Science.gov

Sample records for additional safety factor

  1. 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.

  2. 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.

  3. [Safety of food additives in Japan].

    PubMed

    Ito, Sumio

    2011-01-01

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

  4. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 2 2010-10-01 2010-10-01 false Calculation of safety net additive. 36.605... § 36.605 Calculation of safety net additive. (a) “Safety net additive support.” A rural incumbent local exchange carrier shall receive safety net additive support if it satisfies the conditions set forth...

  5. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety... solid propellants. The FAA may also require the permittee to conduct additional analyses of the cause...

  6. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Additional safety requirements. 437.77 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  7. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Additional safety requirements. 437.77 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  8. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Additional safety requirements. 437.77 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... exchange carriers shall not receive safety net additive for growth of Telecommunications Plant in Service... longer receive safety net additive after January 1, 2012 unless the carrier's realized total growth in Telecommunications Plant in Service was more than 14 percent during the qualifying period, defined as 2010 or...

  14. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... exchange carriers shall not receive safety net additive for growth of Telecommunications Plant in Service... longer receive safety net additive after January 1, 2012 unless the carrier's realized total growth in Telecommunications Plant in Service was more than 14 percent during the qualifying period, defined as 2010 or...

  15. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Additional safety requirements. 437.77 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional...

  16. 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,…

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

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

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

  18. 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....

  19. 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....

  20. Safety evaluation of substances consumed as technical ingredients (food additives).

    PubMed

    Poulsen, E

    1991-01-01

    The different types of acceptable daily intakes (ADIs) are described as used by the FAO/WHO Expert Committee on Food Additives (JECFA) and the EEC Scientific Committee for Food (SCF). The allocation is discussed of a full ADI or a temporary ADI, and examples are given for the establishment (or withdrawal) of these ADIs. The flavours cinnamyl anthranillate and the solvent 2-nitropropane (both withdrawn), the sweeteners cyclamate and saccharin and the antioxidant BHA (all three changed) but not abolished. For BHA and saccharin the ADI was retained by both committees in spite of some evidence of carcinogenicity to experimental animals. ADI--'not specified' is specially discussed and it is recommended that numerical ADIs are used whenever possible. With an ADI--'not specified' it should be stated which use (and intake) levels are toxicologically acceptable. Some compounds evaluated by the two committees are discussed, e.g. the colours: Allura red AC, erythrosine, canthaxanthin and the caramels; three anti-oxidants: BHA, BHT and the gallates; the sweeteners: polyols, aspartame, saccharin and cyclamates. Four recommendations are made: (1) a numerical basis be given for the levels allocated an ADI--'not specified' or 'acceptable'; (2) lowering of the conventional safety factor be considered when the effects found are trivial--higher safety factors be considered when the toxic effects are serious or even irreversible; (3) ADIs should, whenever possible, be based on a combination of human and animal data; (4) ADIs might be allocated to compounds indicating animal carcinogenicity, if the compound is non-genotoxic, the mechanism clearly secondary and/or species-specific.

  1. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... event of inadequate cooling or lubrication of the unit. (d) Each compressor station gas engine that... compressor station must have vent slots or holes in the baffles of each compartment to prevent gas from being... 49 Transportation 3 2010-10-01 2010-10-01 false Compressor stations: Additional safety...

  2. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... event of inadequate cooling or lubrication of the unit. (d) Each compressor station gas engine that... compressor station must have vent slots or holes in the baffles of each compartment to prevent gas from being... 49 Transportation 3 2011-10-01 2011-10-01 false Compressor stations: Additional safety...

  3. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... from the difference between the uncapped expense adjustment for the study area in the qualifying year... receive safety net additive support as calculated in paragraph (b) of this section, if in any study area, the rural incumbent local exchange carrier realizes growth in end of period Telecommunications...

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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.

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

    PubMed

    Gürtler, R

    2010-06-01

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

  11. 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.

  12. Additional information for impact response of the restart safety rods

    SciTech Connect

    Yau, W.W.F.

    1991-10-14

    WSRC-RP-91-677 studied the structural response of the safety rods under the conditions of brake failure and accidental release. It was concluded that the maximum impact loading to the safety rod is 6020 pounds based on conservative considerations that energy dissipation attributable to fluid resistance and reactor superstructure flexibility. The staffers of the Defense Nuclear Facility Safety Board reviewed the results and inquired about the extent of conservatism. By request of the RESTART team, I reassessed the impact force due to these conservative assumptions. This memorandum reports these assessments.

  13. 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...

  14. 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...

  15. 14 CFR 1203.406 - Additional classification factors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Additional classification factors. 1203.406... PROGRAM Guides for Original Classification § 1203.406 Additional classification factors. In determining the appropriate classification category, the following additional factors should be considered:...

  16. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

  17. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

  18. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

  19. 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).

  20. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  1. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  4. 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...

  5. 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment under... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT...

  11. Additional safety risk to exceptionally approved drugs in Europe?

    PubMed Central

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; Eichler, Hans-Georg; de Graeff, Pieter A; Mol, Peter G M

    2011-01-01

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear ‘unmet medical need’. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. METHODS A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. RESULTS In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P = 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P = 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. CONCLUSION The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval. PMID:21501215

  12. 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.

  13. 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.

  14. [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.

  15. 14 CFR 1203.406 - Additional classification factors.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Additional classification factors. 1203.406 Section 1203.406 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION INFORMATION SECURITY PROGRAM Guides for Original Classification § 1203.406 Additional classification factors. In...

  16. 14 CFR 1203.406 - Additional classification factors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Additional classification factors. 1203.406 Section 1203.406 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION INFORMATION SECURITY PROGRAM Guides for Original Classification § 1203.406 Additional classification factors. In...

  17. 14 CFR 1203.406 - Additional classification factors.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Additional classification factors. 1203.406 Section 1203.406 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION INFORMATION SECURITY PROGRAM Guides for Original Classification § 1203.406 Additional classification factors. In...

  18. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... 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...

  19. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the safety of a food additive whether he believes the experiments planned will yield data adequate for... 21 Food and Drugs 3 2011-04-01 2011-04-01 false General principles for evaluating the safety of food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  20. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the safety of a food additive whether he believes the experiments planned will yield data adequate for... 21 Food and Drugs 3 2010-04-01 2009-04-01 true General principles for evaluating the safety of food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  1. The safety and regulatory status of food, drug and cosmetics colour additives exempt from certification.

    PubMed

    Hallagan, J B; Allen, D C; Borzelleca, J F

    1995-06-01

    Colour additives exempt from certification (also known as 'natural colour additives') are commonly used in the United States to colour foods, drugs and cosmetics. The US Food and Drug Administration established regulations governing the use of these colour additives, and the labelling of the products that contain them. The safety of these colour additives has been demonstrated by safety testing programs that have yielded a significant amount of toxicology data, and also by a long and well documented history of safe use in the United States and elsewhere. In this report we review the data supporting the safety of the colour additives that are exempt from certification and approved for use in the USA, and conclude that the safety of these colour additives is well supported by the available data. Relevant aspects of the regulation of these colour additives are also described. PMID:7797179

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Excitotoxic food additives--relevance of animal studies to human safety.

    PubMed

    Olney, J W

    1984-01-01

    Evidence is reviewed supporting the view that excitotoxic food additives pose a significant hazard to the developing nervous system of young children. The following points are stressed: (1) although blood-brain barriers protect most central neurons from excitotoxins, certain brain regions lack such protection (a characteristic common to all vertebrate species); (2) regardless of species, it requires only a transient increase in blood excitotoxin levels for neurons in unprotected brain regions to be "silently" destroyed; (3) humans may be at particularly high risk for this kind of brain damage, since ingestion of a given amount of excitotoxin causes much higher blood excitotoxin levels in humans than in other species; (4) in addition to the heightened risk on a species basis, risk may be further increased for certain consumer sub-populations due to youth, disease or genetic factors; (5) despite these reasons for maintaining a wide margin of safety in the use of excitotoxins in foods, no safety margin is currently being observed, i.e., a comparative evaluation of animal (extensive) and human (limited) data supports the conclusion that excitotoxins, as used in foods today, may produce blood elevations high enough to cause damage to the nervous system of young children, damage which is not detectable at the time of occurrence but which may give rise to subtle disturbances in neuroendocrine function in adolescence and/or adulthood.

  7. 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.

  8. 5 CFR 5201.105 - Additional rules for Mine Safety and Health Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  9. 14 CFR § 1203.406 - Additional classification factors.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Additional classification factors. § 1203.406 Section § 1203.406 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION INFORMATION SECURITY PROGRAM Guides for Original Classification § 1203.406 Additional classification...

  10. 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....

  11. 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....

  12. 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....

  13. 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....

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false General principles for evaluating the safety of food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food...

  1. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    PubMed Central

    Dźwiarek, Marek; Latała, Agata

    2016-01-01

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

  3. 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

  4. Safety basis for the 241-AN-107 mixer pump installation and caustic addition

    SciTech Connect

    Van Vleet, R.J.

    1994-10-05

    This safety Basis was prepared to determine whether or not the proposed activities of installing a 76 HP jet mixer pump and the addition of approximately 50,000 gallons of 19 M (50:50 wt %) aqueous caustic are within the safety envelope as described by Tank Farms (chapter six of WHC-SD-WM-ISB-001, Rev. 0). The safety basis covers the components, structures and systems for the caustic addition and mixer pump installation. These include: installation of the mixer pump and monitoring equipment; operation of the mixer pump, process monitoring equipment and caustic addition; the pump stand, caustic addition skid, the electrical skid, the video camera system and the two densitometers. Also covered is the removal and decontamination of the mixer pump and process monitoring system. Authority for this safety basis is WHC-IP-0842 (Waste Tank Administration). Section 15.9, Rev. 2 (Unreviewed Safety Questions) of WHC-IP-0842 requires that an evaluation be performed for all physical modifications.

  5. 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…

  6. 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.

  7. RECENT ADDITIONS OF CRITICALITY SAFETY RELATED INTEGRAL BENCHMARK DATA TO THE ICSBEP AND IRPHEP HANDBOOKS

    SciTech Connect

    J. Blair Briggs; Lori Scott; Yolanda Rugama; Enrico Sartori

    2009-09-01

    High-quality integral benchmark experiments have always been a priority for criticality safety. However, interest in integral benchmark data is increasing as efforts to quantify and reduce calculational uncertainties accelerate to meet the demands of future criticality safety needs to support next generation reactor and advanced fuel cycle concepts. The importance of drawing upon existing benchmark data is becoming more apparent because of dwindling availability of critical facilities worldwide and the high cost of performing new experiments. Integral benchmark data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the International Handbook of Reactor Physics Benchmark Experiments are widely used. Benchmark data have been added to these two handbooks since the last Nuclear Criticality Safety Division Topical Meeting in Knoxville, Tennessee (September 2005). This paper highlights these additions.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of Sciences-National Research Council. A petition will not be denied, however, by reason of the... of Sciences-National Research Council if, from available evidence, the Commissioner finds that the... data adequate for an evaluation of the safety of the additive....

  13. 47 CFR 5.311 - Additional requirements related to safety of the public.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  14. 47 CFR 5.311 - Additional requirements related to safety of the public.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  15. Phosphazene Based Additives for Improvement of Safety and Battery Lifetimes in Lithium-Ion Batteries

    SciTech Connect

    Mason K Harrup; Kevin L Gering; Harry W Rollins; Sergiy V Sazhin; Michael T Benson; David K Jamison; Christopher J Michelbacher

    2011-10-01

    There need to be significant improvements made in lithium-ion battery technology, principally in the areas of safety and useful lifetimes to truly enable widespread adoption of large format batteries for the electrification of the light transportation fleet. In order to effect the transition to lithium ion technology in a timely fashion, one promising next step is through improvements to the electrolyte in the form of novel additives that simultaneously improve safety and useful lifetimes without impairing performance characteristics over wide temperature and cycle duty ranges. Recent efforts in our laboratory have been focused on the development of such additives with all the requisite properties enumerated above. We present the results of the study of novel phosphazene based electrolytes additives.

  16. 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...

  17. Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment.

    PubMed

    Tobin, Thomas J; Tobin, Mary L

    2015-01-01

    Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions. PMID:26514264

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

    NASA Technical Reports Server (NTRS)

    Jaffe, Richard L.

    2014-01-01

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

  20. 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)…

  1. 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.

  2. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

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

    NASA Technical Reports Server (NTRS)

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

    2014-01-01

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

  4. 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

  5. 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.

  6. 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.

  7. AP-42 ADDITIONS AND REVISIONS - TRANSPORTABILITY FACTORS FOR FUGITIVE DUST

    EPA Science Inventory

    The product is a table of factors, one for each county in the US, reflecting the portion of fugitive dust removed very close to the source via impaction on vegetation and similar mechanisms. Factors were based on land cover in area (county or grid cell) A praft final product was...

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

    NASA Astrophysics Data System (ADS)

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

    2015-02-01

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

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

    PubMed

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

    2015-02-25

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

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

    PubMed

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

    2015-02-25

    A novel strategy which combines iteratively cubic spline fitting baseline correction method with discriminant partial least squares qualitative analysis is employed to analyze the surface enhanced Raman scattering (SERS) spectroscopy of banned food additives, such as Sudan I dye and Rhodamine B in food, Malachite green residues in aquaculture fish. Multivariate qualitative analysis methods, using the combination of spectra preprocessing iteratively cubic spline fitting (ICSF) baseline correction with principal component analysis (PCA) and discriminant partial least squares (DPLS) classification respectively, are applied to investigate the effectiveness of SERS spectroscopy for predicting the class assignments of unknown banned food additives. PCA cannot be used to predict the class assignments of unknown samples. However, the DPLS classification can discriminate the class assignment of unknown banned additives using the information of differences in relative intensities. The results demonstrate that SERS spectroscopy combined with ICSF baseline correction method and exploratory analysis methodology DPLS classification can be potentially used for distinguishing the banned food additives in field of food safety. PMID:25300041

  11. 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...

  12. 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...

  13. 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...

  14. Toxicological safety assessment of genetically modified Bacillus thuringiensis with additional N-acyl homoserine lactonase gene.

    PubMed

    Peng, Donghai; Zhou, Chenfei; Chen, Shouwen; Ruan, Lifang; Yu, Ziniu; Sun, Ming

    2008-01-01

    The aim of the present study is to evaluate the toxicology safety to mammals of a genetically modified (GM) Bacillus thuringiensis with an additional N-acyl homoserine lactones gene (aiiA), which possesses insecticidal activity together with restraint of bacterial pathogenicity and is intended for use as a multifunctional biopesticide. Safety assessments included an acute oral toxicity test and 28-d animal feeding study in Wistar rats, primary eye and dermal irritation in Zealand White rabbits, and delayed contact hypersensitivity in guinea pigs. Tests were conducted using spray-dried powder preparation. This GM product showed toxicity neither in oral acute toxicity test nor in 28-d animal feeding test at a dose of 5,000 mg/kg body weight. During the animal feeding test, there were no significant differences in growth, food and water consumption, hematology, blood biochemical indices, organ weights, and histopathology finding between rats in controls and tested groups. Tested animals in primary eye and dermal irritation and delayed contact hypersensitivity test were also devoid of any toxicity compared to controls. All the above results demonstrated that the GM based multifunctional B. thuringiensis has low toxicity and low eye and dermal irritation and would not cause hypersensitivity to laboratory mammals and therefore could be regarded as safe for use as a pesticide.

  15. 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...

  16. 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...

  17. Factors which Limit the Value of Additional Redundancy in Human Rated Launch Vehicle Systems

    NASA Technical Reports Server (NTRS)

    Anderson, Joel M.; Stott, James E.; Ring, Robert W.; Hatfield, Spencer; Kaltz, Gregory M.

    2008-01-01

    The National Aeronautics and Space Administration (NASA) has embarked on an ambitious program to return humans to the moon and beyond. As NASA moves forward in the development and design of new launch vehicles for future space exploration, it must fully consider the implications that rule-based requirements of redundancy or fault tolerance have on system reliability/risk. These considerations include common cause failure, increased system complexity, combined serial and parallel configurations, and the impact of design features implemented to control premature activation. These factors and others must be considered in trade studies to support design decisions that balance safety, reliability, performance and system complexity to achieve a relatively simple, operable system that provides the safest and most reliable system within the specified performance requirements. This paper describes conditions under which additional functional redundancy can impede improved system reliability. Examples from current NASA programs including the Ares I Upper Stage will be shown.

  18. 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...

  19. 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.

  20. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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...

  12. 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.

  13. 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.

  14. Additional Studies of the Criticality Safety of Failed Used Nuclear Fuel

    SciTech Connect

    Marshall, William BJ J; Wagner, John C

    2013-01-01

    Commercial used nuclear fuel (UNF) in the United States is expected to remain in storage for periods potentially greater than 40 years. Extended storage (ES) time and irradiation to high-burnup values (>45 GWd/t) may increase the potential for fuel failure during normal and accident conditions involving storage and transportation. Fuel failure, depending on the severity, could result in changes to the geometric configuration of the fuel, which has safety and regulatory implications. The likelihood and extent of fuel reconfiguration and its impact on the safety of the UNF is not well understood. The objective of this work is to assess and quantify the impact of fuel reconfiguration due to fuel failure on criticality safety of UNF in storage and transportation casks. Criticality analyses are conducted considering representative UNF designs covering a range of enrichments and burnups in multiple cask systems. Prior work developed a set of failed fuel configuration categories and specific configurations were evaluated to understand trends and quantify the consequences of worst-case potential reconfiguration progressions. These results will be summarized here and indicate that the potential impacts on subcriticality can be rather significant for certain configurations (e.g., >20% keff). It can be concluded that the consequences of credible fuel failure configurations from ES or transportation following ES are manageable (e.g., <5% keff). The current work expands on these efforts and examines some modified scenarios and modified approaches to investigate the effectiveness of some techniques for reducing the calculated increase in keff. The areas included here are more realistic modeling of some assembly types and the effect of reconfiguration of some assemblies in the storage and transportation canister.

  15. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... additives stated in current publications of the National Academy of Sciences-National Research Council. A... those outlined in the publications of the National Academy of Sciences-National Research Council if... additive whether he believes the experiments planned will yield data adequate for an evaluation of...

  16. Safety assessment of butylated hydroxyanisole and butylated hydroxytoluene as antioxidant food additives.

    PubMed

    Williams, G M; Iatropoulos, M J; Whysner, J

    1999-01-01

    Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) are widely used antioxidant food additives. They have been extensively studied for potential toxicities. This review details experimental studies of genotoxicity and carcinogenicity which bear on cancer hazard assessment of exposure to humans. We conclude that BHA and BHT pose no cancer hazard and, to the contrary, may be anticarcinogenic at current levels of food additive use.

  17. 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.

  18. 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.

  19. 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

  20. Evaluation of Herbal Medicines: Value Addition to Traditional Medicines Through Metabolism, Pharmacokinetic and Safety Studies.

    PubMed

    Thelingwani, Roslyn; Masimirembwa, Collen

    2014-01-01

    The safety and efficacy of herbal medicines remain major issues of concern especially in the developing world where the use is high. The World Health Organisation estimates up to 80% of the population in Africa relies on herbal medicines for treatment of many diseases. Minimum safety evaluations need to be done for both the herbal and conventional drugs, in particular when there is a high likelihood of co-administration. This is particularly important in Africa where there is increased access to antiretrovirals in the treatment of HIV/AIDS, which are being used in a population background characterized by rampant use of herbal medicines. Many techniques used in the discovery and evaluation of conventional drugs can be adapted to herbal medicines. Such evaluations will add value to herbal medicines as doctors and patients will be better informed on which drugs and herbal medicines to take or not take together. This can also lead to the adoption of guidelines by regulatory agents such as the European Medicines Agency (EMA), Food and Drug Administration (FDA) and governmental agencies controlling the use of medicines. Of current interest is the evaluation of drug-herb interactions (DHI) involving the absorption, distribution, metabolism and excretion (ADME) of medicines where there is a promising possibility to adopt the current FDA and EMA guidelines on the evaluation of herbal medicines for drug-drug interactions (DDI). In this review we demonstrate progress made so far in DHI and point to possible future developments that will contribute to the safe use of herbal medicines.

  1. 5 CFR 5201.105 - Additional rules for Mine Safety and Health Administration employees.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... that the waiver is not inconsistent with 5 CFR part 2635 or otherwise prohibited by law and that, under... covered relationship or interest is likely to be inconsistent with 5 CFR part 2635 or is otherwise... of 5 CFR 2635.402 and 2635.502. (4) Factors which may be considered in connection with the...

  2. Improvement in safety and cycle life of lithium-ion batteries by employing quercetin as an electrolyte additive

    NASA Astrophysics Data System (ADS)

    Lee, Meng-Lun; Li, Yu-Han; Yeh, Jien-Wei; Shih, Han C.

