Parental safety concerns and active school commute: correlates across multiple domains in the home-to-school journey

PubMed Central

2014-01-01

Background Empirical evidence of the relationship between safety concerns and walking to school (WTS) is growing. However, current research offers limited understanding of the multiple domains of parental safety concerns and the specific mechanisms through which parents articulate safety concerns about WTS. A more detailed understanding is needed to inform environmental and policy interventions. This study examined the relationships between both traffic safety and personal safety concerns and WTS in the U.S. Methods This cross-sectional analysis examined data from the Texas Childhood Obesity Prevention Policy Evaluation (T-COPPE) project, an evaluation of state-wide obesity prevention policy interventions. All study data were from the survey (n = 830) of parents with 4th grade students attending 81 elementary schools across Texas, and living within two miles from their children's schools. Traffic safety and personal safety concerns were captured for the home neighborhood, en-route to school, and school environments. Binary logistic regression analysis was used to assess the odds of WTS controlling for significant covariates. Results Overall, 18% of parents reported that their child walked to school on most days of the week. For traffic safety, students were more likely to walk to school if their parent reported favorable perceptions about the following items in the home neighborhood environment: higher sidewalk availability, well maintained sidewalks and safe road crossings. For the route to school, the odds of WTS were higher for those who reported "no problem" with each one of the following: traffic speed, amount of traffic, sidewalks/pathways, intersection/crossing safety, and crossing guards, when compared to those that reported "always a problem". For personal safety in the en-route to school environment, the odds of WTS were lower when parents reported concerns about: stray or dangerous animals and availability of others with whom to walk. Conclusions Findings offered insights into the specific issues that drive safety concerns for elementary school children’s WTS behaviors. The observed associations between more favorable perceptions of safety and WTS provide further justification for practical intervention strategies to reduce WTS barriers that can potentially bring long-term physical activity and health benefits to school-aged children. PMID:24602213

TOY SAFETY SURVEILLANCE FROM ONLINE REVIEWS

PubMed Central

Winkler, Matt; Abrahams, Alan S.; Gruss, Richard; Ehsani, Johnathan P.

2016-01-01

Toy-related injuries account for a significant number of childhood injuries and the prevention of these injuries remains a goal for regulatory agencies and manufacturers. Text-mining is an increasingly prevalent method for uncovering the significance of words using big data. This research sets out to determine the effectiveness of text-mining in uncovering potentially dangerous children’s toys. We develop a danger word list, also known as a ‘smoke word’ list, from injury and recall text narratives. We then use the smoke word lists to score over one million Amazon reviews, with the top scores denoting potential safety concerns. We compare the smoke word list to conventional sentiment analysis techniques, in terms of both word overlap and effectiveness. We find that smoke word lists are highly distinct from conventional sentiment dictionaries and provide a statistically significant method for identifying safety concerns in children’s toy reviews. Our findings indicate that text-mining is, in fact, an effective method for the surveillance of safety concerns in children’s toys and could be a gateway to effective prevention of toy-product-related injuries. PMID:27942092

Optical sensing technologies for rapid food safety and quality inspection

USDA-ARS?s Scientific Manuscript database

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

Safety of High Speed Magnetic Levitation Transportation Systems : German High-Speed Maglev Train Safety Requirements - Potential For Application in the United States

DOT National Transportation Integrated Search

1992-02-01

The safety of various magnetically levitated (maglev) trains underdevelopment for possible : implementation in the United States is ofdirect concern to the Federal Railroad Administration (FRA). : This report is the second in a series of reports addr...

Emissions impacts on driver safety

DOT National Transportation Integrated Search

2007-07-01

The Federal Motor Carriers Safety Administration (FMCSA) is concerned that truck drivers exposure to high levels of air pollutants and mobile air toxics for potentially long periods of time, may lead to acute and/or long term cognitive impairments...

Electronic Medical Record Documentation of Driving Safety for Veterans with Diagnosed Dementia.

PubMed

Vair, Christina L; King, Paul R; Gass, Julie; Eaker, April; Kusche, Anna; Wray, Laura O

2018-01-01

Many older adults continue to drive following dementia diagnosis, with medical providers increasingly likely to be involved in addressing such safety concerns. This study examined electronic medical record (EMR) documentation of driving safety for veterans with dementia (N = 118) seen in Veterans Affairs primary care and interdisciplinary geriatrics clinics in one geographic region over a 10-year period. Qualitative directed content analysis of retrospective EMR data. Assessment of known risk factors or subjective concerns for unsafe driving were documented in fewer than half of observed cases; specific recommendations for driving safety were evident for a minority of patients, with formal driving evaluation the most frequently documented recommendation by providers. Utilizing data from actual clinical encounters provides a unique snapshot of how driving risk and safety concerns are addressed for veterans with dementia. This information provides a meaningful frame of reference for understanding potential strengths and possible gaps in how this important topic area is being addressed in the course of clinical care. The EMR is an important forum for interprofessional communication, with documentation of driving risk and safety concerns an essential element for continuity of care and ensuring consistency of information delivered to patients and caregivers.

Analysis of the dismounted motorist and road-worker model pedestrian safety regulations

DOT National Transportation Integrated Search

1982-08-01

Two pedestrian model regulations previously developed by NHTSA were studied to determine their potential safety benefits. One regulation was concerned with the disabled-vehicle situation and called on motorists to position themselves and their vehicl...

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

ERIC Educational Resources Information Center

Wyatt-Smith, Claire; Castleton, Geraldine

1995-01-01

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

Safety of High Speed Guided Ground Transportation Systems: Potential Health Effects of Low Frequency Electromagnetic Fields Due to Maglev and Other Electric Rail Systems

DOT National Transportation Integrated Search

1993-08-01

The safety of magnetically-levitated (maglev) and high-speed rail (HSR) trains proposed for use in the United States is : the responsibility of the Federal Railroad Administration. There are concerns for physical safety associated with : equipment op...

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

PubMed

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

2012-12-01

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

Hazards in the hospital.

PubMed

Seibert, P J

1994-02-01

In an earlier article (JAVMA, Jan 15, 1994), the author outlined some of the first steps necessary in establishing a hospital safety program that will comply with current Occupational Safety and Health Administration (OSHA) guidelines. One of the main concerns of the OSHA guidelines is that there be written plans for managing hazardous materials, performing dangerous jobs, and dealing with other potential safety problems. In this article, the author discusses potentially hazardous situations commonly found in veterinary practices and provides details on how to minimize the risks associated with those situations and how to implement safety procedures that will comply with the OSHA guidelines.

Characterizing the health and safety needs of the collision repair industry.

PubMed

Whittaker, Stephen G; Reeb-Whitaker, Carolyn

2009-05-01

Production workers in the collision repair industry are potentially exposed to many harmful chemicals, including isocyanates. Of particular concern is the burden of work-related asthma in this industry that likely reflects exposures to the isocyanates in two-part paints. The main objectives of this study were to gather information about: (i) the collision repair industry business model, (ii) the number of collision repair production workers potentially exposed to isocyanates, (iii) additional chemical and physical exposures of concern, (iv) current health and safety practices in the industry, (v) the health and safety perceptions and needs of business owners and managers, and (vi) strategies to reduce exposure and increase employer and worker awareness. Data were gathered using a combination of key informant interviews, field investigations, and a statewide needs assessment survey. Although a response bias cannot be excluded, the 69% response rate suggests that the survey results are likely representative of Washington State's collision repair industry. Collision repair was determined to be a male-dominated industry chiefly comprising small, nonunionized, family-run businesses. Many shops face numerous safety and health challenges resulting from a combination of misinformation within the industry, insufficient funds to address workplace health and safety concerns, and social barriers to enforcing best practices within the shops. Most notably, inappropriate selection and use of respirators and gloves likely contribute significantly to isocyanate exposures. Collision repair workers are potentially exposed to a variety of additional chemical and physical hazards that deserve attention. This industry requires health and safety intervention of both an educational campaign and technical assistance. Any such intervention must account for the financial, demographic, and social characteristics of this industry.

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

PubMed

Wasser, Tobias D

2015-02-01

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

A Total Management Measurement Model for the Naval Weapons Center

DTIC Science & Technology

1991-02-01

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

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

PubMed

Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J

2016-11-01

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

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

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

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

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

PubMed

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

2013-03-01

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

Accident Journalism and Traffic Safety Education: A Three-Phase Investigation of Accident Reporting in the Canadian Daily Press.

ERIC Educational Resources Information Center

Wilde, Gerald J. S.; Ackersviller, Melody J.

A study examined the potential for development of a traffic accident-reporting form in the Canadian daily press that strengthens concern for road safety in the general population and enhances knowledge, attitudes, and behavior leading to greater safety. The investigation was conducted on three levels: a content analysis, a readership analysis, and…

Working Safety in Confined Spaces. Module SH-32. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on working safely in confined spaces in one of 50 modules concerned with job safety and health. This module explains how to recognize potential hazards in confined spaces, how to deal with these hazards, and how planning can prevent accidents. Following the introduction, 17 objectives (each keyed to a page in the text) the…

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

PubMed

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

2017-01-01

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

Perceptions of nonsurgical permanent contraception among potential users, providers, and influencers in Wardha district and New Delhi, India: Exploratory research.

PubMed

Aengst, Jennifer C; Harrington, Elizabeth K; Bahulekar, Pramod; Shivkumar, Poonam; Jensen, Jeffrey T; Garg, B S

2017-01-01

New permanent contraceptive methods are in development, including nonsurgical permanent contraception (NSPC). In the present study, perceptions of NSPC in India among married women, married men, mothers-in-law, providers, and health advocates in Eastern Maharashtra (Wardha district) and New Delhi were examined. We conducted semi-structured interviews with 40 married women and 20 mothers-in-law; surveys with 150 married men; and focus group discussions with obstetrics/gynecology providers and advocates. Transcripts were coded and analyzed using a grounded theory approach, where emerging themes are analyzed during the data collection period. The majority of female respondents expressed support of permanent contraception and interest in NSPC, stating the importance of avoiding surgery and minimizing recovery time. They expressed concerns about safety and efficacy; many felt that a confirmation test would be necessary regardless of the failure rate. Most male respondents were supportive of female permanent contraception (PC) and preferred NSPC to a surgical method, as long as it was safe and effective. Providers were interested in NSPC yet had specific concerns about safety, efficacy, cost, uptake, and government pressure. They also had concerns that a nonsurgical approach could undermine the inherent seriousness of choosing PC. Advocates were interested in NSPC but had concerns about safety and potential misuse in the Indian context. Although perceptions of NSPC were varied, all study populations indicated interest in NSPC. Concerns about safety, efficacy, appropriate patient counseling, and ethics emerged from the present study and should be considered as NSPC methods continue to be developed.

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.

Comparative Safety and Tolerability of Anti-VEGF therapy in Age-Related Macular Degeneration

PubMed Central

Modi, Yasha S.; Tanchon, Carley; Ehlers, Justis P

2015-01-01

Neovascular age-related macular degeneration (NVAMD) is one of the leading causes of blindness. Over the last decade, the treatment of NVAMD has been revolutionized by the development intravitreal anti-vascular endothelial growth factor (VEGF) therapies. Several anti-VEGF medications are used for the treatment of NVAMD. The safety and tolerability of these medications deserve review given the high prevalence of NVAMD and the significant utilization of these medications. Numerous large randomized clinical trials have not shown any definitive differential safety relative to ocular or systemic safety of these medications. Intravitreal anti-VEGF therapy does appear to impact systemic VEGF levels, but the implications of these changes remain unclear. One unique safety concern relates drug compounding and the potential risks of contamination, specifically for bevacizumab. Continued surveillance for systemic safety concerns, particularly for rare events is merited. Overall these medications are well tolerated and effective in the treatment of NVAMD. PMID:25700714

8 CFR 212.1 - Documentary requirements for nonimmigrants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... special humanitarian concern; and (iv) Poses no threat to the welfare, safety or security of the United States, its territories, or commonwealths. Any potential threats to the welfare, safety, or security of...) of this section: Australia, Brunei, Indonesia, Japan, Malaysia, Nauru, New Zealand, Papua New Guinea...

Intelligent power wheelchair use in long-term care: potential users' experiences and perceptions.

PubMed

Rushton, Paula W; Mortenson, Ben W; Viswanathan, Pooja; Wang, Rosalie H; Miller, William C; Hurd Clarke, Laura

2017-10-01

Long-term care (LTC) residents with cognitive impairments frequently experience limited mobility and participation in preferred activities. Although a power wheelchair could mitigate some of these mobility and participation challenges, this technology is often not prescribed for this population due to safety concerns. An intelligent power wheelchair (IPW) system represents a potential intervention that could help to overcome these concerns. The purpose of this study was to explore a) how residents experienced an IPW that used three different modes of control and b) what perceived effect the IPW would have on their daily lives. We interviewed 10 LTC residents with mild or moderate cognitive impairment twice, once before and once after testing the IPW. Interviews were conducted using a semi-structured interview guide, audio recorded and transcribed verbatim for thematic analyses. Our analyses identified three overarching themes: (1) the difference an IPW would make, (2) the potential impact of the IPW on others and (3) IPW-related concerns. Findings from this study confirm the need for and potential benefits of IPW use in LTC. Future studies will involve testing IPW improvements based on feedback and insights from this study. Implications for rehabilitation Intelligent power wheelchairs may enhance participation and improve safety and feelings of well-being for long-term care residents with cognitive impairments. Intelligent power wheelchairs could potentially have an equally positive impact on facility staff, other residents, and family and friends by decreasing workload and increasing safety.

Biological fate of low-calorie sweeteners.

PubMed

Magnuson, Bernadene A; Carakostas, Michael C; Moore, Nadia H; Poulos, Sylvia P; Renwick, Andrew G

2016-11-01

With continued efforts to find solutions to rising rates of obesity and diabetes, there is increased interest in the potential health benefits of the use of low- and no-calorie sweeteners (LNCSs). Concerns about safety often deter the use of LNCSs as a tool in helping control caloric intake, even though the safety of LNCS use has been affirmed by regulatory agencies worldwide. In many cases, an understanding of the biological fate of the different LNSCs can help health professionals to address safety concerns. The objectives of this review are to compare the similarities and differences in the chemistry, regulatory status, and biological fate (including absorption, distribution, metabolism, and excretion) of the commonly used LNCSs: acesulfame potassium, aspartame, saccharin, stevia leaf extract (steviol glycoside), and sucralose. Understanding the biological fate of the different LNCSs is helpful in evaluating whether reports of biological effects in animal studies or in humans are indicative of possible safety concerns. Illustrations of the usefulness of this information to address questions about LNCSs include discussion of systemic exposure to LNCSs, the use of sweetener combinations, and the potential for effects of LNCSs on the gut microflora. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Potential environmental benefits of feed additives and other strategies for ruminant production

USDA-ARS?s Scientific Manuscript database

Environmental pollution and food safety are two important concerns that impact ruminant production around the world. The growing public concern over chemical residues in animal-derived foods and threats of antibiotic-resistant bacteria have renewed interest in exploring safer alternatives to chemic...

Immunogenicity of therapeutics: a matter of efficacy and safety.

PubMed

Nechansky, Andreas; Kircheis, Ralf

2010-11-01

The unwanted immunogenicity of therapeutic proteins is a major concern regarding patient safety. Furthermore, pharmacokinetic, pharmacodynamic and clinical efficacy can be seriously affected by the immunogenicity of therapeutic proteins. Authorities have fully recognized this issue and demand appropriate and well-characterized assays to detect anti-drug antibodies (ADAs). We provide an overview of the immunogenicity topic in general, the regulatory background and insight into underlying immunological mechanisms and the limited ability to predict clinical immunogenicity a priori. Furthermore, we comment on the analytical testing approach and the status-quo of appropriate method validation. The review provides insight regarding the analytical approach that is expected by regulatory authorities overseeing immunogenicity testing requirements. Additionally, the factors influencing immunogenicity are summarized and key references regarding immunogenicity testing approaches and method validation are discussed. The unwanted immunogenicity of protein therapeutics is of major concern because of its potential to affect patient safety and drug efficacy. Analytical testing is sophisticated and requires more than one assay. Because immunogenicity in humans is hardly predictable, assay development has to start in a timely fashion and for clinical studies immunogenicity assay validation is mandatory prior to analyzing patient serum samples. Regarding ADAs, the question remains as to when such antibodies are regarded of clinical relevance and what levels are, if at all, acceptable. In summary, the detection of ADAs should raise the awareness of the physician concerning patient safety and of the sponsor/manufacture concerning the immunogenic potential of the drug product.

Hydropower: A Regulatory Guide to Permitting and Licensing in Idaho, Montana, Oregon, and Washington.

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

McCoy, Gilbert A.

1992-12-01

The design, construction and operation of a hydropower project can result in many potential impacts. These potential impacts are of concern to a host of federal, state, and local authorities. Early consultation with land and water management, fish and wildlife resource protection, and health and human safety-oriented agencies should occur to determine specific concerns and study requirements for each proposed project. This Guide to Permitting and Licensing outlines the characteristic features of attractive hydropower sites; summarizes an array of developmental constraints; illustrates potential environmental impacts and concerns; and summarizes all federal, state, and local permitting and licensing requirements.

Hydropower : A Regulatory Guide to Permitting and Licensing in Idaho, Montana, Oregon, and Washington.

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

McCoy, Gilbert A.

1992-12-01

The design, construction and operation of a hydropower project can result in many potential impacts. These potential impacts are of concern to a host of federal, state, and local authorities. Early consultation with land and water management, fish and wildlife resource protection, and health and human safety-oriented agencies should occur to determine specific concerns and study requirements for each proposed project. This Guide to Permitting and Licensing outlines the characteristic features of attractive hydropower sites; summarizes an array of developmental constraints; illustrates potential environmental impacts and concerns; and summarizes all federal, state, and local permitting and licensing requirements.

Pandemonium over painkillers persists.

PubMed

Cowan, David

2007-04-01

Chronic non-cancer pain remains under-treated. Five years ago it was highlighted that more research was needed into the safety and efficacy of NSAIDs and opioid drugs in older people (Cowan, 2002). Concerns remain over NSAID-induced pathology and now there are safety concerns over the continued use of supposedly safer COX-2 agents. There also remain concerns over the problematic use of opioids, including the potential for psychological and physical dependence. While more research is still needed to inform prescribing for older people, it is also apparent that we still need long-term studies of commonly used pain medications for the whole spectrum of age groups. Data derived from such studies would inform nurse prescribing.

Ionizing and Nonionizing Radiation Protection. Module SH-35. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on ionizing and nonionizing radiation protection is one of 50 modules concerned with job safety and health. This module describes various types of ionizing and nonionizing radiation, and the situations in the workplace where potential hazards from radiation may exist. Following the introduction, 13 objectives (each keyed to a…

Safety assessment in schools: beyond risk: the role of child psychiatrists and other mental health professionals.

PubMed

Rappaport, Nancy; Pollack, William S; Flaherty, Lois T; Schwartz, Sarah E O; McMickens, Courtney

2015-04-01

This article presents an overview of a comprehensive school safety assessment approach for students whose behavior raises concern about their potential for targeted violence. Case vignettes highlight the features of 2 youngsters who exemplify those seen, the comprehensive nature of the assessment, and the kind of recommendations that enhance a student's safety, connection, well-being; engage families; and share responsibility of assessing safety with the school. Copyright © 2015 Elsevier Inc. All rights reserved.

Ethical considerations and proposed guidelines for the use of radio frequency identification: especially concerning its use for promoting public safety and national security.

PubMed

Anderson, Amber McKee; Labay, Vladimir

2006-04-01

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy.

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

PubMed

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

2010-06-01

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

Economic analysis requirements in support of orbital debris regulatory policy

NASA Astrophysics Data System (ADS)

Greenberg, Joel S.

1996-10-01

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

The home electronic media environment and parental safety concerns: relationships with outdoor time after school and over the weekend among 9-11 year old children.

PubMed

Wilkie, Hannah J; Standage, Martyn; Gillison, Fiona B; Cumming, Sean P; Katzmarzyk, Peter T

2018-04-05

Time spent outdoors is associated with higher physical activity levels among children, yet it may be threatened by parental safety concerns and the attraction of indoor sedentary pursuits. The purpose of this study was to explore the relationships between these factors and outdoor time during children's discretionary periods (i.e., after school and over the weekend). Data from 462 children aged 9-11 years old were analysed using generalised linear mixed models. The odds of spending > 1 h outdoors after school, and > 2 h outdoors on a weekend were computed, according to demographic variables, screen-based behaviours, media access, and parental safety concerns. Interactions with sex and socioeconomic status (SES) were explored. Boys, low SES participants, and children who played on their computer for < 2 h on a school day had higher odds of spending > 1 h outside after school than girls, high SES children and those playing on a computer for ≥2 h, respectively. Counterintuitive results were found for access to media devices and crime-related safety concerns as both of these were positively associated with time spent outdoors after school. A significant interaction for traffic-related concerns*sex was found; higher road safety concerns were associated with lower odds of outdoor time after school in boys only. Age was associated with weekend outdoor time, which interacted with sex and SES; older children were more likely to spend > 2 h outside on weekends but this was only significant among girls and high SES participants. Our results suggest that specific groups of children are less likely to spend their free time outside, and it would seem that only prolonged recreational computer use has a negative association with children's outdoor time after school. Further research is needed to explore potential underlying mechanisms, and parental safety concerns in more detail.

Addressing the human factors issues associated with control room modifications

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

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

1998-03-01

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

47 CFR 101.203 - Communications concerning safety of life and property.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Communications concerning safety of life and... concerning safety of life and property. (a) Handling and transmission of messages concerning the safety of... person may knowingly cause to be transmitted any false or fraudulent message concerning the safety of...

Current controversies in the USA regarding vaccine safety.

PubMed

Chatterjee, Archana; O'Keefe, Catherine

2010-05-01

As a result of the vaccines discovered in the 20th Century, parents and many healthcare providers of the 21st Century have limited or no experience with the devastating effects of diseases such as polio, smallpox or measles. Fear of disease has shifted to concerns regarding vaccine safety. Scientific evidence has refuted many of the misconceptions regarding vaccine safety; however, parental refusal of vaccines is increasing. Here we review six of the most prevalent controversies surrounding vaccine safety: the proposed causal relationship between receipt of the measles-mumps-rubella vaccine and autism; thimerosal as a potential trigger for autism; religious objection based on some vaccine viruses being grown in cell lines from aborted fetal tissues; parental worries that use of the human papillomavirus vaccine may lead to youth promiscuity; fears regarding the purported association between pertussis vaccination and adverse neurological outcomes; and concerns regarding too many vaccines overloading or weakening the infant immune system. Healthcare providers are ideally positioned to correct these misconceptions, but they must recognize and acknowledge parents' concerns, educate themselves on the latest scientific research that addresses these, and dedicate sufficient time to discuss vaccine safety with worried parents.

Assessment of potential aerodynamic effects on personnel and equipment in proximity to high-speed train operations : safety of high-speed ground transportation systems

DOT National Transportation Integrated Search

1999-12-01

Amtrak is planning to provide high-speed passenger train service at speeds significantly higher than their current top speed of 125 mph, and with these higher speeds, there are concerns with safety from the aerodynamic effects created by a passing tr...

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…

Replacement of seam welded hot reheat pipe using narrow groove GTA machine welding

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

Richardson, R.R.; Yanes, J.; Bryant, R.

1995-12-31

Southern California Edison, recognizing a potential safety concern, scrutinized its existing seam welded hot reheat pipe manufactured by the same supplier as that which failed. Alternatives were narrowed to two in dealing with the installed seam welded pipe. The overriding consideration, however, was one of safety. With this in mind, the utility company evaluated replacement of the seam welded hot reheat pipe with seamless pipe or increasing the frequency of its inspection program. Although increased inspection was much costly, pipe replacement was chosen due to potential safety concerns with seam welded pipe even with more frequent inspection. The utility companymore » then proceeded to determine the most effective method to complete this work. Analysis showed machine-made (automatic) gas tungsten arc welds (GTAW) as the method of choice due to cleanliness and superior mechanical properties. In conjunction with this method, the narrow groove (3{degree} bevel) weld joint as opposed to the traditional groove (37 1/2{degree} bevel) was shown to provide significant technical advantages.« less

Nanotechnology in food science: Functionality, applicability, and safety assessment.

PubMed

He, Xiaojia; Hwang, Huey-Min

2016-10-01

Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted. Copyright © 2016. Published by Elsevier B.V.

Blocking Plasmodium falciparum Malaria Transmission with Drugs: The Gametocytocidal and Sporontocidal Properties of Current and Prospective Antimalarials

PubMed Central

Kiszewski, Anthony E.

2011-01-01

Drugs that kill or inhibit the sexual stages of Plasmodium could potentially amplify or synergize the impact of other interventions by blocking transmission to mosquitoes. Primaquine and other 8-aminoquinolines have long offered such potential, but safety and other concerns have limited their use. Although transmission-blocking properties are not often a priority of drug discovery efforts, a number of interesting gametocytocidal and/or sporontocidal drug candidates have emerged in recent years. Some still bear significant technical and safety concerns, while others have passed clinical trials and are on the verge of entering the antimalarial armamentarium. Recent advances in our knowledge of gametocyte differentiation, gametogenesis and sporogony have also led to the identification of a large array of potential new targets for drugs that might interfere with malaria transmission. This review examines the properties of existing and prospective drugs, mechanisms of action, counter-indications and their potential role in regional malaria elimination efforts.

An assessment and validation study of nuclear reactors for low power space applications

NASA Technical Reports Server (NTRS)

Klein, A. C.; Gedeon, S. R.; Morey, D. C.

1987-01-01

The feasibility and safety of six conceptual small, low power nuclear reactor designs was evaluated. Feasibility evaluations included the determination of sufficient reactivity margins for seven years of full power operation and safe shutdown as well as handling during pre-launch assembly phases. Safety evaluations were concerned with the potential for maintaining subcritical conditions in the event of launch or transportation accidents. These included water immersion accident scenarios both with and without water flooding the core. Results show that most of the concepts can potentially meet the feasibility and safety requirements; however, due to the preliminary nature of the designs considered, more detailed designs will be necessary to enable these concepts to fully meet the safety requirements.

Speaking up behaviors and safety climate in an Austrian university hospital.

PubMed

Schwappach, David; Sendlhofer, Gerald; Häsler, Lynn; Gombotz, Veronika; Leitgeb, Karina; Hoffmann, Magdalena; Jantscher, Lydia; Brunner, Gernot

2018-04-26

To analyze speaking up behavior and safety climate with a validated questionnaire for the first time in an Austrian university hospital. Survey amongst healthcare workers (HCW). Data were analyzed using descriptive statistics, Cronbach's alpha was calculated as a measure of internal consistencies of scales. Analysis of variance and t-tests were used. The survey was conducted in 2017. About 2.149 HCW from three departments were asked to participate. To measure speaking up behavior and safety climate. To explore psychological safety, encouraging environment and resignation towards speaking up. About 859 evaluable questionnaires were returned (response rate: 40%). More than 50% of responders perceived specific concerns about patient safety within the last 4 weeks and observed a potential error or noticed rule violations. For the different items, between 16% and 42% of HCW reported that they remained silent though concerns for safety. In contrast, between 96% and 98% answered that they did speak up in certain situations. The psychological safety for speaking up was lower for HCW with a managerial function (P < 0.001). HCW with managerial functions perceived the environment as less encouraging to speak up (P < 0.05) than HCW without managerial function. We identified speaking up behaviors for the first time in an Austrian university hospital. Only moderately frequent concerns were in conflict with frequent speaking up behaviors. These results clearly show that a paradigm shift is needed to increase speaking up culture.

Stuffed in a Locker: A Case Study Involving Guns on Campus

ERIC Educational Resources Information Center

Lampron, Phillip Andrew

2017-01-01

Ensuring that children are safe is imperative for any educational institution. This case presents a realistic scenario of the safety concerns of leaders and staff in a middle school concerned with potential gang activity. Inspired by actual events, this case illustrates burdens that many middle school leaders across the nation face on a daily…

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Why System Safety Professionals Should Read Accident Reports

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, C. W.

2006-01-01

System safety professionals, both researchers and practitioners, who regularly read accident reports reap important benefits. These benefits include an improved ability to separate myths from reality, including both myths about specific accidents and ones concerning accidents in general; an increased understanding of the consequences of unlikely events, which can help inform future designs; a greater recognition of the limits of mathematical models; and guidance on potentially relevant research directions that may contribute to safety improvements in future systems.

Other Safety Concerns and Self-Neglect

MedlinePlus

... Program Application Frequently Asked Questions DONATE Other Safety Concerns and Self-Neglect Other safety concerns focus on ... for additional information. When To Report Other Safety Concerns and Self-Neglect? If you witness a life- ...

Promoting social responsibility amongst health care users: medical tourists' perspectives on an information sheet regarding ethical concerns in medical tourism.

PubMed

Adams, Krystyna; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory

2013-12-06

Medical tourists, persons that travel across international borders with the intention to access non-emergency medical care, may not be adequately informed of safety and ethical concerns related to the practice of medical tourism. Researchers indicate that the sources of information frequently used by medical tourists during their decision-making process may be biased and/or lack comprehensive information regarding individual safety and treatment outcomes, as well as potential impacts of the medical tourism industry on third parties. This paper explores the feedback from former Canadian medical tourists regarding the use of an information sheet to address this knowledge gap and raise awareness of the safety and ethical concerns related to medical tourism. According to feedback provided in interviews with former Canadian medical tourists, the majority of participants responded positively to the information sheet and indicated that this document prompted them to engage in further consideration of these issues. Participants indicated some frustration after reading the information sheet regarding a lack of know-how in terms of learning more about the concerns discussed in the document and changing their decision-making. This frustration was due to participants' desperation for medical care, a topic which participants frequently discussed regarding ethical concerns related to health care provision. The overall perceptions of former medical tourists indicate that an information sheet may promote further consideration of ethical concerns of medical tourism. However, given that these interviews were performed with former medical tourists, it remains unknown whether such a document might impact upon the decision-making of prospective medical tourists. Furthermore, participants indicated a need for an additional tool such as a website for continued discussion about these concerns. As such, along with dissemination of the information sheet, future research implications should include the development of a website for ongoing discussion that could contribute to a raised awareness of these concerns and potentially increase social responsibility in the medical tourism industry.

Promoting social responsibility amongst health care users: medical tourists’ perspectives on an information sheet regarding ethical concerns in medical tourism

PubMed Central

2013-01-01

Background Medical tourists, persons that travel across international borders with the intention to access non-emergency medical care, may not be adequately informed of safety and ethical concerns related to the practice of medical tourism. Researchers indicate that the sources of information frequently used by medical tourists during their decision-making process may be biased and/or lack comprehensive information regarding individual safety and treatment outcomes, as well as potential impacts of the medical tourism industry on third parties. This paper explores the feedback from former Canadian medical tourists regarding the use of an information sheet to address this knowledge gap and raise awareness of the safety and ethical concerns related to medical tourism. Results According to feedback provided in interviews with former Canadian medical tourists, the majority of participants responded positively to the information sheet and indicated that this document prompted them to engage in further consideration of these issues. Participants indicated some frustration after reading the information sheet regarding a lack of know-how in terms of learning more about the concerns discussed in the document and changing their decision-making. This frustration was due to participants’ desperation for medical care, a topic which participants frequently discussed regarding ethical concerns related to health care provision. Conclusions The overall perceptions of former medical tourists indicate that an information sheet may promote further consideration of ethical concerns of medical tourism. However, given that these interviews were performed with former medical tourists, it remains unknown whether such a document might impact upon the decision-making of prospective medical tourists. Furthermore, participants indicated a need for an additional tool such as a website for continued discussion about these concerns. As such, along with dissemination of the information sheet, future research implications should include the development of a website for ongoing discussion that could contribute to a raised awareness of these concerns and potentially increase social responsibility in the medical tourism industry. PMID:24314027

Just another reproductive technology? The ethics of human reproductive cloning as an experimental medical procedure

PubMed Central

Elsner, D

2006-01-01

Human reproductive cloning (HRC) has not yet resulted in any live births. There has been widespread condemnation of the practice in both the scientific world and the public sphere, and many countries explicitly outlaw the practice. Concerns about the procedure range from uncertainties about its physical safety to questions about the psychological well‐being of clones. Yet, key aspects such as the philosophical implications of harm to future entities and a comparison with established reproductive technologies such as in vitro fertilisation (IVF) are often overlooked in discussions about HRC. Furthermore, there are people who are willing to use the technology. Several scientists have been outspoken in their intent to pursue HRC. The importance of concerns about the physical safety of children created by HRC and comparisons with concerns about the safety of IVF are discussed. A model to be used to determine when it is acceptable to use HRC and other new assisted reproductive technologies, balancing reproductive freedom and safety concerns, is proposed. Justifications underpinning potential applications of HRC are discussed, and it is determined that these are highly analogous to rationalisations used to justify IVF treatment. It is concluded that people wishing to conceive using HRC should have a prima facie negative right to do so. PMID:17012502

Just another reproductive technology? The ethics of human reproductive cloning as an experimental medical procedure.

PubMed

Elsner, D

2006-10-01

Human reproductive cloning (HRC) has not yet resulted in any live births. There has been widespread condemnation of the practice in both the scientific world and the public sphere, and many countries explicitly outlaw the practice. Concerns about the procedure range from uncertainties about its physical safety to questions about the psychological well-being of clones. Yet, key aspects such as the philosophical implications of harm to future entities and a comparison with established reproductive technologies such as in vitro fertilisation (IVF) are often overlooked in discussions about HRC. Furthermore, there are people who are willing to use the technology. Several scientists have been outspoken in their intent to pursue HRC. The importance of concerns about the physical safety of children created by HRC and comparisons with concerns about the safety of IVF are discussed. A model to be used to determine when it is acceptable to use HRC and other new assisted reproductive technologies, balancing reproductive freedom and safety concerns, is proposed. Justifications underpinning potential applications of HRC are discussed, and it is determined that these are highly analogous to rationalisations used to justify IVF treatment. It is concluded that people wishing to conceive using HRC should have a prima facie negative right to do so.

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

PubMed Central

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

2011-01-01

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

Occupational safety and health criteria for responsible development of nanotechnology

NASA Astrophysics Data System (ADS)

Schulte, P. A.; Geraci, C. L.; Murashov, V.; Kuempel, E. D.; Zumwalde, R. D.; Castranova, V.; Hoover, M. D.; Hodson, L.; Martinez, K. F.

2014-01-01

Organizations around the world have called for the responsible development of nanotechnology. The goals of this approach are to emphasize the importance of considering and controlling the potential adverse impacts of nanotechnology in order to develop its capabilities and benefits. A primary area of concern is the potential adverse impact on workers, since they are the first people in society who are exposed to the potential hazards of nanotechnology. Occupational safety and health criteria for defining what constitutes responsible development of nanotechnology are needed. This article presents five criterion actions that should be practiced by decision-makers at the business and societal levels—if nanotechnology is to be developed responsibly. These include (1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers' exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits. All these criteria are necessary for responsible development to occur. Since it is early in the commercialization of nanotechnology, there are still many unknowns and concerns about nanomaterials. Therefore, it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments. In this emergent period, it is necessary to be clear about the extent of uncertainty and the need for prudent actions.

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

PubMed

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

2010-10-01

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

Engineering Hematopoietic Cells for Cancer Immunotherapy: Strategies to Address Safety and Toxicity Concerns.

PubMed

Resetca, Diana; Neschadim, Anton; Medin, Jeffrey A

2016-09-01

Advances in cancer immunotherapies utilizing engineered hematopoietic cells have recently generated significant clinical successes. Of great promise are immunotherapies based on chimeric antigen receptor-engineered T (CAR-T) cells that are targeted toward malignant cells expressing defined tumor-associated antigens. CAR-T cells harness the effector function of the adaptive arm of the immune system and redirect it against cancer cells, overcoming the major challenges of immunotherapy, such as breaking tolerance to self-antigens and beating cancer immune system-evasion mechanisms. In early clinical trials, CAR-T cell-based therapies achieved complete and durable responses in a significant proportion of patients. Despite clinical successes and given the side effect profiles of immunotherapies based on engineered cells, potential concerns with the safety and toxicity of various therapeutic modalities remain. We discuss the concerns associated with the safety and stability of the gene delivery vehicles for cell engineering and with toxicities due to off-target and on-target, off-tumor effector functions of the engineered cells. We then overview the various strategies aimed at improving the safety of and resolving toxicities associated with cell-based immunotherapies. Integrating failsafe switches based on different suicide gene therapy systems into engineered cells engenders promising strategies toward ensuring the safety of cancer immunotherapies in the clinic.

Social media in health--what are the safety concerns for health consumers?

PubMed

Lau, Annie Y S; Gabarron, Elia; Fernandez-Luque, Luis; Armayones, Manuel

Recent literature has discussed the unintended consequences of clinical information technologies (IT) on patient safety, yet there has been little discussion about the safety concerns in the area of consumer health IT. This paper presents a range of safety concerns for consumers in social media, with a case study on YouTube. We conducted a scan of abstracts on 'quality criteria' related to YouTube. Five areas regarding the safety of YouTube for consumers were identified: (a) harmful health material targeted at consumers (such as inappropriate marketing of tobacco or direct-to-consumer drug advertising); (b) public display of unhealthy behaviour (such as people displaying self-injury behaviours or hurting others); (c) tainted public health messages (i.e. the rise of negative voices against public health messages); (d) psychological impact from accessing inappropriate, offensive or biased social media content; and (e) using social media to distort policy and research funding agendas. The examples presented should contribute to a better understanding about how to promote a safe consumption and production of social media for consumers, and an evidence-based approach to designing social media interventions for health. The potential harm associated with the use of unsafe social media content on the Internet is a major concern. More empirical and theoretical studies are needed to examine how social media influences consumer health decisions, behaviours and outcomes, and devise ways to deter the dissemination of harmful influences in social media.

Complementary and alternative medicine in child and adolescent psychiatry: legal considerations.

PubMed

Cohen, Michael H; Natbony, Suzanne R; Abbott, Ryan B

2013-07-01

The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy. Copyright © 2013 Elsevier Inc. All rights reserved.

A hierarchical factor analysis of a safety culture survey.

PubMed

Frazier, Christopher B; Ludwig, Timothy D; Whitaker, Brian; Roberts, D Steve

2013-06-01

Recent reviews of safety culture measures have revealed a host of potential factors that could make up a safety culture (Flin, Mearns, O'Connor, & Bryden, 2000; Guldenmund, 2000). However, there is still little consensus regarding what the core factors of safety culture are. The purpose of the current research was to determine the core factors, as well as the structure of those factors that make up a safety culture, and establish which factors add meaningful value by factor analyzing a widely used safety culture survey. A 92-item survey was constructed by subject matter experts and was administered to 25,574 workers across five multi-national organizations in five different industries. Exploratory and hierarchical confirmatory factor analyses were conducted revealing four second-order factors of a Safety Culture consisting of Management Concern, Personal Responsibility for Safety, Peer Support for Safety, and Safety Management Systems. Additionally, a total of 12 first-order factors were found: three on Management Concern, three on Personal Responsibility, two on Peer Support, and four on Safety Management Systems. The resulting safety culture model addresses gaps in the literature by indentifying the core constructs which make up a safety culture. This clarification of the major factors emerging in the measurement of safety cultures should impact the industry through a more accurate description, measurement, and tracking of safety cultures to reduce loss due to injury. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2011-01-01

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

Burden of socio-legal concerns among vulnerable patients seeking cancer care services at an urban safety-net hospital: a cross-sectional survey.

PubMed

Ko, Naomi Yu; Battaglia, Tracy A; Gupta-Lawrence, Rebecca; Schiller, Jessica; Gunn, Christine; Festa, Kate; Nelson, Kerrie; Flacks, JoHanna; Morton, Samantha J; Rosen, Jennifer E

2016-06-14

Social and economic conditions that affect one's ability to satisfy life's most basic needs such as lack of affordable housing, restricted access to education and employment, or inadequate income are increasingly well-documented barriers to optimal health. The burden of these challenges among vulnerable patients accessing cancer care services is unknown. We conducted a cross-sectional survey of patients presenting for ambulatory cancer care services (screening and treatment) at an urban safety-net hospital to assess socio-legal concerns (social problems related to meeting life's basic needs supported by public policy or programming and potentially remedied through legal advocacy/action). Among 104 respondents, 80 (77 %) reported concerns with one or more socio-legal needs in the past month, with a mean of 5.75 concerns per participant. The most common socio-legal concerns related to income supports, housing, and employment/education. Our findings support the need for innovations in cancer care delivery to address socio-legal concerns of a vulnerable patient population.

Investigations of the environmental acceptability of fluorocarbon alternatives to chlorofluorocarbons.

