Evaluating Models of Human Performance: Safety-Critical Systems Applications

NASA Technical Reports Server (NTRS)

Feary, Michael S.

2012-01-01

This presentation is part of panel discussion on Evaluating Models of Human Performance. The purpose of this panel is to discuss the increasing use of models in the world today and specifically focus on how to describe and evaluate models of human performance. My presentation will focus on discussions of generating distributions of performance, and the evaluation of different strategies for humans performing tasks with mixed initiative (Human-Automation) systems. I will also discuss issues with how to provide Human Performance modeling data to support decisions on acceptability and tradeoffs in the design of safety critical systems. I will conclude with challenges for the future.

Human factors in safety and business management.

PubMed

Vogt, Joachim; Leonhardt, Jorg; Koper, Birgit; Pennig, Stefan

2010-02-01

Human factors in safety is concerned with all those factors that influence people and their behaviour in safety-critical situations. In aviation these are, for example, environmental factors in the cockpit, organisational factors such as shift work, human characteristics such as ability and motivation of staff. Careful consideration of human factors is necessary to improve health and safety at work by optimising the interaction of humans with their technical and social (team, supervisor) work environment. This provides considerable benefits for business by increasing efficiency and by preventing incidents/accidents. The aim of this paper is to suggest management tools for this purpose. Management tools such as balanced scorecards (BSC) are widespread instruments and also well known in aviation organisations. Only a few aviation organisations utilise management tools for human factors although they are the most important conditions in the safety management systems of aviation organisations. One reason for this is that human factors are difficult to measure and therefore also difficult to manage. Studies in other domains, such as workplace health promotion, indicate that BSC-based tools are useful for human factor management. Their mission is to develop a set of indicators that are sensitive to organisational performance and help identify driving forces as well as bottlenecks. Another tool presented in this paper is the Human Resources Performance Model (HPM). HPM facilitates the integrative assessment of human factors programmes on the basis of a systematic performance analysis of the whole system. Cause-effect relationships between system elements are defined in process models in a first step and validated empirically in a second step. Thus, a specific representation of the performance processes is developed, which ranges from individual behaviour to system performance. HPM is more analytic than BSC-based tools because HPM also asks why a certain factor is facilitating or obstructing success. A significant need for research and development is seen here because human factors are of increasing importance for organisational success. This paper suggests integrating human factors in safety management of aviation businesses - a top-ranking partner of technology and finance - and managing it with professional tools. The tools HPM and BSC were identified as potentially useful for this purpose. They were successfully applied in case studies briefly presented in this paper. In terms of specific safety-steering tools in the aviation industry, further elaboration and empirical study is crucial. Statement of Relevance: The importance of human factors is recognised by operators at the sharp end of aviation, where flights are conducted or coordinated. At the blunt end, measurement tools are needed to manage operational resources.

The Development of Dynamic Human Reliability Analysis Simulations for Inclusion in Risk Informed Safety Margin Characterization Frameworks

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

Jeffrey C. Joe; Diego Mandelli; Ronald L. Boring

2015-07-01

The United States Department of Energy is sponsoring the Light Water Reactor Sustainability program, which has the overall objective of supporting the near-term and the extended operation of commercial nuclear power plants. One key research and development (R&D) area in this program is the Risk-Informed Safety Margin Characterization pathway, which combines probabilistic risk simulation with thermohydraulic simulation codes to define and manage safety margins. The R&D efforts to date, however, have not included robust simulations of human operators, and how the reliability of human performance or lack thereof (i.e., human errors) can affect risk-margins and plant performance. This paper describesmore » current and planned research efforts to address the absence of robust human reliability simulations and thereby increase the fidelity of simulated accident scenarios.« less

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Integrating Safety in the Aviation System: Interdepartmental Training for Pilots and Maintenance Technicians

NASA Technical Reports Server (NTRS)

Mattson, Marifran; Petrin, Donald A.; Young, John P.

2001-01-01

The study of human factors has had a decisive impact on the aviation industry. However, the entire aviation system often is not considered in researching, training, and evaluating human factors issues especially with regard to safety. In both conceptual and practical terms, we argue for the proactive management of human error from both an individual and organizational systems perspective. The results of a multidisciplinary research project incorporating survey data from professional pilots and maintenance technicians and an exploratory study integrating students from relevant disciplines are reported. Survey findings suggest that latent safety errors may occur during the maintenance discrepancy reporting process because pilots and maintenance technicians do not effectively interact with one another. The importance of interdepartmental or cross-disciplinary training for decreasing these errors and increasing safety is discussed as a primary implication.

Is it time to reassess current safety standards for glyphosate-based herbicides?

PubMed Central

Blumberg, Bruce; Antoniou, Michael N; Benbrook, Charles M; Carroll, Lynn; Colborn, Theo; Everett, Lorne G; Hansen, Michael; Landrigan, Philip J; Lanphear, Bruce P; Mesnage, Robin; vom Saal, Frederick S; Welshons, Wade V; Myers, John Peterson

2017-01-01

Use of glyphosate-based herbicides (GBHs) increased ∼100-fold from 1974 to 2014. Additional increases are expected due to widespread emergence of glyphosate-resistant weeds, increased application of GBHs, and preharvest uses of GBHs as desiccants. Current safety assessments rely heavily on studies conducted over 30 years ago. We have considered information on GBH use, exposures, mechanisms of action, toxicity and epidemiology. Human exposures to glyphosate are rising, and a number of in vitro and in vivo studies challenge the basis for the current safety assessment of glyphosate and GBHs. We conclude that current safety standards for GBHs are outdated and may fail to protect public health or the environment. To improve safety standards, the following are urgently needed: (1) human biomonitoring for glyphosate and its metabolites; (2) prioritisation of glyphosate and GBHs for hazard assessments, including toxicological studies that use state-of-the-art approaches; (3) epidemiological studies, especially of occupationally exposed agricultural workers, pregnant women and their children and (4) evaluations of GBHs in commercially used formulations, recognising that herbicide mixtures likely have effects that are not predicted by studying glyphosate alone. PMID:28320775

A Framework for Reliability and Safety Analysis of Complex Space Missions

NASA Technical Reports Server (NTRS)

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

2017-01-01

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

Utilizing a Human Factors Nursing Worksystem Improvement Framework to Increase Nurses' Time at the Bedside and Enhance Safety.

PubMed

Probst, C Adam; Carter, Megan; Cadigan, Caton; Dalcour, Cortney; Cassity, Cindy; Quinn, Penny; Williams, Tiana; Montgomery, Donna Cook; Wilder, Claudia; Xiao, Yan

2017-02-01

The aim of this study is to increase nurses' time for direct patient care and improve safety via a novel human factors framework for nursing worksystem improvement. Time available for direct patient care influences outcomes, yet worksystem barriers prevent nurses adequate time at the bedside. A novel human factors framework was developed for worksystem improvement in 3 units at 2 facilities. Objectives included improving nurse efficiency as measured by time-and-motion studies, reducing missing medications and subsequent trips to medication rooms and improving medication safety. Worksystem improvement resulted in time savings of 16% to 32% per nurse per 12-hour shift. Requests for missing medications dropped from 3.2 to 1.3 per day. Nurse medication room trips were reduced by 30% and nurse-reported medication errors fell from a range of 1.2 to 0.8 and 6.3 to 4.0 per month. An innovative human factors framework for nursing worksystem improvement provided practical and high priority targets for interventions that significantly improved the nursing worksystem.

Human factors in modern traffic systems.

PubMed

Noy, Y I

1997-10-01

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

Translational science approach for assessment of cardiovascular effects and proarrhythmogenic potential of the beta-3 adrenergic agonist mirabegron.

PubMed

Korstanje, Cees; Suzuki, Masanori; Yuno, Koichiro; Sato, Shuichi; Ukai, Masashi; Schneidkraut, Marlowe J; Yan, Gan X

2017-09-01

Translational assessment of cardiac safety parameters is a challenge in clinical development of beta-3 adrenoceptor agonists. The preclinical tools are presented that were used for assessing human safety for mirabegron. Studies were performed on electrical conductance at ion channels responsible for cardiac repolarization (I Kr , I Ks , I to , I Na , and I Ca,L ), on QT-interval, subendocardial APD 90 , T peak-end interval, and arrhythmia's in ventricular dog wedge tissue in vitro and on cardiovascular function (BP, HR, and QT c ) in conscious dogs. In conscious dogs, mirabegron (0.01-10mg/kg, p.o.) dose-dependently increased HR, reduced SBP but DBP was unchanged. Propranolol blocked the decrease in SBP and attenuated HR increase at 100mg/kg mirabegron. Mirabegron, at 30, 60, or 100mg/kg, p.o., had no significant effect on the QT c interval. In paced dog ventricular wedge, neither mirabegron nor metabolites M5, M11, M12, M14, and M16 prolonged QT, altered transmural dispersion of repolarization, induced premature ventricular contractions, or induced ventricular tachycardia. Mirabegron nor its metabolites inhibited I Kr , I Ks , I to I Na , or I Ca,L at clinically relevant concentrations. Up to exposure levels well exceeding human clinical exposure no discernible effects on ion channel conductance or on arrhythmogenic parameters in ventricular wedge resulted for mirabegron, or its main metabolites, confirming human cardiac safety findings. In vivo, dose-related increases in HR with effects markedly higher than seen clinically, was mediated in part by cross-activation of beta-1 adrenoceptors. This non-clinical cardiac safety test program therefore proved predictive for human cardiac safety for mirabegron. Copyright © 2017. Published by Elsevier Inc.

Safety Metrics for Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Leveson, Nancy G; Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems.This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

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

Human Factors Research in Anesthesia Patient Safety

PubMed Central

Weinger, Matthew B.; Slagle, Jason

2002-01-01

Patient safety has become a major public concern. Human factors research in other high-risk fields has demonstrated how rigorous study of factors that affect job performance can lead to improved outcome and reduced errors after evidence-based redesign of tasks or systems. These techniques have increasingly been applied to the anesthesia work environment. This paper describes data obtained recently using task analysis and workload assessment during actual patient care and the use of cognitive task analysis to study clinical decision making. A novel concept of “non-routine events” is introduced and pilot data are presented. The results support the assertion that human factors research can make important contributions to patient safety. Information technologies play a key role in these efforts.

Human factors research in anesthesia patient safety.

PubMed Central

Weinger, M. B.; Slagle, J.

2001-01-01

Patient safety has become a major public concern. Human factors research in other high-risk fields has demonstrated how rigorous study of factors that affect job performance can lead to improved outcome and reduced errors after evidence-based redesign of tasks or systems. These techniques have increasingly been applied to the anesthesia work environment. This paper describes data obtained recently using task analysis and workload assessment during actual patient care and the use of cognitive task analysis to study clinical decision making. A novel concept of "non-routine events" is introduced and pilot data are presented. The results support the assertion that human factors research can make important contributions to patient safety. Information technologies play a key role in these efforts. PMID:11825287

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

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

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com; Nolte, Marc W.; Solomon, Cristina

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii)more » the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated, with no adverse events. • Overall, human fibrinogen concentrate demonstrated a good safety profile. • This data adds to the safety information available to date on this hemostatic agent.« less

Aflatoxins: A Global Concern for Food Safety, Human Health and Their Management

PubMed Central

Kumar, Pradeep; Mahato, Dipendra K.; Kamle, Madhu; Mohanta, Tapan K.; Kang, Sang G.

2017-01-01

The aflatoxin producing fungi, Aspergillus spp., are widely spread in nature and have severely contaminated food supplies of humans and animals, resulting in health hazards and even death. Therefore, there is great demand for aflatoxins research to develop suitable methods for their quantification, precise detection and control to ensure the safety of consumers’ health. Here, the chemistry and biosynthesis process of the mycotoxins is discussed in brief along with their occurrence, and the health hazards to humans and livestock. This review focuses on resources, production, detection and control measures of aflatoxins to ensure food and feed safety. The review is informative for health-conscious consumers and research experts in the fields. Furthermore, providing knowledge on aflatoxins toxicity will help in ensure food safety and meet the future demands of the increasing population by decreasing the incidence of outbreaks due to aflatoxins. PMID:28144235

Understanding Human Autonomy Teaming Through Applications

NASA Technical Reports Server (NTRS)

Aponso, B.; Stallmann, Summer; Lachter, Joel; Shively, Jay; Benton, J.; Kaneshige, John; Mumaw, Randy; Feary, Michael

2017-01-01

This presentation describes the development and demonstration of human autonomy teaming technologies for improving aviation safety and efficiency during nominal and off-nominal operations by developing and validating increasingly autonomous systems concepts, technologies, and procedures.

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.

Obstetric Safety and Quality.

PubMed

Pettker, Christian M; Grobman, William A

2015-07-01

Obstetric safety and quality is an emerging and important topic not only as a result of the pressures of patient and regulatory expectations, but also because of the genuine interest of caregivers to reduce harm, improve outcomes, and optimize care. Although each seeks to improve care by using scientific approaches beyond human physiology and pathophysiology, patient safety methodologies seek to avoid preventable adverse events, whereas health care quality projects aim to achieve the best possible outcomes. It is well-documented that an increasingly complex medical system controlled by human workers is a circumstance subject to recurrent failure. A safety culture encourages a proactive approach to mitigate failure before, during, and after it occurs. This article highlights the key concepts in health care safety and quality and reviews the background of the quality improvement sciences with particular emphasis on obstetric outcomes and quality measures.

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

PubMed

Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

2018-06-01

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Improving patient safety: patient-focused, high-reliability team training.

PubMed

McKeon, Leslie M; Cunningham, Patricia D; Oswaks, Jill S Detty

2009-01-01

Healthcare systems are recognizing "human factor" flaws that result in adverse outcomes. Nurses work around system failures, although increasing healthcare complexity makes this harder to do without risk of error. Aviation and military organizations achieve ultrasafe outcomes through high-reliability practice. We describe how reliability principles were used to teach nurses to improve patient safety at the front line of care. Outcomes include safety-oriented, teamwork communication competency; reflections on safety culture and clinical leadership are discussed.

Is it time to reassess current safety standards for glyphosate-based herbicides?

PubMed

Vandenberg, Laura N; Blumberg, Bruce; Antoniou, Michael N; Benbrook, Charles M; Carroll, Lynn; Colborn, Theo; Everett, Lorne G; Hansen, Michael; Landrigan, Philip J; Lanphear, Bruce P; Mesnage, Robin; Vom Saal, Frederick S; Welshons, Wade V; Myers, John Peterson

2017-06-01

Use of glyphosate-based herbicides (GBHs) increased ∼100-fold from 1974 to 2014. Additional increases are expected due to widespread emergence of glyphosate-resistant weeds, increased application of GBHs, and preharvest uses of GBHs as desiccants. Current safety assessments rely heavily on studies conducted over 30 years ago. We have considered information on GBH use, exposures, mechanisms of action, toxicity and epidemiology. Human exposures to glyphosate are rising, and a number of in vitro and in vivo studies challenge the basis for the current safety assessment of glyphosate and GBHs. We conclude that current safety standards for GBHs are outdated and may fail to protect public health or the environment. To improve safety standards, the following are urgently needed: (1) human biomonitoring for glyphosate and its metabolites; (2) prioritisation of glyphosate and GBHs for hazard assessments, including toxicological studies that use state-of-the-art approaches; (3) epidemiological studies, especially of occupationally exposed agricultural workers, pregnant women and their children and (4) evaluations of GBHs in commercially used formulations, recognising that herbicide mixtures likely have effects that are not predicted by studying glyphosate alone. 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/.

Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

PubMed

Becker, Lillian C; 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

2015-01-01

The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

Predicting the Impacts of Intravehicular Displays on Driving Performance with Human Performance Modeling

NASA Technical Reports Server (NTRS)

Mitchell, Diane Kuhl; Wojciechowski, Josephine; Samms, Charneta

2012-01-01

A challenge facing the U.S. National Highway Traffic Safety Administration (NHTSA), as well as international safety experts, is the need to educate car drivers about the dangers associated with performing distraction tasks while driving. Researchers working for the U.S. Army Research Laboratory have developed a technique for predicting the increase in mental workload that results when distraction tasks are combined with driving. They implement this technique using human performance modeling. They have predicted workload associated with driving combined with cell phone use. In addition, they have predicted the workload associated with driving military vehicles combined with threat detection. Their technique can be used by safety personnel internationally to demonstrate the dangers of combining distracter tasks with driving and to mitigate the safety risks.

Human Health at the Beach

MedlinePlus

... wade or swim without putting your head under water. Recent research in epidemiology EPA has also linked digging in beach sand to an increased risk of gastrointestinal illness. Other Beach Safety Topics Beyond water pollution, there are other potential threats to human ...

Using Active Learning to Identify Health Information Technology Related Patient Safety Events.

PubMed

Fong, Allan; Howe, Jessica L; Adams, Katharine T; Ratwani, Raj M

2017-01-18

The widespread adoption of health information technology (HIT) has led to new patient safety hazards that are often difficult to identify. Patient safety event reports, which are self-reported descriptions of safety hazards, provide one view of potential HIT-related safety events. However, identifying HIT-related reports can be challenging as they are often categorized under other more predominate clinical categories. This challenge of identifying HIT-related reports is exacerbated by the increasing number and complexity of reports which pose challenges to human annotators that must manually review reports. In this paper, we apply active learning techniques to support classification of patient safety event reports as HIT-related. We evaluated different strategies and demonstrated a 30% increase in average precision of a confirmatory sampling strategy over a baseline no active learning approach after 10 learning iterations.

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

PubMed

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

2015-04-01

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

An Overview of the NASA Aviation Safety Program (AVSP) Systemwide Accident Prevention (SWAP) Human Performance Modeling (HPM) Element

NASA Technical Reports Server (NTRS)

Foyle, David C.; Goodman, Allen; Hooley, Becky L.

2003-01-01

An overview is provided of the Human Performance Modeling (HPM) element within the NASA Aviation Safety Program (AvSP). Two separate model development tracks for performance modeling of real-world aviation environments are described: the first focuses on the advancement of cognitive modeling tools for system design, while the second centers on a prescriptive engineering model of activity tracking for error detection and analysis. A progressive implementation strategy for both tracks is discussed in which increasingly more complex, safety-relevant applications are undertaken to extend the state-of-the-art, as well as to reveal potential human-system vulnerabilities in the aviation domain. Of particular interest is the ability to predict the precursors to error and to assess potential mitigation strategies associated with the operational use of future flight deck technologies.

Human Stem Cell Derived Cardiomyocytes: An Alternative Model to Evaluate Environmental Chemical Cardiac Safety and Development of Predictive Adverse Outcome Pathways

EPA Science Inventory

Chemical spills and associated deaths in the US has increased 2.6-fold and 16-fold from 1983 to 2012, respectfully. In addition, the number of chemicals to which humans are exposed to in the environment has increased almost 10-fold from 2001 to 2013 within the US. Internationally...

MicroRNA-Based Attenuation of Influenza Virus across Susceptible Hosts.

PubMed

Waring, Barbara M; Sjaastad, Louisa E; Fiege, Jessica K; Fay, Elizabeth J; Reyes, Ismarc; Moriarity, Branden; Langlois, Ryan A

2018-01-15

Influenza A virus drives significant morbidity and mortality in humans and livestock. Annual circulation of the virus in livestock and waterfowl contributes to severe economic disruption and increases the risk of zoonotic transmission of novel strains into the human population, where there is no preexisting immunity. Seasonal vaccinations in humans help prevent infection and can reduce symptoms when infection does occur. However, current vaccination regimens available for livestock are limited in part due to safety concerns regarding reassortment/recombination with circulating strains. Therefore, inactivated vaccines are used instead of the more immunostimulatory live attenuated vaccines. MicroRNAs (miRNAs) have been used previously to generate attenuated influenza A viruses for use as a vaccine. Here, we systematically targeted individual influenza gene mRNAs using the same miRNA to determine the segment(s) that yields maximal attenuation potential. This analysis demonstrated that targeting of NP mRNA most efficiently ablates replication. We further increased the plasticity of miRNA-mediated attenuation of influenza A virus by exploiting a miRNA, miR-21, that is ubiquitously expressed across influenza-susceptible hosts. In order to construct this targeted virus, we used CRISPR/Cas9 to eliminate the universally expressed miR-21 from MDCK cells. miR-21-targeted viruses were attenuated in human, mouse, canine, and avian cells and drove protective immunity in mice. This strategy has the potential to enhance the safety of live attenuated vaccines in humans and zoonotic reservoirs. IMPORTANCE Influenza A virus circulates annually in both avian and human populations, causing significant morbidity, mortality, and economic burden. High incidence of zoonotic infections greatly increases the potential for transmission to humans, where no preexisting immunity or vaccine exists. There is a critical need for new vaccine strategies to combat emerging influenza outbreaks. MicroRNAs were used previously to attenuate influenza A viruses. We propose the development of a novel platform to produce live attenuated vaccines that are highly customizable, efficacious across a broad species range, and exhibit enhanced safety over traditional vaccination methods. This strategy exploits a microRNA that is expressed abundantly in influenza virus-susceptible hosts. By eliminating this ubiquitous microRNA from a cell line, targeted viruses that are attenuated across susceptible strains can be generated. This approach greatly increases the plasticity of the microRNA targeting approach and enhances vaccine safety. Copyright © 2018 American Society for Microbiology.

Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex.

PubMed

Oliviero, A; Carrasco-López, M C; Campolo, M; Perez-Borrego, Y A; Soto-León, V; Gonzalez-Rosa, J J; Higuero, A M; Strange, B A; Abad-Rodriguez, J; Foffani, G

2015-01-01

Transcranial static magnetic field stimulation (tSMS) in humans reduces cortical excitability. The objective of this study was to determine if prolonged tSMS (2 h) could be delivered safely in humans. Safety limits for this technique have not been described. tSMS was applied for 2 h with a cylindric magnet on the occiput of 17 healthy subjects. We assessed tSMS-related safety aspects at tissue level by measuring levels of neuron-specific enolase (NSE, a marker of neuronal damage) and S100 (a marker of glial reactivity and damage). We also included an evaluation of cognitive side effects by using a battery of visuomotor and cognitive tests. tSMS did not induce any significant increase in NSE or S100. No cognitive alteration was detected. Our data indicate that the application of tSMS is safe in healthy human subjects, at least within these parameters. Copyright © 2015 Elsevier Inc. All rights reserved.

Animal-assisted interventions: A national survey of health and safety policies in hospitals, eldercare facilities, and therapy animal organizations.

PubMed

Linder, Deborah E; Siebens, Hannah C; Mueller, Megan K; Gibbs, Debra M; Freeman, Lisa M

2017-08-01

Animal-assisted intervention (AAI) programs are increasing in popularity, but it is unknown to what extent therapy animal organizations that provide AAI and the hospitals and eldercare facilities they work with implement effective animal health and safety policies to ensure safety of both animals and humans. Our study objective was to survey hospitals, eldercare facilities, and therapy animal organizations on their AAI policies and procedures. A survey of United States hospitals, eldercare facilities, and therapy animal organizations was administered to assess existing health and safety policies related to AAI programs. Forty-five eldercare facilities, 45 hospitals, and 27 therapy animal organizations were surveyed. Health and safety policies varied widely and potentially compromised human and animal safety. For example, 70% of therapy animal organizations potentially put patients at risk by allowing therapy animals eating raw meat diets to visit facilities. In general, hospitals had stricter requirements than eldercare facilities. This information suggests that there are gaps between the policies of facilities and therapy animal organizations compared with recent guidelines for animal visitation in hospitals. Facilities with AAI programs need to review their policies to address recent AAI guidelines to ensure the safety of animals and humans involved. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Ebola and Human Rights: Post-9/11 Public Health and Safety in Epidemics.

PubMed

Annas, George J

2016-05-01

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism is often counterproductive to the population's health, and undermines human rights. Using the Ebola epidemic of 2014, this Article suggests how the post-9/11 reframing of public health goals as including disaster preparedness and counterterrorism, and the new military metaphors we have adopted to describe public health, have deformed our public health agencies, and have made them less trusted by the public. In turn, these agencies are therefore less able to prevent and respond to new infectious diseases. The United States' response to Ebola gives us an opportunity to reconsider the merger of public health and public safety domestically and globally. This Article suggests that a deeper commitment to human rights, especially to the right to health, has the theoretical and practical strength to act as a countervailing force and refocus public health on the health of populations rather than on safety and national security.

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.

Space Human Factors: Research to Application

NASA Technical Reports Server (NTRS)

Woolford, Barbara

2008-01-01

Human Factors has been instrumental in preventing potential on-orbit hazards and increasing overall crew safety. Poor performance & operational learning curves on-orbit are mitigated. Human-centered design is applied to optimize design and minimize potentially hazardous conditions, especially with larger crew sizes and habitat constraints. Lunar and Mars requirements and design developments are enhanced, based on ISS Lessons Learned.

Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union

PubMed Central

Brodmann, Theodor; Endo, Akihito; Gueimonde, Miguel; Vinderola, Gabriel; Kneifel, Wolfgang; de Vos, Willem M.; Salminen, Seppo; Gómez-Gallego, Carlos

2017-01-01

Novel microbes are either newly isolated genera and species from natural sources or bacterial strains derived from existing bacteria. Novel microbes are gaining increasing attention for the general aims to preserve and modify foods and to modulate gut microbiota. The use of novel microbes to improve health outcomes is of particular interest because growing evidence points to the importance of gut microbiota in human health. As well, some recently isolated microorganisms have promise for use as probiotics, although in-depth assessment of their safety is necessary. Recent examples of microorganisms calling for more detailed evaluation include Bacteroides xylanisolvens, Akkermansia muciniphila, fructophilic lactic acid bacteria (FLAB), and Faecalibacterium prausnitzii. This paper discusses each candidate's safety evaluation for novel food or novel food ingredient approval according to European Union (EU) regulations. The factors evaluated include their beneficial properties, antibiotic resistance profiling, history of safe use (if available), publication of the genomic sequence, toxicological studies in agreement with novel food regulations, and the qualified presumptions of safety. Sufficient evidences have made possible to support and authorize the use of heat-inactivated B. xylanisolvens in the European Union. In the case of A. muciniphila, the discussion focuses on earlier safety studies and the strain's suitability. FLAB are also subjected to standard safety assessments, which, along with their proximity to lactic acid bacteria generally considered to be safe, may lead to novel food authorization in the future. Further research with F. prausnitzii will increase knowledge about its safety and probiotic properties and may lead to its future use as novel food. Upcoming changes in EUU Regulation 2015/2283 on novel food will facilitate the authorization of future novel products and might increase the presence of novel microbes in the food market. PMID:28955311

Effects on Task Performance and Psychophysiological Measures of Performance During Normobaric Hypoxia Exposure

NASA Technical Reports Server (NTRS)

Stephens, Chad; Kennedy, Kellie; Napoli, Nicholas; Demas, Matthew; Barnes, Laura; Crook, Brenda; Williams, Ralph; Last, Mary Carolyn; Schutte, Paul

2017-01-01

Human-autonomous systems have the potential to mitigate pilot cognitive impairment and improve aviation safety. A research team at NASA Langley conducted an experiment to study the impact of mild normobaric hypoxia induction on aircraft pilot performance and psychophysiological state. A within-subjects design involved non-hypoxic and hypoxic exposures while performing three 10-minute tasks. Results indicated the effect of 15,000 feet simulated altitude did not induce significant performance decrement but did produce increase in perceived workload. Analyses of psychophysiological responses evince the potential of biomarkers for hypoxia onset. This study represents on-going work at NASA intending to add to the current knowledge of psychophysiologically-based input to automation to increase aviation safety. Analyses involving coupling across physiological systems and wavelet transforms of cortical activity revealed patterns that can discern between the simulated altitude conditions. Specifically, multivariate entropy of ECG/Respiration components were found to be significant predictors (p< 0.02) of hypoxia. Furthermore, in EEG, there was a significant decrease in mid-level beta (15.19-18.37Hz) during the hypoxic condition in thirteen of sixteen sites across the scalp. Task performance was not appreciably impacted by the effect of 15,000 feet simulated altitude. Analyses of psychophysiological responses evince the potential of biomarkers for mild hypoxia onset.The potential for identifying shifts in underlying cortical and physiological systems could serve as a means to identify the onset of deteriorated cognitive state. Enabling such assessment in future flightdecks could permit increasingly autonomous systems-supported operations. Augmenting human operator through assessment of cognitive impairment has the potential to further improve operator performance and mitigate human error in safety critical contexts. This study represents ongoing work at NASA intending to add to the current knowledge of psychophysiologically-based input to automation to increase aviation safety.

[Patient safety: Glossary].

PubMed

Sabio Paz, Verónica; Panattieri, Néstor D; Cristina Godio, Farmacéutica; Ratto, María E; Arpí, Lucrecia; Dackiewicz, Nora

2015-10-01

Patient safety and quality of care has become a challenge for health systems. Health care is an increasingly complex and risky activity, as it represents a combination of human, technological and organizational processes. It is necessary, therefore, to take effective actions to reduce the adverse events and mitigate its impact. This glossary is a local adaptation of key terms and concepts from the international bibliographic sources. The aim is providing a common language for assessing patient safety processes and compare them.

WTEC monograph on instrumentation, control and safety systems of Canadian nuclear facilities

NASA Technical Reports Server (NTRS)

Uhrig, Robert E.; Carter, Richard J.

1993-01-01

This report updates a 1989-90 survey of advanced instrumentation and controls (I&C) technologies and associated human factors issues in the U.S. and Canadian nuclear industries carried out by a team from Oak Ridge National Laboratory (Carter and Uhrig 1990). The authors found that the most advanced I&C systems are in the Canadian CANDU plants, where the newest plant (Darlington) has digital systems in almost 100 percent of its control systems and in over 70 percent of its plant protection system. Increased emphasis on human factors and cognitive science in modern control rooms has resulted in a reduced workload for the operators and the elimination of many human errors. Automation implemented through digital instrumentation and control is effectively changing the role of the operator to that of a systems manager. The hypothesis that properly introducing digital systems increases safety is supported by the Canadian experience. The performance of these digital systems has been achieved using appropriate quality assurance programs for both hardware and software development. Recent regulatory authority review of the development of safety-critical software has resulted in the creation of isolated software modules with well defined interfaces and more formal structure in the software generation. The ability of digital systems to detect impending failures and initiate a fail-safe action is a significant safety issue that should be of special interest to nuclear utilities and regulatory authorities around the world.

Safety Assessment of Probiotics

NASA Astrophysics Data System (ADS)

Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

Safety of intra-articular transplantation of lentivirally transduced mesenchymal stromal cells for haemophilic arthropathy in a non-human primate.

PubMed

Ohmori, Tsukasa; Mizukami, Hiroaki; Katakai, Yuko; Kawai, Sho; Nakamura, Hitoyasu; Inoue, Makoto; Shu, Tsugumine; Sugimoto, Hideharu; Sakata, Yoichi

2018-05-08

Joint bleeding and resultant arthropathy are major determinants of quality of life in haemophilia patients. We previously developed a mesenchymal stromal cell (MSC)-based treatment approach for haemophilic arthropathy in a mouse model of haemophilia A. Here, we evaluated the long-term safety of intra-articular injection of lentivirally transduced autologous MSCs in non-human primates. Autologous bone-marrow-derived MSCs transduced with a lentiviral vector expressing coagulation factor VIII (FVIII) were injected into the left knee joint of cynomolgus monkeys. We first conducted codon optimization to increase FVIII production in the cells. Lentiviral transduction of autologous MSCs resulted in a significant increase of FVIII in the culture supernatant before transplantation. We did not find any tumour generation around the knee structure at 11-16 months after injection by magnetic resonance imaging. The proviral sequence of the simian immunodeficiency virus lentiviral vector was not detected in the heart, lungs, spleen, liver, testis, or bone marrow by real-time quantitative PCR. We confirmed the long-term safety of intra-articular injection of transduced MSCs in a non-human primate. The procedure may be an attractive therapeutic approach for joint diseases in haemophilia patients.

2009 Human Factors and Roadway Safety Workshop : Teen Driver Safety [SD .WMV (720x480/29fps/177.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Teen Driver Safety : Keynote Speaker Dan McGehee, director, Human Factors & Vehicle Safety Res...

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

PubMed

Becker, Lillian C; 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

2015-09-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

In-Vehicle Information Systems Demand Model (Research Update)

DOT National Transportation Integrated Search

2000-04-01

The goal of in-vehicle information system (IVIS) technologies is to increase the mobility, improve the efficiency, and increase the safety and/or convenience of the motoring public. To achieve this goal, IVISs must be designed to include good human f...

Considerations Related To Human Intrusion In The Context Of Disposal Of Radioactive Waste-The IAEA HIDRA Project

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

Seitz, Roger; Kumano, Yumiko; Bailey, Lucy

2014-01-09

The principal approaches for management of radioactive waste are commonly termed ‘delay and decay’, ‘concentrate and contain’ and ‘dilute and disperse’. Containing the waste and isolating it from the human environment, by burying it, is considered to increase safety and is generally accepted as the preferred approach for managing radioactive waste. However, this approach results in concentrated sources of radioactive waste contained in one location, which can pose hazards should the facility be disrupted by human action in the future. The International Commission on Radiological Protection (ICRP), International Atomic Energy Agency (IAEA), and Organization for Economic Cooperation and Development/Nuclear Energymore » Agency (OECD/NEA) agree that some form of inadvertent human intrusion (HI) needs to be considered to address the potential consequences in the case of loss of institutional control and loss of memory of the disposal facility. Requirements are reflected in national regulations governing radioactive waste disposal. However, in practice, these requirements are often different from country to country, which is then reflected in the actual implementation of HI as part of a safety case. The IAEA project on HI in the context of Disposal of RadioActive waste (HIDRA) has been started to identify potential areas for improved consistency in consideration of HI. The expected outcome is to provide recommendations on how to address human actions in the safety case in the future, and how the safety case may be used to demonstrate robustness and optimize siting, design and waste acceptance criteria within the context of a safety case.« less

Human Milk Handling and Storage Practices Among Peer Milk-Sharing Mothers.

PubMed

Reyes-Foster, Beatriz M; Carter, Shannon K; Hinojosa, Melanie Sberna

2017-02-01

Peer milk sharing, the noncommercial sharing of human milk from one parent or caretaker directly to another for the purposes of feeding a child, appears to be an increasing infant-feeding practice. Although the U.S. Food and Drug Administration has issued a warning against the practice, little is known about how people who share human milk handle and store milk and whether these practices are consistent with clinical safety protocols. Research aim: This study aimed to learn about the milk-handling practices of expressed human milk by milk-sharing donors and recipient caretakers. In this article, we explore the degree to which donors and recipients adhere to the Academy of Breastfeeding Medicine clinical recommendations for safe handling and storage. Online surveys were collected from 321 parents engaged in peer milk sharing. Univariate descriptive statistics were used to describe the safe handling and storage procedures for milk donors and recipients. A two-sample t-test was used to compare safety items common to each group. Multivariate ordinary least squares regression analysis was used to examine sociodemographic correlates of milk safety practices within the sample group. Findings indicate that respondents engaged in peer milk sharing report predominantly positive safety practices. Multivariate analysis did not reveal any relationship between safety practices and sociodemographic characteristics. The number of safe practices did not differ between donors and recipients. Parents and caretakers who participate in peer human milk sharing report engaging in practices that should reduce risk of bacterial contamination of expressed peer shared milk. More research on this particular population is recommended.

Preoperative Safety Briefing Project

PubMed Central

DeFontes, James; Surbida, Stephanie

2004-01-01

Context: Increased media attention on surgical procedures that were performed on the wrong anatomic site or wrong patient has prompted the health care industry to identify and address human factors that lead to medical errors. Objective: To increase patient safety in the perioperative setting, our objective was to create a climate of improved communication, collaboration, team-work, and situational awareness while the surgical team reviewed pertinent information about the patient and the pending procedure. Methods: A team of doctors, nurses, and technicians used human factors principles to develop the Preoperative Safety Briefing for use by surgical teams, a briefing similar to the preflight checklist used by the airline industry. A six-month pilot of the briefing began in the Kaiser Permanente (KP) Anaheim Medical Center in February 2002. Four indicators of safety culture were used to measure success of the pilot: occurrence of wrong-site/wrong procedures, attitudinal survey data, near-miss reports, and nursing personnel turnover data. Results: Wrong-site surgeries decreased from 3 to 0 (300%) per year; employee satisfaction increased 19%; nursing personnel turnover decreased 16%; and perception of the safety climate in the operating room improved from “good” to “outstanding.” Operating suite personnel perception of teamwork quality improved substantially. Operating suite personnel perception of patient safety as a priority, of personnel communication, of their taking responsibility for patient safety, of nurse input being well received, of overall morale, and of medical errors being handled appropriately also improved substantially. Conclusions: Team members who work together and communicate well can quickly detect and more easily avoid errors. The Preoperative Safety Briefing is now standard in many operating suites in the KP Orange County Service Area. The concepts and design of this project are transferable, and similar projects are underway in the Departments of Radiology and of Labor and Delivery at KP Anaheim Medical Center. PMID:26704913

Quantitative evolutionary design

PubMed Central

Diamond, Jared

2002-01-01

The field of quantitative evolutionary design uses evolutionary reasoning (in terms of natural selection and ultimate causation) to understand the magnitudes of biological reserve capacities, i.e. excesses of capacities over natural loads. Ratios of capacities to loads, defined as safety factors, fall in the range 1.2-10 for most engineered and biological components, even though engineered safety factors are specified intentionally by humans while biological safety factors arise through natural selection. Familiar examples of engineered safety factors include those of buildings, bridges and elevators (lifts), while biological examples include factors of bones and other structural elements, of enzymes and transporters, and of organ metabolic performances. Safety factors serve to minimize the overlap zone (resulting in performance failure) between the low tail of capacity distributions and the high tail of load distributions. Safety factors increase with coefficients of variation of load and capacity, with capacity deterioration with time, and with cost of failure, and decrease with costs of initial construction, maintenance, operation, and opportunity. Adaptive regulation of many biological systems involves capacity increases with increasing load; several quantitative examples suggest sublinear increases, such that safety factors decrease towards 1.0. Unsolved questions include safety factors of series systems, parallel or branched pathways, elements with multiple functions, enzyme reaction chains, and equilibrium enzymes. The modest sizes of safety factors imply the existence of costs that penalize excess capacities. Those costs are likely to involve wasted energy or space for large or expensive components, but opportunity costs of wasted space at the molecular level for minor components. PMID:12122135

Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed.

PubMed

Sauer, Ursula G

2011-12-01

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

Role of Fundamental Physics in Human Space Exploration

NASA Technical Reports Server (NTRS)

Turyshev, Slava

2004-01-01

This talk will discuss the critical role that fundamental physics research plays for the human space exploration. In particular, the currently available technologies can already provide significant radiation reduction, minimize bone loss, increase crew productivity and, thus, uniquely contribute to overall mission success. I will discuss how fundamental physics research and emerging technologies may not only further reduce the risks of space travel, but also increase the crew mobility, enhance safety and increase the value of space exploration in the near future.

Human Papillomavirus Vaccination Requirements in US Schools: Recommendations for Moving Forward.

PubMed

North, Anna L; Niccolai, Linda M

2016-10-01

Safe and effective human papillomavirus (HPV) vaccines have been available and recommended for adolescents for a decade in the United States, yet vaccination rates remain suboptimal. School entry requirements have increased uptake of other vaccines for adolescents and made coverage more equitable. However, only 3 jurisdictions require HPV vaccine for school. We summarize the current status of HPV vaccine requirements and discuss the rationales for and against these policies. The rationales for requirements include HPV vaccine efficacy and safety, effectiveness of requirements for increasing vaccine uptake and making it more equitable, and use of requirements as "safety nets" and to achieve herd immunity. The rationales against requirements include low parental acceptance of HPV vaccine, the financial burden on educational systems and health departments, and the possibility for alternatives to increase vaccine uptake. Many challenges to HPV vaccine requirements are addressable, and we conclude with recommendations on how to approach these challenges.

Understanding the relationship between safety investment and safety performance of construction projects through agent-based modeling.

PubMed

Lu, Miaojia; Cheung, Clara Man; Li, Heng; Hsu, Shu-Chien

2016-09-01

The construction industry in Hong Kong increased its safety investment by 300% in the past two decades; however, its accident rate has plateaued to around 50% for one decade. Against this backdrop, researchers have found inconclusive results on the causal relationship between safety investment and safety performance. Using agent-based modeling, this study takes an unconventional bottom-up approach to study safety performance on a construction site as an outcome of a complex system defined by interactions among a worksite, individual construction workers, and different safety investments. Instead of focusing on finding the absolute relationship between safety investment and safety performance, this study contributes to providing a practical framework to investigate how different safety investments interacting with different parameters such as human and environmental factors could affect safety performance. As a result, we could identify cost-effective safety investments under different construction scenarios for delivering optimal safety performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Animal models for microbicide safety and efficacy testing.

PubMed

Veazey, Ronald S

2013-07-01

Early studies have cast doubt on the utility of animal models for predicting success or failure of HIV-prevention strategies, but results of multiple human phase 3 microbicide trials, and interrogations into the discrepancies between human and animal model trials, indicate that animal models were, and are, predictive of safety and efficacy of microbicide candidates. Recent studies have shown that topically applied vaginal gels, and oral prophylaxis using single or combination antiretrovirals are indeed effective in preventing sexual HIV transmission in humans, and all of these successes were predicted in animal models. Further, prior discrepancies between animal and human results are finally being deciphered as inadequacies in study design in the model, or quite often, noncompliance in human trials, the latter being increasingly recognized as a major problem in human microbicide trials. Successful microbicide studies in humans have validated results in animal models, and several ongoing studies are further investigating questions of tissue distribution, duration of efficacy, and continued safety with repeated application of these, and other promising microbicide candidates in both murine and nonhuman primate models. Now that we finally have positive correlations with prevention strategies and protection from HIV transmission, we can retrospectively validate animal models for their ability to predict these results, and more importantly, prospectively use these models to select and advance even safer, more effective, and importantly, more durable microbicide candidates into human trials.

Operator performance-enhancing technologies to improve safety. A US DOT safety initiative for meeting the human-centered systems challenge.

DOT National Transportation Integrated Search

1999-11-01

The program implements DOT Human Factors Coordinating Committee (HFCC) recommendations for a coordinated Departmental Human Factors Research Program to advance the human-centered systems approach for enhancing transportation safety. Human error is a ...

