Science.gov

Sample records for adequate safety factors

  1. ENSURING ADEQUATE SAFETY WHEN USING HYDROGEN AS A FUEL

    SciTech Connect

    Coutts, D

    2007-01-22

    Demonstration projects using hydrogen as a fuel are becoming very common. Often these projects rely on project-specific risk evaluations to support project safety decisions. This is necessary because regulations, codes, and standards (hereafter referred to as standards) are just being developed. This paper will review some of the approaches being used in these evolving standards, and techniques which demonstration projects can implement to bridge the gap between current requirements and stakeholder desires. Many of the evolving standards for hydrogen-fuel use performance-based language, which establishes minimum performance and safety objectives, as compared with prescriptive-based language that prescribes specific design solutions. This is being done for several reasons including: (1) concern that establishing specific design solutions too early will stifle invention, (2) sparse performance data necessary to support selection of design approaches, and (3) a risk-adverse public which is unwilling to accept losses that were incurred in developing previous prescriptive design standards. The evolving standards often contain words such as: ''The manufacturer shall implement the measures and provide the information necessary to minimize the risk of endangering a person's safety or health''. This typically implies that the manufacturer or project manager must produce and document an acceptable level of risk. If accomplished using comprehensive and systematic process the demonstration project risk assessment can ease the transition to widespread commercialization. An approach to adequately evaluate and document the safety risk will be presented.

  2. [Are legal sanctions for improving traffic safety adequate?].

    PubMed

    Geppert, K

    1990-01-01

    Referring to the field of traffic legislation the author examines the different possibilities to improve the safety on the road, within the corresponding range of summary offence and criminal law; (1) As far as the rules of conduct are concerned he demands a uniform threshold value of at least 0.8% for blood alcohol within the limits of the German penal code Sections 315 c I, 316. He rejects the plan to introduce a criminal offence of considerable speeding if imminent danger is provoked. (2) On the level of sanctions the traditional measures of traffic legislation are to be supplied sensibly by supplementary training courses concerning alcohol abuse. The legal instruments of (temporary) suspension of a person's driving license on the part of criminal jurisdiction or public authorities ought to be utilized on a larger scale. The (Flensburg) repeated perpetration point system is to be improved with regard to special preventive measures. (3) To increase the risk of being caught the control of the traffic by the police is to be intensified--especially through a larger application of technical means. (4) The extension of the instruments of traffic legislation to immediate measures by the police--preliminary or "mini" suspension of a person's driving license by resort to preventive rights by the police?--meets with constitutional or legal scruples.

  3. Aerostructural safety factor criteria

    NASA Technical Reports Server (NTRS)

    Verderaime, V.

    1992-01-01

    The present modification of the conventional safety factor method for aircraft structures evaluation involves the expression of deterministic safety factors in probabilistic tolerance limit ratios; these are found to involve a total of three factors that control the interference of applied and resistive stress distributions. The deterministic expression is extended so that it may furnish a 'relative ultimate safety' index that encompasses all three distribution factors. Operational reliability is developed on the basis of the applied and the yield stress distribution interferences. Industry standards are suggested to be derivable from factor selections that are based on the consequences of failure.

  4. Ensuring Adequate Health and Safety Information for Decision Makers during Large-Scale Chemical Releases

    NASA Astrophysics Data System (ADS)

    Petropoulos, Z.; Clavin, C.; Zuckerman, B.

    2015-12-01

    The 2014 4-Methylcyclohexanemethanol (MCHM) spill in the Elk River of West Virginia highlighted existing gaps in emergency planning for, and response to, large-scale chemical releases in the United States. The Emergency Planning and Community Right-to-Know Act requires that facilities with hazardous substances provide Material Safety Data Sheets (MSDSs), which contain health and safety information on the hazardous substances. The MSDS produced by Eastman Chemical Company, the manufacturer of MCHM, listed "no data available" for various human toxicity subcategories, such as reproductive toxicity and carcinogenicity. As a result of incomplete toxicity data, the public and media received conflicting messages on the safety of the contaminated water from government officials, industry, and the public health community. Two days after the governor lifted the ban on water use, the health department partially retracted the ban by warning pregnant women to continue avoiding the contaminated water, which the Centers for Disease Control and Prevention deemed safe three weeks later. The response in West Virginia represents a failure in risk communication and calls to question if government officials have sufficient information to support evidence-based decisions during future incidents. Research capabilities, like the National Science Foundation RAPID funding, can provide a solution to some of the data gaps, such as information on environmental fate in the case of the MCHM spill. In order to inform policy discussions on this issue, a methodology for assessing the outcomes of RAPID and similar National Institutes of Health grants in the context of emergency response is employed to examine the efficacy of research-based capabilities in enhancing public health decision making capacity. The results of this assessment highlight potential roles rapid scientific research can fill in ensuring adequate health and safety data is readily available for decision makers during large

  5. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  6. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  7. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  8. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  9. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  10. [Factors associated with adequate fruit and vegetable intake by schoolchildren in Santa Catarina State, Brazil].

    PubMed

    Costa, Larissa da Cunha Feio; Vasconcelos, Francisco de Assis Guedes de; Corso, Arlete Catarina Tittoni

    2012-06-01

    This study aimed to estimate fruit and vegetable intake and identify associated factors among schoolchildren in Santa Catarina State, Brazil. A cross-sectional study was conducted with 4,964 students from public and private schools in eight districts in the State, analyzing socioeconomic and anthropometric data and dietary intake. Adequate fruit and vegetable intake was defined as five or more servings per day. Poisson regression was performed to test associations between fruit and vegetable intake and independent variables (p < 0.05). Adequate intake was found in 2.7% of children, while 26.6% of the sample did not consume any fruits and vegetables. In the analysis of the association between independent variables and adequate fruit and vegetable intake in the total sample, only geographic region (residents in western Santa Catarina) and consumption of candy were significantly associated. In the stratified analysis by sex, for boys, only geographic region was associated, while among girls, region and candy consumption were significantly associated with adequate fruit and vegetable intake. The findings indicate the need for specific strategies in the school community to improve fruit and vegetable intake by schoolchildren.

  11. 75 FR 69648 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... Administration (NNSA) approved a DSA for the Plutonium Facility at Los Alamos National Laboratory that... 2009-2, Los Alamos National Laboratory Plutonium ] Facility Seismic Safety. The Board followed up its... Plutonium Facility in December 2008 demonstrates that, despite DOE's stated expectations, it is not...

  12. 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,…

  13. Adequate hypoxia inducible factor 1α signaling is indispensable for bone regeneration.

    PubMed

    Stegen, Steve; Deprez, Sanne; Eelen, Guy; Torrekens, Sophie; Van Looveren, Riet; Goveia, Jermaine; Ghesquière, Bart; Carmeliet, Peter; Carmeliet, Geert

    2016-06-01

    Engineered cell-based constructs are an appealing strategy to treat large skeletal defects. However, transplanted cells are often confronted with an environment that is deprived of oxygen and nutrients. Upon hypoxia, most cell types activate hypoxia-inducible factor 1α (HIF-1α) signaling, but its importance for implanted osteoprogenitor cells during bone regeneration is not elucidated. To this end, we specifically deleted the HIF--1α isoform in periosteal progenitor cells and show that activation of HIF-1α signaling in these cells is critical for bone repair by modulating angiogenic and metabolic processes. Activation of HIF-1α is not only crucial for blood vessel invasion, by enhancing angiogenic growth factor production, but also for periosteal cell survival early after implantation, when blood vessels have not yet invaded the construct. HIF-1α signaling limits oxygen consumption to avoid accumulation of harmful ROS and preserve redox balance, and additionally induces a switch to glycolysis to prevent energetic distress. Altogether, our results indicate that the proangiogenic capacity of implanted periosteal cells is HIF-1α regulated and that metabolic adaptations mediate post-implantation cell survival. PMID:27058876

  14. The Dependability of the General Factor of Intelligence: Why Small, Single-Factor Models Do Not Adequately Represent "g"

    ERIC Educational Resources Information Center

    Major, Jason T.; Johnson, Wendy; Bouchard, Thomas J., Jr.

    2011-01-01

    Floyd, Shands, Rafael, Bergeron and McGrew (2009) used generalizability theory to test the reliability of general-factor loadings and to compare three different sources of error in them: the test battery size, the test battery composition, the factor-extraction technique, and their interactions. They found that their general-factor loadings were…

  15. Interrelation Between Safety Factors and Reliability

    NASA Technical Reports Server (NTRS)

    Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

    2001-01-01

    An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

  16. 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. PMID:26466179

  17. Human factors and safety in emergency medicine

    NASA Technical Reports Server (NTRS)

    Schaefer, H. G.; Helmreich, R. L.; Scheidegger, D.

    1994-01-01

    A model based on an input process and outcome conceptualisation is suggested to address safety-relevant factors in emergency medicine. As shown in other dynamic and demanding environments, human factors play a decisive role in attaining high quality service. Attitudes held by health-care providers, organisational shells and work-cultural parameters determine communication, conflict resolution and workload distribution within and between teams. These factors should be taken into account to improve outcomes such as operational integrity, job satisfaction and morale.

  18. 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

  19. 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

  20. White Paper on Factors of Safety

    NASA Technical Reports Server (NTRS)

    Raju, Ivatury; Stadler, John; Kramer-White, Jule; Piascik, Robert

    2012-01-01

    Following the Columbia Accident Investigation Board (CAIB) Report, the "Diaz Team" identified CAIB Report elements with Agency-wide applicability. The "Diaz Report", A Renewed Commitment To Excellence, generated an action to "Review current policies and waivers on safety factors". This document addresses this action.

  1. Space Station crew safety - Human factors model

    NASA Technical Reports Server (NTRS)

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

    1984-01-01

    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.

  2. 14 CFR 27.303 - Factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Factor of safety. 27.303 Section 27.303... STANDARDS: NORMAL CATEGORY ROTORCRAFT Strength Requirements General § 27.303 Factor of safety. Unless otherwise provided, a factor of safety of 1.5 must be used. This factor applies to external and...

  3. 14 CFR 29.303 - Factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Factor of safety. 29.303 Section 29.303... STANDARDS: TRANSPORT CATEGORY ROTORCRAFT Strength Requirements General § 29.303 Factor of safety. Unless otherwise provided, a factor of safety of 1.5 must be used. This factor applies to external and...

  4. Organizational factors and nuclear power plant safety

    SciTech Connect

    Haber, S.B.

    1995-12-31

    There are many organizations in our society that depend on human performance to avoid incidents involving significant adverse consequences. As our culture and technology have become more sophisticated, the management of risk on a broad basis has become more and more critical. The safe operation of military facilities, chemical plants, airlines, and mass transit, to name a few, are substantially dependent on the performance of the organizations that operate those facilities. The nuclear power industry has, within the past 15 years, increased the attention given to the influence of human performance in the safe operation of nuclear power plants (NPP). While NPPs have been designed through engineering disciplines to intercept and mitigate events that could cause adverse consequences, it has been clear from various safety-related incidents that human performance also plays a dominant role in preventing accidents. Initial efforts following the 1979 Three Mile Island incident focused primarily on ergonomic factors (e.g., the best design of control rooms for maximum performance). Greater attention was subsequently directed towards cognitive processes involved in the use of NPP decision support systems and decision making in general, personnel functions such as selection systems, and the influence of work scheduling and planning on employees` performance. Although each of these approaches has contributed to increasing the safety of NPPS, during the last few years, there has been a growing awareness that particular attention must be paid to how organizational processes affect NPP personnel performance, and thus, plant safety. The direct importance of organizational factors on safety performance in the NPP has been well-documented in the reports on the Three Mile Island and Chernobyl accidents as well as numerous other events, especially as evaluated by the U.S. Nuclear Regulatory Commission (NRC).

  5. 14 CFR 31.25 - Factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Factor of safety. 31.25 Section 31.25... STANDARDS: MANNED FREE BALLOONS Strength Requirements § 31.25 Factor of safety. (a) Except as specified in paragraphs (b) and (c) of this section, the factor of safety is 1.5. (b) A factor of safety of at least...

  6. 14 CFR 25.303 - Factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Factor of safety. 25.303 Section 25.303... STANDARDS: TRANSPORT CATEGORY AIRPLANES Structure General § 25.303 Factor of safety. Unless otherwise specified, a factor of safety of 1.5 must be applied to the prescribed limit load which are...

  7. 14 CFR 23.303 - Factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Factor of safety. 23.303 Section 23.303... STANDARDS: NORMAL, UTILITY, ACROBATIC, AND COMMUTER CATEGORY AIRPLANES Structure General § 23.303 Factor of safety. Unless otherwise provided, a factor of safety of 1.5 must be used....

  8. Influence of organizational factors on safety

    SciTech Connect

    Haber, S.B.; Metlay, D.S.; Crouch, D.A.

    1990-01-01

    There is a need for a better understanding of exactly how organizational management factors at a nuclear power plant (NPP) affect plant safety performance, either directly or indirectly, and how these factors might be observed, measured, and evaluated. The purpose of this research project is to respond to that need by developing a general methodology for characterizing these organizational and management factors, systematically collecting information on their status and integrating that information into various types of evaluative activities. Research to date has included the development of the Nuclear Organization and Management Analysis Concept (NOMAC) of a NPP, the identification of key organizational and management factors, and the identification of the methods for systematically measuring and analyzing the influence of these factors on performance. Most recently, two field studies, one at a fossil fuel plant and the other at a NPP, were conducted using the developed methodology. Results are presented from both studies highlighting the acceptability, practicality, and usefulness of the methods used to assess the influence of various organizational and management factors including culture, communication, decision-making, standardization, and oversight. 6 refs., 3 figs., 1 tab.

  9. Organizational safety factors research lessons learned

    SciTech Connect

    Ryan, T.G.

    1995-10-01

    This Paper reports lessons learned and state of knowledge gained from an organizational factors research activity involving commercial nuclear power plants in the United States, through the end of 1991, as seen by the scientists immediately involved in the research. Lessons learned information was gathered from the research teams and individuals using a question and answer format. The following five questions were submitted to each team and individual: (1) What organizational factors appear to influence safety performance in some systematic way, (2) Should organizational factors research focus at the plant level, or should it extend beyond the plant level to the parent company, rate setting commissions, regulatory agencies, (3) How important is having direct access to plants for doing organizational factors research, (4) What lessons have been learned to date as the result of doing organizational factors research in a nuclear regulatory setting, and (5) What organizational research topics and issues should be pursued in the future? Conclusions based on the responses provided for this report are that organizational factors research can be conducted in a regulatory setting and produce useful results. Technologies pioneered in other academic, commercial, and military settings can be adopted for use in a nuclear regulatory setting. The future success of such research depends upon the cooperation of regulators, contractors, and the nuclear industry.

  10. 21 CFR 70.40 - Safety factors to be considered.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.40 Safety factors to be considered. In accordance with section...

  11. [Epidermal growth factor, innovation and safety].

    PubMed

    Esquirol Caussa, Jordi; Herrero Vila, Elisabeth

    2015-10-01

    Bioidentical recombinant human epidermal growth factor (rhEGF) is available in concentrations and purity suitable for therapeutic use in long time stable formulations. Beneficial effects in several skin pathologies and lesions have been reported (traumatic and surgical wound healing, laser induced wounds, abnormal scars, keloids, radiation or chemotherapy induced dermatitis, post inflammatory hyperpigmentation or for skin aging damage repairing) and also may be considered for the treatment of several oropharingeal and high gastroesophageal tract mucosa diseases (mouth sores, pharyngeal fistulas, ulcers), and several corneal or conjunctive mucosa lesions. rhEGF has not shown any important side or collateral effects in humans or in laboratory experimentation animals, showing optimal tolerability and safety with continuous use for months. Compounding gives advantages of versatility, individualization, personalization, molecular stability, safety and effectiveness in ideal conditions, showing good tissue penetration, both on intact skin and skin lesions that expose the lower planes to the surface. rhEGF compounds can be considered for prevention or as a treatment of diverse skin and mucosa diseases and conditions through compounding preparations.

  12. Investigation of structural factors of safety for the space shuttle

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A study was made of the factors governing the structural design of the fully reusable space shuttle booster to establish a rational approach to select optimum structural factors of safety. The study included trade studies of structural factors of safety versus booster service life, weight, cost, and reliability. Similar trade studies can be made on other vehicles using the procedures developed. The major structural components of a selected baseline booster were studied in depth, each being examined to determine the fatigue life, safe-life, and fail-safe capabilities of the baseline design. Each component was further examined to determine its reliability and safety requirements, and the change of structural weight with factors of safety. The apparent factors of safety resulting from fatigue, safe-life, proof test, and fail-safe requirements were identified. The feasibility of reduced factors of safety for design loads such as engine thrust, which are well defined, was examined.

  13. Organizational factors affecting safety implementation in food companies in Thailand.

    PubMed

    Chinda, Thanwadee

    2014-01-01

    Thai food industry employs a massive number of skilled and unskilled workers. This may result in an industry with high incidences and accident rates. To improve safety and reduce the accident figures, this paper investigates factors influencing safety implementation in small, medium, and large food companies in Thailand. Five factors, i.e., management commitment, stakeholders' role, safety information and communication, supportive environment, and risk, are found important in helping to improve safety implementation. The statistical analyses also reveal that small, medium, and large food companies hold similar opinions on the risk factor, but bear different perceptions on the other 4 factors. It is also found that to improve safety implementation, the perceptions of safety goals, communication, feedback, safety resources, and supervision should be aligned in small, medium, and large companies.

  14. Motivational and organizational factors affecting implementation of worker safety training.

    PubMed

    Lindell, M K

    1994-01-01

    Training is unlikely to affect behavior on the job if the worker views it as unnecessary. This chapter describes types of safety behaviors and training activities, the implementation of safety training, current perspectives on motivation, and other motivational and organizational factors affecting the implementation of worker safety training.

  15. Confinement and the safety factor profile

    SciTech Connect

    Batha, S.H.; Levinton, F.M.; Scott, S.D.

    1995-12-01

    The conjecture that the safety factor profile, q(r), controls the improvement in tokamak plasmas from poor confinement in the Low (L-) mode regime to improved confinement in the supershot regime has been tested in two experiments on the Tokamak Fusion Test Reactor (TFTR). First, helium was puffed into the beam-heated phase of a supershot discharge which induced a degradation from supershot to L-mode confinement in about 100 msec, far less than the current relaxation time. The q and shear profiles measured by a motional Stark effect polarimeter showed little change during the confinement degradation. Second, rapid current ramps in supershot plasmas altered the q profile, but were observed not to change significantly the energy confinement. Thus, enhanced confinement in supershot plasmas is not due to a particular q profile which has enhanced stability or transport properties. The discharges making a continuous transition between supershot and L-mode confinement were also used to test the critical-electron-temperature-gradient transport model. It was found that this model could not reproduce the large changes in electron and ion temperature caused by the change in confinement.

  16. 21 CFR 70.40 - Safety factors to be considered.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to... of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice....

  17. 21 CFR 170.22 - Safety factors to be considered.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted... experimental animals....

  18. 21 CFR 170.22 - Safety factors to be considered.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted... experimental animals....

  19. 21 CFR 70.40 - Safety factors to be considered.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to... of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice....

  20. 21 CFR 70.40 - Safety factors to be considered.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to... of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice....

  1. 21 CFR 70.40 - Safety factors to be considered.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to... of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice....

  2. Adequate Wound Care and Use of Bed Nets as Protective Factors against Buruli Ulcer: Results from a Case Control Study in Cameroon

    PubMed Central

    Landier, Jordi; Boisier, Pascal; Fotso Piam, Félix; Noumen-Djeunga, Blanbin; Simé, Joseph; Wantong, Fidèle Gaetan; Marsollier, Laurent; Fontanet, Arnaud; Eyangoh, Sara

    2011-01-01

    Background Buruli ulcer is an infectious disease involving the skin, caused by Mycobacterium ulcerans. Its exact transmission mechanism remains unknown. Several arguments indicate a possible role for insects in its transmission. A previous case-control study in the Nyong valley region in central Cameroon showed an unexpected association between bed net use and protection against Buruli ulcer. We investigated whether this association persisted in a newly discovered endemic Buruli ulcer focus in Bankim, northwestern Cameroon. Methodology/Principal Findings We conducted a case-control study on 77 Buruli ulcer cases and 153 age-, gender- and village-matched controls. Participants were interviewed about their activities and habits. Multivariate conditional logistic regression analysis identified systematic use of a bed net (Odds-Ratio (OR) = 0.4, 95% Confidence Interval [95%CI] = [0.2–0.9], p-value (p) = 0.04), cleansing wounds with soap (OR [95%CI] = 0.1 [0.03–0.3], p<0.0001) and growing cassava (OR [95%CI] = 0.3 [0.2–0.7], p = 0.005) as independent protective factors. Independent risk factors were bathing in the Mbam River (OR [95%CI] = 6.9 [1.4–35], p = 0.02) and reporting scratch lesions after insect bites (OR [95%CI] = 2.7 [1.4–5.4], p = 0.004). The proportion of cases that could be prevented by systematic bed net use was 32%, and by adequate wound care was 34%. Conclusions/Significance Our study confirms that two previously identified factors, adequate wound care and bed net use, significantly decreased the risk of Buruli ulcer. These associations withstand generalization to different geographic, climatic and epidemiologic settings. Involvement of insects in the household environment, and the relationship between wound hygiene and M. ulcerans infection should now be investigated. PMID:22087346

  3. An approach using multi-factor combination to evaluate high rocky slope safety

    NASA Astrophysics Data System (ADS)

    Su, Huaizhi; Yang, Meng; Wen, Zhiping

    2016-06-01

    A high rocky slope is an open complex giant system for which there is contradiction among different influencing factors and coexistence of qualitative and quantitative information. This study presents a comprehensive intelligent evaluation method of high rocky slope safety through an integrated analytic hierarchy process, extension matter element model and entropy weight to assess the safety behavior of the high rocky slope. The proposed intelligent evaluation integrates subjective judgments derived from the analytic hierarchy process with the extension matter model and entropy weight into a multiple indexes dynamic safety evaluation approach. A combined subjective and objective comprehensive evaluation process, a more objective study, through avoiding subjective effects on the weights, and a qualitative safety assessment and quantitative safety amount are presented in the proposed method. The detailed computational procedures were also provided to illustrate the integration process of the above methods. Safety analysis of one high rocky slope is conducted to illustrate that this approach can adequately handle the inherent imprecision and contradiction of the human decision-making process and provide the flexibility and robustness needed for the decision maker to better monitor the safety status of a high rocky slope. This study was the first application of the proposed integrated evaluation method in the safety assessment of a high rocky slope. The study also indicated that it can also be applied to other similar problems.

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

    PubMed

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

    2016-08-01

    While workers' safety risk tolerances have been regarded as a main reason for their unsafe behaviors, little is known about why different people have different risk tolerances even when confronting the same situation. The aim of this research is to identify the critical factors and paths that influence workers' safety risk tolerance and to explore how they contribute to accident causal model from a system thinking perceptive. A number of methods were carried out to analyze the data collected through interviews and questionnaire surveys. In the first and second steps of the research, factor identification, factor ranking and factor analysis were carried out, and the results show that workers' safety risk tolerance can be influenced by four groups of factors, namely: (1) personal subjective perception; (2) work knowledge and experiences; (3) work characteristics; and (4) safety management. In the third step of the research, hypothetical influencing path model was developed and tested by using structural equation modeling (SEM). It is found that the effects of external factors (safety management and work characteristics) on risk tolerance are larger than that of internal factors (personal subjective perception and work knowledge & experiences). Specifically, safety management contributes the most to workers' safety risk tolerance through its direct effect and indirect effect; while personal subjective perception comes the second and can act as an intermedia for work characteristics. This research provides an in-depth insight of workers' unsafe behaviors by depicting the contributing factors as shown in the accident causal model developed in this research. PMID:26775077

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

    PubMed

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

    2016-08-01

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

  6. 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

  7. Structural deterministic safety factors selection criteria and verification

    NASA Technical Reports Server (NTRS)

    Verderaime, V.

    1992-01-01

    Though current deterministic safety factors are arbitrarily and unaccountably specified, its ratio is rooted in resistive and applied stress probability distributions. This study approached the deterministic method from a probabilistic concept leading to a more systematic and coherent philosophy and criterion for designing more uniform and reliable high-performance structures. The deterministic method was noted to consist of three safety factors: a standard deviation multiplier of the applied stress distribution; a K-factor for the A- or B-basis material ultimate stress; and the conventional safety factor to ensure that the applied stress does not operate in the inelastic zone of metallic materials. The conventional safety factor is specifically defined as the ratio of ultimate-to-yield stresses. A deterministic safety index of the combined safety factors was derived from which the corresponding reliability proved the deterministic method is not reliability sensitive. The bases for selecting safety factors are presented and verification requirements are discussed. The suggested deterministic approach is applicable to all NASA, DOD, and commercial high-performance structures under static stresses.

  8. 21 CFR 170.22 - Safety factors to be considered.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to... be applied in determining whether the proposed use of a food additive will be safe: Except where... experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be...

  9. 21 CFR 170.22 - Safety factors to be considered.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to be considered. In accordance with... proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a... used; that is, a food additive for use by man will not be granted a tolerance that will exceed...

  10. 21 CFR 170.22 - Safety factors to be considered.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to... be applied in determining whether the proposed use of a food additive will be safe: Except where... experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be...

  11. Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

    PubMed Central

    2013-01-01

    Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute

  12. Human Factors Research and Nuclear Safety.

    ERIC Educational Resources Information Center

    Moray, Neville P., Ed.; Huey, Beverly M., Ed.

    The Panel on Human Factors Research Needs in Nuclear Regulatory Research was formed by the National Research Council in response to a request from the Nuclear Regulatory Commission (NRC). The NRC asked the research council to conduct an 18-month study of human factors research needs for the safe operation of nuclear power plants. This report…

  13. Failure and factors of safety in piping system design

    SciTech Connect

    Antaki, G.A.

    1993-06-01

    An important body of test and performance data on the behavior of piping systems has led to an ongoing reassessment of the code stress allowables and their safety margin. The codes stress allowables, and their factors of safety, are developed from limits on the incipient yield (for ductile materials), or incipient rupture (for brittle materials), of a test specimen loaded in simple tension. In this paper, we examine the failure theories introduced in the B31 and ASME III codes for piping and their inherent approximations compared to textbook failure theories. We summarize the evolution of factors of safety in ASME and B31 and point out that, for piping systems, it is appropriate to reconsider the concept and definition of factors of safety.

  14. Failure and factors of safety in piping system design

    SciTech Connect

    Antaki, G.A.

    1993-01-01

    An important body of test and performance data on the behavior of piping systems has led to an ongoing reassessment of the code stress allowables and their safety margin. The codes stress allowables, and their factors of safety, are developed from limits on the incipient yield (for ductile materials), or incipient rupture (for brittle materials), of a test specimen loaded in simple tension. In this paper, we examine the failure theories introduced in the B31 and ASME III codes for piping and their inherent approximations compared to textbook failure theories. We summarize the evolution of factors of safety in ASME and B31 and point out that, for piping systems, it is appropriate to reconsider the concept and definition of factors of safety.

  15. 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.

  16. Approaching Safety through Quality: Factors Influencing College Student Perceptions.

    PubMed

    Ramaswamy, S K; Mosher, G A

    2016-04-01

    Quality management practices have been identified by previous literature as a factor that could potentially reduce the level of safety incidents and hazards in agricultural work environments. The present study used multivariate analysis to examine the effect of independent variables such as quality and safety awareness, work experience, safety and quality management experience, and the perceived importance of safety and quality on the role of quality management practices as a mitigating factor for safety hazards and incidents in agriculture. Variables were measured on a five-point scale using a survey questionnaire. Data were collected from approximately 900 undergraduates enrolled in the College of Agriculture and Life Sciences at a large land grant university in the U.S. The level of student work experience and student perceptions of the importance of quality explained a significant amount of the variance in student views of quality management practices as a mitigating factor for safety hazards and incidents. The findings of this study provide further evidence for using quality management practices as a basis for safety interventions targeted at the agricultural workforce. PMID:27373063

  17. 49 CFR 385.7 - Factors to be considered in determining a safety rating.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Factors to be considered in determining a safety... REGULATIONS SAFETY FITNESS PROCEDURES General § 385.7 Factors to be considered in determining a safety rating. The factors to be considered in determining the safety fitness and assigning a safety rating...

  18. Ontogeny of intestinal safety factors: lactase capacities and lactose loads.

    PubMed

    O'Connor, T P; Diamond, J

    1999-03-01

    We measured intestinal safety factors (ratio of a physiological capacity to the load on it) for lactose digestion in developing rat pups. Specifically, we assessed the quantitative relationships between lactose load and the series capacities of lactase and the Na+-glucose cotransporter (SGLT-1). Both capacities increased significantly with age in suckling pups as a result of increasing intestinal mass and maintenance of mass-specific activities. The youngest pups examined (5 days) had surprisingly high safety factors of 8-13 for both lactase and SGLT-1, possibly because milk contains lactase substrates other than lactose; it also, however, suggests that their intestinal capacities were being prepared to meet future demands rather than just current ones. By day 10 (and also at day 15), increased lactose loads resulted in lower safety factors of 4-6, values more typical of adult intestines. The safety factor of SGLT-1 in day 30 (weanling) and day 100 (adult) rats was only approximately 1.0. This was initially unexpected, because most adult intestines maintain a modest reserve capacity beyond nutrient load values, but postweaning rats appear to use hindgut fermentation, assessed by gut morphology and hydrogen production assays, as a built-in reserve capacity. The series capacities of lactase and SGLT-1 varied in concert with each other over ontogeny and as lactose load was manipulated by experimental variation in litter size.

  19. 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.

  20. Using partial safety factors in wind turbine design and testing

    SciTech Connect

    Musial, W.D.

    1997-12-31

    This paper describes the relationship between wind turbine design and testing in terms of the certification process. An overview of the current status of international certification is given along with a description of limit-state design basics. Wind turbine rotor blades are used to illustrate the principles discussed. These concepts are related to both International Electrotechnical Commission and Germanischer Lloyd design standards, and are covered using schematic representations of statistical load and material strength distributions. Wherever possible, interpretations of the partial safety factors are given with descriptions of their intended meaning. Under some circumstances, the authors` interpretations may be subjective. Next, the test-load factors are described in concept and then related to the design factors. Using technical arguments, it is shown that some of the design factors for both load and materials must be used in the test loading, but some should not be used. In addition, some test factors not used in the design may be necessary for an accurate test of the design. The results show that if the design assumptions do not clearly state the effects and uncertainties that are covered by the design`s partial safety factors, outside parties such as test labs or certification agencies could impose their own meaning on these factors.

  1. Using partial safety factors in wind turbine design and testing

    SciTech Connect

    Musial, W D; Butterfield, C

    1997-09-01

    This paper describes the relationship between wind turbine design and testing in terms of the certification process. An overview of the current status of international certification is given along with a description of limit-state design basics. Wind turbine rotor blades are used to illustrate the principles discussed. These concepts are related to both International Electrotechnical Commission and Germanischer Lloyd design standards, and are covered using schematic representations of statistical load and material strength distributions. Wherever possible, interpretations of the partial safety factors are given with descriptions of their intended meaning. Under some circumstances, the authors` interpretations may be subjective. Next, the test-load factors are described in concept and then related to the design factors. Using technical arguments, it is shown that some of the design factors for both load and materials must be used in the test loading, but some should not be used. In addition, some test factors not used in the design may be necessary for an accurate test of the design. The results show that if the design assumptions do not clearly state the effects and uncertainties that are covered by the design`s partial safety factors, outside parties such as test labs or certification agencies could impose their own meaning on these factors.

  2. The scaling of safety factor in spider draglines.

    PubMed

    Ortlepp, Christine; Gosline, John M

    2008-09-01

    This study documents the effect of body mass on the size and strength of draglines produced by the orb-weaving spider Araneus diadematus and the jumping spider Salticus scenicus. Silk samples obtained from individuals spanning the range from first-instar juveniles to gravid adults were tested to determine both the properties of the silk material and the strength and static safety factor of the draglines produced by each individual spider. Analysis of material properties indicates that the tensile strength and extensibility of the silks employed by each species are identical over the entire size range of the species. Analysis of the breaking forces for individual draglines, however, indicates that the draglines scale allometrically with the spider's body mass. For Araneus, breaking force (N) scales with body mass (kg) as Fmax=11.2M0.786, and the static safety factor (S(BW)=Fmax/Mg) scales as S(BW)=1.14M(-0.214). For Salticus, Fmax=0.363M0.66 and S(BW)=0.037M(-0.34). Thus, static safety factors decrease as these spiders grow, with values falling to 4-6 for adult Araneus and to 1-2 for adult Salticus. Analysis of these results suggests that the safety lines produced by these two species are not able to absorb the impact energy of most falls with a fixed length of pre-existing silk, except in the smallest of the Araneus spiders. It is therefore likely that both spiders must draw new silk from their spinnerets during falls to keep the dynamic loads on their safety-lines below failure levels. PMID:18723542

  3. Alaska Humans Factors Safety Study: The Southern Coastal Area

    NASA Technical Reports Server (NTRS)

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

    1995-01-01

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

  4. Alaska Humans Factors Safety Study: The Northern Area

    NASA Technical Reports Server (NTRS)

    Connell, Linda; Reynard, William (Technical Monitor)

    1995-01-01

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

  5. 49 CFR 229.103 - Safe working pressure; factor of safety.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Steam Generators § 229.103 Safe working pressure; factor of safety. The safe working pressure for each steam generator shall be fixed by the chief mechanical officer of the carrier. The minimum factor of safety...

  6. 49 CFR 229.103 - Safe working pressure; factor of safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Steam Generators § 229.103 Safe working pressure; factor of safety. The safe working pressure for each steam generator shall be fixed by the chief mechanical officer of the carrier. The minimum factor of safety...

  7. 49 CFR 229.103 - Safe working pressure; factor of safety.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Steam Generators § 229.103 Safe working pressure; factor of safety. The safe working pressure for each steam generator shall be fixed by the chief mechanical officer of the carrier. The minimum factor of safety...

  8. Factors affecting quality and safety of fresh-cut produce.

    PubMed

    Francis, G A; Gallone, A; Nychas, G J; Sofos, J N; Colelli, G; Amodio, M L; Spano, G

    2012-01-01

    The quality of fresh-cut fruit and vegetable products includes a combination of attributes, such as appearance, texture, and flavor, as well as nutritional and safety aspects that determine their value to the consumer. Nutritionally, fruit and vegetables represent a good source of vitamins, minerals, and dietary fiber, and fresh-cut produce satisfies consumer demand for freshly prepared, convenient, healthy food. However, fresh-cut produce deteriorates faster than corresponding intact produce, as a result of damage caused by minimal processing, which accelerates many physiological changes that lead to a reduction in produce quality and shelf-life. The symptoms of produce deterioration include discoloration, increased oxidative browning at cut surfaces, flaccidity as a result of loss of water, and decreased nutritional value. Damaged plant tissues also represent a better substrate for growth of microorganisms, including spoilage microorganisms and foodborne pathogens. The risk of pathogen contamination and growth is one of the main safety concerns associated with fresh-cut produce, as highlighted by the increasing number of produce-linked foodborne outbreaks in recent years. The pathogens of major concern in fresh-cut produce are Listeria monocytogenes, pathogenic Escherichia coli mainly O157:H7, and Salmonella spp. This article describes the quality of fresh-cut produce, factors affecting quality, and various techniques for evaluating quality. In addition, the microbiological safety of fresh-cut produce and factors affecting pathogen survival and growth on fresh-cut produce are discussed in detail.

  9. 49 CFR 229.103 - Safe working pressure; factor of safety.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Generators § 229.103 Safe working pressure; factor of safety. The safe working pressure for each steam generator shall be fixed by the chief mechanical officer of the carrier. The minimum factor of safety...

  10. 49 CFR 229.103 - Safe working pressure; factor of safety.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Generators § 229.103 Safe working pressure; factor of safety. The safe working pressure for each steam generator shall be fixed by the chief mechanical officer of the carrier. The minimum factor of safety...

  11. Factors associated with cervical cancer screening in a safety net population

    PubMed Central

    Heberer, Meredith A; Komenaka, Ian K; Nodora, Jesse N; Hsu, Chiu-Hsieh; Gandhi, Sonal G; Welch, Lauren E; Bouton, Marcia E; Aristizabal, Paula; Weiss, Barry D; Martinez, Maria Elena

    2016-01-01

    AIM To identify factors associated with Papanicolaou-smear (Pap-smear) cervical cancer screening rates in a safety net population. METHODS From January 2012 to May 2013, the use of Pap-smear was determined for all patients seen at the breast clinic in a safety net hospital. Health literacy assessment was performed using the validated Newest Vital Sign. The records of patients were reviewed to determine if they had undergone Pap-smears for cervical cancer screening. Sociodemographic information was collected included age, education, monthly income, race/ethnicity, employment, insurance status, and primary care provider of the patient. Logistic regression analysis was then performed to determine factors associated with utilization of Pap-smears. Crude and adjusted odds ratios derived from multivariate logistic regression models were calculated as well as the associated 95%CIs and P-values. RESULTS Overall, 39% had Pap-smears in the prior 15 mo, 1377 consecutive women were seen during the study period and their records were reviewed. Significantly more patients with adequate health literacy underwent Pap-smears as compared to those with limited health literacy (59% vs 34%, P < 0.0001). In multivariate analysis, patients with adequate health literacy, younger patients, and those with later age of first live birth were more likely to undergo Pap-smears. Patients whose primary care providers were gynecologists were also significantly more likely to have Pap-smears compared to other specialties (P < 0.0001). Patients younger than 21 years or older than 65 years underwent screening less frequently (11% and 11%, respectively) than those 21-64 years (41%, P < 0.0001). Race, ethnicity, language, and insurance status were not associated with Pap-smear screening rates. CONCLUSION Patient health literacy and primary care physician were associated with Pap-smear utilization. Development of interventions to target low health literacy populations could improve cervical cancer

  12. 75 FR 5536 - Pipeline Safety: Control Room Management/Human Factors, Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... Safety: Control Room Management/Human Factors, Correction AGENCY: Pipeline and Hazardous Materials Safety... Regulations to address human factors and other aspects of control room management for pipelines where... 63310) entitled ``Pipeline Safety: Control Room Management/Human Factors.'' This final rule...

  13. A dispersion safety factor for LNG vapor clouds.

    PubMed

    Vílchez, Juan A; Villafañe, Diana; Casal, Joaquim

    2013-02-15

    The growing importance of liquefied natural gas (LNG) to global energy demand has increased interest in the possible hazards associated with its storage and transportation. Concerning the event of an LNG spill, a study was performed on the relationship between the distance at which the lower flammability limit (LFL) concentration occurs and that corresponding to the visible contour of LNG vapor clouds. A parameter called the dispersion safety factor (DSF) has been defined as the ratio between these two lengths, and two expressions are proposed to estimate it. During an emergency, the DSF can be a helpful parameter to indicate the danger of cloud ignition and flash fire.

  14. A dispersion safety factor for LNG vapor clouds.

    PubMed

    Vílchez, Juan A; Villafañe, Diana; Casal, Joaquim

    2013-02-15

    The growing importance of liquefied natural gas (LNG) to global energy demand has increased interest in the possible hazards associated with its storage and transportation. Concerning the event of an LNG spill, a study was performed on the relationship between the distance at which the lower flammability limit (LFL) concentration occurs and that corresponding to the visible contour of LNG vapor clouds. A parameter called the dispersion safety factor (DSF) has been defined as the ratio between these two lengths, and two expressions are proposed to estimate it. During an emergency, the DSF can be a helpful parameter to indicate the danger of cloud ignition and flash fire. PMID:23305750

  15. 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.

  16. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  17. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  18. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  19. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  20. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  1. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  2. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  3. Human Factors And Safety Considerations Of Night Vision Systems Flight

    NASA Astrophysics Data System (ADS)

    Verona, Robert W.; Rash, Clarence E.

    1989-03-01

    Military aviation night vision systems greatly enhance the capability to operate during periods of low illumination. After flying with night vision devices, most aviators are apprehensive about returning to unaided night flight. Current night vision imaging devices allow aviators to fly during ambient light conditions which would be extremely dangerous, if not impossible, with unaided vision. However, the visual input afforded with these devices does not approach that experienced using the unencumbered, unaided eye during periods of daylight illumination. Many visual parameters, e,g., acuity, field-of-view, depth perception, etc., are compromised when night vision devices are used. The inherent characteristics of image intensification based sensors introduce new problems associated with the interpretation of visual information based on different spatial and spectral content from that of unaided vision. In addition, the mounting of these devices onto the helmet is accompanied by concerns of fatigue resulting from increased head supported weight and shift in center-of-gravity. All of these concerns have produced numerous human factors and safety issues relating to thb use of night vision systems. These issues are identified and discussed in terms of their possible effects on user performance and safety.

  4. Safety culture management: The importance of organizational factors

    SciTech Connect

    Haber, S.B.; Shurberg, D.A.; Jacobs, R.; Hofmann, D.

    1995-05-01

    The concept of safety culture has been used extensively to explain the underlying causes of performance based events, both positive and negative, across the nuclear industry. The work described in this paper represents several years of effort to identify, define and assess the organizational factors important to safe performance in nuclear power plants (NPPs). The research discussed in this paper is primarily conducted in support of the US Nuclear Regulatory Commission`s (NRC) efforts in understanding the impact of organizational performance on safety. As a result of a series of research activities undertaken by numerous NRC contractors, a collection of organizational dimensions has been identified and defined. These dimensions represent what is believed to be a comprehensive taxonomy of organizational elements that relate to the safe operation of nuclear power plants. Techniques were also developed by which to measure these organizational dimensions, and include structured interview protocols, behavioral checklists, and behavioral anchored rating scales (BARS). Recent efforts have focused on devising a methodology for the extraction of information related to the identified organizational dimensions from existing NRC documentation. This type of effort would assess the applicability of the organizational dimensions to existing NRC inspection and evaluation reports, refine the organizational dimensions previously developed so they are more relevant to the task of retrospective analysis, and attempt to rate plants based on the review of existing NRC documentation using the techniques previously developed for the assessment of organizational dimensions.

  5. Safety analysis factors for environmental restoration and decontamination and decommissioning

    SciTech Connect

    Ellingson, D.R.

    1993-04-01

    Environmental restoration (ER) and facility decontamination/decommissioning (D&D) operations can be grouped into two general categories. ``Nonstationary cleanup`` or simply ``cleanup`` activities are where the operation must relocate to the site of new contaminated material at the completion of each task (i.e., the operation moves to the contaminated material). ``Stationary production`` or simply ``production`` activities are where the contaminated material is moved to a centralized location (i.e., the contaminated material is moved to the operation) for analysis, sorting, treatment, storage, and disposal. This paper addresses the issue of nonstationary cleanup design. The following are the specific assigned action items: Collect and compile a list of special safety-related ER/D&D design factors, especially ones that don`t follow DOE Order 6430.1A requirements. Develop proposal of what makes sense to recommend to designers; especially consider recommendations for short-term projects. Present proposal at the January meeting. To achieve the action items, applicable US Department of Energy (DOE) design requirements, and cleanup operations and differences from production activities are reviewed and summarized; basic safety requirements influencing design are summarized; and finally, approaches, considerations, and methods for safe, cost-effective design of cleanup activities are discussed.

  6. Safety factor maximization for trusses subjected to fatigue stresses

    NASA Astrophysics Data System (ADS)

    Hedaya, Mohammed Mohammed; Moneeb Elsabbagh, Adel; Hussein, Ahmed Mohamed

    2015-08-01

    This article presents a mathematical model for sizing optimization of undamped trusses subjected to dynamic loading leading to fatigue. The combined effect of static and dynamic loading, at steady state, is considered. An optimization model, whose objective is the maximization of the safety factor of these trusses, is developed. A new quantity (equivalent fatigue strain energy) combining the effects of static and dynamic stresses is presented. This quantity is used as a global measure of the proximity of fatigue failure. Therefore, the equivalent fatigue strain energy is minimized, and this seems to give a good value for the maximal equivalent static stress. This assumption is verified through two simple examples. The method of moving asymptotes is used in the optimization of trusses. The applicability of the proposed approach is demonstrated through two numerical examples; a 10-bar truss with different loading cases and a helicopter tail subjected to dynamic loading.

  7. Percutaneous renal biopsy of native kidneys: efficiency, safety and risk factors associated with major complications

    PubMed Central

    Torres Muñoz, Abel; Valdez-Ortiz, Rafael; González-Parra, Carlos; Espinoza-Dávila, Elvy; Morales-Buenrostro, Luis E.; Correa-Rotter, Ricardo

    2011-01-01

    Introduction The use of an automated biopsy device and real-time ultrasound (current technology) for percutaneous renal biopsies (PRBs) has improved the likelihood of obtaining adequate tissue for diagnosis and has reduced the complications associated with renal biopsies. Our objective was to evaluate the efficacy and safety of the current PRB procedure and identify possible risk factors for the development of major complications. Material and methods We collected all native kidney PRBs performed with current technology in our institute from January 1998 to April 2008. Studied variables were collected from the patient's chart at the time of the biopsy. Results We analyzed 623 (96.4%) of 646 renal biopsies performed with the current automated procedure guided by real-time ultrasound. Although the effectiveness was 97.6%, there were 110 complications. Fourteen (2.24%) of these complications were major: 9 cases of renal hematoma, 2 cases with macroscopic hematuria (which needed blood transfusion), 1 case of intestinal perforation (which required exploratory laparotomy), 1 nephrectomy and 1 case of a dissecting hematoma. The logistic regression analysis demonstrated the following risk factors for developing major complications: diastolic blood pressure ≥ 90 mmHg, RR 7.6 (95% CI 1.35-43); platelet count ≤ 120×103/µl; RR 7.0 (95% CI 1.9-26.2); and blood urea nitrogen (BUN) ≥ 60 mg/dl, RR 9.27 (95% CI 2.8-30.7). Conclusions The observed efficacy and safety of the current technique in the present study were similar to observations in previous studies. Diastolic blood pressure ≥ 90 mmHg, platelets ≤ 120×103/µl and BUN ≥ 60 mg/dl were independent risk factors for the development of major complications following PRB. PMID:22291827

  8. 75 FR 69912 - Pipeline Safety: Control Room Management/Human Factors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... Safety: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety..., 2010, PHMSA published a Control Room Management/Human Factors notice of proposed rulemaking (NPRM... to expedite the program implementation deadlines of the Control Room Management/Human Factors rule...

  9. Factors associated with the enactment of safety belt and motorcycle helmet laws.

    PubMed

    Law, Teik Hua; Noland, Robert B; Evans, Andrew W

    2013-07-01

    It has been shown that road safety laws, such as motorcycle helmet and safety belt laws, have a significant effect in reducing road fatalities. Although an expanding body of literature has documented the effects of these laws on road safety, it remains unclear which factors influence the likelihood that these laws are enacted. This study attempts to identify the factors that influence the decision to enact safety belt and motorcycle helmet laws. Using panel data from 31 countries between 1963 and 2002, our results reveal that increased democracy, education level, per capita income, political stability, and more equitable income distribution within a country are associated with the enactment of road safety laws.

  10. Analysis of factors influencing safety management for metro construction in China.

    PubMed

    Yu, Q Z; Ding, L Y; Zhou, C; Luo, H B

    2014-07-01

    With the rapid development of urbanization in China, the number and size of metro construction projects are increasing quickly. At the same time, and increasing number of accidents in metro construction make it a disturbing focus of social attention. In order to improve safety management in metro construction, an investigation of the participants' perspectives on safety factors in China metro construction has been conducted to identify the key safety factors, and their ranking consistency among the main participants, including clients, consultants, designers, contractors and supervisors. The result of factor analysis indicates that there are five key factors which influence the safety of metro construction including safety attitude, construction site safety, government supervision, market restrictions and task unpredictability. In addition, ANOVA and Spearman rank correlation coefficients were performed to test the consistency of the means rating and the ranking of safety factors. The results indicated that the main participants have significant disagreement about the importance of safety factors on more than half of the items. Suggestions and recommendations on practical countermeasures to improve metro construction safety management in China are proposed.