PubMed Central

McFarland, M

1992-01-01

Chlorofluorocarbons (CFCs) are currently used in systems for preservation of perishable foods and medical supplies, increasing worker productivity and consumer comfort, conserving energy and increasing product reliability. As use of CFCs is phased out due to concerns of ozone depletion, a variety of new chemicals and technologies will be needed to serve these needs. In choosing alternatives, industry must balance concerns over safety and environmental acceptability and still meet the preformance characteristics of the current technology, the only viable alternatives meeting the safety, performance, and environmental requirements for the remaining 40% of demand are fluorocarbons, hydrochlorofluorocarbons (HCFs), and hydrofluorocarbons (HFCs). HCFCs and HFCs possess many of the desirable properties of the CFCs, but because of the, hydrogen, they results in shorter atmospheric lifetimes compared to CFCs and reduces their potential to contribute to stratospheric ozone depletion or global warming; HFCs do not contain chlorine and have no potential to destroy ozone. This paper provides an overview of challenges faced by industry, regulators, and society in general in continuing to meet societal needs and consumer demands while reducing risk to the enviroment without compromising consumer or worker safety. PMID:11607257

Pre-Teens' Informal Learning with ICT and Web 2.0

ERIC Educational Resources Information Center

Ferguson, Rebecca; Faulkner, Dorothy; Whitelock, Denise; Sheehy, Kieron

2015-01-01

Information and communication technology (ICT) and Web 2.0 have the potential to impact on learning by supporting inquiry, literacies, collaboration and publication. Restrictions on the use of these tools within schools, primarily due to concerns about discipline and child safety, make it difficult to make full use of this potential in formal…

Transforming communication and safety culture in intrapartum care: a multi-organization blueprint.

PubMed

Lyndon, Audrey; Johnson, M Christina; Bingham, Debra; Napolitano, Peter G; Joseph, Gerald; Maxfield, David G; O'Keeffe, Daniel F

2015-01-01

Effective, patient-centered communication facilitates interception and correction of potentially harmful conditions and errors. All team members, including women, their families, physicians, midwives, nurses, and support staff, have a role in identifying the potential for harm during labor and birth. However, the results of collaborative research studies conducted by organizations that represent professionals who care for women during labor and birth indicate that health care providers may frequently witness, but may not always report, problems with safety or clinical performance. Some of these health care providers felt resigned to the continuation of such problems and fearful of retribution if they tried to address them. Speaking up to address safety and quality concerns is a dynamic social process. Every team member must feel empowered to speak up about concerns without fear of put-downs, retribution, or receiving poor-quality care. Patient safety requires mutual accountability: individuals, teams, health care facilities, and professional associations have a shared responsibility for creating and sustaining environments of mutual respect and engaging in highly reliable perinatal care. Defects in human factors, communication, and leadership have been the leading contributors to sentinel events in perinatal care for more than a decade. Organizational commitment and executive leadership are essential to creating an environment that proactively supports safety and quality. The problem is well-known; the time for action is now. © 2015 by the American College of Obstetricians and Gynecologists.

Transforming communication and safety culture in intrapartum care: a multi-organization blueprint.

PubMed

Lyndon, Audrey; Johnson, M Christina; Bingham, Debra; Napolitano, Peter G; Joseph, Gerald; Maxfield, David G; OʼKeeffe, Daniel F

2015-05-01

Effective, patient-centered communication facilitates interception and correction of potentially harmful conditions and errors. All team members, including women, their families, physicians, midwives, nurses, and support staff, have a role in identifying the potential for harm during labor and birth. However, the results of collaborative research studies conducted by organizations that represent professionals who care for women during labor and birth indicate that health care providers may frequently witness, but may not always report, problems with safety or clinical performance. Some of these health care providers felt resigned to the continuation of such problems and fearful of retribution if they tried to address them. Speaking up to address safety and quality concerns is a dynamic social process. Every team member must feel empowered to speak up about concerns without fear of put-downs, retribution, or receiving poor-quality care. Patient safety requires mutual accountability: individuals, teams, health care facilities, and professional associations have a shared responsibility for creating and sustaining environments of mutual respect and engaging in highly reliable perinatal care. Defects in human factors, communication, and leadership have been the leading contributors to sentinel events in perinatal care for more than a decade. Organizational commitment and executive leadership are essential to creating an environment that proactively supports safety and quality. The problem is well-known; the time for action is now.

Transforming communication and safety culture in intrapartum care: a multi-organization blueprint.

PubMed

Lyndon, Audrey; Johnson, M Christina; Bingham, Debra; Napolitano, Peter G; Joseph, Gerald; Maxfield, David G; O'Keeffe, Daniel F

2015-01-01

Effective, patient-centered communication facilitates interception and correction of potentially harmful conditions and errors. All team members, including women, their families, physicians, midwives, nurses, and support staff, have roles in identifying the potential for harm during labor and birth. However, the results of collaborative research studies conducted by organizations that represent professionals who care for women during labor and birth indicate that health care providers may frequently witness, but may not always report, problems with safety or clinical performance. Some of these health care providers felt resigned to the continuation of such problems and fearful of retribution if they tried to address them. Speaking up to address safety and quality concerns is a dynamic social process. Every team member must feel empowered to speak up about concerns without fear of put-downs, retribution, or receiving poor-quality care. Patient safety requires mutual accountability: individuals, teams, health care facilities, and professional associations have a shared responsibility for creating and sustaining environments of mutual respect and engaging in highly reliable perinatal care. Defects in human factors, communication, and leadership have been the leading contributors to sentinel events in perinatal care for more than a decade. Organizational commitment and executive leadership are essential to creating an environment that proactively supports safety and quality. The problem is well-known; the time for action is now. © 2015 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Comparative analysis of the attitudes and perceptions of three types of lake george boaters

Treesearch

Nancy A. Connelly; Tommy L. Brown; Timothy Holmes; Michael White

2007-01-01

The experiences and concerns of three types of Lake George recreational boaters were assessed to see if different levels of investment and experience with the lake lead to potentially different perceptions and concerns regarding congestion, overcrowding, and safety hazards on the lake. Mail questionnaires were sent out in the summer/fall of 2005 to the three types of...

Developing an informational tool for ethical engagement in medical tourism.

PubMed

Adams, Krystyna; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory

2017-08-25

Medical tourism, the practice of persons intentionally travelling across international boundaries to access medical care, has drawn increasing attention from researchers, particularly in relation to potential ethical concerns of this practice. Researchers have expressed concern for potential negative impacts to individual safety, public health within both countries of origin for medical tourists and destination countries, and global health equity. However, these ethical concerns are not discussed within the sources of information commonly provided to medical tourists, and as such, medical tourists may not be aware of these concerns when engaging in medical tourism. This paper describes the methodology utilized to develop an information sheet intended to be disseminated to Canadian medical tourists to encourage contemplation and further public discussion of the ethical concerns in medical tourism. The methodology for developing the information sheet drew on an iterative process to consider stakeholder feedback on the content and use of the information sheet as it might inform prospective medical tourists' decision making. This methodology includes a literature review as well as formative research with Canadian public health professionals and former medical tourists. The final information sheet underwent numerous revisions throughout the formative research process according to feedback from medical tourism stakeholders. These revisions focused primarily on making the information sheet concise with points that encourage individuals considering travelling for medical tourism to do further research regarding their safety both within the destination country, while travelling, and once returning to Canada, and the potential impacts of their trip on third parties. This methodology may be replicated for the development of information sheets intending to communicate ethical concerns of other practices to providers or consumers of a certain service.

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

PubMed

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

2017-07-01

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

Cyber Security Threats to Safety-Critical, Space-Based Infrastructures

NASA Astrophysics Data System (ADS)

Johnson, C. W.; Atencia Yepez, A.

2012-01-01

Space-based systems play an important role within national critical infrastructures. They are being integrated into advanced air-traffic management applications, rail signalling systems, energy distribution software etc. Unfortunately, the end users of communications, location sensing and timing applications often fail to understand that these infrastructures are vulnerable to a wide range of security threats. The following pages focus on concerns associated with potential cyber-attacks. These are important because future attacks may invalidate many of the safety assumptions that support the provision of critical space-based services. These safety assumptions are based on standard forms of hazard analysis that ignore cyber-security considerations This is a significant limitation when, for instance, security attacks can simultaneously exploit multiple vulnerabilities in a manner that would never occur without a deliberate enemy seeking to damage space based systems and ground infrastructures. We address this concern through the development of a combined safety and security risk assessment methodology. The aim is to identify attack scenarios that justify the allocation of additional design resources so that safety barriers can be strengthened to increase our resilience against security threats.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

During the third quarter of operation of the Aviation Safety Reporting System (ASRS), 1429 reports concerning aviation safety were received from pilots, air traffic controllers, and others in the national aviation system. Details of the administration and results of the program are discussed. The design and construction of the ASRS data base are briefly presented. Altitude deviations and potential aircraft conflicts associated with misunderstood clearances were studied and the results are discussed. Summary data regarding alert bulletins, examples of alert bulletins and responses to them, and a sample of deidentified ASRS reports are provided.

Ethical concerns and career satisfaction in obstetrics and gynecology: a review of recent findings from the Collaborative Ambulatory Research Network.

PubMed

Farrow, Victoria A; Leddy, Meaghan A; Lawrence, Hal; Schulkin, Jay

2011-09-01

Obstetricians-gynecologists (ob-gyns) are frequently confronted with situations that have ethical implications (e.g., whether to accept gifts or samples from drug companies or disclosing medical errors to patients). Additionally, various factors, including specific job-related tasks, costs, and benefits, may impact ob-gyns' career satisfaction. Ethical concerns and career satisfaction can play a role in the quality of women's health care. This article summarizes the studies published between 2005 and 2009 by the Research Department of the American College of Obstetricians and Gynecologists, which encompass ethical concerns regarding interactions with pharmaceutical representatives and patient safety/medical error reporting, as well as ob-gyn career satisfaction. Additionally, a brief discussion regarding ethical concerns in the ob-gyn field, in general, highlights key topics for the last 30 years. Ethical dilemmas continue to be of concern for ob-gyns. Familiarity with guidelines on appropriate interactions with industry is associated with lower percentages of potentially problematic relationships with pharmaceutical industries. Physicians report that the expense of patient safety initiatives is one of the top barriers for improving patient safety, followed by fear of liability. Overall, respondents reported being satisfied with their careers. However, half of the respondents reported that they were extremely concerned about the impact of professional liability costs on the duration of their careers. Increased familiarity with guidelines may lead to a decreased ob-gyn reliance on pharmaceutical representatives and free samples, whereas specific and practical tools may help them implement patient safety techniques. The easing of malpractice insurance and threat of litigation may enhance career satisfaction among ob-gyns. This article will discuss related findings in recent years. Obstetricians & Gynecologists and Family Physicians. After the completing the CME activity, physicians should be better able to analyze how interactions with pharmaceutical industry may pose ethical dilemmas, examine current barriers to implementing patient safety initiatives, and evaluate the factors that influence career satisfaction among obstetrician-gynecologists.

Earth based approaches to enhancing the health and safety of space operations

NASA Technical Reports Server (NTRS)

Koller, A. M., Jr.

1985-01-01

This paper provides an overview of the current state of our earth based knowledge of space safety hazards; identification of several key areas of concern for space operations; and proposed approaches to providing technology enhancement and information needed to improve the health and safety to those conducting space operations. Included are a review of the identified hazards for space oeprations by hazard classification; a summarization of the information currently available on space experiences and an assessment of potential hazards for long duration spaceflight; a discussion of potential failure modes and their significance for Space Station work: and an assessment of current work which indicates additional research and experimentation which can only be accomplished in actual space missions.

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

PubMed

Gaal, Sander; Verstappen, Wim; Wensing, Michel

2010-01-21

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

HEALTH EFFECTS OF BROMINATED FLAME RETARDANTS (BFRS)

EPA Science Inventory

Abstract Brominated flame retardant use has increased dramatically in order to provide fire safety to consumers. However, there is growing concern about widespread environmental contamination and potential health risks from some of these products. The most used products...

Common Weight Loss Challenges

MedlinePlus

... think it’s safe for him to be playing outdoors.” Don’t let safety concerns keep your child ... will have the opportunity to discuss the potential benefits of the operation, plus get your ... (Copyright © 2006 American Academy of Pediatrics) The information ...

Potential traceable markers of organic matter in organic and conventional dairy manure using ultraviolet–visible and solid-state 13C nuclear magnetic resonance spectroscopy

USDA-ARS?s Scientific Manuscript database

Organic dairy (OD) production is drawing increasing attention because of public concerns about food safety, animal welfare and the potential environmental impacts of conventional dairy (CD) systems. However, very limited information is available on how organic farming practices affect the chemical ...

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.

Types and patterns of safety concerns in home care: client and family caregiver perspectives

PubMed Central

Tong, Catherine E.; Sims-Gould, Joanie; Martin-Matthews, Anne

2016-01-01

Objective Drawing on interviews with home care clients and their family caregivers, we sought to understand how these individuals conceptualize safety in the provision and receipt of home care, how they promote safety in the home space and how their safety concerns differ from those of home support workers. Design In-depth, semi-structured interviews were conducted with clients and family caregivers. The analysis included topic and analytical coding of participants' verbatim accounts. Setting Interviews were completed in British Columbia, Canada. Participants Totally 82 clients and 55 caregivers participated. Results Clients and family caregivers identified three types of safety concerns: physical, spatial and interpersonal. These concerns are largely multi-dimensional and intersectional. We present a conceptual model of client and caregiver safety concerns. We also examine the factors that intensify and mitigate safety concerns in the home. Conclusions In spite of safety concerns, clients and family caregivers overwhelmingly prefer to receive care in the home setting. Spatial and physical concerns are the most salient. The financial burden of creating a safe care space should not be the client's alone to bear. The conceptualization and promotion of safety in home care must recognize the roles, responsibilities and perspectives of all of the actors involved, including workers, clients and their caregivers. PMID:26832159

Safety huddles to proactively identify and address electronic health record safety

PubMed Central

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

2017-01-01

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

Nuclear criticality safety bounding analysis for the in-tank-precipitation (ITP) process, impacted by fissile isotopic weight fractions

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

Bess, C.E.

The In-Tank Precipitation process (ITP) receives High Level Waste (HLW) supernatant liquid containing radionuclides in waste processing tank 48H. Sodium tetraphenylborate, NaTPB, and monosodium titanate (MST), NaTi{sub 2}O{sub 5}H, are added for removal of radioactive Cs and Sr, respectively. In addition to removal of radio-strontium, MST will also remove plutonium and uranium. The majority of the feed solutions to ITP will come from the dissolution of supernate that had been concentrated by evaporation to a crystallized salt form, commonly referred to as saltcake. The concern for criticality safety arises from the adsorption of U and Pt onto MST. If sufficientmore » mass and optimum conditions are achieved then criticality is credible. The concentration of u and Pt from solution into the smaller volume of precipitate represents a concern for criticality. This report supplements WSRC-TR-93-171, Nuclear Criticality Safety Bounding Analysis For The In-Tank-Precipitation (ITP) Process. Criticality safety in ITP can be analyzed by two bounding conditions: (1) the minimum safe ratio of MST to fissionable material and (2) the maximum fissionable material adsorption capacity of the MST. Calculations have provided the first bounding condition and experimental analysis has established the second. This report combines these conditions with canyon facility data to evaluate the potential for criticality in the ITP process due to the adsorption of the fissionable material from solution. In addition, this report analyzes the potential impact of increased U loading onto MST. Results of this analysis demonstrate a greater safety margin for ITP operations than the previous analysis. This report further demonstrates that the potential for criticality in the ITP process due to adsorption of fissionable material by MST is not credible.« less

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

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

PubMed

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

2016-02-15

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

Gulf War Illnesses: Understanding of Health Effects From Depleted Uranium Evolving But Safety Training Needed

DTIC Science & Technology

2000-03-01

against enemy munitions. Depleted uranium is a low- level radioactive heavy metal , and concerns have surfaced about whether exposure to it could be a...radioactive heavy metal , the potential for health effects are twofold: effects from radiation and effects from chemical toxicity. Two recent expert...depleted uranium safety training. Background Depleted uranium (DU), a low-level radioactive heavy metal , is a by- product of the process used to

76 FR 32372 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... Rica S.A. of Costa Rica, Intel Malaysia Sdn. Bhd of Malaysia, Intel (Philippines) of the Philippines... any public health, safety, or welfare concerns in the United States relating to the potential orders...

An investigation of the safety implications of wireless communications in vehicles

DOT National Transportation Integrated Search

1997-11-01

The extensive growth in the wireless communications industry over the past ten years has been accompanied by growing concern for the potential hazards of drivers using wireless communication devices from moving vehicles. Given the National Highway Tr...

Truck stop and rest area parking study : final report

DOT National Transportation Integrated Search

2001-04-01

Crowding and illegal parking of trucks at existing public rest areas and along the highway ramps and shoulders has been recognized as a growing concern, with potential safety implications. In Connecticut there are approximately 1,200 trucks that trav...

[Hazardous materials and work safety in veterinary practice. 1: Hazardous material definition and characterization, practice documentation and general rules for handling].

PubMed

Sliwinski-Korell, A; Lutz, F

1998-04-01

In the last years the standards for professional handling of hazardous material as well as health and safety in the veterinary practice became considerably more stringent. This is expressed in various safety regulations, particularly the decree of hazardous material and the legislative directives concerning health and safety at work. In part 1, a definition based on the law for hazardous material is given and the potential risks are mentioned. The correct documentation regarding the protection of the purchase, storage, working conditions and removal of hazardous material and of the personal is explained. General rules for the handling of hazardous material are described. In part 2, particular emphasis is put on the handling of flammable liquids, disinfectants, cytostatica, pressurised gas, liquid nitrogen, narcotics, mailing of potentially infectious material and safe disposal of hazardous waste. Advice about possible unrecognized hazards and references is also given.

Space Nuclear Power Public and Stakeholder Risk Communication

NASA Technical Reports Server (NTRS)

Dawson, Sandra M.; Sklar, Maria

2005-01-01

The 1986 Challenger accident coupled with the Chernobyl nuclear reactor accident increased public concern about the safety of spacecraft using nuclear technology. While three nuclear powered spacecraft had been launched before 1986 with little public interest, future nuclear powered missions would see significantly more public concern and require NASA to increase its efforts to communicate mission risks to the public. In 1987 a separate risk communication area within the Launch Approval Planning Group of the Jet Propulsion Laboratory was created to address public concern about the health, environmental, and safety risks of NASA missions. The lessons learned from the risk communication strategies developed for the nuclear powered Galileo, Ulysses, and Cassini missions are reviewed in this paper and recommendations are given as to how these lessons can be applied to future NASA missions that may use nuclear power systems and other potentially controversial NASA missions.

Aerospace safety advisory panel

NASA Technical Reports Server (NTRS)

1995-01-01

The Aerospace Safety Advisory Panel (ASAP) monitored NASA's activities and provided feedback to the NASA Administrator, other NASA officials and Congress throughout the year. Particular attention was paid to the Space Shuttle, its launch processing and planned and potential safety improvements. The Panel monitored Space Shuttle processing at the Kennedy Space Center (KSC) and will continue to follow it as personnel reductions are implemented. There is particular concern that upgrades in hardware, software, and operations with the potential for significant risk reduction not be overlooked due to the extraordinary budget pressures facing the agency. The authorization of all of the Space Shuttle Main Engine (SSME) Block II components portends future Space Shuttle operations at lower risk levels and with greater margins for handling unplanned ascent events. Throughout the year, the Panel attempted to monitor the safety activities related to the Russian involvement in both space and aeronautics programs. This proved difficult as the working relationships between NASA and the Russians were still being defined as the year unfolded. NASA's concern for the unique safety problems inherent in a multi-national endeavor appears appropriate. Actions are underway or contemplated which should be capable of identifying and rectifying problem areas. The balance of this report presents 'Findings and Recommendations' (Section 2), 'Information in Support of Findings and Recommendations' (Section 3) and Appendices describing Panel membership, the NASA response to the March 1994 ASAP report, and a chronology of the panel's activities during the reporting period (Section 4).

Zoonotic diseases: health aspects of Canadian geese.

PubMed

Dieter, R A; Dieter, R S; Dieter, R A; Gulliver, G

2001-11-01

Review zoonotic diseases associated with Canadian geese. Review article: A review of the multiple physical, microbiologic and safety concerns, and methods used in controlling this potential problem. Over the last decade the Canadian goose population (protected by international treaties and protection acts) has increased rapidly such that in many cities they have become a pest rather than an admired wild bird. Their increasing numbers have caused a number of potential healthcare concerns including: physical, bacterial, parasitic, allergic and viral potential problems. The Canadian goose fecal droppings of one per minute have caused falls and the flying geese have caused air traffic accidents. Bacterial concerns, including botulism, salmonella and E. coli have all been reviewed and presented concerns. The viral Newcastle disease may be detected with hemagglutination studies and the Giardia psittaci parasites have been repeatedly found in their droppings. The Cryptosporidium parvum oocytes have been present on stool study. Definite links to human infectious diseases have been difficult to prove. Revision of the current laws and new control programs must be developed.

Survival of Escherichia coli O157:H7 on lettuce harvested from fields irrigated by different irrigation systems and stored under different conditions

USDA-ARS?s Scientific Manuscript database

Escherichia coli O157:H7 outbreaks associated with the consumption of leafy greens have increased food safety concerns in the food industry. Irrigation water could be a major potential source of microbial contamination to vegetables. The potential for irrigation water to contaminate vegetables with ...

HEALTH EFFECTS OF BROMINATED FLAME RETARDANTS (BFRS)

EPA Science Inventory

BFRs are a broad class of compounds providing fire safety. Because of high production and usage and recent findings that they are ubiquitous in environmental samples and biota, concerns exist about potential health effects. Some of the major commercial products, such as tetrabr...

Research Lasers and Air Traffic Safety: Issues, Concerns and Responsibilities of the Research Community

NASA Technical Reports Server (NTRS)

Nessler, Phillip J., Jr.

1998-01-01

The subject of outdoor use of lasers relative to air traffic has become a diverse and dynamic topic. During the past several decades, the use of lasers in outdoor research activities have increased significantly. Increases in the outdoor use of lasers and increases in air traffic densities have changed the levels of risk involved. To date there have been no documented incidents of air traffic interference from research lasers; however, incidents involving display lasers have shown a marked increase. As a result of the national response to these incidents, new concerns over lasers have arisen. Through the efforts of the SAE G-10T Laser Safety Hazards Subcommittee and the ANSI Z136.6 development committee, potential detrimental effects to air traffic beyond the traditional eye damage concerns have been identified. An increased emphasis from the Federal Aviation Administration (FAA), the Center for Devices and Radiological Hazards (CDRH), and the National Transportation Safety Board (NTSB) along with increased concern by the public have resulted in focused scrutiny of potential hazards presented by lasers. The research community needs to rethink the traditional methods of risk evaluation and application of protective measures. The best current approach to assure adequate protection of air traffic is the application of viable hazard and risk analysis and the use of validated protective measures. Standards making efforts and regulatory development must be supported by the research community to assure that reasonable measures are developed. Without input, standards and regulations can be developed that are not compatible with the needs of the research community. Finally, support is needed for the continued development and validation of protective measures.

Current Marijuana Use by Industry and Occupation - Colorado, 2014-2015.

PubMed

Smith, Roberta; Hall, Katelyn E; Etkind, Paul; Van Dyke, Mike

2018-04-13

The effects of marijuana use on workplace safety are of concern for public health and workplace safety professionals. Twenty-nine states and the District of Columbia have enacted laws legalizing marijuana at the state level for recreational and/or medical purposes. Employers and safety professionals in states where marijuana use is legal have expressed concerns about potential increases in occupational injuries, such as on-the-job motor vehicle crashes, related to employee impairment. Data published in 2017 by the Colorado Department of Public Health and Environment (CDPHE) showed that more than one in eight adult state residents aged ≥18 years currently used marijuana in 2014 (13.6%) and 2015 (13.4%) (1). To examine current marijuana use by working adults and the industries and occupations in which they are employed, CDPHE analyzed data from the state's Behavioral Risk Factor Surveillance System (BRFSS) regarding current marijuana use (at least 1 day during the preceding 30 days) among 10,169 persons who responded to the current marijuana use question. During 2014 and 2015, 14.6% of these 10,169 Colorado workers reported current marijuana use, with the highest reported prevalence among workers in the Accommodation and Food Services industry (30.1%) and Food Preparation and Serving (32.2%) occupations. Understanding the industries and occupations of adults with reported marijuana use can help direct and maximize impact of public health messaging and potential safety interventions for adults.

Ethical and Safety Issues of Stem Cell-Based Therapy.

PubMed

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

2018-01-01

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

Ethical and Safety Issues of Stem Cell-Based Therapy

PubMed Central

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

2018-01-01

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

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

Silence That Can Be Dangerous: A Vignette Study to Assess Healthcare Professionals’ Likelihood of Speaking up about Safety Concerns

PubMed Central

Schwappach, David L. B.; Gehring, Katrin

2014-01-01

Purpose To investigate the likelihood of speaking up about patient safety in oncology and to clarify the effect of clinical and situational context factors on the likelihood of voicing concerns. Patients and Methods 1013 nurses and doctors in oncology rated four clinical vignettes describing coworkers’ errors and rule violations in a self-administered factorial survey (65% response rate). Multiple regression analysis was used to model the likelihood of speaking up as outcome of vignette attributes, responder’s evaluations of the situation and personal characteristics. Results Respondents reported a high likelihood of speaking up about patient safety but the variation between and within types of errors and rule violations was substantial. Staff without managerial function provided significantly higher levels of decision difficulty and discomfort to speak up. Based on the information presented in the vignettes, 74%−96% would speak up towards a supervisor failing to check a prescription, 45%−81% would point a coworker to a missed hand disinfection, 82%−94% would speak up towards nurses who violate a safety rule in medication preparation, and 59%−92% would question a doctor violating a safety rule in lumbar puncture. Several vignette attributes predicted the likelihood of speaking up. Perceived potential harm, anticipated discomfort, and decision difficulty were significant predictors of the likelihood of speaking up. Conclusions Clinicians’ willingness to speak up about patient safety is considerably affected by contextual factors. Physicians and nurses without managerial function report substantial discomfort with speaking up. Oncology departments should provide staff with clear guidance and trainings on when and how to voice safety concerns. PMID:25116338

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

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

1976-01-01

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

Best practices: an electronic drug alert program to improve safety in an accountable care environment.

PubMed

Griesbach, Sara; Lustig, Adam; Malsin, Luanne; Carley, Blake; Westrich, Kimberly D; Dubois, Robert W

2015-04-01

The accountable care organization (ACO), one of the most promising and talked about new models of care, focuses on improving communication and care transitions by tying potential shared savings to specific clinical and financial benchmarks. An important factor in meeting these benchmarks is an ACO's ability to manage medications in an environment where medical and pharmacy care has been integrated. The program described in this article highlights the critical components of Marshfield Clinic's Drug Safety Alert Program (DSAP), which focuses on prioritizing and communicating safety issues related to medications with the goal of reducing potential adverse drug events. Once the medication safety concern is identified, it is reviewed to evaluate whether an alert warrants sending prescribers a communication that identifies individual patients or a general communication to all physicians describing the safety concern. Instead of basing its decisions regarding clinician notification about drug alerts on subjective criteria, the Marshfield Clinic's DSAP uses an internally developed scoring system. The scoring system includes criteria developed from previous drug alerts, such as level of evidence, size of population affected, severity of adverse event identified or targeted, litigation risk, available alternatives, and potential for duration of medication use. Each of the 6 criteria is assigned a weight and is scored based upon the content and severity of the alert received.  In its first 12 months, the program targeted 6 medication safety concerns involving the following medications: topiramate, glyburide, simvastatin, citalopram, pioglitazone, and lovastatin. Baseline and follow-up prescribing data were gathered on the targeted medications. Follow-up review of prescribing data demonstrated that the DSAP provided quality up-to-date safety information that led to changes in drug therapy and to decreases in potential adverse drug events. In aggregate, nearly 10,000 total potential adverse drug events were identified with baseline data from the DSAP initiatives, and nearly 8,000 were resolved by changes in prescribing.  Implications and additional thoughts from The Working Group on Optimizing Medication Therapy in Value-Based Healthcare were provided for the following categories: leveraging electronic health records, importance of data collection and reassessment, preventing alert fatigue utilizing various techniques, relevance to ACO quality measurement, and limitations of a retrospective system. While health information technologies have been recognized as a cornerstone for an ACO's success, additional research is needed on comparing these types of technological innovations. Future research should focus on reviewing comparable scoring criteria and alert systems utilized in a variety of ACOs. In addition, an examination of different data mining procedures used within different electronic health record platforms would prove useful to ACOs looking to improve the care of not only the subpopulations with specific metrics associated with them, but their patient population as a whole. The authors also highlight the need for additional research on health information exchanges, including the cost and resource requirements needed to successfully participate in these types of networks.

Nome Offshore Mining Information

Science.gov Websites

Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land potential safety concerns, prevent overcrowding, and provide for efficient processing of the permits and Regulatory Program Large Mine Permitting Mineral Property Management Mining Fact Sheets Mining Forms APMA

Complex conductivity response to silver nanoparticles in partially saturated sand columns

EPA Science Inventory

The increase in the use of nanoscale materials in consumer products has resulted in a growing concern of their potential hazard to ecosystems and public health from their accidental or intentional introduction to the environment. Key environmental, health, and safety research nee...

Cryopreservation of medicinal plants: role of melatonin

USDA-ARS?s Scientific Manuscript database

Many useful plant species found in Canada are of conservation concern. In vitro storage and cryopreservation techniques guarantees safety of these species and have potential applications which may result in sustainable agriculture. Shoot tips of in vitro-grown plantlets of American elm, St John’s Wo...

Ptaquiloside, the major carcinogen of bracken fern, in the pooled raw milk of healthy sheep and goats: an underestimated, global concern of food safety.

PubMed

Virgilio, Antonella; Sinisi, Annamaria; Russo, Valeria; Gerardo, Salvatore; Santoro, Adriano; Galeone, Aldo; Taglialatela-Scafati, Orazio; Roperto, Franco

2015-05-20

Bracken fern (Pteridium aquilinum) is a worldwide plant containing toxic substances, which represent an important chemical hazard for animals, including humans. Ptaquiloside, 1, a norsesquiterpenoid glucoside, is the major carcinogen of bracken detected in the food chain, particularly in the milk from farm animals. To date, ptaquiloside has been shown in the milk of cows feeding on a diet containing bracken fern. This is the first study that shows the systematic detection of ptaquiloside, 1, and reports its direct quantitation in pooled raw milk of healthy sheep and goats grazing on bracken. Ptaquiloside, 1, was detected by a sensitive method based on the chemical conversion of ptaquiloside, 1, into bromopterosine, 4, following gas chromatography-mass spectrometry (GC-MS) analysis. The presence of ptaquiloside, 1, possibly carcinogenic to humans, in the milk of healthy animals is an unknown potential health risk, thus representing a harmful and potential global concern of food safety.

Risk and safety concerns in anesthesiology practice: The present perspective

PubMed Central

Bajwa, Sukhminder Jit Singh; Kaur, Jasbir

2012-01-01

Newer developments and advancements in anesthesiology, surgical, and medical fields have widened the functional scope of anesthesiologist thus increasing his professional responsibilities and obligations. While at workplace, anesthesiologist is exposed to a wide array of potential hazards that can be detrimental to his overall health. Numerous risks and safety concerns have been mentioned in the literature, but the magnitude of challenges in anesthesiology practice are far greater than those cited and anticipated. Many times these challenging situations are unavoidable and the attending anesthesiologist has to deal with them on an individual basis. These hazards not only affect the general health but can be extremely threatening in various other ways that can increase the potential risks of morbidity and mortality. This article is an attempt to bring a general awareness among anesthesia fraternity about the various health hazards associated with anesthesia practice. Also, a genuine attempt has been made to enumerate the various preventive methods and precautions that should be adopted to make practice of anesthesiology safe and smooth. PMID:25885495

Raspberry ketone in food supplements--High intake, few toxicity data--A cause for safety concern?

PubMed

Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev; Hallas-Møller, Torben; Pilegaard, Kirsten

2015-10-01

Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic effects and potential effects on reproduction/development. Taking into account the high intake via supplements, the compound's toxic potential should be clarified with further experimental studies. In UK the pure compound is regarded as novel food requiring authorisation prior to marketing but raspberry ketone is not withdrawn from Internet sites from this country. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving Safety through Human Factors Engineering.

PubMed

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

Qualitative Future Safety Risk Identification an Update

NASA Technical Reports Server (NTRS)

Barr, Lawrence C.

2017-01-01

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

75 FR 80506 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

.... Proposed Project Persistence of Viable Influenza Virus in Aerosols--New--National Institute for... Safety and Health Act. Influenza continues to be a major public health concern because of the substantial health burden from seasonal influenza and the potential for a severe pandemic. Although influenza is...

Automated and connected vehicle (AV/CV) test bed to improve transit, bicycle, and pedestrian safety : technical report.

DOT National Transportation Integrated Search

2017-02-01

Crashes involving transit vehicles, bicyclists, and pedestrians are a concern in Texas, especially in urban areas. This research explored the potential of automated and connected vehicle (AV/CV) technology to reduce or eliminate these crashes. The pr...

Radioactive Waste...The Problem and Some Possible Solutions

ERIC Educational Resources Information Center

Olivier, Jean-Pierre

1977-01-01

Nuclear safety is a highly technical and controversial subject that has caused much heated debate and political concern. This article examines the problems involved in managing radioactive wastes and the techniques now used. Potential solutions are suggested and the need for international cooperation is stressed. (Author/MA)

The antioxidant melatonin boosts recovery of cryopreserved shoot tips

USDA-ARS?s Scientific Manuscript database

Many useful plant species found in Canada are of conservation concern. In vitro storage and cryopreservation techniques guarantee safety of these species and have potential applications which may result in sustainable agriculture. Shoot tips of in vitro-grown plantlets of American elm, St John’s Wor...

Genomics and evolution of secondary metabolism in Fusarium

USDA-ARS?s Scientific Manuscript database

Fusarium is a species-rich genus that causes disease on virtually all plant crops and produces diverse secondary metabolites (SMs), including pigments, plant hormones, and some of the mycotoxins of greatest concern to food and feed safety. To better understand the potential SM diversity in Fusarium ...

A GLOBAL PERSPECTIVE ON ENDOCRINE DISRUPTION, WITH COMMENTS ON THE US EXPERIENCE

EPA Science Inventory

The last two decades have witnessed a growing concern for chemicals that have the potential to adversely affect the normal functioning of the endocrine system. The International Programme on Chemical Safety (IPCS) of the World Health Organization has recently reviewed the curren...

Security analysis of boolean algebra based on Zhang-Wang digital signature scheme

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

Zheng, Jinbin, E-mail: jbzheng518@163.com

2014-10-06

In 2005, Zhang and Wang proposed an improvement signature scheme without using one-way hash function and message redundancy. In this paper, we show that this scheme exits potential safety concerns through the analysis of boolean algebra, such as bitwise exclusive-or, and point out that mapping is not one to one between assembly instructions and machine code actually by means of the analysis of the result of the assembly program segment, and which possibly causes safety problems unknown to the software.

Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards

PubMed Central

Singh, Hardeep; Classen, David C.; Sittig, Dean F.

2013-01-01

Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system. PMID:22080284

Safety-Related Concerns of Parents for Children with Disabilities and Chronic Conditions.

PubMed

Olsen, Lise L; Kruse, Sami; Miller, Anton R; Brussoni, Mariana

2016-01-01

The aim of this study was to explore the safety-related concerns of parents of children with a variety of disabilities and chronic conditions. We sought to examine concerns common to parents as they related to their children's delayed development, behavioral difficulties, and chronic conditions. A qualitative approach guided by grounded theory was used. Participants included parents of children between 1 and 5 years with a disability or chronic condition who resided in British Columbia, Canada. Data were collected using in-depth in-person interviews and analysis conducted using constant comparative methods. Three themes were identified that reflected parental safety concerns. These included concerns about: (1) Child's level of understanding about danger; (2) Child interactions with physical environment (concerns about child movement, concerns about ingestions); (3) Child interactions with social environment. Difficult-to-manage behaviors and cognitive limitations exacerbated parents' safety concerns. Parents were found to share safety concerns about movement and ingestions across a range of types of child health conditions. For themes of child movement and child ingestions, findings supported the utility of a noncategorical approach for the design of injury prevention strategies for these types of concerns. Parent concerns about child lack of understanding about risk and social safety concerns were linked to a smaller number of conditions and supported a more tailored approach. Flexible approaches may be needed that can offer both generic and specific information and to meet the needs of parents and clinicians.

"You can't be cold and scientific": community views on ethical issues in intellectual disability research.

PubMed

McDonald, Katherine E; Schwartz, Nicole M; Gibbons, Colleen M; Olick, Robert S

2015-04-01

Perceptions, attitudes, and ethical concerns related to conducting research with adults with intellectual disability hinder scientific innovation to promote health. Yet we lack an understanding of community views on effective research policy and practice. To address this knowledge void, we qualitatively studied the views of adults with intellectual disability and those who provide them support regarding research participation of adults with intellectual disability. We found substantial support for their inclusion, particularly given the possibility of benefits to adults with intellectual disability, researchers, and society. We also found concerns for potential harm and differing ideas on how to promote safety. Our findings emphasize the importance of their inclusion in research, and the need for policies and practices that promote respect and safety. © The Author(s) 2015.

“You Can’t be Cold and Scientific”: Community Views on Ethical Issues in Intellectual Disability Research

PubMed Central

McDonald, Katherine E.; Schwartz, Nicole M.; Gibbons, Colleen M.; Olick, Robert S.

2015-01-01

Perceptions, attitudes, and ethical concerns related to conducting research with adults with intellectual disability hinder scientific innovation to promote health. Yet we lack an understanding of community views on effective research policy and practice. To address this knowledge void, we qualitatively studied the views of adults with intellectual disability and those who provide them support regarding research participation of adults with intellectual disability. We found substantial support for their inclusion, particularly given the possibility of benefits to adults with intellectual disability, researchers, and society. We also found concerns for potential harm and differing ideas on how to promote safety. Our findings emphasize the importance of their inclusion in research, and the need for policies and practices that promote respect and safety. PMID:25769310

Mishap risk control for advanced aerospace/composite materials

NASA Technical Reports Server (NTRS)

Olson, John M.

1994-01-01

Although advanced aerospace materials and advanced composites provide outstanding performance, they also present several unique post-mishap environmental, safety, and health concerns. The purpose of this paper is to provide information on some of the unique hazards and concerns associated with these materials when damaged by fire, explosion, or high-energy impact. Additionally, recommended procedures and precautions are addressed as they pertain to all phases of a composite aircraft mishap response, including fire-fighting, investigation, recovery, clean-up, and guidelines are general in nature and not application-specific. The goal of this project is to provide factual and realistic information which can be used to develop consistent and effective procedures and policies to minimize the potential environmental, safety, and health impacts of a composite aircraft mishap response effort.

Factors influencing African-American mothers' concerns about immunization safety: a summary of focus group findings.

PubMed Central

Shui, Irene; Kennedy, Allison; Wooten, Karen; Schwartz, Benjamin; Gust, Deborah

2005-01-01

OBJECTIVE: To examine the vaccine safety concerns of African-American mothers who, despite concerns, have their children immunized. METHODS: Six focus groups of Atlanta-area African-American mothers who were very concerned about vaccine safety but whose children were fully vaccinated were conducted. RESULTS: Major factors influencing participants' concerns about immunizations included: lack of information and mistrust of the medical community and government. Factors that convinced parents to have their child immunized despite their concerns included social norms and/or laws supporting immunization and fear of the consequences of not immunizing. Suggestions given to reduce concerns included improving available information that addressed their concerns and provider-patient communication. CONCLUSIONS: Addressing mothers' concerns about immunization is important both from an ethical perspective, in assuring that they are fully informed of the risks and benefits of immunizations, as well as from a practical one, in reducing the possibility that they will decide not to immunize their child. Changes in the childhood immunization process should be made to reduce parental concern about vaccine safety. Some changes that may be considered include improved provider communication about immunizations and additional tailored information about the necessity and safety of vaccines. PMID:15926642

A Communication Training Program to Encourage Speaking-Up Behavior in Surgical Oncology.

PubMed

D'Agostino, Thomas A; Bialer, Philip A; Walters, Chasity B; Killen, Aileen R; Sigurdsson, Hrafn O; Parker, Patricia A

2017-10-01

Patient safety in the OR depends on effective communication. We developed and tested a communication training program for surgical oncology staff members to increase communication about patient safety concerns. In phase one, 34 staff members participated in focus groups to identify and rank factors that affect speaking-up behavior. We compiled ranked items into thematic categories that included role relations and hierarchy, staff rapport, perceived competence, perceived efficacy of speaking up, staff personality, fear of retaliation, institutional regulations, and time pressure. We then developed a communication training program that 42 participants completed during phase two. Participants offered favorable ratings of the usefulness and perceived effect of the training. Participants reported significant improvement in communicating patient safety concerns (t 40  = -2.76, P = .009, d = 0.48). Findings offer insight into communication challenges experienced by surgical oncology staff members and suggest that our training demonstrates the potential to improve team communication. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Environmental benefits and concerns on safety: communicating latest results on nanotechnology safety research-the project DaNa2.0.

