the individual subtasks.« less

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

Crash risk and aberrant driving behaviors among bus drivers: the role of personality and attitudes towards traffic safety.

PubMed

Mallia, Luca; Lazuras, Lambros; Violani, Cristiano; Lucidi, Fabio

2015-06-01

Several studies have shown that personality traits and attitudes toward traffic safety predict aberrant driving behaviors and crash involvement. However, this process has not been adequately investigated in professional drivers, such as bus drivers. The present study used a personality-attitudes model to assess whether personality traits predicted aberrant self-reported driving behaviors (driving violations, lapses, and errors) both directly and indirectly, through the effects of attitudes towards traffic safety in a large sample of bus drivers. Additionally, the relationship between aberrant self-reported driving behaviors and crash risk was also assessed. Three hundred and one bus drivers (mean age=39.1, SD=10.7 years) completed a structured and anonymous questionnaire measuring personality traits, attitudes toward traffic safety, self-reported aberrant driving behaviors (i.e., errors, lapses, and traffic violations), and accident risk in the last 12 months. Structural equation modeling analysis revealed that personality traits were associated to aberrant driving behaviors both directly and indirectly. In particular altruism, excitement seeking, and normlessness directly predicted bus drivers' attitudes toward traffic safety which, in turn, were negatively associated with the three types of self-reported aberrant driving behaviors. Personality traits relevant to emotionality directly predicted bus drivers' aberrant driving behaviors, without any mediation of attitudes. Finally, only self-reported violations were related to bus drivers' accident risk. The present findings suggest that the hypothesized personality-attitudes model accounts for aberrant driving behaviors in bus drivers, and provide the empirical basis for evidence-based road safety interventions in the context of public transport. Copyright © 2015 Elsevier Ltd. All rights reserved.

Analysis of occupational accidents: prevention through the use of additional technical safety measures for machinery

PubMed Central

Dźwiarek, Marek; Latała, Agata

2016-01-01

This article presents an analysis of results of 1035 serious and 341 minor accidents recorded by Poland's National Labour Inspectorate (PIP) in 2005–2011, in view of their prevention by means of additional safety measures applied by machinery users. Since the analysis aimed at formulating principles for the application of technical safety measures, the analysed accidents should bear additional attributes: the type of machine operation, technical safety measures and the type of events causing injuries. The analysis proved that the executed tasks and injury-causing events were closely connected and there was a relation between casualty events and technical safety measures. In the case of tasks consisting of manual feeding and collecting materials, the injuries usually occur because of the rotating motion of tools or crushing due to a closing motion. Numerous accidents also happened in the course of supporting actions, like removing pollutants, correcting material position, cleaning, etc. PMID:26652689

Cost-effectiveness analysis of risk-reduction measures to reach water safety targets.

PubMed

Lindhe, Andreas; Rosén, Lars; Norberg, Tommy; Bergstedt, Olof; Pettersson, Thomas J R

2011-01-01

Identifying the most suitable risk-reduction measures in drinking water systems requires a thorough analysis of possible alternatives. In addition to the effects on the risk level, also the economic aspects of the risk-reduction alternatives are commonly considered important. Drinking water supplies are complex systems and to avoid sub-optimisation of risk-reduction measures, the entire system from source to tap needs to be considered. There is a lack of methods for quantification of water supply risk reduction in an economic context for entire drinking water systems. The aim of this paper is to present a novel approach for risk assessment in combination with economic analysis to evaluate risk-reduction measures based on a source-to-tap approach. The approach combines a probabilistic and dynamic fault tree method with cost-effectiveness analysis (CEA). The developed approach comprises the following main parts: (1) quantification of risk reduction of alternatives using a probabilistic fault tree model of the entire system; (2) combination of the modelling results with CEA; and (3) evaluation of the alternatives with respect to the risk reduction, the probability of not reaching water safety targets and the cost-effectiveness. The fault tree method and CEA enable comparison of risk-reduction measures in the same quantitative unit and consider costs and uncertainties. The approach provides a structured and thorough analysis of risk-reduction measures that facilitates transparency and long-term planning of drinking water systems in order to avoid sub-optimisation of available resources for risk reduction. Copyright © 2010 Elsevier Ltd. All rights reserved.

Danger zone: Men, masculinity and occupational health and safety in high risk occupations

PubMed Central

Stergiou-Kita, Mary; Mansfield, Elizabeth; Bezo, Randy; Colantonio, Angela; Garritano, Enzo; Lafrance, Marc; Lewko, John; Mantis, Steve; Moody, Joel; Power, Nicole; Theberge, Nancy; Westwood, Eleanor; Travers, Krista

2016-01-01

The workplace is a key setting where gender issues and organizational structures may influence occupational health and safety practices. The enactment of dominant norms of masculinity in high risk occupations can be particularly problematic, as it exposes men to significant risks for injuries and fatalities. To encourage multi-disciplinary collaborations and advance knowledge in the intersecting areas of gender studies, men’s health, work and workplace health and safety, a national network of thirteen researchers and health and safety stakeholders completed a critical literature review examining the intersection between masculinities and men’s workplace health and safety in order to: (i) account for research previously undertaken in this area; (ii) identify themes that may inform our understanding of masculinity and workplace health and safety and; (iii) identify research and practice gaps in relation to men’s workplace health and safety. In this paper we present key themes from this review. Recommendations are made regarding: (i) how to define gender; (ii) how to attend to and identify how masculinities may influence workers’ identities, perceptions of occupational risks and how institutionalized practices can reinforce norms of masculinity; (iii) the importance of considering how masculinities may intersect with other variables (e.g. historical context, age, class, race, geographical location) and; (iv) the added significance of present-day labour market forces on men’s occupational health and safety. PMID:27239098

Danger zone: Men, masculinity and occupational health and safety in high risk occupations.

PubMed

Stergiou-Kita, Mary; Mansfield, Elizabeth; Bezo, Randy; Colantonio, Angela; Garritano, Enzo; Lafrance, Marc; Lewko, John; Mantis, Steve; Moody, Joel; Power, Nicole; Theberge, Nancy; Westwood, Eleanor; Travers, Krista

2015-12-01

The workplace is a key setting where gender issues and organizational structures may influence occupational health and safety practices. The enactment of dominant norms of masculinity in high risk occupations can be particularly problematic, as it exposes men to significant risks for injuries and fatalities. To encourage multi-disciplinary collaborations and advance knowledge in the intersecting areas of gender studies, men's health, work and workplace health and safety, a national network of thirteen researchers and health and safety stakeholders completed a critical literature review examining the intersection between masculinities and men's workplace health and safety in order to: (i) account for research previously undertaken in this area; (ii) identify themes that may inform our understanding of masculinity and workplace health and safety and; (iii) identify research and practice gaps in relation to men's workplace health and safety. In this paper we present key themes from this review. Recommendations are made regarding: (i) how to define gender; (ii) how to attend to and identify how masculinities may influence workers' identities, perceptions of occupational risks and how institutionalized practices can reinforce norms of masculinity; (iii) the importance of considering how masculinities may intersect with other variables (e.g. historical context, age, class, race, geographical location) and; (iv) the added significance of present-day labour market forces on men's occupational health and safety.

A 3S Risk ?3SR? Assessment Approach for Nuclear Power: Safety Security and Safeguards.

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

Forrest, Robert; Reinhardt, Jason Christian; Wheeler, Timothy A.

Safety-focused risk analysis and assessment approaches struggle to adequately include malicious, deliberate acts against the nuclear power industry's fissile and waste material, infrastructure, and facilities. Further, existing methods do not adequately address non- proliferation issues. Treating safety, security, and safeguards concerns independently is inefficient because, at best, it may not take explicit advantage of measures that provide benefits against multiple risk domains, and, at worst, it may lead to implementations that increase overall risk due to incompatibilities. What is needed is an integrated safety, security and safeguards risk (or "3SR") framework for describing and assessing nuclear power risks that canmore » enable direct trade-offs and interactions in order to inform risk management processes -- a potential paradigm shift in risk analysis and management. These proceedings of the Sandia ePRA Workshop (held August 22-23, 2017) are an attempt to begin the discussions and deliberations to extend and augment safety focused risk assessment approaches to include security concerns and begin moving towards a 3S Risk approach. Safeguards concerns were not included in this initial workshop and are left to future efforts. This workshop focused on four themes in order to begin building out a the safety and security portions of the 3S Risk toolkit: 1. Historical Approaches and Tools 2. Current Challenges 3. Modern Approaches 4. Paths Forward and Next Steps This report is organized along the four areas described above, and concludes with a summary of key points. 2 Contact: rforres@sandia.gov; +1 (925) 294-2728« less

Risk Compensation in Children: Why Do Children Show It in Reaction to Wearing Safety Gear?

ERIC Educational Resources Information Center

Morrongiello, Barbara A.; Lasenby, Jennifer; Walpole, Beverly

2007-01-01

School-age children's self-reported risk compensation (greater risk-taking when wearing safety gear compared to when not doing so) was investigated using 6 common play situations. Children responded to hypothetical scenarios by rating intended risk-taking when wearing safety gear and not doing so, and by providing explanations for their behavior.…

Influence of safety measures on the risks of transporting dangerous goods through road tunnels.

PubMed

Saccomanno, Frank; Haastrup, Palle

2002-12-01

Quantitative risk assessment (QRA) models are used to estimate the risks of transporting dangerous goods and to assess the merits of introducing alternative risk reduction measures for different transportation scenarios and assumptions. A comprehensive QRA model recently was developed in Europe for application to road tunnels. This model can assess the merits of a limited number of "native safety measures." In this article, we introduce a procedure for extending its scope to include the treatment of a number of important "nonnative safety measures" of interest to tunnel operators and decisionmakers. Nonnative safety measures were not included in the original model specification. The suggested procedure makes use of expert judgment and Monte Carlo simulation methods to model uncertainty in the revised risk estimates. The results of a case study application are presented that involve the risks of transporting a given volume of flammable liquid through a 10-km road tunnel.

Can stress in farm animals increase food safety risk?

PubMed

Rostagno, Marcos H

2009-09-01

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

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

PubMed

Pfeiffer, Yvonne; Schwappach, David

2016-01-01

National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts. Copyright © 2016. Published by Elsevier GmbH.

Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk.

PubMed

Kiely, Philip; Gambhir, Manoj; Cheng, Allen C; McQuilten, Zoe K; Seed, Clive R; Wood, Erica M

2017-07-01

While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

47 CFR 5.311 - Additional requirements related to safety of the public.

Code of Federal Regulations, 2014 CFR

2014-10-01

... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means for...

47 CFR 5.311 - Additional requirements related to safety of the public.

Code of Federal Regulations, 2013 CFR

2013-10-01

... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means for...

Safe patient care - safety culture and risk management in otorhinolaryngology.

PubMed

St Pierre, Michael

2013-12-13

Safety culture is positioned at the heart of an organization's vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture ("top-down process"). A type marker for organizational culture and thus a predictor for an organization's maturity in respect to safety is information flow and in particular an organization's general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed "informed culture". An informed culture is free of blame and open for information provided by incidents. "Incident reporting systems" are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organization's safe surgery checklist" is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality. Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate stimulation based team trainings into their

[Safe patient care: safety culture and risk management in otorhinolaryngology].

PubMed

St Pierre, M

2013-04-01

Safety culture is positioned at the heart of an organisation's vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture ("top-down process"). A type marker for organizational culture and thus a predictor for an organizations maturity in respect to safety is information flow and in particular an organization's general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed "informed culture". An informed culture is free of blame and open for information provided by incidents. "Incident reporting systems" are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organisation's "safe surgery checklist" is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality.Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate simulation based team trainings into their curriculum

Safety in psychiatric inpatient care: The impact of risk management culture on mental health nursing practice.

PubMed

Slemon, Allie; Jenkins, Emily; Bungay, Vicky

2017-10-01

The discourse of safety has informed the care of individuals with mental illness through institutionalization and into modern psychiatric nursing practices. Confinement arose from safety: out of both societal stigma and fear for public safety, as well as benevolently paternalistic aims to protect individuals from self-harm. In this paper, we argue that within current psychiatric inpatient environments, safety is maintained as the predominant value, and risk management is the cornerstone of nursing care. Practices that accord with this value are legitimized and perpetuated through the safety discourse, despite evidence refuting their efficacy, and patient perspectives demonstrating harm. To illustrate this growing concern in mental health nursing care, we provide four exemplars of risk management strategies utilized in psychiatric inpatient settings: close observations, seclusion, door locking and defensive nursing practice. The use of these strategies demonstrates the necessity to shift perspectives on safety and risk in nursing care. We suggest that to re-centre meaningful support and treatment of clients, nurses should provide individualized, flexible care that incorporates safety measures while also fundamentally re-evaluating the risk management culture that gives rise to and legitimizes harmful practices. © 2017 The Authors Nursing Inquiry published by John Wiley & Sons Ltd.

Roles of safety climate and shift work on perceived injury risk: a multi-level analysis.

PubMed

Huang, Yueng-Hsiang; Chen, Jiu-Chiuan; DeArmond, Sarah; Cigularov, Konstantin; Chen, Peter Y

2007-11-01

This study evaluated the relationship between employees' work shift (i.e., day shift versus night shift) and perceptions of injury risk, and how the relationship is affected by company level safety climate and injury frequency. The results showed that night shift workers perceived a higher level of injury risk compared to day shift workers. Both company level safety climate and injury frequency played critical roles in predicting individual perceived work injury risk. Perception of injury risk of night shift workers was significantly lower when they perceived high-level rather than low-level safety climate. However, this pattern was not noticeable for day shift workers. These findings highlighted the importance of considering company level factors when attempting to understand the differences between day shift and night shift work on an individual's perception of injury risk.

Improved safety culture and labor-management relations attributed to changing at-risk behavior process at Union Pacific.

DOT National Transportation Integrated Search

2009-09-01

Changing At-Risk Behavior (CAB) is a safety process that is being conducted at Union Pacifics San Antonio Service Unit (SASU) with the aim of improving road and yard safety. CAB is an example of a proactive safety risk-reduction method called Clea...

An intravenous medication safety system: preventing high-risk medication errors at the point of care.

PubMed

Hatcher, Irene; Sullivan, Mark; Hutchinson, James; Thurman, Susan; Gaffney, F Andrew

2004-10-01

Improving medication safety at the point of care--particularly for high-risk drugs--is a major concern of nursing administrators. The medication errors most likely to cause harm are administration errors related to infusion of high-risk medications. An intravenous medication safety system is designed to prevent high-risk infusion medication errors and to capture continuous quality improvement data for best practice improvement. Initial testing with 50 systems in 2 units at Vanderbilt University Medical Center revealed that, even in the presence of a fully mature computerized prescriber order-entry system, the new safety system averted 99 potential infusion errors in 8 months.

Lithium-Ion Electrolytes Containing Flame Retardant Additives for Increased Safety Characteristics

NASA Technical Reports Server (NTRS)

Bugga, Ratnakumar V. (Inventor); Krause, Frederick Charles (Inventor); Smart, Marshall C. (Inventor); Prakash, Surya G. (Inventor); Smith, Kiah A. (Inventor)

2014-01-01

The invention discloses various embodiments of Li-ion electrolytes containing flame retardant additives that have delivered good performance over a wide temperature range, good cycle life characteristics, and improved safety characteristics, namely, reduced flammability. In one embodiment of the invention there is provided an electrolyte for use in a lithium-ion electrochemical cell, the electrolyte comprising a mixture of an ethylene carbonate (EC), an ethyl methyl carbonate (EMC), a fluorinated co-solvent, a flame retardant additive, and a lithium salt. In another embodiment of the invention there is provided an electrolyte for use in a lithium-ion electrochemical cell, the electrolyte comprising a mixture of an ethylene carbonate (EC), an ethyl methyl carbonate (EMC), a flame retardant additive, a solid electrolyte interface (SEI) film forming agent, and a lithium salt.

The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

PubMed

Piening, Sigrid; de Graeff, Pieter A; Straus, Sabine M J M; Haaijer-Ruskamp, Flora M; Mol, Peter G M

2013-09-01

The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety

Risk-Taking, Safety and Older People. Selected Bibliographies on Ageing 3.

ERIC Educational Resources Information Center

Jackson, Wendy, Comp.

This annotated bibliography, which was developed as part of a series of selected bibliographies on aging for Great Britain's Centre for Policy on Ageing, contains a total of 368 entries organized under the following subject headings: risk (identification, nature, responsibilities, risk taking, security); environmental safety (hazards, design,…

[Communication on health and safety risk control in contemporary society: an interdisciplinary approach].