  11. Time to accelerate integration of human factors and ergonomics in patient safety.

    PubMed

    Gurses, Ayse P; Ozok, A Ant; Pronovost, Peter J

    2012-04-01

    Progress toward improving patient safety has been slow despite engagement of the health care community in improvement efforts. A potential reason for this sluggish pace is the inadequate integration of human factors and ergonomics principles and methods in these efforts. Patient safety problems are complex and rarely caused by one factor or component of a work system. Thus, health care would benefit from human factors and ergonomics evaluations to systematically identify the problems, prioritize the right ones, and develop effective and practical solutions. This paper gives an overview of the discipline of human factors and ergonomics and describes its role in improving patient safety. We provide examples of how human factors and ergonomics principles and methods have improved both care processes and patient outcomes. We provide five major recommendations to better integrate human factors and ergonomics in patient safety improvement efforts: build capacity among health care workers to understand human factors and ergonomics, create market forces that demand the integration of human factors and ergonomics design principles into medical technologies, increase the number of human factors and ergonomic practitioners in health care organizations, expand investments in improvement efforts informed by human factors and ergonomics, and support interdisciplinary research to improve patient safety. In conclusion, human factors and ergonomics must play a more prominent role in health care if we want to increase the pace in improving patient safety.

  12. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Making adequate yearly progress. 200.20 Section 200.20... Basic Programs Operated by Local Educational Agencies Adequate Yearly Progress (ayp) § 200.20 Making... State data system; (vi) Include, as separate factors in determining whether schools are making AYP for...

  13. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Making adequate yearly progress. 200.20 Section 200.20... Basic Programs Operated by Local Educational Agencies Adequate Yearly Progress (ayp) § 200.20 Making... State data system; (vi) Include, as separate factors in determining whether schools are making AYP for...

  14. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Making adequate yearly progress. 200.20 Section 200.20... Basic Programs Operated by Local Educational Agencies Adequate Yearly Progress (ayp) § 200.20 Making... State data system; (vi) Include, as separate factors in determining whether schools are making AYP for...

  15. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Making adequate yearly progress. 200.20 Section 200.20... Basic Programs Operated by Local Educational Agencies Adequate Yearly Progress (ayp) § 200.20 Making... State data system; (vi) Include, as separate factors in determining whether schools are making AYP for...

  16. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Making adequate yearly progress. 200.20 Section 200.20... Basic Programs Operated by Local Educational Agencies Adequate Yearly Progress (ayp) § 200.20 Making... State data system; (vi) Include, as separate factors in determining whether schools are making AYP for...

  17. Safety Factors in Educational Facilities. An Annotated Reference List.

    ERIC Educational Resources Information Center

    Wakefield, Howard E.

    Abstracts and descriptor terms are presented for 26 selected references with safety orientation. Included in addition to several general planning handbooks are topics related to--(1) stairways, (2) air structures, (3) site planning, (4) lighting, (5) bidding practice, (6) physically handicapped, (7) laboratory design, (8) mobile classrooms, (9)…

  18. Impact of Geotechnical Factors on the Safety of Low Embankment Dams From the Perspective of Technical and Safety Supervision

    NASA Astrophysics Data System (ADS)

    Kasana, Andrej; Minárik, Marian; Nikolaj, Maroš

    2015-03-01

    Our research deals with a broad spectrum of problems concerning the variability of geotechnical factors and their influence on the safety of the biggest group of dam constructions in Slovakia, i.e., low earthfill dams. Its specific aim is the observation of their risk factors by using our experience and knowledge gained while working in the sector of technical and safety supervision. To achieve the aims of a research thesis, we analyzed 39 low earthfill dams. We performed observations and documented their conditions with the aim of clarifying the risk factors. After an analysis of the information materials that characterize dams and after a statistical analysis of the measurement results in situ, including measurements from technical and safety supervision databases, we performed an analysis by using mathematical modeling to evaluate the safety of the dam constructions. Out of the total number of 39 dam constructions, an analysis of the stability of the dam slopes was performed on 37 dams, and deformation problems were analyzed on 28 of the dams. Filtration problems were analyzed at 26 dams, and a complete evaluation of the intensity of filtration movements was performed on 19 of the constructions. On the basis of a detailed analysis of the 39 dam constructions, we specified their problems and the concomitant consequences of the problems. Geotechnical risk factors and specific risks that determine the safety of water constructions were characterized. The analysis confirmed the importance of an engineer-geological and geotechnical checkup in the process of preparation and building (alternatively, during reconstructions and sanitation work) of such water constructions and also the importance of monitoring in the process of dam usage. Technical and safety checkups were also shown to be important when analyzing risk factors. The conclusions of the knowledge gained and the recommendations for the practice deal with recommendations to change the flow policy, develop a

  19. 34 CFR 85.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Adequate evidence. 85.900 Section 85.900 Education Office of the Secretary, Department of Education GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 85.900 Adequate evidence. Adequate evidence means information sufficient to support...

  20. 12 CFR 380.52 - Adequate protection.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Adequate protection. 380.52 Section 380.52... ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.52 Adequate protection. (a... interest of a claimant, the receiver shall provide adequate protection by any of the following means:...

  1. 12 CFR 380.52 - Adequate protection.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Adequate protection. 380.52 Section 380.52... ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.52 Adequate protection. (a... interest of a claimant, the receiver shall provide adequate protection by any of the following means:...

  2. 12 CFR 380.52 - Adequate protection.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Adequate protection. 380.52 Section 380.52... ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.52 Adequate protection. (a... interest of a claimant, the receiver shall provide adequate protection by any of the following means:...

  3. 21 CFR 1404.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 1404.900 Adequate evidence. Adequate evidence means information sufficient...

  4. The Ultimate Factor of Safety for Aircraft and Spacecraft Its History, Applications and Misconceptions

    NASA Technical Reports Server (NTRS)

    Zipay, John J.; Modlin, C. Thomas, Jr.; Larsen, Curtis E.

    2016-01-01

    The ultimate factor of safety (FOSULT) concept used in aircraft and spacecraft has evolved over many decades. Currently an FOSULT 1.5 is the FAR-mandated value for aircraft while an FOSULT of 1.4 has been used in various spacecraft. This paper was motivated by the desire to concisely explain the origins, proper interpretation and application of the ultimate factor of safety concept, since the authors have seen throughout their careers many misconceptions and incorrect applications of this concept. The history of the ultimate factor of safety concept is briefly summarized, the proper application of the factor of safety in aircraft design, structural analysis and operations is covered in detail, examples of limit load exceedance in aircraft and spacecraft are discussed, the evolution of the 1.4 FOSULT for spacecraft is described and some misconceptions regarding the ultimate factor of safety concept are addressed. It is hoped that this paper can be a summary resource for engineers to understand the origin, purpose and proper application of the ultimate factor of safety.

  5. Factors associated with the enactment of safety belt and motorcycle helmet laws.

    PubMed

    Law, Teik Hua; Noland, Robert B; Evans, Andrew W

    2013-07-01

    It has been shown that road safety laws, such as motorcycle helmet and safety belt laws, have a significant effect in reducing road fatalities. Although an expanding body of literature has documented the effects of these laws on road safety, it remains unclear which factors influence the likelihood that these laws are enacted. This study attempts to identify the factors that influence the decision to enact safety belt and motorcycle helmet laws. Using panel data from 31 countries between 1963 and 2002, our results reveal that increased democracy, education level, per capita income, political stability, and more equitable income distribution within a country are associated with the enactment of road safety laws. PMID:23106188

  6. 76 FR 51041 - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Hemoglobin Standards and Maintaining Adequate Iron Stores in... Standards and Maintaining Adequate Iron Stores in Blood Donors.'' The purpose of this public workshop is to... donor safety and blood availability, and potential measures to maintain adequate iron stores in...

  7. Determination of safety factor for defibrillator waveforms in cultured heart cells.

    PubMed

    Jones, J L; Jones, R E

    1982-04-01

    We studied excitation thresholds and arrhythmias produced in cultured chick embryo myocardial cells subjected to electric shocks using rectangular, untruncated resistor-capacitor (RC), and critically damped resistor-inductor-capacitor (RLC) waveforms with variable intensities while photocell mechanograms were recorded. Strength-duration curves for excitation and production of a specific postshock arrhythmia (4-s arrest) were constructed. Excitation curves closely resembled those for in situ defibrillation threshold (or specific % success). The ratio between the shock intensity producing a 4-s arrest and that producing excitation at each duration (termed the "safety factor") was determined. Waveforms with a large safety factor in vitro defibrillated most effectively in situ with little postshock dysfunction. Waveforms with low safety factors had a low rate of success in situ and produced much postshock dysfunction. Safety factor of monophasic clinical waveforms were lower than that of the 5-ms rectangular wave. The close correspondence between in vitro safety factor and in situ defibrillating effectiveness, as reported in the literature, suggests that the cell culture system is an effective screening system for determining waveforms that will improve the efficacy and safety of defibrillation procedures. PMID:7065279

  8. Determination of safety factor for defibrillator waveforms in cultured heart cells.

    PubMed

    Jones, J L; Jones, R E

    1982-04-01

    We studied excitation thresholds and arrhythmias produced in cultured chick embryo myocardial cells subjected to electric shocks using rectangular, untruncated resistor-capacitor (RC), and critically damped resistor-inductor-capacitor (RLC) waveforms with variable intensities while photocell mechanograms were recorded. Strength-duration curves for excitation and production of a specific postshock arrhythmia (4-s arrest) were constructed. Excitation curves closely resembled those for in situ defibrillation threshold (or specific % success). The ratio between the shock intensity producing a 4-s arrest and that producing excitation at each duration (termed the "safety factor") was determined. Waveforms with a large safety factor in vitro defibrillated most effectively in situ with little postshock dysfunction. Waveforms with low safety factors had a low rate of success in situ and produced much postshock dysfunction. Safety factor of monophasic clinical waveforms were lower than that of the 5-ms rectangular wave. The close correspondence between in vitro safety factor and in situ defibrillating effectiveness, as reported in the literature, suggests that the cell culture system is an effective screening system for determining waveforms that will improve the efficacy and safety of defibrillation procedures.

  9. Factors Influencing the Safety Behavior of German Equestrians: Attitudes towards Protective Equipment and Peer Behaviors

    PubMed Central

    Ikinger, Christina-Maria; Baldamus, Jana; Spiller, Achim

    2016-01-01

    Simple Summary The handling and riding of horses can be quite dangerous. Although the use of protective gear among equestrians is increasing, a high number of incidents occur and the voluntary use of safety equipment is described as inconsistent to low. Therefore, this study looks at the safety behavior of German equestrians and at factors influencing this behavior to decrease the high number of horse-related injuries. The results reveal that attitudes towards safety products as well as the protective behavior of other horse owners and riding pupils from the stable are key factors that might alter the safety behavior of equestrians. Abstract Human interactions with horses entail certain risks. Although the acceptance and use of protective gear is increasing, a high number of incidents and very low or inconsistent voluntary use of safety equipment are reported. While past studies have examined factors influencing the use of safety gear, they have explored neither their influence on the overall safety behavior, nor their relative influence in relation to each other. The aim of the present study is to fill this gap. We conducted an online survey with 2572 participants. By means of a subsequent multiple regression analysis, we explored 23 different variables in view of their influence on the protective behavior of equestrians. In total, we found 17 variables that exerted a significant influence. The results show that both having positive or negative attitudes towards safety products as well as the protective behavior of other horse owners or riding pupils from the stable have the strongest influence on the safety behavior of German equestrians. We consider such knowledge to be important for both scientists and practitioners, such as producers of protective gear or horse sport associations who might alter safety behavior in such a way that the number of horse-related injuries decreases in the long term. PMID:26901229

  10. Safety update on the use of recombinant activated factor VII in approved indications.

    PubMed

    Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie

    2015-06-01

    This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis.

  11. Computing factors of safety against wind-induced tree stem damage.

    PubMed

    Niklas, K J

    2000-04-01

    The drag forces, bending moments and stresses acting on stems differing in size and location within the mechanical infrastructure of a large wild cherry (Prunus serotina Ehrh.) tree are estimated and used to calculate the factor of safety against wind-induced mechanical failure based on the mean breaking stress of intact stems and samples of wood drawn from this tree. The drag forces acting on stems are calculated based on stem projected areas and field measurements of wind speed taken within the canopy and along the length of the trunk. The bending moments and stresses resulting from these forces are shown to increase basipetally in a nearly log-log linear fashion toward the base of the tree. The factor of safety, however, varies in a sinusoidal manner such that the most distal stems have the highest factors of safety, whereas stems of intermediate location and portions of the trunk near ground level have equivalent and much lower factors of safety. This pattern of variation is interpreted to indicate that, as a course of normal growth and development, trees similar to the one examined in this study maintain a cadre of stems prone to wind-induced mechanical damage that can reduce the probability of catastrophic tree failure by reducing the drag forces acting on older portions of the tree. Comparisons among real and hypothetical stems with different taper experiencing different vertical wind speed profiles show that geometrically self-similar stems have larger factors of safety than stems tapering according to elastic or stress self-similarity, and that safety factors are less significantly influenced by the 'geometry' of the wind-profile. PMID:10938872

  12. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  13. Factors associated with the patient safety climate at a teaching hospital1

    PubMed Central

    Luiz, Raíssa Bianca; Simões, Ana Lúcia de Assis; Barichello, Elizabeth; Barbosa, Maria Helena

    2015-01-01

    Objectives: to investigate the association between the scores of the patient safety climate and socio-demographic and professional variables. Methods: an observational, sectional and quantitative study, conducted at a large public teaching hospital. The Safety Attitudes Questionnaire was used, translated and validated for Brazil. Data analysis used the software Statistical Package for Social Sciences. In the bivariate analysis, we used Student's t-test, analysis of variance and Spearman's correlation of (α=0.05). To identify predictors for the safety climate scores, multiple linear regression was used, having the safety climate domain as the main outcome (α=0.01). Results: most participants were women, nursing staff, who worked in direct care to adult patients in critical areas, without a graduate degree and without any other employment. The average and median total score of the instrument corresponded to 61.8 (SD=13.7) and 63.3, respectively. The variable professional performance was found as a factor associated with the safety environment for the domain perception of service management and hospital management (p=0.01). Conclusion: the identification of factors associated with the safety environment permits the construction of strategies for safe practices in the hospitals. PMID:26487138

  14. 21 CFR 601.32 - General factors relevant to safety and effectiveness.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true General factors relevant to safety and effectiveness. 601.32 Section 601.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... estimated absorbed radiation dose of the diagnostic radiopharmaceutical....

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  18. Factors associated with the activities of safety representatives in Spanish workplaces

    PubMed Central

    García, Ana M; López‐Jacob, Maria José; Dudzinski, Isabel; Gadea, Rafael; Rodrigo, Fernando

    2007-01-01

    Objective To describe the activities of safety representatives in workplaces in Spain. Methods A specific questionnaire was applied to a representative sample of safety representatives. Activities developed during the past year, presented in a closed ended list, were categorised into three groups: information and advising; participation in occupational health management; and pressure on or negotiation with employers. Personal phone interviews were conducted from September to December 2004. A sample of 1201 interviews was attained. Crude and multivariate analyses were carried out. Results Spanish safety representatives were mostly men (76%), aged 26 to 45 years (62%), with fixed contracts (94%), and more than 10 years in their company (57%). On a comparable 0–10 scale, the mean (95% confidence interval (CI)) number of activities relating to information, management, and negotiation developed during the previous year were, respectively, 6.8 (6.7 to 6.9), 4.5 (4.4 to 4.7), and 4.0 (3.8 to 4.1). In multivariate analysis, workplace size (>30 workers), industrial sector, training, and support from the labour inspectorate were the factors most consistently associated with safety representatives' activity. Additionally, support from the employer was associated with participation in occupational health management (odds ratio = 2.38 (95% CI, 1.73 to 3.29)). Conclusions Safety representatives in Spain have a variety of activities, mostly in the category of information and advising. These are necessary but not sufficient for real participation of workers in decisions concerning their health and safety. More participation of safety representatives in occupational health management at workplaces seems to be needed, and factors associated with this participation reinforced. PMID:17699532

  19. Assessing Juvenile Sex Offenders to Determine Adequate Levels of Supervision.

    ERIC Educational Resources Information Center

    Gerdes, Karen E.; And Others

    1995-01-01

    This study analyzed the internal consistency of four inventories used by Utah probation officers to determine adequate and efficacious supervision levels and placement for juvenile sex offenders. Three factors accounted for 41.2 percent of variance (custodian's and juvenile's attitude toward intervention, offense characteristics, and historical…

  20. Mechanics-Based Definition of Safety Factors Against Flow Failure in Unsaturated Shallow Slopes

    NASA Astrophysics Data System (ADS)

    Buscarnera, G.; Lizarraga-Barrera, J.

    2014-12-01

    Physical models for landslide forecasting rely on the combination of hydrologic models for water infiltration and stability criteria based on infinite slope mechanics. Such concepts can be used to derive safety factors for shallow landsliding, in which the mobilization of the soil cover is associated with the attainment of critical values of pore water pressures expressed as a function of the frictional strength. While such models capture the role of important geomorphic features and geotechnical properties, their performance depends on the validity of the postulate of frictional failure. As a result, the safety factors do not to consider a broader range of solid-fluid interactions promoting different slope failure mechanisms, such as flow slides. This work combines principles of soil stability, unsaturated soil mechanics and plasticity theory to derive an alternative set of safety factors. While frictional slips are included in the study as a particular case, the proposed analytical methodology can also be applied to cases in which an increase in degree of saturation promotes liquefaction instabilities, i.e. possible transitions from solid- to fluid-like response. The study shows that the incorporation of principles of unsaturated soil mechanics into slope stability analyses generates suction-dependent coefficients that alter the value of the safety factors. As a result, while the proposed approach can still be combined with standard hydrologic models simulating the evolution of pore pressures in the near-surface, it can also provide a spatially distributed assessment of evolving safety conditions in landscapes susceptible to landslides of the flow type.

  1. Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

    PubMed

    Würtzen, G

    1993-01-01

    The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance. PMID:8359313

  2. Asbestos/NESHAP adequately wet guidance

    SciTech Connect

    Shafer, R.; Throwe, S.; Salgado, O.; Garlow, C.; Hoerath, E.

    1990-12-01

    The Asbestos NESHAP requires facility owners and/or operators involved in demolition and renovation activities to control emissions of particulate asbestos to the outside air because no safe concentration of airborne asbestos has ever been established. The primary method used to control asbestos emissions is to adequately wet the Asbestos Containing Material (ACM) with a wetting agent prior to, during and after demolition/renovation activities. The purpose of the document is to provide guidance to asbestos inspectors and the regulated community on how to determine if friable ACM is adequately wet as required by the Asbestos NESHAP.

  3. Household-level technologies to improve the availability and preparation of adequate and safe complementary foods.

    PubMed

    Mensah, Patience; Tomkins, Andrew

    2003-03-01

    Plant-based complementary foods are the main source of nutrients for many young children in developing countries. They may, however, present problems in providing nutritionally adequate and safe diets for older infants and young children. The high starch content leads to low-nutrient diets that are bulky and dense, with high levels of antinutritive factors such as phytates, tannins, lectins, and enzyme inhibitors. Phytates impair mineral bioavailability, lectins interfere with intestinal structure, and enzyme inhibitors inhibit digestive enzymes. In addition, there is often microbial contamination, which leads to diarrhea, growth-faltering, and impaired development, and the presence of chemical contaminants may lead to neurological disease and goiter. The fact that some fruits containing carotenoids are only available seasonally contributes to the vulnerability of children receiving predominantly plant-based diets. Traditional household food technologies have been used for centuries to improve the quality and safety of complementary foods. These include dehulling, peeling, soaking, germination, fermentation, and drying. While modern communities tend to reject these technologies in favor of more convenient fast-food preparations, there is now a resurgence of interest in older technologies as a possible means of improving the quality and safety of complementary foods when the basic diet cannot be changed for economic reasons. This paper describes the biology, safety, practicability, and acceptability of these traditional processes at the household or community level, as well as the gaps in research, so that more effective policies and programs can be implemented to improve the quality and safety of complementary foods.

  4. Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

    SciTech Connect

    Prueksaritanont, Thomayant . E-mail: thomayant_prueksaritanont@merck.com; Lin, Jiunn H.; Baillie, Thomas A.

    2006-12-01

    This paper aims to provide a scientifically based perspective on issues surrounding the proposed toxicology testing of synthetic drug metabolites as a means of ensuring adequate nonclinical safety evaluation of drug candidates that generate metabolites considered either to be unique to humans or are present at much higher levels in humans than in preclinical species. We put forward a number of theoretical considerations and present several specific examples where the kinetic behavior of a preformed metabolite given to animals or humans differs from that of the corresponding metabolite generated endogenously from its parent. The potential ramifications of this phenomenon are that the results of toxicity testing of the preformed metabolite may be misleading and fail to characterize the true toxicological contribution of the metabolite when formed from the parent. It is anticipated that such complications would be evident in situations where (a) differences exist in the accumulation of the preformed versus generated metabolites in specific tissues, and (b) the metabolite undergoes sequential metabolism to a downstream product that is toxic, leading to differences in tissue-specific toxicity. Owing to the complex nature of this subject, there is a need to treat drug metabolite issues in safety assessment on a case-by-case basis, in which a knowledge of metabolite kinetics is employed to validate experimental paradigms that entail administration of preformed metabolites to animal models.

  5. Factors influencing safety among a group of commercial fishermen along the Texas Gulf Coast.

    PubMed

    Levin, Jeffrey L; Gilmore, Karen; Shepherd, Sara; Wickman, Amanda; Carruth, Ann; Nalbone, J Torey; Gallardo, Gilbert; Nonnenmann, Matthew W

    2010-10-01

    The commercial fishing trades are among the most dangerous jobs in the world. Little published information exists regarding some populations of commercial fishermen such as along the United States Gulf Coast. Studying these unique and often vulnerable groups is important to characterize potential influences on or barriers to safety in anticipation of designing interventions that can change safety behaviors. Working closely with the United States Coast Guard (USCG), a cross-sectional convenience sample of Gulf Coast shrimp fishermen in and near the Port of Galveston, Texas, was surveyed. The survey included demographic factors and broadly covered areas such as type of work and fishing activities, general or global perceptions and beliefs related to safety and accidents, self-report of ability to use safety equipment or apply procedures aboard vessel, and training considerations. Surveys were obtained following informed consent (n = 133). Of the participants, 96.7% were male with 60.9% ≥40 years old. A majority were of Asian descent (57.1% of all fishermen, 82.1% of shrimp fishermen). Over half claimed to speak little or no English and nearly 60% considered the job to be very safe to neutral. A third to half of respondents expressed doubt about their knowledge of using essential safety equipment in the event of emergency. A large portion of the participants preferred hands-on safety training (40.6%). Important findings about this group of commercial fishermen will help with future development of effective prevention practices through the delivery of culturally appropriate safety awareness training. One element that must be addressed in training programs is to increase the awareness among fishermen about the severe occupational risks inherent in this type of work. Community trust and collaborative partnerships are essential to the success of such initiatives.

  6. Factors influencing safety among a group of commercial fishermen along the Texas Gulf Coast.

    PubMed

    Levin, Jeffrey L; Gilmore, Karen; Shepherd, Sara; Wickman, Amanda; Carruth, Ann; Nalbone, J Torey; Gallardo, Gilbert; Nonnenmann, Matthew W

    2010-10-01

    The commercial fishing trades are among the most dangerous jobs in the world. Little published information exists regarding some populations of commercial fishermen such as along the United States Gulf Coast. Studying these unique and often vulnerable groups is important to characterize potential influences on or barriers to safety in anticipation of designing interventions that can change safety behaviors. Working closely with the United States Coast Guard (USCG), a cross-sectional convenience sample of Gulf Coast shrimp fishermen in and near the Port of Galveston, Texas, was surveyed. The survey included demographic factors and broadly covered areas such as type of work and fishing activities, general or global perceptions and beliefs related to safety and accidents, self-report of ability to use safety equipment or apply procedures aboard vessel, and training considerations. Surveys were obtained following informed consent (n = 133). Of the participants, 96.7% were male with 60.9% ≥40 years old. A majority were of Asian descent (57.1% of all fishermen, 82.1% of shrimp fishermen). Over half claimed to speak little or no English and nearly 60% considered the job to be very safe to neutral. A third to half of respondents expressed doubt about their knowledge of using essential safety equipment in the event of emergency. A large portion of the participants preferred hands-on safety training (40.6%). Important findings about this group of commercial fishermen will help with future development of effective prevention practices through the delivery of culturally appropriate safety awareness training. One element that must be addressed in training programs is to increase the awareness among fishermen about the severe occupational risks inherent in this type of work. Community trust and collaborative partnerships are essential to the success of such initiatives. PMID:20954032

  7. Supervision of Student Teachers: How Adequate?

    ERIC Educational Resources Information Center

    Dean, Ken

    This study attempted to ascertain how adequately student teachers are supervised by college supervisors and supervising teachers. Questions to be answered were as follows: a) How do student teachers rate the adequacy of supervision given them by college supervisors and supervising teachers? and b) Are there significant differences between ratings…

  8. Small Rural Schools CAN Have Adequate Curriculums.

    ERIC Educational Resources Information Center

    Loustaunau, Martha

    The small rural school's foremost and largest problem is providing an adequate curriculum for students in a changing world. Often the small district cannot or is not willing to pay the per-pupil cost of curriculum specialists, specialized courses using expensive equipment no more than one period a day, and remodeled rooms to accommodate new…

  9. Toward More Adequate Quantitative Instructional Research.

    ERIC Educational Resources Information Center

    VanSickle, Ronald L.

    1986-01-01

    Sets an agenda for improving instructional research conducted with classical quantitative experimental or quasi-experimental methodology. Includes guidelines regarding the role of a social perspective, adequate conceptual and operational definition, quality instrumentation, control of threats to internal and external validity, and the use of…

  10. An Adequate Education Defined. Fastback 476.

    ERIC Educational Resources Information Center

    Thomas, M. Donald; Davis, E. E. (Gene)

    Court decisions historically have dealt with educational equity; now they are helping to establish "adequacy" as a standard in education. Legislatures, however, have been slow to enact remedies. One debate over education adequacy, though, is settled: Schools are not financed at an adequate level. This fastback is divided into three sections.…

  11. Funding the Formula Adequately in Oklahoma

    ERIC Educational Resources Information Center

    Hancock, Kenneth

    2015-01-01

    This report is a longevity, simulational study that looks at how the ratio of state support to local support effects the number of school districts that breaks the common school's funding formula which in turns effects the equity of distribution to the common schools. After nearly two decades of adequately supporting the funding formula, Oklahoma…

  12. Exploring the possibility of a common structural model measuring associations between safety climate factors and safety behaviour in health care and the petroleum sectors.

    PubMed

    Olsen, Espen

    2010-09-01

    The aim of the present study was to explore the possibility of identifying general safety climate concepts in health care and petroleum sectors, as well as develop and test the possibility of a common cross-industrial structural model. Self-completion questionnaire surveys were administered in two organisations and sectors: (1) a large regional hospital in Norway that offers a wide range of hospital services, and (2) a large petroleum company that produces oil and gas worldwide. In total, 1919 and 1806 questionnaires were returned from the hospital and petroleum organisation, with response rates of 55 percent and 52 percent, respectively. Using a split sample procedure principal factor analysis and confirmatory factor analysis revealed six identical cross-industrial measurement concepts in independent samples-five measures of safety climate and one of safety behaviour. The factors' psychometric properties were explored with satisfactory internal consistency and concept validity. Thus, a common cross-industrial structural model was developed and tested using structural equation modelling (SEM). SEM revealed that a cross-industrial structural model could be identified among health care workers and offshore workers in the North Sea. The most significant contributing variables in the model testing stemmed from organisational management support for safety and supervisor/manager expectations and actions promoting safety. These variables indirectly enhanced safety behaviour (stop working in dangerous situations) through transitions and teamwork across units, and teamwork within units as well as learning, feedback, and improvement. Two new safety climate instruments were validated as part of the study: (1) Short Safety Climate Survey (SSCS) and (2) Hospital Survey on Patient Safety Culture-short (HSOPSC-short). Based on development of measurements and structural model assessment, this study supports the possibility of a common safety climate structural model across health

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

    PubMed Central

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

    2005-01-01

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

  14. Human factors engineering design review acceptance criteria for the safety parameter display

    SciTech Connect

    McGevna, V.; Peterson, L.R.

    1981-10-02

    This report contains human factors engineering design review acceptance criteria developed by the Human Factors Engineering Branch (HFEB) of the Nuclear Regulatory Commission (NRC) to use in evaluating designs of the Safety Parameter Display System (SPDS). These criteria were developed in response to the functional design criteria for the SPDS defined in NUREG-0696, Functional Criteria for Emergency Response Facilities. The purpose of this report is to identify design review acceptance criteria for the SPDS installed in the control room of a nuclear power plant. Use of computer driven cathode ray tube (CRT) displays is anticipated. General acceptance criteria for displays of plant safety status information by the SPDS are developed. In addition, specific SPDS review criteria corresponding to the SPDS functional criteria specified in NUREG-0696 are established.

  15. Magnetic axis safety factor of finite β spheromaks and transition from spheromaks to toroidal magnetic bubbles

    SciTech Connect

    Bellan, Paul M.; Paccagnella, Roberto

    2015-02-15

    The value of the safety factor on the magnetic axis of a finite-beta spheromak is shown to be a function of beta in contrast to what was used in Bellan, Phys. Plasmas 9, 3050 (2002); this dependence on beta substantially reduces the gradient of the safety factor compared to the previous calculation. The method for generating finite-beta spheromak equilibria is extended to generate equilibria describing toroidal magnetic “bubbles,” where the hydrodynamic pressure on the magnetic axis is less than on the toroid surface. This “anti-confinement” configuration can be considered an equilibrium with an inverted beta profile and is relevant to interplanetary magnetic clouds as these clouds have lower hydrodynamic pressure in their interior than on their surface.

  16. Blood safety and the choice of anti-hemophilic factor concentrate.

    PubMed

    Valentino, Leonard A; Oza, Veeral M

    2006-09-01

    Hemophilia is a congenital disorder due to the deficiency of the activity of factor VIII (classical hemophilia A) or IX (Christmas disease or hemophilia B). Bleeding is common and may result in long-term complications or even death. Bleeding may be treated or prevented by infusion of factor concentrates however these drugs are not without risk. Clinicians often feel ill prepared to provide accurate and impartial information regarding these drugs. This review will provide the reader with an historical yet up to date perspective on blood safety as it relates to the choice of concentrates to treat hemophilia.

  17. Safety and tolerability of tumor necrosis factor-α inhibitors in psoriasis: a narrative review.

    PubMed

    Semble, Ashley L; Davis, Scott A; Feldman, Steven R

    2014-02-01

    Tumor necrosis factor (TNF)-α inhibitors are an alternative to oral systemic therapies for psoriasis. Data regarding the safety of TNF-α inhibitors from randomized clinical trials may not fully reflect the effects on the clinic patient population receiving the therapy, but other sources of information are available. We performed a literature review to assess the safety and tolerability of the treatment of moderate-to-severe plaque psoriasis with TNF-α inhibitors. A literature search was conducted using PubMed for articles dating from January 2000 to October 2013. Randomized controlled, cohort, open-label, and observational studies were included, as well as case reports and letters to the editor. Articles found on PubMed describing the safety of anti-TNF-α therapy in psoriasis patients were included, while studies highlighting interleukin (IL)-12 and IL-23 inhibitors were excluded, as were non-English articles. In total, 58 articles were included in the review. TNF-α inhibitors exhibit both efficacy and tolerability in patients with moderate-to-severe plaque psoriasis. Adverse effects associated with these medications are not common and can be minimized with routine clinical monitoring and patient education. While the risk of severe adverse events is low, the lack of very large, long-term, randomized safety trials limits the ability to fully define the safety of these agents. TNF-α inhibitors have a good efficacy/safety ratio for use in patients with moderate-to-severe psoriasis. Serious adverse effects are not common, and common injection-site reactions are usually manageable. The benefits of TNF-α inhibitors outweigh the risks for moderate-to-severe psoriasis; however, there are potential adverse effects and the patient populations at highest risk include the elderly and those with a history of malignancy.

  18. Determination of Slope Safety Factor with Analytical Solution and Searching Critical Slip Surface with Genetic-Traversal Random Method

    PubMed Central

    2014-01-01

    In the current practice, to determine the safety factor of a slope with two-dimensional circular potential failure surface, one of the searching methods for the critical slip surface is Genetic Algorithm (GA), while the method to calculate the slope safety factor is Fellenius' slices method. However GA needs to be validated with more numeric tests, while Fellenius' slices method is just an approximate method like finite element method. This paper proposed a new method to determine the minimum slope safety factor which is the determination of slope safety factor with analytical solution and searching critical slip surface with Genetic-Traversal Random Method. The analytical solution is more accurate than Fellenius' slices method. The Genetic-Traversal Random Method uses random pick to utilize mutation. A computer automatic search program is developed for the Genetic-Traversal Random Method. After comparison with other methods like slope/w software, results indicate that the Genetic-Traversal Random Search Method can give very low safety factor which is about half of the other methods. However the obtained minimum safety factor with Genetic-Traversal Random Search Method is very close to the lower bound solutions of slope safety factor given by the Ansys software. PMID:24782679

  19. Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

    PubMed Central

    Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

    2016-01-01

    Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

  20. Efficacy and safety of recombinant factor VIII products in patients with hemophilia A.

    PubMed

    Musso, Robert

    2008-10-01

    The introduction of recombinant factor VIII (rFVIII) clotting factor concentrates nearly 20 years ago represented a significant advance in the treatment of hemophilia A. The major advantage of rFVIII products compared with plasma-derived FVIII products is related to product safety, with rFVIII products virtually eliminating bloodborne pathogen transmission. The most challenging aspect of hemophilia A management today is the development of FVIII inhibitors; previously untreated patients are at the highest risk for inhibitor formation. Presented in this article are results of clinical trials in previously treated and untreated patients and postmarketing surveillance studies for the four commercially available rFVIII products (Recombinate, ReFacto, Kogenate FS/Kogenate Bayer and Advate). Recombinant FVIII therapies are highly efficacious when used ondemand and prophylactically, and they have excellent safety profiles; there have been no reports of viral- or prion-based disease transmission associated with rFVIII administration. The incidence rate of inhibitors in previously untreated patients ranges from 15% to approximately 30%. Because rFVIII concentrates have proven efficacy and safety profiles, a number of hemophilia treatment groups recommend rFVIII products as first-line therapy in the management of hemophilia A.

  1. Analysis of human factors effects on the safety of transporting radioactive waste materials: Technical report

    SciTech Connect

    Abkowitz, M.D.; Abkowitz, S.B.; Lepofsky, M.

    1989-04-01

    This report examines the extent of human factors effects on the safety of transporting radioactive waste materials. It is seen principally as a scoping effort, to establish whether there is a need for DOE to undertake a more formal approach to studying human factors in radioactive waste transport, and if so, logical directions for that program to follow. Human factors effects are evaluated on driving and loading/transfer operations only. Particular emphasis is placed on the driving function, examining the relationship between human error and safety as it relates to the impairment of driver performance. Although multi-modal in focus, the widespread availability of data and previous literature on truck operations resulted in a primary study focus on the trucking mode from the standpoint of policy development. In addition to the analysis of human factors accident statistics, the report provides relevant background material on several policies that have been instituted or are under consideration, directed at improving human reliability in the transport sector. On the basis of reported findings, preliminary policy areas are identified. 71 refs., 26 figs., 5 tabs.

  2. Application of classification algorithms for analysis of road safety risk factor dependencies.

    PubMed

    Kwon, Oh Hoon; Rhee, Wonjong; Yoon, Yoonjin

    2015-02-01

    Transportation continues to be an integral part of modern life, and the importance of road traffic safety cannot be overstated. Consequently, recent road traffic safety studies have focused on analysis of risk factors that impact fatality and injury level (severity) of traffic accidents. While some of the risk factors, such as drug use and drinking, are widely known to affect severity, an accurate modeling of their influences is still an open research topic. Furthermore, there are innumerable risk factors that are waiting to be discovered or analyzed. A promising approach is to investigate historical traffic accident data that have been collected in the past decades. This study inspects traffic accident reports that have been accumulated by the California Highway Patrol (CHP) since 1973 for which each accident report contains around 100 data fields. Among them, we investigate 25 fields between 2004 and 2010 that are most relevant to car accidents. Using two classification methods, the Naive Bayes classifier and the decision tree classifier, the relative importance of the data fields, i.e., risk factors, is revealed with respect to the resulting severity level. Performances of the classifiers are compared to each other and a binary logistic regression model is used as the basis for the comparisons. Some of the high-ranking risk factors are found to be strongly dependent on each other, and their incremental gains on estimating or modeling severity level are evaluated quantitatively. The analysis shows that only a handful of the risk factors in the data dominate the severity level and that dependency among the top risk factors is an imperative trait to consider for an accurate analysis.

  3. [Safety and risk factor analysis on Polygoni Multiflori Radix base on ancient traditional Chinese medicine literatures].

    PubMed

    Song, Hai-bo; Du, Xiao-xi; Guo, Xiao-xin; Ren, Jing-tian; Yang, Le; Pang, Yu

    2015-03-01

    Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.

  4. Factors shaping effective utilization of health information technology in urban safety-net clinics.

    PubMed

    George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

    2013-09-01

    Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

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

    ERIC Educational Resources Information Center

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

    2006-01-01

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

  6. Mechanics-based statistics of failure risk of quasibrittle structures and size effect on safety factors.

    PubMed

    Bazant, Zdenĕk P; Pang, Sze-Dai

    2006-06-20

    In mechanical design as well as protection from various natural hazards, one must ensure an extremely low failure probability such as 10(-6). How to achieve that goal is adequately understood only for the limiting cases of brittle or ductile structures. Here we present a theory to do that for the transitional class of quasibrittle structures, having brittle constituents and characterized by nonnegligible size of material inhomogeneities. We show that the probability distribution of strength of the representative volume element of material is governed by the Maxwell-Boltzmann distribution of atomic energies and the stress dependence of activation energy barriers; that it is statistically modeled by a hierarchy of series and parallel couplings; and that it consists of a broad Gaussian core having a grafted far-left power-law tail with zero threshold and amplitude depending on temperature and load duration. With increasing structure size, the Gaussian core shrinks and Weibull tail expands according to the weakest-link model for a finite chain of representative volume elements. The model captures experimentally observed deviations of the strength distribution from Weibull distribution and of the mean strength scaling law from a power law. These deviations can be exploited for verification and calibration. The proposed theory will increase the safety of concrete structures, composite parts of aircraft or ships, microelectronic components, microelectromechanical systems, prosthetic devices, etc. It also will improve protection against hazards such as landslides, avalanches, ice breaks, and rock or soil failures. PMID:16769888

  7. Archetypes for Organisational Safety

    NASA Technical Reports Server (NTRS)

    Marais, Karen; Leveson, Nancy G.

    2003-01-01

    We propose a framework using system dynamics to model the dynamic behavior of organizations in accident analysis. Most current accident analysis techniques are event-based and do not adequately capture the dynamic complexity and non-linear interactions that characterize accidents in complex systems. In this paper we propose a set of system safety archetypes that model common safety culture flaws in organizations, i.e., the dynamic behaviour of organizations that often leads to accidents. As accident analysis and investigation tools, the archetypes can be used to develop dynamic models that describe the systemic and organizational factors contributing to the accident. The archetypes help clarify why safety-related decisions do not always result in the desired behavior, and how independent decisions in different parts of the organization can combine to impact safety.

  8. Derivation of safety factors for setting harvest quotas on adult walleyes from past estimates of abundance

    USGS Publications Warehouse

    Hansen, Michael J.; Staggs, Michael D.; Hoff, Michael H.

    1991-01-01

    Past population estimates of adult walleyes Stizostedion vitreum can be used to set harvest quotas, provided that temporal variability in abundance of adult walleyes is accounted for. We used a long-term data set from Escanaba Lake, Wisconsin, to evaluate the accuracy of past population estimates for setting current-year quotas for adult walleyes. The results from Escanaba Lake were corroborated by comparison with other lakes where adult walleye abundance was estimated in more than 1 year. The accuracy of estimates of adult walleye abundance declined over time from the year the estimate was obtained to the year it was used to set a harvest quota. We derived safety factors for application to past estimates of population size; these factors limit the occurrence of an exploitation rate exceeding the maximum sustainable rate (35%) to approximately 1 in 40. These safety factors declined from 35% for 1-year-old estimates to less than 20% for 10-year-old estimates.

  9. Human factors and safety considerations of night-vision systems flight using thermal imaging systems

    NASA Astrophysics Data System (ADS)

    Rash, Clarence E.; Verona, Robert W.; Crowley, John S.

    1990-10-01

    Helmet Mounted Systems (HMS) must be lightweight, balanced and compatible with life support and head protection assemblies. This paper discusses the design of one particular HMS, the GEC Ferranti NITE-OP/NIGHTBIRD aviator's Night Vision Goggle (NVG) developed under contracts to the Ministry of Defence for all three services in the United Kingdom (UK) for Rotary Wing and fast jet aircraft. The existing equipment constraints, safety, human factor and optical performance requirements are discussed before the design solution is presented after consideration of these material and manufacturing options.

  10. Edge safety factor at the onset of plasma disruption during VDEs in JT-60U

    NASA Astrophysics Data System (ADS)

    Sugihara, Masayoshi; Lukash, Victor; Khayrutdinov, Rustam; Neyatani, Yuzuru

    2004-10-01

    Detailed examinations of the value of the edge safety factor (qa) at the onset of thermal quench (TQ) during intentional vertical displacement event (VDE) experiments in JT-60U are carried out using two different reconstruction methods, FBI/FBEQU and DINA. The results from the two methods are very similar and show that the TQ occurs when the qa value is in the range between 1.5 and 2. This result suggests that the predictive simulations for VDEs should be performed within this range of q to examine the subsequent differences in the halo currents, plasma movement and other plasma behaviour during the current quench.

  11. Analysis of safety factors for urban expressways considering the effect of congestion in Shanghai, China.

    PubMed

    Sun, Jian; Li, Tienan; Li, Feng; Chen, Feng

    2016-10-01

    Urban expressways are the key components of the urban traffic network. The traffic safety situation on expressways directly influences the efficiency of the whole network. A total of 48,325 crashes were recorded by Shanghai Expressway Surveillance System in a three-year period. Considering the different crash mechanisms under different congestion levels, models for the total crashes, non-congested-flow crashes and congested-flow crashes were respectively formulated based on the real-time traffic condition corresponding to each crash. Moreover, considering the potential spatial correlation among segments, the adjacent-correlated spatial and distance-correlated spatial models were formulated and compared to the traditional non-spatial-correlated model. A Bayesian approach was employed to estimate the parameters. The results showed that the congestion index, merging ratio, ramp density, and average daily traffic significantly affect the crash frequency. The safety factors in non-congested flow and congested flow are different; diverging behavior is more risky in non-congested flow, more lanes tend to increase the risk of crashes in congested flow, and horizontal curves tend to decrease the crash risk in congested flow but cause high risk in non-congested flow. In addition, the distance-correlated spatial model is found to be the best-fitting model. The results of this study suggested that dedicated safety countermeasures can be designed for different traffic situations on urban expressways.

  12. Analysis of safety factors for urban expressways considering the effect of congestion in Shanghai, China.

    PubMed

    Sun, Jian; Li, Tienan; Li, Feng; Chen, Feng

    2016-10-01

    Urban expressways are the key components of the urban traffic network. The traffic safety situation on expressways directly influences the efficiency of the whole network. A total of 48,325 crashes were recorded by Shanghai Expressway Surveillance System in a three-year period. Considering the different crash mechanisms under different congestion levels, models for the total crashes, non-congested-flow crashes and congested-flow crashes were respectively formulated based on the real-time traffic condition corresponding to each crash. Moreover, considering the potential spatial correlation among segments, the adjacent-correlated spatial and distance-correlated spatial models were formulated and compared to the traditional non-spatial-correlated model. A Bayesian approach was employed to estimate the parameters. The results showed that the congestion index, merging ratio, ramp density, and average daily traffic significantly affect the crash frequency. The safety factors in non-congested flow and congested flow are different; diverging behavior is more risky in non-congested flow, more lanes tend to increase the risk of crashes in congested flow, and horizontal curves tend to decrease the crash risk in congested flow but cause high risk in non-congested flow. In addition, the distance-correlated spatial model is found to be the best-fitting model. The results of this study suggested that dedicated safety countermeasures can be designed for different traffic situations on urban expressways. PMID:26721569

  13. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor.

    PubMed

    Pettengell, Ruth; Bias, Peter; Mueller, Udo; Lang, Nicole

    2016-06-01

    The recombinant human granulocyte colony-stimulating factor (G-CSF) known as filgrastim (Tevagrastim(®), Ratiograstim(®), Biograstim(®)) in Europe (approved in 2008) and tbo-filgrastim (Granix(®)) in the USA (approved in 2012; Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel) is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This article presents pooled clinical data for tbo-filgrastim compared with Neupogen(®) (Amgen, Thousand Oaks, CA, USA) as well as tbo-filgrastim post-marketing safety data. The safety and efficacy of tbo-filgrastim were evaluated in three phase III studies in 677 patients receiving myelosuppressive chemotherapy and study drug (348 patients with breast cancer, 237 with lung cancer, 92 with non-Hodgkin lymphoma). In each study, the efficacy of tbo-filgrastim was similar to that of Neupogen. Overall, 633 (93.5 %) patients receiving the study drug experienced 6093 treatment-emergent adverse events (AEs), most of which were related to chemotherapy. Adverse events related to the study drug (tbo-filgrastim or Neupogen) were experienced by 185 (27.3 %) patients; 19 (2.8 %) had severe drug-related AEs, 5 (0.7 %) had drug-related serious AEs, and 6 (0.9 %) discontinued the study due to drug-related AEs. Overall, the most common drug-related AEs were bone pain (7.1 %), myalgia (4.0 %), and asthenia (4.4 %). The post-marketing safety profile of tbo-filgrastim was consistent with that observed during the clinical studies. The availability of tbo-filgrastim, a G-CSF with safety and efficacy comparable to those of Neupogen, provides physicians with an alternative treatment option for supportive care of patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. PMID:26780505

  14. FED-A, an advanced performance FED based on low safety factor and current drive

    SciTech Connect

    Peng, Y.K.M.; Rutherford, P.H.

    1983-08-01

    The FED-A study aims to quantify the potential improvement in cost-effectiveness of the Fusion Engineering Device (FED) by assuming low safety factor q (less than 2 as opposed to about 3) at the plasma edge and noninductive current drive (as opposed to only inductive current drive). The FED-A performance objectives are set to be : (1) ignition assuming International Tokamak Reactor (INTOR) plamsa confinement scaling, but still achieving a fusion power amplification Q greater than or equal to 5 when the confinement is degraded by a factor of 2; (2) neutron wall loading of about 1 MW/m/sup 2/, with 0.5 MW/m/sup 2/ as a conservative lower bound; and (3) more clearly power-reactor-like operations, such as steady state.

  15. Equilibrium and Stability Characteristics of DIII-D Discharges with Low Edge Safety Factor

    NASA Astrophysics Data System (ADS)

    Jayakumar, R. J.; Garofalo, A. M.; Navratil, G. A.; Reimerdes, H.; Jensen, T. H.; La Haye, R. J.; Scoville, J. T.; Strait, E. J.; Turnbull, A. D.; Okabayashi, M.

    2002-11-01

    A low safety factor plasma has a good potential for reactor applications, since the fusion power and gain increase with reduction in safety factor. Experiments are being carried out in the DIII-D to investigate the equilibrium profiles and stability limits of such plasmas. Plasmas with flat q profiles q_min>1 and q_95<2.5 have been obtained with βN (>2.0) above no wall limits during current ramp and using resistive wall mode feedback. The discharge followed a current profile evolution predicted by the code CORSICA. The ideal wall and no wall beta limits for such discharges are being investigated using the codes GATO and DCON, for different current and pressure profiles. Simultaneously, the current profile and its evolution are being modeled for a variety of plasma cross sectional shapes and discharge formation scenarios to select an optimal scenario for the 2003 experimental run. The experimental results to date and modeling results will be presented.

  16. Tokamak operation with safety factor q95 < 2 via control of MHD stability.

    PubMed

    Piovesan, P; Hanson, J M; Martin, P; Navratil, G A; Turco, F; Bialek, J; Ferraro, N M; La Haye, R J; Lanctot, M J; Okabayashi, M; Paz-Soldan, C; Strait, E J; Turnbull, A D; Zanca, P; Baruzzo, M; Bolzonella, T; Hyatt, A W; Jackson, G L; Marrelli, L; Piron, L; Shiraki, D

    2014-07-25

    Magnetic feedback control of the resistive-wall mode has enabled the DIII-D tokamak to access stable operation at safety factor q(95) = 1.9 in divertor plasmas for 150 instability growth times. Magnetohydrodynamic stability sets a hard, disruptive limit on the minimum edge safety factor achievable in a tokamak, or on the maximum plasma current at a given toroidal magnetic field. In tokamaks with a divertor, the limit occurs at q(95) = 2, as confirmed in DIII-D. Since the energy confinement time scales linearly with current, this also bounds the performance of a fusion reactor. DIII-D has overcome this limit, opening a whole new high-current regime not accessible before. This result brings significant possible benefits in terms of fusion performance, but it also extends resistive-wall mode physics and its control to conditions never explored before. In present experiments, the q(95) < 2 operation is eventually halted by voltage limits reached in the feedback power supplies, not by intrinsic physics issues. Improvements to power supplies and to control algorithms have the potential to further extend this regime.