PubMed

Kühnel, D; Marquardt, C; Nau, K; Krug, H F; Paul, F; Steinbach, C

2017-04-01

The use of nanotechnology and advanced materials promises to revolutionise many areas of technology and improve our daily life. In that respect, many positive effects on the environment are expected, either directly, by developing new technologies for remediation, filtering techniques or energy generation, or indirectly, by e.g. saving resources due to lower consumption of raw materials, or lower energy and fuel consumption due to reduced weight of vehicles. However, such beneficial effects of new technologies are often confronted by concerns regarding the safety of novel substances or materials. During the past 10 years, great effort has been put into research on potential hazards of nanomaterials towards environmental organisms. As the methodology for reliable assessment of nanomaterials was immature, many studies reporting contradictory results have been published, hindering both risk assessment for nanomaterials, as well as the knowledge communication to all involved stakeholders. Thus, DaNa 2.0 serves as a platform to implement trusted knowledge on nanomaterials for an objective discussion.

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

Modeling and analyzing traffic safety perceptions: An application to the speed limit reduction pilot project in Edmonton, Alberta.

PubMed

El-Basyouny, Karim; El-Bassiouni, Mohamed Yahia

2013-03-01

To address the speeding problem in residential areas, the City of Edmonton initiated a pilot project to reduce the posted speed limit from 50km/h to 40km/h within six residential communities. This paper investigates the community perceptions of traffic safety within the six pilot communities in two phases: prior to project initiation (pre-pilot) and following the end of the project (post-pilot). This objective was accomplished by analyzing the results of two random dialing telephone surveys comprising 300 residents each. A preliminary analysis showed compatible demographic configurations for the two samples and confirmed that the residents were aware of both the posted speed limits and the adopted speed management controls. For the confirmatory factor analysis (CFA), a two-group (pre-pilot and post-pilot) three-factor model was used to assess the residents' perceptions of the speeding behavior (Speeding), their concerns about traffic safety issues (Concerns), and their perceptions of traffic safety (Safety). Comparing the CFA results of the post-pilot survey versus those of the pre-pilot survey, it was evident that there was a significant decrease in Speeding and Concerns accompanied by a significant increase in Safety. A structural equations model (SEM) was also fitted to the data in order to assess the impact of Speeding and Concerns on Safety. The results showed that Concerns increase significantly with Speeding, and that both factors have significant negative impacts on Safety. However, while the impact of Concerns on Safety was direct, that of Speeding on Safety was largely indirect (i.e., mediated through Concerns). Overall, the multivariate analysis has demonstrated that the pilot project was successful in improving the residents' perceptions of traffic safety in their community. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

Development of a Computational Approach to Detect Instability and Incipient Motion of Large Riprap Rocks

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

Bojanowski, C.; Lottes, S. A.; Flora, K.

2017-08-01

Local scour at bridge piers is a potential safety hazard of major concern to transportation agencies. If it is determined that scour at bridge piers can adversely affect the stability of a bridge, scour countermeasures to protect the pier should be considered.

75 FR 54151 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... Project Persistence of Viable Influenza Virus in Aerosols--New--National Institute for Occupational Safety... Act. Influenza continues to be a major public health concern because of the substantial health burden from seasonal influenza and the potential for a severe pandemic. Although influenza is known to be...

Earthern embankment overtopping analysis using the WinDAM B software

USDA-ARS?s Scientific Manuscript database

Over 11,000 small watershed dams have been constructed with USDA involvement over an eighty year period. WinDAM B software has been developed to help engineers address dam safety concerns relative to potential overtopping of these earthen embankments. The primary function of the software is threef...

A comprehensive framework for evaluating the environmental health and safety implications of engineered nanomaterials

EPA Science Inventory

Engineered nanomaterials (ENM) are a growing aspect of the global economy, and their safe and sustainable development, use and eventual disposal requires the capability to forecast and avoid potential problems. This review is concerned with the releases of ENM into the environmen...

Exposure to Hazardous Chemical Substances--A Major Campus Environmental Health & Safety Concern.

ERIC Educational Resources Information Center

Robinson, Donald A.; Sorensen, Alfred J.

1980-01-01

A broad spectrum of potentially hazardous chemicals offers serious exposure risks to members of college and university communities. A formal program is needed to minimize exposure to these substances and maintain a prevention oriented protective program. The University of Massachusetts has developed such a program. (JN)

Microbial pesticides

Treesearch

Michael L. McManus

1991-01-01

Interest in the use of microbial pesticides has intensified because of public concern about the safety of chemical pesticides and their impact in the environment. Characteristics of the five groups of entomopathogens that have potential as microbial pesticides are briefly discussed and an update is provided on research and development activities underway to enhance the...

Distribution of mycotoxin biosynthetic genes in 200 Fusarium genomes

USDA-ARS?s Scientific Manuscript database

Fusarium is a species-rich genus of fungi that causes disease on most crop plants and produces diverse secondary metabolites (SMs), including some of the mycotoxins of greatest concern to food and feed safety. To determine the potential SM diversity within Fusarium as well as the distribution and ev...

Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials

DTIC Science & Technology

2006-09-01

tubes ), the report addresses concerns over potential environmental and health risks of nanomaterials. Following the publication of the RS... microfine titanium dioxide as physical UV filter, Int. J. Cosmetic Sci. 22(4), 271–283 (2000). J. Brant, H. Lecoanet, M. Hotze, M. Wiesner, Comparison of

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

PubMed

Symes, Sally; Goldsmith, Paul; Haines, Heather

2015-07-01

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

Barriers to Implementing a Reporting and Learning Patient Safety System: Pediatric Chiropractic Perspective.

PubMed

Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross T; Vohra, Sunita

2016-04-01

A reporting and learning system is a method of monitoring the occurrence of incidents that affect patient safety. This cross-sectional survey asked pediatric chiropractors about factors that may limit their participation in such a system. The list of potential barriers for participation was developed using a systematic approach. All members of the 2 pediatric councils associated with US national chiropractic organizations were invited to complete the survey (N = 400). The cross-sectional survey was created using an online survey tool (REDCap) and sent directly to member emails addressed by the respective executive committees. Of the 400 potential respondents, 81 responded (20.3%). The most common limitations to participating were identified as time pressure (96%) and patient concerns (81%). Reporting and learning systems have been utilized to increase safety awareness in many high-risk industries. To be successful, future patient safety studies with pediatric chiropractors need to ensure these barriers are understood and addressed. © The Author(s) 2015.

Novel strategies in immunotherapy for allergic diseases.

PubMed

Rajakulendran, Mohana; Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, H P

2018-04-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended.

[Hazardous material and safety conditions in veterinary practice. 2: Flammable liquid, disinfectants and cleansing media, cytostatics, pressurized gases, liquid nitrogen, narcotic gases, mailing of diagnostic samples, hazardous waste].

PubMed

Sliwinski-Korell, A; Lutz, F

1998-05-01

In the last years the standards for professional handling of hazardous material as well as health and safety in the veterinary practice became considerably more stringent. This is expressed in various safety regulations, particularly the decree of hazardous material and the legislative directives concerning health and safety at work. In part 1, a definition based on the law for hazardous material was given and the potential risks were mentioned. The correct documentation regarding the protection of personal and the purchase, storage, working conditions and removal of hazardous material was explained. General rules for the handling of hazardous material were described. In part 2, partial emphasis is put on the handling of flammable liquids, disinfectants, cytostatica, pressurised gases, liquid nitrogen, narcotics, mailing of potentially infectious material and safe disposal of hazardous waste. Advice about possible unrecognized hazards and references are also given.

A Decade of e-Cigarettes: Limited Research & Unresolved Safety Concerns

PubMed Central

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-01-01

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. PMID:27477296

78 FR 38771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-27

... information that raises significant identity theft, personal safety, or privacy concerns that are not... raises personal safety or privacy concerns is released to the public when considering whether to release... customer information or information that raises identity theft, personal safety or privacy concerns that do...

Identification of unique food handling practices that could represent food safety risks for minority consumers.

PubMed

Henley, Shauna C; Stein, Susan E; Quinlan, Jennifer J

2012-11-01

Foodborne illness caused by Salmonella and Campylobacter is a concern for consumers, and there is evidence that minority racial-ethnic populations experience greater rates of illness because of these pathogens. The limited body of research concerning food safety knowledge and practices among minority consumers has focused more on general food safety knowledge than on culturally specific food handling practices. The purpose of the research reported here was to explore food handling behaviors of minority racial-ethnic consumers through in-depth discussions in focus group settings. In this way, we hoped to identify potential unique, previously unidentified food handling practices among these consumers. Nine focus groups were held in Philadelphia, PA. Three focus groups were conducted with African American consumers, three with Hispanic consumers, and three with Asian consumers. In all, 56 consumers participated. Data were recorded, transcribed, and analyzed for unique and potentially unsafe food handling behaviors. Potentially unsafe food handling practices identified among all three groups included extended time to transport food from retail to home and washing of raw poultry. Culturally unique behaviors within groups included (i) using hot water (Asian, Hispanic) or acidic solutions (African American, Hispanic) to clean raw poultry, (ii) purchasing live poultry (Asian, Hispanic), (iii) cooking poultry overnight (African American), and (iv) preparing bite-size pieces of meat prior to cooking (Asian, Hispanic). To have focus groups include a limited number of participants and nonrandom sampling means that these themes and trends cannot be extrapolated to represent food mishandling among these populations in general. Results presented here allow modification of an existing food safety survey to identify the prevalence of these food handling practices among consumers of different demographics.

Patient and provider perspectives on the potential value and use of a bilingual online patient portal in a Spanish-speaking safety-net population.

PubMed

Ochoa, Alejandro; Kitayama, Ken; Uijtdehaage, Sebastian; Vermillion, Michelle; Eaton, Michael; Carpio, Felix; Serota, Martin; Hochman, Michael E

2017-11-01

To assess patient and provider perspectives on the potential value and use of a bilingual patient portal in a large safety-net health system serving predominantly Spanish-speaking patients. We captured patient and provider perspectives through the administration of surveys to assess Internet access, barriers, and facilitators to patient portal adoption, along with portal preferences. We report on these survey results using descriptive and comparative statistics. Four hundred patients (82% response rate) and 59 providers (80% response rate) participated in the study. Although 73% of providers believed that the patient portal would increase patient satisfaction, just 39% planned to recommend portal use to patients, citing concerns related to time and reimbursement. In contrast, 72% of patients believed the patient portal would strengthen the patient-provider relationship and 77% believed it would improve the quality of care. Latino patients in particular believed the patient portal would strengthen the patient-provider relationship. Seventy-five percent of patients reported interest in a mobile version of the portal. Patients from a safety-net health system, most of whom were Spanish-speaking, reported a high level of interest in the patient portal. Providers at the same health system expressed reluctance about the portal due to concerns related to time and reimbursement. Bilingual patient portal implementation has considerable potential to promote health care engagement within Spanish-speaking safety-net populations; however, lack of provider engagement in the process could undermine the effort. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Strategy for the lowering and the assessment of exposure to nanoparticles at workspace - Case of study concerning the potential emission of nanoparticles of Lead in an epitaxy laboratory

NASA Astrophysics Data System (ADS)

Artous, Sébastien; Zimmermann, Eric; Douissard, Paul-Antoine; Locatelli, Dominique; Motellier, Sylvie; Derrough, Samir

2015-05-01

The implementation in many products of manufactured nanoparticles is growing fast and raises new questions. For this purpose, the CEA - NanoSafety Platform is developing various research topics for health and safety, environment and nanoparticles exposure in professional activities. The containment optimisation for the exposition lowering, then the exposure assessment to nanoparticles is a strategy for safety improvement at workplace and workspace. The lowering step consists in an optimisation of dynamic and static containment at workplace and/or workspace. Generally, the exposure risk due to the presence of nanoparticles substances does not allow modifying the parameters of containment at workplace and/or workspace. Therefore, gaseous or nanoparticulate tracers are used to evaluate performances of containment. Using a tracer allows to modify safely the parameters of the dynamic containment (ventilation, flow, speed) and to study several configurations of static containment. Moreover, a tracer allows simulating accidental or incidental situation. As a result, a safety procedure can be written more easily in order to manage this type of situation. The step of measurement and characterization of aerosols can therefore be used to assess the exposition at workplace and workspace. The case of study, aim of this paper, concerns the potential emission of Lead nanoparticles at the exhaust of a furnace in an epitaxy laboratory. The use of Helium tracer to evaluate the performance of containment is firstly studied. Secondly, the exposure assessment is characterised in accordance with the French guide “recommendations for characterizing potential emissions and exposure to aerosols released from nanomaterials in workplace operations”. Thirdly the aerosols are sampled, on several places, using collection membranes to try to detect traces of Lead in air.

The Silence of the Unblown Whistle: The Nevada Hepatitis C Public Health Crisis

PubMed Central

Leary, Elizabeth; Diers, Donna

2013-01-01

In 2008, one of the worst public health crises occurred in the state of Nevada, where authorities discovered up to 63,000 patients were potentially exposed to hepatitis C infection, largely due to substandard infection control and other negligent practices at two endoscopy clinics in Las Vegas. In the subsequent grand jury proceedings that followed, it was discovered that several clinic employees not only participated in these egregious practices, but doctors, nurses, and other health care professionals witnessed yet failed to report these incidents, largely due to fears of whistleblower retaliation. In response, the Nevada state legislature attempted to strengthen whistleblower protection laws, but it remains unclear if such laws actually protect employees who attempt to report patient safety concerns. As the push for quality patient outcomes becomes more prominent with health care reform, whistleblower concerns must be effectively addressed to ensure that health care professionals can report patient safety concerns without fear of retaliation. PMID:23483090

Attitudes, perceptions, and trust. Insights from a consumer survey regarding genetically modified banana in Uganda.

PubMed

Kikulwe, Enoch M; Wesseler, Justus; Falck-Zepeda, Jose

2011-10-01

Genetically modified (GM) crops and food are still controversial. This paper analyzes consumers' perceptions and institutional awareness and trust toward GM banana regulation in Uganda. Results are based on a study conducted among 421 banana-consuming households between July and August 2007. Results show a high willingness to purchase GM banana among consumers. An explanatory factor analysis is conducted to identify the perceptions toward genetic modification. The identified factors are used in a cluster analysis that grouped consumers into segments of GM skepticism, government trust, health safety concern, and food and environmental safety concern. Socioeconomic characteristics differed significantly across segments. Consumer characteristics and perception factors influence consumers' willingness to purchase GM banana. The institutional awareness and trust varied significantly across segments as well. The findings would be essential to policy makers when designing risk-communication strategies targeting different consumer segments to ensure proper discussion and addressing potential concerns about GM technology. Copyright © 2011 Elsevier Ltd. All rights reserved.

Electronic cigarettes in North America: history, use, and implications for smoking cessation.

PubMed

Franck, Caroline; Budlovsky, Talia; Windle, Sarah B; Filion, Kristian B; Eisenberg, Mark J

2014-05-13

Designed to mimic the look and feel of tobacco cigarettes, electronic cigarettes (e-cigarettes) may facilitate smoking cessation. However, the efficacy and safety of e-cigarette use for this purpose remain poorly understood. Our objectives were to review the available data on the efficacy and safety of e-cigarettes for smoking cessation and to consider issues relevant to the context in which they are used, including product awareness and regulatory and ethical concerns. We systematically searched PubMed for randomized controlled trials and uncontrolled, experimental studies involving e-cigarettes. Included studies were limited to English or French language reports. Quality assessment was performed according to the Cochrane Risk of Bias tool. We identified 169 publications, of which 7 studies were included. Studies have concluded that e-cigarettes can help reduce the number of cigarettes smoked and may be as effective for smoking cessation as the nicotine patch. Although there is a lack of data concerning the safety and efficacy of e-cigarettes as a smoking cessation therapy, available evidence showed no significant difference in adverse event rates between e-cigarettes and the nicotine patch. E-cigarettes are widely used among smokers attempting to quit. However, significant international variation remains in the regulatory mechanisms governing the sale and distribution of e-cigarettes. Ethical concerns surround the use of e-cigarettes among minors and their potential to undermine efforts to reduce cigarette smoking. Given the limited available evidence on the risks and benefits of e-cigarette use, large, randomized, controlled trials are urgently needed to definitively establish their potential for smoking cessation.

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.

Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

PubMed

Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

2014-01-01

Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06), food safety (1.70; 1.38-2.10), and natural disasters (1.74; 1.39-2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77), food safety (1.38; 1.20-1.59), and natural disasters (1.30; 1.12-1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74) and food safety (1.30; 1.07-1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety). Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

Who Was Concerned about Radiation, Food Safety, and Natural Disasters after the Great East Japan Earthquake and Fukushima Catastrophe? A Nationwide Cross-Sectional Survey in 2012

PubMed Central

Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

2014-01-01

Background Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. Methods The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Results Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35–2.06), food safety (1.70; 1.38–2.10), and natural disasters (1.74; 1.39–2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33–1.77), food safety (1.38; 1.20–1.59), and natural disasters (1.30; 1.12–1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58–2.74) and food safety (1.30; 1.07–1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25–5.01 about radiation, 1.49; 1.08–2.06 about food safety). Conclusions Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively. PMID:25181292

Potential risks associated with traditional herbal medicine use in cancer care: A study of Middle Eastern oncology health care professionals.

PubMed

Ben-Arye, Eran; Samuels, Noah; Goldstein, Lee Hilary; Mutafoglu, Kamer; Omran, Suha; Schiff, Elad; Charalambous, Haris; Dweikat, Tahani; Ghrayeb, Ibtisam; Bar-Sela, Gil; Turker, Ibrahim; Hassan, Azza; Hassan, Esmat; Saad, Bashar; Nimri, Omar; Kebudi, Rejin; Silbermann, Michael

2016-02-15

The authors assessed the use of herbal medicine by Middle Eastern patients with cancer, as reported by their oncology health care professionals (HCPs). Herbal products identified by the study HCPs were evaluated for potential negative effects. Oncology HCPs from 16 Middle Eastern countries received a 17-item questionnaire asking them to list 5 herbal products in use by their patients with cancer. A literature search (PubMed, Micromedex, AltMedDex, and the Natural Medicine Comprehensive Database) was conducted to identify safety-related concerns associated with the products listed. A total of 339 HCPs completed the study questionnaire (response rate of 80.3%), identifying 44 herbal and 3 nonherbal nutritional supplements. Safety-related concerns were associated with 29 products, including herb-drug interactions with altered pharmacodynamics (15 herbs), direct toxic effects (18 herbs), and increased in vitro response of cancer cells to chemotherapy (7 herbs). Herbal medicine use, which is prevalent in Middle Eastern countries, has several potentially negative effects that include direct toxic effects, negative interactions with anticancer drugs, and increased chemosensitivity of cancer cells, requiring a reduction in dose-density. Oncology HCPs working in countries in which herbal medicine use is prevalent need to better understand the implications of this practice. The presence of integrative physicians with training in complementary and traditional medicine can help patients and their HCPs reach an informed decision regarding the safety and effective use of these products. © 2015 American Cancer Society.

‘Saying it without words’: a qualitative study of oncology staff's experiences with speaking up about safety concerns

PubMed Central

Schwappach, D L B; Gehring, K

2014-01-01

Objectives To explore the experiences of oncology staff with communicating safety concerns and to examine situational factors and motivations surrounding the decision whether and how to speak up using semistructured interviews. Setting 7 oncology departments of six hospitals in Switzerland. Participants Diverse sample of 32 experienced oncology healthcare professionals. Results Nurses and doctors commonly experience situations which raise their concerns and require questioning, clarifying and correcting. Participants often used non-verbal communication to signal safety concerns. Speaking-up behaviour was strongly related to a clinical safety issue. Most episodes of ‘silence’ were connected to hygiene, isolation and invasive procedures. In contrast, there seemed to exist a strong culture to communicate questions, doubts and concerns relating to medication. Nearly all interviewees were concerned with ‘how’ to say it and in particular those of lower hierarchical status reflected on deliberate ‘voicing tactics’. Conclusions Our results indicate a widely accepted culture to discuss any concerns relating to medication safety while other issues are more difficult to voice. Clinicians devote considerable efforts to evaluate the situation and sensitively decide whether and how to speak up. Our results can serve as a starting point to develop a shared understanding of risks and appropriate communication of safety concerns among staff in oncology. PMID:24838725

Keeping nurse researchers safe: workplace health and safety issues.

PubMed

Barr, Jennieffer; Welch, Anthony

2012-07-01

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

The SAFER guides: empowering organizations to improve the safety and effectiveness of electronic health records.

PubMed

Sittig, Dean F; Ash, Joan S; Singh, Hardeep

2014-05-01

Electronic health records (EHRs) have potential to improve quality and safety of healthcare. However, EHR users have experienced safety concerns from EHR design and usability features that are not optimally adapted for the complex work flow of real-world practice. Few strategies exist to address unintended consequences from implementation of EHRs and other health information technologies. We propose that organizations equipped with EHRs should consider the strategy of "proactive risk assessment" of their EHR-enabled healthcare system to identify and address EHR-related safety concerns. In this paper, we describe the conceptual underpinning of an EHR-related self-assessment strategy to provide institutions a foundation upon which they could build their safety efforts. With support from the Office of the National Coordinator for Health Information Technology (ONC), we used a rigorous, iterative process to develop a set of 9 self-assessment tools to optimize the safety and safe use of EHRs. These tools, referred to as the Safety Assurance Factors for EHR Resilience (SAFER) guides, could be used to self-assess safety and effectiveness of EHR implementations, identify specific areas of vulnerability, and create solutions and culture change to mitigate risks. A variety of audiences could conduct these assessments, including frontline clinicians or care teams in different practices, or clinical, quality, or administrative leaders within larger institutions. The guides use a multifaceted systems-based approach to assess risk and empower organizations to work with internal or external stakeholders (eg, EHR developers) on optimizing EHR functionality and using EHRs to drive improvements in the quality and safety of healthcare.

Four common herbs seen in dental practice: properties and potential adverse effects.

PubMed

Shankland, Wesley E

2009-04-01

The use of herbal supplements in North America is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The most notable and direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions, which is of particular concern for patients undergoing anesthesia, both general and local anesthesia. In this article, four of the most commonly used herbs today in North America will be discussed: garlic, gingko, ginseng, and ginger. The pharmacology, benefits, and possible side effects of these herbs will be presented. Awareness of the rising use of herbs is important to prevent, recognize, and treat potential problems that can arise from herbal preparations taken alone or in conjunction with prescription medications.

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

PubMed

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

2017-04-01

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

Metrication report to the Congress

NASA Technical Reports Server (NTRS)

1989-01-01

The major NASA metrication activity of 1988 concerned the Space Station. Although the metric system was the baseline measurement system for preliminary design studies, solicitations for final design and development of the Space Station Freedom requested use of the inch-pound system because of concerns with cost impact and potential safety hazards. Under that policy, however use of the metric system would be permitted through waivers where its use was appropriate. Late in 1987, several Department of Defense decisions were made to increase commitment to the metric system, thereby broadening the potential base of metric involvement in the U.S. industry. A re-evaluation of Space Station Freedom units of measure policy was, therefore, initiated in January 1988.

Evolution of a policy disallowing the use of alternative therapies in a health system.

PubMed

Walker, P C

2000-11-01

The evolution of a policy disallowing patients' use of alternative therapies in a health system is described. The pharmacy and therapeutics (P&T) committee at Children's Hospital of Michigan, a part of the Detroit Medical Center (DMC), was asked to review the appropriateness of allowing inpatients to bring in and use alternative therapy products during their hospitalization. Recognizing the interest of consumers in alternative medicines and patients' growing involvement in their own care, the committee drafted a policy that allowed patients to continue taking dietary supplements after being admitted to the hospital. If the physician had no concerns about potential toxicities or drug interactions for a particular product, he or she would write a medication order allowing it to be used. Purchasing and administering the products were deemed the responsibility of the patient or the family. However, many issues concerning supplements remained unresolved, including questions about safety, efficacy, dosing, drug interactions, ethical conflicts, and liability. Ultimately, the P&T committee decided that the potential risks associated with alternative therapies outweighed potential benefits and adopted a policy disallowing the use of alternative therapies by hospitalized patients. The policy was eventually implemented at all eight DMC hospitals. A health system responded to patients' desire to continue their use of alternative therapies during hospitalization by drafting a policy allowing such use. However, concerns related to safety, efficacy, ethics, and liability led to the abandonment of the liberal policy and implementation of a highly restrictive one.

Infant toxicology: state of the science and considerations in evaluation of safety.

PubMed

Neal-Kluever, April; Aungst, Jason; Gu, Yan; Hatwell, Karen; Muldoon-Jacobs, Kristi; Liem, Ayesha; Ogungbesan, Adejoke; Shackelford, Mary

2014-08-01

Differences in the physiology and biological susceptibilities of adults and infants have led to growing interest in safety evaluation methods for exposures from infant formula packaging. In addition to potential physiological differences, infants aged 0-6 months may consume a sole source of food, infant formula or breast milk, and consume higher amounts of food relative to body weight compared to adults. While the duration of the exposure is short compared to the expected lifespan of the individual, it occurs during a period of important developmental processes. The purpose of this document is to (1) review key biological and exposure elements that may impact the evaluation of safety for food contact products intended for use by infants, (2) summarize the current reproductive and developmental toxicity testing protocols available, and (3) identify potential data gaps concerning this period of development. Published by Elsevier Ltd.

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.

Transcranial electric motor evoked potential monitoring during spine surgery: is it safe?

PubMed

Schwartz, Daniel M; Sestokas, Anthony K; Dormans, John P; Vaccaro, Alexander R; Hilibrand, Alan S; Flynn, John M; Li, P Mark; Shah, Suken A; Welch, William; Drummond, Denis S; Albert, Todd J

2011-06-01

Retrospective review. To report on the safety of repetitive transcranial electric stimulation (RTES) for eliciting motor-evoked potentials during spine surgery. Theoretical concerns over the safety of RTES have hindered broader acceptance of transcranial electric motor-evoked potentials (tceMEP), despite successful implementation of spinal cord monitoring with tceMEPs in many large spine centers, as well as their apparent superiority over mixed-nerve somatosensory-evoked potentials (SSEP) for detection of spinal cord injury. The records of 18,862 consecutive patients who met inclusion criteria and underwent spine surgery with tceMEP monitoring were reviewed for RTES-related complications. This large retrospective review identified only 26 (0.14%) cases with RTES-related complications; all but one of these were tongue lacerations, most of which were self-limiting. The results demonstrate that RTES is a highly safe modality for monitoring spinal cord motor tract function intraoperatively.

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

PubMed Central

Lowry, Svetlana Z; Patterson, Emily S

2014-01-01

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

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

PubMed

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

2014-12-18

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

Safety of Patient Mobilization and Rehabilitation in the Intensive Care Unit. Systematic Review with Meta-Analysis.

PubMed

Nydahl, Peter; Sricharoenchai, Thiti; Chandra, Saurabh; Kundt, Firuzan Sari; Huang, Minxuan; Fischill, Magdalena; Needham, Dale M

2017-05-01

Early mobilization and rehabilitation of patients in intensive care units (ICUs) may improve physical function, and reduce the duration of delirium, mechanical ventilation, and ICU length of stay. However, safety concerns are an important barrier to widespread implementation. To synthesize safety data regarding patient mobilization and rehabilitation in the ICU, including falls, removal of endotracheal tubes, removal or dysfunction of intravascular catheters, removal of other catheters/tubes, cardiac arrest, hemodynamic changes, and desaturation. Systematic literature review, including searches of five databases. Eligible studies evaluated patients who received mobilization-related interventions in the ICU. Exclusion criteria included: (1) case series with fewer than 10 patients; (2) majority of patients under 18 years of age; and (3) data not reported to permit calculation of incidence of safety events. Number of patients, mobilization/rehabilitation sessions, potential safety events, and events with negative consequences (e.g., requiring intervention or additional therapy). Heterogeneity was assessed by I 2 statistics, and bias assessed by the Newcastle-Ottawa Scale and Cochrane risk of bias assessment. The literature search identified 20,660 titles. There were 48 eligible publications evaluating 7,546 patients, with 583 potential safety events occurring in 22,351 mobilization/rehabilitation sessions. There was a total of 583 (2.6%) potential safety events with heterogeneity in the definitions for these events. For the safety event types that could be meta-analyzed, pooled incidences per 1,000 mobilization/rehabilitation sessions (95% confidence interval), were: hemodynamic changes, 3.8 (1.3-11.4), and desaturation, 1.9 (0.9-4.3). A total of 24 studies of 3,404 patients reported on any consequences of potential safety events (e.g., needing to increase dose of vasopressor due to mobility-related hypotension), with a frequency of 0.6% in 14,398 mobilization/rehabilitation sessions. Patient mobilization and physical rehabilitation in the ICU appears safe, with a low incidence of potential safety events, and only rare events having any consequences for patient management. Heterogeneity in the definition of safety events across studies emphasizes the importance of implementing existing consensus-based definitions.

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

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

Tokuhiro, Akira; Potirniche, Gabriel; Cogliati, Joshua

2014-07-08

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

Mitigation of Patulin in Fresh and Processed Foods and Beverages

PubMed Central

Ioi, J. David; Zhou, Ting; Tsao, Rong; F. Marcone, Massimo

2017-01-01

Patulin is a mycotoxin of food safety concern. It is produced by numerous species of fungi growing on fruits and vegetables. Exposure to the toxin is connected to issues neurological, immunological, and gastrointestinal in nature. Regulatory agencies worldwide have established maximum allowable levels of 50 µg/kg in foods. Despite regulations, surveys continue to find patulin in commercial food and beverage products, in some cases, to exceed the maximum limits. Patulin content in food can be mitigated throughout the food processing chain. Proper handling, storage, and transportation of food can limit fungal growth and patulin production. Common processing techniques including pasteurisation, filtration, and fermentation all have an effect on patulin content in food but individually are not sufficient safety measures. Novel methods to remove or detoxify patulin have been reviewed. Non-thermal processing techniques such as high hydrostatic pressure, UV radiation, enzymatic degradation, binding to microorganisms, and chemical degradation all have potential but have not been optimised. Until further refinement of these methods, the hurdle approach to processing should be used where food safety is concerned. Future development should focus on determining the nature and safety of chemicals produced from the breakdown of patulin in treatment techniques. PMID:28492465

Antisense apolipoprotein B therapy: where do we stand?

PubMed

Akdim, Fatima; Stroes, Erik S G; Kastelein, John J P

2007-08-01

Antisense oligonucleotides are novel therapeutic agents that reduce the number of specific mRNAs available for translation of the encoded protein. ISIS 301012 is an antisense oligonucleotide developed to reduce the hepatic synthesis of apolipoprotein B-100. Apolipoprotein B-100 is made in the liver, and antisense oligonucleotides preferentially distribute to that organ, so antisense apolipoprotein B-100 may have potential as an efficacious lipid-lowering agent. Recently, in healthy volunteers and in mild dyslipidaemic patients, this strategy as monotherapy or in conjunction with statins has shown unparalleled efficacy in reducing apolipoprotein B-100 and LDL-cholesterol. Tolerance for this novel therapy is encouraging and safety concerns currently only relate to mild injection-site reactions and rare liver-function test abnormalities. It should be noted, however, that these safety results were obtained in relatively few individuals. ISIS 301012 has initially shown promising results in experimental animal models, and in clinical trials in humans. Besides the effect of reducing apolipoprotein B-100 and LDL-cholesterol, this compound also significantly lowers plasma triglycerides. Safety concerns related to the drug include increased liver-function tests. To date no evidence of hepatic steatosis has been reported. Nonetheless, clinical trials of longer duration are required to demonstrate further safety.

We Never See Children in Parks: A Qualitative Examination of the Role of Safety Concerns on Physical Activity Among Children.

PubMed

Rader, Nicole E; Byrd, Sylvia H; Fountain, Brent J; Bounds, Christopher W; Gray, Virginia; Frugé, Andrew Dandridge

2015-07-01

Previous literature indicates physical activity and obesity are interrelated problems, especially among children in disorganized environments. Qualitative focus groups were conducted with parents of elementary school children located within the Mississippi Delta to answer one overarching research question: "What influence do safety concerns have on physical activity for children in the Mississippi Delta?" There were 2 large themes; first was that recreational areas were criminal and the second was that safety concerns were a barrier to physical activity. Safety concerns as a barrier to physical activity rendered 3 sub-themes, including 1) Parental fear of crime inhibited the use of public recreational spaces, 2) Parental perceptions of police as ineffective and untrustworthy reduced the use of public spaces where children might play, and 3) Parents often expressed safety-induced intense supervision requirements that limited the physical activity of their children. Our study provides valuable insights into the mechanisms by which safety concerns limit physical activity of children in the Mississippi Delta.

77 FR 36581 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... Conservation Act of 1978 AGENCY: National Science Foundation. ACTION: Notice of Permit Applications Received.... The presence of these animals pose operation safety concerns as well as potential harm to the animals... for capturing Antarctic fishes to study their physiology and biochemistry. Benthic Otter trawling is...

Calibration and testing of a Raman hyperspectral imaging system to reveal powdered food adulteration

USDA-ARS?s Scientific Manuscript database

The potential adulteration of foodstuffs has led to increasing concern regarding food safety and security, in particular for powdered food products where cheap ground materials or hazardous chemicals can be added to increase the quantity of powder or to obtain the desired aesthetic quality. Due to t...

Screening blood samples to estimate when oxytetverycline residues exceed regulatory tolerances in poultry muscle

USDA-ARS?s Scientific Manuscript database

The presence of antibiotic residues in edible animal products is a human food safety concern. To address this potential problem, the government samples edible tissues, such as muscle, to monitor for residues. Due to loss of valuable product and analytical difficulties only a small percentage of po...

Instructor Liability--A Continuing Dilemma.

ERIC Educational Resources Information Center

McDole, Thomas L.

This brief guide discusses ways to provide safe instruction and to minimize the risk of injury and potential liability in a laboratory environment. The three main concerns covered are: (1) the physical plant must be in compliance with the Occupational Safety and Health Administration (OSHA); (2) the physical facility should have all tools in good…

Soy and other legumes: 'Bean' around a long time but are they the 'superfoods' of the millennium and what are the safety issues for their constituent phytoestrogens?

PubMed

Setchell, K D; Radd, S

2000-09-01

The recognition that legumes and, in particular, soybeans provide not only an excellent source of vegetable protein but also contain appreciable amounts of a number of phytoprotectants has increased general awareness of their potential nutritional and health properties. Since the discovery that soybeans are one of the richest dietary sources of bioavailable phytoestrogens, this legume has been elevated to the forefront of clinical nutritional research. These natural 'selective oestrogen receptor modulators' have been shown to be bioactive. The recent approval by the Food and Drug Administration in the United States for a health claim for soy protein reducing risk for heart disease by its effects on lowering cholesterol levels has led to the increased awareness of the health benefits of soy protein. However, the presence of high levels of phytoestrogens in soybeans has also led to concerns over the potential safety of soy foods. This review will focus on the cardioprotective benefits of legumes and discuss the hypothetical concerns regarding the constituent phytoestrogens.

ESH assessment of advanced lithography materials and processes

NASA Astrophysics Data System (ADS)

Worth, Walter F.; Mallela, Ram

2004-05-01

The ESH Technology group at International SEMATECH is conducting environment, safety, and health (ESH) assessments in collaboration with the lithography technologists evaluating the performance of an increasing number of new materials and technologies being considered for advanced lithography such as 157nm photresist and extreme ultraviolet (EUV). By performing data searches for 75 critical data types, emissions characterizations, and industrial hygiene (IH) monitoring during the use of the resist candidates, it has been shown that the best performing resist formulations, so far, appear to be free of potential ESH concerns. The ESH assessment of the EUV lithography tool that is being developed for SEMATECH has identified several features of the tool that are of ESH concern: high energy consumption, poor energy conversion efficiency, tool complexity, potential ergonomic and safety interlock issues, use of high powered laser(s), generation of ionizing radiation (soft X-rays), need for adequate shielding, and characterization of the debris formed by the extreme temperature of the plasma. By bringing these ESH challenges to the attention of the technologists and tool designers, it is hoped that the processes and tools can be made more ESH friendly.

The case of H.S.: the ethics of reporting alcohol dependence in a bus driver.

PubMed

Karol, David E; Schuermeyer, Isabel N; Brooker, Craig A

2007-01-01

The physician's duty to preserve patient confidentiality is challenged when doing so may endanger third parties. We present the case of a bus driver whose alcohol dependence raised concerns of a risk not only to his own health and safety, but to public safety as well. We first examine the legal and ethical obligations to report his alcohol use to his employer and then stress the importance of weighing the potential harm of violating patient-physician confidentiality against the severity of risk to the general public.

Nuclear health and safety

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

Glenn, J.

1991-02-01

There has been concern over the Department of Energy's (DOE) dual role of producing nuclear weapons and assessing the potential health hazards associated with operating its facilities has raised questions about DOE's ability to effectively manage its health and health effects (epidemiology) research programs. In March 1990, the secrecy of Energy announced several initiatives to address these concerns. These initiatives include, among others, the development of an occupational health and epidemiology program, the transfer of long-term health effects' studies to the Department of Health and Human Services (HHS), the establishment of an advisory committee to oversee DOE's environmental, safety, andmore » health activities, and the design of a data base to store and retrieve health data. This paper provides a brief description of DOE's initiatives, including their status as of December 1990 and general observations of these initiatives.« less

2011 Annual Meeting of the Safety Pharmacology Society: an overview.

PubMed

Cavero, Icilio

2012-03-01

The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization this information should be complemented by a clear clinical proof of safety. The ongoing outsourcing process of Regulatory Safety Pharmacology activities from large Pharmas to contract research organizations should be taken as an opportunity to establish long-overdue in-house Exploratory Safety Pharmacology units fully dedicated to the optimization of clinical candidates on organ safety.

Environmental contaminants of emerging concern in seafood--European database on contaminant levels.

PubMed

Vandermeersch, Griet; Lourenço, Helena Maria; Alvarez-Muñoz, Diana; Cunha, Sara; Diogène, Jorge; Cano-Sancho, German; Sloth, Jens J; Kwadijk, Christiaan; Barcelo, Damia; Allegaert, Wim; Bekaert, Karen; Fernandes, José Oliveira; Marques, Antonio; Robbens, Johan

2015-11-01

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called "contaminants of emerging concern" are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issues related to these contaminants has thus become urgent and imperative. A database (www.ecsafeseafooddbase.eu), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Attitudes toward pharmacological cognitive enhancement—a review

PubMed Central

Schelle, Kimberly J.; Faulmüller, Nadira; Caviola, Lucius; Hewstone, Miles

2014-01-01

A primary means for the augmentation of cognitive brain functions is “pharmacological cognitive enhancement” (PCE). The term usually refers to the off-label use of medical substances to improve mental performance in healthy individuals. With the final aim to advance the normative debate taking place on that topic, several empirical studies have been conducted to assess the attitudes toward PCE in the public, i.e., in groups outside of the academic debate. In this review, we provide an overview of the 40 empirical studies published so far, reporting both their methodology and results. Overall, we find that several concerns about the use of PCE are prevalent in the public. These concerns largely match those discussed in the normative academic debate. We present our findings structured around the three most common concerns: medical safety, coercion, and fairness. Fairness is divided into three subthemes: equality of opportunity, honesty, and authenticity. Attitudes regarding some concerns are coherent across studies (e.g., coercion), whereas for others we find mixed results (e.g., authenticity). Moreover, we find differences in how specific groups—such as users, nonusers, students, parents, and health care providers—perceive PCE: a coherent finding is that nonusers display more concerns regarding medical safety and fairness than users. We discuss potential psychological explanations for these differences. PMID:24860438

Security Implications of Physical Design Attributes in the Emergency Department.

PubMed

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

2016-07-01

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

'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

PubMed

Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

2015-11-01

To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (r<0.85 for all correlations), a measure of discriminant validity. The SUC-Safe and SUC-Prof scales were associated with participants' self-reported speaking up behaviour about safety and professionalism concerns (r=0.21, p<0.001 and r=0.22, p<0.001, respectively), a measure of concurrent validity, while teamwork and safety climate scales were not. We created and provided evidence for the reliability and validity of two measures (SUC-Safe and SUC-Prof scales) associated with self-reported speaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Principles and safety measures of electrosurgery in laparoscopy.

PubMed

Alkatout, Ibrahim; Schollmeyer, Thoralf; Hawaldar, Nusrat A; Sharma, Nidhi; Mettler, Liselotte

2012-01-01

Electrosurgical units are the most common type of electrical equipment in the operating room. A basic understanding of electricity is needed to safely apply electrosurgical technology for patient care. We reviewed the literature concerning the essential biophysics, the incidence of electrosurgical injuries, and the possible mechanisms for injury. Various safety guidelines pertaining to avoidance of injuries were also reviewed. Electrothermal injury may result from direct application, insulation failure, direct coupling, capacitive coupling, and so forth. A thorough knowledge of the fundamentals of electrosurgery by the entire team in the operating room is essential for patient safety and for recognizing potential complications. Newer hemostatic technologies can be used to decrease the incidence of complications.