PubMed

Rangel-S, Maria Ligia

2007-01-01

This paper discusses communication as a technology for risk control with health and safety protection and promotion, within the context of a "risk society". As a component of Risk Analysis, risk communication is a technology that appears in risk literature, with well defined objectives, principles and models. These aspects are described and the difficulties are stressed, taking into consideration the multiple rationales related to risks in the culture and the many different aspects of risk regulation and control in the so-called "late modernity". Consideration is also given to the complexity of the communications process, guided by theoretical and methodological discussions in the field. In order to understand the true value of the communications field for risk control with health and safety protection and promotion, this paper also offers an overview of communication theories that support discussions of this matter, proposing a critical approach to models that include the dimensions of power and culture in the context of a capitalist society.

Relationship among Food-Safety Knowledge, Beliefs, and Risk-Reduction Behavior in University Students in Japan

ERIC Educational Resources Information Center

Takeda, Sayaka; Akamatsu, Rie; Horiguchi, Itsuko; Marui, Eiji

2011-01-01

Objective: To identify whether university students who have both food-safety knowledge and beliefs perform risk-reduction behaviors. Design: Cross-sectional research using a questionnaire that included food-safety knowledge, perceptions, risk-reduction behavior, stages for the selection of safer food based on the Transtheoretical Model, and…

Perceived risk and other predictors and correlates of teenagers' safety belt use during the first year of licensure.

PubMed

Ouimet, Marie Claude; Morton, Bruce G Simons; Noelcke, Elizabeth A; Williams, Allan F; Leaf, William A; Preusser, David F; Hartos, Jessica L

2008-03-01

Teenagers have the lowest rate of safety belt use and the highest crash rate compared to other age groups. Past studies on teenagers' belt use have mostly been cross-sectional. The first goals of this study were to examine, at licensure, teenagers' and parents' perceptions of risk of crash/injury for newly licensed teenagers when driving unbelted and teenagers' perceived and parents' intended consequences for safety belt rule violations. In addition, the comparability of these variables to other risky driving behaviors was explored. The second goal was to evaluate the importance of these variables in the prediction of teenagers' belt use during the first year of licensure, relative to other factors related to belt use, including demographics and substance use. More than 2,000 parent-teenager dyads were interviewed by telephone, parents at permit and licensure and teenagers at permit, licensure, and 3, 6, and 12 months after licensure. Approximately a third of the teenagers reported at least once at 3, 6, or 12 months post-licensure not always using their safety belt in the past week. At licensure, participants' perceived risk of safety belt non-use was high and ranked among the behaviors most related to crash/injury for newly licensed teenagers, behind driving under the influence of alcohol or drugs. Parent-imposed consequences for safety belt rule violations were not as highly rated as parent-imposed consequences for driving under the influence of alcohol or drugs. Sequential logistic regression modeled the relationship between safety belt use and perceived risk and consequences of non-use, as well as other prospective predictors assessed at permit and licensure, and driving correlates measured after licensure. Teenagers' extreme perceived risk and parents' intended sure consequences for non-use were significant prospective predictors of regular use during the first year of licensure. Other significant predictors and correlates were race (White), high school grade

Making Patient Risk Visible: Implementation of a Nursing Document Information System to Improve Patient Safety.

PubMed

Wang, Panfeng; Zhang, Hongjun; Li, Baohua; Lin, Keke

2016-01-01

The aims of this study were to develop a nursing information system (NIS), enhance the visibility of patient risk, and identify challenges and facilitators to adoption of the NIS risk assessment system for nurse leaders. This article describes the function of a nursing risk assessment information system, and the results of a survey on the risk assessment system. The results suggested that quality of information processing in nursing significantly improved patient safety. Nurses surveyed demonstrated a high degree of satisfaction, with saving time and improving safety. The nursing document information system described was introduced to improve patient safety and decrease risk. The application of the system has greatly enhanced the efficiency of nursing work, and guides the nurses to make an accurate, comprehensive and objective assessment of patient information, contributing significantly to further improvement in care standards and care decisions.

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.

Quality, risk management and patient safety: the challenge of effective integration.

PubMed

França, Margarida

2008-01-01

Nowadays we observe the development of three waves of intervention and change within healthcare services: quality management, risk management and patient safety. The Patient Safety movement has been launched at international level as a consequence of the Institute of Medicine's report--To Err is Human, and today patient safety constitutes one basic dimension of health quality subjected to the direct intervention of supranational entities (WHO, EU) and Member States' Governments. The objective of this paper is to raise awareness about the value of quality improvement (QI) methodologies and tools to sustainable healthcare quality outcomes.

Food safety in the domestic environment: the effect of consumer risk information on human disease risks.

PubMed

Nauta, Maarten J; Fischer, Arnout R H; van Asselt, Esther D; de Jong, Aarieke E I; Frewer, Lynn J; de Jonge, Rob

2008-02-01

The improvement of food safety in the domestic environment requires a transdisciplinary approach, involving interaction between both the social and natural sciences. This approach is applied in a study on risks associated with Campylobacter on broiler meat. First, some web-based information interventions were designed and tested on participant motivation and intentions to cook more safely. Based on these self-reported measures, the intervention supported by the emotion "disgust" was selected as the most promising information intervention. Its effect on microbial cross-contamination was tested by recruiting a set of participants who prepared a salad with chicken breast fillet carrying a known amount of tracer bacteria. The amount of tracer that could be recovered from the salad revealed the transfer and survival of Campylobacter and was used as a measure of hygiene. This was introduced into an existing risk model on Campylobacter in the Netherlands to assess the effect of the information intervention both at the level of exposure and the level of human disease risk. We showed that the information intervention supported by the emotion "disgust" alone had no measurable effect on the health risk. However, when a behavioral cue was embedded within the instruction for the salad preparation, the risk decreased sharply. It is shown that a transdisciplinary approach, involving research on risk perception, microbiology, and risk assessment, is successful in evaluating the efficacy of an information intervention in terms of human health risks. The approach offers a novel tool for science-based risk management in the area of food safety.

Listening to Excluded Young People's Experiences of e-Safety and Risk

ERIC Educational Resources Information Center

Cranmer, Sue

2013-01-01

This article reports on excluded young people's experiences with and management of e-safety and risk. It has importance in exploring these concerns given that excluded young people's voices are very often absent in education and technology research and yet they are potentially more at risk when using Information and Communication Technologies than…

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

Lawn Care Pesticides. Risks Remain Uncertain While Prohibited Safety Claims Continue

DTIC Science & Technology

1990-03-23

Trade Commission (FrC), under its own legislative authority to protect consumers against false and deceptive advertising , can take enforcement action...vides to the public about the safety of its products, federal enforcement actions taken against lawn care pesticide safety advertising claims, and...in reassessing the risks of these pesticides. FIFRA also authorizes EPA to take enforcement action against advertising claims made by pesticide

Human health and safety risks management in underground coal mines using fuzzy TOPSIS.

PubMed

Mahdevari, Satar; Shahriar, Kourosh; Esfahanipour, Akbar

2014-08-01

The scrutiny of health and safety of personnel working in underground coal mines is heightened because of fatalities and disasters that occur every year worldwide. A methodology based on fuzzy TOPSIS was proposed to assess the risks associated with human health in order to manage control measures and support decision-making, which could provide the right balance between different concerns, such as safety and costs. For this purpose, information collected from three hazardous coal mines namely Hashouni, Hojedk and Babnizu located at the Kerman coal deposit, Iran, were used to manage the risks affecting the health and safety of their miners. Altogether 86 hazards were identified and classified under eight categories: geomechanical, geochemical, electrical, mechanical, chemical, environmental, personal, and social, cultural and managerial risks. Overcoming the uncertainty of qualitative data, the ranking process is accomplished by fuzzy TOPSIS. After running the model, twelve groups with different risks were obtained. Located in the first group, the most important risks with the highest negative effects are: materials falling, catastrophic failure, instability of coalface and immediate roof, firedamp explosion, gas emission, misfire, stopping of ventilation system, wagon separation at inclines, asphyxiation, inadequate training and poor site management system. According to the results, the proposed methodology can be a reliable technique for management of the minatory hazards and coping with uncertainties affecting the health and safety of miners when performance ratings are imprecise. The proposed model can be primarily designed to identify potential hazards and help in taking appropriate measures to minimize or remove the risks before accidents can occur. Copyright © 2014 Elsevier B.V. All rights reserved.

Are HPV vaccination services accessible to high-risk communities? A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics.

PubMed

Tsui, Jennifer; Rodriguez, Hector P; Gee, Gilbert C; Escobedo, Loraine A; Kominski, Gerald F; Bastani, Roshan

2013-12-01

While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Angeles County with high risk for HPV-associated cancers. We examined proximity to safety-net clinics among neighborhoods with the highest risk. Proximity was measured as the shortest distance between each neighborhood center and the nearest clinic and having a clinic within 3 miles of each neighborhood center. The average 5-year non-age-adjusted rates were 1,940 cases per 100,000 for Chlamydia and 60 per 100,000 for HPV-associated cancers. A large majority, 349 of 386 neighborhoods with high HPV-associated cancer rates and 532 of 537 neighborhoods with high Chlamydia rates, had a clinic within 3 miles of the neighborhood center. Clinics were more likely to be located within close proximity to high-risk neighborhoods in the inner city. High-risk neighborhoods outside of this urban core area were less likely to be near accessible clinics. The majority of high-risk neighborhoods were geographically near safety-net clinics with HPV vaccination services. Due to low rates of vaccination, these findings suggest that while services are geographically accessible, additional efforts are needed to improve uptake. Programs aimed to increase awareness about the vaccine and to link underserved groups to vaccination services are warranted.

Are HPV vaccination services accessible to high-risk communities?: A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics

PubMed Central

Tsui, Jennifer; Rodriguez, Hector P.; Gee, Gilbert C.; Escobedo, Loraine A.; Kominski, Gerald F.; Bastani, Roshan

2013-01-01

Purpose While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. Methods We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Angeles County with high risk for HPV-associated cancers. We examined proximity to safety-net clinics among neighborhoods with the highest risk. Proximity was measured as the shortest distance between each neighborhood center and the nearest clinic and having a clinic within 3 miles of each neighborhood center. Results The average 5-year non-age-adjusted rates were 1,940 cases per 100,000 for Chlamydia and 60 per 100,000 for HPV-associated cancers. A large majority, 349 of 386 neighborhoods with high HPV-associated cancer rates and 532 of 537 neighborhoods with high Chlamydia rates had a clinic within 3 miles of the neighborhood center. Clinics were more likely to be located within close proximity to high-risk neighborhoods in the inner city. High-risk neighborhoods outside of this urban core area were less likely to be near accessible clinics. Conclusions The majority of high-risk neighborhoods were geographically near safety-net clinics with HPV vaccination services. Due to low rates of vaccination, these findings suggest that while services are geographically accessible, additional efforts are needed to improve uptake. Programs aimed to increase awareness about the vaccine and to link underserved groups to vaccination services are warranted. PMID:24043448

Food safety and organic meats.

PubMed

Van Loo, Ellen J; Alali, Walid; Ricke, Steven C

2012-01-01

The organic meat industry in the United States has grown substantially in the past decade in response to consumer demand for nonconventionally produced products. Consumers are often not aware that the United States Department of Agriculture (USDA) organic standards are based only on the methods used for production and processing of the product and not on the product's safety. Food safety hazards associated with organic meats remain unclear because of the limited research conducted to determine the safety of organic meat from farm-to-fork. The objective of this review is to provide an overview of the published results on the microbiological safety of organic meats. In addition, antimicrobial resistance of microbes in organic food animal production is addressed. Determining the food safety risks associated with organic meat production requires systematic longitudinal studies that quantify the risks of microbial and nonmicrobial hazards from farm-to-fork.

21 CFR 570.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of Sciences-National Research Council. A petition will not be denied, however, by reason of the... of Sciences-National Research Council if, from available evidence, the Commissioner finds that the... purposes of this section, the principles for evaluating safety of additives set forth in the above...

Promising evidence of impact on road safety by changing at-risk behavior process at Union Pacific

DOT National Transportation Integrated Search

2008-06-01

Changing At-risk Behavior (CAB) is a safety process that is being conducted at Union Pacifics San Antonio Service Unit with the aim of improving locomotive cab safety related to constraining signals. CAB is an example of a risk reduction method th...

Safety sans Frontières: An International Safety Culture Model.

PubMed

Reader, Tom W; Noort, Mark C; Shorrock, Steven; Kirwan, Barry

2015-05-01

The management of safety culture in international and culturally diverse organizations is a concern for many high-risk industries. Yet, research has primarily developed models of safety culture within Western countries, and there is a need to extend investigations of safety culture to global environments. We examined (i) whether safety culture can be reliably measured within a single industry operating across different cultural environments, and (ii) if there is an association between safety culture and national culture. The psychometric properties of a safety culture model developed for the air traffic management (ATM) industry were examined in 17 European countries from four culturally distinct regions of Europe (North, East, South, West). Participants were ATM operational staff (n = 5,176) and management staff (n = 1,230). Through employing multigroup confirmatory factor analysis, good psychometric properties of the model were established. This demonstrates, for the first time, that when safety culture models are tailored to a specific industry, they can operate consistently across national boundaries and occupational groups. Additionally, safety culture scores at both regional and national levels were associated with country-level data on Hofstede's five national culture dimensions (collectivism, power distance, uncertainty avoidance, masculinity, and long-term orientation). MANOVAs indicated safety culture to be most positive in Northern Europe, less so in Western and Eastern Europe, and least positive in Southern Europe. This indicates that national cultural traits may influence the development of organizational safety culture, with significant implications for safety culture theory and practice. © 2015 Society for Risk Analysis.

Risk Management: Earning Recognition with an Automated Safety Program

ERIC Educational Resources Information Center

Lansberry, Linden; Strasburger, Tom

2012-01-01

Risk management is a huge task that requires diligent oversight to avoid penalties, fines, or lawsuits. Add in the burden of limited resources that schools face today, and the challenge of meeting the required training, reporting, compliance, and other administrative issues associated with a safety program is almost insurmountable. Despite an…

Roy's safety-first portfolio principle in financial risk management of disastrous events.

PubMed

Chiu, Mei Choi; Wong, Hoi Ying; Li, Duan

2012-11-01

Roy pioneers the concept and practice of risk management of disastrous events via his safety-first principle for portfolio selection. More specifically, his safety-first principle advocates an optimal portfolio strategy generated from minimizing the disaster probability, while subject to the budget constraint and the mean constraint that the expected final wealth is not less than a preselected disaster level. This article studies the dynamic safety-first principle in continuous time and its application in asset and liability management. We reveal that the distortion resulting from dropping the mean constraint, as a common practice to approximate the original Roy's setting, either leads to a trivial case or changes the problem nature completely to a target-reaching problem, which produces a highly leveraged trading strategy. Recognizing the ill-posed nature of the corresponding Lagrangian method when retaining the mean constraint, we invoke a wisdom observed from a limited funding-level regulation of pension funds and modify the original safety-first formulation accordingly by imposing an upper bound on the funding level. This model revision enables us to solve completely the safety-first asset-liability problem by a martingale approach and to derive an optimal policy that follows faithfully the spirit of the safety-first principle and demonstrates a prominent nature of fighting for the best and preventing disaster from happening. © 2012 Society for Risk Analysis.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Application of a risk management system to improve drinking water safety.

PubMed

Jayaratne, Asoka

2008-12-01

The use of a comprehensive risk management framework is considered a very effective means of managing water quality risks. There are many risk-based systems available to water utilities such as ISO 9001 and Hazard Analysis and Critical Control Point (HACCP). In 2004, the World Health Organization's (WHO) Guidelines for Drinking Water Quality recommended the use of preventive risk management approaches to manage water quality risks. This paper describes the framework adopted by Yarra Valley Water for the development of its Drinking Water Quality Risk Management Plan incorporating HACCP and ISO 9001 systems and demonstrates benefits of Water Safety Plans such as HACCP. Copyright IWA Publishing 2008.

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of the...

5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of the...

5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of the...

5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of the...

5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of the...

Promoting patient safety through prospective risk identification: example from peri-operative care.

