Virtual Road Safety Audits: Recommended Procedures for Using Driving Simulation and Technology to Expand Existing Practices

DOT National Transportation Integrated Search

2018-02-02

One approach that has been proposed to address the limitations of the current reactive safetymonitoring approaches is the use of road safety audits (RSAs). As part of an RSA, the existing or expected characteristics and traffic conditions of a locati...

Safety Concerns Surrounding Quinolone Use in Children

PubMed Central

Patel, Karisma; Goldman, Jennifer L.

2016-01-01

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

76 FR 8610 - Airworthiness Directives; Airbus Model A340-200, -300, -500, and -600 Series Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

... Section (ALS) Part 2. The issue 11 of Airbus A340 ALI Document introduces more restrictive maintenance... airworthiness limitations are currently included in Airbus A340 Airworthiness Limitations Section (ALS). The... Aviation Safety Agency (EASA) and referenced in Airbus Airworthiness Limitations Section (ALS) Part 2. The...

Low-frequency electrical dosimetry: research agenda of the IEEE International Committee on Electromagnetic Safety.

PubMed

Reilly, J Patrick; Hirata, Akimasa

2016-06-21

This article treats unsettled issues in the use of numerical models of electrical dosimetry as applied to international limits on human exposure to low-frequency (typically  <  100 kHz) electromagnetic fields and contact current. The perspective in this publication is that of Subcommittee 6 of IEEE-ICES (International Committee on Electromagnetic Safety) Technical Committee 95. The paper discusses 25 issues needing attention, fitting into three general categories: induction models; electrostimulation models; and human exposure limits. Of these, 9 were voted as 'high priority' by members of Subcommittee 6. The list is presented as a research agenda for refinements in numerical modeling with applications to human exposure limits. It is likely that such issues are also important in medical and electrical product safety design applications.

76 FR 42024 - Airworthiness Directives; Airbus Model A318, A319, A320, and A321 Series Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

... limitations are currently included in Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS). The... Safety Agency (EASA) and referenced in Airbus Airworthiness Limitations Section (ALS) Part 2. The issue...: Revise Airworthiness Limitations Section (ALS) To Incorporate Safe Life ALIs (g) For Model A318-111 and...

Public Risk Criteria and Rationale for Commercial Launch and Reentry

NASA Astrophysics Data System (ADS)

Wilde, P. D.

2012-01-01

This paper summarizes the rationale for risk criteria intended to protect the public during commercial spaceflight, including launch, reentry, and suborbital missions. The recommended approach includes: (1) safety goals to guide periodic updates of the quantitative collective risk limits if warranted based on the quantity of launch and reentry missions; the demonstrated safety record and benefits provided; technological capabilities and maturity of the industry; and contemporary attitudes about the risks from commercial space transportation; (2) separate limits on the risks from each type of mission with explicit definitions of the extent of launch and reentry missions; and (3) quantitative risk limits consistent with the safety goals. For current conditions, the author's recommends (a) maximum of 1E-6 probability of casualty per-mission (b) a maximum of 100E-6 expected casualties per-mission, and (c) equal per-mission risk limits for orbital and suborbital launches, as well as controlled and uncontrolled reentries.

Traffic safety in the U.S.: re-examining major opportunities.

PubMed

Sivak, Michael; Luoma, Juha; Flannagan, Michael J; Bingham, C Raymond; Eby, David W; Shope, Jean T

2007-01-01

This article examines five major road-safety risk factors: exceeding posted speed limits, not using safety belts, driving while intoxicated, nighttime driving, and young drivers. The importance of each of these factors is documented, known effective countermeasures (both policy and technology based) are discussed, and impediments to the implementation of these countermeasures in the United States are examined. Based on current understanding of the five major risk factors, and of the available countermeasures, there appear to be a variety of opportunities to make substantial gains in road safety using existing knowledge. The limited implementation of a variety of known countermeasures therefore appears to be inconsistent with high-level, strategic goals to improve road safety. Consequently, a recommendation is made to comprehensively re-examine the balance between the countermeasures discussed in this article and economic, mobility, and privacy concerns. IMPACT ON PUBLIC SAFETY: Such a re-examination is likely to result in broad support for these countermeasures, with a consequent major improvement in road safety.

Design of a reusable kinetic energy absorber for an astronaut safety tether to be used during extravehicular activities on the Space Station

NASA Technical Reports Server (NTRS)

Borthwick, Dawn E.; Cronch, Daniel F.; Nixon, Glen R.

1991-01-01

The goal of this project is to design a reusable safety device for a waist tether which will absorb the kinetic energy of an astronaut drifting away from the Space Station. The safety device must limit the tension of the tether line in order to prevent damage to the astronaut's space suit or to the structure of the spacecraft. The tether currently used on shuttle missions must be replaced after the safety feature has been developed. A reusable tether for the Space Station would eliminate the need for replacement tethers, conserving space and mass. This report presents background information, scope and limitations, methods of research and development, alternative designs, a final design solution and its evaluation, and recommendations for further work.

30 CFR 75.327 - Air courses and trolley haulage systems.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Air courses and trolley haulage systems. 75.327... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.327 Air courses and... enough entries or rooms as intake air courses to limit the velocity of air currents in the haulageways to...

30 CFR 75.327 - Air courses and trolley haulage systems.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Air courses and trolley haulage systems. 75.327... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.327 Air courses and... enough entries or rooms as intake air courses to limit the velocity of air currents in the haulageways to...

30 CFR 75.327 - Air courses and trolley haulage systems.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Air courses and trolley haulage systems. 75.327... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.327 Air courses and... enough entries or rooms as intake air courses to limit the velocity of air currents in the haulageways to...

Dynamic Speed Adaptation for Path Tracking Based on Curvature Information and Speed Limits.

PubMed

Gámez Serna, Citlalli; Ruichek, Yassine

2017-06-14

A critical concern of autonomous vehicles is safety. Different approaches have tried to enhance driving safety to reduce the number of fatal crashes and severe injuries. As an example, Intelligent Speed Adaptation (ISA) systems warn the driver when the vehicle exceeds the recommended speed limit. However, these systems only take into account fixed speed limits without considering factors like road geometry. In this paper, we consider road curvature with speed limits to automatically adjust vehicle's speed with the ideal one through our proposed Dynamic Speed Adaptation (DSA) method. Furthermore, 'curve analysis extraction' and 'speed limits database creation' are also part of our contribution. An algorithm that analyzes GPS information off-line identifies high curvature segments and estimates the speed for each curve. The speed limit database contains information about the different speed limit zones for each traveled path. Our DSA senses speed limits and curves of the road using GPS information and ensures smooth speed transitions between current and ideal speeds. Through experimental simulations with different control algorithms on real and simulated datasets, we prove that our method is able to significantly reduce lateral errors on sharp curves, to respect speed limits and consequently increase safety and comfort for the passenger.

Characterization of copper and nichrome wires for safety fuse

NASA Astrophysics Data System (ADS)

Murdani, E.

2016-11-01

Fuse is an important component of an electrical circuit to limiting the current through the electrical circuit for electrical equipment safety. Safety fuses are made of a conductor such as copper and nichrome wires. The aim of this research was to determine the maximum current that can flow in the conductor wires (copper and nichrome). In the experiment used copper and nichrome wires by varying the length of wires (0.2 cm to 20 cm) and diameter of wires (0.1, 0.2, 0.3, 0.4 and 0.5) mm until maximum current reached that marked by melted or broken wire. From this experiment, it will be obtained the dependences data of maximum current to the length and diameter of wires. All data are plotted and it's known as a standard curve. The standard curve will provide an alternative choice of replacing fuse wire according to the maximum current requirement, including the wire type (copper and nichrome wires) and wire dimensions (length and diameter of wire).

Investigation of Metal Oxide/Carbon Nano Material as Anode for High Capacity Lithium-ion Cells

NASA Technical Reports Server (NTRS)

Wu, James Jianjun; Hong, Haiping

2014-01-01

NASA is developing high specific energy and high specific capacity lithium-ion battery (LIB) technology for future NASA missions. Current state-of-art LIBs have issues in terms of safety and thermal stability, and are reaching limits in specific energy capability based on the electrochemical materials selected. For example, the graphite anode has a limited capability to store Li since the theoretical capacity of graphite is 372 mAh/g. To achieve higher specific capacity and energy density, and to improve safety for current LIBs, alternative advanced anode, cathode, and electrolyte materials are pursued under the NASA Advanced Space Power System Project. In this study, the nanostructed metal oxide, such as Fe2O3 on carbon nanotubes (CNT) composite as an LIB anode has been investigated.

Safety Assurance in NextGen

NASA Technical Reports Server (NTRS)

HarrisonFleming, Cody; Spencer, Melissa; Leveson, Nancy; Wilkinson, Chris

2012-01-01

The generation of minimum operational, safety, performance, and interoperability requirements is an important aspect of safely integrating new NextGen components into the Communication Navigation Surveillance and Air Traffic Management (CNS/ATM) system. These requirements are used as part of the implementation and approval processes. In addition, they provide guidance to determine the levels of design assurance and performance that are needed for each element of the new NextGen procedures, including aircraft, operator, and Air Navigation and Service Provider. Using the enhanced Airborne Traffic Situational Awareness for InTrail Procedure (ATSA-ITP) as an example, this report describes some limitations of the current process used for generating safety requirements and levels of required design assurance. An alternative process is described, as well as the argument for why the alternative can generate more comprehensive requirements and greater safety assurance than the current approach.

Impact of Resident Duty Hour Limits on Safety in the ICU: A National Survey of Pediatric and Neonatal Intensivists

PubMed Central

Typpo, Katri V.; Tcharmtchi, M. Hossein; Thomas, Eric J.; Kelly, P. Adam; Castillo, Leticia D.; Singh, Hardeep

2011-01-01

Objective Resident duty-hour regulations potentially shift workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units (ICUs). Design Web-based survey Setting US academic pediatric and neonatal ICUs Subjects Attending pediatric and neonatal intensivists Interventions We evaluated perceptions on four ICU safety-related risk measures potentially affected by current duty-hour regulations: 1) Attending physician and resident fatigue, 2) Attending physician work-load, 3) Errors (self-reported rates by attending physicians or perceived resident error rates), and 4) Safety culture. We also evaluated perceptions of how these risks would change with further duty hour restrictions. Measurements and Main Results We administered our survey between February and April 2010 to 688 eligible physicians, of which 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase. Conclusions Pediatric intensivists do not perceive improved patient safety from current resident duty hour restrictions. Policies to further restrict resident duty hours should consider unintended consequences of worsening certain aspects of ICU safety. PMID:22614570

Impact of resident duty hour limits on safety in the intensive care unit: a national survey of pediatric and neonatal intensivists.

PubMed

Typpo, Katri V; Tcharmtchi, M Hossein; Thomas, Eric J; Kelly, P Adam; Castillo, Leticia D; Singh, Hardeep

2012-09-01

Resident duty-hour regulations potentially shift the workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units. Web-based survey. U.S. academic pediatric and neonatal intensive care units. Attending pediatric and neonatal intensivists. We evaluated perceptions on four intensive care unit safety-related risk measures potentially affected by current duty-hour regulations: 1) attending physician and resident fatigue; 2) attending physician workload; 3) errors (self-reported rates by attending physicians or perceived resident error rates); and 4) safety culture. We also evaluated perceptions of how these risks would change with further duty-hour restrictions. We administered our survey between February and April 2010 to 688 eligible physicians, of whom 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase. Pediatric intensivists do not perceive improved patient safety from current resident duty-hour restrictions. Policies to further restrict resident duty-hours should consider unintended consequences of worsening certain aspects of intensive care unit safety.

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016.

PubMed

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H; Hampstead, Benjamin M; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A; Reis, Janine; Richardson, Jessica D; Rotenberg, Alexander; Turkeltaub, Peter E; Woods, Adam J

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety of transcranial Direct Current Stimulation: Evidence Based Update 2016

PubMed Central

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R.; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H.; Hampstead, Benjamin M.; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A.; Reis, Janine; Richardson, Jessica D.; Rotenberg, Alexander; Turkeltaub, Peter E.; Woods, Adam J.

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1,000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. PMID:27372845

Simulation of leakage current measurement on medical devices using helmholtz coil configuration with different current flow

NASA Astrophysics Data System (ADS)

Sutanto, E.; Chandra, F.; Dinata, R.

2017-05-01

Leakage current measurement which can follow IEC standard for medical device is one of many challenges to be answered. The IEC 60601-1 has defined that the limit for a leakage current for Medical Device can be as low as 10 µA and as high as 500 µA, depending on which type of contact (applied part) connected to the patient. Most people are using ELCB (Earth-leakage circuit breaker) for safety purpose as this is the most common and available safety device in market. One type of ELCB devices is RCD (Residual Current Device) and this RCD type can measure the leakage current directly. This work will show the possibility on how Helmholtz Coil Configuration can be made to be like the RCD. The possibility is explored by comparing the magnetic field formula from each device, then it proceeds with a simulation using software EJS (Easy Java Simulation). The simulation will make sure the concept of magnetic field current cancellation follows the RCD concept. Finally, the possibility of increasing the measurement’s sensitivity is also analyzed. The sensitivity is needed to see the possibility on reaching the minimum leakage current limit defined by IEC, 0.01mA.

Technical Study on Improvement of Endurance Capability of Limit Short-circuit Current of Charge Control SMART Meter

NASA Astrophysics Data System (ADS)

Li, W. W.; Du, Z. Z.; Yuan, R. m.; Xiong, D. Z.; Shi, E. W.; Lu, G. N.; Dai, Z. Y.; Chen, X. Q.; Jiang, Z. Y.; Lv, Y. G.

2017-10-01

Smart meter represents the development direction of energy-saving smart grid in the future. The load switch, one of the core parts of smart meter, should be of high reliability, safety and endurance capability of limit short-circuit current. For this reason, this paper discusses the quick simulation of relationship between attraction and counterforce of load switch without iteration, establishes dual response surface model of attraction and counterforce and optimizes the design scheme of load switch for charge control smart meter, thus increasing electromagnetic attraction and spring counterforce. In this way, this paper puts forward a method to improve the withstand capacity of limit short-circuit current.

Occupational Health and Safety in Ethiopia: A review of Situational Analysis and Needs Assessment

PubMed Central

Kumie, Abera; Amera, Tadesse; Berhane, Kiros; Samet, Jonathan; Hundal, Nuvjote; G/Michael, Fitsum; Gilliland, Frank

2017-01-01

Background The current rapid economic development has brought changes in workplaces in developing countries, including Ethiopia. The organization of occupational health and safety services is not yet resilient enough to handle the growing demands for workers’ health in the context of industrialization. There is limited information on the gaps and needs of occupational health services in workplaces in Ethiopia. Objectives The present review article describes the existing profile of occupational safety and health services in Ethiopia and identifies the current gaps and needs in the services. Methods Secondary data sources were reviewed using a structured checklist to explore the status of occupational safety, health services and related morbidity. Local literature was consulted in order to describe the type and prevalence of work related hazards, patterns of industries and of workforce. Published articles were searched in Google, Google scholar, PUBMED, and HINARI databases. Relevant heads of stakeholder organizations and experts were interviewed to verify the gaps that were synthesized using desk review. Results Ethiopia is an agrarian country that is industrializing rapidly with a focus on construction, manufacturing, mining, and road infrastructure. An estimated work force of about two million is currently engaged in the public and private sectors. Males constitute the majority of this workforce. Most of the workforce has basic primary education. Commonly observed hazards in the workplace include occupational noise and dust of various types in manufacturing sectors and chemical exposures in the flower industry. Injury in both the agriculture and the manufacturing sectors is another workplace hazard commonly observed in the country. A lack of information made assessing workplace exposures in detail difficult. The prevalence of noise exposure was found to be high with the potential to seriously impact hearing capacity. Exposure to dust in textile and cement factories greatly exceeded international permissible limits. There is a high level of workplace injuries that often leads to an extended loss of productive working days. Occupational safety and health services were found to be inadequately organized. There is limited practice in exposure assessment and monitoring. This happens to be true despite the existing favorable environment in areas of policies and regulations. Conclusion and Recommendation There is a severe scarcity of peer-reviewed literature related to workplace exposures and their impact on workplace health and safety. Limited adequately skilled manpower is available. The internal infrastructural capacity is weak and cannot help to identify and assess hazards in the workplace. Monitoring system and laboratory investigation is limited despite the presence of favorable policy and regulatory frameworks. Addressing these gaps is of immediate concern. PMID:28867918

Occupational Health and Safety in Ethiopia: A review of Situational Analysis and Needs Assessment.

PubMed

Kumie, Abera; Amera, Tadesse; Berhane, Kiros; Samet, Jonathan; Hundal, Nuvjote; G/Michael, Fitsum; Gilliland, Frank

2016-01-01

The current rapid economic development has brought changes in workplaces in developing countries, including Ethiopia. The organization of occupational health and safety services is not yet resilient enough to handle the growing demands for workers' health in the context of industrialization. There is limited information on the gaps and needs of occupational health services in workplaces in Ethiopia. The present review article describes the existing profile of occupational safety and health services in Ethiopia and identifies the current gaps and needs in the services. Secondary data sources were reviewed using a structured checklist to explore the status of occupational safety, health services and related morbidity. Local literature was consulted in order to describe the type and prevalence of work related hazards, patterns of industries and of workforce. Published articles were searched in Google, Google scholar, PUBMED, and HINARI databases. Relevant heads of stakeholder organizations and experts were interviewed to verify the gaps that were synthesized using desk review. Ethiopia is an agrarian country that is industrializing rapidly with a focus on construction, manufacturing, mining, and road infrastructure. An estimated work force of about two million is currently engaged in the public and private sectors. Males constitute the majority of this workforce. Most of the workforce has basic primary education. Commonly observed hazards in the workplace include occupational noise and dust of various types in manufacturing sectors and chemical exposures in the flower industry. Injury in both the agriculture and the manufacturing sectors is another workplace hazard commonly observed in the country. A lack of information made assessing workplace exposures in detail difficult. The prevalence of noise exposure was found to be high with the potential to seriously impact hearing capacity. Exposure to dust in textile and cement factories greatly exceeded international permissible limits. There is a high level of workplace injuries that often leads to an extended loss of productive working days. Occupational safety and health services were found to be inadequately organized. There is limited practice in exposure assessment and monitoring. This happens to be true despite the existing favorable environment in areas of policies and regulations. There is a severe scarcity of peer-reviewed literature related to workplace exposures and their impact on workplace health and safety. Limited adequately skilled manpower is available. The internal infrastructural capacity is weak and cannot help to identify and assess hazards in the workplace. Monitoring system and laboratory investigation is limited despite the presence of favorable policy and regulatory frameworks. Addressing these gaps is of immediate concern.

77 FR 63716 - Airworthiness Directives; Airbus Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

.... That AD currently requires revising the Airworthiness Limitations Section (ALS) of the Instructions for... published in the Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS). The Fuel Airworthiness... approved by the European Aviation Safety Agency (EASA) and referenced in the Airbus A318/A319/A320/A321 ALS...

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

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

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

PubMed

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

2017-06-01

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

Deriving exposure limits

NASA Astrophysics Data System (ADS)

Sliney, David H.

1990-07-01

Historically many different agencies and standards organizations have proposed laser occupational exposure limits (EL1s) or maximum permissible exposure (MPE) levels. Although some safety standards have been limited in scope to manufacturer system safety performance standards or to codes of practice most have included occupational EL''s. Initially in the 1960''s attention was drawn to setting EL''s however as greater experience accumulated in the use of lasers and some accident experience had been gained safety procedures were developed. It became clear by 1971 after the first decade of laser use that detailed hazard evaluation of each laser environment was too complex for most users and a scheme of hazard classification evolved. Today most countries follow a scheme of four major hazard classifications as defined in Document WS 825 of the International Electrotechnical Commission (IEC). The classifications and the associated accessible emission limits (AEL''s) were based upon the EL''s. The EL and AEL values today are in surprisingly good agreement worldwide. There exists a greater range of safety requirements for the user for each class of laser. The current MPE''s (i. e. EL''s) and their basis are highlighted in this presentation. 2. 0

Dynamic Speed Adaptation for Path Tracking Based on Curvature Information and Speed Limits †

PubMed Central

Gámez Serna, Citlalli; Ruichek, Yassine

2017-01-01

A critical concern of autonomous vehicles is safety. Different approaches have tried to enhance driving safety to reduce the number of fatal crashes and severe injuries. As an example, Intelligent Speed Adaptation (ISA) systems warn the driver when the vehicle exceeds the recommended speed limit. However, these systems only take into account fixed speed limits without considering factors like road geometry. In this paper, we consider road curvature with speed limits to automatically adjust vehicle’s speed with the ideal one through our proposed Dynamic Speed Adaptation (DSA) method. Furthermore, ‘curve analysis extraction’ and ‘speed limits database creation’ are also part of our contribution. An algorithm that analyzes GPS information off-line identifies high curvature segments and estimates the speed for each curve. The speed limit database contains information about the different speed limit zones for each traveled path. Our DSA senses speed limits and curves of the road using GPS information and ensures smooth speed transitions between current and ideal speeds. Through experimental simulations with different control algorithms on real and simulated datasets, we prove that our method is able to significantly reduce lateral errors on sharp curves, to respect speed limits and consequently increase safety and comfort for the passenger. PMID:28613251

Techniques to evaluate the importance of common cause degradation on reliability and safety of nuclear weapons.

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

Darby, John L.

2011-05-01

As the nuclear weapon stockpile ages, there is increased concern about common degradation ultimately leading to common cause failure of multiple weapons that could significantly impact reliability or safety. Current acceptable limits for the reliability and safety of a weapon are based on upper limits on the probability of failure of an individual item, assuming that failures among items are independent. We expanded the current acceptable limits to apply to situations with common cause failure. Then, we developed a simple screening process to quickly assess the importance of observed common degradation for both reliability and safety to determine if furthermore » action is necessary. The screening process conservatively assumes that common degradation is common cause failure. For a population with between 100 and 5000 items we applied the screening process and conclude the following. In general, for a reliability requirement specified in the Military Characteristics (MCs) for a specific weapon system, common degradation is of concern if more than 100(1-x)% of the weapons are susceptible to common degradation, where x is the required reliability expressed as a fraction. Common degradation is of concern for the safety of a weapon subsystem if more than 0.1% of the population is susceptible to common degradation. Common degradation is of concern for the safety of a weapon component or overall weapon system if two or more components/weapons in the population are susceptible to degradation. Finally, we developed a technique for detailed evaluation of common degradation leading to common cause failure for situations that are determined to be of concern using the screening process. The detailed evaluation requires that best estimates of common cause and independent failure probabilities be produced. Using these techniques, observed common degradation can be evaluated for effects on reliability and safety.« less

Eddy Current, Magnetic Particle and Hardness Testing, Aviation Quality Control (Advanced): 9227.04.

ERIC Educational Resources Information Center

Dade County Public Schools, Miami, FL.

This unit of instruction includes the principles of eddy current, magnetic particle and hardness testing; standards used for analyzing test results; techniques of operating equipment; interpretation of indications; advantages and limitations of these methods of testing; care and calibration of equipment; and safety and work precautions. Motion…

Examination of the current practice of lighting in Virginia : nighttime work zones and improving safety through the development of nighttime lighting specifications : final report.

DOT National Transportation Integrated Search

2017-09-01

This project evaluated current nighttime work zone lighting practices for limited-access highways and primary routes in Virginia through (1) an on-site evaluation of lighting levels in work zones; (2) an illuminance characterization of various commer...

Examination of the current practice of lighting in Virginia : nighttime work zones and improving safety through the development of nighttime lighting specifications : summary report.

DOT National Transportation Integrated Search

2017-09-01

This project evaluated current nighttime work zone lighting practices for limited-access highways and primary routes in Virginia through (1) an on-site evaluation of lighting levels in work zones; (2) an illuminance characterization of various commer...

Pediatric regional anesthesia: what is the current safety record?

PubMed

Polaner, David M; Drescher, Jessica

2011-07-01

The use of regional anesthetics, whether as adjuncts, primary anesthetics or postoperative analgesia, is increasingly common in pediatric practice. Data on safety remain limited because of the paucity of very large-scale prospective studies that are necessary to detect low incidence events, although several studies either have been published or have reported preliminary results. This paper will review the data on complications and risk in pediatric regional anesthesia. Information currently available suggests that regional blockade, when performed properly, carries a very low risk of morbidity and mortality in appropriately selected infants and children. © 2010 Blackwell Publishing Ltd.

Certification Strategies using Run-Time Safety Assurance for Part 23 Autopilot Systems

NASA Technical Reports Server (NTRS)

Hook, Loyd R.; Clark, Matthew; Sizoo, David; Skoog, Mark A.; Brady, James

2016-01-01

Part 23 aircraft operation, and in particular general aviation, is relatively unsafe when compared to other common forms of vehicle travel. Currently, there exists technologies that could increase safety statistics for these aircraft; however, the high burden and cost of performing the requisite safety critical certification processes for these systems limits their proliferation. For this reason, many entities, including the Federal Aviation Administration, NASA, and the US Air Force, are considering new options for certification for technologies that will improve aircraft safety. Of particular interest, are low cost autopilot systems for general aviation aircraft, as these systems have the potential to positively and significantly affect safety statistics. This paper proposes new systems and techniques, leveraging run-time verification, for the assurance of general aviation autopilot systems, which would be used to supplement the current certification process and provide a viable path for near-term low-cost implementation. In addition, discussions on preliminary experimentation and building the assurance case for a system, based on these principles, is provided.

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

PubMed

Waßmuth, Ralf

2015-01-01

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

Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

PubMed

Islam, Md Tazul; El-Basyouny, Karim

2015-07-01

Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

A RE-LOOK AT THE US NRC SAFETY GOALS

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

mubayi v.

2013-09-22

Since they were adopted in 1986, the US NRC’s Safety Goals have played a valuable role as a de facto risk acceptance criterion against which the predicted performance of a commercial nuclear power reactor can be evaluated and assessed. The current safety goals are cast in terms of risk metrics called quantitative health objectives (QHOs), limiting numerical values of the risks of the early and latent health effects of accidental releases of radioactivity to the offsite population. However, while demonstrating compliance with current safety goals has been an important step in assessing the acceptance of the risk posed by LWRs,more » new or somewhat different goals may be needed that go beyond the current early fatality and latent cancer fatality QHOs in assessing reactor risk. Natural phenomena such as hurricanes seem to be suitable candidates for establishing a background rate to derive a risk goal as their order of magnitude cost of damages is similar to those estimated in severe accident Level 3 PRAs done for nuclear power plants. This paper obtains a risk goal that could have a wider applicability, compared to the current QHOs, as a technology-neutral goal applicable to future reactors and multi-unit sites.« less

Nonsteroidal antagonists of the mineralocorticoid receptor.

PubMed

Kolkhof, Peter; Nowack, Christina; Eitner, Frank

2015-09-01

The broad clinical use of steroidal mineralocorticoid receptor antagonists (MRAs) is limited by the potential risk of inducing hyperkalemia when given on top of renin-angiotensin system blockade. Drug discovery campaigns have been launched aiming for the identification of nonsteroidal MRAs with an improved safety profile. This review analyses the evidence for the potential of improved safety profiles of nonsteroidal MRAs and the current landscape of clinical trials with nonsteroidal MRAs. At least three novel nonsteroidal MRAs have reportedly demonstrated an improved therapeutic index (i.e. less risk for hyperkalemia) in comparison to steroidal antagonists in preclinical models. Five pharmaceutical companies have nonsteroidal MRAs in clinical development with a clear focus on the treatment of chronic kidney diseases. No clinical data have been published so far for MT-3995 (Mitsubishi), SC-3150 (Daiichi-Sankyo), LY2623091 (Eli Lilly) and PF-03882845 (Pfizer). In contrast, data from two clinical phase II trials are available for finerenone (Bayer) which demonstrated safety and efficacy in patients with heart failure and additional chronic kidney diseases, and significantly reduced albuminuria in patients with diabetic nephropathy. Neither hyperkalemia nor reductions in kidney function were limiting factors to its use. Novel, nonsteroidal MRAs are currently tested in clinical trials. Based on preclinical and first clinical data, these nonsteroidal MRAs might overcome the limitations of today's steroidal antagonists.

Occupational safety beliefs among Latino residential roofing workers.

PubMed

Arcury, Thomas A; Summers, Phillip; Carrillo, Lourdes; Grzywacz, Joseph G; Quandt, Sara A; Mills, Thomas H

2014-06-01

This analysis describes beliefs about work safety and personal protective equipment (PPE) among Latino roofing workers, it delineates their perceptions of work environment characteristics that affect work safety and PPE use, and it describes how they experience work injuries and the consequences of these injuries. In-depth interviews were completed with 10 current and former Latino residential roofers. Interview transcripts were subjected to systematic qualitative analysis. Participants' valued productivity over safety, and this had a negative influence on their safety behavior and reduced their PPE use. They understood that roofing was hazardous. They limited use of PPE when they felt it reduced productivity and when it was uncomfortable. Work environment characteristics that affected safety included company size, the physical demands of the job, lack of training, the need for work, general life stress, and distractions at work. An injury had to result in lost work time to be considered significant. Access to health care is limited by employers not providing Workers' compensation. Future research is needed to substantiate these descriptive results and to delineate factors that are associated with safety behavior and use of PPE. Interventions, based on a lay health educator model, are needed to improve safety in this population. Safety regulations need to be evaluated and their enforcement needs to be improved. © 2013 Wiley Periodicals, Inc.

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

PubMed

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

2012-12-01

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

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

PubMed Central

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

2012-01-01

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

“Health Courts” and Accountability for Patient Safety

PubMed Central

Mello, Michelle M; Studdert, David M; Kachalia, Allen B; Brennan, Troyen A

2006-01-01

Proposals that medical malpractice claims be removed from the tort system and processed in an alternative system, known as administrative compensation or ‘health courts,’ attract considerable policy interest during malpractice ‘crises,’ including the current one. This article describes current proposals for the design of a health court system and the system's advantages for improving patient safety. Among these advantages are the cultivation of a culture of transparency regarding medical errors and the creation of mechanisms to gather and analyze data on medical injuries. The article discusses the experiences of foreign countries with administrative compensation systems for medical injury, including their use of claims data for research on patient safety; choices regarding the compensation system's relationship to physician disciplinary processes; and the proposed system's possible limitations. PMID:16953807

The impact of health information technology on patient safety.

PubMed

Alotaibi, Yasser K; Federico, Frank

2017-12-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety.  This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient's safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.

The impact of health information technology on patient safety

PubMed Central

Alotaibi, Yasser K.; Federico, Frank

2017-01-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient’s safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes. PMID:29209664

A Safety Index and Method for Flightdeck Evaluation

NASA Technical Reports Server (NTRS)

Latorella, Kara A.

2000-01-01

If our goal is to improve safety through machine, interface, and training design, then we must define a metric of flightdeck safety that is usable in the design process. Current measures associated with our notions of "good" pilot performance and ultimate safety of flightdeck performance fail to provide an adequate index of safe flightdeck performance for design evaluation purposes. The goal of this research effort is to devise a safety index and method that allows us to evaluate flightdeck performance holistically and in a naturalistic experiment. This paper uses Reason's model of accident causation (1990) as a basis for measuring safety, and proposes a relational database system and method for 1) defining a safety index of flightdeck performance, and 2) evaluating the "safety" afforded by flightdeck performance for the purpose of design iteration. Methodological considerations, limitations, and benefits are discussed as well as extensions to this work.

[Objectives and limits of test standards].

PubMed

Kaddick, C; Blömer, W

2014-06-01

Test standards are developed worldwide by extremely committed expert groups working mostly in an honorary capacity and have substantially contributed to the currently achieved safety standards in reconstructive orthopedics. Independent of the distribution and quality of a test specification, the specialist knowledge of the user cannot replace a well founded risk analysis and if used unthinkingly can lead to a false estimation of safety. The limits of standardization are reached where new indications or highly innovative products are concerned. In this case the manufacturer must undertake the time and cost-intensive route of a self-developed testing procedure which in the ideal case leads to a further testing standard. Test standards make a substantial contribution to implant safety but cannot replace the expert knowledge of the user. Tests as an end to themselves take the actual objectives of standardization to absurdity.

Ideal MHD stability and performance of ITER steady-state scenarios with ITBs

NASA Astrophysics Data System (ADS)

Poli, F. M.; Kessel, C. E.; Chance, M. S.; Jardin, S. C.; Manickam, J.

2012-06-01

Non-inductive steady-state scenarios on ITER will need to operate with internal transport barriers (ITBs) in order to reach adequate fusion gain at typical currents of 9 MA. The large pressure gradients at the location of the internal barrier are conducive to the development of ideal MHD instabilities that may limit the plasma performance and may lead to plasma disruptions. Fully non-inductive scenario simulations with five combinations of heating and current drive sources are presented in this work, with plasma currents in the range 7-10 MA. For each configuration the linear, ideal MHD stability is analysed for variations of the Greenwald fraction and of the pressure peaking factor around the operating point, aiming at defining an operational space for stable, steady-state operations at optimized performance. It is shown that plasmas with lower hybrid heating and current drive maintain the minimum safety factor above 1.5, which is desirable in steady-state operations to avoid neoclassical tearing modes. Operating with moderate ITBs at 2/3 of the minor radius, these plasmas have a minimum safety factor above 2, are ideal MHD stable and reach Q ≳ 5 operating above the ideal no-wall limit.

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

PubMed

Putzrath, R M; Wilson, J D

1999-04-01

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

Dienogest in the treatment of endometriosis.

PubMed

Bizzarri, Nicolò; Remorgida, Valentino; Leone Roberti Maggiore, Umberto; Scala, Carolina; Tafi, Emanuela; Ghirardi, Valentina; Salvatore, Stefano; Candiani, Massimo; Venturini, Pier Luigi; Ferrero, Simone

2014-09-01

Dienogest (DNG) is an oral progestin, derivative of 19-nortestosterone, that has recently been introduced for the treatment of endometriosis. This review examines the clinical efficacy, safety and tolerability of DNG in the treatment of endometriosis. The material included in the current manuscript was searched and obtained via Medline, Pubmed and EMBASE, from inception until February 2014. The term 'dienogest' was associated with the following search terms: 'endometriosis', 'pharmacokinetics', 'safety' and 'efficacy'. Several trials demonstrated the clinical efficacy, safety and tolerability of DNG. However the use of DNG is associated with some limitations. So far, no study investigated the potential of contraceptive effect of this treatment and therefore, it should be recommended with other methods of contraception (e.g., barrier methods). A further limitation of the use of DNG as daily therapy in the long term is that the cost of the therapy is higher than other progestins available on the market and combined oral contraceptives. Therefore, future studies should be designed to compare the efficacy and safety of DNG with other progestins.

Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.

PubMed

Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M Stacey; McGuinn, W David; Verbois, S Leigh

2010-03-01

The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

PubMed

Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

2018-03-01

Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

Technical Excellence and Communication: The Cornerstones for Successful Safety and Mission Assurance Programs

NASA Technical Reports Server (NTRS)

Malone, Roy W.; Livingston, John M.

2010-01-01

The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center (MSFC) Safety and Mission Assurance (S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

Technical Excellence and Communication, the Cornerstones for Successful Safety and Mission Assurance Programs

NASA Astrophysics Data System (ADS)

Malone, Roy W.; Livingston, John M.

2010-09-01

The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center(MSFC) Safety and Mission Assurance(S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization’s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

PubMed Central

Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

2006-01-01

For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

New track shift safety limits for high-speed rail applications

DOT National Transportation Integrated Search

2001-11-01

Track shift is defined as the permanent lateral distortion of a track segment due to high vehicle induced lateral loads. Excessive track shift can lead to unsafe conditions leading to ride quality deterioration or vehicle derailment. Current track sh...

Nanoparticles in medicine: Current challenges facing inorganic nanoparticle toxicity assessments and standardizations.

PubMed

Hofmann-Amtenbrink, Margarethe; Grainger, David W; Hofmann, Heinrich

2015-10-01

Although nanoparticles research is ongoing since more than 30years, the development of methods and standard protocols required for their safety and efficacy testing for human use is still in development. The review covers questions on toxicity, safety, risk and legal issues over the lifecycle of inorganic nanoparticles for medical applications. The following topics were covered: (i) In vitro tests may give only a very first indication of possible toxicity as in the actual methods interactions at systemic level are mainly neglected; (ii) the science-driven and the regulation-driven approaches do not really fit for decisive strategies whether or not a nanoparticle should be further developed and may receive a kind of "safety label". (iii) Cost and time of development are the limiting factors for the drug pipeline. Knowing which property of a nanoparticle makes it toxic it may be feasible to re-engineer the particle for higher safety (safety by design). Testing the safety and efficacy of nanoparticles for human use is still in need of standardization. In this concise review, the author described and discussed the current unresolved issues over the application of inorganic nanoparticles for medical applications. Copyright © 2015 Elsevier Inc. All rights reserved.

Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.

MREIT experiments with 200 µA injected currents: a feasibility study using two reconstruction algorithms, SMM and harmonic B(Z).

PubMed

Arpinar, V E; Hamamura, M J; Degirmenci, E; Muftuler, L T

2012-07-07

Magnetic resonance electrical impedance tomography (MREIT) is a technique that produces images of conductivity in tissues and phantoms. In this technique, electrical currents are applied to an object and the resulting magnetic flux density is measured using magnetic resonance imaging (MRI) and the conductivity distribution is reconstructed using these MRI data. Currently, the technique is used in research environments, primarily studying phantoms and animals. In order to translate MREIT to clinical applications, strict safety standards need to be established, especially for safe current limits. However, there are currently no standards for safe current limits specific to MREIT. Until such standards are established, human MREIT applications need to conform to existing electrical safety standards in medical instrumentation, such as IEC601. This protocol limits patient auxiliary currents to 100 µA for low frequencies. However, published MREIT studies have utilized currents 10-400 times larger than this limit, bringing into question whether the clinical applications of MREIT are attainable under current standards. In this study, we investigated the feasibility of MREIT to accurately reconstruct the relative conductivity of a simple agarose phantom using 200 µA total injected current and tested the performance of two MREIT reconstruction algorithms. These reconstruction algorithms used are the iterative sensitivity matrix method (SMM) by Ider and Birgul (1998 Elektrik 6 215-25) with Tikhonov regularization and the harmonic B(Z) proposed by Oh et al (2003 Magn. Reason. Med. 50 875-8). The reconstruction techniques were tested at both 200 µA and 5 mA injected currents to investigate their noise sensitivity at low and high current conditions. It should be noted that 200 µA total injected current into a cylindrical phantom generates only 14.7 µA current in imaging slice. Similarly, 5 mA total injected current results in 367 µA in imaging slice. Total acquisition time for 200 µA and 5 mA experiments was about 1 h and 8.5 min, respectively. The results demonstrate that conductivity imaging is possible at low currents using the suggested imaging parameters and reconstructing the images using iterative SMM with Tikhonov regularization, which appears to be more tolerant to noisy data than harmonic B(Z).

Cannabis for therapeutic purposes and public health and safety: a systematic and critical review.

PubMed

Sznitman, Sharon R; Zolotov, Yuval

2015-01-01

The use of Cannabis for Therapeutic Purposes (CTP) has recently become legal in many places. These policy and legal modifications may be related to changes in cannabis perceptions, availability and use and in the way cannabis is grown and sold. This may in turn have effects on public health and safety. To better understand the potential effects of CTP legalization on public health and safety, the current paper synthesizes and critically discusses the relevant literature. Twenty-eight studies were identified by a comprehensive search strategy, and their characteristics and main findings were systematically reviewed according to the following content themes: CTP and illegal cannabis use; CTP and other public health issues; CTP, crime and neighbourhood disadvantage. The research field is currently limited by a lack of theoretical and methodological rigorous studies. The review shows that the most prevalent theme of investigation so far has been the relation between CTP and illegal cannabis use. In addition, the literature review shows that there is an absence of evidence to support many common concerns related to detrimental public health and safety effects of CTP legalization. Although lack of evidence provides some reassurance that CTP legalization may not have posed a substantial threat to public health and safety, this conclusion needs to be examined in light of the limitations of studies conducted so far. Furthermore, as CTP policy continues to evolve, including incorporation of greater commercialization, it is possible that the full effects of CTP legalization have yet to take place. Ensuring study quality will allow future research to better investigate the complex role that CTP plays in relation to society at large, and public health and safety in particular. Copyright © 2014 Elsevier B.V. All rights reserved.

BSE situation and establishment of Food Safety Commission in Japan

PubMed Central

Kim, Chi-Kyeong

2006-01-01

Eight major policies were implemented by Japanese Government since Oct. 2001, to deal with bovine spongiform encephalopathy (BSE). These are; 1) Surveillance in farm by veterinarian, 2) Prion test at healthy 1.3mi cows/yr, by veterinarian, 3) Elimination of specified risk material (SRM), 4) Ban of MBM for production, sale use, 5) Prion test for fallen stocks, 6) Transparent information and traceability, 7) New Measures such as Food Safety Basic Law, and 8) Establish of Food Safety Commission in the Cabinet Office. At this moment, the extent of SRM risk has only been indicated by several reports employing tests with a limited sensitivity. There is still a possibility that the items in the SRM list will increase in the future, and this indiscriminately applies to Japanese cattle as well. Although current practices of SRM elimination partially guarantee total food safety, additional latent problems and imminent issues remain as potential headaches to be addressed. If the index of SRM elimination cannot guarantee reliable food safety, we have but to resort to total elimination of tissues from high risk-bearing and BSE-infected animals. However, current BSE tests have their limitations and can not yet completely detect high-risk and/or infected animals. Under such circumstances, tissues/wastes and remains of diseased, affected fallen stocks and cohort animals have to be eliminated to prevent BSE invading the human food chain systems. The failure to detect any cohort should never be allowed to occur, and with regular and persistent updating of available stringent records, we are at least adopting the correct and useful approach as a reawakening strategy to securing food safety. In this perspective, traceability based on a National Identification System is required. PMID:16434842

AOTF hyperspectral microscope imaging for foodborne bacteria detection

USDA-ARS?s Scientific Manuscript database

Food safety is an important public health issue worldwide. Researchers have developed many different methods for detecting foodborne pathogens; however, most technologies currently being used have limitations, in terms of speed, sensitivity and selectivity, for practical use in the food industry. Ac...

Transcranial Magnetic Stimulation in Child Neurology: Current and Future Directions

PubMed Central

Frye, Richard E.; Rotenberg, Alexander; Ousley, Molliann; Pascual-Leone, Alvaro

2008-01-01

Transcranial magnetic stimulation (TMS) is a method for focal brain stimulation based on the principle of electromagnetic induction, where small intracranial electric currents are generated by a powerful, rapidly changing extracranial magnetic field. Over the past 2 decades TMS has shown promise in the diagnosis, monitoring, and treatment of neurological and psychiatric disease in adults, but has been used on a more limited basis in children. We reviewed the literature to identify potential diagnostic and therapeutic applications of TMS in child neurology and also its safety in pediatrics. Although TMS has not been associated with any serious side effects in children and appears to be well tolerated, general safety guidelines should be established. The potential for applications of TMS in child neurology and psychiatry is significant. Given its excellent safety profile and possible therapeutic effect, this technique should develop as an important tool in pediatric neurology over the next decade. PMID:18056688

Electronic Nicotine Delivery Systems (ENDS): What Nurses Need to Know.

PubMed

Essenmacher, Carol; Naegle, Madeline; Baird, Carolyn; Vest, Bridgette; Spielmann, Rene; Smith-East, Marie; Powers, Leigh

Efforts to decrease adverse effects of tobacco use are affected by emergence of new nicotine delivery products. Advertising, product promotion, and social media promote use of these products, yet a lack of evidence regarding safety leaves nurses unprepared to counsel patients. To critically evaluate current research, reviews of literature, expert opinion, and stakeholder policy proposals on use and safety of electronic nicotine delivery systems (ENDS). A targeted examination of literature generated by key stakeholders and subject matter experts was conducted using key words, modified by risk factors, and limited to the past 8 years. Current knowledge gaps in research literature and practice implications of the literature are discussed. The safety of ENDS is questionable and unclear. There are clear health risks of nicotine exposure to developing brains. Potential health risks of ENDS secondhand emissions exposure exist. Using ENDS to facilitate total tobacco cessation is not proven.

The Myths and Realities of Age Limits for Law Enforcement and Firefighting Personnel. A Report by the Chairman of the Select Committee on Aging. House of Representatives, Ninety-Eighth Congress, Second Session.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Select Committee on Aging.

A study examined current age limitation policies affecting Federal public safety personnel and the interrelationship between job performance and aging. The study concluded that mandatory retirement of competent law enforcement officers and firefighters is unnecessary and wasteful and that the Federal Government's failure to recognize this problem…

General in-situation safety behaviors are uniquely associated with post-event processing.

PubMed

Mitchell, Melissa A; Schmidt, Norman B

2014-06-01

Research suggests that state anxiety and in-situation safety behaviors are associated with post-event processing (PEP) in social anxiety. Past research has obtained mixed results on whether one or both factors contribute to PEP. The current investigation evaluated state anxiety and in-situation safety behaviors (including subtypes of in-situation safety behaviors) simultaneously to determine their relative contributions to PEP. A prospective study assessed social anxiety, state anxiety, in-situation safety behaviors, PEP, and depression in the context of a speech stressor. Consistent with theory, in-situation safety behaviors were uniquely associated with greater PEP. State anxiety was not uniquely associated with PEP. Furthermore, restricting and active subtypes of in-situation safety behaviors showed specificity to PEP. Limitations of the present study include the use of a nonclinical analog sample and retrospective reporting of PEP. These findings highlight the importance of research on in-situation safety behaviors as a potential contributor to PEP. Published by Elsevier Ltd.

Video Surveillance: All Eyes Turn to IP

ERIC Educational Resources Information Center

Raths, David

2011-01-01

Many university officials recognize the need to upgrade their older analog video surveillance systems. In a 2010 survey by "Campus Safety" magazine, half of university respondents expressed dissatisfaction with the quality and coverage of their current video surveillance systems. Among the limitations of analog closed-circuit television…

Scientific Challenges in the Risk Assessment of Food Contact Materials.

PubMed

Muncke, Jane; Backhaus, Thomas; Geueke, Birgit; Maffini, Maricel V; Martin, Olwenn Viviane; Myers, John Peterson; Soto, Ana M; Trasande, Leonardo; Trier, Xenia; Scheringer, Martin

2017-09-11

Food contact articles (FCAs) are manufactured from food contact materials (FCMs) that include plastics, paper, metal, glass, and printing inks. Chemicals can migrate from FCAs into food during storage, processing, and transportation. Food contact materials' safety is evaluated using chemical risk assessment (RA). Several challenges to the RA of FCAs exist. We review regulatory requirements for RA of FCMs in the United States and Europe, identify gaps in RA, and highlight opportunities for improving the protection of public health. We intend to initiate a discussion in the wider scientific community to enhance the safety of food contact articles. Based on our evaluation of the evidence, we conclude that current regulations are insufficient for addressing chemical exposures from FCAs. RA currently focuses on monomers and additives used in the manufacture of products, but it does not cover all substances formed in the production processes. Several factors hamper effective RA for many FCMs, including a lack of information on chemical identity, inadequate assessment of hazardous properties, and missing exposure data. Companies make decisions about the safety of some food contact chemicals (FCCs) without review by public authorities. Some chemical migration limits cannot be enforced because analytical standards are unavailable. We think that exposures to hazardous substances migrating from FCAs require more attention. We recommend a ) limiting the number and types of chemicals authorized for manufacture and b ) developing novel approaches for assessing the safety of chemicals in FCAs, including unidentified chemicals that form during or after production. https://doi.org/10.1289/EHP644.

At the Crossroads of Nanotoxicology: Past Achievements and Current Challenges

DTIC Science & Technology

2015-01-01

rates of ionic dissolution, improving in vitro to in vivo predictive efficiencies, and establishing safety exposure limits. This Review will discuss...Oberdörster et al., 2005a), which drove the focus of in vitro and in vivo model selection to accommodate these areas of higher NM exposure. Most...Accordingly, a current challenge is the design of simple, in vitro models that reliably predict in vivo effects following a NM challenge. In order

The Safety of Aircraft Exposed to Electromagnetic Fields: HIRF Testing of Aircraft Using Direct Current Injection

DTIC Science & Technology

2007-06-01

massive RF power to the antenna feed points without providing an inductive path to earth. Given all the above challenges, and especially the... circuit theory currents are flowing limited by the three parallel 50 ohm resistances and low inductive reactance. This plateaus at eigencurrent...relative to nett TEM cell input power has been calculated: Figure 86 Expected power output from probe, neglecting probe inductance DSTO-RR-0329

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

PubMed

Leszczynski, Dariusz; Xu, Zhengping

2010-01-27

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

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

PubMed Central

2010-01-01

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

Nursing perceptions of patient safety climate in the Gaza Strip, Palestine.

PubMed

Elsous, A; Akbari Sari, A; AlJeesh, Y; Radwan, M

2017-09-01

This study was undertaken to assess the perception of nurses about patient safety culture and to test whether it is significantly affected by the nurses' position, age, experience and working hours. Patient safety has sparked the interest of healthcare mangers, yet there is limited knowledge about the current patient safety culture among nurses in the Gaza Strip. This was a descriptive cross-sectional study, administering the Arabic Safety Attitude Questionnaire (Short Form 2006) to 210 nurses in four public general hospitals. Job Satisfaction was the most highly perceived factor affecting patient safety, followed by Perception of Management. Safety culture varied across nursing position, age, work experience and working hours. Nurse Managers had more positive attitudes towards patients than frontline clinicians did. The more experience nurses had, the better their attitudes towards patient safety. Nurses who worked the minimum weekly required hours and who were 35 years and older had better attitudes towards all patient safety dimensions except for Stress Recognition. Nurses with a positive attitude had better collaboration with healthcare professionals than those without a positive attitude. Generalization is limited, as nurses who worked in private and specialized hospitals were excluded. Evaluation of the safety culture is the essential starting point to identify hindrances or drivers for safe patient care. Job Satisfaction, Perception of Management and Teamwork necessitate reinforcement, while Working Conditions, Stress Recognition and Safety Climate require improvement. Ensuring job satisfaction through adequate staffing levels, providing incentives and maintaining a collegial environment require both strategic planning and institutional policies at the higher administrative level. Creation of a non-punitive and learning environment, promoting open communication and fostering continuous education should be fundamental aspects of hospital management. A policy of mixing experienced nurses with inexperienced nurses should be considered. © 2017 International Council of Nurses.

Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-08-01

Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities associated with sampling locations showing poor performance.

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

PubMed

2008-02-01

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

Exercise in pregnancy. Part 1: Update on pathophysiology.

PubMed Central

Stevenson, L.

1997-01-01

OBJECTIVE: To review the current data regarding the safety of exercise in pregnancy. QUALITY OF EVIDENCE: MEDLINE search was limited to English literature between 1987 and 1995 with the key MeSH words exercise and pregnancy. Other sources included the Sports and Fitness Database between 1991 and 1995 and a manual search for relevant articles. Previous studies on the safety of exercise in pregnancy are limited in many ways and exhibit difficulties in controlling for confounding factors and in establishing associations while maintaining maternal and fetal safety. MAIN FINDINGS: Concerns about the effect of exercise on pregnancy include exercise-induced hyperthermia, birth weight changes, fetal heart rate responses, miscarriage, labour patterns, maternal injury, and maternal weight gain. Exercise during pregnancy also has many potential benefits. CONCLUSIONS: Important gaps in our knowledge of exercise and pregnancy remain. Available data suggest, however, that moderate exercise on a regular basis during a healthy pregnancy has minimal risk for women and their fetuses. PMID:9626428

Perspectives on setting limits for RF contact currents: a commentary.

PubMed

Tell, Richard A; Tell, Christopher A

2018-01-15

Limits for exposure to radiofrequency (RF) contact currents are specified in the two dominant RF safety standards and guidelines developed by the Institute of Electrical and Electronics Engineers (IEEE) and the International Commission on Non-Ionizing Radiation Protection (ICNIRP). These limits are intended to prevent RF burns when contacting RF energized objects caused by high local tissue current densities. We explain what contact currents are and review some history of the relevant limits with an emphasis on so-called "touch" contacts, i.e., contact between a person and a contact current source during touch via a very small contact area. Contact current limits were originally set on the basis of controlling the specific absorption rate resulting from the current flowing through regions of small conductive cross section within the body, such as the wrist or ankle. More recently, contact currents have been based on thresholds of perceived heating. In the latest standard from the IEEE developed for NATO, contact currents have been based on two research studies in which thresholds for perception of thermal warmth or thermal pain have been measured. Importantly, these studies maximized conductive contact between the subject and the contact current source. This factor was found to dominate the response to heating wherein high resistance contact, such as from dry skin, can result in local heating many times that from a highly conductive contact. Other factors such as electrode size and shape, frequency of the current and the physical force associated with contact are found to introduce uncertainty in threshold values when comparing data across multiple studies. Relying on studies in which the contact current is minimized for a given threshold does not result in conservative protection limits. Future efforts to develop limits on contact currents should include consideration of (1) the basis for the limits (perception, pain, tissue damage); (2) understanding of the practical conditions of real world exposure for contact currents such as contact resistance, size and shape of the contact electrode and applied force at the point of contact; (3) consistency of how contact currents are applied in research studies across different researchers; (4) effects of frequency.

Ohm's Law, Batteries, and the Clean Energy Landscape

NASA Astrophysics Data System (ADS)

Balsara, Nitash

The need for creating safe electrolytes for lithium batteries is significant given the continued safety problems associated with current lithium-ion batteries. Nonflammable polymer electrolytes offer a possible solution but the rate of lithium ion transport is too low for practical applications. In this talk, I will discuss some of the fundamental factors that limit ion transport in polymers. Polymer electrolytes obey Ohm's Law, i.e. in the limit of small applied potentials, the current generated at steady state is proportional to the applied potential. Factors that determine the current generated will be determined using the continuum theory of Newman. Independent measurements of ion diffusion by pulsed-field gradient NMR will also be presented. The talk will end with a discussion of the possibility of commercializing all-solid batteries with polymer electrolytes.

Assessment of softball bat safety performance using mid-compression polyurethane softballs.

PubMed

McDowell, Mark

2004-07-01

There is currently much debate about the safety of the sport of softball. Batted-ball speed and average pitcher reaction time are factors often used to determine safe performance. Batted-ball speed is shown to be the most important factor to consider when determining safe play. Average pitcher reaction time is explained and directly correlated to batted-ball speed. Eleven aluminum multi-wall, three aluminum single-wall and two composite softball bats were tested with mid-compression polyurethane softballs averaging 1721+/-62 N/6.4 mm to represent the relative bat-ball performance for the sport of slowpitch softball. Nine men and six women were chosen for this study out of a test group of over three hundred slowpitch softball players. On average, aluminum bat performance results were within the recommended safety limits established by the national softball associations. However, when composite bats were used, their performance results exceeded the recommended safety limits which can pose a significant safety risk. Using aluminum softball bats, batted-ball speeds ranged from 80 to 145km x h(-1) Using composite softball bats, batted-ball speeds ranged from 146 to 161 km x h(-1). The scientific relevance of this study is to provide performance information that can lead to injury prevention in the sport of softball.

In-flight simulation of high agility through active control: Taming complexity by design

NASA Technical Reports Server (NTRS)

Padfield, Gareth D.; Bradley, Roy

1993-01-01

The motivation for research into helicopter agility stems from the realization that marked improvements relative to current operational types are possible, yet there is a dearth of useful criteria for flying qualities at high performance levels. Several research laboratories are currently investing resources in developing second generation airborne rotorcraft simulators. The UK's focus has been the exploitation of agility through active control technology (ACT); this paper reviews the results of studies conducted to date. The conflict between safety and performance in flight research is highlighted and the various forms of safety net to protect against system failures are described. The role of the safety pilot, and the use of actuator and flight envelope limiting are discussed. It is argued that the deep complexity of a research ACT system can only be tamed through a requirement specification assembled using design principles and cast in an operational simulation form. Work along these lines conducted at DRA is described, including the use of the Jackson System Development method and associated Ada simulation.

Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

NASA Astrophysics Data System (ADS)

Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

2017-10-01

Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

A review of wiring system safety in space power systems

NASA Technical Reports Server (NTRS)

Stavnes, Mark W.; Hammoud, Ahmad N.

1993-01-01

Wiring system failures have resulted from arc propagation in the wiring harnesses of current aerospace vehicles. These failures occur when the insulation becomes conductive upon the initiation of an arc. In some cases, the conductive path of the carbon arc track displays a high enough resistance such that the current is limited, and therefore may be difficult to detect using conventional circuit protection. Often, such wiring failures are not simply the result of insulation failure, but are due to a combination of wiring system factors. Inadequate circuit protection, unforgiving system designs, and careless maintenance procedures can contribute to a wiring system failure. This paper approaches the problem with respect to the overall wiring system, in order to determine what steps can be taken to improve the reliability, maintainability, and safety of space power systems. Power system technologies, system designs, and maintenance procedures which have led to past wiring system failures will be discussed. New technologies, design processes, and management techniques which may lead to improved wiring system safety will be introduced.

Agrichemical safety practices on farms in the western Cape.

PubMed

London, L

1994-05-01

In order to study agrichemical safety practices in a rural farming area in the western Cape, an audit of 45 randomly sampled farms was performed over 3 months in 1992. A response rate of 87% was achieved, and the survey results suggest that approximately 9% of permanent and 14% of seasonal farm workers are employed in jobs with potential exposure to agrichemicals. While protective equipment was widely available, gloves and masks were seldom used, with little enforcement or commercial support from the suppliers of the equipment. Farm workers receive little training on pesticide safety, but interest in the possibility of further training for workers was high. In the absence of a system of pesticide disposal, the presence of residual, unwanted and outdated stocks of pesticides in farmers' stores, and to a lesser extent the presence of empty containers, are identified as important problems. Current pesticide storage practices require improvement by simple industrial hygiene measures. Health facilities available to workers on most farms are extremely limited, particularly in the light of statutory requirements for occupational safety and health under the Machinery and Occupational Safety Act. It is argued that collective solutions to problems of pesticide safety are possible within the ambit of a public health response, particularly given the willingness of the farming community to identify and address potential health problems. As a result, initiatives to meet these needs are currently under way in the region.

Applicability of risk-based management and the need for risk-based economic decision analysis at hazardous waste contaminated sites.

PubMed

Khadam, Ibrahim; Kaluarachchi, Jagath J

2003-07-01

Decision analysis in subsurface contamination management is generally carried out through a traditional engineering economic viewpoint. However, new advances in human health risk assessment, namely, the probabilistic risk assessment, and the growing awareness of the importance of soft data in the decision-making process, require decision analysis methodologies that are capable of accommodating non-technical and politically biased qualitative information. In this work, we discuss the major limitations of the currently practiced decision analysis framework, which evolves around the definition of risk and cost of risk, and its poor ability to communicate risk-related information. A demonstration using a numerical example was conducted to provide insight on these limitations of the current decision analysis framework. The results from this simple ground water contamination and remediation scenario were identical to those obtained from studies carried out on existing Superfund sites, which suggests serious flaws in the current risk management framework. In order to provide a perspective on how these limitations may be avoided in future formulation of the management framework, more matured and well-accepted approaches to decision analysis in dam safety and the utility industry, where public health and public investment are of great concern, are presented and their applicability in subsurface remediation management is discussed. Finally, in light of the success of the application of risk-based decision analysis in dam safety and the utility industry, potential options for decision analysis in subsurface contamination management are discussed.

78 FR 59700 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... reporting to the CDC's current HAI surveillance system, the National Healthcare Safety Network (NHSN 0920...-day period at each of nine acute care hospitals in one U.S. city. This pilot phase was followed in 2010 by a phase 2, limited roll-out HAI and antimicrobial use prevalence survey, conducted during July...

NDE: A key to engine rotor life prediction

NASA Technical Reports Server (NTRS)

Doherty, J. E.

1977-01-01

A key ingredient in the establishment of safe life times for critical components is the means of reliably detecting flaws which may potentially exist. Currently used nondestructive evaluation procedures are successful in detecting life limiting defects; however, the development of automated and computer aided NDE technology permits even greater assurance of flight safety.

76 FR 37255 - Airworthiness Directives; Airbus Model A330-200 and -300 Series Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-27

... Requirements (CMR) are given in Airbus A330 ALS Part 3, which is approved by the European Aviation Safety Agency (EASA). The revision 03 of Airbus A330 ALS Part 3 introduces more restrictive maintenance... currently distributed in the Airbus A330 Airworthiness Limitations Section (ALS). The airworthiness...

Cellular Radio Telecommunication for Health Care: Benefits and Risks

PubMed Central

Sneiderman, Charles A.; Ackerman, Michael J.

2004-01-01

Cellular radio telecommunication has increased exponentially with many applications to health care reported. The authors attempt to summarize published applications with demonstrated effect on health care, review briefly the rapid evolution of hardware and software standards, explain current limitations and future potential of data quality and security, and discuss issues of safety. PMID:15298996

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

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

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

Development of the Consumer Refrigerator Safety Questionnaire: A Measure of Consumer Perceptions and Practices.

PubMed

Cairnduff, Victoria; Dean, Moira; Koidis, Anastasios

2016-09-01

Food preparation and storage behaviors in the home deviating from the "best practice" food safety recommendations may result in foodborne illnesses. Currently, there are limited tools available to fully evaluate the consumer knowledge, perceptions, and behavior in the area of refrigerator safety. The current study aimed to develop a valid and reliable tool in the form of a questionnaire, the Consumer Refrigerator Safety Questionnaire (CRSQ), for assessing systematically all these aspects. Items relating to refrigerator safety knowledge (n =17), perceptions (n =46), and reported behavior (n =30) were developed and pilot tested by an expert reference group and various consumer groups to assess face and content validity (n =20), item difficulty and consistency (n =55), and construct validity (n =23). The findings showed that the CRSQ has acceptable face and content validity with acceptable levels of item difficulty. Item consistency was observed for 12 of 15 in refrigerator safety knowledge. Further, all 5 of the subscales of consumer perceptions of refrigerator safety practices relating to risk of developing foodborne disease showed acceptable internal consistency (Cronbach's α value > 0.8). Construct validity of the CRSQ was shown to be very good (P = 0.022). The CRSQ exhibited acceptable test-retest reliability at 14 days with the majority of knowledge items (93.3%) and reported behavior items (96.4%) having correlation coefficients of greater than 0.70. Overall, the CRSQ was deemed valid and reliable in assessing refrigerator safety knowledge and behavior; therefore, it has the potential for future use in identifying groups of individuals at increased risk of deviating from recommended refrigerator safety practices, as well as the assessment of refrigerator safety knowledge and behavior for use before and after an intervention.

Seafood traceability: current needs, available tools, and biotechnological challenges for origin certification.

PubMed

Leal, Miguel Costa; Pimentel, Tânia; Ricardo, Fernando; Rosa, Rui; Calado, Ricardo

2015-06-01

Market globalization and recurring food safety alerts have resulted in a growing consumer awareness of the need for food traceability. This is particularly relevant for seafood due to its perishable nature and importance as a key protein source for the population of the world. Here, we provide an overview of the current needs for seafood origin traceability, along with the limitations and challenges for its implementation. We focus on geochemical, biochemical, and molecular tools and how they should be optimized to be implemented globally and to address our societal needs. We suggest that seafood traceability is key to enforcing food safety regulations and fisheries control, combat fraud, and fulfill present and future expectations of conscientious producers, consumers, and authorities. Copyright © 2015 Elsevier Ltd. All rights reserved.

Advanced reactors and associated fuel cycle facilities: safety and environmental impacts.

PubMed

Hill, R N; Nutt, W M; Laidler, J J

2011-01-01

The safety and environmental impacts of new technology and fuel cycle approaches being considered in current U.S. nuclear research programs are contrasted to conventional technology options in this paper. Two advanced reactor technologies, the sodium-cooled fast reactor (SFR) and the very high temperature gas-cooled reactor (VHTR), are being developed. In general, the new reactor technologies exploit inherent features for enhanced safety performance. A key distinction of advanced fuel cycles is spent fuel recycle facilities and new waste forms. In this paper, the performance of existing fuel cycle facilities and applicable regulatory limits are reviewed. Technology options to improve recycle efficiency, restrict emissions, and/or improve safety are identified. For a closed fuel cycle, potential benefits in waste management are significant, and key waste form technology alternatives are described. Copyright © 2010 Health Physics Society

Responding to intimate partner violence: Healthcare providers' current practices and views on integrating a safety decision aid into primary care settings.

PubMed

Alvarez, Carmen; Debnam, Katrina; Clough, Amber; Alexander, Kamila; Glass, Nancy E

2018-04-01

Supportive care for survivors of intimate partner violence (IPV) remains limited in primary care settings. Low-income and Spanish-speaking survivors of IPV are even more disadvantaged, given the dearth of linguistically and culturally appropriate interventions for IPV. We conducted semi-structured individual interviews with 17 healthcare workers, including physicians, nurses, and social workers, to describe how healthcare workers serving primarily low-income, Latina populations are currently screening and responding to IPV disclosure, and to explore the acceptability of integrating an interactive, personalized safety decision aid application-myPlan app-into the clinic setting. Despite recognition of IPV as a problem, none of the clinical sites had a protocol to guide screening and response to IPV disclosure. Screening practices varied across the sites, sometimes conducted by medical assistants prior to the provider visit and other times by the physician or nurse provider. When IPV was disclosed, it was often during assessment for a presenting problem such as poor sleep or anxiety. Most healthcare workers felt that clinical and community resources were limited for their patients experiencing IPV. The "warm hand-off" to a social worker was the most common response strategy when possible; otherwise, women were given information about available resources such as hotlines and safe houses. We discuss structural, family, and individual barriers to accessing safety resources for underserved women and review how an easily accessible safety decision app, such as myPlan, could be a resource for women to safely tailor an action plan for her situation. © 2018 Wiley Periodicals, Inc.

Scientific Challenges in the Risk Assessment of Food Contact Materials

PubMed Central

Backhaus, Thomas; Geueke, Birgit; Maffini, Maricel V.; Martin, Olwenn Viviane; Myers, John Peterson; Soto, Ana M.; Trasande, Leonardo; Trier, Xenia; Scheringer, Martin

2017-01-01

Background: Food contact articles (FCAs) are manufactured from food contact materials (FCMs) that include plastics, paper, metal, glass, and printing inks. Chemicals can migrate from FCAs into food during storage, processing, and transportation. Food contact materials’ safety is evaluated using chemical risk assessment (RA). Several challenges to the RA of FCAs exist. Objectives: We review regulatory requirements for RA of FCMs in the United States and Europe, identify gaps in RA, and highlight opportunities for improving the protection of public health. We intend to initiate a discussion in the wider scientific community to enhance the safety of food contact articles. Discussion: Based on our evaluation of the evidence, we conclude that current regulations are insufficient for addressing chemical exposures from FCAs. RA currently focuses on monomers and additives used in the manufacture of products, but it does not cover all substances formed in the production processes. Several factors hamper effective RA for many FCMs, including a lack of information on chemical identity, inadequate assessment of hazardous properties, and missing exposure data. Companies make decisions about the safety of some food contact chemicals (FCCs) without review by public authorities. Some chemical migration limits cannot be enforced because analytical standards are unavailable. Conclusion: We think that exposures to hazardous substances migrating from FCAs require more attention. We recommend a) limiting the number and types of chemicals authorized for manufacture and b) developing novel approaches for assessing the safety of chemicals in FCAs, including unidentified chemicals that form during or after production. https://doi.org/10.1289/EHP644 PMID:28893723

A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?

PubMed

Hatzimouratidis, Konstantinos; Hatzichristou, Dimitrios G

2005-01-01

The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients. All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.

Applications and safety considerations of Lactobacillus salivarius as a probiotic in animal and human health.

PubMed

Chaves, B D; Brashears, M M; Nightingale, K K

2017-03-03

The goals of this review are to summarize the current knowledge on the application of Lactobacillus salivarius as a probiotic in animals and humans, and to address safety concerns with its use on live hosts. Overall, several strains of L. salivarius are well established probiotics with multiple applications in animal health, particularly to reduce colonization by gastrointestinal pathogens, and to a lesser extent, as a production and quality aid. In humans, L. salivarius has been used to prevent and treat a variety of chronic diseases, including asthma, cancer, atopic dermatitis and halitosis, and to a much limited extent, to prevent or treat infections. Based on the results from primary research evidence, it seems that L. salivarius does not pose a health risk to animals or humans in the doses currently used for a variety of applications; however, there is a systematic lack of studies assuring the safety of many of the strains intended for clinical use. This review provides researchers in the field with up-to-date information regarding applications and safety of L. salivarius. Furthermore, it helps researchers identify knowledge gaps and potential opportunities for microbiological and clinical research. © 2017 The Society for Applied Microbiology.

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.

Sensor Technology for Integrated Vehicle Health Management of Aerospace Vehicles

NASA Technical Reports Server (NTRS)

Prosser, W. H.; Brown, T. L.; Woodard, S. E.; Fleming, G. A.; Cooper, E. G.

2002-01-01

NASA is focusing considerable efforts on technology development for Integrated Vehicle Health Management systems. The research in this area is targeted toward increasing aerospace vehicle safety and reliability, while reducing vehicle operating and maintenance costs. Onboard, real-time sensing technologies that can provide detailed information on structural integrity are central to such a health management system. This paper describes a number of sensor technologies currently under development for integrated vehicle health management. The capabilities, current limitations, and future research needs of these technologies are addressed.

DWPF Melter Off-Gas Flammability Assessment for Sludge Batch 9

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

Choi, A. S.

2016-07-11

The slurry feed to the Defense Waste Processing Facility (DWPF) melter contains several organic carbon species that decompose in the cold cap and produce flammable gases that could accumulate in the off-gas system and create potential flammability hazard. To mitigate such a hazard, DWPF has implemented a strategy to impose the Technical Safety Requirement (TSR) limits on all key operating variables affecting off-gas flammability and operate the melter within those limits using both hardwired/software interlocks and administrative controls. The operating variables that are currently being controlled include; (1) total organic carbon (TOC), (2) air purges for combustion and dilution, (3)more » melter vapor space temperature, and (4) feed rate. The safety basis limits for these operating variables are determined using two computer models, 4-stage cold cap and Melter Off-Gas (MOG) dynamics models, under the baseline upset scenario - a surge in off-gas flow due to the inherent cold cap instabilities in the slurry-fed melter.« less

Gene therapy for arthritis

PubMed Central

Traister, Russell S.

2008-01-01

Arthritis is among the leading causes of disability in the developed world. There remains no cure for this disease and the current treatments are only modestly effective at slowing the disease's progression and providing symptomatic relief. The clinical effectiveness of current treatment regimens has been limited by short half-lives of the drugs and the requirement for repeated systemic administration. Utilizing gene transfer approaches for the treatment of arthritis may overcome some of the obstacles associated with current treatment strategies. The present review examines recent developments in gene therapy for arthritis. Delivery strategies, gene transfer vectors, candidate genes, and safety are also discussed. PMID:18176779

Occupational and public health considerations for work-hour limitations policy regarding public health workers during response to natural and human-caused disasters.

PubMed

Berkowitz, Murray R

2012-01-01

This article examines the occupational health considerations that might impact the health and wellbeing of public health workers during responses to natural (eg, floods and hurricanes) and human-caused (eg, terrorism, war, and shootings) disasters. There are a number of articles in the medical literature that argue the impact of how working long hours by house staff physicians, nurses, and first-responders may pose health and safety concerns regarding the patients being treated. The question examined here is how working long hours may pose health and/or safety concerns for the public health workers themselves, as well as to those in the communities they serve. The health problems related to sleep deprivation are reviewed. Current policies and legislations regarding work-hour limitations are examined. Policy implications are discussed.

Responding to Requests of Families for Unproven Interventions in Neurodevelopmental Disorders: Hyperbaric Oxygen "Treatment" and Stem Cell "Therapy" in Cerebral Palsy

ERIC Educational Resources Information Center

Bell, Emily; Wallace, Tessa; Chouinard, Isabelle; Shevell, Michael; Racine, Eric

2011-01-01

Faced with the limitations of currently available mainstream medical treatments and interventions, parents of children with neurodevelopmental disorders often seek information about unproven interventions. These interventions frequently have undetermined efficacy and uncertain safety profiles. In this article, we present a general background and…

Update on EPA’s ToxCast Program: Providing High Throughput Decision Support Tools for Chemical Risk Management

EPA Science Inventory

The field of toxicology is on the cusp of a major transformation in how the safety and hazard of chemicals are evaluated for potential effects on human health and the environment. Brought on by the recognition of the limitations of the current paradigm in terms of cost, time, and...

78 FR 49213 - Airworthiness Directives; Airbus Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-13

... Airbus aeroplanes are currently published in Airworthiness Limitations Section (ALS) documents. The... Airbus A318/A319/A320/ A321 ALS Part 1, which is approved by the European Aviation Safety Agency (EASA... Airbus A318/A319/A320/A321 ALS Part 1 original issue. Failure to comply with the instructions of ALS Part...

40 CFR 142.76 - Request by an Indian Tribe for a determination of eligibility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... functions currently performed by the Tribal governing body such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population; taxation; and the exercise of the power of eminent domain; and (3) Identify the sources of the Tribal...

Industry challenge to best practice risk communication.

PubMed

McEntire, J; Boateng, A

2012-04-01

Effective food safety and food defense risk communication helps to inform consumers without causing panic and alarm. The Risk Communication Team of the Natl. Center for Food Protection and Defense has developed a list of 11 best practices recommended for effective risk communication. These practices, designed for a food defense crisis, are currently applied to food safety issues, since fortunately a food defense crisis has yet to occur. IFT examined the utility of these best practices and the limitations on their use during food safety and food defense crises by academics, trade associations, and the government. It was hypothesized that legal and business considerations as well as the nature of the event would determine the implementation of the best practices. Through the use of focus group meetings, it was discovered that there was a low level of awareness of the best practices. However, stakeholders practiced some aspects of the recommended practices. Participants felt some of the practices were related and could be consolidated. They also agreed that a food defense event will increase the urgency of the communication and include players not typically involved in food safety issues. The challenges reported by the stakeholders varied, but legal liability, as well as the impact their communications could have on an industry, were often cited. From the government perspective, their need to act within their authorities drove some of their actions with respect to communication. Determining the differences in communication limitations during food safety against food defense events can provide key information to further developing and refining risk communications and specific messages targeted for a food defense incident. Effective food safety and food defense risk communication helps to inform consumers without causing panic and alarm. Determining the differences in communication limitations during food safety against food defense events can provide key information to further developing and refining risk communications and specific messages targeted for a food defense incident. © 2012 Institute of Food Technologists®

Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

PubMed Central

West, Jonathan; Ogston, Simon; Foerster, John

2016-01-01

Background Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse. Objective In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods). Results In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time. Limitations Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria. Conclusions These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes. PMID:27168193

Patients' and families' perspectives of patient safety at the end of life: a video-reflexive ethnography study.

PubMed

Collier, Aileen; Sorensen, Ros; Iedema, Rick

2016-02-01

The aim of this study was to investigate patients' and families' perspectives of safety and quality in the setting of a life-limiting illness. Data reported here were generated from a qualitative study using video-reflexive ethnographic methodology. Data were collected over 18 months and generated through participant observation, shadowing of clinicians, field-interviews and semi-structured interviews with patients and families. The study was conducted at two hospital sites in Sydney, Australia and in patients' homes. Patients with an advanced life-limiting illness (n = 29) ranging in age between 27 and 89 years and family members (n = 5) participated in the study. Patient safety remains important to dying patients and families. For dying people, iatrogenic harm is not regarded as 'one off' incidents. Rather, harm is experienced as a result of an unfolding series of negative events. Critically, iatrogenic harm is emotional, social and spiritual and not solely technical-clinical misadventure and is inextricably linked with feeling unsafe. Thus, patient safety extends beyond narrowly defined technical-clinical parameters to include interpersonal safety. Current approaches to patient safety do not address fully the needs of dying patients and their families. Patients and their families regard poor communication with and by health professionals to be harmful in and of itself. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

78 FR 16051 - Vehicle/Track Interaction Safety Standards; High-Speed and High Cant Deficiency Operations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

...FRA is amending the Track Safety Standards and Passenger Equipment Safety Standards to promote the safe interaction of rail vehicles with the track over which they operate under a variety of conditions at speeds up to 220 m.p.h. The final rule revises standards for track geometry and safety limits for vehicle response to track conditions, enhances vehicle/track qualification procedures, and adds flexibility for permitting high cant deficiency train operations through curves at conventional speeds. The rule accounts for a range of vehicle types that are currently in operation, as well as vehicle types that may likely be used in future high-speed or high cant deficiency rail operations, or both. The rule is based on the results of simulation studies designed to identify track geometry irregularities associated with unsafe wheel/rail forces and accelerations, thorough reviews of vehicle qualification and revenue service test data, and consideration of international practices.

An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

PubMed

Strauss, Debra M

2011-01-01

This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.

The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.

PubMed

Karpefors, Martin; Weatherall, James

2018-03-21

In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. We introduce a new means of visualizing the adverse event data across an entire clinical trial. The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.

Revisiting the safety of aspartame.

PubMed

Choudhary, Arbind Kumar; Pretorius, Etheresia

2017-09-01

Aspartame is a synthetic dipeptide artificial sweetener, frequently used in foods, medications, and beverages, notably carbonated and powdered soft drinks. Since 1981, when aspartame was first approved by the US Food and Drug Administration, researchers have debated both its recommended safe dosage (40 mg/kg/d) and its general safety to organ systems. This review examines papers published between 2000 and 2016 on both the safe dosage and higher-than-recommended dosages and presents a concise synthesis of current trends. Data on the safe aspartame dosage are controversial, and the literature suggests there are potential side effects associated with aspartame consumption. Since aspartame consumption is on the rise, the safety of this sweetener should be revisited. Most of the literature available on the safety of aspartame is included in this review. Safety studies are based primarily on animal models, as data from human studies are limited. The existing animal studies and the limited human studies suggest that aspartame and its metabolites, whether consumed in quantities significantly higher than the recommended safe dosage or within recommended safe levels, may disrupt the oxidant/antioxidant balance, induce oxidative stress, and damage cell membrane integrity, potentially affecting a variety of cells and tissues and causing a deregulation of cellular function, ultimately leading to systemic inflammation. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

PubMed

de Luca, Katie E; Fang, Sheng Hung; Ong, Justin; Shin, Ki-Soo; Woods, Samuel; Tuchin, Peter J

2017-09-01

The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required. Copyright © 2017. Published by Elsevier Inc.

75 FR 43092 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... completed a system safety review of the aircraft fuel system against fuel tank safety standards introduced... Limited has completed a system safety review of the aircraft fuel system against fuel tank safety... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

PubMed

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

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

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

PubMed

Co, Michael; Ng, Judy; Kwong, Ava

2018-05-17

Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

Robotics in invasive cardiac electrophysiology.

PubMed

Shurrab, Mohammed; Schilling, Richard; Gang, Eli; Khan, Ejaz M; Crystal, Eugene

2014-07-01

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones.

Surveying rip current survivors: preliminary insights into the experiences of being caught in rip currents

NASA Astrophysics Data System (ADS)

Drozdzewski, D.; Shaw, W.; Dominey-Howes, D.; Brander, R.; Walton, T.; Gero, A.; Sherker, S.; Goff, J.; Edwick, B.

2012-04-01

This paper begins a process of addressing a significant gap in knowledge about people's responses to being caught in rip currents. While rip currents are the primary hazard facing recreational ocean swimmers in Australia, debate exists about the best advice to give swimmers caught in rip currents. Such surf rescue advice - on what to do and how to respond when caught in a rip - relies on empirical evidence. However, at present, knowledge about swimmers reactions and responses to rip currents is limited. This gap is a considerable barrier to providing effective advice to beach goers and to understanding how this advice is utilised (or not) when actually caught in the rip current. This paper reports the findings of a pilot study that focussed on garnering a better understanding of swimmers' experiences when caught in rip currents. A large scale questionnaire survey instrument generated data about rip current survivors' demographics, knowledge of beach safety and their reactions and responses when caught in a rip current. A mix of online and paper surveys produced a total of 671 completed surveys. Respondents were predominantly an informed group in terms of rip current knowledge, beach experience and had a high self-rated swimming ability. Preliminary insights from the survey show that most respondents recalled a "swim across the rip/parallel to the beach" message when caught in the rip and most escaped unassisted by acting on this message. However, while nearly a quarter of respondents recalled a message of "not to panic", short answer responses revealed that the onset of panic inhibited some respondents from recalling or enacting any other type of beach safety message when caught in the rip current. Results also showed that despite the research sample being younger, competent and frequent ocean swimmers, they were more likely to swim at unpatrolled beaches and outside of the red and yellow safety flags. Moreover, they were still caught in a rip current and they panicked. The findings of this study have significant implications for a range of demographic groups of differing beach safety knowledge and swimming ability who may be caught in rip currents behave, we know very little about how beach goers may respond to being caught in them.

Financial Considerations for Health and Safety in the Australian Dairy Industry.

PubMed

Lower, Tony; Pollock, Kirrily

2017-01-01

This study aimed to quantify the burden of fatal and workers' compensation-related injuries on the dairy sector in Australia and to assess current financial inputs for work health and safety actions. The first and second phases entailed a review of the financial costs associated with fatal (2001-2013) and workers' compensation cases (2008-2009 to 2012-2013). The third element was a case-study approach focusing on actual production and cost data from a small sample of dairy farms (n = 6) to ascertain an estimate for current financial inputs to work health and safety. The estimated financial impact was approximately AUD$12.4 million each year, comprising AUD$6.8 million for fatalities and AUD$5.6 million for compensable injuries. All sample businesses were investing in health and safety initiatives; however, this was modest and on average represented 0.4% of total expenditure (AUD$4,472) or

Electronic Nicotine Delivery Systems (“E-Cigarettes”): Review of Safety and Smoking Cessation Efficacy

PubMed Central

Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

2015-01-01

Background and Objectives Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems (“e-cigarettes”) are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. Data Sources The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. Review Methods We conducted a structured search of the current literature up to and including November 2013. Results E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking is suggestive, but ultimately inconclusive. Conclusions Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. Implications for Practice In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients, and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. PMID:24898072

Electronic nicotine delivery systems ("e-cigarettes"): review of safety and smoking cessation efficacy.

PubMed

Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

2014-09-01

Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems ("e-cigarettes") are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. We conducted a structured search of the current literature up to and including November 2013. E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking are suggestive but ultimately inconclusive. Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

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

DOE PAGES

Holcomb, Christopher T.; Ferron, John R.; Luce, Timothy C.; ...

2014-08-15

On DIII-D, a high β scenario with minimum safety factor (q min) 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. Furthermore, 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 q min with a less peaked pressure profile. The observed changes increase the ideal magnetohydrodynamics (MHD) n = 1 mode β N limit thus providing a path forward for increasing the noninductive current drive fraction by operating atmore » high β N. Quasi-stationary discharges free of tearing modes have been sustained at βN = 3.5 and β T = 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 q min remains elevated near 1.4. Our 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 β N. Similar discharges with q min = 1.5–2 were susceptible to tearing modes and off-axis fishbones, and with q min > 2 lower normalized global energy confinement time is observed.« less

Exploring perinatal shift-to-shift handover communication and process: an observational study.

PubMed

Poot, Else P; de Bruijne, Martine C; Wouters, Maurice G A J; de Groot, Christianne J M; Wagner, Cordula

2014-04-01

Loss of situation awareness (SA) by health professionals during handover is a major threat to patient safety in perinatal care. SA refers to knowing what is going on around. Adequate handover communication and process may support situation assessment, a precursor of SA. This study describes current practices and opinions of perinatal handover to identify potential improvements. Structured direct observations of shift-to-shift patient handovers (n = 70) in an academic perinatal setting were used to measure handover communication (presence and order of levels of SA: current situation, background, assessment and recommendation) and process (duration, interruptions/distractions, eye contact, active inquiry and reading information back). Afterwards, receivers' opinions of handover communication (n = 51) were measured by means of a questionnaire. All levels of SA were present in 7% of handovers, the current situation in 86%, the background in 99%, an assessment in 24% and a recommendation in 46%. In 77% of handovers the background was mentioned first, followed by the current situation. Forty-four per cent of handovers took 2 minutes or more per patient. In 52% distractions occurred, in 43% there was no active inquiry, in 32% no eye contact and in 97% information was not read back. The overall mean of the receivers' opinions of handover communication was 4.1 (standard deviation ± 0.7; scale 1-5, where 5 is excellent). Perinatal handovers are currently at risk for inadequate situation assessment because of variability and limitations in handover communication and process. However, receivers' opinions of handover communication were very positive, indicating a lack of awareness of patient safety threats during handover. Therefore, the staff's awareness of current limitations should be raised, for example through video reflection or simulation training. © 2013 John Wiley & Sons, Ltd.

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

PubMed

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

2017-09-01

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

Wavelength dependence of ocular damage thresholds in the near-ir to far-ir transition region: proposed revisions to MPES.

PubMed

Zuclich, Joseph A; Lund, David J; Stuck, Bruce E

2007-01-01

This report summarizes the results of a series of infrared (IR) laser-induced ocular damage studies conducted over the past decade. The studies examined retinal, lens, and corneal effects of laser exposures in the near-IR to far-IR transition region (wavelengths from 1.3-1.4 mum with exposure durations ranging from Q-switched to continuous wave). The corneal and retinal damage thresholds are tabulated for all pulsewidth regimes, and the wavelength dependence of the IR thresholds is discussed and contrasted to laser safety standard maximum permissible exposure limits. The analysis suggests that the current maximum permissible exposure limits could be beneficially revised to (1) relax the IR limits over wavelength ranges where unusually high safety margins may unintentionally hinder applications of recently developed military and telecommunications laser systems; (2) replace step-function discontinuities in the IR limits by continuously varying analytical functions of wavelength and pulsewidth which more closely follow the trends of the experimental retinal (for point-source laser exposures) and corneal ED50 threshold data; and (3) result in an overall simplification of the permissible exposure limits over the wavelength range from 1.2-2.6 mum. A specific proposal for amending the IR maximum permissible exposure limits over this wavelength range is presented.

77 FR 40843 - Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices, and Associated Equipment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

... limiting the impacts of glare. Our current standard primarily treats a headlamp as a separate piece of...) at any time by going to http://www.regulations.gov . Follow the online instructions for accessing the dockets. You may also read the materials at the Docket Management Facility by going to the street address...

Providing Health Care to Latino Immigrants: Community-Based Efforts in the Rural Midwest

PubMed Central

Casey, Michelle M.; Blewett, Lynn A.; Call, Kathleen T.

2004-01-01

We examined case studies of 3 rural Midwestern communities to assess local health care systems’ response to rapidly growing Latino populations. Currently, clinics provide free or low-cost care, and schools, public health, social services, and religious organizations connect Latinos to the health care system. However, many unmet health care needs result from lack of health insurance, limited income, and linguistic and cultural barriers. Targeted safety net funding would help meet Latino health care needs in rural communities with limited resources. PMID:15451737

2-diethylaminoethyl-dextran methyl methacrylate copolymer nonviral vector: still a long way toward the safety of aerosol gene therapy.

PubMed

Zarogoulidis, P; Hohenforst-Schmidt, W; Darwiche, K; Krauss, L; Sparopoulou, D; Sakkas, L; Gschwendtner, A; Huang, H; Turner, F J; Freitag, L; Zarogoulidis, K

2013-10-01

Revealing the lung tumor genome has directed the current treatment strategies toward targeted therapy. First line treatments targeting the genome of lung tumor cells have been approved and are on the market. However, they are limited by the small number of patients with the current investigated genetic mutations. Novel treatment administration modalities have been also investigated in an effort to increase the local drug deposition and disease control. In the current study, we investigated the safety of the new nonviral vector 2-diethylaminoethyl-dextran methyl methacrylate copolymer (DDMC; Ryujyu Science), which belongs to the 2-diethylaminoethyl-dextran family by aerosol administration. Thirty male BALBC mice, 2 month old, were included and divided into three groups. However, pathological findings indicated severe emphysema within three aerosol sessions. In addition, the CytoViva technique was applied for the first time to display the nonviral particles within the pulmonary tissue and emphysema lesions, and a spectral library of the nonviral vector was also established. Although our results in BALBC mice prevented us from further investigation of the DDMC nonviral vector as a vehicle for gene therapy, further investigation in animals with larger airways is warranted to properly evaluate the safety of the vector.

Noninvasive Brain Stimulation in Pediatric Attention-Deficit Hyperactivity Disorder (ADHD): A Review.

PubMed

Rubio, Belen; Boes, Aaron D; Laganiere, Simon; Rotenberg, Alexander; Jeurissen, Danique; Pascual-Leone, Alvaro

2016-05-01

Attention-deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in the pediatric population. The clinical management of ADHD is currently limited by a lack of reliable diagnostic biomarkers and inadequate therapy for a minority of patients who do not respond to standard pharmacotherapy. There is optimism that noninvasive brain stimulation may help to address these limitations. Transcranial magnetic stimulation and transcranial direct current stimulation are 2 methods of noninvasive brain stimulation that modulate cortical excitability and brain network activity. Transcranial magnetic stimulation can be used diagnostically to probe cortical neurophysiology, whereas daily use of repetitive transcranial magnetic stimulation or transcranial direct current stimulation can induce long-lasting and potentially therapeutic changes in targeted networks. In this review, we highlight research showing the potential diagnostic and therapeutic applications of transcranial magnetic stimulation and transcranial direct current stimulation in pediatric ADHD. We also discuss the safety and ethics of using these tools in the pediatric population. © The Author(s) 2015.

A paradigm shift on beta-thalassaemia treatment: How will we manage this old disease with new therapies?

PubMed

Cappellini, Maria Domenica; Porter, John B; Viprakasit, Vip; Taher, Ali T

2018-07-01

Beta-thalassaemia causes defective haemoglobin synthesis leading to ineffective erythropoiesis, chronic haemolytic anaemia, and subsequent clinical complications. Blood transfusion and iron chelation allow long-term disease control, and haematopoietic stem cell transplantation offers a potential cure for some patients. Nonetheless, there are still many challenges in the management of beta-thalassaemia. The main treatment option for most patients is supportive care; furthermore, the long-term efficacy and safety of current therapeutic strategies are limited and adherence is suboptimal. An increasing understanding of the underlying molecular and cellular disease mechanisms plus an awareness of limitations of current management strategies are driving research into novel therapeutic options. Here we provide an overview of the current pathophysiology, clinical manifestations, and global burden of beta-thalassaemia. We reflect on what has been achieved to date, describe the challenges associated with currently available therapy, and discuss how these issues might be addressed by novel therapeutic approaches in development. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Exposure-related health effects of silver and silver compounds: a review.

PubMed

Drake, Pamela L; Hazelwood, Kyle J

2005-10-01

A critical review of studies examining exposures to the various forms of silver was conducted to determine if some silver species are more toxic than others. The impetus behind conducting this review is that several occupational exposure limits and guidelines exist for silver, but the values for each depend on the form of silver as well as the individual agency making the recommendations. For instance, the American Conference of Governmental Industrial Hygienists has established separate threshold limit values for metallic silver (0.1 mg/m3) and soluble compounds of silver (0.01 mg/m3). On the other hand, the permissible exposure limit (PEL) recommended by the Occupational Safety and Health Administration and the Mine Safety and Health Administration and the recommended exposure limit set by the National Institute for Occupational Safety and Health is 0.01 mg/m3 for all forms of silver. The adverse effects of chronic exposure to silver are a permanent bluish-gray discoloration of the skin (argyria) or eyes (argyrosis). Most studies discuss cases of argyria and argyrosis that have resulted primarily from exposure to the soluble forms of silver. Besides argyria and argyrosis, exposure to soluble silver compounds may produce other toxic effects, including liver and kidney damage, irritation of the eyes, skin, respiratory, and intestinal tract, and changes in blood cells. Metallic silver appears to pose minimal risk to health. The current occupational exposure limits do not reflect the apparent difference in toxicities between soluble and metallic silver; thus, many researchers have recommended that separate PELs be established.

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Ferrell, Bob; Santuro, Steve; Simpson, James; Zoerner, Roger; Bull, Barton; Lanzi, Jim

2004-01-01

Autonomous Flight Safety System (AFSS) is an independent flight safety system designed for small to medium sized expendable launch vehicles launching from or needing range safety protection while overlying relatively remote locations. AFSS replaces the need for a man-in-the-loop to make decisions for flight termination. AFSS could also serve as the prototype for an autonomous manned flight crew escape advisory system. AFSS utilizes onboard sensors and processors to emulate the human decision-making process using rule-based software logic and can dramatically reduce safety response time during critical launch phases. The Range Safety flight path nominal trajectory, its deviation allowances, limit zones and other flight safety rules are stored in the onboard computers. Position, velocity and attitude data obtained from onboard global positioning system (GPS) and inertial navigation system (INS) sensors are compared with these rules to determine the appropriate action to ensure that people and property are not jeopardized. The final system will be fully redundant and independent with multiple processors, sensors, and dead man switches to prevent inadvertent flight termination. AFSS is currently in Phase III which includes updated algorithms, integrated GPS/INS sensors, large scale simulation testing and initial aircraft flight testing.

An open simulation approach to identify chances and limitations for vulnerable road user (VRU) active safety.

PubMed

Seiniger, Patrick; Bartels, Oliver; Pastor, Claus; Wisch, Marcus

2013-01-01

It is commonly agreed that active safety will have a significant impact on reducing accident figures for pedestrians and probably also bicyclists. However, chances and limitations for active safety systems have only been derived based on accident data and the current state of the art, based on proprietary simulation models. The objective of this article is to investigate these chances and limitations by developing an open simulation model. This article introduces a simulation model, incorporating accident kinematics, driving dynamics, driver reaction times, pedestrian dynamics, performance parameters of different autonomous emergency braking (AEB) generations, as well as legal and logical limitations. The level of detail for available pedestrian accident data is limited. Relevant variables, especially timing of the pedestrian appearance and the pedestrian's moving speed, are estimated using assumptions. The model in this article uses the fact that a pedestrian and a vehicle in an accident must have been in the same spot at the same time and defines the impact position as a relevant accident parameter, which is usually available from accident data. The calculations done within the model identify the possible timing available for braking by an AEB system as well as the possible speed reduction for different accident scenarios as well as for different system configurations. The simulation model identifies the lateral impact position of the pedestrian as a significant parameter for system performance, and the system layout is designed to brake when the accident becomes unavoidable by the vehicle driver. Scenarios with a pedestrian running from behind an obstruction are the most demanding scenarios and will very likely never be avoidable for all vehicle speeds due to physical limits. Scenarios with an unobstructed person walking will very likely be treatable for a wide speed range for next generation AEB systems.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs) . Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This document contains the appendices to the main report.

[Shuttle Challenger disaster: what lessons can be learned for management of patients in the operating room?].

PubMed

Suva, Domizio; Poizat, Germain

2015-02-04

For many years hospitals have been implementing crew resource management (CRM) programs, inspired by the aviation industry, in order to improve patient safety. However, while contributing to improved patient care, CRM programs are controversial because of their limited impact, a decrease in effectiveness over time, and the underinvestment by some caregivers. By analyzing the space shuttle Challenger accident, the objective of this article is to show the potential impact of the professional culture in decision-making processes. In addition, to present an approach by cultural factors which are an essential complement to current CRM programs in order to enhance the safety of care.

Inherent Conservatism in Deterministic Quasi-Static Structural Analysis

NASA Technical Reports Server (NTRS)

Verderaime, V.

1997-01-01

The cause of the long-suspected excessive conservatism in the prevailing structural deterministic safety factor has been identified as an inherent violation of the error propagation laws when reducing statistical data to deterministic values and then combining them algebraically through successive structural computational processes. These errors are restricted to the applied stress computations, and because mean and variations of the tolerance limit format are added, the errors are positive, serially cumulative, and excessively conservative. Reliability methods circumvent these errors and provide more efficient and uniform safe structures. The document is a tutorial on the deficiencies and nature of the current safety factor and of its improvement and transition to absolute reliability.

Access, interest, and attitudes toward electronic communication for health care among patients in the medical safety net.

PubMed

Schickedanz, Adam; Huang, David; Lopez, Andrea; Cheung, Edna; Lyles, C R; Bodenheimer, Tom; Sarkar, Urmimala

2013-07-01

Electronic and internet-based tools for patient-provider communication are becoming the standard of care, but disparities exist in their adoption among patients. The reasons for these disparities are unclear, and few studies have looked at the potential communication technologies have to benefit vulnerable patient populations. To characterize access to, interest in, and attitudes toward internet-based communication in an ethnically, economically, and linguistically diverse group of patients from a large urban safety net clinic network. Observational, cross-sectional study Adult patients (≥ 18 years) in six resource-limited community clinics in the San Francisco Department of Public Health (SFDPH) MAIN MEASURES: Current email use, interest in communicating electronically with health care professionals, barriers to and facilitators of electronic health-related communication, and demographic data-all self-reported via survey. Sixty percent of patients used email, 71 % were interested in using electronic communication with health care providers, and 19 % reported currently using email informally with these providers for health care. Those already using any email were more likely to express interest in using it for health matters. Most patients agreed electronic communication would improve clinic efficiency and overall communication with clinicians. A significant majority of safety net patients currently use email, text messaging, and the internet, and they expressed an interest in using these tools for electronic communication with their medical providers. This interest is currently unmet within safety net clinics that do not offer a patient portal or secure messaging. Tools such as email encounters and electronic patient portals should be implemented and supported to a greater extent in resource-poor settings, but this will require tailoring these tools to patients' language, literacy level, and experience with communication technology.

Need for new technologies for detection of adventitious agents in vaccines and other biological products.

PubMed

Mallet, Laurent; Gisonni-Lex, Lucy

2014-01-01

From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies. Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests. © PDA, Inc. 2014.

Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

PubMed

Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

2017-08-30

Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

The safety of ezetimibe and simvastatin combination for the treatment of hypercholesterolemia.

PubMed

Kei, Anastazia A; Filippatos, Theodosios D; Elisaf, Moses S

2016-01-01

In the light of the most recent and stricter dyslipidemia treatment guidelines, the need for combination hypolipidemic therapy is increasing. Ezetimibe plus simvastatin is available as a fixed dose therapy offering an efficient hypolipidemic treatment choice. Based on the positive results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) trial, the use of this drug combination is expected to increase in the next years. This review discusses the current evidence regarding the safety of ezetimibe/simvastatin combination. Current evidence regarding possible associated side effects (musculoskeletal, gastrointestinal, endocrine, hematological, renal, ophthalmologic, allergic, malignancy) and drug interactions of this combination is thoroughly discussed. Ezetimibe and simvastatin treatment, either as a single pill or the combined use of the individual compounds, offers limited additional risk compared with simvastatin monotherapy and comprises a safe and efficient choice for dyslipidemia treatment in high-risk and diabetic patients.

Food safety self-reported behaviors and cognitions of young adults: results of a national study.