Minimizing Exposure at Work

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure (chronic) exposure to certain pesticides may increase your risk of chronic health effects. Therefore, it is

Human Stem Cell-Derived Cardiomyocytes: An Alternative Model to Evaluate Environmental Chemical Cardiac Safety and Development of Predictive Adverse Outcome Pathways

EPA Science Inventory

Biomonitoring over the last 14 years has shown human exposure to environmental chemicals has increased ~10-fold (1). In addition, mortality and morbidity related cardiovascular disease continues to be the leading national and global public health issue (2, 3). The association bet...

A Model-based Framework for Risk Assessment in Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems. This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions. Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

State of science: human factors and ergonomics in healthcare.

PubMed

Hignett, Sue; Carayon, Pascale; Buckle, Peter; Catchpole, Ken

2013-01-01

The past decade has seen an increase in the application of human factors and ergonomics (HFE) techniques to healthcare delivery in a broad range of contexts (domains, locations and environments). This paper provides a state of science commentary using four examples of HFE in healthcare to review and discuss analytical and implementation challenges and to identify future issues for HFE. The examples include two domain areas (occupational ergonomics and surgical safety) to illustrate a traditional application of HFE and the area that has probably received the most research attention. The other two examples show how systems and design have been addressed in healthcare with theoretical approaches for organisational and socio-technical systems and design for patient safety. Future opportunities are identified to develop and embed HFE systems thinking in healthcare including new theoretical models and long-term collaborative partnerships. HFE can contribute to systems and design initiatives for both patients and clinicians to improve everyday performance and safety, and help to reduce and control spiralling healthcare costs. There has been an increase in the application of HFE techniques to healthcare delivery in the past 10 years. This paper provides a state of science commentary using four illustrative examples (occupational ergonomics, design for patient safety, surgical safety and organisational and socio-technical systems) to review and discuss analytical and implementation challenges and identify future issues for HFE.

50 CFR 600.355 - National Standard 10-Safety of Life at Sea.

Code of Federal Regulations, 2011 CFR

2011-10-01

... measures shall, to the extent practicable, promote the safety of human life at sea. (b) General. (1... considered the same as “safety of human life at sea. The safety of a vessel and the people aboard is... their development to ensure they recognize any impact on the safety of human life at sea and minimize or...

Patient safety in otolaryngology: a descriptive review.

PubMed

Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

2017-03-01

Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within Otolaryngology, although patient safety has evolved along similar themes as other surgical specialties; there are several specific high-risk areas. Medical error is a common problem and its human cost is of immense importance. Steps to reduce such errors require the identification of high-risk practice within a complex healthcare system. The commitment to patient safety and quality improvement in medicine depend on personal responsibility and professional accountability.

Quantifying Pilot Contribution to Flight Safety during Drive Shaft Failure

NASA Technical Reports Server (NTRS)

Kramer, Lynda J.; Etherington, Tim; Last, Mary Carolyn; Bailey, Randall E.; Kennedy, Kellie D.

2017-01-01

Accident statistics cite the flight crew as a causal factor in over 60% of large transport aircraft fatal accidents. Yet, a well-trained and well-qualified pilot is acknowledged as the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system. The latter statement, while generally accepted, cannot be verified because little or no quantitative data exists on how and how many accidents/incidents are averted by crew actions. A joint NASA/FAA high-fidelity motion-base simulation experiment specifically addressed this void by collecting data to quantify the human (pilot) contribution to safety-of-flight and the methods they use in today's National Airspace System. A human-in-the-loop test was conducted using the FAA's Oklahoma City Flight Simulation Branch Level D-certified B-737-800 simulator to evaluate the pilot's contribution to safety-of-flight during routine air carrier flight operations and in response to aircraft system failures. These data are fundamental to and critical for the design and development of future increasingly autonomous systems that can better support the human in the cockpit. Eighteen U.S. airline crews flew various normal and non-normal procedures over a two-day period and their actions were recorded in response to failures. To quantify the human's contribution to safety of flight, crew complement was used as the experiment independent variable in a between-subjects design. Pilot actions and performance during single pilot and reduced crew operations were measured for comparison against the normal two-crew complement during normal and non-normal situations. This paper details the crew's actions, including decision-making, and responses while dealing with a drive shaft failure - one of 6 non-normal events that were simulated in this experiment.

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

PubMed Central

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

2015-01-01

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

Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

PubMed

Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

2017-07-01

Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

An Interprofessional Course Using Human Patient Simulation to Teach Patient Safety and Teamwork Skills

PubMed Central

McCulloh, Russell; Dyer, Carla; Gregory, Gretchen; Higbee, Dena

2012-01-01

Objectives. To assess the effectiveness of human patient simulation to teach patient safety, team-building skills, and the value of interprofessional collaboration to pharmacy students. Design. Five scenarios simulating semi-urgent situations that required interprofessional collaboration were developed. Groups of 10 to 12 health professions students that included 1 to 2 pharmacy students evaluated patients while addressing patient safety hazards. Assessment. Pharmacy students’ scores on 8 of 30 items on a post-simulation survey of knowledge, skills, and attitudes improved over pre-simulation scores. Students’ scores on 3 of 10 items on a team building and interprofessional communications survey also improved after participating in the simulation exercise. Over 90% of students reported that simulation increased their understanding of professional roles and the importance of interprofessional communication. Conclusions. Simulation training provided an opportunity to improve pharmacy students’ ability to recognize and react to patient safety concerns and enhanced their interprofessional collaboration and communication skills. PMID:22611280

Current and Future Technologies for Microbiological Decontamination of Cereal Grains.

PubMed

Los, Agata; Ziuzina, Dana; Bourke, Paula

2018-06-01

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

Applications of AOPs to ecotoxicology

EPA Science Inventory

Toxicologists conducting safety assessments for either human or ecological health are responsible for generating data for possible adverse effects of a rapidly increasing number of substances. For example, the Registration, Evaluation, Authorisation and Restriction of Chemicals (...

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand.

PubMed

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-06-01

Abstract Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans.

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand

PubMed Central

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-01-01

Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans. PMID:28719258

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.

76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety Administration... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...

Measuring the wildland firefighting safety culture change - an analysis of entrapment rates from 1994 to 2013

Treesearch

Bob Loveless; Adam Hernandez

2015-01-01

The tragic fatality events of the mid-1990s and subsequent studies led to a concentrated effort to increase safety in the US federal wildland firefighter community beginning in 2000. Addressing human factors (HF) as a causal agent in accidents was a major focal point for this cultural change. To examine the effectiveness of this change, we hypothesized a decline in...

Toward an Effective Long-Term Strategy for Preventing Motor Vehicle Crashes and Injuries

PubMed Central

Mawson, Anthony R.; Walley, E. Kenneth

2014-01-01

Casualties due to motor vehicle crashes (MVCs) include some 40,000 deaths each year in the United States and one million deaths worldwide. One strategy that has been recommended for improving automobile safety is to lower speed limits and enforce them with speed cameras. However, motor vehicles can be hazardous even at low speeds whereas properly protected human beings can survive high-speed crashes without injury. Emphasis on changing driver behavior as the focus for road safety improvements has been largely unsuccessful; moreover, drivers today are increasingly distracted by secondary tasks such as cell phone use and texting. Indeed, the true limiting factor in vehicular safety is the capacity of human beings to sense and process information and to make rapid decisions. Given that dramatic reductions in injuries and deaths from MVCs have occurred over the past century due to improvements in safety technology, despite increases in the number of vehicles on the road and miles driven per vehicle, we propose that an effective long-term strategy for reducing MVC-related injury would be continued technological innovation in vehicle design, aimed at progressively removing the driver from routine operational decision-making. Once this is achieved, high rates of speed could be achieved on open highways, with minimal risk of crashes and injury to occupants and pedestrians. PMID:25116634

Toward an effective long-term strategy for preventing motor vehicle crashes and injuries.

PubMed

Mawson, Anthony R; Walley, E Kenneth

2014-08-11

Casualties due to motor vehicle crashes (MVCs) include some 40,000 deaths each year in the United States and one million deaths worldwide. One strategy that has been recommended for improving automobile safety is to lower speed limits and enforce them with speed cameras. However, motor vehicles can be hazardous even at low speeds whereas properly protected human beings can survive high-speed crashes without injury. Emphasis on changing driver behavior as the focus for road safety improvements has been largely unsuccessful; moreover, drivers today are increasingly distracted by secondary tasks such as cell phone use and texting. Indeed, the true limiting factor in vehicular safety is the capacity of human beings to sense and process information and to make rapid decisions. Given that dramatic reductions in injuries and deaths from MVCs have occurred over the past century due to improvements in safety technology, despite increases in the number of vehicles on the road and miles driven per vehicle, we propose that an effective long-term strategy for reducing MVC-related injury would be continued technological innovation in vehicle design, aimed at progressively removing the driver from routine operational decision-making. Once this is achieved, high rates of speed could be achieved on open highways, with minimal risk of crashes and injury to occupants and pedestrians.

CBP for Field Workers – Results and Insights from Three Usability and Interface Design Evaluations

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

Oxstrand, Johanna Helene; Le Blanc, Katya Lee; Bly, Aaron Douglas

2015-09-01

Nearly all activities that involve human interaction with the systems in a nuclear power plant are guided by procedures. Even though the paper-based procedures (PBPs) currently used by industry have a demonstrated history of ensuring safety, improving procedure use could yield significant savings in increased efficiency as well as improved nuclear safety through human performance gains. The nuclear industry is constantly trying to find ways to decrease the human error rate, especially the human errors associated with procedure use. As a step toward the goal of improving procedure use and adherence, researchers in the Light-Water Reactor Sustainability (LWRS) Program, togethermore » with the nuclear industry, have been investigating the possibility and feasibility of replacing the current paper-based procedure process with a computer-based procedure (CBP) system. This report describes a field evaluation of new design concepts of a prototype computer-based procedure system.« less

Safety of the HPV Bivalent and Quadrivalent Vaccines During Pregnancy.

PubMed

Forinash, Alicia B; Yancey, Abigail M; Pitlick, Jamie M; Myles, Thomas D

2011-02-01

To evaluate the safety of the human papillomavirus (HPV) bivalent and quadrivalent vaccines in pregnancy. PubMed (1966-August 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, and pregnancy. References were reviewed for relevant information. All studies including humans that were published in English with data describing HPV vaccine administration in pregnancy were evaluated. Two combined analyses of 7 Phase 3 efficacy trials have retrospectively evaluated the safety of unintentional administration of either the bivalent (n = 1786) or quadrivalent (n = 2085) HPV vaccine during pregnancy. In addition, postmarketing pregnancy registry surveillance data (prospective, n = 787; retrospective, n = 76) for the quadrivalent HPV vaccine have been published. However, only 279 pregnancies from the studies and 90 pregnancies from the registry occurred within 30 days of receiving the vaccination. Overall, the vaccine does not appear to be associated with an increased risk of spontaneous abortion, fetal malformations, or adverse pregnancy outcomes beyond that found in the general population. Although the data are limited, neither HPV vaccine appears to be associated with an increased risk of adverse pregnancy outcomes. However, limitations of the data include small patient populations, minimal to no adjustments for factors known to influence pregnancy outcomes or malformations, and the majority of the available pregnancy data are from retrospective analysis of Phase 3 efficacy trials. Neither HPV vaccine should be routinely administered during pregnancy. If a pregnancy occurs midseries, the remaining vaccines should be given after pregnancy completion. Further studies are required to determine actual risk. © 2011 SAGE Publications.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Reconciling Horse Welfare, Worker Safety, and Public Expectations: Horse Event Incident Management Systems in Australia

PubMed Central

Fiedler, Julie M.; McGreevy, Paul D.

2016-01-01

Simple Summary Although often highly rewarding, human-horse interactions can also be dangerous. Using examples from equine and other contexts, this article acknowledges the growing public awareness of animal welfare, work underway towards safer equestrian workplaces, and the potential for adapting large animal rescue skills for the purposes of horse event incident management. Additionally, we identity the need for further research into communication strategies that address animal welfare and safety issues that arise when humans and horses interact in the workplace. Abstract Human-horse interactions have a rich tradition and can be highly rewarding, particularly within sport and recreation pursuits, but they can also be dangerous or even life-threatening. In parallel, sport and recreation pursuits involving animals, including horses, are facing an increased level of public scrutiny in relation to the use of animals for these purposes. However, the challenge lies with event organisers to reconcile the expectations of the public, the need to meet legal requirements to reduce or eliminate risks to paid and volunteer workers, and address horse welfare. In this article we explore incident management at horse events as an example of a situation where volunteers and horses can be placed at risk during a rescue. We introduce large animal rescue skills as a solution to improving worker safety and improving horse welfare outcomes. Whilst there are government and horse industry initiatives to improve safety and address animal welfare, there remains a pressing need to invest in a strong communication plan which will improve the safety of workplaces in which humans and horses interact. PMID:26927189

Human factors and ergonomics as a patient safety practice

PubMed Central

Carayon, Pascale; Xie, Anping; Kianfar, Sarah

2014-01-01

Background Human factors and ergonomics (HFE) approaches to patient safety have addressed five different domains: usability of technology; human error and its role in patient safety; the role of healthcare worker performance in patient safety; system resilience; and HFE systems approaches to patient safety. Methods A review of various HFE approaches to patient safety and studies on HFE interventions was conducted. Results This paper describes specific examples of HFE-based interventions for patient safety. Studies show that HFE can be used in a variety of domains. Conclusions HFE is a core element of patient safety improvement. Therefore, every effort should be made to support HFE applications in patient safety. PMID:23813211

Incidence of patient safety events and process-related human failures during intra-hospital transportation of patients: retrospective exploration from the institutional incident reporting system.

PubMed

Yang, Shu-Hui; Jerng, Jih-Shuin; Chen, Li-Chin; Li, Yu-Tsu; Huang, Hsiao-Fang; Wu, Chao-Ling; Chan, Jing-Yuan; Huang, Szu-Fen; Liang, Huey-Wen; Sun, Jui-Sheng

2017-11-03

Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited. To perform a retrospective analysis of IHT-related events, human failures and unsafe acts. A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan. All eligible IHT-related patient safety events between January 2010 to December 2015 were included. Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts. There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (p<0.001). Of the events with human failures (n=186), the most common related process step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, p<0.001) was associated with increased patient harm, whereas the presence of omission (OR 0.12, p<0.001) was associated with less patient harm. This study shows a need to reduce human failures to prevent patient harm during intra-hospital transportation. We suggest that the transportation team pay specific attention to the sub-process at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted. © 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.

(13)C MRS of human brain at 7 Tesla using [2-(13)C]glucose infusion and low power broadband stochastic proton decoupling.

PubMed

Li, Shizhe; An, Li; Yu, Shao; Ferraris Araneta, Maria; Johnson, Christopher S; Wang, Shumin; Shen, Jun

2016-03-01

Carbon-13 ((13)C) MR spectroscopy (MRS) of the human brain at 7 Tesla (T) may pose patient safety issues due to high radiofrequency (RF) power deposition for proton decoupling. The purpose of present work is to study the feasibility of in vivo (13)C MRS of human brain at 7 T using broadband low RF power proton decoupling. Carboxylic/amide (13)C MRS of human brain by broadband stochastic proton decoupling was demonstrated on a 7 T scanner. RF safety was evaluated using the finite-difference time-domain method. (13)C signal enhancement by nuclear Overhauser effect (NOE) and proton decoupling was evaluated in both phantoms and in vivo. At 7 T, the peak amplitude of carboxylic/amide (13)C signals was increased by a factor of greater than 4 due to the combined effects of NOE and proton decoupling. The 7 T (13)C MRS technique used decoupling power and average transmit power of less than 35 watts (W) and 3.6 W, respectively. In vivo (13)C MRS studies of human brain can be performed at 7 T, well below the RF safety threshold, by detecting carboxylic/amide carbons with broadband stochastic proton decoupling. © 2015 Wiley Periodicals, Inc.

13C MRS of Human Brain at 7 Tesla Using [2-13C]Glucose Infusion and Low Power Broadband Stochastic Proton Decoupling

PubMed Central

Li, Shizhe; An, Li; Yu, Shao; Araneta, Maria Ferraris; Johnson, Christopher S.; Wang, Shumin; Shen, Jun

2015-01-01

Purpose 13C magnetic resonance spectroscopy (MRS) of human brain at 7 Tesla (T) may pose patient safety issues due to high RF power deposition for proton decoupling. The purpose of present work is to study the feasibility of in vivo 13C MRS of human brain at 7 T using broadband low RF power proton decoupling. Methods Carboxylic/amide 13C MRS of human brain by broadband stochastic proton decoupling was demonstrated on a 7 T scanner. RF safety was evaluated using the finite-difference time-domain method. 13C signal enhancement by nuclear Overhauser effect (NOE) and proton decoupling was evaluated in both phantoms and in vivo. Results At 7 T, the peak amplitude of carboxylic/amide 13C signals was increased by a factor of greater than 4 due to the combined effects of NOE and proton decoupling. The 7 T 13C MRS technique used decoupling power and average transmit power of less than 35 W and 3.6 W, respectively. Conclusion In vivo 13C MRS studies of human brain can be performed at 7 T well below the RF safety threshold by detecting carboxylic/amide carbons with broadband stochastic proton decoupling. PMID:25917936

76 FR 22342 - National Standard 10 Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

... safety of human life at sea.'' NMFS published final guidelines for NS10 in 1998 (63 FR 24212; May 1, 1998... of human life at sea, including whether and to what extent such measures may affect the safety of...; and an explanation that the phrase ``safety of human life at sea'' refers to both the safety of a...

A safety-based decision making architecture for autonomous systems

NASA Technical Reports Server (NTRS)

Musto, Joseph C.; Lauderbaugh, L. K.

1991-01-01

Engineering systems designed specifically for space applications often exhibit a high level of autonomy in the control and decision-making architecture. As the level of autonomy increases, more emphasis must be placed on assimilating the safety functions normally executed at the hardware level or by human supervisors into the control architecture of the system. The development of a decision-making structure which utilizes information on system safety is detailed. A quantitative measure of system safety, called the safety self-information, is defined. This measure is analogous to the reliability self-information defined by McInroy and Saridis, but includes weighting of task constraints to provide a measure of both reliability and cost. An example is presented in which the safety self-information is used as a decision criterion in a mobile robot controller. The safety self-information is shown to be consistent with the entropy-based Theory of Intelligent Machines defined by Saridis.

Materials for lithium-ion battery safety.

PubMed

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

2018-06-01

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

Materials for lithium-ion battery safety

PubMed Central

Liu, Kai

2018-01-01

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

The influence of body mass index and gender on the impact attenuation properties of flooring systems.

PubMed

Bhan, Shivam; Levine, Iris; Laing, Andrew C

2013-12-01

The biomechanical effectiveness of safety floors has never been assessed during sideways falls with human volunteers. Furthermore, the influence of body mass index (BMI) and gender on the protective capacity of safety floors is unknown. The purpose of this study was to test whether safety floors provide greater impact attenuation compared with traditional flooring, and whether BMI and gender modify their impact attenuation properties. Thirty participants (7 men and 7 women of low BMI; 7 men and 9 women of high BMI) underwent lateral pelvis release trials on 2 common floors and 4 safety floors. As a group, the safety floors reduced peak force (by up to 11.7%), and increased the time to peak force (by up to 25.5%) compared with a traditional institutional grade floor. Force attenuation was significantly higher for the low BMI group, and for males. Force attenuation was greatest for the low BMI males, averaging 26.5% (SD = 3.0) across the safety floors. These findings demonstrate an overall protective effect of safety floors during lateral falls on the pelvis, but also suggest augmented benefits for frail older adults (often with low body mass) who are at an increased risk of hip fracture.

Impact of human Campylobacter infections in Southeast Asia: The contribution of the poultry sector.

PubMed

Premarathne, Jayasekara Mudiyanselage Krishanthi Jayarukshi Kumari; Satharasinghe, Dilan Amila; Huat, John Tang Yew; Basri, Dayang Fredalina; Rukayadi, Yaya; Nakaguchi, Yoshitsugu; Nishibuchi, Mitsuaki; Radu, Son

2017-12-12

Campylobacter is globally recognized as a major cause of foodborne infection in humans, whilst the development of antimicrobial resistance and the possibility of repelling therapy increase the threat to public health. Poultry is the most frequent source of Campylobacter infection in humans, and southeast Asia is a global leader in poultry production, consumption, and exports. Though three of the world's top 20 most populated countries are located in southeast Asia, the true burden of Campylobacter infection in the region has not been fully elucidated. Based on published data, Campylobacter has been reported in humans, animals, and food commodities in the region. To our knowledge, this study is the first to review the status of human Campylobacter infection in southeast Asia and to discuss future perspectives. Gaining insight into the true burden of the infection and prevalence levels of Campylobacter spp. in the southeast Asian region is essential to ensuring global and regional food safety through facilitating improvements in surveillance systems, food safety regulations, and mitigation strategies.

Organizational safety climate and supervisor safety enforcement: Multilevel explorations of the causes of accident underreporting.

PubMed

Probst, Tahira M

2015-11-01

According to national surveillance statistics, over 3 million employees are injured each year; yet, research indicates that these may be substantial underestimates of the true prevalence. The purpose of the current project was to empirically test the hypothesis that organizational safety climate and transactional supervisor safety leadership would predict the extent to which accidents go unreported by employees. Using hierarchical linear modeling and survey data collected from 1,238 employees in 33 organizations, employee-level supervisor safety enforcement behaviors (and to a less consistent extent, organizational-level safety climate) predicted employee accident underreporting. There was also a significant cross-level interaction, such that the effect of supervisor enforcement on underreporting was attenuated in organizations with a positive safety climate. These results may benefit human resources and safety professionals by pinpointing methods of increasing the accuracy of accident reporting, reducing actual safety incidents, and reducing the costs to individuals and organizations that result from underreporting. (c) 2015 APA, 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.

2009 Human Factors and Roadway Safety Workshop : Overviews of Safety Initiatives in Iowa [SD .WMV (720x480/29fps/80.2 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Overview of Safety Initiatives in Iowa : Tom Welch, Iowa DOT Highway Division Safety Engineer,...

Future challenges to microbial food safety.

PubMed

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

2010-05-30

Despite significant efforts by all parties involved, there is still a considerable burden of foodborne illness, in which micro-organisms play a prominent role. Microbes can enter the food chain at different steps, are highly versatile and can adapt to the environment allowing survival, growth and production of toxic compounds. This sets them apart from chemical agents and thus their study from food toxicology. We summarize the discussions of a conference organized by the Dutch Food and Consumer Products Safety Authority and the European Food Safety Authority. The goal of the conference was to discuss new challenges to food safety that are caused by micro-organisms as well as strategies and methodologies to counter these. Management of food safety is based on generally accepted principles of Hazard Analysis Critical Control Points and of Good Manufacturing Practices. However, a more pro-active, science-based approach is required, starting with the ability to predict where problems might arise by applying the risk analysis framework. Developments that may influence food safety in the future occur on different scales (from global to molecular) and in different time frames (from decades to less than a minute). This necessitates development of new risk assessment approaches, taking the impact of different drivers of change into account. We provide an overview of drivers that may affect food safety and their potential impact on foodborne pathogens and human disease risks. We conclude that many drivers may result in increased food safety risks, requiring active governmental policy setting and anticipation by food industries whereas other drivers may decrease food safety risks. Monitoring of contamination in the food chain, combined with surveillance of human illness and epidemiological investigations of outbreaks and sporadic cases continue to be important sources of information. New approaches in human illness surveillance include the use of molecular markers for improved outbreak detection and source attribution, sero-epidemiology and disease burden estimation. Current developments in molecular techniques make it possible to rapidly assemble information on the genome of various isolates of microbial species of concern. Such information can be used to develop new tracking and tracing methods, and to investigate the behavior of micro-organisms under environmentally relevant stress conditions. These novel tools and insight need to be applied to objectives for food safety strategies, as well as to models that predict microbial behavior. In addition, the increasing complexity of the global food systems necessitates improved communication between all parties involved: scientists, risk assessors and risk managers, as well as consumers. Copyright 2009 Elsevier B.V. All rights reserved.

Safety of human papillomavirus vaccines: a review.

PubMed

Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

2015-05-01

Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

Evaluation of “Dream Herb,” Calea zacatechichi, for Nephrotoxicity Using Human Kidney Proximal Tubule Cells

PubMed Central

Flynn, Thomas J.; Vohra, Sanah; Wiesenfeld, Paddy; Sprando, Robert L.

2016-01-01

A recent surge in the use of dietary supplements, including herbal remedies, necessitates investigations into their safety profiles. “Dream herb,” Calea zacatechichi, has long been used in traditional folk medicine for a variety of purposes and is currently being marketed in the US for medicinal purposes, including diabetes treatment. Despite the inherent vulnerability of the renal system to xenobiotic toxicity, there is a lack of safety studies on the nephrotoxic potential of this herb. Additionally, the high frequency of diabetes-associated kidney disease makes safety screening of C. zacatechichi for safety especially important. We exposed human proximal tubule HK-2 cells to increasing doses of this herb alongside known toxicant and protectant control compounds to examine potential toxicity effects of C. zacatechichi relative to control compounds. We evaluated both cellular and mitochondrial functional changes related to toxicity of this dietary supplement and found that even at low doses evidence of cellular toxicity was significant. Moreover, these findings correlated with significantly elevated levels of nephrotoxicity biomarkers, lending further support for the need to further scrutinize the safety of this herbal dietary supplement. PMID:27703475

Increased anxiety but normal fear and safety learning in orexin-deficient mice.

PubMed

Khalil, Radwa; Fendt, Markus

2017-03-01

The loss of orexin neurons in humans leads to the disease narcolepsy, characterized by daytime sleepiness and cataplexy. Recent data suggest that orexin is also involved in emotional processing. The goal of the present study was to evaluate fear and safety learning as well as unconditioned fear (anxiety) in orexin-deficient animals. Orexin-deficient mice are an established animal model used to investigate the neuropathology and potential treatments for narcolepsy. Here, we present novel data showing that orexin-deficient mice express increased anxiety in the open field, light-dark box test and carnivore odor-induced avoidance, but are normal in fear and safety learning. These findings suggest an important role of orexin in brain areas involved in anxiety. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

Murashov, Vladimir; Hearl, Frank; Howard, John

2016-01-01

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

Working Safely with Robot Workers: Recommendations for the New Workplace

PubMed Central

Murashov, Vladimir; Hearl, Frank; Howard, John

2016-01-01

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

2009 Human Factors and Roadway Safety Workshop : Opening Session [SD .WMV (720x480/29fps/546.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: 2009 Human Factors and Roadway Safety Workshop Opening Session : Sandra Larson, director, Iowa...

A Framework to Guide the Assessment of Human-Machine Systems.

PubMed

Stowers, Kimberly; Oglesby, James; Sonesh, Shirley; Leyva, Kevin; Iwig, Chelsea; Salas, Eduardo

2017-03-01

We have developed a framework for guiding measurement in human-machine systems. The assessment of safety and performance in human-machine systems often relies on direct measurement, such as tracking reaction time and accidents. However, safety and performance emerge from the combination of several variables. The assessment of precursors to safety and performance are thus an important part of predicting and improving outcomes in human-machine systems. As part of an in-depth literature analysis involving peer-reviewed, empirical articles, we located and classified variables important to human-machine systems, giving a snapshot of the state of science on human-machine system safety and performance. Using this information, we created a framework of safety and performance in human-machine systems. This framework details several inputs and processes that collectively influence safety and performance. Inputs are divided according to human, machine, and environmental inputs. Processes are divided into attitudes, behaviors, and cognitive variables. Each class of inputs influences the processes and, subsequently, outcomes that emerge in human-machine systems. This framework offers a useful starting point for understanding the current state of the science and measuring many of the complex variables relating to safety and performance in human-machine systems. This framework can be applied to the design, development, and implementation of automated machines in spaceflight, military, and health care settings. We present a hypothetical example in our write-up of how it can be used to aid in project success.

The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice.

PubMed

Ginsburg, Liane; Castel, Evan; Tregunno, Deborah; Norton, Peter G

2012-08-01

Enhancing competency in patient safety at entry to practice requires introduction and integration of patient safety into health professional education. As efforts to include patient safety in health professional education increase, it is important to capture new health professionals' perspectives of their own patient safety competence at entry to practice. Existing instruments to measure patient safety knowledge, skills and attitudes have been developed largely to examine the impact of specific patient safety curricular initiatives and the psychometric analyses of the instruments used thus far have been exploratory in nature. Confirmatory factor analytic approaches are used to extensively test the Health Professional Education in Patient Safety Survey (H-PEPSS), a newly designed survey rooted in a patient safety competency framework and designed to measure health professionals' self-reported patient safety competence around the time of entry to practice. The H-PEPSS focuses primarily on the socio-cultural aspects of patient safety including culture, teamwork, communication, managing risk and understanding human factors. Results support a parsimonious six-factor measurement model of health professionals' perceptions of patient safety competency. These results support the validity of a reduced version of the H-PEPSS and suggest it can be appropriately used at or near training completion with a variety of health professional groups. Given increased demands for patient safety competency among health professionals at entry to practice and slow, but emerging changes in health professional education, ongoing research to understand the extent of patient safety competency among health professionals around the time of entry to practice will be important.

The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice

PubMed Central

Castel, Evan; Tregunno, Deborah; Norton, Peter G

2012-01-01

Background Enhancing competency in patient safety at entry to practice requires introduction and integration of patient safety into health professional education. As efforts to include patient safety in health professional education increase, it is important to capture new health professionals' perspectives of their own patient safety competence at entry to practice. Existing instruments to measure patient safety knowledge, skills and attitudes have been developed largely to examine the impact of specific patient safety curricular initiatives and the psychometric analyses of the instruments used thus far have been exploratory in nature. Methods Confirmatory factor analytic approaches are used to extensively test the Health Professional Education in Patient Safety Survey (H-PEPSS), a newly designed survey rooted in a patient safety competency framework and designed to measure health professionals' self-reported patient safety competence around the time of entry to practice. The H-PEPSS focuses primarily on the socio-cultural aspects of patient safety including culture, teamwork, communication, managing risk and understanding human factors. Results Results support a parsimonious six-factor measurement model of health professionals' perceptions of patient safety competency. These results support the validity of a reduced version of the H-PEPSS and suggest it can be appropriately used at or near training completion with a variety of health professional groups. Conclusions Given increased demands for patient safety competency among health professionals at entry to practice and slow, but emerging changes in health professional education, ongoing research to understand the extent of patient safety competency among health professionals around the time of entry to practice will be important. PMID:22562876

Wearing a Bicycle Helmet Can Increase Risk Taking and Sensation Seeking in Adults

PubMed Central

Gamble, Tim; Walker, Ian

2016-01-01

Humans adapt their risk-taking behavior on the basis of perceptions of safety; this risk-compensation phenomenon is typified by people taking increased risks when using protective equipment. Existing studies have looked at people who know they are using safety equipment and have specifically focused on changes in behaviors for which that equipment might reduce risk. Here, we demonstrated that risk taking increases in people who are not explicitly aware they are wearing protective equipment; furthermore, this happens for behaviors that could not be made safer by that equipment. In a controlled study in which a helmet, compared with a baseball cap, was used as the head mount for an eye tracker, participants scored significantly higher on laboratory measures of both risk taking and sensation seeking. This happened despite there being no risk for the helmet to ameliorate and despite it being introduced purely as an eye tracker. The results suggest that unconscious activation of safety-related concepts primes globally increased risk propensity. PMID:26740528

Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans.

PubMed

Qiao, Ming; Shaw, David; Forrat, Remi; Wartel-Tram, Anh; Lang, Jean

2011-10-01

A dengue vaccine effective against all four serotypes is urgently needed. However, safety and immunogenicity could be affected by prior exposure to flaviviruses. This open, controlled, phase IIa study was conducted in 35 healthy adults who had received monovalent, live attenuated Vero cell-derived dengue vaccine against dengue virus 1 (VDV1) or 2 (VDV2) or yellow fever (YF) vaccine 1 year before or who were flavivirus-naïve. All participants received one subcutaneous injection of tetravalent dengue vaccine (TDV) and were followed for 180 days. Previous vaccination did not increase reactogenicity, laboratory abnormalities, or incidence of vaccine viremia, but it did increase the neutralizing antibody response to dengue virus that persisted at day 180. There was no increase in YF antibodies in participants previously immunized with YF vaccine. Prior exposure to YF or monovalent dengue vaccines had no adverse effects on the safety or incidence of viremia associated with this TDV, but it increased immunogenicity.

Microwave and Man—The Direct and Indirect Hazards, and the Precautions

PubMed Central

Merckel, Charles

1972-01-01

Microwave-radar is a form of electromagnetic energy with potential hazards to human health and safety. Its lethal and non-lethal harmful effects have been demonstrated in experimental animals. Lethal effects upon humans from exposure to microwave have not been proved. Alleged non-lethal effects have been limited primarily to cataractogenesis. Increasing use of microwave commercially in communications and domestically, as in micro-ovens, increases the hazard of exposure to microwave. Increasing use of devices which are at risk from microwave, such as implanted cardiac pacemakers and metal surgical appliances and electronic monitoring devices in operating rooms and clinics, present increasing environmental hazards. PMID:5039801

Physical Analysis Work for Slope Stability at Shah Alam, Selangor

NASA Astrophysics Data System (ADS)

Ishak, M. F.; Zaini, M. S. I.

2018-04-01

Slope stability analysis is performed to assess the equilibrium conditions and the safe design of a human-made or natural slope to find the endangered areas. Investigation of potential failure and determination of the slope sensitivity with regard to safety, reliability and economics were parts of this study. Ground anchor is designed to support a structure in this study. Ground anchor were implemented at the Mechanically Stabilized Earth (MSE) wall along Anak Persiaran Jubli Perak to overcome the further cracking of pavement parking, concrete deck and building of the Apartments. A result from the laboratory testing of soil sample such as index test and shear strength test were applied to the Slope/W software with regard to the ground anchors that were implemented. The ground anchors were implemented to increase the value of the factor of safety (FOS) of the MSE Wall. The value of the factor of safety (FOS) before implementing the ground anchor was 0.800 and after the ground anchor was implemented the value increase to 1.555. The increase percentage of factor of safety by implementing on stability of slope was 94.38%.

EHR Safety: The Way Forward to Safe and Effective Systems

PubMed Central

Walker, James M.; Carayon, Pascale; Leveson, Nancy; Paulus, Ronald A.; Tooker, John; Chin, Homer; Bothe, Albert; Stewart, Walter F.

2008-01-01

Diverse stakeholders—clinicians, researchers, business leaders, policy makers, and the public—have good reason to believe that the effective use of electronic health care records (EHRs) is essential to meaningful advances in health care quality and patient safety. However, several reports have documented the potential of EHRs to contribute to health care system flaws and patient harm. As organizations (including small hospitals and physician practices) with limited resources for care-process transformation, human-factors engineering, software safety, and project management begin to use EHRs, the chance of EHR-associated harm may increase. The authors propose a coordinated set of steps to advance the practice and theory of safe EHR design, implementation, and continuous improvement. These include setting EHR implementation in the context of health care process improvement, building safety into the specification and design of EHRs, safety testing and reporting, and rapid communication of EHR-related safety flaws and incidents. PMID:18308981

Safety in passenger ships: The influence of environmental design characteristics on people's perception of safety.

PubMed

Ahola, Markus; Mugge, Ruth

2017-03-01

Although objective safety is a widely studied topic in ergonomics, subjective safety has received far less research attention. Nevertheless, most of human decision-making and behavior depends on how we perceive our environment. This study investigates the effects of various environmental design characteristics on people's safety perception in a passenger ship context. Five different environmental design characteristics were manipulated to increase the openness of the space or to create more clear navigation, resulting in 20 different cabin corridors for a passenger ship. Ninety-seven respondents were asked to rate these corridors on the perceived safety in an experiment. The results showed that people feel more safe when the corridors have a curved ceiling, when the walls do not have a split-level design, and when there is a view to the outside. Designers can use these insights when designing future environments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Climate Change and Food Security: Health Impacts in Developed Countries

PubMed Central

Hooper, Lee; Abdelhamid, Asmaa; Bentham, Graham; Boxall, Alistair B.A.; Draper, Alizon; Fairweather-Tait, Susan; Hulme, Mike; Hunter, Paul R.; Nichols, Gordon; Waldron, Keith W.

2012-01-01

Background: Anthropogenic climate change will affect global food production, with uncertain consequences for human health in developed countries. Objectives: We investigated the potential impact of climate change on food security (nutrition and food safety) and the implications for human health in developed countries. Methods: Expert input and structured literature searches were conducted and synthesized to produce overall assessments of the likely impacts of climate change on global food production and recommendations for future research and policy changes. Results: Increasing food prices may lower the nutritional quality of dietary intakes, exacerbate obesity, and amplify health inequalities. Altered conditions for food production may result in emerging pathogens, new crop and livestock species, and altered use of pesticides and veterinary medicines, and affect the main transfer mechanisms through which contaminants move from the environment into food. All these have implications for food safety and the nutritional content of food. Climate change mitigation may increase consumption of foods whose production reduces greenhouse gas emissions. Impacts may include reduced red meat consumption (with positive effects on saturated fat, but negative impacts on zinc and iron intake) and reduced winter fruit and vegetable consumption. Developed countries have complex structures in place that may be used to adapt to the food safety consequences of climate change, although their effectiveness will vary between countries, and the ability to respond to nutritional challenges is less certain. Conclusions: Climate change will have notable impacts upon nutrition and food safety in developed countries, but further research is necessary to accurately quantify these impacts. Uncertainty about future impacts, coupled with evidence that climate change may lead to more variable food quality, emphasizes the need to maintain and strengthen existing structures and policies to regulate food production, monitor food quality and safety, and respond to nutritional and safety issues that arise. PMID:23124134

Climate change and food security: health impacts in developed countries.

PubMed

Lake, Iain R; Hooper, Lee; Abdelhamid, Asmaa; Bentham, Graham; Boxall, Alistair B A; Draper, Alizon; Fairweather-Tait, Susan; Hulme, Mike; Hunter, Paul R; Nichols, Gordon; Waldron, Keith W

2012-11-01

Anthropogenic climate change will affect global food production, with uncertain consequences for human health in developed countries. We investigated the potential impact of climate change on food security (nutrition and food safety) and the implications for human health in developed countries. Expert input and structured literature searches were conducted and synthesized to produce overall assessments of the likely impacts of climate change on global food production and recommendations for future research and policy changes. Increasing food prices may lower the nutritional quality of dietary intakes, exacerbate obesity, and amplify health inequalities. Altered conditions for food production may result in emerging pathogens, new crop and livestock species, and altered use of pesticides and veterinary medicines, and affect the main transfer mechanisms through which contaminants move from the environment into food. All these have implications for food safety and the nutritional content of food. Climate change mitigation may increase consumption of foods whose production reduces greenhouse gas emissions. Impacts may include reduced red meat consumption (with positive effects on saturated fat, but negative impacts on zinc and iron intake) and reduced winter fruit and vegetable consumption. Developed countries have complex structures in place that may be used to adapt to the food safety consequences of climate change, although their effectiveness will vary between countries, and the ability to respond to nutritional challenges is less certain. Climate change will have notable impacts upon nutrition and food safety in developed countries, but further research is necessary to accurately quantify these impacts. Uncertainty about future impacts, coupled with evidence that climate change may lead to more variable food quality, emphasizes the need to maintain and strengthen existing structures and policies to regulate food production, monitor food quality and safety, and respond to nutritional and safety issues that arise.

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

NASA Technical Reports Server (NTRS)

Generazio, Edward R.

2002-01-01

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

Fear-potentiated startle processing in humans: Parallel fMRI and orbicularis EMG assessment during cue conditioning and extinction.

PubMed

Lindner, Katja; Neubert, Jörg; Pfannmöller, Jörg; Lotze, Martin; Hamm, Alfons O; Wendt, Julia

2015-12-01

Studying neural networks and behavioral indices such as potentiated startle responses during fear conditioning has a long tradition in both animal and human research. However, most of the studies in humans do not link startle potentiation and neural activity during fear acquisition and extinction. Therefore, we examined startle blink responses measured with electromyography (EMG) and brain activity measured with functional MRI simultaneously during differential conditioning. Furthermore, we combined these behavioral fear indices with brain network activity by analyzing the brain activity evoked by the startle probe stimulus presented during conditioned visual threat and safety cues as well as in the absence of visual stimulation. In line with previous research, we found a fear-induced potentiation of the startle blink responses when elicited during a conditioned threat stimulus and a rapid decline of amygdala activity after an initial differentiation of threat and safety cues in early acquisition trials. Increased activation during processing of threat cues was also found in the anterior insula, the anterior cingulate cortex (ACC), and the periaqueductal gray (PAG). More importantly, our results depict an increase of brain activity to probes presented during threatening in comparison to safety cues indicating an involvement of the anterior insula, the ACC, the thalamus, and the PAG in fear-potentiated startle processing during early extinction trials. Our study underlines that parallel assessment of fear-potentiated startle in fMRI paradigms can provide a helpful method to investigate common and distinct processing pathways in humans and animals and, thus, contributes to translational research. Copyright © 2015 Elsevier B.V. All rights reserved.

A toolkit of measures for reducing animal-vehicle collisions.

DOT National Transportation Integrated Search

2006-01-01

Animal-vehicle collisions are a growing concern in terms of human safety; costs related to injury, property damage, and disposal; and the viability of wildlife populations. These collisions are rapidly increasing throughout the United States, and Vir...

Human factors and systems engineering approach to patient safety for radiotherapy.

PubMed

Rivera, A Joy; Karsh, Ben-Tzion

2008-01-01

The traditional approach to solving patient safety problems in healthcare is to blame the last person to touch the patient. But since the publication of To Err is Human, the call has been instead to use human factors and systems engineering methods and principles to solve patient safety problems. However, an understanding of the human factors and systems engineering is lacking, and confusion remains about what it means to apply their principles. This paper provides a primer on them and their applications to patient safety.

Teaching patient safety and human factors in undergraduate nursing curricula in England: a pilot survey.

PubMed

Robson, Wayne; Clark, Debbie; Pinnock, David; White, Nick; Baxendale, Bryn

Patient safety is a key priority for all healthcare systems, and there is growing recognition for the need to educate tomorrow's nurses about the role of human factors in reducing avoidable harm to patients. A pilot survey was sent to 20 schools of nursing in England to explore the teaching of patient safety and human factors. All 13 schools that responded (65% response rate) stated that patient safety was covered in their curricula and was allocated more than 4 hours; all the classes included human factors. Only two respondents indicated their teaching to be multi-professional. Awareness of the World Health Organization's multiprofessional patient safety curriculum guide was poor. Faculties also seemed unaware that the Institute for Healthcare Improvement provides free online patient safety modules for students and that there is a global network of student patient safety chapters.