PubMed

Smith, A; Boult, M; Woods, I; Johnson, S

2010-02-01

Investigation of patient safety incidents has focused on retrospective analyses once incidents have occurred. Prospective risk analysis techniques complement this but have not been widely used in healthcare. Prospective risk identification of non-operative risks associated with adult elective surgery under general anaesthesia using a customised structured "what if" checklist and development of risk matrix. Prioritisation of recommendations arising by cost, ease and likely speed of implementation. Groups totalling 20 clinical and administrative healthcare staff involved in peri-operative care and risk experts convened by the UK National Patient Safety Agency. 102 risks were identified and 95 recommendations made. The top 20 recommendations together were judged to encompass about 75% of the total estimated risk attributable to the processes considered. Staffing and organisational issues (21% of total estimated risk) included recommendations for removing distractions from the operating theatre, ensuring the availability of senior anaesthetists and promoting standards and flexible working among theatre staff. Devices and equipment (19% of total estimated risk) could be improved by training and standardisation; airway control and temperature monitoring were identified as two specific areas. Pre-assessment of patients before admission to hospital (12% of estimated risk) could be improved by defining a data set for adequate pre-assessment and making this available throughout the NHS. This technique can be successfully applied by healthcare staff but expert facilitation of groups is advisable. Such wider-ranging processes can potentially lead to more comprehensive risk reduction than "single-issue" risk alerts.

THE ETHICS OF OCCUPATIONAL HEALTH AND SAFETY IN TURKEY: RESPONSIBILITY AND CONSENT TO RISK.

PubMed

Artvinli, Fatih

2016-06-01

Work-related diseases, injuries, risks and deaths are the issues that have been recently gaining importance especially in developing countries. The ethical dimensions of occupational health and safety have remained as relatively understudied areas. Concepts such as responsibility, consent, autonomy, paternalism, choice, and certain values or justifications that are used in medical ethics and bioethics are also applicable to occupational health and safety. This article examines the ethical issues of responsibility and consent to occupational risk. It will first define the concepts of consent and risk, and then different views on responsibility and consent to risk will be discussed. The article will also examine the responsibility of the society and government regarding these concepts.

Pharmaceutical company perspectives on current safety risk communications in Japan.

PubMed

Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

2014-01-01

In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

Knowledge and perceived implementation of food safety risk analysis framework in Latin America and the Caribbean region.

PubMed

Cherry, C; Mohr, A Hofelich; Lindsay, T; Diez-Gonzalez, F; Hueston, W; Sampedro, F

2014-12-01

Risk analysis is increasingly promoted as a tool to support science-based decisions regarding food safety. An online survey comprising 45 questions was used to gather information on the implementation of food safety risk analysis within the Latin American and Caribbean regions. Professionals working in food safety in academia, government, and private sectors in Latin American and Caribbean countries were contacted by email and surveyed to assess their individual knowledge of risk analysis and perceptions of its implementation in the region. From a total of 279 participants, 97% reported a familiarity with risk analysis concepts; however, fewer than 25% were able to correctly identify its key principles. The reported implementation of risk analysis among the different professional sectors was relatively low (46%). Participants from industries in countries with a long history of trade with the United States and the European Union, such as Mexico, Brazil, and Chile, reported perceptions of a higher degree of risk analysis implementation (56, 50, and 20%, respectively) than those from the rest of the countries, suggesting that commerce may be a driver for achieving higher food safety standards. Disagreement among respondents on the extent of the use of risk analysis in national food safety regulations was common, illustrating a systematic lack of understanding of the current regulatory status of the country. The results of this survey can be used to target further risk analysis training on selected sectors and countries.

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk

Water- and wastewater-related disease and infection risks: what is an appropriate value for the maximum tolerable additional burden of disease?

PubMed

Mara, Duncan

2011-06-01

The maximum additional burden of water- and wastewater-related disease of 10-6 disability-adjusted life year (DALY) loss per person per year (pppy), used in the WHO Drinking-water Quality Guidelines and the WHO Guidelines for Wastewater Use in Agriculture, is based on US EPA'S acceptance of a 70-year lifetime waterborne cancer risk of 10(-5) per person, equivalent to an annual risk of 1.4x10(-7) per person which is four orders of magnitude lower than the actual all-cancer incidence in the USA in 2009 of 1.8x10(-3) pppy. A maximum additional burden of 10(-4) DALY loss pppy would reduce this risk to a more cost-effective, but still low, risk of 1.4x10(-5) pppy. It would increase the DALY loss pppy in low- and middle-income countries due to diarrhoeal diseases from the current level of 0.0119 pppy to 0.0120 pppy, and that due to ascariasis from 0.0026 pppy to 0.0027 pppy, but neither increase is of public-health significance. It is therefore recommended that the maximum additional burden of disease from these activities be increased to a DALY loss of 10(-4) pppy as this provides an adequate margin of public-health safety in relation to waterborne-cancer deaths, diarrhoeal disease and ascariasis in all countries.

Evaluating SafeClub: can risk management training improve the safety activities of community soccer clubs?

PubMed

Abbott, K; Klarenaar, P; Donaldson, A; Sherker, S

2008-06-01

To evaluate a sports safety-focused risk-management training programme. Controlled before and after test. Four community soccer associations in Sydney, Australia. 76 clubs (32 intervention, 44 control) at baseline, and 67 clubs (27 intervention, 40 control) at post-season and 12-month follow-ups. SafeClub, a sports safety-focused risk-management training programme (3x2 hour sessions) based on adult-learning principles and injury-prevention concepts and models. Changes in mean policy, infrastructure and overall safety scores as measured using a modified version of the Sports Safety Audit Tool. There was no significant difference in the mean policy, infrastructure and overall safety scores of intervention and control clubs at baseline. Intervention clubs achieved higher post-season mean policy (11.9 intervention vs 7.5 controls), infrastructure (15.2 vs 10.3) and overall safety (27.0 vs 17.8) scores than did controls. These differences were greater at the 12-month follow-up: policy (16.4 vs 7.6); infrastructure (24.7 vs 10.7); and overall safety (41.1 vs 18.3). General linear modelling indicated that intervention clubs achieved statistically significantly higher policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001) scores compared with control clubs at the post-season and 12-month follow-ups. There was also a significant linear interaction of time and group for all three scores: policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001). SafeClub effectively assisted community soccer clubs to improve their sports safety activities, particularly the foundations and processes for good risk-management practice, in a sustainable way.

The new risk paradigm for chemical process security and safety.

PubMed

Moore, David A

2004-11-11

The world of safety and security in the chemical process industries has certainly changed since 11 September, but the biggest challenges may be yet to come. This paper will explain that there is a new risk management paradigm for chemical security, discuss the differences in interpreting this risk versus accidental risk, and identify the challenges we can anticipate will occur in the future on this issue. Companies need to be ready to manage the new chemical security responsibilities and to exceed the expectations of the public and regulators. This paper will outline the challenge and a suggested course of action.

Gun Safety Management with Patients at Risk for Suicide

ERIC Educational Resources Information Center

Simon, Robert I.

2007-01-01

Guns in the home are associated with a five-fold increase in suicide. All patients at risk for suicide must be asked if guns are available at home or easily accessible elsewhere, or if they have intent to buy or purchase a gun. Gun safety management requires a collaborative team approach including the clinician, patient, and designated person…

Subsurface safety valves: safety asset or safety liability

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

Busch, J.M.; Llewelyn, D.C.G.; Policky, B.J.

1983-10-01

This paper summarizes the methods used to compare the risk of a blowout for a well completed with a subsurface safety valve (SSSV) vs. a completion without an SSSV. These methods, which could be applied to any field, include a combination of SSSV reliability and conventional risk analyses. The Kuparuk River Unit Working Interest Owners recently formed a group to examine the risks associated with installing and maintaining SSSV's in the Kuparuk field. The group was charged with answering the question: ''Assuming Kuparuk field operating conditions, are SSSV's a safety asset, or do numerous operating and maintenance procedures make themmore » a safety liability.'' The results indicate that for the Kuparuk River Unit, an SSSV becomes a safety liability when the mean time between SSSV failures is less than one year. Since current SSSV mean time to failure (MTTF) at Kuparuk is approximately 1000 days, they are considered a safety asset.« less

Perceptions about safety and risks in gender-based violence research: implications for the ethics review process.

PubMed

Sikweyiya, Yandisa; Jewkes, Rachel

2011-10-01

Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.

Gender Effects in Young Road Users on Road Safety Attitudes, Behaviors and Risk Perception

PubMed Central

Cordellieri, Pierluigi; Baralla, Francesca; Ferlazzo, Fabio; Sgalla, Roberto; Piccardi, Laura; Giannini, Anna Maria

2016-01-01

In the present study, we investigated gender-related effects on road safety attitudes in 2681 young drivers (1458 males, 54.4%; aged 18–22) who filled out several scales assessing attitudes toward road safety issues, driving behavior in specific hypothetical situations, accident risk perception, and concerns about such a risk. We focused only on young drivers to better understand the role of gender in road safety attitudes in a period of life in which risky behaviors are widespread for males and females. Indeed, there is still no agreement as to the nature of these gender differences. According to some authors, the effects of gender on being involved in a crash due to driving skills are either non-existent or largely explained by differences in alcohol consumption. In our study, we found gender differences in road safety attitudes (i.e., “negative attitude toward traffic rules and risky driving”; “negative attitude toward drugs and alcohol” and “tolerance toward speeding”) and in driver behavior (i.e., “errors in inattentive driving” and “driving violations”). This result is consistent in all drivers coming from nine different European countries. Our analyses yielded an important finding concerning risk perception. The results indicate that the level of risk perception during driving is the same for males and females. However, these two groups differ in the level of concern about this risk, with males being less concerned about the risk of a road accident. This suggests that the main difference between these two groups is not strictly related to judgment of the perceived risk probability but rather to the level of concern experienced about the consequences of the risk. This difference between risk perception and worry could explain differences in the frequency of car accidents in the two groups. The present findings may provide new insights for the development of gender-based prevention programs. PMID:27729877

Fall risk and prevention agreement: engaging patients and families with a partnership for patient safety.

PubMed

Vonnes, Cassandra; Wolf, Darcy

2017-01-01

Falls are multifactorial in medical oncology units and are potentiated by an older adult's response to anxiolytics, opiates and chemotherapy protocols. In addition, the oncology patient is at an increased risk for injury from a fall due to coagulopathy, thrombocytopenia and advanced age. At our National Cancer Institute-designated inpatient cancer treatment centre located in the southeastern USA, 40% of the total discharges are over the age of 65. As part of a comprehensive fall prevention programme, bimonthly individual fall reports have been presented with the Chief Nursing Officer (CNO), nursing directors, nurse managers, physical therapists and front-line providers in attendance. As a result of these case discussions, in some cases, safety recommendations have not been followed by patients and families and identified as an implication in individual falls. Impulsive behaviour was acknowledged only after a fall occurred. A medical oncology unit was targeted for this initiative due to a prolonged length of stay. This patient population receives chemotherapeutic interventions, management of oncological treatment consequences and cancer progression care. The aim of this project was to explore if initiation of a Fall Prevention Agreement between the nursing team and older adults being admitted to medical oncology units would reduce the incidence of falls and the incidence of falls with injury. In order to promote patient and family participation in the fall reduction and safety plan, the Fall Risk and Prevention Agreement was introduced upon admission. Using the Morse Fall Scoring system, patient's risk for fall was communicated on the Fall Risk and Prevention Agreement. Besides admission, patients were reassessed based on change of status, transfer or after a fall occurs. Fall and fall injuries rates were compared two-quarters prior to implementation of the fall agreement and eight-quarters post implementation. Falls and fall injuries on the medical oncology unit

Constructing definitions of safety risks while nurses care for hospitalised older people: Secondary analysis of qualitative data.

PubMed

Dahlke, Sherry; Hall, Wendy A; Baumbusch, Jennifer

2017-09-01

The aim of this secondary qualitative descriptive analysis was to examine how nurses construct a definition of older peoples' safety risks and provide care while working within organisational contexts that are focused on diminishing patient risks. Numbers of older patients are increasing in acute hospital contexts-contexts that place their focus on patient safety. Nurses need to manage tensions between older peoples' risks, evidence-informed practice decisions, limited resources and organisational emphases on patient falls. To date, their practice dilemmas have not been well examined. A secondary qualitative descriptive analysis was conducted using data that were collected between June 2010 and May 2011 to examine nursing practice with hospitalised older people. All field notes and transcribed data were reviewed to generate themes representing 18 Registered Nurses' perceptions about safe care for hospitalised older people. The first author generated categories that described how nurses construct definitions of safety risks for older people. All authors engaged in an iterative analytic process that resulted in themes capturing nurses' efforts to provide care in limited resource environments while considering older peoples' safety risks. Nurses constructed definitions of patient safety risks in the context of institutional directives. Nurses provided care using available resources as efficiently as possible and accessing co-worker support. They also minimised the importance of older people's functional abilities by setting priorities for medically delegated tasks and immobilising their patients to reduce their risks. Nurses' definitions of patient risk, which were shaped by impoverished institutional resources and nurses' lack of valuing of functional abilities, contributed to suboptimal care for older adults. Nurses' definitions of risk as physical injury reduced their attention to patients' functional abilities, which nurses reported suffered declines as a result

76 FR 37131 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management...: Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General...

Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

NASA Technical Reports Server (NTRS)

Luxhoj, James T.

2003-01-01

Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

Women's perceptions of safety and risk following police intervention for intimate partner violence.

PubMed

Dichter, Melissa E; Gelles, Richard J

2012-01-01

Police intervention is a primary response to intimate partner violence (IPV) but does not guarantee a victim's future safety. This study sought to identify factors associated with IPV survivors' perceptions of safety and risk of revictimization following police intervention. One hundred sixty-four women completed a questionnaire, and 11 of those women also took part in qualitative interviews. The findings revealed that feeling unsafe and perceiving oneself to be at risk of future violence is associated with experiencing particular forms of IPV, including battering, lethality threats, and sexual violence. Having support from others and distance from the partner helps women feel safe.

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

PubMed

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

78 FR 64957 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management... Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To...

Overview of critical risk factors in Power-Two-Wheeler safety.

PubMed

Vlahogianni, Eleni I; Yannis, George; Golias, John C

2012-11-01

Power-Two-Wheelers (PTWs) constitute a vulnerable class of road users with increased frequency and severity of accidents. The present paper focuses of the PTW accident risk factors and reviews existing literature with regard to the PTW drivers' interactions with the automobile drivers, as well as interactions with infrastructure elements and weather conditions. Several critical risk factors are revealed with different levels of influence to PTW accident likelihood and severity. A broad classification based on the magnitude and the need for further research for each risk factor is proposed. The paper concludes by discussing the importance of dealing with accident configurations, the data quality and availability, methods implemented to model risk and exposure and risk identification which are critical for a thorough understanding of the determinants of PTW safety. Copyright © 2012 Elsevier Ltd. All rights reserved.

Geriatric Cyclists: Assessing Risks, Safety, and Benefits

PubMed Central

Ikpeze, Tochukwu C.; Glaun, Gabriel; McCalla, Daren

2018-01-01

Nearly 1 in every 3 Americans ride bicycles each year, but only 20% of the reported 100 million cyclists ride on a weekly basis. Bicycling is a common form of transportation and recreation and has gained popularity among the elderly patients. In recent years, the number of elderly cyclists has increased steadily and studies have cited ease of use, need for exercise, and enjoyment as important contributing factors. The benefits of physical activity on health is well-documented, and elderly individuals are encouraged to remain active to reduce the progression of age-related weakness and loss of muscle mass. Safety concerns, however, have been a prevalent public health issue. According to the Center for Disease Control and Prevention, elderly and teenage cyclists account for the highest number of head injuries and fatalities among all cyclists. Safety measures that include wearing protective gear such as helmets and choosing the appropriate bicycle have been recommended to minimize the risk of sustaining injuries while riding. Despite these concerns, bicycling has remained a popular and exciting activity for the elderly patients. PMID:29383267

An Online Risk Monitor System (ORMS) to Increase Safety and Security Levels in Industry

NASA Astrophysics Data System (ADS)

Zubair, M.; Rahman, Khalil Ur; Hassan, Mehmood Ul

2013-12-01

The main idea of this research is to develop an Online Risk Monitor System (ORMS) based on Living Probabilistic Safety Assessment (LPSA). The article highlights the essential features and functions of ORMS. The basic models and modules such as, Reliability Data Update Model (RDUM), running time update, redundant system unavailability update, Engineered Safety Features (ESF) unavailability update and general system update have been described in this study. ORMS not only provides quantitative analysis but also highlights qualitative aspects of risk measures. ORMS is capable of automatically updating the online risk models and reliability parameters of equipment. ORMS can support in the decision making process of operators and managers in Nuclear Power Plants.