  17. Is a vegetarian diet adequate for children.

    PubMed

    Hackett, A; Nathan, I; Burgess, L

    1998-01-01

    The number of people who avoid eating meat is growing, especially among young people. Benefits to health from a vegetarian diet have been reported in adults but it is not clear to what extent these benefits are due to diet or to other aspects of lifestyles. In children concern has been expressed concerning the adequacy of vegetarian diets especially with regard to growth. The risks/benefits seem to be related to the degree of restriction of he diet; anaemia is probably both the main and the most serious risk but this also applies to omnivores. Vegan diets are more likely to be associated with malnutrition, especially if the diets are the result of authoritarian dogma. Overall, lacto-ovo-vegetarian children consume diets closer to recommendations than omnivores and their pre-pubertal growth is at least as good. The simplest strategy when becoming vegetarian may involve reliance on vegetarian convenience foods which are not necessarily superior in nutritional composition. The vegetarian sector of the food industry could do more to produce foods closer to recommendations. Vegetarian diets can be, but are not necessarily, adequate for children, providing vigilance is maintained, particularly to ensure variety. Identical comments apply to omnivorous diets. Three threats to the diet of children are too much reliance on convenience foods, lack of variety and lack of exercise.

  18. The Dread Factor: How Hazards and Safety Training Influence Learning and Performance

    ERIC Educational Resources Information Center

    Burke, Michael J.; Salvador, Rommel O.; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

    2011-01-01

    On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous…

  19. Why Some Walk and Others Don't: Exploring Interactions of Perceived Safety and Social Neighborhood Factors with Psychosocial Cognitions

    ERIC Educational Resources Information Center

    Beenackers, Marielle A.; Kamphuis, Carlijn B. M.; Mackenbach, Johan P.; Burdorf, Alex; van Lenthe, Frank J.

    2013-01-01

    Although physical activity is often believed to be influenced by both environmental and individual factors, little is known about their interaction. This study explores interactions of perceived safety and social neighborhood factors with psychosocial cognitions for leisure-time walking. Cross-sectional data were obtained from residents (age 25-75…

  20. The refinement of uncertainty/safety factors in risk assessment by the incorporation of data on toxicokinetic variability in humans.

    PubMed

    Dorne, J L C M; Renwick, A G

    2005-07-01

    The derivation of safe levels of exposure in humans for compounds that are assumed to cause threshold toxicity has relied on the application of a 100-fold uncertainty factor to a measure for the threshold, such as the no observed adverse effect level (NOAEL) or the benchmark dose (BMD). This 100-fold safety factor consists of the product of two 10-fold factors allowing for human variability and interspecies differences. The International Programme on Chemical Safety has suggested the subdivision of these 10-fold factors to allow for variability in toxicokinetics and toxicodynamics. This subdivision allows the replacement of the default uncertainty factors with a chemical-specific adjustment factor (CSAF) when suitable data are available. This short review describes potential options to refine safety factors used in risk assessment, with particular emphasis on pathway-related uncertainty factors associated with variability in kinetics. These pathway-related factors were derived from a database that quantified interspecies differences and human variability in phase I metabolism, phase II metabolism, and renal excretion. This approach allows metabolism and pharmacokinetic data in healthy adults and subgroups of the population to be incorporated in the risk-assessment process and constitutes an intermediate approach between simple default factors and chemical-specific adjustment factors. PMID:15800035

  1. The refinement of uncertainty/safety factors in risk assessment by the incorporation of data on toxicokinetic variability in humans.

    PubMed

    Dorne, J L C M; Renwick, A G

    2005-07-01

    The derivation of safe levels of exposure in humans for compounds that are assumed to cause threshold toxicity has relied on the application of a 100-fold uncertainty factor to a measure for the threshold, such as the no observed adverse effect level (NOAEL) or the benchmark dose (BMD). This 100-fold safety factor consists of the product of two 10-fold factors allowing for human variability and interspecies differences. The International Programme on Chemical Safety has suggested the subdivision of these 10-fold factors to allow for variability in toxicokinetics and toxicodynamics. This subdivision allows the replacement of the default uncertainty factors with a chemical-specific adjustment factor (CSAF) when suitable data are available. This short review describes potential options to refine safety factors used in risk assessment, with particular emphasis on pathway-related uncertainty factors associated with variability in kinetics. These pathway-related factors were derived from a database that quantified interspecies differences and human variability in phase I metabolism, phase II metabolism, and renal excretion. This approach allows metabolism and pharmacokinetic data in healthy adults and subgroups of the population to be incorporated in the risk-assessment process and constitutes an intermediate approach between simple default factors and chemical-specific adjustment factors.

  2. Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

    SciTech Connect

    O, J.M.; Higgins, J.; Stephen Fleger - NRC

    2011-09-19

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.

  3. Analysis of Factors Determining Ergonomic Conditions of Driver's Workplace and Safety in Transport of Dangerous Goods

    NASA Astrophysics Data System (ADS)

    Grabarek, Iwona; Beczkowska, Sylwia

    2012-09-01

    The article concerns issues connected with the safety of the carriage of dangerous goods. Raising a subject was justified with the rising number of cartages of these goods and the same height of the probability of the appearance of the environmental risk and remaining road users. A specificity of the arrangement was analyzed driver-vehicleenvironment, paying special attention to ergonomic determinants of working conditions of the driver. In the article data of the National Police Headquarters concerning causes of accident involving dangerous goods in the road transport was also described. Exceeding the permissible speed, the non-observance of traffic regulations, as well as the tiredness which resulted in reducing the psychophysical efficiency for the driver were regarded as the root cause of accidents. Conducted analyses allowed to effect the preliminary selection of factors, which accepting the wrong level can constitute the cause of accidents.

  4. Safety concerns as a factor in pilot desire to change aircraft.

    PubMed

    Ungs, T J

    1993-01-01

    An anonymous and voluntary questionnaire was completed by 461 (73.4%) Coast Guard aviators at 26 participating Air Stations. Most (92%) pilots felt that helicopters had more dangerous missions and were less safe than fixed wing aircraft (FXAC). Two thirds (204) of helicopter and 19.3% (29) of FXAC pilots stated a desire to change to a different aircraft category. Only 1 (3.6%) of the FXAC pilots but 81 (39.8%) of the helicopter pilots stated their wish for aircraft change was influenced by a desire to operate aircraft they perceived as safer. Pilots who desired change in aircraft category were more senior, more experienced, and felt they were currently engaging in dangerous flight operations. In conclusion this study found that: 1) Coast Guard pilots consider helicopters less safe than FXAC; 2) a substantial proportion of helicopter pilots would like to change to FXAC; 3) safety concerns can be a common factor in pilots' desires to change aircraft.

  5. Adequate mathematical modelling of environmental processes

    NASA Astrophysics Data System (ADS)

    Chashechkin, Yu. D.

    2012-04-01

    In environmental observations and laboratory visualization both large scale flow components like currents, jets, vortices, waves and a fine structure are registered (different examples are given). The conventional mathematical modeling both analytical and numerical is directed mostly on description of energetically important flow components. The role of a fine structures is still remains obscured. A variety of existing models makes it difficult to choose the most adequate and to estimate mutual assessment of their degree of correspondence. The goal of the talk is to give scrutiny analysis of kinematics and dynamics of flows. A difference between the concept of "motion" as transformation of vector space into itself with a distance conservation and the concept of "flow" as displacement and rotation of deformable "fluid particles" is underlined. Basic physical quantities of the flow that are density, momentum, energy (entropy) and admixture concentration are selected as physical parameters defined by the fundamental set which includes differential D'Alembert, Navier-Stokes, Fourier's and/or Fick's equations and closing equation of state. All of them are observable and independent. Calculations of continuous Lie groups shown that only the fundamental set is characterized by the ten-parametric Galilelian groups reflecting based principles of mechanics. Presented analysis demonstrates that conventionally used approximations dramatically change the symmetries of the governing equations sets which leads to their incompatibility or even degeneration. The fundamental set is analyzed taking into account condition of compatibility. A high order of the set indicated on complex structure of complete solutions corresponding to physical structure of real flows. Analytical solutions of a number problems including flows induced by diffusion on topography, generation of the periodic internal waves a compact sources in week-dissipative media as well as numerical solutions of the same

  6. Analysis of rainfall-induced slope instability using a field of local factor of safety

    USGS Publications Warehouse

    Lu, Ning; Şener-Kaya, Başak; Wayllace, Alexandra; Godt, Jonathan W.

    2012-01-01

    Slope-stability analyses are mostly conducted by identifying or assuming a potential failure surface and assessing the factor of safety (FS) of that surface. This approach of assigning a single FS to a potentially unstable slope provides little insight on where the failure initiates or the ultimate geometry and location of a landslide rupture surface. We describe a method to quantify a scalar field of FS based on the concept of the Coulomb stress and the shift in the state of stress toward failure that results from rainfall infiltration. The FS at each point within a hillslope is called the local factor of safety (LFS) and is defined as the ratio of the Coulomb stress at the current state of stress to the Coulomb stress of the potential failure state under the Mohr-Coulomb criterion. Comparative assessment with limit-equilibrium and hybrid finite element limit-equilibrium methods show that the proposed LFS is consistent with these approaches and yields additional insight into the geometry and location of the potential failure surface and how instability may initiate and evolve with changes in pore water conditions. Quantitative assessments applying the new LFS field method to slopes under infiltration conditions demonstrate that the LFS has the potential to overcome several major limitations in the classical FS methodologies such as the shape of the failure surface and the inherent underestimation of slope instability. Comparison with infinite-slope methods, including a recent extension to variably saturated conditions, shows further enhancement in assessing shallow landslide occurrence using the LFS methodology. Although we use only a linear elastic solution for the state of stress with no post-failure analysis that require more sophisticated elastoplastic or other theories, the LFS provides a new means to quantify the potential instability zones in hillslopes under variably saturated conditions using stress-field based methods.

  7. New insights into long-bone biomechanics: are limb safety factors invariable across mammalian species?

    PubMed

    Kokshenev, Valery B

    2007-01-01

    The most common function of limb bones is to provide stiff levers acting against muscles and gravity; however, a general mechanical description is not yet available. This research attempts such a description by modeling the bone's intrinsic biomechanics through elastic stability of solid long cylinders considered in non-critical, transient and critical mechanical regimes distinguished conventionally through maximal resisting elastic strains. The non-critical regime controls bones' adaptation through the safety factor (bone strength related to the peak functional stress) S2. This is ensured by bone-diameter (d=1/3+beta) and bone-length (l=1/3-beta) scaling exponents generally following from compressive-stress constraints. Prange's index (0safety factor provides evidence that land-dwelling and land-moving giants are biomechanically accommodated to the peak bending and torsion functional stresses, respectively.

  8. Steps to prevent SUDEP: the validity of risk factors in the SUDEP and seizure safety checklist: a case control study.

    PubMed

    Shankar, Rohit; Walker, Matthew; McLean, Brendan; Laugharne, Richard; Ferrand, Fucundo; Hanna, Jane; Newman, Craig

    2016-09-01

    Our objectives were to compare people with epilepsy (PWE) who died of sudden unexpected death in epilepsy (SUDEP) with live controls using the risk factor items of the SUDEP and Seizure Safety Checklist. All 48 SUDEPs of 93 epilepsy deaths which occurred in Cornwall UK 2004-2012 were compared to 220 live controls using the SUDEP and Seizure Safety Checklist, an evidenced based tool used to communicate person centered risk of SUDEP to PWE. The odds ratio for having a specific factor in those who died was compared to controls and ranked according to P value using a sequential Bonferroni correction for multiple comparisons. Of the 17 modifiable and non-modifiable risk factors analyzed 9 were statistically significant of which 7 are potentially modifiable. Well known modifiable factors such as nocturnal monitoring, compliance and sleeping position featured prominently in the risk association. This is the first case control study exploring the risk factors for SUDEP since 2009. The findings are compared to the current considered risk factors as identified in a major recent review. The study further validates certain SUDEP risk factors. It highlights that the majority of risk factors strongly associated with SUDEP are potentially modifiable. There is an emerging profile to rank the risk factors. It furthers the evidence to use structured risk assessment and communication tools such as the SUDEP and Seizure Safety Checklist in daily clinical practice. It highlights key areas for a person centered discussion to empower PWE to mitigate risk. PMID:27334909

  9. Nurses' perceptions of and factors promoting patient safety culture in Turkey.

    PubMed

    Turkmen, Emine; Baykal, Ulku; Intepeler, Seyda Seren; Altuntas, Serap

    2013-01-01

    This descriptive and cross-sectional study included 561 nurses in hospitals located in Istanbul, Turkey. The Patient Safety Questionnaire was used for data collection. The type of hospital and the amount of education nurses obtained about patient safety and quality improvement were positively associated with patient safety culture. Conversely, the type of work unit negatively affected workers' behaviors and adverse event reporting in terms of patient safety culture.

  10. Pesticide safety among farmworkers: perceived risk and perceived control as factors reflecting environmental justice.

    PubMed Central

    Arcury, Thomas A; Quandt, Sara A; Russell, Gregory B

    2002-01-01

    Farmworkers in the United States constitute a population at risk for serious environmental and occupational illness and injury as well as health disparities typically associated with poverty. Pesticides are a major source of occupational injury and illness to which farmworkers are exposed. Efforts to provide safety training for farmworkers have not been fully evaluated. Based on the Health Belief Model, this analysis examines how safety information affects perceived pesticide safety risk and control among farmworkers and how perceived risk and control affect farmworker knowledge and safety behavior. Data are based on interviews conducted in 1999 with 293 farmworkers in eastern North Carolina as part of the Preventing Agricultural Chemical Exposure in North Carolina Farmworkers' Project. Perceived pesticide risk and perceived pesticide control scales were developed from interview items. Analysis of the items and scales showed that farmworkers had fairly high levels of perceived risk from pesticides and perceived control of pesticide safety. Receiving information about pesticide safety (e.g., warning signs) reduced perceived risk and increased perceived control. Pesticide exposure knowledge was strongly related to perceived risk. However, perceived risk had a limited relationship to safety knowledge and was not related to safety behavior. Perceived control was not related to pesticide exposure knowledge, but was strongly related to safety knowledge and safety behavior. A key tenet of environmental justice is that communities must have control over their environment. These results argue that for pesticide safety education to be effective, it must address issues of farmworker control in implementing workplace pesticide safety. PMID:11929733

  11. Factors Associated with the Adoption of Food Safety Controls by the Mexican Meat Industry

    NASA Astrophysics Data System (ADS)

    Maldonado-Simán, Ema; Martínez-Hernández, Pedro Arturo; García-Muñiz, José G.; Cadena-Meneses, José

    Food marketing at international and domestic markets has focused on processing systems that improve food safety. The objective of this research is to determine the factors influencing the implementation of the HACCP system in the Mexican meat industry, and to identify the main marketing destination of their products. Only 18.5% of enterprises reports fully operational HACCP in their plants. The main destination of their production in the domestic market is supermarkets, suppliers and distributors and specific niches of the domestic market. Exports are to USA, Japan, Korea and Central America and some niches of the domestic market with requirements of higher quality. The four principal factors that motivate enterprises to adopt HACCP are associated with improvement of plant efficiency and profitability, adoption of good practices, improvement of product quality and waste reduction. It is concluded that Mexican enterprises adopt HACCP to successfully remain and face competition by foreign enterprises in the domestic market and to a lesser extent to compete in the international market.

  12. [Abdominal cure procedures. Adequate use of Nobecutan Spray].

    PubMed

    López Soto, Rosa María

    2009-12-01

    Open abdominal wounds, complicated by infection and/or risk of eventration tend to become chronic and usually require frequent prolonged cure. Habitual changing of bandages develop into one of the clearest risk factors leading to the deterioration of perilesional cutaneous integrity. This brings with it new complications which draw out the evolution of the process, provoking an important deterioration in quality of life for the person who suffers this and a considerable increase in health costs. What is needed is a product and a procedure which control the risk of irritation, which protect the skin, which favor a patient's comfort and which shorten treatment requirements while lowering health care expenses. This report invites medical personnel to think seriously about the scientific rationale, and treatment practice, as to why and how to apply Nobecutan adequately, this reports concludes stating the benefits in the adequate use of this product. The objective of this report is to guarantee the adequate use of this product in treatment of complicated abdominal wounds. This product responds to the needs which are present in these clinical cases favoring skin care apt isolation and protection, while at the same time, facilitating the placement and stability of dressings and bandages used to cure wounds. In order for this to happen, the correct use of this product is essential; medical personnel must pay attention to precautions and recommendations for proper application. The author's experiences in habitual handling of this product during various years, included in the procedures for standardized cures for these wounds, corroborates its usefulness; the author considers use of this product to be highly effective while being simple to apply; furthermore, one succeeds in providing quality care and optimizes resources employed.

  13. Human factors and safety issues associated with actinide retrieval from spent light water reactor fuel assemblies

    SciTech Connect

    Spelt, P.F.

    1992-01-01

    A major problem in environmental restoration and waste management is the disposition of used fuel assemblies from the many light water reactors in the United States, which present a radiation hazard to those whose job is to dispose of them, with a similar threat to the general environment associated with long-term storage in fuel repositories around the country. Actinides resident in the fuel pins as a result of their use in reactor cores constitute a significant component of this hazard. Recently, the Department of Energy has initiated an Actinide Recycle Program to study the feasibility of using pyrochemical (molten salt) processes to recover actinides from the spent fuel assemblies of commercial reactors. This project concerns the application of robotics technology to the operation and maintenance functions of a plant whose objective is to recover actinides from spent fuel assemblies, and to dispose of the resulting hardware and chemical components from this process. Such a procedure involves a number of safety and human factors issues. The purpose of the project is to explore the use of robotics and artificial intelligence to facilitate accomplishment of the program goals while maintaining the safety of the humans doing the work and the integrity of the environment. This project will result in a graphic simulation on a Silicon Graphics workstation as a proof of principle demonstration of the feasibility of using robotics along with an intelligent operator interface. A major component of the operator-system interface is a hybrid artificial intelligence system developed at Oak Ridge National Laboratory, which combines artificial neural networks and an expert system into a hybrid, self-improving computer-based system interface. 10 refs.

  14. Human factors and safety issues associated with actinide retrieval from spent light water reactor fuel assemblies

    SciTech Connect

    Spelt, P.F.

    1992-08-01

    A major problem in environmental restoration and waste management is the disposition of used fuel assemblies from the many light water reactors in the United States, which present a radiation hazard to those whose job is to dispose of them, with a similar threat to the general environment associated with long-term storage in fuel repositories around the country. Actinides resident in the fuel pins as a result of their use in reactor cores constitute a significant component of this hazard. Recently, the Department of Energy has initiated an Actinide Recycle Program to study the feasibility of using pyrochemical (molten salt) processes to recover actinides from the spent fuel assemblies of commercial reactors. This project concerns the application of robotics technology to the operation and maintenance functions of a plant whose objective is to recover actinides from spent fuel assemblies, and to dispose of the resulting hardware and chemical components from this process. Such a procedure involves a number of safety and human factors issues. The purpose of the project is to explore the use of robotics and artificial intelligence to facilitate accomplishment of the program goals while maintaining the safety of the humans doing the work and the integrity of the environment. This project will result in a graphic simulation on a Silicon Graphics workstation as a proof of principle demonstration of the feasibility of using robotics along with an intelligent operator interface. A major component of the operator-system interface is a hybrid artificial intelligence system developed at Oak Ridge National Laboratory, which combines artificial neural networks and an expert system into a hybrid, self-improving computer-based system interface. 10 refs.

  15. Safety of Switching Factor VIII Products in the Era of Evolving Concentrates: Myths and Facts.

    PubMed

    Coppola, Antonio; Marrone, Emiliana; Conca, Paolo; Cimino, Ernesto; Mormile, Rosaria; Baldacci, Erminia; Santoro, Cristina

    2016-07-01

    Recent advances in the development of factor VIII (FVIII) concentrates offer patients with hemophilia the opportunity to switch to products considered safer or with improved properties. In some cases, product switch occurs due to side effects, convenience issues, or economic reasons affecting clinical choices. Reluctance to change FVIII concentrates is shown by patients and also by their physicians, because of concerns in particular about the risk of inhibitor development. A literature review was performed to retrieve the best evidence regarding safety issues of switching FVIII concentrate in patients with severe hemophilia A. Product switch was not associated with an increased inhibitor risk in four studies in patients during the first 50 to 75 exposure days, or in three studies reporting national switches in Canada and United Kingdom. The latter, the only available study comparing switcher and nonswitcher patients, showed an inhibitor incidence similar to that historically reported in the United Kingdom. In 16 phase III clinical trials and 6 postmarketing studies of FVIII concentrates, few de novo inhibitors were detected in previously treated patients, mostly transient and low-titer, with some additional recurrent inhibitors in patients with previous positive testing. On the whole, although rigorous controlled studies are lacking, literature data do not support increased risk of inhibitor development or other safety issues related to product switch. Therefore, in the presence of clinical needs, the advantages of switching FVIII products should not be missed because of perceived more than evidence-based challenges, in particular in this era of products with improved properties recently introduced or available in few years. Caution, however, is suggested in patients with high inhibitor risk, including in those in concomitance with surgery or intensive treatment. A careful inhibitor testing prior to and after product switch is always needed, to identify real de

  16. 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

  17. Diversity of limb-bone safety factors for locomotion in terrestrial vertebrates: evolution and mixed chains.

    PubMed

    Blob, Richard W; Espinoza, Nora R; Butcher, Michael T; Lee, Andrew H; D'Amico, Angela R; Baig, Faraz; Sheffield, K Megan

    2014-12-01

    During locomotion over land, vertebrates' limb bones are exposed to loads. Like most biological structures, limb bones have a capacity to withstand greater loads than they usually experience, termed a safety factor (SF). How diverse are limb-bone SFs, and what factors correlate with such variation? We have examined these questions from two perspectives. First, we evaluated locomotor SF for the femur in diverse lineages, including salamanders, frogs, turtles, lizards, crocodilians, and marsupials (opossums). Comparisons with values for hind-limb elements in running birds and eutherian mammals indicate phylogenetic diversity in limb-bone SF. A high SF (∼7) is primitive for tetrapods, but low magnitudes of load and elevated strength of bones contribute to different degrees across lineages; moreover, birds and eutherians appear to have evolved lower SFs independently. Second, we tested the hypothesis that SFs would be similar across limb bones within a taxon by comparing data from the humerus and femur of alligators. Both in bending and in torsion, we found a higher SF for the humerus than for the femur. Such a "mixed chain" of different SFs across elements has been predicted if bones have differing variabilities in load, different costs to maintain, or high SF values in general. Although variability in load is similar for the humerus and femur, a high SF may be less costly for the humerus because it is smaller than the femur. The high SFs of alligators also might facilitate differences in SF among their limb bones. Beyond these specific findings, however, a more general implication of our results is that evaluations of the diversity of limb-bone SFs can provide important perspective to direct future research. In particular, more complete understanding of variation in SF could provide insight into factors that promoted the evolutionary radiation of terrestrial locomotor function in vertebrates.

  18. Adipose Tissue - Adequate, Accessible Regenerative Material

    PubMed Central

    Kolaparthy, Lakshmi Kanth.; Sanivarapu, Sahitya; Moogla, Srinivas; Kutcham, Rupa Sruthi

    2015-01-01

    The potential use of stem cell based therapies for the repair and regeneration of various tissues offers a paradigm shift that may provide alternative therapeutic solutions for a number of diseases. The use of either embryonic stem cells (ESCs) or induced pluripotent stem cells in clinical situations is limited due to cell regulations and to technical and ethical considerations involved in genetic manipulation of human ESCs, even though these cells are highly beneficial. Mesenchymal stem cells seen to be an ideal population of stem cells in particular, Adipose derived stem cells (ASCs) which can be obtained in large number and easily harvested from adipose tissue. It is ubiquitously available and has several advantages compared to other sources as easily accessible in large quantities with minimal invasive harvesting procedure, and isolation of adipose derived mesenchymal stem cells yield a high amount of stem cells which is essential for stem cell based therapies and tissue engineering. Recently, periodontal tissue regeneration using ASCs has been examined in some animal models. This method has potential in the regeneration of functional periodontal tissues because various secreted growth factors from ASCs might not only promote the regeneration of periodontal tissues but also encourage neovascularization of the damaged tissues. This review summarizes the sources, isolation and characteristics of adipose derived stem cells and its potential role in periodontal regeneration is discussed. PMID:26634060

  19. Adipose Tissue - Adequate, Accessible Regenerative Material.

    PubMed

    Kolaparthy, Lakshmi Kanth; Sanivarapu, Sahitya; Moogla, Srinivas; Kutcham, Rupa Sruthi

    2015-11-01

    The potential use of stem cell based therapies for the repair and regeneration of various tissues offers a paradigm shift that may provide alternative therapeutic solutions for a number of diseases. The use of either embryonic stem cells (ESCs) or induced pluripotent stem cells in clinical situations is limited due to cell regulations and to technical and ethical considerations involved in genetic manipulation of human ESCs, even though these cells are highly beneficial. Mesenchymal stem cells seen to be an ideal population of stem cells in particular, Adipose derived stem cells (ASCs) which can be obtained in large number and easily harvested from adipose tissue. It is ubiquitously available and has several advantages compared to other sources as easily accessible in large quantities with minimal invasive harvesting procedure, and isolation of adipose derived mesenchymal stem cells yield a high amount of stem cells which is essential for stem cell based therapies and tissue engineering. Recently, periodontal tissue regeneration using ASCs has been examined in some animal models. This method has potential in the regeneration of functional periodontal tissues because various secreted growth factors from ASCs might not only promote the regeneration of periodontal tissues but also encourage neovascularization of the damaged tissues. This review summarizes the sources, isolation and characteristics of adipose derived stem cells and its potential role in periodontal regeneration is discussed. PMID:26634060

  20. Are shear force methods adequately reported?

    PubMed

    Holman, Benjamin W B; Fowler, Stephanie M; Hopkins, David L

    2016-09-01

    This study aimed to determine the detail to which shear force (SF) protocols and methods have been reported in the scientific literature between 2009 and 2015. Articles (n=734) published in peer-reviewed animal and food science journals and limited to only those testing the SF of unprocessed and non-fabricated mammal meats were evaluated. It was found that most of these SF articles originated in Europe (35.3%), investigated bovine species (49.0%), measured m. longissimus samples (55.2%), used tenderometers manufactured by Instron (31.2%), and equipped with Warner-Bratzler blades (68.8%). SF samples were also predominantly thawed prior to cooking (37.1%) and cooked sous vide, using a water bath (50.5%). Information pertaining to blade crosshead speed (47.5%), recorded SF resistance (56.7%), muscle fibre orientation when tested (49.2%), sub-section or core dimension (21.8%), end-point temperature (29.3%), and other factors contributing to SF variation were often omitted. This base failure diminishes repeatability and accurate SF interpretation, and must therefore be rectified. PMID:27107727

  1. Are shear force methods adequately reported?

    PubMed

    Holman, Benjamin W B; Fowler, Stephanie M; Hopkins, David L

    2016-09-01

    This study aimed to determine the detail to which shear force (SF) protocols and methods have been reported in the scientific literature between 2009 and 2015. Articles (n=734) published in peer-reviewed animal and food science journals and limited to only those testing the SF of unprocessed and non-fabricated mammal meats were evaluated. It was found that most of these SF articles originated in Europe (35.3%), investigated bovine species (49.0%), measured m. longissimus samples (55.2%), used tenderometers manufactured by Instron (31.2%), and equipped with Warner-Bratzler blades (68.8%). SF samples were also predominantly thawed prior to cooking (37.1%) and cooked sous vide, using a water bath (50.5%). Information pertaining to blade crosshead speed (47.5%), recorded SF resistance (56.7%), muscle fibre orientation when tested (49.2%), sub-section or core dimension (21.8%), end-point temperature (29.3%), and other factors contributing to SF variation were often omitted. This base failure diminishes repeatability and accurate SF interpretation, and must therefore be rectified.

  2. Background for Community-Level Work on Physical Health and Safety in Adolescence: Reviewing the Literature on Contributing Factors.

    ERIC Educational Resources Information Center

    Hatcher, Juliet L.; Scarpa, Juliet

    Although adolescence is characterized by general good health, this developmental stage is a key time for promoting a healthy lifestyle and preventing health-compromising behaviors and injuries. This paper presents a selective review of research into factors predicting health and safety behavior patterns and injury occurrence, focusing on…

  3. Food Safety Programs Based on HACCP Principles in School Nutrition Programs: Implementation Status and Factors Related to Implementation

    ERIC Educational Resources Information Center

    Stinson, Wendy Bounds; Carr, Deborah; Nettles, Mary Frances; Johnson, James T.

    2011-01-01

    Purpose/Objectives: The objectives of this study were to assess the extent to which school nutrition (SN) programs have implemented food safety programs based on Hazard Analysis and Critical Control Point (HACCP) principles, as well as factors, barriers, and practices related to implementation of these programs. Methods: An online survey was…

  4. DARHT - an `adequate` EIS: A NEPA case study

    SciTech Connect

    Webb, M.D.

    1997-08-01

    The Dual Axis Radiographic Hydrodynamic Test (DARHT) Facility Environmental Impact Statement (EIS) provides a case study that is interesting for many reasons. The EIS was prepared quickly, in the face of a lawsuit, for a project with unforeseen environmental impacts, for a facility that was deemed urgently essential to national security. Following judicial review the EIS was deemed to be {open_quotes}adequate.{close_quotes} DARHT is a facility now being built at Los Alamos National Laboratory (LANL) as part of the Department of Energy (DOE) nuclear weapons stockpile stewardship program. DARHT will be used to evaluate the safety and reliability of nuclear weapons, evaluate conventional munitions and study high-velocity impact phenomena. DARHT will be equipped with two accelerator-driven, high-intensity X-ray machines to record images of materials driven by high explosives. DARHT will be used for a variety of hydrodynamic tests, and DOE plans to conduct some dynamic experiments using plutonium at DARHT as well.

  5. Choices for achieving adequate dietary calcium with a vegetarian diet.

    PubMed

    Weaver, C M; Proulx, W R; Heaney, R

    1999-09-01

    To achieve adequate dietary calcium intake, several choices are available that accommodate a variety of lifestyles and tastes. Liberal consumption of dairy products in the diet is the approach of most Americans. Some plants provide absorbable calcium, but the quantity of vegetables required to reach sufficient calcium intake make an exclusively plant-based diet impractical for most individuals unless fortified foods or supplements are included. Also, dietary constituents that decrease calcium retention, such as salt, protein, and caffeine, can be high in the vegetarian diet. Although it is possible to obtain calcium balance from a plant-based diet in a Western lifestyle, it may be more convenient to achieve calcium balance by increasing calcium consumption than by limiting other dietary factors.

  6. FED-A, an advanced performance FED based on low safety factor and current drive

    SciTech Connect

    Peng, Yueng Kay Martin; Rutherford, P. H.; Hogan, J.T.; Attenberger, S. E.; Holmes, J.A.; Borowski, S. K.; Brown, T. G.; Carreras, B. A.; Ehst, D. A.; Haines, J.R.; Hively, L. M.; Houlberg, Wayne A; Iida, H.; Lee, V. D.; Lynch, S.J.; Reid, R. L.; Rothe, K. E.; Strickler, Dennis J; Stewart, L. D.

    1983-08-01

    This document is one of four describing studies performed in FY 1982 within the context of the Fusion Engineering Device (FED) Program for the Office of Fusion Energy, U.S. Department of Energy. The documents are: 1. FED Baseline Engineering Studies (ORNL/FEDC-82/2), 2. FED-A, An Advanced Performance FED Based on Low Safety Factor and Current Drive (this document), 3. FED-R, A Fusion Device Utilizing Resistive Magnets (ORNL/FEDC-82/1), and 4. Technology Demonstration Facility TDF. These studies extend the FED Baseline concept of FY 1981 and develop innovative and alternative concepts for the FED. The FED-A study project was carried out as part of the Innovative and Alternative Tokamak FED studies, under the direction of P. H. Rutherford, which were part of the national FED program during FY 1982. The studies were performed jointly by senior scientists in the magnetic fusion community and the staff of the Fusion Engineering Design Center (FEDC). Y-K. M. Peng of the FEDC, on assignment from Oak Ridge National Laboratory, served as the design manager.

  7. Robust Control of the Toroidal Rotation and Safety Factor Profiles in the DIII-D Tokamak

    NASA Astrophysics Data System (ADS)

    Shi, W.; Wehner, W.; Schuster, E.; Walker, M. L.; Humphreys, D. A.

    2011-10-01

    Because of the coupling between the different magnetic and kinetic plasma profiles, multi-input-multi-output (MIMO) model-based controllers are introduced to regulate the plasma rotation and safety factor profiles around particular target profiles. The approach is based on linear two-time-scale models identified from experimental data. The inputs are separated into slow and fast components by a low-pass filter that is incorporated into the overall plant. Then a singular value decomposition (SVD) of the plasma model is carried out to decouple the system and identify the most relevant control channels. Finally, the H∞ technique is used to determine a stabilizing feedback controller that minimizes the reference tracking errors and rejects disturbances with minimal control energy. Computer simulation results illustrate the performance of the robust profile controller, showing potential for improved performance. Experimental results in DIII-D are also reported. Supported by the NSF CAREER award program ECCS-0645086 and the US DOE under DE-FG02-09ER55064 and DE-FC02-04ER54698.

  8. Plant sterols: factors affecting their efficacy and safety as functional food ingredients

    PubMed Central

    Berger, Alvin; Jones, Peter JH; Abumweis, Suhad S

    2004-01-01

    Plant sterols are naturally occurring molecules that humanity has evolved with. Herein, we have critically evaluated recent literature pertaining to the myriad of factors affecting efficacy and safety of plant sterols in free and esterified forms. We conclude that properly solubilized 4-desmetyl plant sterols, in ester or free form, in reasonable doses (0.8–1.0 g of equivalents per day) and in various vehicles including natural sources, and as part of a healthy diet and lifestyle, are important dietary components for lowering low density lipoprotein (LDL) cholesterol and maintaining good heart health. In addition to their cholesterol lowering properties, plant sterols possess anti-cancer, anti-inflammatory, anti-atherogenicity, and anti-oxidation activities, and should thus be of clinical importance, even for those individuals without elevated LDL cholesterol. The carotenoid lowering effect of plant sterols should be corrected by increasing intake of food that is rich in carotenoids. In pregnant and lactating women and children, further study is needed to verify the dose required to decrease blood cholesterol without affecting fat-soluble vitamins and carotenoid status. PMID:15070410

  9. Rate of Corneal Collagen Crosslinking Redo in Private Practice: Risk Factors and Safety

    PubMed Central

    Antoun, Joelle; Slim, Elise; el Hachem, Rami; Chelala, Elias; Jabbour, Elyse; Cherfan, Georges; Jarade, Elias F.

    2015-01-01

    Objective. To report the rate of progression of keratectasia after primary crosslinking (CXL) and evaluate the safety and efficiency of CXL redo. Materials and Methods. We conducted a retrospective analysis of the patients who underwent CXL between 2010 and 2013 at the Beirut Eye Specialist Hospital, Lebanon. Progression of keratectasia was based on the presence of an increase in maximum keratometry of 1.00 D, a change in the map difference between two consecutive topographies of 1.00 D, a deterioration of visual acuity, or any change in the refraction. Primary and redo CXL were done using the same protocol. Results. Among the 221 eyes of 130 patients who underwent CXL, 7 eyes (3.17%) of five patients met the criteria of progression. All patients reported a history of allergic conjunctivitis and eye rubbing and progressed within 9 to 48 months. No complications were noted and all patients were stable 1 year after CXL redo. Conclusion. Allergic conjunctivitis and eye rubbing were the only risk factors associated with keratoconus progression after CXL. A close followup is thus mandatory, even years after the procedure. CXL redo seems to be a safe and efficient technique to halt the progression after a primary CXL. PMID:25874118

  10. Transarterial Chemoembolization for Hepatocellular Carcinomas with Central Bile Duct Invasion: Safety, Prognosis, and Predictive Factors

    SciTech Connect

    Choi, Jin Woo; Chung, Jin Wook; Cho, Yun Ku; Kim, Yoon Jun; Yoon, Jung-Hwan; Kim, Hyo-Cheol; Jae, Hwan Jun

    2015-08-15

    PurposeTo assess the safety and effectiveness of transarterial chemoembolization (TACE) of patients who have hepatocellular carcinomas (HCCs) with central bile duct invasion.Materials and MethodsThe institutional review board approved this retrospective study and waived informed consent. Fifty-three patients, initially treated with TACE for HCCs with central bile duct invasion from January 1999 to September 2012, were included. Clinical, laboratory, and survival data were reviewed. Complications and hospitalization length were evaluated using the χ{sup 2} test, Fisher’s exact test, and logistic regression analysis. Survival was analyzed using the Kaplan–Meier method with log-rank test and Cox proportional hazard model.ResultsSeven patients experienced TACE-related major complications (severe post-embolization syndrome in 3, non-fatal sepsis in 3, and secondary bacterial peritonitis in 1). The overall major complication rate was 13.2 %, but there were no permanent adverse sequelae or deaths within 30 days. Serum total bilirubin ≥3.0 mg/dL was the only significant risk factor for long hospitalization [hazard ratio (HR) = 4.341, p = .022]. The median survival was 12.2 months. Extrahepatic metastasis (HR = 6.145, p < .001), international normalized ratio (PT-INR) ≥1.20 (HR = 4.564, p < .001), vascular invasion (HR = 3.484, p = .001), and intermediate tumor enhancement (HR = 2.417, p = .019) were significantly associated with shorter survival.ConclusionTACE can be a safe and effective treatment for patients who have HCCs with central bile duct invasion. In particular, long-term survival can be expected if patients have strongly enhancing tumors without poor prognostic factors such as extrahepatic metastasis, PT-INR prolongation, and vascular invasion.

  11. Efficacy and safety of liposomal clarithromycin and its effect on Pseudomonas aeruginosa virulence factors.

    PubMed

    Alhajlan, Mai; Alhariri, Moayad; Omri, Abdelwahab

    2013-06-01

    We investigated the efficacy and safety of liposomal clarithromycin formulations with different surface charges against clinical isolates of Pseudomonas aeruginosa from the lungs of cystic fibrosis (CF) patients. The liposomal clarithromycin formulations were prepared by the dehydration-rehydration method, and their sizes were measured using the dynamic-light-scattering technique. Encapsulation efficiency was determined by microbiological assay, and the stabilities of the formulations in biological fluid were evaluated for a period of 48 h. The MICs and minimum bactericidal concentrations (MBCs) of free and liposomal formulations were determined with P. aeruginosa strains isolated from CF patients. Liposomal clarithromycin activity against biofilm-forming P. aeruginosa was compared to that of free antibiotic using the Calgary Biofilm Device (CBD). The effects of subinhibitory concentrations of free and liposomal clarithromycin on bacterial virulence factors and motility on agar were investigated on clinical isolates of P. aeruginosa. The cytotoxicities of the liposome preparations and free drug were evaluated on a pulmonary epithelial cell line (A549). The average diameter of the formulations was >222 nm, with encapsulation efficiencies ranging from 5.7% to 30.4%. The liposomes retained more than 70% of their drug content during the 48-h time period. The highly resistant strains of P. aeruginosa became susceptible to liposome-encapsulated clarithromycin (MIC, 256 mg/liter versus 8 mg/liter; P < 0.001). Liposomal clarithromycin reduced the bacterial growth within the biofilm by 3 to 4 log units (P < 0.001), significantly attenuated virulence factor production, and reduced bacterial twitching, swarming, and swimming motilities. The clarithromycin-entrapped liposomes were less cytotoxic than the free drug (P < 0.001). These data indicate that our novel formulations could be a useful strategy to enhance the efficacy of clarithromycin against resistant P. aeruginosa

  12. Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

    PubMed Central

    Gill, Joan C.; Castaman, Giancarlo; Windyga, Jerzy; Kouides, Peter; Ragni, Margaret; Leebeek, Frank W. G.; Obermann-Slupetzky, Ortrun; Chapman, Miranda; Fritsch, Sandor; Pavlova, Borislava G.; Presch, Isabella

    2015-01-01

    This phase 3 trial evaluated the safety and hemostatic efficacy of a recombinant von Willebrand factor (rVWF) for treatment of bleeds in severe von Willebrand disease (VWD). rVWF was initially administered together with recombinant factor VIII (rFVIII) and subsequently alone, as long as hemostatic factor VIII activity (FVIII:C) levels were maintained. Pharmacokinetics (PK) were evaluated in a randomized cross-over design (rVWF vs rVWF:rFVIII at 50 IU VWF:ristocetin cofactor activity [RCo]/kg). Bleed control for all treated bleeds (N = 192 bleeds in 22 subjects) was rated good or excellent (96.9% excellent; 119 of 122 minor, 59 of 61 moderate, and 6 of 7 major bleeds) on a 4-point scale (4 = none to 1 = excellent). A single infusion was effective in 81.8% of bleeds. Treatment success, defined as the number of subjects with a mean efficacy rating of <2.5, was 100%. The PK profile of rVWF was not influenced by rFVIII (mean VWF:RCo terminal half-life: 21.9 hours for rVWF and 19.6 hours for rVWF:rFVIII). FVIII:C levels increased rapidly after rVWF alone, with hemostatic levels achieved within 6 hours and sustained through 72 hours after infusion. Eight adverse events (AEs; 6 nonserious AEs in 4 subjects and 2 serious AEs [chest discomfort and increased heart rate, without cardiac symptomatology] concurrently in 1 subject) were associated with rVWF. There were no thrombotic events or severe allergic reactions. No VWF or FVIII inhibitors, anti-VWF binding antibodies, or antibodies against host cell proteins were detected. These results show that rVWF was safe and effective in treating bleeds in VWD patients and stabilizes endogenous FVIII:C, which may eliminate the need for rFVIII after the first infusion. This trial was registered at www.clinicaltrials.gov as #NCT01410227. PMID:26239086

  13. School Climate Factors Contributing to Student and Faculty Perceptions of Safety in Select Arizona Schools

    ERIC Educational Resources Information Center

    Bosworth, Kris; Ford, Lysbeth; Hernandaz, Diley

    2011-01-01

    Background: To ensure that schools are safe places where students can learn, researchers and educators must understand student and faculty safety concerns. This study examines student and teacher perceptions of school safety. Methods: Twenty-two focus groups with students and faculty were conducted in 11 secondary schools. Schools were selected…

  14. Hospital safety climate, psychosocial risk factors and needlestick injuries in Japan.

    PubMed

    Smith, Derek R; Muto, Takashi; Sairenchi, Toshimi; Ishikawa, Yumiko; Sayama, Shizue; Yoshida, Atsushi; Townley-Jones, Maureen

    2010-01-01

    To investigate the interactions between safety climate, psychosocial issues and Needlestick and Sharps Injuries (NSI), a cross-sectional study was undertaken among nurses at a university teaching hospital in Japan (89% response rate). NSI were correlated with various aspects of hospital safety climate including supporting one another at work, the protection of staff against blood-borne diseases being a high management priority, managers doing their part to protect staff from blood-borne disease, having unsafe work practices corrected by supervisors, having the opportunity to use safety equipment to protect against blood-borne disease exposures, having an uncluttered work area, and having minimal conflict within their department. In conclusion, this study has demonstrated the importance of hospital safety climate in Japanese health care practice, particularly its relationship with NSI. Although the provision of safer devices remains critical in preventing injuries, ensuring a positive safety climate will also be essential in meeting these important challenges for nurses' occupational health.

  15. Steady state scenario development with elevated minimum safety factor on DIII-D

    NASA Astrophysics Data System (ADS)

    Holcomb, C. T.; Ferron, J. R.; Luce, T. C.; Petrie, T. W.; Park, J. M.; Turco, F.; Van Zeeland, M. A.; Okabayashi, M.; Lasnier, C. T.; Hanson, J. M.; Politzter, P. A.; In, Y.; Hyatt, A. W.; La Haye, R. J.; Lanctot, M. J.

    2014-09-01

    On DIII-D (Luxon 2005 Fusion Sci. Technol. 48 828), a high β scenario with minimum safety factor (qmin) near 1.4 has been optimized with new tools and shown to be a favourable candidate for long pulse or steady state operation in future devices. The new capability to redirect up to 5 MW of neutral beam injection (NBI) from on- to off-axis improves the ability to sustain elevated qmin with a less peaked pressure profile. These changes increase the ideal magnetohydrodynamics (MHD) n = 1 mode βN limit thus providing a path forward for increasing the noninductive current drive fraction by operating at high βN. Quasi-stationary discharges free of tearing modes have been sustained at βN = 3.5 and βT = 3.6% for two current profile diffusion timescales (about 3 s) limited by neutral beam duration. The discharge performance has normalized fusion performance expected to give fusion gain Q ≈ 5 in a device the size of ITER. Analysis of the poloidal flux evolution and current drive balance show that the loop voltage profile is almost relaxed even with 25% of the current driven inductively, and qmin remains elevated near 1.4. These observations increase confidence that the current profile will not evolve to one unstable to a tearing mode. In preliminary tests a divertor heat flux reduction technique based on producing a radiating mantle with neon injection appears compatible with this operating scenario. 0D model extrapolations suggest it may be possible to push this scenario up to 100% noninductive current drive by raising βN. Similar discharges with qmin = 1.5-2 were susceptible to tearing modes and off-axis fishbones, and with qmin > 2 lower normalized global energy confinement time is observed.

  16. Feedback-assisted extension of the tokamak operating space to low safety factor

    SciTech Connect

    Hanson, J. M. Bialek, J. M.; Navratil, G. A.; Olofsson, K. E. J.; Shiraki, D.; Turco, F.; Baruzzo, M.; Bolzonella, T.; Marrelli, L.; Martin, P.; Piovesan, P.; Piron, C.; Piron, L.; Terranova, D.; Zanca, P.; Hyatt, A. W.; Jackson, G. L.; La Haye, R. J.; Lanctot, M. J.; Strait, E. J.; and others

    2014-07-15

    Recent DIII-D and RFX-mod experiments have demonstrated stable tokamak operation at very low values of the edge safety factor q(a) near and below 2. The onset of n = 1 resistive wall mode (RWM) kink instabilities leads to a disruptive stability limit, encountered at q(a) = 2 (limiter plasmas) and q{sub 95} = 2 (divertor plasmas). However, passively stable operation can be attained for q(a) and q{sub 95} values as low as 2.2. RWM damping in the q(a) = 2 regime was measured using active MHD spectroscopy. Although consistent with theoretical predictions, the amplitude of the damped response does not increase significantly as the q(a) = 2 limit is approached, in contrast with damping measurements made approaching the pressure-driven RWM limit. Applying proportional gain magnetic feedback control of the n = 1 modes has resulted in stabilized operation with q{sub 95} values reaching as low as 1.9 in DIII-D and q(a) reaching 1.55 in RFX-mod. In addition to being consistent with the q(a) = 2 external kink mode stability limit, the unstable modes have growth rates on the order of the characteristic wall eddy-current decay timescale in both devices, and a dominant m = 2 poloidal structure that is consistent with ideal MHD predictions. The experiments contribute to validating MHD stability theory and demonstrate that a key tokamak stability limit can be overcome with feedback.

  17. Process and technique factors associated with patient ratings of session safety during psychodynamic psychotherapy.

    PubMed

    Siegel, Deborah F; Hilsenroth, Mark J

    2013-01-01

    This study investigates the relationships between patient ratings of in-session safety with psychotherapeutic techniques and process. Ninety-four participants received Short-Term Dynamic Psychotherapy (STDP) at a university-based clinic. Patient experiences of therapeutic process were self-assessed early in treatment using the Session Evaluation Questionnaire (SEQ Stiles, 1980). Techniques implemented in session were identified using the Comparative Psychotherapy Process Scale (CPPS: Hilsenroth et al., 2005). Alliance was evaluated with the Combined Alliance Short Form-Patient Version (CASF-P; Hatcher and Barends, 1996). Safety significantly correlated with session depth, smoothness, and positivity. Safety was significantly related to the interaction of psychodynamic-interpersonal and cognitive-behavioral techniques, but to neither individual subscale Safety significantly correlated with CASF-P Total, Confident Collaboration, and Bond. Patient experiences of safety are consistent with exploration and depth of session content. Integration of some CB techniques within a psychodynamic model may facilitate a sense of safety. Safety is notably intertwined with the therapeutic relationship.