A knee-mounted biomechanical energy harvester with enhanced efficiency and safety

NASA Astrophysics Data System (ADS)

Chen, Chao; Chau, Li Yin; Liao, Wei-Hsin

2017-06-01

Energy harvesting is becoming a major limiting issue for many portable devices. When undertaking any activity, the human body generates a significant amount of biomechanical energy, which can be collected by means of a portable energy harvester. This energy provides a method of powering portable devices such as prosthetic limbs. In this paper, a knee-mounted energy harvester with enhanced efficiency and safety is proposed and developed to convert mechanical energy into electricity during human motion. This device can change the bi-directional knee input into uni-directional rotation for an electromagnetic generator using a specially designed transmission system. Without the constraint of induced impact on the human body, this device can harvest biomechanical energy from both knee flexion and extension, improving the harvesting efficiency over previous single-direction energy harvesters. It can also provide protection from device malfunction, and increase the safety of current biomechanical energy harvesters. A highly compact and light prototype is developed taking into account human kinematics. The biomechanical energy harvesting system is also modeled and analyzed. The prototype is tested under different conditions including walking, running and climbing stairs, to evaluate the energy harvesting performance and effect on the human gait. The experimental results show that the prototype can harvest an average power of 3.6 W at 1.5 m s-1 walking speed, which is promising for portable electronic devices.

How shall we design the future vehicle for Chinese market.

PubMed

Chen, Fang; Wang, Minjuan; Zhu, Xi Chan; Li, Jiaqi

2012-01-01

Surface transportation system is developing very fast in China and the number of vehicles is increasing quickly as well. This development creates a lot of problems on traffic safety and the number of accident is also increasing. In this paper, we made deep analysis of different possible causes of safety problems through three aspects: the traffic environment and infrastructure, in-vehicle information system design and the characteristics of drivers. There are many factors in each aspects may contribute to the transportation safety problems. Problems with infrastructure design and traffic design contribute over 50% of the traffic accident. Another important factor is that people has very little traffic safety concept and very weak on understanding the important of right behavior on the road. This paper has pointed the urgent needs to study the human factors in road and transportation system and vehicle HMI design, as there are very few such studies available in literature based on Chinese situation. The paper also proposed the needs to develop proactive educational system that can promote driver's understanding of traffic safety and to take the right action during drive.

Role of mixed ion channel effects in the cardiovascular safety assessment of the novel anti-MRSA fluoroquinolone JNJ-Q2.

PubMed

Eichenbaum, G; Pugsley, M K; Gallacher, D J; Towart, R; McIntyre, G; Shukla, U; Davenport, J M; Lu, H R; Rohrbacher, J; Hillsamer, V

2012-07-01

JNJ-Q2, a novel broad-spectrum fluoroquinolone with anti-methicillin-resistant Staphylococcus aureus activity, was evaluated in a comprehensive set of non-clinical and clinical cardiovascular safety studies. The effect of JNJ-Q2 on different cardiovascular parameters was compared with that of moxifloxacin, sparfloxacin and ofloxacin. Through comparisons with these well-known fluoroquinolones, the importance of effects on compensatory ion channels to the cardiovascular safety of JNJ-Q2 was investigated. JNJ-Q2 and comparator fluoroquinolones were evaluated in the following models/test systems: hERG-transfected HEK293 cells sodium channel-transfected CHO cells, guinea pig right atria, arterially perfused rabbit left ventricular wedge preparations and in vivo studies in anaesthetized guinea pigs, anaesthetized and conscious telemetered dogs, and a thorough QT study in humans. The trend for effects of JNJ-Q2 on Tp-Te, QT, QRS and PR intervals in the non-clinical models and the plateau in QTc with increasing plasma concentration in humans are consistent with offsetting sodium and calcium channel activities that were observed in the non-clinical studies. These mixed ion channel activities result in the less pronounced or comparable increase in QTc interval for JNJ-Q2 compared with moxifloxacin and sparfloxacin despite its greater in vitro inhibition of I(Kr). Based on the non-clinical and clinical cardiovascular safety assessment, JNJ-Q2 has a safe cardiovascular profile for administration in humans with comparable or reduced potential to prolong QT intervals, compared with moxifloxacin. The results demonstrate the importance of compensatory sodium and calcium channel activity in offsetting potassium channel activity for compounds with a fluoroquinolone core. © 2012 Janssen Pharmaceutical Companies of Johnson & Johnson. British Journal of Pharmacology © 2012 The British Pharmacological Society.

Safety coaches in radiology: decreasing human error and minimizing patient harm.

PubMed

Dickerson, Julie M; Koch, Bernadette L; Adams, Janet M; Goodfriend, Martha A; Donnelly, Lane F

2010-09-01

Successful programs to improve patient safety require a component aimed at improving safety culture and environment, resulting in a reduced number of human errors that could lead to patient harm. Safety coaching provides peer accountability. It involves observing for safety behaviors and use of error prevention techniques and provides immediate feedback. For more than a decade, behavior-based safety coaching has been a successful strategy for reducing error within the context of occupational safety in industry. We describe the use of safety coaches in radiology. Safety coaches are an important component of our comprehensive patient safety program.

The novel combination of theophylline and bambuterol as a potential treatment of hypoxemia in humans.

PubMed

Strand, Trond-Eirik; Khiabani, Hasse Z; Boico, Alina; Radiloff, Daniel; Zhao, Yulin; Hamilton, Karyn L; Christians, Uwe; Klawitter, Jelena; Noveck, Robert J; Piantadosi, Claude A; Bell, Christopher; Irwin, David; Schroeder, Thies

2017-09-01

Hypoxemia can be life-threatening, both acutely and chronically. Because hypoxemia causes vascular dysregulation that further restricts oxygen availability to tissue, it can be pharmacologically addressed. We hypothesized that theophylline can be safely combined with the β2-adrenergic vasodilator bambuterol to improve oxygen availability in hypoxemic patients. Ergogenicity and hemodynamic effects of bambuterol and theophylline were measured in rats under hypobaric and normobaric hypoxia (12% O 2 ). Feasibility in humans was assessed using randomized, double-blind testing of the influence of combined slow-release theophylline (300 mg) and bambuterol (20 mg) on adverse events (AEs), plasma K + , pulse, blood pressure, and drug interaction. Both drugs and their combination significantly improved hypoxic endurance in rats. In humans, common AEs were low K + (<3.5 mmol/L; bambuterol: 12, theophylline: 4, combination: 13 episodes) and tremors (10, 0, 14 episodes). No exacerbation or serious AE occurred when drugs were combined. A drop in plasma K + coincided with peak bambuterol plasma concentrations. Bambuterol increased heart rate by approximately 13 bpm. Drug interaction was present but small. We report promise, feasibility, and relative safety of combined theophylline and bambuterol as a treatment of hypoxemia in humans. Cardiac safety and blood K + will be important safety endpoints when testing these drugs in hypoxemic subjects.

2009 Human Factors and Roadway Safety Workshop : National Perspectives on Safety [SD .WMV (720x480/29fps/227.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: National Perspectives on Safety : Essie Wagner, program analyst, National Highway Traffic Safe...

75 FR 44967 - National Institute for Occupational Safety and Health

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 877-222...

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.

SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

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

Spraker, M; Nyflot, M; Ford, E

Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposuremore » to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing resident exposure to specific topics may increase their confidence.« less

A first-in-human pharmacodynamic and pharmacokinetic study of a fully human anti-glucagon receptor monoclonal antibody in normal healthy volunteers.

PubMed

Kostic, Ana; King, Thomas Alexander; Yang, Feng; Chan, Kuo-Chen; Yancopoulos, George D; Gromada, Jesper; Harp, Joyce B

2018-02-01

Glucagon receptor (GCGR) blockers are being investigated as potential therapeutics for type 1 and type 2 diabetes. Here we report the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of REGN1193, a fully human glucagon receptor blocking monoclonal antibody from a first-in-human healthy volunteer randomized double-blinded trial. Healthy men and women received single ascending doses of REGN1193 ranging from 0.05 to 0.6 mg/kg (n = 42) or placebo (n = 14) intravenously. Safety, tolerability and PK were assessed over 106 days. The glucose-lowering effect of REGN1193 was assessed after induction of hyperglycaemia by serial glucagon challenges. REGN1193 was generally well tolerated. There were small (<3× the upper limit of normal) and transient dose-dependent increases in hepatic aminotransferases. No increase in LDL-C was observed. Hypoglycaemia, assessed as laboratory blood glucose ≤70 mg/dL, occurred in 6/14 (43%) subjects on placebo and 27/42 (57%) on REGN1193 across all dose groups. All episodes of hypoglycaemia were asymptomatic, >50 mg/dL, and did not require treatment or medical assistance. Concentration-time profiles suggest a 2-compartment disposition and marked nonlinearity, consistent with target-mediated clearance. REGN1193 inhibited the glucagon-stimulated glucose increase in a dose-dependent manner. The 0.6 mg/kg dose inhibited the glucagon-induced glucose area under the curve for 0 to 90 minutes (AUC 0-90 minutes ) by 80% to 90% on days 3 and 15, while blunting the increase in C-peptide. REGN1193 dose-dependently increased total GLP-1, GLP-2 and glucagon, with plasma levels returning to baseline by day 29 in all dose groups. REGN1193, a GCGR-blocking monoclonal antibody, produced a safety, tolerability and PK/PD profile suitable for further clinical development. The occurrence of transient elevations in serum hepatic aminotransferases observed here and reported with several small molecule glucagon receptor antagonists suggests an on-target effect of glucagon receptor blockade. The underlying mechanism is unknown. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

A first‐in‐human pharmacodynamic and pharmacokinetic study of a fully human anti‐glucagon receptor monoclonal antibody in normal healthy volunteers

PubMed Central

Kostic, Ana; King, Thomas Alexander; Yang, Feng; Chan, Kuo‐Chen; Yancopoulos, George D.; Gromada, Jesper

2017-01-01

Aims Glucagon receptor (GCGR) blockers are being investigated as potential therapeutics for type 1 and type 2 diabetes. Here we report the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of REGN1193, a fully human glucagon receptor blocking monoclonal antibody from a first‐in‐human healthy volunteer randomized double‐blinded trial. Methods Healthy men and women received single ascending doses of REGN1193 ranging from 0.05 to 0.6 mg/kg (n = 42) or placebo (n = 14) intravenously. Safety, tolerability and PK were assessed over 106 days. The glucose‐lowering effect of REGN1193 was assessed after induction of hyperglycaemia by serial glucagon challenges. Results REGN1193 was generally well tolerated. There were small (<3× the upper limit of normal) and transient dose‐dependent increases in hepatic aminotransferases. No increase in LDL‐C was observed. Hypoglycaemia, assessed as laboratory blood glucose ≤70 mg/dL, occurred in 6/14 (43%) subjects on placebo and 27/42 (57%) on REGN1193 across all dose groups. All episodes of hypoglycaemia were asymptomatic, >50 mg/dL, and did not require treatment or medical assistance. Concentration‐time profiles suggest a 2‐compartment disposition and marked nonlinearity, consistent with target‐mediated clearance. REGN1193 inhibited the glucagon‐stimulated glucose increase in a dose‐dependent manner. The 0.6 mg/kg dose inhibited the glucagon‐induced glucose area under the curve for 0 to 90 minutes (AUC0‐90 minutes) by 80% to 90% on days 3 and 15, while blunting the increase in C‐peptide. REGN1193 dose‐dependently increased total GLP‐1, GLP‐2 and glucagon, with plasma levels returning to baseline by day 29 in all dose groups. Conclusion REGN1193, a GCGR‐blocking monoclonal antibody, produced a safety, tolerability and PK/PD profile suitable for further clinical development. The occurrence of transient elevations in serum hepatic aminotransferases observed here and reported with several small molecule glucagon receptor antagonists suggests an on‐target effect of glucagon receptor blockade. The underlying mechanism is unknown. PMID:28755409

SEIPS 2.0: a human factors framework for studying and improving the work of healthcare professionals and patients.

PubMed

Holden, Richard J; Carayon, Pascale; Gurses, Ayse P; Hoonakker, Peter; Hundt, Ann Schoofs; Ozok, A Ant; Rivera-Rodriguez, A Joy

2013-01-01

Healthcare practitioners, patient safety leaders, educators and researchers increasingly recognise the value of human factors/ergonomics and make use of the discipline's person-centred models of sociotechnical systems. This paper first reviews one of the most widely used healthcare human factors systems models, the Systems Engineering Initiative for Patient Safety (SEIPS) model, and then introduces an extended model, 'SEIPS 2.0'. SEIPS 2.0 incorporates three novel concepts into the original model: configuration, engagement and adaptation. The concept of configuration highlights the dynamic, hierarchical and interactive properties of sociotechnical systems, making it possible to depict how health-related performance is shaped at 'a moment in time'. Engagement conveys that various individuals and teams can perform health-related activities separately and collaboratively. Engaged individuals often include patients, family caregivers and other non-professionals. Adaptation is introduced as a feedback mechanism that explains how dynamic systems evolve in planned and unplanned ways. Key implications and future directions for human factors research in healthcare are discussed.

Safety Assessment of Two New Lactobacillus Strains as Probiotic for Human Using a Rat Model

PubMed Central

Shokryazdan, Parisa; Faseleh Jahromi, Mohammad; Liang, Juan Boo; Kalavathy, Ramasamy; Sieo, Chin Chin; Ho, Yin Wan

2016-01-01

Two previously isolated Lactobacillus strains (L. fermentum HM3 from human milk and L. buchneri FD2 from fermented dates), intended as probiotic for human, were assessed for their safety using acute and subacute oral toxicity tests in rats. In addition, their effects on cecal microflora and harmful bacterial enzymes (β-glucuronidase and β-glucosidase) of the tested animals were also determined. The results showed that L. buchneri FD2, L. fermentum HM3, or a mixture of them were safe up to a level of 1010 CFU/kg BW/day in a 14-day or 28-day treatment period. Both strains were well tolerated and there were no observed adverse effects on growth, feed consumption, cellular blood components and vital organs of the treated animals. The Lactobacillus strains were also able to reduce harmful intestinal bacterial enzymes, and decrease pathogenic bacterial populations while increasing beneficial bacterial populations. These results suggest that the two Lactobacillus strains are safe and could be potential probiotic for human. PMID:27467068

Safety Assessment of Two New Lactobacillus Strains as Probiotic for Human Using a Rat Model.

PubMed

Shokryazdan, Parisa; Faseleh Jahromi, Mohammad; Liang, Juan Boo; Kalavathy, Ramasamy; Sieo, Chin Chin; Ho, Yin Wan

2016-01-01

Two previously isolated Lactobacillus strains (L. fermentum HM3 from human milk and L. buchneri FD2 from fermented dates), intended as probiotic for human, were assessed for their safety using acute and subacute oral toxicity tests in rats. In addition, their effects on cecal microflora and harmful bacterial enzymes (β-glucuronidase and β-glucosidase) of the tested animals were also determined. The results showed that L. buchneri FD2, L. fermentum HM3, or a mixture of them were safe up to a level of 1010 CFU/kg BW/day in a 14-day or 28-day treatment period. Both strains were well tolerated and there were no observed adverse effects on growth, feed consumption, cellular blood components and vital organs of the treated animals. The Lactobacillus strains were also able to reduce harmful intestinal bacterial enzymes, and decrease pathogenic bacterial populations while increasing beneficial bacterial populations. These results suggest that the two Lactobacillus strains are safe and could be potential probiotic for human.

Safety Guided Design Based on Stamp/STPA for Manned Vehicle in Concept Design Phase

NASA Astrophysics Data System (ADS)

Ujiie, Ryo; Katahira, Masafumi; Miyamoto, Yuko; Umeda, Hiroki; Leveson, Nancy; Hoshino, Nobuyuki

2013-09-01

In manned vehicles, such as the Soyuz and the Space Shuttle, the crew and computer system cooperate to succeed in returning to the earth. While computers increase the functionality of system, they also increase the complexity of the interaction between the controllers (human and computer) and the target dynamics. In some cases, the complexity can produce a serious accident. To prevent such losses, traditional hazard analysis such as FTA has been applied to system development, however it can be used after creating a detailed system because it focuses on detailed component failures. As a result, it's more difficult to eliminate hazard cause early in the process when it is most feasible.STAMP/STPA is a new hazard analysis that can be applied from the early development phase, with the analysis being refined as more detailed decisions are made. In essence, the analysis and design decisions are intertwined and go hand-in-hand. We have applied STAMP/STPA to a concept design of a new JAXA manned vehicle and tried safety guided design of the vehicle. As a result of this trial, it has been shown that STAMP/STPA can be accepted easily by system engineers and the design has been made more sophisticated from a safety viewpoint. The result also shows that the consequences of human errors on system safety can be analysed in the early development phase and the system designed to prevent them. Finally, the paper will discuss an effective way to harmonize this safety guided design approach with system engineering process based on the result of this experience in this project.

Improved cell therapy protocol for Parkinson’s disease based on differentiation efficiency and safety of hESC-, hiPSC and non-human primate iPSC-derived DA neurons

PubMed Central

Maria, Sundberg; Helle, Bogetofte; Tristan, Lawson; Gaynor, Smith; Arnar, Astradsson; Michele, Moore; Teresia, Osborn; Oliver, Cooper; Roger, Spealman; Penelope, Hallett; Ole, Isacson

2013-01-01

The main motor symptoms of Parkinson’s disease are due to the loss of dopaminergic (DA) neurons in the ventral midbrain (VM). For the future treatment of Parkinson’s disease with cell transplantation it is important to develop efficient differentiation methods for production of human iPSCs and hESCs-derived midbrain-type DA neurons. Here we describe an efficient differentiation and sorting strategy for DA-neurons from both human ES/iPS cells and non-human primate iPSCs. The use of non-human primate iPSCs for neuronal differentiation and autologous transplantation is important for pre-clinical evaluation of safety and efficacy of stem cell-derived DA neurons. The aim of this study was to improve the safety of human- and non-human primate-iPSC (PiPSC)-derived DA neurons. According to our results, NCAM+/CD29low sorting enriched VM DA-neurons from pluripotent stem cell-derived neural cell populations. NCAM+/CD29low DA-neurons were positive for FOXA2/TH and EN1/TH and this cell population had increased expression levels of FOXA2, LMX1A, TH, GIRK2, PITX3, EN1, NURR1 mRNA compared to unsorted neural cell populations. PiPSC-derived NCAM+/CD29low DA-neurons were able to restore motor function of 6-OHDA lesioned rats 16 weeks after transplantation. The transplanted sorted cells also integrated in the rodent brain tissue, with robust TH+/hNCAM+ neuritic innervation of the host striatum. One year after autologous transplantation, the primate iPSC-derived neural cells survived in the striatum of one primate without any immunosuppression. These neural cell grafts contained FOXA2/TH-positive neurons in the graft site. This is an important proof of concept for the feasibility and safety of iPSC-derived cell transplantation therapies in the future. PMID:23666606

Sexual Safety Planning as an HIV Prevention Strategy for Survivors of Domestic Violence.

PubMed

Foster, Jill; Núñez, Ana; Spencer, Susan; Wolf, Judith; Robertson-James, Candace

2016-06-01

Victims of domestic violence (DV) are not only subject to physical and emotional abuse but may also be at increased risk for less recognized dangers from infection with human immunodeficiency virus (HIV) and other sexually transmitted pathogens. Because of the close link between DV and sexual risk, women need to be educated about the consequences of acquiring a life-threatening sexually transmitted infection, risk reduction measures, and how to access appropriate HIV services for diagnosis and treatment. It is therefore critical for DV workers to receive sufficient training about the link between DV and HIV risk so that sexual safety planning can be incorporated into activities with their clients in the same way as physical safety plans. In this article, we discuss how the Many Hands Working Together project provides interactive training for workers in DV and DV-affiliated agencies to increase their knowledge about HIV and teach sexual safety planning skills to achieve HIV risk reduction.

Sexual Safety Planning as an HIV Prevention Strategy for Survivors of Domestic Violence

PubMed Central

Foster, Jill; Spencer, Susan; Wolf, Judith; Robertson-James, Candace

2016-01-01

Abstract Victims of domestic violence (DV) are not only subject to physical and emotional abuse but may also be at increased risk for less recognized dangers from infection with human immunodeficiency virus (HIV) and other sexually transmitted pathogens. Because of the close link between DV and sexual risk, women need to be educated about the consequences of acquiring a life-threatening sexually transmitted infection, risk reduction measures, and how to access appropriate HIV services for diagnosis and treatment. It is therefore critical for DV workers to receive sufficient training about the link between DV and HIV risk so that sexual safety planning can be incorporated into activities with their clients in the same way as physical safety plans. In this article, we discuss how the Many Hands Working Together project provides interactive training for workers in DV and DV-affiliated agencies to increase their knowledge about HIV and teach sexual safety planning skills to achieve HIV risk reduction. PMID:26595667

Ethical issues in patient safety: Implications for nursing management.

PubMed

Kangasniemi, Mari; Vaismoradi, Mojtaba; Jasper, Melanie; Turunen, Hannele

2013-12-01

The purpose of this article is to discuss the ethical issues impacting the phenomenon of patient safety and to present implications for nursing management. Previous knowledge of this perspective is fragmented. In this discussion, the main drivers are identified and formulated in 'the ethical imperative' of patient safety. Underlying values and principles are considered, with the aim of increasing their visibility for nurse managers' decision-making. The contradictory nature of individual and utilitarian safety is identified as a challenge in nurse management practice, together with the context of shared responsibility and identification of future challenges. As a conclusion, nurse managers play a strategic role in patient safety. Their role is to incorporate ethical values of patient safety into decision-making at all levels in an organization, and also to encourage clinical nurses to consider values in the provision of care to patients. Patient safety that is sensitive to ethics provides sustainable practice where the humanity and dignity of all stakeholders are respected.

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.

[Performance and safety at work].

PubMed

Bentivegna, M

2010-01-01

The evaluative approach of occupational therapy, centred on the person, on an analysis of performance and an assessment of the work environment, can provide important information for planning interventions to increase safety at work. The reliability of work performance is influenced by many factors, some of which are not directly dependent on humans, such as those related to the environment, to materials, to spaces, to places and to the organization of work; others, however, are closely related to human behaviours. For this reason, for the purpose of ensuring prevention of all harmful events, the process of risk evaluation must also include an analysis of the role of human behaviour and functional capacity. In our daily clinical practice, we Occupational Therapists use work to promote the wellbeing and health of people by involving them in activities, with the knowledge that every occupation is perceived by an individual as something particularly personal and significant.

Applying aviation factors to oral and maxillofacial surgery--the human element.

PubMed

Seager, Leonie; Smith, Dave W; Patel, Anish; Brunt, Howard; Brennan, Peter A

2013-01-01

There are many similarities between flying commercial aircraft and surgery, particularly in relation to minimising risk, and managing potentially fatal or catastrophic complications, or both. Since 1979, the development of Crew Resource Management (CRM) has improved air safety significantly by reducing human factors that are responsible for error. Similar developments in the operating theatre have, to a certain extent, lagged behind aviation, and it is well recognised that we can learn much from the industry. An increasing number of publications on aviation factors relate to surgery but to our knowledge there is a lack of research in our own specialty. We discuss how aviation principles related to human factors can be translated to the operating theatre to improve teamwork and safety for patients. Clinical research is clearly needed to develop this fascinating area more fully. Copyright © 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Cockpit automation

NASA Technical Reports Server (NTRS)

Wiener, Earl L.

1988-01-01

The aims and methods of aircraft cockpit automation are reviewed from a human-factors perspective. Consideration is given to the mixed pilot reception of increased automation, government concern with the safety and reliability of highly automated aircraft, the formal definition of automation, and the ground-proximity warning system and accidents involving controlled flight into terrain. The factors motivating automation include technology availability; safety; economy, reliability, and maintenance; workload reduction and two-pilot certification; more accurate maneuvering and navigation; display flexibility; economy of cockpit space; and military requirements.

Space station crew safety alternatives study. Volume 3: Safety impact of human factors

NASA Technical Reports Server (NTRS)

Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

1985-01-01

The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

Probiotic screening and safety evaluation of Lactobacillus strains from plants, artisanal goat cheese, human stools, and breast milk.

PubMed

Gotteland, Martin; Cires, Maria Jose; Carvallo, Claudia; Vega, Natalia; Ramirez, Maria Antonieta; Morales, Pamela; Rivas, Patricia; Astudillo, Fernanda; Navarrete, Paola; Dubos, Céline; Figueroa, Alvaro; Troncoso, Miriam; Ulloa, Carolina; Mizgier, Maria Luisa; Carrasco-Pozo, Catalina; Speisky, Hernan; Brunser, Oscar; Figueroa, Guillermo

2014-04-01

The aim of this study was to select autochthonous strains of Lactobacillus from stools of healthy infants and adults, human milk, artisanal goat cheese, and fruits and vegetables according to their probiotic properties and safety. From 421 strains of Lactobacillus isolated, 102 (24.2%) were shown to be tolerant to gastric pH and bile salts; they were used to determine their anti-Helicobacter pylori (agar diffusion assay), antioxidant (oxygen radical absorption capacity), and anti-inflammatory (inhibition of interleukin-8 release by tumor necrosis factor-α-stimulated HT-29 cells) activities as well as their ability to adhere to intestinal (Caco-2) and gastric (AGS) epithelial cells. Results obtained were compared with three commercial probiotic Lactobacillus rhamnosus GG, L. plantarum 299v, and L. johnsonii NCC533. The five strains most efficient according to these activities were subsequently identified by sequencing their 16S rRNA gene, their susceptibility to antibiotics was determined, and their safety evaluated in mice. One strain of L. plantarum was discarded due to the higher prevalence of liver bacterial translocation observed in the animals fed this strain. In conclusion, four autochthonous strains of L. rhamnosus were finally selected with probiotic properties and safety allowing their eventual use in human studies. These results contribute to increase the diversity of probiotic strains available for the development of nutraceuticals and functional foods.

Safety of human papillomavirus vaccines: a review

PubMed Central

Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

2015-01-01

Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence. PMID:25689872

76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and.... Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety... Health, on a broad range of issues involving the safety and availability of blood and blood products. The...

Animal vehicle crash mitigation using advanced technology phase I : review, design, and implementation.

DOT National Transportation Integrated Search

2006-08-01

Animal-vehicle collisions affect human safety, property and wildlife. The number of these types of collisions has increased : substantially over the last decades. This report describes the results of a project that explored the prospects for a relati...

Targeting the UPR to Circumvent Endocrine Resistance in Breast Cancer

DTIC Science & Technology

2014-10-01

activity relationship analyses ( QSAR ) to develop rationally designed NPPTA analogs with increased potency and optimized pharmacologic properties...vitro, with the strongest candidates being studied in vivo to provide preclinical safety, efficacy, and toxicology data to support later first-in-human

Assistive Device for Efficient Intravitreal Injections.

PubMed

Ullrich, Franziska; Michels, Stephan; Lehmann, Daniel; Pieters, Roel S; Becker, Matthias; Nelson, Bradley J

2016-08-01

Intravitreal therapy is the most common treatment for many chronic ophthalmic diseases, such as age-related macular degeneration. Due to the increasing worldwide demand for intravitreal injections, there exists a need to render this medical procedure more time- and cost-efficient while increasing patient safety. The authors propose a medical assistive device that injects medication intravitreally. Compared to the manual intravitreal injection procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms. This work demonstrates the development of an assistive injection system that is coarsely positioned over the patient's head by the human operator, followed by automatic fine positioning and intravitreal injection through the pars plana. Several safety features, such as continuous eye tracking and iris recognition, have been implemented. The functioning system is demonstrated through ex vivo experiments with porcine eyes. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:752-762.]. Copyright 2016, SLACK Incorporated.

Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics.

PubMed

Bantseev, Vladimir; Erickson, Rebecca; Leipold, Douglas; Amaya, Caroline; Miller, Paul E; Booler, Helen; Thackaberry, Evan A

The nonclinical toxicology program described here was designed to characterize the safety profile of anti-factor D (AFD; FCFD4514S, lampalizumab) to support intravitreal (ITV) administration in patients with geographic atrophy (GA). The toxicity of AFD was assessed in a single-dose and 6-month repeat-dose study in monkeys at doses up to 10 mg/eye. Toxicity was assessed by clinical ophthalmic examinations, intraocular pressure measurements, ocular photography, electroretinography, fluorescein angiography, optical coherence tomography, and anatomic pathology. Systemic exposure to AFD generally increased with the increase in dose level. The increases in mean maximal concentration and area under the curve values were roughly dose proportional. No accumulation of AFD was observed following 10 doses, and drug exposures were not affected by anti-drug antibodies. AFD was locally and systemically well tolerated in monkeys following ITV doses of up to 10 mg/eye. Ocular effects associated with AFD were limited to transient, reversible, dose-related, aqueous cell responses and injection-related, mild, vitreal cell responses. In the 6-month repeat-dose study, 2 monkeys had a nonspecific immune response to AFD that resulted in severe ocular inflammation, attributed to administration of a heterologous (humanized) protein. The comprehensive toxicology program in monkeys described here was designed to evaluate the safety profile of AFD and to support multiple ITV injections in the clinic. Administration of a heterologous (humanized) protein presents a challenge, and immunogenicity in nonclinical species is not predictive of immunogenicity in humans. Taken together, the results of the nonclinical program described here support the use of AFD in patients with GA.

Perspectives on using a multiplex human kidney safety biomarker panel to detect cisplatin-induced tubular toxicity in male and female Cynomolgus monkeys.

PubMed

Chen, Yafei; Dale Thurman, J; Kinter, Lewis B; Bialecki, Russell; Eric McDuffie, J

2017-12-01

Multiplex biomarker panel assays would enable early de-risking of discovery compound related kidney safety liabilities. The objective of this study was to evaluate the usefulness of the Myriad RBM Human KidneyMAP (Multi-Analyte Profile)® v.1.0 panel to detect experimental nephrotoxicity in Cynomolgus monkeys following a single intravenous administration of cisplatin (2.5mg/kg). Urine samples were collected at baseline on day -2; at approximately 4hr post-dose on day 1; and on days 4, 9, 15 and/or 20. Blood samples were collected at predose on day -2; at 4hr post-dose on day 1; and on days 2, 5, 10 and/or 21. Changes in toxicokinetic and biochemistry parameters in plasma, qualitative/quantitative urinalysis parameters, and urinary kidney safety biomarkers were assessed. Kidney tissues were collected on days 2, 5, 10 and 21 for routine microscopy. Cisplatin-induced tubular alterations were characterized by acute and progressive cortical tubular degeneration/necrosis, regeneration, tubular dilation and proteinaceous cast in the absence of statistically significant changes in traditional plasma biochemistry and urinalysis parameters. When normalized to urinary creatinine, cisplatin-induced significant increases in urinary levels of kidney injury molecule 1 (females on day 4), increases in calbindin D28k (males and females on day 4), decreases in Tamm-Horsfall glycoprotein (males on days 1, 4 and 9), and increases in clusterin (females and males on days 15 and 20, respectively), when compared to concurrent controls. This study revealed the usefulness of the Human KidneyMAP® multiplex panel when measuring changes in urine-based biomarkers to reliably detect cisplatin-induced acute/progressive cortical tubular injury in male and female Cynomolgus monkeys. Copyright © 2017 Elsevier Inc. All rights reserved.

Mild Normobaric Hypoxia Exposure for Human-Autonomy System Testing

NASA Technical Reports Server (NTRS)

Stephens, Chad L.; Kennedy, Kellie D.; Crook, Brenda L.; Williams, Ralph A.; Schutte, Paul

2017-01-01

An experiment investigated the impact of normobaric hypoxia induction on aircraft pilot performance to specifically evaluate the use of hypoxia as a method to induce mild cognitive impairment to explore human-autonomous systems integration opportunities. Results of this exploratory study show that the effect of 15,000 feet simulated altitude did not induce cognitive deficits as indicated by performance on written, computer-based, or simulated flight tasks. However, the subjective data demonstrated increased effort by the human test subject pilots to maintain equivalent performance in a flight simulation task. This study represents current research intended to add to the current knowledge of performance decrement and pilot workload assessment to improve automation support and increase aviation safety.

Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

PubMed

Fu, Xiaping; Ying, Yibin

2016-08-17

In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

The space station: Human factors and productivity

NASA Technical Reports Server (NTRS)

Gillan, D. J.; Burns, M. J.; Nicodemus, C. L.; Smith, R. L.

1986-01-01

Human factor researchers and engineers are making inputs into the early stages of the design of the Space Station to improve both the quality of life and work on-orbit. Effective integration of the human factors information related to various Intravehicular Activity (IVA), Extravehicular Activity (EVA), and teletobotics systems during the Space Station design will result in increased productivity, increased flexibility of the Space Stations systems, lower cost of operations, improved reliability, and increased safety for the crew onboard the Space Station. The major features of productivity examined include the cognitive and physical effort involved in work, the accuracy of worker output and ability to maintain performance at a high level of accuracy, the speed and temporal efficiency with which a worker performs, crewmember satisfaction with their work environment, and the relation between performance and cost.

Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.

PubMed

Rebelo, Sofia P; Dehne, Eva-Maria; Brito, Catarina; Horland, Reyk; Alves, Paula M; Marx, Uwe

2016-01-01

Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stability for longer periods of time. The reproducibility attained with bioreactor operations is, per se, an advantage for the validation of safety assessment. Regulatory agencies have gradually altered the validation concept from exhaustive "product" to rigorous and detailed process characterization, valuing reproducibility as a standard for validation. "Human-on-a-chip" technologies applying micro-physiological systems to the in vitro combination of miniaturized human organ equivalents into functional human micro-organisms are nowadays thought to be the most elaborate solution created to date. They target the replacement of the current most complex models-laboratory animals. Therefore, we provide here a road map towards the validation of such "human-on-a-chip" models and qualification of their respective bioreactor and microchip equipment along a path currently used for the respective animal models.

Human factors systems approach to healthcare quality and patient safety

PubMed Central

Carayon, Pascale; Wetterneck, Tosha B.; Rivera-Rodriguez, A. Joy; Hundt, Ann Schoofs; Hoonakker, Peter; Holden, Richard; Gurses, Ayse P.

2013-01-01

Human factors systems approaches are critical for improving healthcare quality and patient safety. The SEIPS (Systems Engineering Initiative for Patient Safety) model of work system and patient safety is a human factors systems approach that has been successfully applied in healthcare research and practice. Several research and practical applications of the SEIPS model are described. Important implications of the SEIPS model for healthcare system and process redesign are highlighted. Principles for redesigning healthcare systems using the SEIPS model are described. Balancing the work system and encouraging the active and adaptive role of workers are key principles for improving healthcare quality and patient safety. PMID:23845724

Cryptosporidium and Giardia safety margin increase in leafy green vegetables irrigated with treated wastewater.

PubMed

Domenech, Eva; Amorós, Inmaculada; Moreno, Yolanda; Alonso, José L

2018-01-01

The presence of Cryptosporidium and Giardia in waste water is a main concern because water reuse for irrigation can jeopardize human health. Spanish Legislation for water reuse does not oblige to analyze the presence of both pathogens Cryptosporidium and Giardia in reused water for irrigation. Therefore, the objective of this paper is to determine the influence of wastewater treatment in the increase of the consumer safety margin in relation to the presence of Cryptosporidium and Giardia in leafy green vegetables. With this aim in mind, a total of 108 samples from raw (influent) and treated wastewater (effluent) from three wastewater treatment plants in Spain were analysed according to USEPA Method 1623. Effluent results show that Cryptosporidium oocysts average counts ranged from 1.38 to 2.6/L oocysts and Giardia cysts ranged from 0.6 to 1.7/L cysts, which means a removal values of 2.7 log, 2.5 log and 1.8 log for Cryptosporidium oocysts and 1 log, 2 log and 2.2 log for Giardia cysts in the three wastewater treatment plants analysed. In relation to safety margin the highest probability that exposure exceed the dose response was observed for Giardia. In addition, the sensitivity analysis showed that (oo)cysts concentration present in the leafy green vegetables and the human dose-response were the most influential inputs in the safety margin obtained. Copyright © 2017 The Authors. Published by Elsevier GmbH.. All rights reserved.

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

The use of highway underpasses by large mammals in Virginia and factors influencing their effectiveness.

DOT National Transportation Integrated Search

2005-01-01

The rapid increase in animal-vehicle collisions on U.S. roadways is a growing concern in terms of human safety, property damage and injury costs, and viability of wildlife populations. Wildlife crossing structures are gaining national recognition by ...

Characterizing Uncertainty and Variability in PBPK Models: State of the Science and Needs for Research and Implementation

EPA Science Inventory

Mode-of-action based risk and safety assessments can rely upon tissue dosimetry estimates in animals and humans obtained from physiologically-based pharmacokinetic (PBPK) modeling. However, risk assessment also increasingly requires characterization of uncertainty and variabilit...

Safety of High Ground Transportation Systems - Human Factors Phase I: Function Analyses and Theoretical Considerations

DOT National Transportation Integrated Search

1994-10-01

Although the speed of guided ground transportation continues to increase, the reaction : time as well as the sensory and information processing capacities of on- and off-board : operators remain constant. This report, the first of two examining criti...

Cybersecurity in healthcare: A narrative review of trends, threats and ways forward.

PubMed

Coventry, Lynne; Branley, Dawn

2018-07-01

Electronic healthcare technology is prevalent around the world and creates huge potential to improve clinical outcomes and transform care delivery. However, there are increasing concerns relating to the security of healthcare data and devices. Increased connectivity to existing computer networks has exposed medical devices to new cybersecurity vulnerabilities. Healthcare is an attractive target for cybercrime for two fundamental reasons: it is a rich source of valuable data and its defences are weak. Cybersecurity breaches include stealing health information and ransomware attacks on hospitals, and could include attacks on implanted medical devices. Breaches can reduce patient trust, cripple health systems and threaten human life. Ultimately, cybersecurity is critical to patient safety, yet has historically been lax. New legislation and regulations are in place to facilitate change. This requires cybersecurity to become an integral part of patient safety. Changes are required to human behaviour, technology and processes as part of a holistic solution. Copyright © 2018 Elsevier B.V. All rights reserved.

Food safety in the 21st century.

PubMed

Käferstein, F; Abdussalam, M

1999-01-01

The global importance of food safety is not fully appreciated by many public health authorities despite a constant increase in the prevalence of foodborne illness. Numerous devastating outbreaks of salmonellosis, cholera, enterohaemorrhagic Escherichia coli infections, hepatitis A and other diseases have occurred in both industrialized and developing countries. In addition, many of the re-emerging or newly recognized pathogens are foodborne or have the potential of being transmitted by food and/or drinking water. More foodborne pathogens can be expected because of changing production methods, processes, practices and habits. During the early 21st century, foodborne diseases can be expected to increase, especially in developing countries, in part because of environmental and demographic changes. These vary from climatic changes, changes in microbial and other ecological systems, to decreasing freshwater supplies. However, an even greater challenge to food safety will come from changes resulting directly in degradation of sanitation and the immediate human environment. These include the increased age of human populations, unplanned urbanization and migration and mass production of food due to population growth and changed food habits. Mass tourism and the huge international trade in food and feed is causing food and feedborne pathogens to spread transnationally. As new toxic agents are identified and new toxic effects recognized, the health and trade consequences of toxic chemicals in food will also have global implications. Meeting the huge challenge of food safety in the 21st century will require the application of new methods to identify, monitor and assess foodborne hazards. Both traditional and new technologies for assuring food safety should be improved and fully exploited. This needs to be done through legislative measures where suitable, but with much greater reliance on voluntary compliance and education of consumers and professional food handlers. This will be an important task for the primary health care system aiming at "health for all".

Food safety in the 21st century.

PubMed Central

Käferstein, F.; Abdussalam, M.

1999-01-01

The global importance of food safety is not fully appreciated by many public health authorities despite a constant increase in the prevalence of foodborne illness. Numerous devastating outbreaks of salmonellosis, cholera, enterohaemorrhagic Escherichia coli infections, hepatitis A and other diseases have occurred in both industrialized and developing countries. In addition, many of the re-emerging or newly recognized pathogens are foodborne or have the potential of being transmitted by food and/or drinking water. More foodborne pathogens can be expected because of changing production methods, processes, practices and habits. During the early 21st century, foodborne diseases can be expected to increase, especially in developing countries, in part because of environmental and demographic changes. These vary from climatic changes, changes in microbial and other ecological systems, to decreasing freshwater supplies. However, an even greater challenge to food safety will come from changes resulting directly in degradation of sanitation and the immediate human environment. These include the increased age of human populations, unplanned urbanization and migration and mass production of food due to population growth and changed food habits. Mass tourism and the huge international trade in food and feed is causing food and feedborne pathogens to spread transnationally. As new toxic agents are identified and new toxic effects recognized, the health and trade consequences of toxic chemicals in food will also have global implications. Meeting the huge challenge of food safety in the 21st century will require the application of new methods to identify, monitor and assess foodborne hazards. Both traditional and new technologies for assuring food safety should be improved and fully exploited. This needs to be done through legislative measures where suitable, but with much greater reliance on voluntary compliance and education of consumers and professional food handlers. This will be an important task for the primary health care system aiming at "health for all". PMID:10327714

Space station crew safety: Human factors interaction model

NASA Technical Reports Server (NTRS)

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

1985-01-01

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

75 FR 5536 - Pipeline Safety: Control Room Management/Human Factors, Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors, Correction AGENCY: Pipeline and Hazardous Materials Safety... following correcting amendments: PART 192--TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM...

Identification of differences between rural and urban safety cultures.

PubMed

Rakauskas, Michael E; Ward, Nicholas J; Gerberich, Susan G

2009-09-01

The prevailing risk of traffic fatalities is much larger in rural areas compared to urban areas. A number of explanations have been offered to explain this including road design, emergency medical service proximity, and human factors. This research explored the potential contribution of rural driver attitudes that may underlie the increased fatal crash risk in rural environments. This analysis examined differences between rural and urban drivers in terms of self-reported risk taking for driving behaviors associated with fatal crashes and attitudes toward safety interventions using a large-scale survey. The results suggested that rural drivers engage in riskier behavior, such as not wearing seatbelts, because they have lower perceptions of the risks associated with such behaviors. Results also suggested that vehicle type (e.g., pickup trucks versus passenger vehicles) may be related to seatbelt compliance and frequency of driving under the influence of alcohol. Rural drivers perceived the utility of government-sponsored traffic safety interventions to be lower than their urban counterparts. This study provides insights into the role of the human factor in rural fatal crashes and provides policy suggestions for developing safety interventions that are designed with respect to the psychosocial factors that define the rural culture.