Principles and Safety Measures of Electrosurgery in Laparoscopy

PubMed Central

Alkatout, Ibrahim; Schollmeyer, Thoralf; Hawaldar, Nusrat A.; Sharma, Nidhi

2012-01-01

Background: Electrosurgical units are the most common type of electrical equipment in the operating room. A basic understanding of electricity is needed to safely apply electrosurgical technology for patient care. Methods: We reviewed the literature concerning the essential biophysics, the incidence of electrosurgical injuries, and the possible mechanisms for injury. Various safety guidelines pertaining to avoidance of injuries were also reviewed. Results: Electrothermal injury may result from direct application, insulation failure, direct coupling, capacitive coupling, and so forth. Conclusion: A thorough knowledge of the fundamentals of electrosurgery by the entire team in the operating room is essential for patient safety and for recognizing potential complications. Newer hemostatic technologies can be used to decrease the incidence of complications. PMID:22906341

The pharmacology and toxicology of kratom: from traditional herb to drug of abuse.

PubMed

Warner, Marcus L; Kaufman, Nellie C; Grundmann, Oliver

2016-01-01

Mitragyna speciosa (Rubiaceae), commonly known as kratom, is a tropical tree with a long history of traditional use in parts of Africa and Southeast Asia. In recent years, kratom has gained popularity for use as a recreational drug across the globe. Relatively new to the illicit market and used in a manner different from its traditional applications, preparations of kratom are touted by many as a safe and legal psychoactive product that improves mood, relieves pain, and may provide benefits in opiate addiction. Available literature was reviewed for M. speciosa via PubMed, Google Scholar, CINAHL, and EBSCO to summarize its traditional uses, phytochemical composition, pharmacology and toxicology of proposed active constituents, and potential for misuse and abuse. Research has demonstrated that both stimulant and sedative dose-dependent effects do exist, but a growing concern for the drug's effects and safety of use has resulted in national and international attention primarily due to an increase in hospital visits and deaths in several countries that are said to have been caused by extracts of the plant. The main active alkaloid substances in kratom, mitragynine and 7-hydroxymitragynine, present with a range of CNS stimulant and depressant effects mediated primarily through monoaminergic and opioid receptors. Recently, Palm Beach County, located in the southeastern corridor of Florida, has considered regulating kratom due to public safety concerns following the death of a young adult. At the local, state, and even federal levels, governments are now being confronted with the task of determining the safety and the possible regulation of kratom extracts. There are currently no standard analytical screening techniques for mitragynine and its metabolites following ingestion limiting its detection to more sophisticated techniques like liquid chromatography-mass spectrometry to determine kratom use. The growing concern of the abuse potential of kratom requires careful evaluation of its benefits and potential toxicities.

RIFM fragrance ingredient safety assessment, isobornyl isovalerate, CAS registry number 7779-73-9.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lapczynski, A; Liebler, D C; O'Brien, D; Parakhia, R; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2017-12-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization potential, as well as, environmental safety. Data from the suitable read across analog isobornyl acetate (CAS # 125-12-2) show that this material is not genotoxic, provided a MOE > 100 for the repeated dose, developmental and reproductive endpoints, and does not have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (threshold of Toxicological Concern) for a Cramer Class II material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Novel vaccine strategies against emerging viruses

PubMed Central

García-Sastre, Adolfo; Mena, Ignacio

2013-01-01

One of the main public health concerns of emerging viruses is their potential introduction into and sustained circulation among populations of immunologically naïve, susceptible hosts. The induction of protective immunity through vaccination can be a powerful tool to prevent this concern by conferring protection to the population at risk. Conventional approaches to develop vaccines against emerging pathogens have significant limitations: lack of experimental tools for several emerging viruses of concern, poor immunogenicity, safety issues, or lack of cross-protection against antigenic variants. The unpredictability of the emergence of future virus threats demands the capability to rapidly develop safe, effective vaccines. We describe some recent advances in new vaccine strategies that are being explored as alternatives to classical attenuated and inactivated vaccines, and provide examples of potential novel vaccines for emerging viruses. These approaches might be applied to the control of many other emerging pathogens. PMID:23477832

Mechanized Off-Road Equipment Safety. Module SH-17. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on mechanized off-road equipment safety is one of 50 modules concerned with job safety and health. This module aims to encourage the development of a positive approach to safety as it concerns the heavy equipment industry. Following the introduction, 15 objectives (each keyed to a page in the text) the student is expected to…

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.

Fission Systems for Mars Exploration

NASA Technical Reports Server (NTRS)

Houts, Michael G.; Kim, T.; Dorney, D. J.; Swint, Marion Shayne

2012-01-01

Fission systems are used extensively on earth, and 34 such systems have flown in space. The energy density of fission is over 10 million times that of chemical reactions, giving fission the potential to eliminate energy density constraints for many space missions. Potential safety and operational concerns with fission systems are well understood, and strategies exist for affordably developing such systems. By enabling a power-rich environment and highly efficient propulsion, fission systems could enable affordable, sustainable exploration of Mars.

A decade of e-cigarettes: Limited research & unresolved safety concerns.

PubMed

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-07-15

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. Published by Elsevier Ireland Ltd.

Occupational safety and health, green chemistry, and sustainability: a review of areas of convergence

PubMed Central

2013-01-01

With increasing numbers and quantities of chemicals in commerce and use, scientific attention continues to focus on the environmental and public health consequences of chemical production processes and exposures. Concerns about environmental stewardship have been gaining broader traction through emphases on sustainability and “green chemistry” principles. Occupational safety and health has not been fully promoted as a component of environmental sustainability. However, there is a natural convergence of green chemistry/sustainability and occupational safety and health efforts. Addressing both together can have a synergistic effect. Failure to promote this convergence could lead to increasing worker hazards and lack of support for sustainability efforts. The National Institute for Occupational Safety and Health has made a concerted effort involving multiple stakeholders to anticipate and identify potential hazards associated with sustainable practices and green jobs for workers. Examples of potential hazards are presented in case studies with suggested solutions such as implementing the hierarchy of controls and prevention through design principles in green chemistry and green building practices. Practical considerations and strategies for green chemistry, and environmental stewardship could benefit from the incorporation of occupational safety and health concepts which in turn protect affected workers. PMID:23587312

Occupational safety and health, green chemistry, and sustainability: a review of areas of convergence.

PubMed

Schulte, Paul A; McKernan, Lauralynn T; Heidel, Donna S; Okun, Andrea H; Dotson, Gary Scott; Lentz, Thomas J; Geraci, Charles L; Heckel, Pamela E; Branche, Christine M

2013-04-15

With increasing numbers and quantities of chemicals in commerce and use, scientific attention continues to focus on the environmental and public health consequences of chemical production processes and exposures. Concerns about environmental stewardship have been gaining broader traction through emphases on sustainability and "green chemistry" principles. Occupational safety and health has not been fully promoted as a component of environmental sustainability. However, there is a natural convergence of green chemistry/sustainability and occupational safety and health efforts. Addressing both together can have a synergistic effect. Failure to promote this convergence could lead to increasing worker hazards and lack of support for sustainability efforts. The National Institute for Occupational Safety and Health has made a concerted effort involving multiple stakeholders to anticipate and identify potential hazards associated with sustainable practices and green jobs for workers. Examples of potential hazards are presented in case studies with suggested solutions such as implementing the hierarchy of controls and prevention through design principles in green chemistry and green building practices. Practical considerations and strategies for green chemistry, and environmental stewardship could benefit from the incorporation of occupational safety and health concepts which in turn protect affected workers.

Efficacy and Safety of Probiotics and Synbiotics in Liver Transplantation.

PubMed

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

2018-05-26

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

Is Intake of Flavonoid-Based Food Supplements During Pregnancy Safe for the Developing Child? A Literature Review.

PubMed

Barenys, Marta; Masjosthusmann, Stefan; Fritsche, Ellen

2017-01-01

Due to potential health benefits and the general assumption that natural products are safe, there is an increasing trend in the general population - including pregnant women - to supplement their diet with flavonoid-based food supplements. In addition, preclinical studies aim to prevent developmental adverse effects induced by toxic substances, infections, maternal or genetic diseases of the unborn child by administration of flavonoids at doses far above those reached by normal diets. Because these substances do not undergo classical risk assessment processes, our aim was to review the available literature on the potential adverse effects of maternal diet supplementation with flavonoid-based products for the developing child. A systematic literature search was performed in three databases and screened following four exclusion criteria. Selected studies were classified into two groups: 1. Studies on the developmental toxicity of single flavonoids in vitro or in animals in vivo, and 2. Studies on the developmental toxicity of single flavonoids or on flavonoid-mixtures in humans. The data collected indicate that there is a concern for the safety of some flavonoids within realistic human exposure scenarios. This concern is accompanied by a tremendous lack of studies on safety of these compounds during development making definite safety decisions impossible. Besides studies of survival, especially the more specific developmental processes like nervous system development need to be addressed experimentally. Before new high-dose, flavonoid-based therapeutic strategies are developed for pregnant women further research on the safety of these compounds is clearly needed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Fire safety

Treesearch

Robert H. White; Mark A. Dietenberger

1999-01-01

Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

Aviation safety : FAA and DOD response to similar safety concerns

DOT National Transportation Integrated Search

2002-01-01

Report to the Honorable Norman Y. Mineta, Secretary of Transportation, and the Honorable Donald H. Rumsfeld, Secretary of Defense. : Safety of aircraft is a paramount concern in both civilian and military aviation. The Federal Aviation Administration...

Viewer discretion advised: is YouTube a friend or foe in surgical education?

PubMed

Rodriguez, H Alejandro; Young, Monica T; Jackson, Hope T; Oelschlager, Brant K; Wright, Andrew S

2018-04-01

In the current era, trainees frequently use unvetted online resources for their own education, including viewing surgical videos on YouTube. While operative videos are an important resource in surgical education, YouTube content is not selected or organized by quality but instead is ranked by popularity and other factors. This creates a potential for videos that feature poor technique or critical safety violations to become the most viewed for a given procedure. A YouTube search for "Laparoscopic cholecystectomy" was performed. Search results were screened to exclude animations and lectures; the top ten operative videos were evaluated. Three reviewers independently analyzed each of the 10 videos. Technical skill was rated using the GOALS score. Establishment of a critical view of safety (CVS) was scored according to CVS "doublet view" score, where a score of ≥5 points (out of 6) is considered satisfactory. Videos were also screened for safety concerns not listed by the previous tools. Median competence score was 8 (±1.76) and difficulty was 2 (±1.8). GOALS score median was 18 (±3.4). Only one video achieved adequate critical view of safety; median CVS score was 2 (range 0-6). Five videos were noted to have other potentially dangerous safety violations, including placing hot ultrasonic shears on the duodenum, non-clipping of the cystic artery, blind dissection in the hepatocystic triangle, and damage to the liver capsule. Top ranked laparoscopic cholecystectomy videos on YouTube show suboptimal technique with half of videos demonstrating concerning maneuvers and only one in ten having an adequate critical view of safety. While observing operative videos can be an important learning tool, surgical educators should be aware of the low quality of popular videos on YouTube. Dissemination of high-quality content on video sharing platforms should be a priority for surgical societies.

Novel strategies in immunotherapy for allergic diseases

PubMed Central

Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, HP

2018-01-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended. PMID:29732290

Safety of High Speed Guided Ground Transportation Systems - An Overview of Biological Effects and Mechanisms Relevant to EMF Exposures from Mass Transit and Electric Rail Systems

DOT National Transportation Integrated Search

1993-08-01

The U.S. has implemented a national initiative to develop maglev (magnetic levitation) and other high-speed rail (HSR) : systems. There are concerns for potential adverse health effects of the Extremely Lou Frequency (3-3,000 Hz) electric : and magne...

Different responses to soy and estradiol in the reproductive system of prepubertal male rats and neonatal male pigs

USDA-ARS?s Scientific Manuscript database

Concerns have been raised regarding the safety of soy infant formula based on phytochemical components such as genistein, structurally similar to estradiol (E2). To examine potential estrogenic actions on male development, we fed weanling male rats casein-based or soy protein isolate (SPI)-based die...

The Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds - Background and Exposure Research Goals.

EPA Science Inventory

Concerns have been raised by the public about the safety of recycled tire crumb rubber used in synthetic turf fields and playgrounds in the United States (U.S.). Several studies have been identified that examine potential exposure to tire crumb rubber infill in these settings. Th...

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.

Medical abortion: understanding perspectives of rural and marginalized women from rural South India.

PubMed

Sri, B Subha; Ravindran, T K Sundari

2012-09-01

To understand how rural and other groups of marginalized women define safe abortion; their perspectives and concerns regarding medical abortion (MA); and what factors affect their access to safe abortion. Focus group discussions were held with various groups of rural and marginalized women in Tamil Nadu to understand their perspectives and concerns on abortion, especially MA. Nearly a decade after mifepristone was approved for abortion in India, most study participants had never heard of MA. When they learned of the method, most preferred it over other methods of abortion. The women also had questions and concerns about the method and recommendations on how services should be provided. Their definition of a "safe abortion" included criteria beyond medical safety. They placed a high priority on "social safety," including confidentiality and privacy. In their view, factors affecting access to safe abortion and choice of provider included cost, assurance of secrecy, promptness of service provision, and absence of provider gatekeeping and provider-imposed conditions for receiving services. Women's preference for MA shows the potential of this technology to address the problem of unsafe abortion in India. Women need better access to information and services to realize this potential, however. Women's preferences regarding information dissemination and service provision need to be taken into account if policies and programs are to be truly responsive to the needs of marginalized women. Copyright © 2012. Published by Elsevier Ireland Ltd.

Antidepressant use in the elderly: the role of pharmacodynamics and pharmacokinetics in drug safety.

PubMed

Sultana, Janet; Spina, Edoardo; Trifirò, Gianluca

2015-06-01

Antidepressants (ADs) are widely used among elderly persons, making AD-related safety an important issue. This review highlights safety considerations related to AD use including risks associated with inappropriate and off-label use. The age-related pharmacokinetic and pharmacodynamic changes underlying safety concerns connected to ADs are outlined. Drug-drug interactions as a cause of AD-related adverse drug reactions (ADRs) are also discussed. We reviewed scientific evidence concerning three important safety outcomes related to ADs in elderly persons: cardiac arrhythmias, hyponatraemia and falls/fractures. Several AD-related ADRs in elderly people are likely to be preventable. Current evidence suggests that selective serotonin re-uptake inhibitors (SSRIs) are best avoided particularly in persons with kidney disease due to the risk of hyponatraemia. The use of tricyclic antidepressants (TCAs) should be limited in the elderly due to anticholinergic adverse effects. TCAs should also be avoided in elderly persons at high risk of cardiovascular events due to a risk of cardiac arrhythmia. Emerging evidence suggests that SSRIs also have arrhythmogenic potential. Both TCAs and SSRIs should be used cautiously in elderly persons at risk of falls. Future research in this area should aim to investigate the lowest effective dose of AD possible, the relationship between AD dose and adverse effects, and which elderly subgroups are most prone to develop severe ADRs.

The relationship between safety net activities and hospital financial performance

PubMed Central

2010-01-01

Background During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. Methods The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. Results We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. Conclusions Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population. PMID:20074367

Safety of Nanotechnology in Food Industries

PubMed Central

Amini, Seyed Mohammad; Gilaki, Marzieh; Karchani, Mohsen

2014-01-01

The arrival of nanotechnology in various industries has been so rapid and widespread because of its wide-ranging applications in our daily lives. Nutrition and food service is one of the biggest industries to be affected by nanotechnology in all areas, changing even the nature of food itself. Whether it’s farming, food packaging, or the prevention of microbial contamination the major food industries have seen dramatic changes because of nanotechnology. Different nanomaterials such as nanopowders, nanotubes, nano-fibers, quantum dots, and metal and metal-oxide nanoparticles are globally produced in large quantities due to their broad applicability in food-related industries. Because of the unique properties of nanostructures and nanomaterials – such as a large surface area, high activity, and small size, there is some concern about the potential for harmful adverse effects of used nanomaterials on health or the environment. However, because of tremendous advances in different industries, this concern may be unnecessary. This paper presents some uses of nanomaterials in food and related industries and their possible side-effects. This review covers the various aspects of nanomaterials and their impact on human exposure, safety, and environmental concerns. PMID:25763176

Fire safety of wood construction

Treesearch

Robert H. White; Mark A. Dietenberger

2010-01-01

Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements and related fire performance data are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Because basic data...

Machine and Woodworking Tool Safety. Module SH-24. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on machine and woodworking tool safety is one of 50 modules concerned with job safety and health. This module discusses specific practices and precautions concerned with the efficient operation and use of most machine and woodworking tools in use today. Following the introduction, 13 objectives (each keyed to a page in the…

ViSTREET: An Educational Virtual Environment for the Teaching of Road Safety Skills to School Students

NASA Astrophysics Data System (ADS)

Chuah, Kee Man; Chen, Chwen Jen; Teh, Chee Siong

Virtual reality (VR) has been prevalently used as a tool to help students learn and to simulate situations that are too hazardous to practice in real life. The present study aims to explore the capability of VR to achieve these two purposes and demonstrate a novel application of the result, using VR to help school students learn about road safety skills, which are impractical to be carried out in real-life situations. This paper describes the system design of the VR-based learning environment known as Virtual Simulated Traffics for Road Safety Education (ViSTREET) and its various features. An overview of the technical procedures for its development is also included. Ultimately, this paper highlights the potential use of VR in addressing the learning problem concerning road safety education programme in Malaysia.

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

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

1976-01-01

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

Sharpening the focus on occupational safety and health in nanotechnology.

PubMed

Schulte, Paul; Geraci, Charles; Zumwalde, Ralph; Hoover, Mark; Castranova, Vincent; Kuempel, Eileen; Murashov, Vladimir; Vainio, Harri; Savolainen, Kai

2008-12-01

Increasing numbers of workers are involved with the production, use, distribution, and disposal of nanomaterials. At the same time, there is a growing number of reports of adverse biological effects of engineered nanoparticles in test systems. It is useful, at this juncture, to identify critical questions that will help address knowledge gaps concerning the potential occupational hazards of these materials. The questions address (i) hazard classification of engineered nanoparticles, (ii) exposure metrics, (iii) the actual exposures to the different engineered nanoparticles in the workplace, (iv) the limits of engineering controls and personal protective equipment with respect to engineered nanoparticles, (v) the kinds of surveillance programs that may be required at workplaces to protect potentially exposed workers, (vi) whether exposure registers should be established for workers potentially exposed to engineered nanoparticles, and, (vii) whether engineered nanoparticles should be treated as "new" substances and evaluated for safety and hazards?

Safety assessment of combination therapies in the treatment of obesity: focus on naltrexone/bupropion extended release and phentermine-topiramate extended release.

PubMed

Halpern, Bruno; Mancini, Marcio C

2017-01-01

Few studies on combination therapies for the treatment of obesity had been conducted until recently, when two fixed-dose combinations, bupropion-naltrexone ER fixed-dose combination and phentermine-topiramate ER titrated-dose combinations were evaluated in clinical studies that ultimately led to FDA approval. Areas covered: In this review, we discuss safety concerns about both combinations, the rationale and history of combination therapies for obesity (including phentermine plus fenfluramine), and possible future new combinations. Expert opinion: Combination therapies are a promising new area in obesity treatment, similar to what occurs with diabetes and hypertension. Safety assessment is highly important due to the high number of potential users on a chronic basis.

Software Safety Assurance of Programmable Logic

NASA Technical Reports Server (NTRS)

Berens, Kalynnda

2002-01-01

Programmable Logic (PLC, FPGA, ASIC) devices are hybrids - hardware devices that are designed and programmed like software. As such, they fall in an assurance gray area. Programmable Logic is usually tested and verified as hardware, and the software aspects are ignored, potentially leading to safety or mission success concerns. The objective of this proposal is to first determine where and how Programmable Logic (PL) is used within NASA and document the current methods of assurance. Once that is known, raise awareness of the PL software aspects within the NASA engineering community and provide guidance for the use and assurance of PL form a software perspective.

Drivers’ attitudes and behaviors toward bicyclists : intermodal interactions and implications for road safety.

DOT National Transportation Integrated Search

2017-06-01

Road safety concerns are a legitimate concern when promoting increased bicycle use. Currently, bicyclist traffic fatalities and injuries present both a public health concern and a disincentive to people taking up or continuing to bicycle for transpor...

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

NASA Astrophysics Data System (ADS)

Stevens, Kathryn J.

1997-01-01

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

Participation in a mentored quality-improvement program for insulin pen safety: Opportunity to augment internal evaluation and share with peers.

PubMed

Rosenberg, Amy F

2016-10-01

UF Health's participation in a mentored quality-improvement impact program for health professionals as part of an ASHP initiative-"Strategies for Ensuring the Safe Use of Insulin Pens in the Hospital"-is described. ASHP invited hospitals to participate in its initiative at a time when UF Health was evaluating the risks and benefits of insulin pen use due to external reports of safety concerns and making a commitment to continue insulin pen use and optimize safeguards. Improvement opportunities in insulin pen best practices and staff education on insulin pen preparation and injection technique were identified and implemented. The storage of insulin pens for patients with contact isolation precautions was identified as a problem in certain patient care areas, and a practical solution was devised. Other process improvements included implementation of barcode medication administration, with scanning of insulin pens designated for specific patients to avoid inadvertent and intentional sharing of pens among multiple patients. Mentored calls with teams at other hospitals conducted as part of the program provided the opportunity to share experiences and solutions to improve insulin pen use. Participating with a knowledgeable mentor and other hospital teams struggling with the same issues and concerns related to safe insulin pen use facilitated problem solving. Discussing challenges and sharing ideas for solutions to safety concerns with other hospitals identified new process enhancements, which have the potential to improve the safety of insulin pen use at UF Health. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

47 CFR 101.203 - Communications concerning safety of life and property.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 5 2013-10-01 2013-10-01 false Communications concerning safety of life and property. 101.203 Section 101.203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational Requirements § 101.203 Communications...

47 CFR 101.203 - Communications concerning safety of life and property.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Communications concerning safety of life and property. 101.203 Section 101.203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational Requirements § 101.203 Communications...

47 CFR 101.203 - Communications concerning safety of life and property.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 5 2014-10-01 2014-10-01 false Communications concerning safety of life and property. 101.203 Section 101.203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational Requirements § 101.203 Communications...

47 CFR 101.203 - Communications concerning safety of life and property.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Communications concerning safety of life and property. 101.203 Section 101.203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational Requirements § 101.203 Communications...

Bardoxolone brings Nrf2-based therapies to light.

PubMed

Zhang, Donna D

2013-08-10

The targeted activation of nuclear factor erythroid-derived-2-like 2 (Nrf2) to alleviate symptoms of chronic kidney disease has recently garnered much attention. Unfortunately, the greatest clinical success to date, bardoxolone, failed in phase III clinical trial for unspecified safety reasons. The present letter to the editor discusses the clinical development of bardoxolone and explores potential reasons for the ultimate withdrawal from clinical trials. In particular, was the correct clinical indication pursued and would improved specificity have mitigated the safety concerns? Ultimately, it is concluded that the right clinical indication and heightened specificity will lead to successful Nrf2-based therapies. Therefore, the bardoxolone clinical results do not dampen enthusiasm for Nrf2-based therapies; rather it illuminates the clinical potential of the Nrf2 pathway as a drug target.

Concussions in American Football.

PubMed

Womble, Melissa N; Collins, Michael W

Major advancements in sport-related concussion (SRC) management have been made across time to improve the safety of contact sports, including football. Nevertheless, these advances are often overlooked due to concerns regarding the potential long-term effects of SRC. Although further research is needed, it is critical that current efforts are focused on better understanding SRC in order to recognize and change ongoing factors leading to prolonged recoveries, increased risk for injury, and potentially long-term effects. To reduce risk for these outcomes, future focus must be placed on increased education efforts, immediate reporting of injury, prevention techniques, targeted treatment, and the development of multidisciplinary treatment teams nationwide. Finally, with the progress in understanding concussion, it is important to remain vigilant of additional advances that will help to further improve the safety of contact sports, including football.

Clinical governance breakdown: Australian cases of wilful blindness and whistleblowing.

PubMed

Cleary, Sonja; Duke, Maxine

2017-01-01

After their attempts to have patient safety concerns addressed internally were ignored by wilfully blind managers, nurses from Bundaberg Base Hospital and Macarthur Health Service felt compelled to 'blow the whistle'. Wilful blindness is the human desire to prefer ignorance to knowledge; the responsibility to be informed is shirked. To provide an account of instances of wilful blindness identified in two high-profile cases of nurse whistleblowing in Australia. Critical case study methodology using Fay's Critical Social Theory to examine, analyse and interpret existing data generated by the Commissions of Inquiry held into Bundaberg Base Hospital and Macarthur Health Service patient safety breaches. All data was publicly available and assessed according to the requirements of unobtrusive research methods and secondary data analysis. Ethical considerations: Data collection for the case studies relied entirely on publicly available documentary sources recounting and detailing past events. Data from both cases reveal managers demonstrating wilful blindness towards patient safety concerns. Concerns were unaddressed; nurses, instead, experienced retaliatory responses leading to a 'social crisis' in the organisation and to whistleblowing. Managers tasked with clinical governance must be aware of mechanisms with the potential to blind them. The human tendency to favour positive news and avoid conflict is powerful. Understanding wilful blindness can assist managers' awareness of the competing emotions occurring in response to ethical challenges, such as whistleblowing.

Potential of Organic Matrix Composites for Liquid Oxygen Tank

NASA Technical Reports Server (NTRS)

Davis, Samuel E.; Herald, Stephen D.; Stolzfus, Joel M.; Engel, Carl D.; Bohlen, James W.; Palm, Tod; Robinson, Michael J.

2005-01-01

Composite materials are being considered for the tankage of cryogenic propellants in access to space because of potentially lower structural weights. A major hurdle for composites is an inherent concern about the safety of using flammable structural materials in contact with liquid and gaseous oxygen. A hazards analysis approach addresses a series of specific concerns that must be addressed based upon test data. Under the 2nd Generation Reusable Launch Vehicle contracts, testing was begun for a variety of organic matrix composite materials both to aid in the selection of materials and to provide needed test data to support hazards analyses. The work has continued at NASA MSFC and the NASA WSTF to provide information on the potential for using composite materials in oxygen systems. Appropriate methods for oxygen compatibility testing of structural materials and data for a range of composite materials from impact, friction, flammability and electrostatic discharge testing are presented. Remaining concerns and conclusions about composite tank structures, and recommendations for additional testing are discussed. Requirements for system specific hazards analysis are identified.

Occupational health and safety issues among nurses in the Philippines.

PubMed

de Castro, A B; Cabrera, Suzanne L; Gee, Gilbert C; Fujishiro, Kaori; Tagalog, Eularito A

2009-04-01

Nursing is a hazardous occupation in the United States, but little is known about workplace health and safety issues facing the nursing work force in the Philippines. In this article, work-related problems among a sample of nurses in the Philippines are described. Cross-sectional data were collected through a self-administered survey during the Philippine Nurses Association 2007 convention. Measures included four categories: work-related demographics, occupational injury/illness, reporting behavior, and safety concerns. Approximately 40% of nurses had experienced at least one injury or illness in the past year, and 80% had experienced back pain. Most who had an injury did not report it. The top ranking concerns were stress and overwork. Filipino nurses encounter considerable health and safety concerns that are similar to those encountered by nurses in other countries. Future research should examine the work organization factors that contribute to these concerns and strengthen policies to promote health and safety.

Occupational Health and Safety Issues Among Nurses in the Philippines

PubMed Central

de Castro, A. B.; Cabrera, Suzanne L.; Gee, Gilbert C.; Fujishiro, Kaori; Tagalog, Eularito A.

2009-01-01

Nursing is a hazardous occupation in the United States, but little is known about workplace health and safety issues facing the nursing work force in the Philippines. In this article, work-related problems among a sample of nurses in the Philippines are described. Cross-sectional data were collected through a self-administered survey during the Philippine Nurses Association 2007 convention. Measures included four categories: work-related demographics, occupational injury/illness, reporting behavior, and safety concerns. Approximately 40% of nurses had experienced at least one injury or illness in the past year, and 80% had experienced back pain. Most who had an injury did not report it. The top ranking concerns were stress and overwork. Filipino nurses encounter considerable health and safety concerns that are similar to those encountered by nurses in other countries. Future research should examine the work organization factors that contribute to these concerns and strengthen policies to promote health and safety. PMID:19438081

Acceptability and Feasibility of Delivering Pentavalent Vaccines in a Compact, Prefilled, Autodisable Device in Vietnam and Senegal

PubMed Central

Guillermet, Elise; Dicko, Hamadou M.; Mai, Le Thi Phuong; N’Diaye, Mamadou; Hane, Fatoumata; Ba, Seydina Ousmane; Gomis, Khadidjatou; Tho, Nguyen Thi Thi; Lien, Nguyen Thi Phuong; Than, Phan Dang; Dinh, Tran Van; Jaillard, Philippe; Gessner, Bradford D.; Colombini, Anais

2015-01-01

Background Prefilled syringes are the standard in developed countries but logistic and financial barriers prevent their widespread use in developing countries. The current study evaluated use of a compact, prefilled, autodisable device (CPAD) to deliver pentavalent vaccine by field actors in Senegal and Vietnam. Methods We conducted a logistic, programmatic, and anthropological study that included a) interviews of immunization staff at different health system levels and parents attending immunization sessions; b) observation of immunization sessions including CPAD use on oranges; and c) document review. Results Respondents perceived that the CPAD would improve safety by being non-reusable and preventing needle and vaccine exposure during preparation. Preparation was considered simple and may reduce immunization time for staff and caretakers. CPAD impact on cold storage requirements depended on the current pentavalent vaccine being used; in both countries, CPAD would reduce the weight and volume of materials and safety boxes thereby potentially improving outreach strategies and waste disposal. CPAD also would reduce stock outages by bundling vaccine and syringes and reduce wastage by using a non-breakable plastic presentation. Respondents also cited potential challenges including ability to distinguish between CPAD and other pharmaceuticals delivered via a similar mechanism (such as contraceptives), safety, and concerns related to design and ease of administration (such as activation, ease of delivery, and needle diameter and length). Conclusions Compared to current pentavalent vaccine presentations in Vietnam and Senegal, CPAD technology will address some of the main barriers to vaccination, such as supply chain issues and safety concerns among health workers and families. Most of the challenges we identified can be addressed with health worker training, minor design modifications, and health messaging targeting parents and communities. Potentially the largest remaining barrier is the marginal increase in pentavalent cost – if any – from CPAD use, which we did not assess in our study. PMID:26186456

When Vacant Lots Become Urban Gardens: Characterizing the Perceived and Actual Food Safety Concerns of Urban Agriculture in Ohio.

PubMed

Kaiser, Michelle L; Williams, Michele L; Basta, Nicholas; Hand, Michelle; Huber, Sarah

2015-11-01

This study was intended to characterize the perceived risks of urban agriculture by residents of four low-income neighborhoods in which the potential exists for further urban agriculture development and to provide data to support whether any chemical hazards and foodborne pathogens as potential food safety hazards were present. Sixty-seven residents participated in focus groups related to environmental health, food security, and urban gardening. In addition, soils from six locations were tested. Residents expressed interest in the development of urban gardens to improve access to healthy, fresh produce, but they had concerns about soil quality. Soils were contaminated with lead (Pb), zinc, cadmium (Cd), and copper, but not arsenic or chromium. Results from our study suggest paint was the main source of soil contamination. Detectable polyaromatic hydrocarbon (PAH) levels in urban soils were well below levels of concern. These urban soils will require further management to reduce Pb and possibly Cd bioavailability to decrease the potential for uptake into food crops. Although the number of locations in this study is limited, results suggest lower levels of soil contaminants at well-established gardens. Soil tillage associated with long-term gardening could have diluted the soil metal contaminants by mixing the contaminants with clean soil. Also, lower PAH levels in long-term gardening could be due to enhanced microbial activity and PAH degradation, dilution, or both due to mixing, similar to metals. No foodborne pathogen targets were detected by PCR from any of the soils. Residents expressed the need for clearness regarding soil quality and gardening practices in their neighborhoods to consume food grown in these urban areas. Results from this study suggest long-term gardening has the potential to reduce soil contaminants and their potential threat to food quality and human health and to improve access to fresh produce in low-income urban communities.

The potential effects of Ocimum basilicum on health: a review of pharmacological and toxicological studies.

PubMed

Sestili, Piero; Ismail, Tariq; Calcabrini, Cinzia; Guescini, Michele; Catanzaro, Elena; Turrini, Eleonora; Layla, Anam; Akhtar, Saeed; Fimognari, Carmela

2018-07-01

Basil (Ocimum basilicum L., OB) is a plant world widely used as a spice and a typical ingredient of the healthy Mediterranean diet. In traditional medicine, OB is indicated for many maladies and conditions; OB-containing nutritional supplements are increasingly sold. Conversely, safety concerns have been raised about the promutagens and procarcinogens alkenylbenzenes contained in OB. Areas covered: A critical review of the current status of OB as a nutraceutical, the pharmacology of its bioactive components, the rationale for its indications, and its safety. Expert opinion: Due to the polyphenolic and flavonoidic content, OB can be considered as an important ingredient in healthy diets; OB preparations may be effective as chemopreventive agents or adjunctive therapy in the treatment of different clinical conditions. From a toxicological perspective, since the tumorigenic potential of alkenylbenzenes is counteracted by other OB constituents such as nevadensin, it can be concluded that OB consumption in food and preparations is safe. The only concern relates to OB essential oils: in this case, a concentration limit for alkenylbenzenes should be precautionary defined, and the use of plant chemotypes with no or low levels of these alkylbenzenes for the preparation of essential oils should be made compulsory.

[Genetically modified food (food derived from biotechnology): current and future trends in public acceptance and safety assessment].

PubMed

Nishiura, Hiroshi; Imai, Hirohisa; Nakao, Hiroyuki; Tsukino, Hiromasa; Kuroda, Yoshiki; Katoh, Takahiko

2002-11-01

Current and future trends regarding genetically modified (GM) crops and food stuffs were reviewed, with a particular focus on public acceptance and safety assessment. While GM foods, foods derived from biotechnology, are popular with growers and producers, they are still a matter of some concern among consumers. In fact, our recent surveys showed that Japanese consumers had become uneasy about the potential health risks of genetically modified foods. Many Japanese consumers have only vague ideas about the actual health risks, and they appear to be making decisions simply by rejecting GM food because of non-informed doubts. Although the debate about GM foods has increased in the mass media and scientific journals, few articles concerning direct studies on the potential toxicity or adverse health effects of GM foods have appeared. The roles of relevant international regulatory bodies in ensuring that GM crops and food are safe are therefore have summarized. Finally, the current debate on use of GM crops in agriculture and future trends for development of GM foods with enriched nutrients, better functionality, and medicinal ingredients, which will be of direct benefit to the consumer, are covered.

Analysis of food taints and off-flavours: a review.

PubMed

Ridgway, K; Lalljie, S P D; Smith, R M

2010-02-01

Taints and off-flavours in foods are a major concern to the food industry. Identification of the compound(s) causing a taint or off-flavour in food and accurate quantification are critical in assessing the potential safety risks of a product or ingredient. Even when the tainting compound(s) are not at a level that would cause a safety concern, taints and off-flavours can have a significant impact on the quality and consumers' acceptability of products. The analysis of taints and off-flavour compounds presents an analytical challenge especially in an industrial laboratory environment because of the low levels, often complex matrices and potential for contamination from external laboratory sources. This review gives an outline of the origins of chemical taints and off-flavours and looks at the methods used for analysis and the merits and drawbacks of each technique. Extraction methods and instrumentation are covered along with possible future developments. Generic screening methods currently lack the sensitivity required to detect the low levels required for some tainting compounds and a more targeted approach is often required. This review highlights the need for a rapid but sensitive universal method of extraction for the unequivocal determination of tainting compounds in food.

Analysis of eighty-four commercial aviation incidents - Implications for a resource management approach to crew training

NASA Technical Reports Server (NTRS)

Murphy, M. R.

1980-01-01

A resource management approach to aircrew performance is defined and utilized in structuring an analysis of 84 exemplary incidents from the NASA Aviation Safety Reporting System. The distribution of enabling and associated (evolutionary) and recovery factors between and within five analytic categories suggests that resource management training be concentrated on: (1) interpersonal communications, with air traffic control information of major concern; (2) task management, mainly setting priorities and appropriately allocating tasks under varying workload levels; and (3) planning, coordination, and decisionmaking concerned with preventing and recovering from potentially unsafe situations in certain aircraft maneuvers.

Knowledge and concerns related to the human papillomavirus vaccine among underserved Latina women.

PubMed

Wu, Justine P; Porch, Emily; McWeeney, Michelle; Ohman-Strickland, Pamela; Levine, Jeffrey P

2010-07-01

This study's purpose was to assess knowledge and concerns related to the human papillomavirus (HPV) vaccine among underserved Latina women and Latina mothers of female adolescents and to explore differences between those in the vaccinated and those in the unvaccinated groups. We conducted cross-sectional written surveys of 206 Latina women at an urban health center in central New Jersey. Participants included vaccine-eligible women and mothers of vaccine-eligible adolescents. We calculated descriptive statistics, Fisher exact tests, and corresponding risk ratios (RRs) with 95% CIs. Of those who had heard of HPV (71%), 80% knew that HPV is a sexually transmitted infection. Fewer understood the causative link between HPV and cervical cancer (58%) and genital warts (45%). Vaccine safety was the most frequently cited concern. Unvaccinated women and mothers of unvaccinated daughters were more worried that the vaccine could promote risky sexual behavior (RR = 1.6, 95% CI = 1.2-2.1) and more likely to believe that they or their daughters were not at risk for HPV infection (RR = 1.2, 95% CI = 1.1-1.4). To maximize HPV vaccination rates among underserved Latinas, concerns about vaccine safety, potential effects on sexual behavior, and self-perceptions of risk for HPV infection must be addressed.

An Asian perspective on GMO and biotechnology issues.

PubMed

Teng, Paul P S

2008-01-01

Of the 102 million hectares that made up the global area of biotech crops in 2006, less than 8% (7.6 million ha) were in Asia. Three biotech crops are currently planted in significant areas in four Asian countries with government regulatory approval; namely, cotton, corn (maize), and canola. However, the amount of GM crop material imported into the Asian region for processing into food and animal feed is very substantial, and almost every country imports GM food. The issues which concern Asian scientists, regulators, and the lay public resemble those of other regions - biosafety, food safety, ethics and social justice, competitiveness, and the "EU" trade question. Most Asian countries now have regulatory systems for approving the commercialization of GM crops, and for approving food safety of GM crops. In Asia, because of the varied cultures, issues concerning the use of genes derived from animals arouse much emotion for religious and diet choice reasons. Because many Asian producers and farmers are small-scale, there is also concern about technology dependency and to whom the benefits accrue. All consumers surveyed have expressed concern about potential allergenic and long-term toxic effects, neither of which is grounded on scientific facts. Because of Asia's growing demand for high volumes of quality food, it is likely that GM crops will become an increasing feature of our diet.

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Code of Federal Regulations, 2014 CFR

2014-01-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Code of Federal Regulations, 2012 CFR

2012-01-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Code of Federal Regulations, 2011 CFR

2011-01-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Code of Federal Regulations, 2013 CFR

2013-07-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Code of Federal Regulations, 2010 CFR

2010-07-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

Safety in the veterinary medical workplace environment. Common issues and concerns.

PubMed

Brody, M D

1993-09-01

This article addresses some of the major areas of concern related to safety in the veterinary workplace. Some practical guidance is offered for setting up programs in areas such as medical waste, hazard communication, general occupational safety and health requirements, shipments of etiologic agents, and pesticides.

Caregivers' concerns about judgment and safety of patients with brain injury: a preliminary investigation.

PubMed

Kreutzer, Jeffrey S; Livingston, Lee A; Everley, Rachel S; Gary, Kelli W; Arango-Lasprilla, Juan Carlos; Powell, Victoria D; Marwitz, Jennifer H

2009-08-01

To identify caregivers' most common concerns about the judgment and safety of patients with brain injury in home and community environments. To quantify caregivers' stress levels and their level of comfort leaving patients at home unsupervised and examine the interrelationships between caregivers' safety and judgment ratings, stress levels, and levels of comfort leaving patients unattended. Retrospective, cross-sectional design. Outpatient brain injury neuropsychology clinic at a university medical center. A convenience sample of 121 caregivers of traumatic brain injury survivors at least 1 month postinjury and 18 years of age or older. Scores in 9 domains from the Judgment and Safety Screening Inventory; ratings of stress levels and levels of comfort leaving patients at home unattended derived from the General Health and History Questionnaire. Caregivers' most common judgment and safety-related concerns were in the Travel and Financial domains, with many reflecting patients' memory deficits. Heightened caregiver stress levels were prevalent. Higher levels of concern about judgment and safety were associated with higher stress levels and concerns about leaving patients unattended. Consistent with research on patients with other types of neurological disorders, concerns about driving and financial management among caregivers are prevalent. Additional research is needed to identify the most cost-effective methods of evaluating patients and enabling them to function at their highest level in the community.

Recent advances in green nanoparticulate systems for drug delivery: efficient delivery and safety concern.