  18. When are studies adequate for regulatory purposes? View of one regulated.

    PubMed Central

    Bundy, M

    1981-01-01

    The question of adequacy of studies for regulatory purposes has been debated for years. Nine questions need answers to determine adequacy: (1) Does the study deal with a defined problem or a defined segment of it? (2) Do the study data justify the conclusions drawn? (3) Were appropriate statistical analyses used? Is there evidence of bias versus objectivity in the collection or analysis of data? (4) Does the study support, supplement (or complement) or refute information in the literature? Is the study truly new information? (5) Does the study conform to the Interagency Regulatory Liaison Group (IRLG) guidelines for documentation of Epidemiologic Studies? (6) Does the study stand up to peer review? (7) Have other investigators been able to confirm the findings by duplicating the study? (8) Is the study acceptable or can it be made acceptable for publication in a reputable scientific journal? (9) Is the problem of such magnitude or significance that regulation is required? Because there is no such thing as a risk-free environment or absolute safety and there is no definitive "yes" answer to each of the questions, the regulated would hope--yes, insist--that the regulators exercise judgement with great skill in promulgation of rules or regulations. The application of safety factors and the determination of acceptable levels of risk should be social decisions. A discussion of instances where the "regulated" believes that studies have not been adequate, or others habe been ignored, or misinterpreted for regulatory purposes in included.A method of settling controversial questions to eliminate the litigation route is proposed. Judgment which is so often eliminated by regulation needs to find its way back into the regulatory process. The regulated recognize the need for regulations. However, when these regulations are based on less than good scientific judgment, harm will be done to the regulatory process itself in the long run. PMID:7333262

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

    PubMed Central

    Thompson, Kirrilly; Matthews, Chelsea

    2015-01-01

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

  20. Features, events, processes, and safety factor analysis applied to a near-surface low-level radioactive waste disposal facility

    SciTech Connect

    Stephens, M.E.; Dolinar, G.M.; Lange, B.A.

    1995-12-31

    An analysis of features, events, processes (FEPs) and other safety factors was applied to AECL`s proposed IRUS (Intrusion Resistant Underground Structure) near-surface LLRW disposal facility. The FEP analysis process which had been developed for and applied to high-level and transuranic disposal concepts was adapted for application to a low-level facility for which significant efforts in developing a safety case had already been made. The starting point for this process was a series of meetings of the project team to identify and briefly describe FEPs or safety factors which they thought should be considered. At this early stage participants were specifically asked not to screen ideas. This initial list was supplemented by selecting FEPs documented in other programs and comments received from an initial regulatory review. The entire list was then sorted by topic and common issues were grouped, and issues were classified in three priority categories and assigned to individuals for resolution. In this paper, the issue identification and resolution process will be described, from the initial description of an issue to its resolution and inclusion in the various levels of the safety case documentation.

  1. Factors Influencing Attitude, Safety Behavior, and Knowledge regarding Household Waste Management in Guinea: A Cross-Sectional Study

    PubMed Central

    Mamady, Keita

    2016-01-01

    Waste indiscriminate disposal is recognized as an important cause of environmental pollution and is associated with health problems. Safe management and disposal of household waste are an important problem to the capital city of Guinea (Conakry). The objective of this study was to identify socioeconomic and demographic factors associated with practice, knowledge, and safety behavior of family members regarding household waste management and to produce a remedial action plan. I found that no education background, income, and female individuals were independently associated with indiscriminate waste disposal. Unplanned residential area was an additional factor associated with indiscriminate waste disposal. I also found that the community residents had poor knowledge and unsafe behavior in relation to waste management. The promotion of environmental information and public education and implementation of community action programs on disease prevention and health promotion will enhance environmental friendliness and safety of the community. PMID:27092183

  2. Factors Influencing Attitude, Safety Behavior, and Knowledge regarding Household Waste Management in Guinea: A Cross-Sectional Study.

    PubMed

    Mamady, Keita

    2016-01-01

    Waste indiscriminate disposal is recognized as an important cause of environmental pollution and is associated with health problems. Safe management and disposal of household waste are an important problem to the capital city of Guinea (Conakry). The objective of this study was to identify socioeconomic and demographic factors associated with practice, knowledge, and safety behavior of family members regarding household waste management and to produce a remedial action plan. I found that no education background, income, and female individuals were independently associated with indiscriminate waste disposal. Unplanned residential area was an additional factor associated with indiscriminate waste disposal. I also found that the community residents had poor knowledge and unsafe behavior in relation to waste management. The promotion of environmental information and public education and implementation of community action programs on disease prevention and health promotion will enhance environmental friendliness and safety of the community. PMID:27092183

  3. Safety culture evaluation and asset root cause analysis

    SciTech Connect

    Okrent, D.; Xiong, Y.

    1995-12-31

    This paper examines the role of organizational and management factors in nuclear power plant safety through the use of operating experiences. The ASSET (Assessment of Safety Significant Events Team) reports of thirteen plants (total thirty events) have been analyzed in term of twenty organizational dimensions (factors) identified by Brookhaven National Laboratory and Pennsylvania State University. For three plants detailed results are reported in this paper. The results of thirteen plants are summarized in the form of a table. The study tends to confirm that organizational and management factors play an important role in plant safety. The twenty organizational dimensions and their definitions, in general, were adequate in this study. Formalization, Safety Culture, Technical Knowledge, Training, Roles-Responsibilities and Problem Identification appear to be key organizational factors which influence the safety of nuclear power plants studied.

  4. Advances in Measuring Culturally Competent Care: A Confirmatory Factor Analysis of CAHPS-CC in a Safety-net Population

    PubMed Central

    Stern, RJ; Fernandez, A; Jacobs, EA; Neilands, TB; Weech-Maldonado, R; Quan, J; Carle, A; Seligman, HK

    2012-01-01

    Background Providing culturally competent care shows promise as a mechanism to reduce healthcare inequalities. Until the recent development of the CAHPS Cultural Competency Item Set (CAHPS-CC), no measures capturing patient-level experiences with culturally competent care have been suitable for broad-scale administration. Methods We performed confirmatory factor analysis and internal consistency reliability analysis of CAHPS-CC among patients with type 2 diabetes (n=600) receiving primary care in safety-net clinics. CAHPS-CC domains were also correlated with global physician ratings. Results A 7-factor model demonstrated satisfactory fit (χ2(231)=484.34, p<.0001) with significant factor loadings at p<.05. Three domains showed excellent reliability – Doctor Communication- Positive Behaviors (α=.82), Trust (α=.77), and Doctor Communication- Health Promotion (α=.72). Four domains showed inadequate reliability either among Spanish speakers or overall (overall reliabilities listed): Doctor Communication- Negative Behaviors (α=.54), Equitable Treatment (α=.69), Doctor Communication- Alternative Medicine (α=.52), and Shared Decision-Making (α=.51). CAHPS-CC domains were positively and significantly correlated with global physician rating. Conclusions Select CAHPS-CC domains are suitable for broad-scale administration among safety-net patients. Those domains may be used to target quality-improvement efforts focused on providing culturally competent care in safety-net settings. PMID:22895231

  5. Pasteurized, monoclonal antibody factor VIII concentrate: establishing a new standard for purity and viral safety of plasma-derived concentrates.

    PubMed

    Goldsmith, J C

    2000-03-01

    A factor VIII concentrate (Monoclate-P) manufactured using a combination of pasteurization and immunoaffinity chromatography has been chosen to compare and contrast manufacturing aspects of plasma-derived factor VIII concentrates. Pasteurization is a virucidal method with a long safety record in clinical practice, while immuno-affinity chromatography selectively isolates and purifies the procoagulant protein of factor VIII, and partitions potential viral contaminants and nonessential proteins to the unbound fraction. The complete Monoclate-P production process reduces human immunodeficiency virus by > or = 10.5 log10, Sindbis (a model for hepatitis C virus) by > or = 6.5 log10, and murine encephalomyocarditis virus (a non-enveloped model virus) by 7.1 log10. The viral safety of Monoclate-P has been further demonstrated in clinical studies in patients not previously treated with blood or plasma-derived products. Additionally, the manufacture of Monoclate-P includes careful donor screening and plasma testing for antibodies to syphilis and human immunodeficiency, hepatitis B, and hepatitis C viruses to enhance source plasma safety. Combined with donor selection and plasma testing, multiple viral reduction steps effectively eliminate both lipid-enveloped viruses (e.g. human immunodeficiency, hepatitis B and C) and non-lipid-enveloped viruses (e.g. hepatitis A). In addition, polymerase chain reaction-based nucleic acid detection tests for hepatitis B and C viruses and for human immunodeficiency virus-1 have been introduced as part of an investigational new drug mechanism.

  6. Pasteurized, monoclonal antibody factor VIII concentrate: establishing a new standard for purity and viral safety of plasma-derived concentrates.

    PubMed

    Goldsmith, J C

    2000-03-01

    A factor VIII concentrate (Monoclate-P) manufactured using a combination of pasteurization and immunoaffinity chromatography has been chosen to compare and contrast manufacturing aspects of plasma-derived factor VIII concentrates. Pasteurization is a virucidal method with a long safety record in clinical practice, while immuno-affinity chromatography selectively isolates and purifies the procoagulant protein of factor VIII, and partitions potential viral contaminants and nonessential proteins to the unbound fraction. The complete Monoclate-P production process reduces human immunodeficiency virus by > or = 10.5 log10, Sindbis (a model for hepatitis C virus) by > or = 6.5 log10, and murine encephalomyocarditis virus (a non-enveloped model virus) by 7.1 log10. The viral safety of Monoclate-P has been further demonstrated in clinical studies in patients not previously treated with blood or plasma-derived products. Additionally, the manufacture of Monoclate-P includes careful donor screening and plasma testing for antibodies to syphilis and human immunodeficiency, hepatitis B, and hepatitis C viruses to enhance source plasma safety. Combined with donor selection and plasma testing, multiple viral reduction steps effectively eliminate both lipid-enveloped viruses (e.g. human immunodeficiency, hepatitis B and C) and non-lipid-enveloped viruses (e.g. hepatitis A). In addition, polymerase chain reaction-based nucleic acid detection tests for hepatitis B and C viruses and for human immunodeficiency virus-1 have been introduced as part of an investigational new drug mechanism. PMID:10759015

  7. Low edge safety factor operation and passive disruption avoidance in current carrying plasmas by the addition of stellarator rotational transform

    NASA Astrophysics Data System (ADS)

    Pandya, M. D.; ArchMiller, M. C.; Cianciosa, M. R.; Ennis, D. A.; Hanson, J. D.; Hartwell, G. J.; Hebert, J. D.; Herfindal, J. L.; Knowlton, S. F.; Ma, X.; Massidda, S.; Maurer, D. A.; Roberds, N. A.; Traverso, P. J.

    2015-11-01

    Low edge safety factor operation at a value less than two ( q (a )=1 /ι̷tot(a )<2 ) is routine on the Compact Toroidal Hybrid device with the addition of sufficient external rotational transform. Presently, the operational space of this current carrying stellarator extends down to q (a )=1.2 without significant n = 1 kink mode activity after the initial plasma current rise phase of the discharge. The disruption dynamics of these low edge safety factor plasmas depend upon the fraction of helical field rotational transform from external stellarator coils to that generated by the plasma current. We observe that with approximately 10% of the total rotational transform supplied by the stellarator coils, low edge q disruptions are passively suppressed and avoided even though q(a) < 2. When the plasma does disrupt, the instability precursors measured and implicated as the cause are internal tearing modes with poloidal, m, and toroidal, n, helical mode numbers of m /n =3 /2 and 4/3 observed on external magnetic sensors and m /n =1 /1 activity observed on core soft x-ray emissivity measurements. Even though the edge safety factor passes through and becomes much less than q(a) < 2, external n = 1 kink mode activity does not appear to play a significant role in the disruption phenomenology observed.

  8. Slope Stability: Factor of Safety along the Seismically Active Continental Slope Offshore Sumatra

    NASA Astrophysics Data System (ADS)

    Patton, J. R.; Goldfinger, C.; Djadjadihardja, Y.; None, U.

    2013-12-01

    Recent papers have documented the probability that turbidites deposited along and downslope of subduction zone accretionary prisms are likely the result of strong ground shaking from great earthquakes. Given the damaging nature of these earthquakes, along with the casualties from the associated tsunamis, the spatial and temporal patterns of these earthquakes can only be evaluated with paleoseismologic coring and seismic reflection methods. We evaluate slope stability for seafloor topography along the Sunda subduction offshore Sumatra, Indonesia. We use sediment material properties, from local (Sumatra) and analogous sites, to constrain our estimates of static slope stability Factor of Safety (FOS) analyses. We then use ground motion prediction equations (GMPE's) to estimate ground motion intensity (Arias Intensity, AI) and acceleration (Peak Ground Acceleration, PGA), as possibly generated by fault rupture, to constrain seismic loads for pseudostatic slope stability FOS analyses. The ground motions taper rapidly with distance from the fault plane, consistent with ground motion - fault distance relations measured during the 2011 Tohoku-Oki subduction zone earthquake. Our FOS analyses include a Morgenstern method of slices probabilistic analysis for 2-D profiles along with Critical Acceleration (Ac) and Newmark Displacement (Dn) analysis of multibeam bathymetry of the seafloor. In addition, we also use estimates of ground motion modeled with a 2004 Sumatra-Andaman subduction zone (SASZ) earthquake fault slip model, to also compare with our static FOS analyses of seafloor topography. All slope and trench sites are statically stable (FOS < 1) and sensitive to ground motions generated by earthquakes of magnitude greater than 7. We conclude that for earthquakes of magnitude 6 to 9, PGA of 0.4-0.6 to 1.4-2.5 g would be expected, respectively, from existing GMPE's. However, saturation of accelerations in the accretionary wedge may limit actual accelerations to less than 1

  9. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  10. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  11. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  12. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  13. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order to... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Adequate capital for...

  14. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  15. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  16. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  17. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  18. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  19. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  20. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Adequate capital for Licensees. 107.200 Section 107.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Qualifying for an SBIC License Capitalizing An Sbic § 107.200 Adequate capital...

  1. 21 CFR 201.5 - Drugs; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; adequate directions for use. 201.5 Section 201.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.5 Drugs; adequate directions for use....

  2. 21 CFR 201.5 - Drugs; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; adequate directions for use. 201.5 Section 201.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.5 Drugs; adequate directions for use....

  3. 7 CFR 4290.200 - Adequate capital for RBICs.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Adequate capital for RBICs. 4290.200 Section 4290.200 Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND... Qualifications for the RBIC Program Capitalizing A Rbic § 4290.200 Adequate capital for RBICs. You must meet...

  4. "Something Adequate"? In Memoriam Seamus Heaney, Sister Quinlan, Nirbhaya

    ERIC Educational Resources Information Center

    Parker, Jan

    2014-01-01

    Seamus Heaney talked of poetry's responsibility to represent the "bloody miracle", the "terrible beauty" of atrocity; to create "something adequate". This article asks, what is adequate to the burning and eating of a nun and the murderous gang rape and evisceration of a medical student? It considers Njabulo…

  5. Prophylaxis in congenital factor VII deficiency: indications, efficacy and safety. Results from the Seven Treatment Evaluation Registry (STER).

    PubMed

    Napolitano, Mariasanta; Giansily-Blaizot, Muriel; Dolce, Alberto; Schved, Jean F; Auerswald, Guenter; Ingerslev, Jørgen; Bjerre, Jens; Altisent, Carmen; Charoenkwan, Pimlak; Michaels, Lisa; Chuansumrit, Ampaiwan; Di Minno, Giovanni; Caliskan, Umran; Mariani, Guglielmo

    2013-04-01

    Because of the very short half-life of factor VII, prophylaxis in factor VII deficiency is considered a difficult endeavor. The clinical efficacy and safety of prophylactic regimens, and indications for their use, were evaluated in factor VII-deficient patients in the Seven Treatment Evaluation Registry. Prophylaxis data (38 courses) were analyzed from 34 patients with severe factor VII deficiency (<1-45 years of age, 21 female). Severest phenotypes (central nervous system, gastrointestinal, joint bleeding episodes) were highly prevalent. Twenty-one patients received recombinant activated factor VII (24 courses), four received plasma-derived factor VII, and ten received fresh frozen plasma. Prophylactic schedules clustered into "frequent" courses (three times weekly, n=23) and "infrequent" courses (≤ 2 times weekly, n=15). Excluding courses for menorrhagia, "frequent" and "infrequent" courses produced 18/23 (78%) and 5/12 (41%) "excellent" outcomes, respectively; relative risk, 1.88; 95% confidence interval, 0.93-3.79; P=0.079. Long term prophylaxis lasted from 1 to >10 years. No thrombosis or new inhibitors occurred. In conclusion, a subset of patients with factor VII deficiency needed prophylaxis because of severe bleeding. Recombinant activated factor VII schedules based on "frequent" administrations (three times weekly) and a 90 μg/kg total weekly dose were effective. These data provide a rationale for long-term, safe prophylaxis in factor VII deficiency.

  6. Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

    PubMed

    MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

    2014-01-01

    Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

  7. Application of a human factors classification framework for patient safety to identify precursor and contributing factors to adverse clinical incidents in hospital.

    PubMed

    Mitchell, Rebecca J; Williamson, Ann; Molesworth, Brett

    2016-01-01

    This study aimed to identify temporal precursor and associated contributing factors for adverse clinical incidents in a hospital setting using the Human Factors Classification Framework (HFCF) for patient safety. A random sample of 498 clinical incidents were reviewed. The framework identified key precursor events (PE), contributing factors (CF) and the prime causes of incidents. Descriptive statistics and correspondence analysis were used to examine incident characteristics. Staff action was the most common type of PE identified. Correspondence analysis for all PEs that involved staff action by error type showed that rule-based errors were strongly related to performing medical or monitoring tasks or the administration of medication. Skill-based errors were strongly related to misdiagnoses. Factors relating to the organisation (66.9%) or the patient (53.2%) were the most commonly identified CFs. The HFCF for patient safety was able to identify patterns of causation for the clinical incidents, highlighting the need for targeted preventive approaches, based on an understanding of how and why incidents occur. PMID:26360210

  8. Controlling factors of the parental safety perception on children's travel mode choice.

    PubMed

    Nevelsteen, Kristof; Steenberghen, Thérèse; Van Rompaey, Anton; Uyttersprot, Liesbeth

    2012-03-01

    The travel mode of children changed significantly over the last 20 years, with a decrease of children travelling as pedestrians or cyclists. This study focuses on six to twelve year old children. Parents determine to a large extent the mode choice of children in this age category. Based on the analysis of an extensive survey, the research shows that traffic infrastructure has a significant impact on parental decision making concerning children's travel mode choice, by affecting both the real and the perceived traffic safety. Real traffic safety is quantified in terms of numbers of accidents and road infrastructure. For the perceived traffic safety a parental allowance probability is calculated per road type to show that infrastructure characteristics influence parental decision making on the children's mode choice. A binary logistic model shows that this allowance is determined by age, gender and traffic infrastructure near the child's home or near destinations frequently visited by children. Since both real and perceived traffic safety are influenced by infrastructure characteristics, a spatial analysis of parental perception and accident statistics can be used to indicate the locations where infrastructure improvements will be most effective to increase the number of children travelling - safely - as pedestrians or cyclists. PMID:22269483

  9. The Influence of Health Policy and Market Factors on the Hospital Safety Net

    PubMed Central

    Bazzoli, Gloria J; Lindrooth, Richard C; Kang, R ay; Hasnain-Wynia, R omana

    2006-01-01

    Objective To examine how the financial pressures resulting from the Balanced Budget Act (BBA) of 1997 interacted with private sector pressures to affect indigent care provision. Data Sources/Study Setting American Hospital Association Annual Survey, Area Resource File, InterStudy Health Maintenance Organization files, Current Population Survey, and Bureau of Primary Health Care data. Study Design We distinguished core and voluntary safety net hospitals in our analysis. Core safety net hospitals provide a large share of uncompensated care in their markets and have large indigent care patient mix. Voluntary safety net hospitals provide substantial indigent care but less so than core hospitals. We examined the effect of financial pressure in the initial year of the 1997 BBA on uncompensated care for three hospital groups. Data for 1996–2000 were analyzed using approaches that control for hospital and market heterogeneity. Data Collection/Extraction Methods All urban U.S. general acute care hospitals with complete data for at least 2 years between 1996 and 2000, which totaled 1,693 institutions. Principal Findings Core safety net hospitals reduced their uncompensated care in response to Medicaid financial pressure. Voluntary safety net hospitals also responded in this way but only when faced with the combined forces of Medicaid and private sector payment pressures. Nonsafety net hospitals did not exhibit similar responses. Conclusions Our results are consistent with theories of hospital behavior when institutions face reductions in payment. They raise concern given continuing state budget crises plus the focus of recent federal deficit reduction legislation intended to cut Medicaid expenditures. PMID:16899001

  10. Chemical Safety Programs.

    ERIC Educational Resources Information Center

    Shaw, Richard

    2000-01-01

    Discusses the need to enhance understanding of chemical safety in educational facilities that includes adequate staff training and drilling requirements. The question of what is considered proper training is addressed. (GR)

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

    PubMed

    Badri, Adel; Nadeau, Sylvie; Gbodossou, André

    2012-09-01

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

  12. Factors in the Growth and Decline of System Safety within Organizations

    SciTech Connect

    GANTER, JOHN H.; STORAGE, WILLIAM K.

    1999-08-16

    System safety as a technical field faces numerous opportunities, and some challenges, in the high technology, low cost future. As a relatively small field best known in high consequence domains (defense, aviation, space) it may have to tailor its messages and approaches to influence organizations (both private and public) pressured by incessant competition and ''Internet time.'' We present a model of organizations as cultures that carefully ration attention and reward personnel who successfully pursue goals. These evolving goals result from a fusing of both external influences (market share: regulation) and internal influences (dominant group identities such as marketers or engineers). In the context of organizational goals, these same influences cause people to search narrowly and quickly for technologies and ideas that can fit through ''influence gates'' in the organization and that will likely grow there. System safety must thus compete with all manner of cost-cutting and quality management approaches, in an environment currently obsessed with short-term value and return on investment. From this model we develop some ideas for the communication and promotion of system safety that could increase the net impact and effectiveness of the field.

  13. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies.

    PubMed

    Robinson, Jennifer G; Colhoun, Helen M; Bays, Harold E; Jones, Peter H; Du, Yunling; Hanotin, Corinne; Donahue, Stephen

    2014-10-01

    The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in ∼ 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20-40 mg/d) or rosuvastatin (10-20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20-40 mg) or rosuvastatin (10-20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). At week 12, based on week 8 LDL-C levels, the alirocumab dose may be increased from 75 mg to 150 mg Q2W if LDL-C levels remain ≥100 mg/dL or ≥70 mg/dL in patients with high or very high CV risk, respectively. The primary efficacy endpoint in both studies is difference in percent change in calculated LDL-C from baseline to week 24 in the alirocumab vs control arms. The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level. PMID:25269777

  14. Efficacy and Safety of Alirocumab as Add-on Therapy in High–Cardiovascular-Risk Patients With Hypercholesterolemia Not Adequately Controlled With Atorvastatin (20 or 40 mg) or Rosuvastatin (10 or 20 mg): Design and Rationale of the ODYSSEY OPTIONS Studies

    PubMed Central

    Robinson, Jennifer G; Colhoun, Helen M; Bays, Harold E; Jones, Peter H; Du, Yunling; Hanotin, Corinne; Donahue, Stephen

    2014-01-01

    The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in ∼ 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20–40 mg/d) or rosuvastatin (10–20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20–40 mg) or rosuvastatin (10–20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). At week 12, based on week 8 LDL-C levels, the alirocumab dose may be increased from 75 mg to 150 mg Q2W if LDL-C levels remain ≥100 mg/dL or ≥70 mg/dL in patients with high or very high CV risk, respectively. The primary efficacy endpoint in both studies is difference in percent change in calculated LDL-C from baseline to week 24 in the alirocumab vs control arms. The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level. PMID:25269777

  15. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies.

    PubMed

    Robinson, Jennifer G; Colhoun, Helen M; Bays, Harold E; Jones, Peter H; Du, Yunling; Hanotin, Corinne; Donahue, Stephen

    2014-10-01

    The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in ∼ 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20-40 mg/d) or rosuvastatin (10-20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20-40 mg) or rosuvastatin (10-20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). At week 12, based on week 8 LDL-C levels, the alirocumab dose may be increased from 75 mg to 150 mg Q2W if LDL-C levels remain ≥100 mg/dL or ≥70 mg/dL in patients with high or very high CV risk, respectively. The primary efficacy endpoint in both studies is difference in percent change in calculated LDL-C from baseline to week 24 in the alirocumab vs control arms. The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level.

  16. Road safety issues for bus transport management.

    PubMed

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

    2013-11-01

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

  17. Road safety issues for bus transport management.

    PubMed

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

    2013-11-01

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

  18. Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel): Results from a phase I safety trial

    PubMed Central

    Chew, Emily Y.; Clemons, Traci E.; Peto, Tunde; Sallo, Ferenc B.; Ingerman, Avner; Tao, Weng; Singerman, Lawrence; Schwartz, Steven D.; Peachey, Neal S.; Bird, Alan C.

    2015-01-01

    PURPOSE To evaluate the safety and tolerability of intraocular delivery of ciliary neurotrophic factor (CNTF) using an encapsulated cell implant for the treatment of macular telangiectasia type 2. DESIGN An open-labeled safety trial conducted in 2 centers enrolling 7 participants with macular telangiectasia type 2. METHODS The participant’s more severely affected eye (worse baseline visual acuity) received the high dose implant of CNTF. Patients were followed for a period of 36 months. The primary safety outcome was a change in the parameters of the electroretinogram (ERG). Secondary efficacy outcomes were changes in visual acuity, en face measurements of the optical coherence tomography of the disruption in the ellipsoid zone, and microperimetry when compared with baseline. RESULTS The ERG findings demonstrated a reduction in the amplitude of the scotopic b-wave in 4 participants 3 months after implantation (month 3). All parameters returned to baseline values by month 12 and remained so at month 36 with no clinical impact on dark adaptation. There was no change in visual acuity compared with baseline. The area of the defect as measured functionally by microperimetry and structurally by the en face OCT imaging of the ellipsoid zone loss appeared unchanged from baseline. CONCLUSIONS The intraocular delivery of CNTF in the encapsulated cell implant appeared to be safe and well tolerated in eyes with macular telangiectasia type 2. Further evaluation in a randomized controlled clinical trial is warranted to test for efficacy. PMID:25528956

  19. On Adequate Comparisons of Antenna Phase Center Variations

    NASA Astrophysics Data System (ADS)

    Schoen, S.; Kersten, T.

    2013-12-01

    One important part for ensuring the high quality of the International GNSS Service's (IGS) products is the collection and publication of receiver - and satellite antenna phase center variations (PCV). The PCV are crucial for global and regional networks, since they introduce a global scale factor of up to 16ppb or changes in the height component with an amount of up to 10cm, respectively. Furthermore, antenna phase center variations are also important for precise orbit determination, navigation and positioning of mobile platforms, like e.g. the GOCE and GRACE gravity missions, or for the accurate Precise Point Positioning (PPP) processing. Using the EUREF Permanent Network (EPN), Baire et al. (2012) showed that individual PCV values have a significant impact on the geodetic positioning. The statements are further supported by studies of Steigenberger et al. (2013) where the impact of PCV for local-ties are analysed. Currently, there are five calibration institutions including the Institut für Erdmessung (IfE) contributing to the IGS PCV file. Different approaches like field calibrations and anechoic chamber measurements are in use. Additionally, the computation and parameterization of the PCV are completely different within the methods. Therefore, every new approach has to pass a benchmark test in order to ensure that variations of PCV values of an identical antenna obtained from different methods are as consistent as possible. Since the number of approaches to obtain these PCV values rises with the number of calibration institutions, there is the necessity for an adequate comparison concept, taking into account not only the numerical values but also stochastic information and computational issues of the determined PCVs. This is of special importance, since the majority of calibrated receiver antennas published by the IGS origin from absolute field calibrations based on the Hannover Concept, Wübbena et al. (2000). In this contribution, a concept for the adequate

  20. Interaction of Occupational and Personal Risk Factors in Workforce Health and Safety

    PubMed Central

    Pandalai, Sudha; Wulsin, Victoria; Chun, HeeKyoung

    2012-01-01

    Most diseases, injuries, and other health conditions experienced by working people are multifactorial, especially as the workforce ages. Evidence supporting the role of work and personal risk factors in the health of working people is frequently underused in developing interventions. Achieving a longer, healthy working life requires a comprehensive preventive approach. To help develop such an approach, we evaluated the influence of both occupational and personal risk factors on workforce health. We present 32 examples illustrating 4 combinatorial models of occupational hazards and personal risk factors (genetics, age, gender, chronic disease, obesity, smoking, alcohol use, prescription drug use). Models that address occupational and personal risk factors and their interactions can improve our understanding of health hazards and guide research and interventions. PMID:22021293

  1. Road safety in an aging population: risk factors, assessment, interventions, and future directions.

    PubMed

    Anstey, Kaarin J; Eramudugolla, Ranmalee; Ross, Lesley A; Lautenschlager, Nicola T; Wood, Joanne

    2016-03-01

    With the number of older drivers projected to increase by up to 70% over the next 20 years, preventing injury resulting from crashes involving older drivers is a significant concern for both policy-makers and clinicians. While the total number of fatal crashes per annum has steadily decreased since 2005 in Australia, the rate of fatalities has demonstrated an upward trend since 2010 in drivers aged 65 years and above (8.5 per 100,000), such that it is now on par with the fatality rate in drivers aged 17-25 years (8.0 per 100,000) (Austroads, 2015). Similar statistics are reported for the United States (NHTSA, 2012), implying there is a need for better identification of those older drivers who are unsafe and implementation of strategies that can enhance mobility while maximizing road safety. PMID:26888735

  2. Structural Design Requirements and Factors of Safety for Spaceflight Hardware: For Human Spaceflight. Revision A

    NASA Technical Reports Server (NTRS)

    Bernstein, Karen S.; Kujala, Rod; Fogt, Vince; Romine, Paul

    2011-01-01

    This document establishes the structural requirements for human-rated spaceflight hardware including launch vehicles, spacecraft and payloads. These requirements are applicable to Government Furnished Equipment activities as well as all related contractor, subcontractor and commercial efforts. These requirements are not imposed on systems other than human-rated spacecraft, such as ground test articles, but may be tailored for use in specific cases where it is prudent to do so such as for personnel safety or when assets are at risk. The requirements in this document are focused on design rather than verification. Implementation of the requirements is expected to be described in a Structural Verification Plan (SVP), which should describe the verification of each structural item for the applicable requirements. The SVP may also document unique verifications that meet or exceed these requirements with NASA Technical Authority approval.

  3. Risk Factors for Reporting Poor Cultural Competency Among Patients with Diabetes in Safety-Net Clinics

    PubMed Central

    Seligman, Hilary K.; Fernandez, Alicia; Stern, Rachel J.; Weech-Maldonado, Robert; Quan, Judy; Jacobs, Elizabeth A.

    2012-01-01

    Background The Consumer Assessment of Healthcare Providers and Systems Cultural Competency (CAHPS-CC) Item Set assesses patient perceptions of aspects of the cultural competence of their health care. Objective To determine characteristics of patients who identify the care they receive as less culturally competent Research Design Cross-sectional survey consisting of face-to-face interviews Subjects Safety-net population of patients with type 2 diabetes (n=600) receiving ongoing primary care Measures Participants completed the CAHPS-CC and answered questions about their race/ethnicity, gender, age, education, health status, depressive symptoms, insurance coverage, English proficiency, duration of relationship with primary care provider, and co-morbidities. Results In adjusted models, depressive symptoms were significantly associated with poor cultural competency in the Doctor Communication – Positive Behaviors domain (OR 1.73, 95%CI 1.11, 2.69). African-Americans were less likely than Whites to report poor cultural competence in the Doctor Communication – Positive Behaviors domain (OR 0.52, 0.28–0.97). Participants who reported a longer relationship (≥3 years) with their primary care provider were less likely to report poor cultural competence in the Doctor Communication – Health Promotion (OR 0.35, 0.21–0.60) and Trust domains (OR 0.4, 0.24–0.67), while participants with lower educational attainment were less likely to report poor cultural competence in the Trust domain (OR 0.51, 0.30–0.86). Overall, however, sociodemographic and clinical differences in reports of poor cultural competence were insignificant or inconsistent across the various domains of cultural competence examined. Conclusions Cultural competence interventions in safety-net settings should be implemented across populations, rather than being narrowly focused on specific sociodemographic or clinical groups. PMID:22895232

  4. Patient acceptance of adequately filled breast implants using the tilt test.

    PubMed

    Tebbetts, J B

    2000-07-01

    Adequate fill of any breast implant, regardless of shell characteristics, shape, or filler material, is important to prevent implant shell wrinkling, folding, or collapse that could potentially decrease the life of the implant. Implant shell life is a major factor that affects reoperation rates. The greater the necessity of reoperations, regardless of implant type, the greater the rate of local complications, necessitating additional surgery with additional risks and costs to patients. Palpable shell folding, visible wrinkling or rippling, palpable shifts of filler material, sloshing, and compromised aesthetic results can result from an under-filled implant. Any of these complications can necessitate reoperations with increased risks and costs to patients. This is a study of 609 consecutive patients from January of 1993 to December of 1998 who were given detailed preoperative informed consent and a choice of implant shape and type and who chose the increased firmness associated with an implant that is adequately filled to pass the tilt test. This study addresses two questions: (1) Will patients accept the increased firmness of an implant that is filled to pass the tilt test? and (2) Is adequate fill by the tilt test useful clinically to help reduce the incidence of postoperative rippling, wrinkling, and spontaneous deflation in saline implants? Patients were followed by postoperative examinations and questionnaires. No patient requested implant replacement to a softer implant postoperatively, and no reoperations were performed for visible rippling or wrinkling. The spontaneous deflation rate over this 6-year period was 9 of 1218 implants, or 0.739 percent. If patients will accept more firmness with an adequately filled implant, regardless of the filler material, surgeons might worry less about recommending an adequately filled implant to patients, and manufacturers might feel more comfortable producing adequately filled implants and redefining fill volumes for

  5. Understanding Your Adequate Yearly Progress (AYP), 2011-2012

    ERIC Educational Resources Information Center

    Missouri Department of Elementary and Secondary Education, 2011

    2011-01-01

    The "No Child Left Behind Act (NCLB) of 2001" requires all schools, districts/local education agencies (LEAs) and states to show that students are making Adequate Yearly Progress (AYP). NCLB requires states to establish targets in the following ways: (1) Annual Proficiency Target; (2) Attendance/Graduation Rates; and (3) Participation Rates.…

  6. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 15 Commerce and Foreign Trade 3 2014-01-01 2014-01-01 false Adequate exploration plan. 970.404...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE GENERAL REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of...

  7. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Adequate exploration plan. 970.404...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE GENERAL REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of...

  8. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Adequate exploration plan. 970.404...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE GENERAL REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of...

  9. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Adequate exploration plan. 970.404...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE GENERAL REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of...

  10. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Adequate exploration plan. 970.404...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE GENERAL REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of...

  11. Adequate Schools and Inadequate Education: An Anthropological Perspective.

    ERIC Educational Resources Information Center

    Wolcott, Harry F.

    To illustrate his claim that schools generally do a remarkably good job of schooling while the society makes inadequate use of other means to educate young people, the author presents a case history of a young American (identified pseudonymously as "Brad") whose schooling was adequate but whose education was not. Brad, jobless and homeless,…

  12. Comparability and Reliability Considerations of Adequate Yearly Progress

    ERIC Educational Resources Information Center

    Maier, Kimberly S.; Maiti, Tapabrata; Dass, Sarat C.; Lim, Chae Young

    2012-01-01

    The purpose of this study is to develop an estimate of Adequate Yearly Progress (AYP) that will allow for reliable and valid comparisons among student subgroups, schools, and districts. A shrinkage-type estimator of AYP using the Bayesian framework is described. Using simulated data, the performance of the Bayes estimator will be compared to…

  13. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Adequate capital for Licensees. 107.200 Section 107.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS... operate actively in accordance with your Articles and within the context of your business plan,...

  14. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... identifiable personal data and automated systems shall be adequately trained in the security and privacy of... records in which identifiable personal data are processed or maintained, including all reports and output... personal records or data; must minimize, to the extent practicable, the risk that skilled technicians...

  15. Do Beginning Teachers Receive Adequate Support from Their Headteachers?

    ERIC Educational Resources Information Center

    Menon, Maria Eliophotou

    2012-01-01

    The article examines the problems faced by beginning teachers in Cyprus and the extent to which headteachers are considered to provide adequate guidance and support to them. Data were collected through interviews with 25 school teachers in Cyprus, who had recently entered teaching (within 1-5 years) in public primary schools. According to the…

  16. School Support Groups, Other School Factors, and the Safety of Sexual Minority Adolescents

    ERIC Educational Resources Information Center

    Goodenow, Carol; Szalacha, Laura; Westheimer, Kim

    2006-01-01

    Sexual minority adolescents--those self-identifying as lesbian, gay, or bisexual (LGB) or with same-sex desires or sexual experiences--report higher rates of victimization and suicidality than their heterosexual peers, yet little empirical research has examined school factors associated with these risks. This study used data from the Massachusetts…

  17. 76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... on December 3, 2009, in 49 CFR 192.631 and 195.446 (74 FR 63310), as corrected February 3, 2010 (75 FR 5536). By this amendment to the Control Room Management/Human Factors (CRM) rule, an operator must....631 and 195.446 (75 FR 56972). The NPRM proposed to expedite the deadline for implementing all...

  18. 21 CFR 315.3 - General factors relevant to safety and effectiveness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... effectiveness. 315.3 Section 315.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.3 General factors relevant... estimated absorbed radiation dose of the diagnostic radiopharmaceutical....

  19. School Climate and the Safe School: Seven Contributing Factors. Safety in the Schools

    ERIC Educational Resources Information Center

    Noonan, James

    2005-01-01

    Accepting that few lists are comprehensive, but acknowledging that they still have value, here then are seven important factors that contribute to a healthy school climate: (1) Models: Adults are teachers in more ways than one, and the way that has the greater impact is less what they say than what they do; (2) Consistency: The school staff must…

  20. Safe Science Facilities: Reviewing Factors that Affect Classroom Environment, Curriculum, and Safety

    ERIC Educational Resources Information Center

    Texley, Juliana

    2005-01-01

    Science teachers often have two different curricula--the ideal framework on paper and the real, day-to-day instructional program that occurs in the classroom. A number of factors can affect how much of that ideal framework is accomplished. For example, how a facility is designed and how space is used can affect student achievement, classroom…

  1. Conditions for the successful integration of Human and Organizational Factors (HOF) in the nuclear safety analysis.

    PubMed

    Tosello, Michèle; Lévêque, Françoise; Dutillieu, Stéphanie; Hernandez, Guillaume; Vautier, Jean-François

    2012-01-01

    This communication presents some elements which come from the experience feedback at CEA about the conditions for the successful integration of HOF in the nuclear safety analysis. To point out some of these conditions, one of the concepts proposed by Edgar Morin to describe the functioning of "complex" systems: the dialogical principle has been used. The idea is to look for some dialogical pairs. The elements of this kind of pair are both complementary and antagonist to one another. Three dialogical pairs are presented in this communication. The first two pairs are related to the organization of the HOF network and the last one is related to the methods which are used to analyse the working situations. The three pairs are: specialist - non-specialist actors of the network, centralized - distributed human resources in the network and microscopic - macroscopic levels of HOF methods to analyse the working situations. To continuously improve these three dialogical pairs, it is important to keep the differences which exist between the two elements of a pair and to find and maintain a balance between the two elements of the pairs. PMID:22317122

  2. Conditions for the successful integration of Human and Organizational Factors (HOF) in the nuclear safety analysis.

    PubMed

    Tosello, Michèle; Lévêque, Françoise; Dutillieu, Stéphanie; Hernandez, Guillaume; Vautier, Jean-François

    2012-01-01

    This communication presents some elements which come from the experience feedback at CEA about the conditions for the successful integration of HOF in the nuclear safety analysis. To point out some of these conditions, one of the concepts proposed by Edgar Morin to describe the functioning of "complex" systems: the dialogical principle has been used. The idea is to look for some dialogical pairs. The elements of this kind of pair are both complementary and antagonist to one another. Three dialogical pairs are presented in this communication. The first two pairs are related to the organization of the HOF network and the last one is related to the methods which are used to analyse the working situations. The three pairs are: specialist - non-specialist actors of the network, centralized - distributed human resources in the network and microscopic - macroscopic levels of HOF methods to analyse the working situations. To continuously improve these three dialogical pairs, it is important to keep the differences which exist between the two elements of a pair and to find and maintain a balance between the two elements of the pairs.

  3. An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review

    PubMed Central

    Zhang, Longhao; Zhao, Pujing; Chen, Ying; Zhang, Mingming

    2015-01-01

    Background From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. Objective To evaluate the effectiveness of HFE interventions in improving health care workers’ outcomes and patient safety and to assess the quality of the available evidence. Methods We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. Results For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers’ quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers’ attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. Conclusion The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need

  4. Adequate iron stores and the 'Nil nocere' principle.

    PubMed

    Hollán, S; Johansen, K S

    1993-01-01

    There is a need to change the policy of unselective iron supplementation during periods of life with physiologically increased cell proliferation. Levels of iron stores to be regarded as adequate during infancy and pregnancy are still not well established. Recent data support the view that it is not justified to interfere with physiological adaptations developed through millions of years by sophisticated and precisely coordinated regulation of iron absorption, utilization and storage. Recent data suggest that the chelatable intracellular iron pool regulates the expression of proteins with central importance in cellular iron metabolism (TfR, ferritin, and erythroid 5-aminolevulinic synthetase) in a coordinately controlled way through an iron dependent cytosolic mRNA binding protein, the iron regulating factor (IRF). This factor is simultaneously a sensor and a regulator of iron levels. The reduction of ferritin levels during highly increased cell proliferation is a mirror of the increased density of TfRs. An abundance of data support the vigorous competition for growth-essential iron between microbial pathogens and their vertebrate hosts. The highly coordinated regulation of iron metabolism is probably crucial in achieving a balance between the blockade of readily accessible iron to invading organisms and yet providing sufficient iron for the immune system of the host. The most evident adverse clinical effects of excess iron have been observed in immunodeficient patients in tropical countries and in AIDS patients. Excess iron also increases the risk of initiation and promotion of malignant processes by iron binding to DNA and by the iron-catalysed release of free radicals. Oxygen radicals were shown to damage critical biomolecules leading, apart from cancer, to a variety of human disease states, including inflammation and atherosclerosis. They are also involved in processes of aging and thrombosis. Recent clinical trials have suggested that the use of iron

  5. Oxygen safety

    MedlinePlus

    COPD - oxygen safety; Chronic obstructive pulmonary disease - oxygen safety; Chronic obstructive airways disease - oxygen safety; Emphysema - oxygen safety; Heart failure - oxygen-safety; Palliative care - oxygen safety; ...

  6. Immunogenicity and safety of xenogeneic vascular endothelial growth factor receptor-2 DNA vaccination in mice and dogs

    PubMed Central

    Denies, Sofie; Cicchelero, Laetitia; Polis, Ingeborgh; Sanders, Niek N.

    2016-01-01

    Vascular endothelial growth factor receptor-2 (VEGFR-2) is an attractive target in oncology due to its crucial role in angiogenesis. In this study a DNA vaccine coding for human VEGFR-2 was evaluated in healthy mice and dogs, administered by intradermal injection and electroporation. In mice, three doses and vaccination schedules were evaluated. Cellular immune responses were measured by intracellular IFN-gamma staining and a cytotoxicity assay and antibodies by ELISA. Safety was assessed by measuring regulatory T cells and myeloid derived suppressor cells and a wound healing assay. The vaccine was subsequently evaluated in dogs, which were vaccinated three times with 100μg. Cellular immune responses were measured by intracellular IFN-gamma staining and antibodies by a flow cytometric assay. In mice, maximal cellular responses were observed after two vaccinations with 5μg. Humoral responses continued to increase with higher dose and number of vaccinations. No abnormalities in the measured safety parameters were observed. The vaccine was also capable of eliciting a cellular and humoral immune response in dogs. No adverse effects were observed, but tolerability of the electroporation was poor. This study will facilitate the evaluation of the vaccine in tumor bearing animals, ranging from rodent models to dogs with spontaneous tumors. PMID:26871296

  7. Immunogenicity and safety of xenogeneic vascular endothelial growth factor receptor-2 DNA vaccination in mice and dogs.

    PubMed

    Denies, Sofie; Cicchelero, Laetitia; Polis, Ingeborgh; Sanders, Niek N

    2016-03-01

    Vascular endothelial growth factor receptor-2 (VEGFR-2) is an attractive target in oncology due to its crucial role in angiogenesis. In this study a DNA vaccine coding for human VEGFR-2 was evaluated in healthy mice and dogs, administered by intradermal injection and electroporation. In mice, three doses and vaccination schedules were evaluated. Cellular immune responses were measured by intracellular IFN-gamma staining and a cytotoxicity assay and antibodies by ELISA. Safety was assessed by measuring regulatory T cells and myeloid derived suppressor cells and a wound healing assay. The vaccine was subsequently evaluated in dogs, which were vaccinated three times with 100µg. Cellular immune responses were measured by intracellular IFN-gamma staining and antibodies by a flow cytometric assay. In mice, maximal cellular responses were observed after two vaccinations with 5µg. Humoral responses continued to increase with higher dose and number of vaccinations. No abnormalities in the measured safety parameters were observed. The vaccine was also capable of eliciting a cellular and humoral immune response in dogs. No adverse effects were observed, but tolerability of the electroporation was poor. This study will facilitate the evaluation of the vaccine in tumor bearing animals, ranging from rodent models to dogs with spontaneous tumors. PMID:26871296

  8. Predictive Factors for Efficacy and Safety of Prophylactic Theophylline for Extubation in Infants with Apnea of Prematurity

    PubMed Central

    Orita, Yuji; Mitarai, Fumi; Ishitsuka, Yoichi; Irikura, Mitsuru; Shimodozono, Yoshihiro; Douchi, Tsutomu; Takeda, Yasuo; Irie, Tetsumi

    2016-01-01

    Purpose This study aimed to evaluate predictive factors involved in efficacy and safety in Japanese infants who received theophylline therapy to prevent apnea of prematurity (AOP) after weaning from mechanical ventilation. Methods We retrospectively reviewed the medical records of infants who were administered intravenous aminophylline (theophylline ethylenediamine) for AOP at the neonatal intensive care unit, Kagoshima University Hospital, Japan, between January 2009 and June 2013. Results A total of 100 infants were evaluated as two separate groups in terms of efficacy and safety of theophylline. Sixty-seven (67.0%) infants had effective theophylline therapy. Multivariate logistic regression analysis showed that gestational age at birth was significant, with an odds ratio of 0.59 (p < 0.001). Receiver operating characteristic analysis showed that the cut-off value was 31.1 weeks old for predicting the efficacy of theophylline (specificity, 66.7%; sensitivity, 86.6%; p < 0.001; area under the curve, 0.750; 95% confidence interval, 0.45–0.74). Adverse reactions were identified in 21 (21.0%) infants. Multivariate logistic regression analysis showed that the number of days of theophylline administration from birth was associated with an increased risk of adverse reactions after theophylline administration (p = 0.01). Conclusions Physicians need to be aware of the possibility that theophylline fails to produce therapeutic effects for extubation in infants aged less than 31.1 weeks old, and adverse reactions can easily develop when theophylline is administered soon after birth. PMID:27388444

  9. Food safety in raw milk production: risk factors associated to bacterial DNA contamination.

    PubMed

    Cerva, Cristine; Bremm, Carolina; Reis, Emily Marques dos; Bezerra, André Vinícius Andrade; Loiko, Márcia Regina; Cruz, Cláudio Estêvão Farias da; Cenci, Alexander; Mayer, Fabiana Quoos

    2014-06-01

    While human illness from milkborne pathogens may be linked to contamination of the product after pasteurization or improper pasteurization, such diseases are usually associated with consumption of raw milk or its by-products. Molecular biology tools were applied to investigate contamination by Listeria monocytogenes, Salmonella spp., some pathogenic strains of Escherichia coli, and Campylobacter jejuni in 548 raw milk samples from 125 dairy farms established in two regions from southern Brazil. Moreover, 15 variables were evaluated for their association with raw milk contamination levels, and the risk factors were determined by multiple regression analysis. Salmonella spp. were more frequently detected, followed by pathogenic E. coli. There was difference in contamination index between the regions, in which risk factors such as temporary cattle confinement, low milk production, low milking machine cleaning frequency, and milk storage area without tile walls were identified. The risk factors were specific to each region studied. Nevertheless, the data can be used to improve milk quality of dairy farms/herds with similar management practices.