    2012-09-01

    Quercetin, an organic antioxidant, has been employed as an additive in lithium-ion cells to enhance the electrochemical performance to enhance the cycle life and the overcharging characteristics of LiPF6/EC + EMC + DMC (1 M) when used as an electrolyte. A LiCoO2/graphite full cell with 0.05% quercetin showed a significant improvement in safety associated with overcharging tolerance and thermal stability, without causing damage in C-rate capability, and even a small improvement in cycle life performance. The quercetin-containing lithium battery showed an improvement in its electrochemical properties with 92% capacity retention after 350 cycles from 2.8 to 4.3 V, at a rate of 1 C; compared to 85% capacity retention for a cell without quercetin operated under the same conditions. The electrochemical impedance spectroscopy (EIS) results for the LiCoO2 cathode show that the addition of 0.05% quercetin provides a significant suppression in the impedance of the cell after 60 cycles. The improvement might result from the formation of a passivation microstructure (from quercetin oxidation) on the electrode's surface. The quercetin-containing batteries provided long term cycling and a high safety performance, making them a viable power source for applications involving electric devices with significant safety requirements.

  3. 34 CFR 377.22 - What additional factors does the Secretary consider in making grants?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROJECTS TO INCREASE CLIENT CHOICE PROGRAM How Does the Secretary Make an Award? § 377.22 What additional factors does the Secretary consider in making grants? In addition to the criteria in § 377.21, the... strategies to increase client choice, in order to ensure that a variety of approaches are demonstrated...

  4. 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

  5. PAT-1 safety analysis report addendum author responses to request for additional information.

    SciTech Connect

    Weiner, Ruth F.; Schmale, David T.; Kalan, Robert J.; Akin, Lili A.; Miller, David Russell; Knorovsky, Gerald Albert; Yoshimura, Richard Hiroyuki; Lopez, Carlos; Harding, David Cameron; Jones, Perry L.; Morrow, Charles W.

    2010-09-01

    The Plutonium Air Transportable Package, Model PAT-1, is certified under Title 10, Code of Federal Regulations Part 71 by the U.S. Nuclear Regulatory Commission (NRC) per Certificate of Compliance (CoC) USA/0361B(U)F-96 (currently Revision 9). The National Nuclear Security Administration (NNSA) submitted SAND Report SAND2009-5822 to NRC that documented the incorporation of plutonium (Pu) metal as a new payload for the PAT-1 package. NRC responded with a Request for Additional Information (RAI), identifying information needed in connection with its review of the application. The purpose of this SAND report is to provide the authors responses to each RAI. SAND Report SAND2010-6106 containing the proposed changes to the Addendum is provided separately.

  6. Are major behavioral and sociodemographic risk factors for mortality additive or multiplicative in their effects?

    PubMed

    Mehta, Neil; Preston, Samuel

    2016-04-01

    All individuals are subject to multiple risk factors for mortality. In this paper, we consider the nature of interactions between certain major sociodemographic and behavioral risk factors associated with all-cause mortality in the United States. We develop the formal logic pertaining to two forms of interaction between risk factors, additive and multiplicative relations. We then consider the general circumstances in which additive or multiplicative relations might be expected. We argue that expectations about interactions among socio-demographic variables, and their relation to behavioral variables, have been stated in terms of additivity. However, the statistical models typically used to estimate the relation between risk factors and mortality assume that risk factors act multiplicatively. We examine empirically the nature of interactions among five major risk factors associated with all-cause mortality: smoking, obesity, race, sex, and educational attainment. Data were drawn from the cross-sectional NHANES III (1988-1994) and NHANES 1999-2010 surveys, linked to death records through December 31, 2011. Our analytic sample comprised 35,604 respondents and 5369 deaths. We find that obesity is additive with each of the remaining four variables. We speculate that its additivity is a reflection of the fact that obese status is generally achieved later in life. For all pairings of socio-demographic variables, risks are multiplicative. For survival chances, it is much more dangerous to be poorly educated if you are black or if you are male. And it is much riskier to be a male if you are black. These traits, established at birth or during childhood, literally result in deadly combinations. We conclude that the identification of interactions among risk factors can cast valuable light on the nature of the process being studied. It also has public health implications by identifying especially vulnerable groups and by properly identifying the proportion of deaths

  7. 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.

  8. 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

  9. Critical review of the safety assessment of nano-structured silica additives in food.

    PubMed

    Winkler, Hans Christian; Suter, Mark; Naegeli, Hanspeter

    2016-01-01

    The development of nano-materials is viewed as one of the most important technological advances of the 21st century and new applications of nano-sized particles in the production, processing, packaging or storage of food are expected to emerge soon. This trend of growing commercialization of engineered nano-particles as part of modern diet will substantially increase oral exposure. Contrary to the proven benefits of nano-materials, however, possible adverse health effects have generally received less attention. This problem is very well illustrated by nano-structured synthetic amorphous silica (SAS), which is a common food additive since several decades although the relevant risk assessment has never been satisfactorily completed. A no observed adverse effect level of 2500 mg SAS particles/kg body weight per day was derived from the only available long-term administration study in rodents. However, extrapolation to a safe daily intake for humans is problematic due to limitations of this chronic animal study and knowledge gaps as to possible local intestinal effects of SAS particles, primarily on the gut-associated lymphoid system. This uncertainty is aggravated by digestion experiments indicating that dietary SAS particles preserve their nano-sized structure when reaching the intestinal lumen. An important aspect is whether food-borne particles like SAS alter the function of dendritic cells that, embedded in the intestinal mucosa, act as first-line sentinels of foreign materials. We conclude that nano-particles do not represent a completely new threat and that most potential risks can be assessed following procedures established for conventional chemical hazards. However, specific properties of food-borne nano-particles should be further examined and, for that purpose, in vitro tests with decision-making cells of the immune system are needed to complement existing in vivo studies. PMID:27287345

  10. Critical review of the safety assessment of nano-structured silica additives in food.

    PubMed

    Winkler, Hans Christian; Suter, Mark; Naegeli, Hanspeter

    2016-06-10

    The development of nano-materials is viewed as one of the most important technological advances of the 21st century and new applications of nano-sized particles in the production, processing, packaging or storage of food are expected to emerge soon. This trend of growing commercialization of engineered nano-particles as part of modern diet will substantially increase oral exposure. Contrary to the proven benefits of nano-materials, however, possible adverse health effects have generally received less attention. This problem is very well illustrated by nano-structured synthetic amorphous silica (SAS), which is a common food additive since several decades although the relevant risk assessment has never been satisfactorily completed. A no observed adverse effect level of 2500 mg SAS particles/kg body weight per day was derived from the only available long-term administration study in rodents. However, extrapolation to a safe daily intake for humans is problematic due to limitations of this chronic animal study and knowledge gaps as to possible local intestinal effects of SAS particles, primarily on the gut-associated lymphoid system. This uncertainty is aggravated by digestion experiments indicating that dietary SAS particles preserve their nano-sized structure when reaching the intestinal lumen. An important aspect is whether food-borne particles like SAS alter the function of dendritic cells that, embedded in the intestinal mucosa, act as first-line sentinels of foreign materials. We conclude that nano-particles do not represent a completely new threat and that most potential risks can be assessed following procedures established for conventional chemical hazards. However, specific properties of food-borne nano-particles should be further examined and, for that purpose, in vitro tests with decision-making cells of the immune system are needed to complement existing in vivo studies.

  11. 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

  12. 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.

  13. 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

  14. 34 CFR 648.32 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What additional factors does the Secretary consider? 648.32 Section 648.32 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION GRADUATE ASSISTANCE IN AREAS OF NATIONAL...

  15. 34 CFR 491.22 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 3 2013-07-01 2013-07-01 false What additional factor does the Secretary consider? 491.22 Section 491.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION FOR THE...

  16. 34 CFR 491.22 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 3 2012-07-01 2012-07-01 false What additional factor does the Secretary consider? 491.22 Section 491.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION FOR THE...

  17. 34 CFR 491.22 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 3 2014-07-01 2014-07-01 false What additional factor does the Secretary consider? 491.22 Section 491.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION FOR THE...

  18. 34 CFR 491.22 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 3 2011-07-01 2011-07-01 false What additional factor does the Secretary consider? 491.22 Section 491.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION FOR THE...

  19. 34 CFR 491.22 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What additional factor does the Secretary consider? 491.22 Section 491.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION FOR THE...

  20. 34 CFR 636.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What additional factors does the Secretary consider? 636.22 Section 636.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION URBAN COMMUNITY SERVICE PROGRAM How Does...

  1. 34 CFR 636.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 3 2014-07-01 2014-07-01 false What additional factors does the Secretary consider? 636.22 Section 636.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION URBAN COMMUNITY SERVICE PROGRAM How Does...

  2. 34 CFR 636.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 3 2012-07-01 2012-07-01 false What additional factors does the Secretary consider? 636.22 Section 636.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION URBAN COMMUNITY SERVICE PROGRAM How Does...

  3. 34 CFR 636.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 3 2013-07-01 2013-07-01 false What additional factors does the Secretary consider? 636.22 Section 636.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION URBAN COMMUNITY SERVICE PROGRAM How Does...

  4. 34 CFR 636.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 3 2011-07-01 2011-07-01 false What additional factors does the Secretary consider? 636.22 Section 636.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION URBAN COMMUNITY SERVICE PROGRAM How Does...

  5. 21 CFR 1311.115 - Additional requirements for two-factor authentication.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Additional requirements for two-factor authentication. 1311.115 Section 1311.115 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE... criteria of FIPS 140-2 Security Level 1, as incorporated by reference in § 1311.08, for...

  6. 21 CFR 1311.115 - Additional requirements for two-factor authentication.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Additional requirements for two-factor authentication. 1311.115 Section 1311.115 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE... criteria of FIPS 140-2 Security Level 1, as incorporated by reference in § 1311.08, for...

  7. 34 CFR 425.22 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What additional factors does the Secretary consider? 425.22 Section 425.22 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION DEMONSTRATION PROJECTS FOR...

  8. 34 CFR 648.32 - What additional factors does the Secretary consider?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... private institutions of higher education. (Authority: 20 U.S.C. 1135-1135c) ... 34 Education 3 2011-07-01 2011-07-01 false What additional factors does the Secretary consider? 648.32 Section 648.32 Education Regulations of the Offices of the Department of Education...

  9. 34 CFR 472.23 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What additional factor does the Secretary consider? 472.23 Section 472.23 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION NATIONAL WORKPLACE LITERACY PROGRAM...

  10. 34 CFR 472.23 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 3 2012-07-01 2012-07-01 false What additional factor does the Secretary consider? 472.23 Section 472.23 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION NATIONAL WORKPLACE LITERACY PROGRAM...

  11. 34 CFR 472.23 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 3 2014-07-01 2014-07-01 false What additional factor does the Secretary consider? 472.23 Section 472.23 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION NATIONAL WORKPLACE LITERACY PROGRAM...

  12. 34 CFR 472.23 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 3 2011-07-01 2011-07-01 false What additional factor does the Secretary consider? 472.23 Section 472.23 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION NATIONAL WORKPLACE LITERACY PROGRAM...

  13. 34 CFR 472.23 - What additional factor does the Secretary consider?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 3 2013-07-01 2013-07-01 false What additional factor does the Secretary consider? 472.23 Section 472.23 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION NATIONAL WORKPLACE LITERACY PROGRAM...

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. Exploring Typical and Atypical Safety Climate Perceptions of Practitioners in the Repair, Maintenance, Minor Alteration and Addition (RMAA) Sector in Hong Kong.

    PubMed

    Hon, Carol K H; Liu, Yulin

    2016-01-01

    The safety of repair, maintenance, minor alteration and addition (RMAA) work is an under-explored area. This study explored the typical and atypical safety climate perceptions of practitioners in the RMAA sector in Hong Kong, based on a self-administered questionnaire survey of 662 local practitioners in the industry. Profile analysis, via multidimensional scaling of the respondents' scores of three safety climate scales, identified one typical perception: high in management commitment to occupational health and safety (OHS) and employee involvement, low in applicability for safety rules and regulations, and low in responsibility for OHS. The respondents were clustered into typical and atypical perception groups according to their safety climate scores' match to the typical perception. A comparison of demographics between the two groups with logistic regression found that work level and direct employer significantly affect their classification. A multivariate analysis of variance of safety performance measures between the two groups indicated that the typical group had a significantly higher level of safety compliance than the atypical group, with no significant difference in safety participation or injury. The significance of this study lies in revealing the typical safety climate perception profile pattern of RMAA works and offering a new perspective of safety climate research. PMID:27669269

  20. Exploring Typical and Atypical Safety Climate Perceptions of Practitioners in the Repair, Maintenance, Minor Alteration and Addition (RMAA) Sector in Hong Kong.

    PubMed

    Hon, Carol K H; Liu, Yulin

    2016-09-22

    The safety of repair, maintenance, minor alteration and addition (RMAA) work is an under-explored area. This study explored the typical and atypical safety climate perceptions of practitioners in the RMAA sector in Hong Kong, based on a self-administered questionnaire survey of 662 local practitioners in the industry. Profile analysis, via multidimensional scaling of the respondents' scores of three safety climate scales, identified one typical perception: high in management commitment to occupational health and safety (OHS) and employee involvement, low in applicability for safety rules and regulations, and low in responsibility for OHS. The respondents were clustered into typical and atypical perception groups according to their safety climate scores' match to the typical perception. A comparison of demographics between the two groups with logistic regression found that work level and direct employer significantly affect their classification. A multivariate analysis of variance of safety performance measures between the two groups indicated that the typical group had a significantly higher level of safety compliance than the atypical group, with no significant difference in safety participation or injury. The significance of this study lies in revealing the typical safety climate perception profile pattern of RMAA works and offering a new perspective of safety climate research.

  1. Exploring Typical and Atypical Safety Climate Perceptions of Practitioners in the Repair, Maintenance, Minor Alteration and Addition (RMAA) Sector in Hong Kong

    PubMed Central

    Hon, Carol K.H.; Liu, Yulin

    2016-01-01

    The safety of repair, maintenance, minor alteration and addition (RMAA) work is an under-explored area. This study explored the typical and atypical safety climate perceptions of practitioners in the RMAA sector in Hong Kong, based on a self-administered questionnaire survey of 662 local practitioners in the industry. Profile analysis, via multidimensional scaling of the respondents’ scores of three safety climate scales, identified one typical perception: high in management commitment to occupational health and safety (OHS) and employee involvement, low in applicability for safety rules and regulations, and low in responsibility for OHS. The respondents were clustered into typical and atypical perception groups according to their safety climate scores’ match to the typical perception. A comparison of demographics between the two groups with logistic regression found that work level and direct employer significantly affect their classification. A multivariate analysis of variance of safety performance measures between the two groups indicated that the typical group had a significantly higher level of safety compliance than the atypical group, with no significant difference in safety participation or injury. The significance of this study lies in revealing the typical safety climate perception profile pattern of RMAA works and offering a new perspective of safety climate research. PMID:27669269

  2. Isolation of an additional member of the fibroblast growth factor receptor family, FGFR-3.

    PubMed Central

    Keegan, K; Johnson, D E; Williams, L T; Hayman, M J

    1991-01-01

    The fibroblast growth factors are a family of polypeptide growth factors involved in a variety of activities including mitogenesis, angiogenesis, and wound healing. Fibroblast growth factor receptors (FGFRs) have previously been identified in chicken, mouse, and human and have been shown to contain an extracellular domain with either two or three immunoglobulin-like domains, a transmembrane domain, and a cytoplasmic tyrosine kinase domain. We have isolated a human cDNA for another tyrosine kinase receptor that is highly homologous to the previously described FGFR. Expression of this receptor cDNA in COS cells directs the expression of a 125-kDa glycoprotein. We demonstrate that this cDNA encodes a biologically active receptor by showing that human acidic and basic fibroblast growth factors activate this receptor as measured by 45Ca2+ efflux assays. These data establish the existence of an additional member of the FGFR family that we have named FGFR-3. Images PMID:1847508

  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. 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.

  5. The Evaluation of Triphenyl Phosphate as a Flame Retardant Additive to Improve the Safety of Lithium-Ion Battery Electrolytes

    NASA Technical Reports Server (NTRS)

    Smart, M. C.; Krause, F. C.; Hwang, C.; West, W. C.; Soler, J.; Prakash, G. K. S.; Ratnakumar, B. V.

    2011-01-01

    With the intent of improving the safety characteristics of lithium ion cells, electrolytes containing flame retardant additives have been investigated. A number of triphenyl phosphate-containing electrolytes were evaluated in both coin cells and experimental three electrode lithium-ion cells (containing reference electrodes). A number of chemistries were investigated, including MCMB carbon/LiNi(0.8)Co(0.2)O2 (NCO), graphite/LiNi(0.8)Co(0.15)Al(0.05)O2 (NCA), Li/Li(Li(0.17)Ni(0.25)Mn(0.58))O2, Li/LiNiMnCoO2 (NMC) and graphite/LiNiMnCoO2 (NMC), to study the effect that different electrolyte compositions have upon performance. A wide range of TPP-containing electrolytes were demonstrated to have good compatibility with the C/NCO, C/NCA, and Li/NMC systems, however, poor performance was initially observed with the high voltage C/NMC system. This necessitated the development of improved electrolytes with stabilizing additives, leading to formulations containing lithium bis(oxalato)borate (LiBOB) that displayed substantially improved performance.

  6. 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

  7. 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)

  8. 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

  9. 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

  10. Identifying food proteins with allergenic potential: evolution of approaches to safety assessment and research to provide additional tools.

    PubMed

    Ladics, Gregory S; Selgrade, MaryJane K

    2009-08-01

    A safety assessment process exists for genetically engineered crops that includes the evaluation of the expressed protein for allergenic potential. The objectives of this evaluation are twofold: (1) to protect allergic consumers from exposure to known allergenic or cross-reactive proteins, and (2) protect the general population from risks associated with the introduction of genes encoding proteins that are likely to become food allergens. The first systematic approach to address these concerns was formulated by Metcalfe et al. [Metcalfe, D.D., Astwood, J.D., Townsend, R., Sampson, H.A., Taylor, S.L., and Fuchs, R.L. 1996. Assessment of the allergenic potential of foods from genetically engineered crop plants. Crit. Rev. Food Sci. Nutr. 36(5), 165-186.] and subsequently Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO) [FAO/WHO, 2001. Evaluation of allergenicity of genetically modified foods. Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. January 22-25, 2001. Rome, Italy]. More recently, Codex [Codex Alimentarius Commission, 2003. Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, Twenty-Fifth Session, Rome, Italy, 30 June-5 July, 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants, and Appendix IV, Annex on the assessment of possible allergenicity. pp. 47-60], noting that no single factor is recognized as an identifier for protein allergenicity, suggested a weight of evidence approach be conducted that takes into account a variety of factors and approaches for an overall assessment of allergenic potential. These various recommendations are based on what is known about allergens, including the history of exposure and safety of the gene(s) source; amino acid sequence identity to human allergens; stability to pepsin digestion in vitro; protein abundance in the crop and

  11. Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

    SciTech Connect

    Garvin, L.J.

    1997-05-20

    This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements.

  12. 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....

  13. 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

  14. 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.

  15. Three WRKY transcription factors additively repress abscisic acid and gibberellin signaling in aleurone cells.

    PubMed

    Zhang, Liyuan; Gu, Lingkun; Ringler, Patricia; Smith, Stanley; Rushton, Paul J; Shen, Qingxi J

    2015-07-01

    Members of the WRKY transcription factor superfamily are essential for the regulation of many plant pathways. Functional redundancy due to duplications of WRKY transcription factors, however, complicates genetic analysis by allowing single-mutant plants to maintain wild-type phenotypes. Our analyses indicate that three group I WRKY genes, OsWRKY24, -53, and -70, act in a partially redundant manner. All three showed characteristics of typical WRKY transcription factors: each localized to nuclei and yeast one-hybrid assays indicated that they all bind to W-boxes, including those present in their own promoters. Quantitative real time-PCR (qRT-PCR) analyses indicated that the expression levels of the three WRKY genes varied in the different tissues tested. Particle bombardment-mediated transient expression analyses indicated that all three genes repress the GA and ABA signaling in a dosage-dependent manner. Combination of all three WRKY genes showed additive antagonism of ABA and GA signaling. These results suggest that these WRKY proteins function as negative transcriptional regulators of GA and ABA signaling. However, different combinations of these WRKY genes can lead to varied strengths in suppression of their targets.

  16. Safety and efficacy of the addition of simvastatin to panitumumab in previously treated KRAS mutant metastatic colorectal cancer patients.

    PubMed

    Baas, Jara M; Krens, Lisanne L; Bos, Monique M; Portielje, Johanneke E A; Batman, Erdogan; van Wezel, Tom; Morreau, Hans; Guchelaar, Henk-Jan; Gelderblom, Hans

    2015-09-01

    Panitumumab has proven efficacy in patients with metastatic or locally advanced colorectal cancer patients, provided that they have no activating KRAS mutation in their tumour. Simvastatin blocks the mevalonate pathway and thereby interferes with the post-translational modification of KRAS. We hypothesize that the activity of the RAS-induced pathway in patients with a KRAS mutation might be inhibited by simvastatin. This would theoretically result in increased sensitivity to panitumumab, potentially comparable with tumours with wild-type KRAS. A Simon two-stage design single-arm, phase II study was designed to test the safety and efficacy of the addition of simvastatin to panitumumab in colorectal cancer patients with a KRAS mutation after failing fluoropyrimidine-based, oxaliplatin-based and irinotecan-based therapy. The primary endpoint of this study was the proportion of patients alive and free from progression 11 weeks after the first administration of panitumumab, aiming for at least 40%, which is comparable with, although slightly lower than, that in KRAS wild-type patients in this setting. If this 40% was reached, then the study would continue into the second step up to 46 patients. Explorative correlative analysis for mutations in the KRAS and related pathways was carried out. One of 14 patients was free from progression at the primary endpoint time. The median progression-free survival was 8.4 weeks and the median overall survival status was 19.6 weeks. We conclude that the concept of mutant KRAS phenotype expression modulation with simvastatin was not applicable in the clinic.