PubMed

Byrd-Bredbenner, Carol; Maurer, Jaclyn; Wheatley, Virginia; Schaffner, Donald; Bruhn, Christine; Blalock, Lydia

2007-08-01

With limited opportunities to learn safe food handling via observation, many young adults lack the knowledge needed to keep them safe from foodborne disease. It is important to reach young adults with food safety education because of their current and future roles as caregivers. With a nationwide online survey, the demographic characteristics, self-reported food handling and consumption behaviors, food safety beliefs, locus of control, self-efficacy, stage of change, and knowledge of young adults with education beyond high school (n = 4,343) were assessed. Young adults (mean age, 19.92 +/- 1.67 SD) who participated were mainly female, white, never married, and freshmen or sophomores. Participants correctly answered 60% of the knowledge questions and were most knowledgeable about groups at greatest risk for foodborne disease and least knowledgeable about common food sources of foodborne disease pathogens. They reported less than optimal levels of safe food handling practices. Young adults generally had a limited intake of foods that increase the risk of foodborne disease, positive food safety beliefs, an internal food safety locus of control, and confidence in their ability to handle food safely, and they were contemplating an improvement in, or preparing to improve, their food handling practices. Females significantly outperformed males on nearly all study measures. Future food safety educational efforts should focus on increasing knowledge and propelling young adults into the action stage of safe food handling, especially males. Efforts to improve knowledge and, ultimately, food safety behaviors are essential to safeguard the health of these young adults and enable them to fulfill the role of protecting the health of their future families.

Laboratory analysis of risky driving at 0.05% and 0.08% blood alcohol concentration

PubMed Central

Van Dyke, Nicholas A.; Fillmore, Mark T.

2017-01-01

Background The public health costs associated with alcohol-related traffic crashes are a continuing problem for society. One harm reduction strategy has been to employ per se limits for blood alcohol concentrations (BACs) at which drivers can legally operate motor vehicles. This limit is currently 0.08% in all 50 US states. Recently, the National Transportation Safety Board proposed lowering the legal limit to 0.05 % (NTSB, 2013). While research has well-validated the ability of alcohol to impair driving performance and heighten crash-risk at these BACs, relatively little is known about the degree to which alcohol might increase drivers’ risk-taking. Methods Risk-taking was examined in 20 healthy adults who were each tested in a driving simulator following placebo and two doses of alcohol calculated to yield peak BACs of 0.08% and 0.05%, the respective current and proposed BAC limits. The drive test emphasized risk-taking by placing participants in a multiple-lane, high-traffic environment. The primary measure was how close drivers maneuvered relative to other vehicles on the road (i.e., time-to-collision, TTC). Results Alcohol increased risk-taking by decreasing drivers’ TTC at the 0.08% target BAC relative to placebo. Moreover, risk-taking at the 0.05% target was less than risk-taking at 0.08% target BAC. Conclusions These findings provide evidence that reducing the legal BAC limit in the USA to 0.05% would decrease risk-taking among drivers. A clearer understanding of the dose-response relationship between various aspects of driving behaviors, such as drivers’ accepted level of risk while driving, is an important step to improving traffic safety. PMID:28412303

75 FR 70106 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... states: Viking Air Limited has completed a system safety review of the aircraft fuel system against fuel... safety review of the aircraft fuel system against fuel tank safety standards introduced in Chapter 525 of... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

The Demands of Nuclear Safety: Mishaps and USSTRATCOM

DTIC Science & Technology

2011-06-01

maintenance operation—the unexpected will occur. Scott D. Sagan On 30 August 2007 the unexpected occurred. Ironically, the safety problem did... Sagan , The Limits of Safety: Organizations, Accidents, and Nuclear Weapons (Princeton, NJ: Princeton University Press, 1993), 14, 48. 39 Sagan , Limits...1 Scott D. Sagan , The Limits of Safety: Organizations, Accidents, and Nuclear Weapons (Princeton, NJ: Princeton

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

Scientific approach and practical experience for reconstruction of waste water treatment plants in Russia

NASA Astrophysics Data System (ADS)

Makisha, Nikolay; Gogina, Elena

2017-11-01

Protection of water bodies has a strict dependence on reliable operation of engineering systems and facilities for water supply and sewage. The majority of these plants and stations has been constructed in 1970-1980's in accordance with rules and regulations of that time. So now most of them require reconstruction due to serious physical or/and technological wear. The current condition of water supply and sewage systems and facilities frequently means a hidden source of serious danger for normal life support and ecological safety of cities and towns. The article reveals an obtained experience and modern approaches for reconstruction of waste water and sludge treatment plants that proved their efficiency even if applied in limited conditions such as area limits, investments limits. The main directions of reconstruction: overhaul repair and partial modernization of existing facilities on the basis of initial project; - restoration and modernization of existing systems on the basis on the current documents and their current condition; upgrade of waste water treatment plants (WWTPs) performance on the basis of modern technologies and methods; reconstruction of sewage systems and facilities and treatment quality improvement.

Safety of oral tenofovir disoproxil fumarate-based HIV pre-exposure prophylaxis use in lactating HIV-uninfected women.

PubMed

Mugwanya, Kenneth K; John-Stewart, Grace; Baeten, Jared

2017-07-01

In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option for women who are lactating but data are limited on its safety during the lactation period. Areas covered: We provide a concise synthesis and summary of current evidence on the safety of TDF-based PrEP during breastfeeding. We conducted a review, searching Pubmed database and major PrEP conferences for primary studies with TDF-based PrEP exposure during postpartum breastfeeding. Expert opinion: TDF-based oral PrEP is an effective female-controlled HIV prevention option. There is evidence supporting the safety of TDF use for infant outcomes during breastfeeding in antiretroviral treatment regimens for HIV and hepatitis B virus, and more limited, but consistently safe, data from use of TDF as PrEP. The potential for risk is arguably outweighed for at-risk individuals by HIV prevention benefits, including indirect protection to the infant as a result of preventing HIV in the breastfeeding mother. As PrEP delivery is scaled up in heterosexual populations in high HIV prevalence settings and for at-risk persons in other settings, implementation science studies can provide a framework to increase the accrual of safety, acceptability, and use data related to PrEP during lactation.

Health and safety problems associated with long working hours: a review of the current position.

PubMed Central

Spurgeon, A; Harrington, J M; Cooper, C L

1997-01-01

The European Community Directive on Working Time, which should have been implemented in member states of the European Community by November 1996, contains several requirements related to working hours, including the right of employees to refuse to work more than 48 hours a week. The United Kingdom government attempted to oppose the Directive, arguing that there is no convincing evidence that hours of work should be limited on health and safety grounds. Much of the research in this area has focused on the problems of shiftworking and previous reviews have therefore tended to emphasise this aspect of working hours. However, there is much less information about the effects of overtime work, which is a central element of the terms of the Directive. This paper reviews the current evidence relating to the potential effects on health and performance of extensions to the normal working day. Several gaps in the literature are identified. Research to date has been restricted to a limited range of health outcomes--namely, mental health and cardiovascular disorders. Other potential effects which are normally associated with stress--for example, gastrointestinal disorders, musculoskeletal disorders, and problems associated with depression of the immune system, have received little attention. Also, there have been few systematic investigations of performance effects, and little consideration of the implications for occupational exposure limits of extensions to the working day. Existing data relate largely to situations where working hours exceed 50 a week and there is a lack of information on hours below this level, which is of direct relevance to the European Community proposal. Finally, it is clear from investigations relating to shiftwork that a range of modifying factors are likely to influence the level and nature of health and performance outcomes. These include the attitudes and motivation of the people concerned, the job requirements, and other aspects of the organisational and cultural climate. It is concluded that there is currently sufficient evidence to raise concerns about the risks to health and safety of long working hours. However, much more work is required to define the level and nature of those risks. PMID:9245942

Are Latino immigrants a burden to safety net services in nontraditional immigrant states? Lessons from Oregon.

PubMed

López-Cevallos, Daniel

2014-05-01

The significant growth of the Latino population in the midst of an economic recession has invigorated anti-Latino, anti-immigrant sentiments in many US states. One common misconception is that Latino immigrants are a burden to safety net services. This may be particularly true in nontraditional immigrant states that have not historically served Latino immigrants. Oregon data suggest that despite a higher prevalence of poverty, use of safety net services among Latino immigrants in Oregon is lower than that among non-Latino Whites. Immigration status, costs, lack of insurance coverage, and discrimination are among the reasons for this group's limited use of services. Nevertheless, policies designed to strengthen community and institutional support for Latino immigrant families should be considered in the context of current health care and immigration reform efforts.

Are Latino Immigrants a Burden to Safety Net Services in Nontraditional Immigrant States? Lessons From Oregon

PubMed Central

2014-01-01

The significant growth of the Latino population in the midst of an economic recession has invigorated anti-Latino, anti-immigrant sentiments in many US states. One common misconception is that Latino immigrants are a burden to safety net services. This may be particularly true in nontraditional immigrant states that have not historically served Latino immigrants. Oregon data suggest that despite a higher prevalence of poverty, use of safety net services among Latino immigrants in Oregon is lower than that among non-Latino Whites. Immigration status, costs, lack of insurance coverage, and discrimination are among the reasons for this group’s limited use of services. Nevertheless, policies designed to strengthen community and institutional support for Latino immigrant families should be considered in the context of current health care and immigration reform efforts. PMID:24625168

Risk of Cardiovascular Hospitalizations from Exposure to Coarse Particulate Matter (PM10) Below the European Union Safety Threshold.

PubMed

Vaduganathan, Muthiah; De Palma, Giuseppe; Manerba, Alessandra; Goldoni, Matteo; Triggiani, Marco; Apostoli, Pietro; Dei Cas, Livio; Nodari, Savina

2016-04-15

The association between exposure to air pollution and acute cardiovascular (CV) events is well documented; however, limited data are available evaluating the public health safety of various "doses" of particular matter (PM) below currently accepted safety thresholds. We explored the cross-sectional association between PM with aerodynamic diameter <10 μm (PM10) and daily CV hospitalizations in Brescia, Italy, using Poisson regression models adjusted for age, gender, and meteorologic indices. Average daily exposure to PM10 obtained from arithmetic means of air pollution data were captured by 4 selected monitoring stations. PM10 data were expressed as daily means (lag 0-day) or 3-day moving averages (lag 3-day) and categorized according to the European Union daily limit value of 50 μg/m(3). From September 2004 to September 2007, data from 6,000 acute CV admissions to a tertiary referral center were collected. An increase of 1 μg/m(3) PM10 at lag 0-day was independently associated with higher rates of acute hospitalizations for composite CV-related events (relative risk [RR] 1.004, 95% confidence interval [CI] 1.002 to 1.006), acute heart failure (RR 1.004, 95% CI 1.001 to 1.008), acute coronary syndromes (RR 1.002, 95% CI 0.999 to 1.005), malignant ventricular arrhythmias (RR 1.004, 95% CI 0.999 to 1.010), and atrial fibrillation (RR 1.008, 95% CI 1.003 to 1.012). Similar results were obtained using PM10 lag 3-day data. The excess PM10 CV hospitalization risk (by lag 0-day and lag 3-day) did not vary significantly above and below the 50 μg/m(3) safety threshold or by age and gender. In conclusion, increased levels of PM10, even below the current limits set by the European Union, were associated with excess risk for admissions for acute CV events. Copyright © 2016 Elsevier Inc. All rights reserved.

Applying importance-performance analysis to patient safety culture.

PubMed

Lee, Yii-Ching; Wu, Hsin-Hung; Hsieh, Wan-Lin; Weng, Shao-Jen; Hsieh, Liang-Po; Huang, Chih-Hsuan

2015-01-01

The Sexton et al.'s (2006) safety attitudes questionnaire (SAQ) has been widely used to assess staff's attitudes towards patient safety in healthcare organizations. However, to date there have been few studies that discuss the perceptions of patient safety both from hospital staff and upper management. The purpose of this paper is to improve and to develop better strategies regarding patient safety in healthcare organizations. The Chinese version of SAQ based on the Taiwan Joint Commission on Hospital Accreditation is used to evaluate the perceptions of hospital staff. The current study then lies in applying importance-performance analysis technique to identify the major strengths and weaknesses of the safety culture. The results show that teamwork climate, safety climate, job satisfaction, stress recognition and working conditions are major strengths and should be maintained in order to provide a better patient safety culture. On the contrary, perceptions of management and hospital handoffs and transitions are important weaknesses and should be improved immediately. Research limitations/implications - The research is restricted in generalizability. The assessment of hospital staff in patient safety culture is physicians and registered nurses. It would be interesting to further evaluate other staff's (e.g. technicians, pharmacists and others) opinions regarding patient safety culture in the hospital. Few studies have clearly evaluated the perceptions of healthcare organization management regarding patient safety culture. Healthcare managers enable to take more effective actions to improve the level of patient safety by investigating key characteristics (either strengths or weaknesses) that healthcare organizations should focus on.

Intelligent Hardware-Enabled Sensor and Software Safety and Health Management for Autonomous UAS

NASA Technical Reports Server (NTRS)

Rozier, Kristin Y.; Schumann, Johann; Ippolito, Corey

2015-01-01

Unmanned Aerial Systems (UAS) can only be deployed if they can effectively complete their mission and respond to failures and uncertain environmental conditions while maintaining safety with respect to other aircraft as well as humans and property on the ground. We propose to design a real-time, onboard system health management (SHM) capability to continuously monitor essential system components such as sensors, software, and hardware systems for detection and diagnosis of failures and violations of safety or performance rules during the ight of a UAS. Our approach to SHM is three-pronged, providing: (1) real-time monitoring of sensor and software signals; (2) signal analysis, preprocessing, and advanced on-the- y temporal and Bayesian probabilistic fault diagnosis; (3) an unobtrusive, lightweight, read-only, low-power hardware realization using Field Programmable Gate Arrays (FPGAs) in order to avoid overburdening limited computing resources or costly re-certi cation of ight software due to instrumentation. No currently available SHM capabilities (or combinations of currently existing SHM capabilities) come anywhere close to satisfying these three criteria yet NASA will require such intelligent, hardwareenabled sensor and software safety and health management for introducing autonomous UAS into the National Airspace System (NAS). We propose a novel approach of creating modular building blocks for combining responsive runtime monitoring of temporal logic system safety requirements with model-based diagnosis and Bayesian network-based probabilistic analysis. Our proposed research program includes both developing this novel approach and demonstrating its capabilities using the NASA Swift UAS as a demonstration platform.

"Going solid": a model of system dynamics and consequences for patient safety

PubMed Central

Cook, R; Rasmussen, J

2005-01-01



 Rather than being a static property of hospitals and other healthcare facilities, safety is dynamic and often on short time scales. In the past most healthcare delivery systems were loosely coupled—that is, activities and conditions in one part of the system had only limited effect on those elsewhere. Loose coupling allowed the system to buffer many conditions such as short term surges in demand. Modern management techniques and information systems have allowed facilities to reduce inefficiencies in operation. One side effect is the loss of buffers that previously accommodated demand surges. As a result, situations occur in which activities in one area of the hospital become critically dependent on seemingly insignificant events in seemingly distant areas. This tight coupling condition is called "going solid". Rasmussen's dynamic model of risk and safety can be used to formulate a model of patient safety dynamics that includes "going solid" and its consequences. Because the model addresses the dynamic aspects of safety, it is particularly suited to understanding current conditions in modern healthcare delivery and the way these conditions may lead to accidents. PMID:15805459

Factors impacting perceived safety among staff working on mental health wards.

PubMed

Haines, Alina; Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

2017-09-01

Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. None. © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license.

Design and Performance Analysis of an Intrinsically Safe Ultrasonic Ranging Sensor

PubMed Central

Zhang, Hongjuan; Wang, Yu; Zhang, Xu; Wang, Dong; Jin, Baoquan

2016-01-01

In flammable or explosive environments, an ultrasonic sensor for distance measurement poses an important engineering safety challenge, because the driving circuit uses an intermediate frequency transformer as an impedance transformation element, in which the produced heat or spark is available for ignition. In this paper, an intrinsically safe ultrasonic ranging sensor is designed and implemented. The waterproof piezoelectric transducer with integrated transceiver is chosen as an energy transducing element. Then a novel transducer driving circuit is designed based on an impedance matching method considering safety spark parameters to replace an intermediate frequency transformer. Then, an energy limiting circuit is developed to achieve dual levels of over-voltage and over-current protection. The detail calculation and evaluation are executed and the electrical characteristics are analyzed to verify the intrinsic safety of the driving circuit. Finally, an experimental platform of the ultrasonic ranging sensor system is constructed, which involves short-circuit protection. Experimental results show that the proposed ultrasonic ranging sensor is excellent in both ranging performance and intrinsic safety. PMID:27304958

Design and Performance Analysis of an Intrinsically Safe Ultrasonic Ranging Sensor.

PubMed

Zhang, Hongjuan; Wang, Yu; Zhang, Xu; Wang, Dong; Jin, Baoquan

2016-06-13

In flammable or explosive environments, an ultrasonic sensor for distance measurement poses an important engineering safety challenge, because the driving circuit uses an intermediate frequency transformer as an impedance transformation element, in which the produced heat or spark is available for ignition. In this paper, an intrinsically safe ultrasonic ranging sensor is designed and implemented. The waterproof piezoelectric transducer with integrated transceiver is chosen as an energy transducing element. Then a novel transducer driving circuit is designed based on an impedance matching method considering safety spark parameters to replace an intermediate frequency transformer. Then, an energy limiting circuit is developed to achieve dual levels of over-voltage and over-current protection. The detail calculation and evaluation are executed and the electrical characteristics are analyzed to verify the intrinsic safety of the driving circuit. Finally, an experimental platform of the ultrasonic ranging sensor system is constructed, which involves short-circuit protection. Experimental results show that the proposed ultrasonic ranging sensor is excellent in both ranging performance and intrinsic safety.

Safety considerations of lithium-thionyl chloride cells

NASA Astrophysics Data System (ADS)

Subbarao, Surampudi; Halpert, Gerald; Stein, Irving

1986-06-01

The use of spirally wound lithium-thionyl chloride (Li-SOCl2) cells is currently limited because of their hazardous behavior. Safety hazards have ranged from mild venting of toxic materials to violent explosions and fires. These incidents may be related to both user- and manufacturer-induced causes. Many explanations have been offered to explain the unsafe behavior of the cells under operating and abuse conditions. Explanations fall into two categories: (1) thermal mechanisms, and (2) chemical mechanisms. However, it is quite difficult to separate the two. Both may be responsible for cell venting or explosion. Some safety problems encountered with these cells also may be due to design deficiencies and ineffective quality control during cell fabrication. A well-coordinated basic and applied research program is needed to develop safe Li-SOCl2 cells. Recommendations include: (1) learnig more about Li-SOL2 cell chemistry; (2) modeling cell and battery behavior; (3) optimizing cell design for safety and performance, (4) implementing quality control procedures; and (5) educating users.

Safety considerations of lithium-thionyl chloride cells

NASA Technical Reports Server (NTRS)

Subbarao, Surampudi; Halpert, Gerald; Stein, Irving

1986-01-01

The use of spirally wound lithium-thionyl chloride (Li-SOCl2) cells is currently limited because of their hazardous behavior. Safety hazards have ranged from mild venting of toxic materials to violent explosions and fires. These incidents may be related to both user- and manufacturer-induced causes. Many explanations have been offered to explain the unsafe behavior of the cells under operating and abuse conditions. Explanations fall into two categories: (1) thermal mechanisms, and (2) chemical mechanisms. However, it is quite difficult to separate the two. Both may be responsible for cell venting or explosion. Some safety problems encountered with these cells also may be due to design deficiencies and ineffective quality control during cell fabrication. A well-coordinated basic and applied research program is needed to develop safe Li-SOCl2 cells. Recommendations include: (1) learnig more about Li-SOL2 cell chemistry; (2) modeling cell and battery behavior; (3) optimizing cell design for safety and performance, (4) implementing quality control procedures; and (5) educating users.

Assessment of Three “WHO” Patient Safety Solutions: Where Do We Stand and What Can We Do?

PubMed Central

Banihashemi, Sheida; Hatam, Nahid; Zand, Farid; Kharazmi, Erfan; Nasimi, Soheila; Askarian, Mehrdad

2015-01-01

Background: Most medical errors are preventable. The aim of this study was to compare the current execution of the 3 patient safety solutions with WHO suggested actions and standards. Methods: Data collection forms and direct observation were used to determine the status of implementation of existing protocols, resources, and tools. Results: In the field of patient hand-over, there was no standardized approach. In the field of the performance of correct procedure at the correct body site, there were no safety checklists, guideline, and educational content for informing the patients and their families about the procedure. In the field of hand hygiene (HH), although availability of necessary resources was acceptable, availability of promotional HH posters and reminders was substandard. Conclusions: There are some limitations of resources, protocols, and standard checklists in all three areas. We designed some tools that will help both wards to improve patient safety by the implementation of adapted WHO suggested actions. PMID:26900434

[Alcohol and work: the role of the company physician in the occupational health and safety management systems].

PubMed

Patussi, V; Muran, A

2010-01-01

The organization of safety in the working places and the increasing attention to behaviours and life styles of workers that may lead to increasing occupational risks are the pick innovative aspects of the recent changes in our country's legislation about occupational safety. In this organization, the role of the company physician is becoming more and more important and his work of evaluation beginning with the knowledge both of the working places and of the workers's lifestyles, is irreplaceable. His role in organizing the managing standards of occupational safety and health cannot be limited to health supervision but must be an essential element in risk assessment in the prevision of workplaces and of safe working conditions, in workers training and information, in organizing the control system of each business. The present paper examines--referring to the current regulation--the duties and functions of a company physician when facing the problems concerning the working risks tied to alcohol assumption.

New advances in models and strategies for developing anti-obesity drugs

PubMed Central

Kim, Gilbert W.; Lin, Jieru E.; Blomain, Erik S.; Waldman, Scott A.

2014-01-01

Introduction Obesity is a worldwide pandemic. Obesity-related health and economic costs are staggering. Existing strategies to combat obesity through lifestyle improvements and medical intervention have had limited success. Pharmacotherapy, in combination with lifestyle modification, may play a vital role in reversing the disease burden. However, past and current weight-loss medications have had serious safety risks, notably cardiovascular and psychiatric events. Areas covered We review the strategies for designing new anti-obesity drugs by describing those currently in development. We describe their target, mechanism of action, and developmental or regulatory status. We also discuss the problem of weight regain following weight loss, and its relevance to the long-term success of anti-obesity pharmacotherapy. Expert opinion For weight management drugs to achieve the safety and efficacy required to be impactful, current studies are uncovering and characterizing new targets, including new signaling circuits and hormones regulating appetite and metabolism, and re-evaluating the role of pharmacotherapy in weight management. To avoid the safety failures of many past weight-loss drugs, the models and strategies covered in this article incorporate recent advances in knowledge and technology. We discuss the emergence of cGMP signaling as a potentially transformative target in weight management. Modulating cGMP signaling may represent an ideal goal for an anti-obesity pharmacotherapy, reflecting some of the major themes described in the present review: targeting pathways that are newly realized as relevant for weight management; promoting safety by re-purposing drugs that are safe, proven, and approved for clinical use; and having a synergistic effect on multiple, reinforcing pathways. PMID:23621300

The external kink mode in diverted tokamaks

DOE PAGES

Turnbull, Alan D.; Hanson, Jeremy M.; Turco, Francesca; ...

2016-06-16

Here, an explanation is provided for the disruptive instability in diverted tokamaks when the safety factor at the 95% poloidal flux surface, q 95, is driven below 2.0. The instability is a resistive kink counterpart to the current-driven ideal mode that traditionally explained the corresponding disruption in limited cross-sections when q edge, the safety factor at the outermost closed flux surface, lies just below a rational value. Experimentally, external kink modes are observed in limiter configurations as the current in a tokamak is ramped up and q edge decreases through successive rational surfaces. For q edge < 2, the instabilitymore » is always encountered and is highly disruptive. However, diverted plasmas, in which q edge is formally infinite in the magnetohydrodynamic (MHD) model, have presented a longstanding difficulty since the theory would predict stability, yet, the disruptive limit occurs in practice when q 95, reaches 2. It is shown from numerical calculations that a resistive kink mode is linearly destabilized by the rapidly increasing resistivity at the plasma edge when q 95 < 2, but q edge >> 2. The resistive kink behaves much like the ideal kink with predominantly kink or interchange parity and no real sign of a tearing component. However, the growth rates scale with a fractional power of the resistivity near the q = 2 surface. The results have a direct bearing on the conventional edge cutoff procedures used in most ideal MHD codes, as well as implications for ITER and for future reactor options.« less

In Vivo Evaluation and Proof of Radiofrequency Safety of a Novel Diagnostic MR-Electrophysiology Catheter

PubMed Central

Weiss, Steffen; Wirtz, Daniel; David, Bernd; Krueger, Sascha; Lips, Oliver; Caulfield, Dennis; Pedersen, Steen Fjord; Bostock, Julian; Razavi, Reza; Schaeffter, Tobias

2013-01-01

An MR-electrophysiology (EP) catheter is presented that provides full diagnostic EP functionality and a high level of radiofrequency safety achieved by custom-designed transmission lines. Highly resistive wires transmit intracardiac electrograms and currents for intracardiac pacing. A transformer cable transmits the localization signal of a tip coil. Specific absorption rate simulations and temperature measurements at 1.5 T demonstrate that a wire resistance > 3 kΩ/m limits dielectric heating to a physiologically irrelevant level. Additional wires do not increase tip specific absorption rate significantly, which is important because some clinical catheters require up to 20 electrodes. It is further demonstrated that radiofrequency-induced and pacing-induced resistive heating of the wires is negligible under clinical conditions. The MR-EP catheters provided uncompromised recording of electrograms and cardiac pacing in combination with a standard EP recorder in MR-guided in vivo EP studies, and the tip coil enabled fast and robust catheter localization. In vivo temperature measurements during such a study did not detect any device-related heating, which confirms the high level of safety of the catheter, whereas unacceptable heating was found with a standard EP catheter. The presented concept for the first time enables catheters with full diagnostic EP functionality and active tracking and at the same time a sufficient level of radiofrequency safety for MRI without specific absorption rate-related limitations. PMID:21337409

In vivo evaluation and proof of radiofrequency safety of a novel diagnostic MR-electrophysiology catheter.

PubMed

Weiss, Steffen; Wirtz, Daniel; David, Bernd; Krueger, Sascha; Lips, Oliver; Caulfield, Dennis; Pedersen, Steen Fjord; Bostock, Julian; Razavi, Reza; Schaeffter, Tobias

2011-03-01

An MR-electrophysiology (EP) catheter is presented that provides full diagnostic EP functionality and a high level of radiofrequency safety achieved by custom-designed transmission lines. Highly resistive wires transmit intracardiac electrograms and currents for intracardiac pacing. A transformer cable transmits the localization signal of a tip coil. Specific absorption rate simulations and temperature measurements at 1.5 T demonstrate that a wire resistance > 3 kΩ/m limits dielectric heating to a physiologically irrelevant level. Additional wires do not increase tip specific absorption rate significantly, which is important because some clinical catheters require up to 20 electrodes. It is further demonstrated that radiofrequency-induced and pacing-induced resistive heating of the wires is negligible under clinical conditions. The MR-EP catheters provided uncompromised recording of electrograms and cardiac pacing in combination with a standard EP recorder in MR-guided in vivo EP studies, and the tip coil enabled fast and robust catheter localization. In vivo temperature measurements during such a study did not detect any device-related heating, which confirms the high level of safety of the catheter, whereas unacceptable heating was found with a standard EP catheter. The presented concept for the first time enables catheters with full diagnostic EP functionality and active tracking and at the same time a sufficient level of radiofrequency safety for MRI without specific absorption rate-related limitations. Copyright © 2010 Wiley-Liss, Inc.

Current perspectives on the use of ancillary materials for the manufacture of cellular therapies.

PubMed

Solomon, Jennifer; Csontos, Lynn; Clarke, Dominic; Bonyhadi, Mark; Zylberberg, Claudia; McNiece, Ian; Kurtzberg, Joanne; Bell, Rosemarie; Deans, Robert

2016-01-01

Continued growth in the cell therapy industry and commercialization of cell therapies that successfully advance through clinical trials has led to increased awareness around the need for specialized and complex materials utilized in their manufacture. Ancillary materials (AMs) are components or reagents used during the manufacture of cell therapy products but are not intended to be part of the final products. Commonly, there are limitations in the availability of clinical-grade reagents used as AMs. Furthermore, AMs may affect the efficacy of the cell product and subsequent safety of the cell therapy for the patient. As such, AMs must be carefully selected and appropriately qualified during the cell therapy development process. However, the ongoing evolution of cell therapy research, limited number of clinical trials and registered cell therapy products results in the current absence of specific regulations governing the composition, compliance, and qualification of AMs often leads to confusion by suppliers and users in this field. Here we provide an overview and interpretation of the existing global framework surrounding AM use and investigate some common misunderstandings within the industry, with the aim of facilitating the appropriate selection and qualification of AMs. The key message we wish to emphasize is that in order to most effectively mitigate risk around cell therapy development and patient safety, users must work with their suppliers and regulators to qualify each AM to assess source, purity, identity, safety, and suitability in a given application. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

A new approach to identify, classify and count drugrelated events

PubMed Central

Bürkle, Thomas; Müller, Fabian; Patapovas, Andrius; Sonst, Anja; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Dormann, Harald; Maas, Renke

2013-01-01

Aims The incidence of clinical events related to medication errors and/or adverse drug reactions reported in the literature varies by a degree that cannot solely be explained by the clinical setting, the varying scrutiny of investigators or varying definitions of drug-related events. Our hypothesis was that the individual complexity of many clinical cases may pose relevant limitations for current definitions and algorithms used to identify, classify and count adverse drug-related events. Methods Based on clinical cases derived from an observational study we identified and classified common clinical problems that cannot be adequately characterized by the currently used definitions and algorithms. Results It appears that some key models currently used to describe the relation of medication errors (MEs), adverse drug reactions (ADRs) and adverse drug events (ADEs) can easily be misinterpreted or contain logical inconsistencies that limit their accurate use to all but the simplest clinical cases. A key limitation of current models is the inability to deal with complex interactions such as one drug causing two clinically distinct side effects or multiple drugs contributing to a single clinical event. Using a large set of clinical cases we developed a revised model of the interdependence between MEs, ADEs and ADRs and extended current event definitions when multiple medications cause multiple types of problems. We propose algorithms that may help to improve the identification, classification and counting of drug-related events. Conclusions The new model may help to overcome some of the limitations that complex clinical cases pose to current paper- or software-based drug therapy safety. PMID:24007453

The current status of biomarkers for predicting toxicity

PubMed Central

Campion, Sarah; Aubrecht, Jiri; Boekelheide, Kim; Brewster, David W; Vaidya, Vishal S; Anderson, Linnea; Burt, Deborah; Dere, Edward; Hwang, Kathleen; Pacheco, Sara; Saikumar, Janani; Schomaker, Shelli; Sigman, Mark; Goodsaid, Federico

2013-01-01

Introduction There are significant rates of attrition in drug development. A number of compounds fail to progress past preclinical development due to limited tools that accurately monitor toxicity in preclinical studies and in the clinic. Research has focused on improving tools for the detection of organ-specific toxicity through the identification and characterization of biomarkers of toxicity. Areas covered This article reviews what we know about emerging biomarkers in toxicology, with a focus on the 2012 Northeast Society of Toxicology meeting titled ‘Translational Biomarkers in Toxicology.’ The areas covered in this meeting are summarized and include biomarkers of testicular injury and dysfunction, emerging biomarkers of kidney injury and translation of emerging biomarkers from preclinical species to human populations. The authors also provide a discussion about the biomarker qualification process and possible improvements to this process. Expert opinion There is currently a gap between the scientific work in the development and qualification of novel biomarkers for nonclinical drug safety assessment and how these biomarkers are actually used in drug safety assessment. A clear and efficient path to regulatory acceptance is needed so that breakthroughs in the biomarker toolkit for nonclinical drug safety assessment can be utilized to aid in the drug development process. PMID:23961847

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.

PubMed

Lu, Ellen; Wang, Bing Wei; Guimond, Colleen; Synnes, Anne; Sadovnick, A Dessa; Dahlgren, Leanne; Traboulsee, Anthony; Tremlett, Helen

2013-03-01

When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs)

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs). Corrected Copy, Aug. 25, 2014

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

Role of the nurse immuniser in implementing and maintaining the National Human Papillomavirus 'Cervical Cancer' Vaccine rollout through a school-based program in Victoria.

PubMed

Kent, Helen; Heffernan, Margaret E; Silvers, Julie; Moore, Elya; Garland, Suzanne M

2010-09-01

In an effort to understand the strengths and limitations of current approaches to human papillomavirus vaccine (HPV) delivery in schools, we conducted an audit of nurse immunisers (NI). In this survey of 159 Victorian NI, the NI perceived that knowledge, safety and side effects were among the most important issues raised by parents, schoolgirls, and teachers in the school setting. The most common concern identified by NIs was the physical layout of the vaccination setting (41%), followed by safety, then knowledge of the vaccine. There is a need for ongoing assessment of factors that improve or impede the delivery of HPV vaccines.

Critical issues in sensor science to aid food and water safety.

PubMed

Farahi, R H; Passian, A; Tetard, L; Thundat, T

2012-06-26

The stability of food and water supplies is widely recognized as a global issue of fundamental importance. Sensor development for food and water safety by nonconventional assays continues to overcome technological challenges. The delicate balance between attaining adequate limits of detection, chemical fingerprinting of the target species, dealing with the complex food matrix, and operating in difficult environments are still the focus of current efforts. While the traditional pursuit of robust recognition methods remains important, emerging engineered nanomaterials and nanotechnology promise better sensor performance but also bring about new challenges. Both advanced receptor-based sensors and emerging non-receptor-based physical sensors are evaluated for their critical challenges toward out-of-laboratory applications.

Automatic reactor control system for transient operation

NASA Astrophysics Data System (ADS)

Lipinski, Walter C.; Bhattacharyya, Samit K.; Hanan, Nelson A.

Various programmatic considerations have delayed the upgrading of the TREAT reactor and the performance of the control system is not yet experimentally verified. The current schedule calls for the upgrading activities to occur last in the calendar year 1987. Detailed simulation results, coupled with earlier validation of individual components of the control strategy in TREAT, verify the performance of the algorithms. The control system operates within the safety envelope provided by a protection system designed to ensure reactor safety under conditions of spurious reactivity additions. The approach should be directly applicable to MMW systems, with appropriate accounting of temperature rate limitations of key components and of the inertia of the secondary system components.

Dronedarone: current evidence for its safety and efficacy in the management of atrial fibrillation.

PubMed

Schweizer, Patrick A; Becker, Rüdiger; Katus, Hugo A; Thomas, Dierk

2011-01-06

Atrial fibrillation (AF) is the most common sustained arrhythmia. Management of AF includes rate control, rhythm control if necessary, prevention of thromboembolic events, and treatment of the underlying disease. Rate control is usually achieved by pharmacological suppression of calcium currents or by applying β-blockers or digitalis compounds. In contrast, the number of compounds available for rhythm control is still limited. Class Ic agents increase mortality in patients with structural heart disease, and amiodarone harbors an extensive side effect profile despite its efficacy in maintaining sinus rhythm. Furthermore, rhythm control by these compounds has not been shown to reduce patient mortality. Dronedarone is a new anti-arrhythmic drug that has been developed to provide rhythm and rate control in AF patients with fewer side effects compared with amiodarone. This review primarily focuses on clinical trials evaluating efficacy and safety of the novel drug. Conclusions from these studies are critically reviewed, and recommendations for clinical practice are discussed. Dronedarone significantly reduced the incidence of hospitalization due to cardiovascular events or death in high-risk patients with atrial fibrillation (ATHENA trial). However, dronedarone was less efficient than amiodarone in maintaining normal sinus rhythm (DIONYSOS trial) and is contraindicated in severe or deteriorating heart failure (ANDROMEDA trial). In summary, dronedarone represents a valuable addition to the limited spectrum of antiarrhythmic drugs and is currently recommended in patients with paroxysmal and persistent AF to achieve rate and rhythm control, excluding cases of severe or unstable congestive heart failure.

Games that "work": using computer games to teach alcohol-affected children about fire and street safety.

PubMed

Coles, Claire D; Strickland, Dorothy C; Padgett, Lynne; Bellmoff, Lynnae

2007-01-01

Unintentional injuries are a leading cause of death and disability for children. Those with developmental disabilities, including children affected by prenatal alcohol exposure, are at highest risk for injuries. Although teaching safety skills is recommended to prevent injury, cognitive limitations and behavioral problems characteristic of children with fetal alcohol spectrum disorder make teaching these skills challenging for parents and teachers. In the current study, 32 children, ages 4-10, diagnosed with fetal alcohol syndrome (FAS) and partial FAS, learned fire and street safety through computer games that employed "virtual worlds" to teach recommended safety skills. Children were pretested on verbal knowledge of four safety elements for both fire and street safety conditions and then randomly assigned to one condition. After playing the game until mastery, children were retested verbally and asked to "generalize" their newly acquired skills in a behavioral context. They were retested after 1 week follow-up. Children showed significantly better knowledge of the game to which they were exposed, immediately and at follow-up, and the majority (72%) was able to generalize all four steps within a behavioral setting. Results suggested that this is a highly effective method for teaching safety skills to high-risk children who have learning difficulties.

Review: New Vaccine Against Tuberculosis: Current Developments and Future Challenges

NASA Astrophysics Data System (ADS)

Liu, Jun

2009-04-01

Tuberculosis (TB) continues to be a global health threat. BCG was developed as an attenuated live vaccine for tuberculosis control nearly a century ago. Despite being the most widely used vaccine in human history, BCG is not an ideal vaccine and has two major limitations: its poor efficacy against adult pulmonary TB and its disconcerting safety in immunocompromised individuals. A safer and more effective TB vaccine is urgently needed. This review article discusses current strategies to develop the next generation of TB vaccines to replace BCG. While some progresses have been made in the past decade, significant challenges lie ahead.

Porcine dermis implants in soft-tissue reconstruction: current status

PubMed Central

Smart, Neil J; Bryan, Nicholas; Hunt, John A; Daniels, Ian R

2014-01-01

Soft-tissue reconstruction for a variety of surgical conditions, such as abdominal wall hernia or pelvic organ prolapse, remains a challenge. There are numerous meshes available that may be simply categorized as either synthetic or biologic. Within biologic meshes, porcine dermal meshes have come to dominate the market. This review examines the current evidence for their use and the limitations of knowledge. Although there is increasing evidence to support their safety, long-term follow-up studies that support their efficacy are lacking. Numerous clinical trials that remain ongoing may help elucidate their precise role in soft-tissue reconstruction. PMID:24648721

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads with poor safety ratings, the opposite was found on roads with good safety ratings. The main reason for this was that lanes for traffic traveling in opposite directions were more often separated at higher speeds on roads with good safety ratings. On divided roads with good safety ratings, there were no crashes resulting in crash severity above the level corresponding to a 10 percent risk of sustaining serious or fatal injury. This indicates that one of the most important safety measures is divided roads.

Renal denervation in the management of resistant hypertension: current evidence and perspectives.

PubMed

Jin, Yu; Persu, Alexandre; Staessen, Jan A

2013-09-01

Catheter-based renal denervation has emerged as a novel treatment modality for resistant hypertension. This review summarizes the current evidence on this procedure in treatment of resistant hypertension, limitations of available evidence and questions to be answered. The SYMPLICITY studies showed that renal denervation is feasible in treating resistant hypertension, but failed to provide conclusive evidence on the size and durability of the antihypertensive, renal and sympatholytic effects, as well as the long-term safety. The definition of resistant hypertension was loose in the SYMPLICITY studies and the management of resistant hypertension was suboptimal. Future studies should have a randomized design and enroll truly resistant hypertension patients by excluding secondary hypertension, white-coat hypertension and nonadherent patients. Questions to be addressed by the ongoing and future trials include the long-term efficacy and safety of this procedure, identification of responders and uncovering of the underlying mechanisms. Only well-designed, randomized clinical trials addressing the limitations of the SYMPLICITY studies will be able to demonstrate whether renal denervation is an efficacious treatment modality in resistant hypertension and in which patients. For now, renal denervation remains an experimental procedure and should only be offered to truly resistant hypertensive patients in a research context after careful selection.

Drug development strategies for the treatment of obesity: how to ensure efficacy, safety, and sustainable weight loss

PubMed Central

Barja-Fernandez, S; Leis, R; Casanueva, FF; Seoane, LM

2014-01-01

The prevalence of obesity has increased worldwide, and approximately 25%–35% of the adult population is obese in some countries. The excess of body fat is associated with adverse health consequences. Considering the limited efficacy of diet and exercise in the current obese population and the use of bariatric surgery only for morbid obesity, it appears that drug therapy is the only available method to address the problem on a large scale. Currently, pharmacological obesity treatment options are limited. However, new antiobesity drugs acting through central nervous system pathways or the peripheral adiposity signals and gastrointestinal tract are under clinical development. One of the most promising approaches is the use of peptides that influence the peripheral satiety signals and brain–gut axis such as GLP-1 analogs. However, considering that any antiobesity drug may affect one or several of the systems that control food intake and energy expenditure, it is unlikely that a single pharmacological agent will be effective as a striking obesity treatment. Thus, future strategies to treat obesity will need to be directed at sustainable weight loss to ensure maximal safety. This strategy will probably require the coadministration of medications that act through different mechanisms. PMID:25489237

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

PubMed

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A Review of Complementary and Alternative Treatments for Autism Spectrum Disorders

PubMed Central

Lofthouse, Nicholas; Hendren, Robert; Hurt, Elizabeth; Arnold, L. Eugene; Butter, Eric

2012-01-01

Given the severe and chronic problems associated with Autism Spectrum Disorders (ASD) and the limitations of available treatments, there exists a large public health need for additional interventions. As more parents are inquiring about complementary and alternative treatments (CATs), both parents and practitioners require up-to-date information about them and whether and how to integrate them into treatment. After presenting data on CAT usage patterns for ASD, we review 13 ingestible (i.e., orally administered) and 6 noningestible (i.e., externally administered) CATs for ASD. For each CAT we briefly describe its definition; rationale for use; current research support, limitations, and future directions; safety issues; and whether we currently recommend, not recommend, or find it acceptable for the treatment of ASD. We conclude this paper with recommendations for future research and ten clinical recommendations for practitioners. PMID:23243505

Portable recording in the assessment of obstructive sleep apnea. ASDA standards of practice.

PubMed

Ferber, R; Millman, R; Coppola, M; Fleetham, J; Murray, C F; Iber, C; McCall, V; Nino-Murcia, G; Pressman, M; Sanders, M

1994-06-01

The objective assessment of patients with a presumptive diagnosis of obstructive sleep apnea (OSA) has primarily used attended polysomnographic study. Recent technologic advances and issues of availability, convenience and cost have led to a rapid increase in the use of portable recording devices. However, limited scientific information has been published regarding the evaluation of the efficacy, accuracy, validity, utility, cost effectiveness and limitations of this portable equipment. Attaining a clear assessment of the role of portable devices is complicated by the multiplicity of recording systems and the variability of clinical settings in which they have been analyzed. This paper reviews the current knowledge base regarding portable recording in the assessment of OSA, including technical considerations, validation studies, potential advantages and disadvantages, issues of safety, current clinical usage and areas most in need of further study.

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

Metzler, D.; Gibb, J.P.; Glover, W.A.

Compliance with the mandate of the Uranium Mill Tailings Radiation Control Act (UMTRCA) at Uranium Mill Tailings Remedial Action (UMTRA) Project sites requires implementation of a groundwater remedial action plan that meets the requirements of Subpart B of the US Environmental Protection Agency`s proposed groundwater protection standards (40 CFR 192). The UMTRA Groundwater Project will ensure that unacceptable current risk or potential risk to the public health, safety and the environment resulting from the groundwater contamination attributable to the UMTRA sites, is mitigated in a timely and cost-efficient manner. For each UMTRA processing site and vicinity property where contamination exists,more » a groundwater remedial action plan must be developed that identifies hazardous constituents and establishes acceptable concentration limits for the hazardous constituents as either (a) alternate concentration limits (ACL), (b) maximum concentration limits (MCLs), (c) supplemental standards, or (d) background groundwater quality levels. Project optimization is a strategy that will aggressively work within the current regulatory framework using all available options to meet regulatory requirements. This strategy is outlined within.« less

Wi-Fi and health: review of current status of research.

PubMed

Foster, Kenneth R; Moulder, John E

2013-12-01

This review summarizes the current state of research on possible health effects of Wi-Fi (a commercial name for IEEE 802.11-compliant wireless networking). In response to public concerns about health effects of Wi-Fi and wireless networks and calls by government agencies for research on possible health and safety issues with the technology, a considerable amount of technology-specific research has been completed. A series of high quality engineering studies have provided a good, but not complete, understanding of the levels of radiofrequency (RF) exposure to individuals from Wi-Fi. The limited number of technology-specific bioeffects studies done to date are very mixed in terms of quality and outcome. Unequivocally, the RF exposures from Wi-Fi and wireless networks are far below U.S. and international exposure limits for RF energy. While several studies report biological effects due to Wi-Fi-type exposures, technical limitations prevent drawing conclusions from them about possible health risks of the technology. The review concludes with suggestions for future research on the topic.

Resident Perceptions of the Impact of Work Hour Limitations

PubMed Central

Beck, David C.; Stewart, Anita L.; Garbutt, Jane M.

2007-01-01

BACKGROUND Mandatory work hour limitations for residents began in July 2003. There has been little evaluation of the impact of the new limitations on Internal Medicine residency training. OBJECTIVE To assess Internal Medicine residents’ perceptions of the impact of work hour limitations on clinical experiences, patient care, resident education, and well-being, and their compliance with the limitations. DESIGN AND PARTICIPANTS Cross-sectional survey administered to Internal Medicine residents at 1 large U.S. teaching hospital. MEASUREMENTS Resident perceptions using 5-point Likert scales, and self-reported compliance. Exploratory factor analysis was used to identify underlying domains and develop scales. RESULTS The survey response rate was 85%. Five domains were identified by factor analysis: 1) clinical experience, 2) patient care and safety, 3) communication, 4) satisfaction with training, and 5) work–rest balance. Residents perceived work hour limitations to have a negative impact on clinical experience (mean scale score 1.84, 1 = negative, 5 = positive), patient care and safety (2.64), and communication domains (1.98). Effects on satisfaction (3.12) and work–rest balance domains (2.95) were more positive. Senior residents perceived more negative effects of work hour limitations than interns. Compliance was difficult; 94% interns and 70% residents reported violating work hour limits. Patient care and teaching duties were the main reasons for work hour violations. CONCLUSIONS This study suggests that the current work hour limitations may be having unintended negative consequences on residency training. Ongoing monitoring to evaluate the impact of program changes as a result of work hour regulation is crucial to improving residency training. PMID:17468888

The role of OSHA violations in serious workplace accidents.

PubMed

Mendeloff, J

1984-05-01

California accident investigations for 1976 show that violations of the Occupational Safety and Health Administration's safety standards were a contributing factor in 13% to 19% of the 645 deaths reported to the workers' compensation program during that year. However, a panel of safety engineers judged that only about 50% of these violations could have been detected if an inspector had visited the day before the accident. These findings indicate that the potential gains from stronger enforcement of current standards are limited but not insignificant. The likelihood that a violation contributed to a serious accident varied considerably among accident types, industries, and size classes of plants. These findings can be used to increase the efficiency and effectiveness of the OSHA program by means of better targeting of inspections and accident investigations, more intelligent assessment of which violations should be penalized most heavily, and the provision of information to employers and workers about which violations are most consequential.

Developing safety performance functions incorporating reliability-based risk measures.

PubMed

Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

2011-11-01

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

Updates on the role of adrenal steroidogenesis inhibitors in Cushing's syndrome: a focus on novel therapies.

PubMed

Fleseriu, Maria; Castinetti, Frederic

2016-12-01

Endogenous Cushing's syndrome (CS) is a rare disease that results from exposure to high levels of cortisol; Cushing's disease (CD) is the most frequent form of CS. Patients with CS suffer from a variety of comorbidities that increase the risk of mortality. Surgical resection of the disease-causing lesion is generally the first-line treatment of CS. However, some patients may not be eligible for surgery due to comorbidities, and approximately 25 % of patients, especially those with CD, have recurrent disease. For these patients, adrenal steroidogenesis inhibitors may control cortisol elevation and subsequent symptomatology. CS is rare overall, and clinical studies of adrenal steroidogenesis inhibitors are often small and, in many cases, data are limited regarding the efficacy and safety of these treatments. Our aim was to better characterize the profiles of efficacy and safety of currently available adrenal steroidogenesis inhibitors, including drugs currently in development. We performed a systematic review of the literature regarding adrenal steroidogenesis inhibitors, focusing on novel drugs. Currently available adrenal steroidogenesis inhibitors, including ketoconazole, metyrapone, etomidate, and mitotane, have variable efficacy and significant side effects, and none are approved by the US Food and Drug Administration for CS. Therefore, there is a clear need for novel, prospectively studied agents that have greater efficacy and a low rate of adverse side effects. Efficacy and safety data of current and emerging adrenal steroidogenesis inhibitors, including osilodrostat (LCI699) and levoketoconazole (COR-003), show promising results that will have to be confirmed in larger-scale phase 3 studies (currently ongoing). The management of CS, and particularly CD, remains challenging. Adrenal steroidogenesis inhibitors can be of major interest to control the hypercortisolism at any time point, either before or after surgery, as discussed in this review.

Feedback-Assisted Extension of the Tokamak Operating Space to Low Safety Factor

NASA Astrophysics Data System (ADS)

Hanson, J. M.

2013-10-01

Recent DIII-D experiments have demonstrated stable operation at very low edge safety factor, q95 <~ 2 through the use of magnetic feedback to control the n = 1 resistive wall mode (RWM) instability. The performance of tokamak fusion devices may benefit from increased plasma current, and thus, decreased q. However, disruptive stability limits are commonly encountered in experiments at qedge ~ 2 (limited plasmas) and q95 ~ 2 (diverted plasmas), limiting exploration of low q regimes. In the recent DIII-D experiments, the impact and control of key disruptive instabilities was studied. Locked n = 1 modes with exponential growth times on the order of the wall eddy current decay timescale τw preceded disruptions at q95 = 2 . The instabilities have a poloidal structure that is consistent with VALEN simulations of the RWM mode structure at q95 = 2 . Applying proportional gain magnetic feedback control of the n = 1 mode resulted in stabilized operation with q95 reaching 1.9, and an extension of the discharge lifetime for > 100τw . Loss of feedback control was accompanied by power supply saturation, followed by a rapidly growing n = 1 mode and disruption. Comparisons of the feedback dynamics with VALEN simulations will be presented. The DIII-D results complement and will be discussed alongside recent RFX-MOD demonstrations of RWM control using magnetic feedback in limited tokamak discharges with qedge < 2. These results call attention to the utility of magnetic feedback in significantly extending the tokamak operational space and potentially opening a new route to economical fusion power production. Supported by the US Department of Energy under DE-FG02-04ER54761 and DE-FC02-04ER54698.