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

NASA Astrophysics Data System (ADS)

Falakh, Fajrul; Setiani, Onny

2018-02-01

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

Safety Priorities and Underestimations in Recreational Scuba Diving Operations: A European Study Supporting the Implementation of New Risk Management Programmes

PubMed Central

Lucrezi, Serena; Egi, Salih Murat; Pieri, Massimo; Burman, Francois; Ozyigit, Tamer; Cialoni, Danilo; Thomas, Guy; Marroni, Alessandro; Saayman, Melville

2018-01-01

Introduction: Scuba diving is an important marine tourism sector, but requires proper safety standards to reduce the risks and increase accessibility to its market. To achieve safety goals, safety awareness and positive safety attitudes in recreational scuba diving operations are essential. However, there is no published research exclusively focusing on scuba divers’ and dive centres’ perceptions toward safety. This study assessed safety perceptions in recreational scuba diving operations, with the aim to inform and enhance safety and risk management programmes within the scuba diving tourism industry. Materials and Methods: Two structured questionnaire surveys were prepared by the organisation Divers Alert Network and administered online to scuba diving operators in Italy and scuba divers in Europe, using a mixture of convenience and snowball sampling. Questions in the survey included experience and safety offered at the dive centre; the buddy system; equipment and accessories for safe diving activities; safety issues in the certification of new scuba divers; incidents/accidents; and attitudes toward safety. Results: 91 scuba diving centres and 3,766 scuba divers participated in the study. Scuba divers gave importance to safety and the responsiveness of service providers, here represented by the dive centres. However, they underestimated the importance of a personal emergency action/assistance plan and, partly, of the buddy system alongside other safety procedures. Scuba divers agreed that some risks, such as those associated with running out of gas, deserve attention. Dive centres gave importance to aspects such as training and emergency action/assistance plans. However, they were limitedly involved in safety campaigning. Dive centres’ perceptions of safety in part aligned with those of scuba divers, with some exceptions. Conclusion: Greater responsibility is required in raising awareness and educating scuba divers, through participation in prevention

Safety Priorities and Underestimations in Recreational Scuba Diving Operations: A European Study Supporting the Implementation of New Risk Management Programmes.

PubMed

Lucrezi, Serena; Egi, Salih Murat; Pieri, Massimo; Burman, Francois; Ozyigit, Tamer; Cialoni, Danilo; Thomas, Guy; Marroni, Alessandro; Saayman, Melville

2018-01-01

Introduction: Scuba diving is an important marine tourism sector, but requires proper safety standards to reduce the risks and increase accessibility to its market. To achieve safety goals, safety awareness and positive safety attitudes in recreational scuba diving operations are essential. However, there is no published research exclusively focusing on scuba divers' and dive centres' perceptions toward safety. This study assessed safety perceptions in recreational scuba diving operations, with the aim to inform and enhance safety and risk management programmes within the scuba diving tourism industry. Materials and Methods: Two structured questionnaire surveys were prepared by the organisation Divers Alert Network and administered online to scuba diving operators in Italy and scuba divers in Europe, using a mixture of convenience and snowball sampling. Questions in the survey included experience and safety offered at the dive centre; the buddy system; equipment and accessories for safe diving activities; safety issues in the certification of new scuba divers; incidents/accidents; and attitudes toward safety. Results: 91 scuba diving centres and 3,766 scuba divers participated in the study. Scuba divers gave importance to safety and the responsiveness of service providers, here represented by the dive centres. However, they underestimated the importance of a personal emergency action/assistance plan and, partly, of the buddy system alongside other safety procedures. Scuba divers agreed that some risks, such as those associated with running out of gas, deserve attention. Dive centres gave importance to aspects such as training and emergency action/assistance plans. However, they were limitedly involved in safety campaigning. Dive centres' perceptions of safety in part aligned with those of scuba divers, with some exceptions. Conclusion: Greater responsibility is required in raising awareness and educating scuba divers, through participation in prevention campaigns

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.

Microbiological Food Safety Surveillance in China

PubMed Central

Pei, Xiaoyan; Li, Ning; Guo, Yunchang; Liu, Xiumei; Yan, Lin; Li, Ying; Yang, Shuran; Hu, Jing; Zhu, Jianghui; Yang, Dajin

2015-01-01

Microbiological food safety surveillance is a system that collects data regarding food contamination by foodborne pathogens, parasites, viruses, and other harmful microbiological factors. It helps to understand the spectrum of food safety, timely detect food safety hazards, and provide relevant data for food safety supervision, risk assessment, and standards-setting. The study discusses the microbiological surveillance of food safety in China, and introduces the policies and history of the national microbiological surveillance system. In addition, the function and duties of different organizations and institutions are provided in this work, as well as the generation and content of the surveillance plan, quality control, database, and achievement of the microbiological surveillance of food safety in China. PMID:26343705

[Sleepiness, safety on the road and management of risk].

PubMed

Garbarino, S; Traversa, F; Spigno, F

2012-01-01

Public health studies have shown that sleepiness at the wheel and other risks associated with sleep are responsible for 5% to 30% of road accidents, depending on the type of driver and/or road. In industrialized countries one-fifth of all traffic accidents can be ascribed to sleepiness behind the wheel. Sleep disorders and various common acute and chronic medical conditions together with lifestyles, extended work hours and prolonged wakefulness directly or indirectly affect the quality and quantity of one's sleep increasing the number of workers with sleep debt and staggered hours. These conditions may increase the risk of road accidents. Strategies to reduce this risk of both commercial and non-commercial drivers related to sleepiness include reliable diagnosis and treatment of sleep disorders, management of chronobiological conflicts, adequate catch-up sleep, and countermeasures against sleepiness at the wheel. Road transport safety requires the adoption of occupational health measures, including risk assessment, health education, technical-environmental prevention and health surveillance.

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

[New international initiatives to create systems of effective risk prediction and food safety].

PubMed

Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V

2016-01-01

Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.

Language barriers and patient safety risks in hospital care. A mixed methods study.

PubMed

van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula

2016-02-01

A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

PubMed Central

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R

2005-01-01

resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities. PMID:15805453

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions.

PubMed

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R E

2005-04-01

shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities.

Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

PubMed

Evans, Ellen W; Redmond, Elizabeth C

2014-03-01

Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

Identification of Patient Safety Risks Associated with Electronic Health Records: A Software Quality Perspective.

PubMed

Virginio, Luiz A; Ricarte, Ivan Luiz Marques

2015-01-01

Although Electronic Health Records (EHR) can offer benefits to the health care process, there is a growing body of evidence that these systems can also incur risks to patient safety when developed or used improperly. This work is a literature review to identify these risks from a software quality perspective. Therefore, the risks were classified based on the ISO/IEC 25010 software quality model. The risks identified were related mainly to the characteristics of "functional suitability" (i.e., software bugs) and "usability" (i.e., interface prone to user error). This work elucidates the fact that EHR quality problems can adversely affect patient safety, resulting in errors such as incorrect patient identification, incorrect calculation of medication dosages, and lack of access to patient data. Therefore, the risks presented here provide the basis for developers and EHR regulating bodies to pay attention to the quality aspects of these systems that can result in patient harm.

Semi-Markov Approach to the Shipping Safety Modelling

NASA Astrophysics Data System (ADS)

Guze, Sambor; Smolarek, Leszek

2012-02-01

In the paper the navigational safety model of a ship on the open area has been studied under conditions of incomplete information. Moreover the structure of semi-Markov processes is used to analyse the stochastic ship safety according to the subjective acceptance of risk by the navigator. In addition, the navigator’s behaviour can be analysed by using the numerical simulation to estimate the probability of collision in the safety model.

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.

Violence and legalized brothel prostitution in Nevada: examining safety, risk, and prostitution policy.

PubMed

Brents, Barbara G; Hausbeck, Kathryn

2005-03-01

This article examines violence in legalized brothels in Nevada. Debates over prostitution policies in the United States have long focused on questions of safety and risk. These discourses inevitably invoke the coupling of violence and prostitution, though systematic examinations of the relationship between the two are sparse. This article explores the issue of violence in the Nevada brothel industry. By drawing on interviews with prostitutes, managers, and policy makers, this article examines both prostitutes' perceptions of safety and risk and brothel managers' practices designed to mitigate violence. Discourses relate to three types of violence: interpersonal violence against prostitutes, violence against community order, and sexually transmitted diseases as violence. The authors conclude by arguing that the legalization of prostitution brings a level of public scrutiny, official regulation, and bureaucratization to brothels that decreases the risk of these 3 types of systematic violence.

Downsizing, reengineering and patient safety: numbers, newness and resultant risk.

PubMed

Knox, G E; Kelley, M; Hodgson, S; Simpson, K R; Carrier, L; Berry, D

1999-01-01

Downsizing and reengineering are facts of life in contemporary healthcare organizations. In most instances, these organizational changes are undertaken in an attempt to increase productivity or cut operational costs with results measured in these terms. Less often considered are potential detrimental effects on patient safety or strategies, which might be used to minimize these risks.

High Energy Density Additives for Hybrid Fuel Rockets to Improve Performance and Enhance Safety

NASA Technical Reports Server (NTRS)

Jaffe, Richard L.

2014-01-01

We propose a conceptual study of prototype strained hydrocarbon molecules as high energy density additives for hybrid rocket fuels to boost the performance of these rockets without compromising safety and reliability. Use of these additives could extend the range of applications for which hybrid rockets become an attractive alternative to conventional solid or liquid fuel rockets. The objectives of the study were to confirm and quantify the high enthalpy of these strained molecules and to assess improvement in rocket performance that would be expected if these additives were blended with conventional fuels. We confirmed the chemical properties (including enthalpy) of these additives. However, the predicted improvement in rocket performance was too small to make this a useful strategy for boosting hybrid rocket performance.

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.

Compound risk judgment in tasks with both idiosyncratic and systematic risk: The "Robust Beauty" of additive probability integration.

PubMed

Sundh, Joakim; Juslin, Peter

2018-02-01

In this study, we explore how people integrate risks of assets in a simulated financial market into a judgment of the conjunctive risk that all assets decrease in value, both when assets are independent and when there is a systematic risk present affecting all assets. Simulations indicate that while mental calculation according to naïve application of probability theory is best when the assets are independent, additive or exemplar-based algorithms perform better when systematic risk is high. Considering that people tend to intuitively approach compound probability tasks using additive heuristics, we expected the participants to find it easiest to master tasks with high systematic risk - the most complex tasks from the standpoint of probability theory - while they should shift to probability theory or exemplar memory with independence between the assets. The results from 3 experiments confirm that participants shift between strategies depending on the task, starting off with the default of additive integration. In contrast to results in similar multiple cue judgment tasks, there is little evidence for use of exemplar memory. The additive heuristics also appear to be surprisingly context-sensitive, with limited generalization across formally very similar tasks. Copyright © 2017 Elsevier B.V. All rights reserved.

Apheresis and intravenous immunoglobulins used in addition to conventional therapy to treat high-risk pregnant antiphospholipid antibody syndrome patients. A prospective study.

PubMed

Ruffatti, Amelia; Favaro, Maria; Hoxha, Ariela; Zambon, Alessandra; Marson, Piero; Del Ross, Teresa; Calligaro, Antonia; Tonello, Marta; Nardelli, Giovanni B

2016-06-01

Pregnant women with triple antibody positive antiphospholipid syndrome (APS) who have had thrombosis or a history of early, severe pregnancy complications are generally considered at high risk of pregnancy loss. The objectives of this study were to investigate the efficacy and safety of a relatively new treatment protocol used in addition to conventional therapy in high-risk pregnant patients affected with primary APS. The study's two inclusion criteria were: (1) the presence of triple antiphospholipid positivity, (2) previous thrombosis and/or a history of one or more early, severe pregnancy complications. Eighteen pregnancies occurring between 2002 and 2015 in 14 APS patients, (mean age 34.8±3.6 SD) were monitored. All 14 (100%) patients had triple antiphospholipid positivity. In addition, six of them (42.8%) had a history of thrombosis, four (28.6%) had one or more previous early and severe pregnancy complications, and four (30.8%) met both clinical study criteria. The study protocol included weekly plasmapheresis or immunoadsorption and fortnightly 1g/kg intravenous immunoglobulins. Seventeen of the pregnancies (94.4%) produced live neonates, all born between the 26th and 37th weeks of gestation (mean 33.1±3.5 SD). One female (5.5%), born prematurely at 24 weeks, died of sepsis a week after birth. There were two cases (11.1%) of severe pregnancy complications. No treatment side effects were registered. Given the high live birth rate and the safety associated to it, the study protocol described here could be taken into consideration by medical teams treating high-risk APS pregnant patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Reliability and safety, and the risk of construction damage in mining areas

NASA Astrophysics Data System (ADS)

Skrzypczak, Izabela; Kogut, Janusz P.; Kokoszka, Wanda; Oleniacz, Grzegorz

2018-04-01

This article concerns the reliability and safety of building structures in mining areas, with a particular emphasis on the quantitative risk analysis of buildings. The issues of threat assessment and risk estimation, in the design of facilities in mining exploitation areas, are presented here, indicating the difficulties and ambiguities associated with their quantification and quantitative analysis. This article presents the concept of quantitative risk assessment of the impact of mining exploitation, in accordance with ISO 13824 [1]. The risk analysis is illustrated through an example of a construction located within an area affected by mining exploitation.

75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

Confirming criticality safety of TRU waste with neutron measurements and risk analyses

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

Winn, W.G.; Hochel, R.D.

1992-04-01

The criticality safety of {sup 239}Pu in 55-gallon drums stored in TRU waste containers (culverts) is confirmed using NDA neutron measurements and risk analyses. The neutron measurements yield a {sup 239}Pu mass and k{sub eff} for a culvert, which contains up to 14 drums. Conservative probabilistic risk analyses were developed for both drums and culverts. Overall {sup 239}Pu mass estimates are less than a calculated safety limit of 2800 g per culvert. The largest measured k{sub eff} is 0.904. The largest probability for a critical drum is 6.9 {times} 10{sup {minus}8} and that for a culvert is 1.72 {times} 10{supmore » {minus}7}. All examined suspect culverts, totaling 118 in number, are appraised as safe based on these observations.« less

Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

ERIC Educational Resources Information Center

Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

2015-01-01

Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

A national standard for psychosocial safety climate (PSC): PSC 41 as the benchmark for low risk of job strain and depressive symptoms.

PubMed

Bailey, Tessa S; Dollard, Maureen F; Richards, Penny A M

2015-01-01

Despite decades of research from around the world now permeating occupational health and safety (OHS) legislation and guidelines, there remains a lack of tools to guide practice. Our main goal was to establish benchmark levels of psychosocial safety climate (PSC) that would signify risk of job strain (jobs with high demands and low control) and depression in organizations. First, to justify our focus on PSC, using interview data from Australian employees matched at 2 time points 12 months apart (n = 1081), we verified PSC as a significant leading predictor of job strain and in turn depression. Next, using 2 additional data sets (n = 2097 and n = 1043) we determined benchmarks of organizational PSC (range 12-60) for low-risk (PSC at 41 or above) and high-risk (PSC at 37 or below) of employee job strain and depressive symptoms. Finally, using the newly created benchmarks we estimated the population attributable risk (PAR) and found that improving PSC in organizations to above 37 could reduce 14% of job strain and 16% of depressive symptoms in the working population. The results provide national standards that organizations and regulatory agencies can utilize to promote safer working environments and lower the risk of harm to employee mental health. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Assessment of occupational safety risks in Floridian solid waste systems using Bayesian analysis.

PubMed

Bastani, Mehrad; Celik, Nurcin

2015-10-01

Safety risks embedded within solid waste management systems continue to be a significant issue and are prevalent at every step in the solid waste management process. To recognise and address these occupational hazards, it is necessary to discover the potential safety concerns that cause them, as well as their direct and/or indirect impacts on the different types of solid waste workers. In this research, our goal is to statistically assess occupational safety risks to solid waste workers in the state of Florida. Here, we first review the related standard industrial codes to major solid waste management methods including recycling, incineration, landfilling, and composting. Then, a quantitative assessment of major risks is conducted based on the data collected using a Bayesian data analysis and predictive methods. The risks estimated in this study for the period of 2005-2012 are then compared with historical statistics (1993-1997) from previous assessment studies. The results have shown that the injury rates among refuse collectors in both musculoskeletal and dermal injuries have decreased from 88 and 15 to 16 and three injuries per 1000 workers, respectively. However, a contrasting trend is observed for the injury rates among recycling workers, for whom musculoskeletal and dermal injuries have increased from 13 and four injuries to 14 and six injuries per 1000 workers, respectively. Lastly, a linear regression model has been proposed to identify major elements of the high number of musculoskeletal and dermal injuries. © The Author(s) 2015.

[Perception of health and safety risks among workers pathology laboratories].