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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

  2. 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.

  3. Additive Factors Do Not Imply Discrete Processing Stages: A Worked Example Using Models of the Stroop Task

    PubMed Central

    Stafford, Tom; Gurney, Kevin N.

    2011-01-01

    Previously, it has been shown experimentally that the psychophysical law known as Piéron’s Law holds for color intensity and that the size of the effect is additive with that of Stroop condition (Stafford et al., 2011). According to the additive factors method (Donders, 1868–1869/1969; Sternberg, 1998), additivity is assumed to indicate independent and discrete processing stages. We present computational modeling work, using an existing Parallel Distributed Processing model of the Stroop task (Cohen et al., 1990) and a standard model of decision making (Ratcliff, 1978). This demonstrates that additive factors can be successfully accounted for by existing single stage models of the Stroop effect. Consequently, it is not valid to infer either discrete stages or separate loci of effects from additive factors. Further, our modeling work suggests that information binding may be a more important architectural property for producing additive factors than discrete stages. PMID:22102842

  4. The Evaluation of Triphenyl Phosphate as a Flame Retardant Additive to Improve the Safety of Lithium-Ion Battery Electrolytes

    NASA Technical Reports Server (NTRS)

    Smart, M. C.; Krause, F. C.; Hwang, C.; Westa, W. C.; Soler, J.; Prakash, G. K. S.; Ratnakumar, B. V.

    2011-01-01

    NASA is actively pursuing the development of advanced electrochemical energy storage and conversion devices for future lunar and Mars missions. The Exploration Technology Development Program, Energy Storage Project is sponsoring the development of advanced Li-ion batteries and PEM fuel cell and regenerative fuel cell systems for the Altair Lunar Lander, Extravehicular Activities (EVA), and rovers and as the primary energy storage system for Lunar Surface Systems. At JPL, in collaboration with NASA-GRC, NASA-JSC and industry, we are actively developing advanced Li-ion batteries with improved specific energy, energy density and safety. One effort is focused upon developing Li-ion battery electrolyte with enhanced safety characteristics (i.e., low flammability). A number of commercial applications also require Li-ion batteries with enhanced safety, especially for automotive applications.

  5. 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.

  6. 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.

  7. 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.

  8. Additive cytotoxicity of different monoclonal antibody-cobra venom factor conjugates for human neuroblastoma cells.

    PubMed

    Juhl, H; Petrella, E C; Cheung, N K; Bredehorst, R; Vogel, C W

    1997-11-01

    Insufficient numbers of antigen molecules and heterogeneity of antigen expression on tumor cells are major factors limiting the immunotherapeutic potential of the few clinically useful monoclonal antibodies capable of mediating complement cytotoxicity and antibody-dependent cellular cytotoxicity. To overcome this limitation, we converted two non-cytotoxic monoclonal anti-neuroblastoma antibodies, designated 3E7 (IgG2b) and 8H9 (IgG1), and the non-cytotoxic F(ab')2 fragment of the cytotoxic monoclonal anti-GD2 antibody 3F8 (IgG3) into cytotoxic antibody conjugates by covalent attachment of cobra venom factor (CVF), a structural and functional homologue of the activated third component of complement. Competitive binding experiments confirmed the different specificities of the three antibodies. In the presence of human complement, all three antibody-CVF conjugates mediated selective complement-dependent lysis of human neuroblastoma cells. Consistent with the kinetics of the alternative pathway of complement, approximately seven hours incubation were required to reach maximum cytotoxicity of up to 25% for the 3E7-CVF conjugate, up to 60% for the 8H9-CVF conjugate, and up to 95% for the 3F8 F(ab')2-CVF conjugate. The different extent of maximal cytotoxic activity of the three conjugates was reflected by corresponding differences in the extent of binding of both unconjugated antibodies and the respective conjugates. Any combination of the three antibody-CVF conjugates caused an additive effect in complement-mediated lysis. Using a cocktail of all three conjugates, the extent of complement-mediated killing could be increased up to 100%. These data demonstrate that by coupling of CVF the relative large number of non-cytotoxic monoclonal anti-tumor antibodies of interesting specificity can be used to design cocktails of cytotoxic conjugates and, thereby, to overcome the problem of insufficient and heterogeneous antigen expression on tumor cells for immunotherapy.

  9. Integrating products of Bessel functions with an additional exponential or rational factor

    NASA Astrophysics Data System (ADS)

    Van Deun, Joris; Cools, Ronald

    2008-04-01

    We provide two MATLAB programs to compute integrals of the form ex∏i=1kJν_i(ax)dxand 0∞xr+x∏i=1kJν_i(ax)dx with Jν_i(x) the Bessel function of the first kind and (real) order ν. The parameter m is a real number such that ∑ν+m>-1 (to assure integrability near zero), r is real and the numbers c and a are all strictly positive. The program can deliver accurate error estimates. Program summaryProgram title: BESSELINTR, BESSELINTC Catalogue identifier: AEAH_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEAH_v1_0.html Program obtainable from: CPC Program Library, Queen's University, Belfast, N. Ireland Licensing provisions: Standard CPC licence, http://cpc.cs.qub.ac.uk/licence/licence.html No. of lines in distributed program, including test data, etc.: 1601 No. of bytes in distributed program, including test data, etc.: 13 161 Distribution format: tar.gz Programming language: Matlab (version ⩾6.5), Octave (version ⩾2.1.69) Computer: All supporting Matlab or Octave Operating system: All supporting Matlab or Octave RAM: For k Bessel functions our program needs approximately ( 500+140k) double precision variables Classification: 4.11 Nature of problem: The problem consists in integrating an arbitrary product of Bessel functions with an additional rational or exponential factor over a semi-infinite interval. Difficulties arise from the irregular oscillatory behaviour and the possible slow decay of the integrand, which prevents truncation at a finite point. Solution method: The interval of integration is split into a finite and infinite part. The integral over the finite part is computed using Gauss-Legendre quadrature. The integrand on the infinite part is approximated using asymptotic expansions and this approximation is integrated exactly with the aid of the upper incomplete gamma function. In the case where a rational factor is present, this factor is first expanded in a Taylor series around infinity. Restrictions: Some (and eventually all

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. [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.

  15. 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.

  16. 34 CFR 359.32 - What additional factors does the Secretary consider in making a grant under this program?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EDUCATION DISABILITY AND REHABILITATION RESEARCH: SPECIAL PROJECTS AND DEMONSTRATIONS FOR SPINAL CORD INJURIES How Does the Secretary Make a Grant? § 359.32 What additional factors does the Secretary...

  17. 34 CFR 359.32 - What additional factors does the Secretary consider in making a grant under this program?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... EDUCATION DISABILITY AND REHABILITATION RESEARCH: SPECIAL PROJECTS AND DEMONSTRATIONS FOR SPINAL CORD INJURIES How Does the Secretary Make a Grant? § 359.32 What additional factors does the Secretary...

  18. 34 CFR 359.32 - What additional factors does the Secretary consider in making a grant under this program?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... EDUCATION DISABILITY AND REHABILITATION RESEARCH: SPECIAL PROJECTS AND DEMONSTRATIONS FOR SPINAL CORD INJURIES How Does the Secretary Make a Grant? § 359.32 What additional factors does the Secretary...

  19. 34 CFR 359.32 - What additional factors does the Secretary consider in making a grant under this program?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... EDUCATION DISABILITY AND REHABILITATION RESEARCH: SPECIAL PROJECTS AND DEMONSTRATIONS FOR SPINAL CORD INJURIES How Does the Secretary Make a Grant? § 359.32 What additional factors does the Secretary...

  20. 34 CFR 359.32 - What additional factors does the Secretary consider in making a grant under this program?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... EDUCATION DISABILITY AND REHABILITATION RESEARCH: SPECIAL PROJECTS AND DEMONSTRATIONS FOR SPINAL CORD INJURIES How Does the Secretary Make a Grant? § 359.32 What additional factors does the Secretary...

  1. 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,…

  2. 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.

  3. Relative Importance and Additive Effects of Maternal and Infant Risk Factors on Childhood Asthma

    PubMed Central

    Rosas-Salazar, Christian; James, Kristina; Escobar, Gabriel; Gebretsadik, Tebeb; Li, Sherian Xu; Carroll, Kecia N.; Walsh, Eileen; Mitchel, Edward; Das, Suman; Kumar, Rajesh; Yu, Chang; Dupont, William D.; Hartert, Tina V.

    2016-01-01

    Background Environmental exposures that occur in utero and during early life may contribute to the development of childhood asthma through alteration of the human microbiome. The objectives of this study were to estimate the cumulative effect and relative importance of environmental exposures on the risk of childhood asthma. Methods We conducted a population-based birth cohort study of mother-child dyads who were born between 1995 and 2003 and were continuously enrolled in the PRIMA (Prevention of RSV: Impact on Morbidity and Asthma) cohort. The individual and cumulative impact of maternal urinary tract infections (UTI) during pregnancy, maternal colonization with group B streptococcus (GBS), mode of delivery, infant antibiotic use, and older siblings at home, on the risk of childhood asthma were estimated using logistic regression. Dose-response effect on childhood asthma risk was assessed for continuous risk factors: number of maternal UTIs during pregnancy, courses of infant antibiotics, and number of older siblings at home. We further assessed and compared the relative importance of these exposures on the asthma risk. In a subgroup of children for whom maternal antibiotic use during pregnancy information was available, the effect of maternal antibiotic use on the risk of childhood asthma was estimated. Results Among 136,098 singleton birth infants, 13.29% developed asthma. In both univariate and adjusted analyses, maternal UTI during pregnancy (odds ratio [OR] 1.2, 95% confidence interval [CI] 1.18, 1.25; adjusted OR [AOR] 1.04, 95%CI 1.02, 1.07 for every additional UTI) and infant antibiotic use (OR 1.21, 95%CI 1.20, 1.22; AOR 1.16, 95%CI 1.15, 1.17 for every additional course) were associated with an increased risk of childhood asthma, while having older siblings at home (OR 0.92, 95%CI 0.91, 0.93; AOR 0.85, 95%CI 0.84, 0.87 for each additional sibling) was associated with a decreased risk of childhood asthma, in a dose-dependent manner. Compared with vaginal

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. Combined Effects of High Pressure Processing and Addition of Soy Sauce and Olive Oil on Safety and Quality Characteristics of Chicken Breast Meat

    PubMed Central

    Kruk, Zbigniew A.; Kim, Hyun Joo; Kim, Yun Ji; Rutley, David L.; Jung, Samooel; Lee, Soo Kee; Jo, Cheorun

    2014-01-01

    This study was conducted to evaluate the combined effect of high pressure (HP) with the addition of soy sauce and/or olive oil on the quality and safety of chicken breast meats. Samples were cut into 100 g pieces and 10% (w/w) of soy sauce (SS), 10% (w/w) of olive oil (OO), and a mixture of both 5% of soy sauce and 5% olive oil (w/w) (SO) were pressurized into meat with high pressure at 300 or 600 MPa. Cooking loss was lower in OO samples than SS samples. With increased pressure to 600 MPa, the oleic acid content of OO samples increased. The total unsaturated fatty acids were the highest in SO and OO 600 MPa samples. Lipid oxidation was retarded by addition of olive oil combined with HP. The addition of olive oil and soy sauce followed by HP decreased the amount of volatile basic nitrogen during storage and reduced the population of pathogens. Sensory evaluation indicated that the addition of olive oil enhanced the overall acceptance and willingness to buy. In conclusion, the combination of HP with the addition of soy sauce and/or olive oil is an effective technology that can improve chemical, health, sensory qualities and safety of chicken breast. PMID:25049950

  9. 21 CFR 1311.115 - Additional requirements for two-factor authentication.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., such as a password or response to a challenge question. (2) Something the practitioner is, biometric... modules or one-time-password devices. (c) If one factor is a biometric, the biometric subsystem...

  10. 21 CFR 1311.115 - Additional requirements for two-factor authentication.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., such as a password or response to a challenge question. (2) Something the practitioner is, biometric... modules or one-time-password devices. (c) If one factor is a biometric, the biometric subsystem...

  11. 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.

  12. 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.

  13. 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.

  14. The efficacy and safety of maraviroc addition to a stable antiretroviral regimen in subjects with suppressed plasma HIV-RNA is not influenced by age.

    PubMed

    Blanco, José-Ramón; Arroyo-Manzano, David; Rojas-Liévano, John F; Crespo, Manuel; Bravo, Isa; Pasquau, Juan; Garcia Del Toro, Miguel; Herrero, Cristina; Rivero, Antonio; Moreno, Santiago; Llibre, Josep Maria

    2015-09-01

    There are few data about the immunovirological efficacy, safety/tolerability, and durability of maraviroc (MVC) addition to aging patients on suppressive antiretroviral therapy (cART) and undetectable viral load (<50 copies/ml). The aging population is underrepresented in most HIV clinical trials. This study included 80 patients aged ≥50 years and 161 aged <50 years and showed that after 48 weeks of treatment, there was no between-group differences in the median increase of CD4(+) T cells or the virological suppression rate. Safety and tolerability were also comparable. In multivariable analysis, the effect of age was not modified and was independent of the response to MVC. An immunological recovery of ≥100 CD4(+) T cells was significantly less common in those with a longer HIV history (≥15 years) (OR 0.43; p=0.016) or having <200/mm(3) CD4(+) T cells at MVC initiation (OR 0.27; p=0.004). Meanwhile, achieving a CD4/CD8 ratio ≥0.5 at week 48 was less likely in those with CD4(+) T cell counts <200 at MVC initiation (OR 0.09; p<0.0001) or with a previous AIDS event (OR 0.43; p=0.028). In summary, the immunovirological efficacy, safety/tolerability, and durability of MVC addition in patients virologically suppressed were independent of the patient's age at treatment onset.

  15. Calcifying nanoparticles (nanobacteria): an additional potential factor for urolithiasis in space flight crews.

    PubMed

    Jones, Jeffrey A; Ciftcioglu, Neva; Schmid, Josef F; Barr, Yael R; Griffith, Donald

    2009-01-01

    Spaceflight-induced microgravity appears to be a risk factor for the development of urinary calculi, resulting in urolithiasis during and after spaceflight. Calcifying nanoparticles, or nanobacteria, multiply more rapidly in simulated microgravity and create external shells of calcium phosphate. The question arises whether calcifying nanoparticles are nidi for calculi and contribute to the development of clinically significant urolithiasis in those who are predisposed to the development of urinary calculi because of intrinsic or extrinsic factors. This case report describes a calculus recovered after flight from an astronaut that, on morphologic and immunochemical analysis (including specific monoclonal antibody staining), demonstrated characteristics of calcifying nanoparticles. PMID:18718644

  16. Effect of tiger nut fibre addition on the quality and safety of a dry-cured pork sausage ("Chorizo") during the dry-curing process.

    PubMed

    Sánchez-Zapata, E; Zunino, V; Pérez-Alvarez, J A; Fernández-López, J

    2013-11-01

    There is a growing interest in the revalorization of co-products from the food industry. Co-products from tiger nuts (Cyperus esculentus) milk production are a suitable fibre source. "Chorizo" is the most popular dry-cured meat product in Spain. The aim of this work was to study the effect of the tiger nut fibre addition (0, 5, and 7.5%) on the quality (composition, physicochemical, and sensorial properties) and safety (oxidation and microbial quality) of a Spanish dry-cured sausage, during the 28days of its dry-curing process. Tiger nut fibre (TNF) addition decreased fat and increased moisture content. The addition of TNF significantly increased (p<0.05) the total dietary fibre content of "Chorizo". Lightness (L*), yellowness (b*) and redness index (a*/b*) were significantly (p<0.05) affected by the fibre content. The addition of 5% and 7.5% TNF to chorizo provided rich fibre and a healthier product. Although there were slight changes in the physicochemical properties, its quality (traditional characteristics) and its safety remained.

  17. Effect of tiger nut fibre addition on the quality and safety of a dry-cured pork sausage ("Chorizo") during the dry-curing process.

    PubMed

    Sánchez-Zapata, E; Zunino, V; Pérez-Alvarez, J A; Fernández-López, J

    2013-11-01

    There is a growing interest in the revalorization of co-products from the food industry. Co-products from tiger nuts (Cyperus esculentus) milk production are a suitable fibre source. "Chorizo" is the most popular dry-cured meat product in Spain. The aim of this work was to study the effect of the tiger nut fibre addition (0, 5, and 7.5%) on the quality (composition, physicochemical, and sensorial properties) and safety (oxidation and microbial quality) of a Spanish dry-cured sausage, during the 28days of its dry-curing process. Tiger nut fibre (TNF) addition decreased fat and increased moisture content. The addition of TNF significantly increased (p<0.05) the total dietary fibre content of "Chorizo". Lightness (L*), yellowness (b*) and redness index (a*/b*) were significantly (p<0.05) affected by the fibre content. The addition of 5% and 7.5% TNF to chorizo provided rich fibre and a healthier product. Although there were slight changes in the physicochemical properties, its quality (traditional characteristics) and its safety remained. PMID:23793111

  18. 21 CFR 1311.115 - Additional requirements for two-factor authentication.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) separate from the computer to which the practitioner is gaining access. (b) If one factor is a hard token, it must be separate from the computer to which it is gaining access and must meet at least the criteria of FIPS 140-2 Security Level 1, as incorporated by reference in § 1311.08, for...

  19. 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

  20. The effect of nutritional additives on anti-infective factors in human milk.

    PubMed

    Quan, R; Yang, C; Rubinstein, S; Lewiston, N J; Stevenson, D K; Kerner, J A

    1994-06-01

    It has become a common practice to supplement human milk with a variety of additives to improve the nutritive content of the feeding for the premature infant. Twenty-two freshly frozen human milk samples were measured for lysozyme activity, total IgA, and specific IgA to Escherichia coli serotypes 01, 04, and 06. One mL aliquots were mixed with the following: 1 mL of Similac, Similac Special Care, Enfamil, Enfamil Premature Formula, and sterile water; 33 mL of Poly-Vi-Sol, 33 mg of Moducal, and 38 mg of breast-milk fortifier, and then reanalyzed. Significant decreases (41% to 74%) in lysozyme activity were seen with the addition of all formulas; breast-milk fortifier reduced activity by 19%, while no differences were seen with Moducal, sterile water, or Poly-Vi-Sol. No differences were seen in total IgA content, but some decreases were seen in specific IgA to E. coli serotypes 04 and 06. E. coli growth was determined after 3 1/2 hours of incubation at 37 degrees C after mixing. All cow-milk formulas enhanced E. coli growth; soy formulas and other additives preserved inhibition of bacterial growth. Nutritional additives can impair anti-infective properties of human milk, and such interplay should be considered in the decision on the feeding regimen of premature infants.

  1. 34 CFR 377.22 - What additional factors does the Secretary consider in making grants?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION DEMONSTRATION PROJECTS TO INCREASE CLIENT CHOICE PROGRAM How Does the Secretary Make an Award? § 377.22 What additional... strategies to increase client choice, in order to ensure that a variety of approaches are demonstrated...

  2. 34 CFR 377.22 - What additional factors does the Secretary consider in making grants?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION DEMONSTRATION PROJECTS TO INCREASE CLIENT CHOICE PROGRAM How Does the Secretary Make an Award? § 377.22 What additional... strategies to increase client choice, in order to ensure that a variety of approaches are demonstrated...

  3. 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…

  4. Evidence for the safety of gum tragacanth (Asiatic Astragalus spp.) and modern criteria for the evaluation of food additives.

    PubMed

    Anderson, D M

    1989-01-01

    Gum tragacanth (GT), affirmed as GRAS within the USA since 1961, was evaluated as 'ADI not specified' by JECFA in 1985. Within the EEC, GT has been permitted temporarily as a food additive (E413), without an ADI, since 1974; a decision regarding its permanent status must be reached before the end of 1988. This review collates the dietary, toxicological, immunological and chemical data available and presents the pre-requisite data concerning the 'Need' and low levels of utilization of GT.

  5. 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…

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Experimental Simulation of the Radionuclide Behaviour in the Process of Creating Additional Safety Barriers in Solid Radioactive Waste Repositories Containing Irradiated Graphite

    NASA Astrophysics Data System (ADS)

    Pavliuk, A. O.; Kotlyarevskiy, S. G.; Bespala, E. V.; Zakarova, E. V.; Rodygina, N. I.; Ermolaev, V. M.; Proshin, I. M.; Volkova, A.

    2016-08-01

    Results of the experimental modeling of radionuclide behavior when creating additional safety barriers in solid radioactive waste repositories are presented. The experiments were run on the repository mockup containing solid radioactive waste fragments including irradiated graphite. The repository mockup layout is given; the processes with radionuclides that occur during the barrier creation with a clayey solution and during the following barrier operation are investigated. The results obtained confirm high anti-migration and anti-filtration properties of clay used for the barrier creation even under the long-term excessive water saturation of rocks confining the repository.