Creatine metabolism and safety profiles after six-week oral guanidinoacetic acid administration in healthy humans.

PubMed

Ostojic, Sergej M; Niess, Barbara; Stojanovic, Marko; Obrenovic, Milos

2013-01-01

Guanidinoacetic acid (GAA) is a natural precursor of creatine, yet the potential use of GAA as a nutritional additive for restoring creatine availability in humans has been limited by unclear efficacy and safety after exogenous GAA administration. The present study evaluated the effects of orally administered GAA on serum and urinary GAA, creatine and creatinine concentration, and on the occurrence of adverse events in healthy humans. Twenty-four healthy volunteers were randomized in a double-blind design to receive either GAA (2.4 grams daily) or placebo (PLA) by oral administration for 6 weeks. www.clinicaltrials.gov, identification number NCT01133899. Serum creatine and creatinine increased significantly from before to after administration in GAA-supplemented participants (P < 0.05). The proportion of participants who reported minor side effects was 58.3% in the GAA group and 45.5% in the placebo group (P = 0.68). A few participants experienced serum creatine levels above 70 µmol/L. Exogenous GAA is metabolized to creatine, resulting in a significant increase of fasting serum creatine after intervention. GAA had an acceptable side-effects profile with a low incidence of biochemical abnormalities.

Creatine Metabolism and Safety Profiles after Six-Week Oral Guanidinoacetic Acid Administration in Healthy Humans

PubMed Central

Ostojic, Sergej M.; Niess, Barbara; Stojanovic, Marko; Obrenovic, Milos

2013-01-01

Objectives; Guanidinoacetic acid (GAA) is a natural precursor of creatine, yet the potential use of GAA as a nutritional additive for restoring creatine availability in humans has been limited by unclear efficacy and safety after exogenous GAA administration. The present study evaluated the effects of orally administered GAA on serum and urinary GAA, creatine and creatinine concentration, and on the occurrence of adverse events in healthy humans. Methods and Results; Twenty-four healthy volunteers were randomized in a double-blind design to receive either GAA (2.4 grams daily) or placebo (PLA) by oral administration for 6 weeks. Clinical trial registration: www.clinicaltrials.gov, identification number NCT01133899. Serum creatine and creatinine increased significantly from before to after administration in GAA-supplemented participants (P < 0.05). The proportion of participants who reported minor side effects was 58.3% in the GAA group and 45.5% in the placebo group (P = 0.68). A few participants experienced serum creatine levels above 70 µmol/L. Conclusion; Exogenous GAA is metabolized to creatine, resulting in a significant increase of fasting serum creatine after intervention. GAA had an acceptable side-effects profile with a low incidence of biochemical abnormalities. PMID:23329885

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

Radi, Zaher, E-mail: zaher.radi@pfizer.com; Bartholomew, Phillip, E-mail: phillip.m.bartholomew@pfizer.com; Elwell, Michael, E-mail: michael.elwell@covance.com

In humans, hibernoma is a very rare, benign neoplasm of brown adipose tissue (BAT) that typically occurs at subcutaneous locations and is successfully treated by surgical excision. No single cause has been accepted to explain these very rare human tumors. In contrast, spontaneous hibernoma in rats is rare, often malignant, usually occurs in the thoracic or abdominal cavity, and metastases are common. In recent years, there has been an increased incidence of spontaneous hibernomas in rat carcinogenicity studies, but overall the occurrence remains relatively low and highly variable across studies. There have only been four reported examples of pharmaceutical-induced hibernomamore » in rat carcinogenicity studies. These include phentolamine, an alpha-adrenergic antagonist; varenicline, a nicotine partial agonist; tofacitinib, a Janus kinase (JAK) inhibitor; and hydromorphone, an opiod analgesic. Potential non-genotoxic mechanisms that may contribute to the pathogenesis of BAT activation/proliferation and/or subsequent hibernoma development in rats include: (1) physiological stimuli, (2) sympathetic stimulation, (3) peroxisome proliferator-activated receptor (PPAR) agonism, and/or (4) interference or inhibition of JAK/Signal Transducer and Activator of Transcription (JAK/STAT) signaling. The evaluation of an apparent increase of hibernoma in rats from 2-year carcinogenicity studies of novel pharmaceutical therapeutics and its relevance to human safety risk assessment is complex. One should consider: the genotoxicity of the test article, dose/exposure and safety margins, and pathophysiologic and morphologic differences and similarities of hibernoma between rats and humans. Hibernomas observed to date in carcinogenicity studies of pharmaceutical agents do not appear to be relevant for human risk at therapeutic dosages. - Highlights: • Highly variable incidence of spontaneous hibernoma in carcinogenicity studies • Recent increase in the spontaneous incidence of hibernomas in Sprague–Dawley rats • Pharmaceutical-related hibernoma has been observed in rats, but not in humans. • Pathophysiologic and morphologic differences of hibernoma between rats and 7 humans. • Hibernomas are unlikely to be relevant to human risk assessment.« less

Safety assessment of modified terephthalate polymers as used in cosmetics.

PubMed

Becker, Lillian C; 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

2014-01-01

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

The influence of environmental conditions on safety management in hospitals: a qualitative study.

PubMed

Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

2018-05-02

Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced approach is required. A strong focus on control-based management generates extrinsic motivation in employees but may, at the same time, undermine or even diminish intrinsic motivation to work on patient safety. Emphasising commitment-based management may, in contrast, strengthen intrinsic motivation but increases the risk of priorities being set elsewhere. Currently, external pressures frequently lead to the adoption of control-based management. A balanced approach requires a shift towards more trust-based safety demands.

Halogenated flame retardants: do the fire safety benefits justify the risks?

PubMed

Shaw, Susan D; Blum, Arlene; Weber, Roland; Kannan, Kurunthachalam; Rich, David; Lucas, Donald; Koshland, Catherine P; Dobraca, Dina; Hanson, Sarah; Birnbaum, Linda S

2010-01-01

Since the 1970s, an increasing number of regulations have expanded the use of brominated and chlorinated flame retardants. Many of these chemicals are now recognized as global contaminants and are associated with adverse health effects in animals and humans, including endocrine and thyroid disruption, immunotoxicity, reproductive toxicity, cancer, and adverse effects on fetal and child development and neurologic function. Some flame retardants such as polybrominated diphenyl ethers (PBDEs) have been banned or voluntarily phased out by manufacturers because of their environmental persistence and toxicity, only to be replaced by other organohalogens of unknown toxicity. Despite restrictions on further production in some countries, consumer products previously treated with banned retardants are still in use and continue to release toxic chemicals into the environment, and the worldwide use of organohalogen retardants continues to increase. This paper examines major uses and known toxic effects of commonly-used organohalogen flame retardants, replacements for those that have been phased out, their combustion by-products, and their effectiveness at reducing fire hazard. Policy and other solutions to maintain fire safety while reducing toxicity are suggested. The major conclusions are: (1) Flammability regulations can cause greater adverse environmental and health impacts than fire safety benefits. (2) The current options for end-of-life disposal of products treated with organohalogens retardants are problematic. (3) Life-cycle analyses evaluating benefits and risks should consider the health and environmental effects of the chemicals, as well as their fire safety impacts. (4) Most fire deaths and most fire injuries result from inhaling carbon monoxide, irritant gases, and soot. The incorporation of organohalogens can increase the yield of these toxic by-products during combustion. (5) Fire-safe cigarettes, fire-safe candles, child-resistant lighters, sprinklers, and smoke detectors can prevent fires without the potential adverse effects of flame retardant chemicals. (6) Alternatives to organohalogen flame retardant chemicals include using less flammable materials, design changes, and safer chemicals. To date, before evaluating their health and environmental impacts, many flame retardant chemicals have been produced and used, resulting in high levels of human exposure. As a growing literature continues to find adverse impacts from such chemicals, a more systematic approach to their regulation is needed. Before implementing new flammability standards, decision-makers should evaluate the potential fire safety benefit versus the health and environmental impacts of the chemicals, materials, or technologies likely to be used to meet the standard. Reducing the use of toxic or untested flame retardant chemicals in consumer products can protect human and animal health and the global environment without compromising fire safety.

Space Life Support Technology Applications to Terrestrial Environmental Problems

NASA Technical Reports Server (NTRS)

Schwartzkopf, Steven H.; Sleeper, Howard L.

1993-01-01

Many of the problems now facing the human race on Earth are, in fact, life support issues. Decline of air Quality as a result of industrial and automotive emissions, pollution of ground water by organic pesticides or solvents, and the disposal of solid wastes are all examples of environmental problems that we must solve to sustain human life. The technologies currently under development to solve the problems of supporting human life for advanced space missions are extraordinarily synergistic with these environmental problems. The development of these technologies (including both physicochemical and bioregenerative types) is increasingly focused on closing the life support loop by removing and recycling contaminants and wastes to produce the materials necessary to sustain human life. By so doing, this technology development effort also focuses automatically on reducing resupply logistics requirements and increasing crew safety through increased self-sufficiency. This paper describes several technologies that have been developed to support human life in space and illustrates the applicability of the technologies to environmental problems including environmental remediation and pollution prevention.

Space Tourism and Safety from Infection

NASA Astrophysics Data System (ADS)

Ilyin, V. K.; Tiurina, D. A.; Usanova, N. A.; Starkova, L. V.; Soloviova, Z. O.; Morozova, Ju. A.; Kirjukhina, N. V.; Webb, A.

This paper highlights the major scenarios of the microbiological changes which occur in the human organism in space missions, i.e. the increasing of the conventional pathogen population share in human microflora and changes in antibiotic susceptibility, and substantiates compatible countermeasures based on probiotics consumption. Special attention is given to the prospects of the consumption of probiotics made of strains which are representative of human commensurate microflora for the support of resistance during a space journey. It is a most important technique and one which will be acceptable for space tourists.

CE: Nursing's Evolving Role in Patient Safety.

PubMed

Kowalski, Sonya L; Anthony, Maureen

2017-02-01

: Background: In its 1999 report To Err Is Human: Building a Safer Health System, the Institute of Medicine (IOM) suggested that between 44,000 and 98,000 Americans die annually as a result of medical errors. The report urged health care institutions to break the silence surrounding such errors and to implement changes that would promote a culture of safety. Our aim in conducting this content analysis of AJN articles was to explore the nurse's historical and contemporary role in promoting patient safety. We chose to focus on AJN because, as the oldest continuously published nursing journal, it provided a unique opportunity for us to view trends in nursing practice over more than 100 years. We reviewed all AJN tables of contents from 1900 through 2015, identifying for inclusion articles with titles that suggested a focus on nursing care, patient safety, or clinical content. We then read and analyzed each of the final 1,086 articles over a period of nine months. Our content analysis indicates that the early articles (from 1900 through 1920) focused on such safety measures as asepsis and the newly understood germ theory. In the 1930s, articles proposed methods for preventing medication errors and encouraged the development of written procedures to standardize care. During World War II, nurse authors identified improved patient survival rates with the use of "shock wards" and recovery rooms. The 1950s saw the emergence of progressive patient care initiatives, through which patients were assigned to various levels of care (intensive, intermediate, self, long-term, or home care) based on patient acuity. The 1960s brought increasingly complex equipment and medication regimens, which created safety problems. Hospital-acquired infections were recognized. Unit-dose medication was instituted in the 1970s. In the next two decades, medication and nursing-procedure safety were emphasized. From 2000 to 2015, articles looked beyond human performance as causes of health care errors to systemic factors, such as poor communication, patient-nurse ratios, provider skill mix, disruptive or inappropriate provider behavior, shift work, and long working hours. Emphasis on patient safety increased as patient care became more complex. As nurses developed a professional identity, they often put a spotlight on safety concerns and solutions. The IOM report, which encouraged research focused on systemic solutions to errors, was instrumental in furthering the very culture of safety that the nursing profession had championed.

Is social drinking during pregnancy harmless? There is reason to think not.

PubMed

Blume, S B

This paper reviews the scientific evidence bearing on the safety of social drinking in pregnancy (that is, patterns or levels of alcohol intake that cannot be diagnosed as alcohol abuse or alcohol dependence). Human studies have shown an increased incidence of spontaneous abortion, greater risk for a growth-retarded infant, measurable changes in newborn behavior, differences in development at age eight months, and differences in behavior at age four years, related to patterns of social drinking during pregnancy. Animal studies and in vitro studies of human umbilical vessels add to doubts about the safety of social drinking. In view of the individual differences in susceptibility to alcohol toxicity, the only reasonable policy at this time is to recommend abstinence as the safest course for pregnant women and those planning pregnancy.

Missing focus on Human Factors – organizational and cognitive ergonomics – in the safety management for the petroleum industry

PubMed Central

Johnsen, Stig O; Kilskar, Stine Skaufel; Fossum, Knut Robert

2017-01-01

More attention has recently been given to Human Factors in petroleum accident investigations. The Human Factors areas examined in this article are organizational, cognitive and physical ergonomics. A key question to be explored is as follows: To what degree are the petroleum industry and safety authorities in Norway focusing on these Human Factors areas from the design phase? To investigate this, we conducted an innovative exploratory study of the development of four control centres in Norwegian oil and gas industry in collaboration between users, management and Human Factors experts. We also performed a literature survey and discussion with the professional Human Factors network in Norway. We investigated the Human Factors focus, reasons for not considering Human Factors and consequences of missing Human Factors in safety management. The results revealed an immature focus and organization of Human Factors. Expertise on organizational ergonomics and cognitive ergonomics are missing from companies and safety authorities and are poorly prioritized during the development. The easy observable part of Human Factors (i.e. physical ergonomics) is often in focus. Poor focus on Human Factors in the design process creates demanding conditions for human operators and impact safety and resilience. There is lack of non-technical skills such as communication and decision-making. New technical equipment such as Closed Circuit Television is implemented without appropriate use of Human Factors standards. Human Factors expertise should be involved as early as possible in the responsible organizations. Verification and validation of Human Factors should be improved and performed from the start, by certified Human Factors experts in collaboration with the workforce. The authorities should check-back that the regulatory framework of Human Factors is communicated, understood and followed. PMID:29278242

The Rated Voltage Determination of DC Building Power Supply System Considering Human Beings Safety

NASA Astrophysics Data System (ADS)

Wang, Zhicheng; Yu, Kansheng; Xie, Guoqiang; Zou, Jin

2018-01-01

Generally two-level voltages are adopted for DC building power supply system. From the point of view of human beings safety, only the lower level voltage which may be contacted barehanded is discussed in this paper based on the related safety thresholds of human beings current effect. For several voltage levels below 100V recommended by IEC, the body current and current density of human electric shock under device normal work condition, as well as effect of unidirectional single impulse currents of short durations are calculated and analyzed respectively. Finally, DC 60V is recommended as the lower level rating voltage through the comprehensive consideration of technical condition and cost of safety criteria.

Safety of High Speed Guided Ground Transportation Systems: Human Factors Phase I: Function Analyses and Theoretical Considerations

DOT National Transportation Integrated Search

1994-10-01

Although the speed of guided ground transportation continues to increase, the reaction : time as well as the sensory and information processing capacities of on- and off-board : operators remain constant. This report, the first of two examining criti...

16 CFR 1207.11 - References.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR 1207.11 - References.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR § 1207.11 - References.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR 1207.11 - References.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

21 CFR 172.809 - Curdlan.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition... examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100...

Establishing a culture for patient safety - the role of education.

PubMed

Milligan, Frank J

2007-02-01

This paper argues that the process of making significant moves towards a patient safety culture requires changes in healthcare education. Improvements in patient safety are a shared international priority as too many errors and other forms of unnecessary harm are currently occurring in the process of caring for and treating patients. A description of the patient safety agenda is given followed by a brief analysis of human factors theory and its use in other safety critical industries, most notably aviation. The all too common problem of drug administration errors is used to illustrate the relevance of human factors theory to healthcare education with specific mention made of the Human Factors Analysis and Classification System (HFACS).

ACOG committee opinion number 398, February 2008: fatigue and patient safety.

PubMed

2008-02-01

It has long been recognized that fatigue can affect human cognitive and physical function. Although there are limited published data on the effects of fatigue on health care providers, including full-time practicing physicians, there is increasing awareness within the patient safety movement that fatigue, even partial sleep deprivation, impairs performance. Most of the current literature reviews resident function after recent work reform changes. However, the information available from many studies in health care and other occupations can be applied to the work habits of practicing obstetrician-gynecologists.

Bayesian Safety Risk Modeling of Human-Flightdeck Automation Interaction

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2015-01-01

Usage of automatic systems in airliners has increased fuel efficiency, added extra capabilities, enhanced safety and reliability, as well as provide improved passenger comfort since its introduction in the late 80's. However, original automation benefits, including reduced flight crew workload, human errors or training requirements, were not achieved as originally expected. Instead, automation introduced new failure modes, redistributed, and sometimes increased workload, brought in new cognitive and attention demands, and increased training requirements. Modern airliners have numerous flight modes, providing more flexibility (and inherently more complexity) to the flight crew. However, the price to pay for the increased flexibility is the need for increased mode awareness, as well as the need to supervise, understand, and predict automated system behavior. Also, over-reliance on automation is linked to manual flight skill degradation and complacency in commercial pilots. As a result, recent accidents involving human errors are often caused by the interactions between humans and the automated systems (e.g., the breakdown in man-machine coordination), deteriorated manual flying skills, and/or loss of situational awareness due to heavy dependence on automated systems. This paper describes the development of the increased complexity and reliance on automation baseline model, named FLAP for FLightdeck Automation Problems. The model development process starts with a comprehensive literature review followed by the construction of a framework comprised of high-level causal factors leading to an automation-related flight anomaly. The framework was then converted into a Bayesian Belief Network (BBN) using the Hugin Software v7.8. The effects of automation on flight crew are incorporated into the model, including flight skill degradation, increased cognitive demand and training requirements along with their interactions. Besides flight crew deficiencies, automation system failures and anomalies of avionic systems are also incorporated. The resultant model helps simulate the emergence of automation-related issues in today's modern airliners from a top-down, generalized approach, which serves as a platform to evaluate NASA developed technologies

Advanced spacecraft fire safety: Proposed projects and program plan

NASA Technical Reports Server (NTRS)

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

1989-01-01

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

Navigating towards improved surgical safety using aviation-based strategies.

PubMed

Kao, Lillian S; Thomas, Eric J

2008-04-01

Safety practices in the aviation industry are being increasingly adapted to healthcare in an effort to reduce medical errors and patient harm. However, caution should be applied in embracing these practices because of limited experience in surgical disciplines, lack of rigorous research linking these practices to outcome, and fundamental differences between the two industries. Surgeons should have an in-depth understanding of the principles and data supporting aviation-based safety strategies before routinely adopting them. This paper serves as a review of strategies adapted to improve surgical safety, including the following: implementation of crew resource management in training operative teams; incorporation of simulation in training of technical and nontechnical skills; and analysis of contributory factors to errors using surveys, behavioral marker systems, human factors analysis, and incident reporting. Avenues and challenges for future research are also discussed.

SEIPS 2.0: A human factors framework for studying and improving the work of healthcare professionals and patients

PubMed Central

Holden, Richard J.; Carayon, Pascale; Gurses, Ayse P.; Hoonakker, Peter; Hundt, Ann Schoofs; Ozok, A. Ant; Rivera-Rodriguez, A. Joy

2013-01-01

Healthcare practitioners, patient safety leaders, educators, and researchers increasingly recognize the value of human factors/ergonomics and make use of the discipline’s person-centered models of sociotechnical systems. This paper first reviews one of the most widely used healthcare human factors systems models, the Systems Engineering Initiative for Patient Safety (SEIPS) model, and then introduces an extended model, “SEIPS 2.0.” SEIPS 2.0 incorporates three novel concepts into the original model: configuration, engagement, and adaptation. The concept of configuration highlights the dynamic, hierarchical, and interactive properties of sociotechnical systems, making it possible to depict how health-related performance is shaped at “a moment in time.” Engagement conveys that various individuals and teams can perform health-related activities separately and collaboratively. Engaged individuals often include patients, family caregivers, and other non-professionals. Adaptation is introduced as a feedback mechanism that explains how dynamic systems evolve in planned and unplanned ways. Key implications and future directions for human factors research in healthcare are discussed. PMID:24088063

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

2001-01-01

This annual report is based on the activities of the Aerospace Safety Advisory Panel in calendar year 2000. During this year, the construction of the International Space Station (ISS) moved into high gear. The launch of the Russian Service Module was followed by three Space Shuttle construction and logistics flights and the deployment of the Expedition One crew. Continuous habitation of the ISS has begun. To date, both the ISS and Space Shuttle programs have met or exceeded most of their flight objectives. In spite of the intensity of these efforts, it is clear that safety was always placed ahead of cost and schedule. This safety consciousness permitted the Panel to devote more of its efforts to examining the long-term picture. With ISS construction accelerating, demands on the Space Shuttle will increase. While Russian Soyuz and Progress spacecraft will make some flights, the Space Shuttle remains the primary vehicle to sustain the ISS and all other U.S. activities that require humans in space. Development of a next generation, human-rated vehicle has slowed due to a variety of technological problems and the absence of an approach that can accomplish the task significantly better than the Space Shuttle. Moreover, even if a viable design were currently available, the realities of funding and development cycles suggest that it would take many years to bring it to fruition. Thus, it is inescapable that for the foreseeable future the Space Shuttle will be the only human-rated vehicle available to the U.S. space program for support of the ISS and other missions requiring humans. Use of the Space Shuttle will extend well beyond current planning, and is likely to continue for the life of the ISS.

Nonclinical Profile of BLZ-100, a Tumor-Targeting Fluorescent Imaging Agent.

PubMed

Parrish-Novak, Julia; Byrnes-Blake, Kelly; Lalayeva, Narine; Burleson, Stefanie; Fidel, Janean; Gilmore, Rhonda; Gayheart-Walsten, Pamela; Bricker, Gregory A; Crumb, William J; Tarlo, K S; Hansen, Stacey; Wiss, Valorie; Malta, Errol; Dernell, William S; Olson, James M; Miller, Dennis M

BLZ-100 is a single intravenous use, fluorescent imaging agent that labels tumor tissue to enable more complete and precise surgical resection. It is composed of a chlorotoxin peptide covalently bound to the near-infrared fluorophore indocyanine green. BLZ-100 is in clinical development for intraoperative visualization of human tumors. The nonclinical safety and pharmacokinetic (PK) profile of BLZ-100 was evaluated in mice, rats, canines, and nonhuman primates (NHP). Single bolus intravenous administration of BLZ-100 was well tolerated, and no adverse changes were observed in cardiovascular safety pharmacology, PK, and toxicology studies in rats and NHP. The single-dose no-observed-adverse-effect-levels (NOAELs) were 7 mg (28 mg/kg) in rats and 60 mg (20 mg/kg) in NHP, corresponding to peak concentration values of 89 400 and 436 000 ng/mL and area-under-the-curve exposure values of 130 000 and 1 240 000 h·ng/mL, respectively. Based on a human imaging dose of 3 mg, dose safety margins are >100 for rat and monkey. BLZ-100 produced hypersensitivity reactions in canine imaging studies (lethargy, pruritus, swollen muzzle, etc). The severity of the reactions was not dose related. In a follow-up study in dogs, plasma histamine concentrations were increased 5 to 60 minutes after BLZ-100 injection; this coincided with signs of hypersensitivity, supporting the conclusion that the reactions were histamine based. Hypersensitivity reactions were not observed in other species or in BLZ-100 human clinical studies conducted to date. The combined imaging, safety pharmacology, PK, and toxicology studies contributed to an extensive initial nonclinical profile for BLZ-100, supporting first-in-human clinical trials.

[Current status of occupational health activities and the way that occupational health services should be offered to small- and medium-scale enterprises].

PubMed

Kayashima, Kotaro

2013-10-01

Activating occupational safety and health activities among Small- and Medium-scale Enterprises (SMEs) is a major issue because more than 80% of Japanese workers belong to these enterprises, in which the number of workers are less than 300 people. However, as the size of the enterprise decreases, the occurrence of problems of safety and health management systems and safety and health activities increases. Reasons for this include both the limitations of investments shortages of human resources. Occupational health services in SMEs has been provided by the cooperation of the following institutions: public associations (such as Regional Occupational Health Centers, Occupational Health Promotion Centers, Japan Industrial Safety and Health Association (JISHA)), occupational health agencies which provide checkup services, health insurance associations, and regional medical services. In contrast to the low coverage of occupational health services among SMEs in Japan, there are some countries in Europe in which this coverage is almost 100%. This is because of the development of occupational health services outside the company. To show the benefits of the safety and health activities to managers of SMEs, and to motivate them to take advantage of the services, it is important to consider measurements. Also, establishing systems that provide those services, improving the quality of specialists such as occupational physicians, and educating human resources, are all necessary.

Myths and Misconceptions Revisited - What are the (Statistically Significant) methods to prevent employee injuries

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

Potts, T.T.; Hylko, J.M.; Almond, D.

2007-07-01

A company's overall safety program becomes an important consideration to continue performing work and for procuring future contract awards. When injuries or accidents occur, the employer ultimately loses on two counts - increased medical costs and employee absences. This paper summarizes the human and organizational components that contributed to successful safety programs implemented by WESKEM, LLC's Environmental, Safety, and Health Departments located in Paducah, Kentucky, and Oak Ridge, Tennessee. The philosophy of 'safety, compliance, and then production' and programmatic components implemented at the start of the contracts were qualitatively identified as contributing factors resulting in a significant accumulation of safemore » work hours and an Experience Modification Rate (EMR) of <1.0. Furthermore, a study by the Associated General Contractors of America quantitatively validated components, already found in the WESKEM, LLC programs, as contributing factors to prevent employee accidents and injuries. Therefore, an investment in the human and organizational components now can pay dividends later by reducing the EMR, which is the key to reducing Workers' Compensation premiums. Also, knowing your employees' demographics and taking an active approach to evaluate and prevent fatigue may help employees balance work and non-work responsibilities. In turn, this approach can assist employers in maintaining a healthy and productive workforce. For these reasons, it is essential that safety needs be considered as the starting point when performing work. (authors)« less

Dingoes at the Doorstep: Home Range Sizes and Activity Patterns of Dingoes and Other Wild Dogs around Urban Areas of North-Eastern Australia

PubMed Central

McNeill, Alice T.; Leung, Luke K. -P.; Goullet, Mark S.; Gentle, Matthew N.; Allen, Benjamin L.

2016-01-01

Simple summary Conflicts with dingoes and other wild dogs are becoming increasingly common in and around urban areas of Australia. A lack of basic information about wild dog movement ecology hampers efficient planning and allocation of resources to mitigate human–wild dog conflicts. We captured, collared and released 37 wild dogs in urban areas of north-eastern Australia to investigate their movement ecology. In general, wild dogs occupied small fragments of bushland within an urban matrix, were active at all times of the day, and lived within a few hundred meters of houses and humans at all times. We conclude that wild dog management strategies in urban areas should focus on the mitigation of impacts at the individual or group level, and not population-level reductions in numbers. Abstract Top-predators around the world are becoming increasingly intertwined with humans, sometimes causing conflict and increasing safety risks in urban areas. In Australia, dingoes and dingo × domestic dog hybrids are common in many urban areas, and pose a variety of human health and safety risks. However, data on urban dingo ecology is scant. We GPS-collared 37 dingoes in north-eastern Australia and continuously monitored them each 30 min for 11–394 days. Most dingoes were nocturnal, with an overall mean home range size of 17.47 km2. Overall mean daily distance travelled was 6.86 km/day. At all times dingoes were within 1000 m of houses and buildings. Home ranges appeared to be constrained to patches of suitable vegetation fragments within and around human habitation. These data can be used to reallocate dingo management effort towards mitigating actual conflicts between humans and dingoes in urban areas. PMID:27537916

Low-Cost Avoidance Behaviors are Resistant to Fear Extinction in Humans

PubMed Central

Vervliet, Bram; Indekeu, Ellen

2015-01-01

Elevated levels of fear and avoidance are core symptoms across the anxiety disorders. It has long been known that fear serves to motivate avoidance. Consequently, fear extinction has been the primary focus in pre-clinical anxiety research for decades, under the implicit assumption that removing the motivator of avoidance (fear) would automatically mitigate the avoidance behaviors as well. Although this assumption has intuitive appeal, it has received little scientific scrutiny. The scarce evidence from animal studies is mixed, while the assumption remains untested in humans. The current study applied an avoidance conditioning protocol in humans to investigate the effects of fear extinction on the persistence of low-cost avoidance. Online danger-safety ratings and skin conductance responses documented the dynamics of conditioned fear across avoidance and extinction phases. Anxiety- and avoidance-related questionnaires explored individual differences in rates of avoidance. Participants first learned to click a button during a predictive danger signal, in order to cancel an upcoming aversive electrical shock (avoidance conditioning). Next, fear extinction was induced by presenting the signal in the absence of shocks while button-clicks were prevented (by removing the button in Experiment 1, or by instructing not to click the button in Experiment 2). Most importantly, post-extinction availability of the button caused a significant return of avoidant button-clicks. In addition, trait-anxiety levels correlated positively with rates of avoidance during a predictive safety signal, and with the rate of pre- to post-extinction decrease during this signal. Fear measures gradually decreased during avoidance conditioning, as participants learned that button-clicks effectively canceled the shock. Preventing button-clicks elicited a sharp increase in fear, which subsequently extinguished. Fear remained low during avoidance testing, but danger-safety ratings increased again when button-clicks were subsequently prevented. Together, these results show that low-cost avoidance behaviors can persist following fear extinction and induce increased threat appraisal. On the other hand, fear extinction did reduce augmented rates of unnecessary avoidance during safety in trait-anxious individuals, and instruction-based response prevention was more effective than removal of response cues. More research is needed to characterize the conditions under which fear extinction might mitigate avoidance. PMID:26733837

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

PubMed

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

2017-08-01

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

Practical Applications of Cosmic Ray Science: Spacecraft, Aircraft, Ground Based Computation and Control Systems and Human Health and Safety

NASA Technical Reports Server (NTRS)

Atwell, William; Koontz, Steve; Normand, Eugene

2012-01-01

In this paper we review the discovery of cosmic ray effects on the performance and reliability of microelectronic systems as well as on human health and safety, as well as the development of the engineering and health science tools used to evaluate and mitigate cosmic ray effects in earth surface, atmospheric flight, and space flight environments. Three twentieth century technological developments, 1) high altitude commercial and military aircraft; 2) manned and unmanned spacecraft; and 3) increasingly complex and sensitive solid state micro-electronics systems, have driven an ongoing evolution of basic cosmic ray science into a set of practical engineering tools (e.g. ground based test methods as well as high energy particle transport and reaction codes) needed to design, test, and verify the safety and reliability of modern complex electronic systems as well as effects on human health and safety. The effects of primary cosmic ray particles, and secondary particle showers produced by nuclear reactions with spacecraft materials, can determine the design and verification processes (as well as the total dollar cost) for manned and unmanned spacecraft avionics systems. Similar considerations apply to commercial and military aircraft operating at high latitudes and altitudes near the atmospheric Pfotzer maximum. Even ground based computational and controls systems can be negatively affected by secondary particle showers at the Earth's surface, especially if the net target area of the sensitive electronic system components is large. Accumulation of both primary cosmic ray and secondary cosmic ray induced particle shower radiation dose is an important health and safety consideration for commercial or military air crews operating at high altitude/latitude and is also one of the most important factors presently limiting manned space flight operations beyond low-Earth orbit (LEO).

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

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.

Bacterial vaccines: old and new, veterinary and medical.

PubMed

Walker, P D

1992-01-01

Developments in veterinary and medical bacterial vaccines are outlined. In the former case, economic considerations are paramount, and cruder, less purified products of proven efficacy continue to be employed. For human use, however, safety and absence of side effects are increasingly demanded. Various examples of human and veterinary vaccines are discussed, and interaction between the two fields is illustrated by reference to the pig-bel disease in New Guinea and the possible aetiology of Sudden Infant Death Syndrome.

Prevalence of veterinary drug residues and heavy metals in catfish nuggets

USDA-ARS?s Scientific Manuscript database

Seafood, including catfish, can sometimes become contaminated with chemicals and heavy metals at levels which would harm human health. Seafood safety has been increasing concerns to the consumers in the United States and limited availability of domestic fresh products in retail stores have been rais...

The changing face of (eco)toxicology in the 21st Century: New solutions to old problems

EPA Science Inventory

Regulatory toxicologists involved in chemical safety assessments either for human or ecological health are being tasked with generating technically-robust data for a rapidly increasing number of chemicals and chemical mixtures. In the US alone, for example, the recently reauthor...

Evaluating Natural Variability of Soybean proteins by Proteomic Tools

USDA-ARS?s Scientific Manuscript database

Soybean is an inexpensive source of protein for humans and animals. Genetic modifications (GMO) to soybean have become inevitable on two fronts, both quality and yield will need to improve to meet increasing global demand. To ensure the safety of the crop for consumers it is important to determine...

Implications of Negative Pressure Imaging for Microcrack Detection and Salmonella Contamination in Shell Eggs

USDA-ARS?s Scientific Manuscript database

Microcracks in eggshells are difficult for human graders to detect and pose an important food safety risk. Negative pressure imaging technology has been developed with 99.6% accuracy in detecting microcracks. A study was conducted to determine if the microcrack detection system would increase pene...

Treating urine by Spirulina platensis

NASA Astrophysics Data System (ADS)

Yang, Chenliang; Liu, Hong; Li, Ming; Yu, Chengying; Yu, Gurevich

In this paper Spirulina platensis with relatively high nutrition was cultivated to treat human urine. Batch culture showed that the consumption of N in human urine could reach to 99%, and the consumption of P was more than 99.9%, and 1.05 g biomass was obtained by treating 12.5 ml synthetic human urine; continuous culture showed that S. platensis could consume N, Cl, K and S in human urine effectively, and the consumption could reach to 99.9%, 75.0%, 83.7% and 96.0%, respectively, and the consumption of P was over 99.9%, which is very important to increase the closure and safety of the bioregenerative life support system (BLSS).

Department of Pesticide Regulation Databases

Science.gov Websites

; Safety Report an Illness | Food Safety | Risk Assessment & Mitigation | Human Health | Physicians Endangered Species Enforcement Food Safety Forms Human Health Laws Licensing Mill Assessment Permitting Pest Statewide search: Search Search Search this site: Search Search DPR California Home Programs Health &

California Department of Pesticide Regulation Home Page

Science.gov Websites

; Safety Report an Illness | Food Safety | Risk Assessment & Mitigation | Human Health | Physicians Endangered Species Enforcement Food Safety Forms Human Health Laws Licensing Mill Assessment Permitting Pest Statewide search: Search Search Search this site: Search Search DPR California Home Programs Health &

The Naturalistic Flight Deck System: An Integrated System Concept for Improved Single-Pilot Operations

NASA Technical Reports Server (NTRS)

Schutte, Paul C.; Goodrich, Kenneth H.; Cox, David E.; Jackson, Bruce; Palmer, Michael T.; Pope, Alan T.; Schlecht, Robin W.; Tedjojuwono, Ken K.; Trujillo, Anna C.; Williams, Ralph A.;

Health and safety and the Human Rights Act 1998.

PubMed

Tearle, P

2001-03-01

The Human Rights Act 1998 came into effect on 2 October 2000. The list of human rights now embodied in United Kingdom law reflects the ideas and values of our changing and developing society. As a dynamic document the act has parallels with the ideals found in health and safety law. This article looks at the act and considers its implications for employers with regard to existing health and safety law.

Does the concept of safety culture help or hinder systems thinking in safety?

PubMed

Reiman, Teemu; Rollenhagen, Carl

2014-07-01

The concept of safety culture has become established in safety management applications in all major safety-critical domains. The idea that safety culture somehow represents a "systemic view" on safety is seldom explicitly spoken out, but nevertheless seem to linger behind many safety culture discourses. However, in this paper we argue that the "new" contribution to safety management from safety culture never really became integrated with classical engineering principles and concepts. This integration would have been necessary for the development of a more genuine systems-oriented view on safety; e.g. a conception of safety in which human, technological, organisational and cultural factors are understood as mutually interacting elements. Without of this integration, researchers and the users of the various tools and methods associated with safety culture have sometimes fostered a belief that "safety culture" in fact represents such a systemic view about safety. This belief is, however, not backed up by theoretical or empirical evidence. It is true that safety culture, at least in some sense, represents a holistic term-a totality of factors that include human, organisational and technological aspects. However, the departure for such safety culture models is still human and organisational factors rather than technology (or safety) itself. The aim of this paper is to critically review the various uses of the concept of safety culture as representing a systemic view on safety. The article will take a look at the concepts of culture and safety culture based on previous studies, and outlines in more detail the theoretical challenges in safety culture as a systems concept. The paper also presents recommendations on how to make safety culture more systemic. Copyright © 2013 Elsevier Ltd. All rights reserved.

Mode of action associated with development of hemangiosarcoma in mice given pregabalin and assessment of human relevance.

PubMed

Criswell, Kay A; Cook, Jon C; Wojcinski, Zbigniew; Pegg, David; Herman, James; Wesche, David; Giddings, John; Brady, Joseph T; Anderson, Timothy

2012-07-01

Pregabalin increased the incidence of hemangiosarcomas in carcinogenicity studies of 2-year mice but was not tumorigenic in rats. Serum bicarbonate increased within 24 h of pregabalin administration in mice and rats. Rats compensated appropriately, but mice developed metabolic alkalosis and increased blood pH. Local tissue hypoxia and increased endothelial cell proliferation were also confirmed in mice alone. The combination of hypoxia and sustained increases in endothelial cell proliferation, angiogenic growth factors, dysregulated erythropoiesis, and macrophage activation is proposed as the key event in the mode of action (MOA) for hemangiosarcoma formation. Hemangiosarcomas occur spontaneously in untreated control mice but occur only rarely in humans. The International Programme on Chemical Safety and International Life Sciences Institute developed a Human Relevance Framework (HRF) analysis whereby presence or absence of key events can be used to assess human relevance. The HRF combines the MOA with an assessment of biologic plausibility in humans to assess human relevance. This manuscript compares the proposed MOA with Hill criteria, a component of the HRF, for strength, consistency, specificity, temporality, and dose response, with an assessment of key biomarkers in humans, species differences in response to disease conditions, and spontaneous incidence of hemangiosarcoma to evaluate human relevance. Lack of key biomarker events in the MOA in rats, monkeys, and humans supports a species-specific process and demonstrates that the tumor findings in mice are not relevant to humans at the clinical dose of pregabalin. Based on this collective dataset, clinical use of pregabalin would not pose an increased risk for hemangiosarcoma to humans.

Safety and the Human Factor.

ERIC Educational Resources Information Center

Smith, Ann

1982-01-01

Discusses four elements of safety programs: (1) safety training; (2) safety inspections; (3) accident investigations; and (4) protective safety equipment. Also discusses safety considerations in water/wastewater treatment facilities focusing on falls, drowning hazards, trickling filters, confined space entry, collection/distribution system safety,…

Linking insomnia to workplace injuries: A moderated mediation model of supervisor safety priority and safety behavior.

PubMed

Kao, Kuo-Yang; Spitzmueller, Christiane; Cigularov, Konstantin; Wu, Hao

2016-01-01

This study investigated why and how insomnia can relate to workplace injuries, which continue to have high human and economic costs. Utilizing the self-regulatory resource theory, we argue that insomnia decreases workers' safety behaviors, resulting in increased workplace injuries. Moreover, in order to ultimately derive organizational interventions to alleviate the detrimental impact of insomnia on workplace injuries, we propose that supervisor safety priority can create situational strength that can prevent workers from behaving unsafely despite experiencing insomnia. Our theoretical model was examined and empirically supported using hierarchically nested data collected from supervisors (N = 482) and workers (N = 2,737) in a midsized construction services company. Results were consistent with the proposed conceptual framework; the relationship between insomnia and injuries is explained by the influence of insomnia on safety behaviors. For workers supervised by supervisors with high safety priority, both the relationship between insomnia and safety behaviors and the indirect relationship between insomnia and workplace injuries were weaker. We provide theoretical implications for future safety research and suggest tentative directions for practitioners working to reduce workplace injuries through sleep-oriented interventions. (c) 2016 APA, all rights reserved).

Threats to safety during sedation outside of the operating room and the death of Michael Jackson.

PubMed

Webster, Craig S; Mason, Keira P; Shafer, Steven L

2016-03-01

From an understanding of human psychology and the reliability of high-technology systems, this review considers critical threats to the safety of patients undergoing sedation outside of the operating room, and will stratify these threats along what we define as the 'Patient Risk Continuum'. We then consider interventions suitable for addressing identified risks. The technology, organization and delivery of healthcare continue to become more complex, highlighting the importance of maintaining the safety of patients. Sedation outside of the operating room is known to be associated with higher rates of adverse events. However, a number of recent safety initiatives have shown benefit in improving patient safety. The following threats to patients undergoing sedation, in increasing order of risk, are discussed: equipment and environmental factors, known patient risks, poor team performance, combinatorial problems and egregious violations. To address these threats, we discuss a number of approaches consistent with the systems approach to safety, namely: encouraging functions, forcing functions, cognitive safety nets, information sharing, recovery strategies and regulatory change. Demonstrating improvement with any safety initiative relies critically on quality data collected on the problem area in question.

HFE safety reviews of advanced nuclear power plant control rooms

NASA Technical Reports Server (NTRS)

Ohara, John

1994-01-01

Advanced control rooms (ACR's) will utilize human-system interface (HSI) technologies that may have significant implications for plant safety in that they will affect the operator's overall role and means of interacting with the system. The Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) aspects of HSI's to ensure that they are designed to good HFE principles and support performance and reliability in order to protect public health and safety. However, the only available NRC guidance was developed more than ten years ago, and does not adequately address the human performance issues and technology changes associated with ACR's. Accordingly, a new approach to ACR safety reviews was developed based upon the concept of 'convergent validity'. This approach to ACR safety reviews is described.

Fall Protection Characteristics of Safety Belts and Human Impact Tolerance.

PubMed

Hino, Yasumichi; Ohdo, Katsutoshi; Takahashi, Hiroki

2014-08-23

Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt 1) , which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness 2, 3) , which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference 4-9) to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model 10) was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls.