PubMed

Lam, Pik-Ling; Wong, Wai-Yeung; Bian, Zhaoxiang; Chui, Chung-Hin; Gambari, Roberto

2017-02-01

Nanotechnology manipulates therapeutic agents at the nanoscale for the development of nanomedicines. However, there are current concerns over nanomedicines, mainly related to the possible toxicity of nanomaterials used for health medications. Due to their small size, they can enter the human body more readily than larger sized particles. Green chemistry encompasses the green synthesis of drug-loaded nanoparticles by reducing the use of hazardous materials in the synthesis process, thus reducing the adverse health impacts of pharmaceutics. This would greatly expand their potential in biomedical treatments. This review highlights the potential risks of nanomedicine formulations to health, delivery routes of green nanomedicines, recent advances in the development of green nanoscale systems for biomedical applications and future perspectives for the green development of nanomedicines.

State of art of nanotechnology applications in the meat chain: A qualitative synthesis.

PubMed

Belluco, Simone; Gallocchio, Federica; Losasso, Carmen; Ricci, Antonia

2018-05-03

Nanotechnology is a promising area in industry with a broad range of applications including in the agri-food sector. Several studies have investigated the potential benefits deriving from use of nanomaterials in the context of the whole food chain drawing scenarios of benefits but also potential for concerns. Among the agri-food sector, animal production has potential for nanomaterial application but also for safety concerns due to the possibility of nanomaterial accumulation along the farm-to-fork path. Scope and Approach: The aim of this work was to define the state of the art of nanomaterial applications in the animal production sector by assessing data belonging to recently publishes studies. To do this, a qualitative synthesis approach was applied to build a fit-for-purpose framework and to summarise relevant themes in the context of effectiveness, feasibility and health concerns. Key findings and conclusions: Nanomaterials have potential for use in a wide range of applications from feed production and farming to food packaging, including several detection tools designed for the benefit of consumer protection. The current high degree of variability in nanomaterials tested and in study designs impairs external validation of research results. Further research is required to clearly define which safe nanomaterial applications have the potential to reach the market.

Knowledge and attitude of Turkish parents regarding car safety seats for children.

PubMed

Sevketoğlu, Esra; Hatipoğlu, Sami; Esin, Gülbaran; Oztora, Serdar

2009-09-01

One of the major causes of death among children younger than 15 years is vehicular injury. Car safety seats protect children in a crash if they are used correctly. The objective of this study was to assess the level of parental knowledge and their attitudes regarding car safety seats. The survey was conducted in May and June 2007 at Bakirkoy Dr. Sadi Konuk Research-Training Hospital. Randomly selected parents were asked to complete an anonymous self-administered questionnaire after providing informed consent. Five hundred thirty-two Turkish parents were sampled. Twenty-eight percent of the parents did not know what a car safety seat was. While 20% of parents reported using a car safety seat, only 10% used them correctly. Car safety seat use was correlated with higher socioeconomic status. Increased education of parents regarding the proper use of child safety seats can protect children from potentially fatal injuries. Health care professionals are obligated to give information to parents regarding car safety seats and their proper use. This study should alert planners and policy makers regarding the need to implement educational prevention programs concerning car safety for children in Turkey.

“We can’t get along without each other”: Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety

PubMed Central

Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia

2017-01-01

Objectives Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. Design A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Results Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Conclusions Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard. PMID:28358886

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

PubMed

Gagliardi, Anna R; Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia; Urbach, David R

2017-01-01

Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Safety issues with herbal products.

PubMed

Marrone, C M

1999-12-01

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

41 CFR 102-80.20 - What are Federal agencies' responsibilities concerning the abatement of radon?

Code of Federal Regulations, 2010 CFR

2010-07-01

... agencies' responsibilities concerning the abatement of radon? 102-80.20 Section 102-80.20 Public Contracts... REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Radon § 102-80.20 What are Federal agencies' responsibilities concerning the abatement of radon? Federal...

41 CFR 102-80.20 - What are Federal agencies' responsibilities concerning the abatement of radon?

Code of Federal Regulations, 2011 CFR

2011-01-01

... agencies' responsibilities concerning the abatement of radon? 102-80.20 Section 102-80.20 Public Contracts... REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Radon § 102-80.20 What are Federal agencies' responsibilities concerning the abatement of radon? Federal...

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

Do the potential benefits outweigh the risks? An update on the use of ziconotide in clinical practice.

PubMed

Bäckryd, E

2018-04-10

Ziconotide is a selective and potent blocker of N-type voltage-gated calcium channels. It was approved by the Food and Drug Administration in 2004 and by the European Medicines Agency in 2005 for the treatment of severe chronic pain in patients needing intrathecal analgesia (ITA). The aim of this paper is to provide a practitioner-oriented, educational, narrative, up-to-date review on the use of ziconotide in clinical pain medicine. Of special concern regarding safety is the partial incongruity between dosing statements in the Summary of Product Characteristics and novel low-dosage, slow uptitration recommendations. Even though ziconotide has obvious advantages compared to opioids, pain practitioners pondering the use of ziconotide nonetheless have to balance its proved potential analgesic effect against its neurological side effects, with special consideration being given to dosing and neuropsychiatric dangers. Using a seesaw analogy, the paper discusses what factors pain physicians should weigh in when considering ziconotide as ITA drug, the non-opioid advantages of ziconotide being counterbalanced by its potential psychiatric side effects. Ziconotide is an important part of the armamentarium of modern interventional pain medicine. If ITA is deemed necessary, ziconotide is a rational alternative, at least in chronic (neuropathic) non-cancer pain. However, in many European countries, ziconotide treatment is only available in a few (if any) centres. The safety profile of ziconotide is not fundamentally more worrying than that of opioids or cannabinoids; it is just different. This paper provides a concise, up-to-date and clinically-oriented summary of the use of ziconotide in clinical practice, not least concerning safety and dosage issues. © 2018 European Pain Federation - EFIC®.

Blowing Dust on Highway Safety: Characterizing and Modeling of Dust Emission Hot Spots in the Southern Plains

NASA Astrophysics Data System (ADS)

Blackwell, J., III; Li, J. J.; Kandakji, T.; Collins, J. D., Jr.; Lee, J.; Gill, T. E.

2016-12-01

Blowing dust and highway safety have become increasingly prevalent problems concerning human safety and welfare. Two factors precipitate wind-blown dust accidents: sudden loss of visibility, and loss of traction due to soil particles on the road surface. The project, using remote sensing and in situ measurements of surface and subsurface characteristics, will identify the location of dust emission "hotspots" and associated geomorphic features within the southwest region and panhandle (New Mexico, Texas, and Oklahoma), measure the threshold shear velocity and vegetative cover and model the results. The results of this study will provide critical information for land managers, policy makers, and highway authorities when making timely and informed potentially life-saving decisions and modifications here, in the southwest region and panhandle, as well as, anywhere else in the world where blowing dust is a hazard to highway safety.

Safety of inhaled corticosteroids in the treatment of persistent asthma.

PubMed Central

Peters, Stephen P.

2006-01-01

OBJECTIVE: Inhaled corticosteroids (ICSs) are the most effective medications available for patients with persistent asthma of all severities and currently are recommended as the preferred asthma controller therapy by the National Heart, Lung and Blood Institute. Nevertheless, lingering concerns about potential adverse systemic effects of ICSs contribute to their underuse. This review discusses the safety of ICSs with respect to potential systemic effects of most concern to physicians and patients. METHODS: Articles reporting on the safety of ICSs in children and adults with persistent asthma were identified from the Medline database from January 1966 through December 2003, reference lists of review articles and international respiratory meetings. RESULTS: Ocular effects of ICSs and ICS effects on bone mineral density and adrenal function are minimal in patients maintained on recommended ICS doses. One-year growth studies in children have shown decreased growth velocity with ICSs, but long-term studies with inhaled budesonide and beclomethasone show no effect on final adult height, suggesting that these effects are transient. In addition, extensive data from the Swedish Medical Birth Registry show no increased risk of adverse perinatal outcomes when inhaled budesonide is administered to pregnant women with asthma. CONCLUSIONS: ICSs have minimal systemic effects in most patients when taken at recommended doses. The benefits of ICS therapy clearly outweigh the risks of uncontrolled asthma, and ICSs should be prescribed routinely as first-line therapy for children and adults with persistent disease. PMID:16775906

Sexual assault consultations - from high risk to high reliability.

PubMed

Cunningham, Nicola

2012-02-01

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

Occupational safety and health implications of increased coal utilization.

PubMed Central

Bridbord, K; Costello, J; Gamble, J; Groce, D; Hutchison, M; Jones, W; Merchant, J; Ortmeyer, C; Reger, R; Wagner, W L

1979-01-01

An area of major concern in considering increased coal production and utilization is the health and safety of increased numbers of workers who mine, process, or utilize coal. Hazards related to mining activities in the past have been especially serious, resulting in many mine related accidental deaths, disabling injuries, and disability and death from chronic lung disease. Underground coal mines are clearly less safe than surface mines. Over one-third of currently employed underground miners experience chronic lung disease. Other stresses include noise and extremes of heat and cold. Newly emphasized technologies of the use of diesel powered mining equipment and the use of longwall mining techniques may be associated with serious health effects. Workers at coal-fired power plants are also potentially at risk of occupational diseases. Occupational safety and health aspects of coal mining are understood well enough today to justify implementing necessary and technically feasible and available control measures to minimize potential problems associated with increased coal production and use in the future. Increased emphasis on safety and health training for inexperienced coal miners expected to enter the work force is clearly needed. The recently enacted Federal Mine Safety and Health Act of 1977 will provide impetus for increased control over hazards in coal mining. PMID:540621

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

PubMed

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

2007-10-01

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

Aviation Safety Concerns for the Future

NASA Technical Reports Server (NTRS)

Smith, Brian E.; Roelen, Alfred L. C.; den Hertog, Rudi

2016-01-01

The Future Aviation Safety Team (FAST) is a multidisciplinary international group of aviation professionals that was established to identify possible future aviation safety hazards. The principle was adopted that future hazards are undesirable consequences of changes, and a primary activity of FAST became identification and prioritization of possible future changes affecting aviation. Since 2004, FAST has been maintaining a catalogue of "Areas of Change" (AoC) that could potentially influence aviation safety. The horizon for such changes is between 5 to 20 years. In this context, changes must be understood as broadly as possible. An AoC is a description of the change, not an identification of the hazards that result from the change. An ex-post analysis of the AoCs identified in 2004 demonstrates that changes catalogued many years previous were directly implicated in the majority of fatal aviation accidents over the past ten years. This paper presents an overview of the current content of the AoC catalogue and a subsequent discussion of aviation safety concerns related to these possible changes. Interactions among these future changes may weaken critical functions that must be maintained to ensure safe operations. Safety assessments that do not appreciate or reflect the consequences of significant interaction complexity will not be fully informative and can lead to inappropriate trade-offs and increases in other risks. The FAST strongly encourages a system-wide approach to safety risk assessment across the global aviation system, not just within the domain for which future technologies or operational concepts are being considered. The FAST advocates the use of the "Areas of Change" concept, considering that several possible future phenomena may interact with a technology or operational concept under study producing unanticipated hazards.

Cabin Safety Issues Related to Pre-Departure and Inflight Issues

NASA Technical Reports Server (NTRS)

Connell, Linda

2014-01-01

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

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements

PubMed Central

Sprouse, Alyssa A.

2016-01-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug–botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John’s wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug–botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug–botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. PMID:26438626

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements.

PubMed

Sprouse, Alyssa A; van Breemen, Richard B

2016-02-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug-botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John's wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug-botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug-botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues

DTIC Science & Technology

2011-03-25

commercialization, including environmental, health, and safety (EHS) concerns and their implications for workplace, environmental, food , and drug...development of technologies that will enable commercial scale manufacturing of nanotechnology materials and products; environmental, health, and safety (EHS...concerns; and maintenance of public confidence in its safety . Congress established programs, assigned responsibilities, and initiated research and

Early Childhood Safety Checklist #3: Kitchen and Food Preparation and Storage Areas.

ERIC Educational Resources Information Center

Aronson, Susan S.

1994-01-01

This checklist of 24 specific health and safety concerns dealing with kitchen and food preparation storage areas can be used by day-care staff to identify and correct hazardous conditions. Areas of concern include hand washing, refrigeration, cooking, trash disposal, cleanliness, fire safety, burn hazards, and adult supervision. (MDM)

78 FR 56745 - Bradley D. Bastow, D. O., South Haven, Michigan; Confirmatory Order Modifying License

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

... or document justification for not implementing the recommended actions. C. Safety Culture C.1. Within 30 days of the date of the Order, the licensee will document a written Safety Culture Policy that... concerned individual understands why the concern cannot be resolved. The Safety Culture Policy must iterate...

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

PubMed

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

2010-12-01

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

Regulatory Science in Professional Education.

PubMed

Akiyama, Hiroshi

2017-01-01

In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

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

PubMed Central

Ekor, Martins

2014-01-01

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

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.

14 CFR 189.3 - Kinds of messages accepted or relayed.

Code of Federal Regulations, 2012 CFR

2012-01-01

... address: (1) Distress messages and distress traffic. (2) Messages concerning the safety of human life. (3) Flight safety messages concerning— (i) Air traffic control, including— (A) Messages concerning aircraft...

Bardoxolone Brings Nrf2-Based Therapies to Light

PubMed Central

2013-01-01

Abstract The targeted activation of nuclear factor erythroid-derived-2-like 2 (Nrf2) to alleviate symptoms of chronic kidney disease has recently garnered much attention. Unfortunately, the greatest clinical success to date, bardoxolone, failed in phase III clinical trial for unspecified safety reasons. The present letter to the editor discusses the clinical development of bardoxolone and explores potential reasons for the ultimate withdrawal from clinical trials. In particular, was the correct clinical indication pursued and would improved specificity have mitigated the safety concerns? Ultimately, it is concluded that the right clinical indication and heightened specificity will lead to successful Nrf2-based therapies. Therefore, the bardoxolone clinical results do not dampen enthusiasm for Nrf2-based therapies; rather it illuminates the clinical potential of the Nrf2 pathway as a drug target. Antioxid. Redox Signal. 19, 517–518. PMID:23227819

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

NASA Astrophysics Data System (ADS)

Barletta, William

2016-05-01

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

Advanced Outage and Control Center: Strategies for Nuclear Plant Outage Work Status Capabilities

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

Gregory Weatherby

The research effort is a part of the Light Water Reactor Sustainability (LWRS) Program. LWRS is a research and development program sponsored by the Department of Energy, performed in close collaboration with industry to provide the technical foundations for licensing and managing the long-term, safe and economical operation of current nuclear power plants. The LWRS Program serves to help the US nuclear industry adopt new technologies and engineering solutions that facilitate the continued safe operation of the plants and extension of the current operating licenses. The Outage Control Center (OCC) Pilot Project was directed at carrying out the applied researchmore » for development and pilot of technology designed to enhance safe outage and maintenance operations, improve human performance and reliability, increase overall operational efficiency, and improve plant status control. Plant outage management is a high priority concern for the nuclear industry from cost and safety perspectives. Unfortunately, many of the underlying technologies supporting outage control are the same as those used in the 1980’s. They depend heavily upon large teams of staff, multiple work and coordination locations, and manual administrative actions that require large amounts of paper. Previous work in human reliability analysis suggests that many repetitive tasks, including paper work tasks, may have a failure rate of 1.0E-3 or higher (Gertman, 1996). With between 10,000 and 45,000 subtasks being performed during an outage (Gomes, 1996), the opportunity for human error of some consequence is a realistic concern. Although a number of factors exist that can make these errors recoverable, reducing and effectively coordinating the sheer number of tasks to be performed, particularly those that are error prone, has the potential to enhance outage efficiency and safety. Additionally, outage management requires precise coordination of work groups that do not always share similar objectives. Outage managers are concerned with schedule and cost, union workers are concerned with performing work that is commensurate with their trade, and support functions (safety, quality assurance, and radiological controls, etc.) are concerned with performing the work within the plants controls and procedures. Approaches to outage management should be designed to increase the active participation of work groups and managers in making decisions that closed the gap between competing objectives and the potential for error and process inefficiency.« less

Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

PubMed

Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

2016-02-01

This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. © 2015 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for SHIL.

Effects of environmental parameters on the dual-species biofilms formed by Escherichia coli O157:H7 and Ralstonia insidiosa, a strong biofilm producer isolated from a fresh-cut processing plant

USDA-ARS?s Scientific Manuscript database

Biofilm forming bacteria resident to food processing facilities are a food safety concern due to the potential of biofilms to harbor foodborne bacterial pathogens. When cultured together, Ralstonia insidiosa, a strong biofilm former frequently isolated from produce processing environments, has been ...

Speaking up about traditional and professionalism-related patient safety threats: a national survey of interns and residents.

PubMed

Martinez, William; Lehmann, Lisa Soleymani; Thomas, Eric J; Etchegaray, Jason M; Shelburne, Julia T; Hickson, Gerald B; Brady, Donald W; Schleyer, Anneliese M; Best, Jennifer A; May, Natalie B; Bell, Sigall K

2017-11-01

Open communication between healthcare professionals about care concerns, also known as 'speaking up', is essential to patient safety. Compare interns' and residents' experiences, attitudes and factors associated with speaking up about traditional versus professionalism-related safety threats. Anonymous, cross-sectional survey. Six US academic medical centres, 2013-2014. 1800 medical and surgical interns and residents (47% responded). Attitudes about, barriers and facilitators for, and self-reported experience with speaking up. Likelihood of speaking up and the potential for patient harm in two vignettes. Safety Attitude Questionnaire (SAQ) teamwork and safety scales; and Speaking Up Climate for Patient Safety (SUC-Safe) and Speaking Up Climate for Professionalism (SUC-Prof) scales. Respondents more commonly observed unprofessional behaviour (75%, 628/837) than traditional safety threats (49%, 410/837); p<0.001, but reported speaking up about unprofessional behaviour less commonly (46%, 287/628 vs 71%, 291/410; p<0.001). Respondents more commonly reported fear of conflict as a barrier to speaking up about unprofessional behaviour compared with traditional safety threats (58%, 482/837 vs 42%, 348/837; p<0.001). Respondents were also less likely to speak up to an attending physician in the professionalism vignette than the traditional safety vignette, even when they perceived high potential patient harm (20%, 49/251 vs 71%, 179/251; p<0.001). Positive perceptions of SAQ teamwork climate and SUC-Safe were independently associated with speaking up in the traditional safety vignette (OR 1.90, 99% CI 1.36 to 2.66 and 1.46, 1.02 to 2.09, respectively), while only a positive perception of SUC-Prof was associated with speaking up in the professionalism vignette (1.76, 1.23 to 2.50). Interns and residents commonly observed unprofessional behaviour yet were less likely to speak up about it compared with traditional safety threats even when they perceived high potential patient harm. Measuring SUC-Safe, and particularly SUC-Prof, may fill an existing gap in safety culture assessment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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.

Improving Student Concern for Safety in a Production Technology Lab through the Use of Teambuilding.

ERIC Educational Resources Information Center

Lacina, Dale Robert

The effectiveness of team building as a strategy for improving students' concern for safety in a production technology laboratory was examined in a study involving a group of grade 9 and 10 production technology students from an urban, lower-middle-class community in western Illinois. Students' safety test scores, teacher checklists, and…

Knowledge of Food and Drug Interactions among Nurses: Assessment Strategy for Continuing Education

ERIC Educational Resources Information Center

Enwerem, Nkechi M.; Okunji, Priscilla O.

2017-01-01

The effect of medication errors on patient quality care and safety is a critical ongoing concern requiring solutions. Although medication safety has been a concern of all healthcare professions, registered nurses play an important role in medication safety as patients' advocates. A cross sectional study with structured questionnaire on common FDI…

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

PubMed

Roberts, Sheila; Campbell, Anne

2017-01-12

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

FMDP reactor alternative summary report. Volume 1 - existing LWR alternative

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

Greene, S.R.; Bevard, B.B.

1996-10-07

Significant quantities of weapons-usable fissile materials [primarily plutonium and highly enriched uranium (HEU)] are becoming surplus to national defense needs in both the United States and Russia. These stocks of fissile materials pose significant dangers to national and international security. The dangers exist not only in the potential proliferation of nuclear weapons but also in the potential for environmental, safety, and health (ES&H) consequences if surplus fissile materials are not properly managed. This document summarizes the results of analysis concerned with existing light water reactor plutonium disposition alternatives.

Environmental contaminants of emerging concern in seafood – European database on contaminant levels

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

Vandermeersch, Griet, E-mail: griet.vandermeersch@ilvo.vlaanderen.be; Lourenço, Helena Maria; Alvarez-Muñoz, Diana

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called “contaminants of emerging concern” are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issuesmore » related to these contaminants has thus become urgent and imperative. A database ( (www.ecsafeseafooddbase.eu)), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. - Highlights: • Development of a European database regarding contaminants of emerging concern. • Current status on knowledge of human exposure, toxicity and legislation. • Review on the occurrence of contaminants of emerging concern in seafood.« less

A review of seafood safety after the deepwater horizon blowout.

PubMed

Gohlke, Julia M; Doke, Dzigbodi; Tipre, Meghan; Leader, Mark; Fitzgerald, Timothy

2011-08-01

The Deepwater Horizon (DH) blowout resulted in fisheries closings across the Gulf of Mexico. Federal agencies, in collaboration with impacted Gulf states, developed a protocol to determine when it is safe to reopen fisheries based on sensory and chemical analyses of seafood. All federal waters have been reopened, yet concerns have been raised regarding the robustness of the protocol to identify all potential harmful exposures and protect the most sensitive populations. We aimed to assess this protocol based on comparisons with previous oil spills, published testing results, and current knowledge regarding chemicals released during the DH oil spill. We performed a comprehensive review of relevant scientific journal articles and government documents concerning seafood contamination and oil spills and consulted with academic and government experts. Protocols to evaluate seafood safety before reopening fisheries have relied on risk assessment of health impacts from polycyclic aromatic hydrocarbon (PAH) exposures, but metal contamination may also be a concern. Assumptions used to determine levels of concern (LOCs) after oil spills have not been consistent across risk assessments performed after oil spills. Chemical testing results after the DH oil spill suggest PAH levels are at or below levels reported after previous oil spills, and well below LOCs, even when more conservative parameters are used to estimate risk. We recommend use of a range of plausible risk parameters to set bounds around LOCs, comparisons of post-spill measurements with baseline levels, and the development and implementation of long-term monitoring strategies for metals as well as PAHs and dispersant components. In addition, the methods, results, and uncertainties associated with estimating seafood safety after oil spills should be communicated in a transparent and timely manner, and stakeholders should be actively involved in developing a long-term monitoring strategy.

Safety Concerns Surrounding Quinolone Use in Children

PubMed Central

Patel, Karisma; Goldman, Jennifer L.

2016-01-01

Fluoroquinolones are highly effective antibiotics with many desirable pharmacokinetic and pharmacodynamic properties including high bioavailability, large volume of distribution, and a broad spectrum of antimicrobial activity. Despite their attractive profile as anti-infective agents, their use in children is limited, primarily due to safety concerns. In this review we highlight the pharmacological properties of fluoroquinolones and describe their current use in pediatrics. In addition, we provide a comprehensive assessment of the safety data associated with fluoroquinolone use in children. Although permanent or destructive arthropathy remains a significant concern, currently available data demonstrate that arthralgia and arthropathy are relatively uncommon in children and resolve following cessation of fluoroquinolone exposure without resulting in long-term sequelae. The concern for safety and risk of adverse events associated with pediatric fluoroquinolone use is likely driving the limited prescribing of this drug class in pediatrics. However, in adults, fluoroquinolones are the most commonly prescribed broad-spectrum antibiotics, resulting in the development of drug-resistant bacteria that can be challenging to treat effectively. The consequence of misuse and overuse of fluoroquinolones leading to drug resistance is a greater, but frequently overlooked, safety concern that applies to both children and adults and one that should be considered at the point of prescribing. PMID:26865283

Moving forward in plant food safety and security through NanoBioSensors: Adopt or adapt biomedical technologies?

PubMed

Sharma, Tarun K; Ramanathan, Rajesh; Rakwal, Randeep; Agrawal, Ganesh K; Bansal, Vipul

2015-05-01

Plant-based foods are integral part of our day-to-day diet. Increasing world population has put forth an ever increasing demand for plant-based foods, and food security remains a major concern. Similarly, biological, chemical, and physical threats to our food and increasing regulatory demands to control the presence of foreign species in food products have made food safety a growing issue. Nanotechnology has already established its roots in diverse disciplines. However, the food industry is yet to harness the full potential of the unique capabilities offered by this next-generation technology. While there might be safety concerns in regards to integration of nanoproducts with our food products, an aspect of nanotechnology that can make remarkable contribution to different elements of the food chain is the use of nanobiosensors and diagnostic platforms for monitoring food traceability, quality, safety, and nutritional value. This brings us to an important question that whether existing diagnostic platforms that have already been well developed for biomedical and clinical application are suitable for food industry or whether the demands of the food industry are altogether different that may not allow adoption/adaptation of the existing technology. This review is an effort to raise this important "uncomfortable" yet "timely" question. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis.

PubMed

Cai, Weiyan; Gu, Youyi; Cui, Huanqin; Cao, Yinyin; Wang, Xiaoliang; Yao, Yi; Wang, Mingyu

2018-01-01

Background: The mainstream medications for rheumatoid arthritis (RA) include conventional disease-modifying antirheumatic drugs (cDMARDs), which mostly are methotrexate (MTX), and biologic agents such as adalimumab (ADA), certolizumab (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX), and tocilizumab (TCZ). This network meta-analysis was aimed at evaluating the efficacy and safety of the medications above and interventions combining cDMARDs and biologic agents for patients with RA. Methods: PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched systematically for eligible randomized controlled trials (RCTs). Outcomes concerning efficacy and safety were evaluated utilizing odds ratios (ORs) and 95% credible intervals ( CrI ). The outcomes of efficacy would be evaluated through remission and American College of Rheumatology (ACR) scores. The surface under the cumulative ranking curve (SUCRA) was calculated to rank each treatment on each index. Results: A total of 20 RCTs with 9,047 patients were included, and the efficacy and safety of the concerning interventions for RA were evaluated. Compared with cDMARDs alone, TCZ+MTX, ETN+MTX, IFX+MTX, TCZ, and ADA+MTX showed significant statistical advantage on ACR20, ACR50, and ACR70. Apart from that, as for remission, TCZ+MTX, IFX+MTX, TCZ, and CZP+MTX performed better compared to cDMARDs alone. The SUCRA ranking also indicated that TCZ+MTX was the intervention with best ranking in the entire four efficacy indexes followed by ETX+MTX and IFX+MTX. However, there was no obvious difference among these medications compared with cDMARDs when it comes to safety, which need more specific studies on that. Conclusion: TCZ+MTX was potentially the most recommended combination of medications for RA due to its good performance in all outcomes of efficacy. ETX+MTX and IFX+MTX, which also performed well, could be introduced as alternative treatments. However, considering the adverse events, the treatments concerning should be introduced with caution.

Do aluminium-based phosphate binders continue to have a role in contemporary nephrology practice?

PubMed

Mudge, David W; Johnson, David W; Hawley, Carmel M; Campbell, Scott B; Isbel, Nicole M; van Eps, Carolyn L; Petrie, James J B

2011-05-13

Aluminium-containing phosphate binders have long been used for treatment of hyperphosphatemia in dialysis patients. Their safety became controversial in the early 1980's after reports of aluminium related neurological and bone disease began to appear. Available historical evidence however, suggests that neurological toxicity may have primarily been caused by excessive exposure to aluminium in dialysis fluid, rather than aluminium-containing oral phosphate binders. Limited evidence suggests that aluminium bone disease may also be on the decline in the era of aluminium removal from dialysis fluid, even with continued use of aluminium binders. The K/DOQI and KDIGO guidelines both suggest avoiding aluminium-containing binders. These guidelines will tend to promote the use of the newer, more expensive binders (lanthanum, sevelamer), which have limited evidence for benefit and, like aluminium, limited long-term safety data. Treating hyperphosphatemia in dialysis patients continues to represent a major challenge, and there is a large body of evidence linking serum phosphate concentrations with mortality. Most nephrologists agree that phosphate binders have the potential to meaningfully reduce mortality in dialysis patients. Aluminium is one of the cheapest, most effective and well tolerated of the class, however there are no prospective or randomised trials examining the efficacy and safety of aluminium as a binder. Aluminium continues to be used as a binder in Australia as well as some other countries, despite concern about the potential for toxicity. There are some data from selected case series that aluminium bone disease may be declining in the era of reduced aluminium content in dialysis fluid, due to rigorous water testing. This paper seeks to revisit the contemporary evidence for the safety record of aluminium-containing binders in dialysis patients. It puts their use into the context of the newer, more expensive binders and increasing concerns about the risks of calcium binders, which continue to be widely used. The paper seeks to answer whether the continued use of aluminium is justifiable in the absence of prospective data establishing its safety, and we call for prospective trials to be conducted comparing the available binders both in terms of efficacy and safety. © 2011 Mudge et al; licensee BioMed Central Ltd.

Do aluminium-based phosphate binders continue to have a role in contemporary nephrology practice?

PubMed Central

2011-01-01

Background Aluminium-containing phosphate binders have long been used for treatment of hyperphosphatemia in dialysis patients. Their safety became controversial in the early 1980's after reports of aluminium related neurological and bone disease began to appear. Available historical evidence however, suggests that neurological toxicity may have primarily been caused by excessive exposure to aluminium in dialysis fluid, rather than aluminium-containing oral phosphate binders. Limited evidence suggests that aluminium bone disease may also be on the decline in the era of aluminium removal from dialysis fluid, even with continued use of aluminium binders. Discussion The K/DOQI and KDIGO guidelines both suggest avoiding aluminium-containing binders. These guidelines will tend to promote the use of the newer, more expensive binders (lanthanum, sevelamer), which have limited evidence for benefit and, like aluminium, limited long-term safety data. Treating hyperphosphatemia in dialysis patients continues to represent a major challenge, and there is a large body of evidence linking serum phosphate concentrations with mortality. Most nephrologists agree that phosphate binders have the potential to meaningfully reduce mortality in dialysis patients. Aluminium is one of the cheapest, most effective and well tolerated of the class, however there are no prospective or randomised trials examining the efficacy and safety of aluminium as a binder. Aluminium continues to be used as a binder in Australia as well as some other countries, despite concern about the potential for toxicity. There are some data from selected case series that aluminium bone disease may be declining in the era of reduced aluminium content in dialysis fluid, due to rigorous water testing. Summary This paper seeks to revisit the contemporary evidence for the safety record of aluminium-containing binders in dialysis patients. It puts their use into the context of the newer, more expensive binders and increasing concerns about the risks of calcium binders, which continue to be widely used. The paper seeks to answer whether the continued use of aluminium is justifiable in the absence of prospective data establishing its safety, and we call for prospective trials to be conducted comparing the available binders both in terms of efficacy and safety. PMID:21569446

Airborne transmission of respiratory diseases.

PubMed

Baker, S A

1995-01-01

In surveys during the past decade, CEs and BMETs have reported an increasing frequency of respiratory illnesses they believed to be acquired as a result of their occupation. These illnesses varied from mild to severe in terms of long-term prognosis. With the increasing numbers of cases of drug-resistant organisms, respiratory infections are a growing concern for healthcare workers, employers, and government officials. Armed with a better knowledge base about symptoms, transmission and prevention, CEs and BMETs will be more aware of potential biohazardous situations and the necessary personal protective measures to be employed. Both the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDCP) have issued guidelines for preventing airborne transmission of infectious diseases. This paper addresses the respiratory illnesses reported by CEs and BMETs as occupational concerns, as well as briefly discussing potential epidemic pulmonary conditions.

Psychological predictors of problem mobile phone use.

PubMed

Bianchi, Adriana; Phillips, James G

2005-02-01

Mobile phone use is banned or illegal under certain circumstances and in some jurisdictions. Nevertheless, some people still use their mobile phones despite recognized safety concerns, legislation, and informal bans. Drawing potential predictors from the addiction literature, this study sought to predict usage and, specifically, problematic mobile phone use from extraversion, self-esteem, neuroticism, gender, and age. To measure problem use, the Mobile Phone Problem Use Scale was devised and validated as a reliable self-report instrument, against the Addiction Potential Scale and overall mobile phone usage levels. Problem use was a function of age, extraversion, and low self-esteem, but not neuroticism. As extraverts are more likely to take risks, and young drivers feature prominently in automobile accidents, this study supports community concerns about mobile phone use, and identifies groups that should be targeted in any intervention campaigns.

Today's challenges in pharmacovigilance: what can we learn from epoetins?

PubMed

Ebbers, Hans C; Mantel-Teeuwisse, Aukje K; Moors, Ellen H M; Schellekens, Huub; Leufkens, Hubert G

2011-04-01

Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of both pharmaceutical companies and regulators to characterize and minimize known and potential safety concerns. Concurrently, comprehensive surveillance systems are implemented, intended to identify and confirm adverse drug reactions, including the creation of large pharmacovigilance databases and the cooperation with epidemiological centres. Although the ambitions are high, not much is known about how effective all these measures are, or will be. In this review we analyse how the pharmacovigilance community has acted upon two adverse events associated with the use of erythropoiesis-stimulating agents: the sudden increase in pure red cell aplasia and the possible risk of tumour progression associated with these products. These incidents provide important insight for improving pharmacovigilance, but also pose new challenges for regulatory decision making.

Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics.

PubMed

Johnson, Wilbur; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

Formic acid functions as a fragrance ingredient, preservative, and pH adjuster in cosmetic products, whereas sodium formate functions as a preservative. Because of its acidic properties, formic acid is a dermal and ocular irritant. However, when used as a pH adjuster in cosmetic formulations, formic acid will be neutralized to yield formate salts, for example, sodium formate, thus minimizing safety concerns. Formic acid and sodium formate have been used at concentrations up to 0.2% and 0.34%, respectively, with hair care products accounting for the highest use concentrations of both ingredients. The low use concentrations of these ingredients in leave-on products and uses in rinse-off products minimize concerns relating to skin/ocular irritation or respiratory irritation potential. The Cosmetic Ingredient Review Expert Panel concluded that formic acid and sodium formate are safe in the present practices of use and concentration in cosmetics, when formulated to be nonirritating. © The Author(s) 2016.

Reducing Our Ignorance: Finding Answers to Certain Epistemic Questions for Software Systems

NASA Technical Reports Server (NTRS)

Holloway, C. Michael; Johnson, Christopher W.

2011-01-01

In previous papers, we asserted that software system safety is primarily concerned with epistemic questions, that is, questions concerning knowledge and the degree of confidence that can be placed in that knowledge. We also enumerated a set of 21 foundational epistemic questions, discussed some of the difficulties that exist in answering these questions adequately today, and speculated briefly on possible research that may provide improved confidence in the sufficiency of answers in the future. This paper focuses on three of the foundational questions. For each of these questions, current answers are discussed and potential research is proposed to help increase the justifiable level of confidence.

Confronting Safety Gaps across Labor and Delivery Teams

PubMed Central

Maxfield, David G.; Lyndon, Audrey; Kennedy, Holly Powell; O’Keeffe, Dan; Zlatnik, Marya G.

2013-01-01

We assessed the occurrence of four safety concerns among labor and delivery teams: dangerous shortcuts, missing competencies, disrespect, and performance problems. 3282 participants completed surveys. 92% of physicians (906/985), 93% of midwives (385/414), and 98% of nurses (1846/1884) observed at least one concern within the preceding year. A majority of respondents said these concerns undermined patient safety, harmed patients, or led them to seriously consider transferring or leaving their positions. Only 9% of physicians, 13% of midwives, and 13% of nurses shared their full concerns with the person involved. Organizational silence is evident within labor and delivery teams. Improvement will require multiple strategies, employed at the personal, social, and structural levels. PMID:23871951

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

PubMed

Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Applications and toxicity of graphene family nanomaterials and their composites

PubMed Central

Singh, Zorawar

2016-01-01

Graphene has attracted much attention of scientific community due to its enormous potential in different fields, including medical sciences, agriculture, food safety, cancer research, and tissue engineering. The potential for widespread human exposure raises safety concerns about graphene and its derivatives, referred to as graphene family nanomaterials (GFNs). Due to their unique chemical and physical properties, graphene and its derivatives have found important places in their respective application fields, yet they are being found to have cytotoxic and genotoxic effects too. Since the discovery of graphene, a number of researches are being conducted to find out the toxic potential of GFNs to different cell and animal models, finding their suitability for being used in new and varied innovative fields. This paper presents a systematic review of the research done on GFNs and gives an insight into the mode and action of these nanosized moieties. The paper also emphasizes on the recent and up-to-date developments in research on GFNs and their nanocomposites for their toxic effects. PMID:27051278

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

PubMed

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

2017-05-08

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

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

PubMed Central

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

2017-01-01

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

Safety assessment of plant food supplements (PFS).

PubMed

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

2011-12-01

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

Engineered inorganic nanoparticles and cosmetics: facts, issues, knowledge gaps and challenges.

PubMed

Wiechers, Johann W; Musee, Ndeke

2010-10-01

The cosmetic industry is among the first adaptors of nanotechnology through the use of engineered nanoparticles (ENPs) to enhance the performance of their products and meet the customers' needs. Recently, there have been increasing concerns from different societal stakeholders (e.g., governments, environmental activist pressure groups, scientists, general public, etc.) concerning the safety and environmental impact of ENPs used in cosmetics. This review paper seeks to address the twin concerns of the safety of cosmetics and the potential environmental impacts due to the constituent chemicals-the ENPs. The safety aspect is addressed by examining recently published scientific data on the possibility of ENPs penetrating human skin. Data indicates that although particular types of ENPs can penetrate into the skin, until now no penetration has been detected beyond the stratum corneum of the ENPs used in cosmetics. Yet, important lessons can be learned from the more recent studies that identify the characteristics of ENPs penetrating into and permeating through human skin. On the part of the environmental impact, the scientific literature has very limited or none existent specific articles addressing the environmental impacts of ENPs owing to the cosmetic products. Therefore, general ecotoxicological data on risk assessment of ENPs has been applied to ascertain if there are potential environmental impacts from cosmetics. Results include some of the first studies on the qualitative and quantitative risk assessment of ENPs from cosmetics and suggest that further research is required as the knowledge is incomplete to make definitive conclusions as is the case with skin penetration. The authors conclude that the cosmetic industry should be more transparent in its use of nanotechnology in cosmetic products to facilitate realistic risk assessments as well as scientists and pressure groups being accurate in their conclusions on the general applicability of their findings. Transparency in cosmetics needs nanotechnology, but nanotechnology in cosmetics also needs transparency...

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.

Quality and Safety Implications of Emergency Department Information Systems

PubMed Central

Farley, Heather L.; Baumlin, Kevin M.; Hamedani, Azita G.; Cheung, Dickson S.; Edwards, Michael R.; Fuller, Drew C.; Genes, Nicholas; Griffey, Richard T.; Kelly, John J.; McClay, James C.; Nielson, Jeff; Phelan, Michael P.; Shapiro, Jason S.; Stone-Griffith, Suzanne; Pines, Jesse M.

2013-01-01

The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services “meaningful use” incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals’ electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital’s or physician group’s approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system’s ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or enterprise systems. PMID:23796627

Space station internal environmental and safety concerns

NASA Technical Reports Server (NTRS)

Cole, Matthew B.

1987-01-01

Space station environmental and safety concerns, especially those involving fires, are discussed. Several types of space station modules and the particular hazards associated with each are briefly surveyed. A brief history of fire detection and suppression aboard spacecraft is given. Microgravity fire behavior, spacecraft fire detector systems, space station fire suppression equipment and procedures, and fire safety in hyperbaric chambers are discussed.

Patient Safety Executive Walkarounds

PubMed Central

Feitelberg, Steven P

2006-01-01

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

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

An update on anesthetics and impact on the brain.

PubMed

Fodale, Vincenzo; Tripodi, Vincenzo F; Penna, Olivia; Famà, Fausto; Squadrito, Francesco; Mondello, Epifanio; David, Antonio

2017-09-01

While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder. Expert opinion: Exposure to general anesthetics is potentially harmful to the human brain, and the consequent long-term cognitive deficits should be classified as an iatrogenic pathology, and considered a public health problem. The fact that in laboratory and clinical research only certain anesthetic agents and techniques, but not others, appear to be involved, raises the problem on what is the safest and the least safe anesthetic to maximize anesthesia efficiency, avoid occurrence of adverse events, and ensure patient safety. New trends in research are moving toward the theory that neuroinflammation could be the hallmark of, or could have a pivotal role in, several neurological disorders.

Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

PubMed Central

2016-01-01

Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.

PubMed

Antman, Elliott M

2017-05-23

Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The choices made by investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of cardiovascular safety can influence the ability to compare the standard and test agents. Multiple factors reflecting the conduct of a phase 4 RCT for a general medical condition may influence interpretation of a cardiovascular safety signal. The higher the rates of failure to adhere to the protocol and dropout from the study, the greater the risk of bias. Trials evaluating the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) when used for arthritis are difficult to conduct and even more challenging to interpret. Concerns include the comparison of drug regimens that do not provide comparable analgesic efficacy and problems with adherence to the protocol and retention in the study. On the basis of phase 4 RCTs of NSAIDs to date, it appears that a comparatively low dose of celecoxib administered to low-risk subjects is associated with approximately the same cardiovascular risk as NSAIDs with less cyclooxygenase-2 inhibitory activity, but at the cost of not controlling arthritic pain as effectively. © 2017 American Heart Association, Inc.