  12. Molecular cloning and expression of an additional epidermal growth factor receptor-related gene.

    PubMed Central

    Plowman, G D; Whitney, G S; Neubauer, M G; Green, J M; McDonald, V L; Todaro, G J; Shoyab, M

    1990-01-01

    Epidermal growth factor (EGF), transforming growth factor alpha (TGF-alpha), and amphiregulin are structurally and functionally related growth regulatory proteins. These secreted polypeptides all bind to the 170-kDa cell-surface EGF receptor, activating its intrinsic kinase activity. However, amphiregulin exhibits different activities than EGF and TGF-alpha in a number of biological assays. Amphiregulin only partially competes with EGF for binding EGF receptor, and amphiregulin does not induce anchorage-independent growth of normal rat kidney cells (NRK) in the presence of TGF-beta. Amphiregulin also appears to abrogate the stimulatory effect of TGF-alpha on the growth of several aggressive epithelial carcinomas that overexpress EGF receptor. These findings suggest that amphiregulin may interact with a separate receptor in certain cell types. Here we report the cloning of another member of the human EGF receptor (HER) family of receptor tyrosine kinases, which we have named "HER3/ERRB3." The cDNA was isolated from a human carcinoma cell line, and its 6-kilobase transcript was identified in various human tissues. We have generated peptide-specific antisera that recognizes the 160-kDa HER3 protein when transiently expressed in COS cells. These reagents will allow us to determine whether HER3 binds amphiregulin or other growth regulatory proteins and what role HER3 protein plays in the regulation of cell growth. Images PMID:2164210

  13. 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.

  14. 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

  15. 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

  16. Aitchbone hanging and ageing period are additive factors influencing pork eating quality.

    PubMed

    Channon, H A; Taverner, M R; D'Souza, D N; Warner, R D

    2014-01-01

    The effects of abattoir, carcase weight (60 or 80 kg HCW), hanging method (Achilles or aitchbone) and ageing period (2 or 7 day post-slaughter) on eating quality attributes of pork were investigated in this 3×2×2×2 factorial study. A total of 144 Large White×Landrace female pigs were slaughtered at one of three abattoirs and sides hung from either the Achilles tendon or the aitchbone. After 24 h chilling, loin (M. longissimus thoracis et lumborum) and topside (M. semimembranosus) muscles were individually vacuum packaged and aged for 2 or 7 days post-slaughter. Consumers (n=852) evaluated eating quality. Neither abattoir nor carcase weight influenced tenderness, flavour or overall liking of pork. Improvements in tenderness, flavour and overall liking were found due to aitchbone hanging (P<0.001) and ageing (P<0.001) for 7 days compared with Achilles-hung carcases and pork aged for 2 days, respectively. This study demonstrated that aitchbone hanging and 7 day ageing can improve eating quality, but these effects were additive as the interaction term was not significant. PMID:24013699

  17. 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.

  18. Electrical inhibition of lens epithelial cell proliferation: an additional factor in secondary cataract?

    PubMed Central

    Wang, Entong; Reid, Brian; Lois, Noemi; Forrester, John V.; McCaig, Colin D.; Zhao, Min

    2005-01-01

    Cataract is the most common cause of blindness but is at least curable by surgery. Unfortunately, many patients gradually develop the complication of posterior capsule opacification (PCO) or secondary cataract. This arises from stimulated cell growth within the lens capsule and can greatly impair vision. It is not fully understood why residual lens epithelial cell growth occurs after surgery. We propose and show that cataract surgery might remove an important inhibitory factor for lens cell growth, namely electric fields. The lens generates a unique pattern of electric currents constantly flowing out from the equator and entering the anterior and posterior poles. We show here that cutting and removing part of the anterior capsule as in cataract surgery significantly decreases the equatorial outward electric currents. Application of electric fields in culture inhibits proliferation of human lens epithelial cells. This inhibitory effect is likely to be mediated through a cell cycle control mechanism that decreases entry of cells into S phase from G1 phase by decreasing the G1-specific cell cycle protein cyclin E and increasing the cyclin-Cdk complex inhibitor p27kip1. Capsulorrhexis in vivo, which reduced endogenous lens electric fields, significantly increased LEC growth. This, together with our previous findings that electric fields have significant effects on the direction of lens cell migration, points to a controlling mechanism for the aberrant cell growth in posterior capsule opacification. A novel approach to control growth of lens epithelial cells using electric fields combined with other controlling mechanisms may be more effective in the prevention and treatment of this common complication of cataract surgery. PMID:15764648

  19. Insulin resistance: an additional risk factor in the pathogenesis of cardiovascular disease in type 2 diabetes.

    PubMed

    Patel, Tushar P; Rawal, Komal; Bagchi, Ashim K; Akolkar, Gauri; Bernardes, Nathalia; Dias, Danielle da Silva; Gupta, Sarita; Singal, Pawan K

    2016-01-01

    Sedentary life style and high calorie dietary habits are prominent leading cause of metabolic syndrome in modern world. Obesity plays a central role in occurrence of various diseases like hyperinsulinemia, hyperglycemia and hyperlipidemia, which lead to insulin resistance and metabolic derangements like cardiovascular diseases (CVDs) mediated by oxidative stress. The mortality rate due to CVDs is on the rise in developing countries. Insulin resistance (IR) leads to micro or macro angiopathy, peripheral arterial dysfunction, hampered blood flow, hypertension, as well as the cardiomyocyte and the endothelial cell dysfunctions, thus increasing risk factors for coronary artery blockage, stroke and heart failure suggesting that there is a strong association between IR and CVDs. The plausible linkages between these two pathophysiological conditions are altered levels of insulin signaling proteins such as IR-β, IRS-1, PI3K, Akt, Glut4 and PGC-1α that hamper insulin-mediated glucose uptake as well as other functions of insulin in the cardiomyocytes and the endothelial cells of the heart. Reduced AMPK, PFK-2 and elevated levels of NADP(H)-dependent oxidases produced by activated M1 macrophages of the adipose tissue and elevated levels of circulating angiotensin are also cause of CVD in diabetes mellitus condition. Insulin sensitizers, angiotensin blockers, superoxide scavengers are used as therapeutics in the amelioration of CVD. It evidently becomes important to unravel the mechanisms of the association between IR and CVDs in order to formulate novel efficient drugs to treat patients suffering from insulin resistance-mediated cardiovascular diseases. The possible associations between insulin resistance and cardiovascular diseases are reviewed here. PMID:26542377

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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 ...

  8. 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…

  9. 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…

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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

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

    PubMed

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

    2015-10-01

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

  16. 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

  17. 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…

  18. 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.

  19. 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.

  20. 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.

  1. Food additive carrageenan: Part I: A critical review of carrageenan in vitro studies, potential pitfalls, and implications for human health and safety.

    PubMed

    McKim, James M

    2014-03-01

    Carrageenan (CGN) has been used as a safe food additive for several decades. Confusion over nomenclature, basic CGN chemistry, type of CGN tested, interspecies biology, and misinterpretation of both in vivo and in vitro data has resulted in the dissemination of incorrect information regarding the human safety of CGN. The issue is exacerbated when mechanistic data obtained from in vitro experiments are directly translated to human hazard and used for risk assessment. This can lead to information that is taken out of experimental context and reported as a definitive effect in humans. In recent years, the use of cell-based models has increased and their ability to provide key information regarding chemical or drug safety is well established. In many instances, these new alternative approaches have started to replace the need to use animals altogether. In vitro systems can be extremely useful for understanding subcellular targets and mechanisms of adverse effects. However, care must be exercised when extrapolating the in vitro findings to in vivo effects. Often, issues such as chemical identity and purity, relevant dose, pharmacokinetic properties, solubility, protein binding, adsorption to plastics, and the use of cell models that are biologically and mechanistically relevant are overlooked or ignored. When this occurs, in vitro findings can provide misleading information that is not causally linked to in vivo events in animals or in humans. To date, there has not been a comprehensive review of the CGN in vitro literature, which has reported a wide range of biochemical effects related to this compound. An extensive effort has been made to evaluate as much of this literature as possible. This review focuses on the in vitro observation, the unique chemistry of CGN, and potential pitfalls of in vitro models used for hazard identification. The discussion of the in vitro studies discussed this review are supported by numerous in vivo studies. This provides a unique

  2. 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

  3. 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.

  4. Efficacy and Safety Assessment of the Addition of Bevacizumab to Adjuvant Therapy Agents in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Ahmadizar, Fariba; Onland-Moret, N. Charlotte; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H.

    2015-01-01

    Aim To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/ Results PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials comparing bevacizumab and adjuvant therapy with adjuvant therapy alone published from January 1966 to 7th of May 2014. Progression free survival, overall survival, overall response rate, safety and quality of life were analyzed using random- or fixed-effects models according to the PRISMA guidelines. We obtained data from 44 randomized controlled trials (30,828 patients). Combining bevacizumab with different adjuvant therapies resulted in significant improvement of progression free survival (log hazard ratio, 0.87; 95% confidence interval (CI), 0.84–0.89), overall survival (log hazard ratio, 0.96; 95% CI, 0.94–0.98) and overall response rate (relative risk, 1.46; 95% CI: 1.33–1.59) compared to adjuvant therapy alone in all studied tumor types. In subgroup analyses, there were no interactions of bevacizumab with baseline characteristics on progression free survival and overall survival, while overall response rate was influenced by tumor type and bevacizumab dose (p-value: 0.02). Although bevacizumab use resulted in additional expected adverse drug reactions except anemia and fatigue, it was not associated with a significant decline in quality of life. There was a trend towards a higher risk of several side effects in patients treated by high-dose bevacizumab compared to the low-dose e.g. all grade proteinuria (9.24; 95% CI: 6.60–12.94 vs. 2.64; 95% CI: 1.29–5.40). Conclusions Combining bevacizumab with different adjuvant therapies provides a survival benefit across all major subsets of patients, including by tumor type, type of adjuvant therapy, and duration and dose of bevacizumab therapy. Though bevacizumab was associated with increased risks of some adverse drug

  5. 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

  6. Workplace safety perceptions and perceived organizational support: do supportive perceptions influence safety perceptions?

    PubMed

    Gyekye, Seth Ayim; Salminen, Simo

    2007-01-01

    The current study investigated the relationship between organizational safety climate and perceived organizational support. Additionally, it examined the relationship with job satisfaction, worker compliance with safety management policies, and accident frequency. Safety climate and supportive perceptions were assessed with Hayes, Perander, Smecko, et al. 's (1998) and Eisenberger, Fasolo and LaMastro's (1990) scales respectively. Confirmatory factors analysis confirmed the 5-factor structure of Hayes et al. 's WSS scale. Regression analysis and t-tests indicated that workers with positive perspectives regarding supportive perceptions similarly expressed positive perceptions concerning workplace safety. Furthermore, they expressed greater job satisfaction, were more compliant with safety management policies, and registered lower accident rates. The perceived level of support in an organization is apparently closely associated with workplace safety perception and other organizational and social factors which are important for safety. The results are discussed in light of escalating interest in how organizational factors affect employee safety and supportive perceptions. PMID:17599793

  7. 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

  8. 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

  9. Improvement of microbiological safety and sensorial quality of pork jerky by electron beam irradiation and by addition of onion peel extract and barbecue flavor

    NASA Astrophysics Data System (ADS)

    Kim, Hyun-Joo; Jung, Samooel; Yong, Hae In; Bae, Young Sik; Kang, Suk Nam; Kim, Il Suk; Jo, Cheorun

    2014-05-01

    The combined effects of electron-beam (EB) irradiation and addition of onion peel (OP) extract and barbecue flavor (BF) on inactivation of foodborne pathogens and the quality of pork jerky was investigated. Prepared pork jerky samples were irradiated (0, 1, 2, and 4 kGy) and stored for 2 month at 25 °C. The D10 values of Listeria monocytogenes, Escherichia coli, and Salmonella typhimurium observed in the OP treated samples were 0.19, 0.18, and 0.19 kGy, whereas those in control were 0.25, 0.23, and 0.20 kGy, respectively. Irradiated samples with OP extract and BF had substantially lower total aerobic bacterial counts than the control had. Samples with added OP extract and BF had lower peroxide values than the control had. Sensory evaluation indicated that overall acceptability of treated samples was not changed up to 2 kGy. Therefore, EB irradiation, combined with OP extract and BF, has improved the microbiological safety with no negative effects on the quality of pork jerky.

  10. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds.

    PubMed

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne; Haase, Lone; Lundquist, Rasmus

    2011-12-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.

  11. 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.

  12. 25 CFR 39.1101 - Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in fiscal year 1982. 39.1101 Section 39.1101 Indians BUREAU OF INDIAN... Programs § 39.1101 Addition of pre-kindergarten as a weight factor to the Indian School...

  13. 25 CFR 39.1101 - Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in fiscal year 1982. 39.1101 Section 39.1101 Indians BUREAU OF INDIAN... Programs § 39.1101 Addition of pre-kindergarten as a weight factor to the Indian School...

  14. 25 CFR 39.1101 - Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 1 2014-04-01 2014-04-01 false Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in fiscal year 1982. 39.1101 Section 39.1101 Indians BUREAU OF INDIAN... Programs § 39.1101 Addition of pre-kindergarten as a weight factor to the Indian School...

  15. 25 CFR 39.1101 - Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in fiscal year 1982. 39.1101 Section 39.1101 Indians BUREAU OF INDIAN... Programs § 39.1101 Addition of pre-kindergarten as a weight factor to the Indian School...

  16. 25 CFR 39.1101 - Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 1 2013-04-01 2013-04-01 false Addition of pre-kindergarten as a weight factor to the Indian School Equalization Formula in fiscal year 1982. 39.1101 Section 39.1101 Indians BUREAU OF INDIAN... Programs § 39.1101 Addition of pre-kindergarten as a weight factor to the Indian School...

  17. 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

  18. 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

  19. 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

  20. 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.

  1. Sodium Benzoate, a Metabolite of Cinnamon and a Food Additive, Upregulates Ciliary Neurotrophic Factor in Astrocytes and Oligodendrocytes.

    PubMed

    Modi, Khushbu K; Jana, Malabendu; Mondal, Susanta; Pahan, Kalipada

    2015-11-01

    Ciliary neurotrophic factor (CNTF) is a promyelinating trophic factor that plays an important role in multiple sclerosis (MS). However, mechanisms by which CNTF expression could be increased in the brain are poorly understood. Recently we have discovered anti-inflammatory and immunomodulatory activities of sodium benzoate (NaB), a metabolite of cinnamon and a widely-used food additive. Here, we delineate that NaB is also capable of increasing the mRNA and protein expression of CNTF in primary mouse astrocytes and oligodendrocytes and primary human astrocytes. Accordingly, oral administration of NaB and cinnamon led to the upregulation of astroglial and oligodendroglial CNTF in vivo in mouse brain. Induction of experimental allergic encephalomyelitis, an animal model of MS, reduced the level of CNTF in the brain, which was restored by oral administration of cinnamon. While investigating underlying mechanisms, we observed that NaB induced the activation of protein kinase A (PKA) and H-89, an inhibitor of PKA, abrogated NaB-induced expression of CNTF. The activation of cAMP response element binding (CREB) protein by NaB, the recruitment of CREB and CREB-binding protein to the CNTF promoter by NaB and the abrogation of NaB-induced expression of CNTF in astrocytes by siRNA knockdown of CREB suggest that NaB increases the expression of CNTF via the activation of CREB. These results highlight a novel myelinogenic property of NaB and cinnamon, which may be of benefit for MS and other demyelinating disorders.

  2. Additional cytosine inside mitochondrial C-tract D-loop as a progression risk factor in oral precancer cases

    PubMed Central

    Pandey, Rahul; Mehrotra, Divya; Mahdi, Abbas Ali; Sarin, Rajiv; Kowtal, Pradnya

    2014-01-01

    Introduction Alterations inside Polycytosine tract (C-tract) of mitochondrial DNA (mtDNA) have been described in many different tumor types. The Poly-Cytosine region is located within the mtDNA D-loop region which acts as point of mitochondrial replication origin. A suggested pathogenesis is that it interferes with the replication process of mtDNA which in turn affects the mitochondrial functioning and generates disease. Methodology 100 premalignant cases (50 leukoplakia & 50 oral submucous fibrosis) were selected and the mitochondrial DNA were isolated from the lesion tissues and from the blood samples. Polycytosine tract in mtDNA was sequenced by direct capillary sequencing. Results 40 (25 leukoplakia & 15 oral submucous fibrosis) patients harbored lesions that displayed one additional cytosine after nucleotide thymidine (7CT6C) at nt position 316 in C-tract of mtDNA which were absent in corresponding mtDNA derived from blood samples. Conclusion Our results show an additional cytosine in the mtDNA at polycytosine site in oral precancer cases. It is postulated that any increase/decrease in the number of cytosine residues in the Poly-Cytosine region may affect the rate of mtDNA replication by impairing the binding of polymerase and other transacting factors. By promoting mitochondrial genomic instability, it may have a central role in the dysregulation of mtDNA functioning, for example alterations in energy metabolism that may promote tumor development. We, therefore, report and propose that this alteration may represent the early development of oral cancer. Further studies with large number of samples are needed in to confirm the role of such mutation in carcinogenesis. PMID:25737911

  3. 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.

  4. 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.

  5. The effectiveness of power-generating complexes constructed on the basis of nuclear power plants combined with additional sources of energy determined taking risk factors into account

    NASA Astrophysics Data System (ADS)

    Aminov, R. Z.; Khrustalev, V. A.; Portyankin, A. V.

    2015-02-01

    The effectiveness of combining nuclear power plants equipped with water-cooled water-moderated power-generating reactors (VVER) with other sources of energy within unified power-generating complexes is analyzed. The use of such power-generating complexes makes it possible to achieve the necessary load pickup capability and flexibility in performing the mandatory selective primary and emergency control of load, as well as participation in passing the night minimums of electric load curves while retaining high values of the capacity utilization factor of the entire power-generating complex at higher levels of the steam-turbine part efficiency. Versions involving combined use of nuclear power plants with hydrogen toppings and gas turbine units for generating electricity are considered. In view of the fact that hydrogen is an unsafe energy carrier, the use of which introduces additional elements of risk, a procedure for evaluating these risks under different conditions of implementing the fuel-and-hydrogen cycle at nuclear power plants is proposed. Risk accounting technique with the use of statistical data is considered, including the characteristics of hydrogen and gas pipelines, and the process pipelines equipment tightness loss occurrence rate. The expected intensities of fires and explosions at nuclear power plants fitted with hydrogen toppings and gas turbine units are calculated. In estimating the damage inflicted by events (fires and explosions) occurred in nuclear power plant turbine buildings, the US statistical data were used. Conservative scenarios of fires and explosions of hydrogen-air mixtures in nuclear power plant turbine buildings are presented. Results from calculations of the introduced annual risk to the attained net annual profit ratio in commensurable versions are given. This ratio can be used in selecting projects characterized by the most technically attainable and socially acceptable safety.

  6. 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

  7. 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

  8. 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

  9. Effects of Factor XIII Deficiency on Thromboelastography. Thromboelastography with Calcium and Streptokinase Addition is more Sensitive than Solubility Tests

    PubMed Central

    Martinuzzo, M.; Barrera, L.; Altuna, D.; Baña, F. Tisi; Bieti, J.; Amigo, Q.; D’Adamo, M.; López, M.S.; Oyhamburu, J.; Otaso, J.C.

    2016-01-01

    Background Homozygous or double heterozygous factor XIII (FXIII) deficiency is characterized by soft tissue hematomas, intracranial and delayed spontaneous bleeding. Alterations of thromboelastography (TEG) parameters in these patients have been reported. The aim of the study was to show results of TEG, TEG Lysis (Lys 60) induced by subthreshold concentrations of streptokinase (SK), and to compare them to the clot solubility studies results in samples of a 1-year-old girl with homozygous or double heterozygous FXIII deficiency. Case A year one girl with a history of bleeding from the umbilical cord. During her first year of life, several hematomas appeared in soft upper limb tissue after punctures for vaccination and a gluteal hematoma. One additional sample of a heterozygous patient and three samples of acquired FXIII deficiency were also evaluated. Materials and Methods Clotting tests, von Willebrand factor (vWF) antigen and activity, plasma FXIII-A subunit (pFXIII-A) were measured by an immunoturbidimetric assay in a photo-optical coagulometer. Solubility tests were performed with Ca2+-5 M urea and thrombin-2% acetic acid. Basal and post-FXIII concentrate infusion samples were studied. TEG was performed with CaCl2 or CaCl2 + SK (3.2 U/mL) in a Thromboelastograph. Results Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time, fibrinogen, factor VIIIc, vWF, and platelet aggregation were normal. Antigenic pFXIII-A subunit was < 2%. TEG, evaluated at diagnosis and post FXIII concentrate infusion (pFXIII-A= 37%), presented a normal reaction time (R), 8 min, prolonged k (14 and 11min respectively), a low Maximum-Amplitude (MA) ( 39 and 52 mm respectively), and Clot Lysis (Lys60) slightly increased (23 and 30% respectively). In the sample at diagnosis, clot solubility was abnormal, 50 and 45 min with Ca-Urea and thrombin-acetic acid, respectively, but normal (>16 hours) 1-day post-FXIII infusion. Analysis of FXIII deficient and normal

  10. Effects of Factor XIII Deficiency on Thromboelastography. Thromboelastography with Calcium and Streptokinase Addition is more Sensitive than Solubility Tests

    PubMed Central

    Martinuzzo, M.; Barrera, L.; Altuna, D.; Baña, F. Tisi; Bieti, J.; Amigo, Q.; D’Adamo, M.; López, M.S.; Oyhamburu, J.; Otaso, J.C.