Fall protection characteristics of safety belts and human impact tolerance.

PubMed

Hino, Yasumichi; Ohdo, Katsutoshi; Takahashi, Hiroki

2014-01-01

Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt, which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness, which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls.

Fall Protection Characteristics of Safety Belts and Human Impact Tolerance

PubMed Central

HINO, Yasumichi; OHDO, Katsutoshi; TAKAHASHI, Hiroki

2014-01-01

Abstract: Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt1), which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness2, 3), which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference4,5,6,7,8,9) to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model10) was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls. PMID:25345426

Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.

PubMed

Golpanian, Samuel; DiFede, Darcy L; Pujol, Marietsy V; Lowery, Maureen H; Levis-Dusseau, Silvina; Goldstein, Bradley J; Schulman, Ivonne H; Longsomboon, Bangon; Wolf, Ariel; Khan, Aisha; Heldman, Alan W; Goldschmidt-Clermont, Pascal J; Hare, Joshua M

2016-03-15

Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.

Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the United States.

PubMed

2017-01-01

The use of donor human milk is increasing for high-risk infants, primarily for infants born weighing <1500 g or those who have severe intestinal disorders. Pasteurized donor milk may be considered in situations in which the supply of maternal milk is insufficient. The use of pasteurized donor milk is safe when appropriate measures are used to screen donors and collect, store, and pasteurize the milk and then distribute it through established human milk banks. The use of nonpasteurized donor milk and other forms of direct, Internet-based, or informal human milk sharing does not involve this level of safety and is not recommended. It is important that health care providers counsel families considering milk sharing about the risks of bacterial or viral contamination of nonpasteurized human milk and about the possibilities of exposure to medications, drugs, or herbs in human milk. Currently, the use of pasteurized donor milk is limited by its availability and affordability. The development of public policy to improve and expand access to pasteurized donor milk, including policies that support improved governmental and private financial support for donor milk banks and the use of donor milk, is important. Copyright © 2017 by the American Academy of Pediatrics.

Assessment of methods used to determine the safety of the topical insect repellent N,N-diethyl-m-toluamide (DEET).

PubMed

Chen-Hussey, Vanessa; Behrens, Ron; Logan, James G

2014-06-03

N,N-diethyl-m-toluamide (DEET) has been registered for commercial use as an insect repellent for over five decades, and is used widely across the world. Concerns over the safety of DEET first emerged during the 1980s after reports of encephalopathy following DEET exposure, particularly in children. However, the role of DEET in either the illness or deaths was and remains purely speculative. In response to these cases a number of reviews and investigations of DEET safety were carried out. Here we examine the methods used and information available to determine the safety of DEET in humans. Animal testing, observational studies and intervention trials have found no evidence of severe adverse events associated with recommended DEET use. Minor adverse effects noted in animal trials were associated with very large doses and were not replicated between different test species. The safety surveillance from extensive humans use reveals no association with severe adverse events. This review compares the toxicity assessment using three different models to define the risk assessment and safety threshold for DEET use in humans and discusses the clinical consequences of the thresholds derived from the models.The theoretical risks associated with wearing an insect repellent should be weighed against the reduction or prevention of the risk of fatal or debilitating diseases including malaria, dengue, yellow fever and filariasis. With over 48 million European residents travelling to regions where vector borne diseases are a threat in 2009, restricting the concentration of DEET containing repellents to 15% or less, as modelled in the 2010 EU directive, is likely to result in extensive sub-therapeutic activity where repellents are infrequently applied. Future European travellers, as a consequence of inadequate personal protection, could potentially be at increased risk of vector borne diseases. Risk assessments of repellents should take these factors into account when setting safe limits.

Final amended safety assessment of hydroquinone as used in cosmetics.

PubMed

Andersen, F Alan; 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

2010-01-01

Hydroquinone is an aromatic compound that functions in cosmetics as an antioxidant, fragrance, reducing agent, or polymerization inhibitor. Hydroquinone is also used as a skin bleaching agent. Safety and toxicity information indicate that hydroquinone is dermally absorbed in humans from both aqueous and alcoholic formulations and is excreted mainly as the glucuronide or sulfate conjugates. Hydroquinone is associated with altered immune function in vitro and in vivo in animals and an increased incidence of renal tubule cell tumors and leukemia in F344 rats, but the relevance to humans is uncertain. Quantitatively, however, the use of hydroquinone in cosmetics is unlikely to result in renal neoplasia through this mode of action. Thus, hydroquinone is safe at concentrations of ≤1% in hair dyes and is safe for use in nail adhesives. Hydroquinone should not be used in other leave-on cosmetics.

Understanding Risk Tolerance and Building an Effective Safety Culture

NASA Technical Reports Server (NTRS)

Loyd, David

2018-01-01

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

A pre-clinical safety study of PEGylated recombinant human endostatin (M2ES) in Sprague Dawley rats.

PubMed

Geng, Xingchao; Guo, Lifang; Liu, Li; Wang, Chao; Peng, Qian; Qi, Weihong; Sun, Li; Liu, Xiaomeng; Miao, Yufa; Lin, Zhi; Fu, Yan; Luo, Yongzhang; Li, Bo

2018-06-01

PEGylated recombinant human endostatin (M 2 ES) exhibited prolonged serum half-life and enhanced antitumor activity when compared with endostatin. A pre-clinical study was performed to evaluate the safety of M 2 ES in rats. After intravenous (IV) infusions of M 2 ES at a dose level of 3, 15 and 75 mg/kg in Sprague Dawley (SD) rats, M 2 ES was well tolerated in animals, with no observable changes in clinical observation, body weight, food consumption, urine analysis, hematology and serum biochemical analysis. The increase of kidney weights, and slight to severe vacuolation and necrosis of proximal tubule epithelial cells in kidney were observed in 15 and 75 mg/kg M 2 ES groups, but this adverse-effect was reversible. In summary, the major toxicity target organ of M 2 ES might be kidney, and the no observed adverse effect level (NOAEL) of M 2 ES in rats was 3 mg/kg in this study. These pre-clinical safety data contribute to the initiation of the ongoing clinical study. Copyright © 2018. Published by Elsevier Inc.

Food Safety Practices in the U.S. Meat Slaughter and Processing Industry: Changes from 2005 to 2015.

PubMed

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

2017-08-01

Meat slaughter establishments use a multipronged approach to ensure beef and pork products are safe for human consumption. To determine the approaches most commonly used, we conducted a national survey of federally inspected meat slaughter and processing establishments (376 completed surveys, 66% response rate) in 2015. We compared the results with a survey that was conducted in 2005, albeit of potentially different establishments, by using a similar questionnaire and similar data collection methods, thus allowing for an evaluation of trends in food safety practices over time. The use of some food safety practices has increased over the 10-yr time period, whereas others remained the same or decreased. For example, the use of chemical sanitizers or hot water for food contact surfaces and tools increased from 51 to 93%. As another example, microbiological testing of raw meat after fabrication, in addition to that required by regulation, increased from 50 to 72%. However, the use of organic acid rinse on carcasses in the slaughter area remained the same, at 66% of establishments. Written policies and procedures to control the use of hazardous chemicals decreased from 75 to 65% of establishments. The survey findings can be used to characterize food safety practices and technologies in the meat slaughter and processing industry and identify areas for improvement.

Agricultural Safety. FMO: Fundamentals of Machine Operation. Second Edition.

ERIC Educational Resources Information Center

John Deere Co., Moline, IL.

This manual is intended to provide students with basic information on the safe operation of farm machinery. The following topics are covered in the individual chapters: safe farm machinery operation (the importance of safety, the role of communication in safety, and types of farm accidents); human factors (human limitations and capabilities;…

75 FR 74733 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... days aggregating at least 250 work days, occurring either solely under this employment or in...

75 FR 74733 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... aggregating at least 250 work days, occurring either solely under this employment, or in combination with work...

75 FR 51816 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

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75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

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75 FR 32783 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-09

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75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... work days aggregating at least 250 work days, occurring either solely under this employment or in...

75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... number of work days aggregating at least 250 work days, occurring either solely under this employment or...

75 FR 57024 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

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

Code of Federal Regulations, 2013 CFR

2013-04-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

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

Human Systems Integration in Expeditionary Medical Treatment Facilities

DTIC Science & Technology

2010-04-01

mental models and situation awareness Human Factors Engineering, Personnel, and Safety / Occupational Health The following issue is associated with...domains are human factors engineering, manpower, personnel, training, safety and occupational health , survivability, habitability, and environment...certain responsibilities to less-qualified personnel. Human error is a particularly sensitive topic across all sectors of health care, but the time

The Introduction of "Safety Science" into an Undergraduate Nursing Programme at a Large University in the United Kingdom.

PubMed

White, Nick; Clark, Deborah; Lewis, Robin; Robson, Wayne

2016-04-13

Implementing safety science {a term adopted by the authors which incorporates both patient safety and human factors (Sherwood, G. (2011). Integrating quality and safety science in nursing education and practice. Journal of Research in Nursing, 16(3), 226-240. doi: 10.1177/1744987111400960)} into healthcare programmes is a major challenge facing healthcare educators worldwide (National Advisory Group on the Safety of Patients in England, 2013; World Health Organisation, 2009). Patient safety concerns relating to human factors have been well-documented over the years, and the root cause(s) of as many as 65-80 % of these events are linked to human error (Dunn et al., 2007; Reason, 2005). This paper will describe how safety science education was embedded into a pre-registration nursing programme at a large UK university. The authors argue that the processes described in this paper, may be successfully applied to other pre-registration healthcare programmes in addition to nursing.

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

NASA Technical Reports Server (NTRS)

Johnson, Christopher W.; Holloway, C. Michael

2011-01-01

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

Non-technical skills training to enhance patient safety.

PubMed

Gordon, Morris

2013-06-01

  Patient safety is an increasingly recognised issue in health care. Systems-based and organisational methods of quality improvement, as well as education focusing on key clinical areas, are common, but there are few reports of educational interventions that focus on non-technical skills to address human factor sources of error. A flexible model for non-technical skills training for health care professionals has been designed based on the best available evidence, and with sound theoretical foundations.   Educational sessions to improve non-technical skills in health care have been described before. The descriptions lack the details to allow educators to replicate and innovate further.   A non-technical skills training course that can be delivered as either a half- or full-day intervention has been designed and delivered to a number of mixed groups of undergraduate medical students and doctors in postgraduate training. Participant satisfaction has been high and patient safety attitudes have improved post-intervention.   This non-technical skills educational intervention has been built on a sound evidence base, and is described so as to facilitate replication and dissemination. With the key themes laid out, clinical educators will be able to build interventions focused on numerous clinical issues that pay attention to human factor contributors to safety. © 2013 John Wiley & Sons Ltd.

An interprofessional training course in crises and human factors for perioperative teams.

PubMed

Stephens, Tim; Hunningher, Annie; Mills, Helen; Freeth, Della

2016-09-01

Improving patient safety and the culture of care are health service priorities that coexist with financial pressures on organisations. Research suggests team training and better team processes can improve team culture, safety, performance, and clinical outcomes, yet opportunities for interprofessional learning remain scarce. Perioperative practitioners work in a high pressure, high-risk environment without the benefits of stable team membership: this limits opportunities and momentum for team-initiated collaborative improvements. This article describes an interprofessional course focused on crises and human factors which comprised a 1-day event and a multifaceted sustainment programme for perioperative practitioners, grouped by surgical specialty. Participants reported increased understanding and confidence to enact processes and behaviours that support patient safety, including: team behaviours (communication, coordination, cooperation and back-up, leadership, situational awareness); recognising different perspectives and expectations within the team; briefing and debriefing; after action review; and using specialty-specific incident reports to generate specialty-specific interprofessional improvement plans. Participants valued working with specialty colleagues away from normal work pressures. In the high-pressure arena of front-line healthcare delivery, improving patient safety and theatre efficiency can often be erroneously considered conflicting agendas. Interprofessional collaboration amongst staff participating in this initiative enabled general and specialty-specific interprofessional learning that transcended this conflict.

Assessment of the effects of naringenin-type flavanones in uterus and vagina.

PubMed

Keiler, Annekathrin Martina; Dörfelt, Peggy; Chatterjee, Namita; Helle, Janina; Bader, Manuela I; Vollmer, Günter; Kretzschmar, Georg; Kuhlee, Franziska; Thieme, Detlef; Zierau, Oliver

2015-01-01

The potential utilization of plant secondary metabolites possessing estrogenic properties as alternatives to the classical hormone replacement therapy (HRT) for the relief of postmenopausal complaints asks for an evaluation regarding the safety in reproductive organs. In order to contribute to the estimation of the safety profile of the flavanones naringenin (Nar), 8‑prenylnaringenin (8PN) and 6‑(1,1‑dimethylally) naringenin (6DMAN), we investigated uterus and vagina derived from a three‑day uterotrophic assay in rats. Also, we investigated the metabolite profile resulting from the incubation of the three substances with liver microsomes. While no metabolites were detectable for naringenin, hydroxylation products were observed for 8PN and 6DMAN after incubation with human as well as rat liver microsomes. The parent compound naringenin did not evoke any estrogenic responses in the investigated parameters. A significant increase of the uterine wet weight, uterine epithelial thickness and proliferating vaginal cells was observed in response to 8PN, questioning the safety of 8PN if applied in the human situation. In contrast, no estrogenic effects on the reproductive organs were observed for 6DMAN in the conducted study, rendering it the compound with a more promising safety profile, therefore justifying further investigations into its efficacy to alleviate postmenopausal discomforts. Copyright © 2014 Elsevier Ltd. All rights reserved.

Use of Foodomics for Control of Food Processing and Assessing of Food Safety.

PubMed

Josić, D; Peršurić, Ž; Rešetar, D; Martinović, T; Saftić, L; Kraljević Pavelić, S

Food chain, food safety, and food-processing sectors face new challenges due to globalization of food chain and changes in the modern consumer preferences. In addition, gradually increasing microbial resistance, changes in climate, and human errors in food handling remain a pending barrier for the efficient global food safety management. Consequently, a need for development, validation, and implementation of rapid, sensitive, and accurate methods for assessment of food safety often termed as foodomics methods is required. Even though, the growing role of these high-throughput foodomic methods based on genomic, transcriptomic, proteomic, and metabolomic techniques has yet to be completely acknowledged by the regulatory agencies and bodies. The sensitivity and accuracy of these methods are superior to previously used standard analytical procedures and new methods are suitable to address a number of novel requirements posed by the food production sector and global food market. © 2017 Elsevier Inc. All rights reserved.

Translating cognitive neuroscience to the driver’s operational environment: a neuroergonomics approach

PubMed Central

Lees, Monica N.; Cosman, Joshua D.; Lee, John D.; Rizzo, Matthew; Fricke, Nicola

2012-01-01

Neuroergonomics provides a multidisciplinary translational approach that merges elements of neuroscience, human factors, cognitive psychology, and ergonomics to study brain structure and function in everyday environments. Driving safety, particularly that of older drivers with cognitive impairments, is a fruitful application domain for neuroergonomics. Driving makes demands on multiple cognitive processes that are often studied in isolation and so presents a useful challenge in generalizing findings from controlled laboratory tasks to predict safety outcomes. Neurology and the cognitive sciences help explain the mechanisms of cognitive breakdowns that undermine driving safety. Ergonomics complements this explanation with the tools for systematically exploring the various layers of complexity that define the activity of driving. A variety of tools, such as part task simulators, driving simulators, and instrumented vehicles provide a window into cognition in the natural settings needed to assess the generalizability of laboratory findings and can provide an array of potential interventions to increase safety. PMID:21291157

Intravenous medication safety and smart infusion systems: lessons learned and future opportunities.

PubMed

Keohane, Carol A; Hayes, Judy; Saniuk, Catherine; Rothschild, Jeffrey M; Bates, David W

2005-01-01

The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.

An Organizational Learning Framework for Patient Safety.

PubMed

Edwards, Marc T

Despite concerted effort to improve quality and safety, high reliability remains a distant goal. Although this likely reflects the challenge of organizational change, persistent controversy over basic issues suggests that weaknesses in conceptual models may contribute. The essence of operational improvement is organizational learning. This article presents a framework for identifying leverage points for improvement based on organizational learning theory and applies it to an analysis of current practice and controversy. Organizations learn from others, from defects, from measurement, and from mindfulness. These learning modes correspond with contemporary themes of collaboration, no blame for human error, accountability for performance, and managing the unexpected. The collaborative model has dominated improvement efforts. Greater attention to the underdeveloped modes of organizational learning may foster more rapid progress in patient safety by increasing organizational capabilities, strengthening a culture of safety, and fixing more of the process problems that contribute to patient harm.

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.

First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers.

PubMed

Stevens, Misty W; Henry, Ralph L; Owens, S Michael; Schutz, Ralph; Gentry, W Brooks

2014-01-01

This first-in-human study examined the safety and pharmacokinetics of ch-mAb7F9, an anti-methamphetamine monoclonal antibody, in healthy volunteers. Single, escalating doses of ch-mAb7F9 over the range of 0.2 to 20 mg/kg were administered to 42 subjects who were followed for 147 d. Safety was measured by physical examinations, adverse events, vital signs, electrocardiograms, and clinical laboratory testing. Serum ch-mAb7F9 concentration and immunogenicity analyses were performed. There were no serious adverse reactions or discontinuations from the study due to adverse events. No trends emerged in the frequency, relatedness, or severity of adverse events with increased dose or between active and placebo treated subjects. Ch-mAb7F9 displayed expected IgG pharmacokinetic parameters, including a half-life of 17-19 d in the 3 highest dose groups and volume of distribution of 5-6 L, suggesting the antibody is confined primarily to the vascular compartment. Four (12.5%) of the 32 subjects receiving ch-mAb7F9 were confirmed to have developed a human anti-chimeric antibody response by the end of the study; however, this response did not appear to be dose related. Overall, no apparent safety or tolerability concerns were identified; a maximum tolerated dose was not reached in this Phase 1 study. Ch-mAb7F9 therefore appears safe for human administration.

The safety of bone allografts used in dentistry: a review.

PubMed

Holtzclaw, Dan; Toscano, Nicholas; Eisenlohr, Lisa; Callan, Don

2008-09-01

Recent media reports concerning "stolen body parts" have shaken the public's trust in the safety of and the use of ethical practices involving human allografts. The authors provide a comprehensive review of the safety aspects of human bone allografts. The authors reviewed U.S. government regulations, industry standards, independent industry association guidelines, company guidelines and scientific articles related to the use of human bone allografts in the practice of dentistry published in the English language. The use of human bone allografts in the practice of dentistry involves the steps of procurement, processing, use and tracking. Rigorous donor screening and aseptic proprietary processing programs have rendered the use of human bone allografts safe and effective as a treatment option. When purchasing human bone allografts for the practice of dentistry, one should choose products accredited by the American Association of Tissue Banks for meeting uniformly high safety and quality control measures. Knowledge of human bone allograft procurement, processing, use and tracking procedures may allow dental clinicians to better educate their patients and address concerns about this valuable treatment option.

Generalized railway tank car safety design optimization for hazardous materials transport: addressing the trade-off between transportation efficiency and safety.

PubMed

Saat, Mohd Rapik; Barkan, Christopher P L

2011-05-15

North America railways offer safe and generally the most economical means of long distance transport of hazardous materials. Nevertheless, in the event of a train accident releases of these materials can pose substantial risk to human health, property or the environment. The majority of railway shipments of hazardous materials are in tank cars. Improving the safety design of these cars to make them more robust in accidents generally increases their weight thereby reducing their capacity and consequent transportation efficiency. This paper presents a generalized tank car safety design optimization model that addresses this tradeoff. The optimization model enables evaluation of each element of tank car safety design, independently and in combination with one another. We present the optimization model by identifying a set of Pareto-optimal solutions for a baseline tank car design in a bicriteria decision problem. This model provides a quantitative framework for a rational decision-making process involving tank car safety design enhancements to reduce the risk of transporting hazardous materials. Copyright © 2011 Elsevier B.V. All rights reserved.

Establishment of minimal positive-control conditions to ensure brain safety during rapid development of emergency vaccines.

PubMed

Baek, Hyekyung; Kim, Kwang Ho; Park, Min Young; Kim, Kyeongryun; Ko, Bokyeong; Seo, Hyung Seok; Kim, Byoung Soo; Hahn, Tae-Wook; Yi, Sun Shin

2017-08-31

With the increase in international human and material exchanges, contagious and infectious epidemics are occurring. One of the effective methods of epidemic inhibition is the rapid development and supply of vaccines. Considering the safety of the brain during vaccine development is very important. However, manuals for brain safety assays for new vaccines are not uniform or effective globally. Therefore, the aim of this study is to establish a positive-control protocol for an effective brain safety test to enhance rapid vaccine development. The blood-brain barrier's tight junctions provide selective defense of the brain; however, it is possible to destroy these important microstructures by administering lipopolysaccharides (LPSs), thereby artificially increasing the permeability of brain parenchyma. In this study, test conditions are established so that the degree of brain penetration or brain destruction of newly developed vaccines can be quantitatively identified. The most effective conditions were suggested by measuring time-dependent expressions of tight junction biomarkers (zonula occludens-1 [ZO-1] and occludin) in two types of mice (C57BL/6 and ICR) following exposure to two types of LPS ( Salmonella and Escherichia ). In the future, we hope that use of the developed positive-control protocol will help speed up the determination of brain safety of novel vaccines.

Preclinical safety study of a recombinant Streptococcus pyogenes vaccine formulated with aluminum adjuvant.

PubMed

HogenEsch, Harm; Dunham, Anisa; Burlet, Elodie; Lu, Fangjia; Mosley, Yung-Yi C; Morefield, Garry

2017-02-01

A recombinant vaccine composed of a fusion protein formulated with aluminum hydroxide adjuvant is under development for protection against diseases caused by Streptococcus pyogenes. The safety and local reactogenicity of the vaccine was assessed by a comprehensive series of clinical, pathologic and immunologic tests in preclinical experiments. Outbred mice received three intramuscular injections of 1/5th of the human dose (0.1 ml) and rabbits received two injections of the full human dose. Control groups received adjuvant or protein antigen. The vaccine did not cause clinical evidence of systemic toxicity in mice or rabbits. There was a transient increase of peripheral blood neutrophils after the third vaccination of mice. In addition, the concentration of acute phase proteins serum amyloid A and haptoglobin was significantly increased 1 day after injection of the vaccine in mice. There was mild transient swelling and erythema of the injection site in both mice and rabbits. Treatment-related pathology was limited to inflammation at the injection site and accumulation of adjuvant-containing macrophages in the draining lymph nodes. In conclusion, the absence of clinical toxicity in two animal species suggest that the vaccine is safe for use in a phase I human clinical trial. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Human Stem Cell Derived Cardiomyocytes: An Alternative ...

EPA Pesticide Factsheets

Chemical spills and associated deaths in the US has increased 2.6-fold and 16-fold from 1983 to 2012, respectfully. In addition, the number of chemicals to which humans are exposed to in the environment has increased almost 10-fold from 2001 to 2013 within the US. Internationally, a WHO report on the global composite impact of chemicals on health reported that 16% of the total burden of cardiovascular disease was attributed to environmental chemical exposure with 2.5 million deaths per year. Clearly, the cardiovascular system, at all its various developmental and life stages, represents a critical target organ system that can be adversely affected by existing and emerging chemicals (e.g., engineered nanomaterials) in a variety of environmental media. The ability to assess chemical cardiac risk and safety is critically needed but extremely challenging due to the number and categories of chemicals in commerce, as indicated. This presentation\\session will evaluate the use of adult human stem cell derived cardiomyocytes, and existing platforms, as an alternative model to evaluate environmental chemical cardiac toxicity as well as provide key information for the development of predictive adverse outcomes pathways associated with environmental chemical exposures. (This abstract does not represent EPA policy) Rapid and translatable chemical safety screening models for cardiotoxicity current status for informing regulatory decisions, a workshop sponsored by the Society

Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials.

PubMed

Veyrand, Julien; Marin-Kuan, Maricel; Bezencon, Claudine; Frank, Nancy; Guérin, Violaine; Koster, Sander; Latado, Hélia; Mollergues, Julie; Patin, Amaury; Piguet, Dominique; Serrant, Patrick; Varela, Jesus; Schilter, Benoît

2017-10-01

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

Ocean Engineering Studies Compiled 1991. Volume 7. Acrylic Windows- Diverse Design Features and Types of Service

DTIC Science & Technology

1991-01-01

acrylic plastic windows in chambers for human occupancy, the design stress should not exceed 800 psi (i.e., conversion factor of 20). 3. installed...pressure vessels for human occupancy Is 10 yr based on the conserva- tive assumption that in that length of time even stressed acrylic in a tropioal...the Safety Standard for Pressure Ves- sels for Human Oc-upancy (ASME PVHO-1 Safety Standard). Since that time, this ASME Safety Standard has

Assessing post-fire values-at-risk with a new calculation tool

Treesearch

David E. Calkin; Kevin D. Hyde; Peter R. Robichaud; J. Greg Jones; Louise E. Ashmun; Loeffler Dan

2007-01-01

Wildfire effects include loss of vegetative cover and changes to soil properties that may lead to secondary effects of increased runoff, erosion, flooding, sedimentation, and vulnerability to invasive weeds. These secondary effects may threaten human life and safety, cultural and ecological resources, land use, and existing infrastructure. Current Burned Area Emergency...

16 CFR 1700.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053). (3) Dietary supplement means any vitamin and... conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or...

16 CFR § 1700.1 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053). (3) Dietary supplement means any vitamin and... conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or...

16 CFR 1700.1 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053). (3) Dietary supplement means any vitamin and... conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or...

16 CFR 1700.1 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053). (3) Dietary supplement means any vitamin and... conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or...

16 CFR 1700.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053). (3) Dietary supplement means any vitamin and... conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or...

A lipid transfer protein increases the glutathione content and enhances Arabidopsis resistance to a trichothecene mycotoxin

USDA-ARS?s Scientific Manuscript database

Fusarium head blight (FHB) or scab is one of the most important plant diseases worldwide, affecting wheat, barley and other small grains. Trichothecene mycotoxins such as deoxynivalenol (DON) accumulate in the grain, presenting a food safety risk and health hazard to humans and animals. Despite cons...

Safety of High Speed Ground Transportation Systems - Human Factors Phase II: Design and Evaluation of Decision Aids for Control of High-Speed Trains: Experiments and Model

DOT National Transportation Integrated Search

1996-12-01

Although the speed of some guided ground transportation systems continues to : increase, the reaction time and the sensory and information processing : capacities of railroad personnel remain constant. This second report in a : series examining criti...

Sustaining the Human Spirit of the High School Principal Leading for Equity

ERIC Educational Resources Information Center

Richardson, Ryan David

2017-01-01

Shrinking budgets and swelling public accountability characterize public education in the 21st century. Pressures to increase achievement while assuring the emotional and physical safety of all students make the work of the secondary principal daunting. A leader for equity must be a symbolic, visionary, and instructional leader that creates…

Validation Report for the Title IV-C Health Through Science Project, 1979-80.

ERIC Educational Resources Information Center

McLean, James E.; And Others

Three objectives were identified regarding the Health Through Science Project, a comprehensive K-12 health project designed to increase student knowledge and understanding of health topic. Topics composing the core curriculum of the project were nutrition, safety, family living skills, personal hygiene and health, and human reproduction. Upon full…

Avoiding biohazards in medical, veterinary and research laboratories.

PubMed

Grizzle, W E; Fredenburgh, J

2001-07-01

Personnel in medical, veterinary or research laboratories may be exposed to a wide variety of pathogens that range from deadly to debilitating. For some of these pathogens, no treatment is available, and in other cases the treatment does not fully control the disease. It is important that personnel in laboratories that process human or microbiological specimens follow universal precautions when handling tissues, cells, or microbiological specimens owing to the increasing numbers of individuals infected with hepatitis C and HIV in the US and the possibility that an individual may be asymptomatic when a specimen is obtained. Similar precautions must be followed in laboratories that use animal tissues owing to the possibility of exposure to agents that are pathogenic in humans. Personnel with conditions associated with immunosuppression should evaluate carefully whether or not specific laboratory environments put them at increased risk of disease. We offer here some general approaches to identifying biohazards and to minimizing the potential risk of exposure. The issues discussed can be used to develop a general safety program as required by regulatory or accrediting agencies, including the Occupational Safety and Health Administration.

A decade of plant proteomics and mass spectrometry: translation of technical advancements to food security and safety issues.

PubMed

Agrawal, Ganesh Kumar; Sarkar, Abhijit; Righetti, Pier Giorgio; Pedreschi, Romina; Carpentier, Sebastien; Wang, Tai; Barkla, Bronwyn J; Kohli, Ajay; Ndimba, Bongani Kaiser; Bykova, Natalia V; Rampitsch, Christof; Zolla, Lello; Rafudeen, Mohamed Suhail; Cramer, Rainer; Bindschedler, Laurence Veronique; Tsakirpaloglou, Nikolaos; Ndimba, Roya Janeen; Farrant, Jill M; Renaut, Jenny; Job, Dominique; Kikuchi, Shoshi; Rakwal, Randeep

2013-01-01

Tremendous progress in plant proteomics driven by mass spectrometry (MS) techniques has been made since 2000 when few proteomics reports were published and plant proteomics was in its infancy. These achievements include the refinement of existing techniques and the search for new techniques to address food security, safety, and health issues. It is projected that in 2050, the world's population will reach 9-12 billion people demanding a food production increase of 34-70% (FAO, 2009) from today's food production. Provision of food in a sustainable and environmentally committed manner for such a demand without threatening natural resources, requires that agricultural production increases significantly and that postharvest handling and food manufacturing systems become more efficient requiring lower energy expenditure, a decrease in postharvest losses, less waste generation and food with longer shelf life. There is also a need to look for alternative protein sources to animal based (i.e., plant based) to be able to fulfill the increase in protein demands by 2050. Thus, plant biology has a critical role to play as a science capable of addressing such challenges. In this review, we discuss proteomics especially MS, as a platform, being utilized in plant biology research for the past 10 years having the potential to expedite the process of understanding plant biology for human benefits. The increasing application of proteomics technologies in food security, analysis, and safety is emphasized in this review. But, we are aware that no unique approach/technology is capable to address the global food issues. Proteomics-generated information/resources must be integrated and correlated with other omics-based approaches, information, and conventional programs to ensure sufficient food and resources for human development now and in the future. © 2013 Wiley Periodicals, Inc.

More explicit communication after classroom-based crew resource management training: results of a pragmatic trial.

PubMed

Verbeek-van Noord, Inge; de Bruijne, Martine C; Twisk, Jos W R; van Dyck, Cathy; Wagner, Cordula

2015-02-01

Aviation-based crew resource management trainings to optimize non-technical skills among professionals are often suggested for health care as a way to increase patient safety. Our aim was to evaluate the effect of a 2-day classroom-based crew resource management (CRM) training at emergency departments (EDs) on explicit professional oral communication (EPOC; non-technical skills). A pragmatic controlled before-after trial was conducted. Four EDs of general teaching hospitals were recruited (two intervention and two control departments). ED nurses and ED doctors were observed on their non-technical skills by means of a validated observation tool (EPOC). Our main outcome measure was the amount of EPOC observed per interaction in 30 minutes direct observations. Three outcome measures from EPOC were analysed: human interaction, anticipation on environment and an overall EPOC score. Linear and logistic mixed model analyses were performed. Models were corrected for the outcome measurement at baseline, days between training and observation, patient safety culture and error management culture at baseline. A statistically significant increase after the training was found on human interaction (β=0.27, 95% CI 0.08-0.49) and the overall EPOC score (β=0.25, 95% CI 0.06-0.43), but not for anticipation on environment (OR=1.19, 95% CI .45-3.15). This means that approximately 25% more explicit communication was shown after CRM training. We found an increase in the use of CRM skills after classroom-based crew resource management training. This study adds to the body of evidence that CRM trainings have the potential to increase patient safety by reducing communication flaws, which play an important role in health care-related adverse events. © 2014 John Wiley & Sons, Ltd.

Food Safety Hazards and Microbiological Zoonoses in European Meat Imports Detected in Border Inspection in the Period 2008-2013.

PubMed

Jansen, W; Grabowski, N; Gerulat, B; Klein, G

2016-02-01

Microbiological contaminations and other food safety hazards are omnipresent within the European Union (EU) and a considerable risk for consumers, particularly in imported meat and meat products. The number of rejections at external EU borders has been increasing in recent years. Official authorities in each member state are therefore obliged to notify border rejections of food and animal feed due to a direct or indirect risk to human or animal health. This study explored the trends and temporal and spatial distribution of notifications on food safety hazards between January 2008 and December 2013 with a special emphasis on microbiological zoonoses in meat and meat products including poultry at border checks resulting from the rapid alert system for food and feed (RASFF). Results indicated that border rejection notifications are increasing exponentially, frequently due to Salmonella in poultry and shiga-toxin-producing E. coli in meat and meat products. © 2015 Blackwell Verlag GmbH.

The Design of Transportation Equipment in Terms of Human Capabilities. The Role of Engineering Psychology in Transport Safety.

ERIC Educational Resources Information Center

McFarland, Ross A.

Human factors engineering is considered with regard to the design of safety factors for aviation and highway transportation equipment. Current trends and problem areas are identified for jet air transportation and for highway transportation. Suggested solutions to transportation safety problems are developed by applying the techniques of human…

76 FR 62409 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS..., from January 1, 1961 through June 30, 1970, for a number of work days aggregating at least 250 work...

The integration of Human Factors (HF) in the SAR process training course text

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

Ryan, T.G.

1995-03-01

This text provides the technical basis for a two-day course on human factors (HF), as applied to the Safety Analysis Report (SAR) process. The overall objective of this text and course is to: provide the participant with a working knowledge of human factors-related requirements, suggestions for doing a human safety analysis applying a graded approach, and an ability to demonstrate using the results of the human safety analysis, that human factors elements as defined by DOE (human factors engineering, procedures, training, oversight, staffing, qualifications), can support wherever necessary, nuclear safety commitments in the SAR. More specifically, the objectives of themore » text and course are: (1) To provide the SAR preparer with general guidelines for doing HE within the context of a graded approach for the SAR; (2) To sensitize DOE facility managers and staff, safety analysts and SAR preparers, independent reviewers, and DOE reviewers and regulators, to DOE Order 5480.23 requirements for HE in the SAR; (3) To provide managers, analysts, reviewers and regulators with a working knowledge of HE concepts and techniques within the context of a graded approach for the SAR, and (4) To provide SAR managers and DOE reviewers and regulators with general guidelines for monitoring and coordinating the work of preparers of HE inputs throughout the SAR process, and for making decisions regarding the safety relevance of HE inputs to the SAR. As a ready reference for implementing the human factors requirements of DOE Order 5480.22 and DOE Standard 3009-94, this course text and accompanying two-day course are intended for all persons who are involved in the SAR.« less

Management of radioactive waste gases from PET radiopharmaceutical synthesis using cost effective capture systems integrated with a cyclotron safety system.

PubMed

Stimson, D H R; Pringle, A J; Maillet, D; King, A R; Nevin, S T; Venkatachalam, T K; Reutens, D C; Bhalla, R

2016-09-01

The emphasis on the reduction of gaseous radioactive effluent associated with PET radiochemistry laboratories has increased. Various radioactive gas capture strategies have been employed historically including expensive automated compression systems. We have implemented a new cost-effective strategy employing gas capture bags with electronic feedback that are integrated with the cyclotron safety system. Our strategy is suitable for multiple automated 18 F radiosynthesis modules and individual automated 11 C radiosynthesis modules. We describe novel gas capture systems that minimize the risk of human error and are routinely used in our facility.

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

Human factors in airport surface incidents : an analysis of pilot reports submitted to the Aviation Safety Reporting System (ASRS)

DOT National Transportation Integrated Search

2006-12-01

The purpose of this study was to examine human factors involved in airport surface incidents as reported by pilots. Reports submitted to the : Aviation Safety Reporting System (ASRS) are a good source of information regarding the human performance is...

Flat H Frangible Joint Evolution

NASA Technical Reports Server (NTRS)

Diegelman, Thomas E.; Hinkel, Todd J.; Benjamin, Andrew; Rochon, Brian V.; Brown, Christopher W.

2016-01-01

Space vehicle staging and separation events require pyrotechnic devices. They are single-use mechanisms that cannot be tested, nor can failure-tolerant performance be demonstrated in actual flight articles prior to flight use. This necessitates the implementation of a robust design and test approach coupled with a fully redundant, failure-tolerant explosive mechanism to ensure that the system functions even in the event of a single failure. Historically, NASA has followed the single failure-tolerant (SFT) design philosophy for all human-rated spacecraft, including the Space Shuttle Program. Following the end of this program, aerospace companies proposed building the next generation human-rated vehicles with off-the-shelf, non-redundant, zero-failure-tolerant (ZFT) separation systems. Currently, spacecraft and launch vehicle providers for both the Orion and Commercial Crew Programs (CCPs) plan to deviate from the heritage safety approach and NASA's SFT human rating requirements. Both programs' partners have base-lined ZFT frangible joints for vehicle staging and fairing separation. These joints are commercially available from pyrotechnic vendors. Non-human-rated missions have flown them numerous times. The joints are relatively easy to integrate structurally within the spacecraft. In addition, the separation event is debris free, and the resultant pyro shock is lower than that of other design solutions. It is, however, a serious deficiency to lack failure tolerance. When used for critical applications on human-rated vehicles, a single failure could potentially lead to loss of crew (LOC) or loss of mission (LOM)). The Engineering and Safety & Mission Assurance directorates within the NASA Johnson Space Center took action to address this safety issue by initiating a project to develop a fully redundant, SFT frangible joint design, known as the Flat H. Critical to the ability to retrofit on launch vehicles being developed, the SFT mechanisms must fit within the same three-dimensional envelope as current designs as well as meet structural loads requirements. There is increased mass associated with the redundant design, and the goal is to minimize the weight impact as much as possible. These requirements presented significant challenges, both technically and financially; these challenges will be explored in this paper. Perhaps greater than the technical issues confronted during this design process, were the financial considerations. These were a significant part of the story of this design and development plan. Insufficient financial and labor resources were formidable barriers to completing this project. Nevertheless, JSC personnel successfully conducted several test series at JSC with very useful results. The many lessons learned drove design improvements, performance efficiency, and increased functional reliability. This paper examines the significant technical and financial challenges that these requirements posed to the project team. It discusses the evolution of the SFT frangible joint design, including optimization, testing, and successful partnering of the Johnson Space Center (JSC) engineering and JSC safety organizations, to enhance the flight safety margin for America's next generation of human-rated space vehicles.

The interface between veterinary and human antibiotic use.

PubMed

Shryock, Thomas R; Richwine, Amy

2010-12-01

The identification and early development of novel antimicrobial agents for use in veterinary medicine is subject to many of the same business and technical challenges as those found in antimicrobial agent use for human infectious disease. However, as awareness that some of the antimicrobial classes used in veterinary medicine are the same as used in human medicine, concern by multiple stakeholders has increased that this nonhuman use might be contributing to the problem of antimicrobial resistance to pathogens in humans, particularly with regard to food-borne diseases, such as salmonellosis and campylobacteriosis. Consequently, the interface between veterinary and human antibiotic use and resistance, especially with respect to human microbial food safety, has begun to redirect the industry pipeline of novel antimicrobial agents to be commercialized for use in veterinary medicine.

[Preclinical evaluation of the safety of biotechnology products: specific aspects].

PubMed

Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

2003-01-01

Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.

A research model--forecasting incident rates from optimized safety program intervention strategies.

PubMed

Iyer, P S; Haight, J M; Del Castillo, E; Tink, B W; Hawkins, P W

2005-01-01

INTRODUCTION/PROBLEM: Property damage incidents, workplace injuries, and safety programs designed to prevent them, are expensive aspects of doing business in contemporary industry. The National Safety Council (2002) estimated that workplace injuries cost $146.6 billion per year. Because companies are resource limited, optimizing intervention strategies to decrease incidents with less costly programs can contribute to improved productivity. Systematic data collection methods were employed and the forecasting ability of a time-lag relationship between interventions and incident rates was studied using various statistical methods (an intervention is not expected to have an immediate nor infinitely lasting effect on the incident rate). As a follow up to the initial work, researchers developed two models designed to forecast incident rates. One is based on past incident rate performance and the other on the configuration and level of effort applied to the safety and health program. Researchers compared actual incident performance to the prediction capability of each model over 18 months in the forestry operations at an electricity distribution company and found the models to allow accurate prediction of incident rates. These models potentially have powerful implications as a business-planning tool for human resource allocation and for designing an optimized safety and health intervention program to minimize incidents. Depending on the mathematical relationship, one can determine what interventions, where and how much to apply them, and when to increase or reduce human resource input as determined by the forecasted performance.

Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV‐1106, a Long‐Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects

PubMed Central

Barkay, Hadas; Rasamoelisolo, Michele; Butler, Kathleen; Yamada, Kazumasa; Bassan, Merav; Yoon, Esther; Spiegelstein, Ofer

2016-01-01

Abstract TV‐1106 is a human serum albumin genetically fused to recombinant human growth hormone, designed to provide a long‐acting alternative to daily growth hormone (GH) injections in patients with GH deficiency. This study investigated the pharmacokinetics, pharmacodynamics, and safety of single subcutaneous doses of TV‐1106 (7.5, 15, 50, and 100 mg) in Japanese (n = 44) and caucasian (n = 44) healthy subjects. TV‐1106 pharmacokinetics and pharmacodynamics were comparable in Japanese and caucasian populations. TV‐1106 demonstrated relatively slow absorption (median tmax, 10–30 hours) and a mean elimination half‐life of 26–36 hours. Apparent clearance and volume of distribution decreased with increasing TV‐1106 doses in both populations and appeared to increase more than dose proportionality across the tested doses. Insulin‐like growth factor‐1 (IGF‐1) and IGF binding protein‐3 (IGFBP‐3) increased in a dose‐related manner, with maximum responses observed at 33–96 and 42–109 hours, respectively. IGF‐1 and IGFBP‐3 returned to baseline values at 168 hours following 7.5 and 15 mg of TV‐1106, and 336 hours following 50 and 100 mg of TV‐1106. TV‐1106 appeared safe in both populations. There was no evidence of differences in pharmacokinetics, pharmacodynamics, or safety of TV‐1106 between Japanese and caucasian populations. The data also demonstrate long‐acting growth hormone properties of TV‐1106 and support its potential for once‐weekly dosing. PMID:27489211

Integrated Safety Assessment of 2′-O-Methoxyethyl Chimeric Antisense Oligonucleotides in NonHuman Primates and Healthy Human Volunteers

PubMed Central

Crooke, Stanley T; Baker, Brenda F; Kwoh, T Jesse; Cheng, Wei; Schulz, Dan J; Xia, Shuting; Salgado, Nelson; Bui, Huynh-Hoa; Hart, Christopher E; Burel, Sebastien A; Younis, Husam S; Geary, Richard S; Henry, Scott P; Bhanot, Sanjay

2016-01-01

The common chemical and biological properties of antisense oligonucleotides provide the opportunity to identify and characterize chemical class effects across species. The chemical class that has proven to be the most versatile and best characterized is the 2′-O-methoxyethyl chimeric antisense oligonucleotides. In this report we present an integrated safety assessment of data obtained from controlled dose-ranging studies in nonhuman primates (macaques) and healthy human volunteers for 12 unique 2′-O-methoxyethyl chimeric antisense oligonucleotides. Safety was assessed by the incidence of safety signals in standardized laboratory tests for kidney and liver function, hematology, and complement activation; as well as by the mean test results as a function of dose level over time. At high doses a number of toxicities were observed in nonhuman primates. However, no class safety effects were identified in healthy human volunteers from this integrated data analysis. Effects on complement in nonhuman primates were not observed in humans. Nonhuman primates predicted safe doses in humans, but over predicted risk of complement activation and effects on platelets. Although limited to a single chemical class, comparisons from this analysis are considered valid and accurate based on the carefully controlled setting for the specified study populations and within the total exposures studied. PMID:27357629

Children and Youth Camp Safety Act, 1978. Hearing Before the Subcommittee on Child and Human Development of the Committee on Human Resources, United States Senate, 95th Congress, 2nd Session on S. 258--To Provide for the Development and Implementation of Programs for Children and Youth Camp Safety (March 21, 1978).

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. Senate Committee on Human Resources.

The product of some 10 years of work directed toward federal legislation addressing and defining youth camp safety, the Youth Camp Safety Act (S. 258), as presented in these hearings, calls for the federal government to assume a role in the development of state health and safety standards for children attending youth camps in any state in the…

Power Goals for NASA's Exploration Program

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith A.

2009-01-01

Exciting Future Programs ahead for NASA. Power is needed for all Exploration vehicles and for the missions. For long term missions as in Lunar and Mars programs, safe, high energy/ultra high energy batteries are required. Safety is top priority for human-rated missions. Two-fault tolerance to catastrophic failures is required for human-rated safety To meet power safety goals -inherent cell safety may be required; it can lessen complexity of external protective electronics and prevents dependency on hardware that may also have limitations. Inherent cell safety will eliminate the need to carry out screening of all cells (X-rays, vibration, etc.)

Human Papillomavirus (HPV)

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 ...

NASA human factors programmatic overview

NASA Technical Reports Server (NTRS)

Connors, Mary M.

1992-01-01

Human factors addresses humans in their active and interactive capacities, i.e., in the mental and physical activities that they perform and in the contributions they make to achieving the goals of the mission. The overall goal of space human factors in NASA is to support the safety, productivity, and reliability of both the on-board crew and the ground support staff. Safety and reliability are fundamental requirements that human factors shares with other disciplines, while productivity represents the defining contribution of the human factors discipline.

A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional

PubMed Central

Karsh, B‐T; Holden, R J; Alper, S J; Or, C K L

2006-01-01

The goal of improving patient safety has led to a number of paradigms for directing improvement efforts. The main paradigms to date have focused on reducing injuries, reducing errors, or improving evidence based practice. In this paper a human factors engineering paradigm is proposed that focuses on designing systems to improve the performance of healthcare professionals and to reduce hazards. Both goals are necessary, but neither is sufficient to improve safety. We suggest that the road to patient and employee safety runs through the healthcare professional who delivers care. To that end, several arguments are provided to show that designing healthcare delivery systems to support healthcare professional performance and hazard reduction should yield significant patient safety benefits. The concepts of human performance and hazard reduction are explained. PMID:17142611

77 FR 40622 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH..., oxygen supply partnership, safety culture, occupational health and safety management systems, preventing...

Effects of an Advanced Reactor’s Design, Use of Automation, and Mission on Human Operators

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

Jeffrey C. Joe; Johanna H. Oxstrand

The roles, functions, and tasks of the human operator in existing light water nuclear power plants (NPPs) are based on sound nuclear and human factors engineering (HFE) principles, are well defined by the plant’s conduct of operations, and have been validated by years of operating experience. However, advanced NPPs whose engineering designs differ from existing light-water reactors (LWRs) will impose changes on the roles, functions, and tasks of the human operators. The plans to increase the use of automation, reduce staffing levels, and add to the mission of these advanced NPPs will also affect the operator’s roles, functions, and tasks.more » We assert that these factors, which do not appear to have received a lot of attention by the design engineers of advanced NPPs relative to the attention given to conceptual design of these reactors, can have significant risk implications for the operators and overall plant safety if not mitigated appropriately. This paper presents a high-level analysis of a specific advanced NPP and how its engineered design, its plan to use greater levels of automation, and its expanded mission have risk significant implications on operator performance and overall plant safety.« less

Evaluation of helper-dependent canine adenovirus vectors in a 3D human CNS model

PubMed Central

Simão, Daniel; Pinto, Catarina; Fernandes, Paulo; Peddie, Christopher J.; Piersanti, Stefania; Collinson, Lucy M.; Salinas, Sara; Saggio, Isabella; Schiavo, Giampietro; Kremer, Eric J.; Brito, Catarina; Alves, Paula M.

2017-01-01

Gene therapy is a promising approach with enormous potential for treatment of neurodegenerative disorders. Viral vectors derived from canine adenovirus type 2 (CAV-2) present attractive features for gene delivery strategies in the human brain, by preferentially transducing neurons, are capable of efficient axonal transport to afferent brain structures, have a 30-kb cloning capacity and have low innate and induced immunogenicity in pre-clinical tests. For clinical translation, in-depth pre-clinical evaluation of efficacy and safety in a human setting is primordial. Stem cell-derived human neural cells have a great potential as complementary tools by bridging the gap between animal models, which often diverge considerably from human phenotype, and clinical trials. Herein, we explore helper-dependent CAV-2 (hd-CAV-2) efficacy and safety for gene delivery in a human stem cell-derived 3D neural in vitro model. Assessment of hd-CAV-2 vector efficacy was performed at different multiplicities of infection, by evaluating transgene expression and impact on cell viability, ultrastructural cellular organization and neuronal gene expression. Under optimized conditions, hd-CAV-2 transduction led to stable long-term transgene expression with minimal toxicity. hd-CAV-2 preferentially transduced neurons, while human adenovirus type 5 (HAdV5) showed increased tropism towards glial cells. This work demonstrates, in a physiologically relevant 3D model, that hd-CAV-2 vectors are efficient tools for gene delivery to human neurons, with stable long-term transgene expression and minimal cytotoxicity. PMID:26181626

Evaluation of helper-dependent canine adenovirus vectors in a 3D human CNS model.

PubMed

Simão, D; Pinto, C; Fernandes, P; Peddie, C J; Piersanti, S; Collinson, L M; Salinas, S; Saggio, I; Schiavo, G; Kremer, E J; Brito, C; Alves, P M

2016-01-01

Gene therapy is a promising approach with enormous potential for treatment of neurodegenerative disorders. Viral vectors derived from canine adenovirus type 2 (CAV-2) present attractive features for gene delivery strategies in the human brain, by preferentially transducing neurons, are capable of efficient axonal transport to afferent brain structures, have a 30-kb cloning capacity and have low innate and induced immunogenicity in preclinical tests. For clinical translation, in-depth preclinical evaluation of efficacy and safety in a human setting is primordial. Stem cell-derived human neural cells have a great potential as complementary tools by bridging the gap between animal models, which often diverge considerably from human phenotype, and clinical trials. Herein, we explore helper-dependent CAV-2 (hd-CAV-2) efficacy and safety for gene delivery in a human stem cell-derived 3D neural in vitro model. Assessment of hd-CAV-2 vector efficacy was performed at different multiplicities of infection, by evaluating transgene expression and impact on cell viability, ultrastructural cellular organization and neuronal gene expression. Under optimized conditions, hd-CAV-2 transduction led to stable long-term transgene expression with minimal toxicity. hd-CAV-2 preferentially transduced neurons, whereas human adenovirus type 5 (HAdV5) showed increased tropism toward glial cells. This work demonstrates, in a physiologically relevant 3D model, that hd-CAV-2 vectors are efficient tools for gene delivery to human neurons, with stable long-term transgene expression and minimal cytotoxicity.

Principles and Guidelines for Duty and Rest Scheduling in Commercial Aviation

NASA Technical Reports Server (NTRS)

Dinges, David F.; Graeber, R. Curtis; Rosekind, Mark R.; Samel, Alexander

1996-01-01

The aviation industry requires 24-hour activities to meet operational demands. Growth in global long-haul, regional, overnight cargo, and short-haul domestic operations will continue to increase these round-the-clock requirements. Flight crews must be available to support 24-hour-a-day operations to meet these industry demands. Both domestic and international aviation can also require crossing multiple time zones. Therefore, shift work, night work, irregular work schedules, unpredictable work schedules, and dm zone changes will continue to be commonplace components of the aviation industry. These factors pose known challenges to human physiology, and because they result in performance-impairing fatigue, they pose a risk to safety. It is critical to acknowledge and, whenever possible, incorporate scientific information on fatigue, human sleep, and circadian physiology into 24-hour aviation operations. Utilization of such scientific information can help promote crew performance and alertness during flight operations and thereby maintain and improve the safety margin.

Safety of oral sulfates in rats and dogs contrasted with phosphate-induced nephropathy in rats.

PubMed

Pelham, Russell W; Russell, Robert G; Padgett, Eric L; Reno, Frederick E; Cleveland, Mark vB

2009-01-01

An oral sulfate salt solution (OSS), under development as a bowel cleansing agent for colonoscopy in humans, is studied in rats and dogs. In rats, amaximumpractical oral OSS dose (5 g/kg/d) is compared with an oral sodium phosphate (OSP) solution, both at about 7 times the clinical dose. OSS induces the intended effects of loose stools and diarrhea. In rats, higher urine sodium and potassium accompany higher clearance rates, considered adaptive to the osmotic load of OSS. OSS for 28 days is well tolerated in rats and dogs. In contrast, OSP causes increased mortality, reduced body weight and food consumption, severe kidney tubular degeneration, and calcium phosphate deposition in rats. These are accompanied by mineralization in the stomach and aorta, along with cardiac and hepatic degeneration and necrosis. The greater safety margin of OSS over OSP at similarmultiples of the clinical dose indicates its suitability for human use.

76 FR 65734 - Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0733] Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant.... Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Blood...

78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office... Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory...

Food Safety

Science.gov Websites

veggies? Federal Pesticide Regulation Pesticides and Human Health Regulating Organic Food Production fruit and veggies? Federal Pesticide Regulation Pesticides and Human Health Regulating Organic Food ; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

75 FR 69912 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... 192 and 195 [Docket ID PHMSA-2007-27954] RIN 2137-AE64 Pipeline Safety: Control Room Management/Human... rulemaking; Extension of comment period. SUMMARY: On September 17, 2010, PHMSA published a Control Room... Control Room Management/Human Factors rule at 49 CFR 192.631 and 195.446. The NPRM proposes to expedite...

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...

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

U.S. Rep. Pete Olson, R-Texas, speaks during a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

Dr. Joseph R. Fragola, Vice President, Valador, Inc., testifies during a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

75 FR 34365 - Safety Zone, Alligator River, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... interest, since immediate action is needed to ensure the safety of human life and property from the hazards... do not individually or cumulatively have a significant effect on the human environment. This rule is...

On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products.

PubMed

Varshney, Kush R; Alemzadeh, Homa

2017-09-01

Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this article, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. We discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

[Risk and risk management in aviation].

PubMed

Müller, Manfred

2004-10-01

RISK MANAGEMENT: The large proportion of human errors in aviation accidents suggested the solution--at first sight brilliant--to replace the fallible human being by an "infallible" digitally-operating computer. However, even after the introduction of the so-called HITEC-airplanes, the factor human error still accounts for 75% of all accidents. Thus, if the computer is ruled out as the ultimate safety system, how else can complex operations involving quick and difficult decisions be controlled? OPTIMIZED TEAM INTERACTION/PARALLEL CONNECTION OF THOUGHT MACHINES: Since a single person is always "highly error-prone", support and control have to be guaranteed by a second person. The independent work of mind results in a safety network that more efficiently cushions human errors. NON-PUNITIVE ERROR MANAGEMENT: To be able to tackle the actual problems, the open discussion of intervened errors must not be endangered by the threat of punishment. It has been shown in the past that progress is primarily achieved by investigating and following up mistakes, failures and catastrophes shortly after they happened. HUMAN FACTOR RESEARCH PROJECT: A comprehensive survey showed the following result: By far the most frequent safety-critical situation (37.8% of all events) consists of the following combination of risk factors: 1. A complication develops. 2. In this situation of increased stress a human error occurs. 3. The negative effects of the error cannot be corrected or eased because there are deficiencies in team interaction on the flight deck. This means, for example, that a negative social climate has the effect of a "turbocharger" when a human error occurs. It needs to be pointed out that a negative social climate is not identical with a dispute. In many cases the working climate is burdened without the responsible person even noticing it: A first negative impression, too much or too little respect, contempt, misunderstandings, not expressing unclear concern, etc. can considerably reduce the efficiency of a team.

Risks of carcinogenesis from electromagnetic radiation of mobile telephony devices.

PubMed

Yakymenko, I; Sidorik, E

2010-07-01

Intensive implementation of mobile telephony technology in everyday human life during last two decades has given a possibility for epidemiological estimation of long-term effects of chronic exposure of human organism to low-intensive microwave (MW) radiation. Latest epidemiological data reveal a significant increase in risk of development of some types of tumors in chronic (over 10 years) users of mobile phone. It was detected a significant increase in incidence of brain tumors (glioma, acoustic neuroma, meningioma), parotid gland tumor, seminoma in long-term users of mobile phone, especially in cases of ipsilateral use (case-control odds ratios from 1.3 up to 6.1). Two epidemiological studies have indicated a significant increase of cancer incidence in people living close to the mobile telephony base station as compared with the population from distant area. These data raise a question of adequacy of modern safety limits of electromagnetic radiation (EMR) exposure for humans. For today the limits were based solely on the conception of thermal mechanism of biological effects of RF/MW radiation. Meantime the latest experimental data indicate the significant metabolic changes in living cell under the low-intensive (non-thermal) EMR exposure. Among reproducible biological effects of low-intensive MWs are reactive oxygen species overproduction, heat shock proteins expression, DNA damages, apoptosis. The lack of generally accepted mechanism of biological effects of low-intensive non-ionizing radiation doesn't permit to disregard the obvious epidemiological and experimental data of its biological activity. Practical steps must be done for reasonable limitation of excessive EMR exposure, along with the implementation of new safety limits of mobile telephony devices radiation, and new technological decisions, which would take out the source of radiation from human brain.

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.

Model-based analysis of thromboxane B{sub 2} and prostaglandin E{sub 2} as biomarkers in the safety evaluation of naproxen

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

Sahota, Tarjinder; Sanderson, Ian; Danhof, Meindert

The assessment of safety in traditional toxicology protocols relies on evidence arising from observed adverse events (AEs) in animals and on establishing their correlation with different measures of drug exposure (e.g., C{sub max} and AUC). Such correlations, however, ignore the role of biomarkers, which can provide further insight into the underlying pharmacological mechanisms. Here we use naproxen as a paradigm drug to explore the feasibility of a biomarker-guided approach for the prediction of AEs in humans. A standard toxicology protocol was set up for the evaluation of effects of naproxen in rat, in which four doses were tested (7.5, 15,more » 40 and 80 mg/kg). In addition to sparse blood sampling for the assessment of exposure, thromboxane B{sub 2} and prostaglandin E{sub 2} were also collected in satellite groups. Nonlinear mixed effects modelling was used to evaluate the predictive performance of the approach. A one-compartmental model with first order absorption was found to best describe the pharmacokinetics of naproxen. A nonlinear relationship between dose and bioavailability was observed which leads to a less than proportional increase in naproxen concentrations with increasing doses. The pharmacodynamics of TXB{sub 2} and PGE{sub 2} was described by direct inhibition models with maximum pharmacological effects achieved at doses > 7.5 mg/kg. The predicted PKPD relationship in humans was within 10-fold of the values previously published. Moreover, our results indicate that biomarkers can be used to assess interspecies differences in PKPD and extrapolated data from animals to humans. Biomarker sampling should be used systematically in general toxicity studies. - Highlights: • Prediction of a drug's safety profile from preclinical protocols remains challenging. • Pharmacokinetic measures of safe exposure (e.g., AUC) ignore the role of biomarkers. • PKPD relationships enable the evaluation of adverse events in a mechanistic manner. • Major differences exist between rats and humans in the effects of naproxen on TXB{sub 2}. • A biomarker-guided approach may facilitate the prediction of adverse events in humans.« less

Flexible Control of Safety Margins for Action Based on Environmental Variability.

PubMed

Hadjiosif, Alkis M; Smith, Maurice A

2015-06-17

To reduce the risk of slip, grip force (GF) control includes a safety margin above the force level ordinarily sufficient for the expected load force (LF) dynamics. The current view is that this safety margin is based on the expected LF dynamics, amounting to a static safety factor like that often used in engineering design. More efficient control could be achieved, however, if the motor system reduces the safety margin when LF variability is low and increases it when this variability is high. Here we show that this is indeed the case by demonstrating that the human motor system sizes the GF safety margin in proportion to an internal estimate of LF variability to maintain a fixed statistical confidence against slip. In contrast to current models of GF control that neglect the variability of LF dynamics, we demonstrate that GF is threefold more sensitive to the SD than the expected value of LF dynamics, in line with the maintenance of a 3-sigma confidence level. We then show that a computational model of GF control that includes a variability-driven safety margin predicts highly asymmetric GF adaptation between increases versus decreases in load. We find clear experimental evidence for this asymmetry and show that it explains previously reported differences in how rapidly GFs and manipulatory forces adapt. This model further predicts bizarre nonmonotonic shapes for GF learning curves, which are faithfully borne out in our experimental data. Our findings establish a new role for environmental variability in the control of action. Copyright © 2015 the authors 0270-6474/15/359106-16$15.00/0.

Immunological effects of ayahuasca in humans.

PubMed

dos Santos, Rafael Guimarães

2014-01-01

Ayahuasca is a botanical hallucinogen traditionally used by indigenous groups of the northwest Amazon. In the last decade, the use of ayahuasca has spread from Brazil, Colombia, Ecuador, and Peru to the U.S., Europe, Asia, and Africa. Despite acute and long-term evidence of good tolerability and safety for ayahuasca administered in the laboratory or ritually consumed in religious contexts, little is known about the immunological impact of ayahuasca on humans. Since ayahuasca is used by an increasing number of consumers, and considering its therapeutic potential, more information is needed regarding ayahuasca potential risks. This article presents a brief overview of the available data regarding the immunological impact of ayahuasca in humans.

Human Factors Science: Brief History and Applications to Healthcare.

PubMed

Parker, Sarah Henrickson

2015-12-01

This section will define the science of human factors, its origins, its impact on safety in other domains, and its impact and potential for impact on patient safety. Copyright © 2015 Mosby, Inc. All rights reserved.

Worldwide Emerging Environmental Issues Affecting the U.S. Military. July 2006 - December 2006

DTIC Science & Technology

2006-12-01

and Biological Safety Eleventh Chemical Weapons Convention Better International Controls Needed to Prevent Bioterrorism Human Biomonitoring for...Environmental Cooperation to Increase Enforcement of Environmental Regulations and Public Participation Sixth Review Conference of the Biological Weapons ...scanning reports.] [September 2006. Military Implications, Sources] Chemical and Biological Safey Eleventh Chemical Weapons Convention The 11th

Prevalence of E. coli, Salmonella spp. and L. monocytogenes in non-traditional irrigation waters in the Mid-Atlantic U.S.: a conserve project

USDA-ARS?s Scientific Manuscript database

Introduction: Surface and non-traditional irrigation water (SNIW) sources can increase the irrigation water supplies without consuming potable water. However, these sources must be evaluated for enteric pathogens that could adulterate crops intended for human consumption and comply with Food Safety ...

Multi-component biocide protects wood from fungi and insects in UC2 applications

Treesearch

Carol A. Clausen; Vina W. Yang

2007-01-01

Development of synergistic biocides to protect wood in interior applications has been of particular interest since the recent increase of indoor mold infestations. Many products have been developed to address the recent influx of indoor mold infestations. Researchers must emphasize the use of environmentally benign chemicals due to the need for safety of human...

Flammability tests for regulation of building and construction materials

Treesearch

K. Sumathipala

2006-01-01

The regulation of building materials and products for flammability is critical to ensure the safety of occupants in buildings and other structures. The involvement of exposed building materials and products in fires resulting in the loss of human life often spurs an increase in regulation and new test methods to address the problem. Flammability tests range from those...

The use of adverse outcome pathway-based toxicity predictions: A case study evaluating the effects of imazalil on fathead minnow reproduction

EPA Science Inventory

Product Description: As a means to increase the efficiency of chemical safety assessment, there is an interest in using data from molecular and cellular bioassays, conducted in a highly automated fashion using modern robotics, to predict toxicity in humans and wildlife. The prese...

The Transition From Event Reports to Measurable Organizational Impact: Workshop Proceedings Report

DTIC Science & Technology

2014-03-01

Airlines Colin Drury - - - - - - - - - - - - - Applied Ergonomics Douglas Farrow - - - - - - - - - - - - - - - FAA AFS-280 Terry Gober... cost , at their Seattle location. Also, Boeing supports presentations regarding MEDA at international conferences, which greatly increased the number...approach to a true safety culture involves human factors and error management training that includes management; a Just Policy and accountability , an

Numerical human models for accident research and safety - potentials and limitations.

PubMed

Praxl, Norbert; Adamec, Jiri; Muggenthaler, Holger; von Merten, Katja

2008-01-01

The method of numerical simulation is frequently used in the area of automotive safety. Recently, numerical models of the human body have been developed for the numerical simulation of occupants. Different approaches in modelling the human body have been used: the finite-element and the multibody technique. Numerical human models representing the two modelling approaches are introduced and the potentials and limitations of these models are discussed.

Pigs in Toxicology: Breed Differences in Metabolism and Background Findings.

PubMed

Helke, Kristi L; Nelson, Keith N; Sargeant, Aaron M; Jacob, Binod; McKeag, Sean; Haruna, Julius; Vemireddi, Vimala; Greeley, Melanie; Brocksmith, Derek; Navratil, Nicole; Stricker-Krongrad, Alain; Hollinger, Charlotte

2016-06-01

Both a rodent and a nonrodent species are required for evaluation in nonclinical safety studies conducted to support human clinical trials. Historically, dogs and nonhuman primates have been the nonrodent species of choice. Swine, especially the miniature swine or minipigs, are increasingly being used in preclinical safety as an alternate nonrodent species. The pig is an appropriate option for these toxicology studies based on metabolic pathways utilized in xenobiotic biotransformation. Both similarities and differences exist in phase I and phase II biotransformation pathways between humans and pigs. There are numerous breeds of pigs, yet only a few of these breeds are characterized with regard to both xenobiotic-metabolizing enzymes and background pathology findings. Some specific differences in these enzymes based on breed and sex are known. Although swine have been used extensively in biomedical research, there is also a paucity of information in the current literature detailing the incidence of background lesions and differences between commonly used breeds. Here, the xenobiotic-metabolizing enzymes are compared between humans and pigs, and minipig background pathology changes are reviewed with emphasis on breed differences. © The Author(s) 2016.

On an efficient and effective intelligent transportation system (ITS) safety and traffic efficiency application with corresponding driver behavior

NASA Astrophysics Data System (ADS)

Ekedebe, Nnanna; Yu, Wei; Lu, Chao

2015-06-01

Driver distraction could result in safety compromises attributable to distractions from in-vehicle equipment usage [1]. The effective design of driver-vehicle interfaces (DVIs) and other human-machine interfaces (HMIs) together with their usability, and accessibility while driving become important [2]. Driving distractions can be classified as: visual distractions (any activity that takes your eyes away from the road), cognitive distraction (any activity that takes your mind away from the course of driving), and manual distractions (any activity that takes your hands away from the steering wheel [2]). Besides, multitasking during driving is a distractive activity that can increase the risks of vehicular accidents. To study the driver's behaviors on the safety of transportation system, using an in-vehicle driver notification application, we examined the effects of increasing driver distraction levels on the evaluation metrics of traffic efficiency and safety by using two types of driver models: young drivers (ages 16-25 years) and middle-age drivers (ages 30-45 years). Our evaluation data demonstrates that as a drivers distraction level is increased, less heed is given to change route directives from the in-vehicle on-board unit (OBU) using textual, visual, audio, and haptic notifications. Interestingly, middle-age drivers proved more effective/resilient in mitigating the negative effects of driver distraction over young drivers [2].

75 FR 3471 - International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...

77 FR 47662 - Proposed Supplementary Rules for Public Lands Within the Lower Lake Creek Special Recreation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

... certain recreational activities on certain public lands to protect natural resources and human health and... resources and the environment and provide for human health and safety. Therefore, the BLM has determined... resources and the environment and human health and safety. Therefore, the BLM is not required to prepare a...

Spacecraft and propulsion technician error

NASA Astrophysics Data System (ADS)

Schultz, Daniel Clyde

Commercial aviation and commercial space similarly launch, fly, and land passenger vehicles. Unlike aviation, the U.S. government has not established maintenance policies for commercial space. This study conducted a mixed methods review of 610 U.S. space launches from 1984 through 2011, which included 31 failures. An analysis of the failure causal factors showed that human error accounted for 76% of those failures, which included workmanship error accounting for 29% of the failures. With the imminent future of commercial space travel, the increased potential for the loss of human life demands that changes be made to the standardized procedures, training, and certification to reduce human error and failure rates. Several recommendations were made by this study to the FAA's Office of Commercial Space Transportation, space launch vehicle operators, and maintenance technician schools in an effort to increase the safety of the space transportation passengers.

Human papilloma virus vaccination: perceptions of young Korean women.

PubMed

Kang, Hee Sun; Shin, Hyunsook; Hyun, Myung-Sun; Kim, Mi Ja

2010-09-01

This paper is a report of a descriptive study of young Korean women's perceptions of use of the human papilloma virus vaccine. In Korea, cervical cancer is one of the leading cancers in women, and the rate of human papilloma virus infection is increasing. A national media campaign has recently begun to promote human papilloma virus vaccination. However, research addressing the acceptability of this vaccine to women in Korea has been limited. Twenty-five Korean women, 21-30 years of age, participated in seven focus groups. The data were collected in 2007. Participants were concerned about the potential harmful effects of the human papilloma virus vaccine, a possible increase in unsafe sexual behaviours, and the high cost of the vaccine, which is not covered by health insurance. They suggested group vaccination at-cost or free of charge. They discussed ambivalence about the vaccination, the need for more information about the vaccine, and questions about its effectiveness. Most preferred to wait until more people have been vaccinated. There is a need for more aggressive dissemination of information about the safety and efficacy of the human papilloma virus vaccine. More reasonable cost, insurance coverage, or free vaccination using a group approach might increase young Korean women's acceptance and use of the human papilloma virus vaccine.

The health abnormalities under the technogenic exposures risks analysis

NASA Astrophysics Data System (ADS)

Fedorova, E. V.; Malyshev, V. S.; Borovkova, A. M.

2017-11-01

A number of the medico-ecological orientation subjects are included in the curricula of the masters being trained in the teaching course 13.04.02 “Power industry and electrical equipment” and had elected the courses “Anthropogenic safety in power industry and electrical equipment” of the engineering ecology and labor safety department (EE and LS) of NRU “MPEI”. The anthropogenic safety specialist is to know all consequences suffers of such disciplines on account of the human person being influenced with the anthropogenic stress firstly. Energetic is to be obviously foreground in the environment pollution. Carbon, sulfurs, nitrogen oxides, heavy metals compounds, soot particles, benzapiren are arrived to the atmospheric air. The receipt of the harmful substances with an inhaled air leads to the respiratory organs pathology, organism adaptation properties tension and the population morbidity increase. The discipline “The Human physiology” developed on EE and LS chair and being taught of the first course of a magistracy first semester, helps to understand these above-mentioned processes. The general questions of human physiology being besides, all the students are gotten acquainted with ecological and production factors on a human body adverse impacts consequences and with the methods of its analysis, prevention and health risks studies. The most part of a course is presented with the practical trainings permitting the students to gain the basic skills of an organism functional condition main systems for analysis. The innovative “bronkhofonografiya” technique (with the CDC applications “Pattern-1” EE and LS chairs developed) is used for the respiratory organs conditions analysis along with the traditional spirometry methods.

The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes.

PubMed

Schiborr, Christina; Kocher, Alexa; Behnam, Dariush; Jandasek, Josef; Toelstede, Simone; Frank, Jan

2014-03-01

Curcumin revealed various health-beneficial properties in numerous studies. However its bioavailability is low due to its limited intestinal uptake and rapid metabolism. The aim of our project was to develop novel curcumin formulations with improved oral bioavailability and to study their safety as well as potential sex-differences. In this crossover study, healthy subjects (13 women, 10 men) took, in random order, a single oral dose of 500 mg curcuminoids as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected for 24 h and total curcuminoids and safety parameters were quantified. Based on the area under the plasma concentration-time curve (AUC), the micronized curcumin was 14-, 5-, and 9-fold and micellar curcumin 277-, 114-, and 185-fold better bioavailable than native curcumin in women, men, and all subjects, respectively. Thus, women absorbed curcumin more efficiently than men. All safety parameters remained within the reference ranges following the consumption of all formulations. Both, the micronized powder and in particular the liquid micellar formulation of curcumin significantly improved its oral bioavailability without altering safety parameters and may thus be ideally suited to deliver curcumin in human intervention trials. The observed sex differences in curcumin absorption warrant further investigation. © 2014 The Authors. Molecular Nutrition & Food Research published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Development of β-lactoglobulin-specific chimeric human IgEκ monoclonal antibodies for in vitro safety assessment of whey hydrolysates.

PubMed

Knipping, Karen; Simons, Peter J; Buelens-Sleumer, Laura S; Cox, Linda; den Hartog, Marcel; de Jong, Niels; Teshima, Reiko; Garssen, Johan; Boon, Louis; Knippels, Léon M J

2014-01-01

Cow's milk-derived whey hydrolysates are nutritional substitutes for allergic infants. Safety or residual allergenicity assessment of these whey hydrolysates is crucial. Currently, rat basophilic leukemia RBL-2H3 cells expressing the human IgE receptor α-chain (huFcεRIα-RBL-2H3), sensitized with serum IgE from cow's milk allergic children, are being employed to assess in vitro residual allergenicity of these whey hydrolysates. However, limited availability and inter-lot variation of these allergic sera impede standardization of whey hydrolysate safety testing in degranulation assays. An oligoclonal pool of chimeric human (chu)IgE antibodies against bovine β-lactoglobulin (a major allergen in whey) was generated to increase sensitivity, specificity, and reproducibility of existing degranulation assays. Mice were immunized with bovine β-lactoglobulin, and subsequently the variable domains of dissimilar anti-β-lactoglobulin mouse IgG antibodies were cloned and sequenced. Six chimeric antibodies were generated comprising mouse variable domains and human constant IgE/κ domains. After sensitization with this pool of anti-β-lactoglobulin chuIgEs, huFcεRIα-expressing RBL-2H3 cells demonstrated degranulation upon cross-linking with whey, native 18 kDa β-lactoglobulin, and 5-10 kDa whey hydrolysates, whereas a 3 kDa whey hydrolysate and cow's milk powder (mainly casein) showed no degranulation. In parallel, allergic serum IgEs were less sensitive. In addition, our pool anti-β-lactoglobulin chuIgEs recognized multiple allergenic immunodominant regions on β-lactoglobulin, which were also recognized by serum IgEs from cow's milk allergic children. Usage of our 'unlimited' source and well-defined pool of β-lactoglobulin-specific recombinant chuIgEs to sensitize huFcεRIα on RBL-2H3 cells showed to be a relevant and sensitive alternative for serum IgEs from cow's milk allergic patients to assess safety of whey-based non-allergic hydrolyzed formula.

Human ergology that promotes participatory approach to improving safety, health and working conditions at grassroots workplaces: achievements and actions.

PubMed

Kawakami, Tsuyoshi

2011-12-01

Participatory approaches are increasingly applied to improve safety, health and working conditions of grassroots workplaces in Asia. The core concepts and methods in human ergology research such as promoting real work life studies, relying on positive efforts of local people (daily life-technology), promoting active participation of local people to identify practical solutions, and learning from local human networks to reach grassroots workplaces, have provided useful viewpoints to devise such participatory training programmes. This study was aimed to study and analyze how human ergology approaches were applied in the actual development and application of three typical participatory training programmes: WISH (Work Improvement for Safe Home) with home workers in Cambodia, WISCON (Work Improvement in Small Construction Sites) with construction workers in Thailand, and WARM (Work Adjustment for Recycling and Managing Waste) with waste collectors in Fiji. The results revealed that all the three programmes, in the course of their developments, commonly applied direct observation methods of the work of target workers before devising the training programmes, learned from existing local good examples and efforts, and emphasized local human networks for cooperation. These methods and approaches were repeatedly applied in grassroots workplaces by taking advantage of their the sustainability and impacts. It was concluded that human ergology approaches largely contributed to the developments and expansion of participatory training programmes and could continue to support the self-help initiatives of local people for promoting human-centred work.

Environmental and anthropogenic factors affecting the increasing occurrence of shark-human interactions around a fast-developing Indian Ocean island.

PubMed

Lagabrielle, Erwann; Allibert, Agathe; Kiszka, Jeremy J; Loiseau, Nicolas; Kilfoil, James P; Lemahieu, Anne

2018-02-27

Understanding the environmental drivers of interactions between predators and humans is critical for public safety and management purposes. In the marine environment, this issue is exemplified by shark-human interactions. The annual shark bite incidence rate (SBIR) in La Réunion (Indian Ocean) is among the highest in the world (up to 1 event per 24,000 hours of surfing) and has experienced a 23-fold increase over the 2005-2016 period. Since 1988, 86% of shark bite events on ocean-users involved surfers off the leeward coast, where 96% of surfing activities took place. We modeled the SBIR as a function of environmental variables, including benthic substrate, sea temperature and period of day. The SBIR peaked in winter, during the afternoon and dramatically increased on coral substrate since the mid-2000s. Seasonal patterns of increasing SBIR followed similar fluctuations of large coastal shark occurrences (particularly the bull shark Carcharhinus leucas), consistent with the hypothesis that higher shark presence may result in an increasing likelihood of shark bite events. Potential contributing factors and adaptation of ocean-users to the increasing shark bite hazard are discussed. This interdisciplinary research contributes to a better understanding of shark-human interactions. The modeling method is relevant for wildlife hazard management in general.

Methods for addressing "innocent bystanders" when evaluating safety of concomitant vaccines.

PubMed

Wang, Shirley V; Abdurrob, Abdurrahman; Spoendlin, Julia; Lewis, Edwin; Newcomer, Sophia R; Fireman, Bruce; Daley, Matthew F; Glanz, Jason M; Duffy, Jonathan; Weintraub, Eric S; Kulldorff, Martin

2018-04-01

The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of Medicine and Department of Health and Human Services. The recommended childhood immunization schedule includes multiple vaccines in a visit. A key concern is safety of concomitant (same day) versus separate day vaccination. This paper addresses a methodological challenge for observational studies using a self-controlled design to investigate the safety of concomitant vaccination. We propose a process for distinguishing which of several concomitantly administered vaccines is responsible for increased risk of an adverse event while adjusting for confounding due to relationships between effect modifying risk factors and concomitant vaccine combinations. We illustrate the approach by re-examining the known increase in risk of seizure 7 to 10 days after measles-mumps-rubella (MMR) vaccination and evaluating potential independent or modifying effects of other vaccines. Initial analyses suggested that DTaP had both an independent and potentiating effect on seizure. After accounting for the relationship between age at vaccination and vaccine combination, there was little evidence for increased risk of seizure with same day administration of DTaP and MMR; incidence rate ratio, 95% confidence interval 1.2 (0.9-1.6), P value = θ.226. We have shown that when using a self-controlled design to investigate safety of concomitant vaccination, it can be critically important to adjust for time-invariant effect modifying risk factors, such as age at time of vaccination, which are structurally related to vaccination patterns due to recommended immunization schedules. Copyright © 2018 John Wiley & Sons, Ltd.

Nonclinical safety of the sodium-glucose cotransporter 2 inhibitor empagliflozin.

PubMed

Bogdanffy, Matthew S; Stachlewitz, Robert F; van Tongeren, Susan; Knight, Brian; Sharp, Dale E; Ku, Warren; Hart, Susan Emeigh; Blanchard, Kerry

2014-01-01

Empagliflozin, a selective inhibitor of the renal tubular sodium-glucose cotransporter 2, was developed for treatment of type 2 diabetes mellitus. Nonclinical safety of empagliflozin was studied in a battery of tests to support global market authorization. Safety pharmacology studies indicated no effect of empagliflozin on measures of respiratory or central nervous system function in rats or cardiovascular safety in telemeterized dogs. In CD-1 mouse, Wistar Han rat, or beagle dogs up to 13, 26, or 52 weeks of treatment, respectively, empagliflozin exhibited a toxicity profile consistent with secondary supratherapeutic pharmacology related to glucose loss and included decreased body weight and body fat, increased food consumption, diarrhea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein catabolism, gluconeogenesis, and electrolyte imbalances, and urinary changes such as polyuria and glucosuria. Microscopic changes were consistently observed in kidney and included tubular nephropathy and interstitial nephritis (dog), renal mineralization (rat) and tubular epithelial cell karyomegaly, single cell necrosis, cystic hyperplasia, and hypertrophy (mouse). Empagliflozin was not genotoxic. Empagliflozin was not carcinogenic in female mice or female rats. Renal adenoma and carcinoma were induced in male mice only at exposures 45 times the maximum clinical dose. These tumors were associated with a spectrum of nonneoplastic changes suggestive of a nongenotoxic, cytotoxic, and cellular proliferation-driven mechanism. In male rats, testicular interstitial cell tumors and hemangiomas of the mesenteric lymph node were observed; both tumors are common in rats and are unlikely to be relevant to humans. These studies demonstrate the nonclinical safety of empagliflozin. © The Author(s) 2014.

Engineering nucleases for gene targeting: safety and regulatory considerations.

PubMed

Pauwels, Katia; Podevin, Nancy; Breyer, Didier; Carroll, Dana; Herman, Philippe

2014-01-25

Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight. Copyright © 2013 Elsevier B.V. All rights reserved.

Molecular assessment of bacterial pathogens - a contribution to drinking water safety.

PubMed

Brettar, Ingrid; Höfle, Manfred G

2008-06-01

Human bacterial pathogens are considered as an increasing threat to drinking water supplies worldwide because of the growing demand of high-quality drinking water and the decreasing quality and quantity of available raw water. Moreover, a negative impact of climate change on freshwater resources is expected. Recent advances in molecular detection technologies for bacterial pathogens in drinking water bear the promise in improving the safety of drinking water supplies by precise detection and identification of the pathogens. More importantly, the array of molecular approaches allows understanding details of infection routes of waterborne diseases, the effects of changes in drinking water treatment, and management of freshwater resources.

Cognitive decision errors and organization vulnerabilities in nuclear power plant safety management: Modeling using the TOGA meta-theory framework

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

Cappelli, M.; Gadomski, A. M.; Sepiellis, M.

In the field of nuclear power plant (NPP) safety modeling, the perception of the role of socio-cognitive engineering (SCE) is continuously increasing. Today, the focus is especially on the identification of human and organization decisional errors caused by operators and managers under high-risk conditions, as evident by analyzing reports on nuclear incidents occurred in the past. At present, the engineering and social safety requirements need to enlarge their domain of interest in such a way to include all possible losses generating events that could be the consequences of an abnormal state of a NPP. Socio-cognitive modeling of Integrated Nuclear Safetymore » Management (INSM) using the TOGA meta-theory has been discussed during the ICCAP 2011 Conference. In this paper, more detailed aspects of the cognitive decision-making and its possible human errors and organizational vulnerability are presented. The formal TOGA-based network model for cognitive decision-making enables to indicate and analyze nodes and arcs in which plant operators and managers errors may appear. The TOGA's multi-level IPK (Information, Preferences, Knowledge) model of abstract intelligent agents (AIAs) is applied. In the NPP context, super-safety approach is also discussed, by taking under consideration unexpected events and managing them from a systemic perspective. As the nature of human errors depends on the specific properties of the decision-maker and the decisional context of operation, a classification of decision-making using IPK is suggested. Several types of initial situations of decision-making useful for the diagnosis of NPP operators and managers errors are considered. The developed models can be used as a basis for applications to NPP educational or engineering simulators to be used for training the NPP executive staff. (authors)« less

The need for agriculture phenotyping: "moving from genotype to phenotype".

PubMed

Boggess, Mark V; Lippolis, John D; Hurkman, William J; Fagerquist, Clifton K; Briggs, Steve P; Gomes, Aldrin V; Righetti, Pier Giorgio; Bala, Kumar

2013-11-20

Increase in the world population has called for the increased demand for agricultural productivity. Traditional methods to augment crop and animal production are facing exacerbating pressures in keeping up with population growth. This challenge has in turn led to the transformational change in the use of biotechnology tools to meet increased productivity for both plant and animal systems. Although many challenges exist, the use of proteomic techniques to understand agricultural problems is steadily increasing. This review discusses the impact of genomics, proteomics, metabolomics and phenotypes on plant, animal and bacterial systems to achieve global food security and safety and we highlight examples of intra and extra mural research work that is currently being done to increase agricultural productivity. This review focuses on the global demand for increased agricultural productivity arising from population growth and how we can address this challenge using biotechnology. With a population well above seven billion humans, in a very unbalanced nutritional state (20% overweight, 20% risking starvation) drastic measures have to be taken at the political, infrastructure and scientific levels. While we cannot influence politics, it is our duty as scientists to see what can be done to feed humanity. Hence we highlight the transformational change in the use of biotechnology tools over traditional methods to increase agricultural productivity (plant and animal). Specifically, this review deals at length on how a three-pronged attack, namely combined genomics, proteomics and metabolomics, can help to ensure global food security and safety. This article is part of a Special Issue entitled: Translational Plant Proteomics. Copyright © 2013 Elsevier B.V. All rights reserved.