Influencing the Forgotten Half of the Population in Counterinsurgency Operations

DTIC Science & Technology

2008-03-01

and the constant threat of violence , it is often left to women to gather any remaining family and seek safety, sustenance, and shelter. When the family...Counterinsurgency Operations FORMAT: Strategy Research Project DATE: 20 March 2008 WORD COUNT: 6,392 PAGES: 30 KEY TERMS: Women , Gender Concerns...contact with indigenous populations, it is critical for the Army to understand and appreciate the capabilities and potential of indigenous women as

Concern-driven integrated approaches for the grouping, testing and assessment of nanomaterials.

PubMed

Landsiedel, Robert

2016-11-01

NM's potential to induce adverse effects in humans or the environment is being addressed in numerous research projects, and methods and tools for NM hazard identification and risk assessment are advancing. This article describes how integrated approaches for the testing and assessment of NMs can ensure the safety of nanomaterials, while adhering to the 3Rs principle. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review.

PubMed

Ahmed, Mansoor; Hwang, Jung Hye; Choi, Soojeung; Han, Dongwoon

2017-11-14

High prevalence of herbal medicines used in pregnancy and the lack of information on their safety is a public concern. Despite this, no significant research has been done regarding potential adverse effects of using herbal medicines during pregnancy, especially among developing Asian countries. Cross-sectional studies were searched up to year 2016 on PubMed/Medline and EMBASE, the data were extracted and quality of studies was assessed using the quality appraisal tool. The findings are reported in accordance to the PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Classification on safety of identified herbal medicines was done based on current scientific literature. This study included eight cross-sectional studies (2729 participants) from seven different Asian countries, of which 1283 (47.01%) women used one or more herbal medicines during pregnancy. Peppermint (22.8%), aniseed (14.7%), olibanum (12.9%), flixweed seed (12.2%) and ginger (11.5%) were the most frequently used herbal medicines. Out of the 33 identified herbal medicines, 13 were classified as safe to use, five as use with caution, eight were potentially harmful to use in pregnancy and information on seven herbal medicines was not available in the current literature. Several herbal medicines identified in this review were classified to be potentially harmful or the information regarding safety in pregnancy was missing. It is recommended that contraindicated herbal medicines should be avoided and other herbals should be taken under supervision of a qualified health care practitioner. The classification regarding safety of herbal medicines in pregnancy can be utilized to create awareness on prevention of adverse effects.

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.

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial.

PubMed

Nel, Annaléne; Martins, Janine; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides.

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial

PubMed Central

Nel, Annaléne; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Background Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. Methods 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. Results No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. Conclusions The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides. PMID:29813074

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

NASA Technical Reports Server (NTRS)

Huls, Dale thomas

2005-01-01

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

Food safety concerns deriving from the use of silver based food packaging materials.

PubMed

Pezzuto, Alessandra; Losasso, Carmen; Mancin, Marzia; Gallocchio, Federica; Piovesana, Alessia; Binato, Giovanni; Gallina, Albino; Marangon, Alberto; Mioni, Renzo; Favretti, Michela; Ricci, Antonia

2015-01-01

The formulation of innovative packaging solutions, exerting a functional antimicrobial role in slowing down food spoilage, is expected to have a significant impact on the food industry, allowing both the maintenance of food safety criteria for longer periods and the reduction of food waste. Different materials are considered able to exert the required antimicrobial activity, among which are materials containing silver. However, challenges exist in the application of silver to food contact materials due to knowledge gaps in the production of ingredients, stability of delivery systems in food matrices and health risks caused by the same properties which also offer the benefits. Aims of the present study were to test the effectiveness and suitability of two packaging systems, one of which contained silver, for packaging and storing Stracchino cheese, a typical Italian fresh cheese, and to investigate if there was any potential for consumers to be exposed to silver, via migration from the packaging to the cheese. Results did not show any significant difference in the effectiveness of the packaging systems on packaged Stracchino cheese, excluding that the active packaging systems exerted an inhibitory effect on the growth of spoilage microorganisms. Moreover, silver migrated into the cheese matrix throughout the storage time (24 days). Silver levels in cheese finally exceeded the maximum established level for the migration of a non-authorised substance through a functional barrier (Commission of the European Communities, 2009). This result poses safety concerns and strongly suggests the need for more research aimed at better characterizing the new packaging materials in terms of their potential impacts on human health and the environment.

Psychiatric education in the correctional setting: challenges and opportunities.

PubMed

Holoyda, Brian J; Scott, Charles L

2017-02-01

As the need for mental healthcare services within correctional settings in the US increases, so does the need for a mental health workforce that is motivated to work within such systems. One potentially effective method by which to increase the number of psychiatrists working in jails, prisons, and parole clinics is to provide exposure to these environments during their training. Correctional settings can serve as unique training sites for medical students and psychiatric residents and fellows. Such training experiences can provide a host of benefits to both trainees and staff within the correctional mental health system. Alongside many potential benefits exist substantial potential barriers to coordinating correctional training experiences, including both programme directors' and residents' concerns regarding safety and enjoyment and negative perceptions of inmate and prisoner patients. The establishment of academic affiliations with correctional institutions and didactic instruction on commonly encountered clinical issues with inmate populations may be methods of diffusing these concerns. Improving residents' and fellows' training experiences offers a hope for increasing the attractiveness of a career in correctional psychiatry.

Driving and dementia: Efficient approach to driving safety concerns in family practice.

PubMed

Lee, Linda; Molnar, Frank

2017-01-01

To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

A comparative safety review between GLP-1 receptor agonists and SGLT2 inhibitors for diabetes treatment.

PubMed

Consoli, Agostino; Formoso, Gloria; Baldassarre, Maria Pompea Antonia; Febo, Fabrizio

2018-03-01

Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it is more and more important to gather and discuss information about their safety profile. Area Covered: adverse events and the safety concerns most often emerged in trials with GLP-1RA namely, exenatide long acting release (LAR), dulaglutide, liraglutide, semaglutide, lixisenatide or SGLT2i, namely empagliflozin, dapagliflozin, canagliflozin and SGLT2i with an attempt at comparing the safety profiles of molecules of these two classes. Expert opinion: GLP-1RA and SGLT2i, although each associated with different specific side effects, share a 'similar' safety profile and are both drugs relatively easy to handle. The potentially complementary mechanisms of action, the cardio and nephroprotective effects demonstrated by molecules of both classes, make these drugs potentially useful even in add on to each other.

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

PubMed

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

2013-02-01

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

Problems of ergonomics in Bali, Indonesia.

PubMed

Manuaba, A

1976-12-01

Development in Indonesia, particularly in Bali, has been planned and done through several stages of the Five-Year Development Programs, which started in 1969, and emphasized intensification of agriculture and extensification of industries related to potential resources available in the region. In the process, industrialization, being regarded as a prerequisite to higher living standards, brought with it problems concerning safety, health, and work conditions, especially with respect to transfer of technology. As examples, experiences and data, related particularly to ergonomics in the sectors of agriculture, hotel business, textile mills, transportation, and others in Bali, Indonesia, are reported. In dealing with such possible consequences of development, efforts to find fundamental solutions should be given the highest priority. It is necessary to make use of all the existing institutions having potential functions and roles in the policy of development planning, and to take into consideration the factors of safety, health, and work conditions in specifying technical and financial development projects for industrialization.

Advanced low-activation materials. Fibre-reinforced ceramic composites

NASA Astrophysics Data System (ADS)

Fenici, P.; Scholz, H. W.

1994-09-01

A serious safety and environmental concern for thermonuclear fusion reactor development regards the induced radioactivity of the first wall and structural components. The use of low-activation materials (LAM) in a demonstration reactor would reduce considerably its potential risk and facilitate its maintenance. Moreover, decommissioning and waste management including disposal or even recycling of structural materials would be simplified. Ceramic fibre-reinforced SiC materials offer highly appreciable low activation characteristics in combination with good thermomechanical properties. This class of materials is now under experimental investigation for structural application in future fusion reactors. An overview on the recent results is given, covering coolant leak rates, thermophysical properties, compatibility with tritium breeder materials, irradiation effects, and LAM-consistent purity. SiC/SiC materials present characteristics likely to be optimised in order to meet the fusion application challenge. The scope is to put into practice the enormous potential of inherent safety with fusion energy.

Hospital board oversight of quality and safety: a stakeholder analysis exploring the role of trust and intelligence.

PubMed

Millar, Ross; Freeman, Tim; Mannion, Russell

2015-06-16

Hospital boards, those executive members charged with developing appropriate organisational strategies and cultures, have an important role to play in safeguarding the care provided by their organisation. However, recent concerns have been raised over boards' ability to enact their duty to ensure the quality and safety of care. This paper offers critical reflection on the relationship between hospital board oversight and patient safety. In doing so it highlights new perspectives and suggestions for developing this area of study. The article draws on 10 interviews with key informants and policy actors who form part of the 'issue network' interested in the promotion of patient safety in the English National Health Service. The interviews surfaced a series of narratives regarding hospital board oversight of patient safety. These elaborated on the role of trust and intelligence in highlighting the potential dangers and limitations of approaches to hospital board oversight which have been narrowly focused on a risk-based view of organisational performance. In response, a need to engage with the development of trust based organisational relationships is identified, in which effective board oversight is built on 'trust' characterised by styles of leadership and behaviours that are attentive to the needs and concerns of both staff and patients. Effective board oversight also requires the gathering and triangulating of 'intelligence' generated from both national and local information sources. We call for a re-imagination of hospital board oversight in the light of these different perspectives and articulate an emerging research agenda in this area.

Safety assessment and detection methods of genetically modified organisms.

PubMed

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

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

PubMed

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

2018-02-27

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

Evaluation of a school re-entry nursing intervention for children with cancer.

PubMed

McCarthy, A M; Williams, J; Plumer, C

1998-07-01

A retrospective qualitative design was used to identify and compare the concerns, parents, teachers, and children have regarding school re-entry after a cancer diagnosis and to describe the impact of a school re-entry program on parents', teachers', and children's concerns. Audiotaped, semistructured interviews were obtained from a convenience sample of 10 children with cancer (ages 5 to 13 years), 10 mothers, and nine teachers. All participants were positive about the school re-entry nursing intervention, which is described. Results of content analyses indicate that before the intervention, mothers were concerned about their child's safety and peer teasing; teachers were concerned about their own knowledge and peers' adjustment, and children were concerned with keeping up with school activities. After the intervention, mothers were less concerned about peer teasing but continued to be worried about their child's safety in the school setting and began to have concerns about academic progress and physical stamina; teachers reported increased concerns for the child's safety and academic progress, and a desire to return to normal routines in the classroom: and the children continued to have concerns with maintaining academic and/physical progress. Clinical and research implications are discussed.

Nanotechnology and glaucoma: a review of the potential implications of glaucoma nanomedicine.

PubMed

Kim, Nathaniel J; Harris, Alon; Gerber, Austin; Tobe, Leslie Abrams; Amireskandari, Annahita; Huck, Andrew; Siesky, Brent

2014-04-01

The purpose of this review is to discuss the evolution of nanotechnology and its potential diagnostic and therapeutic applications in the field of ophthalmology, particularly as it pertains to glaucoma. We reviewed literature using MEDLINE and PubMed databases with the following search terms: glaucoma, nanotechnology, nanomedicine, nanoparticles, ophthalmology and liposomes. We also reviewed pertinent references from articles found in this search. A brief history of nanotechnology and nanomedicine will be covered, followed by a discussion of the advantages and concerns of using this technology in the field of glaucoma. We will look at various studies concerning the development of nanomedicine, its potential applications in ocular drug delivery, diagnostic and imaging modalities and, surgical techniques. In particular, the challenges of assuring safety and efficacy of nanomedicine will be examined. We conclude that nanotechnology offers a novel approach to expanding diagnostic, imaging and surgical modalities in glaucoma and may contribute to the knowledge of disease pathogenesis at a molecular level. However, more research is needed to better elucidate the mechanism of cellular entry, the potential for nanoparticle cytotoxicity and the assurance of clinical efficacy.

Adolescent Workers' Experiences of and Training for Workplace Violence.

PubMed

Smith, Carolyn R; Gillespie, Gordon L; Beery, Theresa A

2015-07-01

Adolescent workers may not be aware that violence is a safety concern in the workplace. As part of a larger mixed-methods pilot study, investigators used a self-administered survey and individual interviews with 30 adolescent workers from a chain of food service stores in a Midwestern metropolitan area to explore experiences of workplace violence (WPV) and ways of learning WPV-specific information. Participants reported experiencing verbal and sexual harassment and robberies. Most participants reported awareness of WPV-specific policies and procedures at their workplace; the ways participants reported learning WPV-specific information varied. Findings support the need for occupational safety training to assist adolescent workers prevent and mitigate potential WPV. © 2015 The Author(s).

Ebola: Facing a New Transboundary Animal Disease?

PubMed Central

Feldmann, F.; Feldmann, H.

2016-01-01

Ebola viruses are zoonotic pathogens with the potential of causing severe viral hemorrhagic fever in humans and nonhuman primates. Bats have been identified as a reservoir for Ebola viruses but it remains unclear if transmission to an end host involves intermediate hosts. Recently, one of the Ebola species has been found in Philippine pigs raising concerns regarding animal health and food safety. Diagnostics have so far focused on human application, but enhanced pig surveillance and diagnostics, particularly in Asia, for Ebola virus infections seem to be needed to establish reasonable guidelines for public and animal health and food safety. Livestock vaccination against Ebola seems currently not justified but proper preparedness may include experimental vaccine approaches. PMID:23689898

RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

PubMed

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

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

PubMed

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

2012-07-01

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

Addressing safety liabilities of TfR bispecific antibodies that cross the blood-brain barrier.

PubMed

Couch, Jessica A; Yu, Y Joy; Zhang, Yin; Tarrant, Jacqueline M; Fuji, Reina N; Meilandt, William J; Solanoy, Hilda; Tong, Raymond K; Hoyte, Kwame; Luk, Wilman; Lu, Yanmei; Gadkar, Kapil; Prabhu, Saileta; Ordonia, Benjamin A; Nguyen, Quyen; Lin, Yuwen; Lin, Zhonghua; Balazs, Mercedesz; Scearce-Levie, Kimberly; Ernst, James A; Dennis, Mark S; Watts, Ryan J

2013-05-01

Bispecific antibodies using the transferrin receptor (TfR) have shown promise for boosting antibody uptake in brain. Nevertheless, there are limited data on the therapeutic properties including safety liabilities that will enable successful development of TfR-based therapeutics. We evaluate TfR/BACE1 bispecific antibody variants in mouse and show that reducing TfR binding affinity improves not only brain uptake but also peripheral exposure and the safety profile of these antibodies. We identify and seek to address liabilities of targeting TfR with antibodies, namely, acute clinical signs and decreased circulating reticulocytes observed after dosing. By eliminating Fc effector function, we ameliorated the acute clinical signs and partially rescued a reduction in reticulocytes. Furthermore, we show that complement mediates a residual decrease in reticulocytes observed after Fc effector function is eliminated. These data raise important safety concerns and potential mitigation strategies for the development of TfR-based therapies that are designed to cross the blood-brain barrier.

User-Centered Collaborative Design and Development of an Inpatient Safety Dashboard.

PubMed

Mlaver, Eli; Schnipper, Jeffrey L; Boxer, Robert B; Breuer, Dominic J; Gershanik, Esteban F; Dykes, Patricia C; Massaro, Anthony F; Benneyan, James; Bates, David W; Lehmann, Lisa S

2017-12-01

Patient safety remains a key concern in hospital care. This article summarizes the iterative participatory development, features, functions, and preliminary evaluation of a patient safety dashboard for interdisciplinary rounding teams on inpatient medical services. This electronic health record (EHR)-embedded dashboard collects real-time data covering 13 safety domains through web services and applies logic to generate stratified alerts with an interactive check-box function. The technological infrastructure is adaptable to other EHR environments. Surveyed users perceived the tool as highly usable and useful. Integration of the dashboard into clinical care is intended to promote communication about patient safety and facilitate identification and management of safety concerns. Copyright © 2017 The Joint Commission. All rights reserved.

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

PubMed

Thompson, Kirrilly; Matthews, Chelsea

2015-07-22

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

Exploiting Pharmacological Similarity to Identify Safety Concerns - Listen to What the Data Tells You.

PubMed

Muthas, Daniel; Boyer, Scott

2013-01-01

Whilst most new drugs are designed to act on a single target or a small number of targets, many do show broad pharmacological activity. In some cases this can be beneficial and necessary for efficacy and in others it can be detrimental, leading to increased safety liability. To probe off-target pharmacology most drug discovery programs include screening against a broad panel of targets that represent known troublesome pharmacology. Hits against any one of these targets can then be subjected to a risk assessment for potential safety problems in preclinical or clinical studies. In addition, the secondary pharmacology profile can also be thought of as an alternative description of the compound and as such can be used as a method for assessing 'similarity'. Consequently, inspection of the in vivo findings of pharmacological neighbors can give important insights into potential safety liabilities that are neither identified by pure chemical similarity searches nor by risk assessment on individual targets. Here we show that the pharmacological profile contains additional information as compared to chemical similarity, and also demonstrate how this can be used in the hazard assessment done during drug discovery and development. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A Tiered Approach for the Evaluation of the Safety of Botanicals Used as Dietary Supplements: An Industry Strategy.

PubMed

Roe, Amy L; McMillan, Donna A; Mahony, Catherine

2018-06-08

Exposure to botanicals in dietary supplements is increasing across many geographies; with increased expectations from consumers, regulators, and industry stewards centered on quality and safety of these products. We present a tiered approach to assess the safety of botanicals, and an in silico decision tree to address toxicity data gaps. Tier 1 describes a Threshold of Toxicologic Concern (TTC) approach that can be used to assess the safety of conceptual levels of botanicals. Tier 2 is an approach to document a history of safe human use for botanical exposures higher than the TTC. An assessment of botanical-drug interaction (BDI) may also be necessary at this stage. Tier 3 involves botanical chemical constituent identification and safety assessment and the in silico approach as needed. Our novel approaches to identify potential hazards and establish safe human use levels for botanicals is cost and time efficient and minimizes reliance on animal testing. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

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

Thermal decomposition of nano-enabled thermoplastics: Possible environmental health and safety implications

PubMed Central

Sotiriou, Georgios A.; Singh, Dilpreet; Zhang, Fang; Chalbot, Marie-Cecile G.; Spielman-Sun, Eleanor; Hoering, Lutz; Kavouras, Ilias G.; Lowry, Gregory V.; Wohlleben, Wendel; Demokritou, Philip

2015-01-01

Nano-enabled products (NEPs) are currently part of our life prompting for detailed investigation of potential nano-release across their life-cycle. Particularly interesting is their end-of-life thermal decomposition scenario. Here, we examine the thermal decomposition of a widely used NEP, namely thermoplastic nanocomposites, and assess the properties of the byproducts (released aerosol and residual ash) and possible environmental health and safety implications. We focus on establishing a fundamental understanding on the effect of thermal decomposition parameters, such as polymer matrix, nanofiller properties, decomposition temperature, on the properties of byproducts using a recently-developed lab-based experimental integrated platform. Our results indicate that thermoplastic polymer matrix strongly influences size and morphology of released aerosol, while there was minimal but detectable nano-release, especially when inorganic nanofillers were used. The chemical composition of the released aerosol was found not to be strongly influenced by the presence of nanofiller at least for the low, industry-relevant loadings assessed here. Furthermore, the morphology and composition of residual ash was found to be strongly influenced by the presence of nanofiller. The findings presented here on thermal decomposition/incineration of NEPs raise important questions and concerns regarding the potential fate and transport of released engineered nanomaterials in environmental media and potential environmental health and safety implications. PMID:26642449

Impacts of weatherization on indoor air quality: A field study of 514 homes.

PubMed

Pigg, S; Cautley, D; Francisco, P W

2018-03-01

Residential energy efficiency retrofits continue to be common in the United States, especially through governmental and utility programs. Because of the potential for reduced air exchange, there have been concerns raised regarding the potential for negative impacts on health and safety of residents when air sealing occurs. To address this concern, a study was undertaken in 2009-2010 to evaluate the indoor air quality impacts of weatherization performed through the U.S. Department of Energy's Weatherization Assistance Program. Testing was conducted on 514 homes throughout the United States. The results show that weatherization, as performed at the time of the study, could result in small but statistically significant increases in some indoor contaminants such as radon and humidity, while also reducing exposures to elevated carbon monoxide in some homes. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Legitimacy of concerns about caffeine and energy drink consumption.

PubMed

Wesensten, Nancy J

2014-10-01

Whether caffeine and energy drink consumption presents a critical emerging health problem is not currently known. Available evidence suggests that energy drink consumption represents a change in the ways in which individuals in the United States consume caffeine but that the amount of caffeine consumed daily has not appreciably increased. In the present review, the question of whether Americans are sleep deprived (a potential reason for using caffeine) is briefly explored. Reported rates of daily caffeine consumption (based on beverage formulation) and data obtained from both civilian and military populations in the United States are examined, the efficacy of ingredients other than caffeine in energy drinks is discussed, and the safety and side effects of caffeine are addressed, including whether evidence supports the contention that excessive caffeine/energy drink consumption induces risky behavior. The available evidence suggests that the main legitimate concern regarding caffeine and energy drink use is the potential negative impact on sleep but that, otherwise, there is no cause for concern regarding caffeine use in the general population. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products.

PubMed

Re, T A; Mooney, D; Antignac, E; Dufour, E; Bark, I; Srinivasan, V; Nohynek, G

2009-06-01

Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal irritation and sensitization of CF and CFE's are available, the risk of subchronic systemic toxicity following dermal application has not been evaluated. The threshold of toxicological concern (TTC) is a pragmatic, risk assessment based approach that has gained regulatory acceptance for food and has been recently adapted to address cosmetic ingredient safety. The purpose of this paper is to determine if the safe use of CF and CFE can be established based upon the TTC class for each of its known constituents. For each constituent, the concentration in the plant, the molecular weight, and the estimated skin penetration potential were used to calculate a maximal daily systemic exposure which was then compared to its corresponding TTC class value. Since the composition of plant extracts are variable, back calculation was used to determine the maximum acceptable concentration of a given constituent in an extract of CF. This paper demonstrates the utility and practical application of the TTC concept when used as a tool in the safety evaluation of botanical extracts.

Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

PubMed

Adams, David Z; Gruss, Richard; Abrahams, Alan S

2017-04-01

Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

The health and safety concerns of immigrant women workers in the Toronto sportswear industry.

PubMed

Gannagé, C M

1999-01-01

Immigrant women's conditions of work have worsened with new government and managerial strategies to restructure the Canadian apparel industry. Changes in occupational health and safety legislation have both given and taken away tools that immigrant women workers could use to improve the quality of their working lives. The author outlines a methodology for eliciting the health and safety concerns of immigrant women workers.

Cause for Concern: A Mixed-Methods Study of Campus Safety and Security Practices in United States-Mexico Border Institutions of Higher Education

ERIC Educational Resources Information Center

Holmes, Ryan Clevis

2014-01-01

Campus safety has been a source of concern since the 1990s. However, in 2007, the tragedy at the Virginia Polytechnic and State University sent a sense of alarm through many institutions of higher education. Immediately following this tragedy, institutions across the country began to evaluate and question their safety and security practices. While…

Repackaging of Intravenous Fat Emulsions: A Clinical Conundrum.

PubMed

Cober, M Petrea

2016-10-01

To accommodate small fluid volumes, repackaging of intravenous fat emulsions (IVFEs) is frequently performed in institutions providing parenteral nutrition to neonates and smaller pediatric patients. However, some consider this an unsafe practice. Concerns for potential administration errors leading to an overdose of IVFEs are weighed against the potential for microbial contamination from the repackaging process. The clinician providing pediatric nutrition support should tailor repackaging practices to ensure patient safety and quality. This discussion aims to describe the strengths and limitations surrounding IVFE repackaging to provide guidance regarding the practice. © 2016 American Society for Parenteral and Enteral Nutrition.

The immune boundaries for stem cell based therapies: problems and prospective solutions

PubMed Central

Abdelkrim, Hmadcha; Juan, Domínguez-Bendala; Jane, Wakeman; Mohamed, Arredouani; Bernat, Soria

2009-01-01

Stem cells have fascinated the scientific and clinical communities for over a century. Despite the controversy that surrounds this field, it is clear that stem cells have the potential to revolutionize medicine. However, a number of significant hurdles still stand in the way of the realization of this potential. Chiefly among these are safety concerns, differentiation efficiency and overcoming immune rejection. Here we review current progress made in this field to optimize the safe use of stem cells with particular emphasis on prospective interventions to deal with challenges generated by immune rejection. PMID:19583810

Health and safety needs in early care and education programs: what do directors, child health records, and national standards tell us?

PubMed

Alkon, Abbey; To, Kim; Mackie, Joanna F; Wolff, Mimi; Bernzweig, Jane

2010-01-01

To identify the overlapping and unique health and safety needs and concerns identified by early care and education (ECE) directors, health records, and observed compliance with national health and safety (NHS) standards. Cross-sectional study. 127 ECE programs from 5 California counties participated in the study, including 118 directors and 2,498 children's health records. Qualitative data were collected using standardized ECE directors' interviews to identify their health and safety concerns; and objective, quantitative data were collected using child health record reviews to assess regular health care, immunizations, health insurance, special health care needs, and screening tests and an observation Checklist of 66 key NHS standards collected by research assistants. The overlapping health and safety needs and concerns identified by the directors and through observations were hygiene and handwashing, sanitation and disinfection, supervision, and the safety of indoor and outdoor equipment. Some of the health and safety needs identified by only one assessment method were health and safety staff training, medical plans for children with special health care needs and follow-up on positive screening tests. Comprehensive, multimethod assessments are useful to identify health and safety needs and develop public health nursing interventions for ECE programs.

Novel lipophilic chloroquine analogues for a highly efficient gene transfer into gynecological tumors.

PubMed

Keil, O; Bojar, H; Prisack, H B; Dall, P

2001-10-08

Liposomal vectors based on cationic lipids have been proven to be an attractive alternative to viral vectors in gene therapy protocols with regard to safety and manufacturing concerns. In order to improve the transfection efficiency we have synthesized two novel carboxycholesteryl-modified chloroquine analogues. Due to their potential endosomal buffering capacity these compounds enable the efficient transfection of various gynecological tumors and therefore are promising reagents in gene therapy applications.

Building a Culture of Safety in Ophthalmology.

PubMed

Custer, Philip L; Fitzgerald, Matthew E; Herman, David C; Lee, Paul P; Cowan, Claude L; Cantor, Louis B; Bartley, George B

2016-09-01

Patient safety focused on a reduction in both procedural and diagnostic error is the number one concern of the United States healthcare system in the 21st century. The American Board of Ophthalmology has a longstanding interest in patient safety, and in 2015, teamed with the American Academy of Ophthalmology to convene all ophthalmology subspecialties and other prominent national organizations to address patient safety in ophthalmology. This article reviews the topic and highlights concerns for ophthalmologists. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Regulatory guidance concerning the applicability of the Federal Motor Carrier Safety regulations to texting by commercial motor vehicle drivers

DOT National Transportation Integrated Search

2010-01-10

The FMCSA announces regulatory guidance concerning texting while driving a commercial motor vehicle (CMV). The guidance is applicable to all interstate drivers of CMVs subject to the Federal Motor Carrier Safety Regulations (FMCSRs).

Are There Potential Safety Problems Concerning the Use of Electronic Performance-Tracking Systems? The Experience of a Multisport Elite Club.

PubMed

Medina, Daniel; Pons, Eduard; Gomez, Antonio; Guitart, Marc; Martin, Andres; Vazquez-Guerrero, Jairo; Camenforte, Ismael; Carles, Berta; Font, Roger

2017-09-01

Despite approval of the use of electronic performance-tracking systems (EPTSs) during competition by the International Football Association Board, other team-sport organizations and leagues have banned their use due to "safety concerns," with no evidence to support this assertion. The aim of the current brief report was to provide empirical evidence to support the widespread use of EPTSs across all sports by examining safety issues concerning their use in a multi-team-sport club. Five outdoor football teams (1st team, 2nd team, under 19 [U-19], under 18 [U-18], and 1st team female) and 3 indoor-sport (basketball, futsal, and handball) teams were monitored, accounting for a total of 63,734 h of training and 12,748 h of game time. A questionnaire was sent to all fitness coaches involved, and the clinical history was reviewed for every medical issue reported. Six minor chest contusions were recorded in female football goalkeepers wearing the frontal chest strap (3.17 episodes per 1000 training h). During training, 3 episodes of minor skin abrasion affecting the thoracic area due to wearing vests too tight were recorded in the U-19 football team (0.21 per 1000 h) and 2 episodes in U-18 (0.39 per 1000 h). It must be noted that none of these episodes resulted in lost days of training or games, and none required medical assistance. In conclusion, empirical evidence confirms that EPTSs are safe to use across team sports.

The photovoltaic industry on the path to a sustainable future--environmental and occupational health issues.

PubMed

Bakhiyi, Bouchra; Labrèche, France; Zayed, Joseph

2014-12-01

As it supplies solar power, a priori considered harmless for the environment and human health compared with fossil fuels, the photovoltaic (PV) industry seems to contribute optimally to reduce greenhouse gas emissions and, overall, to sustainable development. However, considering the forecast for rapid growth, its use of potentially toxic substances and manufacturing processes presenting health and safety problems may jeopardize its benefits. This paper aims to establish a profile of the PV industry in order to determine current and emerging environmental and health concerns. A review of PV system life cycle assessments, in light of the current state of the industry and its developmental prospects, reveals information deficits concerning some sensitive life cycle indicators and environmental impacts, together with incomplete information on toxicological data and studies of workers' exposure to different chemical and physical hazards. Although solar panel installation is generally considered relatively safe, the occupational health concerns related to the growing number of hazardous materials handled in the PV industry warrants an all-inclusive occupational health and safety approach in order to achieve an optimal equilibrium with sustainability. To prevent eco-health problems from offsetting the benefits currently offered by the PV industry, manufacturers should cooperate actively with workers, researchers and government agencies toward improved and more transparent research, the adoption of specific and stricter regulations, the implementation of preventive risk management of occupational health and safety and, lastly, greater responsibilization toward PV systems from their design until their end of life. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safer Electrolytes for Lithium-Ion Batteries: State of the Art and Perspectives.

PubMed

Kalhoff, Julian; Eshetu, Gebrekidan Gebresilassie; Bresser, Dominic; Passerini, Stefano

2015-07-08

Lithium-ion batteries are becoming increasingly important for electrifying the modern transportation system and, thus, hold the promise to enable sustainable mobility in the future. However, their large-scale application is hindered by severe safety concerns when the cells are exposed to mechanical, thermal, or electrical abuse conditions. These safety issues are intrinsically related to their superior energy density, combined with the (present) utilization of highly volatile and flammable organic-solvent-based electrolytes. Herein, state-of-the-art electrolyte systems and potential alternatives are briefly surveyed, with a particular focus on their (inherent) safety characteristics. The challenges, which so far prevent the widespread replacement of organic carbonate-based electrolytes with LiPF6 as the conducting salt, are also reviewed herein. Starting from rather "facile" electrolyte modifications by (partially) replacing the organic solvent or lithium salt and/or the addition of functional electrolyte additives, conceptually new electrolyte systems, including ionic liquids, solvent-free, and/or gelled polymer-based electrolytes, as well as solid-state electrolytes, are also considered. Indeed, the opportunities for designing new electrolytes appear to be almost infinite, which certainly complicates strict classification of such systems and a fundamental understanding of their properties. Nevertheless, these innumerable opportunities also provide a great chance of developing highly functionalized, new electrolyte systems, which may overcome the afore-mentioned safety concerns, while also offering enhanced mechanical, thermal, physicochemical, and electrochemical performance. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The impact of regulations, safety considerations and physical limitations on research progress at maximum biocontainment.

PubMed

Shurtleff, Amy C; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S; Bavari, Sina

2012-12-01

We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.

Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base.

PubMed

Ranapurwala, Shabbar I; Naumann, Rebecca B; Austin, Anna E; Dasgupta, Nabarun; Marshall, Stephen W

2018-06-03

The ongoing opioid epidemic has claimed more than a quarter million Americans' lives over the past 15 years. The epidemic began with an escalation of prescription opioid deaths and has now evolved to include secondary waves of illicit heroin and fentanyl deaths, while the deaths due to prescription opioid overdoses are still increasing. In response, the Centers for Disease Control and Prevention (CDC) moved to limit opioid prescribing with the release of opioid prescribing guidelines for chronic noncancer pain in March 2016. The guidelines represent a logical and timely federal response to this growing crisis. However, CDC acknowledged that the evidence base linking opioid prescribing to opioid use disorders and overdose was grades 3 and 4. Motivated by the need to strengthen the evidence base, this review details limitations of the opioid safety studies cited in the CDC guidelines with a focus on methodological limitations related to internal and external validity. Internal validity concerns were related to poor confounding control, variable misclassification, selection bias, competing risks, and potential competing interventions. External validity concerns arose from the use of limited source populations, historical data (in a fast-changing epidemic), and issues with handling of cancer and acute pain patients' data. We provide a nonexhaustive list of 7 recommendations to address these limitations in future opioid safety studies. Strengthening the opioid safety evidence base will aid any future revisions of the CDC guidelines and enhance their prevention impact. Copyright © 2018 John Wiley & Sons, Ltd.

The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment

PubMed Central

Shurtleff, Amy C.; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S.; Bavari, Sina

2012-01-01

We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review. PMID:23342380

Sociotechnical attributes of safe and unsafe work systems.

PubMed

Kleiner, Brian M; Hettinger, Lawrence J; DeJoy, David M; Huang, Yuang-Hsiang; Love, Peter E D

2015-01-01

Theoretical and practical approaches to safety based on sociotechnical systems principles place heavy emphasis on the intersections between social-organisational and technical-work process factors. Within this perspective, work system design emphasises factors such as the joint optimisation of social and technical processes, a focus on reliable human-system performance and safety metrics as design and analysis criteria, the maintenance of a realistic and consistent set of safety objectives and policies, and regular access to the expertise and input of workers. We discuss three current approaches to the analysis and design of complex sociotechnical systems: human-systems integration, macroergonomics and safety climate. Each approach emphasises key sociotechnical systems themes, and each prescribes a more holistic perspective on work systems than do traditional theories and methods. We contrast these perspectives with historical precedents such as system safety and traditional human factors and ergonomics, and describe potential future directions for their application in research and practice. The identification of factors that can reliably distinguish between safe and unsafe work systems is an important concern for ergonomists and other safety professionals. This paper presents a variety of sociotechnical systems perspectives on intersections between social--organisational and technology--work process factors as they impact work system analysis, design and operation.

Selecting indicators for patient safety at the health system level in OECD countries.

PubMed

McLoughlin, Vivienne; Millar, John; Mattke, Soeren; Franca, Margarida; Jonsson, Pia Maria; Somekh, David; Bates, David

2006-09-01

Concerns about patient safety have arisen with growing documentation of the extent and nature of harm. Yet there are no robust and meaningful data that can be used internationally to assess the extent of the problem and considerable methodological difficulties. This article describes a project undertaken as part of the Organization for Economic Cooperation and Development (OECD) Quality Indicator Project, which aimed at developing an initial set of patient safety indicators. Patient safety indicators from OECD countries were identified and then rated against three principal criteria: importance to patient safety, scientific soundness, and potential feasibility. Although some countries are developing multi-source monitoring systems, these are not yet mature enough for international exchange. This project reviewed routine data collections as a starting point. Of an initial set of 59 candidate indicators identified, 21 were selected which cover known areas of harm to patients. This project is an important initial step towards defining a usable set of patient safety indicators that will allow comparisons to be made internationally and will support mutual learning and quality improvement in health care. Measures of harm should be complemented over time with measures of effective improvement factors.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1992-01-01

The results of the Panel's activities are presented in a set of findings and recommendations. Highlighted here are both improvements in NASA's safety and reliability activities and specific areas where additional gains might be realized. One area of particular concern involves the curtailment or elimination of Space Shuttle safety and reliability enhancements. Several findings and recommendations address this area of concern, reflecting the opinion that safety and reliability enhancements are essential to the continued successful operation of the Space Shuttle. It is recommended that a comprehensive and continuing program of safety and reliability improvements in all areas of Space Shuttle hardware/software be considered an inherent component of ongoing Space Shuttle operations.

Confronting safety gaps across labor and delivery teams.

PubMed

Maxfield, David G; Lyndon, Audrey; Kennedy, Holly Powell; O'Keeffe, Daniel F; Zlatnik, Marya G

2013-11-01

We assessed the occurrence of 4 safety concerns among labor and delivery teams: dangerous shortcuts, missing competencies, disrespect, and performance problems. A total of 3282 participants completed surveys, and 92% of physicians (906 of 985), 93% of midwives (385 of 414), and 98% of nurses (1846 of 1884) observed at least 1 concern within the preceding year. A majority of respondents said these concerns undermined patient safety, harmed patients, or led them to seriously consider transferring or leaving their positions. Only 9% of physicians, 13% of midwives, and 13% of nurses shared their full concerns with the person involved. Organizational silence is evident within labor-and-delivery teams. Improvement will require multiple strategies, used at the personal, social, and structural levels. Copyright © 2013 Mosby, Inc. All rights reserved.

Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Maintenance Area

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

Not Available

1993-01-01

Tiger Team Assessments and Technical Safety Appraisals (TSA) were reviewed and evaluated for concerns in the Maintenance Area (MA). Two hundred and thirty one (231) maintenance concerns were identified by the Tiger Team Assessments and TSA reports. These recurring concerns appear below. A summary of the Noteworthy Practices that were identified and a compilation of the maintenance concerns for each performance objective that were not considered as recurring are also included. Where the Tiger Team Assessment and TSA identified the operating contractor or facility by name, the concern has been modified to remove the name while retaining the intent ofmore » the comment.« less

Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

McGreevy, Michael W.

1996-01-01

A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

Preservation of food products by irradiation.

PubMed

McGivney, W T

1988-01-01

The use of irradiation to preserve food has the potential to significantly enhance our capacity to maximize the quality and quantity of the food we consume. In a world in which distribution of food occurs across continents and in which malnourished populations are in dire need of basic food products, any safe, effective, and efficient means of preserving food is more than welcome. Irradiation, as a method for food preservation, has been studied for more than 30 years. This discussion focuses on this most recent method for the preservation of food with particular emphasis on its effects on the safety, nutritive, and aesthetic values of the food preserved by irradiation. The use of ionizing radiation as a method to preserve foods is one that has been demonstrated to be effective for a variety of food classes. Irradiation offers a means to decontaminate, disinfest, and retard the spoilage of the food supply. At the same time, it appears that the wholesomeness of these food products is maintained. Nutritive value can be sustained by use of effective doses of radiation. Concerns over the safety of irradiated food are rooted in questions regarding the potential induction of radioactivity, harmful radiolytic products, and pathogenic radiation-resistant or mutant strains of microorganisms. Research findings have allayed concerns over safety. However, more research is necessary to conclusively resolve these safety issues. Food irradiation is a promising technology that has and will contribute to our ability to feed the people of this world. This technology is but one of many available ways to preserve our greatest natural resource, the food supply. Enhancement of the ability to preserve food by irradiation will facilitate the distribution of food from fertile developed regions to the malnourished peoples of underdeveloped countries. It is in diminishing the problem of malnourishment and starvation that irradiation as a means to preserve food may find the greatest acceptance.

Massive parallelization of serial inference algorithms for a complex generalized linear model

PubMed Central

Suchard, Marc A.; Simpson, Shawn E.; Zorych, Ivan; Ryan, Patrick; Madigan, David

2014-01-01

Following a series of high-profile drug safety disasters in recent years, many countries are redoubling their efforts to ensure the safety of licensed medical products. Large-scale observational databases such as claims databases or electronic health record systems are attracting particular attention in this regard, but present significant methodological and computational concerns. In this paper we show how high-performance statistical computation, including graphics processing units, relatively inexpensive highly parallel computing devices, can enable complex methods in large databases. We focus on optimization and massive parallelization of cyclic coordinate descent approaches to fit a conditioned generalized linear model involving tens of millions of observations and thousands of predictors in a Bayesian context. We find orders-of-magnitude improvement in overall run-time. Coordinate descent approaches are ubiquitous in high-dimensional statistics and the algorithms we propose open up exciting new methodological possibilities with the potential to significantly improve drug safety. PMID:25328363

Ketorolac as an analgesic agent for infants and children after cardiac surgery: safety profile and appropriate patient selection.

PubMed

Jalkut, Meredith K

2014-01-01

Ketorolac has been used safely as an analgesic agent for children following cardiac surgery in selected populations. Controversy exists among institutions about the risks involved with this medication in this patient group. This article reviews the current literature regarding the safety of ketorolac for postoperative pain management in children after cardiac surgery. Specifically, concerns about renal dysfunction and increased bleeding risk are addressed. Additionally, the article details pharmacokinetics and potential benefits of ketorolac, such as its opioid-sparing effect. The literature reflects that the use of this medication is not well studied in certain pediatric cardiac patients such as neonates and those with single-ventricle physiology, and the safety of this medication in regards to these special populations is reviewed. In conclusion, ketorolac can be used in specific pediatric patients after cardiac surgery with minimal risk of bleeding or renal dysfunction with appropriate dosing and duration of use.