    2016-01-01

    Background Homozygous or double heterozygous factor XIII (FXIII) deficiency is characterized by soft tissue hematomas, intracranial and delayed spontaneous bleeding. Alterations of thromboelastography (TEG) parameters in these patients have been reported. The aim of the study was to show results of TEG, TEG Lysis (Lys 60) induced by subthreshold concentrations of streptokinase (SK), and to compare them to the clot solubility studies results in samples of a 1-year-old girl with homozygous or double heterozygous FXIII deficiency. Case A year one girl with a history of bleeding from the umbilical cord. During her first year of life, several hematomas appeared in soft upper limb tissue after punctures for vaccination and a gluteal hematoma. One additional sample of a heterozygous patient and three samples of acquired FXIII deficiency were also evaluated. Materials and Methods Clotting tests, von Willebrand factor (vWF) antigen and activity, plasma FXIII-A subunit (pFXIII-A) were measured by an immunoturbidimetric assay in a photo-optical coagulometer. Solubility tests were performed with Ca2+-5 M urea and thrombin-2% acetic acid. Basal and post-FXIII concentrate infusion samples were studied. TEG was performed with CaCl2 or CaCl2 + SK (3.2 U/mL) in a Thromboelastograph. Results Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time, fibrinogen, factor VIIIc, vWF, and platelet aggregation were normal. Antigenic pFXIII-A subunit was < 2%. TEG, evaluated at diagnosis and post FXIII concentrate infusion (pFXIII-A= 37%), presented a normal reaction time (R), 8 min, prolonged k (14 and 11min respectively), a low Maximum-Amplitude (MA) ( 39 and 52 mm respectively), and Clot Lysis (Lys60) slightly increased (23 and 30% respectively). In the sample at diagnosis, clot solubility was abnormal, 50 and 45 min with Ca-Urea and thrombin-acetic acid, respectively, but normal (>16 hours) 1-day post-FXIII infusion. Analysis of FXIII deficient and normal

  11. 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.

  12. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... hydrocarbon flow? You must take the following safety measures when you conduct drilling operations on a platform with producing wells or that has other hydrocarbon flow: (a) You must install an...

  13. 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

  14. 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

  15. 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.

  16. Contamination and changes of food factors during processing with modeling applications-safety related issues

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Chemical and microbiological contamination of food during processing and preservation can result in foodborne illness outbreaks and food poisoning. Chemical contaminations can occur through exposure of foods to illegal additives, pesticides and fertilizer residues, toxic compounds formed by microbes...

  17. 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

  18. Mexican American First-Generation Students' Perceptions of Siblings and Additional Factors Influencing Their College Choice Process

    ERIC Educational Resources Information Center

    Elias McAllister, Dora

    2012-01-01

    The purpose of this study was to understand the factors influencing the college choice process of Mexican American first-generation students who had an older sibling with college experience. While a considerable amount of research exists on factors influencing the college choice process of first-generation college students, and a few studies…

  19. Non-valvular atrial fibrillation patients with none or one additional risk factor of the CHA2DS2-VASc score. A comprehensive net clinical benefit analysis for warfarin, aspirin, or no therapy.

    PubMed

    Lip, Gregory Y H; Skjøth, Flemming; Nielsen, Peter B; Larsen, Torben Bjerregaard

    2015-10-01

    Oral anticoagulation (OAC) to prevent stroke has to be balanced against the potential harm of serious bleeding, especially intracranial haemorrhage (ICH). We determined the net clinical benefit (NCB) balancing effectiveness and safety of no antithrombotic therapy, aspirin and warfarin in AF patients with none or one stroke risk factor. Using Danish registries, we determined NCB using various definitions intrinsic to our cohort (Danish weights at 1 and 5 year follow-up), with risk weights which were derived from the hazard ratio (HR) of death following an event, relative to HR of death after ischaemic stroke. When aspirin was compared to no treatment, NCB was neutral or negative for both risk strata. For warfarin vs no treatment, NCB using Danish weights was neutral where no risk factors were present and using five years follow-up. For one stroke risk factor, NCB was positive for warfarin vs no treatment, for one year and five year follow-up. For warfarin vs aspirin use in patients with no risk factors, NCB was positive with one year follow-up, but neutral with five year follow-up. With one risk factor, NCB was generally positive for warfarin vs aspirin. In conclusion, we show a positive overall advantage (i.e. positive NCB) of effective stroke prevention with OAC, compared to no therapy or aspirin with one additional stroke risk factor, using Danish weights. 'Low risk' AF patients with no additional stroke risk factors (i.e.CHA2DS2-VASc 0 in males, 1 in females) do not derive any advantage (neutral or negative NCB) with aspirin, nor with warfarin therapy in the long run.

  20. 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…

  1. 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...

  2. 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....

  3. 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…

  4. 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…

  5. 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

  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. 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.

  8. 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.

  9. 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

  10. 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

  11. 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; ...

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. An Additional Potential Factor for Kidney Stone Formation during Space Flights: Calcifying Nanoparticles (Nanobacteria): A Case Report

    NASA Technical Reports Server (NTRS)

    Jones, Jeffrey A.; Ciftcioglu, Neva; Schmid, Joseph; Griffith, Donald

    2007-01-01

    Spaceflight-induced microgravity appears to be a risk factor for the development of urinary calculi due to skeletal calcium liberation and other undefined factors, resulting in stone disease in crewmembers during and after spaceflight. Calcifying nanoparticles, or nanobacteria, reproduce at a more rapid rate in simulated microgravity conditions and create external shells of calcium phosphate in the form of apatite. The questions arises whether calcifying nanoparticles are niduses for calculi and contribute to the development of clinical stone disease in humans, who possess environmental factors predisposing to the development of urinary calculi and potentially impaired immunological defenses during spaceflight. A case of a urinary calculus passed from an astronaut post-flight with morphological characteristics of calcifying nanoparticles and staining positive for a calcifying nanoparticle unique antigen, is presented.

  20. 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.

  1. 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.

  2. Employing Lead Thiocyanate Additive to Reduce the Hysteresis and Boost the Fill Factor of Planar Perovskite Solar Cells.

    PubMed

    Ke, Weijun; Xiao, Chuanxiao; Wang, Changlei; Saparov, Bayrammurad; Duan, Hsin-Sheng; Zhao, Dewei; Xiao, Zewen; Schulz, Philip; Harvey, Steven P; Liao, Weiqiang; Meng, Weiwei; Yu, Yue; Cimaroli, Alexander J; Jiang, Chun-Sheng; Zhu, Kai; Al-Jassim, Mowafak; Fang, Guojia; Mitzi, David B; Yan, Yanfa

    2016-07-01

    Lead thiocyanate in the perovskite precursor can increase the grain size of a perovskite thin film and reduce the conductivity of the grain boundaries, leading to perovskite solar cells with reduced hysteresis and enhanced fill factor. A planar perovskite solar cell with grain boundary and interface passivation achieves a steady-state efficiency of 18.42%.

  3. 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 ...

  4. 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 ...

  5. Factors affecting the microbial and chemical composition of silage. III. Effect of urea additions on maize silage.

    PubMed

    Mahmoud, S A; Abd-el-Hafez, A; Zaki, M M; Saleh, E A

    1978-01-01

    The effect of urea additions on the microbiological and chemical properties of silage, produced from young maize plants (Darawa stage), was studied. Urea treatments, i.e., 0.25%, 0.50%, 0.75%, and 1.00%, stimulated higher densities of the desired microorganisms than the control, while undesired organisms showed lower counts (proteolytic and saccharolytic anaerobes). Addition of 0.25 to 0.50% or urea resulted in the production of high quality silage with pleasant small and high nutritive value, as confirmed by the various microbiological and chemical analyses conducted. Higher levels (0.75 and 1.00%) of urea decreased the quality of the product. PMID:29417

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. c-Fos: an AP-1 transcription factor with an additional cytoplasmic, non-genomic lipid synthesis activation capacity.

    PubMed

    Caputto, Beatriz L; Cardozo Gizzi, Andrés M; Gil, Germán A

    2014-09-01

    The mechanisms that co-ordinately activate lipid synthesis when high rates of membrane biogenesis are needed to support cell growth are largely unknown. c-Fos, a well known AP-1 transcription factor, has emerged as a unique protein with the capacity to associate to specific enzymes of the pathway of synthesis of phospholipids at the endoplasmic reticulum and activate their synthesis to accompany genomic decisions of growth. Herein, we discuss this cytoplasmic, non-genomic effect of c-Fos in the context of other mechanisms that have been proposed to regulate lipid synthesis.

  11. 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

  12. 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

  13. 42 CFR 136.408 - What are other factors, in addition to the minimum standards of character, that may be considered...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false What are other factors, in addition to the minimum standards of character, that may be considered in determining placement of an individual in a position that involves regular contact with or control over Indian children? 136.408 Section 136.408 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT...

  14. 42 CFR 136.408 - What are other factors, in addition to the minimum standards of character, that may be considered...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false What are other factors, in addition to the minimum standards of character, that may be considered in determining placement of an individual in a position that involves regular contact with or control over Indian children? 136.408 Section 136.408 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT...

  15. Ameliorative effects of telmisartan on the inflammatory response and impaired spatial memory in a rat model of Alzheimer's disease incorporating additional cerebrovascular disease factors.

    PubMed

    Shindo, Taro; Takasaki, Kotaro; Uchida, Kanako; Onimura, Rika; Kubota, Kaori; Uchida, Naoki; Irie, Keiichi; Katsurabayashi, Shutaro; Mishima, Kenichi; Nishimura, Ryoji; Fujiwara, Michihiro; Iwasaki, Katsunori

    2012-01-01

    Telmisartan, an angiotensin type 1 receptor blocker, is used in the management of hypertension to control blood pressure. In addition, telmisartan has a partial agonistic effect on peroxisome proliferator activated receptor γ (PPARγ). Recently, the effects of telmisartan on spatial memory or the inflammatory response were monitored in a mouse model of Alzheimer's disease (AD). However, to date, no studies have investigated the ameliorative effects of telmisartan on impaired spatial memory and the inflammatory response in an AD animal model incorporating additional cerebrovascular disease factors. In this study, we examined the effect of telmisartan on spatial memory impairment and the inflammatory response in a rat model of AD incorporating additional cerebrovascular disease factors. Rats were subjected to cerebral ischemia and an intracerebroventricular injection of oligomeric or aggregated amyloid-β (Aβ). Oral administration of telmisartan (0.3, 1, 3 mg/kg/d) seven days after ischemia and Aβ treatment resulted in better performance in the eight arm radial maze task in a dose-dependent manner. Telmisartan also reduced tumor necrosis factor α mRNA expression in the hippocampal region of rats with impaired spatial memory. These effects of telmisartan were antagonized by GW9662, an antagonist of PPARγ. These results suggest that telmisartan has ameliorative effects on the impairment of spatial memory in a rat model of AD incorporating additional cerebrovascular disease factors via its anti-inflammatory effect.

  16. Breeding site selection by coho salmon (Oncorhynchus kisutch) in relation to large wood additions and factors that influence reproductive success

    USGS Publications Warehouse

    Clark, Steven M.; Dunham, Jason B.; McEnroe, Jeffery R.; Lightcap, Scott W.

    2014-01-01

    The fitness of female Pacific salmon (Oncorhynchus spp.) with respect to breeding behavior can be partitioned into at least four fitness components: survival to reproduction, competition for breeding sites, success of egg incubation, and suitability of the local environment near breeding sites for early rearing of juveniles. We evaluated the relative influences of habitat features linked to these fitness components with respect to selection of breeding sites by coho salmon (Oncorhynchus kisutch). We also evaluated associations between breeding site selection and additions of large wood, as the latter were introduced into the study system as a means of restoring habitat conditions to benefit coho salmon. We used a model selection approach to organize specific habitat features into groupings reflecting fitness components and influences of large wood. Results of this work suggest that female coho salmon likely select breeding sites based on a wide range of habitat features linked to all four hypothesized fitness components. More specifically, model parameter estimates indicated that breeding site selection was most strongly influenced by proximity to pool-tail crests and deeper water (mean and maximum depths). Linkages between large wood and breeding site selection were less clear. Overall, our findings suggest that breeding site selection by coho salmon is influenced by a suite of fitness components in addition to the egg incubation environment, which has been the emphasis of much work in the past.

  17. Structural basis for the requirement of additional factors for MLL1 SET domain activity and recognition of epigenetic marks.

    PubMed

    Southall, Stacey M; Wong, Poon-Sheng; Odho, Zain; Roe, S Mark; Wilson, Jon R

    2009-01-30

    The mixed-lineage leukemia protein MLL1 is a transcriptional regulator with an essential role in early development and hematopoiesis. The biological function of MLL1 is mediated by the histone H3K4 methyltransferase activity of the carboxyl-terminal SET domain. We have determined the crystal structure of the MLL1 SET domain in complex with cofactor product AdoHcy and a histone H3 peptide. This structure indicates that, in order to form a well-ordered active site, a highly variable but essential component of the SET domain must be repositioned. To test this idea, we compared the effect of the addition of MLL complex members on methyltransferase activity and show that both RbBP5 and Ash2L but not Wdr5 stimulate activity. Additionally, we have determined the effect of posttranslational modifications on histone H3 residues downstream and upstream from the target lysine and provide a structural explanation for why H3T3 phosphorylation and H3K9 acetylation regulate activity. PMID:19187761

  18. Epidermal growth factor (EGF)-receptor is phosphorylated at threonine-654 in A431 cells following EGF addition

    SciTech Connect

    Whiteley, B.; Glaser, L.

    1986-05-01

    It has been shown that activation of protein kinase C by tumor-promoting phorbol diesters causes phorphorylation of the EGF-receptor at threonine-654 and is believed to thereby regulate the EGF receptor tyrosine kinase and EGF binding activity. In their present studies, /sup 32/P-labeled A431 cells were treated with and without 10 nM phorbol 12-myristate 13-acetate (PMA), or with 200 ng/ml EGF. Analysis of /sup 32/P-labeled EGF receptor tryptic phosphopeptides by reverse-phase HPLC confirmed the known effects of PMA and revealed that EGF caused phosphorylation at threonine-654 as well as various tyrosine residues. This effect occurred as early as 1 minute after EGF addition and was maximal after 5 minutes. The magnitude of the response appears to be 50% of a 15 minute treatment with 10 nM PMA. Direct measurement of diacylglycerol using an E. coli diacylglycerol kinase confirmed that EGF-stimulated phosphoinositide turnover could cause very rapid activation of protein kinase C. These results imply that protein kinase C is playing a role in negative modulation of EGF-receptor activity following EGF addition to A431 cells.

  19. 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

  20. 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

  1. Allergic and immunologic reactions to food additives.

    PubMed

    Gultekin, Fatih; Doguc, Duygu Kumbul

    2013-08-01

    For centuries, food additives have been used for flavouring, colouring and extension of the useful shelf life of food, as well as the promotion of food safety. During the last 20 years, the studies implicating the additives contained in foods and medicine as a causative factor of allergic reactions have been proliferated considerably. In this review, we aimed to overview all of the food additives which were approved to consume in EU and find out how common and serious allergic reactions come into existence following the consuming of food additives.

  2. [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.

  3. [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

  4. Influence of physico-chemical factors on leaching of chemical additives from aluminium foils used for packaging of food materials.

    PubMed

    Ojha, Priyanka; Ojha, C S; Sharma, V P

    2007-01-01

    In recent years, the use of aluminium foils to wrap foodstuff and commodities has been increased to a great extent. Aluminium was found to leach out from the foil in different simulants particularly in distilled water, acidic and alkaline medium at 60 +/- 2 degrees C for 2 hours and 40 +/- 2 degrees C for 24 hours. The migration was found to be above the permissible limit as laid down by WHO guidelines, that is of 0.2 mg/L of water. The protocol used for this study was based on the recommendation of Bureau of Indian Standard regarding the migration of chemical additives from packaging materials used to pack food items. Migration of the aluminium metal was found significantly higher in acidic and aqueous medium in comparison to alcoholic and saline medium. Higher temperature conditions also enhanced the rate of migration of aluminium in acidic and aqueous medium. Leaching of aluminium metal occurred in double distilled water, acetic acid 3%, normal saline and sodium carbonate, except ethanol 8%, in which aluminium migration was below the detection limit of the instrument where three brands of the aluminium foil samples studied.

  5. The severity of retinal pathology in homozygous Crb1rd8/rd8 mice is dependent on additional genetic factors.

    PubMed

    Luhmann, Ulrich F O; Carvalho, Livia S; Holthaus, Sophia-Martha Kleine; Cowing, Jill A; Greenaway, Simon; Chu, Colin J; Herrmann, Philipp; Smith, Alexander J; Munro, Peter M G; Potter, Paul; Bainbridge, James W B; Ali, Robin R

    2015-01-01

    Understanding phenotype-genotype correlations in retinal degeneration is a major challenge. Mutations in CRB1 lead to a spectrum of autosomal recessive retinal dystrophies with variable phenotypes suggesting the influence of modifying factors. To establish the contribution of the genetic background to phenotypic variability associated with the Crb1(rd8/rd8) mutation, we compared the retinal pathology of Crb1(rd8/rd8)/J inbred mice with that of two Crb1(rd8/rd8) lines backcrossed with C57BL/6JOlaHsd mice. Topical endoscopic fundal imaging and scanning laser ophthalmoscopy fundus images of all three Crb1(rd8/rd8) lines showed a significant increase in the number of inferior retinal lesions that was strikingly variable between the lines. Optical coherence tomography, semithin, ultrastructural morphology and assessment of inflammatory and vascular marker by immunohistochemistry and quantitative reverse transcriptase-polymerase chain reaction revealed that the lesions were associated with photoreceptor death, Müller and microglia activation and telangiectasia-like vascular remodelling-features that were stable in the inbred, variable in the second, but virtually absent in the third Crb1(rd8/rd8) line, even at 12 months of age. This suggests that the Crb1(rd8/rd8) mutation is necessary, but not sufficient for the development of these degenerative features. By whole-genome SNP analysis of the genotype-phenotype correlation, a candidate region on chromosome 15 was identified. This may carry one or more genetic modifiers for the manifestation of the retinal pathology associated with mutations in Crb1. This study also provides insight into the nature of the retinal vascular lesions that likely represent a clinical correlate for the formation of retinal telangiectasia or Coats-like vasculopathy in patients with CRB1 mutations that are thought to depend on such genetic modifiers.

  6. Physiological basis of tolerance to complete submergence in rice involves genetic factors in addition to the SUB1 gene.

    PubMed

    Singh, Sudhanshu; Mackill, David J; Ismail, Abdelbagi M

    2014-01-01

    1 lines. This suggests the possibility of further improvements in submergence tolerance by incorporating additional traits present in FR13A or other similar landraces. PMID:25281725

  7. Chemistry of Food Additives: Direct and Indirect Effects.

    ERIC Educational Resources Information Center

    Pauli, George H.

    1984-01-01

    The primary component(s), impurities, and degradation products of polysorbate 80, nitrate and nitrite salts, and diethylpyrocarbonate (DEPC) are discussed. Safety considerations related to these food additives are also noted. The chick-edema factor which results from an additive in poultry feed is also discussed. (JN)

  8. Symbolic integration of a product of two spherical Bessel functions with an additional exponential and polynomial factor

    NASA Astrophysics Data System (ADS)

    Gebremariam, B.; Duguet, T.; Bogner, S. K.

    2010-06-01

    We present a Mathematica package that performs the symbolic calculation of integrals of the form ∫0∞exj(x)j(x)dx where j(x) and j(x) denote spherical Bessel functions of integer orders, with ν⩾0 and μ⩾0. With the real parameter u>0 and the integer n, convergence of the integral requires that n+ν+μ⩾0. The package provides analytical result for the integral in its most simplified form. In cases where direct Mathematica implementations succeed in evaluating these integrals, the novel symbolic method implemented in this work obtains the same result and in general, it takes a fraction of the time required for the direct implementation. We test the accuracy of such analytical expressions by comparing the results with their numerical counterparts. Program summaryProgram title: SymbBesselJInteg Catalogue identifier: AEFY_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEFY_v1_0.html Program obtainable from: CPC Program Library, Queen's University, Belfast, N. Ireland Licensing provisions: Standard CPC licence, http://cpc.cs.qub.ac.uk/licence/licence.html No. of lines in distributed program, including test data, etc.: 275 934 No. of bytes in distributed program, including test data, etc.: 399 705 Distribution format: tar.gz Programming language: Mathematica 7.1 Computer: Any computer running Mathematica 6.0 and later versions. Operating system: Windows Xp, Linux/Unix. RAM: 256 Mb Classification: 5. Nature of problem: Integration, both analytical and numerical, of products of two spherical Bessel functions with an exponential and polynomial multiplying factor can be a very complex task depending on the orders of the spherical Bessel functions. The Mathematica package discussed in this paper solves this problem using a novel symbolic approach. Solution method: The problem is first cast into a related limit problem which can be broken into two related subproblems involving exponential and exponential integral functions. Solving the cores of each

  9. Modeling the impact of spatial relationships on horizontal curve safety.

    PubMed

    Findley, Daniel J; Hummer, Joseph E; Rasdorf, William; Zegeer, Charles V; Fowler, Tyler J

    2012-03-01

    The curved segments of roadways are more hazardous because of the additional centripetalforces exerted on a vehicle, driver expectations, and other factors. The safety of a curve is dependent on various factors, most notably by geometric factors, but the location of a curve in relation to other curves is also thought to influence the safety of those curves because of a driver's expectation to encounter additional curves. The link between an individual curve's geometric characteristics and its safety performance has been established, but spatial considerations are typically not included in a safety analysis. The spatial considerations included in this research consisted of four components: distance to adjacent curves, direction of turn of the adjacent curves, and radius and length of the adjacent curves. The primary objective of this paper is to quantify the spatial relationship between adjacent horizontal curves and horizontal curve safety using a crash modification factor. Doing so enables a safety professional to more accurately estimate safety to allocate funding to reduce or prevent future collisions and more efficiently design new roadway sections to minimize crash risk where there will be a series of curves along a route. The most important finding from this research is the statistical significance of spatial considerations for the prediction of horizontal curve safety. The distances to adjacent curves were found to be a reliable predictor of observed collisions. This research recommends a model which utilizes spatial considerations for horizontal curve safety prediction in addition to current Highway Safety Manual prediction capabilities using individual curve geometric features.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. 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)

  20. 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.