Proceedings of the human factors workshop : improving railroad safety through understanding close calls.

DOT National Transportation Integrated Search

2004-05-01

On April 23 and 24, 2003, the Federal Railroad Administrations Office of Research and Development held a Human Factors Workshop: Improving Railroad Safety Through Understanding Close Calls in Baltimore, Maryland. The purpose of the workshop ...

77 FR 32018 - Safety Zone; Kemah Boardwalk Summer Season Fireworks, Galveston Bay, Kemah, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... significant effect on the human environment. This rule involves the establishment of a safety zone for the protection of human life. This rule is categorically excluded from further review under paragraph 34(g) of...

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.

PubMed

2001-07-13

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.

Road Lane Detection by Discriminating Dashed and Solid Road Lanes Using a Visible Light Camera Sensor.

PubMed

Hoang, Toan Minh; Hong, Hyung Gil; Vokhidov, Husan; Park, Kang Ryoung

2016-08-18

With the increasing need for road lane detection used in lane departure warning systems and autonomous vehicles, many studies have been conducted to turn road lane detection into a virtual assistant to improve driving safety and reduce car accidents. Most of the previous research approaches detect the central line of a road lane and not the accurate left and right boundaries of the lane. In addition, they do not discriminate between dashed and solid lanes when detecting the road lanes. However, this discrimination is necessary for the safety of autonomous vehicles and the safety of vehicles driven by human drivers. To overcome these problems, we propose a method for road lane detection that distinguishes between dashed and solid lanes. Experimental results with the Caltech open database showed that our method outperforms conventional methods.

Road Lane Detection by Discriminating Dashed and Solid Road Lanes Using a Visible Light Camera Sensor

PubMed Central

Hoang, Toan Minh; Hong, Hyung Gil; Vokhidov, Husan; Park, Kang Ryoung

2016-01-01

With the increasing need for road lane detection used in lane departure warning systems and autonomous vehicles, many studies have been conducted to turn road lane detection into a virtual assistant to improve driving safety and reduce car accidents. Most of the previous research approaches detect the central line of a road lane and not the accurate left and right boundaries of the lane. In addition, they do not discriminate between dashed and solid lanes when detecting the road lanes. However, this discrimination is necessary for the safety of autonomous vehicles and the safety of vehicles driven by human drivers. To overcome these problems, we propose a method for road lane detection that distinguishes between dashed and solid lanes. Experimental results with the Caltech open database showed that our method outperforms conventional methods. PMID:27548176

Fire safety distances for open pool fires

NASA Astrophysics Data System (ADS)

Sudheer, S.; Kumar, Lokendra; Manjunath, B. S.; Pasi, Amit; Meenakshi, G.; Prabhu, S. V.

2013-11-01

Fire accidents that carry huge loss with them have increased in the previous two decades than at any time in the history. Hence, there is a need for understanding the safety distances from different fires with different fuels. Fire safety distances are computed for different open pool fires. Diesel, gasoline and hexane are used as fuels for circular pool diameters of 0.5 m, 0.7 m and 1.0 m. A large square pool fire of 4 m × 4 m is also conducted with diesel as a fuel. All the prescribed distances in this study are purely based on the thermal analysis. IR camera is used to get the thermal images of pool fires and there by the irradiance at different locations is computed. The computed irradiance is presented with the threshold heat flux limits for human beings.

Species-specific effects of neuregulin-1β (cimaglermin alfa) on glucose handling in animal models and humans with heart failure.

PubMed

Huang, Zhihong; Sawyer, Douglas B; Troy, Erika L; McEwen, Corissa; Cleator, John H; Murphy, Abigail; Caggiano, Anthony O; Eisen, Andrew; Parry, Tom J

2017-10-01

Neuregulin-1β is a member of the neuregulin family of growth factors and is critically important for normal development and functioning of the heart and brain. A recombinant version of neuregulin-1β, cimaglermin alfa (also known as glial growth factor 2 or GGF2) is being investigated as a possible therapy for heart failure. Previous studies suggest that neuregulin-1β stimulation of skeletal muscle increases glucose uptake and, specifically, sufficient doses of cimaglermin alfa acutely produce hypoglycemia in pigs. Since acute hypoglycemia could be a safety concern, blood glucose changes in the above pig study were further investigated. In addition, basal glucose and glucose disposal were investigated in mice. Finally, as part of standard clinical chemistry profiling in a single ascending-dose human safety study, blood glucose levels were evaluated in patients with heart failure after cimaglermin alfa treatment. A single intravenous injection of cimaglermin alfa at doses of 0.8mg/kg and 2.6mg/kg in mice resulted in a transient reduction of blood glucose concentrations of approximately 20% and 34%, respectively, at 2h after the treatment compared to pre-treatment levels. Similar results were observed in diabetic mice. Treatment with cimaglermin alfa also increased blood glucose disposal following oral challenge in mice. However, no significant alterations in blood glucose concentrations were found in human heart failure patients at 0.5 and 2h after treatment with cimaglermin alfa over an equivalent human dose range, based on body surface area. Taken together, these data indicate strong species differences in blood glucose handling after cimaglermin alfa treatment, and particularly do not indicate that this phenomenon should affect human subjects. Copyright © 2017 Elsevier Inc. All rights reserved.

In Vitro and in Vivo Characterization of MOD-4023, a Long-Acting Carboxy-Terminal Peptide (CTP)-Modified Human Growth Hormone.

PubMed

Hershkovitz, Oren; Bar-Ilan, Ahuva; Guy, Rachel; Felikman, Yana; Moschcovich, Laura; Hwa, Vivian; Rosenfeld, Ron G; Fima, Eyal; Hart, Gili

2016-02-01

MOD-4023 is a novel long-acting version of human growth hormone (hGH), containing the carboxy-terminal peptide (CTP) of human chorionic gonadotropin (hCG). MOD-4023 is being developed as a treatment for adults and children with growth hormone deficiency (GHD), which would require fewer injections than currently available GH formulations and thus reduce patient discomfort and increase compliance. This study characterizes MOD-4023's binding affinities for the growth hormone receptor, as well as the pharmacokinetic and pharmacodynamics, toxicology, and safety profiles of repeated dosing of MOD-4023 in Sprague-Dawley rats and Rhesus monkeys. Although MOD-4023 exhibited reduced in vitro potency and lower affinity to the GH receptor than recombinant hGH (rhGH), administration of MOD-4023 every 5 days in rats and monkeys resulted in exposure comparable to daily rhGH, and the serum half-life of MOD-4023 was significantly longer. Repeated administration of MOD-4023 led to elevated levels of insulin-like growth factor 1 (IGF-1), and twice-weekly injections of MOD-4023 resulted in larger increase in weight gain with fewer injections and a lower accumulative hGH dose. Thus, the increased half-life of MOD-4023 in comparison to hGH may increase the frequency of protein-receptor interactions and compensate for its decreased in vitro potency. MOD-4023 was found to be well-tolerated in rats and monkeys, with minimal adverse events, suggesting an acceptable safety profile. These results provide a basis for the continued clinical development of MOD-4023 as a novel treatment of GHD in children and adults.

The Line Operations Safety Audit Program: Transitioning From Flight Operations to Maintenance and Ramp Operations

DTIC Science & Technology

2011-09-01

Transport Association ( ATA ) Maintenance & Ramp Human Factors Task Force committee members—we are deeply grateful for their contributions in the...6 Air Transport Association ( ATA ) Human Factors Task Force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Form Development...garnered many valuable les- sons, safety improvements, and significant returns on their investment. 1The FAA ATA Human Factors Taskforce has

[Biomedical foundation for human safety in aviation].

PubMed

Ushakov, I B

2004-01-01

According to the author, preventive medical issues of providing human safety in aviation are related to the fundamental biomedical and socio-psychological problems of human beings in the present-day world. Factual material for analysis was compiled in the study performed at the State Research and Test Institute of Military Medicine. Outlined are main vectors of the future attack on the problem.

Ring the Alarm! A Memo to the Schools on Fire and Human Beings.

ERIC Educational Resources Information Center

Educational Facilities Labs., Inc., New York, NY.

An analysis is presented of the handling of the human elements in fire safety. Emphasis is given to considerations such as how fires kill children, the school's responsibility for fire safety, causes of human failure, and the necessity for organized emergency programs and drills. Also included is a check list of items concerned with protection…

78 FR 40743 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such...

Do code of conduct audits improve chemical safety in garment factories? Lessons on corporate social responsibility in the supply chain from Fair Wear Foundation.

PubMed

Lindholm, Henrik; Egels-Zandén, Niklas; Rudén, Christina

2016-10-01

In managing chemical risks to the environment and human health in supply chains, voluntary corporate social responsibility (CSR) measures, such as auditing code of conduct compliance, play an important role. To examine how well suppliers' chemical health and safety performance complies with buyers' CSR policies and whether audited factories improve their performance. CSR audits (n = 288) of garment factories conducted by Fair Wear Foundation (FWF), an independent non-profit organization, were analyzed using descriptive statistics and statistical modeling. Forty-three per cent of factories did not comply with the FWF code of conduct, i.e. received remarks on chemical safety. Only among factories audited 10 or more times was there a significant increase in the number of factories receiving no remarks. Compliance with chemical safety requirements in garment supply chains is low and auditing is statistically correlated with improvements only at factories that have undergone numerous audits.

Do code of conduct audits improve chemical safety in garment factories? Lessons on corporate social responsibility in the supply chain from Fair Wear Foundation

PubMed Central

2016-01-01

Background In managing chemical risks to the environment and human health in supply chains, voluntary corporate social responsibility (CSR) measures, such as auditing code of conduct compliance, play an important role. Objectives To examine how well suppliers’ chemical health and safety performance complies with buyers’ CSR policies and whether audited factories improve their performance. Methods CSR audits (n = 288) of garment factories conducted by Fair Wear Foundation (FWF), an independent non-profit organization, were analyzed using descriptive statistics and statistical modeling. Results Forty-three per cent of factories did not comply with the FWF code of conduct, i.e. received remarks on chemical safety. Only among factories audited 10 or more times was there a significant increase in the number of factories receiving no remarks. Conclusions Compliance with chemical safety requirements in garment supply chains is low and auditing is statistically correlated with improvements only at factories that have undergone numerous audits. PMID:27611103

Integrated therapy safety management system

PubMed Central

Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

2013-01-01

Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

Gastrointestinal microbial ecology and the safety of our food supply as related to Salmonella.

PubMed

Callaway, T R; Edrington, T S; Anderson, R C; Byrd, J A; Nisbet, D J

2008-04-01

Salmonella causes an estimated 1.3 million human foodborne illnesses and more than 500 deaths each year in the United States, representing an annual estimated cost to the economy of approximately $2.4 billion. Salmonella enterica comprises more than 2,500 serotypes. With this genetic and environmental diversity, serotypes are adapted to live in a variety of hosts, which may or may not manifest with clinical illness. Thus, Salmonella presents a multifaceted threat to food production and safety. Salmonella have been isolated from all food animals and can cause morbidity and mortality in swine, cattle, sheep, and poultry. The link between human salmonellosis and host animals is most clear in poultry. During the early part of the 20th century, a successful campaign was waged to eliminate fowl typhoid caused by Salmonella Gallinarum/Pullorum. Microbial ecology is much like macroecology; environmental niches are filled by adapted and specialized species. Elimination of S. Gallinarum cleared a niche in the on-farm and intestinal microbial ecology that was quickly exploited by Salmonella Enteritidis and other serotypes that live in other hosts, such as rodents. In the years since, human salmonellosis cases linked to poultry have increased to the point that uncooked chicken and eggs are regarded as toxic in the zeitgeist. Salmonellosis caused by poultry products have increased significantly in the past 5 yr, leading to a USDA Food Safety and Inspection Service "Salmonella Attack Plan" that aims to reduce the incidence of Salmonella in chickens below the current 19%. The prevalence of Salmonella in swine and cattle is lower, but still poses a threat to food safety and production efficiency. Thus, approaches to reducing Salmonella in animals must take into consideration that the microbial ecology of the animal is a critical factor that should be accounted for when designing intervention strategies. Use of competitive exclusion, sodium chlorate, vaccination, and bacteriophage are all strategies that can reduce Salmonella in the live animal, but it is vital to understand how they function so that we do not invoke the law of unintended consequences.

The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS).

PubMed

Vinardell, M P

2015-03-01

In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition. Copyright © 2014 Elsevier Inc. All rights reserved.

The Microphysiology Systems Database for Analyzing and Modeling Compound Interactions with Human and Animal Organ Models

PubMed Central

Vernetti, Lawrence; Bergenthal, Luke; Shun, Tong Ying; Taylor, D. Lansing

2016-01-01

Abstract Microfluidic human organ models, microphysiology systems (MPS), are currently being developed as predictive models of drug safety and efficacy in humans. To design and validate MPS as predictive of human safety liabilities requires safety data for a reference set of compounds, combined with in vitro data from the human organ models. To address this need, we have developed an internet database, the MPS database (MPS-Db), as a powerful platform for experimental design, data management, and analysis, and to combine experimental data with reference data, to enable computational modeling. The present study demonstrates the capability of the MPS-Db in early safety testing using a human liver MPS to relate the effects of tolcapone and entacapone in the in vitro model to human in vivo effects. These two compounds were chosen to be evaluated as a representative pair of marketed drugs because they are structurally similar, have the same target, and were found safe or had an acceptable risk in preclinical and clinical trials, yet tolcapone induced unacceptable levels of hepatotoxicity while entacapone was found to be safe. Results demonstrate the utility of the MPS-Db as an essential resource for relating in vitro organ model data to the multiple biochemical, preclinical, and clinical data sources on in vivo drug effects. PMID:28781990

Long-Term Safety of Repeated Blood-Brain Barrier Opening via Focused Ultrasound with Microbubbles in Non-Human Primates Performing a Cognitive Task.

PubMed

Downs, Matthew E; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Teichert, Tobias; Chen, Shangshang; Konofagou, Elisa E; Ferrera, Vincent P

2015-01-01

Focused Ultrasound (FUS) coupled with intravenous administration of microbubbles (MB) is a non-invasive technique that has been shown to reliably open (increase the permeability of) the blood-brain barrier (BBB) in multiple in vivo models including non-human primates (NHP). This procedure has shown promise for clinical and basic science applications, yet the safety and potential neurological effects of long term application in NHP requires further investigation under parameters shown to be efficacious in that species (500 kHz, 200-400 kPa, 4-5 μm MB, 2 minute sonication). In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4-20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of' visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4-5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used.

21 CFR 184.1444 - Maltodextrin.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or...

21 CFR 172.809 - Curdlan.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... available from the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition... the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint...

21 CFR 173.370 - Peroxyacids.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug... Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the...

21 CFR 172.831 - Sucralose.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint... Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives...

21 CFR 184.1444 - Maltodextrin.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or...

21 CFR 173.370 - Peroxyacids.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug... Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the...

Canadian Pacific Railway Investigation of Safety-Related Occurrences Protocol considered helpful by both labor and management.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program sponsored an Alternative Safety Measures Program designed to explore alternative methods for evaluating whether safety programs improve safety outcomes and...

Canadian Pacific Railway mechanical services' 5-Alive safety program shows promise in reducing injuries.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program is sponsoring an Alternative Safety Measures Program to explore alternative methods for evaluating whether safety programs improve safety outcomes and the ...

Novel effects of diosgenin on skin aging.

PubMed

Tada, Yayoi; Kanda, Naoko; Haratake, Akinori; Tobiishi, Megumi; Uchiwa, Hideyo; Watanabe, Shinichi

2009-06-01

Extracts of Dioscorea coomposita or Dioscorea villosa are consumed as supplemental health foods at the time of climacteric. The extracts contain large amounts of the plant steroid, diosgenin. Here, we studied the safety and efficacy of diosgenin against skin aging at the time of climacteric. In vitro, diosgenin enhanced DNA synthesis in a human 3D skin equivalent model, and increased bromodeoxyuridine uptake and intracellular cAMP level in adult human keratinocytes. The increase of bromodeoxyuridine uptake by diosgenin was blocked by an adenylate cyclase inhibitor, but not by antisense oligonucleotides against estrogen receptor alpha, estrogen receptor beta or an orphan G-protein-coupled receptor, GPR30, indicating the involvement of cAMP but not estrogen receptor alpha, estrogen receptor beta or GPR30. In vivo, administration of diosgenin improved the epidermal thickness in the ovariectomized mice, a climacteric model, without altering the degree of fat accumulation. In order to examine the safety of diosgenin, diosgenin and 17beta-estradiol were administered to breast cancer-burdened mice. The results revealed that while 17beta-estradiol accelerated the tumor growth, diosgenin did not show this effect. Our finding, a restoration of keratinocyte proliferation in aged skin, suggests that diosgenin may have potential as a safe health food for climacteric.

Dental metal-induced innate reactivity in keratinocytes.

PubMed

Mortazavi, S M J; Mortazavi, Ghazal; Paknahad, Maryam

2016-06-01

In their paper that is published in Toxicology in Vitro, Rachmawati et al. have recently claimed that in spite of the growing concern about the safety of amalgam, negative reports about the health effects of dental amalgam are still scarce or controversial. Substantial evidence indicates that mercury release from dental amalgam fillings may adversely affect human health. Over the past years, we have shown that exposure to electromagnetic fields (EMFs) can increase the release of mercury from dental amalgam fillings. It is worth mentioning that the results of investigations on the microleakage of amalgam fillings following MRI have confirmed our results. Furthermore, exposure to X-rays as a part of the electromagnetic spectrum has also been linked to increased mercury release from dental amalgam fillings. Considering the explosive rise in human exposure to electromagnetic fields, the role of human exposure to EMF as a key factor in increasing the release of mercury from dental amalgam restorations cannot be simply ignored. Copyright © 2016 Elsevier B.V. All rights reserved.

Two NextGen Air Safety Tools: An ADS-B Equipped UAV and a Wake Turbulence Estimator

NASA Astrophysics Data System (ADS)

Handley, Ward A.

Two air safety tools are developed in the context of the FAA's NextGen program. The first tool addresses the alarming increase in the frequency of near-collisions between manned and unmanned aircraft by equipping a common hobby class UAV with an ADS-B transponder that broadcasts its position, speed, heading and unique identification number to all local air traffic. The second tool estimates and outputs the location of dangerous wake vortex corridors in real time based on the ADS-B data collected and processed using a custom software package developed for this project. The TRansponder based Position Information System (TRAPIS) consists of data packet decoders, an aircraft database, Graphical User Interface (GUI) and the wake vortex extension application. Output from TRAPIS can be visualized in Google Earth and alleviates the problem of pilots being left to imagine where invisible wake vortex corridors are based solely on intuition or verbal warnings from ATC. The result of these two tools is the increased situational awareness, and hence safety, of human pilots in the National Airspace System (NAS).

Heat Recovery Incinerator-Equipment Selection and Plant Layout for Safety, Human Engineering and Maintainability.

DTIC Science & Technology

1984-10-01

16 4.2 Solid Waste Receiving and Storage Area ........................ 17 4.3 Equipment Location and Spacing...10OROS (Ccr4n-ifl. **,0d. d - -eet -.d tdonfffy by bltk -P-+) HRI, RAM, Human factors, HRI design, IRI safety, solid waste , energy recovery 10 AOSTNACT...health and safety hazards to individuals hand-sorting the conglomerate of solid waste , the potential of dangerous substances and inflammable or ex

Current Characteristics and Trends of the Tracked Satellite Population in the Human Space Flight Regime

NASA Technical Reports Server (NTRS)

Johnson, Nicholas L.

2006-01-01

Since the end of the Apollo program in 1972, human space flight has been restricted to altitudes below 600 km above the Earth s surface with most missions restricted to a ceiling below 400 km. An investigation of the tracked satellite population transiting and influencing the human space flight regime during the past 11 years (equivalent to a full solar cycle) has recently been completed. The overall effects of satellite breakups and solar activity are typically less pronounced in the human space flight regime than other regions of low Earth orbit. As of January 2006 nearly 1500 tracked objects resided in or traversed the human space flight regime, although two-thirds of these objects were in orbits of moderate to high eccentricity, significantly reducing their effect on human space flight safety. During the period investigated, the spatial density of tracked objects in the 350-400 km altitude regime of the International Space Station demonstrated a steady decline, actually decreasing by 50% by the end of the period. On the other hand, the region immediately above 600 km experienced a significant increase in its population density. This regime is important for future risk assessments, since this region represents the reservoir of debris which will influence human space flight safety in the future. The paper seeks to put into sharper perspective the risks posed to human space flight by the tracked satellite population, as well as the influences of solar activity and the effects of compliance with orbital debris mitigation guidelines on human space flight missions. Finally, the methods and successes of characterizing the population of smaller debris at human space flight regimes are addressed.

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

PubMed

Evans, Ellen W; Redmond, Elizabeth C

2014-03-01

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

Microscopic information processing and communication in crowd dynamics

NASA Astrophysics Data System (ADS)

Henein, Colin Marc; White, Tony

2010-11-01

Due, perhaps, to the historical division of crowd dynamics research into psychological and engineering approaches, microscopic crowd models have tended toward modelling simple interchangeable particles with an emphasis on the simulation of physical factors. Despite the fact that people have complex (non-panic) behaviours in crowd disasters, important human factors in crowd dynamics such as information discovery and processing, changing goals and communication have not yet been well integrated at the microscopic level. We use our Microscopic Human Factors methodology to fuse a microscopic simulation of these human factors with a popular microscopic crowd model. By tightly integrating human factors with the existing model we can study the effects on the physical domain (movement, force and crowd safety) when human behaviour (information processing and communication) is introduced. In a large-room egress scenario with ample exits, information discovery and processing yields a crowd of non-interchangeable individuals who, despite close proximity, have different goals due to their different beliefs. This crowd heterogeneity leads to complex inter-particle interactions such as jamming transitions in open space; at high crowd energies, we found a freezing by heating effect (reminiscent of the disaster at Central Lenin Stadium in 1982) in which a barrier formation of naïve individuals trying to reach blocked exits prevented knowledgeable ones from exiting. Communication, when introduced, reduced this barrier formation, increasing both exit rates and crowd safety.

78 FR 11237 - Public Hearing

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

... management of human error in its operations and system safety programs, and the status of PTC implementation... UP's safety management policies and programs associated with human error, operational accident and... Chairman of the Board of Inquiry 2. Introduction of the Board of Inquiry and Technical Panel 3...

21 CFR 172.105 - Anoxomer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200... incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200...

21 CFR 172.105 - Anoxomer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200... incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200...

78 FR 12065 - National Institute for Occupational Safety and Health Personal Protective Technology for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Personal Protective Technology for Pesticide Handlers... for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION...

A Review of General Aviation Safety (1984-2017).

PubMed

Boyd, Douglas D

2017-07-01

General aviation includes all civilian aviation apart from operations involving paid passenger transport. Unfortunately, this category of aviation holds a lackluster safety record, accounting for 94% of civil aviation fatalities. In 2014, of 1143 general aviation accidents, 20% were fatal compared with 0 of 29 airline mishaps in the United States. Herein, research findings over the past 30 yr will be reviewed. Accident risk factors (e.g., adverse weather, geographical region, post-impact fire, gender differences) will be discussed. The review will also summarize the development and implementation of stringent crashworthiness designs with multi-axis dynamic testing and head-injury protection and its impact on mitigating occupant injury severity. The benefits and drawbacks of new technology and human factor considerations associated with increased general aviation automation will be debated. Data on the safety of the aging general aviation population and increased drug usage will also be described. Finally, areas in which general aviation occupant survival could be improved and injury severity mitigated will be discussed with the view of equipping aircraft with 1) crash-resistant fuel tanks to reduce post-impact conflagration; 2) after-market ballistic parachutes for older aircraft; and 3) current generation electronic locator beacons to hasten site access by first responders.Boyd DD. A review of general aviation safety (1984-2017). Aerosp Med Hum Perform. 2017; 88(7):657-664.

42 CFR 85.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND... Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined... Occupational Safety and Health Act of 1970 (29 U.S.C. 651, et seq.). FMSH Act means the Federal Mine Safety and...

42 CFR 85.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND... Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined... Occupational Safety and Health Act of 1970 (29 U.S.C. 651, et seq.). FMSH Act means the Federal Mine Safety and...

75 FR 12554 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C...

42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of patient...

ESA Human rating Requirements:Status

NASA Astrophysics Data System (ADS)

Trujillo, M.; Sgobba, T.

2012-01-01

The European Space Agency (ESA) human rating safety requirements are based on heritage requirements of the International Space Station as well as the knowledge and experience derived from European participation on international partnerships. This expertise in conjunction with recommendations derived from past accidents (i.e.: Columbia) and lessons learned have led to the identification of m inimum core safety tech nical requirements for hum an rated space syst ems. These requirements apply to th e crewed space vehicle, integrated space system (i.e.: cre wed vehicle on its launcher) and its interfaces with control centres, la unch pad, etc. In 2009, a first draft was issued. Then, in the summer of 2010, ESA established a working group comprised of more than twenty experts (from disciplines including propulsion, pyrotechnics, structures, avionics, human factors and life support among others) across the Agency to review this draft. This paper provides an overview of ESA "Safety technical re quirements for human rated s pace systems" document, its scope a nd structure, as well as the planned steps for verification of these requirements in term s of achieving the identified safety objectives for crew safety in t erms of a quantitative risk evaluation.

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.

PubMed

Brennan, Frank R; Baumann, Andreas; Blaich, Guenter; de Haan, Lolke; Fagg, Rajni; Kiessling, Andrea; Kronenberg, Sven; Locher, Mathias; Milton, Mark; Tibbitts, Jay; Ulrich, Peter; Weir, Lucinda

2015-10-01

Non-clinical safety testing of biopharmaceuticals can present significant challenges to human risk assessment with these often innovative and complex drugs. Hot Topics in this field were discussed recently at the 4th Annual European Biosafe General Membership meeting. In this feature article, the presentations and subsequent discussions from the main sessions are summarized. The topics covered include: (i) wanted versus unwanted immune activation, (ii) bi-specific protein scaffolds, (iii) use of Pharmacokinetic (PK)/Pharmacodynamic (PD) data to impact/optimize toxicology study design, (iv) cytokine release and challenges to human translation (v) safety testing of cell and gene therapies including chimeric antigen receptor T (CAR-T) cells and retroviral vectors and (vi) biopharmaceutical development strategies encompassing a range of diverse topics including optimizing entry of monoclonal antibodies (mAbs) into the brain, safety testing of therapeutic vaccines, non-clinical testing of biosimilars, infection in toxicology studies with immunomodulators and challenges to human risk assessment, maternal and infant anti-drug antibody (ADA) development and impact in non-human primate (NHP) developmental toxicity studies, and a summary of an NC3Rs workshop on the future vision for non-clinical safety assessment of biopharmaceuticals. Copyright © 2015 Elsevier Inc. All rights reserved.

Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care.

PubMed

Alikani, Mina; Go, Kathryn J; McCaffrey, Caroline; McCulloh, David H

2014-11-01

To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction technology (ART) laboratory practice. Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for contemporary ART laboratory activities to determine adequate staffing levels. University-based and private ART programs. None. None. Human resource requirements for ART procedures. Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with the same requirements for the "traditional cycle" of the past. The latter required roughly 9 personnel hours, but a contemporary cycle can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel Calculator is introduced that can help determine staffing needs. The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human resources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a view to increasing the safety and efficiency of operations. The work could serve as the basis for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guidelines. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Human Factors and Ergonomics in the Design of Health Information Technology: Trends and Progress in 2014

PubMed Central

Ong, MS.

2015-01-01

Summary Objective To summarize significant contributions to the research on human factors and organizational issues in medical informatics. Methods An extensive search using PubMed/Medline and Web of Science® was conducted to identify the scientific contributions, published in 2014, to human factors and organizational issues in medical informatics, with a focus on health information technology (HIT) usability. The selection process comprised three steps: (i) 15 candidate best papers were selected by the two section editors, (ii) external reviewers from a pool of international experts reviewed each candidate best paper, and (iii) the final selection of three best papers was made by the editorial board of the IMIA Yearbook. Results Noteworthy papers published in 2014 describe an efficient, easy to implement, and useful process for detecting and mitigating human factors and ergonomics (HFE) issues of HIT. They contribute to promote the HFE approach with interventions based on rigorous and well-conducted methods when designing and implementing HIT. Conclusion The application of HFE in the design and implementation of HIT remains limited, and the impact of incorporating HFE principles on patient safety is understudied. Future works should be conducted to advance this field of research, so that the safety and quality of patient care are not compromised by the increasing adoption of HIT. PMID:26293852

Isolation of GMP Grade Human Hepatocytes from Remnant Liver Tissue of Living Donor Liver Transplantation.

PubMed

Enosawa, Shin

2017-01-01

For the purpose of clinical research of hepatocyte transplantation, procedures for isolation, cryopreservation, thawing, and functional assessment of hepatocytes are described. Although demands for human hepatocytes are increasing in not only cell therapy but also drug development, it is highly difficult to obtain good lots of hepatocytes from human liver tissue. This chapter describes essential issues such as alleviation of warm ischemia, prevention of shear stress, optimization of cryopreservation, and functional assessment, along with securement of quality. All procedures described here are compliant with good manufacturing procedure (GMP) in cell processing facility, approved by the act on measures to ensure safety of regenerative medicine and ethical regulations in Japan.

Conservation biology: lion attacks on humans in Tanzania.

PubMed

Packer, Craig; Ikanda, Dennis; Kissui, Bernard; Kushnir, Hadas

2005-08-18

Large carnivores inspire opposition to conservation efforts owing to their impact on livestock and human safety. Here we analyse the pattern of lion attacks over the past 15 years on humans in Tanzania, which has the largest population of lions in Africa, and find that they have killed more than 563 Tanzanians since 1990 and injured at least 308. Attacks have increased dramatically during this time: they peak at harvest time each year and are most frequent in areas with few prey apart from bush pigs (Potamochoerus larvatus), the most common nocturnal crop pest. Our findings provide an important starting point for devising strategies to reduce the risk to rural Tanzanians of lion attacks.

Luminous fabric devices for wearable low-level light therapy

PubMed Central

Shen, Jing; Chui, Chunghin; Tao, Xiaoming

2013-01-01

In this paper, a flexible luminous fabric device was developed and investigated for wearable three-dimensionally fitted low-level light therapy. The fabric device exhibited excellent optical and thermal properties. Its optical power density and operating temperature were stable during usage for 10 hours. In vitro experiments demonstrated a significant increase in collagen production in human fibroblast irradiated by the fabric device, compared with the fibroblast without light irradiation. A series of tests were conducted for the safety of the fabric for human skin contact according to ISO standard ISO 10993-1:2003. The results showed that there was no potential hazard when the luminous fabrics were in direct contact with human skin. PMID:24409391

Oceans and Human Health: Linking Ocean, Organism, and Human Health for Sustainable Management of Coastal Ecosystems

NASA Astrophysics Data System (ADS)

Sandifer, P. A.; Trtanj, J.; Collier, T. K.

2012-12-01

Scientists and policy-makers are increasingly recognizing that sustainable coastal communities depend on healthy and resilient economies, ecosystems, and people, and that the condition or "health" of the coastal ocean and humans are intimately and inextricably connected. A wealth of ecosystem services provided by ocean and coastal environments are crucial for human survival and well being. Nonetheless, the health of coastal communities, their economies, connected ecosystems and ecosystem services, and people are under increasing threats from health risks associated with environmental degradation, climate change, and unwise land use practices, all of which contribute to growing burdens of naturally-occurring and introduced pathogens, noxious algae, and chemical contaminants. The occurrence, frequency, intensity, geographic range, and number and kinds of ocean health threats are increasing, with concomitant health and economic effects and eroding public confidence in the safety and wholesomeness of coastal environments and resources. Concerns in the research and public health communities, many summarized in the seminal 1999 NRC Report, From Monsoons to Microbes and the 2004 final report of the US Commission on Ocean Policy, resulted in establishment of a new "meta-discipline" known as Oceans and Human Health (OHH). OHH brings together practitioners in oceanography, marine biology, ecology, biomedical science, medicine, economics and other social sciences, epidemiology, environmental management, and public health to focus on water- and food-borne causes of human and animal illnesses associated with ocean and coastal systems and on health benefits of seafood and other marine products. It integrates information across multiple disciplines to increase knowledge of ocean health risks and benefits and communicate such information to enhance public safety. Recognizing the need for a comprehensive approach to ocean health threats and benefits, Congress passed the Oceans and Human Health Act of 2004. Major outcomes of the OHH Act of 2004 include: --A national focus on ocean health and its relation to human health and well-being; --Enhanced interagency coordination and cooperation in research, development, and education; --Emphasis on development of a new, interdisciplinary community of practice; --Increased understanding of linkages between marine animal health and human health and the dangers of transmission of zoonotic diseases from the marine environment; --A richer understanding of factors affecting the occurrence and impacts of ocean health threats; --An enhanced ability of the ocean science and public health communities to respond to health-related emergencies; --A strong focus on development of ecological forecasts that are providing early warning of ocean health threats and impacts, thus improving the effectiveness of protection and mitigation actions. Taken together, these outcomes contribute significantly to more sustainable management of coastal resources and communities.

Human-centered aircraft automation: A concept and guidelines

NASA Technical Reports Server (NTRS)

Billings, Charles E.

1991-01-01

Aircraft automation is examined and its effects on flight crews. Generic guidelines are proposed for the design and use of automation in transport aircraft, in the hope of stimulating increased and more effective dialogue among designers of automated cockpits, purchasers of automated aircraft, and the pilots who must fly those aircraft in line operations. The goal is to explore the means whereby automation may be a maximally effective tool or resource for pilots without compromising human authority and with an increase in system safety. After definition of the domain of the aircraft pilot and brief discussion of the history of aircraft automation, a concept of human centered automation is presented and discussed. Automated devices are categorized as a control automation, information automation, and management automation. The environment and context of aircraft automation are then considered, followed by thoughts on the likely future of automation of that category.

Autonomous System Technologies for Resilient Airspace Operations

NASA Technical Reports Server (NTRS)

Houston, Vincent E.; Le Vie, Lisa R.

2017-01-01

Increasing autonomous systems within the aircraft cockpit begins with an effort to understand what autonomy is and developing the technology that encompasses it. Autonomy allows an agent, human or machine, to act independently within a circumscribed set of goals; delegating responsibility to the agent(s) to achieve overall system objective(s). Increasingly Autonomous Systems (IAS) are the highly sophisticated progression of current automated systems toward full autonomy. Working in concert with humans, these types of technologies are expected to improve the safety, reliability, costs, and operational efficiency of aviation. IAS implementation is imminent, which makes the development and the proper performance of such technologies, with respect to cockpit operation efficiency, the management of air traffic and data communication information, vital. A prototype IAS agent that attempts to optimize the identification and distribution of "relevant" air traffic data to be utilized by human crews during complex airspace operations has been developed.

77 FR 14838 - General Electric-Hitachi Global Laser Enrichment LLC, Commercial Laser-Based Uranium Enrichment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... safety, chemical process safety, fire safety, emergency management, environmental protection... the transportation of SNM of low strategic significance, human factors engineering, and electrical...

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association Federal Patient Safety...

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

U.S. Rep. Gabrielle Giffords, D-Ariz., left, speaks with reitred astronaut Lt. Gen. Thomas Stafford prior to the start of a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

45 CFR 1321.75 - Licenses and safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Licenses and safety. 1321.75 Section 1321.75 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO STATE...

John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety.

PubMed

Heget, Jeffrey R; Bagian, James P; Lee, Caryl Z; Gosbee, John W

2002-12-01

In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

In-situ Resources In Space

NASA Technical Reports Server (NTRS)

Curreri, Peter A.

2005-01-01

This tutorial is a primer on the motivational and materials science basis for utilizing space resources to lower the cost and increase the safety and reliability of human systems beyond Earth's orbit. Past research in materials processing in orbit will be briefly reviewed to emphasize the challenges and advantages inherent in processing materials in space. Data on resource availability from human Lunar and robotic/sensor missions beyond the Moon will be overviewed for resource relevance to human exploration and development of space. Specific scenarios such as propellant production on the Moon and Mars, and lunar photovoltaic power production from in-situ materials will be discussed in relation to exploration and commercialization of space. A conclusion will cover some of the visionary proposals for the use of space resources to extend human society and prosperity beyond Earth.

An in vitro approach for comparative interspecies metabolism of agrochemicals.

PubMed

Whalley, Paul M; Bartels, Michael; Bentley, Karin S; Corvaro, Marco; Funk, Dorothee; Himmelstein, Matthew W; Neumann, Birgit; Strupp, Christian; Zhang, Fagen; Mehta, Jyotigna

2017-08-01

The metabolism and elimination of a xenobiotic has a direct bearing on its potential to cause toxicity in an organism. The confidence with which data from safety studies can be extrapolated to humans depends, among other factors, upon knowing whether humans are systemically exposed to the same chemical entities (i.e. a parent compound and its metabolites) as the laboratory animals used to study toxicity. Ideally, to understand a metabolite in terms of safety, both the chemical structure and the systemic exposure would need to be determined. However, as systemic exposure data (i.e. blood concentration/time data of test material or metabolites) in humans will not be available for agrochemicals, an in vitro approach must be taken. This paper outlines an in vitro experimental approach for evaluating interspecies metabolic comparisons between humans and animal species used in safety studies. The aim is to ensure, where possible, that all potential human metabolites are also present in the species used in the safety studies. If a metabolite is only observed in human in vitro samples and is not present in a metabolic pathway defined in the toxicological species already, the toxicological relevance of this metabolite must be evaluated. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A risk assessment of topical tretinoin as a potential human developmental toxin based on animal and comparative human data.

PubMed

Johnson, E M

1997-03-01

Although topically applied all-trans-retinoic acid (tretinoin) undergoes minimal absorption and adds negligibly to normal endogenous levels, its safety in humans is occasionally questioned because oral ingestion of retinoids at therapeutic levels is known to entail teratogenic risks. To assess the actual potential for developmental toxicity from treatment with topical tretinoin. Risk assessments were conducted on four known human developmental toxicants (valproic acid, methotrexate, thalidomide, and isotretinoin) and a potential developmental toxicant (acetylsalicylic acid). The margin of safety for each chemical was calculated from the ratio of animal no-observed adverse effect levels to human lowest-observed adverse effect levels or estimated exposure doses. The derived safety margin of more than 100 for topical tretinoin (with 2% absorption) contrasted sharply with the near unity values for valproic acid, methotrexate, thalidomide, and isotretinoin and was larger than that for acetylsalicylic acid. These data support other epidemiologic and animal data that topical tretinoin is not a potential human developmental toxicant.

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

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,...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

Pesticide Ingredients

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure Fact Sheets Types of Pesticides Pest Control Information Pesticide Health and Safety Information

2009 Human Factors and Roadway Safety Workshop : Context and Objectives [SD .WMV (720x480/29fps/37.3 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Context and Objectives : Mark Lowe, director, Iowa DOT Motor Vehicle Division, speaks on the d...

21 CFR 184.1472 - Menhaden oil.

Code of Federal Regulations, 2010 CFR

2010-04-01

... available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Menhaden oil. 184.1472 Section 184.1472 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

75 FR 12688 - Safety Zone; Gallants Channel, Beaufort, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

... immediate action is needed to ensure the safety of human life and property from the hazards of falling... life and property on navigable waters and due to the hazards associated with potential falling debris... which do not individually or cumulatively have a significant effect on the human environment. This rule...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2013 CFR

2013-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2011 CFR

2011-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2014 CFR

2014-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2012 CFR

2012-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

Self-Extinguishing Lithium Ion Batteries Based on Internally Embedded Fire-Extinguishing Microcapsules with Temperature-Responsiveness.

PubMed

Yim, Taeeun; Park, Min-Sik; Woo, Sang-Gil; Kwon, Hyuk-Kwon; Yoo, Jung-Keun; Jung, Yeon Sik; Kim, Ki Jae; Yu, Ji-Sang; Kim, Young-Jun

2015-08-12

User safety is one of the most critical issues for the successful implementation of lithium ion batteries (LIBs) in electric vehicles and their further expansion in large-scale energy storage systems. Herein, we propose a novel approach to realize self-extinguishing capability of LIBs for effective safety improvement by integrating temperature-responsive microcapsules containing a fire-extinguishing agent. The microcapsules are designed to release an extinguisher agent upon increased internal temperature of an LIB, resulting in rapid heat absorption through an in situ endothermic reaction and suppression of further temperature rise and undesirable thermal runaway. In a standard nail penetration test, the temperature rise is reduced by 74% without compromising electrochemical performances. It is anticipated that on the strengths of excellent scalability, simplicity, and cost-effectiveness, this novel strategy can be extensively applied to various high energy-density devices to ensure human safety.

Defining health information technology-related errors: new developments since to err is human.

PubMed

Sittig, Dean F; Singh, Hardeep

2011-07-25

Despite the promise of health information technology (HIT), recent literature has revealed possible safety hazards associated with its use. The Office of the National Coordinator for HIT recently sponsored an Institute of Medicine committee to synthesize evidence and experience from the field on how HIT affects patient safety. To lay the groundwork for defining, measuring, and analyzing HIT-related safety hazards, we propose that HIT-related error occurs anytime HIT is unavailable for use, malfunctions during use, is used incorrectly by someone, or when HIT interacts with another system component incorrectly, resulting in data being lost or incorrectly entered, displayed, or transmitted. These errors, or the decisions that result from them, significantly increase the risk of adverse events and patient harm. We describe how a sociotechnical approach can be used to understand the complex origins of HIT errors, which may have roots in rapidly evolving technological, professional, organizational, and policy initiatives.