PubMed

Alvarado-Cabrero, Isabel; Valencia-Cedillo, Raquel

2015-01-01

Health care workers are experiencing increasing numbers of occupational illnesses. Safety practices in anatomical pathology laboratories (APL) are crucial to prevent unnecessary exposures to both chemical and biological agents. The main goal of this study was to determine if pathologists perceptions and actual practice mirror regulatory guidelines. Current available recommendations for APL were reviewed and used to construct an online survey distributed to pathologists. The survey was completed by 121 participants. Eighty-seven (72 %) of respondents reported receiving inadequate safety training. Most pathologists (82 %) were not well-informed about biosafety practices. Sixty-three (52 %) participants felt that the risks of chemical and infectious disease exposures in the APL were low. Most respondents reported having a needle stick or cut (71 %). Eighty-six (71 %) of participants reported musculo skeletal problems. This study indicated that there is a need for improving training in anatomical pathology safety practices in Mexican laboratories as daily practices do not reflected current guidelines.

The association of road safety knowledge and risk behaviour with paediatric road traffic injury in Guangzhou, China.

PubMed

Dong, Xiaomei; Peek-Asa, Corinne; Yang, Jingzhen; Wang, Shengyong; Chen, Xiongfei; Chi, Guibo; Ramirez, Marizen

2011-02-01

This study describes road traffic injuries among school-aged children in Guangzhou, China, and examines the effect of road safety knowledge and risk behaviours on road traffic injuries. A stratified cluster sample of 3747 children from six primary schools and six middle schools in Guangzhou, China, was surveyed. Data were collected on sociodemographic factors and road traffic injuries during the past year. Knowledge about road safety rules was assessed using a 14-item road safety knowledge index, and risky road safety behaviours were measured using a 25-item road safety behaviour index. A total of 403 (10.8%) students reported having at least one road traffic injury during the past 12 months. A high proportion of injuries was found among children who were boys, in primary school and from the suburbs. Bicycle-related injuries were the most common (46.0% of all injuries). Motor vehicle-related injuries had higher hospitalisation rates and worse psychological impact than bicycle or pedestrian injuries. Children with low and medium road safety knowledge had 1.5 to 3 times the odds of injury compared with students with high road safety knowledge. Students with high scores on the risky road behaviour index had twice the odds of injury (OR 2.04, 95% CI 1.47 to 2.84) compared with students with low scores. Better road safety knowledge and the avoidance of walking or cycling-related risk behaviours are protective factors for road traffic injuries among Chinese school children. More injury prevention programmes are needed to improve road safety knowledge and reduce risk behaviours.

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

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

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

1996-12-31

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

Extracting additional risk managers information from a risk assessment of Listeria monocytogenes in deli meats.

PubMed

Pérez-Rodríguez, F; van Asselt, E D; Garcia-Gimeno, R M; Zurera, G; Zwietering, M H

2007-05-01

The risk assessment study of Listeria monocytogenes in ready-to-eat foods conducted by the U.S. Food and Drug Administration is an example of an extensive quantitative microbiological risk assessment that could be used by risk analysts and other scientists to obtain information and by managers and stakeholders to make decisions on food safety management. The present study was conducted to investigate how detailed sensitivity analysis can be used by assessors to extract more information on risk factors and how results can be communicated to managers and stakeholders in an understandable way. The extended sensitivity analysis revealed that the extremes at the right side of the dose distribution (at consumption, 9 to 11.5 log CFU per serving) were responsible for most of the cases of listeriosis simulated. For concentration at retail, values below the detection limit of 0.04 CFU/g and the often used limit for L. monocytogenes of 100 CFU/g (also at retail) were associated with a high number of annual cases of listeriosis (about 29 and 82%, respectively). This association can be explained by growth of L. monocytogenes at both average and extreme values of temperature and time, indicating that a wide distribution can lead to high risk levels. Another finding is the importance of the maximal population density (i.e., the maximum concentration of L. monocytogenes assumed at a certain temperature) for accurately estimating the risk of infection by opportunistic pathogens such as L. monocytogenes. According to the obtained results, mainly concentrations corresponding to the highest maximal population densities caused risk in the simulation. However, sensitivity analysis applied to the uncertainty parameters revealed that prevalence at retail was the most important source of uncertainty in the model.

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory

PubMed Central

Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim

2017-01-01

Background: Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Method: Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. Results: Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Conclusion: Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. PMID:28340232

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory.

PubMed

Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-Hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim; Dennis, Eslie

2017-05-01

Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. : Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. © American Society for Clinical Pathology 2017.

The occupational health and safety of flight attendants.

PubMed

Griffiths, Robin F; Powell, David M C

2012-05-01

In order to perform safety-critical roles in emergency situations, flight attendants should meet minimum health standards and not be impaired by factors such as fatigue. In addition, the unique occupational and environmental characteristics of flight attendant employment may have consequential occupational health and safety implications, including radiation exposure, cancer, mental ill-health, musculoskeletal injury, reproductive disorders, and symptoms from cabin air contamination. The respective roles of governments and employers in managing these are controversial. A structured literature review was undertaken to identify key themes for promoting a future agenda for flight attendant health and safety. Recommendations include breast cancer health promotion, implementation of Fatigue Risk Management Systems, standardization of data collection on radiation exposure and health outcomes, and more coordinated approaches to occupational health and safety risk management. Research is ongoing into cabin air contamination incidents, cancer, and fatigue as health and safety concerns. Concerns are raised that statutory medical certification for flight attendants will not benefit either flight safety or occupational health.

[OCCUPATIONAL HEALTH RISK ASSESSMENT AND MANAGEMENT IN WORKERS IN IMPROVEMENT OF NATIONAL POLICY IN OCCUPATIONAL HYGIENE AND SAFETY].

PubMed

Shur, P Z; Zaĭtseva, N V; Alekseev, V B; Shliapnikov, D M

2015-01-01

In accordance with the international documents in the field of occupational safety and hygiene, the assessment and minimization of occupational risks is a key instrument for the health maintenance of workers. One of the main ways to achieve it is the minimization of occupational risks. Correspondingly, the instrument for the implementation of this method is the methodology of analysis of occupational risks. In Russian Federation there were the preconditions for the formation of the system for the assessment and management of occupational risks. As the target of the national (state) policy in the field of occupational safety in accordance with ILO Conventions it can be offered the prevention of accidents and injuries to health arising from work or related with it, minimizing the causes of hazards inherent in the working environment, as far as it is reasonably and practically feasible. Global trend ofusing the methodology of the assessment and management of occupational risks to life and health of citizens requires the improvement of national policies in the field of occupational hygiene and safety. Achieving an acceptable level of occupational risk in the formation of national policy in the field of occupational hygiene and safety can be considered as one of the main tasks.

Natural Disasters and Safety Risks at Nuclear Power Stations

NASA Astrophysics Data System (ADS)

Tutnova, T.

2012-04-01

In the aftermath of Fukushima natural-technological disaster the global opinion on nuclear energy divided even deeper. While Germany, Italy and the USA are currently reevaluating their previous plans on nuclear growth, many states are committed to expand nuclear energy output. In China and France, where the industry is widely supported by policymakers, there is little talk about abandoning further development of nuclear energy. Moreover, China displays the most remarkable pace of nuclear development in the world: it is responsible for 40% of worldwide reactors under construction, and aims at least to quadruple its nuclear capacity by 2020. In these states the consequences of Fukushima natural-technological accident will probably result in safety checks and advancement of new reactor technologies. Thus, China is buying newer reactor design from the USA which relies on "passive safety systems". It means that emergency power generators, crucial for reactor cooling in case of an accident, won't depend on electricity, so that tsunami won't disable them like it happened in the case of Fukushima. Nuclear energy managed to draw lessons from previous nuclear accidents where technological and human factors played crucial role. But the Fukushima lesson shows that the natural hazards, nevertheless, were undervalued. Though the ongoing technological advancements make it possible to increase the safety of nuclear power plants with consideration of natural risks, it is not just a question of technology improvement. A necessary action that must be taken is the reevaluation of the character and sources of the potential hazards which natural disasters can bring to nuclear industry. One of the examples is a devastating impact of more than one natural disaster happening at the same time. This subject, in fact, was not taken into account before, while it must be a significant point in planning sites for new nuclear power plants. Another important lesson unveiled is that world nuclear

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

NASA Technical Reports Server (NTRS)

Guarro, Sergio B.

2010-01-01

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

Work, obesity, and occupational safety and health.

PubMed

Schulte, Paul A; Wagner, Gregory R; Ostry, Aleck; Blanciforti, Laura A; Cutlip, Robert G; Krajnak, Kristine M; Luster, Michael; Munson, Albert E; O'Callaghan, James P; Parks, Christine G; Simeonova, Petia P; Miller, Diane B

2007-03-01

There is increasing evidence that obesity and overweight may be related, in part, to adverse work conditions. In particular, the risk of obesity may increase in high-demand, low-control work environments, and for those who work long hours. In addition, obesity may modify the risk for vibration-induced injury and certain occupational musculoskeletal disorders. We hypothesized that obesity may also be a co-risk factor for the development of occupational asthma and cardiovascular disease that and it may modify the worker's response to occupational stress, immune response to chemical exposures, and risk of disease from occupational neurotoxins. We developed 5 conceptual models of the interrelationship of work, obesity, and occupational safety and health and highlighted the ethical, legal, and social issues related to fuller consideration of obesity's role in occupational health and safety.

Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

PubMed

Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

2012-09-01

Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those

Safety-critical event risk associated with cell phone tasks as measured in naturalistic driving studies: A systematic review and meta-analysis.

PubMed

Simmons, Sarah M; Hicks, Anne; Caird, Jeff K

2016-02-01

A systematic review and meta-analysis of naturalistic driving studies involving estimates of safety-critical event risk associated with handheld device use while driving is described. Fifty-seven studies identified from targeted databases, journals and websites were reviewed in depth, and six were ultimately included. These six studies, published between 2006 and 2014, encompass seven sets of naturalistic driver data and describe original research that utilized naturalistic methods to assess the effects of distracting behaviors. Four studies involved non-commercial drivers of light vehicles and two studies involved commercial drivers of trucks and buses. Odds ratios quantifying safety-critical event (SCE) risk associated with talking, dialing, locating or answering, and texting or browsing were extracted. Stratified meta-analysis of pooled odds ratios was used to estimate SCE risk by distraction type; meta-regression was used to test for sources of heterogeneity. The results indicate that tasks that require drivers to take their eyes off the road, such as dialing, locating a phone and texting, increase SCE risk to a greater extent than tasks that do not require eyes off the road such as talking. Although talking on a handheld device did not increase SCE risk, further research is required to determine whether it indirectly influences SCE risk (e.g., by encouraging other cell phone activities). In addition, a number of study biases and quality issues of naturalistic driving studies are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

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

49 CFR 192.171 - Compressor stations: Additional safety equipment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design of... must have adequate fire protection facilities. If fire pumps are a part of these facilities, their... event of inadequate cooling or lubrication of the unit. (d) Each compressor station gas engine that...

Safety skills of mental health workers: empirical evidence of a risk management strategy.

PubMed

Flannery, Raymond B; Walker, Andrew P

2003-01-01

To reduce violence in the workplace, health care facilities invest time and resources in risk management strategies such as photo identification and controlled access and surveillance. Studies of assaultive psychiatric patients continue to document that mental health workers (MHWs) are the most frequent targets of the patient violence. Unexamined in these findings is the role skilled MHWs contribute in restoring safety and order in the aftermath of these assaults. This six-year, empirical retrospective study examined the safety skills of MHWs in containing violence. Although they were 28% of the workforce, MHWs restored order in the majority of single assault incidents and restraint procedures. Their skills appear to be a risk management strategy in their own right. The implications are discussed.

Risk-adjusted morbidity in teaching hospitals correlates with reported levels of communication and collaboration on surgical teams but not with scale measures of teamwork climate, safety climate, or working conditions.

PubMed

Davenport, Daniel L; Henderson, William G; Mosca, Cecilia L; Khuri, Shukri F; Mentzer, Robert M

2007-12-01

Since the Institute of Medicine patient safety reports, a number of survey-based measures of organizational climate safety factors (OCSFs) have been developed. The goal of this study was to measure the impact of OCSFs on risk-adjusted surgical morbidity and mortality. Surveys were administered to staff on general/vascular surgery services during a year. Surveys included multiitem scales measuring OCSFs. Additionally, perceived levels of communication and collaboration with coworkers were assessed. The National Surgical Quality Improvement Program was used to assess risk-adjusted morbidity and mortality. Correlations between outcomes and OCSFs were calculated and between outcomes and communication/collaboration with attending and resident doctors, nurses, and other providers. Fifty-two sites participated in the survey: 44 Veterans Affairs and 8 academic medical centers. A total of 6,083 surveys were returned, for a response rate of 52%. The OCSF measures of teamwork climate, safety climate, working conditions, recognition of stress effects, job satisfaction, and burnout demonstrated internal validity but did not correlate with risk-adjusted outcomes. Reported levels of communication/collaboration with attending and resident doctors correlated with risk-adjusted morbidity. Survey-based teamwork, safety climate, and working conditions scales are not confirmed to measure organizational factors that influence risk-adjusted surgical outcomes. Reported communication/collaboration with attending and resident doctors on surgical services influenced patient morbidity. This suggests the importance of doctors' coordination and decision-making roles on surgical teams in providing high-quality and safe care. We propose risk-adjusted morbidity as an effective measure of surgical patient safety.

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

PubMed

Morrato, Elaine H; Ling, Sarah B

2012-11-01

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

Use of System Safety Risk Assessments for the Space Shuttle Reusable Solid Rocket Motor (RSRM)

NASA Technical Reports Server (NTRS)

Greenhalgh, Phillip O.; McCool, Alex (Technical Monitor)

2001-01-01

This paper discusses the System Safety approach used to assess risk for the Space Shuttle Reusable Solid Rocket Motor (RSRM). Previous to the first RSRM flight in the fall of 1988, all systems were analyzed extensively to assure that hazards were identified, assessed and that the baseline risk was understood and appropriately communicated. Since the original RSRM baseline was established, Thiokol and NASA have implemented a number of initiatives that have further improved the RSRM. The robust design, completion of rigorous testing and flight success of the RSRM has resulted in a wise reluctance to make changes. One of the primary assessments required to accompany the documentation of each proposed change and aid in the decision making process is a risk assessment. Documentation supporting proposed changes, including the risk assessments from System Safety, are reviewed and assessed by Thiokol and NASA technical management. After thorough consideration, approved changes are implemented adding improvements to and reducing risk of the Space Shuttle RSRM.

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Risk management systems for health care and safety development on transplantation: a review and a proposal.

PubMed

Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

2010-05-01

Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding

2009 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

2010-01-01

This year, NASA Range Safety transitioned to a condensed annual report to allow for Secretariat support to the Range Safety Group, Risk Committee. Although much shorter than in previous years, this report contains full-length articles concerning various subject areas, as well as links to past reports. Additionally, summaries from various NASA Range Safety Program activities that took place throughout the year are presented, as well as information on several projects that may have a profound impact on the way business will be done in the future. The sections include a program overview and 2009 highlights; Range Safety Training; Range Safety Policy; Independent Assessments Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities.

Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

PubMed Central

Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

2013-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

PubMed

Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

2012-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

An assessment of food safety information provision for UK chemotherapy patients to reduce the risk of foodborne infection.

PubMed

Evans, E W; Redmond, E C

2017-12-01

Given the increased risk of foodborne infection to cancer patients receiving chemotherapy treatment, and the risk of listeriosis reportedly five-times greater to this immunocompromised patient group, there is a need to ensure the implementation of domestic food safety practices among chemotherapy patients and their family caregivers. However, information regarding the adequacy of resources to inform and enable patients to implement domestic food safety practices to reduce the risk of foodborne infection is limited. Consequently, this study aimed to evaluate the provision of food safety information available to UK chemotherapy patients. In-depth semi-structured interviews and content analysis of online patient information resources. Interviews with patients and family caregivers (n = 15) were conducted to explore food-related experiences during chemotherapy treatment. Online food-related information resources for chemotherapy patients (n = 45) were obtained from 35 of 154 National Health Service chemotherapy providers in England, Scotland, and Wales, the Department of Health (DoH) and three of 184 identified UK cancer charities. Identified food-related information resources were reviewed using a content-analysis approach to assess the inclusion of food safety information for chemotherapy patients. In-depth interviews established that many patients indicated awareness of immunosuppression during treatment. Although patients reported practicing caution to reduce the risk of communicable diseases by avoiding crowded spaces/public transport, food safety was reported to be of minimal concern during treatment and the risk of foodborne infection was often underestimated. The review of online food-related patient information resources established that many resources failed to highlight the increased risk of foodborne infection and emphasize the importance of food safety for patients during chemotherapy treatment. Considerable information gaps exist, particularly in

Food Safety Program in Asian Countries.