  1. 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

  2. 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

  3. Microbiological Food Safety Surveillance in China.

    PubMed

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

    2015-09-01

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

  4. Microbiological Food Safety Surveillance in China

    PubMed Central

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

    2015-01-01

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

  5. 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.

  6. Analysis of Air Toxics From NOAA WP-3 Aircraft Measurements During the TexAQS 2006 Campaign: Comparison With Emission Inventories and Additive Inhalation Risk Factors

    NASA Astrophysics Data System (ADS)

    Del Negro, L. A.; Warneke, C.; de Gouw, J. A.; Atlas, E.; Lueb, R.; Zhu, X.; Pope, L.; Schauffler, S.; Hendershot, R.; Washenfelder, R.; Fried, A.; Richter, D.; Walega, J. G.; Weibring, P.

    2007-12-01

    Benzene and nine other air toxics classified as human carcinogens by the International Agency for Research on Cancer (IARC) were measured from the NOAA WP-3 aircraft during the TexAQS 2006 campaign. In-situ measurements of benzene, measured with a PTR-MS instrument, are used to estimate emission fluxes for comparison with point source emission inventories developed by the Texas Commission on Environmental Quality. Mean and median mixing ratios for benzene, acetaldehyde, formaldehyde, 1,3-butadiene, carbon tetrachloride, chloroform, 1,2-dichloroethane, dibromoethane, dichloromethane, and vinyl chloride, encountered over the city of Houston during the campaign, are combined with inhalation unit risk factor values developed by the California Environmental Protection Agency and the United States Environmental Protection Agency to estimate the additive inhalation risk factor. This additive risk factor represents the risk associated with lifetime (70 year) exposure at the levels measured and should not be used as an absolute indicator of risk to individuals. However, the results are useful for assessments of changing relative risk over time, and for identifying dominant contributions to the overall air toxic risk.

  7. [Food additives and healthiness].

    PubMed

    Heinonen, Marina

    2014-01-01

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

  8. 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.

  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. 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.

  11. Outpatient Management of Postbiopsy Pneumothorax with Small-Caliber Chest Tubes: Factors Affecting the Need for Prolonged Drainage and Additional Interventions

    SciTech Connect

    Gupta, Sanjay Hicks, Marshall E.; Wallace, Michael J.; Ahrar, Kamran; Madoff, David C.; Murthy, Ravi

    2008-03-15

    The aim of this study was to evaluate the efficacy of outpatient management of postbiopsy pneumothoraces with small-caliber chest tubes and to assess the factors that influence the need for prolonged drainage or additional interventions.We evaluated the medical records of patients who were treated with small-caliber chest tubes attached to Heimlich valves for pneumothoraces resulting from image-guided transthoracic needle biopsy to determine the hospital admission rates, the number of days the catheters were left in place, and the need for further interventions. We also evaluated the patient, lesion, and biopsy technique characteristics to determine their influence on the need for prolonged catheter drainage or additional interventions. Of the 191 patients included in our study, 178 (93.2%) were treated as outpatients. Ten patients (5.2%) were admitted for chest tube-related problems, either for underwater suction (n = 8) or for pain control (n = 2). No further interventions were required in 146 patients (76.4%), with successful removal of the chest tubes the day after the biopsy procedure. Prolonged catheter drainage (mean, 4.3 days) was required in 44 patients (23%). Nineteen patients (9.9%) underwent additional interventions for management of pneumothorax. Presence of emphysema was noted more frequently in patients who required additional interventions or prolonged chest tube drainage than in those who did not (51.1% vs. 24.7%; p = 0.001).We conclude that use of the Heimlich valve allows safe and successful outpatient treatment of most patients requiring chest tube placement for postbiopsy pneumothorax. Additional interventions or prolonged chest tube drainage are needed more frequently in patients with emphysema in the needle path.

  12. 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.

  13. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  14. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  15. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  16. Transcriptional Regulation of Zein Gene Expression in Maize through the Additive and Synergistic Action of opaque2, Prolamine-Box Binding Factor, and O2 Heterodimerizing Proteins

    PubMed Central

    Zhang, Zhiyong; Yang, Jun; Wu, Yongrui

    2015-01-01

    Maize (Zea mays) zeins are some of the most abundant cereal seed storage proteins (SSPs). Their abundance influences kernel hardness but compromises its nutritional quality. Transcription factors regulating the expression of zein and other SSP genes in cereals are endosperm-specific and homologs of maize opaque2 (O2) and prolamine-box binding factor (PBF). This study demonstrates that the ubiquitously expressed transcription factors, O2 heterodimerizing proteins (OHPs), specifically regulate 27-kD γ-zein gene expression (through binding to an O2-like box in its promoter) and interact with PBF. The zein content of double mutants OhpRNAi;o2 and PbfRNAi;o2 and the triple mutant PbfRNAi;OhpRNAi;o2 is reduced by 83, 89, and 90%, respectively, compared with the wild type. The triple mutant developed the smallest zein protein bodies, which were merely one-tenth the wild type’s size. Total protein levels in these mutants were maintained in a relatively constant range through proteome rebalancing. These data show that OHPs, O2, and PBF are master regulators of zein storage protein synthesis, acting in an additive and synergistic mode. The differential expression patterns of OHP and O2 genes may cause the slight differences in the timing of 27-kD γ-zein and 22-kD α-zein accumulation during protein body formation. PMID:25901087

  17. Biobased lubricant additives

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fully biobased lubricants are those formulated using all biobased ingredients, i.e. biobased base oils and biobased additives. Such formulations provide the maximum environmental, safety, and economic benefits expected from a biobased product. Currently, there are a number of biobased base oils that...

  18. Public risk perception of food additives and food scares. The case in Suzhou, China.

    PubMed

    Wu, Linhai; Zhong, Yingqi; Shan, Lijie; Qin, Wei

    2013-11-01

    This study examined the factors affecting public risk perception of food additive safety and possible resulting food scares using a survey conducted in Suzhou, Jiangsu Province, China. The model was proposed based on literature relating to the role of risk perception and information perception of public purchase intention under food scares. Structural equation modeling (SEM) was used for data analysis. The results showed that attitude towards behavior, subjective norm and information perception exerted moderate to high effect on food scares, and the effects were also mediated by risk perceptions of additive safety. Significant covariance was observed between attitudes toward behavior, subjective norm and information perception. Establishing an effective mechanism of food safety risk communication, releasing information of government supervision on food safety in a timely manner, curbing misleading media reports on public food safety risk, and enhancing public knowledge of the food additives are key to the development and implementation of food safety risk management policies by the Chinese government. PMID:23831014

  19. Public risk perception of food additives and food scares. The case in Suzhou, China.

    PubMed

    Wu, Linhai; Zhong, Yingqi; Shan, Lijie; Qin, Wei

    2013-11-01

    This study examined the factors affecting public risk perception of food additive safety and possible resulting food scares using a survey conducted in Suzhou, Jiangsu Province, China. The model was proposed based on literature relating to the role of risk perception and information perception of public purchase intention under food scares. Structural equation modeling (SEM) was used for data analysis. The results showed that attitude towards behavior, subjective norm and information perception exerted moderate to high effect on food scares, and the effects were also mediated by risk perceptions of additive safety. Significant covariance was observed between attitudes toward behavior, subjective norm and information perception. Establishing an effective mechanism of food safety risk communication, releasing information of government supervision on food safety in a timely manner, curbing misleading media reports on public food safety risk, and enhancing public knowledge of the food additives are key to the development and implementation of food safety risk management policies by the Chinese government.

  20. Safety sans Frontières: An International Safety Culture Model.

    PubMed

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

    2015-05-01

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

  1. 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…

  2. 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…

  3. Food additives

    PubMed Central

    Spencer, Michael

    1974-01-01

    Food additives are discussed from the food technology point of view. The reasons for their use are summarized: (1) to protect food from chemical and microbiological attack; (2) to even out seasonal supplies; (3) to improve their eating quality; (4) to improve their nutritional value. The various types of food additives are considered, e.g. colours, flavours, emulsifiers, bread and flour additives, preservatives, and nutritional additives. The paper concludes with consideration of those circumstances in which the use of additives is (a) justified and (b) unjustified. PMID:4467857

  4. Additive influence of genetic predisposition and conventional risk factors in the incidence of coronary heart disease: a population-based study in Greece

    PubMed Central

    Yiannakouris, Nikos; Katsoulis, Michail; Trichopoulou, Antonia; Ordovas, Jose M; Trichopoulos, Dimitrios

    2014-01-01

    Objectives An additive genetic risk score (GRS) for coronary heart disease (CHD) has previously been associated with incident CHD in the population-based Greek European Prospective Investigation into Cancer and nutrition (EPIC) cohort. In this study, we explore GRS-‘environment’ joint actions on CHD for several conventional cardiovascular risk factors (ConvRFs), including smoking, hypertension, type-2 diabetes mellitus (T2DM), body mass index (BMI), physical activity and adherence to the Mediterranean diet. Design A case–control study. Setting The general Greek population of the EPIC study. Participants and outcome measures 477 patients with medically confirmed incident CHD and 1271 controls participated in this study. We estimated the ORs for CHD by dividing participants at higher or lower GRS and, alternatively, at higher or lower ConvRF, and calculated the relative excess risk due to interaction (RERI) as a measure of deviation from additivity. Results The joint presence of higher GRS and higher risk ConvRF was in all instances associated with an increased risk of CHD, compared with the joint presence of lower GRS and lower risk ConvRF. The OR (95% CI) was 1.7 (1.2 to 2.4) for smoking, 2.7 (1.9 to 3.8) for hypertension, 4.1 (2.8 to 6.1) for T2DM, 1.9 (1.4 to 2.5) for lower physical activity, 2.0 (1.3 to 3.2) for high BMI and 1.5 (1.1 to 2.1) for poor adherence to the Mediterranean diet. In all instances, RERI values were fairly small and not statistically significant, suggesting that the GRS and the ConvRFs do not have effects beyond additivity. Conclusions Genetic predisposition to CHD, operationalised through a multilocus GRS, and ConvRFs have essentially additive effects on CHD risk. PMID:24500614

  5. Stretching human mesenchymal stromal cells on stiffness-customized collagen type I generates a smooth muscle marker profile without growth factor addition

    PubMed Central

    Rothdiener, Miriam; Hegemann, Miriam; Uynuk-Ool, Tatiana; Walters, Brandan; Papugy, Piruntha; Nguyen, Phong; Claus, Valentin; Seeger, Tanja; Stoeckle, Ulrich; Boehme, Karen A.; Aicher, Wilhelm K.; Stegemann, Jan P.; Hart, Melanie L.; Kurz, Bodo; Klein, Gerd; Rolauffs, Bernd

    2016-01-01

    Using matrix elasticity and cyclic stretch have been investigated for inducing mesenchymal stromal cell (MSC) differentiation towards the smooth muscle cell (SMC) lineage but not in combination. We hypothesized that combining lineage-specific stiffness with cyclic stretch would result in a significantly increased expression of SMC markers, compared to non-stretched controls. First, we generated dense collagen type I sheets by mechanically compressing collagen hydrogels. Atomic force microscopy revealed a nanoscale stiffness range known to support myogenic differentiation. Further characterization revealed viscoelasticity and stable biomechanical properties under cyclic stretch with >99% viable adherent human MSC. MSCs on collagen sheets demonstrated a significantly increased mRNA but not protein expression of SMC markers, compared to on culture flasks. However, cyclic stretch of MSCs on collagen sheets significantly increased both mRNA and protein expression of α-smooth muscle actin, transgelin, and calponin versus plastic and non-stretched sheets. Thus, lineage-specific stiffness and cyclic stretch can be applied together for inducing MSC differentiation towards SMCs without the addition of recombinant growth factors or other soluble factors. This represents a novel stimulation method for modulating the phenotype of MSCs towards SMCs that could easily be incorporated into currently available methodologies to obtain a more targeted control of MSC phenotype. PMID:27775041

  6. Short-term salivary acetaldehyde increase due to direct exposure to alcoholic beverages as an additional cancer risk factor beyond ethanol metabolism

    PubMed Central

    2011-01-01

    Background An increasing body of evidence now implicates acetaldehyde as a major underlying factor for the carcinogenicity of alcoholic beverages and especially for oesophageal and oral cancer. Acetaldehyde associated with alcohol consumption is regarded as 'carcinogenic to humans' (IARC Group 1), with sufficient evidence available for the oesophagus, head and neck as sites of carcinogenicity. At present, research into the mechanistic aspects of acetaldehyde-related oral cancer has been focused on salivary acetaldehyde that is formed either from ethanol metabolism in the epithelia or from microbial oxidation of ethanol by the oral microflora. This study was conducted to evaluate the role of the acetaldehyde that is found as a component of alcoholic beverages as an additional factor in the aetiology of oral cancer. Methods Salivary acetaldehyde levels were determined in the context of sensory analysis of different alcoholic beverages (beer, cider, wine, sherry, vodka, calvados, grape marc spirit, tequila, cherry spirit), without swallowing, to exclude systemic ethanol metabolism. Results The rinsing of the mouth for 30 seconds with an alcoholic beverage is able to increase salivary acetaldehyde above levels previously judged to be carcinogenic in vitro, with levels up to 1000 μM in cases of beverages with extreme acetaldehyde content. In general, the highest salivary acetaldehyde concentration was found in all cases in the saliva 30 sec after using the beverages (average 353 μM). The average concentration then decreased at the 2-min (156 μM), 5-min (76 μM) and 10-min (40 μM) sampling points. The salivary acetaldehyde concentration depends primarily on the direct ingestion of acetaldehyde contained in the beverages at the 30-sec sampling, while the influence of the metabolic formation from ethanol becomes the major factor at the 2-min sampling point. Conclusions This study offers a plausible mechanism to explain the increased risk for oral cancer associated with

  7. Changes in diet, cardiovascular risk factors and modelled cardiovascular risk following diagnosis of diabetes: 1-year results from the ADDITION-Cambridge trial cohort

    PubMed Central

    Savory, L A; Griffin, S J; Williams, K M; Prevost, A T; Kinmonth, A-L; Wareham, N J; Simmons, R K

    2014-01-01

    Aims To describe change in self-reported diet and plasma vitamin C, and to examine associations between change in diet and cardiovascular disease risk factors and modelled 10-year cardiovascular disease risk in the year following diagnosis of Type 2 diabetes. Methods Eight hundred and sixty-seven individuals with screen-detected diabetes underwent assessment of self-reported diet, plasma vitamin C, cardiovascular disease risk factors and modelled cardiovascular disease risk at baseline and 1 year (n = 736) in the ADDITION-Cambridge trial. Multivariable linear regression was used to quantify the association between change in diet and cardiovascular disease risk at 1 year, adjusting for change in physical activity and cardio-protective medication. Results Participants reported significant reductions in energy, fat and sodium intake, and increases in fruit, vegetable and fibre intake over 1 year. The reduction in energy was equivalent to an average-sized chocolate bar; the increase in fruit was equal to one plum per day. There was a small increase in plasma vitamin C levels. Increases in fruit intake and plasma vitamin C were associated with small reductions in anthropometric and metabolic risk factors. Increased vegetable intake was associated with an increase in BMI and waist circumference. Reductions in fat, energy and sodium intake were associated with reduction in HbA1c, waist circumference and total cholesterol/modelled cardiovascular disease risk, respectively. Conclusions Improvements in dietary behaviour in this screen-detected population were associated with small reductions in cardiovascular disease risk, independently of change in cardio-protective medication and physical activity. Dietary change may have a role to play in the reduction of cardiovascular disease risk following diagnosis of diabetes. PMID:24102972

  8. A Risk Score with Additional Four Independent Factors to Predict the Incidence and Recovery from Metabolic Syndrome: Development and Validation in Large Japanese Cohorts

    PubMed Central

    Obokata, Masaru; Negishi, Kazuaki; Ohyama, Yoshiaki; Okada, Haruka; Imai, Kunihiko; Kurabayashi, Masahiko

    2015-01-01

    Background Although many risk factors for Metabolic syndrome (MetS) have been reported, there is no clinical score that predicts its incidence. The purposes of this study were to create and validate a risk score for predicting both incidence and recovery from MetS in a large cohort. Methods Subjects without MetS at enrollment (n = 13,634) were randomly divided into 2 groups and followed to record incidence of MetS. We also examined recovery from it in rest 2,743 individuals with prevalent MetS. Results During median follow-up of 3.0 years, 878 subjects in the derivation and 757 in validation cohorts developed MetS. Multiple logistic regression analysis identified 12 independent variables from the derivation cohort and initial score for subsequent MetS was created, which showed good discrimination both in the derivation (c-statistics 0.82) and validation cohorts (0.83). The predictability of the initial score for recovery from MetS was tested in the 2,743 MetS population (906 subjects recovered from MetS), where nine variables (including age, sex, γ-glutamyl transpeptidase, uric acid and five MetS diagnostic criteria constituents.) remained significant. Then, the final score was created using the nine variables. This score significantly predicted both the recovery from MetS (c-statistics 0.70, p<0.001, 78% sensitivity and 54% specificity) and incident MetS (c-statistics 0.80) with an incremental discriminative ability over the model derived from five factors used in the diagnosis of MetS (continuous net reclassification improvement: 0.35, p < 0.001 and integrated discrimination improvement: 0.01, p<0.001). Conclusions We identified four additional independent risk factors associated with subsequent MetS, developed and validated a risk score to predict both incident and recovery from MetS. PMID:26230621

  9. 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

  10. TWRS safety program plan

    SciTech Connect

    Calderon, L.M., Westinghouse Hanford

    1996-08-01

    Management of Nuclear Safety, Industrial Safety, Industrial Hygiene, and Fire Protection programs, functions, and field support resources for Tank Waste Remediation Systems (TWRS) has, until recently, been centralized in TWRS Safety, under the Emergency, Safety, and Quality organization. Industrial hygiene technician services were also provided to support operational needs related to safety basis compliance. Due to WHC decentralization of safety and reengineering efforts in West Tank Farms, staffing and safety responsibilities have been transferred to the facilities. Under the new structure, safety personnel for TWRS are assigned directly to East Tank Farms, West Tank Farms, and a core Safety Group in TWRS Engineering. The Characterization Project Operations (CPO) safety organization will remain in tact as it currently exists. Personnel assigned to East Tank Farms, West Tank Farms, and CPO will perform facility-specific or project-specific duties and provide field implementation of programs. Those assigned to the core group will focus on activities having a TWRS-wide or programmatic focus. Hanford-wide activities will be the responsibility of the Safety Center of Expertise. In order to ensure an effective and consistent safety program for TWRS under the new organization program functions, goals, organizational structure, roles, responsibilities, and path forward must be clearly established. The purpose of the TWRS Safety Program Plan is to define the overall safety program, responsibilities, relationships, and communication linkages for safety personnel under the new structure. In addition, issues associated with reorganization transition are addressed, including training, project ownership, records management, and dissemination of equipment. For the purpose of this document ``TWRS Safety`` refers to all safety professionals and technicians (Industrial Safety, Industrial Hygiene, Fire Protection, and Nuclear Safety) within the TWRS organization, regardless of their

  11. 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.

  12. 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.

  13. 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.

  14. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study.

    PubMed

    Povsic, Thomas J; Roe, Matthew T; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-04-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in a nominal reduction in cardiovascular death, when added to background DAPT in the ATLAS ACS 2-TIMI 51 trial; however, there was excessive bleeding with this "triple-therapy" approach. The combination of rivaroxaban with P2Y12 inhibition in a "dual-pathway" approach may be an effective therapeutic regimen for the treatment of ACS, given the known importance of P2Y12 inhibition after stenting and intriguing data that the combination of an anticoagulant with clopidogrel after stenting in patients with atrial fibrillation appears an attractive option to this patient population. GEMINI-ACS-1 is a prospective, randomized, double-dummy, double-blind, active-controlled trial that will assess the safety of dual antithrombotic therapy (rivaroxaban [2.5 mg twice daily] + P2Y12 inhibitor) as compared with DAPT (aspirin [100 mg] + P2Y12 inhibitor) within 10 days of an ACS event in 3,000 patients. Patients will be randomized in a 1:1 ratio stratified by intended P2Y12 inhibitor use (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily), with 1500 patients expected in each P2Y12 inhibitor strata. The primary end point is Thrombolysis in Myocardial Infarction clinically significant bleeding (major, minor, or requiring medical attention). The exploratory efficacy determination will be a composite of cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis. GEMINI-ACS-1 will assess the safety and feasibility of dual antithrombotic therapy with rivaroxaban and a P2Y

  15. Fat and starch as additive risk factors for milk fat depression in dairy diets containing corn dried distillers grains with solubles.