A Qualitative Study on Organizational Factors Affecting Occupational Accidents

PubMed Central

ESKANDARI, Davood; JAFARI, Mohammad Javad; MEHRABI, Yadollah; KIAN, Mostafa Pouya; CHARKHAND, Hossein; MIRGHOTBI, Mostafa

2017-01-01

Background: Technical, human, operational and organizational factors have been influencing the sequence of occupational accidents. Among them, organizational factors play a major role in causing occupational accidents. The aim of this research was to understand the Iranian safety experts’ experiences and perception of organizational factors. Methods: This qualitative study was conducted in 2015 by using the content analysis technique. Data were collected through semi-structured interviews with 17 safety experts working in Iranian universities and industries and analyzed with a conventional qualitative content analysis method using the MAXQDA software. Results: Eleven organizational factors’ sub-themes were identified: management commitment, management participation, employee involvement, communication, blame culture, education and training, job satisfaction, interpersonal relationship, supervision, continuous improvement, and reward system. The participants considered these factors as effective on occupational accidents. Conclusion: The mentioned 11 organizational factors are probably involved in occupational accidents in Iran. Naturally, improving organizational factors can increase the safety performance and reduce occupational accidents. PMID:28435824

A Qualitative Study on Organizational Factors Affecting Occupational Accidents.

PubMed

Eskandari, Davood; Jafari, Mohammad Javad; Mehrabi, Yadollah; Kian, Mostafa Pouya; Charkhand, Hossein; Mirghotbi, Mostafa

2017-03-01

Technical, human, operational and organizational factors have been influencing the sequence of occupational accidents. Among them, organizational factors play a major role in causing occupational accidents. The aim of this research was to understand the Iranian safety experts' experiences and perception of organizational factors. This qualitative study was conducted in 2015 by using the content analysis technique. Data were collected through semi-structured interviews with 17 safety experts working in Iranian universities and industries and analyzed with a conventional qualitative content analysis method using the MAXQDA software. Eleven organizational factors' sub-themes were identified: management commitment, management participation, employee involvement, communication, blame culture, education and training, job satisfaction, interpersonal relationship, supervision, continuous improvement, and reward system. The participants considered these factors as effective on occupational accidents. The mentioned 11 organizational factors are probably involved in occupational accidents in Iran. Naturally, improving organizational factors can increase the safety performance and reduce occupational accidents.

Effect of directional speech warnings on road hazard detection.

PubMed

Serrano, Jesús; Di Stasi, Leandro L; Megías, Alberto; Catena, Andrés

2011-12-01

In the last 2 decades, cognitive science and the transportation psychology field have dedicated a lot of effort to designing advanced driver support systems. Verbal warning systems are increasingly being implemented in modern automobiles in an effort to increase road safety. The study presented here investigated the impact of directional speech alert messages on the participants' speed to judge whether or not naturalistic road scenes depicted a situation of impending danger. Thirty-eight volunteers performed a computer-based key-press reaction time task. Findings indicated that semantic content of verbal warning signals can be used for increasing driving safety and improving hazard detection. Furthermore, the classical result regarding signal accuracy is confirmed: directional informative speech messages lead to faster hazard detection compared to drivers who received a high rate of false alarms. Notwithstanding some study limitations (lack of driver experience and low ecological validity), this evidence could provide important information for the specification of future Human-Machine-interaction (HMI) design guidelines.

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.

Pathological classification of human iPSC-derived neural stem/progenitor cells towards safety assessment of transplantation therapy for CNS diseases.

PubMed

Sugai, Keiko; Fukuzawa, Ryuji; Shofuda, Tomoko; Fukusumi, Hayato; Kawabata, Soya; Nishiyama, Yuichiro; Higuchi, Yuichiro; Kawai, Kenji; Isoda, Miho; Kanematsu, Daisuke; Hashimoto-Tamaoki, Tomoko; Kohyama, Jun; Iwanami, Akio; Suemizu, Hiroshi; Ikeda, Eiji; Matsumoto, Morio; Kanemura, Yonehiro; Nakamura, Masaya; Okano, Hideyuki

2016-09-19

The risk of tumorigenicity is a hurdle for regenerative medicine using induced pluripotent stem cells (iPSCs). Although teratoma formation is readily distinguishable, the malignant transformation of iPSC derivatives has not been clearly defined due to insufficient analysis of histology and phenotype. In the present study, we evaluated the histology of neural stem/progenitor cells (NSPCs) generated from integration-free human peripheral blood mononuclear cell (PBMC)-derived iPSCs (iPSC-NSPCs) following transplantation into central nervous system (CNS) of immunodeficient mice. We found that transplanted iPSC-NSPCs produced differentiation patterns resembling those in embryonic CNS development, and that the microenvironment of the final site of migration affected their maturational stage. Genomic instability of iPSCs correlated with increased proliferation of transplants, although no carcinogenesis was evident. The histological classifications presented here may provide cues for addressing potential safety issues confronting regenerative medicine involving iPSCs.

The Human Dimension of Closing the Training Gap for Fifth-Generation Fighters

NASA Technical Reports Server (NTRS)

Hoke, Jaclyn; Postnikov, Alex; Schnell, Thomas

2012-01-01

Based on a review of the recent technical literature there is little question that a serious training gap exists for fifth-generation fighters, primarily arising from the need to provide their own red-air. There are several methods for reducing this gap, including injecting virtual and constructive threats into the live cockpit. This live-virtual-constructive (LVC) training approach provides a cost effective means for addressing training needs but faces several challenges. Technical challenges include data links and information assurance. A more serious challenge may be the human factors dimension of representing virtual and constructive entities in the cockpit while ensuring safety-of-flight. This also needs to happen without increasing pilot workload. This paper discusses the methods Rockwell Collins and the University of Iowa's Operator Performance Lab use to assess pilot workload and training fidelity measures in an LVC training environment and the research we are conducting in safety-of-flight requirements of integrated LVC symbology.

FDA-approved drugs that protect mammalian neurons from glucose toxicity slow aging dependent on cbp and protect against proteotoxicity.

PubMed

Lublin, Alex; Isoda, Fumiko; Patel, Harshil; Yen, Kelvin; Nguyen, Linda; Hajje, Daher; Schwartz, Marc; Mobbs, Charles

2011-01-01

Screening a library of drugs with known safety profiles in humans yielded 30 drugs that reliably protected mammalian neurons against glucose toxicity. Subsequent screening demonstrated that 6 of these 30 drugs increase lifespan in C. elegans: caffeine, ciclopirox olamine, tannic acid, acetaminophen, bacitracin, and baicalein. Every drug significantly reduced the age-dependent acceleration of mortality rate. These protective effects were blocked by RNAi inhibition of cbp-1 in adults only, which also blocks protective effects of dietary restriction. Only 2 drugs, caffeine and tannic acid, exhibited a similar dependency on DAF-16. Caffeine, tannic acid, and bacitracin also reduced pathology in a transgenic model of proteotoxicity associated with Alzheimer's disease. These results further support a key role for glucose toxicity in driving age-related pathologies and for CBP-1 in protection against age-related pathologies. These results also provide novel lead compounds with known safety profiles in human for treatment of age-related diseases, including Alzheimer's disease and diabetic complications.

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

Meta-Analysis of Maternal and Neonatal Outcomes Associated with the Use of Insulin Glargine versus NPH Insulin during Pregnancy

PubMed Central

Lepercq, Jacques; Lin, Jay; Hall, Gillian C.; Wang, Edward; Dain, Marie-Paule; Riddle, Matthew C.; Home, Philip D.

2012-01-01

As glargine, an analog of human insulin, is increasingly used during pregnancy, a meta-analysis assessed its safety in this population. A systematic literature search identified studies of gestational or pregestational diabetes comparing use of insulin glargine with human NPH insulin, with at least 15 women in both arms. Data was extracted for maternal outcomes (weight at delivery, weight gain, 1st/3rd trimester HbA1c, severe hypoglycemia, gestation/new-onset hypertension, preeclampsia, and cesarean section) and neonatal outcomes (congenital malformations, gestational age at delivery, birth weight, macrosomia, LGA, 5 minute Apgar score >7, NICU admissions, respiratory distress syndrome, neonatal hypoglycemia, and hyperbilirubinemia). Relative risk ratios and weighted mean differences were determined using a random effect model. Eight studies of women using glargine (331) or NPH (371) were analyzed. No significant differences in the efficacy and safety-related outcomes were found between glargine and NPH use during pregnancy. PMID:22685467

Safety and regulation of yeasts used for biocontrol or biopreservation in the food or feed chain.

PubMed

Sundh, Ingvar; Melin, Petter

2011-01-01

Yeasts have been important components of spontaneous fermentations in food and beverage processing for millennia. More recently, the potential of utilising antagonistic yeasts, e.g. Pichia anomala and Candida spp., for post-harvest biological control of spoilage fungi during storage of plant-derived produce ('biopreservation') has been clearly demonstrated. Although some yeast species are among the safest microorganisms known, several have been reported in opportunistic infections in humans, including P. anomala and bakers' yeast, Saccharomyces cerevisiae. More research is needed about the dominant pathogenicity and virulence factors in opportunistic yeasts, and whether increased utilisation of biopreservative yeasts in general could contribute to an increased prevalence of yeast infections. The regulatory situation for yeasts used in post-harvest biocontrol is complex and the few products that have reached the market are mainly registered as biological pesticides. The qualified presumption of safety (QPS) approach to safety assessments of microorganisms intentionally added to food or feed, recently launched by the European Food Safety Authority, can lead to more efficient evaluations of new products containing microbial species with a sufficient body of knowledge or long-term experience on their safety. P. anomala is one of several yeast species that have been given QPS status, although the status is restricted to use of this yeast for enzyme and metabolite production purposes. With regard to authorisation of new biopreservative yeasts, we recommend that the possibility to regulate microorganisms for food biopreservation as food additives be considered.

Human-centered design of a cyber-physical system for advanced response to Ebola (CARE).

PubMed

Dimitrov, Velin; Jagtap, Vinayak; Skorinko, Jeanine; Chernova, Sonia; Gennert, Michael; Padir, Taşkin

2015-01-01

We describe the process towards the design of a safe, reliable, and intuitive emergency treatment unit to facilitate a higher degree of safety and situational awareness for medical staff, leading to an increased level of patient care during an epidemic outbreak in an unprepared, underdeveloped, or disaster stricken area. We start with a human-centered design process to understand the design challenge of working with Ebola treatment units in Western Africa in the latest Ebola outbreak, and show preliminary work towards cyber-physical technologies applicable to potentially helping during the next outbreak.

Nanotechnology in global medicine and human biosecurity: private interests, policy dilemmas, and the calibration of public health law.

PubMed

Faunce, Thomas A

2007-01-01

This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: (1) expenditure of public funds, (2) public-funded research priorities, (3) public confidence in government and science and, finally, (4) public safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-influenced norms issuing from bioethics and international human rights.

Leucoreduction of blood components: an effective way to increase blood safety?

PubMed Central

Bianchi, Maria; Vaglio, Stefania; Pupella, Simonetta; Marano, Giuseppe; Facco, Giuseppina; Liumbruno, Giancarlo M.; Grazzini, Giuliano

2016-01-01

Over the past 30 years, it has been demonstrated that removal of white blood cells from blood components is effective in preventing some adverse reactions such as febrile non-haemolytic transfusion reactions, immunisation against human leucocyte antigens and human platelet antigens, and transmission of cytomegalovirus. In this review we discuss indications for leucoreduction and classify them into three categories: evidence-based indications for which the clinical efficacy is proven, indications based on the analysis of observational clinical studies with very consistent results and indications for which the clinical efficacy is partial or unproven. PMID:26710353

Application of Disposable Bag Bioreactors in Tissue Engineering and for the Production of Therapeutic Agents

NASA Astrophysics Data System (ADS)

Eibl, R.; Eibl, D.

In order to increase process efficiency, many pharmaceutical and biotechnology companies have introduced disposable bag technology over the last 10 years. Because this technology also greatly reduces the risk of cross-contamination, disposable bags are preferred in applications in which an absolute or improved process safety is a necessity, namely the production of functional tissue for implantation (tissue engineering), the production of human cells for the treatment of cancer and immune system diseases (cellular therapy), the production of viruses for gene therapies, the production of therapeutic proteins, and veterinary as well as human vaccines.

Energy Storage Technology Development for Space Exploration

NASA Technical Reports Server (NTRS)

Mercer, Carolyn R.; Jankovsky, Amy L.; Reid, Concha M.; Miller, Thomas B.; Hoberecht, Mark A.

2011-01-01

The National Aeronautics and Space Administration is developing battery and fuel cell technology to meet the expected energy storage needs of human exploration systems. Improving battery performance and safety for human missions enhances a number of exploration systems, including un-tethered extravehicular activity suits and transportation systems including landers and rovers. Similarly, improved fuel cell and electrolyzer systems can reduce mass and increase the reliability of electrical power, oxygen, and water generation for crewed vehicles, depots and outposts. To achieve this, NASA is developing non-flow-through proton-exchange-membrane fuel cell stacks, and electrolyzers coupled with low permeability membranes for high pressure operation. The primary advantage of this technology set is the reduction of ancillary parts in the balance-of-plant fewer pumps, separators and related components should result in fewer failure modes and hence a higher probability of achieving very reliable operation, and reduced parasitic power losses enable smaller reactant tanks and therefore systems with lower mass and volume. Key accomplishments over the past year include the fabrication and testing of several robust, small-scale non-flow-through fuel cell stacks that have demonstrated proof-of-concept. NASA is also developing advanced lithium-ion battery cells, targeting cell-level safety and very high specific energy and energy density. Key accomplishments include the development of silicon composite anodes, lithiatedmixed- metal-oxide cathodes, low-flammability electrolytes, and cell-incorporated safety devices that promise to substantially improve battery performance while providing a high level of safety.

Wildfire risk reduction in the United States: Leadership staff perceptions of local fire department roles and responsibilities

Treesearch

Rachel S. Madsen; Hylton J. G. Haynes; Sarah M. McCaffrey

2018-01-01

As wildland fires have had increasing negative impacts on a range of human values, in many parts of the United States (U.S.) and around the world, collaborative risk reduction efforts among agencies, homeowners, and fire departments are needed to improve wildfire safety and mitigate risk. Using interview data from 46 senior officers from local fire departments around...

Life in extreme environments: how will humans perform on Mars?

NASA Technical Reports Server (NTRS)

Newman, D. J.

2000-01-01

This review of astronaut extravehicular activity (EVA) and the details of American and Soviet/Russian spacesuit design focuses on design recommendations to enhance astronaut safety and effectiveness. Innovative spacesuit design is essential, given the challenges of future exploration-class missions in which astronauts will be called upon to perform increasingly complex and physically demanding tasks in the extreme environments of microgravity and partial gravity.

Model-based safety analysis of human-robot interactions: the MIRAS walking assistance robot.

PubMed

Guiochet, Jérémie; Hoang, Quynh Anh Do; Kaaniche, Mohamed; Powell, David

2013-06-01

Robotic systems have to cope with various execution environments while guaranteeing safety, and in particular when they interact with humans during rehabilitation tasks. These systems are often critical since their failure can lead to human injury or even death. However, such systems are difficult to validate due to their high complexity and the fact that they operate within complex, variable and uncertain environments (including users), in which it is difficult to foresee all possible system behaviors. Because of the complexity of human-robot interactions, rigorous and systematic approaches are needed to assist the developers in the identification of significant threats and the implementation of efficient protection mechanisms, and in the elaboration of a sound argumentation to justify the level of safety that can be achieved by the system. For threat identification, we propose a method called HAZOP-UML based on a risk analysis technique adapted to system description models, focusing on human-robot interaction models. The output of this step is then injected in a structured safety argumentation using the GSN graphical notation. Those approaches have been successfully applied to the development of a walking assistant robot which is now in clinical validation.

Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study.

PubMed

Vangsness, C Thomas; Farr, Jack; Boyd, Joel; Dellaero, David T; Mills, C Randal; LeRoux-Williams, Michelle

2014-01-15

There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee. Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation. In a randomized, double-blind, controlled study, the safety of the intra-articular injection of human mesenchymal stem cells into the knee, the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy, and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated. A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy. A single superolateral knee injection was given within seven to ten days after the meniscectomy. Patients were randomized to one of three treatment groups: Group A, in which patients received an injection of 50 × 10⁶ allogeneic mesenchymal stem cells; Group B, 150 × 10⁶ allogeneic mesenchymal stem cells; and the control group, a sodium hyaluronate (hyaluronic acid/hyaluronan) vehicle control. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI). No ectopic tissue formation or clinically important safety issues were identified. There was significantly increased meniscal volume (defined a priori as a 15% threshold) determined by quantitative MRI in 24% of patients in Group A and 6% in Group B at twelve months post meniscectomy (p = 0.022). No patients in the control group met the 15% threshold for increased meniscal volume. Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments. There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

Interactions With Robots: The Truths We Reveal About Ourselves.

PubMed

Broadbent, Elizabeth

2017-01-03

In movies, robots are often extremely humanlike. Although these robots are not yet reality, robots are currently being used in healthcare, education, and business. Robots provide benefits such as relieving loneliness and enabling communication. Engineers are trying to build robots that look and behave like humans and thus need comprehensive knowledge not only of technology but also of human cognition, emotion, and behavior. This need is driving engineers to study human behavior toward other humans and toward robots, leading to greater understanding of how humans think, feel, and behave in these contexts, including our tendencies for mindless social behaviors, anthropomorphism, uncanny feelings toward robots, and the formation of emotional attachments. However, in considering the increased use of robots, many people have concerns about deception, privacy, job loss, safety, and the loss of human relationships. Human-robot interaction is a fascinating field and one in which psychologists have much to contribute, both to the development of robots and to the study of human behavior.

Safety through Education and Training.

ERIC Educational Resources Information Center

Thorburn, S.

1990-01-01

Addresses the need for safety education as a continuous process through elementary and secondary phases of education in the context of human risk within modern society. Discusses the teaching of safety subjects in civil engineering curriculum. (YP)

Risk Management in the Human Spaceflight Program

NASA Technical Reports Server (NTRS)

Hoffman, William

2009-01-01

The contents include:1) NASA Mission and Organization; 2) Major Mission Failures and Causes; 3) Cultural Changes Resulting from Failures; 3) Safety at NASA Today; 4) Best Safety Practices; 5) Safety Challenges; and 6) Future Commitment.

How Agricultural Media Cover Safety Compared with Periodicals in Two Other Hazardous Industries.

PubMed

Marolf, Amanda; Heiberger, Scott; Evans, James; Joseph, Lura

2017-01-26

This analysis featured a uniquely broad look at challenges and potentials for engaging agricultural and other industrial media more effectively in covering safety. It involved a content analysis of selected industry periodicals serving agriculture, mining, and transportation, which are three of the nation's most hazardous industries, in terms of human safety. Use of the social amplification of risk framework (SARF) provided insight on safety coverage. In particular, it tested previous research indicating that media coverage tends to amplify (increase) more than attenuate (decrease) a sense of risk. Analysis involved 18 periodicals (9 agriculture, 7 transportation, and 2 mining) spanning a five-year period from 2008 to 2012. Full-text digital analysis identified terms found in safety articles across all three industries. A manual review of articles revealed the quantity and nature of safety coverage within and among these industries. Results identified 528 safety-related articles published during the period. Transportation and mining periodicals averaged more than twice as many safety articles as the agricultural periodicals. The amount of coverage within the three industries also varied greatly. Findings on the nature of coverage supported previous media research within the SARF. Coverage across all three industries was clearly oriented more to amplifying than to attenuating risk. This study adds to the understanding of variations, commonalities, challenges, and potentials for enhancing safety coverage by media serving these three industries. It also provides direction for engaging industry media more effectively in the public safety mission. The authors recommend seven areas of opportunity for further research. Copyright© by the American Society of Agricultural Engineers.

Chitosan Dilutable and Dilactin Forte: Assessment of Their Efficiency for Safety and Quality of Foodstuff

NASA Astrophysics Data System (ADS)

Iurchikova, N.; Khlebosolova, O.

2018-01-01

The modern natural food preservatives used to process and store foodstuff allow to ensure its safety and high quality. Chitosan and dilactin-forte are among such medicines. These preservatives are not only safe, but also are beneficial to a human body in virtue of their effects onto human digestive system. The article describes the results of the research conducted to identify the impact of these natural preservatives on safety of carrot (Daucus carota subsp. sativus)

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.

Effects of heated hydrotherapy on muscle HSP70 and glucose metabolism in old and young vervet monkeys.

PubMed

Kavanagh, Kylie; Davis, Ashely T; Jenkins, Kurt A; Flynn, D Mickey

2016-07-01

Increasing heat shock protein 70 (HSP70) in aged and/or insulin-resistant animal models confers benefits to healthspan and lifespan. Heat application to increase core temperature induces HSPs in metabolically important tissues, and preliminary human and animal data suggest that heated hydrotherapy is an effective method to achieve increased HSPs. However, safety concerns exist, particularly in geriatric medicine where organ and cardiovascular disease commonly will preexist. We evaluated young vervet monkeys compared to old, insulin-resistant vervet monkeys (Chlorocebus aethiops sabaeus) in their core temperatures, glucose tolerance, muscle HSP70 level, and selected safety biomarkers after 10 sessions of hot water immersions administered twice weekly. Hot water immersion robustly induced the heat shock response in muscles. We observed that heat-treated old and young monkeys have significantly higher muscle HSP70 than control monkeys and treatment was without significant adverse effects on organ or cardiovascular health. Heat therapy improved pancreatic responses to glucose challenge and tended to normalize glucose excursions. A trend for worsened blood pressure and glucose values in the control monkeys and improved values in heat-treated monkeys were seen to support further investigation into the safety and efficacy of this intervention for metabolic syndrome or diabetes in young or old persons unable to exercise.

Creatine and creatine forms intended for sports nutrition.

PubMed

Andres, Susanne; Ziegenhagen, Rainer; Trefflich, Iris; Pevny, Sophie; Schultrich, Katharina; Braun, Hans; Schänzer, Wilhelm; Hirsch-Ernst, Karen Ildico; Schäfer, Bernd; Lampen, Alfonso

2017-06-01

Creatine is a popular ergogenic supplement in sports nutrition. Yet, supplementation of creatine occasionally caused adverse effects such as gastrointestinal complaints, muscle cramps and an increase in body weight. Creatine monohydrate has already been evaluated by different competent authorities and several have come to the conclusion that a daily intake of 3 g creatine per person is unlikely to pose safety concerns, focusing on healthy adults with exclusion of pregnant and breastfeeding women. Possible vulnerable subgroups were also discussed in relation to the safety of creatine. The present review provides an up-to-date overview of the relevant information with special focus on human studies regarding the safety of creatine monohydrate and other marketed creatine forms, in particular creatine pyruvate, creatine citrate, creatine malate, creatine taurinate, creatine phosphate, creatine orotate, creatine ethyl ester, creatine pyroglutamate, creatine gluconate, and magnesium creatine chelate. Limited data are available with regard to the safety of the latter creatine forms. Considering an acceptable creatine intake of 3 g per day, most of the evaluated creatine forms are unlikely to pose safety concerns, however some safety concerns regarding a supplementary intake of creatine orotate, creatine phosphate, and magnesium creatine chelate are discussed here. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Evaluation of a community based childhood injury prevention program.

PubMed Central

Bablouzian, L.; Freedman, E. S.; Wolski, K. E.; Fried, L. E.

1997-01-01

OBJECTIVES: This pilot study evaluates the effectiveness of a community based childhood injury prevention program on the reduction of home hazards. METHODS: High risk pregnant women, who were enrolled in a home visiting program that augments existing health and human services, received initial home safety assessments. Clients received education about injury prevention practices, in addition to receiving selected home safety supplies. Fourteen questions from the initial assessment tool were repeated upon discharge from the program. Matched analyses were conducted to evaluate differences from initial assessment to discharge. RESULTS: A significantly larger proportion of homes were assessed as safe at discharge, compared with the initial assessment, for the following hazards: children riding unbuckled in all auto travel, Massachusetts Poison Center sticker on the telephone, outlet plugs in all unused electrical outlets, safety latches on cabinets and drawers, and syrup of ipecac in the home. CONCLUSIONS: A community based childhood injury prevention program providing education and safety supplies to clients significantly reduced four home hazards for which safety supplies were provided. Education and promotion of the proper use of child restraint systems in automobiles significantly reduced a fifth hazard, children riding unbuckled in auto travel. This program appears to reduce the prevalence of home hazards and, therefore, to increase home safety. PMID:9113841

The Impact of Participatory Safety Rules Revision on Incident Rates, Liability Claims, and Safety Culture in the U.S. Railroad Industry

DOT National Transportation Integrated Search

2007-07-01

The Federal Railroad Administration Human Factors Research and Development Program sponsored a lessons learned study to examine the impact of safety rules revision on safety culture, incident rates, and liability claims in the railroad industry. Safe...

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From the BREF PSO

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: The Patient Safety and Quality Improvement Act of...

42 CFR 3.208 - Continued protection of patient safety work product.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Continued protection of patient safety work product. 3.208 Section 3.208 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

Professional Preparation for Careers in Safety.

ERIC Educational Resources Information Center

Della-Giustina, Daniel

There has been a long existing need for individuals with extensive training and concentration in safety studies. The foundation areas upon which a curriculum for training safety practitioners is based should include: (1) trends in accident prevention and control; (2) safety analysis of human and machine tasks; (3) hazard identification and control…

78 FR 64504 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or..., Number 177, Pages 56235-56236. Contact Person for More Information: Price Connor, Ph.D., NIOSH Health...

Identification and in Vivo Evaluation of Liver X Receptor β-Selective Agonists for the Potential Treatment of Alzheimer’s Disease

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

Stachel, Shawn J.; Zerbinatti, Celina; Rudd, Michael T.

2016-04-14

Herein, we describe the development of a functionally selective liver X receptor β (LXRβ) agonist series optimized for Emax selectivity, solubility, and physical properties to allow efficacy and safety studies in vivo. Compound 9 showed central pharmacodynamic effects in rodent models, evidenced by statistically significant increases in apolipoprotein E (apoE) and ATP-binding cassette transporter levels in the brain, along with a greatly improved peripheral lipid safety profile when compared to those of full dual agonists. These findings were replicated by subchronic dosing studies in non-human primates, where cerebrospinal fluid levels of apoE and amyloid-β peptides were increased concomitantly with anmore » improved peripheral lipid profile relative to that of nonselective compounds. These results suggest that optimization of LXR agonists for Emax selectivity may have the potential to circumvent the adverse lipid-related effects of hepatic LXR activity.« less

Text messaging for sexual communication and safety among African American young adults.

PubMed

Broaddus, Michelle R; Dickson-Gomez, Julia

2013-10-01

African American young adults are at high risk of HIV infection during their lifetimes, and the male condom remains the best method of prevention. Efforts to increase condom use should address the barrier of condom negotiation. We conducted a thematic analysis of qualitative, semistructured interviews with African American young adults to examine their use of text messaging for requesting human immunodeficiency virus (HIV) or sexually transmitted infection (STI) testing and condom use within the larger context of general sexual communication using text messages. Text messaging gave participants a level of comfort and disinhibition to discuss sexual topics and negotiate sexual safety. Benefits of text messages included ease of communication, privacy, and increased ability to express condom desires. Difficulties reflected the potential relationship implications of suggesting HIV/STI testing and condom use. Condom negotiation strategies using text messages also mirrored those found to be used in face-to-face communication.

Text Messaging for Sexual Communication and Safety Among African American Young Adults

PubMed Central

Broaddus, Michelle R.; Dickson-Gomez, Julia

2014-01-01

African American young adults are at high risk of HIV infection during their lifetimes, and the male condom remains the best method of prevention. Efforts to increase condom use should address the barrier of condom negotiation. We conducted a thematic analysis of qualitative, semi-structured interviews with African American young adults to examine their use of text messaging for requesting Human Immunodeficiency Virus (HIV) or sexually transmitted infection (STI) testing and condom use within the larger context of general sexual communication using text messages. Text messaging gave participants a level of comfort and disinhibition to discuss sexual topics and negotiate sexual safety. Benefits of text messages included ease of communication, privacy, and increased ability to express condom desires. Difficulties reflected the potential relationship implications of suggesting HIV/STI testing and condom use. Condom negotiation strategies using text messages also mirrored those used found to be used in face-to-face communication. PMID:24045286

The influence of anatomical and physiological parameters on the interference voltage at the input of unipolar cardiac pacemakers in low frequency electric fields.

PubMed

Joosten, S; Pammler, K; Silny, J

2009-02-07

The problem of electromagnetic interference of electronic implants such as cardiac pacemakers has been well known for many years. An increasing number of field sources in everyday life and occupational environment leads unavoidably to an increased risk for patients with electronic implants. However, no obligatory national or international safety regulations exist for the protection of this patient group. The aim of this study is to find out the anatomical and physiological worst-case conditions for patients with an implanted pacemaker adjusted to unipolar sensing in external time-varying electric fields. The results of this study with 15 volunteers show that, in electric fields, variation of the interference voltage at the input of a cardiac pacemaker adds up to 200% only because of individual factors. These factors should be considered in human studies and in the setting of safety regulations.

Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer’s Disease

PubMed Central

Arendash, Gary W.

2016-01-01

We have demonstrated in multiple studies that daily, long-term electromagnetic field (EMF) treatment in the ultra-high frequency range not only protects Alzheimer’s disease (AD) transgenic mice from cognitive impairment, but also reverses such impairment in aged AD mice. Moreover, these beneficial cognitive effects appear to be through direct actions on the AD process. Based on a large array of pre-clinical data, we have initiated a pilot clinical trial to determine the safety and efficacy of EMF treatment to mild-moderate AD subjects. Since it is important to establish the safety of this new neuromodulatory approach, the main purpose of this review is to provide a comprehensive assessment of evidence supporting the safety of EMFs, particularly through transcranial electromagnetic treatment (TEMT). In addition to our own pre-clinical studies, a rich variety of both animal and cell culture studies performed by others have underscored the anticipated safety of TEMT in clinical AD trials. Moreover, numerous clinical studies have determined that short- or long-term human exposure to EMFs similar to those to be provided clinically by TEMT do not have deleterious effects on general health, cognitive function, or a variety of physiologic measures—to the contrary, beneficial effects on brain function/activity have been reported. Importantly, such EMF exposure has not been shown to increase the risk of any type of cancer in human epidemiologic studies, as well as animal and cell culture studies. In view of all the above, clinical trials of safety/efficacy with TEMT to AD subjects are clearly warranted and now in progress. PMID:27258417

2005 Tri-Service Infrastructure Systems Conference and Exhibition. Volume 12. Tracks 15, 16 and 17

DTIC Science & Technology

2005-08-04

glare, surface luminances, and uniformity. Also, the importance of daylight on human health and productivity is emphasized. • Exterior lighting design...Electrical Safety Requirements – OSHA CFR Title 29 Part 1910 Occupational Safety and Health Standard, Subpart S – Electrical – Design Safety...Standards and Safety Related Work Practices Part 1926 Safety and Health Regulations for Construction, Subpart K – Electrical – Installation Safety

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.

National plan to enhance aviation safety through human factors improvements

NASA Technical Reports Server (NTRS)

Foushee, Clay

1990-01-01

The purpose of this section of the plan is to establish a development and implementation strategy plan for improving safety and efficiency in the Air Traffic Control (ATC) system. These improvements will be achieved through the proper applications of human factors considerations to the present and future systems. The program will have four basic goals: (1) prepare for the future system through proper hiring and training; (2) develop a controller work station team concept (managing human errors); (3) understand and address the human factors implications of negative system results; and (4) define the proper division of responsibilities and interactions between the human and the machine in ATC systems. This plan addresses six program elements which together address the overall purpose. The six program elements are: (1) determine principles of human-centered automation that will enhance aviation safety and the efficiency of the air traffic controller; (2) provide new and/or enhanced methods and techniques to measure, assess, and improve human performance in the ATC environment; (3) determine system needs and methods for information transfer between and within controller teams and between controller teams and the cockpit; (4) determine how new controller work station technology can optimally be applied and integrated to enhance safety and efficiency; (5) assess training needs and develop improved techniques and strategies for selection, training, and evaluation of controllers; and (6) develop standards, methods, and procedures for the certification and validation of human engineering in the design, testing, and implementation of any hardware or software system element which affects information flow to or from the human.

Human Rating Requirements for NASA's Constellation Program

NASA Technical Reports Server (NTRS)

Berdich, Debbie

2008-01-01

NASA s Constellation Program (CxP) will conduct a series of human space expeditions of increasing scope, starting with missions supporting the International Space Station and expanding to encompass the Moon and Mars. Although human-rating is an integral part of all CxP activities throughout their life cycle, NASA Procedural Requirements document NPR 8705.2B, Human-Rating Requirements (HRR) for Space Flight Systems, defines the additional processes, procedures, and requirements necessary to produce human-rated space systems that protect the safety of crew members and passengers on these NASA missions. In order to be in compliance with 8705.2B the CxP must show appropriate implementation or progression toward the HRR, or justification for an exception. Compliance includes an explanation of how the CxP intends to meet the HRR, analyses to be performed to determine implementation; and a matrix to trace the HRR to CxP requirements. The HRR requires the CxP to establish a human system integration team (HSIT), consisting of astronauts, mission operations personnel, training personnel, ground processing personnel, human factors personnel, and human engineering experts, with clearly defined authority, responsibility, and accountability to lead the human-system integration. For example, per the HRR the HSIT is involved in the evaluation of crew workload, human-in-the-loop usability evaluations, determining associated criteria, and in assessment of how these activities influenced system design. In essence, the HSIT is invaluable in CxP s ability to meet the three fundamental tenets of human rating: the process of designing, evaluating, and assuring that the total system can safely conduct the required human missions; the incorporation of design features and capabilities that accommodate human interaction with the system to enhance overall safety and mission success; and the incorporation of design features and capabilities to enable safe recovery of the crew from hazardous situations.

Patient safety: lessons learned.

PubMed

Bagian, James P

2006-04-01

The traditional approach to patient safety in health care has ranged from reticence to outward denial of serious flaws. This undermines the otherwise remarkable advances in technology and information that have characterized the specialty of medical practice. In addition, lessons learned in industries outside health care, such as in aviation, provide opportunities for improvements that successfully reduce mishaps and errors while maintaining a standard of excellence. This is precisely the call in medicine prompted by the 1999 Institute of Medicine report "To Err Is Human: Building a Safer Health System." However, to effect these changes, key components of a successful safety system must include: (1) communication, (2) a shift from a posture of reliance on human infallibility (hence "shame and blame") to checklists that recognize the contribution of the system and account for human limitations, and (3) a cultivation of non-punitive open and/or de-identified/anonymous reporting of safety concerns, including close calls, in addition to adverse events.

Beyond usability: designing effective technology implementation systems to promote patient safety.

PubMed

Karsh, B-T

2004-10-01

Evidence is emerging that certain technologies such as computerized provider order entry may reduce the likelihood of patient harm. However, many technologies that should reduce medical errors have been abandoned because of problems with their design, their impact on workflow, and general dissatisfaction with them by end users. Patient safety researchers have therefore looked to human factors engineering for guidance on how to design technologies to be usable (easy to use) and useful (improving job performance, efficiency, and/or quality). While this is a necessary step towards improving the likelihood of end user satisfaction, it is still not sufficient. Human factors engineering research has shown that the manner in which technologies are implemented also needs to be designed carefully if benefits are to be realized. This paper reviews the theoretical knowledge on what leads to successful technology implementation and how this can be translated into specifically designed processes for successful technology change. The literature on diffusion of innovations, technology acceptance, organisational justice, participative decision making, and organisational change is reviewed and strategies for promoting successful implementation are provided. Given the rapid and ever increasing pace of technology implementation in health care, it is critical for the science of technology implementation to be understood and incorporated into efforts to improve patient safety.

Safety and tolerability of injectable lipid-lowering drugs: a review of available clinical data.

PubMed

Cicero, Arrigo F G; Tartagni, Elisa; Ertek, Sibel

2014-08-01

To answer the need of a better low-density lipoprotein (LDL) cholesterol control in statin-treated patients at high risk for cardiovascular disease, new injectable lipid-lowering drugs with innovative mechanisms of action are in advanced phase of development or have just been approved. Evolocumab and alirocumab are fully human monoclonal antibodies inhibiting the proprotein convertase subtilisin/kexin type 9 (PCSK9) that binds to hepatic LDL receptor and prevents it from normal recycling by targeting it for degradation. Mipomersen specifically binds to a segment of the human apolipoprotein B100 messenger RNA, blocking the translation of the gene product. Phase II (for evolocumab and alirocumab) and III (for evolocumab) trials show that PCSK9 inhibitors are equally well tolerated, with adverse events mainly limited to mild-to-moderate nasopharyngitis, injection-site pain, arthralgia and back pain. Mipomersen use is mainly associated to hepatosteatosis, increased transaminases (> 3 times the upper limit of normal), mild-to-moderate injection-site reactions and flu-like symptoms. PCSK9 inhibitors have demonstrated their good safety and tolerability in a large number of subjects with different clinical conditions, including statin-intolerance, enlarging their potential use in a broader range of patients. Further data on long-term mipomersen safety are required.

Three-dimensional T1rho-weighted MRI at 1.5 Tesla.

PubMed

Borthakur, Arijitt; Wheaton, Andrew; Charagundla, Sridhar R; Shapiro, Erik M; Regatte, Ravinder R; Akella, Sarma V S; Kneeland, J Bruce; Reddy, Ravinder

2003-06-01

To design and implement a magnetic resonance imaging (MRI) pulse sequence capable of performing three-dimensional T(1rho)-weighted MRI on a 1.5-T clinical scanner, and determine the optimal sequence parameters, both theoretically and experimentally, so that the energy deposition by the radiofrequency pulses in the sequence, measured as the specific absorption rate (SAR), does not exceed safety guidelines for imaging human subjects. A three-pulse cluster was pre-encoded to a three-dimensional gradient-echo imaging sequence to create a three-dimensional, T(1rho)-weighted MRI pulse sequence. Imaging experiments were performed on a GE clinical scanner with a custom-built knee-coil. We validated the performance of this sequence by imaging articular cartilage of a bovine patella and comparing T(1rho) values measured by this sequence to those obtained with a previously tested two-dimensional imaging sequence. Using a previously developed model for SAR calculation, the imaging parameters were adjusted such that the energy deposition by the radiofrequency pulses in the sequence did not exceed safety guidelines for imaging human subjects. The actual temperature increase due to the sequence was measured in a phantom by a MRI-based temperature mapping technique. Following these experiments, the performance of this sequence was demonstrated in vivo by obtaining T(1rho)-weighted images of the knee joint of a healthy individual. Calculated T(1rho) of articular cartilage in the specimen was similar for both and three-dimensional and two-dimensional methods (84 +/- 2 msec and 80 +/- 3 msec, respectively). The temperature increase in the phantom resulting from the sequence was 0.015 degrees C, which is well below the established safety guidelines. Images of the human knee joint in vivo demonstrate a clear delineation of cartilage from surrounding tissues. We developed and implemented a three-dimensional T(1rho)-weighted pulse sequence on a 1.5-T clinical scanner. Copyright 2003 Wiley-Liss, Inc.

Measurement of SAR-induced temperature increase in a phantom and in vivo with comparison to numerical simulation

PubMed Central

Oh, Sukhoon; Ryu, Yeun-Chul; Carluccio, Giuseppe; Sica, Christopher T.; Collins, Christopher M.

2013-01-01

Purpose Compare numerically-simulated and experimentally-measured temperature increase due to Specific energy Absorption Rate (SAR) from radiofrequency fields. Methods Temperature increase induced in both a phantom and in the human forearm when driving an adjacent circular surface coil was mapped using the proton resonance frequency shift technique of Magnetic Resonance (MR) thermography. The phantom and forearm were also modeled from MR image data, and both SAR and temperature change as induced by the same coil were simulated numerically. Results The simulated and measured temperature increase distributions were generally in good agreement for the phantom. The relative distributions for the human forearm were very similar, with the simulations giving maximum temperature increase about 25% higher than measured. Conclusion Although a number of parameters and uncertainties are involved, it should be possible to use numerical simulations to produce reasonably accurate and conservative estimates of temperature distribution to ensure safety in MR imaging. PMID:23804188

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

PubMed

Monticello, Thomas M

2015-01-01

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

From Pasteur to Probiotics: A Historical Overview of Cheese and Microbes.

PubMed

Donnelly, Catherine W

2013-10-01

Cheese is a food which has been produced for centuries. While cheese was originally developed as a product which extended the shelf life of milk, over time distinct cheese varieties arose, being shaped by geographic, climate, cultural, and economic factors. Global demand for artisan cheeses is creating new economic opportunities. Consumers seeking distinctive products with regional flavor, or terroir, are becoming connoisseurs of hand-crafted cheeses with distinctive tastes and character. These demands have spurred new inquiry into microorganisms used as starter cultures and adjunct cultures, as well as the microbiological consortia of finished cheeses. Such demands have also created new concerns for food safety and international trade. New bacterial pathogens such as Escherichia coli O157:H7 and Salmonella enterica serovar Typhimurium DT104 have emerged in the food supply, causing a reevaluation of the efficacy of traditional cheesemaking procedures to control these pathogens. Similarly, pathogens such as Listeria monocytogenes pose problems to susceptible human populations, and cheese can be a vehicle of transmission for this deadly pathogen. With changes in sanitary requirements due to the globalization of the food industry, governments around the world are increasingly requiring assurances of cheese safety. While many governments recognize the safety of traditional artisan cheeses manufactured from raw milk, others are demanding pasteurization of all milk intended for cheesemaking to provide assurance of microbiological safety. In response, new technologies are being proposed to increase cheese safety, but these technologies fundamentally alter the traditional artisan practices and may not enhance microbiological safety. A reevaluation of the safety of traditional artisan practices, validation thereof, and communication of the scientific principles which promote safety will be necessary to enable the continued production of traditional artisan cheeses in global commerce. This also affords the opportunity to more fully explore the microbial diversity and microbial ecology of the great cheeses of the world.

A first step toward understanding patient safety

PubMed Central

2016-01-01

Patient safety has become an important policy agenda in healthcare systems since publication of the 1999 report entitled "To Err Is Human." The paradigm has changed from blaming the individual for the error to identifying the weakness in the system that led to the adverse events. Anesthesia is one of the first healthcare specialties to adopt techniques and lessons from the aviation industry. The widespread use of simulation programs and the application of human factors engineering to clinical practice are the influences of the aviation industry. Despite holding relatively advanced medical technology and comparable safety records, the Korean health industry has little understanding of the systems approach to patient safety. Because implementation of the existing system and program requires time, dedication, and financial support, the Korean healthcare industry is in urgent need of developing patient safety policies and putting them into practice to improve patient safety before it is too late. PMID:27703622

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

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

Safe Use Practices for Pesticides

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure Home Page Pesticide Health and Safety Information Safe Use Practices for Pesticides Related Topics