Preventing construction worker injury incidents through the management of personal stress and organizational stressors.

PubMed

Leung, Mei-yung; Chan, Isabelle Yee Shan; Yu, Jingyu

2012-09-01

Construction workers (CWs) are positioned at the lowest level of an organization and thus have limited control over their work. For this reason, they are often deprived of their due rewards and training or sometimes are even compelled to focus on production at the expense of their own safety. These organizational stressors not only cause the CWs stress but also impair their safety behaviors. The impairment of safety behaviors is the major cause of CW injury incidents. Hence, to prevent injury incidents and enhance safety behaviors of CWs, the current study aimed to identify the impact of various organizational stressors and stress on CW safety behaviors and injury incidents. To achieve this aim, we surveyed 395 CWs. Using factor analysis, we identified five organizational stressors (unfair reward and treatment, inappropriate safety equipment, provision of training, lack of goal setting, and poor physical environment), two types of stress (emotional and physical), and safety behaviors. The results of correlation and regression analyses revealed the following: (1) injury incidents were minimized by safety behaviors but escalated by a lack of goal setting, (2) safety behaviors were maximized by moderate levels of emotional stress (i.e., an inverted U-shape relationship between these two variables) and increased in line with physical stress and inappropriate safety equipment, (3) emotional stress was positively predicted by the provision of training and inappropriate safety equipment, and (4) physical stress was predicted only by inappropriate safety equipment. Based on these results, we suggest various recommendations to construction stakeholders on how to prevent CW injury incidents. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

Hurt, Christopher J.; Freels, James D.; Hobbs, Randy W.

There has been a considerable effort over the previous few years to demonstrate and optimize the production of plutonium-238 ( 238Pu) at the High Flux Isotope Reactor (HFIR). This effort has involved resources from multiple divisions and facilities at the Oak Ridge National Laboratory (ORNL) to demonstrate the fabrication, irradiation, and chemical processing of targets containing neptunium-237 ( 237Np) dioxide (NpO 2)/aluminum (Al) cermet pellets. A critical preliminary step to irradiation at the HFIR is to demonstrate the safety of the target under irradiation via documented experiment safety analyses. The steady-state thermal safety analyses of the target are simulated inmore » a finite element model with the COMSOL Multiphysics code that determines, among other crucial parameters, the limiting maximum temperature in the target. Safety analysis efforts for this model discussed in the present report include: (1) initial modeling of single and reduced-length pellet capsules in order to generate an experimental knowledge base that incorporate initial non-linear contact heat transfer and fission gas equations, (2) modeling efforts for prototypical designs of partially loaded and fully loaded targets using limited available knowledge of fabrication and irradiation characteristics, and (3) the most recent and comprehensive modeling effort of a fully coupled thermo-mechanical approach over the entire fully loaded target domain incorporating burn-up dependent irradiation behavior and measured target and pellet properties, hereafter referred to as the production model. These models are used to conservatively determine several important steady-state parameters including target stresses and temperatures, the limiting condition of which is the maximum temperature with respect to the melting point. The single pellet model results provide a basis for the safety of the irradiations, followed by parametric analyses in the initial prototypical designs that were necessary due to the limiting fabrication and irradiation data available. The calculated parameters in the final production target model are the most accurate and comprehensive, while still conservative. Over 210 permutations in irradiation time and position were evaluated, and are supported by the most recent inputs and highest fidelity methodology. The results of these analyses show that the models presented in this report provide a robust and reliable basis for previous, current and future experiment safety analyses. In addition, they reveal an evolving knowledge of the steady-state behavior of the NpO 2/Al pellets under irradiation for a variety of target encapsulations and potential conditions.« less

Evaluation of features to support safety and quality in general practice clinical software

PubMed Central

2011-01-01

Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

Off-axis current drive and real-time control of current profile in JT-60U

NASA Astrophysics Data System (ADS)

Suzuki, T.; Ide, S.; Oikawa, T.; Fujita, T.; Ishikawa, M.; Seki, M.; Matsunaga, G.; Hatae, T.; Naito, O.; Hamamatsu, K.; Sueoka, M.; Hosoyama, H.; Nakazato, M.; JT-60 Team

2008-04-01

Aiming at optimization of current profile in high-β plasmas for higher confinement and stability, a real-time control system of the minimum of the safety factor (qmin) using the off-axis current drive has been developed. The off-axis current drive can raise the safety factor in the centre and help to avoid instability that limits the performance of the plasma. The system controls the injection power of lower-hybrid waves, and hence its off-axis driven current in order to control qmin. The real-time control of qmin is demonstrated in a high-β plasma, where qmin follows the temporally changing reference qmin,ref from 1.3 to 1.7. Applying the control to another high-β discharge (βN = 1.7, βp = 1.5) with m/n = 2/1 neo-classical tearing mode (NTM), qmin was raised above 2 and the NTM was suppressed. The stored energy increased by 16% with the NTM suppressed, since the resonant rational surface was eliminated. For the future use for current profile control, current density profile for off-axis neutral beam current drive (NBCD) is for the first time measured, using the motional Stark effect diagnostic. Spatially localized NBCD profile was clearly observed at the normalized minor radius ρ of about 0.6-0.8. The location was also confirmed by multi-chordal neutron emission profile measurement. The total amount of the measured beam driven current was consistent with the theoretical calculation using the ACCOME code. The CD location in the calculation was inward shifted than the measurement.

Low-cost bioanalysis on paper-based and its hybrid microfluidic platforms.

PubMed

Dou, Maowei; Sanjay, Sharma Timilsina; Benhabib, Merwan; Xu, Feng; Li, XiuJun

2015-12-01

Low-cost assays have broad applications ranging from human health diagnostics and food safety inspection to environmental analysis. Hence, low-cost assays are especially attractive for rural areas and developing countries, where financial resources are limited. Recently, paper-based microfluidic devices have emerged as a low-cost platform which greatly accelerates the point of care (POC) analysis in low-resource settings. This paper reviews recent advances of low-cost bioanalysis on paper-based microfluidic platforms, including fully paper-based and paper hybrid microfluidic platforms. In this review paper, we first summarized the fabrication techniques of fully paper-based microfluidic platforms, followed with their applications in human health diagnostics and food safety analysis. Then we highlighted paper hybrid microfluidic platforms and their applications, because hybrid platforms could draw benefits from multiple device substrates. Finally, we discussed the current limitations and perspective trends of paper-based microfluidic platforms for low-cost assays. Copyright © 2015 Elsevier B.V. All rights reserved.

Use of tocilizumab in systemic sclerosis: A brief literature review.

PubMed

Fernández-Codina, A; Fernández-Fernández, J; Fernández-Pantiga, A

2018-03-27

The available treatments for systemic sclerosis (SS) have limited effectiveness. Treatment with tocilizumab (TCZ), a biological drug that inhibits interleukin 6 (IL-6), has recently been proposed. In this study, we conducted a literature review to assess the safety and efficacy of TCZ in SS. We found 52 articles, 10 of which we selected after evaluating the articles. In a randomised clinical trial, TCZ showed a nonsignificant improvement in the degree of skin induration, while another observational study showed neutral results. In this same clinical trial, the functional respiratory parameters showed a certain degree of stabilization. The safety profile of TCZ is acceptable; however, the current evidence regarding treatment of SS with TCZ is highly limited, although the drug could have a beneficial effect in skin disorder. New clinical trials are needed to determine the usefulness of TCZ in SS. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme.

PubMed

Ourso, André

2012-01-01

Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.

Are metals emitted from electronic cigarettes a reason for health concern? A risk-assessment analysis of currently available literature.

PubMed

Farsalinos, Konstantinos E; Voudris, Vassilis; Poulas, Konstantinos

2015-05-15

Studies have found that metals are emitted to the electronic cigarette (EC) aerosol. However, the potential health impact of exposure to such metals has not been adequately defined. The purpose of this study was to perform a risk assessment analysis, evaluating the exposure of electronic cigarette (EC) users to metal emissions based on findings from the published literature. Two studies were found in the literature, measuring metals emitted to the aerosol from 13 EC products. We estimated that users take on average 600 EC puffs per day, but we evaluated the daily exposure from 1200 puffs. Estimates of exposure were compared with the chronic Permissible Daily Exposure (PDE) from inhalational medications defined by the U.S. Pharmacopeia (cadmium, chromium, copper, lead and nickel), the Minimal Risk Level (MRL) defined by the Agency for Toxic Substances and Disease Registry (manganese) and the Recommended Exposure Limit (REL) defined by the National Institute of Occupational Safety and Health (aluminum, barium, iron, tin, titanium, zinc and zirconium). The average daily exposure from 13 EC products was 2.6 to 387 times lower than the safety cut-off point of PDEs, 325 times lower than the safety limit of MRL and 665 to 77,514 times lower than the safety cut-off point of RELs. Only one of the 13 products was found to result in exposure 10% higher than PDE for one metal (cadmium) at the extreme daily use of 1200 puffs. Significant differences in emissions between products were observed. Based on currently available data, overall exposure to metals from EC use is not expected to be of significant health concern for smokers switching to EC use, but is an unnecessary source of exposure for never-smokers. Metal analysis should be expanded to more products and exposure can be further reduced through improvements in product quality and appropriate choice of materials.

Application of the Life Safety Code to a Historic Test Stand

NASA Technical Reports Server (NTRS)

Askins, Bruce; Lemke, Paul R.; Lewis, William L.; Covell, Carol C.

2011-01-01

NASA has conducted a study to assess alternatives to refurbishing existing launch vehicle modal test facilities as opposed to developing new test facilities to meet the demands of a very fiscally constrained test and evaluation environment. The results of this study showed that Marshall Space Flight Center (MSFC) Test Stand (TS) 4550 could be made compliant, within reasonable cost and schedule impacts, if safety processes and operational limitations were put in place to meet the safety codes and concerns of the Fire Marshall. Trades were performed with key selection criteria to ensure that appropriate levels of occupant safety are incorporated into test facility design modifications. In preparation for the ground vibration tests that were to be performed on the Ares I launch vehicle, the Ares Flight and Integrated Test Office (FITO) organization evaluated the available test facility options, which included the existing mothballed structural dynamic TS4550 used by Apollo and Shuttle, alternative ground vibration test facilities at other locations, and construction of a new dynamic test stand. After an exhaustive assessment of the alternatives, the results favored modifying the TS4550 because it was the lowest cost option and presented the least schedule risk to the NASA Constellation Program for Ares Integrated Vehicle Ground Vibration Test (IVGVT). As the renovation design plans and drawings were being developed for TS4550, a safety concern was discovered the original design for the construction of the test stand, originally built for the Apollo Program and renovated for the Shuttle Program, was completed before NASA s adoption of the currently imposed safety and building codes per National Fire Protection Association Life Safety Code [NFPA 101] and International Building Codes. The initial FITO assessment of the design changes, required to make TS4550 compliant with current safety and building standards, identified a significant cost increase and schedule impact. An effort was launched to thoroughly evaluate the applicable life safety requirements, examine the context in which they were derived, and determine a means by which the TS4550 modifications could be made within budget and on schedule, while still providing the occupants with appropriate levels of safety.

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

Roussel, G.

Leak-Before-Break (LBB) technology has not been applied in the first design of the seven Pressurized Water Reactors the Belgian utility is currently operating. The design basis of these plants required to consider the dynamic effects associated with the ruptures to be postulated in the high energy piping. The application of the LBB technology to the existing plants has been recently approved by the Belgian Safety Authorities but with a limitation to the primary coolant loop. LBB analysis has been initiated for the Doel 3 and Tihange 2 plants to allow the withdrawal of some of the reactor coolant pump snubbersmore » at both plants and not reinstall some of the restraints after steam generator replacement at Doel 3. LBB analysis was also found beneficial to demonstrate the acceptability of the primary components and piping to the new conditions resulting from power uprating and stretch-out operation. LBB analysis has been subsequently performed on the primary coolant loop of the Tihange I plant and is currently being performed for the Doel 4 plant. Application of the LBB to the primary coolant loop is based in Belgium on the U.S. Nuclear Regulatory Commission requirements. However the Belgian Safety Authorities required some additional analyses and put some restrictions on the benefits of the LBB analysis to maintain the global safety of the plant at a sufficient level. This paper develops the main steps of the safety evaluation performed by the Belgian Safety Authorities for accepting the application of the LBB technology to existing plants and summarizes the requirements asked for in addition to the U.S. Nuclear Regulatory Commission rules.« less

Safety of human papillomavirus vaccines: a review.

PubMed

Macartney, Kristine K; Chiu, Clayton; Georgousakis, Melina; Brotherton, Julia M L

2013-06-01

Vaccination to prevent human papillomavirus (HPV)-related infection leading to cancer, particularly cervical cancer, is a major public health breakthrough. There are currently two licensed HPV vaccines, both of which contain recombinant virus-like particles of HPV types 16 and 18 (which account for approximately 70 % of cervical cancer). One vaccine also protects against HPV types 6 and 11, which cause genital warts. The safety profile of both vaccines was assessed extensively in randomised controlled clinical trials conducted prior to licensure and has been further elucidated following licensure from surveillance and specific studies in large populations. This review aims to examine current evidence regarding the safety of HPV vaccines. In summary, both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions. Whilst this reassuring safety profile affirms the positive risk benefit of vaccination, as HPV vaccine use expands into more diverse populations, including males, ongoing safety assessment using well-conducted studies is appropriate.

Gas Generation Testing of Spherical Resorcinol-Formaldehyde (sRF) Resin

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

Colburn, Heather A.; Bryan, Samuel A.; Camaioni, Donald M.

This report describes gas generation testing of the spherical resorcinol-formaldehyde (sRF) resin that was conducted to support the technology maturation of the LAWPS facility. The current safety basis for the LAWPS facility is based primarily on two studies that had limited or inconclusive data sets. The two studies indicated a 40% increase in hydrogen generation rate of water (as predicted by the Hu model) with sRF resin over water alone. However, the previous studies did not test the range of conditions (process fluids and temperatures) that are expected in the LAWPS facility. Additionally, the previous studies did not obtain replicatemore » test results or comparable liquid-only control samples. All of the testing described in this report, conducted with water, 0.45M nitric acid, and waste simulants with and without sRF resin, returned hydrogen generation rates that are within the current safety basis for the facility of 1.4 times the Hu model output for water.« less

Flucelvax (Optaflu) for seasonal influenza.

PubMed

Manini, Ilaria; Domnich, Alexander; Amicizia, Daniela; Rossi, Stefania; Pozzi, Teresa; Gasparini, Roberto; Panatto, Donatella; Montomoli, Emanuele

2015-06-01

Conventional egg-based manufacturing technology for seasonal influenza vaccines has several drawbacks, including its inflexibility, reliance on egg supplies, risk of contamination, absence of growth of some isolates and egg-adaptive viral mutations that threaten vaccine matching. To overcome these limitations, cell culture-derived vaccines have been designed, including the trivalent inactivated vaccine Flucelvax®/Optaflu® (brand names in the US/EU, respectively). Flucelvax®/Optaflu® has gained wide regulatory approval and is currently implemented in several countries. Non-clinical studies have assuaged hypothetical concerns regarding oncogenicity and use in persons allergic to dogs. Ample clinical data suggest the non-inferiority of Flucelvax®/Optaflu® to egg-based vaccines in terms of immunogenicity, safety and tolerability, and it has fulfilled American and European mandatory requirements. Although Flucelvax®/Optaflu® is currently indicated only for adults and the elderly, pediatric data indicate its good immunogenicity and safety. This paper provides an update on the clinical development of Flucelvax®/Optaflu®, its seasonal trials and available post-marketing surveillance data.

NASA Occupant Protection Standards Development

NASA Technical Reports Server (NTRS)

Somers, Jeffrey; Gernhardt, Michael; Lawrence, Charles

2012-01-01

Historically, spacecraft landing systems have been tested with human volunteers, because analytical methods for estimating injury risk were insufficient. These tests were conducted with flight-like suits and seats to verify the safety of the landing systems. Currently, NASA uses the Brinkley Dynamic Response Index to estimate injury risk, although applying it to the NASA environment has drawbacks: (1) Does not indicate severity or anatomical location of injury (2) Unclear if model applies to NASA applications. Because of these limitations, a new validated, analytical approach was desired. Leveraging off of the current state of the art in automotive safety and racing, a new approach was developed. The approach has several aspects: (1) Define the acceptable level of injury risk by injury severity (2) Determine the appropriate human surrogate for testing and modeling (3) Mine existing human injury data to determine appropriate Injury Assessment Reference Values (IARV). (4) Rigorously Validate the IARVs with sub-injurious human testing (5) Use validated IARVs to update standards and vehicle requirement

Sodium Sulfur Technology Program Nastec

NASA Technical Reports Server (NTRS)

Highley, Bob; Somerville, W. Andrew

1992-01-01

The NaSTEC program focuses on developing currently available sodium sulfur cells for use in space applications and investigating the operational parameters of the cells. The specific goals of the program are to determine the operational parameters and verify safety limits of Na/S technology battery cells; test long term zero-g operation; and create a life test database. The program approach and ground and flight test objectives are described in textual and graphic form.

Unfavourable outcomes of liposuction and their management

PubMed Central

Dixit, Varun V.; Wagh, Milind S.

2013-01-01

Liposuction is one of the most popular cosmetic surgery procedures currently performed by plastic surgeons around the world. It must be clear at the outset that liposuction is not primarily a modality for weight loss, it is meant to be a body contouring procedure and therefore the inherent limitations and safety issues related to this must always be respected if complications and unfavourable results are to be avoided as far as possible. PMID:24501474

The Federal Aviation Administration Plan for Research, Engineering and Development. Volume 2. Project Descriptions

DTIC Science & Technology

1989-01-01

managerial areas , including: management and control of the operational requirements of the NAS F& E Plan; preparation, management, and control of the annual... areas (capacity, safety, security, and efficiency), highlights of key programs, and a discussion of the relationships of the RE&D Plan to the NAS F& E ...release of SUA , such as restricted airspace and military operations areas , are currently limited by several factors, including manual interagency

Ceftazidime-avibactam: novel antimicrobial combination for the treatment of complicated urinary tract infections.

PubMed

Alidjanov, Jakhongir F; Fritzenwanker, Moritz; Hoffman, Ivan; Wagenlehner, Florian M

2017-06-01

Ceftazidime-avibactam is a combination of a third-generation cephalosporin and a novel non-beta-lactam beta-lactamase inhibitor. This combination was recently recommended for the treatment of complicated urinary tract infections, including acute pyelonephritis, in adults with limited or no alternative treatment options. The current review is aimed to determine activity, efficacy and safety of ceftazidime-avibactam in the treatment of patients with complicated urinary tract infections.

Mathematical modeling of processes of heat and mass transfer in channels of water evaporating coolers

NASA Astrophysics Data System (ADS)

Gulevsky, V. A.; Ryazantsev, A. A.; Nikulichev, A. A.; Menzhulova, A. S.

2018-05-01

The variety of cooling systems is dictated by a wide range of demands placed on them. This is the price, operating costs, quality of work, ecological safety, etc. These requirements in a positive sense are put into correspondence by water evaporating plate coolers. Currently, their widespread use is limited by a lack of theoretical base. To solve this problem, the best method is mathematical modeling.

Prevalence of Neck and Back Pain amongst Aircrew at the Extremes of Anthropometric Measurements

DTIC Science & Technology

2012-09-06

of these safety systems, with potential to exceed the designed upper load limits. Current ergonomics assessments use the 1988 National Health and...position in UH-60 Long goggle flights NVG weight- neck sore. Long hours in poorly designed seats ; helmet/ NVGs and hours of manipulating control...landing Long hours in poorly designed seats ; helmet/ NVGs and hours of manipulating control display units in glass cockpits Repetitive use Poor ramp

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

DOE PAGES

Hanson, Jeremy M.; Bialek, James M.; Baruzzo, M.; ...

2014-07-07

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 95 = 2 (divertor plasmas). However, passively stable operation can be attained for q( a) and q 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 themore » 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 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. As a result, the experiments contribute to validating MHD stability theory and demonstrate that a key tokamak stability limit can be overcome with feedback.« less

Analysis of governmental Web sites on food safety issues: a global perspective.

PubMed

Namkung, Young; Almanza, Barbara A

2006-10-01

Despite a growing concern over food safety issues, as well as a growing dependence on the Internet as a source of information, little research has been done to examine the presence and relevance of food safety-related information on Web sites. The study reported here conducted Web site analysis in order to examine the current operational status of governmental Web sites on food safety issues. The study also evaluated Web site usability, especially information dimensionalities such as utility, currency, and relevance of content, from the perspective of the English-speaking consumer. Results showed that out of 192 World Health Organization members, 111 countries operated governmental Web sites that provide information about food safety issues. Among 171 searchable Web sites from the 111 countries, 123 Web sites (71.9 percent) were accessible, and 81 of those 123 (65.9 percent) were available in English. The majority of Web sites offered search engine tools and related links for more information, but their availability and utility was limited. In terms of content, 69.9 percent of Web sites offered information on foodborne-disease outbreaks, compared with 31.5 percent that had travel- and health-related information.

Visualising differences in professionals' perspectives on quality and safety.

PubMed

Travaglia, Joanne Francis; Nugus, Peter Ivan; Greenfield, David; Westbrook, Johanna Irene; Braithwaite, Jeffrey

2012-09-01

The safety-and-quality movement is now two decades old. Errors persist despite best efforts, indicating that there are entrenched overt and perhaps less explicit barriers limiting the success of improvement efforts. OBJECTIVES AND HYPOTHESES: To examine the perspectives of five groups of healthcare workers (administrative staff, nurses, medical practitioners, allied health and managers) and to compare and contrast their descriptions of quality-and-safety activities within their organisation. Differences in perspectives can be an indicator of divergence in the conceptualisation of, and impetus for, quality-improvement strategies which are intended to engage healthcare professions and staff. Study data were collected in a defined geographical healthcare jurisdiction in Australia, via individual and group interviews held across four service streams (aged care and rehabilitation; mental health; community health; and cancer services). Data were collected in 2008 and analysed, using data-mining software, in 2009. Clear differences in the perspectives of professional groups were evident, suggesting variations in the perceptions of, and priorities for, quality and safety. The visual representation of quality and safety perspectives provides insights into the conceptual maps currently utilised by healthcare workers. Understanding the similarity and differences in these maps may enable more effective targeting of interprofessional improvement strategies.

Unique agricultural safety and health issues of migrant and immigrant children.

PubMed

McLaurin, Jennie A; Liebman, Amy K

2012-01-01

Immigrant and migrant youth who live and work in agricultural settings experience unique agricultural safety and health issues. Mobility, poverty, cultural differences, immigration status, language, education, housing, food security, regulatory standards and enforcement, and access to childcare and health care influence exposure risk and the well-being of this population. Approximately 10% of the migrant agricultural labor force is composed of unaccompanied minors, whose safety and health is further compounded by lack of social supports and additional stresses associated with economic independence. This paper examines the current demographic and health data, regulatory protections, and programs and practices addressing safety and health in this sector of youth in agriculture. Gaps in knowledge and practice are identified, with emphasis on data collection and regulatory limitations. Best practices in programs addressing the special needs of this population are highlighted. Recommendations identify seven priority areas for impact to promote transformative change in the agricultural health and safety concerns of unaccompanied minors and children of immigrant, migrant and seasonal farmworkers. This framework may be used to examine similar needs in other identified subpopulations of children as they merit attention, whether now or in the future.

The enhanced knowledge translation and exchange framework for road safety: a brief report on its development and potential impacts.

PubMed

Hinchcliff, Reece; Senserrick, Teresa; Travaglia, Joanne; Greenfield, David; Ivers, Rebecca

2017-04-01

Knowledge translation and exchange (KTE) can enable evidence-informed road safety policy and practice by reducing the gap between what is known to be effective and what actually occurs. A quality improvement project, undertaken within a government policy frame, was implemented in 2015 to produce an enhanced KTE framework for road safety (the framework). Information was collected from 35 road safety stakeholders in the UK, the Netherlands, Norway and Sweden. Thirteen KTE facilitators were identified that covered research funding and production, the expertise of knowledge users and dissemination practices. The framework was subsequently developed, which separated facilitators seen as essential for a KTE system, from others perceived as aspirational due to their lesser influence and the considerable time and resources required for their implementation. The framework provides a heuristic device to enable policy agencies to holistically assess and improve current KTE systems for road safety, to encourage evidence-informed policy and practice. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Factors impacting perceived safety among staff working on mental health wards

PubMed Central

Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

2017-01-01

Background Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. Aims This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. Method A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Results Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. Conclusions The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license. PMID:28904814

Current controversies in the USA regarding vaccine safety.

PubMed

Chatterjee, Archana; O'Keefe, Catherine

2010-05-01

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

[Comprehensive drug safety plan in a health department].

PubMed

Bujaldón-Querejeta, N; Aznar-Saliente, T; Esplá-González, S; Ruíz-Darbonnéns, S; Pons-Martínez, L; Talens-Bolos, A; Martínez-Ramírez, M; Camacho-Romera, D; Aranaz-Andrés, J M

2014-01-01

To develop and implement a comprehensive drug safety plan in a hospital for the years 2009-2011. Applying the Strengths Weaknesses/Limitations Opportunities Threats (SWOT) methodology, the baseline situation was analyzed and a broad strategy or plan was subsequently developed, defining the scope, responsibilities, objectives and strategic actions and indicators in order to measure the achievement of the results. A comprehensive drug safety plan with the main objective of identifying and reducing the medication-related problems in patients treated in the Hospital de San Juan in Alicante has been developed. The plan contains five strategic objectives, twenty strategic actions and the indicators to assess its outcomes. It also contains a timetable for its establishment and evaluation. Developing a comprehensive strategic plan allows the current situation relating to drug safety to be determined. The results obtained after its introduction will define its applicability. Due to the lack of publications of similar plans and results, the evaluation of this plan will be useful whether it is favorable or not. As a side benefit of the development, the multidisciplinary team continues to work on improving patient safety in the care process, and the safety culture continues to grow among the professionals. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

Intelligent vehicle safety control strategy in various driving situations

NASA Astrophysics Data System (ADS)

Moon, Seungwuk; Cho, Wanki; Yi, Kyongsu

2010-12-01

This paper describes a safety control strategy for intelligent vehicles with the objective of optimally coordinating the throttle, brake, and active front steering actuator inputs to obtain both lateral stability and longitudinal safety. The control system consists of a supervisor, control algorithms, and a coordinator. From the measurement and estimation signals, the supervisor determines the active control modes among normal driving, longitudinal safety, lateral stability, and integrated safety control mode. The control algorithms consist of longitudinal and lateral stability controllers. The longitudinal controller is designed to improve the driver's comfort during normal, safe-driving situations, and to avoid rear-end collision in vehicle-following situations. The lateral stability controller is designed to obtain the required manoeuvrability and to limit the vehicle body's side-slip angle. To obtain both longitudinal safety and lateral stability control in various driving situations, the coordinator optimally determines the throttle, brake, and active front steering inputs based on the current status of the subject vehicle. Closed-loop simulations with the driver-vehicle-controller system are conducted to investigate the performance of the proposed control strategy. From these simulation results, it is shown that the proposed control algorithm assists the driver in combined severe braking/large steering manoeuvring so that the driver can maintain good manoeuvrability and prevent the vehicle from crashing in vehicle-following situations.

Environmental exposure scenarios: development, challenges and possible solutions.

PubMed

Ahrens, Andreas; Traas, Theo P

2007-12-01

Under the new REACH system, companies importing, producing and marketing chemical substances will be obliged to register the single substances and to carry out a safety assessment for all identified uses during the life cycle of the substance. This duty will apply to about 10,000 existing substances in the EU market exceeding an annual production or import volume of 10 t per company. If the substance is already known to be dangerous or turns out to be dangerous(1) during the hazard assessment, the registrant is obliged to carry out an exposure assessment and a risk characterisation for all identified uses. The goal of the safety assessment is to define the conditions of use that allow for adequate control of risk with regard to health and safety at the work place, consumer safety and protection of the environment. Once the registrant has established and documented these conditions in the Chemicals Safety Report (CSR), that information is to be communicated down the supply chain by means of the Extended Safety Data Sheet (eSDS). The ultimate aim of the new legislation is to establish duties and mechanisms that systematically prevent or limit exposure to dangerous industrial chemicals. The current paper explains this concept with regard to environmental exposure and highlights the challenges and possible solutions.

A composite system approach to aircraft cabin fire safety

NASA Technical Reports Server (NTRS)

Kourtides, D. A.; Parker, J. A.; Gilwee, W. J., Jr.; Lerner, N. R.; Hilado, C. J.; Labossiere, L. A.; Hsu, M.-T.

1976-01-01

The thermochemical and flammability characteristics of two polymeric composites currently in use and seven others being considered for use as aircraft interior panels are described. The properties studied included: (1) limiting oxygen index of the composite constituents; (2) fire containment capability of the composite; (3) smoke evolution from the composite; (4) thermogravimetric analysis; (5) composition of the volatile products of thermal degradation; and (6) relative toxicity of the volatile products of pyrolysis. The performance of high-temperature laminating resins such as bismaleimides is compared with the performance of phenolics and epoxies. The relationship of increased fire safety with the use of polymers with high anaerobic char yield is shown. Processing parameters of one of the bismaleimide composites is detailed.

A composite system approach to aircraft cabin fire safety

NASA Technical Reports Server (NTRS)

Kourtides, D. A.; Parker, J. A.; Gilwee, W. J., Jr.; Lerner, N. R.; Hilado, C. J.; Labossiere, L. A.; Hsu, M. T. S.

1976-01-01

The thermochemical and flammability characteristics of two polymeric composites currently in use and seven others being considered for use as aircraft interior panels are described. The properties studied included: (1) limiting oxygen index of the composite constituents; (2) fire containment capability of the composite; (3) smoke evolution from the composite; (4) thermogravimetric analysis; (5) composition of the volatile products of thermal degradation; and (6) relative toxicity of the volatile products of pyrolysis. The performance of high temperature laminating resins such as bismaleimides is compared with the performance of phenolics and epoxies. The relationship of increased fire safety with the use of polymers with high anaerobic char yield is shown. Processing parameters of one of the baremaleimide composites are detailed.

Materials research for aircraft fire safety

NASA Technical Reports Server (NTRS)

Kourtides, D. A.; Parker, J. A.; Bricker, R. W.

1976-01-01

The thermochemical and flammability characteristics of two polymeric composites currently in use and seven others being considered for use as aircraft interior panels are described. The properties studied included: (1) limiting oxygen index of the composite constituents; (2) fire containment capability of the composite; (3) smoke evolution from the composite; (4) thermogravimetric analysis; (5) composition of the volatile products of thermal degradation; and (6) relative toxicity of the volatile products of pyrolysis. The performance of high-temperature laminating resins such as bismaleimides is compared with the performance of phenolics and epoxies. The relationship of increased fire safety with the use of polymers with high anaerobic char yield is shown. Processing parameters of the state-of-the-art and the advanced bismaleimide composites are detailed.

Benefits, safety, and prescription of exercise in persons with multiple sclerosis.

PubMed

Motl, Robert W

2014-12-01

Exercise represents a behavioral approach for the restoration of function and management of symptoms among persons with multiple sclerosis (MS). The current paper provides a review on the topic of exercise in MS and is separated into four sections. The first section defines exercise and related constructs. The second section summarizes evidence for the benefits of exercise in MS based on literature reviews and meta-analyses. The third section focuses on the safety of exercise in MS based on the reporting of relapses and other adverse events, and the last section describes guidelines for exercise. The paper concludes with a discussion of major limitations with the existing body of research and highlights some of the pressing areas for future research on exercise in MS.

Dose limits to the lens of the eye: International Basic Safety Standards and related guidance.

PubMed

Boal, T J; Pinak, M

2015-06-01

The International Atomic Energy Agency (IAEA) safety requirements: 'General Safety Requirements Part 3--Radiation protection and safety of radiation sources: International Basic Safety Standards' (BSS) was approved by the IAEA Board of Governors at its meeting in September 2011, and was issued as General Safety Requirements Part 3 in July 2014. The equivalent dose limit for the lens of the eye for occupational exposure in planned exposure situations was reduced from 150 mSv year(-1) to 20 mSv year(-1), averaged over defined periods of 5 years, with no annual dose in a single year exceeding 50 mSv. This reduction in the dose limit for the lens of the eye followed the recommendation of the International Commission on Radiological Protection in its statement on tissue reactions of 21 April 2011. IAEA has developed guidance on the implications of the new dose limit for the lens of the eye. This paper summarises the process that led to the inclusion of the new dose limit for the lens of the eye in the BSS, and the implications of the new dose limit. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Interleukin-21: updated review of Phase I and II clinical trials in metastatic renal cell carcinoma, metastatic melanoma and relapsed/refractory indolent non-Hodgkin's lymphoma.

PubMed

Hashmi, Mehmood H; Van Veldhuizen, Peter J

2010-05-01

In advanced renal cell cancer and malignant melanoma, the current FDA approved immune modulators, such as IL-2, are the only agents which provide a durable complete remission. These responses, however, occur in < 10% of treated patients and their applicability is limited to selected patients because of their toxicity. The identification of new immunotherapeutic agents with an improved response rate and toxicity profile would represent a significant advancement in the treatment of these malignancies. This is a comprehensive review of IL-21 including its pharmacology and current developmental status. A literature review was performed using all PubMed listed publications involving IL-21, including original research articles, reviews and abstracts. It also includes a review of current ongoing trials and information from the official product website. Recombinant IL-21 (rIL-21) is a new immune modulator currently undergoing Phase I and II testing. It is a cytokine with a four helix structure that has structural and sequence homology to IL-2 and -15, but also possesses many unique biological properties. In this review, we evaluate the development, pharmacologic properties, safety profile and current clinical efficacy of rIL-21. rIL-21 has an acceptable safety profile and encouraging single agent activity in early phase renal cell carcinoma and melanoma clinical trials.

Design of disturbances control model at automotive company

NASA Astrophysics Data System (ADS)

Marie, I. A.; Sari, D. K.; Astuti, P.; Teorema, M.

2017-12-01

The discussion was conducted at PT. XYZ which produces automotive components and motorcycle products. The company produced X123 type cylinder head which is a motor vehicle forming component. The disturbances in the production system has affected the company performance in achieving the target of Key Performance Indicator (KPI). Currently, the determination of the percentage of safety stock of cylinder head products is not in accordance to the control limits set by the company (60% - 80%), and tends to exceed the control limits that cause increasing the inventory wastage in the company. This study aims to identify the production system disturbances that occurs in the production process of manufacturing components of X123 type cylinder head products and design the control model of disturbance to obtain control action and determine the safety stock policy in accordance with the needs of the company. The design stage has been done based on the Disturbance Control Model which already existing and customized with the company need in controlling the production system disturbances at the company. The design of the disturbances control model consists of sub-model of the risk level of the disturbance, sub-model of action status, sub-model action control of the disturbance, and sub-model of determining the safety stock. The model can assist the automotive company in taking the decision to perform the disturbances control action in production system cylinder head while controlling the percentage of the safety stock.

Health economics and outcomes methods in risk-based decision-making for blood safety.

PubMed

Custer, Brian; Janssen, Mart P

2015-08-01

Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making. © 2015 AABB.

Case cluster of pneumoconiosis at a coal slag processing facility.

PubMed

Fagan, Kathleen M; Cropsey, Erin B; Armstrong, Jenna L

2015-05-01

During an inspection by the Occupational Safety and Health Administration (OSHA) of a small coal slag processing plant with 12 current workers, four cases of pneumoconiosis were identified among former workers. The OSHA investigation consisted of industrial hygiene sampling, a review of medical records, and case interviews. Some personal sampling measurements exceeded the OSHA Permissible Exposure Limit (PEL) for total dust exposures of 15 mg/m(3), and the measured respirable silica exposure of 0.043 mg/m(3), although below OSHA's current PEL for respirable dust containing silica, was above the American Conference of Governmental Industrial Hygienists' Threshold Limit Value (TLV). Chest x-rays for all four workers identified small opacities consistent with pneumoconiosis. This is the first known report of lung disease in workers processing coal slag and raises concerns for workers exposed to coal slag dust. © 2015 Wiley Periodicals, Inc.

Noninvasive Brain Stimulation in Pediatric ADHD: A Review

PubMed Central

Rubio, Belen; Boes, Aaron D.; Laganiere, Simon; Rotenberg, Alexander; Jeurissen, Danique; Pascual-Leone, Alvaro

2015-01-01

Attention-deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in the pediatric population. The clinical management of ADHD is currently limited by a lack of reliable diagnostic biomarkers and inadequate therapy for a minority of patients that do not respond to standard pharmacotherapy. There is optimism that noninvasive brain stimulation may help to address these limitations. Transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are two methods of noninvasive brain stimulation that modulate cortical excitability and brain network activity. TMS can be used diagnostically to probe cortical neurophysiology, while daily use of repetitive TMS or tDCS can induce long-lasting and potentially therapeutic changes in targeted networks. In this review we highlight research showing the potential diagnostic and therapeutic applications of TMS and tDCS in pediatric ADHD. We also discuss the safety and ethics of using these tools in the pediatric population. PMID:26661481

Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature.

PubMed

Alessandro, Pontis; Luigi, Nappi; Felice, Sorrentino; Maria, Paoletti Anna; Benedetto, Melis Gian; Stefano, Angioni

2017-04-01

Limitated studies have reported the efficacy of GnRH antagonist on endometriosis symptoms. The aim of our study was to review all available trials to investigate the medical treatment of endometriosis with only GnRH antagonists, with special attention to pharmacodynamic activity, safety, and efficacy. Pub Med and Sciencedirect database were searched using terms of "endometriosis treatment", "GnRH antagonist", and "Elagolix". The search was limited to clinical studies published in English. Title and abstract were screened to identify relevant articles. Five studies covering use of GnRH antagonist were found. A phase 1 study evaluated the safety, pharmacokinetics, and inhibitory effects on gonadotropins and estradiol of single dose and 7 day elagolix administration to healthy premenopausal women; two phase II studies evaluated efficacy in patient with endometriosis. Moreover, there are two Phase III clinical trials just completed. GnRH antagonists may have the advantage of oral administration and lower incidence of adverse events. Currently, only Phase II studies have been published demonstrating promising results in terms of efficacy, safety, and tolerability. From the results of the phase III studies, elagolix may become a valuable addition to the armamentarium of pharmacological agents to treat endometriosis-related pain.

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

An update of safety of clinically used atypical antipsychotics.

PubMed

Orsolini, L; Tomasetti, C; Valchera, A; Vecchiotti, R; Matarazzo, I; Vellante, F; Iasevoli, F; Buonaguro, E F; Fornaro, M; Fiengo, A L C; Martinotti, G; Mazza, M; Perna, G; Carano, A; De Bartolomeis, A; Di Giannantonio, M; De Berardis, D

2016-10-01

The atypical antipsychotic (APs) drugs have become the most widely used agents to treat a variety of psychoses because of their superiority with regard to safety and tolerability profile compared to conventional/'typical' APs. We aimed at providing a synthesis of most current evidence about the safety and tolerability profile of the most clinically used atypical APs so far marketed. Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO and the Cochrane Library from inception until January 2016, combining free terms and MESH headings for the topics of psychiatric disorders and all atypical APs as following: ((safety OR adverse events OR side effects) AND (aripiprazole OR asenapine OR quetiapine OR olanzapine OR risperidone OR paliperidone OR ziprasidone OR lurasidone OR clozapine OR amisulpride OR iloperidone)). A critical issue in the treatment with atypical APs is represented by their metabolic side effect profile (e.g. weight gain, lipid and glycaemic imbalance, risk of diabetes mellitus and diabetic ketoacidosis) which may limit their use in particular clinical samples. Electrolyte imbalance, ECG abnormalities and cardiovascular adverse effects may recommend a careful baseline and periodic assessments.

29 CFR 5.15 - Limitations, variations, tolerances, and exemptions under the Contract Work Hours and Safety...

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Contract Work Hours and Safety Standards Act. 5.15 Section 5.15 Labor Office of the Secretary of... WORK HOURS AND SAFETY STANDARDS ACT) Davis-Bacon and Related Acts Provisions and Procedures § 5.15 Limitations, variations, tolerances, and exemptions under the Contract Work Hours and Safety Standards Act. (a...

Design and development of a low-cost biphasic charge-balanced functional electric stimulator and its clinical validation.

PubMed

Shendkar, Chandrashekhar; Lenka, Prasanna K; Biswas, Abhishek; Kumar, Ratnesh; Mahadevappa, Manjunatha

2015-10-01

Functional electric stimulators that produce near-ideal, charge-balanced biphasic stimulation waveforms with interphase delay are considered safer and more efficacious than conventional stimulators. An indigenously designed, low-cost, portable FES device named InStim is developed. It features a charge-balanced biphasic single channel. The authors present the complete design, mathematical analysis of the circuit and the clinical evaluation of the device. The developed circuit was tested on stroke patients affected by foot drop problems. It was tested both under laboratory conditions and in clinical settings. The key building blocks of this circuit are low dropout regulators, a DC-DC voltage booster and a single high-power current source OP-Amp with current-limiting capabilities. This allows the device to deliver high-voltage, constant current, biphasic pulses without the use of a bulky step-up transformer. The advantages of the proposed design over the currently existing devices include improved safety features (zero DC current, current-limiting mechanism and safe pulses), waveform morphology that causes less muscle fatigue, cost-effectiveness and compact power-efficient circuit design with minimal components. The device is also capable of producing appropriate ankle dorsiflexion in patients having foot drop problems of various Medical Research Council scale grades.

Structural Evaluation of the RSRM Nozzle Replacement Adhesive

NASA Technical Reports Server (NTRS)

Batista-Rodriguez, A.; McLennan, M. L.; Palumbos, A. V.; Richardson, D. E.

1999-01-01

This paper describes the structural performance evaluation of a replacement adhesive for the Reusable Solid Rocket Motor (RSRM) nozzle utilizing finite element analysis. Due to material obsolescence and industrial safety issues, the two current structural adhesives, EA 913 and EA 946 are to be replaced with a new adhesive. TIGA 321. The structural evaluation in support of the adhesive replacement effort includes residual stress, transportation, and flight analyses. Factors of safety are calculated using the stress response from each analysis. The factors of safety are used as the limiting criteria to compare the replacement adhesive against the current adhesives. Included in this paper are the analytical approach, assumptions and modeling techniques as well as the results of the evaluation. An important factor to the evaluation is the similarity in constitutive material properties (elastic modulus and Poisson's ratio) between TIGA 321 and EA 913. This similarity leads to equivalent material response from the two adhesives. However, TIGA 321 surpasses EA 913's performance due to higher material capabilities. Conversely, the change in stress response from EA 946 to TIGA 321 is more apparent: this is primarily attributed to the difference in the modulii of the two adhesives, which differ by two orders of magnitude. The results of the bondline evaluation indicate that the replacement adhesive provides superior performance than the current adhesives with only minor exceptions. Furthermore, TIGA 321 causes only a minor chance in the response of the phenolic and metal components.

Real-world aspects of the nuclear criticality safety program at the University of Tennessee-Knoxville

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

Bentley, C.L.; Dunn, M.E.; Goluoglu, S.

1996-12-31

The nuclear criticality safety (NCS) program at the University of Tennessee-Knoxville (UTK) emphasizes the {open_quotes}real world{close_quotes} in the NCS courses that are offered and also the NCS research that is conducted. Two NCS courses are offered at UTK. The first course is an introduction to the NCS field, which uses the text by Knief and includes an overview of criticality accidents that have actually happened, standards that are currently in use and being developed, and state-of-the-art computer methods and codes. The students learn the same codes, including both theory and application, that are used by most professionals in the NCSmore » field. Thus, if a student accepts a job offer in the NCS area after graduation, he or she is capable of doing productive NCS work the first day on the job. Subcritical limits, hand-calculation methods, current regulations [both U.S. Department of Energy (DOE) and U.S. Nuclear Regulatory Commission (NRC)] and current practices are also discussed in the introductory course. The second course emphasizes real world experience and is taught by five instructors with over 100 years of combined experience.« less

Nano-food packaging: an overview of market, migration research, and safety regulations.

PubMed

Bumbudsanpharoke, Nattinee; Ko, Seonghyuk

2015-05-01

Recently, food packages produced with nanoparticles, "nano-food packaging," have become more available in the current market. However, although the use of nanomaterials is increasing in food packaging applications, concern over toxicity affects consumer perceptions and acceptance. Quite a number of commercialized forms of nano-food packaging are coated or composited product with inorganic materials, for example, nanosilver and nanoclay as representative examples. Several studies have shown the possibility of nanomaterial migration from packaging or containers to foodstuff. The debate is still ongoing among researchers about the extent of migration and whether it is negligible and safe. Government agencies and stakeholders must hurry to determine use limitations and release conclusive legislation and regulations as soon as possible since nano-food packaging may have great impacts on human health. This paper aims to review the availability of nano-food packaging in the current market, report case studies on nanomaterial migration, and present the current status of safety regulations and management of nano-food packaging in leading countries across regions. This review should enable governments and researchers to develop further nanomaterial risk assessment studies. © 2015 Institute of Food Technologists®

Calculation of induced current densities for humans by magnetic fields from electronic article surveillance devices

NASA Astrophysics Data System (ADS)

Gandhi, Om P.; Kang, Gang

2001-11-01

This paper illustrates the use of the impedance method to calculate the electric fields and current densities induced in millimetre resolution anatomic models of the human body, namely an adult and 10- and 5-year-old children, for exposure to nonuniform magnetic fields typical of two assumed but representative electronic article surveillance (EAS) devices at 1 and 30 kHz, respectively. The devices assumed for the calculations are a solenoid type magnetic deactivator used at store checkouts and a pass-by panel-type EAS system consisting of two overlapping rectangular current-carrying coils used at entry and exit from a store. The impedance method code is modified to obtain induced current densities averaged over a cross section of 1 cm2 perpendicular to the direction of induced currents. This is done to compare the peak current densities with the limits or the basic restrictions given in the ICNIRP safety guidelines. Because of the stronger magnetic fields at lower heights for both the assumed devices, the peak 1 cm2 area-averaged current densities for the CNS tissues such as the brain and the spinal cord are increasingly larger for smaller models and are the highest for the model of the 5-year-old child. For both the EAS devices, the maximum 1 cm2 area-averaged current densities for the brain of the model of the adult are lower than the ICNIRP safety guideline, but may approach or exceed the ICNIRP basic restrictions for models of 10- and 5-year-old children if sufficiently strong magnetic fields are used.

Calculation of induced current densities for humans by magnetic fields from electronic article surveillance devices.

PubMed

Gandhi, O P; Kang, G

2001-11-01

This paper illustrates the use of the impedance method to calculate the electric fields and current densities induced in millimetre resolution anatomic models of the human body, namely an adult and 10- and 5-year-old children, for exposure to nonuniform magnetic fields typical of two assumed but representative electronic article surveillance (EAS) devices at 1 and 30 kHz, respectively. The devices assumed for the calculations are a solenoid type magnetic deactivator used at store checkouts and a pass-by panel-type EAS system consisting of two overlapping rectangular current-carrying coils used at entry and exit from a store. The impedance method code is modified to obtain induced current densities averaged over a cross section of 1 cm2 perpendicular to the direction of induced currents. This is done to compare the peak current densities with the limits or the basic restrictions given in the ICNIRP safety guidelines. Because of the stronger magnetic fields at lower heights for both the assumed devices, the peak 1 cm2 area-averaged current densities for the CNS tissues such as the brain and the spinal cord are increasingly larger for smaller models and are the highest for the model of the 5-year-old child. For both the EAS devices, the maximum 1 cm2 area-averaged current densities for the brain of the model of the adult are lower than the ICNIRP safety guideline, but may approach or exceed the ICNIRP basic restrictions for models of 10- and 5-year-old children if sufficiently strong magnetic fields are used.

Risk assessment principle for engineered nanotechnology in food and drug.

PubMed

Hwang, Myungsil; Lee, Eun Ji; Kweon, Se Young; Park, Mi Sun; Jeong, Ji Yoon; Um, Jun Ho; Kim, Sun Ah; Han, Bum Suk; Lee, Kwang Ho; Yoon, Hae Jung

2012-06-01

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

Predoctoral and Postdoctoral Education on Cone-Beam Computed Tomography.

PubMed

Buchanan, Allison; Thachil, Karan; Haggard, Chris; Kalathingal, Sajitha

2017-12-01

As the use of cone beam computed tomography (CBCT) in dentistry continues to grow, questions related to appropriate radiation safety, training, and interpretation arise. Recognizing this need, the American Dental Association published an advisory statement for the safe use of CBCT in dentistry and recommended that guidelines for appropriate training be established. The purpose of this study was to assess radiation safety concerns related to CBCT and identify voids in current education on CBCT for the predoctoral dental curriculum and continuing dental education. A survey was mailed to general practitioners, oral surgeons, and periodontists in the Georgia Dental Association (n = 415). One hundred twenty-one surveys were received for a response rate of 29%. Sixty-eight percent of practitioners reported using CBCT, with 89% having used it for over 2 years. Few (12.4%) had experience with CBCT in dental school. Interest in continuing dental education on CBCT was reported at 59.8% and 43.6% for current users and nonusers of CBCT, respectively. Approximately 50% reported using precautionary radiation safety measures, and the methods used were varied. Although a higher survey return rate would allow for stronger evidence, this project identified some areas of education voids including radiation safety and the factors that contribute to patient dose; CBCT basics including instruction on the limitations of CBCT; CBCT anatomy and pathology with additional time dedicated to the paranasal sinuses; and interpretation. Copyright © 2017 Elsevier Inc. All rights reserved.