PubMed

Yamaguchi, Ryuji; Hwang, Lucy Sun

2015-01-01

By using the ILSI network in Asia, we are holding a session focused on food safety programs in several Asian areas. In view of the external environment, it is expected to impact the global food system in the near future, including the rapid increase in food demand and in public health services due to population growth, as well as the threats to biosecurity and food safety due to the rapid globalization of the food trade. Facilitating effective information sharing holds promise for the activation of the food industry. At this session, Prof. Hwang shares the current situation of Food Safety and Sanitation Regulations in Taiwan. Dr. Liu provides a talk on the role of risk assessment in food regulatory control focused on aluminum-containing food additives in China. After the JECFA evaluation of aluminum-containing food additives in 2011, each country has carried out risk assessment based on dietary intake surveys. Ms. Chan reports on the activities of a working group on Food Standards Harmonization in ASEAN. She also explains that the ILSI Southeast Asia Region has actively supported the various ASEAN Working Groups in utilizing science to harmonize food standards. Prof. Park provides current research activities in Korea focused on the effect of climate change on food safety. Climate change is generally seen as having a negative impact on food security, particularly in developing countries. We use these four presentations as a springboard to vigorous discussion on issues related to Food Safety in Asia.

SEMIPARAMETRIC ADDITIVE RISKS REGRESSION FOR TWO-STAGE DESIGN SURVIVAL STUDIES

PubMed Central

Li, Gang; Wu, Tong Tong

2011-01-01

In this article we study a semiparametric additive risks model (McKeague and Sasieni (1994)) for two-stage design survival data where accurate information is available only on second stage subjects, a subset of the first stage study. We derive two-stage estimators by combining data from both stages. Large sample inferences are developed. As a by-product, we also obtain asymptotic properties of the single stage estimators of McKeague and Sasieni (1994) when the semiparametric additive risks model is misspecified. The proposed two-stage estimators are shown to be asymptotically more efficient than the second stage estimators. They also demonstrate smaller bias and variance for finite samples. The developed methods are illustrated using small intestine cancer data from the SEER (Surveillance, Epidemiology, and End Results) Program. PMID:21931467

Safety and risks of nitrous oxide labor analgesia: a review.

PubMed

Rooks, Judith P

2011-01-01

This review of the safety and risks of nitrous oxide (N(2) O) labor analgesia presents results of a search for evidence of its effects on labor, the mother, the fetus, the neonate, breastfeeding, and maternal-infant bonding. Concerns about apoptotic damage to the brains of immature mammals exposed to high doses of N(2) O during late gestation, possible cardiovascular risks from hyperhomocysteinemia caused by N(2) O, a hypothesis that children exposed to N(2) O during birth are more likely to become addicted to amphetamine drugs as adults, and possible occupational risks for those who provide care to women using N(2) O/O(2) labor analgesia are discussed in detail. Research relevant to the 4 special concerns and to the effects of N(2) O analgesia on labor and the mother-child dyad were examined in depth. Three recent reviews of the biologic, toxicologic, anesthetic, analgesic, and anxiolytic effects of N(2) O; 3 reviews of the safety of 50% N(2) O/oxygen (O(2) ) in providing analgesia in a variety of health care settings; and a 2002 systematic review of N(2) O/O(2) labor analgesia were used. Nitrous oxide analgesia is safe for mothers, neonates, and those who care for women during childbirth if the N(2) O is delivered as a 50% blend with O(2) , is self-administered, and good occupational hygiene is practiced. Because of the strong correlation between dose and harm from exposure to N(2) O, concerns based on effects of long exposure to high anesthetic-level doses of N(2) O have only tenuous, hypothetical pertinence to the safety of N(2) O/O(2) labor analgesia. Nitrous oxide labor analgesia is safe for the mother, fetus, and neonate and can be made safe for caregivers. It is simple to administer, does not interfere with the release and function of endogenous oxytocin, and has no adverse effects on the normal physiology and progress of labor. © 2011 by the American College of Nurse-Midwives.

A Synthetic Vision Preliminary Integrated Safety Analysis

NASA Technical Reports Server (NTRS)

Hemm, Robert; Houser, Scott

2001-01-01

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

Hip fracture risk and safety with alendronate treatment in the oldest-old.

PubMed

Axelsson, K F; Wallander, M; Johansson, H; Lundh, D; Lorentzon, M

2017-12-01

There is high evidence for secondary prevention of fractures, including hip fracture, with alendronate treatment, but alendronate's efficacy to prevent hip fractures in the oldest-old (≥80 years old), the population with the highest fracture risk, has not been studied. To investigate whether alendronate treatment amongst the oldest-old with prior fracture was related to decreased hip fracture rate and sustained safety. Using a national database of men and women undergoing a fall risk assessment at a Swedish healthcare facility, we identified 90 795 patients who were 80 years or older and had a prior fracture. Propensity score matching (four to one) was then used to identify 7844 controls to 1961 alendronate-treated patients. The risk of incident hip fracture was investigated with Cox models and the interaction between age and treatment was investigated using an interaction term. The case and control groups were well balanced in regard to age, sex, anthropometrics and comorbidity. Alendronate treatment was associated with a decreased risk of hip fracture in crude (hazard ratio (HR) 0.62 (0.49-0.79), P < 0.001) and multivariable models (HR 0.66 (0.51-0.86), P < 0.01). Alendronate was related to reduced mortality risk (HR 0.88 (0.82-0.95) but increased risk of mild upper gastrointestinal symptoms (UGI) (HR 1.58 (1.12-2.24). The alendronate association did not change with age for hip fractures or mild UGI. In old patients with prior fracture, alendronate treatment reduces the risk of hip fracture with sustained safety, indicating that this treatment should be considered in these high-risk patients. © 2017 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.

Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients.

PubMed

Ghahramanlou-Holloway, Marjan; Brown, Gregory K; Currier, Glenn W; Brenner, Lisa; Knox, Kerry L; Grammer, Geoffrey; Carreno-Ponce, Jaime T; Stanley, Barbara

2014-09-01

Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18-24 months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap. Published by Elsevier Inc.

Medication Safety of Five Oral Chemotherapies: A Proactive Risk Assessment

PubMed Central

Weingart, Saul N.; Spencer, Justin; Buia, Stephanie; Duncombe, Deborah; Singh, Prabhjyot; Gadkari, Mrinalini; Connor, Maureen

2011-01-01

Purpose: Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment. Methods: We convened interdisciplinary teams and conducted failure mode and effects analyses (FMEAs) for five oral chemotherapy agents: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs. Results: Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method. Conclusion: Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm. PMID:21532801

Characterization and safety evaluation of a Deinococcus member as feed additive for hens.

PubMed

Wu, Szu-Yin; Li, I-Chen; Lin, Yi-Chin; Chen, Chin-Chu

2016-04-01

As previous studies mainly focus on understanding the mechanisms of radioresistance in Deinococcus bacteria, the present study aimed at characterizing and verifying the safety use of the GKB-Aid 1995 strain, a member of the radiation-resistant bacterial genus Deinococcus, as an ingredient in feed supplements. Using Vitek 2 system and 16S rRNA gene sequencing, GKB-Aid 1995 most resembles Deinococcus grandis. The Ames test, in vitro chromosomal test, in vivo micronucleus test and acute toxicity test were performed subsequently for its safety evaluation. As there is a possibility that the pigment of GKB-Aid 1995 can pass from feed to eggs intended for human consumption, an acute toxicity test was also carried out in pigmented egg yolk. The results confirmed that GKB-Aid 1995 was non-genotoxic in three genotoxicity experiments, and the LD50 of GKB-Aid 1995 and the pigmented egg yolk in ICR mice was greater than 10 and 12 g kg(-1) body weight, respectively. Overall, these data indicate that GKB-Aid 1995 is a non-toxic substance with no genotoxicity and is therefore safe to be used as a feed supplement or feed additive. This study suggests there is potential in developing GKB-Aid 1995 as an animal feed additive intended to enhance yolk coloration to meet the demand of consumers. Copyright © 2016 Elsevier Inc. All rights reserved.

A Risk Assessment Model for Reduced Aircraft Separation: A Quantitative Method to Evaluate the Safety of Free Flight

NASA Technical Reports Server (NTRS)

Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)

1996-01-01

As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in

Risk factors for fishermen's health and safety in Greece.

PubMed

Frantzeskou, Elpida; Kastania, Anastasia N; Riza, Elena; Jensen, Olaf C; Linos, Athena

2012-01-01

This is, to the best of our knowledge, the first occupational health study in Greek fishing. The aim of the study is to determine the risks for health and safety in Greek fisheries workers by exploring their health status and the health risk factors present in their occupational environment, thus providing a current baseline for further research in the future and for documentation of the needs for prevention. A questionnaire pilot study was carried out in a random sample of 100 Greek fishermen. Twenty-eight per cent (28%) had experienced at least one injury, of which half caused more than one day absence, while 14% had a near drowning experience. The health risks factors studied include excessive weight, cardiovascular incidents and dermatological, musculoskeletal, respiratory, hearing, stress, and anxiety problems. The occupational health risk factors include alcohol, fatty food consumption, smoking, and lack of physical exercise. The health effects observed are causally related to diet, smoking, and exercise, which in turn relate to the specific working conditions and culture in small-scale fishing that need to be taken into consideration in prevention programmes. The results are comparable with international fisheries experience, mainly from Poland, Denmark, and Turkey.

Setting priorities for reducing risk and advancing patient safety.

PubMed

Gaffey, Ann D

2016-04-01

We set priorities every day in both our personal and professional lives. Some decisions are easy, while others require much more thought, participation, and resources. The difficult or less appealing priorities may not be popular, may receive push-back, and may be resource intensive. Whether personal or professional, the urgency that accompanies true priorities becomes a driving force. It is that urgency to ensure our patients' safety that brings many of us to work each day. This is not easy work. It requires us to be knowledgeable about the enterprise we are working in and to have the professional skills and competence to facilitate setting the priorities that allow our organizations to minimize risk and maximize value. © 2016 American Society for Healthcare Risk Management of the American Hospital Association.

Cardiovascular risk assessment: addition of CKD and race to the Framingham equation

PubMed Central

Drawz, Paul E.; Baraniuk, Sarah; Davis, Barry R.; Brown, Clinton D.; Colon, Pedro J.; Cujyet, Aloysius B.; Dart, Richard A.; Graumlich, James F.; Henriquez, Mario A.; Moloo, Jamaluddin; Sakalayen, Mohammed G.; Simmons, Debra L.; Stanford, Carol; Sweeney, Mary Ellen; Wong, Nathan D.; Rahman, Mahboob

2012-01-01

Background/Aims The value of the Framingham equation in predicting cardiovascular risk in African Americans and patients with chronic kidney disease (CKD) is unclear. The purpose of the study was to evaluate whether the addition of CKD and race to the Framingham equation improves risk stratification in hypertensive patients. Methods Participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were studied. Those randomized to doxazosin, age greater than 74 years, and those with a history of coronary heart disease (CHD) were excluded. Two risk stratification models were developed using Cox proportional hazards models in a two-thirds developmental sample. The first model included the traditional Framingham risk factors. The second model included the traditional risk factors plus CKD, defined by eGFR categories, and stratification by race (Black vs. Non-Black). The primary outcome was a composite of fatal CHD, nonfatal MI, coronary revascularization, and hospitalized angina. Results There were a total of 19,811 eligible subjects. In the validation cohort, there was no difference in C-statistics between the Framingham equation and the ALLHAT model including CKD and race. This was consistent across subgroups by race and gender and among those with CKD. One exception was among Non-Black women where the C-statistic was higher for the Framingham equation (0.68 vs 0.65, P=0.02). Additionally, net reclassification improvement was not significant for any subgroup based on race and gender, ranging from −5.5% to 4.4%. Conclusion The addition of CKD status and stratification by race does not improve risk prediction in high-risk hypertensive patients. PMID:23194494

Evaluating the Safety In Numbers effect for pedestrians at urban intersections.

PubMed

Murphy, Brendan; Levinson, David M; Owen, Andrew

2017-09-01

Assessment of collision risk between pedestrians and automobiles offers a powerful and informative tool in urban planning applications, and can be leveraged to inform proper placement of improvements and treatment projects to improve pedestrian safety. Such assessment can be performed using existing datasets of crashes, pedestrian counts, and automobile traffic flows to identify intersections or corridors characterized by elevated collision risks to pedestrians. The Safety In Numbers phenomenon, which refers to the observable effect that pedestrian safety is positively correlated with increased pedestrian traffic in a given area (i.e. that the individual per-pedestrian risk of a collision decreases with additional pedestrians), is a readily observed phenomenon that has been studied previously, though its directional causality is not yet known. A sample of 488 intersections in Minneapolis were analyzed, and statistically-significant log-linear relationships between pedestrian traffic flows and the per-pedestrian crash risk were found, indicating the Safety In Numbers effect. Potential planning applications of this analysis framework towards improving pedestrian safety in urban environments are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving risk assessment of color additives in medical device polymers.

PubMed

Chandrasekar, Vaishnavi; Janes, Dustin W; Forrey, Christopher; Saylor, David M; Bajaj, Akhil; Duncan, Timothy V; Zheng, Jiwen; Riaz Ahmed, Kausar B; Casey, Brendan J

2018-01-01

Many polymeric medical device materials contain color additives which could lead to adverse health effects. The potential health risk of color additives may be assessed by comparing the amount of color additive released over time to levels deemed to be safe based on available toxicity data. We propose a conservative model for exposure that requires only the diffusion coefficient of the additive in the polymer matrix, D, to be specified. The model is applied here using a model polymer (poly(ether-block-amide), PEBAX 2533) and color additive (quinizarin blue) system. Sorption experiments performed in an aqueous dispersion of quinizarin blue (QB) into neat PEBAX yielded a diffusivity D = 4.8 × 10 -10 cm 2  s -1 , and solubility S = 0.32 wt %. On the basis of these measurements, we validated the model by comparing predictions to the leaching profile of QB from a PEBAX matrix into physiologically representative media. Toxicity data are not available to estimate a safe level of exposure to QB, as a result, we used a Threshold of Toxicological Concern (TTC) value for QB of 90 µg/adult/day. Because only 30% of the QB is released in the first day of leaching for our film thickness and calculated D, we demonstrate that a device may contain significantly more color additive than the TTC value without giving rise to a toxicological concern. The findings suggest that an initial screening-level risk assessment of color additives and other potentially toxic compounds found in device polymers can be improved. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 310-319, 2018. © 2017 Wiley Periodicals, Inc.

From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care.

PubMed

Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

2003-02-01

The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1). errors inevitably occur and usually derive from faulty system design, not from negligence; (2). accident prevention should be an ongoing process based on open and full reporting; (3). major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff.

An Investigation into Risks Awareness and E-Safety Needs of Children on the Internet: A Study of Devon, UK

ERIC Educational Resources Information Center

Annansingh, Fenio; Veli, Thomas

2016-01-01

Purpose: This paper aims to investigate children interaction in cyberspace and their use of Web 2.0 technologies. It sought their perception of internet risks as well as their knowledge and experience with electronic safety (e-safety) measures. It also considered parents', teachers' and other stakeholders' perception of internet risks, e-safety…

Nuclear power: Siting and safety

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

Openshaw, S.

1986-01-01

By 2030, half, or even two-thirds, of all electricity may be generated by nuclear power. Major reactor accidents are still expected to be rare occurrences, but nuclear safety is largely a matter of faith. Terrorist attacks, sabotage, and human error could cause a significant accident. Reactor siting can offer an additional, design-independent margin of safety. Remote geographical sites for new plants would minimize health risks, protect the industry from negative changes in public opinion concerning nuclear energy, and improve long-term public acceptance of nuclear power. U.K. siting practices usually do not consider the contribution to safety that could be obtainedmore » from remote sites. This book discusses the present trends of siting policies of nuclear power and their design-independent margin of safety.« less

Evidence That Environmental and Familial Risks for Psychosis Additively Impact a Multidimensional Subthreshold Psychosis Syndrome.