The oral and craniofacial relevance of chemically modified RNA therapeutics.

PubMed

Elangovan, Satheesh; Kormann, Michael S D; Khorsand, Behnoush; Salem, Aliasger K

2016-01-01

Several tissue engineering strategies in the form of protein therapy, gene therapy, cell therapy, and their combinations are currently being explored for oral and craniofacial regeneration and repair. Though each of these approaches has advantages, they all have common inherent drawbacks of being expensive and raising safety concerns. Using RNA (encoding therapeutic protein) has several advantages that have the potential to overcome these limitations. Chemically modifying the RNA improves its stability and mitigates immunogenicity allowing for the potential of RNA to become an alternative to protein and gene based therapies. This brief review article focuses on the potential of RNA therapeutics in the treatment of disorders in the oral and craniofacial regions.

The Oral and Craniofacial Relevance of Chemically Modified RNA Therapeutics

PubMed Central

Kormann, Michael S.D.; Khorsand, Behnoush

2016-01-01

Several tissue engineering strategies in the form of protein therapy, gene therapy, cell therapy and its combinations are currently being explored for oral and cranio-facial regeneration and repair. Though each of these approaches has advantages, they all have common inherent drawbacks of being expensive and raising safety concerns. Using RNA (encoding therapeutic protein) has several advantages that have the potential to overcome these limitations. Chemically modifying the RNA improves its stability and mitigates immunogenicity allowing for the potential of RNA to become an alternative to protein and gene based therapies. This brief review article focuses on the potential of RNA therapeutics in the treatment of disorders in the oral and craniofacial regions. PMID:26896600

The International Student Safety Debate: Moving beyond Denial

ERIC Educational Resources Information Center

Nyland, C.; Forbes-Mewett, H.; Marginson, S.

2010-01-01

In 2009 international student safety became an issue of immediate concern to Australian international education exporters following a series of demonstrations by Indian students and interventions by concerned foreign governments. With these developments the "industry" became fixated on how best to secure Australia's share of the…

49 CFR Appendix C to Part 209 - FRA's Policy Statement Concerning Small Entities

Code of Federal Regulations, 2010 CFR

2010-10-01

... new regulations, persistent safety concerns, emerging technology, and compliance issues. Also, FRA... history of compliance, FRA inspectors consider “such other factors as the immediate circumstances make... eliminating the safety hazard; the entity's culpability; the entity's compliance history; the entity's ability...

Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists.

PubMed

Kirschenbaum, Bonnie E

2009-12-15

To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists' concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as "brown bagging," raises concerns about product integrity and institutional liability. An institution's finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter's role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a fourth tier of drugs with a large copayment based on a substantial percentage of the cost of the drug. The number and cost of specialty drugs are expected to increase in the future. New approaches and reimbursement models are emerging to manage the high cost of new pharmaceuticals. Health-system pharmacists can improve drug safety and manage costs by collaborating with group purchasing organizations, establishing policies for brown bagging, and making efforts to reconcile drug therapy provided in different settings through traditional drug channels and specialty pharmacies or other restricted drug distribution systems.

Container lid gasket protective strip for double door transfer system

DOEpatents

Allen, Jr., Burgess M

2013-02-19

An apparatus and a process for forming a protective barrier seal along a "ring of concern" of a transfer container used with double door systems is provided. A protective substrate is supplied between a "ring of concern" and a safety cover in which an adhesive layer of the substrate engages the "ring of concern". A compressive foam strip along an opposite side of the substrate engages a safety cover such that a compressive force is maintained between the "ring of concern" and the adhesive layer of the substrate.

Roadway safety design workbook.

DOT National Transportation Integrated Search

2009-07-01

Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

Highway safety design workshops.

DOT National Transportation Integrated Search

2010-11-01

Highway safety is an ongoing concern for the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project develop...

Safety Guidelines for Field Data Collection

DOT National Transportation Integrated Search

2010-02-01

Safety concerns are always present when personnel are working near or adjacent to a highway. Safety considerations must include the workers as well as the motoring public. Construction safety has received extensive attention, but this research focuse...

49 CFR 1.94 - The National Highway Traffic Safety Administration.

Code of Federal Regulations, 2012 CFR

2012-10-01

... information system improvements, motorcyclist safety, and child safety restraints; administering a nationwide... concerning motor vehicle safety, including vehicle to vehicle and vehicle to infrastructure technologies and other new or advanced vehicle technologies; and investigating safety-related defects and non-compliance...

49 CFR 1.94 - The National Highway Traffic Safety Administration.

Code of Federal Regulations, 2014 CFR

2014-10-01

... information system improvements, motorcyclist safety, and child safety restraints; administering a nationwide... concerning motor vehicle safety, including vehicle to vehicle and vehicle to infrastructure technologies and other new or advanced vehicle technologies; and investigating safety-related defects and non-compliance...

49 CFR 1.94 - The National Highway Traffic Safety Administration.

Code of Federal Regulations, 2013 CFR

2013-10-01

... information system improvements, motorcyclist safety, and child safety restraints; administering a nationwide... concerning motor vehicle safety, including vehicle to vehicle and vehicle to infrastructure technologies and other new or advanced vehicle technologies; and investigating safety-related defects and non-compliance...

Annotated Bibliography of Rail Transit Safety, 1975-1980, with Emphasis on Safety Research and Development.

DOT National Transportation Integrated Search

1981-09-01

The bibliography provides a comprehensive review of published literature concerning rail transit safety and includes 186 annotated entries. The report covers domestic and foreign material on rail transit safety and related safety research and develop...

Application of elements of microbiological risk assessment in the food industry via a tiered approach.

PubMed

van Gerwen, Suzanne J C; Gorris, Leon G M

2004-09-01

Food safety control is a matter for concern for all parts of the food supply chain, including governments that develop food safety policy, food industries that must control potential hazards, and consumers who need to keep to the intended use of the food. In the future, food safety policy may be set using the framework of risk analysis, part of which is the development of (inter)national microbiological risk assessment (MRA) studies. MRA studies increase our understanding of the impact of risk management interventions and of the relationships among subsequent parts of food supply chains with regard to the safety of the food when it reaches the consumer. Application of aspects of MRA in the development of new food concepts has potential benefits for the food industry. A tiered approach to applying MRA can best realize these benefits. The tiered MRA approach involves calculation of microbial fate for a product and process design on the basis of experimental data (e.g., monitoring data on prevalence) and predictive microbiological models. Calculations on new product formulations and novel processing technologies provide improved understanding of microbial fate beyond currently known boundaries, which enables identification of new opportunities in process design. The outcome of the tiered approach focuses on developing benchmarks of potential consumer exposure to hazards associated with new products by comparison with exposure associated with products that are already on the market and have a safe history of use. The tiered prototype is a tool to be used by experienced microbiologists as a basis for advice to product developers and can help to make safety assurance for new food concepts transparent to food inspection services.

The potential for bias in reporting of industry-sponsored clinical trials.

PubMed

Pyke, Stephen; Julious, Steven A; Day, Simon; O'Kelly, Michael; Todd, Susan; Matcham, James; Seldrup, Jorgen

2011-01-01

Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell. In 2005 an Editorial in Journal of the American Medical Association made clear that, so great was their concern about misleading reporting of industry-sponsored studies, henceforth no article would be published that was not also guaranteed by independent statistical analysis. We examine the precursors to this Editorial, as well as its immediate and lasting effects for statisticians, for the manner in which statistical analysis is carried out, and for the industry more generally. Copyright © 2010 John Wiley & Sons, Ltd.

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

PubMed

Cox, Leonie G; Simpson, Alan

2015-12-01

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

Ecological Threshold for Toxicological Concern (eco-TTC): exploring the importance of non-standard species

EPA Science Inventory

The Threshold for Toxicological Concern (TTC) is well-established for assessing human safety of indirect food-contact substances and has been applied to a variety of endpoints. Recently, we have proposed an extension to the human safety TTC concept for environmental applications,...

School Safety Concerns All Students.

ERIC Educational Resources Information Center

Henderson, Megan

1999-01-01

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

Human factors and ergonomics in home care: Current concerns and future considerations for health information technology

PubMed Central

Or, Calvin K.L.; Valdez, Rupa S.; Casper, Gail R.; Carayon, Pascale; Burke, Laura J.; Brennan, Patricia Flatley; Karsh, Ben-Tzion

2010-01-01

Sicker patients with greater care needs are being discharged to their homes to assume responsibility for their own care with fewer nurses available to aid them. This situation brings with it a host of human factors and ergonomic (HFE) concerns, both for the home care nurse and the home dwelling patient, that can affect quality of care and patient safety. Many of these concerns are related to the critical home care tasks of information access, communication, and patient self-monitoring and self-management. Currently, a variety of health information technologies (HITs) are being promoted as possible solutions to those problems, but those same technologies bring with them a new set of HFE concerns. This paper reviews the HFE considerations for information access, communication, and patients self-monitoring and self-management, discusses how HIT can potentially mitigate current problems, and explains how the design and implementation of HIT itself requires careful HFE attention. PMID:19713630

Associations of perceived neighborhood safety and crime with cardiometabolic risk factors among a population with type 2 diabetes.

PubMed

Tamayo, Aracely; Karter, Andrew J; Mujahid, Mahasin S; Warton, E Margaret; Moffet, Howard H; Adler, Nancy; Schillinger, Dean; Hendrickson O'Connell, Bethany; Laraia, Barbara

2016-05-01

Little is known about how neighborhood crime may relate to health in diabetes patients. We examined associations between individuals' perceptions of neighborhood safety or violent crime and stress, physical activity, body mass index (BMI) or hemoglobin A1c (HbA1c) in a sample (n=721) of adults (mean age:63) with diabetes. Self-reported neighborhood safety, violent crime, physical activity, and stress were collected and linked to clinical measures of BMI and HbA1c. Approximately 54% and 15% of patients reported neighborhood safety concerns and violent crimes, respectively. Any neighborhood safety concerns (β=1.14, 95% C.I. 0.04-2.24) and violent crime (β=2.04, 95% C.I. 0.34-3.73) were associated with BMI in adjusted analysis. Any violent crime was associated with class II-III obesity (BMI≥35) (OR=1.34, 95% C.I.: 1.02, 1.75). There were no significant associations between neighborhood safety concerns or violent crime with stress, physical activity, or HbA1c. Neighborhood safety is associated with BMI and obesity. Further studies, including longitudinal designs, are needed to study how people with diabetes may be influenced by a sense of poor personal safety in their neighborhoods. Copyright © 2016 Elsevier Ltd. All rights reserved.

Multiple Intravenous Infusions Phase 2a: Ontario Survey

PubMed Central

Fan, Mark; Koczmara, Christine; Masino, Caterina; Cassano-Piché, Andrea; Trbovich, Patricia; Easty, Anthony

2014-01-01

Background Research conducted in earlier phases of this study prospectively identified a number of concerns related to the safe administration of multiple intravenous (IV) infusions in Ontario hospitals. Objective To investigate the potential prevalence of practices or policies that may contribute to the patient safety risks identified in Phase 1b of this study. Data Sources and Review Methods Sixty-four survey responses were analyzed from clinical units where multiple IV infusions may occur (e.g., adult intensive care units). Survey questions were organized according to the topics identified in Phase 1b as potential contributors to patient harm (e.g., labelling practices, patient transfer practices, secondary infusion policies). Results Survey results indicated suboptimal practices and policies in some clinical units, and variability in a number of infusion practices. Key areas of concern included the following: use of primary IV tubing without back check valves when administering secondary infusions administration of secondary infusions with/as high-alert continuous IV medications potential confusion about how IV tubing should be labelled to reflect replacement date and time interruptions to IV therapy due to IV pump and/or tubing changes when patients are transferred between clinical units coadministration of continuous or intermittent infusions on central venous pressure monitoring ports variability in respondents’ awareness of the infusion pump's bolus capabilities Limitations Due to the limited sample size, survey responses may not be representative of infusion practices across Ontario. Answers to some questions indicated that the intent of the questions might have been misunderstood. Due to a design error, 1 question about bolus administration methods was not shown to as many respondents as appropriate. Conclusions The Ontario survey revealed variability in IV infusion practice across the province and potential opportunities to improve safety. PMID:26257837

The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

PubMed

Chawla, Anita; Carls, Ginger; Deng, Edmund; Tuttle, Edward

2015-07-01

Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

Safety Considerations in the Use of Ketorolac for Postoperative Pain.

PubMed

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

2017-01-01

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

Development of safety performance monitoring procedures.

DOT National Transportation Integrated Search

2010-02-01

Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

Digital Social Media, Youth, and Nonmedical Use of Prescription Drugs: The Need for Reform

PubMed Central

Liang, Bryan A; Strathdee, Steffanie A

2013-01-01

The tragic death of 18-year-old Ryan Haight highlighted the ethical, public health, and youth patient safety concerns posed by illicit online nonmedical use of prescription drugs (NUPM) sourcing, leading to a federal law in an effort to address this concern. Yet despite the tragedy and resulting law, the NUPM epidemic in the United States has continued to escalate and represents a dangerous and growing trend among youth and adolescents. A critical point of access associated with youth NUPM is the Internet. Internet use among this vulnerable patient group is ubiquitous and includes new, emerging, and rapidly developing technologies—particularly social media networking (eg, Facebook and Twitter). These unregulated technologies may pose a potential risk for enabling youth NUPM behavior. In order to address limitations of current regulations and promote online safety, we advocate for legislative reform to specifically address NUPM promotion via social media and other new online platforms. Using more comprehensive and modernized federal legislation that anticipates future online developments is critical in substantively addressing youth NUPM behavior occurring through the Internet. PMID:23892156

A Dividend in Food Safety

NASA Technical Reports Server (NTRS)

1991-01-01

When NASA faced the problem of how and what to feed an astronaut in a sealed capsule under weightless conditions while planning for manned space mission, they enlisted the aid of The Pillsbury Company. There were two principal concerns: barring crumbs of food that might contaminate the spacecraft's atmosphere or float their way into sensitive instruments; and assuring absolute freedom from potentially catastrophic disease-producing bacteria and toxins. Pillsbury quickly solved the first concern, but the other part of the problem was not as easy. They found that with using standard methods, there was no way to be assured there would not be any bacteria. It was concluded that the only way to succeed was to establish control over the entire process, the raw materials, the processing environment and the people involved. Pillsbury developed the Hazard Analysis and Critical Control Point (HACCP) concept. The HACCP is designed to prevent food safety problems rather than to catch them after they have occurred. Three other government agencies are taking preliminary steps toward extending HACCP to meat/poultry and seafood inspection operations. Today, Pillsbury plants are still operating under HACCP.

Pandemic influenza A (H1N1) 2009 vaccination in children: a UK perspective.

PubMed

de Whalley, Philip C S; Pollard, Andrew J

2013-03-01

Pandemic H1N1 influenza infection was common in the UK in 2009 and children were particularly vulnerable. Most cases were mild or subclinical, but there was significant mortality, predominantly in those with pre-existing disease. Despite the rapid development of monovalent pandemic vaccines, and the fast-tracked approval process, these products were not available for large-scale use until the end of the second wave of infection. Vaccine uptake was relatively low, both among children and health-care workers. The monovalent pandemic vaccines and the 2010/2011 trivalent seasonal influenza vaccines were immunogenic and effective, and they probably reduced the impact of the third wave of infection. Vaccines containing novel adjuvants enabled antigen sparing, but safety concerns could limit the future use of these adjuvanted influenza vaccines in children. Public perceptions that the threat of the pandemic was exaggerated by the authorities, and concerns about vaccine safety, might prompt an inadequate response to the next influenza pandemic, potentially compromising public health. © 2012 The Authors. Journal of Paediatrics and Child Health © 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Designing a community engagement framework for a new dengue control method: a case study from central Vietnam.

PubMed

McNaughton, Darlene; Duong, Thi Thu Huong

2014-05-01

The Wolbachia strategy aims to manipulate mosquito populations to make them incapable of transmitting dengue viruses between people. To test its efficacy, this strategy requires field trials. Public consultation and engagement are recognized as critical to the future success of these programs, but questions remain regarding how to proceed. This paper reports on a case study where social research was used to design a community engagement framework for a new dengue control method, at a potential release site in central Vietnam. The approach described here, draws on an anthropological methodology and uses both qualitative and quantitative methods to design an engagement framework tailored to the concerns, expectations, and socio-political setting of a potential trial release site for Wolbachia-infected Aedes aegypti mosquitoes. The process, research activities, key findings and how these were responded to are described. Safety of the method to humans and the environment was the most common and significant concern, followed by efficacy and impact on local lives. Residents expected to be fully informed and engaged about the science, the project, its safety, the release and who would be responsible should something go wrong. They desired a level of engagement that included regular updates and authorization from government and at least one member of every household at the release site. Results demonstrate that social research can provide important and reliable insights into public concerns and expectations at a potential release site, as well as guidance on how these might be addressed. Findings support the argument that using research to develop more targeted, engagement frameworks can lead to more sensitive, thorough, culturally comprehensible and therefore ethical consultation processes. This approach has now been used successfully to seek public input and eventually support for releases Wolbachia-infected mosquitoes, in two different international settings--Australia and Vietnam.

Designing a Community Engagement Framework for a New Dengue Control Method: A Case Study from Central Vietnam

PubMed Central

McNaughton, Darlene; Duong, Thi Thu Huong

2014-01-01

Background The Wolbachia strategy aims to manipulate mosquito populations to make them incapable of transmitting dengue viruses between people. To test its efficacy, this strategy requires field trials. Public consultation and engagement are recognized as critical to the future success of these programs, but questions remain regarding how to proceed. This paper reports on a case study where social research was used to design a community engagement framework for a new dengue control method, at a potential release site in central Vietnam. Methodology/Principal Findings The approach described here, draws on an anthropological methodology and uses both qualitative and quantitative methods to design an engagement framework tailored to the concerns, expectations, and socio-political setting of a potential trial release site for Wolbachia-infected Aedes aegypti mosquitoes. The process, research activities, key findings and how these were responded to are described. Safety of the method to humans and the environment was the most common and significant concern, followed by efficacy and impact on local lives. Residents expected to be fully informed and engaged about the science, the project, its safety, the release and who would be responsible should something go wrong. They desired a level of engagement that included regular updates and authorization from government and at least one member of every household at the release site. Conclusions/Significance Results demonstrate that social research can provide important and reliable insights into public concerns and expectations at a potential release site, as well as guidance on how these might be addressed. Findings support the argument that using research to develop more targeted, engagement frameworks can lead to more sensitive, thorough, culturally comprehensible and therefore ethical consultation processes. This approach has now been used successfully to seek public input and eventually support for releases Wolbachia-infected mosquitoes, in two different international settings - Australia and Vietnam. PMID:24853391

Bridging cross-cultural gaps: monitoring herbal use during chemotherapy in patients referred to integrative medicine consultation in Israel.

PubMed

Almog, Limor; Lev, Efraim; Schiff, Elad; Linn, Shai; Ben-Arye, Eran

2014-10-01

The high prevalence of the use of traditional herbs among patients with cancer is a cause for concern with regard to potentially adverse interactions with conventional oncology treatments. In this study, we explore herbal use among patients with cancer in northern Israel who are referred by their health care providers to complementary and traditional medicine (CTM) consultations provided to them within the conventional oncology department. The study's objectives were to identify which herbs patients use and to examine the scope of current research on the efficacy and safety regarding the identified herbs. Herbal use by patients receiving oncology care was assessed prospectively from July 2009 to July 2012 by integrative physicians (IPs) trained in herbal medicine. Historical, ethnobotanical, basic research, and clinical data regarding the identified herbs were explored by using a keyword search in PubMed and Middle Eastern ethnohistorical literature. Disclosure of herbal use was reported by 154 of the 305 patients (50.5 %) interviewed by IPs. The use of 85 single herbs and 30 different herbal formulas was documented during the initial or follow-up IP assessments. Patients reported 14 quality of life-associated indications for herbal use. The ten most prevalent herbs displaying in vitro/in vivo anticancer activity and nine other herbs were preliminarily assessed concerning potential risks, safety, and interaction with chemotherapy. Herbal use by patients with cancer in northern Israel is widespread and calls for further study in order to address issues of safety and effectiveness. We recommend constructing a multinational and multidisciplinary team of researchers with ethnopharmacological and clinical expertise that will explore the use of herbs among patients with cancer in a cross-cultural perspective attuned with patients' affinity to traditional herbal medicine.

Influence of Design Variations on Systems Performance

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Stone, Robert B.; Huff, Edward M.; Norvig, Peter (Technical Monitor)

2000-01-01

High-risk aerospace components have to meet very stringent quality, performance, and safety requirements. Any source of variation is a concern, as it may result in scrap or rework. poor performance, and potentially unsafe flying conditions. The sources of variation during product development, including design, manufacturing, and assembly, and during operation are shown. Sources of static and dynamic variation during development need to be detected accurately in order to prevent failure when the components are placed in operation. The Systems' Health and Safety (SHAS) research at the NASA Ames Research Center addresses the problem of detecting and evaluating the statistical variation in helicopter transmissions. In this work, we focus on the variations caused by design, manufacturing, and assembly of these components, prior to being placed in operation (DMV). In particular, we aim to understand and represent the failure and variation information, and their correlation to performance and safety and feed this information back into the development cycle at an early stage. The feedback of such critical information will assure the development of more reliable components with less rework and scrap. Variations during design and manufacturing are a common source of concern in the development and production of such components. Accounting for these variations, especially those that have the potential to affect performance, is accomplished in a variety ways, including Taguchi methods, FMEA, quality control, statistical process control, and variation risk management. In this work, we start with the assumption that any of these variations can be represented mathematically, and accounted for by using analytical tools incorporating these mathematical representations. In this paper, we concentrate on variations that are introduced during design. Variations introduced during manufacturing are investigated in parallel work.

Consumer concerns: motivating to action.

PubMed Central

Bruhn, C. M.

1997-01-01

Microbiologic safety is consumers' most frequently volunteered food safety concern. An increase in the level of concern in recent years suggests that consumers are more receptive to educational information. However, changing lifestyles have lessened the awareness of foodborne illness, especially among younger consumers. Failure to fully recognize the symptoms or sources of foodborne disease prevents consumers from taking corrective action. Consumer education messages should include the ubiquity of microorganisms, a comprehensive description of foodborne illnesses, and prevention strategies. Product labels should contain food-handling information and warnings for special populations, and foods processed by newer safety-enhancing technologies should be more widely available. Knowledge of the consequences of unsafe practices can enhance motivation and adherence to safety guidelines. When consumers mishandle food during preparation, the health community, food industry, regulators, and the media are ultimately responsible. Whether inappropriate temperature control, poor hygiene, or another factor, the error occurs because consumers have not been informed about how to handle food and protect themselves. The food safety message has not been delivered effectively. PMID:9366604

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1984-01-01

An assessment of NASA's safety performance for 1983 affirms that NASA Headquarters and Center management teams continue to hold the safety of manned flight to be their prime concern, and that essential effort and resources are allocated for maintaining safety in all of the development and operational programs. Those conclusions most worthy of NASA management concentration are given along with recommendations for action concerning; product quality and utility; space shuttle main engine; landing gear; logistics and management; orbiter structural loads, landing speed, and pitch control; the shuttle processing contractor; and the safety of flight operations. It appears that much needs to be done before the Space Transportation System can achieve the reliability necessary for safe, high rate, low cost operations.

[Is It Time to Implement a 12-Hour Shift for Nurses in Taiwan?

PubMed

Lin, Yi-Fung; Chang, Shiow-Ru; Wang, Li-Ting

2017-04-01

The twelve-hour shift system, first introduced in the U.S. in 1967 to address a nursing shortage, is now the main system of shift rotation used in numerous countries. In recent years, several hospitals in Taiwan have implemented the 12-hour shift model as one initiative to improve the problems of overtime and high turnover rate among nursing staff. Under this model, nurses work only three to four days per week for 12-hour shifts per day. Despite the increase in numbers of days off, there is growing concern that long shift hours may harm both the safety of patients and the well being of the nurses. The aim of the present article is to explain the application of the 12-hour shift system and to review the potential impacts of this model. Benefits of the 12-hour shift system include improving quality of life for nursing staff, reducing the turnover rate, and increasing job satisfaction. Primary concerns regarding this system include patient safety, nurse fatigue, and the potential negative effects on the sleep quality of nurses. These findings may be referenced by policymakers considering the development / implementation of flexible work schedules in Taiwan. The government must set a ceiling on work hours allowed per week and impose limits on overtime in order to prevent burnout in nursing staff.

The Immunogenicity and Immune Tolerance of Pluripotent Stem Cell Derivatives

PubMed Central

Liu, Xin; Li, Wenjuan; Fu, Xuemei; Xu, Yang

2017-01-01

Human embryonic stem cells (hESCs) can undergo unlimited self-renewal and differentiate into all cell types in human body, and therefore hold great potential for cell therapy of currently incurable diseases including neural degenerative diseases, heart failure, and macular degeneration. This potential is further underscored by the promising safety and efficacy data from the ongoing clinical trials of hESC-based therapy of macular degeneration. However, one main challenge for the clinical application of hESC-based therapy is the allogeneic immune rejection of hESC-derived cells by the recipient. The breakthrough of the technology to generate autologous-induced pluripotent stem cells (iPSCs) by nuclear reprogramming of patient’s somatic cells raised the possibility that autologous iPSC-derived cells can be transplanted into the patients without the concern of immune rejection. However, accumulating data indicate that certain iPSC-derived cells can be immunogenic. In addition, the genomic instability associated with iPSCs raises additional safety concern to use iPSC-derived cells in human cell therapy. In this review, we will discuss the mechanism underlying the immunogenicity of the pluripotent stem cells and recent progress in developing immune tolerance strategies of human pluripotent stem cell (hPSC)-derived allografts. The successful development of safe and effective immune tolerance strategy will greatly facilitate the clinical development of hPSC-based cell therapy. PMID:28626459

Periodontal Ligament Stem Cells: Current Status, Concerns, and Future Prospects

PubMed Central

Zhu, Wenjun; Liang, Min

2015-01-01

Periodontal ligament stem cells (PDLSCs), which reside in the perivascular space of the periodontium, possess characteristics of mesenchymal stem cells and are a promising tool for periodontal regeneration. Recently, great progress has been made in PDLSC transplantation. Investigators are attempting to maximize the proliferation and differentiation potential of PDLSCs by modifying culture conditions and applying growth factors. Nevertheless, problems remain. First, incomparability among different studies must be minimized by establishing standard guidelines for culture and identification of PDLSCs. Notably, attention should be paid to the biological safety of PDLSC transplantation. The present review updates the latest findings regarding PDLSCs and discusses standard criteria for culture and identification of PDLSCs. Finally, the review calls for careful consideration of PDLSC transplantation safety. PMID:25861283

Driving safety in elderly individuals.

PubMed

Marottoli, R A

1993-05-01

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

Cyclooxygenase-2 inhibitors: promise or peril?

PubMed Central

Mengle-Gaw, Laurel J; Schwartz, Benjamin D

2002-01-01

The discovery of two isoforms of the cyclooxygenase enzyme, COX-1 and COX-2, and the development of COX-2-specific inhibitors as anti-inflammatories and analgesics have offered great promise that the therapeutic benefits of NSAIDs could be optimized through inhibition of COX-2, while minimizing their adverse side effect profile associated with inhibition of COX-1. While COX-2 specific inhibitors have proven to be efficacious in a variety of inflammatory conditions, exposure of large numbers of patients to these drugs in postmarketing studies have uncovered potential safety concerns that raise questions about the benefit/risk ratio of COX-2-specific NSAIDs compared to conventional NSAIDs. This article reviews the efficacy and safety profiles of COX-2-specific inhibitors, comparing them with conventional NSDAIDs. PMID:12467519

Phenomenology of men with body dysmorphic disorder concerning penis size compared to men anxious about their penis size and to men without concerns: a cohort study.

PubMed

Veale, David; Miles, Sarah; Read, Julie; Troglia, Andrea; Carmona, Lina; Fiorito, Chiara; Wells, Hannah; Wylie, Kevan; Muir, Gordon

2015-03-01

Men with body dysmorphic disorder (BDD) may be preoccupied with the size or shape of the penis, which may be causing significant shame or impairment. Little is known about the characteristics and phenomenology of such men and whether they can be differentiated from men with small penis anxiety (SPA) (who do not have BDD), and men with no penile concerns. Twenty-six men with BDD, 31 men with SPA, and 33 men without penile concerns were compared on psychopathology, experiences of recurrent imagery, avoidance and safety-seeking behaviours. Men with BDD had significantly higher scores than both the SPA group and no penile concern group for measures of imagery, avoidance, safety seeking and general psychopathology. The groups differed on the phenomenology of BDD specific to penile size preoccupation clearly from the worries of SPA, which in turn were different to those of the men without concerns. The common avoidance and safety seeking behaviours were identified in such men that may be used clinically. Copyright © 2014 Elsevier Ltd. All rights reserved.

How Can We Make PV Modules Safer?: Preprint

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

Wohlgemuth, J. H.; Kurtz, S. R.

2012-06-01

Safety is a prime concern for the photovoltaics (PV) industry. As a technology deployed on residential and commercial buildings, it is critical that PV not cause damage to the buildings nor harm the occupants. Many of the PV systems on buildings are of sufficiently high voltage (300 to 600 Volts dc) that they may present potential hazards. These PV systems must be safe in terms of mechanical damage (nothing falls on someone), shock hazard (no risk of electrical shock when touching an exposed circuit element), and fire (the modules neither cause nor promote a fire). The present safety standards (IECmore » 61730 and UL 1703) do a good job of providing for design rules and test requirements for mechanical, shock, and spread of flame dangers. However, neither standard addresses the issue of electrical arcing within a module that can cause a fire. To make PV modules, they must be designed, built, and installed with an emphasis on minimizing the potential for open circuits and ground faults. This paper provides recommendations on redundant connection designs, robust mounting methods, and changes to the safety standards to yield safer PV modules.« less

Evaluation of biotechnology-derived novel proteins for the risk of food-allergic potential: advances in the development of animal models and future challenges.

PubMed

Ahuja, Varun; Quatchadze, Maria; Ahuja, Vaishali; Stelter, Daniela; Albrecht, Achim; Stahlmann, Ralf

2010-12-01

Increasing concern from the public about the safety of genetically modified food has made critical to have suitable methods for recognizing associated potential hazards. Hierarchical approaches to allergenicity determination were proposed, and these include evaluation of the structural and sequence homology and serological identity of novel proteins with existing allergens, measuring the resistance to proteolytic digestion and assessment of sensitizing potential using animal models. Allergic individuals have a predisposed (i.e. atopic) genetic background, and a close resemblance to this setup is therefore desirable in animal models, which is possible by using a strain of an animal species that is prone for allergic disorders. So far, none of the animal model has been validated for the purpose of hazard identification in the context of safety assessment. However, the available knowledge suggests that the judicious use of an appropriate animal model could provide important information about the allergic potential of novel proteins. This paper provides an up-to-date review of the progress made in the field of development of in vivo models in this direction and the further goals that have to be achieved.

Application of Function-Failure Similarity Method to Rotorcraft Component Design

NASA Technical Reports Server (NTRS)

Roberts, Rory A.; Stone, Robert E.; Tumer, Irem Y.; Clancy, Daniel (Technical Monitor)

2002-01-01

Performance and safety are the top concerns of high-risk aerospace applications at NASA. Eliminating or reducing performance and safety problems can be achieved with a thorough understanding of potential failure modes in the designs that lead to these problems. The majority of techniques use prior knowledge and experience as well as Failure Modes and Effects as methods to determine potential failure modes of aircraft. During the design of aircraft, a general technique is needed to ensure that every potential failure mode is considered, while avoiding spending time on improbable failure modes. In this work, this is accomplished by mapping failure modes to specific components, which are described by their functionality. The failure modes are then linked to the basic functions that are carried within the components of the aircraft. Using this technique, designers can examine the basic functions, and select appropriate analyses to eliminate or design out the potential failure modes. The fundamentals of this method were previously introduced for a simple rotating machine test rig with basic functions that are common to a rotorcraft. In this paper, this technique is applied to the engine and power train of a rotorcraft, using failures and functions obtained from accident reports and engineering drawings.

"Defense-in-Depth" Laser Safety and the National Ignition Facility

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

King, J J

The National Ignition Facility (NIF) is the largest and most energetic laser in the world contained in a complex the size of a football stadium. From the initial laser pulse, provided by telecommunication style infrared nanoJoule pulsed lasers, to the final 192 laser beams (1.8 Mega Joules total energy in the ultraviolet) converging on a target the size of a pencil eraser, laser safety is of paramount concern. In addition to this, there are numerous high-powered (Class 3B and 4) diagnostic lasers in use that can potentially send their laser radiation travelling throughout the facility. With individual beam paths ofmore » up to 1500 meters and a workforce of more than one thousand, the potential for exposure is significant. Simple laser safety practices utilized in typical laser labs just don't apply. To mitigate these hazards, NIF incorporates a multi layered approach to laser safety or 'Defense in Depth.' Most typical high-powered laser operations are contained and controlled within a single room using relatively simplistic controls to protect both the worker and the public. Laser workers are trained, use a standard operating procedure, and are required to wear Personal Protective Equipment (PPE) such as Laser Protective Eyewear (LPE) if the system is not fully enclosed. Non-workers are protected by means of posting the room with a warning sign and a flashing light. In the best of cases, a Safety Interlock System (SIS) will be employed which will 'safe' the laser in the case of unauthorized access. This type of laser operation is relatively easy to employ and manage. As the operation becomes more complex, higher levels of control are required to ensure personnel safety. Examples requiring enhanced controls are outdoor and multi-room laser operations. At the NIF there are 192 beam lines and numerous other Class 4 diagnostic lasers that can potentially deliver their hazardous energy to locations far from the laser source. This presents a serious and complex potential hazard to personnel. Because of this, a multilayered approach to safety is taken. This paper presents the philosophy and approach taken at the NIF in the multi-layered 'defense-in-depth' approach to laser safety.« less

Identifying and prioritizing gaming workers' health and safety concerns using mapping for data collection.

PubMed

Keith, M M; Cann, B; Brophy, J T; Hellyer, D; Day, M; Egan, S; Mayville, K; Watterson, A

2001-01-01

This research was prompted by the clinical presentation of workers from a variety of gaming occupations with injuries and illnesses and multiple health and safety concerns. Using participatory action research principles, 51 gaming workers in Ontario and 20 gaming workers in Manitoba were consulted during a series of focus group sessions. Mapping exercises were used to survey the participants about their health concerns, perceived occupational hazards and the impact of working conditions on their personal lives. Participants were then asked to prioritize their concerns and make recommendations for improvements. Gaming workers from both provinces identified similar health, hazard and psycho-social concerns. They prioritized the issues of stress, ergonomics, indoor air quality (including second-hand smoke and temperature), biological hazards, physical hazards and noise. This study points to a need to more fully investigate and address health and safety issues in the gaming industry. It also demonstrates the effectiveness of a worker-driven, participatory consultation. Copyright 2001 Wiley-Liss, Inc.

Federal Research Action Plan on Recycled Tire Crumb Used ...

EPA Pesticide Factsheets

Over the past several years, parents, athletes, schools, and communities have raised concerns about the safety of recycled tire crumb rubber used as infill for playing fields and playgrounds in the United States. The public has expressed concerns that the use of these fields could potentially be related to certain health effects. Studies to date have not shown an elevated health risk from playing on fields with tire crumb rubber, but these studies have limitations and do not comprehensively evaluate the concerns about health risks from exposure to tire crumb rubber. This status report provides a summary of activities to date, including: (1) stakeholder outreach, (2) the tire crumb rubber manufacturing industry, (3) the final peer-reviewed Literature Review/Gaps Analysis (LRGA), (4) progress on the research activities, and (5) next steps and a timeline for completion of the final report. The status report does not include research findings.

Radio frequency identification (RFID) in health care: privacy and security concerns limiting adoption.

PubMed

Rosenbaum, Benjamin P

2014-03-01

Radio frequency identification (RFID) technology has been implemented in a wide variety of industries. Health care is no exception. This article explores implementations and limitations of RFID in several health care domains: authentication, medication safety, patient tracking, and blood transfusion medicine. Each domain has seen increasing utilization of unique applications of RFID technology. Given the importance of protecting patient and data privacy, potential privacy and security concerns in each domain are discussed. Such concerns, some of which are inherent to existing RFID hardware and software technology, may limit ubiquitous adoption. In addition, an apparent lack of security standards within the RFID domain and specifically health care may also hinder the growth and utility of RFID within health care for the foreseeable future. Safeguarding the privacy of patient data may be the most important obstacle to overcome to allow the health care industry to take advantage of the numerous benefits RFID technology affords.

It is time to develop ecological thresholds of toxicological concern to assist environmental hazard assessment.

PubMed

Belanger, Scott E; Sanderson, Hans; Embry, Michelle R; Coady, Katie; DeZwart, Dick; Farr, Brianna A; Gutsell, Steve; Halder, Marlies; Sternberg, Robin; Wilson, Peter

2015-12-01

The threshold of toxicological concern (TTC) concept is well established for assessing human safety of food-contact substances and has been reapplied for a variety of endpoints, including carcinogenicity, teratogenicity, and reproductive toxicity. The TTC establishes an exposure level for chemicals below which no appreciable risk to human health or the environment is expected, based on a de minimis value for toxicity identified for many chemicals. Threshold of toxicological concern approaches have benefits for screening-level risk assessments, including the potential for rapid decision-making, fully utilizing existing knowledge, reasonable conservativeness for chemicals used in lower volumes (low production volume chemicals (e.g., < 1 t/yr), and reduction or elimination of unnecessary animal tests. Higher production volume chemicals (>1 t/yr) would in principle always require specific information because of the presumed higher exposure potential. The TTC approach has found particular favor in the assessment of chemicals used in cosmetics and personal care products, as well as other chemicals traditionally used in low volumes. Use of the TTC in environmental safety is just beginning, and initial attempts are being published. Key questions focus on hazard extrapolation of diverse taxa across trophic levels, importance of mode of action, and whether safe concentrations for ecosystems estimated from acute or chronic toxicity data are equally useful and in what contexts. The present study provides an overview of the theoretical basis for developing an ecological (eco)-TTC, with an initial exploration of chemical assessment and boundary conditions for use. An international collaboration under the International Life Sciences Institute Health and Environmental Sciences Institute has been established to address challenges related to developing and applying useful eco-TTC concepts. © 2015 SETAC.

Notification of abnormal lab test results in an electronic medical record: do any safety concerns remain?

PubMed Central

Singh, Hardeep; Thomas, Eric J.; Sittig, Dean F.; Wilson, Lindsey; Espadas, Donna; Khan, Myrna M.; Petersen, Laura A.

2010-01-01

Background: Follow-up of abnormal outpatient laboratory test results is a major patient safety concern. Electronic medical records can potentially address this concern through automated notification. We examined whether automated notifications of abnormal laboratory results (alerts) in an integrated electronic medical record resulted in timely follow-up actions. Methods: We studied four alerts: hemoglobin A1c (HbA1c) ≥15%, positive hepatitis C antibody (HCV), prostate specific antigen (PSA) ≥15 ng/mL, and thyroid stimulating hormone (TSH) ≥ 15 mIU/L. An alert tracking system determined whether the alert was acknowledged (i.e. provider clicked on and opened the message) within two weeks of transmission; acknowledged alerts were considered read. Within 30 days of result transmission, record review and provider contact determined follow-up actions (e.g. patient contact, treatment etc.). Multivariable logistic regression models analyzed predictors for lack of timely follow-up. Results: Between May 2008 and December 2008, 78,158 tests (HbA1c, HCV, TSH and PSA) were performed, of which 1163 (1.48%) were transmitted as alerts; 10.2% of these (119/1163) were unacknowledged. Timely follow-up was lacking in 79 (6.8%) and was statistically not different for acknowledged and unacknowledged alerts (6.4% vs. 10.1%; p =.13). Two-hundred two alerts (17.4% of 1163) arose from unnecessarily ordered (redundant) tests. Alerts for a new versus known diagnosis were more likely to lack timely follow-up (OR: 7.35; 95% CI: 4.16-12.97) whereas alerts related to redundant tests were less likely to lack timely follow-up (OR: 0.24; 95% CI: 0.07-0.84). Conclusions: Safety concerns related to timely patient follow-up remain despite automated notification of non-life threatening abnormal laboratory results in the outpatient setting. PMID:20193832

Review of proton pump inhibitors for the initial treatment of heartburn: is there a dose ceiling effect?