    PubMed

    Ramirez Ramirez, H A; Castillo Lopez, E; Harvatine, K J; Kononoff, P J

    2015-03-01

    Two experiments were conducted to evaluate the additive effects of starch and fat as risk factors associated with milk fat depression in dairy diets containing corn dried distillers grains with solubles. In experiment 1, 4 multiparous ruminally cannulated Holstein cows, averaging 114±14 d in milk and 662±52 kg of body weight, were randomly assigned to 4 treatments in a 4×4 Latin square to determine the effect of these risk factors on rumen fermentation and milk fatty acid profile. In each 21-d period, cows were assigned to 1 of 4 dietary treatments: a control diet (CON; ether extract 5.2%, starch 19%); CON with added oil (OL; ether extract 6.4%, starch 18%); CON with added starch (STR; ether extract 5.5%, starch 22%); and CON with added oil and starch (COMBO; ether extract 6.5%, starch 23%). After completion of experiment 1, milk production response was evaluated in a second experiment with a similar approach to diet formulation. Twenty Holstein cows, 12 primiparous and 8 multiparous, averaging 117±17 d in milk and 641±82 kg, were used in replicated 4×4 Latin squares with 21-d periods. Results from experiment 1 showed that ruminal pH was not affected by treatment averaging 5.87±0.08. Molar proportion of propionate in rumen fluid was greatest on the COMBO diet, followed by OL and STR, and lowest for CON. The concentration of trans-10,cis-12 conjugated linoleic acid in milk fat increased with the COMBO diet. Adding oil, starch, or a combination of both resulted in lower concentration and yield of fatty acids<16 carbons. Compared with the control, OL and STR resulted in 13% lower concentration, whereas the COMBO diet resulted in a 27% reduction; similarly yield was reduced by 24% with the OL and STR treatments and 54% with the COMBO diet. In experiment 2, milk yield, milk protein percentage, and milk protein yield were similar across treatments, averaging 26.6±1.01 kg/d, 3.2±0.05%, and 0.84±0.03 kg/d, respectively. Fat-corrected milk was greatest for CON, 26

  16. Restaurant manager and worker food safety certification and knowledge.

    PubMed

    Brown, Laura G; Le, Brenda; Wong, Melissa R; Reimann, David; Nicholas, David; Faw, Brenda; Davis, Ernestine; Selman, Carol A

    2014-11-01

    Over half of foodborne illness outbreaks occur in restaurants. To combat these outbreaks, many public health agencies require food safety certification for restaurant managers, and sometimes workers. Certification entails passing a food safety knowledge examination, which is typically preceded by food safety training. Current certification efforts are based on the assumption that certification leads to greater food safety knowledge. The Centers for Disease Control and Prevention conducted this study to examine the relationship between food safety knowledge and certification. We also examined the relationships between food safety knowledge and restaurant, manager, and worker characteristics. We interviewed managers (N=387) and workers (N=365) about their characteristics and assessed their food safety knowledge. Analyses showed that certified managers and workers had greater food safety knowledge than noncertified managers and workers. Additionally, managers and workers whose primary language was English had greater food safety knowledge than those whose primary language was not English. Other factors associated with greater food safety knowledge included working in a chain restaurant, working in a larger restaurant, having more experience, and having more duties. These findings indicate that certification improves food safety knowledge, and that complex relationships exist among restaurant, manager, and worker characteristics and food safety knowledge.

  17. 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.

  18. Phosphazene additives

    DOEpatents

    Harrup, Mason K; Rollins, Harry W

    2013-11-26

    An additive comprising a phosphazene compound that has at least two reactive functional groups and at least one capping functional group bonded to phosphorus atoms of the phosphazene compound. One of the at least two reactive functional groups is configured to react with cellulose and the other of the at least two reactive functional groups is configured to react with a resin, such as an amine resin of a polycarboxylic acid resin. The at least one capping functional group is selected from the group consisting of a short chain ether group, an alkoxy group, or an aryloxy group. Also disclosed are an additive-resin admixture, a method of treating a wood product, and a wood product.

  19. Potlining Additives

    SciTech Connect

    Rudolf Keller

    2004-08-10

    In this project, a concept to improve the performance of aluminum production cells by introducing potlining additives was examined and tested. Boron oxide was added to cathode blocks, and titanium was dissolved in the metal pool; this resulted in the formation of titanium diboride and caused the molten aluminum to wet the carbonaceous cathode surface. Such wetting reportedly leads to operational improvements and extended cell life. In addition, boron oxide suppresses cyanide formation. This final report presents and discusses the results of this project. Substantial economic benefits for the practical implementation of the technology are projected, especially for modern cells with graphitized blocks. For example, with an energy savings of about 5% and an increase in pot life from 1500 to 2500 days, a cost savings of $ 0.023 per pound of aluminum produced is projected for a 200 kA pot.

  20. Social and Demographic Factors Associated with Morbidities in Young Children in Egypt: A Bayesian Geo-Additive Semi-Parametric Multinomial Model

    PubMed Central

    Khatab, Khaled; Adegboye, Oyelola; Mohammed, Taofeeq Ibn

    2016-01-01

    Background Globally, the burden of mortality in children, especially in poor developing countries, is alarming and has precipitated concern and calls for concerted efforts in combating such health problems. Examples of diseases that contribute to this burden of mortality include diarrhoea, cough, fever, and the overlap between these illnesses, causing childhood morbidity and mortality. Methods To gain insight into these health issues, we employed the 2008 Demographic and Health Survey Data of Egypt, which recorded details from 10,872 children under five. This data focused on the demographic and socio-economic characteristics of household members. We applied a Bayesian multinomial model to assess the area-specific spatial effects and risk factors of co-morbidity of fever, diarrhoea and cough for children under the age of five. Results The results showed that children under 20 months of age were more likely to have the three diseases (OR: 6.8; 95% CI: 4.6–10.2) than children between 20 and 40 months (OR: 2.14; 95% CI: 1.38–3.3). In multivariate Bayesian geo-additive models, the children of mothers who were over 20 years of age were more likely to have only cough (OR: 1.2; 95% CI: 0.9–1.5) and only fever (OR: 1.2; 95% CI: 0.91–1.51) compared with their counterparts. Spatial results showed that the North-eastern region of Egypt has a higher incidence than most of other regions. Conclusions This study showed geographic patterns of Egyptian governorates in the combined prevalence of morbidity among Egyptian children. It is obvious that the Nile Delta, Upper Egypt, and south-eastern Egypt have high rates of diseases and are more affected. Therefore, more attention is needed in these areas. PMID:27442018

  1. 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.

  2. Ferrocyanide Safety Program: Safety criteria for ferrocyanide watch list tanks

    SciTech Connect

    Postma, A.K.; Meacham, J.E.; Barney, G.S.

    1994-01-01

    This report provides a technical basis for closing the ferrocyanide Unreviewed Safety Question (USQ) at the Hanford Site. Three work efforts were performed in developing this technical basis. The efforts described herein are: 1. The formulation of criteria for ranking the relative safety of waste in each ferrocyanide tank. 2. The current classification of tanks into safety categories by comparing available information on tank contents with the safety criteria; 3. The identification of additional information required to resolve the ferrocyanide safety issue.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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).

  9. 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 ...

  10. 42 CFR 86.20 - Additional conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES GRANTS FOR EDUCATION PROGRAMS IN OCCUPATIONAL SAFETY AND HEALTH Occupational Safety and Health Training Grants § 86.20 Additional conditions. The Secretary may with respect...

  11. 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.

  12. School Safety and Security.

    ERIC Educational Resources Information Center

    California State Dept. of Education, Sacramento.

    This document offers additional guidelines for school facilities in California in the areas of safety and security, lighting, and cleanliness. It also offers a description of technology resources available on the World Wide Web. On the topic of safety and security, the document offers guidelines in the areas of entrances, doors, and controlled…

  13. Radiological Safety Handbook.

    ERIC Educational Resources Information Center

    Army Ordnance Center and School, Aberdeen Proving Ground, MD.

    Written to be used concurrently with the U.S. Army's Radiological Safety Course, this publication discusses the causes, sources, and detection of nuclear radiation. In addition, the transportation and disposal of radioactive materials are covered. The report also deals with the safety precautions to be observed when working with lasers, microwave…

  14. Lichenoid Reactions in Association with Tumor Necrosis Factor Alpha Inhibitors: A Review of the Literature and Addition of a Fourth Lichenoid Reaction.

    PubMed

    McCarty, Morgan; Basile, Amy; Bair, Brooke; Fivenson, David

    2015-06-01

    In this manuscript, a clinical case of a patient treated with adalimumab for Behcet's disease develops lichen planopilaris. A variety of mucocutaneous lichenoid eruptions have recently been described in association with tumor necrosis factor alpha inhibitors. The authors briefly discuss the clinical and pathological presentation of lichen planopilaris as well as a potential pathogenesis of cutaneous adverse effects seen as the result of tumor necrosis factor alpha inhibitor therapy. They review all case reports of lichen planopilaris occurring on tumor necrosis factor alpha inhibitors and suggest its classification as a fourth recognized pattern on this therapy.

  15. 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

  16. 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.

  17. Nuclear Protections and Safety Act of 1987. Report of the Committee on Governmental Affairs, United States Senate together with Additional Views to Accompany S. 1085, One Hundredth Congress, First Session

    SciTech Connect

    Not Available

    1987-01-01

    The Senate report on S. 1085 suggests several amendments to the recommended bill which would make oversight of nuclear facility safety an independent board. The legislation responds to concerns that there is no justification for DOE facilities to be exempt from this kind of oversight, and that health and safety standards are as important at nuclear weapons and materials facilities as elsewhere. The report traces the emergence of the nuclear age and the different treatment of government and commercial facilities. There is evidence of a lack of concern for employee health and safety at some government installations. The report summarizes the four titles of the bill, reviews the four days of public hearings, and analyzes the bill by section. It notes changes that will result in the Energy Reorganization Act of 1974, the Atomic Energy Act of 1954, and the Department of Energy Organization Act.

  18. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1992-01-01

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

  19. 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

  20. 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.

  1. 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.

  2. Structure/function analysis of human factor XII using recombinant deletion mutants. Evidence for an additional region involved in the binding to negatively charged surfaces.

    PubMed

    Citarella, F; Ravon, D M; Pascucci, B; Felici, A; Fantoni, A; Hack, C E

    1996-05-15

    The binding site of human factor XII (FXII) for negatively charged surfaces has been proposed to be localized in the N-terminal region of factor XII. We have generated two recombinant factor XII proteins that lack this region: one protein consisting of the second growth-factor-like domain, the kringle domain, the proline-rich region and the catalytic domain of FXII (rFXII-U-like), and another consisting of only 16 amino acids of the proline-rich region of the heavy-chain region and the catalytic domain (rFXII-1pc). Each recombinant truncated protein, as well as recombinant full-length FXII (rFXII), were produced in HepG2 cells and purified by immunoaffinity chromatography. The capability of these recombinant proteins to bind to negatively charged surfaces and to initiate contact activation was studied. Radiolabeled rFXII-U-like and, to a lesser extent, rFXII-lpc bound to glass in a concentration-dependent manner, yet with lower efficiency than rFXII. The binding of the recombinant proteins was inhibited by a 100-fold molar excess of non-labeled native factor XII. On native polyacrylamide gel electrophoresis, both truncated proteins appeared to bind also to dextran sulfate, a soluble negatively charged compound. Glass-bound rFXII-U-like was able to activate prekallikrein in FXII-deficient plasma (assessed by measuring the generation of kallikrein-C1-inhibitor complexes), but less efficiently than rFXII, rFXII-U-like and rFXII-lpc exhibited coagulant activity, but this activity was significantly lower than that of rFXII. These data confirm that the N-terminal part of the heavy-chain region of factor XII contains a binding site for negatively charged activating surfaces, and indicate that other sequences, possibly located on the second epidermal-growth-factor-like domain and/or the kringle domain, contribute to the binding of factor XII to these surfaces.

  3. Pre-flight safety briefings, mood and information retention.

    PubMed

    Tehrani, Morteza; Molesworth, Brett R C

    2015-11-01

    Mood is a moderating factor that is known to affect performance. For airlines, the delivery of the pre-flight safety briefing prior to a commercial flight is not only an opportunity to inform passengers about the safety features on-board the aircraft they are flying, but an opportunity to positively influence their mood, and hence performance in the unlikely event of an emergency. The present research examined whether indeed the pre-flight safety briefing could be used to positively impact passengers' mood. In addition, the present research examined whether the recall of key safety messages contained within the pre-flight safety briefing was influenced by the style of briefing. Eighty-two participants were recruited for the research and divided into three groups; each group exposed to a different pre-flight cabin safety briefing video (standard, humorous, movie theme). Mood was measured prior and post safety briefing. The results revealed that pre-flight safety briefing videos can be used to manipulate passengers' mood. Safety briefings that are humorous or use movie themes to model their briefing were found to positively affect mood. However, there was a trade-off between entertainment and education, the greater the entertainment value, the poorer the retention of key safety messages. The results of the research are discussed from both an applied and theoretical perspective.

  4. Pre-flight safety briefings, mood and information retention.

    PubMed

    Tehrani, Morteza; Molesworth, Brett R C

    2015-11-01

    Mood is a moderating factor that is known to affect performance. For airlines, the delivery of the pre-flight safety briefing prior to a commercial flight is not only an opportunity to inform passengers about the safety features on-board the aircraft they are flying, but an opportunity to positively influence their mood, and hence performance in the unlikely event of an emergency. The present research examined whether indeed the pre-flight safety briefing could be used to positively impact passengers' mood. In addition, the present research examined whether the recall of key safety messages contained within the pre-flight safety briefing was influenced by the style of briefing. Eighty-two participants were recruited for the research and divided into three groups; each group exposed to a different pre-flight cabin safety briefing video (standard, humorous, movie theme). Mood was measured prior and post safety briefing. The results revealed that pre-flight safety briefing videos can be used to manipulate passengers' mood. Safety briefings that are humorous or use movie themes to model their briefing were found to positively affect mood. However, there was a trade-off between entertainment and education, the greater the entertainment value, the poorer the retention of key safety messages. The results of the research are discussed from both an applied and theoretical perspective. PMID:26154236

  5. Transportation Safety Excellence in Operations Through Improved Transportation Safety Document

    SciTech Connect

    Dr. Michael A. Lehto; MAL

    2007-05-01

    A recent accomplishment of the Idaho National Laboratory (INL) Materials and Fuels Complex (MFC) Nuclear Safety analysis group was to obtain DOE-ID approval for the inter-facility transfer of greater-than-Hazard-Category-3 quantity radioactive/fissionable waste in Department of Transportation (DOT) Type A drums at MFC. This accomplishment supported excellence in operations through safety analysis by better integrating nuclear safety requirements with waste requirements in the Transportation Safety Document (TSD); reducing container and transport costs; and making facility operations more efficient. The MFC TSD governs and controls the inter-facility transfer of greater-than-Hazard-Category-3 radioactive and/or fissionable materials in non-DOT approved containers. Previously, the TSD did not include the capability to transfer payloads of greater-than-Hazard-Category-3 radioactive and/or fissionable materials using DOT Type A drums. Previous practice was to package the waste materials to less-than-Hazard-Category-3 quantities when loading DOT Type A drums for transfer out of facilities to reduce facility waste accumulations. This practice allowed operations to proceed, but resulted in drums being loaded to less than the Waste Isolation Pilot Plant (WIPP) waste acceptance criteria (WAC) waste limits, which was not cost effective or operations friendly. An improved and revised safety analysis was used to gain DOE-ID approval for adding this container configuration to the MFC TSD safety basis. In the process of obtaining approval of the revised safety basis, safety analysis practices were used effectively to directly support excellence in operations. Several factors contributed to the success of MFC’s effort to obtain approval for the use of DOT Type A drums, including two practices that could help in future safety basis changes at other facilities. 1) The process of incorporating the DOT Type A drums into the TSD at MFC helped to better integrate nuclear safety

  6. 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

  7. Antecedents of Charter School Success in New York State: Charter School Management Agencies and Additional Factors That Affect English/Language Arts Test Scores in Elementary Charter Schools

    ERIC Educational Resources Information Center

    Schwarz, Jennifer

    2013-01-01

    Charter schools frequently receive public as well as federal attention, and there is a growing body of research becoming available examining charter schools. With all this research there is still a need for further studies which deal specifically with antecedents of charter school success. This study examined factors contributing toward the…

  8. Additivity of Factor Effects in Reading Tasks Is Still a Challenge for Computational Models: Reply to Ziegler, Perry, and Zorzi (2009)

    ERIC Educational Resources Information Center

    Besner, Derek; O'Malley, Shannon

    2009-01-01

    J. C. Ziegler, C. Perry, and M. Zorzi (2009) have claimed that their connectionist dual process model (CDP+) can simulate the data reported by S. O'Malley and D. Besner. Most centrally, they have claimed that the model simulates additive effects of stimulus quality and word frequency on the time to read aloud when words and nonwords are randomly…

  9. Additive influence of genetic predisposition and conventional risk factors in the incidence of coronary heart disease: a population-based study in Greece

    Technology Transfer Automated Retrieval System (TEKTRAN)

    An additive genetic risk score (GRS) for coronary heart disease (CHD) has previously been associated with incident CHD in the population-based Greek European Prospective Investigation into Cancer and nutrition (EPIC) cohort. In this study, we explore GRS-‘environment’ joint actions on CHD for severa...

  10. Additive Manufacturing/Diagnostics via the High Frequency Induction Heating of Metal Powders: The Determination of the Power Transfer Factor for Fine Metallic Spheres

    SciTech Connect

    Rios, Orlando; Radhakrishnan, Balasubramaniam; Caravias, George; Holcomb, Matthew

    2015-03-11

    Grid Logic Inc. is developing a method for sintering and melting fine metallic powders for additive manufacturing using spatially-compact, high-frequency magnetic fields called Micro-Induction Sintering (MIS). One of the challenges in advancing MIS technology for additive manufacturing is in understanding the power transfer to the particles in a powder bed. This knowledge is important to achieving efficient power transfer, control, and selective particle heating during the MIS process needed for commercialization of the technology. The project s work provided a rigorous physics-based model for induction heating of fine spherical particles as a function of frequency and particle size. This simulation improved upon Grid Logic s earlier models and provides guidance that will make the MIS technology more effective. The project model will be incorporated into Grid Logic s power control circuit of the MIS 3D printer product and its diagnostics technology to optimize the sintering process for part quality and energy efficiency.

  11. FLUOR HANFORD SAFETY MANAGEMENT PROGRAMS

    SciTech Connect

    GARVIN, L. J.; JENSEN, M. A.

    2004-04-13

    This document summarizes safety management programs used within the scope of the ''Project Hanford Management Contract''. The document has been developed to meet the format and content requirements of DOE-STD-3009-94, ''Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses''. This document provides summary descriptions of Fluor Hanford safety management programs, which Fluor Hanford nuclear facilities may reference and incorporate into their safety basis when producing facility- or activity-specific documented safety analyses (DSA). Facility- or activity-specific DSAs will identify any variances to the safety management programs described in this document and any specific attributes of these safety management programs that are important for controlling potentially hazardous conditions. In addition, facility- or activity-specific DSAs may identify unique additions to the safety management programs that are needed to control potentially hazardous conditions.

  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. 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

  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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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 ...

  20. Opportunistic virus DNA levels after pediatric stem cell transplantation: serostatus matching, anti-thymocyte globulin, and total body irradiation are additive risk factors.

    PubMed

    Kullberg-Lindh, C; Mellgren, K; Friman, V; Fasth, A; Ascher, H; Nilsson, S; Lindh, M

    2011-04-01

    Viral opportunistic infections remain a threat to survival after stem cell transplantation (SCT). We retrospectively investigated infections caused by cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus type 6 (HHV6), or adenovirus (AdV) during the first 6-12 months after pediatric SCT. Serum samples from 47 consecutive patients were analyzed by quantitative real-time polymerase chain reaction assay. DNAemia at any time point occurred for CMV in 47%, for EBV in 45%, for HHV6 in 28%, and for AdV in 28%. Three patients (6.3%) died of CMV-, EBV-, or AdV-related complications 4, 9, and 24 weeks after SCT, respectively, representing 21% of total mortality. These 3 cases were clearly distinguishable by DNAemia increasing to high levels. Serum positivity for CMV immunoglobulin G in either recipient or donor at the time of SCT, total body irradiation, and anti-thymocyte globulin conditioning were independent risk factors for high CMV or EBV DNA levels. We conclude that DNAemia levels help to distinguish significant viral infections, and that surveillance and prophylactic measures should be focused on patients with risk factors in whom viral complications rapidly can become fatal.