  10. Fear factor: do dugongs (Dugong dugon) trade food for safety from tiger sharks (Galeocerdo cuvier)?

    PubMed

    Wirsing, Aaron J; Heithaus, Michael R; Dill, Lawrence M

    2007-10-01

    Predators can influence plants indirectly by altering spatial patterns of herbivory, so studies assessing the relationship between perceived predation risk and habitat use by herbivores may improve our understanding of community organization. In marine systems, the effects of predation danger on space use by large herbivores have received little attention, despite the possibility that predator-mediated alterations in patterns of grazing by these animals influence benthic community structure. We evaluated the relationship between habitat use by foraging dugongs (Dugong dugon) and the threat of tiger shark predation in an Australian embayment (Shark Bay) between 1997 and 2004. Dugong densities were quantified in shallow (putatively dangerous) and deep (putatively safe) habitats (seven survey zones allocated to each habitat), and predation hazard was indexed using catch rates of tiger sharks (Galeocerdo cuvier); seagrass volume provided a measure of food biomass within each zone. Overall, dugongs selected shallow habitats, where their food is concentrated. Foragers used shallow and deep habitats in proportion to food availability (input matching) when large tiger sharks were scarce and overused deep habitats when sharks were common. Furthermore, strong synchrony existed between daily measures of shark abundance and the extent to which deep habitats were overused. Thus, dugongs appear to adaptively manage their risk of death by allocating time to safe but impoverished foraging patches in proportion to the likelihood of encountering predators in profitable but more dangerous areas. This apparent food-safety trade-off has important implications for seagrass community structure in Shark Bay, as it may result in marked temporal variability in grazing pressure.

  11. 75 FR 74022 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... November 15, 2010 (75 FR 69648). The corrected text of the recommendation approved by the Board is below... or telephone number (202) 694-7000. Correction: In the Federal Register of November 15, 2010 (75 FR... the Plutonium Facility at Los Alamos National Laboratory that represented a significant departure...

  12. Comparison between monitored and modeled pore water pressure and safety factor in a slope susceptible to shallow landslides

    NASA Astrophysics Data System (ADS)

    Bordoni, Massimiliano; Meisina, Claudia; Zizioli, Davide; Valentino, Roberto; Bittelli, Marco; Chersich, Silvia

    2014-05-01

    Shallow landslides can be defined as slope movements affecting superficial deposits of small thicknesses which are usually triggered due to extreme rainfall events, also very concentrated in time. Shallow landslides are hazardous phenomena: in particular, if they happen close to urbanized areas they could cause significant damages to cultivations, structures, infrastructures and, sometimes, human losses. The triggering mechanism of rainfall-induced shallow landslides is strictly linked with the hydrological and mechanical responses of usually unsaturated soils to rainfall events. For this reason, it is fundamental knowing the intrinsic hydro-mechanical properties of the soils in order to assess both susceptibility and hazard of shallow landslide and to develop early-warning systems at large scale. The hydrological data collected by a 20 months monitoring on a slope susceptible to shallow landslides in an area of the North -Eastern Oltrepo Pavese (Northern Apennines, Italy) were used to identify the hydrological behaviors of the investigated soils towards rainfall events. Field conditions under different rainfall trends have also been modeled by using both hydrological and physically-based stability models for the evaluation of the slope safety factor . The main objectives of this research are: (a) to compare the field measured pore water pressures at different depths with results of hydrological models, in order to evaluate the efficiency of the tested models and to determine how precipitations affect pore pressure development; (b) to compare the time trends of the safety factor that have been obtained by applying different stability models; (c) to evaluate, through a sensitivity analysis, the effects of soil hydrological properties on modeling pore water pressure and safety factor. The test site slope where field measurements were acquired is representative of other sites in Northern Apennines affected by shallow landslides and is characterized by medium

  13. Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack

    PubMed Central

    Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

    2016-01-01

    Problem Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Approach Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom’s National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Outcomes Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. Next Steps A mixed-methods evaluation is currently under way in five NHS organizations. PMID:26579792

  14. DEVELOPMENT OF HUMAN FACTORS ENGINEERING GUIDANCE FOR SAFETY EVALUATIONS OF ADVANCED REACTORS.

    SciTech Connect

    O'HARA, J.; PERSENSKY, J.; SZABO, A.

    2006-10-01

    Advanced reactors are expected to be based on a concept of operations that is different from what is currently used in today's reactors. Therefore, regulatory staff may need new tools, developed from the best available technical bases, to support licensing evaluations. The areas in which new review guidance may be needed and the efforts underway to address the needs will be discussed. Our preliminary results focus on some of the technical issues to be addressed in three areas for which new guidance may be developed: automation and control, operations under degraded conditions, and new human factors engineering methods and tools.

  15. Safety assessment of boron by application of new uncertainty factors and their subdivision.

    PubMed

    Hasegawa, Ryuichi; Hirata-Koizumi, Mutsuko; Dourson, Michael L; Parker, Ann; Ono, Atsushi; Hirose, Akihiko

    2013-02-01

    The available toxicity information for boron was reevaluated and four appropriate toxicity studies were selected in order to derive a tolerable daily intake (TDI) using newly proposed uncertainty factors (UFs) presented in Hasegawa et al. (2010). No observed adverse effect levels (NOAELs) of 17.5 and 8.8 mgB/kg/day for the critical effect of testicular toxicity were found in 2-year rat and dog feeding studies. Also, the 95% lower confidence limit of the benchmark doses for 5% reduction of fetal body weight (BMDL(05)) was calculated as 44.9 and 10.3 mgB/kg/day in mouse and rat developmental toxicity studies, respectively. Measured values available for differences in boron clearance between rats and humans and variability in the glomerular filtration rate (GFR) in pregnant women were used to derive chemical specific UFs. For the remaining uncertainty, newly proposed default UFs, which were derived from the latest applicable information with a probabilistic approach, and their subdivided factors for toxicokinetic and toxicodynamic variability were applied. Finally, overall UFs were calculated as 68 for rat testicular toxicity, 40 for dog testicular toxicity, 247 for mouse developmental toxicity and 78 for rat developmental toxicity. It is concluded that 0.13 mgB/kg/day is the most appropriate TDI for boron, based on rat developmental toxicity.

  16. Shift work in nursing: is it really a risk factor for nurses' health and patients' safety?

    PubMed

    Admi, Hanna; Tzischinsky, Orna; Epstein, Rachel; Herer, Paula; Lavie, Peretz

    2008-01-01

    There is evidence in the scientific literature of the adverse physiological and psychological effects of shift work, including disruption to biological rhythm, sleep disorders, health problems, diminished performance at work, job dissatisfaction, and social isolation. In this study, the results of health problems and sleep disorders between female and male nurses, between daytime and shift nurses, and between sleep-adjusted and non-sleep-adjusted shift nurses were compared. Also the relationship between adjustment to shift work and organizational outcomes (errors and incidents and absenteeism from work) was analyzed. Gender, age, and weight were more significant factors than shift work in determining the well-being of nurses. Shift work by itself was not found to be a risk factor for nurses' health and organizational outcomes in this study. Moreover, nurses who were identified as being "non-adaptive" to shift work were found to work as effectively and safely as their adaptive colleagues in terms of absenteeism from work and involvement in professional errors and accidents. This research adds two additional findings to the field of shift work studies. The first finding is that female shift workers complain significantly more about sleep disorders than male shift workers. Second, although high rates of nurses whose sleep was not adapted to shift work were found, this did not have a more adverse impact on their health, absenteeism rates, or performance (reported errors and incidents), compared to their "adaptive" and "daytime" colleagues. PMID:18777974

  17. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  18. Hand Safety

    MedlinePlus

    ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ...

  19. Safety experience with IMC-C225, an anti-epidermal growth factor receptor antibody.

    PubMed

    Needle, Michael N

    2002-10-01

    In phase II trials, the anti-epidermal growth factor receptor antibody IMC-C225 did not appear to significantly exacerbate the common toxicities associated with cytotoxic chemotherapy when combined with standard anticancer treatments in patients with colorectal cancer, squamous cell carcinoma of the head and neck, or pancreatic cancer. The most common treatment-related adverse events reported during therapy with IMC-C225 were an acne-like rash and hypersensitivity reactions. The acne-like rash appeared as a sterile, suppurative form of folliculitis, commonly starting on the face, scalp, chest, and upper back. It resolved without scarring once treatment was stopped. Notably, the appearance of acne-like rash, particularly grade 3, was associated with higher treatment responses in patients with refractory colorectal cancer. The hypersensitivity reactions occurred less often than acne-like rash. They responded to standard treatments and were less common after the first dose. In summary, IMC-C225 is generally well tolerated as a single agent and when combined with chemotherapy or radiotherapy and possesses a manageable toxicity profile.

  20. Estimation Of TMDLs And Margin Of Safety Under Conditions Of Uncertainty

    EPA Science Inventory

    In TMDL development, an adequate margin of safety (MOS) is required in the calculation process to provide a cushion needed because of uncertainties in the data and analysis. Current practices, however, rarely factor analysis' uncertainty in TMDL development and the MOS is largel...

  1. Choosing the best treatment for multiple sclerosis: comparative effectiveness, safety, and other factors involved in disease-modifying therapy choice.

    PubMed

    Happe, Laura E

    2013-11-01

    Comparative effectiveness research (CER) has emerged as a priority for outlining the advantages and disadvantages of disease-modifying therapies (DMTs) for multiple sclerosis (MS). CER can provide physicians with valuable information to assist them in selecting the most appropriate therapeutics for their patients with MS. For payers, data from CER could inform decisions regarding the level of coverage for current and developing MS therapeutics, and drive the use of the most effective treatments for patients with MS. The base of CER data for DMTs has been expanding, and findings from a number of CER studies for currently available DMTs have been published, while further CER studies are planned to evaluate currently available and new DMTs or DMTs in development. While CER can be used to guide DMT selection for physicians and payers, the safety and tolerability of these treatments must be considered as well. Other emerging factors (eg, biomarkers and patient-specific factors) may also serve as important determinants of DMT choice in the future.

  2. Monitoring human factor risk characteristics at nuclear legacy sites in northwest Russia in support of radiation safety regulation.

    PubMed

    Scheblanov, V Y; Sneve, M K; Bobrov, A F

    2012-12-01

    This paper describes research aimed at improving regulatory supervision of radiation safety during work associated with the management of spent nuclear fuel and radioactive waste at legacy sites in northwest Russia through timely identification of employees presenting unfavourable human factor risk characteristics. The legacy sites of interest include sites of temporary storage now operated by SevRAO on behalf of Rosatom. The sites were previously operational bases for servicing nuclear powered submarines and are now subject to major remediation activities. These activities include hazardous operations for recovery of spent nuclear fuel and radioactive waste from sub-optimal storage conditions. The paper describes the results of analysis of methods, procedures, techniques and informational issues leading to the development of an expert-diagnostic information system for monitoring of workers involved in carrying out the most hazardous operations. The system serves as a tool for human factor and professional reliability risk monitoring and has been tested in practical working environments and implemented as part of regulatory supervision. The work has been carried out by the Burnasyan Federal Medical Biophysical Center, within the framework of the regulatory cooperation programme between the Federal Medical-Biological Agency of Russia and the Norwegian Radiation Protection Authority. PMID:23186692

  3. Monitoring human factor risk characteristics at nuclear legacy sites in northwest Russia in support of radiation safety regulation.

    PubMed

    Scheblanov, V Y; Sneve, M K; Bobrov, A F

    2012-12-01

    This paper describes research aimed at improving regulatory supervision of radiation safety during work associated with the management of spent nuclear fuel and radioactive waste at legacy sites in northwest Russia through timely identification of employees presenting unfavourable human factor risk characteristics. The legacy sites of interest include sites of temporary storage now operated by SevRAO on behalf of Rosatom. The sites were previously operational bases for servicing nuclear powered submarines and are now subject to major remediation activities. These activities include hazardous operations for recovery of spent nuclear fuel and radioactive waste from sub-optimal storage conditions. The paper describes the results of analysis of methods, procedures, techniques and informational issues leading to the development of an expert-diagnostic information system for monitoring of workers involved in carrying out the most hazardous operations. The system serves as a tool for human factor and professional reliability risk monitoring and has been tested in practical working environments and implemented as part of regulatory supervision. The work has been carried out by the Burnasyan Federal Medical Biophysical Center, within the framework of the regulatory cooperation programme between the Federal Medical-Biological Agency of Russia and the Norwegian Radiation Protection Authority.

  4. Assessment of region, farming system, irrigation source and sampling time as food safety risk factors for tomatoes.

    PubMed

    Pagadala, Sivaranjani; Marine, Sasha C; Micallef, Shirley A; Wang, Fei; Pahl, Donna M; Melendez, Meredith V; Kline, Wesley L; Oni, Ruth A; Walsh, Christopher S; Everts, Kathryne L; Buchanan, Robert L

    2015-03-01

    In the mid-Atlantic region of the United States, small- and medium-sized farmers use varied farm management methods and water sources to produce tomatoes. It is unclear whether these practices affect the food safety risk for tomatoes. This study was conducted to determine the prevalence, and assess risk factors for Salmonella enterica, Shiga toxin-producing Escherichia coli (STEC) and bacterial indicators in pre-harvest tomatoes and their production areas. A total of 24 organic and conventional, small- to medium-sized farms were sampled for six weeks in Maryland (MD), Delaware (DE) and New Jersey (NJ) between July and September 2012, and analyzed for indicator bacteria, Salmonella and STEC. A total of 422 samples--tomato fruit, irrigation water, compost, field soil and pond sediment samples--were collected, 259 of which were tomato samples. A low level of Salmonella-specific invA and Shiga toxin genes (stx1 or stx2) were detected, but no Salmonella or STEC isolates were recovered. Of the 422 samples analyzed, 9.5% were positive for generic E. coli, found in 5.4% (n=259) of tomato fruits, 22.5% (n=102) of irrigation water, 8.9% (n=45) of soil, 3/9 of pond sediment and 0/7 of compost samples. For tomato fruit, farming system (organic versus conventional) was not a significant factor for levels of indicator bacteria. However, the total number of organic tomato samples positive for generic E. coli (1.6%; 2/129) was significantly lower than for conventional tomatoes (6.9% (9/130); (χ(2) (1)=4.60, p=0.032)). Region was a significant factor for levels of Total Coliforms (TC) (p=0.046), although differences were marginal, with western MD having the highest TC counts (2.6 log CFU/g) and NJ having the lowest (2.0 log CFU/g). Tomatoes touching the ground or plastic mulch harbored significantly higher levels of TC compared to vine tomatoes, signaling a potential risk factor. Source of irrigation water was a significant factor for all indicator bacteria (p<0.0001), and

  5. Factors Influencing Learning Satisfaction of Migrant Workers in Korea with E-learning-Based Occupational Safety and Health Education

    PubMed Central

    Lee, Young Joo; Lee, Dongjoo

    2015-01-01

    Background E-learning-based programs have recently been introduced to the occupational safety and health (OSH) education for migrant workers in Korea. The purpose of this study was to investigate how the factors related to migrant workers' backgrounds and the instructional design affect the migrant workers' satisfaction with e-learning-based OSH education. Methods The data were collected from the surveys of 300 migrant workers who had participated in an OSH education program. Independent sample t test and one-way analysis of variance were conducted to examine differences in the degree of learning satisfaction using background variables. In addition, correlation analysis and multiple regression analysis were conducted to examine relationships between the instructional design variables and the degree of learning satisfaction. Results There was no significant difference in the degree of learning satisfaction by gender, age, level of education, number of employees, or type of occupation, except for nationality. Among the instructional design variables, “learning content” (β = 0.344, p < 0.001) affected the degree of learning satisfaction most significantly, followed by “motivation to learn” (β = 0.293, p < 0.001), “interactions with learners and instructors” (β = 0.149, p < 0.01), and “previous experience related to e-learning” (β = 0.095, p < 0.05). “Learning environment” had no significant influence on the degree of learning satisfaction. Conclusion E-learning-based OSH education for migrant workers may be an effective way to increase their safety knowledge and behavior if the accuracy, credibility, and novelty of learning content; strategies to promote learners' motivation to learn; and interactions with learners and instructors are systematically applied during the development and implementation of e-learning programs. PMID:26929830

  6. Assessment of safety of enterococci isolated throughout traditional Terrincho cheesemaking: virulence factors and antibiotic susceptibility.

    PubMed

    Pimentel, Lígia L; Semedo, Teresa; Tenreiro, Rogério; Crespo, M Teresa B; Pintado, M Manuela E; Malcata, F Xavier

    2007-09-01

    Enterococci account for an important fraction of the adventitious microflora of traditional cheeses manufactured in Mediterranean countries from small ruminants' raw milk and play an important role in the development of suitable organoleptic characteristics of the final product. It has been suggested that animals used for food or animals that supply edible products are a reservoir of antibiotic-resistant enterococci. The main purpose of this research effort was thus to identify, to the species level, a total of 73 enterococci with high tolerance to acidic pH and bile salts (as prevailing environmental conditions in the first portion of the gastrointestinal tract), which were previously isolated from the milk feedstock to the final product of Terrincho cheesemaking, and to determine their profiles of antibiotic susceptibility, coupled with the occurrence of specific virulence factors (especially in those that might eventually be claimed to exhibit suitable probiotic and technological performances). Isolates, identified by both API 20 STREP and PCR methods, were found to belong to the following Enterococcus species: E. casseliflavus, E. durans, E. faecalis, E. faecium, and E. gallinarum. Susceptibility of those isolates was observed to most antibiotics tested, whereas none harbored aminoglycoside resistance genes. PCR screenings for cytolysin genes (cylL(L), cylL(s), cylM, cylB, and cylA), surface adhesin genes (efaA(fs), efaA(fm), and esp), the aggregation protein gene (agg), and the extracellular metalloendopeptidase gene (gelE) were performed. All isolates proved negative for cylL(L), cylM, cylB, and agg genes. Both E. faecalis strains were positive for the cell wall-associated protein Esp and the cell wall adhesin efaA(fs), whereas the cell wall adhesin efaA(fm) was detected in 11 of the 12 E. faecium strains. Only one strain possessed the cylL(s) determinant, and another possessed the cylA gene. Incidence of virulence determinants was thus very low; hence, the

  7. Optimization of the Safety Factor Profile for High Noninductive Current Fraction Discharges in DIII-D

    SciTech Connect

    Ferron, J.R.; Holcomb, C T; Luce, T.C.; Politzer, P. A.; Turco, F.; White, A. E.; DeBoo, J. C.; Doyle, E. J.; Hyatt, A. W.; La Haye, R.; Murakami, Masanori; Petrie, T W; Petty, C C.; Rhodes, T. L.; Zeng, L.

    2011-01-01

    In order to assess the optimum q profile for discharges in DIII-D with 100% of the current driven noninductively (f(NI) = 1), the self-consistent response of the plasma profiles to changes in the q profile was studied in high f(NI), high beta(N) discharges through a scan of q(min) and q(95) at two values of beta(N). As expected, both the bootstrap current fraction, f(BS), and f(NI) increased with q(95). The temperature and density profiles were found to broaden as either q(min) or beta(N) is increased. A consequence is that f(BS) does not continue to increase at the highest values of q(min). A scaling function that depends on q(min), q(95), and the peaking factor for the thermal pressure was found to represent well the f(BS)/beta(N) inferred from the experimental profiles. The changes in the shapes of the density and temperature profiles as beta(N) is increased modify the bootstrap current density (J(BS)) profile from peaked close to the axis to relatively flat in the region between the axis and the H-mode pedestal. Therefore, significant externally driven current density in the region inside the H-mode pedestal is required in addition to J(BS) in order to match the profiles of the noninductive current density (J(NI)) to the desired total current density (J). In this experiment, the additional current density was provided mostly by neutral beam current drive with the neutral-beam-driven current fraction 40-90% of f(BS). The profiles of J(NI) and J were most similar at q(min) approximate to 1.35-1.65, q(95) approximate to 6.8, where f(BS) is also maximum, establishing this q profile as the optimal choice for f(NI) = 1 operation in DIII-D with the existing set of external current drive sources.

  8. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)

    PubMed Central

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. PMID:27799968

  9. [Bone and joint diseases in children. Adequate calcium intake and dietary habit especially breakfast in children and adolescents].

    PubMed

    Kodama, Momoko; Uenishi, Kazuhiro

    2010-06-01

    Childhood and adolescence are important periods for body growth. Calcium is one of the critical dietary factors especially for bone growth. Although recommended dietary allowance (RDA) of calcium has been determined higher in Dietary reference intakes for Japanese, 2010, calcium intake of Japanese children and adolescent are not necessarily adequate. Furthermore, breakfast skippers in this period tend to increase. So, it is very important to acquire an adequate dietary habit from childhood and adolescent. PMID:20513944

  10. Health and safety at work in the transport industry (TRANS-18): factorial structure, reliability and validity.

    PubMed

    Boada-Grau, Joan; Sánchez-García, José-Carlos; Prizmic-Kuzmica, Aldo-Javier; Vigil-Colet, Andreu

    2012-03-01

    In this article, we study the psychometric properties of a short scale (TRANS-18) which was designed to detect safe behaviors (personal and vehicle-related) and psychophysiological disorders. 244 drivers participated in the study, including drivers of freight transport vehicles (regular, dangerous and special), cranes, and passenger transport (regular transport and chartered coaches), ambulances and taxis. After carrying out an exploratory factor analysis of the scale, the findings show a structure comprised of three factors related to psychophysiological disorders, and to both personal and vehicle-related safety behaviors. Furthermore, these three factors had adequate reliability and all three also showed validity with regard to burnout, fatigue and job tension. In short, this scale may be ideally suited for adequately identifying the safety behaviors and safety problems of transport drivers. Future research could use the TRANS-18 as a screening tool in combination with other instruments. PMID:22379725

  11. Quantifying dose to the reconstructed breast: Can we adequately treat?

    SciTech Connect

    Chung, Eugene; Marsh, Robin B.; Griffith, Kent A.; Moran, Jean M.; Pierce, Lori J.

    2013-04-01

    To evaluate how immediate reconstruction (IR) impacts postmastectomy radiotherapy (PMRT) dose distributions to the reconstructed breast (RB), internal mammary nodes (IMN), heart, and lungs using quantifiable dosimetric end points. 3D conformal plans were developed for 20 IR patients, 10 autologous reconstruction (AR), and 10 expander-implant (EI) reconstruction. For each reconstruction type, 5 right- and 5 left-sided reconstructions were selected. Two plans were created for each patient, 1 with RB coverage alone and 1 with RB + IMN coverage. Left-sided EI plans without IMN coverage had higher heart Dmean than left-sided AR plans (2.97 and 0.84 Gy, p = 0.03). Otherwise, results did not vary by reconstruction type and all remaining metrics were evaluated using a combined AR and EI dataset. RB coverage was adequate regardless of laterality or IMN coverage (Dmean 50.61 Gy, D95 45.76 Gy). When included, IMN Dmean and D95 were 49.57 and 40.96 Gy, respectively. Mean heart doses increased with left-sided treatment plans and IMN inclusion. Right-sided treatment plans and IMN inclusion increased mean lung V{sub 20}. Using standard field arrangements and 3D planning, we observed excellent coverage of the RB and IMN, regardless of laterality or reconstruction type. Our results demonstrate that adequate doses can be delivered to the RB with or without IMN coverage.

  12. Bioelement effects on thyroid gland in children living in iodine-adequate territory.

    PubMed

    Gorbachev, Anatoly L; Skalny, Anatoly V; Koubassov, Roman V

    2007-01-01

    Endemic goitre is a primary pathology of thyroid gland and critical medico social problem in many countries. A dominant cause of endemic goitre is iodine deficiency. However, besides primary iodine deficiency, the goitre may probably develop due to effects of other bioelement imbalances, essential to thyroid function maintenance. Here we studied 44 cases of endemic goitre in prepubertal children (7-10 y.o.) living in iodine-adequate territory. Thyroid volume was estimated by ultrasonometry. Main bioelements (Al, Ca, Cd, Co, Cr, Cu, Fe, Hg, I, Mg, Mn, Pb, Se, Si, Zn) were determined in hair samples by ICP-OES/ICP-MS method. Relationships between hair content of bioelements and thyroid gland size were estimated by multiple regressions. The regression model revealed significant positive relations between thyroid volume and Cr, Si, Mn contents. However, the actual factor of thyroid gland increase was only Si excess in organism. Significant negative relations of thyroid volume were revealed with I, Mg, Zn, Se, Co and Cd. In spite of this, the actual factors of thyroid gland volume increasing were I, Co, Mg and Se deficiency. Total bioelement contribution in thyroid impairment was estimated as 24%. Thus, it was suggested that endemic goitre in iodine-adequate territory can be formed by bioelement imbalances, namely Si excess and Co, Mg, Se shortage as well as endogenous I deficiency in spite of iodine-adequate environment.

  13. Dissipation Pattern, Processing Factors, and Safety Evaluation for Dimethoate and Its Metabolite (Omethoate) in Tea (Camellia Sinensis).

    PubMed

    Pan, Rong; Chen, Hong-Ping; Zhang, Ming-Lu; Wang, Qing-Hua; Jiang, Ying; Liu, Xin

    2015-01-01

    Residue levels of dimethoate and its oxon metabolite (omethoate) during tea planting, manufacturing, and brewing were investigated using a modified QuEChERS sample preparation and gas chromatography. Dissipation of dimethoate and its metabolite in tea plantation followed the first-order kinetic with a half-life of 1.08-1.27 d. Tea manufacturing has positive effects on dimethoate dissipation. Processing factors of dimethoate are in the range of 2.11-2.41 and 1.41-1.70 during green tea and black tea manufacturing, respectively. Omethoate underwent generation as well as dissipation during tea manufacturing. Sum of dimethoate and omethoate led to a large portion of 80.5-84.9% transferring into tea infusion. Results of safety evaluation indicated that omethoate could bring higher human health risk than dimethoate due to its higher hazard quotient by drinking tea. These results would provide information for the establishment of maximum residue limit and instruction for the application of dimethoate formulation on tea crop.

  14. Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia.

    PubMed

    Kibbe, M R; Hirsch, A T; Mendelsohn, F O; Davies, M G; Pham, H; Saucedo, J; Marston, W; Pyun, W-B; Min, S-K; Peterson, B G; Comerota, A; Choi, D; Ballard, J; Bartow, R A; Losordo, D W; Sherman, W; Driver, V; Perin, E C

    2016-03-01

    VM202, a plasmid DNA that expresses two isoforms of hepatocyte growth factor, may elicit angiogenic effects that could benefit patients with critical limb ischemia (CLI). In a phase 2, double-blind trial in 52 CLI patients, we examined the safety and potential efficacy of intramuscular injections of low-dose (n=21) or high-dose (n=20) VM202 or placebo (n=11) in the affected limb (days 0, 14, 28 and 42). Adverse events and serious adverse events were similar among the groups; no malignancy or proliferative retinopathy was seen. In exploratory efficacy analyses, we found no differences in ankle or toe-brachial index, VAS, VascuQuol or amputation rate among the groups. Complete ulcer healing was significantly better in high-dose (8/13 ulcers; P<0.01) versus placebo (1/9) patients. Clinically meaningful reductions (>50%) in ulcer area occurred in high-dose (9/13 ulcers) and low-dose (19/27) groups versus placebo (1/9; P<0.05 and P<0.005, respectively). At 12 months, significant differences were seen in TcPO2 between the high-dose and placebo groups (47.5 ± 17.8 versus 36.6 ± 24.0 mm Hg, respectively; P<0.05) and in the change from baseline among the groups (P<0.05). These data suggest that VM202 is safe and may provide therapeutic bioactivity in CLI patients. PMID:26649448

  15. Dissipation Pattern, Processing Factors, and Safety Evaluation for Dimethoate and Its Metabolite (Omethoate) in Tea (Camellia Sinensis)

    PubMed Central

    Pan, Rong; Chen, Hong-Ping; Zhang, Ming-Lu; Wang, Qing-Hua; Jiang, Ying; Liu, Xin

    2015-01-01

    Residue levels of dimethoate and its oxon metabolite (omethoate) during tea planting, manufacturing, and brewing were investigated using a modified QuEChERS sample preparation and gas chromatography. Dissipation of dimethoate and its metabolite in tea plantation followed the first-order kinetic with a half-life of 1.08–1.27 d. Tea manufacturing has positive effects on dimethoate dissipation. Processing factors of dimethoate are in the range of 2.11–2.41 and 1.41–1.70 during green tea and black tea manufacturing, respectively. Omethoate underwent generation as well as dissipation during tea manufacturing. Sum of dimethoate and omethoate led to a large portion of 80.5–84.9% transferring into tea infusion. Results of safety evaluation indicated that omethoate could bring higher human health risk than dimethoate due to its higher hazard quotient by drinking tea. These results would provide information for the establishment of maximum residue limit and instruction for the application of dimethoate formulation on tea crop. PMID:26406463

  16. Hind limb scaling of kangaroos and wallabies (superfamily Macropodoidea): implications for hopping performance, safety factor and elastic savings.

    PubMed

    McGowan, C P; Skinner, J; Biewener, A A

    2008-02-01

    The aim of this study was to examine hind limb scaling of the musculoskeletal system in the Macropodoidea, the superfamily containing wallabies and kangaroos, to re-examine the effect of size on the locomotor mechanics and physiology of marsupial hopping. Morphometric musculoskeletal analyses were conducted of 15 species and skeletal specimens of 21 species spanning a size range from 0.8 to 80 kg that included representatives of 12 of the 16 extant genera of macropodoids. We found that unlike other groups, macropodoids are able to match force demands associated with increasing body size primarily through a combination of positive allometry in muscle area and muscle moment arms. Isometric scaling of primary hind limb bones suggests, however, that larger species experience relatively greater bone stresses. Muscle to tendon area ratios of the ankle extensors scale with strong positive allometry, indicating that peak tendon stresses also increase with increasing body size but to a lesser degree than previously reported. Consistent with previous morphological and experimental studies, large macropodoids are therefore better suited for elastic strain energy recovery but operate at lower safety factors, which likely poses an upper limit to body size. Scaling patterns for extant macropodoids suggest that extinct giant kangaroos (approximately 250 kg) were likely limited in locomotor capacity.

  17. Sport participation, sport injury, risk factors and sport safety practices in Calgary and area junior high schools

    PubMed Central

    Emery, CA; Tyreman, H

    2009-01-01

    OBJECTIVES: To examine rates of sport participation, sport injury, risk factors and sport safety practices in young adolescents. DESIGN: Cross-sectional. SETTING: Calgary and area junior high schools. PARTICIPANTS: A random sample of 1466 students (aged 12 to 15 years). OUTCOME MEASURES: Sport injury within one year prior to completing the survey. RESULTS: Ninety-three per cent of students participated in sports in the previous year. The injury rate was 60.85 injuries/100 students/year (95% CI 58.29 to 63.35) for students reporting at least one sport injury, 29.4 injuries/100 students/year (95% CI 27.08 to 31.81) for medically treated injuries, and 12.28 injuries/100 students/year (95% CI 10.64 to 14.07) for injuries presenting to a hospital emergency department. The greatest proportion of injuries occurred in basketball (14%), soccer (12%), hockey (8.6%) and snowboarding/skiing (7.1%). CONCLUSIONS: The rates of participation and injury in sports are high in junior high school students. Future research should focus on prevention strategies in sports with high participation and injury rates to have the greatest population health impact. PMID:20808471

  18. Genetic Modification of Preimplantation Embryos: Toward Adequate Human Research Policies

    PubMed Central

    Dresser, Rebecca

    2004-01-01

    Citing advances in transgenic animal research and setbacks in human trials of somatic cell genetic interventions, some scientists and others want to begin planning for research involving the genetic modification of human embryos. Because this form of genetic modification could affect later-born children and their offspring, the protection of human subjects should be a priority in decisions about whether to proceed with such research. Yet because of gaps in existing federal policies, embryo modification proposals might not receive adequate scientific and ethical scrutiny. This article describes current policy shortcomings and recommends policy actions designed to ensure that the investigational genetic modification of embryos meets accepted standards for research on human subjects. PMID:15016248

  19. A systematic review of Human Factors and Ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety

    PubMed Central

    Xie, Anping; Carayon, Pascale

    2014-01-01

    Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how Human Factors and Ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified twelve projects representing 23 studies and addressing different physical, cognitive and organizational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care. Practitioner Summary Existing evidence shows that HFE-based healthcare system redesign has the potential to improve quality of care and patient safety. Healthcare organizations need to recognize the importance of HFE-based healthcare system redesign to quality of care and patient safety, and invest resources to integrate HFE in healthcare improvement activities. PMID:25323570

  20. Safety and efficacy of sustained release of basic fibroblast growth factor using gelatin hydrogel in patients with critical limb ischemia.

    PubMed

    Kumagai, Motoyuki; Marui, Akira; Tabata, Yasuhiko; Takeda, Takahide; Yamamoto, Masaya; Yonezawa, Atsushi; Tanaka, Shiro; Yanagi, Shigeki; Ito-Ihara, Toshiko; Ikeda, Takafumi; Murayama, Toshinori; Teramukai, Satoshi; Katsura, Toshiya; Matsubara, Kazuo; Kawakami, Koji; Yokode, Masayuki; Shimizu, Akira; Sakata, Ryuzo

    2016-05-01

    As a form of therapeutic angiogenesis, we sought to investigate the safety and efficacy of a sustained-release system of basic fibroblast growth factor (bFGF) using biodegradable gelatin hydrogel in patients with critical limb ischemia (CLI). We conducted a phase I-IIa study that analyzed 10 CLI patients following a 200-μg intramuscular injection of bFGF-incorporated gelatin hydrogel microspheres into the ischemic limb. Primary endpoints were safety and transcutaneous oxygen pressure (TcO2) at 4 and 24 weeks after treatment. During the follow-up, there was no death or serious procedure-related adverse event. After 24 weeks, TcO2 (28.4 ± 8.4 vs. 46.2 ± 13.0 mmHg for pretreatment vs after 24 weeks, p < 0.01) showed significant improvement. Regarding secondary endpoints, the distance walked in 6 min (255 ± 105 vs. 318 ± 127 m, p = 0.02), the Rutherford classification (4.4 ± 0.5 vs. 3.1 ± 1.4, p = 0.02), the rest pain scale (1.7 ± 1.0 vs. 1.2 ± 1.3, p = 0.03), and the cyanotic scale (2.0 ± 1.1 vs. 0.9 ± 0.9, p < 0.01) also showed improvement. The blood levels of bFGF were within the normal range in all patients. A subanalysis of patients with arteriosclerosis obliterans (n = 7) or thromboangiitis obliterans (Buerger's disease) (n = 3) revealed that TcO2 had significantly improved in both subgroups. TcO2 did not differ between patients with or without chronic kidney disease. The sustained release of bFGF from biodegradable gelatin hydrogel may offer a safe and effective form of angiogenesis for patients with CLI.

  1. Pharmacokinetics, thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a prothrombin complex concentrate.

    PubMed

    Ruiz-Sáez, A; Hong, A; Arguello, A; Echenagucia, M; Boadas, A; Fabbrizzi, F; Minichilli, F; Bosch, N B

    2005-11-01

    Therapeutic options for developing countries have to assure an optimum safety and efficacy and low-cost antihaemophilic concentrates. A single blind randomized crossover study was carried out in 12 previously treated HB patients, comparing the pharmacokinetics (PK), thrombogenicity (TG) and safety of two plasma-derived double-inactivated (solvent/detergent heating at 100 degrees C, 30 min) factor IX (FIX) concentrates, UMAN COMPLEX DI (product A) [plasma-derived prothrombin concentrates (PCC)] and a high purity FIX concentrate AIMAFIX DI (product B, HPFIX). In a non-bleeding state, they received one single intravenous dose 50 IU FIX kg(-1) of PCC or HPFIX, and after a wash-out period of 14 days, the other product. We evaluated acute tolerance and determined PK parameters based on FIX levels measured over a 50 h postinfusion period. We studied fibrinogen, platelets, antithrombin, F1 + 2, TAT, D-dimer, over a 360 min postinfusion period. Ten cases remained in on-demand treatment for 6 months, five with PCC and five with HPFIX. PK and anti-FIX inhibitors were repeated at 3 and 6 months. No inhibitors were detected. PK values (PCC vs. HPFIX): clearence (CL; mL h(-1) kg(-1)) 5.2 +/- 1.4 vs. 6.5 +/- 1.4; the volume of distribution at steady state (mL kg(-1)) 154.9 +/- 54.9 vs. 197.5 +/- 72.5; mean residence time (h) 29.7 +/- 8.1 vs. 30.7 +/- 9.2; T(1/2) (h) 22.3 +/- 7 vs. 23.5 +/- 12.3; incremental recovery (IR; U dL(-1) U(-1) kg(-1)) 0.96 +/- 0.17 vs. 0.76 +/- 0.13. HPFIX showed significant lower IR and higher CL. There were no differences in PK at 3 and 6 months. In TG, significant increments in TAT and F1 + 2 at 30 min and 6 h were found with PCC. Product B PK results agrees with reported results for other HPFIX preparations. Use of PCC product A has to consider its thrombogenic activity.

  2. Assessment of region, farming system, irrigation source and sampling time as food safety risk factors for tomatoes.

    PubMed

    Pagadala, Sivaranjani; Marine, Sasha C; Micallef, Shirley A; Wang, Fei; Pahl, Donna M; Melendez, Meredith V; Kline, Wesley L; Oni, Ruth A; Walsh, Christopher S; Everts, Kathryne L; Buchanan, Robert L

    2015-03-01

    In the mid-Atlantic region of the United States, small- and medium-sized farmers use varied farm management methods and water sources to produce tomatoes. It is unclear whether these practices affect the food safety risk for tomatoes. This study was conducted to determine the prevalence, and assess risk factors for Salmonella enterica, Shiga toxin-producing Escherichia coli (STEC) and bacterial indicators in pre-harvest tomatoes and their production areas. A total of 24 organic and conventional, small- to medium-sized farms were sampled for six weeks in Maryland (MD), Delaware (DE) and New Jersey (NJ) between July and September 2012, and analyzed for indicator bacteria, Salmonella and STEC. A total of 422 samples--tomato fruit, irrigation water, compost, field soil and pond sediment samples--were collected, 259 of which were tomato samples. A low level of Salmonella-specific invA and Shiga toxin genes (stx1 or stx2) were detected, but no Salmonella or STEC isolates were recovered. Of the 422 samples analyzed, 9.5% were positive for generic E. coli, found in 5.4% (n=259) of tomato fruits, 22.5% (n=102) of irrigation water, 8.9% (n=45) of soil, 3/9 of pond sediment and 0/7 of compost samples. For tomato fruit, farming system (organic versus conventional) was not a significant factor for levels of indicator bacteria. However, the total number of organic tomato samples positive for generic E. coli (1.6%; 2/129) was significantly lower than for conventional tomatoes (6.9% (9/130); (χ(2) (1)=4.60, p=0.032)). Region was a significant factor for levels of Total Coliforms (TC) (p=0.046), although differences were marginal, with western MD having the highest TC counts (2.6 log CFU/g) and NJ having the lowest (2.0 log CFU/g). Tomatoes touching the ground or plastic mulch harbored significantly higher levels of TC compared to vine tomatoes, signaling a potential risk factor. Source of irrigation water was a significant factor for all indicator bacteria (p<0.0001), and

  3. 1981 NRC/BNL/IEEE standards workshop on human factors and nuclear safety. The man-machine interface and human reliability: an assessment and projection

    SciTech Connect

    Hall, R.E.; Fragola, J.R.; Luckas, W.J. Jr.

    1981-09-01

    The role of the human in the safety of nuclear power plant operations was addressed in a meeting held in Myrtle Beach, SC in August 1981. Presentation were made on Control Room reviews, safety parameter display systems, the integration of human factors in the entire design process, and the use of automated control features. A need was shown for the development of a taxonomy or model to structure future data gathering and the need for models and data to address the issue of cognitive behavior. The primary effect of this behavior on risk was identified. Discussion sessions on the human impact on reliability, and control room design and evaluation were included. (ACR)

  4. Risk Factors in the Pediatric Ward Recognized by Students Before Pediatric Nursing Practice -Basic Data for Medical Safety Education Based on Student's Learning Readiness-.

    PubMed

    Hirowatari, Kanako; Nakamura, Emi

    2016-09-01

    The purpose of this study was to extract the risk factors recognized by students before pediatric nursing practice in order to conduct medical safety education based on student's learning readiness. Third-year nursing students of A nursing college used the P-mSHELL model to find the risk factors in a simulated pediatric hospital room, and the researchers analyzed the contents. The students recognized four categories of risk factors: "burden on the family", "characteristics of the infant", "characteristics of children with disease", and "the family's cognition and understanding". There were three categories of risk factors related to "the environment": "environment that can cause a dangerous action", "unsafe environment", and "sickroom as a living space". There were four categories of risk factors related to "the student": "students' own physical/mental condition", "anxiety caused by pediatric nursing practice", "learning process in nursing practice" and "students' understanding of pediatric nursing". The students recognized that there were various risk factors in the child, the family, and the environment, and, by the P-mSHELL model, they recognized that they themselves could become a risk factor. Based on the risk factors that students extracted, teachers should think about what kind of preparation is necessary for students in pediatric nursing practice, and it is important to conduct medical safety education.

  5. Risk Factors in the Pediatric Ward Recognized by Students Before Pediatric Nursing Practice -Basic Data for Medical Safety Education Based on Student's Learning Readiness-.

    PubMed

    Hirowatari, Kanako; Nakamura, Emi

    2016-09-01

    The purpose of this study was to extract the risk factors recognized by students before pediatric nursing practice in order to conduct medical safety education based on student's learning readiness. Third-year nursing students of A nursing college used the P-mSHELL model to find the risk factors in a simulated pediatric hospital room, and the researchers analyzed the contents. The students recognized four categories of risk factors: "burden on the family", "characteristics of the infant", "characteristics of children with disease", and "the family's cognition and understanding". There were three categories of risk factors related to "the environment": "environment that can cause a dangerous action", "unsafe environment", and "sickroom as a living space". There were four categories of risk factors related to "the student": "students' own physical/mental condition", "anxiety caused by pediatric nursing practice", "learning process in nursing practice" and "students' understanding of pediatric nursing". The students recognized that there were various risk factors in the child, the family, and the environment, and, by the P-mSHELL model, they recognized that they themselves could become a risk factor. Based on the risk factors that students extracted, teachers should think about what kind of preparation is necessary for students in pediatric nursing practice, and it is important to conduct medical safety education. PMID:27627974

  6. Dose Limits for Man do not Adequately Protect the Ecosystem

    SciTech Connect

    Higley, Kathryn A.; Alexakhin, Rudolf M.; McDonald, Joseph C.

    2004-08-01

    It has been known for quite some time that different organisms display differing degrees of sensitivity to the effects of ionizing radiations. Some microorganisms such as the bacterium Micrococcus radiodurans, along with many species of invertebrates, are extremely radio-resistant. Humans might be categorized as being relatively sensitive to radiation, and are a bit more resistant than some pine trees. Therefore, it could be argued that maintaining the dose limits necessary to protect humans will also result in the protection of most other species of flora and fauna. This concept is usually referred to as the anthropocentric approach. In other words, if man is protected then the environment is also adequately protected. The ecocentric approach might be stated as; the health of humans is effectively protected only when the environment is not unduly exposed to radiation. The ICRP is working on new recommendations dealing with the protection of the environment, and this debate should help to highlight a number of relevant issues concerning that topic.

  7. Quantifying variability within water samples: the need for adequate subsampling.

    PubMed

    Donohue, Ian; Irvine, Kenneth

    2008-01-01

    Accurate and precise determination of the concentration of nutrients and other substances in waterbodies is an essential requirement for supporting effective management and legislation. Owing primarily to logistic and financial constraints, however, national and regional agencies responsible for monitoring surface waters tend to quantify chemical indicators of water quality using a single sample from each waterbody, thus largely ignoring spatial variability. We show here that total sample variability, which comprises both analytical variability and within-sample heterogeneity, of a number of important chemical indicators of water quality (chlorophyll a, total phosphorus, total nitrogen, soluble molybdate-reactive phosphorus and dissolved inorganic nitrogen) varies significantly both over time and among determinands, and can be extremely high. Within-sample heterogeneity, whose mean contribution to total sample variability ranged between 62% and 100%, was significantly higher in samples taken from rivers compared with those from lakes, and was shown to be reduced by filtration. Our results show clearly that neither a single sample, nor even two sub-samples from that sample is adequate for the reliable, and statistically robust, detection of changes in the quality of surface waters. We recommend strongly that, in situations where it is practicable to take only a single sample from a waterbody, a minimum of three sub-samples are analysed from that sample for robust quantification of both the concentrations of determinands and total sample variability. PMID:17706740

  8. A statistical evaluation of the safety factor and species sensitivity distribution approaches to deriving environmental quality guidelines.

    PubMed

    Zajdlik, Barry Alan

    2016-04-01

    The species sensitivity distribution (SSD) distribution approach to estimating water quality guidelines (WQGs) is the preferred method in all jurisdictions reviewed (Australia, Canada, New Zealand, Organisation for Economic Co-operation and Development [OECD] members, South Africa, United States) and is one of the recommended methods for European Commission members for 33 priority and priority hazardous substances. In the event that jurisdiction-specific criteria for data quality, quantity, and taxonomic representation are not met, all of these jurisdictions endorse the use of additional safety factors (SFs) applied to either the SSD-based WQG or, the lowest suitable toxicity test endpoint. In Canada, the British Columbia Ministry of Environment endorses this latter approach as the preferred approach in the belief that so-derived WQGs are more protective than SSD-based WQGs. The level of protection afforded by the latter SF approach was evaluated by statistically sampling minima from random samples of the following distributions: normal, Gumbel, logistic, and Weibull, using a range of coefficients of variation (cVs) and applying the SFs of 2 or 10 used in British Columbia. The simulations indicate that the potentially affected fraction of species (PAF) can be as high as 20%, or, approach 0%. The PAF varies with sample size and CV. Because CVs can vary systematically with mode of toxic action, the PAF using SF-based WQGs can also vary systematically with analyte class. The varying levels of protection afforded by SF-based WQGs are generally inconsistent with the common water quality management goal that allows for a small degree of change under long-term exposure. The findings suggest that further efforts be made to develop high-quality WQGs that support informed decision making and are consistent with the environmental management goal instead of using SFs in the hope of achieving an acceptable but unknown, degree of environmental protection. PMID:26272692

  9. Safety and Efficacy of Growth Factor Concentrate in the Treatment of Nasolabial Fold Correction: Split Face Pilot Study

    PubMed Central

    Sevilla, Gema P; Dhurat, Rachita S; Shetty, Geetanjali; Kadam, Prashant P; Totey, Satish M

    2015-01-01

    Background: Growth factors have long been known as an effective treatment for facial wrinkles. We developed growth factor concentrate (GFC) from the platelets and evaluated their clinical outcome in nasolabial folds. Aims and Objectives: We evaluated safety and efficacy of autologous GFC on patients with nasolabial folds. Materials and Methods: Study was conducted on 80 patients for nasolabial folds in two groups. Group I (20) received bilateral single injection of GFC and group II (60) received single injection of GFC on the right side of the face and platelet-rich plasma (PRP) on the left side of the face. Severity of nasolabial folds was determined at the baseline and 3 months of follow-up visits based on wrinkle severity rating scale (WSRS), Global aesthetic improvement scale (GAIS) and atlas photographic grading at rest and at full smile. Objective clinical assessment and subjective satisfaction scale was determined for overall improvement at the end of the study. Results: In group I, 2 subjects showed improvement after GFC treatment with the score of 3.1–4 (76–100%), 3 subjects with the score of 2.1–3 (51–75%), 14 with the score of 1.1–2 (26–50%) and 1 subject with the score of 0–1 (<25%) at the end of study. In group II, 51 subjects were evaluated at the end of study where, 34 (66%) showed superior improvements after GFC, 6 (11%) patients showed similar improvement on both side of the face, 10 (19.6%) patients showed no noticeable improvement on the either side of the face and only 1 patient (1.96%) showed superior improvement for PRP at the end of the study. Overall improvement score analysis showed that GFC was significantly superior to PRP (P < 0.001). Conclusion: Present study is a strong evidence to support the use of GFC for nasolabial folds. The results showed that the single application of GFC is highly effective and safe. PMID:26538718

  10. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  11. Improving access to adequate pain management in Taiwan.