Risks and issues in fire safety on the Space Station

NASA Technical Reports Server (NTRS)

Friedman, Robert

1993-01-01

A fire in the inhabited portion of a spacecraft is a greatly feared hazard, but fire protection in space operations is complicated by two factors. First, the spacecraft cabin is an enclosed volume, which limits the resources for fire fighting and the options for crew escape. Second, an orbiting spacecraft experiences a balance of forces, creating a near-zero-gravity (microgravity) environment that profoundly affects the characteristics of fire initiation, spread, and suppression. The current Shuttle Orbiter is protected by a fire-detection and suppression system whose requirements are derived of necessity from accepted terrestrial and aircraft standards. While experience has shown that Shuttle fire safety is adequate, designers recognize that improved systems to respond specifically to microgravity fire characteristics are highly desirable. Innovative technology is particularly advisable for the Space Station, a forthcoming space community with a complex configuration and long-duration orbital missions, in which the effectiveness of current fire-protection systems is unpredictable. The development of risk assessments to evaluate the probabilities and consequences of fire incidents in spacecraft are briefly reviewed. It further discusses the important unresolved issues and needs for improved fire safety in the Space Station, including those of material selection, spacecraft atmospheres, fire detection, fire suppression, and post-fire restoration.

36 CFR § 1004.11 - Load, weight and size limits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... designate more restrictive limits when appropriate for traffic safety or protection of the road surface. The... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true Load, weight and size limits... TRAFFIC SAFETY § 1004.11 Load, weight and size limits. (a) Vehicle load, weight and size limits...

Therapeutic Use of Prebiotics, Probiotics, and Postbiotics to Prevent Necrotizing Enterocolitis: What is the Current Evidence?

PubMed Central

Patel, Ravi Mangal; Denning, Patricia Wei

2013-01-01

Synopsis Necrotizing enterocolitis (NEC) is a leading cause of neonatal morbidity and mortality and preventative therapies that are both effective and safe are urgently needed. Current evidence from therapeutic trials suggests that probiotics are effective in decreasing NEC in preterm infants and probiotics are currently the most promising therapy on the horizon for this devastating disease. However, concerns regarding safety and optimal dosing have limited the widespread adoption of routine clinical use of probiotics in preterm infants. In addition, prebiotics and postbiotics may be potential alternatives or adjunctive therapies to the administration of live microorganisms, although studies demonstrating their clinical efficacy in preventing NEC are lacking. This review summarizes the current evidence regarding the use of probiotics, prebiotics and postbiotics in the preterm infant, including its therapeutic role in preventing NEC. PMID:23415261

Phase 2 SBIR Final Report: An Ultra-Sensitive Optical Biosensor for Flood Safety

DTIC Science & Technology

2002-08-23

can be completed in 2 to 4 hours. Currently accepted tests using commercial test kits based on immunochemical techniques offer results in 22 to 24...tagging is imperfect, leading to a background of non-specific surface and molecular binding limiting the signal. The use of a reporter fluorochrome can ...Waveguide Patterning: Surface flow channels: The rectangular cuvettes (as shown in Section II, Figure 4-3) can be etched using standard techniques. The

Simple battery armor to protect against gastrointestinal injury from accidental ingestion

PubMed Central

Laulicht, Bryan; Deshpande, Vikram; Langer, Robert; Karp, Jeffrey M.

2014-01-01

Inadvertent battery ingestion in children and the associated morbidity and mortality results in thousands of emergency room visits every year. Given the risk for serious electrochemical burns within hours of ingestion, the current standard of care for the treatment of batteries in the esophagus is emergent endoscopic removal. Safety standards now regulate locked battery compartments in toys, which have resulted in a modest reduction in inadvertent battery ingestion; specifically, 3,461 ingestions were reported in 2009, and 3,366 in 2013. Aside from legislation, minimal technological development has taken place at the level of the battery to limit injury. We have constructed a waterproof, pressure-sensitive coating, harnessing a commercially available quantum tunneling composite. Quantum tunneling composite coated (QTCC) batteries are nonconductive in the low-pressure gastrointestinal environment yet conduct within the higher pressure of standard battery housings. Importantly, this coating technology enables most battery-operated equipment to be powered without modification. If these new batteries are swallowed, they limit the external electrolytic currents responsible for tissue injury. We demonstrate in a large-animal model a significant decrease in tissue injury with QTCC batteries compared with uncoated control batteries. In summary, here we describe a facile approach to increasing the safety of batteries by minimizing the risk for electrochemical burn if the batteries are inadvertently ingested, without the need for modification of most battery-powered devices. PMID:25368176

Simple battery armor to protect against gastrointestinal injury from accidental ingestion.

PubMed

Laulicht, Bryan; Traverso, Giovanni; Deshpande, Vikram; Langer, Robert; Karp, Jeffrey M

2014-11-18

Inadvertent battery ingestion in children and the associated morbidity and mortality results in thousands of emergency room visits every year. Given the risk for serious electrochemical burns within hours of ingestion, the current standard of care for the treatment of batteries in the esophagus is emergent endoscopic removal. Safety standards now regulate locked battery compartments in toys, which have resulted in a modest reduction in inadvertent battery ingestion; specifically, 3,461 ingestions were reported in 2009, and 3,366 in 2013. Aside from legislation, minimal technological development has taken place at the level of the battery to limit injury. We have constructed a waterproof, pressure-sensitive coating, harnessing a commercially available quantum tunneling composite. Quantum tunneling composite coated (QTCC) batteries are nonconductive in the low-pressure gastrointestinal environment yet conduct within the higher pressure of standard battery housings. Importantly, this coating technology enables most battery-operated equipment to be powered without modification. If these new batteries are swallowed, they limit the external electrolytic currents responsible for tissue injury. We demonstrate in a large-animal model a significant decrease in tissue injury with QTCC batteries compared with uncoated control batteries. In summary, here we describe a facile approach to increasing the safety of batteries by minimizing the risk for electrochemical burn if the batteries are inadvertently ingested, without the need for modification of most battery-powered devices.

Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies.

PubMed

Prior, Helen; Bottomley, Anna; Champéroux, Pascal; Cordes, Jason; Delpy, Eric; Dybdal, Noel; Edmunds, Nick; Engwall, Mike; Foley, Mike; Hoffmann, Michael; Kaiser, Robert; Meecham, Ken; Milano, Stéphane; Milne, Aileen; Nelson, Rick; Roche, Brian; Valentin, Jean-Pierre; Ward, Gemma; Chapman, Kathryn

2016-01-01

The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing. Thirty-nine sites, either running studies (Sponsors or Contract Research Organisations, CROs) and/or outsourcing work responded to the survey (51% from Europe; 41% from USA). During safety pharmacology studies, 84, 67 and 100% of respondents socially house dogs, minipigs and non-human primates (NHPs) respectively on non-recording days. However, on recording days 20, 20 and 33% of respondents socially house the animals, respectively. The main barriers for social housing were limitations in the recording equipment used, study design and animal temperament/activity. During toxicology studies, 94, 100 and 100% of respondents socially house dogs, minipigs and NHPs respectively on non-recording days. However, on recording days 31, 25 and 50% of respondents socially house the animals, respectively. The main barriers for social housing were risk of damage to and limitations in the recording equipment used, food consumption recording and temperament/activity of the animals. Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best practice and data from companies already socially housing, combined with technology improvements and investments in infrastructure are required to maintain the forward momentum of this refinement across the industry. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Perioperative Lidocaine Infusions for the Prevention of Chronic Post-Surgical Pain: A Systematic Review and Meta-Analysis of Efficacy and Safety.

PubMed

Bailey, Martin; Corcoran, Tomas; Schug, Stephan; Toner, Andrew

2018-05-11

Chronic post-surgical pain (CPSP) occurs in 12% of surgical populations and is a high priority for perioperative research. Systemic lidocaine may modulate several of the pathophysiological processes linked to CPSP. This systematic review aims to identify and synthesize the evidence linking lidocaine infusions and CPSP.The authors conducted a systematic literature search of the major medical databases from inception until October 2017. Trials that randomized adults without baseline pain to perioperative lidocaine infusion or placebo were included if they reported on CPSP. The primary outcome was the presence of procedure-related pain at three months or longer after surgery. The secondary outcomes of pain intensity, adverse safety events and local anesthetic toxicity were also assessed.Six trials from four countries (n=420) were identified. CPSP incidence was consistent with existing epidemiological data. Perioperative lidocaine infusions significantly reduced the primary outcome (odds ratio, 0.29; 95% CI, 0.18 to 0.48), although the difference in intensity of CPSP assessed by the short form McGill pain questionnaire (four trials) was not statistically significant (weighted mean difference, -1.55; 95% CI, -3.16 to 0.06). Publication and other bias were highly apparent, as were limitations in trial design. Each study included a statement reporting no adverse events attributable to lidocaine, but systematic safety surveillance strategies were absent.Current limited clinical trial data and biological plausibility support lidocaine infusions use to reduce the development of CPSP without full assurances as to its safety. This hypothesis should be addressed in future definitive clinical trials with comprehensive safety assessment and reporting.

49 CFR 214.319 - Working limits, generally.

Code of Federal Regulations, 2010 CFR

2010-10-01

... control over working limits for the purpose of establishing on-track safety. (b) Only one roadway worker shall have control over working limits on any one segment of track. (c) All affected roadway workers..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.319 Working limits...

Hours of work and rest in the rail industry.

PubMed

Anderson, C; Grunstein, R R; Rajaratnam, S M W

2013-06-01

Currently, the National Transport Commission is considering four options to form the regulatory framework for rail safety within Australia with respect to fatigue. While the National Transport Commission currently recommends no limitations around hours of work or rest, we provide evidence which suggests regulatory frameworks should incorporate a traditional hours of service regulation over more flexible policies. Our review highlights: Shift durations >12 h are associated with a doubling of risk for accident and injury. Fatigue builds cumulatively with each successive shift where rest in between is inadequate (<12 h). A regulatory framework for fatigue management within the rail industry should prescribe limits on hours of work and rest, including maximum shift duration and successive number of shifts. Appropriately, validated biomathematical models and technologies may be used as a part of a fatigue management system, to augment the protection afforded by limits on hours of work and rest. A comprehensive sleep disorder screening and management programme should form an essential component of any regulatory framework. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

Influencing Safety in Australian Agriculture and Fisheries.

PubMed

McBain-Rigg, Kristin E; Franklin, Richard C; King, Jemma C; Lower, Tony

2017-01-01

Improving the health and safety of those working in Australian agriculture and fishery industries is a recognized priority area for preventative activities. With Australian agricultural industries being among the nation's most dangerous workplaces, there is a need for action. While there are currently known solutions, their implementation is limited. Influential agents, i.e., people who can influence others, are important for helping engender action to enact solutions into practice. This study examines agents that influence safety behavior either negatively (barriers) or positively (facilitators), in the Australian agriculture and fishery industries. Focus groups were conducted with producers and industry representatives. Thematic analysis identified barriers and facilitators to improve health and safety. These were assessed against the Socioecological Model, which considers the various, and often intersecting, human (intrapersonal, i.e. values and attitudes, peers, familial, and cultural) factors influencing safety behavior. Seven categories of human influences were identified: self, peers, family, intergenerational change, industry agents, government agents, and other. Peers (including direct managers) and family were seen to be direct influencers. Individuals signal to others that safety is valued and important. This is reinforced by experience, skill, attitudes, and behavior. Safety practice knowledge acquisition occurred via the family unit, specific training, industry, or knowledge transfer between industries. Government influence predominately focused on legislation and while the source of this influence is distant, it does influence behavior. There is a need to support comprehensive programs. These should include strengthening relationships via peer-to-peer networking, sharing information about safety initiatives, appropriate legislation, and enhancing leadership of all influencers with regard to safety.

Maximizing optical efficacy and color gamut in projection applications by combining four laser wavelengths

NASA Astrophysics Data System (ADS)

Wallhead, Ian; Ocaña, Roberto

2014-05-01

Laser projection devices should be designed to maximize their luminous efficacy and color gamut. This is for two main reasons. Firstly, being either stand alone devices or embedded in other products, they could be powered by battery, and lifetime is an important factor. Secondly, the increasing use of lasers to project images calls for a consideration of eye safety issues. The brightness of the projected image may be limited by the Class II accessible emission limit. There is reason to believe that current laser beam scanning projection technology is already close to the power ceiling based on eye safety limits. Consequently, it would be desirable to improve luminous efficacy to increase the output luminous flux whilst maintaining or improving color gamut for the same eye-safe optical power limit. Here we present a novel study about the combination of four laser wavelengths in order to maximize both color gamut and efficacy to produce the color white. Firstly, an analytic method to calculate efficacy as function of both four laser wavelengths and four laser powers is derived. Secondly we provide a new way to present the results by providing the diagram efficacy vs color gamut area that summarizes the performance of any wavelength combination for projection purposes. The results indicate that the maximal efficacy for the D65 white is only achievable by using a suitable combination of both laser power ratios and wavelengths.

Public perceptions of a rip current hazard education program: "Break the Grip of the Rip!"

NASA Astrophysics Data System (ADS)

Houser, Chris; Trimble, Sarah; Brander, Robert; Brewster, B. Chris; Dusek, Greg; Jones, Deborah; Kuhn, John

2017-07-01

Rip currents pose a major global beach hazard; estimates of annual rip-current-related deaths in the United States alone range from 35 to 100 per year. Despite increased social research into beach-goer experience, little is known about levels of rip current knowledge within the general population. This study describes the results of an online survey to determine the extent of rip current knowledge across the United States, with the aim of improving and enhancing existing beach safety education material. Results suggest that the US-based Break the Grip of the Rip!® campaign has been successful in educating the public about rip current safety directly or indirectly, with the majority of respondents able to provide an accurate description of how to escape a rip current. However, the success of the campaign is limited by discrepancies between personal observations at the beach and rip forecasts that are broadcasted for a large area and time. It was the infrequent beach user that identified the largest discrepancies between the forecast and their observations. Since infrequent beach users also do not seek out lifeguards or take the same precautions as frequent beach users, it is argued that they are also at greatest risk of being caught in a dangerous situation. Results of this study suggest a need for the national campaign to provide greater focus on locally specific and verified rip forecasts and signage in coordination with lifeguards, but not at the expense of the successful national awareness program.

Registered dietitian's personal beliefs and characteristics predict their teaching or intention to teach fresh vegetable food safety.

PubMed

Casagrande, Gina; LeJeune, Jeffery; Belury, Martha A; Medeiros, Lydia C

2011-04-01

The Theory of Planned Behavior was used to determine if dietitians personal characteristics and beliefs about fresh vegetable food safety predict whether they currently teach, intend to teach, or neither currently teach nor intend to teach food safety information to their clients. Dietitians who participated in direct client education responded to this web-based survey (n=327). The survey evaluated three independent belief variables: Subjective Norm, Attitudes, and Perceived Behavioral Control. Spearman rho correlations were completed to determine variables that correlated best with current teaching behavior. Multinomial logistical regression was conducted to determine if the belief variables significantly predicted dietitians teaching behavior. Binary logistic regression was used to determine which independent variable was the better predictor of whether dietitians currently taught. Controlling for age, income, education, and gender, the multinomial logistical regression was significant. Perceived behavioral control was the best predictor of whether a dietitian currently taught fresh vegetable food safety. Factors affecting whether dietitians currently taught were confidence in fresh vegetable food safety knowledge, being socially influenced, and a positive attitude toward the teaching behavior. These results validate the importance of teaching food safety effectively and may be used to create more informed food safety curriculum for dietitians. Copyright © 2011 Elsevier Ltd. All rights reserved.

Electrolyte additive enabled fast charging and stable cycling lithium metal batteries

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

Zheng, Jianming; Engelhard, Mark H.; Mei, Donghai

2017-03-01

Batteries using lithium (Li) metal as anodes are considered promising energy storage systems because of their high energy densities. However, safety concerns associated with dendrite growth along with limited cycle life, especially at high charge current densities, hinder their practical uses. Here we report that an optimal amount (0.05 M) of LiPF6 as an additive in LiTFSI-LiBOB dual-salt/carbonate-solvent-based electrolytes significantly enhances the charging capability and cycling stability of Li metal batteries. In a Li metal battery using a 4-V Li-ion cathode at a moderately high loading of 1.75mAh cm(-2), a cyclability of 97.1% capacity retention after 500 cycles along withmore » very limited increase in electrode overpotential is accomplished at a charge/discharge current density up to 1.75 mA cm(-2). The fast charging and stable cycling performances are ascribed to the generation of a robust and conductive solid electrolyte interphase at the Li metal surface and stabilization of the Al cathode current collector.« less

Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

PubMed

Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

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

PubMed

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

2013-03-01

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

AgHalo: A Facile Fluorogenic Sensor to Detect Drug-Induced Proteome Stress.

PubMed

Liu, Yu; Fares, Matthew; Dunham, Noah P; Gao, Zi; Miao, Kun; Jiang, Xueyuan; Bollinger, Samuel S; Boal, Amie K; Zhang, Xin

2017-07-17

Drug-induced proteome stress that involves protein aggregation may cause adverse effects and undermine the safety profile of a drug. Safety of drugs is regularly evaluated using cytotoxicity assays that measure cell death. However, these assays provide limited insights into the presence of proteome stress in live cells. A fluorogenic protein sensor is reported to detect drug-induced proteome stress prior to cell death. An aggregation prone Halo-tag mutant (AgHalo) was evolved to sense proteome stress through its aggregation. Detection of such conformational changes was enabled by a fluorogenic ligand that fluoresces upon AgHalo forming soluble aggregates. Using 5 common anticancer drugs, we exemplified detection of differential proteome stress before any cell death was observed. Thus, this sensor can be used to evaluate drug safety in a regime that the current cytotoxicity assays cannot cover and be generally applied to detect proteome stress induced by other toxins. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Clinical imaging in regenerative medicine

PubMed Central

Naumova, Anna V; Modo, Michel; Moore, Anna; Murry, Charles E; Frank, Joseph A

2014-01-01

In regenerative medicine, clinical imaging is indispensable for characterizing damaged tissue and for measuring the safety and efficacy of therapy. However, the ability to track the fate and function of transplanted cells with current technologies is limited. Exogenous contrast labels such as nanoparticles give a strong signal in the short term but are unreliable long term. Genetically encoded labels are good both short- and long-term in animals, but in the human setting they raise regulatory issues related to the safety of genomic integration and potential immunogenicity of reporter proteins. Imaging studies in brain, heart and islets share a common set of challenges, including developing novel labeling approaches to improve detection thresholds and early delineation of toxicity and function. Key areas for future research include addressing safety concerns associated with genetic labels and developing methods to follow cell survival, differentiation and integration with host tissue. Imaging may bridge the gap between cell therapies and health outcomes by elucidating mechanisms of action through longitudinal monitoring. PMID:25093889

The efficacy and safety of newer anticonvulsants in patients with dementia.

PubMed

Dolder, Christian R; Nealy, Kimberly L

2012-08-01

Anticonvulsants are a class of medications that have received considerable interest as possible treatments in patients with behavioural disturbances in dementia. The role of these medications for such a use remains controversial. The current paper reviews the published evidence surrounding the safety and efficacy (i.e. as a behavioural and cognitive treatment) of newer anticonvulsants in patients with dementia. A MEDLINE, International Pharmaceutical Abstracts, PsycINFO and clinicaltrials.gov search through to December 2011 was conducted for anticonvulsants that have received regulatory approval since 1996. Studies reporting behavioural or cognitive outcomes in patients with dementia were included. Nine trials involving only four medications met selection criteria and were included: levetiracetam (n = 4), oxcarbazepine (n = 1), topiramate (n = 2) and zonisamide (n = 2). Levetiracetam may have a role in the treatment of behavioural symptoms in dementia but study limitations substantially hinder the strength of such a recommendation. Oxcarbazepine and topiramate, based on limited data, do not appear to be effective treatments of behavioural symptoms in dementia. A lack of trials do not allow for conclusions to be made regarding zonisamide. From a cognitive standpoint, levetiracetam was the anticonvulsant most examined in patients with dementia, it appears to have less deleterious effects than some anticonvulsants. Limited data are available on the safety of these medications in elderly patients; however, studies completed thus far have demonstrated some adverse events that are more common or problematic with the use of these drugs in this patient population (i.e. somnolence, dizziness, hyponatraemia, weight loss).

Defining and Measuring Safety Climate: A Review of the Construction Industry Literature.

PubMed

Schwatka, Natalie V; Hecker, Steven; Goldenhar, Linda M

2016-06-01

Safety climate measurements can be used to proactively assess an organization's effectiveness in identifying and remediating work-related hazards, thereby reducing or preventing work-related ill health and injury. This review article focuses on construction-specific articles that developed and/or measured safety climate, assessed safety climate's relationship with other safety and health performance indicators, and/or used safety climate measures to evaluate interventions targeting one or more indicators of safety climate. Fifty-six articles met our inclusion criteria, 80% of which were published after 2008. Our findings demonstrate that researchers commonly defined safety climate as perception based, but the object of those perceptions varies widely. Within the wide range of indicators used to measure safety climate, safety policies, procedures, and practices were the most common, followed by general management commitment to safety. The most frequently used indicators should and do reflect that the prevention of work-related ill health and injury depends on both organizational and employee actions. Safety climate scores were commonly compared between groups (e.g. management and workers, different trades), and often correlated with subjective measures of safety behavior rather than measures of ill health or objective safety and health outcomes. Despite the observed limitations of current research, safety climate has been promised as a useful feature of research and practice activities to prevent work-related ill health and injury. Safety climate survey data can reveal gaps between management and employee perceptions, or between espoused and enacted policies, and trigger communication and action to narrow those gaps. The validation of safety climate with safety and health performance data offers the potential for using safety climate measures as a leading indicator of performance. We discuss these findings in relation to the related concept of safety culture and offer suggestions for future research and practice including (i) deriving a common definition of safety climate, (ii) developing and testing construction-specific indicators of safety climate, and (iii) focusing on construction-specific issues such as the transient workforce, subcontracting, work organization, and induction/acculturation processes. © The Author 2016. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

Methodological guidelines for developing accident modification functions.

PubMed

Elvik, Rune

2015-07-01

This paper proposes methodological guidelines for developing accident modification functions. An accident modification function is a mathematical function describing systematic variation in the effects of road safety measures. The paper describes ten guidelines. An example is given of how to use the guidelines. The importance of exploratory analysis and an iterative approach in developing accident modification functions is stressed. The example shows that strict compliance with all the guidelines may be difficult, but represents a level of stringency that should be strived for. Currently the main limitations in developing accident modification functions are the small number of good evaluation studies and the often huge variation in estimates of effect. It is therefore still not possible to develop accident modification functions for very many road safety measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Towards high-speed autonomous navigation of unknown environments

NASA Astrophysics Data System (ADS)

Richter, Charles; Roy, Nicholas

2015-05-01

In this paper, we summarize recent research enabling high-speed navigation in unknown environments for dynamic robots that perceive the world through onboard sensors. Many existing solutions to this problem guarantee safety by making the conservative assumption that any unknown portion of the map may contain an obstacle, and therefore constrain planned motions to lie entirely within known free space. In this work, we observe that safety constraints may significantly limit performance and that faster navigation is possible if the planner reasons about collision with unobserved obstacles probabilistically. Our overall approach is to use machine learning to approximate the expected costs of collision using the current state of the map and the planned trajectory. Our contribution is to demonstrate fast but safe planning using a learned function to predict future collision probabilities.

Pilot-Induced Oscillation Research: Status at the End of the Century. Volume 2

NASA Technical Reports Server (NTRS)

Shafer, Mary F. (Compiler); Steinmetz, Paul (Compiler)

2001-01-01

The workshop "Pilot-Induced Oscillation Research: The Status at the End of the Century," was held at NASA Dryden Flight Research Center on 6-8 April 1999. The presentations at this conference addressed the most current information available, addressing regulatory issues, flight test, safety, modeling, prediction, simulation, mitigation or prevention, and areas that require further research. All presentations were approved for publication as unclassified documents with no limits on their distribution. This proceedings includes the viewgraphs (some with author's notes) used for thirty presentations that were actually given and two presentations that were not given because of time limitations. Four technical papers on this subject are also included.

Pilot-Induced Oscillation Research: Status at the End of the Century. Volume 3

NASA Technical Reports Server (NTRS)

Shafer, Mary F. (Compiler); Steinmetz, Paul (Compiler)

2001-01-01

The workshop "Pilot-Induced Oscillation Research: The Status at the End of the Century," was held at NASA Dryden Flight Research Center on 6-8 April 1999. The presentations at this conference addressed the most current information available, addressing regulatory issues, flight test, safety, modeling, prediction, simulation, mitigation or prevention, and areas that require further research. All presentations were approved for publication as unclassified documents with no limits on their distribution. This proceedings includes the viewgraphs (some with author's notes) used for thirty presentations that were actually given and two presentations that were not given because of time limitations. Four technical papers on this subject are also included.

Pilot-Induced Oscillation Research: The Status at the End of the Century. Volume 1

NASA Technical Reports Server (NTRS)

Shafer, Mary F. (Compiler); Steinmetz, Paul (Compiler)

2001-01-01

The workshop "Pilot-Induced Oscillation Research: The Status at the End of the Century," was held at NASA Dryden Flight Research Center on 6-8 April 1999. The presentations at this conference addressed the most current information available, addressing regulatory issues, flight test, safety, modeling, prediction, simulation, mitigation or prevention, and areas that require further research. All presentations were approved for publication as unclassified documents with no limits on their distribution. This proceedings includes the viewgraphs (some with author's notes) used for thirty presentations that were actually given and two presentations that were not given because of time limitations. Four technical papers on this subject are also included.

Prototype Training Materials for Acceptance Criteria of Maintenance ASAP Events Occurring Within Social Context

NASA Technical Reports Server (NTRS)

Taylor, J. C.

2004-01-01

The aviation maintenance community is at a crossroads with respect to implementing the Aviation Safety Action Program (ASAP). While there is considerable interest, several key issues have emerged that cast doubt on how to assure a successful implementation, including buy-in from all levels of the company and training for key participants. There are two objectives for the present report. The first is to provide an examination of limits (or more properly, examples) of the degree of acceptability of more problematic events for risk-based decisions within the current ASAP guidelines. The second objective is to apply these limits of community standards to a set of further refined ASAP training scenarios.

Integrating teamwork, clinician occupational well-being and patient safety - development of a conceptual framework based on a systematic review.

PubMed

Welp, Annalena; Manser, Tanja

2016-07-19

There is growing evidence that teamwork in hospitals is related to both patient outcomes and clinician occupational well-being. Furthermore, clinician well-being is associated with patient safety. Despite considerable research activity, few studies include all three concepts, and their interrelations have not yet been investigated systematically. To advance our understanding of these potentially complex interrelations we propose an integrative framework taking into account current evidence and research gaps identified in a systematic review. We conducted a literature search in six major databases (Medline, PsycArticles, PsycInfo, Psyndex, ScienceDirect, and Web of Knowledge). Inclusion criteria were: peer reviewed papers published between January 2000 and June 2015 investigating a statistical relationship between at least two of the three concepts; teamwork, patient safety, and clinician occupational well-being in hospital settings, including practicing nurses and physicians. We assessed methodological quality using a standardized rating system and qualitatively appraised and extracted relevant data, such as instruments, analyses and outcomes. The 98 studies included in this review were highly diverse regarding quality, methodology and outcomes. We found support for the existence of independent associations between teamwork, clinician occupational well-being and patient safety. However, we identified several conceptual and methodological limitations. The main barrier to advancing our understanding of the causal relationships between teamwork, clinician well-being and patient safety is the lack of an integrative, theory-based, and methodologically thorough approach investigating the three concepts simultaneously and longitudinally. Based on psychological theory and our findings, we developed an integrative framework that addresses these limitations and proposes mechanisms by which these concepts might be linked. Knowledge about the mechanisms underlying the relationships between these concepts helps to identify avenues for future research, aimed at benefiting clinicians and patients by using the synergies between teamwork, clinician occupational well-being and patient safety.

36 CFR 4.11 - Load, weight and size limits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.11 Load, weight and size limits. (a) Vehicle load, weight and size limits established by State law apply to a vehicle operated on a park road. However, the superintendent may designate more restrictive limits when appropriate for traffic safety or protection of the road...

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

2002-01-01

This Annual Report of the Aerospace Safety Advisory Panel (ASAP) presents results of activities during calendar year 2001. The year was marked by significant achievements in the Space Shuttle and International Space Station (ISS) programs and encouraging accomplishments by the Aerospace Technology Enterprise. Unfortunately, there were also disquieting mishaps with the X-43, a LearJet, and a wind tunnel. Each mishap was analyzed in an orderly process to ascertain causes and derive lessons learned. Both these accomplishments and the responses to the mishaps led the Panel to conclude that safety and risk management is currently being well served within NASA. NASA's operations evidence high levels of safety consciousness and sincere efforts to place safety foremost. Nevertheless, the Panel's safety concerns have never been greater. This dichotomy has arisen because the focus of most NASA programs has been directed toward program survival rather than effective life cycle planning. Last year's Annual Report focused on the need for NASA to adopt a realistically long planning horizon for the aging Space Shuttle so that safety would not erode. NASA's response to the report concurred with this finding. Nevertheless, there has been a greater emphasis on current operations to the apparent detriment of long-term planning. Budget cutbacks and shifts in priorities have severely limited the resources available to the Space Shuttle and ISS for application to risk-reduction and life-extension efforts. As a result, funds originally intended for long-term safety-related activities have been used for operations. Thus, while safety continues to be well served at present, the basis for future safety has eroded. Section II of this report develops this theme in more detail and presents several important, overarching findings and recommendations that apply to many if not all of NASA's programs. Section III of the report presents other significant findings, recommendations and supporting material applicable to specific program areas. Appendix A presents a list of Panel members. Appendix B contains the reaction of the ASAP to NASA's response to the calendar year 2000 findings and recommendations. In accordance with a practice started last year, this Appendix includes brief narratives as well as classifications of the responses as 'open,' 'closed,' or 'continuing.' Appendix C details the Panel's activities during the reporting period.

Anesthesia and the developing brain.

PubMed

Aker, John; Block, Robert I; Biddle, Chuck

2015-04-01

Despite the profound evolution in the safety and efficacy of neonatal and pediatric anesthesia, questions remain concerning the long-term neurotoxic and neurocognitive effects of the drugs used in anesthetic care. A variety of prospective animal models and retrospective human studies exist that inconsistently demonstrate a detrimental effect of early life exposure to anesthetic drugs and subsequent learning performance. Limitations associated with both non-human and human observational studies are critiqued. Research currently underway is briefly described. A framework for discussing the relevant issues with concerned parents is presented.

PRELIMINARY NUCLEAR CRITICALITY NUCLEAR SAFETY EVLAUATION FOR THE CONTAINER SURVEILLANCE AND STORAGE CAPABILITY PROJECT

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

Low, M; Matthew02 Miller, M; Thomas Reilly, T

2007-04-30

Washington Safety Management Solutions (WSMS) provides criticality safety services to Washington Savannah River Company (WSRC) at the Savannah River Site. One activity at SRS is the Container Surveillance and Storage Capability (CSSC) Project, which will perform surveillances on 3013 containers (hereafter referred to as 3013s) to verify that they meet the Department of Energy (DOE) Standard (STD) 3013 for plutonium storage. The project will handle quantities of material that are greater than ANS/ANSI-8.1 single parameter mass limits, and thus required a Nuclear Criticality Safety Evaluation (NCSE). The WSMS methodology for conducting an NCSE is outlined in the WSMS methods manual.more » The WSMS methods manual currently follows the requirements of DOE-O-420.1B, DOE-STD-3007-2007, and the Washington Savannah River Company (WSRC) SCD-3 manual. DOE-STD-3007-2007 describes how a NCSE should be performed, while DOE-O-420.1B outlines the requirements for a Criticality Safety Program (CSP). The WSRC SCD-3 manual implements DOE requirements and ANS standards. NCSEs do not address the Nuclear Criticality Safety (NCS) of non-reactor nuclear facilities that may be affected by overt or covert activities of sabotage, espionage, terrorism or other security malevolence. Events which are beyond the Design Basis Accidents (DBAs) are outside the scope of a double contingency analysis.« less

Drug development and nonclinical to clinical translational databases: past and current efforts.

PubMed

Monticello, Thomas M

2015-01-01

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

High-Throughput Toxicity Testing: New Strategies for ...

EPA Pesticide Factsheets

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct additives, and food contact substances. With the rapidly growing use of new food additives, as well as innovation in food contact substance development, an interest in exploring the use of high-throughput chemical safety testing approaches has emerged. Currently, the field of toxicology is undergoing a paradigm shift in how chemical hazards can be evaluated. Since there are tens of thousands of chemicals in use, many of which have little to no hazard information and there are limited resources (namely time and money) for testing these chemicals, it is necessary to prioritize which chemicals require further safety testing to better protect human health. Advances in biochemistry and computational toxicology have paved the way for animal-free (in vitro) high-throughput screening which can characterize chemical interactions with highly specific biological processes. Screening approaches are not novel; in fact, quantitative high-throughput screening (qHTS) methods that incorporate dose-response evaluation have been widely used in the pharmaceutical industry. For toxicological evaluation and prioritization, it is the throughput as well as the cost- and time-efficient nature of qHTS that makes it

New design and operating techniques and requirements for improved aircraft terminal area operations

NASA Technical Reports Server (NTRS)

Reeder, J. P.; Taylor, R. T.; Walsh, T. M.

1974-01-01

Current aircraft operating problems that must be alleviated for future high-density terminal areas are safety, dependence on weather, congestion, energy conservation, noise, and atmospheric pollution. The Microwave Landing System (MLS) under development by FAA provides increased capabilities over the current ILS. The development of the airborne system's capability to take maximum advantage of the MLS capabilities in order to solve terminal area problems are discussed. A major limiting factor in longitudinal spacing for capacity increase is the trailing vortex hazard. Promising methods for causing early dissipation of the vortices were explored. Flight procedures for avoiding the hazard were investigated. Terminal configured vehicles and their flight test development are discussed.

[Navigated retinal laser therapy].

PubMed

Kernt, M; Ulbig, M; Kampik, A; Neubauer, A S

2013-08-01

Navigated laser therapy introduces for the first time computerized assistance systems for retinal laser therapy. The Navilas system offers high precision and safety and provides additional benefits regarding standardization of planning, execution, documentation and quality assurance. The current focus of clinical application for navigated laser therapy besides laser treatment after retinal vein occlusion and panretinal laser photocoagulation in proliferative diabetic retinopathy (PDR) is diabetic macular edema. Recent data indicate that combined initial anti-vascular endothelial growth factor (anti-VEGF) and navigated macular laser therapy allows achievement and maintenance of treatment success with a minimum number of interventions. Despite very promising results the current assessment of navigated laser therapy is still limited by the evidence available worldwide.

Exercise as an adjunct treatment for opiate agonist treatment: review of the current research and implementation strategies.

PubMed

Weinstock, Jeremiah; Wadeson, Heather K; VanHeest, Jaci L

2012-01-01

Opiate dependence is a significant public health concern linked to poor quality of life, comorbid psychiatric disorders, and high costs to society. Current opiate agonist treatments are an effective but limited intervention. Adjunctive interventions could improve and augment opiate agonist treatment outcomes, including drug abstinence, quality of life, and physical health. This article reviews exercise as an adjunctive intervention for opiate agonist treatment, especially in regards to improving mood and overall quality of life, while reducing other substance use. Poor adherence and dropout frequently prevent many individuals from garnering the many physical and mental health benefits of exercise. Strategies for implementing an exercise intervention, including safety considerations, are discussed.

How 3 rural safety net clinics integrate care for patients: a qualitative case study.

PubMed

Derrett, Sarah; Gunter, Kathryn E; Nocon, Robert S; Quinn, Michael T; Coleman, Katie; Daniel, Donna M; Wagner, Edward H; Chin, Marshall H

2014-11-01

Integrated care focuses on care coordination and patient centeredness. Integrated care supports continuity of care over time, with care that is coordinated within and between settings and is responsive to patients' needs. Currently, little is known about care integration for rural patients. To examine challenges to care integration in rural safety net clinics and strategies to address these challenges. Qualitative case study. Thirty-six providers and staff from 3 rural clinics in the Safety Net Medical Home Initiative. Interviews were analyzed using the framework method with themes organized within 3 constructs: Team Coordination and Empanelment, External Coordination and Partnerships, and Patient-centered and Community-centered Care. Participants described challenges common to safety net clinics, including limited access to specialists for Medicaid and uninsured patients, difficulty communicating with external providers, and payment models with limited support for care integration activities. Rurality compounded these challenges. Respondents reported benefits of empanelment and team-based care, and leveraged local resources to support care for patients. Rural clinics diversified roles within teams, shared responsibility for patient care, and colocated providers, as strategies to support care integration. Care integration was supported by 2 fundamental changes to organize and deliver care to patients-(1) empanelment with a designated group of patients being cared for by a provider; and (2) a multidisciplinary team able to address rural issues. New funding and organizational initiatives of the Affordable Care Act may help to further improve care integration, although additional solutions may be necessary to address particular needs of rural communities.

Quality improvement in medical education: current state and future directions.

PubMed

Wong, Brian M; Levinson, Wendy; Shojania, Kaveh G

2012-01-01

During the last decade, there has been a drive to improve the quality of patient care and prevent the occurrence of avoidable errors. This review describes current efforts to teach or engage trainees in patient safety and quality improvement (QI), summarises progress to date, as well as successes and challenges, and lists our recommendations for the next steps that will shape the future of patient safety and QI in medical education. Trainees encounter patient safety and QI through three main groups of activity. First are formal curricula that teach concepts or methods intended to facilitate trainees' participation in QI activities. These curricula increase learner knowledge and may improve clinical processes, but demonstrate limited capacity to modify learner behaviours. Second are educational activities that impart specific skills related to safety or quality which are considered to represent core doctor competencies (e.g. effective patient handover). These are frequently taught effectively, but without emphasis on the general safety or quality principles that inform the relevant skills. Third are real-life QI initiatives that involve trainees as active or passive participants. These innovative approaches expose trainees to safety and quality by integrating QI activities into trainees' day-to-day work. However, this integration can be challenging and can sometimes result in tension with broader educational goals. To prepare the next generation of doctors to make meaningful contributions to the quality mission, we propose the following call to action. Firstly, a major effort to build faculty capacity, especially among teachers of QI, should be instigated. Secondly, accreditation standards and assessment methods, both during training and at end-of-training certification examinations, should explicitly target these competencies. Finally, and perhaps most importantly, we must refocus our attention at all levels of training and instil fundamental, collaborative, open-minded behaviours so that future clinicians are primed to promote a culture of safer, higher-quality care. © Blackwell Publishing Ltd 2012.

The promise of ketamine for treatment-resistant depression: current evidence and future directions

PubMed Central

DeWilde, Kaitlin E.; Levitch, Cara F.; Murrough, James W.; Mathew, Sanjay J.; Iosifescu, Dan V.

2014-01-01

Major depressive disorder (MDD) is one of the most disabling diseases worldwide and is a significant public health threat. Current treatments for MDD primarily consist of monoamine-targeting agents and have limited efficacy. However, the glutamate neurotransmitter system has recently come into focus as a promising alternative for novel antidepressant treatments. We review the current data on the glutamate NMDA receptor antagonist ketamine, which has been shown in clinical trials to act as a rapid antidepressant in MDD. We also examine ketamine efficacy on dimensions of psychopathology, including anhedonia, cognition, and suicidality, consistent with the NIMH Research Domain Criteria (RDoC) initiative. Other aspects of ketamine reviewed in this paper include safety and efficacy, different administration methods, and the risks of misuse of ketamine outside of medical settings. Finally, we conclude with a discussion of other glutamatergic agents other than ketamine currently being tested as novel antidepressants. PMID:25649308

Plant xylem hydraulics: What we understand, current research, and future challenges.

PubMed

Venturas, Martin D; Sperry, John S; Hacke, Uwe G

2017-06-01

Herein we review the current state-of-the-art of plant hydraulics in the context of plant physiology, ecology, and evolution, focusing on current and future research opportunities. We explain the physics of water transport in plants and the limits of this transport system, highlighting the relationships between xylem structure and function. We describe the great variety of techniques existing for evaluating xylem resistance to cavitation. We address several methodological issues and their connection with current debates on conduit refilling and exponentially shaped vulnerability curves. We analyze the trade-offs existing between water transport safety and efficiency. We also stress how little information is available on molecular biology of cavitation and the potential role of aquaporins in conduit refilling. Finally, we draw attention to how plant hydraulic traits can be used for modeling stomatal responses to environmental variables and climate change, including drought mortality. © 2017 Institute of Botany, Chinese Academy of Sciences.

Contemporary surgical devices for male stress urinary incontinence: a review of technological advances in current continence surgery.

PubMed

Chung, Eric

2017-07-01

Male stress urinary incontinence (SUI) remains a debilitating condition that adversely impacts all domains of quality of life and is associated with significant social stigma and health economic burden. The incidence of post-prostatectomy urinary incontinence (PPI) depends on the definition of urinary incontinence and the length of patient follow up. In patients with persistent PPI following failure of conservative measures, surgical treatment is recommended although there is no published guideline on when surgery should be performed, and what the best surgical option is. Male slings (MS) can be divided into adjustable or non-adjustable types, and offers an attractive option for patients who wish to avoid mechanical handling during urinary voiding. Published intermediate data supports good safety and efficacy rate in men with mild to moderate degree of SUI. The AMS 800 artificial urinary sphincter (AUS) remains the standard of treatment for complete continence and has the longest efficacy and safety records. Other AUS-like devices are designed to address current AMS 800 limitations but themselves are fraught with their own issues.

Preparation of alpha sources using magnetohydrodynamic electrodeposition for radionuclide metrology.

PubMed

Panta, Yogendra M; Farmer, Dennis E; Johnson, Paula; Cheney, Marcos A; Qian, Shizhi

2010-02-01

Expanded use of nuclear fuel as an energy resource and terrorist threats to public safety clearly require the development of new state-of-the-art technologies and improvement of safety measures to minimize the exposure of people to radiation and the accidental release of radiation into the environment. The precision in radionuclide metrology is currently limited by the source quality rather than the detector performance. Electrodeposition is a commonly used technique to prepare massless radioactive sources. Unfortunately, the radioactive sources prepared by the conventional electrodeposition method produce poor resolution in alpha spectrometric measurements. Preparing radioactive sources with better resolution and higher yield in the alpha spectrometric range by integrating magnetohydrodynamic convection with the conventional electrodeposition technique was proposed and tested by preparing mixed alpha sources containing uranium isotopes ((238)U, (234)U), plutonium ((239)Pu), and americium ((241)Am) for alpha spectrometric determination. The effects of various parameters such as magnetic flux density, deposition current and time, and pH of the sample solution on the formed massless radioactive sources were also experimentally investigated. Copyright 2009 Elsevier Inc. All rights reserved.

A lithium superionic conductor.

PubMed

Kamaya, Noriaki; Homma, Kenji; Yamakawa, Yuichiro; Hirayama, Masaaki; Kanno, Ryoji; Yonemura, Masao; Kamiyama, Takashi; Kato, Yuki; Hama, Shigenori; Kawamoto, Koji; Mitsui, Akio

2011-07-31

Batteries are a key technology in modern society. They are used to power electric and hybrid electric vehicles and to store wind and solar energy in smart grids. Electrochemical devices with high energy and power densities can currently be powered only by batteries with organic liquid electrolytes. However, such batteries require relatively stringent safety precautions, making large-scale systems very complicated and expensive. The application of solid electrolytes is currently limited because they attain practically useful conductivities (10(-2) S cm(-1)) only at 50-80 °C, which is one order of magnitude lower than those of organic liquid electrolytes. Here, we report a lithium superionic conductor, Li(10)GeP(2)S(12) that has a new three-dimensional framework structure. It exhibits an extremely high lithium ionic conductivity of 12 mS cm(-1) at room temperature. This represents the highest conductivity achieved in a solid electrolyte, exceeding even those of liquid organic electrolytes. This new solid-state battery electrolyte has many advantages in terms of device fabrication (facile shaping, patterning and integration), stability (non-volatile), safety (non-explosive) and excellent electrochemical properties (high conductivity and wide potential window).

A randomized, investigator-masked clinical evaluation of the efficacy and safety of clobetasol propionate 0.05% shampoo and tar blend 1% shampoo in the treatment of moderate to severe scalp psoriasis.

PubMed

Griffiths, Christopher E M; Finlay, Andrew Y; Fleming, Colin J; Barker, Jonathan N W N; Mizzi, Fabienne; Arsonnaud, Stéphanie

2006-01-01

The clinical benefit of currently available tar blend shampoos for the treatment of scalp psoriasis is restricted due to their limited efficacy, low cosmetic appeal and potential for carcinogenicity. This 4-week multicentre, randomized, parallel-group, investigator-masked study included 162 subjects and aimed to compare the efficacy, safety and cosmetic acceptability of clobetasol propionate 0.05% shampoo versus a currently marketed tar blend 1% shampoo in subjects with moderate to severe scalp psoriasis. Clobetasol propionate shampoo was superior to tar blend shampoo with respect to all efficacy variables tested (p<0.001): Total and Global Severity Score; erythema; plaque thickening; desquamation; pruritus; total scalp area involved; and the subject's global assessment of clinical improvement. Both treatments were safe and well-tolerated. Furthermore, more subjects indicated that clobetasol propionate shampoo was more cosmetically acceptable than tar blend shampoo. Clobetasol propionate 0.05% shampoo is a good alternative to tar blend shampoo in the treatment of moderate to severe scalp psoriasis.

Flooding Experiments and Modeling for Improved Reactor Safety

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

Solmos, M.; Hogan, K. J.; Vierow, K.

2008-09-14

Countercurrent two-phase flow and “flooding” phenomena in light water reactor systems are being investigated experimentally and analytically to improve reactor safety of current and future reactors. The aspects that will be better clarified are the effects of condensation and tube inclination on flooding in large diameter tubes. The current project aims to improve the level of understanding of flooding mechanisms and to develop an analysis model for more accurate evaluations of flooding in the pressurizer surge line of a Pressurized Water Reactor (PWR). Interest in flooding has recently increased because Countercurrent Flow Limitation (CCFL) in the AP600 pressurizer surge linemore » can affect the vessel refill rate following a small break LOCA and because analysis of hypothetical severe accidents with the current flooding models in reactor safety codes shows that these models represent the largest uncertainty in analysis of steam generator tube creep rupture. During a hypothetical station blackout without auxiliary feedwater recovery, should the hot leg become voided, the pressurizer liquid will drain to the hot leg and flooding may occur in the surge line. The flooding model heavily influences the pressurizer emptying rate and the potential for surge line structural failure due to overheating and creep rupture. The air-water test results in vertical tubes are presented in this paper along with a semi-empirical correlation for the onset of flooding. The unique aspects of the study include careful experimentation on large-diameter tubes and an integrated program in which air-water testing provides benchmark knowledge and visualization data from which to conduct steam-water testing.« less

Renal denervation: unde venis et quo vadis?

PubMed

Nähle, C P; Düsing, R; Schild, H

2015-04-01

Renal denervation is a minimally invasive, catheter-based option for the treatment of refractory hypertension. Indications and contraindications for renal denervation have been defined in an interdisciplinary manner. The efficacy and safety of the procedure were evaluated. Currently, indication for renal denervation is limited to patients with primary hypertension and a systolic blood pressure of ≥ 160 mm Hg (or ≥ 150 mm Hg in diabetes type 2) despite optimal medical therapy with ≥ 3 different antihypertensive drugs. In this specific patient population, an average blood pressure reduction of 32/14 mmHg was observed in non-randomized/-controlled trials after renal denervation. These results were not confirmed in the first randomized controlled trial with a non-significantly superior blood pressure reduction of 14.1 ± 23.9 mm Hg compared to controls (-11.74 ± 25.94 mm Hg, difference -2.39 mm Hg p = 0.26 for superiority with a margin of 5 mm Hg) who underwent a sham procedure. The efficacy and long-term effects of renal denervation need to be re-evaluated in light of the HTN3 study results. To date, renal denervation should not be performed outside of clinical trials. Future trials should also assess if renal denervation can be performed with sufficient safety and efficacy in patients with hypertension-associated diseases. The use of renal denervation as an alternative therapy (e. g. in patients with drug intolerance) can currently not be advocated. The indication for renal denervation should be assessed in an interdisciplinary fashion and according to current guidelines with a special focus on ruling out secondary causes for arterial hypertension. 5 - 10 % of patients with hypertension suffer from refractory hypertension, but only about 1 % of patients meet the criteria for a renal denervation. Renal denervation leads to a significant decrease in office blood pressure; however, the impact on 24-hour blood pressure measurements remains unclear. In the first randomized controlled trial on renal denervation with a control group undergoing a sham procedure, blood pressure reduction failed to reach the anticipated level of superiority over best medical treatment. Periprocedural complications are rare, but long-term safety can currently not be appraised due to the limited data available. © Georg Thieme Verlag KG Stuttgart · New York.

33 CFR 165.1156 - Safety Zone; Offshore Marine Terminal, El Segundo, CA.

Code of Federal Regulations, 2010 CFR

2010-07-01

... area of the safety zone may contact the Captain of the Port at telephone number 1-800-221-8724 or on... OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS Specific Regulated Navigation Areas and Limited Access Areas Eleventh Coast Guard District...

Safety impacts of differential speed limits on rural interstate highways

DOT National Transportation Integrated Search

2005-10-01

To compare the safety effects of a uniform speed limit (USL) for all vehicles as opposed to a differential speed limit (DSL) for cars and heavy trucks, detailed crash data, speed monitoring data, and traffic volumes were sought for rural interstate h...