  1. 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…

  2. Solving the Big Data (BD) Problem in Advanced Manufacturing (Subcategory for work done at Georgia Tech. Study Process and Design Factors for Additive Manufacturing Improvement)

    SciTech Connect

    Clark, Brett W.; Diaz, Kimberly A.; Ochiobi, Chinaza Darlene; Paynabar, Kamran

    2015-09-01

    3D printing originally known as additive manufacturing is a process of making 3 dimensional solid objects from a CAD file. This ground breaking technology is widely used for industrial and biomedical purposes such as building objects, tools, body parts and cosmetics. An important benefit of 3D printing is the cost reduction and manufacturing flexibility; complex parts are built at the fraction of the price. However, layer by layer printing of complex shapes adds error due to the surface roughness. Any such error results in poor quality products with inaccurate dimensions. The main purpose of this research is to measure the amount of printing errors for parts with different geometric shapes and to analyze them for finding optimal printing settings to minimize the error. We use a Design of Experiments framework, and focus on studying parts with cone and ellipsoid shapes. We found that the orientation and the shape of geometric shapes have significant effect on the printing error. From our analysis, we also determined the optimal orientation that gives the least printing error.

  3. 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.

  4. 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.

  5. High levels of acute phase proteins and soluble 70 kDa heat shock proteins are independent and additive risk factors for mortality in colorectal cancer

    PubMed Central

    Kocsis, Judit; Mészáros, Tamás; Madaras, Balázs; Tóth, Éva Katalin; Kamondi, Szilárd; Gál, Péter; Varga, Lilian; Prohászka, Zoltán

    2010-01-01

    Recently, we reported that high soluble Hsp70 (sHsp70) level was a significant predictor of mortality during an almost 3-year-long follow-up period in patients with colorectal cancer. This association was the strongest in the group of <70-year-old female patients as well as in those who were in a less advanced stage of the disease at baseline. According to these observations, measurement of the serum level of sHsp70 is a useful, stage-independent prognostic marker in colorectal cancer, especially in patients without distant metastasis. Since many literature data indicated that measurement of C-reactive protein (CRP) and other acute phase proteins (APPs) may also be suitable for predicting the mortality of patients with colorectal cancer, it seemed reasonable to study whether the effect of sHsp70 and other APPs are related or independent. In order to answer this question, we measured the concentrations of CRP as well as of other complement-related APPs (C1 inhibitor, C3, and C9) along with that of the MASP-2 complement component in the sera of 175 patients with colorectal cancer and known levels of sHsp70, which have been used in our previous study. High (above median) levels of CRP, C1 esterase inhibitor (C1-INH), and sHsp70 were found to be independently associated with poor patient survival, whereas no such association was observed with the other proteins tested. According to the adjusted Cox proportional hazards analysis, the additive effect of high sHsp70, CRP, and C1-INH levels on the survival of patients exceeded that of high sHsp70 alone, with a hazard ratio (HR) of 2.83 (1.13–70.9). In some subgroups of patients, such as in females [HR 4.80 (1.07–21.60)] or in ≤70-year-old patients [HR 11.53 (2.78–47.70)], even greater differences were obtained. These findings indicate that the clinical mortality–prediction value of combined measurements of sHsp70, CRP, and C1-INH with inexpensive methods can be very high, especially in specific subgroups of

  6. 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

  7. 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

  8. 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 ...

  9. 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…

  10. Electrophilic addition of astatine

    SciTech Connect

    Norseev, Yu.V.; Vasaros, L.; Nhan, D.D.; Huan, N.K.

    1988-03-01

    It has been shown for the first time that astatine is capable of undergoing addition reactions to unsaturated hydrocarbons. A new compound of astatine, viz., ethylene astatohydrin, has been obtained, and its retention numbers of squalane, Apiezon, and tricresyl phosphate have been found. The influence of various factors on the formation of ethylene astatohydrin has been studied. It has been concluded on the basis of the results obtained that the univalent cations of astatine in an acidic medium is protonated hypoastatous acid.

  11. 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

  12. 77 FR 41899 - Indirect Food Additives: Polymers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-17

    ... the Federal Register of February 17, 2012 (77 FR 9608), FDA announced that a food additive petition..., discussed further in this document. A. The Safety of BPA As indicated in the filing notice (77 FR 9608 at..., FDA is actively assessing the safety of BPA (see 75 FR 17145, April 5, 2010; see also...

  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. Additively Manufactured 3D Porous Ti-6Al-4V Constructs Mimic Trabecular Bone Structure and Regulate Osteoblast Proliferation, Differentiation and Local Factor Production in a Porosity and Surface Roughness Dependent Manner

    PubMed Central

    Cheng, Alice; Humayun, Aiza; Cohen, David J.; Boyan, Barbara D.; Schwartz, Zvi

    2014-01-01

    Additive manufacturing by laser sintering is able to produce high resolution metal constructs for orthopaedic and dental implants. In this study, we used a human trabecular bone template to design and manufacture Ti-6Al-4V constructs with varying porosity via laser sintering. Characterization of constructs revealed interconnected porosities ranging from 15–70% with compressive moduli of 2063–2954 MPa. These constructs with macro porosity were further surface-treated to create a desirable multi-scale micro-/nano-roughness, which has been shown to enhance the osseointegration process. Osteoblasts (MG63 cells) exhibited high viability when grown on the constructs. Proliferation (DNA) and alkaline phosphatase specific activity (ALP), an early differentiation marker, decreased as porosity increased, while osteocalcin (OCN), a late differentiation marker, as well as osteoprotegerin (OPG), vascular endothelial growth factor (VEGF) and bone morphogenetic proteins 2 and 4 (BMP2, BMP4) increased with increasing porosity. 3D constructs with the highest porosity and surface modification supported the greatest osteoblast differentiation and local factor production. These results indicate that additively manufactured 3D porous constructs mimicking human trabecular bone and produced with additional surface treatment can be customized for increased osteoblast response. Increased factors for osteoblast maturation and differentiation on high porosity constructs suggest the enhanced performance of these surfaces for increasing osseointegration in vivo. PMID:25287305

  16. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Content Requirements... notices, the CPSC shall include in the Database any additional information it determines to be in...

  17. 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.

  18. 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.

  19. 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)

  20. 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…

  1. 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…

  2. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1993-01-01

    The Aerospace Safety Advisory Panel (ASAP) provided oversight on the safety aspects of many NASA programs. In addition, ASAP undertook three special studies. At the request of the Administrator, the panel assessed the requirements for an assured crew return vehicle (ACRV) for the space station and reviewed the organization of the safety and mission quality function within NASA. At the behest of Congress, the panel formed an independent, ad hoc working group to examine the safety and reliability of the space shuttle main engine. Section 2 presents findings and recommendations. Section 3 consists of information in support of these findings and recommendations. Appendices A, B, C, and D, respectively, cover the panel membership, the NASA response to the findings and recommendations in the March 1992 report, a chronology of the panel's activities during the reporting period, and the entire ACRV study report.

  3. [Additional administration of dutasteride in patients with benign prostatic hyperplasia who did not respond sufficiently to α1-adrenoceptor antagonist : investigation of clinical factors affecting the therapeutic effect of dutasteride].

    PubMed

    Masuda, Mitsunobu; Murai, Tetsuo; Osada, Yutaka; Kawai, Masaki; Kasuga, Jun; Yokomizo, Yumiko; Kuroda, Shinnosuke; Nakamura, Mami; Noguchi, Go

    2014-02-01

    We performed additional administration of dutasteride in patients who did not respond sufficiently to α1-adrenoceptor antagonist treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) (LUTS/BPH). Among 76 registered patients, efficacy was analyzed in 58 patients. International Prostate Symptom Score (IPSS), subscores for voiding and storage symptoms and quality of life (QOL) on the IPSS, and Overactive Bladder Symptom Score (OABSS) were all significantly improved from the third month of administration compared to the time of initiating additional administration of dutasteride. Additional administration of dutasteride also significantly reduced prostate volume, and residual urine with the exception of the sixth month after administration. Age at initiation of administration and voiding symptom subscore on the IPSS were clinical factors affecting the therapeutic effects of dutasteride. The rate of improvement with treatment decreased with increasing age at initiation of dutasteride administration, and increased as voiding symptom subscore on the IPSS increased. Therefore, additional administration of dutasteride appears useful for cases of LUTS/BPH in which a sufficient response is not achieved with α1-adrenoceptor antagonist treatment. Because patients who have severe voiding symptoms or begin dutasteride at an early age may be expected to respond particularly well to dutasteride in terms of clinical efficacy, they were considered to be suitable targets for additional administration. PMID:24755815

  4. Safety of Disposable Diaper Materials: Extensive Evaluations Validate Use.

    PubMed

    Dey, Swatee; Helmes, C Tucker; White, Jeffrey C; Zhou, Shaoying

    2014-06-24

    Disposable diapers are primarily composed of polymers, such as cellulose, polypropylene, polyester, and polyethylene, which are biologically inert and not bioavailable. They are used in clothes, fabrics, personal hygiene products, and other materials that are commonly in contact with the skin. Each component used throughout the production process must undergo rigorous safety evaluations and assessments and are proven to be well tolerated and safe for their intended uses. No materials are incorporated into a diaper until their safety is confirmed through robust assessments, and additional factors are integrated into the process to compensate for the uncertainty associated with extrapolating toxicity data. After a thorough assessment of the materials and final product, extensive skin compatibility evaluations are conducted as appropriate. This rigorous safety process provides reassurance that consumers can rely on the safety of these diapers.

  5. Food safety.

    PubMed

    Borchers, Andrea; Teuber, Suzanne S; Keen, Carl L; Gershwin, M Eric

    2010-10-01

    Food can never be entirely safe. Food safety is threatened by numerous pathogens that cause a variety of foodborne diseases, algal toxins that cause mostly acute disease, and fungal toxins that may be acutely toxic but may also have chronic sequelae, such as teratogenic, immunotoxic, nephrotoxic, and estrogenic effects. Perhaps more worrisome, the industrial activities of the last century and more have resulted in massive increases in our exposure to toxic metals such as lead, cadmium, mercury, and arsenic, which now are present in the entire food chain and exhibit various toxicities. Industrial processes also released chemicals that, although banned a long time ago, persist in the environment and contaminate our food. These include organochlorine compounds, such as 1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane (dichlorodiphenyl dichloroethene) (DDT), other pesticides, dioxins, and dioxin-like compounds. DDT and its breakdown product dichlorophenyl dichloroethylene affect the developing male and female reproductive organs. In addition, there is increasing evidence that they exhibit neurodevelopmental toxicities in human infants and children. They share this characteristic with the dioxins and dioxin-like compounds. Other food contaminants can arise from the treatment of animals with veterinary drugs or the spraying of food crops, which may leave residues. Among the pesticides applied to food crops, the organophosphates have been the focus of much regulatory attention because there is growing evidence that they, too, affect the developing brain. Numerous chemical contaminants are formed during the processing and cooking of foods. Many of them are known or suspected carcinogens. Other food contaminants leach from the packaging or storage containers. Examples that have garnered increasing attention in recent years are phthalates, which have been shown to induce malformations in the male reproductive system in laboratory animals, and bisphenol A, which negatively

  6. 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.

  7. 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.

  8. 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.

  9. 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…

  10. 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)

  11. Tractor Safety. Unit A-9.

    ERIC Educational Resources Information Center

    Luft, Vernon D.; Backlund, Paul

    This document is a teacher's guide for a unit in tractor and machinery safety for college freshmen. It is intended to be used for 10 hours of instruction for freshmen who are intending to work on or around machinery. Safety hazards directly and indirectly related to many types of machinery are covered in addition to tractors. The objectives of the…

  12. Safety Basis Report

    SciTech Connect

    R.J. Garrett

    2002-01-14

    As part of the internal Integrated Safety Management Assessment verification process, it was determined that there was a lack of documentation that summarizes the safety basis of the current Yucca Mountain Project (YMP) site characterization activities. It was noted that a safety basis would make it possible to establish a technically justifiable graded approach to the implementation of the requirements identified in the Standards/Requirements Identification Document. The Standards/Requirements Identification Documents commit a facility to compliance with specific requirements and, together with the hazard baseline documentation, provide a technical basis for ensuring that the public and workers are protected. This Safety Basis Report has been developed to establish and document the safety basis of the current site characterization activities, establish and document the hazard baseline, and provide the technical basis for identifying structures, systems, and components (SSCs) that perform functions necessary to protect the public, the worker, and the environment from hazards unique to the YMP site characterization activities. This technical basis for identifying SSCs serves as a grading process for the implementation of programs such as Conduct of Operations (DOE Order 5480.19) and the Suspect/Counterfeit Items Program. In addition, this report provides a consolidated summary of the hazards analyses processes developed to support the design, construction, and operation of the YMP site characterization facilities and, therefore, provides a tool for evaluating the safety impacts of changes to the design and operation of the YMP site characterization activities.

  13. Aspartame: review of safety.

    PubMed

    Butchko, Harriett H; Stargel, W Wayne; Comer, C Phil; Mayhew, Dale A; Benninger, Christian; Blackburn, George L; de Sonneville, Leo M J; Geha, Raif S; Hertelendy, Zsolt; Koestner, Adalbert; Leon, Arthur S; Liepa, George U; McMartin, Kenneth E; Mendenhall, Charles L; Munro, Ian C; Novotny, Edward J; Renwick, Andrew G; Schiffman, Susan S; Schomer, Donald L; Shaywitz, Bennett A; Spiers, Paul A; Tephly, Thomas R; Thomas, John A; Trefz, Friedrich K

    2002-04-01

    Over 20 years have elapsed since aspartame was approved by regulatory agencies as a sweetener and flavor enhancer. The safety of aspartame and its metabolic constituents was established through extensive toxicology studies in laboratory animals, using much greater doses than people could possibly consume. Its safety was further confirmed through studies in several human subpopulations, including healthy infants, children, adolescents, and adults; obese individuals; diabetics; lactating women; and individuals heterozygous (PKUH) for the genetic disease phenylketonuria (PKU) who have a decreased ability to metabolize the essential amino acid, phenylalanine. Several scientific issues continued to be raised after approval, largely as a concern for theoretical toxicity from its metabolic components--the amino acids, aspartate and phenylalanine, and methanol--even though dietary exposure to these components is much greater than from aspartame. Nonetheless, additional research, including evaluations of possible associations between aspartame and headaches, seizures, behavior, cognition, and mood as well as allergic-type reactions and use by potentially sensitive subpopulations, has continued after approval. These findings are reviewed here. The safety testing of aspartame has gone well beyond that required to evaluate the safety of a food additive. When all the research on aspartame, including evaluations in both the premarketing and postmarketing periods, is examined as a whole, it is clear that aspartame is safe, and there are no unresolved questions regarding its safety under conditions of intended use.

  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. Safety Performance of Airborne Separation: Preliminary Baseline Testing

    NASA Technical Reports Server (NTRS)

    Consiglio, Maria C.; Hoadley, Sherwood T.; Wing, David J.; Baxley, Brian T.

    2007-01-01

    The Safety Performance of Airborne Separation (SPAS) study is a suite of Monte Carlo simulation experiments designed to analyze and quantify safety behavior of airborne separation. This paper presents results of preliminary baseline testing. The preliminary baseline scenario is designed to be very challenging, consisting of randomized routes in generic high-density airspace in which all aircraft are constrained to the same flight level. Sustained traffic density is varied from approximately 3 to 15 aircraft per 10,000 square miles, approximating up to about 5 times today s traffic density in a typical sector. Research at high traffic densities and at multiple flight levels are planned within the next two years. Basic safety metrics for aircraft separation are collected and analyzed. During the progression of experiments, various errors, uncertainties, delays, and other variables potentially impacting system safety will be incrementally introduced to analyze the effect on safety of the individual factors as well as their interaction and collective effect. In this paper we report the results of the first experiment that addresses the preliminary baseline condition tested over a range of traffic densities. Early results at five times the typical traffic density in today s NAS indicate that, under the assumptions of this study, airborne separation can be safely performed. In addition, we report on initial observations from an exploration of four additional factors tested at a single traffic density: broadcast surveillance signal interference, extent of intent sharing, pilot delay, and wind prediction error.

  16. Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg⁻¹) rFVIIa doses across clinical trials and registries.

    PubMed

    Shapiro, A D; Neufeld, E J; Blanchette, V; Salaj, P; Gut, R Z; Cooper, D L

    2014-01-01

    Recombinant activated factor VII (rFVIIa) is indicated for treatment of bleeding in congenital haemophilia with inhibitors (CHwI) using 90 μg kg(-1) every 2-3 h (EU and US) or a single 270 μg kg(-1) dose (EU only) with ~90% efficacy reported for both regimens. Dosing of rFVIIa varies, and home treatment makes assessment of frequency of doses >90 μg kg(-1), the intervals before additional treatment, and the risk for thromboembolic events (TEs) more difficult. This post hoc analysis assessed the safety and distribution of rFVIIa dosing in CHwI and the impact of >240 μg kg(-1) dosing on subsequent bypassing agent (BPA) dosing interval and frequency. Data regarding on-demand or prophylactic rFVIIa dosing, TE incidence and subsequent BPA dosing after high rFVIIa doses were compiled from multiple sources incorporating safety surveillance. A total of 61 734 rFVIIa doses were reported in 481 patients treated for 3947 bleeds and for 43 135 prophylaxis days. Over half (52%) exceeded 120 μg kg(-1), 37% exceeded 160 μg kg(-1) and 15% exceeded 240 μg kg(-1). Subsequent doses of BPA(s) were administered after 38% of initial and 49% of any rFVIIa dose >240 μg kg(-1), and were most frequently administered ≥24 h after initial (40%) or any (53%) doses >240 μg kg(-1). No TEs were reported. The findings of this analysis show that rFVIIa doses >90 μg kg(-1) are utilized for 'real-world' treatment of children and adults. When additional BPA was administered following an rFVIIa dose >240 μg kg(-1), reported intervals were prolonged, often ≥24 h. No safety issues were identified in the 61,734 doses analysed.

  17. Critical questions for preclinical trials on safety and efficacy of vascular endothelial growth factor-based therapeutic angiogenesis for ischemic stroke.

    PubMed

    Manoonkitiwongsa, P S

    2011-03-01

    Therapeutic angiogenesis is a novel treatment for ischemic stroke, and vascular endothelial growth factor (VEGF) is a key angiogenic and neuroprotective pharmacological candidate for therapy. However, the greatest challenge of preclinical studies is demonstrating that VEGF-based therapeutic angiogenesis is safe and effective for ischemic stroke patients. This review presents the following crucial questions which must first be answered by preclinical studies before VEGF-based therapeutic angiogenesis advances to human stroke trials, (1) Does angiogenesis induced by VEGF monotherapy promote neuroprotection or further damage the nervous tissue? (2) Does angiogenesis by VEGF in combination with other agents (combination therapy) promote greater neuroprotection than monotherapy, and without additional side effects? (3) Which exogenous VEGF isoform best promotes angiogenesis and neuroprotection, with least adverse effects on other organs? (4) Does angiogenesis induced by exogenous VEGF produce similar results in different animal models of ischemic stroke, including variations in age, gender and coexisting chronic diseases? (5) Can angiogenesis be induced by exogenous VEGF without clinically-significant alterations of systemic hemodynamics? (6) Are gene therapy and stem cells more beneficial than recombinant protein for VEGF-based therapeutic angiogenesis? (7) What are the best routes, timing and duration for administering VEGF, and how do these parameters influence inflammation? (8) Does exogenous VEGF exacerbate inflammation when traumatic or other injuries are present with ischemia? (9) Are VEGF doses not causing tissue alterations at the light microscopy level associated with clinically-significant ultrastructural damages of the neurovascular unit? Both published and unpublished preclinical data from the author's laboratory are presented. PMID:20874695

  18. 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.

  19. Does safety climate predict safety performance in Italy and the USA? Cross-cultural validation of a theoretical model of safety climate.

    PubMed

    Barbaranelli, Claudio; Petitta, Laura; Probst, Tahira M

    2015-04-01

    Previous studies have acknowledged the relevance of assessing the measurement equivalence of safety related measures across different groups, and demonstrating whether the existence of disparities in safety perceptions might impair direct group comparisons. The Griffin and Neal (2000) model of safety climate, and the accompanying measure (Neal et al. [NGH], 2000), are both widely cited and utilized. Yet neither the model in its entirety nor the measure have been previously validated across different national contexts. The current study is the first to examine the NGH measurement equivalence by testing whether their model of safety climate predicting safety performance is tenable in both English speaking and non-English speaking countries. The study involved 616 employees from 21 organizations in the US, and 738 employees from 20 organizations in Italy. A multi-group confirmatory factor analytic approach was used to assess the equivalence of the measures across the two countries. Similarly, the structural model of relations among the NGH variables was examined in order to demonstrate its cross-country invariance. Results substantially support strict invariance across groups for the NGH safety scales. Moreover, the invariance across countries is also demonstrated for the effects of safety climate on safety knowledge and motivation, which in turn positively relate to both compliance and participation. Our findings have relevant theoretical implications by establishing measurement and relational equivalence of the NGH model. Practical implications are discussed for managers and practitioners dealing with multi-national organizational contexts. Future research should continue to investigate potential differences in safety related perceptions across additional non-English speaking countries.

  20. 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.