    PubMed

    Scholten, Willem

    2015-06-01

    There is a global crisis in access to pain management in the world. WHO estimates that 4.65 billion people live in countries where medical opioid consumption is near to zero. For 2010, WHO considered a per capita consumption of 216.7 mg morphine equivalents adequate, while Taiwan had a per capita consumption of 0.05 mg morphine equivalents in 2007. In Asia, the use of opioids is sensitive because of the Opium Wars in the 19th century and for this reason, the focus of controlled substances policies has been on the prevention of diversion and dependence. However, an optimal public health outcome requires that also the beneficial aspects of these substances are acknowledged. Therefore, WHO recommends a policy based on the Principle of Balance: ensuring access for medical and scientific purposes while preventing diversion, harmful use and dependence. Furthermore, international law requires that countries ensure access to opioid analgesics for medical and scientific purposes. There is evidence that opioid analgesics for chronic pain are not associated with a major risk for developing dependence. Barriers for access can be classified in the categories of overly restrictive laws and regulations; insufficient medical training on pain management and problems related to assessment of medical needs; attitudes like an excessive fear for dependence or diversion; and economic and logistical problems. The GOPI project found many examples of such barriers in Asia. Access to opioid medicines in Taiwan can be improved by analysing the national situation and drafting a plan. The WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances can be helpful for achieving this purpose, as well as international guidelines for pain treatment.

  12. Are women with psychosis receiving adequate cervical cancer screening?

    PubMed Central

    Tilbrook, Devon; Polsky, Jane; Lofters, Aisha

    2010-01-01

    ABSTRACT OBJECTIVE To investigate the rates of cervical cancer screening among female patients with psychosis compared with similar patients without psychosis, as an indicator of the quality of primary preventive health care. DESIGN A retrospective cohort study using medical records between November 1, 2004, and November 1, 2007. SETTING Two urban family medicine clinics associated with an academic hospital in Toronto, Ont. PARTICIPANTS A random sample of female patients with and without psychosis between the ages of 20 and 69 years. MAIN OUTCOME MEASURES Number of Papanicolaou tests in a 3-year period. RESULTS Charts for 51 female patients with psychosis and 118 female patients without psychosis were reviewed. Of those women with psychosis, 62.7% were diagnosed with schizophrenia, 19.6% with bipolar disorder, 17.6% with schizoaffective disorder, and 29.4% with other psychotic disorders. Women in both groups were similar in age, rate of comorbidities, and number of full physical examinations. Women with psychosis were significantly more likely to smoke (P < .0001), to have more primary care appointments (P = .035), and to miss appointments (P = .0002) than women without psychosis. After adjustment for age, other psychiatric illnesses, number of physical examinations, number of missed appointments, and having a gynecologist, women with psychosis were significantly less likely to have had a Pap test in the previous 3 years compared with women without psychosis (47.1% vs 73.7%, respectively; odds ratio 0.19, 95% confidence interval 0.06 to 0.58). CONCLUSION Women with psychosis are more than 5 times less likely to receive adequate Pap screening compared with the general population despite their increased rates of smoking and increased number of primary care visits. PMID:20393098

  13. Improving access to adequate pain management in Taiwan.

    PubMed

    Scholten, Willem

    2015-06-01

    There is a global crisis in access to pain management in the world. WHO estimates that 4.65 billion people live in countries where medical opioid consumption is near to zero. For 2010, WHO considered a per capita consumption of 216.7 mg morphine equivalents adequate, while Taiwan had a per capita consumption of 0.05 mg morphine equivalents in 2007. In Asia, the use of opioids is sensitive because of the Opium Wars in the 19th century and for this reason, the focus of controlled substances policies has been on the prevention of diversion and dependence. However, an optimal public health outcome requires that also the beneficial aspects of these substances are acknowledged. Therefore, WHO recommends a policy based on the Principle of Balance: ensuring access for medical and scientific purposes while preventing diversion, harmful use and dependence. Furthermore, international law requires that countries ensure access to opioid analgesics for medical and scientific purposes. There is evidence that opioid analgesics for chronic pain are not associated with a major risk for developing dependence. Barriers for access can be classified in the categories of overly restrictive laws and regulations; insufficient medical training on pain management and problems related to assessment of medical needs; attitudes like an excessive fear for dependence or diversion; and economic and logistical problems. The GOPI project found many examples of such barriers in Asia. Access to opioid medicines in Taiwan can be improved by analysing the national situation and drafting a plan. The WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances can be helpful for achieving this purpose, as well as international guidelines for pain treatment. PMID:26068436

  14. 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.

  15. SNAP benefits: Can an adequate benefit be defined?

    PubMed

    Yaktine, Ann L; Caswell, Julie A

    2014-01-01

    The Supplemental Nutrition Assistance Program (SNAP) increases the food purchasing power of participating households. A committee convened by the Institute of Medicine (IOM) examined the question of whether it is feasible to define SNAP allotment adequacy. Total resources; individual, household, and environmental factors; and SNAP program characteristics that affect allotment adequacy were identified from a framework developed by the IOM committee. The committee concluded that it is feasible to define SNAP allotment adequacy; however, such a definition must take into account the degree to which participants' total resources and individual, household, and environmental factors influence the purchasing power of SNAP benefits and the impact of SNAP program characteristics on the calculation of the dollar value of the SNAP allotment. The committee recommended that the USDA Food and Nutrition Service investigate ways to incorporate these factors and program characteristics into research aimed at defining allotment adequacy.

  16. SNAP benefits: Can an adequate benefit be defined?

    PubMed

    Yaktine, Ann L; Caswell, Julie A

    2014-01-01

    The Supplemental Nutrition Assistance Program (SNAP) increases the food purchasing power of participating households. A committee convened by the Institute of Medicine (IOM) examined the question of whether it is feasible to define SNAP allotment adequacy. Total resources; individual, household, and environmental factors; and SNAP program characteristics that affect allotment adequacy were identified from a framework developed by the IOM committee. The committee concluded that it is feasible to define SNAP allotment adequacy; however, such a definition must take into account the degree to which participants' total resources and individual, household, and environmental factors influence the purchasing power of SNAP benefits and the impact of SNAP program characteristics on the calculation of the dollar value of the SNAP allotment. The committee recommended that the USDA Food and Nutrition Service investigate ways to incorporate these factors and program characteristics into research aimed at defining allotment adequacy. PMID:24425718

  17. European Society of Biomechanics S.M. Perren Award 2014: Safety factor of the proximal femur during gait: a population-based finite element study.

    PubMed

    Taddei, Fulvia; Palmadori, Ilaria; Taylor, William R; Heller, Markus O; Bordini, Barbara; Toni, Aldo; Schileo, Enrico

    2014-11-01

    It has been suggested that the mechanical competence of the proximal femur is preserved with respect to physiological loading conditions rather than accidental overloading, but the consequences of this adaptation for fracture risk in the elderly remain unclear. The goal of the present study was to analyse the safety factor of the human femur in the two most frequent daily activities, level walking and stair climbing, and to understand the dependence, if any, of this safety factor on age, volumetric bone mineral density (vBMD), and gender. To this aim, a finite element study was performed on 200 subjects (116 women and 84 men), spanning a large range of age (23-84 years) and vBMD levels (T-score from 0 to -3.59). For the first time, finite element models that included a subject-specific description of the anatomy and mineral density distribution of each bone were coupled with a personalisation of the loads acting on the proximal femur during movement, including the action of the muscles and their variability across the population. The results demonstrate that the human proximal femur is characterised by a high safety factor (on average five, never reaching fracture threshold), even in the presence of advanced age and low mineral content. These results corroborate the hypothesis that the relationship between loading and mechanical competence is generally preserved in the elderly population for the most frequent motor activities, walking and stair climbing. Interestingly, a decrease of the safety factor was observed with increasing lifespan and reduced mineral content in women but not in men.

  18. 49 CFR 385.107 - The safety audit.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... safety management controls are specified in Appendix A to this part. (b) If the FMCSA determines, based on the safety audit, that the Mexico-domiciled carrier has adequate basic safety management controls... on the safety audit, that the Mexico-domiciled carrier's basic safety management controls...

  19. Bronchoalveolar Lavage (BAL) for Research; Obtaining Adequate Sample Yield

    PubMed Central

    Collins, Andrea M.; Rylance, Jamie; Wootton, Daniel G.; Wright, Angela D.; Wright, Adam K. A.; Fullerton, Duncan G.; Gordon, Stephen B.

    2014-01-01

    We describe a research technique for fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) using manual hand held suction in order to remove nonadherent cells and lung lining fluid from the mucosal surface. In research environments, BAL allows sampling of innate (lung macrophage), cellular (B- and T- cells), and humoral (immunoglobulin) responses within the lung. BAL is internationally accepted for research purposes and since 1999 the technique has been performed in > 1,000 subjects in the UK and Malawi by our group. Our technique uses gentle hand-held suction of instilled fluid; this is designed to maximize BAL volume returned and apply minimum shear force on ciliated epithelia in order to preserve the structure and function of cells within the BAL fluid and to preserve viability to facilitate the growth of cells in ex vivo culture. The research technique therefore uses a larger volume instillate (typically in the order of 200 ml) and employs manual suction to reduce cell damage. Patients are given local anesthetic, offered conscious sedation (midazolam), and tolerate the procedure well with minimal side effects. Verbal and written subject information improves tolerance and written informed consent is mandatory. Safety of the subject is paramount. Subjects are carefully selected using clear inclusion and exclusion criteria. This protocol includes a description of the potential risks, and the steps taken to mitigate them, a list of contraindications, pre- and post-procedure checks, as well as precise bronchoscopy and laboratory techniques. PMID:24686157

  20. Bronchoalveolar lavage (BAL) for research; obtaining adequate sample yield.

    PubMed

    Collins, Andrea M; Rylance, Jamie; Wootton, Daniel G; Wright, Angela D; Wright, Adam K A; Fullerton, Duncan G; Gordon, Stephen B

    2014-01-01

    We describe a research technique for fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) using manual hand held suction in order to remove nonadherent cells and lung lining fluid from the mucosal surface. In research environments, BAL allows sampling of innate (lung macrophage), cellular (B- and T- cells), and humoral (immunoglobulin) responses within the lung. BAL is internationally accepted for research purposes and since 1999 the technique has been performed in > 1,000 subjects in the UK and Malawi by our group. Our technique uses gentle hand-held suction of instilled fluid; this is designed to maximize BAL volume returned and apply minimum shear force on ciliated epithelia in order to preserve the structure and function of cells within the BAL fluid and to preserve viability to facilitate the growth of cells in ex vivo culture. The research technique therefore uses a larger volume instillate (typically in the order of 200 ml) and employs manual suction to reduce cell damage. Patients are given local anesthetic, offered conscious sedation (midazolam), and tolerate the procedure well with minimal side effects. Verbal and written subject information improves tolerance and written informed consent is mandatory. Safety of the subject is paramount. Subjects are carefully selected using clear inclusion and exclusion criteria. This protocol includes a description of the potential risks, and the steps taken to mitigate them, a list of contraindications, pre- and post-procedure checks, as well as precise bronchoscopy and laboratory techniques.

  1. Use of Burnup Credit as a Safety Factor in Handling of NIST Fuel Assemblies in the L Basin of SRS

    SciTech Connect

    Eghbali, DA

    2004-01-07

    Burnup credit was recently used for the first time in criticality safety analysis to support the handling of the National Institute of Standards and Technology spent fuel assemblies in the L Basin of Savannah River Site. Previous criticality safety analyses were based on the fissile content of fresh, unirradiated fuel assemblies, resulting in handling of a group of 10 or less fuel assemblies at a time. Using burnup credit, it was demonstrated that an isolated configuration of up to 14 NITS fuel assemblies, the maximum number of fuel assemblies in a full basket, submerged in a concrete-lined, water-filled pool is subcritical, resulting in several administrative controls being modified or eliminated without compromising safety.

  2. Ecological risk analysis as a key factor in environmental safety system development in the Arctic region of the Russian Federation

    NASA Astrophysics Data System (ADS)

    Bolsunovskaya, Y. A.; Bolsunovskaya, L. M.

    2015-02-01

    Due to specific natural and climatic conditions combined with human intervention, the Arctic is regarded as a highly sensitive region to any environmental pressures. Arctic projects require continuous environmental monitoring. This poses for the government of the Russian Federation (RF) a tremendous task concerning the formation and implementation of sustainable nature management policy within the international framework. The current article examines the basic constraints to the effective ecological safety system implementation in the Arctic region of the RF. The ecological risks and their effects which influence the sustainable development of the region were analyzed. The model of complex environmental safety system was proposed.

  3. DETERMINATION OF THE APPROPRIATE FQPA SAFETY FACTOR(S) IN THE ORGANOPHOSPHOROUS PESTICIDE CUMULATIVE RISK ASSESSMENT: SUSCEPTIBILITY AND SENSITIVITY TO THE COMMON MECHANISM, ACETYLCHOLINESTERASE INHIBITION

    EPA Science Inventory

    The Food Quality Protection Act of 1996 (FQPA) directs EPA, in setting pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology and ...

  4. Adapting Extension Food Safety Programming for Vegetable Growers to Accommodate Differences in Ethnicity, Farming Scale, and Other Individual Factors

    ERIC Educational Resources Information Center

    Kline, Terence R.; Kneen, Harold; Barrett, Eric; Kleinschmidt, Andy; Doohan, Doug

    2012-01-01

    Differences in vegetable production methods utilized by American growers create distinct challenges for Extension personnel providing food safety training to producer groups. A program employing computers and projectors will not be accepted by an Amish group that does not accept modern technology. We have developed an outreach program that covers…

  5. Safety-Related Improvisation in Led Outdoor Activities: An Exploratory Investigation into Its Occurrence and Influencing Factors

    ERIC Educational Resources Information Center

    Trotter, Margaret J.; Salmon, Paul M.; Lenné, Michael G.

    2014-01-01

    The dynamic nature of led outdoor activities means that, despite activity providers' best efforts, activity leaders can be exposed to unanticipated situations for which no procedures exist. Improvisation, the spontaneous, real-time conception and execution of a novel response, has been identified as a potential means of maintaining safety in…

  6. Which kind of psychometrics is adequate for patient satisfaction questionnaires?

    PubMed Central

    Konerding, Uwe

    2016-01-01

    The construction and psychometric analysis of patient satisfaction questionnaires are discussed. The discussion is based upon the classification of multi-item questionnaires into scales or indices. Scales consist of items that describe the effects of the latent psychological variable to be measured, and indices consist of items that describe the causes of this variable. Whether patient satisfaction questionnaires should be constructed and analyzed as scales or as indices depends upon the purpose for which these questionnaires are required. If the final aim is improving care with regard to patients’ preferences, then these questionnaires should be constructed and analyzed as indices. This implies two requirements: 1) items for patient satisfaction questionnaires should be selected in such a way that the universe of possible causes of patient satisfaction is covered optimally and 2) Cronbach’s alpha, principal component analysis, exploratory factor analysis, confirmatory factor analysis, and analyses with models from item response theory, such as the Rasch Model, should not be applied for psychometric analyses. Instead, multivariate regression analyses with a direct rating of patient satisfaction as the dependent variable and the individual questionnaire items as independent variables should be performed. The coefficients produced by such an analysis can be applied for selecting the best items and for weighting the selected items when a sum score is determined. The lower boundaries of the validity of the unweighted and the weighted sum scores can be estimated by their correlations with the direct satisfaction rating. While the first requirement is fulfilled in the majority of the previous patient satisfaction questionnaires, the second one deviates from previous practice. Hence, if patient satisfaction is actually measured with the final aim of improving care with regard to patients’ preferences, then future practice should be changed so that the second

  7. Adequate iodine levels in healthy pregnant women. A cross-sectional survey of dietary intake in Turkey

    PubMed Central

    Kasap, Burcu; Akbaba, Gülhan; Yeniçeri, Emine N.; Akın, Melike N.; Akbaba, Eren; Öner, Gökalp; Turhan, Nilgün Ö.; Duru, Mehmet E.

    2016-01-01

    Objectives: To assess current iodine levels and related factors among healthy pregnant women. Methods: In this cross-sectional, hospital-based study, healthy pregnant women (n=135) were scanned for thyroid volume, provided urine samples for urinary iodine concentration and completed a questionnaire including sociodemographic characteristics and dietary habits targeted for iodine consumption at the Department of Obstetrics and Gynecology, School of Medicine, Muğla Sıtkı Koçman University, Muğla, Turkey, between August 2014 and February 2015. Sociodemographic data were analyzed by simple descriptive statistics. Results: Median urinary iodine concentration was 222.0 µg/L, indicating adequate iodine intake during pregnancy. According to World Health Organization (WHO) criteria, 28.1% of subjects had iodine deficiency, 34.1% had adequate iodine intake, 34.8% had more than adequate iodine intake, and 3.0% had excessive iodine intake during pregnancy. Education level, higher monthly income, current employment, consuming iodized salt, and adding salt to food during, or after cooking were associated with higher urinary iodine concentration. Conclusion: Iodine status of healthy pregnant women was adequate, although the percentage of women with more than adequate iodine intake was higher than the reported literature. PMID:27279519

  8. Safety system status monitoring

    SciTech Connect

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  9. Are family medicine residents adequately trained to deliver palliative care?

    PubMed Central

    Mahtani, Ramona; Kurahashi, Allison M.; Buchman, Sandy; Webster, Fiona; Husain, Amna; Goldman, Russell

    2015-01-01

    Objective To explore educational factors that influence family medicine residents’ (FMRs’) intentions to offer palliative care and palliative care home visits to patients. Design Qualitative descriptive study. Setting A Canadian, urban, specialized palliative care centre. Participants First-year (n = 9) and second-year (n = 6) FMRs. Methods Semistructured interviews were conducted with FMRs following a 4-week palliative care rotation. Questions focused on participant experiences during the rotation and perceptions about their roles as family physicians in the delivery of palliative care and home visits. Participant responses were analyzed to summarize and interpret patterns related to their educational experience during their rotation. Main findings Four interrelated themes were identified that described this experience: foundational skill development owing to training in a specialized setting; additional need for education and support; unaddressed gaps in pragmatic skills; and uncertainty about family physicians’ role in palliative care. Conclusion Residents described experiences that both supported and inadvertently discouraged them from considering future engagement in palliative care. Reassuringly, residents were also able to underscore opportunities for improvement in palliative care education. PMID:27035008

  10. Percentage of Adults with High Blood Pressure Whose Hypertension Is Adequately Controlled

    MedlinePlus

    ... is Adequately Controlled Percentage of Adults with High Blood Pressure Whose Hypertension is Adequately Controlled Heart disease ... Survey. Age Group Percentage of People with High Blood Pressure that is Controlled by Age Group f94q- ...

  11. [Do our elderly have an adequate nutritional status?].

    PubMed

    Méndez Estévez, Eugenia; Romero Pita, Juana; Fernández Domínguez, Ma José; Troitiño Álvarez, Patricia; García Dopazo, Silvia; Jardón Blanco, Milagros; Rey Charlo, Manuela; Rivero Cotilla, María Isabel; Rodríguez Fernández, Cristina; Menéndez Rodríguez, Martín

    2013-01-01

    Determinar el estado nutricional de los ancianos de un área de salud rural y ver si la institucionalización es un factor de riesgo. Diseño del estudio: Estudio observacional descriptivo en SAP de Xinzo de Limia 3. Sujetos: El tamaño muestral fue de 311 pacientes mayores de 75 años, seleccionados por muestreo aleatorio simple. Mediciones: Edad, sexo, estado civil, nivel de estudios, institucionalización o no, estado nutricional: valorado mediante el cuestionario MNA y parámetros antropométricos; apoyo social: medido mediante la escala de Duke- Unc; Calidad de vida: con la escala Euro-Quol; patologías asociadas; trastornos de la deglución; tratamiento habitual: tipo de dieta, fármacos. Resultados principales: La mediana de edad era de 82,55 años (DT 4,83 años) y el 51,8% eran mujeres, el 52,7% estaba casado y el 76,8% referían estudios primarios. La mediana de patologías por individuo era del 3 (DT: 1,42) y del número de fármacos usados era de 4 (DT 2,44). El 54,70% vivía acompañado por su pareja u otro familiar. Estaban institucionalizados el 17,4%. La mediana de calidad de vida era de 6,84. Según los resultados del MNA no encontramos ningún caso de desnutrición, pero un 20.3% de los pacientes presentan valores de riesgo. En el análisis multivariante encontramos relación entre la presencia o no de desnutrición y la institucionalización OR = 0,40 (IC 95%, 0,18- 0,87), con el nº de patologías OR = 1,30 (IC 95%, 1,03-1,64), calidad de vida OR = 1,40 (IC 95%, 1,14-1,71). Conclusiones: Los pacientes ancianos validos estudiados presentan un buen estado nutricional. Los pacientes con riesgo de presentar desnutrición son un 20,3%, siendo la institucionalización, los mayores de 85 años con mayor número de patologías los que presentan mayor riesgo de desnutrición. La peor calidad de vida y el menor apoyo social influyen negativamente.

  12. Post-marketing safety evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir: A drug-use investigation in patients with high risk factors.

    PubMed

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2016-10-01

    Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined. In total, 412 adverse events were observed in 219 patients (28.4%). Of these, 155 events were adverse drug reactions (ADRs) observed in 98 patients (12.7%). Major ADRs (≥2%) were increased aspartate aminotransferase (5.1%), increased alanine aminotransferase (3.8%) and decreased white blood cell count (2.5%). Fourteen serious ADRs were observed in 12 patients (1.6%). All serious ADRs were resolved or improved except for two events for which outcomes were unknown. Multivariate analyses revealed that ADR incidences were significantly associated with these four backgrounds of patients: medical history, no influenza vaccination, renal impairment and other infection(s). With regard to its effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration, which was the same as in other previous surveillance studies. This surveillance study indicated the safety of peramivir in the treatment of influenza inpatients with high risk factors under routine clinical settings. PMID:27497712

  13. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  14. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  15. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  16. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  17. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  18. Improved ASTM G72 Test Method for Ensuring Adequate Fuel-to-Oxidizer Ratios

    NASA Technical Reports Server (NTRS)

    Juarez, Alfredo; Harper, Susana Tapia

    2016-01-01

    The ASTM G72/G72M-15 Standard Test Method for Autogenous Ignition Temperature of Liquids and Solids in a High-Pressure Oxygen-Enriched Environment is currently used to evaluate materials for the ignition susceptibility driven by exposure to external heat in an enriched oxygen environment. Testing performed on highly volatile liquids such as cleaning solvents has proven problematic due to inconsistent test results (non-ignitions). Non-ignition results can be misinterpreted as favorable oxygen compatibility, although they are more likely associated with inadequate fuel-to-oxidizer ratios. Forced evaporation during purging and inadequate sample size were identified as two potential causes for inadequate available sample material during testing. In an effort to maintain adequate fuel-to-oxidizer ratios within the reaction vessel during test, several parameters were considered, including sample size, pretest sample chilling, pretest purging, and test pressure. Tests on a variety of solvents exhibiting a range of volatilities are presented in this paper. A proposed improvement to the standard test protocol as a result of this evaluation is also presented. Execution of the final proposed improved test protocol outlines an incremental step method of determining optimal conditions using increased sample sizes while considering test system safety limits. The proposed improved test method increases confidence in results obtained by utilizing the ASTM G72 autogenous ignition temperature test method and can aid in the oxygen compatibility assessment of highly volatile liquids and other conditions that may lead to false non-ignition results.

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

    PubMed

    Waßmuth, Ralf

    2015-01-01

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

  20. Space capsule recovery—Evaluation of risk factors, safety plans and procedures and design of experiments for systems qualification

    NASA Astrophysics Data System (ADS)

    Narasaiah, N.; Varaprasad, R.; Seshagiri Rao, V.; Krishnamurty, V.; Sanyal, M. K.

    2009-11-01

    The Indian Space capsule (SRE-1) launched aboard PSLV-C7 rocket, was recovered successfully in the Bay of Bengal on January 22, 2007 after its orbital sojourn of 12 days. Apart from serving as a platform for micro-gravity experiments, SRE-1 demonstrated ISRO's capability in the field of orbital reentry and recovery technologies. Satish Dhawan Space Centre (SDSC SHAR), the Spaceport of India was given the prime responsibility of assessment of mission risk, formulation and execution of safety plans and procedures, design and conduct of trials for validating the mission-critical sub-systems as well as the physical recovery of the capsule. To achieve these objectives, a number of drop tests were designed and conducted by SDSC SHAR involving real time computer network, ground-based tracking and telemetry stations, communication systems, safety and material handling systems, target identification and recovery systems. Dissemination of relevant information and coordination with multiple external organizations such as Indian Coast Guard, Indian Air Force and Indian Navy is an important aspect of these experiments. This paper delineates the methodologies designed and implemented at SDSC SHAR for validating those critical systems whose functionality finally culminated in the success of the mission, enabling India to join the elite group of nations with reentry module recovery capability.

  1. Examining the validity of AHRQ's patient safety indicators (PSIs): is variation in PSI composite score related to hospital organizational factors?

    PubMed

    Shin, Marlena H; Sullivan, Jennifer L; Rosen, Amy K; Solomon, Jeffrey L; Dunn, Edward J; Shimada, Stephanie L; Hayes, Jennifer; Rivard, Peter E

    2014-12-01

    Increasing use of Agency for Healthcare Research and Quality's Patient Safety Indicators (PSIs) for hospital performance measurement intensifies the need to critically assess their validity. Our study examined the extent to which variation in PSI composite score is related to differences in hospital organizational structures or processes (i.e., criterion validity). In site visits to three Veterans Health Administration hospitals with high and three with low PSI composite scores ("low performers" and "high performers," respectively), we interviewed a cross-section of hospital staff. We then coded interview transcripts for evidence in 13 safety-related domains and assessed variation across high and low performers. Evidence of leadership and coordination of work/communication (organizational process domains) was predominantly favorable for high performers only. Evidence in the other domains was either mixed, or there were insufficient data to rate the domains. While we found some evidence of criterion validity, the extent to which variation in PSI rates is related to differences in hospitals' organizational structures/processes needs further study.

  2. SAFETY FACTORS FOR XYLEM FAILURE BY IMPLOSION AND AIR-SEEDING WITHIN ROOTS, TRUNKS AND BRANCHES OF YOUNG AND OLD CONIFER TREES

    SciTech Connect

    Domec, Jean-Christophe; Warren, Jeffrey M.; Meinzer, Rick; Lachenbruch, Barbara

    2009-01-01

    The cohesion-tension theory of water transport states that hydrogen bonds hold water molecules together and that they are pulled through the xylem under tension. This tension could cause transport failure in at least two ways: collapse of the conduit walls (implosion), or rupture of the water column through air-seeding. The objective of this research was to elucidate the functional significance of variations in tracheid anatomical features, earlywood to latewood ratios and wood densities with position in young and old Douglas-fir and ponderosa pine trees in terms of their consequences for the safety factors for tracheid implosion and air-seeding. For both species, wood density increased linearly with percent latewood for root, trunk and branch samples. However, the relationships between anatomy and hydraulic function in trunks differed from those in roots and branches. In roots and branches increased hydraulic efficiency was achieved at the cost of increased vulnerability to air-seeding. Mature wood of trunks had earlywood with wide tracheids that optimized water transport and had a high percentage of latewood that optimized structural support. Juvenile wood had higher resistance to air-seeding and cell wall implosion. The two safety factors followed similar axial trends from roots to terminal branches and were similar for both species studied and between juvenile and mature wood.

  3. Demographic factors associated with perceptions about water safety and tap water consumption among adults in Santa Clara County, California, 2011.

    PubMed

    van Erp, Brianna; Webber, Whitney L; Stoddard, Pamela; Shah, Roshni; Martin, Lori; Broderick, Bonnie; Induni, Marta

    2014-06-12

    The objective of this study was to examine differences in tap water consumption and perceptions of bottle versus tap water safety for Hispanics and non-Hispanic whites, as well as associations with other demographic characteristics. Data are from the Santa Clara County, California, Dietary Practices Survey (2011; N = 306). We used logistic regression to examine associations between demographic characteristics and 1) perceptions that bottled water is safer than tap and 2) primarily consuming tap water. Hispanics were less likely than non-Hispanic whites to primarily drink tap water (OR = 0.33; 95% CI, 0.11-0.99), although there was no significant difference in perceptions that bottled water is safer between these groups (OR = 0.50; 95% CI, 0.11-2.27). Hispanics may be an important population for interventions promoting tap water consumption.

  4. Iodine Status of Women of Reproductive Age in Sierra Leone and Its Association with Household Coverage with Adequately Iodized Salt.

    PubMed

    Rohner, Fabian; Wirth, James P; Woodruff, Bradley A; Chiwile, Faraja; Yankson, Hannah; Sesay, Fatmata; Koroma, Aminata S; Petry, Nicolai; Pyne-Bailey, Solade; Dominguez, Elisa; Kupka, Roland; Hodges, Mary H; de Onis, Mercedes

    2016-02-01

    Salt iodization programs are a public health success in tackling iodine deficiency. Yet, a large proportion of the world's population remains at risk for iodine deficiency. In a nationally representative cross-sectional survey in Sierra Leone, household salt samples and women's urine samples were quantitatively analyzed for iodine content. Salt was collected from 1123 households, and urine samples from 817 non-pregnant and 154 pregnant women. Household coverage with adequately iodized salt (≥15 mg/kg iodine) was 80.7%. The median urinary iodine concentration (UIC) of pregnant women was 175.8 µg/L and of non-pregnant women 190.8 µg/L. Women living in households with adequately iodized salt had higher median UIC (for pregnant women: 180.6 µg/L vs. 100.8 µg/L, respectively, p < 0.05; and for non-pregnant women: 211.3 µg/L vs. 97.8 µg/L, p < 0.001). Differences in UIC by residence, region, household wealth, and women's education were much smaller in women living in households with adequately iodized salt than in households without. Despite the high household coverage of iodized salt in Sierra Leone, it is important to reach the 20% of households not consuming adequately iodized salt. Salt iodization has the potential for increasing equity in iodine status even with the persistence of other risk factors for deficiency. PMID:26848685

  5. Iodine Status of Women of Reproductive Age in Sierra Leone and Its Association with Household Coverage with Adequately Iodized Salt

    PubMed Central

    Rohner, Fabian; Wirth, James P.; Woodruff, Bradley A.; Chiwile, Faraja; Yankson, Hannah; Sesay, Fatmata; Koroma, Aminata S.; Petry, Nicolai; Pyne-Bailey, Solade; Dominguez, Elisa; Kupka, Roland; Hodges, Mary H.; de Onis, Mercedes

    2016-01-01

    Salt iodization programs are a public health success in tackling iodine deficiency. Yet, a large proportion of the world’s population remains at risk for iodine deficiency. In a nationally representative cross-sectional survey in Sierra Leone, household salt samples and women’s urine samples were quantitatively analyzed for iodine content. Salt was collected from 1123 households, and urine samples from 817 non-pregnant and 154 pregnant women. Household coverage with adequately iodized salt (≥15 mg/kg iodine) was 80.7%. The median urinary iodine concentration (UIC) of pregnant women was 175.8 µg/L and of non-pregnant women 190.8 µg/L. Women living in households with adequately iodized salt had higher median UIC (for pregnant women: 180.6 µg/L vs. 100.8 µg/L, respectively, p < 0.05; and for non-pregnant women: 211.3 µg/L vs. 97.8 µg/L, p < 0.001). Differences in UIC by residence, region, household wealth, and women’s education were much smaller in women living in households with adequately iodized salt than in households without. Despite the high household coverage of iodized salt in Sierra Leone, it is important to reach the 20% of households not consuming adequately iodized salt. Salt iodization has the potential for increasing equity in iodine status even with the persistence of other risk factors for deficiency. PMID:26848685

  6. Iodine Status of Women of Reproductive Age in Sierra Leone and Its Association with Household Coverage with Adequately Iodized Salt.

    PubMed

    Rohner, Fabian; Wirth, James P; Woodruff, Bradley A; Chiwile, Faraja; Yankson, Hannah; Sesay, Fatmata; Koroma, Aminata S; Petry, Nicolai; Pyne-Bailey, Solade; Dominguez, Elisa; Kupka, Roland; Hodges, Mary H; de Onis, Mercedes

    2016-02-03

    Salt iodization programs are a public health success in tackling iodine deficiency. Yet, a large proportion of the world's population remains at risk for iodine deficiency. In a nationally representative cross-sectional survey in Sierra Leone, household salt samples and women's urine samples were quantitatively analyzed for iodine content. Salt was collected from 1123 households, and urine samples from 817 non-pregnant and 154 pregnant women. Household coverage with adequately iodized salt (≥15 mg/kg iodine) was 80.7%. The median urinary iodine concentration (UIC) of pregnant women was 175.8 µg/L and of non-pregnant women 190.8 µg/L. Women living in households with adequately iodized salt had higher median UIC (for pregnant women: 180.6 µg/L vs. 100.8 µg/L, respectively, p < 0.05; and for non-pregnant women: 211.3 µg/L vs. 97.8 µg/L, p < 0.001). Differences in UIC by residence, region, household wealth, and women's education were much smaller in women living in households with adequately iodized salt than in households without. Despite the high household coverage of iodized salt in Sierra Leone, it is important to reach the 20% of households not consuming adequately iodized salt. Salt iodization has the potential for increasing equity in iodine status even with the persistence of other risk factors for deficiency.

  7. Maintaining Adequate Carbon Dioxide Washout for an Advanced Extravehicular Mobility Unit

    NASA Technical Reports Server (NTRS)

    Chullen, Cinda; Navarro, Moses; Conger, Bruce; Korona, Adam; McMillin, Summer; Norcross, Jason; Swickrath, Mike

    2013-01-01

    Over the past several years, NASA has realized tremendous progress in technology development that is aimed at the production of an Advanced Extravehicular Mobility Unit (AEMU). Of the many functions provided by the spacesuit and portable life support subsystem within the AEMU, delivering breathing gas to the astronaut along with removing the carbon dioxide (CO2) remains one of the most important environmental functions that the AEMU can control. Carbon dioxide washout is the capability of the ventilation flow in the spacesuit helmet to provide low concentrations of CO2 to the crew member to meet breathing requirements. CO2 washout performance is a critical parameter needed to ensure proper and sufficient designs in a spacesuit and in vehicle applications such as sleep stations and hygiene compartments. Human testing to fully evaluate and validate CO2 washout performance is necessary but also expensive due to the levied safety requirements. Moreover, correlation of math models becomes challenging because of human variability and movement. To supplement human CO2 washout testing, a breathing capability will be integrated into a suited manikin test apparatus to provide a safe, lower cost, stable, easily modeled alternative to human testing. Additionally, this configuration provides NASA Johnson Space Center (JSC) the capability to evaluate CO2 washout under off-nominal conditions that would otherwise be unsafe for human testing or difficult due to fatigue of a test subject. Testing has been under way in-house at JSC and analysis has been initiated to evaluate whether the technology provides sufficient performance in ensuring that the CO2 is removed sufficiently and the ventilation flow is adequate for maintaining CO2 washout in the AEMU spacesuit helmet of the crew member during an extravehicular activity. This paper will review recent CO2 washout testing and analysis activities, testing planned in-house with a spacesuit simulator, and the associated analytical work

  8. Safety and human factors considerations in control rooms of oil and gas pipeline systems: conceptual issues and practical observations.

    PubMed

    Meshkati, Najmedin

    2006-01-01

    All oil and gas pipeline systems are run by human operators (called controllers) who use computer-based workstations in control rooms to "control" pipelines. Several human factor elements could contribute to the lack of controller success in preventing or mitigating pipeline accidents/incidents. These elements exist in both the work environment and also in the computer system design/operation (such as data presentation and alarm configuration). Some work environment examples include shift hours, shift length, circadian rhythms, shift change-over processes, fatigue countermeasures, ergonomics factors, workplace distractions, and physical interaction with control system computers. The major objective of this paper is to demonstrate the critical effects of human and organizational factors and also to highlight the role of their interactions with automation (and automated devices) in the safe operation of complex, large-scale pipeline systems. A case study to demonstrate the critical role of human organizational factors in the control room of an oil and gas pipeline system is also presented.

  9. Efficacy and safety of nerve growth factor for the treatment of neurological diseases: a meta-analysis of 64 randomized controlled trials involving 6,297 patients

    PubMed Central

    Zhao, Meng; Li, Xiao-yan; Xu, Chun-ying; Zou, Li-ping

    2015-01-01

    OBJECTIVE: China is the only country where nerve growth factor is approved for large-scale use as a clinical medicine. More than 10 years ago, in 2003, nerve growth factor injection was listed as a national drug. The goal of this article is to evaluate comprehensively the efficacy and safety of nerve growth factor for the treatment of neurological diseases. DATA RETRIEVAL: A computer-based retrieval was performed from six databases, including the Cochrane Library, PubMed, EMBASE, Sino Med, CNKI, and the VIP database, searching from the clinical establishment of nerve growth factor for treatment until December 31, 2013. The key words for the searches were “nerve growth factor, randomized controlled trials” in Chinese and in English. DATA SELECTION: Inclusion criteria: any study published in English or Chinese referring to randomized controlled trials of nerve growth factor; patients with neurological diseases such as peripheral nerve injury, central nerve injury, cranial neuropathy, and nervous system infections; patients older than 7 years; similar research methods and outcomes assessing symptoms; and measurement of nerve conduction velocities. The meta-analysis was conducted using Review Manager 5.2.3 software. MAIN OUTCOME MEASURES: The total effective rate, the incidence of adverse effects, and the nerve conduction velocity were recorded for each study. RESULTS: Sixty-four studies involving 6,297 patients with neurological diseases were included. The total effective rate in the group treated with nerve growth factor was significantly higher than that in the control group (P < 0.0001, RR: 1.35, 95%CI: 1.30–1.40). The average nerve conduction velocity in the nerve growth factor group was significantly higher than that in the control group (P < 0.00001, MD: 4.59 m/s, 95%CI: 4.12–5.06). The incidence of pain or scleroma at the injection site in the nerve growth factor group was also higher than that in the control group (P < 0.00001, RR: 6.30, 95%CI: 3.53

  10. Recent RF Experiments and Application of RF Waves to Real-Time Control of Safety Factor Profile in JT-60U

    SciTech Connect

    Suzuki, T.; Isayama, A.; Ide, S.; Fujita, T.; Oikawa, T.; Sakata, S.; Sueoka, M.; Hosoyama, H.; Seki, M.

    2005-09-26

    Two topics of applications of RF waves to current profile control in JT-60U are presented; application of lower-hybrid (LH) waves to safety factor profile control and electron cyclotron (EC) waves to neo-classical tearing mode (NTM) control. A real-time control system of safety factor (q) profile was developed. This system, for the first time, enables 1) real time evaluation of q profile using local magnetic pitch angle measurement by motional Stark effect (MSE) diagnostic and 2) control of current drive (CD) location ({rho}CD) by controlling the parallel refractive index N parallel of LH waves through control of phase difference ({delta}{phi}) of LH waves between multi-junction launcher modules. The method for real-time q profile evaluation was newly developed, without time-consuming reconstruction of equilibrium, so that the method requires less computational time. Safety factor profile by the real-time calculation agrees well with that by equilibrium reconstruction with MSE. The control system controls {rho}CD through {delta}{phi} in such a way to decrease the largest residual between the real-time evaluated q profile q(r) and its reference profile qref(r). The real-time control system was applied to a positive shear plasma (q(0){approx}1). The reference q profile was set to monotonic positive shear profile having qref(0)=1.3. The real-time q profile approached to the qref(r) during application of real-time control, and was sustained for 3s, which was limited by the duration of the injected LH power. Temporal evolution of current profile was consistent with relaxation of inductive electric field induced by theoretical LH driven current. An m/n=3/2 NTM that appeared at {beta}N{approx}3 was completely stabilized by ECCD applied to a fully-developed NTM. Precise ECCD at NTM island was essential for the stabilization. ECCD that was applied to resonant rational surface (q=3/2) before an NTM onset suppressed appearance of NTM. In order to keep NTM intensity below a

  11. Thermal reactor safety

    SciTech Connect

    Not Available

    1980-06-01

    Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

  12. Guidelines for nuclear power plant safety issue prioritization information development. Supplement 3

    SciTech Connect

    Andrews, W.B.; Bickford, W.E.; Counts, C.A.; Gallucci, R.H.V.; Heaberlin, S.W.; Powers, T.B.; Weakley, S.A.

    1985-09-01

    This supplemental report is the fourth in a series that document and use methods developed to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues. The initial report in this series was published by Andrews et al. in 1983 as NUREG/CR-2800. This supplement consists of two parts describing separate research efforts: (1) an alternative human factors methodology approach, and (2) a prioritization of the NRC's Human Factors Program Plan. The alternative human factors methodology approach may be used in specific future cases in which the methods identified in the initial report (NUREG/CR-2800) may not adequately assess the proper impact for resolution of new safety issues. The alternative methodology included in this supplement is entitled ''Methodology for Estimating the Public Risk Reduction Affected by Human Factors Improvement.'' The prioritization section of this report is entitled ''Prioritization of the US Nuclear Regulatory Commission Human Factors Program Plan.''

  13. Failure-to-register laws and public safety: an examination of risk factors and sex offense recidivism.

    PubMed

    Levenson, Jill S; Sandler, Jeffrey C; Freeman, Naomi J

    2012-12-01

    The goals of this study were to describe the characteristics of a sample of sex offenders charged with failure to register (FTR) in New York State, compare the FTR and non-FTR groups on relevant risk factors, identify risk factors associated with failing to register, and investigate the relationship between registration noncompliance and both general and sexual rearrest. FTR offenders were found to be younger, more likely to be a minority race, and have more extensive and varied prior criminal histories as well as a record of supervision violations. Results also indicated that FTR was more strongly correlated with nonsexual recidivism (r = .44) than sexual recidivism (r = .09). FTR contributed to the likelihood of sexual recidivism for rapists of adult victims, but not for sex offenders with child victims, and occurred in combination with a history of prior sexual crimes and versatility in criminal offending.

  14. Safety of a non-viral plasmid-encoding dual isoforms of hepatocyte growth factor in critical limb ischemia patients: a phase I study.

    PubMed

    Henry, T D; Hirsch, A T; Goldman, J; Wang, Y L; Lips, D L; McMillan, W D; Duval, S; Biggs, T A; Keo, H H

    2011-08-01

    We aimed to evaluate in a phase I dose-escalation study, the safety of intramuscular injections of a novel non-viral plasmid DNA expressing two isoforms of human hepatocyte growth factor (HGF) (VM202) in patients with critical limb ischemia (CLI). In total, 12 patients with CLI and unsuitable for revascularization were consecutively assigned to increasing doses (2 to 16 mg) of VM202 administered into the ischemic calf muscle at days 1 and 15. Patients were evaluated for safety and tolerability, changes in ankle- and toe brachial index (ABI and TBI), and pain severity score using a visual analog scale (VAS) throughout a 12-month follow-up period. Median age was 72 years and 53% of the patients were male. VM202 was safe and well tolerated with no death during the 12-month follow-up. Median ABI and TBI significantly increased from 0.35 to 0.52 (P=0.005) and from 0.15 to 0.24 (P=0.01) at 12 months follow-up. Median VAS decreased from 57.5 to 16.0 mm at 6 months follow-up (P=0.03). In this first human clinical trial, VM202, which expresses two isoforms of human HGF, appear to be safe and well tolerated with encouraging clinical results and thus supports the performance of a phase II randomized controlled trial. PMID:21430785

  15. Pathways and factors for food safety and food security at PFOS contaminated sites within a problem based learning approach.

    PubMed

    Brambilla, Gianfranco; D'Hollander, Wendy; Oliaei, Fardin; Stahl, Thorsten; Weber, Roland

    2015-06-01

    Perfluorooctanesulfonic acid (PFOS) and related substances have been listed in Annex B of the Stockholm Convention. The implementation requires inventories of use, stockpiles, and environmental contamination including contaminated sites and measures for (risk) reduction and phase out. In most countries monitoring capacity is not available and therefore other approaches for assessment of contaminated sites are needed. Available informations about PFOS contamination in hot spot areas and its bio-accumulation in the food webs have been merged to build up a worst-case scenario We model PFOS transfer from 1 to 100ngL(-1) range in water to extensive and free-range food producing animals, also via the spread of contaminated sludges on agriculture soils. The modeling indicates that forages represented 78% of the exposure in ruminants, while soil accounted for >80% in outdoor poultry/eggs and pigs. From the carry-over rates derived from literature, in pork liver, egg, and feral fish computed concentration falls at 101, 28 and 2.7ngg(-1), respectively, under the 1ngL(-1) PFOS scenario. Assuming a major consumption of food produced from a contaminated area, advisories on egg and fish, supported by good agriculture/farming practices could abate 75% of the human food intake. Such advisories would allow people to become resilient in a PFOS contaminated area through an empowerment of the food choices, bringing the alimentary exposure toward the current Tolerable Daily Intake (TDI) of 150ngkg(-1)bodyweightd(-1) proposed by the European Food Safety Authority (EFSA).

  16. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  17. Calculation of the Cost of an Adequate Education in Kentucky: A Professional Judgment Approach

    ERIC Educational Resources Information Center

    Verstegen, Deborah A.

    2004-01-01

    What is an adequate education and how much does it cost? In 1989, Kentucky's State Supreme Court found the entire system of education unconstitutional--"all of its parts and parcels". The Court called for all children to have access to an adequate education, one that is uniform and has as its goal the development of seven capacities, including:…

  18. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  19. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  20. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate...

  1. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate...

  2. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate...

  3. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate...

  4. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL... Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The pesticides... has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by...

  5. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL... Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The pesticides... has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by...

  6. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL... Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The pesticides... has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by...

  7. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  8. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  9. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  10. A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

    NASA Astrophysics Data System (ADS)

    Tabibzadeh, Maryam

    According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test

  11. A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

    NASA Astrophysics Data System (ADS)

    Tabibzadeh, Maryam

    According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test

  12. Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

    PubMed

    Sinclair, Robert R; Martin, James E; Sears, Lindsay E

    2010-09-01

    Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research.

  13. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety.

    PubMed Central

    Milstien, J. B.; Gibson, J. J.

    1990-01-01

    WHO oversees the quality control of BCG vaccine via a system that includes regular testing of products by in vitro methods and clinical trials. Three parent strains of BCG (Glaxo-1077, Tokyo-172, and Pasteur-1173P2) account for over 90% of the vaccines currently in use worldwide. Important characteristics of the vaccine preparations are summarized here, along with their physical-chemical properties. In instances where diagnostic criteria for tuberculosis are stringent, there is no evidence that when administered to newborns different preparations of BCG vaccine exhibit different efficacies; however, the incidence of BCG-associated adverse reactions does correlate with the type of preparation. Other factors, including dose, administration technique, and recipient characteristics are also important in determining vaccine-associated reactions. PMID:2189588

  14. Strengthening the safety net for online seniors: factors influencing differences in health information seeking among older internet users.

    PubMed

    McMillan, Sally J; Macias, Wendy

    2008-12-01

    Earlier studies clearly have shown that older adults are going online and accessing health information, but they are not a monolithic group. The goal of this study is to identify different types of older online Americans and to examine their online health information attitudes and behaviors. A total of 424 individuals age 55+ responded to an online survey. Three types of users were found based on demographic and computer-use factors: power users, well-to-do, and older men. Two types were found based on health attitudes and behaviors: health traditionalists and health technologists. The study found interesting relationships among these groups and also explored their use and evaluation of specific types of health-related websites and their motivations for going online. Suggestions are made for extending this research to other populations and further exploring the theoretical model of senior's online health interactions (SOHI) that drives the study.

  15. 45 CFR 1159.15 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... of maintaining adequate technical, physical, and security safeguards to prevent...

  16. 49 CFR 385.319 - What happens after completion of the safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... adequate basic safety management controls, the Agency will provide the new entrant written notice as soon... basic safety management controls. The new entrant's safety performance will continue to be closely... determines the safety audit discloses the new entrant's basic safety management controls are inadequate,...