PubMed

Kushner, Pamela R; Peura, David A

2011-05-01

Proton pump inhibitors (PPIs) are widely used in clinical practice. However, concerns have been expressed about their long-term use, particularly with regard to bone health, Clostridium difficile infections, and drug interactions with platelet aggregation inhibitors. There has been limited guidance for clinicians concerning appropriate dose selection of PPIs for the initial treatment of heartburn. This review explored whether published clinical trials provide evidence of a ceiling above which higher PPI doses do not provide additional clinical benefit over the lowest approved dose. All articles of randomized, controlled clinical trials in nonerosive gastroesophageal reflux disease (GERD) in which the effects of two or more doses of the same PPI on symptomatic relief of heartburn were quantified as a study endpoint were identified and analyzed through PubMed searches up to the end of September 2010. The majority of trials evaluated provided no evidence that higher PPI doses were superior to the lowest approved dose for the initial treatment of heartburn. There were no clinically relevant findings with respect to dose dependence and safety outcomes in these studies. Efficacy outcomes from the trials suggest there may be a dose ceiling effect and highlight the need for further research on the use of the lowest effective PPI doses as an appropriate strategy in the initial treatment of uncomplicated heartburn. Observational studies and some meta-analyses have suggested that long-term PPI pharmacotherapy might be associated with safety concerns, which necessitate the periodic evaluation of therapeutic benefit in terms of symptom resolution and regimen tolerability. However, evidence to date suggests that use of the lowest effective dose for the indication is not associated with significant adverse events, particularly in the short term. Clinical practice suggests that patients requiring long-term treatment should be maintained on the lowest dose necessary to control symptoms, and monitored for potentially confounding factors that may lead to safety concerns.

What is Hepatitis C and Why Should I Be Concerned about It?

MedlinePlus

... Healthy Living Healthy Living Healthy Living Nutrition Fitness Sports Oral Health Emotional Wellness Growing Healthy Sleep Safety & Prevention Safety & Prevention Safety and Prevention Immunizations ...

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

PubMed

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

2010-03-01

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

Safety assessment of personal care products/cosmetics and their ingredients

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

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

2010-03-01

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

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-trail approaches. This research was performed under contract to NASA and in cooperation with the FAA's Safety Division (ASY).

76 FR 45582 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human... concerning the safety and effectiveness of marketed and investigational human drug products for use in... and evaluates available data concerning the safety and effectiveness of marketed and investigational...

Food safety concerns of fast food consumers in urban Ghana.

PubMed

Omari, Rose; Frempong, Godfred

2016-03-01

In Ghana, out-of-home ready-to-eat foods including fast food generally have been associated with food safety problems. Notwithstanding, fast food production and consumption are increasing in Ghana and therefore this study sought to determine the food safety issues of importance to consumers and the extent to which they worry about them. First, through three focus group discussions on consumers' personal opinions about food safety issues, some emergent themes were obtained, which were used to construct an open-ended questionnaire administered face-to-face to 425 respondents systematically sampled from 20 fast food restaurants in Accra. Findings showed that most fast food consumers were concerned about food hazards such as pesticide residue in vegetables, excessive use of artificial flavour enhancers and colouring substances, bacterial contamination, migrated harmful substances from plastic packages, and general unhygienic conditions under which food is prepared and sold. Consumers also raised concerns about foodborne diseases such as cholera, typhoid, food poisoning, diarrhoea, bird flu and swine flu. The logistic regression model showed that being male increased the likelihood of worrying about general food safety issues and excessive use of flavour enhancers than in females while being youthful increased the likelihood of being worried about typhoid fever than in older consumers. These findings imply that consumers in urban Ghana are aware and concerned about current trends of food safety and foodborne disease challenges in the country. Therefore, efforts targeted at improving food safety and reducing incidences of foodborne diseases should not only focus on public awareness creation but should also design more comprehensive programmes to ensure the making of food safety rules and guidelines and enforcing compliance to facilitate availability and consumers' choice of safe foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

International nuclear safety concerns. Hearing before the Subcommittee on Energy, Nuclear Proliferation, and Government Processes of the Committee on Governmental Affairs, United States Senate, Ninety-Ninth Congress, Second Session, May 8, 1986

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

Not Available

1986-01-01

Allan I. Mendelowitz of the General Accounting Office (GAO) and James R. Shea of the Nuclear Regulatory Commission were the principal witnesses at a hearing on international concerns about reactor safety. The hearing focused on the Soviet accident at Chernobyl as a demonstration that safety matters are a legitimate area of international concern. Among the issues under discussion were safety standards and inspection procedures of the International Atomic Energy Agency (IAEA). Estimates developed by the GAO show that developing countries, which lack a strong technical base or nuclear background to handle emergencies, will have half the reactors in the worldmore » by the year 2000. Mendelowitz and Shea, together with supporting testimony from others in their agencies described international efforts to improve safeguards.« less

An observational survey of safety belt and child safety seat use in Virginia : the 1989 update.

DOT National Transportation Integrated Search

1991-01-01

The report has been prepared in response to a request from the Transportation Safety Administration of the Department of Motor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virginia l...

An observational survey of safety belt and child safety seat use in Virginia : final report : the 1990 update.

DOT National Transportation Integrated Search

1992-01-01

This report was prepared in response to a request from the Transportation Safety Administration of the Virginia Department ofMotor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virgin...

Safety and health concerns in forestry operations

Treesearch

Robert B. Rummer

1997-01-01

The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

Assuring Safety in Bus Transportation--Update on Federal Legislation.

ERIC Educational Resources Information Center

Craft, Nick

2003-01-01

Discusses the growing use of vans for transportation by child care centers and increasing concerns about van safety. Presents information on relevant federal legislation related to motor vehicle safety and the safety standards of the National Highway Traffic Safety Administration. Recommends that child care programs replace retiring vans with…

Calibration factors handbook : safety prediction models calibrated with Texas highway system.

DOT National Transportation Integrated Search

2009-10-01

Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.

PubMed

Godman, Brian; Malmström, Rickard E; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Fürst, Jurij; Garuoliene, Kristina; Gutiérrez-Ibarluzea, Iñaki; Hviding, Krystyna; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Vončina, Luka; Vlahović-Palčevski, Vera; Wale, Janet; Wladysiuk, Magdalena; van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars L

2014-01-01

There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

PubMed Central

Godman, Brian; Malmström, Rickard E.; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Fürst, Jurij; Garuoliene, Kristina; Gutiérrez-Ibarluzea, Iñaki; Hviding, Krystyna; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B.; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Vončina, Luka; Vlahović-Palčevski, Vera; Wale, Janet; Wladysiuk, Magdalena; van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars L.

2014-01-01

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding. PMID:24959145

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

NASA Astrophysics Data System (ADS)

Doshi, Bharat; Reddy, D. Chenna

2017-04-01

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

Safety evaluation of tangeretin and the effect of using emulsion-based delivery system: Oral acute and 28-day sub-acute toxicity study using mice.

PubMed

Ting, Yuwen; Chiou, Yi-Shiou; Jiang, Yike; Pan, Min-Hsiung; Lin, Zhengyu; Huang, Qingrong

2015-08-01

Polymethoxyflavones, found widely in the peel of citrus fruits, is an emerging group of bioactive compounds with wide arrays of disease prevention functionalities. To understand the potential oral toxicity, tangeretin, being one of the most abundant polymethoxyflavones from natural sources, was used as model compound for the safety evaluation. Acute oral toxicity study was conducted using both male and female mice giving 1000, 2000, or 3000mg/kgbody weight (bw) of tangeretin in oil suspension from single gavage administration. No evidence of death was observed during 14-day post-administration period. Alterations of the hepatic cell and clinical chemistry profile increased dose dependently and exhibited distinct injury recovery pattern among different sexes. To determine the potential safety concern related to emulsification, the sub-acute toxicity of tangeretin in emulsion was evaluated and compared with un-processed oil suspension when conducting the sub-acute toxicity study over 28days. In the sub-acute study, emulsion system did not induce a significant increase of toxicity response. However, the daily low-dose application of tangeretin showed U-shaped dose-response pattern in regard to hepatic alteration. The result from this study can serve as a good safety reference for future application of polymethoxyflavone as a functional ingredient in food. Copyright © 2015 Elsevier Ltd. All rights reserved.

Why patients need leaders: introducing a ward safety checklist

PubMed Central

Amin, Yogen; Grewcock, Dave; Andrews, Steve; Halligan, Aidan

2012-01-01

The safety and consistency of the care given to hospital inpatients has recently become a particular political and public concern. The traditional ‘ward round’ presents an obvious opportunity for systematically and collectively ensuring that proper standards of care are being achieved for individual patients. This paper describes the design and implementation of a ‘ward safety checklist’ that defines a set of potential risk factors that should be checked on a daily basis, and offers multidisciplinary teams a number of prompts for sharing and clarifying information between themselves, and with the patient, during a round. The concept of the checklist and the desire to improve ward rounds were well received in many teams, but the barriers to adoption were informative about the current culture on many inpatient wards. Although the ‘multidisciplinary ward round’ is widely accepted as good practice, the medical and nursing staff in many teams are failing to coordinate their workloads well enough to make multidisciplinary rounds a working reality. ‘Nursing’ and ‘medical’ care on the ward have become ‘de-coupled’ and the potential consequences for patient safety and good communication are largely self-evident. This problem is further complicated by a medical culture which values the primacy of clinical autonomy and as a result can be resistant to perceived attempts to ‘systematize’ medical care through instruments such as checklists. PMID:22977047

Responsibility for quality improvement and patient safety: hospital board and medical staff leadership challenges.

PubMed

Goeschel, Christine A; Wachter, Robert M; Pronovost, Peter J

2010-07-01

Concern about the quality and safety of health care persists, 10 years after the 1999 Institute of Medicine report To Err is Human. Despite growing awareness of quality and safety risks, and significant efforts to improve, progress is difficult to measure. Hospital leaders, including boards and medical staffs, are accountable to improve care, yet they often address this duty independently. Shared responsibility for quality and patient safety improvement presents unique challenges and unprecedented opportunities for boards and medical staffs. To capitalize on the pressure to improve, both groups may benefit from a better understanding of their synergistic potential. Boards should be educated about the quality of care provided in their institutions and about the challenges of valid measurement and accurate reporting. Boards strengthen their quality oversight capacity by recruiting physicians for vacant board seats. Medical staff members strengthen their role as hospital leaders when they understand the unique duties of the governing board. A quality improvement strategy rooted in synergistic efforts by the board and the medical staff may offer the greatest potential for safer care. Such a mutually advantageous approach requires a clear appreciation of roles and responsibilities and respect for differences. In this article, we review these responsibilities, describe opportunities for boards and medical staffs to collaborate as leaders, and offer recommendations for how boards and medical staff members can address the challenges of shared responsibility for quality of care.

One-to-one comparison of sunscreen efficacy, aesthetics and potential nanotoxicity

NASA Astrophysics Data System (ADS)

Barnard, Amanda S.

2010-04-01

Numerous reports have described the superior properties of nanoparticles and their diverse range of applications. Issues of toxicity, workplace safety and environmental impact have also been a concern. Here we show a theoretical comparison of how the size of titanium dioxide nanoparticles and their concentration in sunscreens can affect efficacy, aesthetics and potential toxicity from free radical production. The simulation results reveal that, unless very small nanoparticles can be shown to be safe, there is no combination of particle size and concentration that will deliver optimal performance in terms of sun protection and aesthetics. Such a theoretical method complements well the experimental approach for identifying these characteristics.

Addictive personality and problematic mobile phone use.

PubMed

Takao, Motoharu; Takahashi, Susumu; Kitamura, Masayoshi

2009-10-01

Mobile phone use is banned or regulated in some circumstances. Despite recognized safety concerns and legal regulations, some people do not refrain from using mobile phones. Such problematic mobile phone use can be considered to be an addiction-like behavior. To find the potential predictors, we examined the correlation between problematic mobile phone use and personality traits reported in addiction literature, which indicated that problematic mobile phone use was a function of gender, self-monitoring, and approval motivation but not of loneliness. These findings suggest that the measurements of these addictive personality traits would be helpful in the screening and intervention of potential problematic users of mobile phones.

Level of concern and sources of information of a group of Brisbane hostelers for personal safety and terrorism when traveling abroad.

PubMed

Leggat, Peter A; Mills, Deborah; Speare, Richard

2007-01-01

Little is known about the level of concern and sources of information of hostelers concerning personal safety and terrorism. This study was designed to investigate these in the Australian context. In 2006, self-administered questionnaires were distributed to hostelers attending a travelers' information evening in Brisbane. Forty questionnaires (60.8%) were returned. Over two thirds of attendees were women (71.4%). About two thirds of the hostelers attending the travelers' information evening reported being aged 29 years or younger (64.2%). Anticipated main destinations were Europe (68.3%), Asia (14.3%), and North America (11.9%). Nearly two thirds (63.4%) intended to travel in more than 8 weeks time or were not sure. Of those departing within 8 weeks, only 40% had sought travel health advice from their general practitioner and/or travel clinic. Nonmedical sources of information on travel health included travel books and guides (40.5%), Internet (35.7%), and travel agents (19.0%). On a five-point rating scale (1 being not concerned to 5 being extremely concerned), median ratings of hostelers' concern for personal safety (4.0) was significantly higher than for terrorism (2.5), with the range being 1 to 5 in each case (p < 0.001). Nearly three quarters (73.8%) of hostelers would seek personal safety advice from multiple sources, and sources of information included the Internet (69.0%, 29), travel books and guides (59.5%), physicians (57.1%), and travel agents (45.2%). Only three (7.1%) nominated the physician as their only source of personal safety advice. Hostelers attending a travelers' information night in Australia expressed more concern for their personal safety when traveling than for terrorism. Since this group of travelers uses multiple sources of information with the Internet most commonly used, Web sites that provide accurate and relevant information in an acceptable format could play an important role in supporting this group. It is important that policies being promoted by travel health advocacy groups in Australia continue to advocate that travelers seek travel health advice from a qualified source early, preferably around 6 to 8 weeks before travel, and that personal safety be discussed as part of the travel health consultation.

Hydrogen permeation in FeCrAl alloys for LWR cladding application

NASA Astrophysics Data System (ADS)

Hu, Xunxiang; Terrani, Kurt A.; Wirth, Brian D.; Snead, Lance L.

2015-06-01

FeCrAl, an advanced oxidation-resistant iron-based alloy class, is a highly prevalent candidate as an accident-tolerant fuel cladding material. Compared with traditional zirconium alloy fuel cladding, increased tritium permeation through FeCrAl fuel cladding to the primary coolant is expected, raising potential safety concerns. In this study, the hydrogen permeability of several FeCrAl alloys was obtained using a static permeation test station, which was calibrated and validated using 304 stainless steel. The high hydrogen permeability of FeCrAl alloys leads to concerns with respect to potentially significant tritium release when used for fuel cladding in LWRs. The total tritium inventory inside the primary coolant of a light water reactor was quantified by applying a 1-dimensional steady state tritium diffusion model to demonstrate the dependence of tritium inventory on fuel cladding type. Furthermore, potential mitigation strategies for tritium release from FeCrAl fuel cladding were discussed and indicate the potential for application of an alumina layer on the inner clad surface to serve as a tritium barrier. More effort is required to develop a robust, economical mitigation strategy for tritium permeation in reactors using FeCrAl clad fuel assemblies.

Evaluation of biological and male reproductive-function responses to potential lead exposures in 155-mm-howitzer crewmen. Technical report, Jul 90-Dec 91

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

Weyandt, T.B.

1992-01-01

A collaborative pilot study between the U.S. Army Biomedical Research and Development Laboratory and the National Institute for Occupational Safety and Health was designed to assess the fecundity of male artillery soldiers with potential exposures to airborne lead aerosols. Many soldiers in the initial control population reported possible job-related microwave exposure as radar equipment operators. As a result, a third group of soldiers without potential for lead or microwave exposure, but with similar duty-associated environmental exposure conditions, was selected as a comparison population. Blood hormone levels and semen analyses were conducted on artillerymen (n=30), radar equipment operators (n=20), and themore » comparison group (n=31). Analysis of the questionnaire information revealed that concern about fertility problems motivated participation of some soldiers with potential artillery or microwave exposures. Data analysis was complicated by the small study population size and the confounding variable of perceived infertility. Although the small number of subjects and infertility concerns somewhat compromise the statistical power and general applicability of the study, several statistically significant findings were identified.« less

ED accreditation update. Physicians, medical staff may report safety concerns without fear of disciplinary action.

PubMed

2007-11-01

Educating your staff about The Joint Commission's requirements for concerns about hospital safety and quality of care requires the ED manager to set a tone of openness and cooperation, while at the same time emphasizing your department's role in addressing such concerns: * The ED should be the first place that staff members communicate quality and safety concerns. It is only when a problem is not addressed that they should take the issue to hospital administration and, if necessary, The Joint Commission. * A single event should not trigger a report to The Joint Commission, unless it is unusually serious. Otherwise, only a series of events should trigger a report. * Reassure your staff that you care about what is reported and will act quickly on it. Educate your staff about the reporting forms, and follow up with random audits to ensure compliance.

Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

PubMed

MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

2014-01-01

Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

The effect of red light irradiation on spermatozoa DNA

NASA Astrophysics Data System (ADS)

Chow, Kay W.; Preece, Daryl; Gomez-Godinez, Veronica; Berns, Michael W.

2016-09-01

A key goal in the conservation of endangered species is to increase successful reproduction. In cases where traditional methods of in vitro fertilization are unsuccessful, new methods of assisted reproduction are needed. One option is selective fertilization via optically trapped sperm. A more passive option is red light irradiation. Red light irradiation has been shown to increase sperm motility, thus increasing fertilizing potential. However, there is some concern that exposure to laser irradiation induces the production of oxidative species in cells, which can be damaging to DNA. In order to test the safety of irradiating sperm, sperm samples were exposed to 633 nm laser light and their DNA were tested for oxidative damage. Using fluorescence microscopy, antibody staining, and ELISA to detect oxidative DNA damage, it was concluded that red light irradiation does not pose a safety risk to sperm DNA. The use of red light on sperm has potential in both animal conservation and human reproduction techniques. This method can also be used in conjunction with optical trapping for viable sperm selection.

How safe is safe enough. The relation of environmental characteristics and economic competitiveness in fusion-reactor design

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

Holdren, J.P.

The need for fusion energy depends strongly on fusion's potential to achieve ambitious safety goals more completely or more economically than fission can. The history and present complexion of public opinion about environment and safety gives little basis for expecting either that these concerns will prove to be a passing fad or that the public will make demands for zero risk that no energy source can meet. Hazard indices based on ''worst case'' accidents and exposures should be used as design tools to promote combinations of fusion-reactor materials and configurations that bring the worst cases down to levels small comparedmore » to the hazards people tolerate from electricity at the point of end use. It may well be possible, by building such safety into fusion from the ground up, to accomplish this goal at costs competitive with other inexhaustible electricity sources. Indeed, the still rising and ultimately indeterminate costs of meeting safety and environmental requirements in nonbreeder fission reactors and coal-burning power plants mean that fusion reactors meeting ambitious safety goals may be able to compete economically with these ''interim'' electricity sources as well.« less

Sustaining Vaccine Confidence in the 21st Century

PubMed Central

Hardt, Karin; Schmidt-Ott, Ruprecht; Glismann, Steffen; Adegbola, Richard A.; Meurice, François P.

2013-01-01

Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-making procedures and recommendations, controlled processes for licensing and monitoring vaccine safety and effectiveness and disease surveillance. Community engagement with appropriate communication approaches for each audience is a key factor in building trust in vaccines. Vaccine safety/quality issues should be handled rapidly and transparently by informing and involving those most affected and those concerned with public health in effective ways. Openness and transparency in the exchange of information between industry and other stakeholders is also important. To maximize the safety of vaccines, and thus sustain trust in vaccines, partnerships are needed between public health sector stakeholders. Vaccine confidence can be improved through collaborations that ensure high vaccine uptake rates and that inform the public and other stakeholders of the benefits of vaccines and how vaccine safety is constantly assessed, assured and communicated. PMID:26344109

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Qianliguang (Senecio scandens) safety dilemma: dose is the key?

PubMed

Lin, Ge; Li, Song-Lin; Li, Mi; Li, Na; Sun-Kin Chan, Sunny; Chan, Wood-Yee; Zhao, Zhong-Zhen

2009-08-01

Qianliguang ( SENECIO SCANDENS) is a common Chinese medicinal herb. Qianliguang-containing herbal proprietary products are registered as over-the-counter remedies in China and exported to Western countries. The safety of using Qianliguang and its products has raised general concerns because of a potential risk of the presence of hepatotoxic pyrrolizidine alkaloids (PAs). A systematic toxicological study is thus required to verify this public concern. In the present article, we report, for the first time, that S. SCANDENS contains nine hepatotoxic PAs with a content of 6.95-7.19 microg/g. At a dose equivalent to the daily intake recommended by the Pharmacopoeia of China, the total content of toxic PAs in Qianliguang was determined to be 3.48 microg/kg/day, which is far below the lowest dose to cause hepatotoxicity (15 microg/kg/day) suggested by the International Program on Chemical Safety. No significant hepatotoxic effects were observed in rats fed with the extract at this human-equivalent dose for 14 consecutive days. However, a single overdose of the herbal water extract (6 g/kg), which was about 8-fold higher than the recommended dose, produced typical PA-induced hepatotoxicity in rats. Therefore, appropriate dosage guidelines should be implemented for the herbal industry, for export/import retailers, and for herbal medicine practitioners to ensure the safe and beneficial use of these herbal medicines. Georg Thieme Verlag KG Stuttgart.New York.

Safety update regarding intranasal corticosteroids for the treatment of allergic rhinitis.

PubMed

Blaiss, Michael S

2011-01-01

Intranasal corticosteroids (INSs) are the most efficacious medication for the treatment of allergic rhinitis. In 2006, the Joint Task Force of the American College of Allergy, Asthma, and Immunology, and the American Academy of Allergy, Asthma, and Immunology, published a white paper on the potential over-the-counter switch of INS (Bielory L, Blaiss M, Fineman SM, et al. Concerns about intranasal corticosteroids for over-the-counter use: Position statement of the Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 96:514-525, 2006). The concern of the paper was the safety of the use of these agents without oversight by a health care professional. The objective of this paper was to review published literature on the safety of INS since the publication of the task force white paper. Recent studies, which evaluated topical and systemic adverse events associated with ciclesonide (CIC), fluticasone furoate (FF), mometasone furoate (MF), triamcinolone acetonide, fluticasone propionate, budesonide, and beclomethasone dipropionate were summarized. In general, no significant topical or systemic complications were observed in these studies, although none were >1 year in duration. The newer formulations of topical corticosteroids for allergic rhinitis, such as CIC, FF, and MF, which have less systemic bioavailability, may be safer for long-term use. New studies continue to add to the reassurance of the safety of INSs in the treatment of allergic rhinitis but still do not answer the question if these agents are appropriate for long-term use without oversight by a health care professional.

Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Margle, Janice M. (Editor)

1987-01-01

Fire detection, fire standards and testing, fire extinguishment, inerting and atmospheres, fire-related medical science, aircraft fire safety, Space Station safety concerns, microgravity combustion, spacecraft material flammability testing, and metal combustion are among the topics considered.

Research notes : are safety corridors really safe? Evaluation of the corridor safety improvement program.

DOT National Transportation Integrated Search

1998-08-26

High accident frequencies on Oregons highway corridors are of concern to the Oregon Department of Transportation (ODOT). : ODOT adopted the Corridor Safety Improvement Program as part of an overall program of safety improvements using federal and ...

The safety of treatment options available for gout.

PubMed

Schlesinger, Naomi

2017-04-01

Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management. However, clinicians should be aware of some of the safety concerns of medications used to treat acute and chronic gout. When prescribing medications for gout one has to be mindful of the presence of comorbidities commonly affecting gout patients that may affect drug safety and efficacy, especially in the elderly and in patients treated with multiple drugs. The benefits of gout drugs, usually, outweigh their safety concerns. Studies are needed in gout patients with chronic kidney disease and/or cardiovascular disease, so that escalation of dosing /combination of anti-inflammatory drugs needed to suppress gouty inflammation as well as escalation of dosing/combination of urate lowering drugs needed to achieve target serum urate level will lead to better understanding of gout treatment safety issues.

Safety assessment in macaques of light exposures for functional two-photon ophthalmoscopy in humans

PubMed Central

Schwarz, Christina; Sharma, Robin; Fischer, William S.; Chung, Mina; Palczewska, Grazyna; Palczewski, Krzysztof; Williams, David R.; Hunter, Jennifer J.

2016-01-01

Two-photon ophthalmoscopy has potential for in vivo assessment of function of normal and diseased retina. However, light safety of the sub-100 fs laser typically used is a major concern and safety standards are not well established. To test the feasibility of safe in vivo two-photon excitation fluorescence (TPEF) imaging of photoreceptors in humans, we examined the effects of ultrashort pulsed light and the required light levels with a variety of clinical and high resolution imaging methods in macaques. The only measure that revealed a significant effect due to exposure to pulsed light within existing safety standards was infrared autofluorescence (IRAF) intensity. No other structural or functional alterations were detected by other imaging techniques for any of the exposures. Photoreceptors and retinal pigment epithelium appeared normal in adaptive optics images. No effect of repeated exposures on TPEF time course was detected, suggesting that visual cycle function was maintained. If IRAF reduction is hazardous, it is the only hurdle to applying two-photon retinal imaging in humans. To date, no harmful effects of IRAF reduction have been detected. PMID:28018732

Final report on the safety assessment of amino nitrophenols as used in hair dyes.

PubMed

Burnett, Christina L; Bergfeld, Wilma F; Belsito, Donald V; Klaassen, Curtis D; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Alan Andersen, F

2009-01-01

2-Amino-3-nitrophenol, 2-amino-4-nitrophenol, 2-amino-5-nitrophenol, 4-amino-3-nitrophenol, 4-amino-2-nitrophenol, 2-amino-4-nitrophenol sulfate, 3-nitro-p-hydroxyethylaminophenol, and 4-hydroxypropylamino-3-nitrophenol are substituted aromatic compounds used as semipermanent (nonoxidative) hair colorants and as toners in permanent (oxidative) hair dye products. All ingredients in this group except 2-amino-4-nitrophenol sulfate, 2-amino-5-nitrophenol, and 4-amino-2-nitrophenol have reported uses in cosmetics at use concentrations from 2% to 9%. The available toxicity studies for these amino nitrophenol hair dyes did not suggest safety concerns except for the potential carcinogenicity and mutagenicity of 4-amino-2-nitrophenol. 2-Amino-3-nitrophenol, 2-amino-4-nitrophenol, 2-amino-4-nitrophenol sulfate, 2-amino-5-nitrophenol, 4-amino-3-nitrophenol, 3-nitro-p-hydroxyethylaminophenol, and 4-hydroxypropylamino-3-nitrophenol are safe as hair dye ingredients in the practices of use and concentration as described in this safety assessment, but the data are insufficient to make a safety determination for 4-amino-2-nitrophenol.

Current safety issues with quadrivalent meningococcal conjugate vaccines.

PubMed

Myers, Tanya R; McNeil, Michael M

2018-05-04

Invasive meningococcal disease, although rare, can present as sudden, life-threatening disease with high risk of mortality or severe long-term sequelae. The main prevention strategy for invasive meningococcal disease in the United States is the routine vaccination of adolescents and other persons at increased risk of meningococcal disease with quadrivalent meningococcal conjugate vaccines. Two such vaccines are currently licensed and available in the United States, Menactra® (Sanofi Pasteur) and Menveo® (GlaxoSmithKline), and usage in the adolescent population has steadily increased since their introduction. Although early reports raised concerns about a possible association of Menactra with Guillain-Barré syndrome, a comprehensive safety review determined that if such risk existed it was no more than 0.66 cases per 1 million vaccinations. More recently, a study found an elevated risk of Bell's palsy when Menveo was administered concomitantly with other vaccines but no association was found when the vaccine was administered alone. In this commentary, we describe the current state of knowledge with respect to the safety of quadrivalent meningococcal conjugate vaccines, and we identify potential areas for safety research for these vaccines.

Techniques to evaluate the importance of common cause degradation on reliability and safety of nuclear weapons.

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

Darby, John L.

2011-05-01

As the nuclear weapon stockpile ages, there is increased concern about common degradation ultimately leading to common cause failure of multiple weapons that could significantly impact reliability or safety. Current acceptable limits for the reliability and safety of a weapon are based on upper limits on the probability of failure of an individual item, assuming that failures among items are independent. We expanded the current acceptable limits to apply to situations with common cause failure. Then, we developed a simple screening process to quickly assess the importance of observed common degradation for both reliability and safety to determine if furthermore » action is necessary. The screening process conservatively assumes that common degradation is common cause failure. For a population with between 100 and 5000 items we applied the screening process and conclude the following. In general, for a reliability requirement specified in the Military Characteristics (MCs) for a specific weapon system, common degradation is of concern if more than 100(1-x)% of the weapons are susceptible to common degradation, where x is the required reliability expressed as a fraction. Common degradation is of concern for the safety of a weapon subsystem if more than 0.1% of the population is susceptible to common degradation. Common degradation is of concern for the safety of a weapon component or overall weapon system if two or more components/weapons in the population are susceptible to degradation. Finally, we developed a technique for detailed evaluation of common degradation leading to common cause failure for situations that are determined to be of concern using the screening process. The detailed evaluation requires that best estimates of common cause and independent failure probabilities be produced. Using these techniques, observed common degradation can be evaluated for effects on reliability and safety.« less

Trade associations and labor organizations as intermediaries for disseminating workplace safety and health information.

PubMed

Okun, Andrea H; Watkins, Janice P; Schulte, Paul A

2017-09-01

There has not been a systematic study of the nature and extent to which business and professional trade associations and labor organizations obtain and communicate workplace safety and health information to their members. These organizations can serve as important intermediaries and play a central role in transferring this information to their members. A sample of 2294 business and professional trade associations and labor organizations in eight industrial sectors identified by the National Occupational Research Agenda was surveyed via telephone. A small percent of these organizations (40.9% of labor organizations, 15.6% of business associations, and 9.6% of professional associations) were shown to distribute workplace safety and health information to their members. Large differences were also observed between industrial sectors with construction having the highest total percent of organizations disseminating workplace safety and health information. There appears to be significant potential to utilize trade and labor organizations as intermediaries for transferring workplace safety and health information to their members. Government agencies have a unique opportunity to partner with these organizations and to utilize their existing communication channels to address high risk workplace safety and health concerns. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Provincial drug plan officials' views of the Canadian drug safety system.

PubMed

Lexchin, Joel; Wiktorowicz, Mary; Moscou, Kathy; Eggertson, Laura

2013-06-01

The Canadian constitution divides the responsibility for pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified.

Sociotechnical attributes of safe and unsafe work systems

PubMed Central

Kleiner, Brian M.; Hettinger, Lawrence J.; DeJoy, David M.; Huang, Yuang-Hsiang; Love, Peter E.D.

2015-01-01

Theoretical and practical approaches to safety based on sociotechnical systems principles place heavy emphasis on the intersections between social–organisational and technical–work process factors. Within this perspective, work system design emphasises factors such as the joint optimisation of social and technical processes, a focus on reliable human–system performance and safety metrics as design and analysis criteria, the maintenance of a realistic and consistent set of safety objectives and policies, and regular access to the expertise and input of workers. We discuss three current approaches to the analysis and design of complex sociotechnical systems: human–systems integration, macroergonomics and safety climate. Each approach emphasises key sociotechnical systems themes, and each prescribes a more holistic perspective on work systems than do traditional theories and methods. We contrast these perspectives with historical precedents such as system safety and traditional human factors and ergonomics, and describe potential future directions for their application in research and practice. Practitioner Summary: The identification of factors that can reliably distinguish between safe and unsafe work systems is an important concern for ergonomists and other safety professionals. This paper presents a variety of sociotechnical systems perspectives on intersections between social–organisational and technology–work process factors as they impact work system analysis, design and operation. PMID:25909756

Global harmonization of safety regulations for the use of industrial robots-permission of collaborative operation and a related study by JNIOSH.

PubMed

Saito, Tsuyoshi; Hoshi, Toshiro; Ikeda, Hiroyasu; Okabe, Kohei

2015-01-01

In December 2013, the Japanese Ministry of Health, Labour and Welfare (MHLW) partially amended the safety regulations for use of industrial robots so that "collaborative operation" could be performed at Japanese worksites as allowed in the ISO standard for industrial robots. In order to show global harmonization of Japanese legislation on machinery safety and problems with applying ISO safety standards to Japanese worksites, this paper reports the progress of a research study which have been conducted in National Institute of Occupational Safety and Health, Japan from 2011 to the present at the request of MHLW to examine the necessity and effect of the amendment. In the first phase of this study, a questionnaire survey was conducted among domestic robot manufacturers and users. The obtained results revealed their potential demand for the collaborative operation and problems concerning their risk assessment and rule-based risk reduction. To solve the problems, we propose a method based on an investigation result of the regulatory framework for safety of machinery in the European Union. Furthermore, a model of robot system capable of demonstrating the collaborative operation and risk reduction measures which is being developed to support appropriate implementation of the amendment is also described.

Pharmacy layout: What are consumers' perceptions?.

PubMed

Emmett, Dennis; Paul, David P; Chandra, Ashish; Barrett, Hilton

2006-01-01

The physical layout of a retail pharmacy can play a significant role in the development of the customers' perceptions which can have a positive (or negative) impact on its sales potential. Compared to most general merchandise stores, pharmacies are more concerned about safety and security issues due to the nature of their products. This paper will discuss these aspects as well as the physical and professional environments of retail pharmacies that influence the perceptions of customers and how these vary whether chain, independent, or hospital pharmacies.

Antifoam degradation testing

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

Lambert, D. P.; Zamecnik, J. R.; Newell, D. D.

2015-08-20

This report describes the results of testing to quantify the degradation products resulting from the dilution and storage of Antifoam 747. Antifoam degradation is of concern to the Defense Waste Processing Facility (DWPF) due to flammable decomposition products in the vapor phase of the Chemical Process Cell vessels, as well as the collection of flammable and organic species in the offgas condensate. The discovery that hexamethyldisiloxane is formed from the antifoam decomposition was the basis for a Potential Inadequacy in the Safety Analysis declaration by the DWPF.

Digging up the Dirt on Soil Safety

ERIC Educational Resources Information Center

Roy, Ken

2010-01-01

Should middle school science teachers be concerned about students bringing in unknown sources of soil to work on in class as the activity suggests? The science is well intended, but is it safe? What are some possible safety issues that might be of concern in dealing with soil samples? This month's column provides several examples of unsuspecting…

Mitigating Hazards in School Facilities

ERIC Educational Resources Information Center

National Clearinghouse for Educational Facilities, 2008

2008-01-01

School safety is a human concern, one that every school and community must take seriously and strive continually to achieve. It is also a legal concern; schools can be held liable if they do not make good-faith efforts to provide a safe and secure school environment. How schools are built and maintained is an integral part of school safety and…

Agricultural Chemical and Pesticide Hazards. Module SH-50. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on agricultural chemical and pesticide hazards is one of 50 modules concerned with job safety and health. This module contains information concerning the safe handling, use, and storage of many chemicals that are frequently used in the control of pests. Following the introduction, 10 objectives (each keyed to a page in the…

Injury Incidence and Patterns in Workers with Intellectual Disability: A Comparative Study

ERIC Educational Resources Information Center

Lysaght, Rosemary; Sparring, Cynthia; Ouellette-Kuntz, Helene; Marshall, Carrie Anne

2011-01-01

Background: Workplace safety is a concern in the employment of persons with intellectual disability, due to both real concerns for employee well-being, and the effect that negative perceptions of safety risk can have on hiring. Method: This study involved a retrospective analysis of workplace insurance claim records for workers with and without…

Defining contamination control requirements for non-human research on Space Station Freedom

NASA Technical Reports Server (NTRS)

Corbin, Barbara J.; Funk, Glenn A.

1992-01-01

The use of non-human biological specimens for life sciences research on Space Station Freedom has generated concerns about spacecraft internal contamination, crew safety and hardware utility. Various NASA organizations convened to discuss the concerns and determine how they should be addressed. This paper will present the issues raised at this meeting, the process by which safety concerns were identified, and the means by which contamination control requirements for all biological payloads were recommended for incorporation into Space Station Freedom safety requirements. The microbiological, toxicological and particulate contamination criteria for long-term spaceflight will be based on realistic assessment of risk and hardware will be designed to meet established contamination criteria while facilitating crew operations, thereby meeting the needs of the investigator.

Safety analysis of interchanges

DOT National Transportation Integrated Search

2007-06-01

The objectives of this research are to synthesize the current state of knowledge concerning the safety assessment of new or modified interchanges; develop a spreadsheet-based computational tool for performing safety assessments of interchanges; and i...

Food Safety for Pregnant and Breastfeeding Women

MedlinePlus

... on eating seafood while you are pregnant or breastfeeding. Learn more from the link below. Check with ... or concern. Food safety advice while you are breastfeeding your baby: Follow the food safety advice for ...

Experimental investigation of the effect orifice shape and fluid pressure has on high aspect ratio cross-sectional jet behaviour.

PubMed

Wakes, S J; Holdø, A E; Meares, A J

2002-01-04

Prevention of major disasters such as Piper Alpha is a concern of oil and gas companies when commissioning a new offshore superstructure. Safety studies are undertaken to identify potential major hazards, risks to personnel and that sufficient precautions have been employed to minimise these. Such an assessment will also include the consideration of the protection from gas leaks such as the optimum positions of gas leak detectors and startup safety procedures after a leak. This requires a comprehensive knowledge of the behaviour of the leaking hydrocarbons as they emerge from the leak into the area of concern. Such leaks are most likely to emanate from a high aspect ratio cross-sectional curved slot in a pipeline. This paper challenges the conventional view that it is sufficient to model such leaks as axisymmetric jets. This paper is therefore concerned with an experimental study carried out on a series of more realistic high aspect ratio cross-sectional jets issuing from a flange orifice. Both high quality photographs in both planes of the jets and some quantitative pressure data is examined for a high aspect ratio cross-sectional jet of air at pressures up to 4.136bar. The effect of changing aspect ratio, fluid pressure and orifice shape will be discussed and put into context with regard to how this relates to offshore analysis studies.

A Geospatial Mixed Methods Approach to Assessing Campus Safety

ERIC Educational Resources Information Center

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

2013-01-01

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

Safety of High Speed Magnetic Levitation Transportation Systems: Preliminary Safety Review of the Transrapid Maglev System

DOT National Transportation Integrated Search

1990-11-01

The safety of various magnetically levitated trains under development for possible : implementation in the United States is of direct concern to the Federal Railroad : Administration. This report, one in a series of planned reports on maglev safety, ...

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study.

PubMed

O'Hara, Jane K; Reynolds, Caroline; Moore, Sally; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Watt, Ian; Wright, John; Lawton, Rebecca

2018-03-15

Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. ISRCTN07689702; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

PubMed

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity). Guidances concerning the design of preclinical studies for such therapies are generally based on the clinical indication. Risk versus benefit decisions are made with an understanding of the nature of the patient population, the severity of disease, and the availability of alternative therapies. Key components of protocol design for preclinical studies addressing the risks of these agents include (a) a safe starting dose in humans, (b) identification of potential target organs, (c) identification of clinical parameters that should be monitored in humans, and (d) identification of at-risk populations. One of the distinct aspects of the safety evaluation of biotechnology-derived pharmaceuticals is the use of relevant and often nontraditional species and the use of animal models of disease in preclinical safety evaluation. Extensive contributions were made by the Center for Biologics Evaluation and Research to the ICH document on the safety of biotherapeutics, which is intended to provide worldwide guidance for a framework approach to the design and review of preclinical programs. Rational, scientifically sound study design and early identification of the potential safety concerns that may be anticipated in the clinical trial can result in preclinical data that facilitate use of these novel therapies for use in humans without duplication of effort or the unnecessary use of animals.

Safety issues involving marine containers on chassis.

DOT National Transportation Integrated Search

2009-01-01

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

School Safety Study: Phase I.

ERIC Educational Resources Information Center

Arora, Alka

This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

Occupational Safety and Health Professionals

ERIC Educational Resources Information Center

Wash, Pat

1975-01-01

The growing concern for safety in both the workplace and in consumer products will create many new jobs through the mid-1980's--especially in private industry. The largest number of safety professionals are safety engineers; others include fire protection engineers, industrial hygienists, loss control and occupational health consultants, and…

Safety Training--A Special Case?

ERIC Educational Resources Information Center

Cooper, Mark; Cotton, David

2000-01-01

Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

Anger and Pedagogy

ERIC Educational Resources Information Center

Mayo, Cris

2016-01-01

In his discussion of safety on campus, Eamonn Callan (2016) suggests a way to distinguish between two sorts of safety: "dignity safety" and "intellectual safety." As much as this author has some concerns that student activists should think more about pedagogy, she is not sure that "dignity" is the best approach to…

Health and the Environment: Miscellaneous--Part 7. Hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce. House of Representatives, Ninety-Eighth Congress, Second Session (May 31, 1984; August 3, 1984; and August 6, 1984).

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on Energy and Commerce.

In these hearings consideration was given to: the Toy Safety Act of 1984, House Resolution (H.R.) 5630 (May 31, 1984); H.R. 1797, concerning steel-jaw leghold traps (August 3, 1984); and House Resolutions concerning amusement park safety (H.R. 5788, 5790, and 5982 (August 6, 1984). The Toy Safety Act of 1984 amends the Federal Hazardous Substances…