PubMed

Pries, Lotta-Katrin; Guloksuz, Sinan; Ten Have, Margreet; de Graaf, Ron; van Dorsselaer, Saskia; Gunther, Nicole; Rauschenberg, Christian; Reininghaus, Ulrich; Radhakrishnan, Rajiv; Bak, Maarten; Rutten, Bart P F; van Os, Jim

2018-06-06

The observed link between positive psychotic experiences (PE) and psychosis spectrum disorder (PSD) may be stronger depending on concomitant presence of PE with other dimensions of psychopathology. We examined whether the effect of common risk factors for PSD on PE is additive and whether the impact of risk factors on the occurrence of PE depends on the co-occurrence of other symptom dimensions (affective dysregulation, negative symptoms, and cognitive alteration). Data from the Netherlands Mental Health Survey and Incidence Study 2 were used. Risk factors included childhood adversity, cannabis use, urbanicity, foreign born, hearing impairment, and family history of affective disorders. Logistic regression models were applied to test (1) the additive effect of risk factors (4 levels) on PE and (2) the moderating effects of symptom dimensions on the association between risk factors (present/absent) and PE, using additive interaction, expressed as the interaction contrast ratio. Risk factors were additive: the greater the number of risk factors, the greater the odds of PE. Furthermore, concomitant presence of the other symptom dimensions all increased the impact of risk factors on PE. After controlling for age, sex, and education, only affective dysregulation and negative symptoms remained significant moderators; only affective dysregulation remained a significant moderator if all dimensions were adjusted for each other. Risk factors may not be directly associated with PE but additively give rise to a multidimensional subthreshold state anticipating the multidimensional clinical syndrome. Early motivational and cognitive impairments in the context of PE may be reducible to affective dysregulation.

Work Safety Climate, Safety Behaviors, and Occupational Injuries of Youth Farmworkers in North Carolina

PubMed Central

Rodriguez, Guadalupe; Quandt, Sara A.; Arcury, Justin T.; Arcury, Thomas A.

2015-01-01

Objectives. The aims of this project were to describe the work safety climate and the association between occupational safety behaviors and injuries among hired youth farmworkers in North Carolina (n = 87). Methods. We conducted personal interviews among a cross-sectional sample of youth farmworkers aged 10 to 17 years. Results. The majority of youths reported that work safety practices were very important to management, yet 38% stated that supervisors were only interested in “doing the job quickly and cheaply.” Few youths reported appropriate work safety behavior, and 14% experienced an injury within the past 12 months. In bivariate analysis, perceptions of work safety climate were significantly associated with pesticide exposure risk factors for rewearing wet shoes (P = .01), wet clothes (P = .01), and shorts (P = .03). Conclusions. Youth farmworkers perceived their work safety climate as being poor. Although additional research is needed to support these findings, these results strengthen the need to increase employer awareness to improve the safety climate for protecting youth farmworkers from harmful exposures and injuries. PMID:25973817

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

Deploying and measuring a risk and patient safety program.

PubMed

Orel, Howard; McGroarty, Molly; Marchegiani, Heather

2017-01-01

Health care continues to evolve at a rapid rate. Over just the past decade, the industry has seen the introduction and widespread implementation of an electronic health record, increase in presence of nurse practitioners and physician assistants to help manage the shortage of physicians, and the introduction of accountable care organizations. It is with these changes that new challenges and opportunities emerge. One such challenge is the increase in the severity of medical malpractice claims throughout the nation. Another emerging challenge is the introduction of outcome-based reimbursements, with providers potentially losing a portion of their payment should the patient experience result in a preventable adverse event. These trends are resulting in providers continuously seeking innovative approaches to reducing risk and improving patient safety. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

Future challenges to microbial food safety.

PubMed

Havelaar, Arie H; Brul, Stanley; de Jong, Aarieke; de Jonge, Rob; Zwietering, Marcel H; Ter Kuile, Benno H

2010-05-30

improved outbreak detection and source attribution, sero-epidemiology and disease burden estimation. Current developments in molecular techniques make it possible to rapidly assemble information on the genome of various isolates of microbial species of concern. Such information can be used to develop new tracking and tracing methods, and to investigate the behavior of micro-organisms under environmentally relevant stress conditions. These novel tools and insight need to be applied to objectives for food safety strategies, as well as to models that predict microbial behavior. In addition, the increasing complexity of the global food systems necessitates improved communication between all parties involved: scientists, risk assessors and risk managers, as well as consumers. Copyright 2009 Elsevier B.V. All rights reserved.

Tweens at risk: examining car safety practices in four economically disadvantaged urban elementary schools in Virginia.

PubMed

Will, Kelli England; Dunaway, Krystall E; Lorek, Edward J

2013-09-01

Children aged 8- to 12-years-old ("tweens") are at high risk for crash injury, and motor vehicle crashes are their leading cause of death. Data are presented from behavioral observations (N=243), surveys (N=677), and focus groups (N=26) conducted with tweens attending four urban elementary schools in Virginia. The populations assessed were predominantly black (77.9%) and economically disadvantaged (61.9%). Focus groups revealed a number of inconsistencies in and misconceptions about safety practices. Among the 677 tweens who completed anonymous surveys, the majority (58.1%) reported wearing their seat belts "not very much at all" or "never." Many students (47.8%) reported usually sitting in the front seat or sitting in the front and back seats equally. This is despite the fact that most (92.0%) knew that the back seat was the safest place to sit. Of the 243 tweens observed in vehicles, 65.0% were unrestrained and 60.1% were seated in the front passenger seat. Findings of this study shed light on the great disparity between the national rates for child safety practices and those of children living in an economically disadvantaged urban school district. Additional intervention programs that are culturally appropriate and specifically target this age group are needed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Corporate financial decision makers' perceptions of their company's safety performance, programs and personnel: Do company size and industry injury risk matter?

PubMed

DeArmond, Sarah; Huang, Yueng-Hsiang; Chen, Peter Y; Courtney, Theodore K

2010-01-01

Top-level managers make important decisions about safety-related issues, yet little research has been done involving these individuals. The current study explored corporate financial decisions makers' perceptions of their company's safety and their justifications for these perceptions. This study also explored whether their perceptions and justifications varied as a function of company size or industry injury risk. A total of 404 individuals who were the most senior managers responsible for making decisions about property and casualty risk at their companies participated in this study. The participants took part in a telephone survey. The results suggest that corporate financial decision makers have positive views of safety at their companies relative to safety at other companies within their industries. Further, many believe their company's safety is influenced by the attention/emphasis placed on safety and the selection and training of safety personnel. Participants' perceptions varied somewhat based on the size of their company and the level of injury risk in their industry. While definitive conclusions about corporate financial decision makers' perceptions of safety cannot be reached as a result of this single study, this work does lay groundwork for future research aimed at better understanding the perceptions top-level managers.

Safety and risk assessment of ceramide 3 in cosmetic products.

PubMed

Choi, Seul Min; Lee, Byung-Mu

2015-10-01

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

Towards a Fuzzy Bayesian Network Based Approach for Safety Risk Analysis of Tunnel-Induced Pipeline Damage.

PubMed

Zhang, Limao; Wu, Xianguo; Qin, Yawei; Skibniewski, Miroslaw J; Liu, Wenli

2016-02-01

Tunneling excavation is bound to produce significant disturbances to surrounding environments, and the tunnel-induced damage to adjacent underground buried pipelines is of considerable importance for geotechnical practice. A fuzzy Bayesian networks (FBNs) based approach for safety risk analysis is developed in this article with detailed step-by-step procedures, consisting of risk mechanism analysis, the FBN model establishment, fuzzification, FBN-based inference, defuzzification, and decision making. In accordance with the failure mechanism analysis, a tunnel-induced pipeline damage model is proposed to reveal the cause-effect relationships between the pipeline damage and its influential variables. In terms of the fuzzification process, an expert confidence indicator is proposed to reveal the reliability of the data when determining the fuzzy probability of occurrence of basic events, with both the judgment ability level and the subjectivity reliability level taken into account. By means of the fuzzy Bayesian inference, the approach proposed in this article is capable of calculating the probability distribution of potential safety risks and identifying the most likely potential causes of accidents under both prior knowledge and given evidence circumstances. A case concerning the safety analysis of underground buried pipelines adjacent to the construction of the Wuhan Yangtze River Tunnel is presented. The results demonstrate the feasibility of the proposed FBN approach and its application potential. The proposed approach can be used as a decision tool to provide support for safety assurance and management in tunnel construction, and thus increase the likelihood of a successful project in a complex project environment. © 2015 Society for Risk Analysis.

From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care

PubMed Central

Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

2003-01-01



 The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1) errors inevitably occur and usually derive from faulty system design, not from negligence; (2) accident prevention should be an ongoing process based on open and full reporting; (3) major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff. PMID:12571343

A fuzzy model for assessing risk of occupational safety in the processing industry.

PubMed

Tadic, Danijela; Djapan, Marko; Misita, Mirjana; Stefanovic, Miladin; Milanovic, Dragan D

2012-01-01

Managing occupational safety in any kind of industry, especially in processing, is very important and complex. This paper develops a new method for occupational risk assessment in the presence of uncertainties. Uncertain values of hazardous factors and consequence frequencies are described with linguistic expressions defined by a safety management team. They are modeled with fuzzy sets. Consequence severities depend on current hazardous factors, and their values are calculated with the proposed procedure. The proposed model is tested with real-life data from fruit processing firms in Central Serbia.

Obstetrics Hospitalists: Risk Management Implications.

PubMed

Veltman, Larry

2015-09-01

The concept of having an in-house obstetrician (serving as an obstetrics [OB] hospitalist) available 24 hours a day, 7 days a week provides a safety net for OB events that many need immediate intervention for a successful outcome. A key precept of risk management, that of loss prevention, fits perfectly with the addition of an OB hospitalist role in the perinatal department. Inherent in the role of OB hospitalists are the patient safety and risk management principles of improved communication, enhanced readiness, and immediate availability. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of the antimicrobial efficacy and skin safety of a novel color additive in combination with chlorine disinfectants.

PubMed

Tyan, Kevin; Kang, Jason; Jin, Katherine; Kyle, Aaron M

2018-05-23

A novel color additive colorizes chlorine disinfectants blue to improve visibility and enhance spray surface coverage, and it fades to colorless to indicate elapsed contact time. We investigated its interactions with 3 chlorine disinfectants to determine if the additive would adversely affect the disinfectants' antimicrobial efficacy or skin safety. We tested 0.5% sodium hypochlorite, 0.2% calcium hypochlorite, and 0.5% sodium dichloroisocyanurate (NaDCC) alone versus with color additive. An independent laboratory tested efficacy against Staphylococcus aureus, Pseudomonas aeruginosa, Vibrio cholerae, and human coronavirus 229E. An independent laboratory also tested direct skin irritation. Chlorine disinfectants with and without color additive achieved equal levels of efficacy against the tested pathogens. Against S. aureus, 0.5% sodium hypochlorite with and without color additive met Environmental Protection Agency criteria for disinfection success. Against human coronavirus 229E, 0.5% sodium hypochlorite alone failed disinfection success criteria, whereas 0.5% sodium hypochlorite with color additive achieved full viral inactivation (≥4.50 log 10 reduction). Against V. cholerae, 0.2% calcium hypochlorite alone and with color additive achieved 5.99 log 10 and >6.03 log 10 reductions, respectively. Against S. aureus and P. aeruginosa, 0.5% NaDCC with and without color additive achieved >4.9 log 10 and >3.54 log 10 reductions, respectively. All 3 chlorine disinfectants with color additive tested as negligible skin irritants. This color additive can be combined with chlorine disinfectants without adversely affecting antimicrobial efficacy or skin safety. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

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

The risks of opioid treatment: Perspectives of primary care practitioners and patients from safety-net clinics

PubMed Central

Hurstak, Emily E.; Kushel, Margot; Chang, Jamie; Ceasar, Rachel; Zamora, Kara; Miaskowski, Christine; Knight, Kelly

2017-01-01

Background Patients with a history of substance use are more likely than those without substance use to experience chronic noncancer pain (CNCP), to be prescribed opioids, and to experience opioid misuse or overdose. Primary care practitioners (PCPs) in safety-net settings care for low-income patients with CNCP and substance use, usually without specialist consultation. To inform communication related to opioid risk, we explored PCPs’ and patients’ perceptions of the risks of chronic opioid therapy. Methods We conducted semistructured interviews with 23 PCPs and 46 of their patients, who had a history of CNCP and substance use. We recruited from 6 safety-net health care settings in the San Francisco Bay Area. We transcribed interviews verbatim and analyzed transcripts using grounded theory methodology. Results (1) PCPs feared harming patients and the community by opioid prescribing. PCPs emphasized fear of opioid overdose. (2) Patients did not highlight concerns about the adverse health consequences of opioids, except for addiction. (3) Both patients and PCPs were concerned about PCPs’ medicolegal risks related to opioid prescribing. (4) Patients reported feeling stigmatized by policies aimed at reducing opioid misuse. Conclusion We identified differences in how clinicians and patients perceive opioid risk. To improve the informed consent process for opioid therapy, patients and PCPs need to have a shared understanding of the risks of opioids and engage in discussions that promote patient autonomy and safety. As clinics implement opioid prescribing policies, clinicians must develop effective communication strategies in order to educate patients about opioid risks and decrease patients’ experiences of stigma and discrimination. PMID:28394752

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

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

Ohi, J M

1992-09-01

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

Safety Culture and Senior Leadership Behavior: Using Negative Safety Ratings to Align Clinical Staff and Senior Leadership.

PubMed

O'Connor, Shawn; Carlson, Elizabeth

2016-04-01

This report describes how staff-designed behavior changes among senior leaders can have a positive impact on clinical nursing staff and enhance the culture of safety in a community hospital. A positive culture of safety in a hospital improves outcomes for patients and staff. Senior leaders are accountable for developing an environment that supports a culture of safety. At 1 community hospital, surveys demonstrated that staff members did not view senior leaders as supportive of or competent in creating a culture of safety. After approval from the hospital's institutional review board was obtained, clinical nurses generated and selected ideas for senior leader behavior change. The new behaviors were assessed by a convenience sample survey of clinical nurses. In addition, culture of safety survey results were compared. Risk reports and harm events were also measured before and after behavior changes. The volume of risk and near-miss reports increased, showing that clinical staff were more inclined to report events after senior leader communication, access, and visibility increased. Harm events went down. The culture of safety survey demonstrated an improvement in the senior leadership domain in 4 of 6 units. The anonymous convenience survey demonstrated that staff members recognized changes that senior leaders had made and felt that these changes positively impacted the culture of safety. By developing skills in communication, advocacy, visibility, and access, senior leaders can enhance a hospital's culture of safety and create stronger ties with clinical staff.

Evaluating the Cost, Safety, and Proliferation Risks of Small Floating Nuclear Reactors.

PubMed

Ford, Michael J; Abdulla, Ahmed; Morgan, M Granger

2017-11-01

It is hard to see how our energy system can be decarbonized if the world abandons nuclear power, but equally hard to introduce the technology in nonnuclear energy states. This is especially true in countries with limited technical, institutional, and regulatory capabilities, where safety and proliferation concerns are acute. Given the need to achieve serious emissions mitigation by mid-century, and the multidecadal effort required to develop robust nuclear governance institutions, we must look to other models that might facilitate nuclear plant deployment while mitigating the technology's risks. One such deployment paradigm is the build-own-operate-return model. Because returning small land-based reactors containing spent fuel is infeasible, we evaluate the cost, safety, and proliferation risks of a system in which small modular reactors are manufactured in a factory, and then deployed to a customer nation on a floating platform. This floating small modular reactor would be owned and operated by a single entity and returned unopened to the developed state for refueling. We developed a decision model that allows for a comparison of floating and land-based alternatives considering key International Atomic Energy Agency plant-siting criteria. Abandoning onsite refueling is beneficial, and floating reactors built in a central facility can potentially reduce the risk of cost overruns and the consequences of accidents. However, if the floating platform must be built to military-grade specifications, then the cost would be much higher than a land-based system. The analysis tool presented is flexible, and can assist planners in determining the scope of risks and uncertainty associated with different deployment options. © 2017 Society for Risk Analysis.

Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.

PubMed

Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E

2018-03-01

Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.

Risk assessment for safety laboratories in Politeknik Negeri Medan

NASA Astrophysics Data System (ADS)

Viyata Sundawa, Bakti; Hutajulu, Elferida; Sirait, Regina; Banurea, Waldemar; Indrayadi; Mulyadi, Sangap

2017-09-01

International Labour Organization (ILO) estimated 2.34 million people die each year because accidents and diseases in workplace. It also impact to economic losses in some countries. It need to do safety and healthy in working environment especially in laboratory. Identification of potential hazards and risks must be done in Telecommunication Laboratory Politeknik Negeri Medan. Therefore, this study was assessed 5 of potential hazards and risks in our laboratory by Likert Scale. This object was divided into 2 assessment namely likelihood of hazards and severity of consequences. Collecting data is taken from questionnaire who involved 100 students at random academic level. The result showed The highest score is chemical hazards 73.2% in likelihood of hazards and electrical hazards 85% in severity of consequences. This condition is classified as “high” state. Big attention must be given to “high” state because it can help us to determine mitigate action.