The high-βN hybrid scenario for ITER and FNSF steady-state missions

DOE PAGES

Turco, Francesca; Petty, Clinton C.; Luce, Timothy C.; ...

2015-05-15

New experiments on DIII-D have demonstrated the steady-state potential of the hybrid scenario, with 1 MA of plasma current driven fully non-inductively and βN up to 3.7 sustained for ~3 s (~1.5 current diffusion time, τ R, in DIII-D), providing the basis for an attractive option for steady-state operation in ITER and FNSF. Excellent confinement is achieved (H 98y2~1.6) without performance limiting tearing modes. Furthermore, the hybrid regime overcomes the need for off-axis current drive efficiency, taking advantage of poloidal magnetic flux pumping that is believed to be the result of a saturated 3/2 tearing mode. This allows for efficientmore » current drive close to the axis, without deleterious sawtooth instabilities. In these experiments, the edge surface loop voltage is driven down to zero for >1 τ R when the poloidal β is increased above 1.9 at a plasma current of 1.0 MA and the ECH power is increased to 3.2 MW. Stationary operation of hybrid plasmas with all on-axis current drive is sustained at pressures slightly above the ideal no-wall limit, while the calculated ideal with-wall MHD limit is β N~4-4.5. Off-axis NBI power has been used to broaden the pressure and current profiles in this scenario, seeking to take advantage of higher predicted kink stability limits and lower values of the tearing stability index Δ', as calculated by the DCON and PEST3 codes. Our results are based on measured profiles that predict ideal limits at βN>4.5, 10% higher than the cases with on-axis NBI. A 0-D model, based on the present confinement, βN and shape values of the DIII-D hybrid scenario, shows that these plasmas are consistent with the ITER 9 MA, Q=5 mission and the FNSF 6.7 MA scenario with Q=3.5. With collisionality and edge safety factor values comparable to those envisioned for ITER and FNSF, the high-βN hybrid represents an attractive high performance option for the steady-state missions of these devices.« less

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.

PubMed

Chhatbar, Pratik Y; Chen, Rong; Deardorff, Rachael; Dellenbach, Blair; Kautz, Steven A; George, Mark S; Feng, Wuwei

A prior meta-analysis revealed that higher doses of transcranial direct current stimulation (tDCS) have a better post-stroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability of single session of up to 4 mA in stroke patients. We adapted a traditional 3 + 3 study design with a current escalation schedule of 1»2»2.5»3»3.5»4 mA for this tDCS safety study. We administered one 30-min session of bihemispheric montage tDCS and simultaneous customary occupational therapy to patients with first-ever ischemic stroke. We assessed safety with pre-defined stopping rules and investigated tolerability through a questionnaire. Additionally, we monitored body resistance and skin temperature in real-time at the electrode contact site. Eighteen patients completed the study. The current was escalated to 4 mA without meeting the pre-defined stopping rules or causing any major safety concern. 50% of patients experienced transient skin redness without injury. No rise in temperature (range 26°C-35 °C) was noted and skin barrier function remained intact (i.e. body resistance >1 kΩ). Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients. A phase II study to further test the safety and preliminary efficacy with multi-session tDCS at 4 mA (as compared with lower current and sham stimulation) is a logical next step. ClinicalTrials.gov Identifier: NCT02763826. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving access to school based education for South African children in rural areas who have a tracheostomy: A case series and recommendations.

PubMed

Mahomva, Chengetai; Harris, Sue; Seebran, Narvanie; Mudge, Bridget; Catlin, Brian; Davies, Louise

2017-01-01

Currently few children with tracheostomies attend rural mainstreams schools in South Africa limiting their ability to gain an education. We sought to document the current school experience for the few children attending school who have tracheostomies and devise educational tools for teachers and administrators that will facilitate greater acceptance and safety in classrooms for this population. The four patients that are currently attending school with a tracheostomy were identified from the patient records of a tertiary hospital with a pediatric tracheostomy home based care service. With the aid of a Zulu language translator, the mothers and classroom teachers completed a semi structured interview and closed item questionnaire in their home and school, respectively. Schools were visited to understand and describe the settings in which the children and their teachers were being asked to function. Tools for education were developed in conjunction with key stakeholders at schools already hosting such children. The key teacher-identified barriers to enrollment were: teacher unfamiliarity with tracheostomies, uncertainty about the school's liability, and concerns about the response of other children. The safety barriers identified were: greater than 60 children per classroom - limiting teacher's ability to attend to the child with a tracheostomy, lack of running water, pit latrines separate from school threatening hygiene and isolating the child when they leave to use the latrines & sandy classrooms which can result in sand entering the airway. Identified needs for successful school placement include providing tracheostomy supplies and suctioning equipment, hand hygiene materials and training teachers in: identification of respiratory distress, performance of emergency tracheostomy changes, CPR. Children with tracheostomies could likely successfully attend South African rural mainstream public schools with a training program for teachers. As a first step, an introductory booklet for teachers that explains tracheostomies and provides educational and safety suggestions was created. A list of recommendations for successful inclusion of students in the school system was developed together with and delivered to key stakeholders. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Treatment recommendations for DSM-5-defined mixed features.

PubMed

Rosenblat, Joshua D; McIntyre, Roger S

2017-04-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) mixed features specifier provides a less restrictive definition of mixed mood states, compared to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), including mood episodes that manifest with subthreshold symptoms of the opposite mood state. A limited number of studies have assessed the efficacy of treatments specifically for DSM-5-defined mixed features in mood disorders. As such, there is currently an inadequate amount of data to appropriately inform evidence-based treatment guidelines of DSM-5 defined mixed features. However, given the high prevalence and morbidity of mixed features, treatment recommendations based on the currently available evidence along with expert opinion may be of benefit. This article serves to provide these interim treatment recommendations while humbly acknowledging the limited amount of evidence currently available. Second-generation antipsychotics (SGAs) appear to have the greatest promise in the treatment of bipolar disorder (BD) with mixed features. Conventional mood stabilizing agents (ie, lithium and divalproex) may also be of benefit; however, they have been inadequately studied. In the treatment of major depressive disorder (MDD) with mixed features, the comparable efficacy of antidepressants versus other treatments, such as SGAs, remains unknown. As such, antidepressants remain first-line treatment of MDD with or without mixed features; however, there are significant safety concerns associated with antidepressant monotherapy when mixed features are present, which merits increased monitoring. Lurasidone is the only SGA monotherapy that has been shown to be efficacious specifically in the treatment of MDD with mixed features. Further research is needed to accurately determine the efficacy, safety, and tolerability of treatments specifically for mood episodes with mixed features to adequately inform future treatment guidelines.

Efficacy and safety of haloperidol for in-hospital delirium prevention and treatment: A systematic review of current evidence.

PubMed

Schrijver, E J M; de Graaf, K; de Vries, O J; Maier, A B; Nanayakkara, P W B

2016-01-01

Haloperidol is generally considered the drug of choice for in-hospital delirium management. We conducted a systematic review to evaluate the evidence for the efficacy and safety of haloperidol for the prevention and treatment of delirium in hospitalized patients. PubMed, Embase, Cumulative Index to Nursing and Allied Health (CINAHL), PsycINFO, and the Cochrane Library were systematically searched up to April 21, 2015. We included English full-text randomized controlled trials using haloperidol for the prevention or treatment of delirium in adult hospitalized patients reporting on delirium incidence, duration, or severity as primary outcome. Quality of evidence was graded. Meta-analysis was not conducted because of between-study heterogeneity. Twelve studies met our inclusion criteria, four prevention and eight treatment trials. Methodological limitations decreased the graded quality of included studies. Results from placebo-controlled prevention studies suggest a haloperidol-induced protective effect for delirium in older patients scheduled for surgery: two studies reported a significant reduction in ICU delirium incidence and one study found a significant reduction in delirium severity and duration. Although placebo-controlled trials are missing, pharmacological treatment of established delirium reduced symptom severity. Haloperidol administration was not associated with treatment-limiting side-effects, but few studies used a systematic approach to identify adverse events. Although results on haloperidol for delirium management seem promising, current prevention trials lack external validity and treatment trials did not include a placebo arm on top of standard nonpharmacological care. We therefore conclude that the current use of haloperidol for in-hospital delirium is not based on robust and generalizable evidence. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Effect of joint mechanism on vehicle redirectional capability of water-filled road safety barrier systems.

PubMed

Thiyahuddin, M I; Thambiratnam, D P; Gu, Y T

2014-10-01

Portable water-filled barriers (PWFBs) are roadside appurtenances that prevent vehicles from penetrating into temporary construction zones on roadways. PWFBs are required to satisfy the strict regulations for vehicle re-direction in tests. However, many of the current PWFBs fail to re-direct the vehicle at high speeds due to the inability of the joints to provide appropriate stiffness. The joint mechanism hence plays a crucial role in the performance of a PWFB system at high speed impacts. This paper investigates the desired features of the joint mechanism in a PWFB system that can re-direct vehicles at high speeds, while limiting the lateral displacement to acceptable limits. A rectangular "wall" representative of a 30m long barrier system was modeled and a novel method of joining adjacent road barriers was introduced through appropriate pin-joint connections. The impact response of the barrier "wall" and the vehicle was obtained and the results show that a rotational stiffness of 3000kNm/rad at the joints seems to provide the desired features of the PWFB system to re-direct impacting vehicles and restrict the lateral deflection. These research findings will be useful to safety engineers and road barrier designers in developing a new generation of PWFBs for increased road safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya

PubMed Central

Abong', George Ooko

2018-01-01

Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly (P < 0.05) reduced microbial load in OFSP cooked roots but the counts significantly (P < 0.05) increased in the puree due to postprocessing contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree. PMID:29808161

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya.

PubMed

Malavi, Derick Nyabera; Muzhingi, Tawanda; Abong', George Ooko

2018-01-01

Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly ( P < 0.05) reduced microbial load in OFSP cooked roots but the counts significantly ( P < 0.05) increased in the puree due to postprocessing contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log 10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree.

Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors.

PubMed

Sowan, Azizeh Khaled; Reed, Charles Calhoun; Staggers, Nancy

2016-09-30

Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. The audit log is a function of current capabilities of the physiologic monitoring systems, monitor's configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices' log capacity.

A statistical approach to nuclear fuel design and performance

NASA Astrophysics Data System (ADS)

Cunning, Travis Andrew

As CANDU fuel failures can have significant economic and operational consequences on the Canadian nuclear power industry, it is essential that factors impacting fuel performance are adequately understood. Current industrial practice relies on deterministic safety analysis and the highly conservative "limit of operating envelope" approach, where all parameters are assumed to be at their limits simultaneously. This results in a conservative prediction of event consequences with little consideration given to the high quality and precision of current manufacturing processes. This study employs a novel approach to the prediction of CANDU fuel reliability. Probability distributions are fitted to actual fuel manufacturing datasets provided by Cameco Fuel Manufacturing, Inc. They are used to form input for two industry-standard fuel performance codes: ELESTRES for the steady-state case and ELOCA for the transient case---a hypothesized 80% reactor outlet header break loss of coolant accident. Using a Monte Carlo technique for input generation, 105 independent trials are conducted and probability distributions are fitted to key model output quantities. Comparing model output against recognized industrial acceptance criteria, no fuel failures are predicted for either case. Output distributions are well removed from failure limit values, implying that margin exists in current fuel manufacturing and design. To validate the results and attempt to reduce the simulation burden of the methodology, two dimensional reduction methods are assessed. Using just 36 trials, both methods are able to produce output distributions that agree strongly with those obtained via the brute-force Monte Carlo method, often to a relative discrepancy of less than 0.3% when predicting the first statistical moment, and a relative discrepancy of less than 5% when predicting the second statistical moment. In terms of global sensitivity, pellet density proves to have the greatest impact on fuel performance, with an average sensitivity index of 48.93% on key output quantities. Pellet grain size and dish depth are also significant contributors, at 31.53% and 13.46%, respectively. A traditional limit of operating envelope case is also evaluated. This case produces output values that exceed the maximum values observed during the 105 Monte Carlo trials for all output quantities of interest. In many cases the difference between the predictions of the two methods is very prominent, and the highly conservative nature of the deterministic approach is demonstrated. A reliability analysis of CANDU fuel manufacturing parametric data, specifically pertaining to the quantification of fuel performance margins, has not been conducted previously. Key Words: CANDU, nuclear fuel, Cameco, fuel manufacturing, fuel modelling, fuel performance, fuel reliability, ELESTRES, ELOCA, dimensional reduction methods, global sensitivity analysis, deterministic safety analysis, probabilistic safety analysis.

Evaluation and comparison of 50 Hz current threshold of electrocutaneous sensations using different methods

PubMed Central

Lindenblatt, G.; Silny, J.

2006-01-01

Leakage currents, tiny currents flowing from an everyday-life appliance through the body to the ground, can cause a non-adequate perception (called electrocutaneous sensation, ECS) or even pain and should be avoided. Safety standards for low-frequency range are based on experimental results of current thresholds of electrocutaneous sensations, which however show a wide range between about 50 μA (rms) and 1000 μA (rms). In order to be able to explain these differences, the perception threshold was measured repeatedly in experiments with test persons under identical experimental setup, but by means of different methods (measuring strategies), namely: direct adjustment, classical threshold as amperage of 50% perception probability, and confidence rating procedure of signal detection theory. The current is injected using a 1 cm2 electrode at the highly touch sensitive part of the index fingertip. These investigations show for the first time that the threshold of electrocutaneous sensations is influenced both by adaptation to the non-adequate stimulus and individual, emotional factors. Therefore, classical methods, on which the majority of the safety investigations are based, cannot be used to determine a leakage current threshold. The confidence rating procedure of the modern signal detection theory yields a value of 179.5 μA (rms) at 50 Hz power supply net frequency as the lower end of the 95% confidence range considering the variance in the investigated group. This value is expected to be free of adaptation influences, and is distinctly lower than the European limits and supports the stricter regulations of Canada and USA. PMID:17111461

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

PubMed Central

2008-01-01

Introduction Herbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs. Results Unfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products. Conclusions Herbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products. PMID:18415652

Safety focused modeling of lithium-ion batteries: A review

NASA Astrophysics Data System (ADS)

Abada, S.; Marlair, G.; Lecocq, A.; Petit, M.; Sauvant-Moynot, V.; Huet, F.

2016-02-01

Safety issues pertaining to Li-ion batteries justify intensive testing all along their value chain. However, progress in scientific knowledge regarding lithium based battery failure modes, as well as remarkable technologic breakthroughs in computing science, now allow for development and use of prediction tools to assist designers in developing safer batteries. Subsequently, this paper offers a review of significant modeling works performed in the area with a focus on the characterization of the thermal runaway hazard and their relating triggering events. Progress made in models aiming at integrating battery ageing effect and related physics is also discussed, as well as the strong interaction with modeling-focused use of testing, and the main achievements obtained towards marketing safer systems. Current limitations and new challenges or opportunities that are expected to shape future modeling activity are also put in perspective. According to market trends, it is anticipated that safety may still act as a restraint in the search for acceptable compromise with overall performance and cost of lithium-ion based and post lithium-ion rechargeable batteries of the future. In that context, high-throughput prediction tools capable of screening adequate new components properties allowing access to both functional and safety related aspects are highly desirable.

40 CFR 1611.3 - Scope of permissible testimony.

Code of Federal Regulations, 2010 CFR

2010-07-01

... other types of CSB documents, including but not limited to safety recommendations, safety studies, safety proposals, safety accomplishments, reports labeled studies, and analysis reports, as they contain...

Is the current public health message on UV exposure correct?

PubMed Central

Lucas, Robyn M.; Repacholi, Mike H.; McMichael, Anthony J.

2006-01-01

Current sun safety messages stress the importance of sun protection in avoiding the consequences of excessive exposure to ultraviolet radiation (UVR), such as skin cancers, cataracts and other eye diseases, and viral infections caused by UV-induced immunosuppression. However, adequate exposure to UVR has an important role in human health, primarily through UV-induced production of vitamin D, a hormone essential to bone health. Vitamin D insufficiency may be associated with increased risks of some cancers, autoimmune diseases and mental health disorders such as schizophrenia. Here, we review the evolution of current sun exposure practices and sun-safe messages and consider not only the benefits, but also the detrimental effects that such messages may have. UVR-induced vitamin D production can be inhibited by factors such as deep skin pigmentation, indoor lifestyles, older age, sun avoidance behaviours and clothing habits that limit skin exposure, with deleterious consequences for health. There is some early evidence that sun-safe messages are beginning to cause a decrease in skin cancer rates in young people. After the widespread promotion of sun safety, it may now be appropriate to refine public health messages to take better account of variations between groups and their susceptibility to the dangers and benefits of sun exposure. PMID:16799733

Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook

PubMed Central

Kelly, Colleen R.; Kahn, Stacy; Kashyap, Purna; Laine, Loren; Rubin, David; Atreja, Ashish; Moore, Thomas; Wu, Gary

2016-01-01

The community of microorganisms within the human gut (or microbiota) is critical to health and functions with a level of complexity comparable to an organ system. Alterations of this ecology (or dysbiosis) has been implicated in a number of disease states, the prototypical example being Clostridium difficile infection (CDI). Fecal microbiota transplantation (FMT) has been demonstrated to durably alter the gut microbiota of the recipient and has shown efficacy in the treatment of recurrent CDI. There is hope that FMT may eventually prove beneficial for treatment of other disease associated with alterations in gut microbiota, such as inflammatory bowel disease, irritable bowel syndrome and the metabolic syndrome, to name a few. Although the basic principles that underlie the mechanisms by which FMT demonstrates therapeutic efficacy in CDI are becoming apparent, further research is needed to understand the possible role of FMT in these other conditions. Though relatively simple to perform, questions regarding both short- and long-term safety, as well as the complex and rapidly evolving regulatory landscape has limited widespread utilization. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current “whole stool” transplants to increase safety and tolerability. Encapsulated formulations, full spectrum stool-based products and defined microbial consortia are all in the immediate future. PMID:25982290

Food Safety Crisis Management-A Comparison between Germany and the Netherlands.

PubMed

van Asselt, E D; van der Fels-Klerx, H J; Breuer, O; Helsloot, I

2017-02-01

In order to prevent food safety incidents from becoming a crisis, a good crisis management structure is essential. The aim of the current study was to compare and evaluate the national food incident response plans of 2 neighboring EU Member States: Germany and the Netherlands. This revealed that the structure of these plans is comparable, starting with initial alerting, assessment of the problem, upscaling, an execution phase and finally an evaluation of the crisis management. However, the German communication structure is more complex than the Dutch one and cross-border communication between both countries is currently limited. In general, the presence of national response plans does not guarantee a good and swift response to a food safety incident as this is often hampered by difficulties in tracing the source of the problem as well as difficulties in communication between organizations involved in crisis management. A timely detection can be improved through the development of fast screening and detecting systems and through combining various data sources using computer software systems. Mutual cooperation and communication can be improved through joint exercises or projects. This will help to streamline communication toward consumers and trade partners. Such communication should be transparent relaying not only the facts but also the uncertainties in a crisis in order to gain consumer trust and safeguard international trade. © 2017 Institute of Food Technologists®.

Systematic review of reusable versus disposable laparoscopic instruments: costs and safety.

PubMed

Siu, Joey; Hill, Andrew G; MacCormick, Andrew D

2017-01-01

The quality of instruments and surgical expertise in minimally invasive surgery has developed markedly in the last two decades. Attention is now being turned to ways to allow surgeons to adopt more cost-effective and environmental-friendly approaches. This review explores current evidence on the cost and environmental impact of reusable versus single-use instruments. In addition, we aim to compare their quality, functionality and associated clinical outcomes. The Medline and EMBASE databases were searched for relevant literature from January 2000 to May 2015. Subject headings were Equipment Reuse/, Disposable Equipment/, Cholecystectomy/, Laparoscopic/, Laparoscopy/, Surgical Instruments/, Medical Waste Disposal/, Waste Management/, Medical Waste/, Environmental Sustainability/ and Sterilization/. There are few objective comparative analyses between single-use versus reusable instruments. Current evidence suggests that limiting use of disposal instruments to necessity may hold both economical and environmental advantages. Theoretical advantages of single-use instruments in quality, safety, sterility, ease of use and importantly patient outcomes have rarely been examined. Cost-saving methods, environmental-friendly methods, global operative costs, hidden costs, sterilization methods and quality assurance systems vary greatly between studies making it difficult to gain an overview of the comparison between single-use and reusable instruments. Further examination of cost comparisons between disposable and reusable instruments is necessary while externalized environmental costs, instrument function and safety are also important to consider in future studies. © 2016 Royal Australasian College of Surgeons.

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

NASA Astrophysics Data System (ADS)

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

2018-01-01

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

LAVIA--an evaluation of the potential safety benefits of the French intelligent speed adaptation project.

PubMed

Driscoll, R; Page, Y; Lassarre, S; Ehrlich, J

2007-01-01

This paper presents the potential safety benefits of the experimental French LAVIA Intelligent Speed Adaptation system, according to road network and system mode, based on observed driving speeds, distributions of crash severity and crash injury risk. Results are given for car frontal and side impacts that together, represent 80% of all serious and fatal injuries in France. Of the three system modes tested (advisory, driver select, mandatory), our results suggest that driver select would most significantly reduce serious injuries and death. We estimate this 100% utilization of cars equipped with this type of speed adaptation system would decrease injury rates by 6% to 16% over existing conditions depending on the type of crash (frontal or side) and road environment considered. Some limitations associated with the analysis are also identified. LAVIA is the acronym for Limiteur s'Adaptant à la VItesse Autorisée, a French Intelligent Speed Adaptation (ISA) project that was set up towards the end of 1999. At the time, 1998 French national road safety statistics recorded 8437 road related deaths, a figure which had shown virtually no positive evolution since 1994. Detailed analysis of the contributory factors involved in fatal road crashes highlighted the time-honoured crash and injury causation mechanisms - alcohol, speed and seatbelts. Of the three, excessive speed (over and above the posted speed limit) was a contributory factor in half of all fatal crashes Inappropriate behaviour such as excessive speeding can be dealt with either by legislative or driver-incentive programmes. The first of these two solutions involves the introduction of new legislation and/or the enforcement of existing laws. This is the domain of Public Authorities and will not be discussed in detail here. Alternatively, incentive schemes can involve the implementation of speed related driver assistance systems, categorised according to their voluntary or mandatory character and the degree of autonomy proposed to or imposed on the driver. The LAVIA project set out to address several possible combinations of these two factors. The generic term Intelligent Speed Adaptation (ISA) encompasses a wide range of different technologies aimed at improving road safety by reducing traffic speed and homogenising traffic flow, within the limit of posted speed limits. "Fixed speed limit" systems inform the vehicle of the posted speed limit whereas "variable speed limit" systems take into account certain locations on the road network where a speed below the posted limit is desirable, such as sharp curves, pedestrian crossings or crash black spots. Taken one step further, speed limit systems may also take into account weather and traffic flow conditions. These systems are known as "dynamic speed limit" systems and benefit from real time updates for a specific location. The different ISA systems are generally characterised by the degree of freedom of choice given to the driver in moderating his or her speed. Speed limit technologies may be advisory (informing drivers of the current speed limit and speed limit changes), voluntary (allowing the driver to decide whether or not to implement speed limitation) or mandatory (imposing the current speed limit). The information supplied may be provided by way of the road infrastructure (and associated equipment), may be acquired autonomously by the vehicle or may be based on an interaction between the infrastructure and the vehicle. Even the most basic of these systems should be considered as a very useful driver aid, helping the driver to stay within the posted speed limit, avoiding "unnecessary" speeding fines through inattention, modelling driver behaviour through the long term reduction of speeds and reducing driver workload by limiting visual speedometer controls. Vehicle-based ISA systems should not be confused with internal systems. These latter systems rely upon the driver entering the desired travel speed, which is then maintained by cruise control or set as a maximum value by automatic speed regulators. Although these systems will not be discussed in detail here, it should be noted that the engine management technologies that they employ are a vital component of ISA systems.

Non-Use of Motor Vehicle Safety Belts as an Issue in Civil Litigation

DOT National Transportation Integrated Search

1983-08-01

The current and potential role of the "safety belt defense" in civil litigation is studied. The paper presents an overview of the safety belt defense, including an evaluation of current precedent. Based on interviews with leading motor vehicle civil ...

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

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

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

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

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

NASA Astrophysics Data System (ADS)

Suzuki, T.; Isayama, A.; Ide, S.; Fujita, T.; Oikawa, T.; Sakata, S.; Sueoka, M.; Hosoyama, H.; JT-60 Team

2005-09-01

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 (ρCD) by controlling the parallel refractive index N∥ of LH waves through control of phase difference (Δφ) 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 ρCD through Δφ 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)˜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 βN˜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 level, ECCD before the mode onset was more effective than that after mode saturation.

Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22 844 patient years of follow-up from randomised trials

PubMed Central

Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Kirtane, Ajay J; Byrne, Robert A; Williams, David O; Slater, James; Cutlip, Donald E; Feit, Frederick

2012-01-01

Objectives To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. Design Mixed treatment comparison meta-analysis. Data sources and study selection PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes. Primary outcomes Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis). Results From 42 trials with 22 844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents∼sirolimus eluting stents>paclitaxel eluting stents∼zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of “any” stent thrombosis. Conclusions Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such that the everolimus eluting stent was the most efficacious and safe. PMID:22885395

Safety Climate Among Nontraditional Workers in Construction: Arguing for a Focus on Construed External Safety Image.

PubMed

Stiehl, Emily; Forst, Linda

2018-05-01

Safety climate, employees' perceptions of work-related safety, 1 has been promoted as a leading indicator of workplace safety in construction. 2 , 3 While research has primarily examined internal organizational sources (e.g., manager attitudes, formal organizational policies) on these perceptions, external sources of information might be more relevant to construction workers in nontraditional jobs who work for a limited time and/or have limited interaction with other employees. This paper argues for the future development of a construed external safety image scale to measure employees' perceptions about how external groups view their organization's safety. 4 The construed external safety image would capture the external sources that nontraditional workers use to assess safety climate and will allow public health researchers to identify and change dangerous workplaces while more effectively communicating information about safe workplaces to workers. The public health relevance of safety climate and construed external safety image for monitoring and communicating safety to nontraditional workers require examination.

Telepsychiatry in the 21st Century: Transforming Healthcare with Technology

PubMed Central

Deslich, Stacie; Stec, Bruce; Tomblin, Shane; Coustasse, Alberto

2013-01-01

This article describes the benefits and constraints of telemedicine, focusing primarily on the field of psychiatry in the United States with the current system of healthcare. Telepsychiatry is believed to provide better access and higher-quality care to patients who need psychiatric care and cost savings to providers of such care. Telemedicine has been successfully integrated into psychiatric facilities reaching rural areas, prisons, and urban facilities. It has increased the volume of patients that physicians can reach and diagnose, as well as allowing them to treat patients with limitations in mobility. While telepsychiatry has been shown to be beneficial, this technology does have some limitations. Concerns about reimbursement, licensure, privacy, security, patient safety, and interoperability have been identified and present current challenges that providers using telepsychiatry must overcome in order to provide the most effective patient care. As more insurance companies start to reimburse for telepsychiatry treatments at the same rate as for face-to-face visits, this evolving medical field has the potential to grow exponentially. PMID:23861676

Uses and Doses of Local Anesthetics in Fish, Amphibians, and Reptiles.

PubMed

Chatigny, Frederic; Kamunde, Collins; Creighton, Catherine M; Stevens, E Don

2017-05-01

Local anesthetics are an integral part of routine pain management in mammals, yet their use is relatively limited in fish, amphibians and reptiles. These animals frequently undergo potentially painful surgical procedures and therefore could possibly benefit from those drugs. Some recommendations are currently available in the literature concerning analgesic use in these animals. However the pharmacological properties, safety and often efficacy of local anesthetic drugs have not been investigated yet in fish, amphibians, or reptiles. This review compiled current information concerning the use of those agents in fish, reptiles and amphibians to help clinicians make an informed decision as to which dose and drug to use. The resulting literature search showed that the literature concerning use of local analgesics in fish and amphibians is very limited while the literature for reptiles is more extensive. We found few experimental studies evaluating the efficacy of local anesthetics. Further studies would provide additional information for developing guidelines to improve the welfare of fish, amphibians and reptiles.

Uses and Doses of Local Anesthetics in Fish, Amphibians, and Reptiles

PubMed Central

Chatigny, Frederic; Kamunde, Collins; Creighton, Catherine M; Stevens, E Don

2017-01-01

Local anesthetics are an integral part of routine pain management in mammals, yet their use is relatively limited in fish, amphibians and reptiles. These animals frequently undergo potentially painful surgical procedures and therefore could possibly benefit from those drugs. Some recommendations are currently available in the literature concerning analgesic use in these animals. However the pharmacological properties, safety and often efficacy of local anesthetic drugs have not been investigated yet in fish, amphibians, or reptiles. This review compiled current information concerning the use of those agents in fish, reptiles and amphibians to help clinicians make an informed decision as to which dose and drug to use. The resulting literature search showed that the literature concerning use of local analgesics in fish and amphibians is very limited while the literature for reptiles is more extensive. We found few experimental studies evaluating the efficacy of local anesthetics. Further studies would provide additional information for developing guidelines to improve the welfare of fish, amphibians and reptiles. PMID:28535859

Clinical Uses of Botulinum Neurotoxins: Current Indications, Limitations and Future Developments

PubMed Central

Chen, Sheng

2012-01-01

Botulinum neurotoxins (BoNTs) cause flaccid paralysis by interfering with vesicle fusion and neurotransmitter release in the neuronal cells. BoNTs are the most widely used therapeutic proteins. BoNT/A was approved by the U.S. FDA to treat strabismus, blepharospam, and hemificial spasm as early as 1989 and then for treatment of cervical dystonia, glabellar facial lines, axillary hyperhidrosis, chronic migraine and for cosmetic use. Due to its high efficacy, longevity of action and satisfactory safety profile, it has been used empirically in a variety of ophthalmological, gastrointestinal, urological, orthopedic, dermatological, secretory, and painful disorders. Currently available BoNT therapies are limited to neuronal indications with the requirement of periodic injections resulting in immune-resistance for some indications. Recent understanding of the structure-function relationship of BoNTs prompted the engineering of novel BoNTs to extend therapeutic interventions in non-neuronal systems and to overcome the immune-resistance issue. Much research still needs to be done to improve and extend the medical uses of BoNTs. PMID:23162705

Some inadequacies of the current human factors certification process of advanced aircraft technologies

NASA Technical Reports Server (NTRS)

Paries, Jean

1994-01-01

Automation related accidents or serious incidents are not limited to advanced technology aircraft. There is a full history of such accidents with conventional technology aircraft. However, this type of occurrence is far from sparing the newest 'glass cockpit' generation, and it even seems to be a growing contributor to its accident rate. Nevertheless, all these aircraft have been properly certificated according to the relevant airworthiness regulations. Therefore, there is a growing concern that with the technological advancement of air transport aircraft cockpits, the current airworthiness regulations addressing cockpit design and human factors may have reached some level of inadequacy. This paper reviews some aspects of the current airworthiness regulations and certification process related to human factors of cockpit design and focuses on questioning their ability to guarantee the intended safety objectives.

Assessment of the occupational eye lens dose for clinical staff in interventional radiology, cardiology and neuroradiology.

PubMed

Omar, Artur; Kadesjö, Nils; Palmgren, Charlotta; Marteinsdottir, Maria; Segerdahl, Tony; Fransson, Annette

2017-03-20

In accordance with recommendations by the International Commission on Radiological Protection, the current European Basic Safety Standards has adopted a reduced occupational eye lens dose limit of 20 mSv yr -1 . The radiation safety implications of this dose limit is of concern for clinical staff that work with relatively high dose x-ray angiography and interventional radiology. Presented in this work is a thorough assessment of the occupational eye lens dose based on clinical measurements with active personal dosimeters worn by staff during various types of procedures in interventional radiology, cardiology and neuroradiology. Results are presented in terms of the estimated equivalent eye lens dose for various medical professions. In order to compare the risk of exceeding the regulatory annual eye lens dose limit for the widely different clinical situations investigated in this work, the different medical professions were separated into categories based on their distinct work pattern: staff that work (a) regularly beside the patient, (b) in proximity to the patient and (c) typically at a distance from the patient. The results demonstrate that the risk of exceeding the annual eye lens dose limit is of concern for staff category (a), i.e. mainly the primary radiologist/cardiologist. However, the results also demonstrate that the risk can be greatly mitigated if radiation protection shields are used in the clinical routine. The results presented in this work cover a wide range of clinical situations, and can be used as a first indication of the risk of exceeding the annual eye lens dose limit for staff at other medical centres.

Stability of DIII-D high-performance, negative central shear discharges

DOE PAGES

Hanson, Jeremy M.; Berkery, John W.; Bialek, James M.; ...

2017-03-20

Tokamak plasma experiments on the DIII-D device demonstrate high-performance, negative central shear (NCS) equilibria with enhanced stability when the minimum safety factor q min exceeds 2, qualitatively confirming theoretical predictions of favorable stability in the NCS regime. The discharges exhibit good confinement with an L-mode enhancement factor H 89 = 2.5, and are ultimately limited by the ideal-wall external kink stability boundary as predicted by ideal MHD theory, as long as tearing mode (TM) locking events, resistive wall modes (RWMs), and internal kink modes are properly avoided or controlled. Although the discharges exhibit rotating TMs, locking events are avoided asmore » long as a threshold minimum safety factor value q min > 2 is maintained. Fast timescale magnetic feedback control ameliorates RWM activity, expanding the stable operating space and allowing access to β N values approaching the ideal-wall limit. Quickly growing and rotating instabilities consistent with internal kink mode dynamics are encountered when the ideal-wall limit is reached. The RWM events largely occur between the no- and ideal-wall pressure limits predicted by ideal MHD. However, evaluating kinetic contributions to the RWM dispersion relation results in a prediction of passive stability in this regime due to high plasma rotation. In addition, the ideal MHD stability analysis predicts that the ideal-wall limit can be further increased to β N > 4 by broadening the current profile. Furthermore, this path toward improved stability has the potential advantage of being compatible with the bootstrap-dominated equilibria envisioned for advanced tokamak (AT) fusion reactors.« less

Stability of DIII-D high-performance, negative central shear discharges

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

Hanson, Jeremy M.; Berkery, John W.; Bialek, James M.

Tokamak plasma experiments on the DIII-D device demonstrate high-performance, negative central shear (NCS) equilibria with enhanced stability when the minimum safety factor q min exceeds 2, qualitatively confirming theoretical predictions of favorable stability in the NCS regime. The discharges exhibit good confinement with an L-mode enhancement factor H 89 = 2.5, and are ultimately limited by the ideal-wall external kink stability boundary as predicted by ideal MHD theory, as long as tearing mode (TM) locking events, resistive wall modes (RWMs), and internal kink modes are properly avoided or controlled. Although the discharges exhibit rotating TMs, locking events are avoided asmore » long as a threshold minimum safety factor value q min > 2 is maintained. Fast timescale magnetic feedback control ameliorates RWM activity, expanding the stable operating space and allowing access to β N values approaching the ideal-wall limit. Quickly growing and rotating instabilities consistent with internal kink mode dynamics are encountered when the ideal-wall limit is reached. The RWM events largely occur between the no- and ideal-wall pressure limits predicted by ideal MHD. However, evaluating kinetic contributions to the RWM dispersion relation results in a prediction of passive stability in this regime due to high plasma rotation. In addition, the ideal MHD stability analysis predicts that the ideal-wall limit can be further increased to β N > 4 by broadening the current profile. Furthermore, this path toward improved stability has the potential advantage of being compatible with the bootstrap-dominated equilibria envisioned for advanced tokamak (AT) fusion reactors.« less

Current Perspectives on Viable but Non-culturable State in Foodborne Pathogens

PubMed Central

Zhao, Xihong; Zhong, Junliang; Wei, Caijiao; Lin, Chii-Wann; Ding, Tian

2017-01-01

The viable but non-culturable (VBNC) state, a unique state in which a number of bacteria respond to adverse circumstances, was first discovered in 1982. Unfortunately, it has been reported that many foodborne pathogens can be induced to enter the VBNC state by the limiting environmental conditions during food processing and preservation, such as extreme temperatures, drying, irradiation, pulsed electric field, and high pressure stress, as well as the addition of preservatives and disinfectants. After entering the VBNC state, foodborne pathogens will introduce a serious crisis to food safety and public health because they cannot be detected using conventional plate counting techniques. This review provides an overview of the various features of the VBNC state, including the biological characteristics, induction and resuscitation factors, formation and resuscitation mechanisms, detection methods, and relationship to food safety. PMID:28421064

33 CFR 165.20 - Safety zones.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety zones. 165.20 Section 165... WATERWAYS SAFETY REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS Safety Zones § 165.20 Safety zones. A Safety Zone is a water area, shore area, or water and shore area to which, for safety or environmental...

33 CFR 165.20 - Safety zones.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety zones. 165.20 Section 165... WATERWAYS SAFETY REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS Safety Zones § 165.20 Safety zones. A Safety Zone is a water area, shore area, or water and shore area to which, for safety or environmental...

Localized Cell and Drug Delivery for Auditory Prostheses

PubMed Central

Hendricks, Jeffrey L.; Chikar, Jennifer A.; Crumling, Mark A.; Raphael, Yehoash; Martin, David C.

2011-01-01

Localized cell and drug delivery to the cochlea and central auditory pathway can improve the safety and performance of implanted auditory prostheses (APs). While generally successful, these devices have a number of limitations and adverse effects including limited tonal and dynamic ranges, channel interactions, unwanted stimulation of non-auditory nerves, immune rejection, and infections including meningitis. Many of these limitations are associated with the tissue reactions to implanted auditory prosthetic devices and the gradual degeneration of the auditory system following deafness. Strategies to reduce the insertion trauma, degeneration of target neurons, fibrous and bony tissue encapsulation, and immune activation can improve the viability of tissue required for AP function as well as improve the resolution of stimulation for reduced channel interaction and improved place-pitch and level discrimination. Many pharmaceutical compounds have been identified that promote the viability of auditory tissue and prevent inflammation and infection. Cell delivery and gene therapy have provided promising results for treating hearing loss and reversing degeneration. Currently, many clinical and experimental methods can produce extremely localized and sustained drug delivery to address AP limitations. These methods provide better control over drug concentrations while eliminating the adverse effects of systemic delivery. Many of these drug delivery techniques can be integrated into modern auditory prosthetic devices to optimize the tissue response to the implanted device and reduce the risk of infection or rejection. Together, these methods and pharmaceutical agents can be used to optimize the tissue-device interface for improved AP safety and effectiveness. PMID:18573323

Should HRT be duration limited?

PubMed

Pitkin, Joan

2013-12-01

Hormone Replacement Therapy (HRT) has received consistently bad press, despite re-analysis of previous data new studies and supporting Consensus Statements from leading national and international societies. Many women have been convinced by women's journals and the media not to even consider HRT as an option and, General Practitioners, still limit duration to 5 years or, will, arbitrarily, discontinue prescriptions in the early 50s. This article seeks to make sense of our current position. Previous and new evidence on the safety of HRT is reviewed. New data on the long-term consequences of non-treatment of women with Premature Ovarian Insufficiency (POI) is presented and the dichotomy of the older female workforce is explored. From this, a logical plan of management emerges.

Viral hepatitis vaccination during pregnancy.

PubMed

Zhao, Yueyuan; Jin, Hui; Zhang, Xuefeng; Wang, Bei; Liu, Pei

2016-04-02

Viral hepatitis is a serious global public health problem. It is also a common cause of jaundice and gestational complications in pregnant women. Moreover, infected mothers can transmit the virus to their fetus or neonate, which may increase disease burden and decrease quality of life. To date, commercial vaccines have been developed for hepatitis A, B, and E and are available to the general population. The Advisory Committee on Immunization Practices currently accepts emergency vaccination against hepatitis A and B during pregnancy due to benefits that overweight the potential risks. While there are limited data from trials with limited numbers of samples that suggest the efficacy or safety of hepatitis B and E vaccines in pregnant women, additional data are necessary to provide evidence of vaccination during pregnancy.

Effects of materials and design on the criticality and shielding assessment of canister concepts for the disposal of spent nuclear fuel.

PubMed

Gutiérrez, Miguel Morales; Caruso, Stefano; Diomidis, Nikitas

2018-05-19

According to the Swiss disposal concept, the safety of a deep geological repository for spent nuclear fuel (SNF) is based on a multi-barrier system. The disposal canister is an important component of the engineered barrier system, aiming to provide containment of the SNF for thousands of years. This study evaluates the criticality safety and shielding of candidate disposal canister concepts, focusing on the fulfilment of the sub-criticality criterion and on limiting radiolysis processes at the outer surface of the canister which can enhance corrosion mechanisms. The effective neutron multiplication factor (k-eff) and the surface dose rates are calculated for three different canister designs and material combinations for boiling water reactor (BWR) canisters, containing 12 spent fuel assemblies (SFA), and pressurized water reactor (PWR) canisters, with 4 SFAs. For each configuration, individual criticality and shielding calculations were carried out. The results show that k-eff falls below the defined upper safety limit (USL) of 0.95 for all BWR configurations, while staying above USL for the PWR ones. Therefore, the application of a burnup credit methodology for the PWR case is required, being currently under development. Relevant is also the influence of canister material and internal geometry on criticality, enabling the identification of safer fuel arrangements. For a final burnup of 55MWd/kgHM and 30y cooling time, the combined photon-neutron surface dose rate is well below the threshold of 1 Gy/h defined to limit radiation-induced corrosion of the canister in all cases. Copyright © 2018 Elsevier Ltd. All rights reserved.

Assessment of vehicle safety problems for special driving populations

DOT National Transportation Integrated Search

1979-02-16

The report describes vehicle safety problems reported in interviews with 460 physically limited drivers and 41 physically limited non-drivers. The problems reported involved operation of primary and secondary controls, operating other vehicle mechani...

The effect of terrain slope on firefighter safety zone effectiveness

Treesearch

Bret Butler; J. Forthofer; K. Shannon; D. Jimenez; D. Frankman

2010-01-01

The current safety zone guidelines used in the US were developed based on the assumption that the fire and safety zone were located on flat terrain. The minimum safe distance for a firefighter to be from a flame was calculated as that corresponding to a radiant incident energy flux level of 7.0kW-m-2. Current firefighter safety guidelines are based on the assumption...

Evaluating the safety impact of adaptive cruise control in traffic oscillations on freeways.

PubMed

Li, Ye; Li, Zhibin; Wang, Hao; Wang, Wei; Xing, Lu

2017-07-01

Adaptive cruise control (ACC) has been considered one of the critical components of automated driving. ACC adjusts vehicle speeds automatically by measuring the status of the ego-vehicle and leading vehicle. Current commercial ACCs are designed to be comfortable and convenient driving systems. Little attention is paid to the safety impacts of ACC, especially in traffic oscillations when crash risks are the highest. The primary objective of this study was to evaluate the impacts of ACC parameter settings on rear-end collisions on freeways. First, the occurrence of a rear-end collision in a stop-and-go wave was analyzed. A car-following model in an integrated ACC was developed for a simulation analysis. The time-to-collision based factors were calculated as surrogate safety measures of the collision risk. We also evaluated different market penetration rates considering that the application of ACC will be a gradual process. The results showed that the safety impacts of ACC were largely affected by the parameters. Smaller time delays and larger time gaps improved safety performance, but inappropriate parameter settings increased the collision risks and caused traffic disturbances. A higher reduction of the collision risk was achieved as the ACC vehicle penetration rate increased, especially in the initial stage with penetration rates of less than 30%. This study also showed that in the initial stage, the combination of ACC and a variable speed limit achieved better safety improvements on congested freeways than each single technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

Burn injury models of care: A review of quality and cultural safety for care of Indigenous children.

PubMed

Fraser, Sarah; Grant, Julian; Mackean, Tamara; Hunter, Kate; Holland, Andrew J A; Clapham, Kathleen; Teague, Warwick J; Ivers, Rebecca Q

2018-05-01

Safety and quality in the systematic management of burn care is important to ensure optimal outcomes. It is not clear if or how burn injury models of care uphold these qualities, or if they provide a space for culturally safe healthcare for Indigenous peoples, especially for children. This review is a critique of publically available models of care analysing their ability to facilitate safe, high-quality burn care for Indigenous children. Models of care were identified and mapped against cultural safety principles in healthcare, and against the National Health and Medical Research Council standard for clinical practice guidelines. An initial search and appraisal of tools was conducted to assess suitability of the tools in providing a mechanism to address quality and cultural safety. From the 53 documents found, 6 were eligible for review. Aspects of cultural safety were addressed in the models, but not explicitly, and were recorded very differently across all models. There was also limited or no cultural consultation documented in the models of care reviewed. Quality in the documents against National Health and Medical Research Council guidelines was evident; however, description or application of quality measures was inconsistent and incomplete. Gaps concerning safety and quality in the documented care pathways for Indigenous peoples' who sustain a burn injury and require burn care highlight the need for investigation and reform of current practices. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Identification of serious and reportable events in home care: a Delphi survey to develop consensus.

PubMed

Doran, Diane M; Baker, G Ross; Szabo, Cathy; McShane, Julie; Carryer, Jennifer

2014-04-01

To assess which client events should be considered reportable and preventable in home care (HC) settings in the opinion of HC safety experts. Patient safety in acute care settings has been well documented; however, there are limited data about this issue in HC. While many organizations collect information about 'incidents', there are no standards for reporting and it is challenging to compare incident rates among organizations. A 29-item electronic survey that included potential HC safety issues was used in a two-round Delphi study. Twenty-four pan-Canadian HC safety experts participated in an electronic survey. Perceived reportability and preventability of patient safety events, HC. The events that were perceived as being most reportable and preventable included the following: a serious injury related to inappropriate client service plan (e.g. incomplete/inaccurate assessments, poor care plan design, flawed implementation); an adverse reaction requiring emergency room visit or hospitalization related to a medication-related event; a catheter-site infection (e.g. a new peritoneal dialysis infection or peritonitis); any serious event related to care or services that are contrary to current professional or other practice standards (e.g. incorrect treatment regimen, theft, retention of a foreign object in a wound, individual practicing outside scope or competence). These data represent an important step in the development and validation of standard metrics about client safety in HC. The results address an expanding area of health services where there is a need to improve standardization and reporting.

Restricting resident work hours: the good, the bad, and the ugly.

PubMed

Peets, Adam; Ayas, Najib T

2012-03-01

Inadequate sleep and long work hours are long-standing traditions in the medical profession, and work schedules are especially intense in resident physicians. However, it has been increasingly recognized that the extreme hours commonly worked by residents may have substantial occupational and patient safety consequences. Largely because of these concerns, new regulations related to resident work hours came into effect July 2011, in the United States. Residents in their first year of training are now restricted to a maximum shift length of 16 hrs, with residents in subsequent years restricted to a maximum of 24 hrs. The purpose of this review is to summarize the literature regarding resident work hours in the intensive care unit, focusing on the potential positive and negative impacts of work hour limits. The authors electronically searched MEDLINE, manually searched reference lists from retrieved articles, and reviewed their own personal databases for articles relevant to resident work hour limits. To function well, humans, including physicians, require adequate sleep. Resident work hour limits will likely reduce the incidence of fatigue-related medical errors and improve resident safety and quality of life. However, a reduction in work hours may not represent the panacea for patient safety given the potential for increased errors because of discontinuity. Furthermore, there may be other substantial negative impacts, including reduced clinical exposure, erosion of professionalism, and inadequate preparation for independent practice. Costs of implementation are likely to be substantial. Currently, there is fairly limited evidence available, and a more in-depth understanding of this complex topic is required to design a residency experience that will provide the next generation of physicians the best compromise between education, experience, and quality patient care. In the end, the primary goal of the postgraduate medical education system must be to ensure the creation of healthy physicians who can provide excellent clinical care in this complex interdisciplinary medical industry and who will have long fulfilling careers providing this outstanding care to their patients.

Paper-based analytical devices for clinical diagnosis: recent advances in the fabrication techniques and sensing mechanisms

PubMed Central

Sher, Mazhar; Zhuang, Rachel; Demirci, Utkan; Asghar, Waseem

2017-01-01

Introduction There is a significant interest in developing inexpensive portable biosensing platforms for various applications including disease diagnostics, environmental monitoring, food safety, and water testing at the point-of-care (POC) settings. Current diagnostic assays available in the developed world require sophisticated laboratory infrastructure and expensive reagents. Hence, they are not suitable for resource-constrained settings with limited financial resources, basic health infrastructure, and few trained technicians. Cellulose and flexible transparency paper-based analytical devices have demonstrated enormous potential for developing robust, inexpensive and portable devices for disease diagnostics. These devices offer promising solutions to disease management in resource-constrained settings where the vast majority of the population cannot afford expensive and highly sophisticated treatment options. Areas covered In this review, the authors describe currently developed cellulose and flexible transparency paper-based microfluidic devices, device fabrication techniques, and sensing technologies that are integrated with these devices. The authors also discuss the limitations and challenges associated with these devices and their potential in clinical settings. Expert commentary In recent years, cellulose and flexible transparency paper-based microfluidic devices have demonstrated the potential to become future healthcare options despite a few limitations such as low sensitivity and reproducibility. PMID:28103450

Paper-based analytical devices for clinical diagnosis: recent advances in the fabrication techniques and sensing mechanisms.