  17. Emotional Experiences of Obese Women with Adequate Gestational Weight Variation: A Qualitative Study

    PubMed Central

    Faria-Schützer, Débora Bicudo; Surita, Fernanda Garanhani de Castro; Alves, Vera Lucia Pereira; Vieira, Carla Maria; Turato, Egberto Ribeiro

    2015-01-01

    Background As a result of the growth of the obese population, the number of obese women of fertile age has increased in the last few years. Obesity in pregnancy is related to greater levels of anxiety, depression and physical harm. However, pregnancy is an opportune moment for the intervention of health care professionals to address obesity. The objective of this study was to describe how obese pregnant women emotionally experience success in adequate weight control. Methods and Findings Using a qualitative design that seeks to understand content in the field of health, the sample of subjects was deliberated, with thirteen obese pregnant women selected to participate in an individual interview. Data was analysed by inductive content analysis and includes complete transcription of the interviews, re-readings using suspended attention, categorization in discussion topics and the qualitative and inductive analysis of the content. The analysis revealed four categories, three of which show the trajectory of body care that obese women experience during pregnancy: 1) The obese pregnant woman starts to think about her body;2) The challenge of the diet for the obese pregnant woman; 3) The relation of the obese pregnant woman with the team of antenatal professionals. The fourth category reveals the origin of the motivation for the change: 4) The potentializing factors for change: the motivation of the obese woman while pregnant. Conclusions During pregnancy, obese women are more in touch with themselves and with their emotional conflicts. Through the transformations of their bodies, women can start a more refined self-care process and experience of the body-mind unit. The fear for their own and their baby's life, due to the risks posed by obesity, appears to be a great potentializing factor for change. The relationship with the professionals of the health care team plays an important role in the motivational support of the obese pregnant woman. PMID:26529600

  18. Pharmacokinetics and safety of a novel recombinant human von Willebrand factor manufactured with a plasma-free method: a prospective clinical trial

    PubMed Central

    Mannucci, Pier Mannuccio; Kempton, Christine; Millar, Carolyn; Romond, Edward; Shapiro, Amy; Birschmann, Ingvild; Ragni, Margaret V.; Gill, Joan Cox; Yee, Thynn Thynn; Klamroth, Robert; Wong, Wing-Yen; Chapman, Miranda; Engl, Werner; Turecek, Peter L.; Suiter, Tobias M.

    2013-01-01

    Safety and pharmacokinetics (PK) of recombinant von Willebrand factor (rVWF) combined at a fixed ratio with recombinant factor VIII (rFVIII) were investigated in 32 subjects with type 3 or severe type 1 von Willebrand disease (VWD) in a prospective phase 1, multicenter, randomized clinical trial. rVWF was well tolerated and no thrombotic events, inhibitors, or serious adverse events were observed. The PK of rVWF ristocetin cofactor activity, VWF antigen, and collagen-binding activity were similar to those of the comparator plasma-derived (pd) VWF-pdFVIII. In vivo cleavage of ultra-large molecular-weight rVWF multimers by ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; the endogenous VWF protease) and generation of characteristic satellite bands were demonstrated. In 2 subjects with specific nonneutralizing anti-VWF–binding antibodies already detectable before rVWF infusion, a reduction in VWF multimers and VWF activity was observed. Stabilization of endogenous FVIII was enhanced following post–rVWF-rFVIII infusion as shown by the difference in area under the plasma concentration curve compared with pdVWF-pdFVIII (AUC0-∞) (P < .01). These data support the concept of administering rVWF alone once a therapeutic level of endogenous FVIII is achieved. This trial was registered at www.clinicaltrials.gov as #NCT00816660. PMID:23777763

  19. Understanding Clinical Alarm Safety.

    PubMed

    Lukasewicz, Carol L; Mattox, Elizabeth Andersson

    2015-08-01

    Patient safety organizations and health care accreditation agencies recognize the significance of clinical alarm hazards. The Association for the Advancement of Medical Instrumentation, a nonprofit organization focused on development and use of safe and effective medical equipment, identifies alarm management as a major issue for health care organizations. ECRI Institute, a nonprofit organization that researches approaches for improving patient safety and quality of care, identifies alarm hazards as the most significant of the "Top Ten Health Technology Hazards" for 2014. A new Joint Commission National Patient Safety Goal focusing on clinical alarm safety contains new requirements for accredited hospitals to be fully implemented by 2016. Through a fictional unfolding case study, this article reviews selected contributing factors to clinical alarm hazards present in inpatient, high-acuity settings. Understanding these factors improves contributions by nurses to clinical alarm safety practice.

  20. Safety-factor profile tailoring by improved electron cyclotron system for sawtooth control and reverse shear scenarios in ITER

    SciTech Connect

    Zucca, C.; Sauter, O.; Fable, E.; Henderson, M. A.; Polevoi, A.; Saibene, G.

    2008-11-01

    The effect of the predicted local electron cyclotron current driven by the optimized electron cyclotron system on ITER is discussed. A design variant was recently proposed to enlarge the physics program covered by the upper and equatorial launchers. By extending the functionality range of the upper launcher, significant control capabilities of the sawtooth period can be obtained. The upper launcher improvement still allows enough margin to exceed the requirements for neoclassical tearing mode stabilization, for which it was originally designed. The analysis of the sawtooth control is carried on with the ASTRA transport code, coupled with the threshold model by Por-celli, to study the control capabilities of the improved upper launcher on the sawtooth instability. The simulations take into account the significant stabilizing effect of the fusion alpha particles. The sawtooth period can be increased by a factor of 1.5 with co-ECCD outside the q = 1 surface, and decreased by at least 30% with co-ECCD inside q = 1. The present ITER base-line design has the electron cyclotron launchers providing only co-ECCD. The variant for the equatorial launcher proposes the possibility to drive counter-ECCD with 1 of the 3 rows of mirrors: the counter-ECCD can then be balanced with co-ECCD and provide pure ECH with no net driven current. The difference between full co-ECCD off-axis using all 20MW from the equatorial launcher and 20MW co-ECCD driven by 2/3 from the equatorial launcher and 1/3 from the upper launcher is shown to be negligible. Cnt-ECCD also offers greater control of the plasma current density, therefore this analysis addresses the performance of the equatorial launcher to control the central q profile. The equatorial launcher is shown to control very efficiently the value of q{sub 0.2}-q{sub min} in advanced scenarios, if one row provides counter-ECCD.

  1. BAY 81-8973, a full-length recombinant factor VIII: Human heat shock protein 70 improves the manufacturing process without affecting clinical safety.

    PubMed

    Maas Enriquez, Monika; Thrift, John; Garger, Stephen; Katterle, Yvonne

    2016-11-01

    BAY 81-8973 is a full-length, unmodified recombinant human factor VIII (FVIII) approved for the treatment of hemophilia A. BAY 81-8973 has the same amino acid sequence as the currently marketed sucrose-formulated recombinant FVIII (rFVIII-FS) product and is produced using additional advanced manufacturing technologies. One of the key manufacturing advances for BAY 81-8973 is introduction of the gene for human heat shock protein 70 (HSP70) into the rFVIII-FS cell line. HSP70 facilitates proper folding of proteins, enhances cell survival by inhibiting apoptosis, and potentially impacts rFVIII glycosylation. HSP70 expression in the BAY 81-8973 cell line along with other manufacturing advances resulted in a higher-producing cell line and improvements in the pharmacokinetics of the final product as determined in clinical studies. HSP70 protein is not detected in the harvest or in the final BAY 81-8973 product. However, because this is a new process, clinical trial safety assessments included monitoring for anti-HSP70 antibodies. Most patients, across all age groups, had low levels of anti-HSP70 antibodies before exposure to the investigational product. During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. In conclusion, addition of HSP70 to the BAY 81-8973 cell line is an innovative technology for manufacturing rFVIII aimed at improving protein folding and expression. Improved pharmacokinetics and no effect on safety of BAY 81-8973 were observed in clinical trials in patients with hemophilia A.

  2. BAY 81-8973, a full-length recombinant factor VIII: Human heat shock protein 70 improves the manufacturing process without affecting clinical safety.

    PubMed

    Maas Enriquez, Monika; Thrift, John; Garger, Stephen; Katterle, Yvonne

    2016-11-01

    BAY 81-8973 is a full-length, unmodified recombinant human factor VIII (FVIII) approved for the treatment of hemophilia A. BAY 81-8973 has the same amino acid sequence as the currently marketed sucrose-formulated recombinant FVIII (rFVIII-FS) product and is produced using additional advanced manufacturing technologies. One of the key manufacturing advances for BAY 81-8973 is introduction of the gene for human heat shock protein 70 (HSP70) into the rFVIII-FS cell line. HSP70 facilitates proper folding of proteins, enhances cell survival by inhibiting apoptosis, and potentially impacts rFVIII glycosylation. HSP70 expression in the BAY 81-8973 cell line along with other manufacturing advances resulted in a higher-producing cell line and improvements in the pharmacokinetics of the final product as determined in clinical studies. HSP70 protein is not detected in the harvest or in the final BAY 81-8973 product. However, because this is a new process, clinical trial safety assessments included monitoring for anti-HSP70 antibodies. Most patients, across all age groups, had low levels of anti-HSP70 antibodies before exposure to the investigational product. During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. In conclusion, addition of HSP70 to the BAY 81-8973 cell line is an innovative technology for manufacturing rFVIII aimed at improving protein folding and expression. Improved pharmacokinetics and no effect on safety of BAY 81-8973 were observed in clinical trials in patients with hemophilia A. PMID:27436242

  3. Safety, Pharmacokinetics, and Pharmacodynamics of the Insulin-Like Growth Factor Type 1 Receptor Inhibitor Figitumumab (CP-751,871) in Combination with Paclitaxel and Carboplatin

    PubMed Central

    Karp, Daniel D.; Pollak, Michael N.; Cohen, Roger B.; Eisenberg, Peter D.; Haluska, Paul; Yin, Donghua; Lipton, Allan; Demers, Laurence; Leitzel, Kim; Hixon, Mary L.; Terstappen, Leon W.; Garland, Linda; Paz-Ares, Luis G.; Cardenal, Felipe; Langer, Corey J.; Gualberto, Antonio

    2010-01-01

    Introduction This phase 1 study was conducted to determine the recommended phase 2 dose of the selective insulin-like growth factor type 1 receptor (IGF-IR) inhibitor figitumumab (F, CP-751,871) given in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Methods Patients received paclitaxel 200 mg/m2, carboplatin (area under the curve of 6), and F (0.05–20 mg/kg) q3 weeks for up to six cycles. Patients with objective response or stable disease were eligible to receive additional cycles of single agent F until disease progression. Safety, efficacy, pharmacokinetic, and pharmacodynamic endpoints were investigated. Results Forty-two patients, including 35 with stages IIIB and IV non-small cell lung cancer (NSCLC), were enrolled in eight dose escalation cohorts. A maximum tolerated dose was not identified. Severe adverse events possibly related to F included fatigue, diarrhea, hyperglycemia, gamma glutamyl transpeptidase elevation, and thrombocytopenia (one case each). F plasma exposure parameters increased with dose. Fifteen objective responses (RECIST) were reported, including two complete responses in NSCLC and ovarian carcinoma. Notably, levels of bioactive IGF-1 seemed to influence response to treatment with objective responses in patients with a high baseline-free IGF-1 to IGF binding protein-3 ratio seen only in the 10 and 20 mg/kg dosing cohorts. Conclusions F was well tolerated in combination with paclitaxel and carboplatin. Based on its favorable safety, pharmacokinetic, and pharmacodynamic properties, the maximal feasible dose of 20 mg/kg has been selected for further investigation. PMID:19745765

  4. Exploring the transferability of safety performance functions.

    PubMed

    Farid, Ahmed; Abdel-Aty, Mohamed; Lee, Jaeyoung; Eluru, Naveen; Wang, Jung-Han

    2016-09-01

    Safety performance functions (SPFs), by predicting the number of crashes on roadway facilities, have been a vital tool in the highway safety area. The SPFs are typically applied for identifying hot spots in network screening and evaluating the effectiveness of road safety countermeasures. The Highway Safety Manual (HSM) provides a series of SPFs for several crash types by various roadway facilities. The SPFs, provided in the HSM, were developed using data from multiple states. In regions without local jurisdiction based SPFs it is common practice to adopt national SPFs for crash prediction. There has been little research to examine the viability of such national level models for local jurisdictions. Towards understanding the influence of SPF transferability, we examine the rural divided multilane highway models from Florida, Ohio, and California. Traffic, roadway geometry and crash data from the three states are employed to estimate single-state SPFs, two-state SPFs and three-state SPFs. The SPFs are estimated using the negative binomial model formulation for several crash types and severities. To evaluate transferability of models, we estimate a transfer index that allows us to understand which models transfer adequately to other regions. The results indicate that models from Florida and California seem to be more transferable compared to models from Ohio. More importantly, we observe that the transfer index increases when we used pooled data (from two or three states). Finally, to assist in model transferability, we propose a Modified Empirical Bayes (MEB) measure that provides segment specific calibration factors for transferring SPFs to local jurisdictions. The proposed measure is shown to outperform the HSM calibration factor for transferring SPFs. PMID:27322637

  5. Perceptions of safety at work: a framework for linking safety climate to safety performance, knowledge, and motivation.

    PubMed

    Griffin, M A; Neal, A

    2000-07-01

    Research in the areas of organizational climate and work performance was used to develop a framework for measuring perceptions of safety at work. The framework distinguished perceptions of the work environment from perceptions of performance related to safety. Two studies supported application of the framework to employee perceptions of safety in the workplace. Safety compliance and safety participation were distinguished as separate components of safety-related performance. Perceptions of knowledge about safety and motivation to perform safely influenced individual reports of safety performance and also mediated the link between safety climate and safety performance. Specific dimensions of safety climate were identified and constituted a higher order safety climate factor. The results support conceptualizing safety climate as an antecedent to safety performance in organizations. PMID:10912498

  6. Polyphenol oxidase activity as a potential intrinsic index of adequate thermal pasteurization of apple cider.

    PubMed

    Chen, L; Ingham, B H; Ingham, S C

    2004-05-01

    In response to increasing concerns about microbial safety of apple cider, the U.S. Food and Drug Administration has mandated treatment of cider sufficient for a 5-log reduction of the target pathogen. Pasteurization has been suggested as the treatment most likely to achieve a 5-log reduction, with Escherichia coli O157:H7 as the target pathogen. Regulators and processors need a reliable method for verifying pasteurization, and apple cider polyphenol oxidase (PPO) activity was studied as a potential intrinsic index for thermal pasteurization. The effect of pasteurization conditions and apple cider properties on PPO activity and survival of three pathogens (E. coli O157:H7, Salmonella, and Listeria monocytogenes) was studied using a Box-Behnken response surface design. Factors considered in the design were pasteurization conditions, i.e., hold temperature (60, 68, and 76 degrees C), preheat time (10, 20, 30 s), and hold time (0, 15, 30 s), pH, and sugar content ((o)Brix) of apple cider. Response surface contour plots were constructed to illustrate the effect of these factors on PPO activity and pathogen survival. Reduction in PPO activity of at least 50% was equivalent to a 5-log reduction in E. coli O157:H7 or L. monocytogenes for cider at pH 3.7 and 12.5 (o)Brix. Further studies, however, are needed to verify the relationship between PPO activity and pathogen reduction in cider with various pH and (o)Brix values.

  7. The challenge of maximizing safety in radiation oncology.

    PubMed

    Marks, Lawrence B; Jackson, Marianne; Xie, Liyi; Chang, Sha X; Burkhardt, Katharin Deschesne; Mazur, Lukasz; Jones, Ellen L; Saponaro, Patricia; Lachapelle, Dana; Baynes, Dee C; Adams, Robert D

    2011-01-01

    There is a growing interest in the evolving nature of safety challenges in radiation oncology. Understandably, there has been a great deal of focus on the mechanical and computer aspects of new high-technology treatments (eg, intensity-modulated radiation therapy). However, safety concerns are not limited to dose calculations and data transfer associated with advanced technologies. They also stem from fundamental changes in our workflow (eg, multiple hand-offs), the relative loss of some traditional "end of the line" quality assurance tools (port films and light fields), condensed fractionation schedules, and an under-appreciation for the physical limitations of new techniques. Furthermore, changes in our workspace and tools (eg, electronic records, planning systems), and workloads (eg, billing, insurance, regulations) may have unforeseen effects on safety. Safety initiatives need to acknowledge the multiple factors affecting risk. Our current challenges will not be adequately addressed simply by defining new policies and procedures. Rather, we need to understand the frequency and causes of errors better, particularly those that are most likely to cause harm. Then we can incorporate principles into our workspace that minimize these risks (eg, automation, standardization, checklists, redundancy, and consideration of "human factors" in the design of products and workspaces). Opportunities to enhance safety involve providing support through diligent examinations of staffing, schedules, communications, teamwork, and work environments. We need to develop a culture of safety in which all team members are alerted to the possibility of harm, and they all work together to maximize safety. The goal is not to eliminate every error. Rather, we should focus our attention on conditions (eg, rushing) that can cause real patient harm, and/or those conditions that reflect systemic problems that might lead to errors more likely to cause harm. Ongoing changes in clinical practice

  8. The Need for Domestic Violence Laws with Adequate Legal and Social Support Services.

    ERIC Educational Resources Information Center

    Hemmons, Willa M.

    1981-01-01

    Describes the need for comprehensive domestic violence programs that include medical, legal, economic, psychological, and child care services. Although most states have family violence legislation, more work is needed to adequately implement these programs. (Author/JAC)

  9. 43 CFR 3162.5-3 - Safety precautions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Safety precautions. 3162.5-3 Section 3162... for Operating Rights Owners and Operators § 3162.5-3 Safety precautions. The operator shall perform... necessary to provide adequate protection for the health and safety of life and the protection of...

  10. 43 CFR 3162.5-3 - Safety precautions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Safety precautions. 3162.5-3 Section 3162... for Operating Rights Owners and Operators § 3162.5-3 Safety precautions. The operator shall perform... necessary to provide adequate protection for the health and safety of life and the protection of...

  11. 43 CFR 3162.5-3 - Safety precautions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Safety precautions. 3162.5-3 Section 3162... for Operating Rights Owners and Operators § 3162.5-3 Safety precautions. The operator shall perform... necessary to provide adequate protection for the health and safety of life and the protection of...

  12. A Phase II clinical trial of a mixture of plasma-derived factor VIIa and factor X (MC710) in haemophilia patients with inhibitors: haemostatic efficacy, safety and pharmacokinetics/pharmacodynamics.

    PubMed

    Shirahata, A; Fukutake, K; Takamatsu, J; Shima, M; Hanabusa, H; Mugishima, H; Amano, K; Takedani, H; Tamashima, S; Matsushita, T; Tawa, A; Tanaka, I; Higasa, S; Kosaka, Y; Fujii, T; Sakai, M; Migita, M; Kawakami, K; Ohashi, Y; Saito, H

    2013-11-01

    MC710, a mixture of plasma-derived activated factor VII and factor X at a protein weight ratio of 1:10, is a novel bypassing agent for haemostasis in haemophilia patients with inhibitors. In a Phase II trial, we evaluated the haemostatic efficacy and safety of single doses of MC710, and investigated pharmacokinetic and pharmacodynamic parameters in nine joint bleeding episodes in six male haemophilia patients with inhibitors. This trial was a multi-centre, open-label, non-randomized study of two doses (60 and 120 μg kg(-1) as FVIIa dose), allowing the re-administration of different MC710 dosages to the same subjects. Haemostatic efficacy was assessed by evaluating reduction in pain and swelling, as well as increase in range of motion in a bleeding joint. The results of the study showed that in nine bleeding episodes, seven treatments were rated as 'excellent' or 'effective' according to investigator's rating system of efficacy at 8 h after administration. No serious or severe adverse events were observed after administration; furthermore, measurement of several diagnostic markers revealed no signs or symptoms of disseminated intravascular coagulation (DIC). The haemostatic potential of MC710 was confirmed at doses of 60 and 120 μg kg(-1) in this trial. MC710 is thus expected to be a safe and efficacious novel bypassing agent for controlling bleeding in haemophilia patients with inhibitors. PMID:23738888

  13. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  14. Comparative limb bone loading in the humerus and femur of the tiger salamander: testing the 'mixed-chain' hypothesis for skeletal safety factors.

    PubMed

    Kawano, Sandy M; Economy, D Ross; Kennedy, Marian S; Dean, Delphine; Blob, Richard W

    2016-02-01

    Locomotion imposes some of the highest loads upon the skeleton, and diverse bone designs have evolved to withstand these demands. Excessive loads can fatally injure organisms; however, bones have a margin of extra protection, called a 'safety factor' (SF), to accommodate loads that are higher than normal. The extent to which SFs might vary amongst an animal's limb bones is unclear. If the limbs are likened to a chain composed of bones as 'links', then similar SFs might be expected for all limb bones because failure of the system would be determined by the weakest link, and extra protection in other links could waste energetic resources. However, Alexander proposed that a 'mixed-chain' of SFs might be found amongst bones if: (1) their energetic costs differ, (2) some elements face variable demands, or (3) SFs are generally high. To test whether such conditions contribute to diversity in limb bone SFs, we compared the biomechanical properties and locomotor loading of the humerus and femur in the tiger salamander (Ambystoma tigrinum). Despite high SFs in salamanders and similar sizes of the humerus and femur that would suggest similar energetic costs, the humerus had lower bone stresses, higher mechanical hardness and larger SFs. SFs were greatest in the anatomical regions where yield stresses were highest in the humerus and lowest in the femur. Such intraspecific variation between and within bones may relate to their different biomechanical functions, providing insight into the emergence of novel locomotor capabilities during the invasion of land by tetrapods. PMID:26596535

  15. Comparative limb bone loading in the humerus and femur of the tiger salamander: testing the 'mixed-chain' hypothesis for skeletal safety factors.

    PubMed

    Kawano, Sandy M; Economy, D Ross; Kennedy, Marian S; Dean, Delphine; Blob, Richard W

    2016-02-01

    Locomotion imposes some of the highest loads upon the skeleton, and diverse bone designs have evolved to withstand these demands. Excessive loads can fatally injure organisms; however, bones have a margin of extra protection, called a 'safety factor' (SF), to accommodate loads that are higher than normal. The extent to which SFs might vary amongst an animal's limb bones is unclear. If the limbs are likened to a chain composed of bones as 'links', then similar SFs might be expected for all limb bones because failure of the system would be determined by the weakest link, and extra protection in other links could waste energetic resources. However, Alexander proposed that a 'mixed-chain' of SFs might be found amongst bones if: (1) their energetic costs differ, (2) some elements face variable demands, or (3) SFs are generally high. To test whether such conditions contribute to diversity in limb bone SFs, we compared the biomechanical properties and locomotor loading of the humerus and femur in the tiger salamander (Ambystoma tigrinum). Despite high SFs in salamanders and similar sizes of the humerus and femur that would suggest similar energetic costs, the humerus had lower bone stresses, higher mechanical hardness and larger SFs. SFs were greatest in the anatomical regions where yield stresses were highest in the humerus and lowest in the femur. Such intraspecific variation between and within bones may relate to their different biomechanical functions, providing insight into the emergence of novel locomotor capabilities during the invasion of land by tetrapods.

  16. Feasibility and Safety of Local Treatment with Recombinant Human Tissue Factor Pathway Inhibitor in a Rat Model of Streptococcus pneumoniae Pneumonia

    PubMed Central

    van den Boogaard, Florry E.; Hofstra, Jorrit J.; van ‘t Veer, Cornelis; Levi, Marcel M.; Roelofs, Joris J. T. H.; van der Poll, Tom; Schultz, Marcus J.

    2015-01-01

    Pulmonary coagulopathy is intrinsic to pulmonary injury including pneumonia. Anticoagulant strategies could benefit patients with pneumonia, but systemic administration of anticoagulant agents may lead to suboptimal local levels and may cause systemic hemorrhage. We hypothesized nebulization to provide a safer and more effective route for local administration of anticoagulants. Therefore, we aimed to examine feasibility and safety of nebulization of recombinant human tissue factor pathway inhibitor (rh-TFPI) in a well-established rat model of Streptococcus (S.) pneumoniae pneumonia. Thirty minutes before and every 6 hours after intratracheal instillation of S. pneumonia causing pneumonia, rats were subjected to local treatment with rh-TFPI or placebo, and sacrificed after 42 hours. Pneumonia was associated with local as well as systemic activation of coagulation. Nebulization of rh-TFPI resulted in high levels of rh-TFPI in bronchoalveolar lavage fluid, which was accompanied by an attenuation of pulmonary coagulation. Systemic rh-TFPI levels remained undetectable, and systemic TFPI activity and systemic coagulation were not affected. Histopathology revealed no bleeding in the lungs. We conclude that nebulization of rh-TFPI seems feasible and safe; local anticoagulant treatment with rh-TFPI attenuates pulmonary coagulation, while not affecting systemic coagulation in a rat model of S. pneumoniae pneumonia. PMID:25992779

  17. Adenoviral-mediated gene transfer of vascular endothelial growth factor in critical limb ischemia: safety results from a phase I trial.

    PubMed

    Mohler, Emile R; Rajagopalan, Sanjay; Olin, Jeffrey W; Trachtenberg, Jeffrey D; Rasmussen, Henrik; Pak, Raphael; Crystal, Ronald G

    2003-01-01

    Critical limb ischemia (CLI) is typified by rest pain and/or tissue necrosis secondary to advanced peripheral arterial disease (PAD) and is characterized by diminution in limb perfusion at rest. We tested the safety of an angiogenic strategy with CI-1023 (Ad(GV)VEGF121.10), a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121 in patients with CLI as part of a phase I trial. Fifteen subjects >35 years of age with CLI and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x 10(8) to 4 x 10(10) particle units, n = 13) or placebo (n = 2). All of the patients tolerated the injection well and there were no serious complications related to the procedure. Transient edema was noted in one patient. A total of 79 adverse events were reported over the course of one year. One death (day 136) and one malignancy (day 332) occurred in the CI-1023 group. CI-1023 appears to be well tolerated and safe for single-dose administration in patients with critical limb ischemia due to PAD. Further studies are needed to determine the efficacy of this form of therapeutic angiogenesis. PMID:12866606

  18. CFD [computational fluid dynamics] And Safety Factors. Computer modeling of complex processes needs old-fashioned experiments to stay in touch with reality.

    SciTech Connect

    Leishear, Robert A.; Lee, Si Y.; Poirier, Michael R.; Steeper, Timothy J.; Ervin, Robert C.; Giddings, Billy J.; Stefanko, David B.; Harp, Keith D.; Fowley, Mark D.; Van Pelt, William B.

    2012-10-07

    Computational fluid dynamics (CFD) is recognized as a powerful engineering tool. That is, CFD has advanced over the years to the point where it can now give us deep insight into the analysis of very complex processes. There is a danger, though, that an engineer can place too much confidence in a simulation. If a user is not careful, it is easy to believe that if you plug in the numbers, the answer comes out, and you are done. This assumption can lead to significant errors. As we discovered in the course of a study on behalf of the Department of Energy's Savannah River Site in South Carolina, CFD models fail to capture some of the large variations inherent in complex processes. These variations, or scatter, in experimental data emerge from physical tests and are inadequately captured or expressed by calculated mean values for a process. This anomaly between experiment and theory can lead to serious errors in engineering analysis and design unless a correction factor, or safety factor, is experimentally validated. For this study, blending times for the mixing of salt solutions in large storage tanks were the process of concern under investigation. This study focused on the blending processes needed to mix salt solutions to ensure homogeneity within waste tanks, where homogeneity is required to control radioactivity levels during subsequent processing. Two of the requirements for this task were to determine the minimum number of submerged, centrifugal pumps required to blend the salt mixtures in a full-scale tank in half a day or less, and to recommend reasonable blending times to achieve nearly homogeneous salt mixtures. A full-scale, low-flow pump with a total discharge flow rate of 500 to 800 gpm was recommended with two opposing 2.27-inch diameter nozzles. To make this recommendation, both experimental and CFD modeling were performed. Lab researchers found that, although CFD provided good estimates of an average blending time, experimental blending times varied

  19. TJC: HCOs need to be on alert for HIT problems related to sociotechnical factors, take steps to improve safety culture, process, and leadership.

    PubMed

    2015-06-01

    Noting that too many errors related to health information technology (HIT) are resulting in adverse consequences, The Joint Commission (TJC) has issued a Sentinel Event Alert, urging health care providers to take steps to improve their safety culture, approach to process improvement, and leadership in this area. In this latest alert, the accrediting agency is taking particular aim at risks posed by sociotechnical factors--or the ways in which HIT is implemented and used. Experts say that many of these risks are, in fact, exemplified at a higher level in the emergency setting, where providers are under constant pressure to see more patients and move them though the system faster. In an analysis of 3,375 sentinel events that resulted in permanent patient harm or death between January 1, 2010, and June 20, 2013, The Joint Commission (TJC) found that 120 events included HIT-related contributing factors. Many of the problems cited by TJC relate to orders or medicines being prescribed for the wrong patients. These can result from toggling errors or pop-up screens where providers are asked to click on the appropriate patient or medicine, and they mistakenly click on the wrong selection. In the ED, experts recommend the creation of a multidisciplinary performance improvement group to continuously monitor the ED information system (EDIS), recognize problems, and work with the vendor to resolve them. Also important is a quick and easy way for providers to report HIT-related problems. Experts add that emergency providers need to be fully engaged in the process of selecting HIT that they will be using, and that health care organizations should arrange for usability assessments before purchasing HIT.

  20. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  1. Barriers to help-seeking, detection, and adequate treatment for anxiety and mood disorders: implications for health care policy.

    PubMed

    Mechanic, David

    2007-01-01

    Recently, the focus of health policies and initiatives has been directed toward mental health. More precisely, depressive and anxiety disorders have received particular attention because of their disabling outcomes and prevalence among most populations. Despite this increased interest, numerous issues regarding patients' willingness to seek treatment and the adequate recognition and treatment of these disorders by clinicians remain to be addressed. This article considers the factors that influence patients and physicians in their reticence to acknowledge and adequately treat depression and anxiety disorders. It also reviews the impact of society and the media, together with other factors relating to health care organization and administration that affect the treatment of depression and anxiety. In view of the multifaceted challenge involved, efforts to achieve a consensus in determining treatment for those with depressive and anxiety disorders are essential. A consensus will require easy, measurable, and reliable disability indicators; evidence that treatment of patients with varying levels of need is cost effective; and that persons who most need and would benefit from care can be reliably identified among the highly prevalent population of persons with more transient symptoms. Governments and other policymakers should be encouraged to provide appropriate coverage for access to primary and secondary care, the treatments required, and sufficient resources so that care is available when necessary. An important aspect of the challenge is to incorporate these efforts within the realistic constraints of primary care. PMID:17288503

  2. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  3. Broadband inversion of 1J(CC) responses in 1,n-ADEQUATE spectra.

    PubMed

    Reibarkh, Mikhail; Williamson, R Thomas; Martin, Gary E; Bermel, Wolfgang

    2013-11-01

    Establishing the carbon skeleton of a molecule greatly facilitates the process of structure elucidation, both manual and computer-assisted. Recent advances in the family of ADEQUATE experiments demonstrated their potential in this regard. 1,1-ADEQUATE, which provides direct (13)C-(13)C correlation via (1)J(CC), and 1,n-ADEQUATE, which typically yields (3)J(CC) and (1)J(CC) correlations, are more sensitive and more widely applicable experiments than INADEQUATE and PANACEA. A recently reported modified pulse sequence that semi-selectively inverts (1)J(CC) correlations in 1,n-ADEQUATE spectra provided a significant improvement, allowing (1)J(CC) and (n)J(CC) correlations to be discerned in the same spectrum. However, the reported experiment requires a careful matching of the amplitude transfer function with (1)J(CC) coupling constants in order to achieve the inversion, and even then some (1)J(CC) correlations could still have positive intensity due to the oscillatory nature of the transfer function. Both shortcomings limit the practicality of the method. We now report a new, dual-optimized inverted (1)J(CC) 1,n-ADEQUATE experiment, which provides more uniform inversion of (1)J(CC) correlations across the range of 29-82 Hz. Unlike the original method, the dual optimization experiment does not require fine-tuning for the molecule's (1)J(CC) coupling constant values. Even more usefully, the dual-optimized version provides up to two-fold improvement in signal-to-noise for some long-range correlations. Using modern, cryogenically-cooled probes, the experiment can be successfully applied to samples of ~1 mg under favorable circumstances. The improvements afforded by dual optimization inverted (1)J(CC) 1,n-ADEQUATE experiment make it a useful and practical tool for NMR structure elucidation and should facilitate the implementation and utilization of the experiment.

  4. Self-reported segregation experience throughout the life course and its association with adequate health literacy.

    PubMed

    Goodman, Melody S; Gaskin, Darrell J; Si, Xuemei; Stafford, Jewel D; Lachance, Christina; Kaphingst, Kimberly A

    2012-09-01

    Residential segregation has been shown to be associated with health outcomes and health care utilization. We examined the association between racial composition of five physical environments throughout the life course and adequate health literacy among 836 community health center patients in Suffolk County, NY. Respondents who attended a mostly White junior high school or currently lived in a mostly White neighborhood were more likely to have adequate health literacy compared to those educated or living in predominantly minority or diverse environments. This association was independent of the respondent's race, ethnicity, age, education, and country of birth.

  5. Ensuring patient safety.

    PubMed

    Novo, Ahmed; Masic, Izet

    2007-01-01

    Patient safety is key factor in the process of health care improvement. World Health Organization (WHO) as coordinating authority for health within the United Nations launched a World Alliance for Patient Safety dedicated to bringing significant benefits to patients. Patients for Patient Safety, one of ten action areas of the World Alliance, is designed to ensure that the perspective of patients and families, consumers and citizens, is a central reference point in shaping this important work. This action area is led by the patient safety consumer movement. In Bosnia and Herzegovina has not State Law to regulate patient safety, but Law on the System of Quality and Safety Improvement, and Accreditation in Healthcare in Federation of Bosnia and Herzegovina (FB&H) established Agency for Quality and Accreditation in the Health Care System of the FB&H as a competent entity in the field of improvement of quality and safety, and accreditation in healthcare. Beside the Agency, all service providers need to promote a culture of openness, fairness, accountability and transparency. Also, stakeholders involved in health care should recognize that patients can actively contribute to strengthening thũality and safety of health servicesthrough active participation and to insist on open dialogue, transparency and appropriate information on the potential risks that the health service incurs, as part of enhancing patient health literacy and involvement.

  6. IMPORTANCE OF SAFETY CULTURE ASSESSMENT

    SciTech Connect

    Spitalnik, J.

    2004-10-06

    Safety Management has lately been considered by some Nuclear Regulatory agencies as the tool on which to concentrate their efforts to implement modern regulation structures, because Safety Culture was said to be difficult to monitor. However, Safety Culture can be assessed and monitored even if it is problematical to make Safety Culture the object of regulation. This paper stresses the feasibility and importance of Safety Culture Assessment based on self-assessment applications performed in several nuclear organizations in Latin America. Reasons and ownership for assessing Safety Culture are discussed, and relevant aspects considered for setting up and programming such an assessment are shown. Basic principles that were taken into account, as well as financial and human resources used in actual self-assessments are reviewed, including the importance of adequate statistical analyses and the necessity of proper feed-back of results. The setting up of action plans to enhance Safety Culture is the final step of the assessment program that once implemented will enable to establish a Safety Culture monitoring process within the organization.

  7. Organizational culture, safety culture, and safety performance at research facilities

    SciTech Connect

    Brown, William S.

    2000-07-30

    Organizational culture surveys of research facilities conducted several years ago and archival occupational injury reports were used to determine whether differences in safety performance are related to general organizational factors or to ''safety culture'' as reflected in specific safety-related dimensions. From among the organizations surveyed, a pair of facilities was chosen that were similar in size and scientific mission while differing on indices of work-related injuries. There were reliable differences in organizational style between the facilities, especially among workers in environment, safety, and health functions; differences between the facilities (and among job categories) on the safety scale were more modest and less regular.

  8. Efficacy and safety of recombinant human tumor necrosis factor application for the treatment of malignant pleural effusion caused by lung cancer.

    PubMed

    Li, Qian; Sun, Wenkui; Yuan, Dongmei; Lv, Tangfeng; Yin, Jie; Cao, Ehong; Xiao, Xinwu; Song, Yong

    2016-01-01

    Malignant pleural effusion (MPE) signifies a poor prognosis for patients with lung cancer. For treating physicians, the primary goals are to achieve sufficient control of MPE and minimize invasive intervention. Recombinant human mutant tumor necrosis factor-alpha (rhu-TNF) has been used in the treatment of MPE. The aim of our research was to evaluate the efficacy and safety of rhu-TNF application via ultrasound-guided chest tube for the treatment of MPE. rhu-TNF was administered as a single dose to 102 patients with MPE caused by lung cancer, and dexamethasone (Dxm, 5 mg) was administered 30 minutes before rhu-TNF in 35 randomly selected patients in order test its ability to prevent side effects. The primary endpoint was the efficacy of the rhu-TNF treatment (disease response rate) and side effects (pain, fever, and flu-like symptoms), evaluated four weeks after instillation. The disease response rate of rhu-TNF treatment was 81.37%. Side effects included 13 (12.75%) patients complaining of flu-like symptoms, 15 (14.71%) with fever/chill, and 14 (13.73%) with chest pain. A significantly higher efficacy was observed for treatment with 3 MU versus 2 MU of rhu-TNF (P = 0.036), while the adverse effects were similar. There was no significant association between the dose of rhu-TNF and progression-free survival (P = 0.752). In conclusion, our study shows that intra-pleural instillation of rhu-TNF achieves sufficient control of MPE and minimizes invasive intervention. PMID:26816548

  9. Efficacy, safety and tolerability of recombinant factor VIII (REFACTO) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and Austria.

    PubMed

    Pollmann, H; Externest, D; Ganser, A; Eifrig, B; Kreuz, W; Lenk, H; Pabinger, I; Schramm, W; Schwarz, T F; Zimmermann, R; Zavazava, N; Oldenburg, J; Klamroth, R

    2007-03-01

    An open-label, multicentre, postmarketing surveillance study conducted in Germany and Austria with recombinant factor VIII (REFACTO) has enrolled 217 patients (mean age 26.3 years) from 38 haemophilia centres during the first 4.8 years. Most patients (188/217; 86.6%) had severe to moderately severe haemophilia A, of whom 153 completed sufficient diary information for the main efficacy analysis. These 153 patients experienced a median of 6.6 (interquartile range 1.4-18.6) bleeding episodes per year. Patients treated with prophylaxis experienced a median of 4.4 (1.1-9.3) bleeds per year, while patients treated on-demand experienced a median of 22.8 (11.3-29.0) bleeds per year. Overall, most physicians (41/43 [95.3%]) were 'very satisfied' or 'satisfied' with the efficacy of REFACTO in the treatment of bleeding episodes. A total of 137 non-serious adverse events have been reported in 52/217 patients (24.0%) to date. In addition, 129 serious adverse events in 87 patients (40%) were reported, including 41 cases of 'less than expected therapeutic effect' (LETE). Of these, 39 LETE cases were reported in one centre; however, patients in this centre experienced considerably fewer bleeding episodes per year than patients outside this centre. Overall, six patients (2.8%) have developed de novo inhibitors, three of which were considered high titre. Four of these patients were at high risk (0-50 exposure days [ED]) of inhibitor formation, one was at intermediate risk (51-100 ED) and one was at low risk (>100 ED). These results emphasize the benefit of postmarketing surveillance and, overall, this study confirms the efficacy, safety and tolerability of REFACTO in the treatment of patients with haemophilia A. PMID:17286765

  10. Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients

    PubMed Central

    Ragni, Margaret V.; Valentino, Leonard A.; Key, Nigel S.; Josephson, Neil C.; Powell, Jerry S.; Cheng, Gregory; Thompson, Arthur R.; Goyal, Jaya; Tubridy, Karen L.; Peters, Robert T.; Dumont, Jennifer A.; Euwart, Donald; Li, Lian; Hallén, Bengt; Gozzi, Peter; Bitonti, Alan J.; Jiang, Haiyan; Luk, Alvin

    2012-01-01

    Current factor IX (FIX) products display a half-life (t1/2) of ∼ 18 hours, requiring frequent intravenous infusions for prophylaxis and treatment in patients with hemophilia B. This open-label, dose-escalation trial in previously treated adult subjects with hemophilia B examined the safety and pharmacokinetics of rFIXFc. rFIXFc is a recombinant fusion protein composed of FIX and the Fc domain of human IgG1, to extend circulating time. Fourteen subjects received a single dose of rFIXFc; 1 subject each received 1, 5, 12.5, or 25 IU/kg, and 5 subjects each received 50 or 100 IU/kg. rFIXFc was well tolerated, and most adverse events were mild or moderate in intensity. No inhibitors were detected in any subject. Dose-proportional increases in rFIXFc activity and Ag exposure were observed. With baseline subtraction, mean activity terminal t1/2 and mean residence time for rFIXFc were 56.7 and 71.8 hours, respectively. This is ∼ 3-fold longer than that reported for current rFIX products. The incremental recovery of rFIXFc was 0.93 IU/dL per IU/kg, similar to plasma-derived FIX. These results show that rFIXFc may offer a viable therapeutic approach to achieve prolonged hemostatic protection and less frequent dosing in patients with hemophilia B. The trial was registered at www.clinicaltrials.gov as NCT00716716. PMID:22110246

  11. National Safety Council

    MedlinePlus

    ... Introduction Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ... Safety Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ...

  12. Safety in Children's Formal Play Environments.

    ERIC Educational Resources Information Center

    Wilkinson, Paul F.; Lockhart, Robert

    This study was designed to examine the issue of the safety of children's formal play environments. Safety was defined in terms of morbidity and mortality data. Protection and safety education were considered the prime factors in accident prevention while the goal of a safety program was considered to be the minimizing of injuries. Several data…

  13. System Safety Analysis Application Guide. Safety Analysis Report Update Program

    SciTech Connect

    Not Available

    1993-05-01

    Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Safety analyses are performed to identify hazards and potential accidents; to analyze the adequacy of measures taken to eliminate, control, or mitigate hazards; and to evaluate potential accidents and determine associated risks. Safety Analysis Reports (SARs) are prepared to document the safety analysis to ensure facilities can be operated safely and in accordance with regulations. SARs include Technical Safety Requirements (TSRs), which are specific technical and administrative requirements that prescribe limits and controls to ensure safe operation of DOE facilities. These documented descriptions and analyses contribute to the authorization basis for facility operation. Energy Systems has established a process to perform Unreviewed Safety Question Determinations (USQDs) for planned changes and as-found conditions that are not described and analyzed in existing safety analyses. The process evaluates changes and as-found conditions to determine whether revisions to the authorization basis must be reviewed and approved by DOE. There is an Unreviewed Safety Question (USQ) if a change introduces conditions not bounded by the facility authorization basis. When it is necessary to request DOE approval to revise the authorization basis, preparation of a System Safety Analysis (SSA) is recommended. This application guide describes the process of preparing an SSA and the desired contents of an SSA. Guidance is provided on how to identify items and practices which are important to safety; how to determine the credibility and significance of consequences of proposed accident scenarios; how to evaluate accident prevention and mitigation features of the planned change; and how to establish special requirements to ensure that a change can be implemented with adequate safety.

  14. A Study on Factors Affecting Low Back Pain and Safety and Efficacy of NSAIDs in Acute Low Back Pain in a Tertiary Care Hospital of Western Nepal

    PubMed Central

    Bhattarai, Srijana; Chhetri, Himal Paudel; Alam, Kadir; Thapa, Pabin

    2013-01-01

    Introduction: Low back pain is characterized by a range of symptoms which include pain, muscle tension or stiffness, and is localized between the shoulder blades and the folds of the buttocks, with or without spreading to the legs. Non-Steroidal Anti Inflammatory Drugs (NSAIDs) are the drugs of choice which provide an analgesic effect for acute low back pain. Aim: To study the factors affecting low back pain, efficacy and safety of different non-steroidal anti-inflammatory drugs (aceclofenac, diclofenac, naproxen and nimesulide) in low back pain. Methodology: Data collection form and numeric pain rating scale were used as study tools for studying patients’ demographies and severities of pain respectively. Patients prescribed with aceclofenac 100 mg , diclofenac 100 mg, naproxen 500 mg and nimesulide 100 mg for acute low back pain at Orthopaedics Outpatients Department of Manipal Teaching Hospital, Nepal, were enrolled in this study. The decrease in pain scores was recorded on 5th and 10th days of follow-up and pain scores were calculated. Descriptive statistics and Kruskal Wallis non parametric test were used for analysis. Results: Among 150 patients, 67.3% were females (n=101). Low back pain was more prevalent (24.7%) in age-group of 59-68 years and a positive correlation was seen. Similarly, low back pain was found to be high among people involved in agriculture, heavy weight lifters and non smokers. The decrease in average pain scores was more in the patients treated with aceclofenac (4.83 ± 0.537), followed by that in those who were treated with naproxen (4.13 ± 0.067) and diclofenac (3.84 ± 0.086). The decrease in pain scores was found to be lowest among patients who were treated with nimesulide (2.11 ± 0.148). Nimesulide presented more number of side-effects than the comparative drugs. Conclusion: Different factors affect low back pain, such as age, gender, personal habit, posture, occupation, weight lifting. Aceclofenac showed greater decrease in pain

  15. 75 FR 5893 - Suspension of Community Eligibility for Failure To Maintain Adequate Floodplain Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... FR 51735. Executive Order 13132, Federalism. This rule involves no policies that have ] federalism....C. 4001 et seq., Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR... To Maintain Adequate Floodplain Management Regulations AGENCY: Federal Emergency Management...

  16. 26 CFR 1.467-2 - Rent accrual for section 467 rental agreements without adequate interest.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... interest (the stated rate of interest) on deferred or prepaid fixed rent at a single fixed rate (as defined in § 1.1273-1(c)(1)(iii)); (B) The stated rate of interest on fixed rent is no lower than 110 percent... provide for a variable rate of interest. For purposes of the adequate interest test under paragraph...

  17. Towards Defining Adequate Lithium Trials for Individuals with Mental Retardation and Mental Illness.

    ERIC Educational Resources Information Center

    Pary, Robert J.

    1991-01-01

    Use of lithium with mentally retarded individuals with psychiatric conditions and/or behavior disturbances is discussed. The paper describes components of an adequate clinical trial and reviews case studies and double-blind cases. The paper concludes that aggression is the best indicator for lithium use, and reviews treatment parameters and…

  18. How Much and What Kind? Identifying an Adequate Technology Infrastructure for Early Childhood Education. Policy Brief

    ERIC Educational Resources Information Center

    Daugherty, Lindsay; Dossani, Rafiq; Johnson, Erin-Elizabeth; Wright, Cameron

    2014-01-01

    To realize the potential benefits of technology use in early childhood education (ECE), and to ensure that technology can help to address the digital divide, providers, families of young children, and young children themselves must have access to an adequate technology infrastructure. The goals for technology use in ECE that a technology…

  19. Evaluating the Reliability of Selected School-Based Indices of Adequate Reading Progress

    ERIC Educational Resources Information Center

    Wheeler, Courtney E.

    2010-01-01

    The present study examined the stability (i.e., 4-month and 12-month test-retest reliability) of six selected school-based indices of adequate reading progress. The total sampling frame included between 3970 and 5655 schools depending on the index and research question. Each school had at least 40 second-grade students that had complete Oral…

  20. Understanding the pelvic pain mechanism is key to find an adequate therapeutic approach.

    PubMed

    Van Kerrebroeck, Philip

    2016-06-25

    Pain is a natural mechanism to actual or potential tissue damage and involves both a sensory and an emotional experience. In chronic pelvic pain, localisation of pain can be widespread and can cause considerable distress. A multidisciplinary approach is needed in order to fully understand the pelvic pain mechanism and to identify an adequate therapeutic approach.

  1. 33 CFR 155.4050 - Ensuring that the salvors and marine firefighters are adequate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Ensuring that the salvors and marine firefighters are adequate. 155.4050 Section 155.4050 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION OIL OR HAZARDOUS MATERIAL POLLUTION...

  2. Performance Effects of Failure to Make Adequate Yearly Progress (AYP): Evidence from a Regression Discontinuity Framework

    ERIC Educational Resources Information Center

    Hemelt, Steven W.

    2011-01-01

    As the No Child Left Behind (NCLB) law moves through the reauthorization process, it is important to understand the basic performance impacts of its central structure of accountability. In this paper, I examine the effects of failure to make Adequate Yearly Progress (AYP) under NCLB on subsequent student math and reading performance at the school…

  3. Determining Adequate Yearly Progress in a State Performance or Proficiency Index Model

    ERIC Educational Resources Information Center

    Erpenbach, William J.