Data Analysis Approaches for the Risk-Informed Safety Margins Characterization Toolkit

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

Mandelli, Diego; Alfonsi, Andrea; Maljovec, Daniel P.

2016-09-01

In the past decades, several numerical simulation codes have been employed to simulate accident dynamics (e.g., RELAP5-3D, RELAP-7, MELCOR, MAAP). In order to evaluate the impact of uncertainties into accident dynamics, several stochastic methodologies have been coupled with these codes. These stochastic methods range from classical Monte-Carlo and Latin Hypercube sampling to stochastic polynomial methods. Similar approaches have been introduced into the risk and safety community where stochastic methods (such as RAVEN, ADAPT, MCDET, ADS) have been coupled with safety analysis codes in order to evaluate the safety impact of timing and sequencing of events. These approaches are usually calledmore » Dynamic PRA or simulation-based PRA methods. These uncertainties and safety methods usually generate a large number of simulation runs (database storage may be on the order of gigabytes or higher). The scope of this paper is to present a broad overview of methods and algorithms that can be used to analyze and extract information from large data sets containing time dependent data. In this context, “extracting information” means constructing input-output correlations, finding commonalities, and identifying outliers. Some of the algorithms presented here have been developed or are under development within the RAVEN statistical framework.« less

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

A Review of Recent Advances in Perioperative Patient Safety.

PubMed

Fowler, Alexander J

2013-01-01

Major complications in surgery affect up to 16% of surgical procedures. Over the past 50 years, many patient safety initiatives have attempted to reduce such complications. Since the formation of the National Patient Safety Agency in 2001, there have been major advances in patient safety. Most recently, the production and implementation of the Surgical Safety Checklist by the World Health Organisation (WHO), a checklist ensuring that certain 'never events' (wrong-site surgery, wrong operation etc.) do not occur, irrespective of healthcare allowance. In this review, a summary of recent advances in patient safety are considered - including improvements in communication, understanding of human factors that cause mistakes, and strategies developed to minimise these. Additionally, the synthesis of best medical practice and harm minimisation is examined, with particular emphasis on communication and appreciation of human factors in the operating theatre. This is based on the resource management systems developed in other high risk industries (e.g. nuclear), and has also been adopted for other high risk medical areas. The WHO global movement to reduce surgical mortality has been highly successful, especially in the healthcare systems of developing nations where mortality reductions of up to 50% have been observed, and reductions in patient complications of 4%. Incident reporting has long been a key component of patient safety and continues to be so; allowing reflection and improved guideline formation. All patients are placed at risk in the surgical environment. It is crucial that this risk is minimised, whilst optimising the patient's outcome. In this review, recent advances in perioperative patient safety are examined and placed in context.

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

PubMed

Cruz, Jennifer L; Brown, Jamie N

2015-06-01

Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system

PubMed Central

Brown, Jamie N.

2015-01-01

Objectives: Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists’ perceptions about safety risks posed by investigational drugs. Methods: An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Results: Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Conclusions: Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies. PMID:26240744

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Eye Protection: Safety Glasses. Safety Spotlight

ERIC Educational Resources Information Center

Deck, Anita; Roy, Ken

2017-01-01

When it comes to eye safety, there are some situations in which regular safety glasses will work adequately for the needs of the STEM education classroom or laboratory. However, there are certain instances in which safety goggles must be used for safer protection. Taking the time to analyze hazards and assess the risks prior to any activity in the…

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

2012-01-01

Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

Safety risks associated with physical interactions between patients and caregivers during treatment and care delivery in Home Care settings: A systematic review.

PubMed

Hignett, Sue; Edmunds Otter, Mary; Keen, Christine

2016-07-01

To explore the safety risks associated with physical interactions between patients and caregivers during treatment and care delivery in Home Care settings. Seven-stage framework from the PRISMA statement for research question, eligibility (definition), search, identification of relevant papers from title and abstract, selection and retrieval of papers, appraisal and synthesis. British Nursing Index (BNI), Allied and Complementary Medicine Database (AMED), Applied Social Sciences Index and Abstracts (ASSIA), Cinahl, Cochrane Library, Embase, Ergonomics Abstracts, Health Business Elite, Health Management Information Consortium (HMIC), Medline, PsycInfo, Scopus, Social Care online, Social Science Citation Index. The included references (n=42) were critically appraised using a modified version of Downs and Black checklist and the Mixed Methods Appraisal Tool. The risk factors are reported using the modified model of human factors of health care in the home to represent the roles of both patients and caregivers in the system. The results are grouped as environment (health policy, physical and social), artefacts (equipment and technology), tasks (procedures and work schedules) and care recipient/provider. These include permanent and temporary building design and access, communication and lone working, provision of equipment and consumables, and clinical tasks. The topics with strong evidence from at least 2 papers relate to risks associated with awkward working positions, social environment issues (additional tasks and distractions), abuse and violence, inadequate team (peer) support, problems with workload planning, needle stick injuries and physical workload (moving and handling patients). As home care increases, there is a need to ensure the safety of both patients and caregivers with an understanding of the physical interactions and tasks to manage safety risks and plan safer care delivery systems. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

Extended Editorial: Research and Education in Reliability, Maintenance, Quality Control, Risk and Safety.

ERIC Educational Resources Information Center

Ramalhoto, M. F.

1999-01-01

Introduces a special theme journal issue on research and education in quality control, maintenance, reliability, risk analysis, and safety. Discusses each of these theme concepts and their applications to naval architecture, marine engineering, and industrial engineering. Considers the effects of the rapid transfer of research results through…

Road Infrastructure Safety Management in Poland

NASA Astrophysics Data System (ADS)

Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

2017-10-01

The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road

Geotechnical risk analysis user's guide

DOT National Transportation Integrated Search

1987-03-01

All geotechnical predictions involve uncertainties. These are accounted for additionally by conservative factors of safety. Risk based design, on the other hand, attempts to quantify uncertainties and to adjust design conservatism accordingly. Such m...

Risk for household safety hazards: Socioeconomic and sociodemographic factors.

PubMed

Mayes, Sunnye; Roberts, Michael C; Stough, Cathleen Odar

2014-12-01

Many unintentional injuries to young children occur in the home. The current study examines the relation between family socioeconomic and sociodemographic factors and risk factors for home injury. Presence of household hazards was examined in 80 families with toddler-aged children. Parental ability to identify household hazards in pictures was also assessed. ANOVAs and Pearson product-moment correlations examined the relationship between presence of household hazards, knowledge to identify hazards, and factors of yearly family income, parental age, parental education, parental marital status, child ethnicity, and the number of children living in the home. A greater number of hazards were found in the homes of both the lowest and highest income families, but poorer knowledge to identify household hazards was found only among parents of the lowest income families and younger parents. Across family socioeconomic status, parent knowledge of hazards was related to observed household hazards. The relationship between family income and risk for injury is complex, and children of both lower and higher SES families may be at risk for injury. While historically particular focus has been placed on risk for injury among children in low income families, injury prevention efforts should target reducing presence of household hazards in both high and low SES families. Copyright © 2014 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Conservative Exposure Predictions for Rapid Risk Assessment of Phase-Separated Additives in Medical Device Polymers.

PubMed

Chandrasekar, Vaishnavi; Janes, Dustin W; Saylor, David M; Hood, Alan; Bajaj, Akhil; Duncan, Timothy V; Zheng, Jiwen; Isayeva, Irada S; Forrey, Christopher; Casey, Brendan J

2018-01-01

A novel approach for rapid risk assessment of targeted leachables in medical device polymers is proposed and validated. Risk evaluation involves understanding the potential of these additives to migrate out of the polymer, and comparing their exposure to a toxicological threshold value. In this study, we propose that a simple diffusive transport model can be used to provide conservative exposure estimates for phase separated color additives in device polymers. This model has been illustrated using a representative phthalocyanine color additive (manganese phthalocyanine, MnPC) and polymer (PEBAX 2533) system. Sorption experiments of MnPC into PEBAX were conducted in order to experimentally determine the diffusion coefficient, D = (1.6 ± 0.5) × 10 -11  cm 2 /s, and matrix solubility limit, C s  = 0.089 wt.%, and model predicted exposure values were validated by extraction experiments. Exposure values for the color additive were compared to a toxicological threshold for a sample risk assessment. Results from this study indicate that a diffusion model-based approach to predict exposure has considerable potential for use as a rapid, screening-level tool to assess the risk of color additives and other small molecule additives in medical device polymers.

Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

PubMed

Groves, Patricia S; Bunch, Jacinda L

2018-05-18

The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

Genetically modified foods: safety, risks and public concerns-a review.

PubMed

Bawa, A S; Anilakumar, K R

2013-12-01

Genetic modification is a special set of gene technology that alters the genetic machinery of such living organisms as animals, plants or microorganisms. Combining genes from different organisms is known as recombinant DNA technology and the resulting organism is said to be 'Genetically modified (GM)', 'Genetically engineered' or 'Transgenic'. The principal transgenic crops grown commercially in field are herbicide and insecticide resistant soybeans, corn, cotton and canola. Other crops grown commercially and/or field-tested are sweet potato resistant to a virus that could destroy most of the African harvest, rice with increased iron and vitamins that may alleviate chronic malnutrition in Asian countries and a variety of plants that are able to survive weather extremes. There are bananas that produce human vaccines against infectious diseases such as hepatitis B, fish that mature more quickly, fruit and nut trees that yield years earlier and plants that produce new plastics with unique properties. Technologies for genetically modifying foods offer dramatic promise for meeting some areas of greatest challenge for the 21st century. Like all new technologies, they also pose some risks, both known and unknown. Controversies and public concern surrounding GM foods and crops commonly focus on human and environmental safety, labelling and consumer choice, intellectual property rights, ethics, food security, poverty reduction and environmental conservation. With this new technology on gene manipulation what are the risks of "tampering with Mother Nature"?, what effects will this have on the environment?, what are the health concerns that consumers should be aware of? and is recombinant technology really beneficial? This review will also address some major concerns about the safety, environmental and ecological risks and health hazards involved with GM foods and recombinant technology.

Mobile phone radiation health risk controversy: the reliability and sufficiency of science behind the safety standards.

PubMed

Leszczynski, Dariusz; Xu, Zhengping

2010-01-27

There is ongoing discussion whether the mobile phone radiation causes any health effects. The International Commission on Non-Ionizing Radiation Protection, the International Committee on Electromagnetic Safety and the World Health Organization are assuring that there is no proven health risk and that the present safety limits protect all mobile phone users. However, based on the available scientific evidence, the situation is not as clear. The majority of the evidence comes from in vitro laboratory studies and is of very limited use for determining health risk. Animal toxicology studies are inadequate because it is not possible to "overdose" microwave radiation, as it is done with chemical agents, due to simultaneous induction of heating side-effects. There is a lack of human volunteer studies that would, in unbiased way, demonstrate whether human body responds at all to mobile phone radiation. Finally, the epidemiological evidence is insufficient due to, among others, selection and misclassification bias and the low sensitivity of this approach in detection of health risk within the population. This indicates that the presently available scientific evidence is insufficient to prove reliability of the current safety standards. Therefore, we recommend to use precaution when dealing with mobile phones and, whenever possible and feasible, to limit body exposure to this radiation. Continuation of the research on mobile phone radiation effects is needed in order to improve the basis and the reliability of the safety standards.

Mobile phone radiation health risk controversy: the reliability and sufficiency of science behind the safety standards

PubMed Central

2010-01-01

There is ongoing discussion whether the mobile phone radiation causes any health effects. The International Commission on Non-Ionizing Radiation Protection, the International Committee on Electromagnetic Safety and the World Health Organization are assuring that there is no proven health risk and that the present safety limits protect all mobile phone users. However, based on the available scientific evidence, the situation is not as clear. The majority of the evidence comes from in vitro laboratory studies and is of very limited use for determining health risk. Animal toxicology studies are inadequate because it is not possible to "overdose" microwave radiation, as it is done with chemical agents, due to simultaneous induction of heating side-effects. There is a lack of human volunteer studies that would, in unbiased way, demonstrate whether human body responds at all to mobile phone radiation. Finally, the epidemiological evidence is insufficient due to, among others, selection and misclassification bias and the low sensitivity of this approach in detection of health risk within the population. This indicates that the presently available scientific evidence is insufficient to prove reliability of the current safety standards. Therefore, we recommend to use precaution when dealing with mobile phones and, whenever possible and feasible, to limit body exposure to this radiation. Continuation of the research on mobile phone radiation effects is needed in order to improve the basis and the reliability of the safety standards. PMID:20205835

Multivariate qualitative analysis of banned additives in food safety using surface enhanced Raman scattering spectroscopy

NASA Astrophysics Data System (ADS)

He, Shixuan; Xie, Wanyi; Zhang, Wei; Zhang, Liqun; Wang, Yunxia; Liu, Xiaoling; Liu, Yulong; Du, Chunlei

2015-02-01

A novel strategy which combines iteratively cubic spline fitting baseline correction method with discriminant partial least squares qualitative analysis is employed to analyze the surface enhanced Raman scattering (SERS) spectroscopy of banned food additives, such as Sudan I dye and Rhodamine B in food, Malachite green residues in aquaculture fish. Multivariate qualitative analysis methods, using the combination of spectra preprocessing iteratively cubic spline fitting (ICSF) baseline correction with principal component analysis (PCA) and discriminant partial least squares (DPLS) classification respectively, are applied to investigate the effectiveness of SERS spectroscopy for predicting the class assignments of unknown banned food additives. PCA cannot be used to predict the class assignments of unknown samples. However, the DPLS classification can discriminate the class assignment of unknown banned additives using the information of differences in relative intensities. The results demonstrate that SERS spectroscopy combined with ICSF baseline correction method and exploratory analysis methodology DPLS classification can be potentially used for distinguishing the banned food additives in field of food safety.

A Safety Evaluation of Empagliflozin for the Treatment of Type 2 Diabetes

PubMed Central

Neeland, Ian J.; Salahuddin, Usman; McGuire, Darren K.

2016-01-01

Introduction Empagliflozin is a sodium glucose co-transporter 2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) by enhancing urinary glucose excretion. Empagliflozin is effective at lowering glycosylated hemoglobin and was recently proven superior to placebo for reduction of cardiovascular disease (CVD) risk. As with any new drug, there are safety considerations that inform its potential use in patients with T2DM. Areas Covered Here, we evaluate the safety of empagliflozin and provide an expert opinion as to its current and future role in the treatment of patients with T2DM. A search of the English language literature was performed using PubMed search terms: “empagliflozin”, “sodium glucose cotransporter 2 inhibitors”, and “drug safety”. Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included. Expert Opinion The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD. Ongoing trials will continue to address the safety and efficacy of empagliflozin and expand our clinical knowledge of this medication. PMID:26695551

Mapping Sources of Food Safety Information for U.S. Consumers: Findings From a National Survey.

PubMed

Nan, Xiaoli; Verrill, Linda; Kim, Jarim

2017-03-01

This research examines the sources from which U.S. consumers obtain their food safety information. It seeks to determine differences in the types of information sources used by U.S. consumers of different sociodemographic background, as well as the relationships between the types of information sources used and food safety risk perceptions. Analyzing the 2010 Food Safety Survey (N = 4,568) conducted by the U.S. Food and Drug Administration, we found that age, gender, education, and race predicted the use of different sources for food safety information. Additionally, use of several information sources predicted perceived susceptibility to foodborne illnesses and severity of food contamination. Implications of the findings for food safety risk communication are discussed.

Health reform holds both risks and rewards for safety-net providers and racially and ethnically diverse patients.

PubMed

Andrulis, Dennis P; Siddiqui, Nadia J

2011-10-01

The Affordable Care Act of 2010 creates both opportunities and risks for safety-net providers in caring for low-income, diverse patients. New funding for health centers; support for coordinated, patient-centered care; and expansion of the primary care workforce are some of the opportunities that potentially strengthen the safety net. However, declining payments to safety-net hospitals, existing financial hardships, and shifts in the health care marketplace may intensify competition, thwart the ability to innovate, and endanger the financial viability of safety-net providers. Support of state and local governments, as well as philanthropies, will be crucial to helping safety-net providers transition to the new health care environment and to preventing the unintended erosion of the safety net for racially and ethnically diverse populations.

[Safety evaluation and risk control measures of Cassiae Semen].