PubMed

Sher, Mazhar; Zhuang, Rachel; Demirci, Utkan; Asghar, Waseem

2017-04-01

There is a significant interest in developing inexpensive portable biosensing platforms for various applications including disease diagnostics, environmental monitoring, food safety, and water testing at the point-of-care (POC) settings. Current diagnostic assays available in the developed world require sophisticated laboratory infrastructure and expensive reagents. Hence, they are not suitable for resource-constrained settings with limited financial resources, basic health infrastructure, and few trained technicians. Cellulose and flexible transparency paper-based analytical devices have demonstrated enormous potential for developing robust, inexpensive and portable devices for disease diagnostics. These devices offer promising solutions to disease management in resource-constrained settings where the vast majority of the population cannot afford expensive and highly sophisticated treatment options. Areas covered: In this review, the authors describe currently developed cellulose and flexible transparency paper-based microfluidic devices, device fabrication techniques, and sensing technologies that are integrated with these devices. The authors also discuss the limitations and challenges associated with these devices and their potential in clinical settings. Expert commentary: In recent years, cellulose and flexible transparency paper-based microfluidic devices have demonstrated the potential to become future healthcare options despite a few limitations such as low sensitivity and reproducibility.

If I had a magic wand....Wish list of a dermatologist (Conference Presentation)

NASA Astrophysics Data System (ADS)

Kelly, Kristen M.

2016-02-01

Challenges in dermatology that can be addressed by photonics research will be explored. Non-invasive, real-time diagnosis of skin lesions would eliminate biopsy risks, minimize patient anxiety by providing more rapid answers and allow diagnosis and treatment in a single visit. Multiple approaches have been tried, but significant limitations of current technologies make them impractical for routine clinic implementation. Photonics can also be used for treatment assessment to determine if intervention is adequate or if further treatment is needed. Ideal feedback should be non-invasive, rapid and accurate. Monitoring for potential adverse effects can greatly improve treatment safety, allowing clinicians to push the limits of therapy while preventing serious complications. Light based therapies can also be improved by increasing photon penetration and selectivity for targeted cells or skin structures. Current light based treatments are in many cases limited by photon penetration. In addition, we often seek to damage a specific chromophore but are not able to distinguish between targeted disease and non-targeted normal structures such as the cells of a melanoma and normal melanocytes and port wine stain versus normal vasculature. Scientist and clinician collaboration can address these and other issues and greatly improve patient care.

Organization of research team for nano-associated safety assessment in effort to study nanotoxicology of zinc oxide and silica nanoparticles

PubMed Central

Kim, Yu-Ri; Park, Sung Ha; Lee, Jong-Kwon; Jeong, Jayoung; Kim, Ja Hei; Meang, Eun-Ho; Yoon, Tae Hyun; Lim, Seok Tae; Oh, Jae-Min; An, Seong Soo A; Kim, Meyoung-Kon

2014-01-01

Currently, products made with nanomaterials are used widely, especially in biology, bio-technologies, and medical areas. However, limited investigations on potential toxicities of nanomaterials are available. Hence, diverse and systemic toxicological data with new methods for nanomaterials are needed. In order to investigate the nanotoxicology of nanoparticles (NPs), the Research Team for Nano-Associated Safety Assessment (RT-NASA) was organized in three parts and launched. Each part focused on different contents of research directions: investigators in part I were responsible for the efficient management and international cooperation on nano-safety studies; investigators in part II performed the toxicity evaluations on target organs such as assessment of genotoxicity, immunotoxicity, or skin penetration; and investigators in part III evaluated the toxicokinetics of NPs with newly developed techniques for toxicokinetic analyses and methods for estimating nanotoxicity. The RT-NASA study was carried out in six steps: need assessment, physicochemical property, toxicity evaluation, toxicokinetics, peer review, and risk communication. During the need assessment step, consumer responses were analyzed based on sex, age, education level, and household income. Different sizes of zinc oxide and silica NPs were purchased and coated with citrate, L-serine, and L-arginine in order to modify surface charges (eight different NPs), and each of the NPs were characterized by various techniques, for example, zeta potentials, scanning electron microscopy, and transmission electron microscopy. Evaluation of the “no observed adverse effect level” and systemic toxicities of all NPs were performed by thorough evaluation steps and the toxicokinetics step, which included in vivo studies with zinc oxide and silica NPs. A peer review committee was organized to evaluate and verify the reliability of toxicity tests, and the risk communication step was also needed to convey the current findings to academia, industry, and consumers. Several limitations were encountered in the RT-NASA project, and they are discussed for consideration for improvements in future studies. PMID:25565821

Organization of research team for nano-associated safety assessment in effort to study nanotoxicology of zinc oxide and silica nanoparticles.

PubMed

Kim, Yu-Ri; Park, Sung Ha; Lee, Jong-Kwon; Jeong, Jayoung; Kim, Ja Hei; Meang, Eun-Ho; Yoon, Tae Hyun; Lim, Seok Tae; Oh, Jae-Min; An, Seong Soo A; Kim, Meyoung-Kon

2014-01-01

Currently, products made with nanomaterials are used widely, especially in biology, bio-technologies, and medical areas. However, limited investigations on potential toxicities of nanomaterials are available. Hence, diverse and systemic toxicological data with new methods for nanomaterials are needed. In order to investigate the nanotoxicology of nanoparticles (NPs), the Research Team for Nano-Associated Safety Assessment (RT-NASA) was organized in three parts and launched. Each part focused on different contents of research directions: investigators in part I were responsible for the efficient management and international cooperation on nano-safety studies; investigators in part II performed the toxicity evaluations on target organs such as assessment of genotoxicity, immunotoxicity, or skin penetration; and investigators in part III evaluated the toxicokinetics of NPs with newly developed techniques for toxicokinetic analyses and methods for estimating nanotoxicity. The RT-NASA study was carried out in six steps: need assessment, physicochemical property, toxicity evaluation, toxicokinetics, peer review, and risk communication. During the need assessment step, consumer responses were analyzed based on sex, age, education level, and household income. Different sizes of zinc oxide and silica NPs were purchased and coated with citrate, L-serine, and L-arginine in order to modify surface charges (eight different NPs), and each of the NPs were characterized by various techniques, for example, zeta potentials, scanning electron microscopy, and transmission electron microscopy. Evaluation of the "no observed adverse effect level" and systemic toxicities of all NPs were performed by thorough evaluation steps and the toxicokinetics step, which included in vivo studies with zinc oxide and silica NPs. A peer review committee was organized to evaluate and verify the reliability of toxicity tests, and the risk communication step was also needed to convey the current findings to academia, industry, and consumers. Several limitations were encountered in the RT-NASA project, and they are discussed for consideration for improvements in future studies.

Risk analysis for worker exposure to benzene

NASA Astrophysics Data System (ADS)

Hallenbeck, William H.; Flowers, Roxanne E.

1992-05-01

Cancer risk factors (characterized by route, dose, dose rate per kilogram, fraction of lifetime exposed, species, and sex) were derived for workers exposed to benzene via inhalation or ingestion. Exposure at the current Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) and at leaking underground storage tank (LUST) sites were evaluated. At the current PEL of 1 ppm, the theoretical lifetime excess risk of cancer from benzene inhalation is ten per 1000. The theoretical lifetime excess risk for worker inhalation exposure at LUST sites ranged from 10 to 40 per 1000. These results indicate that personal protection should be required. The theoretical lifetime excess risk due to soil ingestion is five to seven orders of magnitude less than the inhalation risks.

On the use of naturalistic methods to examine safety-relevant behaviours amongst children and evaluate a cycling education program.

PubMed

Hatfield, J; Dozza, M; Patton, D A; Maharaj, P; Boufous, S; Eveston, T

2017-11-01

School-based cycling education programs aim to improve cycling safety and participation amongst children. Available research suggests that typical programs, which focus on bicycle manoeuvring skills, have limited effects on behaviour observed on a track or planned route. The current study uses theoretically more valid, naturalistic cycling data, to evaluate Safe Cycle, a program that incorporates hazard and self-awareness training. Soon after Safe Cycle was delivered at treatment schools, research bicycles instrumented with a rearward- and a forward-facing camera were loaned to six children from treatment schools and six children from (waitlist) control schools. In each group half the children were in Year 6, and half were in Year 7/8. Each child was instructed to ride the research bicycle instead of their own bicycle for the 1-2 weeks that they had a research bicycle. Video data were reduced using a purpose-designed coding scheme that identified whether participants performed specific safety-relevant behaviours in appropriate circumstances. While the participants controlled their bicycles well, gave way appropriately to traffic at intersections, and stopped at red lights, participants frequently removed one or both hands from the handlebars, and seldom signalled turns, conducted over-shoulder-checks when changing lanes, or looked in multiple directions at intersections (except when crossing a road). While aspects of design and small sample sizes limited evaluation findings, this research demonstrated the feasibility and potential of naturalistic data to support cycling education program evaluation. Further, the study substantially extended available naturalistic study of children's cycling behaviour to highlight behaviours which might be targeted by cycling safety initiatives. Copyright © 2017 Elsevier Ltd. All rights reserved.

A new understanding of multiple-pulsed laser-induced retinal injury thresholds.

PubMed

Lund, David J; Sliney, David H

2014-04-01

Laser safety standards committees have struggled for years to formulate adequately a sound method for treating repetitive-pulse laser exposures. Safety standards for lamps and LEDs have ignored this issue because averaged irradiance appeared to treat the issue adequately for large retinal image sizes and skin exposures. Several authors have recently questioned the current approach of three test conditions (i.e., limiting single-pulse exposure, average irradiance, and a single-pulse-reduction factor) as still insufficient to treat pulses of unequal energies or certain pulse groupings. Schulmeister et al. employed thermal modeling to show that a total-on-time pulse (TOTP) rule was conservative. Lund further developed the approach of probability summation proposed by Menendez et al. to explain pulse-additivity, whereby additivity is the result of an increasing probability of detecting injury with multiple pulse exposures. This latter argument relates the increase in detection probability to the slope of the probit curve for the threshold studies. Since the uncertainty in the threshold for producing an ophthalmoscopically detectable minimal visible lesion (MVL) is large for retinal exposure to a collimated laser beam, safety committees traditionally applied large risk reduction factors ("safety factors") of one order of magnitude when deriving intrabeam, "point-source" exposure limits. This reduction factor took into account the probability of visually detecting the low-contrast lesion among other factors. The reduction factor is smaller for large spot sizes where these difficulties are quite reduced. Thus the N⁻⁰·²⁵ reduction factor may result from the difficulties in detecting the lesion. Recent studies on repetitive pulse exposures in both animal and in vitro (retinal explant) models support this interpretation of the available data.

Electrolyte additive enabled fast charging and stable cycling lithium metal batteries

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

Zheng, Jianming; Engelhard, Mark H.; Mei, Donghai

2017-03-01

Lithium (Li) metal battery is an attractive energy storage system owing to the ultrahigh specific capacity and the lowest redox potential of Li metal anode. However, safety concern associated with dendrite growth and limited cycle life especially at a high charge current density are two critical challenges hindering the practical applications of rechargeable Li metal batteries. Here, we report for the first time that an optimal amount (0.05 M) of LiPF6 as additive in the LiTFSI-LiBOB dual-salt/carbonate-based electrolyte can significantly enhance the charging capability and the long-term cycle life of Li metal batteries with a moderately high cathode loading ofmore » 1.75 mAh cm-2. Unprecedented stable-cycling (97.1% capacity retention after 500 cycles) along with very limited increase in electrode over-potential has been achieved at a high current density of 1.75 mA cm-2. This unparalleled fast charging and stable cycling performance is contributed from both the stabilized Al cathode current collector, and, more importantly, the robust and conductive SEI layer formed on Li metal anode in the presence of the LiPF6 additive.« less

Budesonide for the Treatment of Ulcerative Colitis

PubMed Central

Abdalla, Maisa I.; Herfarth, Hans

2016-01-01

Introduction Budesonide is a synthetic corticosteroid characterized by enhanced topical potency and limited systemic bioavailability. Its use in ulcerative colitis (UC) was limited to rectal preparations until recently when the new oral budesonide formulation incorporating the multi-matrix system technology was introduced. The purpose of this review is to evaluate the current role of oral and rectal budesonide in managing UC patients Areas Covered In this paper, we described the chemical structure and pharmacologic characteristics of the different oral and rectal budesonide preparations, provided a summary of the published trials that evaluated the efficacy and safety of budesonide in UC, and discussed the current status of its use in this population Expert Opinion Budesonide is effective in inducing remission in a subset of patients with mild-moderate UC. Nevertheless, the current evidence suggests inferiority of oral budesonide to 5-aminosalisylates (5-ASA) and systemic steroids, whereas rectal applications are comparable to other rectal steroid preparations but still inferior to rectal 5-ASA. In clinical practice, several issues need clarification including, its exact position in the line of induction agents; the role of combining budesonide and 5-ASAs; the role of combining oral and rectal budesonide; and the role of budesonide in maintenance therapy. PMID:27157244

Budesonide for the treatment of ulcerative colitis.

PubMed

Abdalla, Maisa I; Herfarth, Hans

2016-08-01

Budesonide is a synthetic corticosteroid characterized by enhanced topical potency and limited systemic bioavailability. Its use in ulcerative colitis (UC) was limited to rectal preparations until recently when the new oral budesonide formulation incorporating the multi-matrix system technology was introduced. The purpose of this review is to evaluate the current role of oral and rectal budesonide in managing UC patients Areas covered: In this paper, we described the chemical structure and pharmacologic characteristics of the different oral and rectal budesonide preparations, provided a summary of the published trials that evaluated the efficacy and safety of budesonide in UC, and discussed the current status of its use in this population Expert opinion: Budesonide is effective in inducing remission in a subset of patients with mild-moderate UC. Nevertheless, the current evidence suggests inferiority of oral budesonide to 5-aminosalisylates (5-ASA) and systemic steroids, whereas rectal applications are comparable to other rectal steroid preparations, but still inferior to rectal 5-ASA. In clinical practice, several issues need clarification including, its exact position in the line of induction agents; the role of combining budesonide and 5-ASAs; the role of combining oral and rectal budesonide; and the role of budesonide in maintenance therapy.

Food safety management systems performance in African food processing companies: a review of deficiencies and possible improvement strategies.

PubMed

Kussaga, Jamal B; Jacxsens, Liesbeth; Tiisekwa, Bendantunguka Pm; Luning, Pieternel A

2014-08-01

This study seeks to provide insight into current deficiencies in food safety management systems (FSMS) in African food-processing companies and to identify possible strategies for improvement so as to contribute to African countries' efforts to provide safe food to both local and international markets. This study found that most African food products had high microbiological and chemical contamination levels exceeding the set (legal) limits. Relative to industrialized countries, the study identified various deficiencies at government, sector/branch, retail and company levels which affect performance of FSMS in Africa. For instance, very few companies (except exporting and large companies) have implemented HACCP and ISO 22000:2005. Various measures were proposed to be taken at government (e.g. construction of risk-based legislative frameworks, strengthening of food safety authorities, recommend use of ISO 22000:2005, and consumers' food safety training), branch/sector (e.g. sector-specific guidelines and third-party certification), retail (develop stringent certification standards and impose product specifications) and company levels (improving hygiene, strict raw material control, production process efficacy, and enhancing monitoring systems, assurance activities and supportive administrative structures). By working on those four levels, FSMS of African food-processing companies could be better designed and tailored towards their production processes and specific needs to ensure food safety. © 2014 Society of Chemical Industry.

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

PubMed

Kayashima, Kotaro

2013-10-01

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

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

PubMed

Sultana, Janet; Spina, Edoardo; Trifirò, Gianluca

2015-06-01

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

Methodology, status, and plans for development and assessment of the RELAP5 code

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

Johnson, G.W.; Riemke, R.A.

1997-07-01

RELAP/MOD3 is a computer code used for the simulation of transients and accidents in light-water nuclear power plants. The objective of the program to develop and maintain RELAP5 was and is to provide the U.S. Nuclear Regulatory Commission with an independent tool for assessing reactor safety. This paper describes code requirements, models, solution scheme, language and structure, user interface validation, and documentation. The paper also describes the current and near term development program and provides an assessment of the code`s strengths and limitations.

Structural interaction with transportation and handling systems

NASA Technical Reports Server (NTRS)

1973-01-01

Problems involved in the handling and transportation of finished space vehicles from the factory to the launch site are presented, in addition to recommendations for properly accounting for in space vehicle structural design, adverse interactions during transportation. Emphasis is given to the protection of vehicle structures against those environments and loads encountered during transportation (including temporary storage) which would exceed the levels that the vehicle can safely withstand. Current practices for verifying vehicle safety are appraised, and some of the capabilities and limitations of transportation and handling systems are summarized.

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

PubMed

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

2018-01-01

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

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Integrated photoacoustic microscopy, optical coherence tomography, and fluorescence microscopy for multimodal chorioretinal imaging

NASA Astrophysics Data System (ADS)

Tian, Chao; Zhang, Wei; Nguyen, Van Phuc; Huang, Ziyi; Wang, Xueding; Paulus, Yannis M.

2018-02-01

Current clinical available retinal imaging techniques have limitations, including limited depth of penetration or requirement for the invasive injection of exogenous contrast agents. Here, we developed a novel multimodal imaging system for high-speed, high-resolution retinal imaging of larger animals, such as rabbits. The system integrates three state-of-the-art imaging modalities, including photoacoustic microscopy (PAM), optical coherence tomography (OCT), and fluorescence microscopy (FM). In vivo experimental results of rabbit eyes show that the PAM is able to visualize laser-induced retinal burns and distinguish individual eye blood vessels using a laser exposure dose of 80 nJ, which is well below the American National Standards Institute (ANSI) safety limit 160 nJ. The OCT can discern different retinal layers and visualize laser burns and choroidal detachments. The novel multi-modal imaging platform holds great promise in ophthalmic imaging.

Burn Control Mechanisms in Tokamaks

NASA Astrophysics Data System (ADS)

Hill, M. A.; Stacey, W. M.

2015-11-01

Burn control and passive safety in accident scenarios will be an important design consideration in future tokamak reactors, in particular fusion-fission hybrid reactors, e.g. the Subcritical Advanced Burner Reactor. We are developing a burning plasma dynamics code to explore various aspects of burn control, with the intent to identify feedback mechanisms that would prevent power excursions. This code solves the coupled set of global density and temperature equations, using scaling relations from experimental fits. Predictions of densities and temperatures have been benchmarked against DIII-D data. We are examining several potential feedback mechanisms to limit power excursions: i) ion-orbit loss, ii) thermal instability density limits, iii) MHD instability limits, iv) the degradation of alpha-particle confinement, v) modifications to the radial current profile, vi) ``divertor choking'' and vii) Type 1 ELMs. Work supported by the US DOE under DE-FG02-00ER54538, DE-FC02-04ER54698.

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 the current levels of patient safety to a broad range of factors and believe that many different solutions can contribute to enhanced patient safety in the future, suggesting that this work must be multifactorial. PMID:23391301

Safety Surveillance of Traditional Chinese Medicine: Current and Future

PubMed Central

Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli

2015-01-01

Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. PMID:25647717

14 CFR 414.11 - Application.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

14 CFR 414.11 - Application.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety.

PubMed

Beran, Jiří; Xie, Fang; Zent, Olaf

2014-07-23

Long-term vaccination programs are recommended for individuals living in regions endemic for tick-borne encephalitis (TBE). Current recommendations suggest a first booster vaccine be administered 3 years after a conventional regimen or 12-18 months after a rapid regimen. However, the research supporting subsequent booster intervals is limited. The aim of this study was thus to evaluate the long-term persistence of TBE antibodies in adults and adolescents after a first booster dose with Encepur(®). A total of 323 subjects aged 15 years and over, who had received one of four different primary TBE vaccination series in a parent study, participated in this follow-up Phase IV trial. Immunogenicity and safety were assessed for up to five years after a first booster dose, which was administered three years after completion of the primary series. One subset of subjects was excluded from the booster vaccination since they had already received their booster prior to enrollment. For comparison, immune responses were still recorded for these subjects on Day 0 and on an annual basis until Year 5, but safety information was not collected. Following a booster vaccination, high antibody titers were recorded in all groups throughout the study. Neutralization test (NT) titers of ≥ 10 were noted in at least 94% of subjects at every time point post-booster (on Day 21 and through Years 1-5). These results demonstrated that a first booster vaccination following any primary immunization schedule results in high and long-lasting (>5 years) immune responses. These data lend support to the current belief that subsequent TBE booster intervals could be extended from the current recommendation. NCT00387634. Copyright © 2014 Elsevier Ltd. All rights reserved.

The novel antiarrhythmic drug dronedarone: comparison with amiodarone.

PubMed

Kathofer, Sven; Thomas, Dierk; Karle, Christoph A

2005-01-01

Dronedarone is a noniodinated benzofuran derivative that has been developed to overcome the limiting iodine-associated adverse effects of the commonly used antiarrhythmic drug, amiodarone. It displays a wide cellular electrophysiological spectrum largely similar to amiodarone, inhibiting the potassium currents I(Kr), I(Ks), I(KI), I(KACh), and I(sus), as well as sodium currents and L-type calcium currents in isolated cardiomyocytes. In addition, dronedarone exhibits antiadrenergic properties. In vivo, dronedarone has been shown to be more effective than amiodarone in several arrhythmia models, particularly in preventing ischemia- and reperfusion-induced ventricular fibrillation and in reducing mortality. However, an increased incidence of torsades de pointes with dronedarone in dogs shows that possible proarrhythmic effects of dronedarone require further evaluation. The clinical trails DAFNE, EURIDIS, and ADONIS indicated safety, antiarrhythmic efficacy and low proarrhythmic potential of the drug in low-risk patients. In contrast, the increased incidence of death in the dronedarone group of the discontinued ANDROMEDA trial raises safety concerns for patients with congestive heart failure and moderate to severe left ventricular dysfunction. Dronedarone appears to be effective in preventing relapses of atrial fibrillation and atrial flutter. Torsades de pointes, the most severe adverse effect associated with amiodarone, has not yet been reported in humans with dronedarone. Unlike amiodarone, dronedarone had little effect on thyroid function and hormone levels in animal models and had no significant effects on human thyroid function in clinical trials. In conclusion, dronedarone could be a useful drug for prevention of atrial fibrillation and atrial flutter relapses in low-risk patients. However, further experimental studies and long-term clinical trials are required to provide additional evidence of efficacy and safety of dronedarone.

Shelf Life of Food Products: From Open Labeling to Real-Time Measurements.

PubMed

Corradini, Maria G

2018-03-25

The labels currently used on food and beverage products only provide consumers with a rough guide to their expected shelf lives because they assume that a product only experiences a limited range of predefined handling and storage conditions. These static labels do not take into consideration conditions that might shorten a product's shelf life (such as temperature abuse), which can lead to problems associated with food safety and waste. Advances in shelf-life estimation have the potential to improve the safety, reliability, and sustainability of the food supply. Selection of appropriate kinetic models and data-analysis techniques is essential to predict shelf life, to account for variability in environmental conditions, and to allow real-time monitoring. Novel analytical tools to determine safety and quality attributes in situ coupled with modern tracking technologies and appropriate predictive tools have the potential to provide accurate estimations of the remaining shelf life of a food product in real time. This review summarizes the necessary steps to attain a transition from open labeling to real-time shelf-life measurements.

The road against fatalities: infrastructure spending vs. regulation??

PubMed

Albalate, Daniel; Fernández, Laura; Yarygina, Anastasiya

2013-10-01

The road safety literature is typified by a high degree of compartmentalization between studies that focus on infrastructure and traffic conditions and those devoted to the evaluation of public policies and regulations. As a result, few studies adopt a unified empirical framework in their attempts at evaluating the road safety performance of public interventions, thus limiting our understanding of successful strategies in this regard. This paper considers both types of determinants in an analysis of a European country that has enjoyed considerable success in reducing road fatalities. After constructing a panel data set with road safety outcomes for all Spanish provinces between 1990 and 2009, we evaluate the role of the technical characteristics of infrastructure and recent infrastructure spending together with the main regulatory changes introduced. Our results show the importance of considering both types of determinants in a unified framework. Moreover, we highlight the importance of maintenance spending given its effectiveness in reducing fatalities and casualties in the current economic context of austerity that is having such a marked impact on investment efforts in Spain. Copyright © 2013 Elsevier Ltd. All rights reserved.

Sensor Selection and Optimization for Health Assessment of Aerospace Systems

NASA Technical Reports Server (NTRS)

Maul, William A.; Kopasakis, George; Santi, Louis M.; Sowers, Thomas S.; Chicatelli, Amy

2007-01-01

Aerospace systems are developed similarly to other large-scale systems through a series of reviews, where designs are modified as system requirements are refined. For space-based systems few are built and placed into service. These research vehicles have limited historical experience to draw from and formidable reliability and safety requirements, due to the remote and severe environment of space. Aeronautical systems have similar reliability and safety requirements, and while these systems may have historical information to access, commercial and military systems require longevity under a range of operational conditions and applied loads. Historically, the design of aerospace systems, particularly the selection of sensors, is based on the requirements for control and performance rather than on health assessment needs. Furthermore, the safety and reliability requirements are met through sensor suite augmentation in an ad hoc, heuristic manner, rather than any systematic approach. A review of the current sensor selection practice within and outside of the aerospace community was conducted and a sensor selection architecture is proposed that will provide a justifiable, dependable sensor suite to address system health assessment requirements.

Sensor Selection and Optimization for Health Assessment of Aerospace Systems

NASA Technical Reports Server (NTRS)

Maul, William A.; Kopasakis, George; Santi, Louis M.; Sowers, Thomas S.; Chicatelli, Amy

2008-01-01

Aerospace systems are developed similarly to other large-scale systems through a series of reviews, where designs are modified as system requirements are refined. For space-based systems few are built and placed into service these research vehicles have limited historical experience to draw from and formidable reliability and safety requirements, due to the remote and severe environment of space. Aeronautical systems have similar reliability and safety requirements, and while these systems may have historical information to access, commercial and military systems require longevity under a range of operational conditions and applied loads. Historically, the design of aerospace systems, particularly the selection of sensors, is based on the requirements for control and performance rather than on health assessment needs. Furthermore, the safety and reliability requirements are met through sensor suite augmentation in an ad hoc, heuristic manner, rather than any systematic approach. A review of the current sensor selection practice within and outside of the aerospace community was conducted and a sensor selection architecture is proposed that will provide a justifiable, defendable sensor suite to address system health assessment requirements.

Novel approaches to the pharmacotherapy of obesity.

PubMed

Gouni-Berthold, Ioanna; Brüning, Jens C; Berthold, Heiner K

2013-01-01

Although the obesity epidemic is constantly expanding at very high costs for health care systems, the currently available options for the pharmacotherapy of obesity are very limited. This is not due to lack of interest or research on the subject but rather to the poor efficacy and/or safety profile of the majority of the antiobesity drugs developed up to now. Since the late fifties, various medications were brought to advanced states of clinical development but either never made it to the market or were initially approved only to be withdrawn some years later because of safety issues. However, our understanding of the pathophysiology of obesity has been steadily increasing and new, promising drugs targeting various selected obesity-associated and energy-homeostasis-related pathways are now under development. Nonetheless, obesity remains a disease mainly caused by an excess of caloric intake in relation to energy expenditure and on that basis, its treatment should be a healthy diet and physical activity. When these options alone are not sufficient, then additional pharmacotherapy with an acceptable efficacy and safety profile could provide a useful option.

Probabilistic exposure assessment to face and oral care cosmetic products by the French population.

PubMed

Bernard, A; Dornic, N; Roudot, Ac; Ficheux, As

2018-01-01

Cosmetic exposure data for face and mouth are limited in Europe. The aim of the study was to assess the exposure to face cosmetics using recent French consumption data (Ficheux et al., 2016b, 2015). Exposure was assessed using a probabilistic method for thirty one face products from four lines of products: cleanser, care, make-up and make-up remover products and two oral care products. Probabilistic exposure was assessed for different subpopulation according to sex and age in adults and children. Pregnant women were also studied. The levels of exposure to moisturizing cream, lip balm, mascara, eyeliner, cream foundation, toothpaste and mouthwash were higher than the values currently used by the Scientific Committee on Consumer Safety (SCCS). Exposure values found for eye shadow, lipstick, lotion and milk (make-up remover) were lower than SCCS values. These new French exposure values will be useful for safety assessors and for safety agencies in order to protect the general population and the at risk populations. Copyright © 2017. Published by Elsevier Ltd.

Identifying and preventing medical errors in patients with limited English proficiency: key findings and tools for the field.

PubMed

Wasserman, Melanie; Renfrew, Megan R; Green, Alexander R; Lopez, Lenny; Tan-McGrory, Aswita; Brach, Cindy; Betancourt, Joseph R

2014-01-01

Since the 1999 Institute of Medicine (IOM) report To Err is Human, progress has been made in patient safety, but few efforts have focused on safety in patients with limited English proficiency (LEP). This article describes the development, content, and testing of two new evidence-based Agency for Healthcare Research and Quality (AHRQ) tools for LEP patient safety. In the content development phase, a comprehensive mixed-methods approach was used to identify common causes of errors for LEP patients, high-risk scenarios, and evidence-based strategies to address them. Based on our findings, Improving Patient Safety Systems for Limited English Proficient Patients: A Guide for Hospitals contains recommendations to improve detection and prevention of medical errors across diverse populations, and TeamSTEPPS Enhancing Safety for Patients with Limited English Proficiency Module trains staff to improve safety through team communication and incorporating interpreters in the care process. The Hospital Guide was validated with leaders in quality and safety at diverse hospitals, and the TeamSTEPPS LEP module was field-tested in varied settings within three hospitals. Both tools were found to be implementable, acceptable to their audiences, and conducive to learning. Further research on the impact of the combined use of the guide and module would shed light on their value as a multifaceted intervention. © 2014 National Association for Healthcare Quality.

Are Students Aware of the Speed Limits on a University Campus?

ERIC Educational Resources Information Center

Brooks, Johnell; Raines, Stephanie; Klein, Nathan; Crisler, Matt; Wills, Rebekkah; Mossey, Mary; Koon, Beatrice; McKibben, Eric; Ogle, Jennifer; Robinson, Geary

2010-01-01

Driving speed is an important traffic safety issue. The lack of adherence to posted speed limits is a safety concern, especially on university campuses where the populations of drivers are at increased risk for crashes involving speeding due to their young age. Thus, driver speed and knowledge of speed limits on university campuses is an important…

78 FR 25256 - Petition Requesting Exception From Lead Content Limits: BIC USA Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... Exception From Lead Content Limits: BIC USA Inc. AGENCY: Consumer Product Safety Commission. ACTION: Notice... exception from the 100 ppm lead content limit under section 101(b) of the Consumer Product Safety... intended primarily for children 12 years old and younger that contain lead content in excess of 100 ppm are...

77 FR 478 - Petition Requesting Exception From the Lead Content Limits; Reopening of the Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-05

... the Lead Content Limits; Reopening of the Comment Period AGENCY: U.S. Consumer Product Safety... content limit under section 101(b) of the Consumer Product Safety Improvement Act of 2008 (``CPSIA''), as... contain lead content in excess of 100 ppm manufactured after August 12, 2011, are considered to be banned...

Efficacy of Web-Based Instruction to Provide Training on Federal Motor Carrier Safety Regulations

DOT National Transportation Integrated Search

2011-05-01

This report presents an evaluation of the current state-of-the-art Web-based instruction (WBI), reviews the current computer platforms of potential users of WBI, reviews the current status of WBI applications for Federal Motor Carrier Safety Administ...

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

PubMed

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

Engineered nanomaterials: exposures, hazards, and risk prevention

PubMed Central

2011-01-01

Nanotechnology presents the possibility of revolutionizing many aspects of our lives. People in many settings (academic, small and large industrial, and the general public in industrialized nations) are either developing or using engineered nanomaterials (ENMs) or ENM-containing products. However, our understanding of the occupational, health and safety aspects of ENMs is still in its formative stage. A survey of the literature indicates the available information is incomplete, many of the early findings have not been independently verified, and some may have been over-interpreted. This review describes ENMs briefly, their application, the ENM workforce, the major routes of human exposure, some examples of uptake and adverse effects, what little has been reported on occupational exposure assessment, and approaches to minimize exposure and health hazards. These latter approaches include engineering controls such as fume hoods and personal protective equipment. Results showing the effectiveness - or lack thereof - of some of these controls are also included. This review is presented in the context of the Risk Assessment/Risk Management framework, as a paradigm to systematically work through issues regarding human health hazards of ENMs. Examples are discussed of current knowledge of nanoscale materials for each component of the Risk Assessment/Risk Management framework. Given the notable lack of information, current recommendations to minimize exposure and hazards are largely based on common sense, knowledge by analogy to ultrafine material toxicity, and general health and safety recommendations. This review may serve as an overview for health and safety personnel, management, and ENM workers to establish and maintain a safe work environment. Small start-up companies and research institutions with limited personnel or expertise in nanotechnology health and safety issues may find this review particularly useful. PMID:21418643

High-resolution disruption halo current measurements using Langmuir probes in Alcator C-Mod

NASA Astrophysics Data System (ADS)

Tinguely, R. A.; Granetz, R. S.; Berg, A.; Kuang, A. Q.; Brunner, D.; LaBombard, B.

2018-01-01

Halo currents generated during disruptions on Alcator C-Mod have been measured with Langmuir ‘rail’ probes. These rail probes are embedded in a lower outboard divertor module in a closely-spaced vertical (poloidal) array. The dense array provides detailed resolution of the spatial dependence (~1 cm spacing) of the halo current distribution in the plasma scrape-off region with high time resolution (400 kHz digitization rate). As the plasma limits on the outboard divertor plate, the contact point is clearly discernible in the halo current data (as an inversion of current) and moves vertically down the divertor plate on many disruptions. These data are consistent with filament reconstructions of the plasma boundary, from which the edge safety factor of the disrupting plasma can be calculated. Additionally, the halo current ‘footprint’ on the divertor plate is obtained and related to the halo flux width. The voltage driving halo current and the effective resistance of the plasma region through which the halo current flows to reach the probes are also investigated. Estimations of the sheath resistance and halo region resistivity and temperature are given. This information could prove useful for modeling halo current dynamics.

Sleep deprivation in resident physicians, work hour limitations, and related outcomes: a systematic review of the literature.

PubMed

Mansukhani, Meghna P; Kolla, Bhanu Prakash; Surani, Salim; Varon, Joseph; Ramar, Kannan

2012-07-01

Extended work hours, interrupted sleep, and shift work are integral parts of medical training among all specialties. The need for 24-hour patient care coverage and economic factors have resulted in prolonged work hours for resident physicians. This has traditionally been thought to enhance medical educational experience. These long and erratic work hours lead to acute and chronic sleep deprivation and poor sleep quality, resulting in numerous adverse consequences. Impairments may occur in several domains, including attention, cognition, motor skills, and mood. Resident performance, professionalism, safety, and well-being are affected by sleep deprivation, causing potentially adverse implications for patient care. Studies have shown adverse health consequences, motor vehicle accidents, increased alcohol and medication use, and serious medical errors to occur in association with both sleep deprivation and shift work. Resident work hour limitations have been mandated by the Accreditation Council for Graduate Medical Education in response to patient safety concerns. Studies evaluating the impact of these regulations on resident physicians have generated conflicting reports on patient outcomes, demonstrating only a modest increase in sleep duration for resident physicians, along with negative perceptions regarding their education. This literature review summarizes research on the effects of sleep deprivation and shift work, and examines current literature on the impact of recent work hour limitations on resident physicians and patient-related outcomes.

Brivaracetam: An Adjunctive Treatment for Partial-Onset Seizures.

PubMed

Kappes, John A; Hayes, William J; Strain, Joe D; Farver, Debra K

2017-07-01

Brivaracetam is an analogue of levetiracetam that is Food and Drug Administration-approved for adjunctive treatment of partial-onset seizures in patients 16 years and older. In placebo-controlled trials adjunct brivaracetam demonstrated efficacy in reducing the frequency of seizures. The most commonly reported adverse effects are somnolence, dizziness, and fatigue. Clinical trials have evaluated brivaracetam for safety and efficacy in adjunctive treatment of partial-onset seizures in patients 16 years and older for up to 16 weeks. Brivaracetam's mechanism is similar to that of levetiracetam but with greater receptor binding affinity on synaptic vesicle protein 2A and inhibitory effects on sodium channels. Clinically significant differences between these agents are undetermined. Brivaracetam is available as oral tablets, oral solution, and intravenous solution. The Food and Drug Administration-approved dose is 50 mg twice daily, and titration is not required. Brivaracetam does not need dose adjustment for renal impairment and has minimal drug-drug interactions. Current limitations of brivaracetam include lack of head-to-head trials, limited long-term safety and efficacy data, and cost. Overall, brivaracetam is a viable adjunct therapeutic option for refractory partial-onset seizures in those who have failed conventional therapies. © 2017, The American College of Clinical Pharmacology.

Ambipolar zinc-polyiodide electrolyte for a high-energy density aqueous redox flow battery

DOE PAGES

Li, Bin; Nie, Zimin; Vijayakumar, M.; ...

2015-02-24

Large-scale energy storage systems are crucial for substantial deployment of renewable energy sources. Energy storage systems with high energy density, high safety, and low cost and environmental friendliness are desired. To overcome the major limitations of the current aqueous redox flow battery systems, namely lower energy density (~25 Wh L -1) and presence of strong acids and/or other hazardous, a high energy density aqueous zinc/polyiodide flow battery (ZIB) is designed with near neutral ZnI 2 solutions as catholytes. The energy density of ZIB could reach 322 Wh L -1 at the solubility limit of ZnI 2 in water (~7 M).more » We demonstrate charge and discharge energy densities of 245.9 Wh/L and 166.7 Wh L-1 with ZnI 2 electrolyte at 5.0 M, respectively. The addition of ethanol (EtOH) in ZnI 2 electrolyte can effectively mitigate the growth of zinc dendrite at the anode and improve the stability of catholytes with wider temperature window (-20 to 50°C), which enable ZIB system to be a promising alternative as a high-energy and high- safety stationary energy storage system.« less

Phosphodiesterase 4 inhibitors.

PubMed

Zebda, Rema; Paller, Amy S

2018-03-01

Historically, drugs available for treating atopic dermatitis (AD) have been limited to topical corticosteroids and topical calcineurin inhibitors, with systemic immunosuppressants and phototherapy reserved for severe AD. Despite their efficacy and infrequent adverse events, phobia about the use of topical steroids and calcineurin inhibitors has limited their use. More targeted options with fewer systemic and cutaneous side effects are needed for treating AD. Phosphodiesterase 4 (PDE4) is involved in the regulation of proinflammatory cytokines via the degradation of cyclic adenosine monophosphate. PDE4 activity is increased in the inflammatory cells of patients with AD, leading to increased production of proinflammatory cytokines and chemokines. Targeting PDE4 reduces the production of these proinflammatory mediators in AD. Both topical and oral PDE4 inhibitors have a favorable safety profile. Crisaborole 2% ointment, a topical PDE4, is now US Food and Drug Administration-approved for children older than 2 years and adults in the treatment of AD. Crisaborole 2% ointment shows early and sustained improvement in disease severity and pruritus and other AD symptoms, with burning and/or stinging upon application as the only related adverse event. Other PDE4 inhibitors are currently in trials with promising efficacy and safety. Copyright © 2017. Published by Elsevier Inc.

Optimizing Quality of Care and Patient Safety in Malaysia: The Current Global Initiatives, Gaps and Suggested Solutions.

PubMed

Jarrar, Mu'taman; Abdul Rahman, Hamzah; Don, Mohammad Sobri

2015-10-20

Demand for health care service has significantly increased, while the quality of healthcare and patient safety has become national and international priorities. This paper aims to identify the gaps and the current initiatives for optimizing the quality of care and patient safety in Malaysia. Review of the current literature. Highly cited articles were used as the basis to retrieve and review the current initiatives for optimizing the quality of care and patient safety. The country health plan of Ministry of Health (MOH) Malaysia and the MOH Malaysia Annual Reports were reviewed. The MOH has set four strategies for optimizing quality and sustaining quality of life. The 10th Malaysia Health Plan promotes the theme "1 Care for 1 Malaysia" in order to sustain the quality of care. Despite of these efforts, the total number of complaints received by the medico-legal section of the MOH Malaysia is increasing. The current global initiatives indicted that quality performance generally belong to three main categories: patient; staffing; and working environment related factors. There is no single intervention for optimizing quality of care to maintain patient safety. Multidimensional efforts and interventions are recommended in order to optimize the quality of care and patient safety in Malaysia.

Optimizing Quality of Care and Patient Safety in Malaysia: The Current Global Initiatives, Gaps and Suggested Solutions

PubMed Central

Jarrar, Mu’taman; Rahman, Hamzah Abdul; Don, Mohammad Sobri

2016-01-01

Background and Objective: Demand for health care service has significantly increased, while the quality of healthcare and patient safety has become national and international priorities. This paper aims to identify the gaps and the current initiatives for optimizing the quality of care and patient safety in Malaysia. Design: Review of the current literature. Highly cited articles were used as the basis to retrieve and review the current initiatives for optimizing the quality of care and patient safety. The country health plan of Ministry of Health (MOH) Malaysia and the MOH Malaysia Annual Reports were reviewed. Results: The MOH has set four strategies for optimizing quality and sustaining quality of life. The 10th Malaysia Health Plan promotes the theme “1 Care for 1 Malaysia” in order to sustain the quality of care. Despite of these efforts, the total number of complaints received by the medico-legal section of the MOH Malaysia is increasing. The current global initiatives indicted that quality performance generally belong to three main categories: patient; staffing; and working environment related factors. Conclusions: There is no single intervention for optimizing quality of care to maintain patient safety. Multidimensional efforts and interventions are recommended in order to optimize the quality of care and patient safety in Malaysia. PMID:26755459

The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity.

PubMed

Amacher, David E

2010-05-15

Biomarkers are biometric measurements that provide critical quantitative information about the biological condition of the animal or individual being tested. In drug safety studies, established toxicity biomarkers are used along with other conventional study data to determine dose-limiting organ toxicity, and to define species sensitivity for new chemical entities intended for possible use as human medicines. A continuing goal of drug safety scientists in the pharmaceutical industry is to discover and develop better trans-species biomarkers that can be used to determine target organ toxicities for preclinical species in short-term studies at dose levels that are some multiple of the intended human dose and again later in full development for monitoring clinical trials at lower therapeutic doses. Of particular value are early, predictive, noninvasive biomarkers that have in vitro, in vivo, and clinical transferability. Such translational biomarkers bridge animal testing used in preclinical science and human studies that are part of subsequent clinical testing. Although suitable for in vivo preclinical regulatory studies, conventional hepatic safety biomarkers are basically confirmatory markers because they signal organ toxicity after some pathological damage has occurred, and are therefore not well-suited for short-term, predictive screening assays early in the discovery-to-development progression of new chemical entities (NCEs) available in limited quantities. Efforts between regulatory agencies and the pharmaceutical industry are underway for the coordinated discovery, qualification, verification and validation of early predictive toxicity biomarkers. Early predictive safety biomarkers are those that are detectable and quantifiable prior to the onset of irreversible tissue injury and which are associated with a mechanism of action relevant to a specific type of potential hepatic injury. Potential drug toxicity biomarkers are typically endogenous macromolecules in biological fluids with varying immunoreactivity which can present bioanalytical challenges when first discovered. The potential success of these efforts is greatly enhanced by recent advances in two closely linked technologies, toxicoproteomics and targeted, quantitative mass spectrometry. This review focuses on the examination of the current status of these technologies as they relate to the discovery and development of novel preclinical biomarkers of hepatotoxicity. A critical assessment of the current literature reveals two distinct lines of safety biomarker investigation, (1) peripheral fluid biomarkers of organ toxicity and (2) tissue or cell-based toxicity signatures. Improved peripheral fluid biomarkers should allow the sensitive detection of potential organ toxicity prior to the onset of overt organ pathology. Advancements in tissue or cell-based toxicity biomarkers will provide sensitive in vitro or ex vivo screening systems based on toxicity pathway markers. An examination of the current practices in clinical pathology and the critical evaluation of some recently proposed biomarker candidates in comparison to the desired characteristics of an ideal toxicity biomarker lead this author to conclude that a combination of selected biomarkers will be more informative if not predictive of potential animal organ toxicity than any single biomarker, new or old. For the practical assessment of combinations of conventional and/or novel toxicity biomarkers in rodent and large animal preclinical species, mass spectrometry has emerged as the premier analytical tool compared to specific immunoassays or functional assays. Selected and multiple reaction monitoring mass spectrometry applications make it possible for this same basic technology to be used in the progressive stages of biomarker discovery, development, and more importantly, routine study applications without the use of specific antibody reagents. This technology combined with other "omics" technologies can provide added selectivity and sensitivity in preclinical drug safety testing.

Lessons learned from measuring safety culture: an Australian case study.

PubMed

Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

2010-10-01

adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture. Undertaking research in this way requires local engagement, commitment and capacity from the study site. The absence of these factors is likely to limit the practicality of this approach in the clinical setting. the use of safety culture surveys as the only method of assessing safety culture is of limited value in identifying strategies to potentially improve the safety culture. Copyright © 2010 Elsevier Ltd. All rights reserved.

Plug-in Plan Tool v3.0.3.1

NASA Technical Reports Server (NTRS)

Andrea-Liner, Kathleen E.; Au, Brion J.; Fisher, Blake R.; Rodbumrung, Watchara; Hamic, Jeffrey C.; Smith, Kary; Beadle, David S.

2012-01-01

The role of PLUTO (Plug-in Port UTilization Officer) and the growth of the International Space Station (ISS) have exceeded the capabilities of the current tool PiP (Plug-in Plan). Its users (crew and flight controllers) have expressed an interest in a new, easy-to-use tool with a higher level of interactivity and functionality that is not bound by the limitations of Excel. The PiP Tool assists crewmembers and ground controllers in making real-time decisions concerning the safety and compatibility of hardware plugged into the UOPs (Utility Outlet Panels) onboard the ISS. The PiP Tool also provides a reference to the current configuration of the hardware plugged in to the UOPs, and enables the PLUTO and crew to test Plug-in locations for constraint violations (such as cable connector mismatches or amp limit violations), to see the amps and volts for an end item, to see whether or not the end item uses 1553 data, and the cable length between the outlet and the end item. As new equipment is flown or returned, the database can be updated appropriately as needed. The current tool is a macroheavy Excel spreadsheet with its own database and reporting functionality. The new tool captures the capabilities of the original tool, ports them to new software, defines a new dataset, and compensates for ever-growing unique constraints associated with the Plug-in Plan. New constraints were designed into the tool, and updates to existing constraints were added to provide more flexibility and customizability. In addition, there is an option to associate a "Flag" with each device that will let the user know there is a unique constraint associated with it when they use it. This helps improve the safety and efficiency of real-time calls by limiting the amount of "corporate knowledge" overhead that has to be trained and learned through use. The tool helps save time by automating previous manual processes, such as calculating connector types and deciding which cables are required and in what order.

Communicating vaccine safety in the context of immunization programs in low resource settings.

PubMed

Arwanire, Edison M; Mbabazi, William; Mugyenyi, Possy

2015-01-01

Vaccines are effective in preventing infectious diseases and their complications, hence reducing morbidity and infectious disease mortaity. Successful immunization programs, however, depend on high vaccine acceptance and coverage rates. In recent years there has been an increased level of public concern towards real or perceived adverse events associated with immunizations, leading to many people in high- as well as low-resource settings to refuse vaccines. Health care workers therefore must be able to provide parents and guardians of children with the most current and accurate information about the benefits and risks of vaccination. Communicating vaccine safety using appropriate channels plays a crucial role in maintaining public trust and confidence in vaccination programs. Several factors render this endeavor especially challenging in low-resource settings where literacy rates are low and access to information is often limited. Many languages are spoken in most countries in low-resource settings, making the provision of appropriate information difficult. Poor infrastructure often results in inadequate logistics. Recently, some concerned consumer groups have been able to propagate misinformation and rumors. To successfully communicate vaccine safety in a resource limited setting it is crucial to use a mix of communication channels that are both culturally acceptable and effective. Social mobilization through cultural, administrative and political leaders, the media or text messages (SMS) as well as the adoption of the Village Health Team (VHT) strategy whereby trained community members (Community Health Workers (CHWs)) are providing primary healthcare, can all be effective in increasing the demand for immunization.

Practical on-board weigh-in-motion system for commercial vehicles

NASA Astrophysics Data System (ADS)

Kenyon, Chase H.

1997-01-01

Many commercial carriers are currently operating vehicles which are overweight, creating an unsafe and illegal situation. However, the cost to law enforcement agencies to stop vehicles for roadside weight checks is prohibitive, while the cost to the nation in lost travel time adds shipping costs which are reflected in the price of every product transported by truck. Overweight trucks also become a threat to public safety when, on public highways, solid cargo breaks loose or liquid cargo leaks. The solution is an on-board monitoring system. With such a system, trucks under their legal weight limit would be allowed to travel past state borders and checkpoints without being stopped. THis would save money both in law enforcement and shipping costs to the nation as a whole. A properly designed system would also have the capability to warn both the driver and local safety and enforcement personnel when the truck is loaded beyond capacity or any other unsafe condition. This paper will detail a system that would even in early limited production be cost effective for both the law enforcement agencies and the operators of trucking fleets. In full production the systems would be cost effective even for smaller or owner/operator trucks. This is a safety system that could become standard equipment similar to seat belts, ABS, and airbags. The initial testing of sub-assemblies and sub-systems which could be deployed now for beta test has been completed.

Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study.

PubMed

Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette; Møller Beck, Carsten; Sabroe, Svend; Bartels, Paul; Mainz, Jan

2016-05-13

Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture in a Danish psychiatric department before and after a leadership intervention. A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. In total, 358 and 325 staff members participated before and after the intervention, respectively. 19 of the staff members were clinical area level leaders. In both surveys, the response rate was >75%. The proportion of frontline staff with positive attitudes improved by ≥5% for 5 of the 7 patient safety culture dimensions over time. 6 patient safety culture dimensions became more positive (increase in mean) (p<0.05). Frontline staff became more positive on all dimensions except stress recognition (p<0.05). For the leaders, the opposite was the case (p<0.05). Staff leaving the department after the first measurement had rated job satisfaction lower than the staff staying on (p<0.05). The improvements documented in the patient safety culture are remarkable, and imply that strengthening the leadership can act as a significant catalyst for patient safety culture improvement. Further studies using a longitudinal study design are recommended to investigate the mechanism behind leadership's influence on patient safety culture, sustainability of improvements over time, and the association of change in the patient safety culture measures with change in psychiatric patient safety outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Survey of community pharmacists' perception of electronic cigarettes in London.