    2009-01-01

    The purpose of this paper is to present an overview regarding how several states use a performance or proficiency index in their determination of adequate yearly progress (AYP) under the No Child Left Behind Act of 2001 (NCLB). Typically, indexes are based on one of two weighting schemes: (1) either they weight academic performance levels--also…

  4. The Relationship between Parental Involvement and Adequate Yearly Progress among Urban, Suburban, and Rural Schools

    ERIC Educational Resources Information Center

    Ma, Xin; Shen, Jianping; Krenn, Huilan Y.

    2014-01-01

    Using national data from the 2007-08 School and Staffing Survey, we compared the relationships between parental involvement and school outcomes related to adequate yearly progress (AYP) in urban, suburban, and rural schools. Parent-initiated parental involvement demonstrated significantly positive relationships with both making AYP and staying off…

  5. Effect of tranquilizers on animal resistance to the adequate stimuli of the vestibular apparatus

    NASA Technical Reports Server (NTRS)

    Maksimovich, Y. B.; Khinchikashvili, N. V.

    1980-01-01

    The effect of tranquilizers on vestibulospinal reflexes and motor activity was studied in 900 centrifuged albino mice. Actometric studies have shown that the tranquilizers have a group capacity for increasing animal resistance to the action of adequate stimuli to the vestibular apparatus.

  6. Human milk feeding supports adequate growth in infants

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Despite current nutritional strategies, premature infants remain at high risk for extrauterine growth restriction. The use of an exclusive human milk-based diet is associated with decreased incidence of necrotizing enterocolitis (NEC), but concerns exist about infants achieving adequate growth. The ...

  7. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Assurances of adequate capacity and services. 438.207 Section 438.207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and...

  8. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Assurances of adequate capacity and services. 438.207 Section 438.207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and...

  9. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Assurances of adequate capacity and services. 438.207 Section 438.207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and...

  10. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Assurances of adequate capacity and services. 438.207 Section 438.207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and...

  11. Percentage of Adults with High Cholesterol Whose LDL Cholesterol Levels Are Adequately Controlled

    MedlinePlus

    ... of Adults with High Cholesterol Whose LDL Cholesterol Levels are Adequately Controlled High cholesterol can double a ... with High Cholesterol that is Controlled by Education Level 8k4c-k22f Download these data » Click on legends ...

  12. Perceptions of Teachers in Their First Year of School Restructuring: Failure to Make Adequate Yearly Progress

    ERIC Educational Resources Information Center

    Moser, Sharon

    2010-01-01

    The 2007-2008 school year marked the first year Florida's Title I schools that did not made Adequate Yearly Progress (AYP) for five consecutive years entered into restructuring as mandated by the "No Child Left Behind Act" of 2001. My study examines the perceptions of teacher entering into their first year of school restructuring due to failure to…

  13. The Unequal Effect of Adequate Yearly Progress: Evidence from School Visits

    ERIC Educational Resources Information Center

    Brown, Abigail B.; Clift, Jack W.

    2010-01-01

    The authors report insights, based on annual site visits to elementary and middle schools in three states from 2004 to 2006, into the incentive effect of the No Child Left Behind Act's requirement that increasing percentages of students make Adequate Yearly Progress (AYP) in every public school. They develop a framework, drawing on the physics…

  14. Influenza 2005-2006: vaccine supplies adequate, but bird flu looms.

    PubMed

    Mossad, Sherif B

    2005-11-01

    Influenza vaccine supplies appear to be adequate for the 2005-2006 season, though delivery has been somewhat delayed. However, in the event of a pandemic of avian flu-considered inevitable by most experts, although no one knows when it will happen-the United States would be woefully unprepared. PMID:16315443

  15. Prenatal zinc supplementation of zinc-adequate rats adversely affects immunity in offspring

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We previously showed that zinc (Zn) supplementation of Zn-adequate dams induced immunosuppressive effects that persist in the offspring after weaning. We investigated whether the immunosuppressive effects were due to in utero exposure and/or mediated via milk using a cross-fostering design. Pregnant...

  16. Inferential Processing among Adequate and Struggling Adolescent Comprehenders and Relations to Reading Comprehension

    ERIC Educational Resources Information Center

    Barth, Amy E.; Barnes, Marcia; Francis, David; Vaughn, Sharon; York, Mary

    2015-01-01

    Separate mixed model analyses of variance were conducted to examine the effect of textual distance on the accuracy and speed of text consistency judgments among adequate and struggling comprehenders across grades 6-12 (n = 1,203). Multiple regressions examined whether accuracy in text consistency judgments uniquely accounted for variance in…

  17. What Is the Cost of an Adequate Vermont High School Education?

    ERIC Educational Resources Information Center

    Rucker, Frank D.

    2010-01-01

    Access to an adequate education has been widely considered an undeniable right since Chief Justice Warren stated in his landmark decision that "Today, education is perhaps the most important function of state and local governments...it is doubtful that any child may reasonably be expected to succeed in life if he is denied the opportunity of an…

  18. Calculating and Reducing Errors Associated with the Evaluation of Adequate Yearly Progress.

    ERIC Educational Resources Information Center

    Hill, Richard

    In the Spring, 1996, issue of "CRESST Line," E. Baker and R. Linn commented that, in efforts to measure the progress of schools, "the fluctuations due to differences in the students themselves could conceal differences in instructional effects." This is particularly true in the context of the evaluation of adequate yearly progress required by…

  19. 26 CFR 1.467-2 - Rent accrual for section 467 rental agreements without adequate interest.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... provide for a variable rate of interest. For purposes of the adequate interest test under paragraph (b)(1) of this section, if a section 467 rental agreement provides for variable interest, the rental... date as the issue date) for the variable rates called for by the rental agreement. For purposes of...

  20. 26 CFR 1.467-2 - Rent accrual for section 467 rental agreements without adequate interest.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... provide for a variable rate of interest. For purposes of the adequate interest test under paragraph (b)(1) of this section, if a section 467 rental agreement provides for variable interest, the rental... date as the issue date) for the variable rates called for by the rental agreement. For purposes of...

  1. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  2. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  3. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian...

  4. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  5. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  6. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian...

  7. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian...

  8. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian...

  9. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  10. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian...

  11. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  12. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Adequate financial records, statistical data, and... financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination of costs payable by...

  13. Skateboard Safety.

    ERIC Educational Resources Information Center

    Della-Giustina, Daniel

    1979-01-01

    The growing number of skateboard injuries clearly indicates a need for both recreational facilities designed exclusively for skateboarders, and for accident- prevention-oriented safety education programs. (LH)

  14. Medication safety.

    PubMed

    Keohane, Carol A; Bates, David W

    2008-03-01

    Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

  15. Minimally adequate mental health care and latent classes of PTSD symptoms in female Iraq and Afghanistan veterans.

    PubMed

    Hebenstreit, Claire L; Madden, Erin; Koo, Kelly H; Maguen, Shira

    2015-11-30

    Female veterans of Operations Enduring and Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) represent a growing segment of Department of Veterans Affairs (VA) health care users. A retrospective analysis used national VA medical records to identify factors associated with female OEF/OIF/OND veterans' completion of minimally adequate care (MAC) for PTSD, defined as the completion of at least nine mental health outpatient visits within a 15-week period or at least twelve consecutive weeks of medication use. The sample included female OEF/OIF/OND veterans with PTSD who initiated VA health care between 2007-2013, and were seen in outpatient mental health (N=2183). Multivariable logistic regression models examined factors associated with completing MAC for PTSD, including PTSD symptom expression (represented by latent class analysis), sociodemographic, military, clinical, and VA access factors. Within one year of initiating mental health care, 48.3% of female veterans completed MAC. Race/ethnicity, age, PTSD symptom class, additional psychiatric diagnoses, and VA primary care use were significantly associated with completion of MAC for PTSD. Results suggest that veterans presenting for PTSD treatment should be comprehensively evaluated to identify factors associated with inadequate completion of care. Treatments that are tailored to PTSD symptom class may help to address potential barriers.

  16. Impact of Passive Safety on FHR Instrumentation Systems Design and Classification

    SciTech Connect

    Holcomb, David Eugene

    2015-01-01

    Fluoride salt-cooled high-temperature reactors (FHRs) will rely more extensively on passive safety than earlier reactor classes. 10CFR50 Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum design requirements to provide reasonable assurance of adequate safety. 10CFR50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, provides guidance on how the safety significance of systems, structures, and components (SSCs) should be reflected in their regulatory treatment. The Nuclear Energy Institute (NEI) has provided 10 CFR 50.69 SSC Categorization Guideline (NEI-00-04) that factors in probabilistic risk assessment (PRA) model insights, as well as deterministic insights, through an integrated decision-making panel. Employing the PRA to inform deterministic requirements enables an appropriately balanced, technically sound categorization to be established. No FHR currently has an adequate PRA or set of design basis accidents to enable establishing the safety classification of its SSCs. While all SSCs used to comply with the general design criteria (GDCs) will be safety related, the intent is to limit the instrumentation risk significance through effective design and reliance on inherent passive safety characteristics. For example, FHRs have no safety-significant temperature threshold phenomena, thus enabling the primary and reserve reactivity control systems required by GDC 26 to be passively, thermally triggered at temperatures well below those for which core or primary coolant boundary damage would occur. Moreover, the passive thermal triggering of the primary and reserve shutdown systems may relegate the control rod drive motors to the control system, substantially decreasing the amount of safety-significant wiring needed. Similarly, FHR decay heat removal systems are intended to be running continuously to minimize the amount of safety-significant instrumentation needed to initiate

  17. Organizational Culture and Safety

    NASA Technical Reports Server (NTRS)

    Adams, Catherine A.

    2003-01-01

    '..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

  18. Lab Safety.

    ERIC Educational Resources Information Center

    West, Sandra S.

    1991-01-01

    In response to the Texas Hazardous Communication Act (THCA) of 1986 which raised many new health and liability issues regarding students in science laboratories, a laboratory safety survey was generated for use in evaluating laboratory safety. This article contains the easy-to-use survey. (ZWH)

  19. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  20. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

    Ned Miller does not take security lightly. As director of campus safety and emergency management at the Des Moines Area Community College (DMACC), any threat requires serious consideration. As community college administrators adopt a more proactive approach to campus safety, many institutions are experimenting with emerging technologies, including…

  1. Ensuring smokers are adequately informed: reflections on consumer rights, manufacturer responsibilities, and policy implications

    PubMed Central

    Chapman, S; Liberman, J

    2005-01-01

    The right to information is a fundamental consumer value. Following the advent of health warnings, the tobacco industry has repeatedly asserted that smokers are fully informed of the risks they take, while evidence demonstrates widespread superficial levels of awareness and understanding. There remains much that tobacco companies could do to fulfil their responsibilities to inform smokers. We explore issues involved in the meaning of "adequately informed" smoking and discuss some of the key policy and regulatory implications. We use the idea of a smoker licensing scheme—under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness—as a device to explore some of these issues. We also explore some of the difficulties that addiction poses for the notion that smokers might ever voluntarily assume the risks of smoking. PMID:16046703

  2. The concept of adequate causation and Max Weber's comparative sociology of religion.

    PubMed

    Buss, A

    1999-06-01

    Max Weber's The Protestant Ethic and the Spirit of Capitalism, studied in isolation, shows mainly an elective affinity or an adequacy on the level of meaning between the Protestant ethic and the 'spirit' of capitalism. Here it is suggested that Weber's subsequent essays on 'The Economic Ethics of World Religions' are the result of his opinion that adequacy on the level of meaning needs and can be verified by causal adequacy. After some introductory remarks, particularly on elective affinity, the paper tries to develop the concept of adequate causation and the related concept of objective possibility on the basis of the work of v. Kries on whom Weber heavily relied. In the second part, this concept is used to show how the study of the economic ethics of India, China, Rome and orthodox Russia can support the thesis that the 'spirit' of capitalism, although it may not have been caused by the Protestant ethic, was perhaps adequately caused by it. PMID:15260028

  3. Ensuring smokers are adequately informed: reflections on consumer rights, manufacturer responsibilities, and policy implications.

    PubMed

    Chapman, S; Liberman, J

    2005-08-01

    The right to information is a fundamental consumer value. Following the advent of health warnings, the tobacco industry has repeatedly asserted that smokers are fully informed of the risks they take, while evidence demonstrates widespread superficial levels of awareness and understanding. There remains much that tobacco companies could do to fulfil their responsibilities to inform smokers. We explore issues involved in the meaning of "adequately informed" smoking and discuss some of the key policy and regulatory implications. We use the idea of a smoker licensing scheme-under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness-as a device to explore some of these issues. We also explore some of the difficulties that addiction poses for the notion that smokers might ever voluntarily assume the risks of smoking. PMID:16046703

  4. Myth 19: Is Advanced Placement an Adequate Program for Gifted Students?

    ERIC Educational Resources Information Center

    Gallagher, Shelagh A.

    2009-01-01

    Is it a myth that Advanced Placement (AP) is an adequate program for gifted students? AP is so covered with myths and assumptions that it is hard to get a clear view of the issues. In this article, the author finds the answer about AP by looking at current realties. First, AP is hard for gifted students to avoid. Second, AP never was a program…

  5. AFR-100 safety analyses

    SciTech Connect

    Sumner, T.; Moisseytsev, A.; Wei, T. Y. C.

    2012-07-01

    The Advanced Fast Reactor-100 (AFR-100) is Argonne National Laboratory's 250 MWth metal-fueled modular sodium-cooled pool-type fast reactor concept. [1] A series of accident sequences that focused on the AFR-100's ability to provide protection against reactor damage during low probability accident sequences resulting from multiple equipment failures were examined. Protected and Unprotected Loss of Flow (PLOF and ULOF) and Unprotected Transient Over-Power (UTOP) accidents were simulated using the SAS4A/SASSYS-1 safety analysis code. The large heat capacity of the sodium in the pool-type reactor allows the AFR-100 to absorb large amounts of energy during a PLOF with relatively small temperature increases throughout the system. During a ULOF with a 25-second flow halving time, coolant and cladding temperatures peak around 720 deg. C within the first minute before reactivity feedback effects decrease power to match the flow. Core radial expansion and fuel Doppler provide the necessary feedback during the UTOP to bring the system back to critical before system temperatures exceed allowable limits. Simulation results indicate that adequate ULOF safety margins exist for the AFR-100 design with flow halving times of twenty-five seconds. Significant safety margins are maintained for PLOF accidents as well as UTOP accidents if a rod stop is used. (authors)

  6. Global Risk Assessment of Aflatoxins in Maize and Peanuts: Are Regulatory Standards Adequately Protective?

    PubMed Central

    Wu, Felicia

    2013-01-01

    The aflatoxins are a group of fungal metabolites that contaminate a variety of staple crops, including maize and peanuts, and cause an array of acute and chronic human health effects. Aflatoxin B1 in particular is a potent liver carcinogen, and hepatocellular carcinoma (HCC) risk is multiplicatively higher for individuals exposed to both aflatoxin and chronic infection with hepatitis B virus (HBV). In this work, we sought to answer the question: do current aflatoxin regulatory standards around the world adequately protect human health? Depending upon the level of protection desired, the answer to this question varies. Currently, most nations have a maximum tolerable level of total aflatoxins in maize and peanuts ranging from 4 to 20ng/g. If the level of protection desired is that aflatoxin exposures would not increase lifetime HCC risk by more than 1 in 100,000 cases in the population, then most current regulatory standards are not adequately protective even if enforced, especially in low-income countries where large amounts of maize and peanuts are consumed and HBV prevalence is high. At the protection level of 1 in 10,000 lifetime HCC cases in the population, however, almost all aflatoxin regulations worldwide are adequately protective, with the exception of several nations in Africa and Latin America. PMID:23761295

  7. Global risk assessment of aflatoxins in maize and peanuts: are regulatory standards adequately protective?

    PubMed

    Wu, Felicia; Stacy, Shaina L; Kensler, Thomas W

    2013-09-01

    The aflatoxins are a group of fungal metabolites that contaminate a variety of staple crops, including maize and peanuts, and cause an array of acute and chronic human health effects. Aflatoxin B1 in particular is a potent liver carcinogen, and hepatocellular carcinoma (HCC) risk is multiplicatively higher for individuals exposed to both aflatoxin and chronic infection with hepatitis B virus (HBV). In this work, we sought to answer the question: do current aflatoxin regulatory standards around the world adequately protect human health? Depending upon the level of protection desired, the answer to this question varies. Currently, most nations have a maximum tolerable level of total aflatoxins in maize and peanuts ranging from 4 to 20ng/g. If the level of protection desired is that aflatoxin exposures would not increase lifetime HCC risk by more than 1 in 100,000 cases in the population, then most current regulatory standards are not adequately protective even if enforced, especially in low-income countries where large amounts of maize and peanuts are consumed and HBV prevalence is high. At the protection level of 1 in 10,000 lifetime HCC cases in the population, however, almost all aflatoxin regulations worldwide are adequately protective, with the exception of several nations in Africa and Latin America.

  8. An adequate Fe nutritional status of maize suppresses infection and biotrophic growth of Colletotrichum graminicola.

    PubMed

    Ye, Fanghua; Albarouki, Emad; Lingam, Brahmasivasenkar; Deising, Holger B; von Wirén, Nicolaus

    2014-07-01

    Iron (Fe) is an essential element for plant pathogens as well as for their host plants. As Fe plays a central role in pathogen virulence, most plants have evolved Fe-withholding strategies to reduce Fe availability to pathogens. On the other hand, plants need Fe for an oxidative burst in their basal defense response against pathogens. To investigate how the plant Fe nutritional status affects plant tolerance to a hemibiotrophic fungal pathogen, we employed the maize-Colletotrichum graminicola pathosystem. Fungal infection progressed rapidly via biotrophic to necrotrophic growth in Fe-deficient leaves, while an adequate Fe nutritional status suppressed the formation of infection structures of C. graminicola already during the early biotrophic growth phase. As indicated by Prussian blue and 3,3'-diaminobenzidine (DAB) staining, the retarding effect of an adequate Fe nutritional status on fungal development coincided temporally and spatially with the recruitment of Fe to infection sites and a local production of H2 O2 . A similar coincidence between local Fe and H2 O2 accumulation was found in a parallel approach employing C. graminicola mutants affected in Fe acquisition and differing in virulence. These results indicate that an adequate Fe nutritional status delays and partially suppresses the fungal infection process and the biotrophic growth phase of C. graminicola, most likely via the recruitment of free Fe to the fungal infection site for a timely oxidative burst.

  9. Navigating the perfect storm: balancing a culture of safety with workforce challenges.

    PubMed

    Hinshaw, Ada Sue

    2008-01-01

    Balancing the development of cultures of safety with nursing workforce challenges is similar to navigating the perfect storm. The perfect storm is characterized as a tempest of extreme intensity that happens rarely, maybe once every 100 years, as a result of multiple factors that end in a situation worse than people have ever seen. Such a storm is currently evident when attempting to ensure patient safety while being confronted with a shortage of nurses and nursing faculty unlike any other shortage experienced in over a number of decades. Based on research, the threats to patient safety from healthcare system and health professional errors have become of paramount concern. The prevention of such errors is the focus of healthcare organizations as they create cultures of safety. A major aspect of cultures of safety is nurses with their many roles in caring for patients and families, especially the constant surveillance they provide, which often prevents complications and deaths secondary to failure to rescue. However, providing such surveillance requires adequate numbers of well-prepared nurses in attendance. The perfect storm is created because of the existence of a steadily worsening shortage of nurses and nursing faculty. Multiple factors have converged to develop and sustain such a shortage. A blueprint for healthcare organizations is proposed, with examples of numerous innovative strategies that are being developed and studied for handling the major challenges posed by this perfect storm.

  10. The Evolution of System Safety at NASA

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Everett, Chris; Groen, Frank

    2014-01-01

    The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

  11. Obstacles to Laser Safety

    SciTech Connect

    Barat, K

    2005-04-25

    The growth of laser development & technology has been remarkable. Unfortunately, a number of traps or obstacles to laser safety have also developed with that growth. The goal of this article is to highlight those traps, in the hope that an aware laser user will avoid them. These traps have been the cause or contributing factor of many a preventable laser accident.

  12. Software safety

    NASA Technical Reports Server (NTRS)

    Leveson, Nancy

    1987-01-01

    Software safety and its relationship to other qualities are discussed. It is shown that standard reliability and fault tolerance techniques will not solve the safety problem for the present. A new attitude requires: looking at what you do NOT want software to do along with what you want it to do; and assuming things will go wrong. New procedures and changes to entire software development process are necessary: special software safety analysis techniques are needed; and design techniques, especially eliminating complexity, can be very helpful.

  13. Involving regional expertise in nationwide modeling for adequate prediction of climate change effects on different demands for fresh water

    NASA Astrophysics Data System (ADS)

    de Lange, W. J.

    2014-05-01

    Wim J. de Lange, Geert F. Prinsen, Jacco H. Hoogewoud, Ab A Veldhuizen, Joachim Hunink, Erik F.W. Ruijgh, Timo Kroon Nationwide modeling aims to produce a balanced distribution of climate change effects (e.g. harm on crops) and possible compensation (e.g. volume fresh water) based on consistent calculation. The present work is based on the Netherlands Hydrological Instrument (NHI, www.nhi.nu), which is a national, integrated, hydrological model that simulates distribution, flow and storage of all water in the surface water and groundwater systems. The instrument is developed to assess the impact on water use on land-surface (sprinkling crops, drinking water) and in surface water (navigation, cooling). The regional expertise involved in the development of NHI come from all parties involved in the use, production and management of water, such as waterboards, drinking water supply companies, provinces, ngo's, and so on. Adequate prediction implies that the model computes changes in the order of magnitude that is relevant to the effects. In scenarios related to drought, adequate prediction applies to the water demand and the hydrological effects during average, dry, very dry and extremely dry periods. The NHI acts as a part of the so-called Deltamodel (www.deltamodel.nl), which aims to predict effects and compensating measures of climate change both on safety against flooding and on water shortage during drought. To assess the effects, a limited number of well-defined scenarios is used within the Deltamodel. The effects on demand of fresh water consist of an increase of the demand e.g. for surface water level control to prevent dike burst, for flushing salt in ditches, for sprinkling of crops, for preserving wet nature and so on. Many of the effects are dealt with by regional and local parties. Therefore, these parties have large interest in the outcome of the scenario analyses. They are participating in the assessment of the NHI previous to the start of the analyses

  14. Involving regional expertise in nationwide modeling for adequate prediction of climate change effects on different demands for fresh water

    NASA Astrophysics Data System (ADS)

    de Lange, Wim; Prinsen, Geert.; Hoogewoud, Jacco; Veldhuizen, Ab; Ruijgh, Erik; Kroon, Timo

    2013-04-01

    Nationwide modeling aims to produce a balanced distribution of climate change effects (e.g. harm on crops) and possible compensation (e.g. volume fresh water) based on consistent calculation. The present work is based on the Netherlands Hydrological Instrument (NHI, www.nhi.nu), which is a national, integrated, hydrological model that simulates distribution, flow and storage of all water in the surface water and groundwater systems. The instrument is developed to assess the impact on water use on land-surface (sprinkling crops, drinking water) and in surface water (navigation, cooling). The regional expertise involved in the development of NHI come from all parties involved in the use, production and management of water, such as waterboards, drinking water supply companies, provinces, ngo's, and so on. Adequate prediction implies that the model computes changes in the order of magnitude that is relevant to the effects. In scenarios related to drought, adequate prediction applies to the water demand and the hydrological effects during average, dry, very dry and extremely dry periods. The NHI acts as a part of the so-called Deltamodel (www.deltamodel.nl), which aims to predict effects and compensating measures of climate change both on safety against flooding and on water shortage during drought. To assess the effects, a limited number of well-defined scenarios is used within the Deltamodel. The effects on demand of fresh water consist of an increase of the demand e.g. for surface water level control to prevent dike burst, for flushing salt in ditches, for sprinkling of crops, for preserving wet nature and so on. Many of the effects are dealt with? by regional and local parties. Therefore, these parties have large interest in the outcome of the scenario analyses. They are participating in the assessment of the NHI previous to the start of the analyses. Regional expertise is welcomed in the calibration phase of NHI. It aims to reduce uncertainties by improving the

  15. NASA aviation safety reporting system

    NASA Technical Reports Server (NTRS)

    1979-01-01

    The human factors frequency considered a cause of or contributor to hazardous events onboard air carriers are examined with emphasis on distractions. Safety reports that have been analyzed, processed, and entered into the aviation safety reporting system data base are discussed. A sampling of alert bulletins and responses to them is also presented.

  16. Electronic Informational and Educational Environment as a Factor of Competence-Oriented Higher Pedagogical Education in the Sphere of Health, Safety and Environment

    ERIC Educational Resources Information Center

    Kamerilova, Galina S.; Kartavykh, Marina A.; Ageeva, Elena L.; Veryaskina, Marina A.; Ruban, Elena M.

    2016-01-01

    The authors consider the question of computerisation in health, safety and environment teachers' training in the context of the general approaches and requirements of the Federal National Standard of Higher Education, which is realised through designing of electronic informational and educational environment. The researchers argue indispensability…

  17. Safety Tips.

    ERIC Educational Resources Information Center

    Nagel, Miriam C., Ed.

    1984-01-01

    Outlines a cooperative effort in Iowa to eliminate dangerous or unwanted chemicals from school science storerooms. Also reviews the Council of State Science Supervisor's safety program and discusses how to prevent cuts and punctures from jagged glass tubing. (JN)

  18. 43 CFR 3162.5-3 - Safety precautions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Safety precautions. 3162.5-3 Section 3162.5-3 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND... necessary to provide adequate protection for the health and safety of life and the protection of...

  19. [Functional restoration--it depends on an adequate mixture of treatment].

    PubMed

    Pfingsten, M

    2001-12-01

    In the last 50 years conventional treatments have not been able to slow down the expanding chronic low back pain problem. However, nowadays health care has changed according to a broad biopsychosocial model of health, the positive effect of activity on health and healing, emphasis on function rather than pain or impairment, and reliance upon clinical evidence. In search for new solutions "functional restoration" (FR) programs have been developed. They include multidisciplinary treatment of patients in groups, consisting of 6-8 h of treatment a day, lasting 3 to 6 weeks and usually integrating intense physical and ergonomic training, psychological (behavioral) therapy, patient education, and instruction in social- and work-related issues. FR programs have yet to demonstrate their effectiveness in several countries. Controlled studies in the USA were very positive regarding the return-to-work rate, whereas studies in Scandinavian countries did not demonstrate similar results. Possible reasons for the different results concerning back-to-work ratios might be that study design, patient population, content of the program, and other external factors are different and studies as well as effects are therefore not directly comparable. According to several well-controlled studies, the most probable reason for this different effect may be that social and security (health care) systems and cultures differ among countries and that patients with chronic low back pain respond differently to this combination. Sick absenteeism and inability to work may be influenced by many factors besides pain that cannot be addressed by intervention or prevention programs, e.g., job satisfaction, education level, and the compensation systems. It may be that the lower economic benefit during sick leave in the United States leads to favorable results from functional restoration programs. Concerning the prediction of success, several studies have shown that medical background, diagnosis and physical

  20. [Functional restoration--it depends on an adequate mixture of treatment].

    PubMed

    Pfingsten, M

    2001-12-01

    In the last 50 years conventional treatments have not been able to slow down the expanding chronic low back pain problem. However, nowadays health care has changed according to a broad biopsychosocial model of health, the positive effect of activity on health and healing, emphasis on function rather than pain or impairment, and reliance upon clinical evidence. In search for new solutions "functional restoration" (FR) programs have been developed. They include multidisciplinary treatment of patients in groups, consisting of 6-8 h of treatment a day, lasting 3 to 6 weeks and usually integrating intense physical and ergonomic training, psychological (behavioral) therapy, patient education, and instruction in social- and work-related issues. FR programs have yet to demonstrate their effectiveness in several countries. Controlled studies in the USA were very positive regarding the return-to-work rate, whereas studies in Scandinavian countries did not demonstrate similar results. Possible reasons for the different results concerning back-to-work ratios might be that study design, patient population, content of the program, and other external factors are different and studies as well as effects are therefore not directly comparable. According to several well-controlled studies, the most probable reason for this different effect may be that social and security (health care) systems and cultures differ among countries and that patients with chronic low back pain respond differently to this combination. Sick absenteeism and inability to work may be influenced by many factors besides pain that cannot be addressed by intervention or prevention programs, e.g., job satisfaction, education level, and the compensation systems. It may be that the lower economic benefit during sick leave in the United States leads to favorable results from functional restoration programs. Concerning the prediction of success, several studies have shown that medical background, diagnosis and physical

  1. Supplemental Escherichia coli phytase and strontium enhance bone strength of young pigs fed a phosphorus-adequate diet.

    PubMed

    Pagano, Angela R; Yasuda, Koji; Roneker, Karl R; Crenshaw, Thomas D; Lei, Xin Gen

    2007-07-01

    Young pigs represent an excellent model of youth to assess potentials of dietary factors for improving bone structure and function. We conducted 2 experiments to determine whether adding microbial phytase (2,000 U/kg, OptiPhos, JBS United) and Sr (50 mg/kg, SrCO3 Alfa Aesar) into a P-adequate diet further improved bone strength of young pigs. In Expt. 1, 24 gilts (8.6 +/- 0.1 kg body wt) were divided into 2 groups (n = 12), and fed a corn-soybean-meal basal diet (BD, 0.33% available P) or BD + phytase for 6 wk. In Expt. 2, 32 pigs (11.4 +/- 0.2 kg) were divided into 4 groups (n = 8), and fed BD, BD + phytase, BD + Sr, or BD + phytase and Sr for 5 wk. Both supplemental phytase and Sr enhanced (P < 0.05) breaking strengths (11-20%), mineral content (6-15%), and mineral density (6-11%) of metatarsals and femurs. Supplemental phytase also resulted in larger total bone areas (P < 0.05) and a larger cross-sectional area of femur (P = 0.06). Concentrations of Sr were elevated 4-fold (P < 0.001) in both bones by Sr, and moderately increased (P = 0.05-0.07) in metatarsal by phytase. In conclusion, supplemental phytase at 2000 U/kg of P-adequate diets enhanced bone mechanical function of weanling pigs by modulating both geometrical and chemical properties of bone. The similar benefit of supplemental Sr was mainly due to an effect on bone chemical properties. PMID:17585033

  2. Adequate Iodine Status in New Zealand School Children Post-Fortification of Bread with Iodised Salt.

    PubMed

    Jones, Emma; McLean, Rachael; Davies, Briar; Hawkins, Rochelle; Meiklejohn, Eva; Ma, Zheng Feei; Skeaff, Sheila

    2016-01-01

    Iodine deficiency re-emerged in New Zealand in the 1990s, prompting the mandatory fortification of bread with iodised salt from 2009. This study aimed to determine the iodine status of New Zealand children when the fortification of bread was well established. A cross-sectional survey of children aged 8-10 years was conducted in the cities of Auckland and Christchurch, New Zealand, from March to May 2015. Children provided a spot urine sample for the determination of urinary iodine concentration (UIC), a fingerpick blood sample for Thyroglobulin (Tg) concentration, and completed a questionnaire ascertaining socio-demographic information that also included an iodine-specific food frequency questionnaire (FFQ). The FFQ was used to estimate iodine intake from all main food sources including bread and iodised salt. The median UIC for all children (n = 415) was 116 μg/L (females 106 μg/L, males 131 μg/L) indicative of adequate iodine status according to the World Health Organisation (WHO, i.e., median UIC of 100-199 μg/L). The median Tg concentration was 8.7 μg/L, which was <10 μg/L confirming adequate iodine status. There was a significant difference in UIC by sex (p = 0.001) and ethnicity (p = 0.006). The mean iodine intake from the food-only model was 65 μg/day. Bread contributed 51% of total iodine intake in the food-only model, providing a mean iodine intake of 35 μg/day. The mean iodine intake from the food-plus-iodised salt model was 101 μg/day. In conclusion, the results of this study confirm that the iodine status in New Zealand school children is now adequate. PMID:27196925

  3. Are the current Australian sun exposure guidelines effective in maintaining adequate levels of 25-hydroxyvitamin D?

    PubMed

    Kimlin, Michael; Sun, Jiandong; Sinclair, Craig; Heward, Sue; Hill, Jane; Dunstone, Kimberley; Brodie, Alison

    2016-01-01

    An adequate vitamin D status, as measured by serum 25-hydroxyvitamin D (25(OH)D) concentration, is important in humans for maintenance of healthy bones and muscle function. Serum 25(OH)D concentration was assessed in participants from Melbourne, Australia (37.81S, 144.96E), who were provided with the current Australian guidelines on sun exposure for 25(OH)D adequacy (25(OH)D ≥50 nmol/L). Participants were interviewed in February (summer, n=104) and August (winter, n=99) of 2013. Serum 25(OH)D concentration was examined as a function of measures of sun exposure and sun protection habits with control of key characteristics such as dietary intake of vitamin D, body mass index (BMI) and skin colour, that may modify this relationship. The mean 25(OH)D concentration in participants who complied with the current sun exposure guidelines was 67.3 nmol/L in summer and 41.9 nmol/L in winter. At the end of the study, 69.3% of participants who complied with the summer sun exposure guidelines were 25(OH)D adequate, while only 27.6% of participants who complied with the winter sun exposure guidelines were 25(OH)D adequate at the end of the study. The results suggest that the current Australian guidelines for sun exposure for 25(OH)D adequacy are effective for most in summer and ineffective for most in winter. This article is part of a Special Issue entitled '17th Vitamin D Workshop'.

  4. Adequate Iodine Status in New Zealand School Children Post-Fortification of Bread with Iodised Salt

    PubMed Central

    Jones, Emma; McLean, Rachael; Davies, Briar; Hawkins, Rochelle; Meiklejohn, Eva; Ma, Zheng Feei; Skeaff, Sheila

    2016-01-01

    Iodine deficiency re-emerged in New Zealand in the 1990s, prompting the mandatory fortification of bread with iodised salt from 2009. This study aimed to determine the iodine status of New Zealand children when the fortification of bread was well established. A cross-sectional survey of children aged 8–10 years was conducted in the cities of Auckland and Christchurch, New Zealand, from March to May 2015. Children provided a spot urine sample for the determination of urinary iodine concentration (UIC), a fingerpick blood sample for Thyroglobulin (Tg) concentration, and completed a questionnaire ascertaining socio-demographic information that also included an iodine-specific food frequency questionnaire (FFQ). The FFQ was used to estimate iodine intake from all main food sources including bread and iodised salt. The median UIC for all children (n = 415) was 116 μg/L (females 106 μg/L, males 131 μg/L) indicative of adequate iodine status according to the World Health Organisation (WHO, i.e., median UIC of 100–199 μg/L). The median Tg concentration was 8.7 μg/L, which was <10 μg/L confirming adequate iodine status. There was a significant difference in UIC by sex (p = 0.001) and ethnicity (p = 0.006). The mean iodine intake from the food-only model was 65 μg/day. Bread contributed 51% of total iodine intake in the food-only model, providing a mean iodine intake of 35 μg/day. The mean iodine intake from the food-plus-iodised salt model was 101 μg/day. In conclusion, the results of this study confirm that the iodine status in New Zealand school children is now adequate. PMID:27196925

  5. Thrombography reveals thrombin generation potential continues to deteriorate following cardiopulmonary bypass surgery despite adequate hemostasis.

    PubMed

    Wong, Raymond K; Sleep, Joseph R; Visner, Allison J; Raasch, David J; Lanza, Louis A; DeValeria, Patrick A; Torloni, Antonio S; Arabia, Francisco A

    2011-03-01

    The intrinsic and extrinsic activation pathways of the hemostatic system converge when prothrombin is converted to thrombin. The ability to generate an adequate thrombin burst is the most central aspect of the coagulation cascade. The thrombin-generating potential in patients following cardiopulmonary bypass (CPB) may be indicative of their hemostatic status. In this report, thrombography, a unique technique for directly measuring the potential of patients' blood samples to generate adequate thrombin bursts, is used to characterize the coagulopathic profile in post-CPB patients. Post-CPB hemostasis is typically achieved with protamine reversal of heparin anticoagulation and occasionally supplemented with blood product component transfusions. In this pilot study, platelet poor plasma samples were derived from 11 primary cardiac surgery patients at five time points: prior to CPB, immediately post-protamine, upon arrival to the intensive care unit (ICU), 3 hours post-ICU admission, and 24 hours after ICU arrival. Thrombography revealed that the Endogenous Thrombin Potential (ETP) was not different between [Baseline] and [PostProtamine] but proceeded to deteriorate in the immediate postoperative period. At the [3HourPostICU] time point, the ETP was significantly lower than the [Baseline] values, 1233 +/- 591 versus 595 +/- 379 nM.min (mean +/- SD; n=9, p < .005), despite continued adequacy of hemostasis. ETPs returned to baseline values the day after surgery. Transfusions received, conventional blood coagulation testing results, and blood loss volumes are also presented. Despite adequate hemostasis, thrombography reveals an underlying coagulopathic process that could put some cardiac surgical patients at risk for postoperative bleeding. Thrombography is a novel technique that could be developed into a useful tool for perfusionists and physicians to identify coagulopathies and optimize blood management following CPB. PMID:21449230

  6. Chronic leg ulcer: does a patient always get a correct diagnosis and adequate treatment?

    PubMed

    Mooij, Michael C; Huisman, Laurens C

    2016-03-01

    Patients with chronic leg ulcers have severely impaired quality of life and account for a high percentage of annual healthcare costs. To establish the cause of a chronic leg ulcer, referral to a center with a multidisciplinary team of professionals is often necessary. Treating the underlying cause diminishes healing time and reduces costs. In venous leg ulcers adequate compression therapy is still a problem. It can be improved by training the professionals with pressure measuring devices. A perfect fitting of elastic stockings is important to prevent venous leg ulcer recurrence. In most cases, custom-made stockings are the best choice for this purpose. PMID:26916772

  7. Determining Adequate Margins in Head and Neck Cancers: Practice and Continued Challenges.

    PubMed

    Williams, Michelle D

    2016-09-01

    Margin assessment remains a critical component of oncologic care for head and neck cancer patients. As an integrated team, both surgeons and pathologists work together to assess margins in these complex patients. Differences in method of margin sampling can impact obtainable information and effect outcomes. Additionally, what distance is an "adequate or clear" margin for patient care continues to be debated. Ultimately, future studies and potentially secondary modalities to augment pathologic assessment of margin assessment (i.e., in situ imaging or molecular assessment) may enhance local control in head and neck cancer patients. PMID:27469263

  8. Nebulized antibiotics. An adequate option for treating ventilator-associated respiratory infection?

    PubMed

    Rodríguez, A; Barcenilla, F

    2015-03-01

    Ventilator-associated tracheobronchitis (VAT) is a frequent complication in critical patients. The 90% of those who develop it receive broad-spectrum antibiotic (ATB) treatment, without any strong evidence of its favorable impact. The use of nebulized ATB could be a valid treatment option, to reduce the use of systemic ATB and the pressure of selection on the local flora. Several studies suggest that an adequate nebulization technique can ensure high levels of ATB even in areas of lung consolidation, and to obtain clinical and microbiological cure. New studies are needed to properly assess the impact of treatment with nebulized ATB on the emergence of resistance.

  9. Developing an adequate "pneumatraumatology": understanding the spiritual impacts of traumatic injury.

    PubMed

    Bidwell, Duane R

    2002-01-01

    Psychosocial interventions and systematic theology are primary resources for chaplains and congregational pastors who care for victims of physical trauma. Yet these resources may not be adequate to address the spiritual impacts of trauma. This article proposes a preliminary "pneumatraumatology," drawing on early Christian asceticism and Buddhist mysticism to describe one way of understanding the spiritual impacts of traumatic injury. It also suggests possible responses to these impacts informed by narrative/constructionist perspectives and Breggemann's understanding of the dimensions of spiritual transformation in the Hebrew Bible.

  10. Optimal detection pinhole for lowering speckle noise while maintaining adequate optical sectioning in confocal reflectance microscopes.

    PubMed

    Glazowski, Christopher; Rajadhyaksha, Milind

    2012-08-01

    Coherent speckle influences the resulting image when narrow spectral line-width and single spatial mode illumination are used, though these are the same light-source properties that provide the best radiance-to-cost ratio. However, a suitable size of the detection pinhole can be chosen to maintain adequate optical sectioning while making the probability density of the speckle noise more normal and reducing its effect. The result is a qualitatively better image with improved contrast, which is easier to read. With theoretical statistics and experimental results, we show that the detection pinhole size is a fundamental parameter for designing imaging systems for use in turbid media.

  11. [Evaluation of the risk of delayed adverse effects of chronic combined exposure to radiation and chemical factors with the purpose to ensure safety in orbital and exploration space missions].

    PubMed

    Shafirkin, A V; Mukhamedieva, L N; Tatarkin, S V; Barantseva, M Iu

    2012-01-01

    The work had the aim to anatomize the existing issues with providing safety in extended orbital and exploration missions for ensuing estimation of actual values of the total radiation risk for the crew, and risks of other delayed effects of simultaneous exposure to ionizing radiation and chemical pollutants in cabin air, and a number of other stressful factors inevitable in space flight. The flow of chronic experiments for separate and combined studies with reproduction of air makeup and radiation doses in actual orbital and predicted exploration missions is outlined. To set safety limits, new approaches should be applied to the description of gradual norm degradation to pathologies in addition to several generalized quantitative indices of adaptation and straining of the regulatory systems, as well as of effectiveness of the compensatory body reserve against separate and combined exposure.

  12. [Evaluation of the risk of delayed adverse effects of chronic combined exposure to radiation and chemical factors with the purpose to ensure safety in orbital and exploration space missions].

    PubMed

    Shafirkin, A V; Mukhamedieva, L N; Tatarkin, S V; Barantseva, M Iu

    2012-01-01

    The work had the aim to anatomize the existing issues with providing safety in extended orbital and exploration missions for ensuing estimation of actual values of the total radiation risk for the crew, and risks of other delayed effects of simultaneous exposure to ionizing radiation and chemical pollutants in cabin air, and a number of other stressful factors inevitable in space flight. The flow of chronic experiments for separate and combined studies with reproduction of air makeup and radiation doses in actual orbital and predicted exploration missions is outlined. To set safety limits, new approaches should be applied to the description of gradual norm degradation to pathologies in addition to several generalized quantitative indices of adaptation and straining of the regulatory systems, as well as of effectiveness of the compensatory body reserve against separate and combined exposure. PMID:22624477

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

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  14. Evaluation of safety and effectiveness of factor VIII treatment in haemophilia A patients with low titre inhibitors or a personal history of inhibitor. Patient Data Meta-analysis of rAFH-PFM Post-Authorization Safety Studies.

    PubMed

    Romanov, Vadim; Marcucci, Maura; Cheng, Ji; Thabane, Lehana; Iorio, Alfonso

    2015-07-01

    There is no prospective evidence on inhibitor recurrence among haemophilia A patients with low titre inhibitors or history of inhibitors, and whether or how therapeutic choices affect the risk of recurrence. The aims of this study were to synthesise safety data in patients with moderate-severe haemophilia A and with low titre inhibitors or inhibitor history enrolled in the rAHF PFM (ADVATE) - Post-Authorization Safety Studies (ADVATE-PASS) international programme. The study was conducted in clinics participating to the ADVATE PASS programme. The patient population consisted of patients entering the studies with low titre (≤ 5 BU) inhibitors or a positive personal history of inhibitors. Patients on Immune Tolerance Induction at study entry were excluded. Primary outcome was new or recurrent inhibitor titre > 5 BU. Secondary outcomes were any increase of inhibitor titre not reaching 5 BU; any unexplained change in treatment regimen. Primary analysis was done by two-stage random effects meta-analysis. Secondary analysis was done by a hierarchical Bayesian random effects logistic model. A total of 219 patients from seven studies were included. Of these 214 (97.7 %) patients had been previously treated for more than 50 exposure days. Two hundred ten patients had positive history for inhibitors, nine a baseline measurable titre. No patient presented a primary outcome event (95 % confidence interval [CI] 0-1.6 %). Six patients with previous history developed a low titre recurrence (overall rate 2.2, 95 %CI 0-4.8 %). When any increase of inhibitor titre or any treatment change was accounted for, overall 3.7 % (95 % CI 0 %-8.0 %) of patients experienced the outcome. In conclusion, the observed rate of events does not support the definition of this population as at high risk for inhibitor development.

  15. Maintaining Adequate CO2 Washout for an Advanced EMU via a New Rapid Cycle Amine Technology

    NASA Technical Reports Server (NTRS)

    Chullen, Cinda; Conger, Bruce

    2012-01-01

    Over the past several years, NASA has realized tremendous progress in Extravehicular Activity (EVA) technology development. This has been evidenced by the progressive development of a new Rapid Cycle Amine (RCA) system for the Advanced Extravehicular Mobility Unit (AEMU) Portable Life Support Subsystem (PLSS). The PLSS is responsible for the life support of the crew member in the spacesuit. The RCA technology is responsible for carbon dioxide (CO2) and humidity control. Another aspect of the RCA is that it is on-back vacuum-regenerable, efficient, and reliable. The RCA also simplifies the PLSS schematic by eliminating the need for a condensing heat exchanger for humidity control in the current EMU. As development progresses on the RCA, it is important that the sizing be optimized so that the demand on the PLSS battery is minimized. As well, maintaining the CO2 washout at adequate levels during an EVA is an absolute requirement of the RCA and associated ventilation system. Testing has been underway in-house at NASA Johnson Space Center and analysis has been initiated to evaluate whether the technology provides exemplary performance in ensuring that the CO2 is removed sufficiently and the ventilation flow is adequate for maintaining CO2 washout in the AEMU spacesuit helmet of the crew member during an EVA. This paper will review the recent developments of the RCA unit, testing planned in-house with a spacesuit simulator, and the associated analytical work along with insights from the medical aspect on the testing. 1

  16. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

    The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

  17. The two-layer geochemical structure of modern biogeochemical provinces and its significance for spatially adequate ecological evaluations and decisions

    NASA Astrophysics Data System (ADS)

    Korobova, Elena; Romanov, Sergey

    2014-05-01

    Contamination of the environment has reached such a scale that ecogeochemical situation in any area can be interpreted now as a result of the combined effect of natural and anthropogenic factors. The areas that appear uncomfortable for a long stay can have natural and anthropogenic genesis, but the spatial structure of such biogeochemical provinces is in any case formed of a combination of natural and technogenic fields of chemical elements. Features of structural organization and the difference in factors and specific time of their formation allow their separation on one hand and help in identification of areas with different ecological risks due to overlay of the two structures on the other. Geochemistry of soil cover reflects the long-term result of the naturally balanced biogeochemical cycles, therefore the soil geochemical maps of the undisturbed areas may serve the basis for evaluation of the natural geochemical background with due regard to the main factors of geochemical differentiation in biosphere. Purposeful and incidental technogenic concentrations and dispersions of chemical elements of specific (mainly mono- or polycentric) structure are also fixed in soils that serve as secondary sources of contamination of the vegetation cover and local food chains. Overlay of the two structures forms specific heterogeneity of modern biogeochemical provinces with different risk for particular groups of people, animals and plants adapted to specific natural geochemical background within particular concentration interval. The developed approach is believed to be helpful for biogeochemical regionalizing of modern biosphere (noosphere) and for spatially adequate ecogeochemical evaluation of the environment and landuse decisions. It allows production of a set of applied geochemical maps such as: 1) health risk due to chemical elements deficiency and technogenic contamination accounting of possible additive effects; 2) adequate soil fertilization and melioration with due

  18. Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

    PubMed

    Gyekye, Seth Ayim; Haybatollahi, Mohammad

    2014-01-01

    This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

  19. Safety analysis report for the Waste Storage Facility. Revision 2

    SciTech Connect

    Bengston, S.J.

    1994-05-01

    This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

  20. (Q)SAR modeling and safety assessment in regulatory review.

    PubMed

    Kruhlak, N L; Benz, R D; Zhou, H; Colatsky, T J

    2012-03-01

    The ability to predict clinical safety based on chemical structures is becoming an increasingly important part of regulatory decision making. (Quantitative) structure-activity relationship ((Q)SAR) models are currently used to evaluate late-arising safety concerns and possible nonclinical effects of a drug and its related compounds when adequate safety data are absent or equivocal. Regulatory use will likely increase with the standardization of analytical approaches, more complete and reliable data collection methods, and a better understanding of toxicity mechanisms.