PubMed

Marques Gomes, Ana C N; Nabhani-Gebara, Shereen; Kayyali, Reem; Buonocore, Federico; Calabrese, Gianpiero

2016-11-10

To seek community pharmacists' perception on use, safety and possible effectiveness of e-cigarettes as quit smoking tools, and their future regulation. A survey of a sample of 154 community pharmacies across London, UK. E-cigarettes have exclusively established themselves in the market through consumers-led demand. To date, e-cigarettes still remain unregulated and can be easily purchased in shops, over the internet, but more controversially also in pharmacies in the UK. Pharmacists find themselves with a shortage of information on their safety and efficacy, and may experience an ethical dilemma when consulted by patients/customers. Response rate: 60% (n=92). Independent pharmacies accounted for 90% of the sample. The majority of participants (73%) sell e-cigarettes. A minority of participants (20%) have been presented with adverse effects such as cough and dry mouth. As possible reasons for their use, pharmacists ranked 'aid in stop smoking' as the most important (56%), with 'cheaper alternative' (43%) and 'social/recreational use' (31%) being the least important ones. Safety issues were raised as statements such as 'e-liquid in cartridges may be toxic' were agreed by 52% of respondents. The majority of pharmacists (97%) were supportive of e-cigarettes being regulated, expressing current concerns regarding excipients (42%) and nicotine content (34%). Participants indicated that they would require training in the form of information packs (88%), online tutorials (67%), continuous professional development (CPD) workshops (43%) to cover safety, counselling, dosage instructions, adverse effects and role in the smoking cessation care pathway in the future. Pharmacists expressed concerns about the safety of e-cigarettes, especially regarding the amounts of excipients and nicotine as these still remain unregulated. Currently, there are no guidelines for pharmacists regarding e-cigarettes. Community pharmacists look forward to regulations so to conduct their duties in a more confident and legislated fashion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

PubMed

Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D

2018-06-07

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

Recognizing the value of assistance dogs in society.

PubMed

Audrestch, Hilary M; Whelan, Chantelle T; Grice, David; Asher, Lucy; England, Gary C W; Freeman, Sarah L

2015-10-01

Assistance dogs are specially trained to undertake a variety of tasks to help individuals with disabilities. This review gives an overview of the different types of assistance dogs in the UK, including guide dogs, hearing dogs, mobility assistance dogs, service dogs and dual-purpose dogs. The literature describes many benefits of assistance dogs, including their impact on physical wellbeing and safety of their 'owners,' as well as on psychological wellbeing and social inclusion. The role of assistance dogs in society is widely recognized by the public, but is not currently acknowledged in government social policy. The current evidence on the benefits of assistance dogs is limited by the type and scale of current research. This article highlights the need for independent funding for high quality research to enable social care and policy makers to make evidence-based decisions on the value of assistance dogs to people with disabilities. Copyright © 2015 Elsevier Inc. All rights reserved.

Burner ignition system

DOEpatents

Carignan, Forest J.

1986-01-21

An electronic ignition system for a gas burner is battery operated. The battery voltage is applied through a DC-DC chopper to a step-up transformer to charge a capacitor which provides the ignition spark. The step-up transformer has a significant leakage reactance in order to limit current flow from the battery during initial charging of the capacitor. A tank circuit at the input of the transformer returns magnetizing current resulting from the leakage reactance to the primary in succeeding cycles. An SCR in the output circuit is gated through a voltage divider which senses current flow through a flame. Once the flame is sensed, further sparks are precluded. The same flame sensor enables a thermopile driven main valve actuating circuit. A safety valve in series with the main gas valve responds to a control pressure thermostatically applied through a diaphragm. The valve closes after a predetermined delay determined by a time delay orifice if the pilot gas is not ignited.

Bicycle and pedestrian safety in the highway safety manual : final report.

DOT National Transportation Integrated Search

2016-07-01

An accurate understanding of the expected effectiveness of bicycle and pedestrian safety : countermeasures is needed to support decisions about how to best allocate limited public : resources to increase safety for non-motorized users. However, the k...

Safety impacts of different speed limits on cars and trucks : final report

DOT National Transportation Integrated Search

1994-05-01

The objectives of this study were to determine whether differential or uniform speed limits are more beneficial to transportation safety and traffic operations on Interstate highways. The approach to achieving this objective was to examine speed and ...

Waterborne GI Illness

Science.gov Websites

Outbreaks in North Dakota Handwashing Education Materials Contact Us Current Issues Healthy Swimming Food Safety Current Recalls Food Safety and Raw Milk Norovirus Copyright © 2014 North Dakota Department of

Large Scale Experiments on Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Urban, David L.; Ruff, Gary A.; Minster, Olivier; Toth, Balazs; Fernandez-Pello, A. Carlos; T'ien, James S.; Torero, Jose L.; Cowlard, Adam J.; Legros, Guillaume; Eigenbrod, Christian;

Large Scale Experiments on Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Urban, David; Ruff, Gary A.; Minster, Olivier; Fernandez-Pello, A. Carlos; Tien, James S.; Torero, Jose L.; Legros, Guillaume; Eigenbrod, Christian; Smirnov, Nickolay; Fujita, Osamu;

Current Evidence for the Management of Inflammatory Bowel Diseases Using Fecal Microbiota Transplantation.

PubMed

Jeon, Seong Ran; Chai, Jocelyn; Kim, Christiana; Lee, Christine H

2018-05-26

Fecal microbiota transplantation (FMT) has been investigated as a potential treatment for inflammatory bowel disease (IBD). This review examines current evidence around the efficacy and safety of FMT for patients with IBD. Randomized controlled trials (RCTs) and meta-analyses have suggested that FMT may facilitate clinical and endoscopic remission in patients with active ulcerative colitis (UC). Although the evidence for FMT in Crohn's disease (CD) is more limited, positive outcomes have been observed in small cohort studies. Most adverse events (AEs) were mild and included transient gastrointestinal symptoms. Serious adverse events (SAEs) did not differ significantly between the FMT and control groups, and a marginal increased rate of IBD flares following FMT was observed. Microbiota analysis following FMT showed increased intestinal bacterial diversity and a shift towards the donor microbial profile in recipients' stools. FMT for patients with IBD is promising as RCTs have shown the benefit of FMT for UC, although the efficacy of FMT for CD is less clear. Further large and well-designed trials are necessary to resolve critical issues such as the donor selection, the ideal route of administration, duration, frequency of FMT, and the long-term sustained efficacy and safety.

System Analysis and Performance Benefits of an Optimized Rotorcraft Propulsion System

NASA Technical Reports Server (NTRS)

Bruckner, Robert J.

2007-01-01

The propulsion system of rotorcraft vehicles is the most critical system to the vehicle in terms of safety and performance. The propulsion system must provide both vertical lift and forward flight propulsion during the entire mission. Whereas propulsion is a critical element for all flight vehicles, it is particularly critical for rotorcraft due to their limited safe, un-powered landing capability. This unparalleled reliability requirement has led rotorcraft power plants down a certain evolutionary path in which the system looks and performs quite similarly to those of the 1960 s. By and large the advancements in rotorcraft propulsion have come in terms of safety and reliability and not in terms of performance. The concept of the optimized propulsion system is a means by which both reliability and performance can be improved for rotorcraft vehicles. The optimized rotorcraft propulsion system which couples an oil-free turboshaft engine to a highly loaded gearbox that provides axial load support for the power turbine can be designed with current laboratory proven technology. Such a system can provide up to 60% weight reduction of the propulsion system of rotorcraft vehicles. Several technical challenges are apparent at the conceptual design level and should be addressed with current research.

Crew Exploration Vehicle Ascent Abort Coverage Analysis

NASA Technical Reports Server (NTRS)

Abadie, Marc J.; Berndt, Jon S.; Burke, Laura M.; Falck, Robert D.; Gowan, John W., Jr.; Madsen, Jennifer M.

2007-01-01

An important element in the design of NASA's Crew Exploration Vehicle (CEV) is the consideration given to crew safety during various ascent phase failure scenarios. To help ensure crew safety during this critical and dynamic flight phase, the CEV requirements specify that an abort capability must be continuously available from lift-off through orbit insertion. To address this requirement, various CEV ascent abort modes are analyzed using 3-DOF (Degree Of Freedom) and 6-DOF simulations. The analysis involves an evaluation of the feasibility and survivability of each abort mode and an assessment of the abort mode coverage using the current baseline vehicle design. Factors such as abort system performance, crew load limits, thermal environments, crew recovery, and vehicle element disposal are investigated to determine if the current vehicle requirements are appropriate and achievable. Sensitivity studies and design trades are also completed so that more informed decisions can be made regarding the vehicle design. An overview of the CEV ascent abort modes is presented along with the driving requirements for abort scenarios. The results of the analysis completed as part of the requirements validation process are then discussed. Finally, the conclusions of the study are presented, and future analysis tasks are recommended.

Concise Review: Workshop Review: Understanding and Assessing the Risks of Stem Cell-Based Therapies

PubMed Central

Heslop, James A.; Hammond, Thomas G.; Santeramo, Ilaria; Tort Piella, Agnès; Hopp, Isabel; Zhou, Jing; Baty, Roua; Graziano, Enrique I.; Proto Marco, Bernabé; Caron, Alexis; Sköld, Patrik; Andrews, Peter W.; Baxter, Melissa A.; Hay, David C.; Hamdam, Junnat; Sharpe, Michaela E.; Patel, Sara; Jones, David R.; Reinhardt, Jens; Danen, Erik H.J.; Ben-David, Uri; Stacey, Glyn; Björquist, Petter; Piner, Jacqueline; Mills, John; Rowe, Cliff; Pellegrini, Giovanni; Sethu, Swaminathan; Antoine, Daniel J.; Cross, Michael J.; Murray, Patricia; Williams, Dominic P.; Kitteringham, Neil R.; Park, B. Kevin

2015-01-01

The field of stem cell therapeutics is moving ever closer to widespread application in the clinic. However, despite the undoubted potential held by these therapies, the balance between risk and benefit remains difficult to predict. As in any new field, a lack of previous application in man and gaps in the underlying science mean that regulators and investigators continue to look for a balance between minimizing potential risk and ensuring therapies are not needlessly kept from patients. Here, we attempt to identify the important safety issues, assessing the current advances in scientific knowledge and how they may translate to clinical therapeutic strategies in the identification and management of these risks. We also investigate the tools and techniques currently available to researchers during preclinical and clinical development of stem cell products, their utility and limitations, and how these tools may be strategically used in the development of these therapies. We conclude that ensuring safety through cutting-edge science and robust assays, coupled with regular and open discussions between regulators and academic/industrial investigators, is likely to prove the most fruitful route to ensuring the safest possible development of new products. PMID:25722427

Picture perfect: benefits and risk of fetal 3D ultrasound.

PubMed

Wiseman, Claudia S; Kiehl, Ermalynn M

2007-01-01

The purpose of this literature review was to survey available information and research related to routine three-dimensional (3D) ultrasound technology in obstetrics, with an emphasis on current medical uses, safety, and availability issues. Several data bases, including Cochrane, WHO, NIH, CINALH, Blackwell Synergy, ERIC, PubMed, and Medline, were used along with information from Internet search engines. Although fetal 3D ultrasound is used in both medical and commercial settings, recent studies focus on its possible uses rather than the more difficult issues of safety and commercial applications. Professional organizations associated with ultrasound technology support limiting ultrasounds in pregnancy to medically necessary events, whereas commercial venues use "direct to consumer" marketing to promote this technology as a way to "see" the baby before it is born. How safe is routine or frequent use of 3D ultrasound? Further research is needed to address these important questions.

On the safety of ITER accelerators.

PubMed

Li, Ge

2013-01-01

Three 1 MV/40A accelerators in heating neutral beams (HNB) are on track to be implemented in the International Thermonuclear Experimental Reactor (ITER). ITER may produce 500 MWt of power by 2026 and may serve as a green energy roadmap for the world. They will generate -1 MV 1 h long-pulse ion beams to be neutralised for plasma heating. Due to frequently occurring vacuum sparking in the accelerators, the snubbers are used to limit the fault arc current to improve ITER safety. However, recent analyses of its reference design have raised concerns. General nonlinear transformer theory is developed for the snubber to unify the former snubbers' different design models with a clear mechanism. Satisfactory agreement between theory and tests indicates that scaling up to a 1 MV voltage may be possible. These results confirm the nonlinear process behind transformer theory and map out a reliable snubber design for a safer ITER.

Decay heat uncertainty quantification of MYRRHA

NASA Astrophysics Data System (ADS)

Fiorito, Luca; Buss, Oliver; Hoefer, Axel; Stankovskiy, Alexey; Eynde, Gert Van den

2017-09-01

MYRRHA is a lead-bismuth cooled MOX-fueled accelerator driven system (ADS) currently in the design phase at SCK·CEN in Belgium. The correct evaluation of the decay heat and of its uncertainty level is very important for the safety demonstration of the reactor. In the first part of this work we assessed the decay heat released by the MYRRHA core using the ALEPH-2 burnup code. The second part of the study focused on the nuclear data uncertainty and covariance propagation to the MYRRHA decay heat. Radioactive decay data, independent fission yield and cross section uncertainties/covariances were propagated using two nuclear data sampling codes, namely NUDUNA and SANDY. According to the results, 238U cross sections and fission yield data are the largest contributors to the MYRRHA decay heat uncertainty. The calculated uncertainty values are deemed acceptable from the safety point of view as they are well within the available regulatory limits.

Feminist theoretical perspectives on ethics in radiology.

PubMed

Condren, Mary

2009-07-01

The substantive safety of radiological and other medical procedures can be radically reduced by unconscious factors governing scientific thought. In addition, the historical exclusion of women from these disciplines has possibly skewed their development in directions that now need to be addressed. This paper focuses on three such factors: gendered libidos that privilege risk taking over prevention, fragmented forms of knowledge that encourage displaced forms of responsibility and group dynamics that discourage critique of accepted practices and limit the definition of one's group. The substantive safety of the practice and scientific contribution of radiologists might be considerably enhanced were the focus to switch from radiology to diagnosis. Such enlargement might redefine the brief of radiologists towards preventing as well as curing; evaluating some non-invasive and low-tech options, adopting some inclusive paradigms of clinical ecology and enlarging group identities to include those currently excluded through geography or social class from participating in the benefits of science.

On the safety of ITER accelerators

PubMed Central

Li, Ge

2013-01-01

Three 1 MV/40A accelerators in heating neutral beams (HNB) are on track to be implemented in the International Thermonuclear Experimental Reactor (ITER). ITER may produce 500 MWt of power by 2026 and may serve as a green energy roadmap for the world. They will generate −1 MV 1 h long-pulse ion beams to be neutralised for plasma heating. Due to frequently occurring vacuum sparking in the accelerators, the snubbers are used to limit the fault arc current to improve ITER safety. However, recent analyses of its reference design have raised concerns. General nonlinear transformer theory is developed for the snubber to unify the former snubbers' different design models with a clear mechanism. Satisfactory agreement between theory and tests indicates that scaling up to a 1 MV voltage may be possible. These results confirm the nonlinear process behind transformer theory and map out a reliable snubber design for a safer ITER. PMID:24008267

Cannabis microbiome sequencing reveals several mycotoxic fungi native to dispensary grade Cannabis flowers

PubMed Central

McKernan, Kevin; Spangler, Jessica; Zhang, Lei; Tadigotla, Vasisht; Helbert, Yvonne; Foss, Theodore; Smith, Douglas

2016-01-01

The Center for Disease Control estimates 128,000 people in the U.S. are hospitalized annually due to food borne illnesses. This has created a demand for food safety testing targeting the detection of pathogenic mold and bacteria on agricultural products. This risk extends to medical Cannabis and is of particular concern with inhaled, vaporized and even concentrated Cannabis products . As a result, third party microbial testing has become a regulatory requirement in the medical and recreational Cannabis markets, yet knowledge of the Cannabis microbiome is limited. Here we describe the first next generation sequencing survey of the fungal communities found in dispensary based Cannabis flowers by ITS2 sequencing, and demonstrate the sensitive detection of several toxigenic Penicillium and Aspergillus species, including P. citrinum and P. paxilli, that were not detected by one or more culture-based methods currently in use for safety testing. PMID:27303623

Acceptance of wearable technology by people with Alzheimer's disease: issues and accommodations.

PubMed

Mahoney, Edward L; Mahoney, Diane F

2010-09-01

The increasing number of cognitively impaired older adults who exhibit wandering tendencies raises safety concerns. The purpose of the current study was to research the State-of the-Art in Wearable Technologies for persons with Alzheimer's Disease and identify challenges unique to this population and lessons learned. Inclusion criteria specified systems/devices that completed laboratory testing and were commercially available for usage by community-based Alzheimer's family caregivers. Methods included a series of Internet product searches and telephone interviews with related corporate representatives and participant's referrals. Results indicated many products in development or academic research use but only a limited number were available that met the study criteria. The interviews with key informants revealed features necessary to consider when making products to be worn by persons with cognitive impairment. In conclusion, there is no ideal solution and opportunities remain for marketplace innovations and for addressing the challenges associated with balancing safety and security.

Ensuring Patient Safety in Care Transitions: An Empirical Evaluation of a Handoff Intervention Tool

PubMed Central

Abraham, Joanna; Kannampallil, Thomas; Patel, Bela; Almoosa, Khalid; Patel, Vimla L.

2012-01-01

Successful handoffs ensure smooth, efficient and safe patient care transitions. Tools and systems designed for standardization of clinician handoffs often focuses on ensuring the communication activity during transitions, with limited support for preparatory activities such as information seeking and organization. We designed and evaluated a Handoff Intervention Tool (HAND-IT) based on a checklist-inspired, body system format allowing structured information organization, and a problem-case narrative format allowing temporal description of patient care events. Based on a pre-post prospective study using a multi-method analysis we evaluated the effectiveness of HAND-IT as a documentation tool. We found that the use of HAND-IT led to fewer transition breakdowns, greater tool resilience, and likely led to better learning outcomes for less-experienced clinicians when compared to the current tool. We discuss the implications of our results for improving patient safety with a continuity of care-based approach. PMID:23304268

Turbulence in high-beta ASDEX upgrade advanced scenarios

NASA Astrophysics Data System (ADS)

Doerk, H.; Bock, A.; Di Siena, A.; Fable, E.; Görler, T.; Jenko, F.; Stober, J.; The ASDEX Upgrade Team

2018-01-01

Recent experiments at ASDEX Upgrade achieve non-inductive operation in full tungsten wall conditions by applying electron cyclotron and neutral beam current drive. These discharges are characterised by a well-measured safety factor profile, which does not drop below one, and a good energy confinement. By reproducing the experimental heat fluxes, nonlinear gyrokinetic simulations suggest that the observed strong peaking of the ion temperature in the core is caused by the stabilising impact of a significant beam ion content, as well as strong electromagnetic effects on turbulent transport. Quasilinear transport models are not yet applicable in this interesting and reactor relevant parameter regime, but available simulation data may serve as a testbed for improvements. As the present plasma is close to the kinetic ballooning (KBM) threshold, elevating the safety factor profile under otherwise identical conditions is proposed to clarify, whether profiles are ultimately limited by KBM turbulence, or by global stability constraints.

Organizational capacity of nonprofit social service agencies.

PubMed

Paynter, Sharon; Berner, Marueen

2014-01-01

The U.S. social safety net is formed by governmental and nonprofit organizations, which are trying to respond to record levels of need. This is especially true for local level organizations, such as food pantries. The organizational capacity literature has not covered front-line, local, mostly volunteer and low resource organizations in the same depth as larger ones. This analysis is a consideration of whether grassroots nonprofit organizations have the ability to be a strong component of the social safety net. Based on the literature on organizational capacity, a model is developed to examine how service delivery at the local level is affected by organizational capacity. Surprisingly, we find few of the characteristics previously identified as important are statistically significant in this study. Even when so, the material effect is negligible. Current organizational capacity research may apply to larger nonprofits, but not to the tens of thousands of small community nonprofits, a significant limitation to the research to date.

Best practices for preventing musculoskeletal disorders in masonry: stakeholder perspectives.

PubMed

Entzel, Pamela; Albers, Jim; Welch, Laura

2007-09-01

Brick masons and mason tenders report a high prevalence of work-related musculoskeletal disorders (WMSDs), many of which can be prevented with changes in materials, work equipment or work practices. To explore the use of "best practices" in the masonry industry, NIOSH organized a 2-day meeting of masonry stakeholders. Attendees included 30 industry representatives, 5 health and safety researchers, 4 health/safety specialists, 2 ergonomic consultants, and 2 representatives of state workers' compensation programs. Small groups discussed ergonomic interventions currently utilized in the masonry industry, including factors affecting intervention implementation and ways to promote diffusion of interventions. Meeting participants also identified various barriers to intervention implementation, including business considerations, quality concerns, design issues, supply problems, jobsite conditions and management practices that can slow or limit intervention diffusion. To be successful, future diffusion efforts must not only raise awareness of available solutions but also address these practical concerns.

Nuclear and chemical safety analysis: Purex Plant 1970 thorium campaign

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

Boldt, A.L.; Oberg, G.C.

The purpose of this document is to discuss the flowsheet and the related processing equipment with respect to nuclear and chemical safety. The analyses presented are based on equipment utilization and revised piping as outlined in the design criteria. Processing of thorium and uranium-233 in the Purex Plant can be accomplished within currently accepted levels of risk with respect to chemical and nuclear safety if minor instrumentation changes are made. Uranium-233 processing is limited to a rate of about 670 grams per hour by equipment capacities and criticality safety considerations. The major criticality prevention problems result from the potential accumulationmore » of uranium-233 in a solvent phase in E-H4 (ICU concentrator), TK-J1 (IUC receiver), and TK-J21 (2AF pump tank). The same potential problems exist in TK-J5 (3AF pump tank) and TK-N1 (3BU receiver), but the probabilities of reaching a critical condition are not as great. In order to prevent the excessive accumulation of uranium-233 in any of these vessels by an extraction mechanism, it is necessary to maintain the uranium-233 and salting agent concentrations below the point at which a critical concentration of uranium-233 could be reached in a solvent phase.« less

Bilastine: a new antihistamine with an optimal benefit-to-risk ratio for safety during driving.

PubMed

Jáuregui, Ignacio; Ramaekers, Johannes G; Yanai, Kazuhiko; Farré, Magí; Redondo, Esther; Valiente, Román; Labeaga, Luis

2016-01-01

Rational selection of a second-generation H1-antihistamine requires efficacy and safety considerations, particularly regarding central nervous system (CNS) effects (cognitive and psychomotor function), potential for driving impairment, minimal sedative effects and a lack of interactions. This review evaluates the key safety features of the non-sedating antihistamine, bilastine, during driving and in preventing road traffic accidents. Among the second-generation H1-antihistamines, sedative effects which can affect cognitive and psychomotor performance, and possibly driving ability, may not be similar. Bilastine is absorbed rapidly, undergoes no hepatic metabolism or cytochrome P450 interaction (minimal drug-drug interaction potential), and is a substrate for P-glycoprotein (limiting CNS entry). Positron emission tomography showed that, compared with other second-generation H1-antihistamines, bilastine has the lowest cerebral histamine H1-receptor occupancy. Bilastine 20 mg once daily (therapeutic dose) is non-sedating, does not enhance the effects of alcohol or CNS sedatives, does not impair driving performance and has at least similar efficacy as other second-generation H1-antihistamines in the treatment of allergic rhinoconjunctivitis and urticaria. Current evidence shows that bilastine has an optimal benefit-to-risk ratio, meeting all conditions for contributing to safety in drivers who need antihistamines, and hence for being considered as an antihistamine of choice for drivers.

Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

PubMed

Morgan, Sherry J; Couch, Jessica; Guzzie-Peck, Peggy; Keller, Douglas A; Kemper, Ray; Otieno, Monicah A; Schulingkamp, Robert J; Jones, Thomas W

2017-04-01

An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities.

Supervisor vs. employee safety perceptions and association with future injury in US limited-service restaurant workers.

PubMed

Huang, Yueng-Hsiang; Verma, Santosh K; Chang, Wen-Ruey; Courtney, Theodore K; Lombardi, David A; Brennan, Melanye J; Perry, Melissa J

2012-07-01

Many studies have found management commitment to safety to be an important construct of safety climate. This study examined the association between supervisor and employee (shared and individual) perceptions of management commitment to safety and the rate of future injuries in limited-service restaurant workers. A total of 453 participants (34 supervisors/managers and 419 employees) from 34 limited-service restaurants participated in a prospective cohort study. Employees' and managers' perceptions of management commitment to safety and demographic variables were collected at the baseline. The survey questions were made available in three languages: English, Spanish, and Portuguese. For the following 12 weeks, participants reported their injury experience and weekly work hours. A multivariate negative binomial generalized estimating equation model with compound symmetry covariance structure was used to assess the association between the rate of self-reported injuries and measures of safety perceptions. There were no significant relationships between supervisor and either individual or shared employee perceptions of management commitment to safety. Only individual employee perceptions were significantly associated with future employee injury experience but not supervisor safety perceptions or shared employee perceptions. Individual employee perception of management commitment to safety is a significant predictor for future injuries in restaurant environments. A study focusing on employee perceptions would be more predictive of injury outcomes than supervisor/manager perceptions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Occupational health and safety surveillance and research using workers' compensation data.

PubMed

Utterback, David F; Schnorr, Teresa M; Silverstein, Barbara A; Spieler, Emily A; Leamon, Tom B; Amick, Benjamin C

2012-02-01

Examine uses of US workers' compensation (WC) data for occupational safety and health purposes. This article is a summary of the proceedings from an invitational workshop held in September 2009 to discuss the use of WC data for occupational safety and health prevention purposes. Workers' compensation data systems, although limited in many ways, contain information such as medical treatments, their costs and outcomes, and disability causes that are unavailable from national occupational surveillance sources. Despite their limitations, WC records are collected in a manner consistent with many occupational health and safety surveillance needs. Reports are available on the use of WC data for surveillance and research purposes such as estimating the frequency, magnitude, severity, and cost of compensated injuries. Inconsistencies in WC data can limit generalization of research results.

MHD Calculation of halo currents and vessel forces in NSTX VDEs

NASA Astrophysics Data System (ADS)

Breslau, J. A.; Strauss, H. R.; Paccagnella, R.

2012-10-01

Research tokamaks such as ITER must be designed to tolerate a limited number of disruptions without sustaining significant damage. It is therefore vital to have numerical tools that can accurately predict the effects of these events. The 3D nonlinear extended MHD code M3D [1] can be used to simulate disruptions and calculate the associated wall currents and forces. It has now been validated against halo current data from NSTX experiments in which vertical displacement events (VDEs) were deliberately induced by turning off vertical feedback control. The results of high-resolution numerical simulations at realistic Lundquist numbers show reasonable agreement with the data, supporting a model in which the most dangerously asymmetric currents and heat loads, and the largest horizontal forces, arise in situations where a fast-growing ideal 2,1 external kink mode is destabilized by the scraping-off of flux surfaces with safety factor q>2 during the course of the VDE. [4pt] [1] W. Park, et al., Phys. Plasmas 6 (1999) 1796.

46 CFR 11.305 - Radar-Observer certificates and qualifying courses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... appropriate curriculum as follows: (1) Radar Observer (Unlimited). Classroom instruction—including... conditions. (D) Limitations of radar resulting from design factors. (E) Safety precautions associated with...) Limitations of radar resulting from design factors. (E) Safety precautions associated with use and maintenance...

Posttraumatic stress disorder, depression, and perceived safety 13 months after September 11.

PubMed

Grieger, Thomas A; Fullerton, Carol S; Ursano, Robert J

2004-09-01

This study assessed relationships between exposure to the September 11, 2001, terrorist attack, current posttraumatic stress disorder (PTSD), current major depression, and current safety perceptions in a sample of 212 Pentagon staff members 13 months after the attack. Forty-eight respondents (23 percent) had possible PTSD; eight (4 percent) had probable major depression. Respondents who were directly exposed to the attack were more likely to have PTSD and major depression and were less likely to have a perception of safety at work and in usual activities and travel only. In contrast, respondents with PTSD reported a lower perception of safety at home, at work, and in usual activities and travel.

A Vision of the Future Air Traffic Control System

NASA Technical Reports Server (NTRS)

Erzberger, Heinz

2000-01-01

The air transportation system is on the verge of gridlock, with delays and cancelled flights this summer reaching all time highs. As demand for air transportation continues to increase, the capacity needed to accommodate the growth in traffic is falling farther and farther behind. Moreover, it has become increasingly apparent that the present system cannot be scaled up to provide the capacity increases needed to meet demand over the next 25 years. NASA, working with the Federal Aviation Administration and industry, is pursuing a major research program to develop air traffic management technologies that have the ultimate goal of doubling capacity while increasing safety and efficiency. This seminar will describe how the current system operates, what its limitations are and why a revolutionary "shift in paradigm" is needed to overcome fundamental limitations in capacity and safety. For the near term, NASA has developed a portfolio of software tools for air traffic controllers, called the Center-TRACON Automation System (CTAS), that provides modest gains in capacity and efficiency while staying within the current paradigm. The outline of a concept for the long term, with a deployment date of 2015 at the earliest, has recently been formulated and presented by NASA to a select group of industry and government stakeholders. Automated decision making software, combined with an Internet in the sky that enables sharing of information and distributes control between the cockpit and the ground, is key to this concept. However, its most revolutionary feature is a fundamental change in the roles and responsibilities assigned to air traffic controllers.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian; Munafo, Paul M. (Technical Monitor)

2002-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA's Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aid in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI.

Developing integrated benchmarks for DOE performance measurement

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

Barancik, J.I.; Kramer, C.F.; Thode, Jr. H.C.

1992-09-30

The objectives of this task were to describe and evaluate selected existing sources of information on occupational safety and health with emphasis on hazard and exposure assessment, abatement, training, reporting, and control identifying for exposure and outcome in preparation for developing DOE performance benchmarks. Existing resources and methodologies were assessed for their potential use as practical performance benchmarks. Strengths and limitations of current data resources were identified. Guidelines were outlined for developing new or improved performance factors, which then could become the basis for selecting performance benchmarks. Data bases for non-DOE comparison populations were identified so that DOE performance couldmore » be assessed relative to non-DOE occupational and industrial groups. Systems approaches were described which can be used to link hazards and exposure, event occurrence, and adverse outcome factors, as needed to generate valid, reliable, and predictive performance benchmarks. Data bases were identified which contain information relevant to one or more performance assessment categories . A list of 72 potential performance benchmarks was prepared to illustrate the kinds of information that can be produced through a benchmark development program. Current information resources which may be used to develop potential performance benchmarks are limited. There is need to develop an occupational safety and health information and data system in DOE, which is capable of incorporating demonstrated and documented performance benchmarks prior to, or concurrent with the development of hardware and software. A key to the success of this systems approach is rigorous development and demonstration of performance benchmark equivalents to users of such data before system hardware and software commitments are institutionalized.« less

Humidified high flow nasal cannulae: current practice in Australasian nurseries, a survey.

PubMed

Hough, Judith L; Shearman, Andrew D; Jardine, Luke A; Davies, Mark W

2012-02-01

Humidified High Flow Nasal Cannula (HHFNC) has been increasingly adopted as a new means of respiratory support throughout the world. However, evidence to support its safety and efficacy is limited. The aim of the present survey was to determine current practices regarding the usage of HHFNC by neonatologists in Australia and New Zealand. Surveys were sent to all 167 neonatologists identified by the list of centres in the Australia and New Zealand Neonatal Network. A total of 157 surveys were sent to valid email addresses: 111 (71%) responded of which 105 (67%) had completed the questionnaire. HHFNC is used in 17 (63%) of neonatal intensive care units in Australia and New Zealand. It is most commonly used to reduce nasal trauma (91%) and provide continuous positive airways pressure (62%). The main perceived benefits of HHFNC were the easier application and care of the infant (86%), and improved tolerance by the baby (84%). Rain out leading to fluid instillation into the upper airway (59%) was the most common problem. This survey has provided a snapshot of the practice of HHFNC usage in Australia and New Zealand in 2010 and has revealed that HHFNC use is widespread and that clinical practices are diverse. The majority of neonatologists acknowledge that there is limited evidence to support its efficacy and safety, and would be happy to participate in clinical trials to address how best to deliver HHFNC. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Feasibility Study of a Rotorcraft Health and Usage Monitoring System (HUMS): Results of Operator's Evaluation

NASA Technical Reports Server (NTRS)

Romero, Raylund; Summers, Harold; Cronkhite, James

1996-01-01

The objective was to evaluate the feasibility of a state-of-the-art health and usage monitoring system (HUMS) to provide monitoring of critical mechanical systems on the helicopter, including motors, drive train, engines, and life-limited components. The implementation of HUMS and cost integration with current maintenance procedures was assessed from the operator's viewpoint in order to achieve expected benefits from these systems, such as enhanced safety, reduced maintenance cost, and increased availability. An operational HUMS that was installed and operated under an independent flight trial program was used as a basis for this study. The HUMS equipment and software were commercially available. Based on the results of the feasibility study, the HUMS used in the flight trial program generally demonstrated a high level of reliability in monitoring the rotor system, engines, drive train, and life-limited components. The system acted as a sentinel to warn of impending failures. A worn tail rotor pitch bearing was detected by HUMS, which had the capability for self testing to diagnose system and sensor faults. Examples of potential payback to the operator with HUMS were identified, including reduced insurance cost through enhanced safety, lower operating costs derived from maintenance credits, increased aircraft availability, and improved operating efficiency. The interfacing of HUMS with current operational procedures was assessed to require only minimal revisions to the operator's maintenance manuals. Finally the success in realizing the potential benefits from HUMS technology was found to depend on the operator, helicopter manufacturer, regulator (FAA), and HUMS supplier working together.

Supplemental Thermal-Hydraulic Transient Analyses of BR2 in Support of Conversion to LEU Fuel

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

Licht, J.; Dionne, B.; Sikik, E.

2016-01-01

Belgian Reactor 2 (BR2) is a research and test reactor located in Mol, Belgium and is primarily used for radioisotope production and materials testing. The Materials Management and Minimization (M3) Reactor Conversion Program of the National Nuclear Security Administration (NNSA) is supporting the conversion of the BR2 reactor from Highly Enriched Uranium (HEU) fuel to Low Enriched Uranium (LEU) fuel. The RELAP5/Mod 3.3 code has been used to perform transient thermal-hydraulic safety analyses of the BR2 reactor to support reactor conversion. A RELAP5 model of BR2 has been validated against select transient BR2 reactor experiments performed in 1963 by showingmore » agreement with measured cladding temperatures. Following the validation, the RELAP5 model was then updated to represent the current use of the reactor; taking into account core configuration, neutronic parameters, trip settings, component changes, etc. Simulations of the 1963 experiments were repeated with this updated model to re-evaluate the boiling risks associated with the currently allowed maximum heat flux limit of 470 W/cm 2 and temporary heat flux limit of 600 W/cm 2. This document provides analysis of additional transient simulations that are required as part of a modern BR2 safety analysis report (SAR). The additional simulations included in this report are effect of pool temperature, reduced steady-state flow rate, in-pool loss of coolant accidents, and loss of external cooling. The simulations described in this document have been performed for both an HEU- and LEU-fueled core.« less

78 FR 8575 - Ocean Energy Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... energy safety, including but not limited to, drilling and workplace safety, well intervention and containment, and oil spill response. The Committee will also facilitate collaborative research and development...

Validation of Battery Safety for Space Missions

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith

2012-01-01

Presentation covers: (1) Safety Certification Process at NASA (2) Safety Testing for Lithium-ion Batteries (3) Limitations Observed with Li-ion Batteries in High Voltage and High Capacity Configurations.

Neurovirulence safety testing of mumps vaccines--historical perspective and current status.

PubMed

Rubin, S A; Afzal, M A

2011-04-05

Many live, attenuated viral vaccines are derived from wild type viruses with known neurovirulent properties. To assure the absence of residual neurotoxicity, pre-clinical neurovirulence safety testing of candidate vaccines is performed. For mumps virus, a highly neurotropic virus, neurovirulence safety testing is performed in monkeys. However, laboratory studies suggest an inability of this test to correctly discern among virus strains of varying neurovirulence potential in man, and, further, some vaccines found to be neuroattenuated in monkeys were later found to be neurovirulent in humans when administered in large numbers. Over the past decade, concerted efforts have been made to replace monkey-based neurovirulence safety testing with more informative, alternative methods. This review summarizes the current status of mumps vaccine neurovirulence safety testing and insights into models currently approved and those under development. Published by Elsevier Ltd.

Stability of DIII-D high-performance, negative central shear discharges

NASA Astrophysics Data System (ADS)

Hanson, J. M.; Berkery, J. W.; Bialek, J.; Clement, M.; Ferron, J. R.; Garofalo, A. M.; Holcomb, C. T.; La Haye, R. J.; Lanctot, M. J.; Luce, T. C.; Navratil, G. A.; Olofsson, K. E. J.; Strait, E. J.; Turco, F.; Turnbull, A. D.

2017-05-01

Tokamak plasma experiments on the DIII-D device (Luxon et al 2005 Fusion Sci. Tech. 48 807) demonstrate high-performance, negative central shear (NCS) equilibria with enhanced stability when the minimum safety factor {{q}\\text{min}} exceeds 2, qualitatively confirming theoretical predictions of favorable stability in the NCS regime. The discharges exhibit good confinement with an L-mode enhancement factor H 89  =  2.5, and are ultimately limited by the ideal-wall external kink stability boundary as predicted by ideal MHD theory, as long as tearing mode (TM) locking events, resistive wall modes (RWMs), and internal kink modes are properly avoided or controlled. Although the discharges exhibit rotating TMs, locking events are avoided as long as a threshold minimum safety factor value {{q}\\text{min}}>2 is maintained. Fast timescale magnetic feedback control ameliorates RWM activity, expanding the stable operating space and allowing access to {β\\text{N}} values approaching the ideal-wall limit. Quickly growing and rotating instabilities consistent with internal kink mode dynamics are encountered when the ideal-wall limit is reached. The RWM events largely occur between the no- and ideal-wall pressure limits predicted by ideal MHD. However, evaluating kinetic contributions to the RWM dispersion relation results in a prediction of passive stability in this regime due to high plasma rotation. In addition, the ideal MHD stability analysis predicts that the ideal-wall limit can be further increased to {β\\text{N}}>4 by broadening the current profile. This path toward improved stability has the potential advantage of being compatible with the bootstrap-dominated equilibria envisioned for advanced tokamak (AT) fusion reactors.

Impact of Passive Safety on FHR Instrumentation Systems Design and Classification

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

Holcomb, David Eugene

2015-01-01

Fluoride salt-cooled high-temperature reactors (FHRs) will rely more extensively on passive safety than earlier reactor classes. 10CFR50 Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum design requirements to provide reasonable assurance of adequate safety. 10CFR50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, provides guidance on how the safety significance of systems, structures, and components (SSCs) should be reflected in their regulatory treatment. The Nuclear Energy Institute (NEI) has provided 10 CFR 50.69 SSC Categorization Guideline (NEI-00-04) that factors in probabilistic risk assessment (PRA) model insights, as well as deterministic insights, throughmore » an integrated decision-making panel. Employing the PRA to inform deterministic requirements enables an appropriately balanced, technically sound categorization to be established. No FHR currently has an adequate PRA or set of design basis accidents to enable establishing the safety classification of its SSCs. While all SSCs used to comply with the general design criteria (GDCs) will be safety related, the intent is to limit the instrumentation risk significance through effective design and reliance on inherent passive safety characteristics. For example, FHRs have no safety-significant temperature threshold phenomena, thus enabling the primary and reserve reactivity control systems required by GDC 26 to be passively, thermally triggered at temperatures well below those for which core or primary coolant boundary damage would occur. Moreover, the passive thermal triggering of the primary and reserve shutdown systems may relegate the control rod drive motors to the control system, substantially decreasing the amount of safety-significant wiring needed. Similarly, FHR decay heat removal systems are intended to be running continuously to minimize the amount of safety-significant instrumentation needed to initiate operation of systems and components important to safety as required in GDC 20. This paper provides an overview of the design process employed to develop a pre-conceptual FHR instrumentation architecture intended to lower plant capital and operational costs by minimizing reliance on expensive, safety related, safety-significant instrumentation through the use of inherent passive features of FHRs.« less

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

PubMed Central

2014-01-01

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

Viral hepatitis vaccination during pregnancy

PubMed Central

Zhao, Yueyuan; Jin, Hui; Zhang, Xuefeng; Wang, Bei; Liu, Pei

2016-01-01

Abstract Viral hepatitis is a serious global public health problem. It is also a common cause of jaundice and gestational complications in pregnant women. Moreover, infected mothers can transmit the virus to their fetus or neonate, which may increase disease burden and decrease quality of life. To date, commercial vaccines have been developed for hepatitis A, B, and E and are available to the general population. The Advisory Committee on Immunization Practices currently accepts emergency vaccination against hepatitis A and B during pregnancy due to benefits that overweight the potential risks. While there are limited data from trials with limited numbers of samples that suggest the efficacy or safety of hepatitis B and E vaccines in pregnant women, additional data are necessary to provide evidence of vaccination during pregnancy. PMID:26833263

Current collectors for improved safety

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

Abdelmalak, Michael Naguib; Allu, Srikanth; Dudney, Nancy J.

A battery electrode assembly includes a current collector with conduction barrier regions having a conductive state in which electrical conductivity through the conduction barrier region is permitted, and a safety state in which electrical conductivity through the conduction barrier regions is reduced. The conduction barrier regions change from the conductive state to the safety state when the current collector receives a short-threatening event. An electrode material can be connected to the current collector. The conduction barrier regions can define electrical isolation subregions. A battery is also disclosed, and methods for making the electrode assembly, methods for making a battery, andmore » methods for operating a battery.« less

U.S. Food System Working Conditions as an Issue of Food Safety.

PubMed

Clayton, Megan L; Smith, Katherine C; Pollack, Keshia M; Neff, Roni A; Rutkow, Lainie

2017-02-01

Food workers' health and hygiene are common pathways to foodborne disease outbreaks. Improving food system jobs is important to food safety because working conditions impact workers' health, hygiene, and safe food handling. Stakeholders from key industries have advanced working conditions as an issue of public safety in the United States. Yet, for the food industry, stakeholder engagement with this topic is seemingly limited. To understand this lack of action, we interviewed key informants from organizations recognized for their agenda-setting role on food-worker issues. Findings suggest that participants recognize the work standards/food safety connection, yet perceived barriers limit adoption of a food safety frame, including more pressing priorities (e.g., occupational safety); poor fit with organizational strategies and mission; and questionable utility, including potential negative consequences. Using these findings, we consider how public health advocates may connect food working conditions to food and public safety and elevate it to the public policy agenda.

Safety practices in Jordanian manufacturing enterprises within industrial estates.

PubMed

Khrais, Samir; Al-Araidah, Omar; Aweisi, Assaf Mohammad; Elias, Fadia; Al-Ayyoub, Enas

2013-01-01

This paper investigates occupational health and safety practices in manufacturing enterprises within Jordanian industrial estates. Response rates were 21.9%, 58.6% and 70.8% for small, medium and large sized enterprises, respectively. Survey results show that most companies comply with state regulations, provide necessary facilities to enhance safety and provide several measures to limit and control hazards. On the negative side, little attention is given to safety training that might be due to the lack of related regulations and follow-up, financial limitations or lack of awareness on the importance of safety training. In addition, results show that ergonomic hazards, noise and hazardous chemicals are largely present. Accident statistics show that medium enterprises have the highest accident cases per enterprise, and chemical industries reported highest total number of accidents per enterprise. The outcomes of this study establish a base for appropriate safety recommendations to enhance the awareness and commitment of companies to appropriate safety rules.

Discussing Firearm Ownership and Access as Part of Suicide Risk Assessment and Prevention: "Means Safety" versus "Means Restriction".

PubMed

Stanley, Ian H; Hom, Melanie A; Rogers, Megan L; Anestis, Michael D; Joiner, Thomas E

2017-01-01

The goal of this study was to describe the relative utility of the terms "means safety" versus "means restriction" in counseling individuals to limit their access to firearms in the context of a mock suicide risk assessment. Overall, 370 participants were randomized to read a vignette depicting a clinical scenario in which managing firearm ownership and access was discussed either using the term "means safety" or "means restriction." Participants rated the term "means safety" as significantly more acceptable and preferable than "means restriction." Participants randomized to the "means safety" condition reported greater intentions to adhere to clinicians' recommendations to limit access to a firearm for safety purposes (F[1,367] = 7.393, p = .007, [Formula: see text]). The term "means safety" may be more advantageous than "means restriction" when discussing firearm ownership and access in clinical settings and public health-oriented suicide prevention efforts.

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

Thermal Modeling for the Next Generation of Radiofrequency Exposure Limits: Commentary.

PubMed

Foster, Kenneth R; Ziskin, Marvin C; Balzano, Quirino

2017-07-01

This commentary evaluates two sets of guidelines for human exposure to radiofrequency (RF) energy, focusing on the frequency range above the "transition" frequency at 3-10 GHz where the guidelines change their basic restrictions from specific absorption rate to incident power density, through the end of the RF band at 300 GHz. The analysis is based on a simple thermal model based on Pennes' bioheat equation (BHTE) (Pennes 1948) assuming purely surface heating; an Appendix provides more details about the model and its range of applicability. This analysis suggests that present limits are highly conservative relative to their stated goals of limiting temperature increase in tissue. As applied to transmitting devices used against the body, they are much more conservative than product safety standards for touch temperature for personal electronics equipment that are used in contact with the body. Provisions in the current guidelines for "averaging time" and "averaging area" are not consistent with scaling characteristics of the bioheat equation and should be refined. The authors suggest the need for additional limits on fluence for protection against brief, high intensity pulses at millimeter wave frequencies. This commentary considers only thermal hazards, which form the basis of the current guidelines, and excludes considerations of reported "non-thermal" effects of exposure that would have to be evaluated in the process of updating the guidelines.

Safety and fitness electronic records system (SAFER) : user and system requirements document

DOT National Transportation Integrated Search

1996-10-28

The Federal Highway Administration (FHWA) is currently testing and evaluating Intelligent : Transportation Systems (ITS) technologies to enhance the safety and efficiency of interstate and : intrastate commercial vehicle operations. The current focus...

Status report on the effects of the 65 mph speed limit on Virginia's rural interstate highway system : submitted to the Secretary of Transportation and Public Safety from the Secretarial Task Force on Interstate Highway Speed limits.

DOT National Transportation Integrated Search

1989-01-01

In 1987, the Secretary of Transportation and Public Safety created a task force to study the potential effects of raising the speed limit on rural interstate highways in Virginia. In its 1988 session, the Virginia General Assembly passed legislation ...

1995 Bicycle and Pedestrian Safety Report

DOT National Transportation Integrated Search

1995-03-01

This report provides a review of the current data on bicycle and pedestrian : safety across the United States, finding that safety and education : programs could significantly improve bicycle and pedestrian safety in the : Dallas-Fort Worth Metropoli...

Geopolymer concrete for structural use: Recent findings and limitations

NASA Astrophysics Data System (ADS)

Nuruddin, M. F.; Malkawi, A. B.; Fauzi, A.; Mohammed, B. S.; Almattarneh, H. M.

2016-06-01

Geopolymer binders offer a possible solution for several problems that facing the current cement industry. These binders exhibit similar or better engineering properties compared to cement and can utilize several types of waste materials. This paper presents the recent research progress regarding the structural behaviour of reinforced geopolymer concrete members including beams, columns and slabs. The reported results showed that the structural behaviour of the reinforced geopolymer concrete members is similar to the known behaviour of the ordinary reinforced concrete members. In addition, the currently available standards have been conservatively used for analysis and designing of reinforced geopolymer concrete structures. On the other hand, the main hurdles facing the spread of geopolymer concrete was the absence of standards and the concerns about the long-term properties. Other issues included the safety, cost and liability.

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

PubMed

Sax, Joanna K

2015-01-01

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

PubMed Central

Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

2015-01-01

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. PMID:25413621

49 CFR 374.401 - Minimum permissible limitations for baggage liability.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS PASSENGER CARRIER REGULATIONS Notice of and Procedures for Baggage Excess Value Declaration § 374... permit the passenger, for an additional charge, to declare a value in excess of the limited amount, and...

75 FR 25785 - Airworthiness Directives; BAE Systems (Operations) Limited Model 4101 Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-10

... Airworthiness Directives; BAE Systems (Operations) Limited Model 4101 Airplanes AGENCY: Federal Aviation... the propeller blades, which can result in dangerous blade cracks. The European Aviation Safety Agency... issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA...

The management of staghorn calculi in children

PubMed Central

Horuz, Rahim; Sarica, Kemal

2012-01-01

Objectives To review reports focusing on the surgical treatment of staghorn stones in children, as despite all the improvements in the surgical treatment of paediatric urolithiasis the management of staghorn calculi still represents a challenging problem in urology practice. Methods To evaluate current knowledge about treating staghorn calculi in children, we searched PubMed for relevant articles published between 1991 and 2011, using a combination of related keywords, i.e. staghorn stone, child, kidney calculi, surgical treatment, electrohydraulic shockwave therapy (ESWL), percutaneous nephrolithotomy (PCNL), and open surgery. Reports relating to the treatment of paediatric stone disease in general (open surgery, PCNL, ESWL) were also searched with the same method. Additional references were obtained from the reference list of full-text reports. Results Although open surgery had been widely used in the past for treating such stones in children, currently it has only limited indications in highly selected patients. Current published data clearly indicate that, in experienced hands, both PCNL and ESWL are now effective methods for treating staghorn calculi in children. Conclusions Due to advanced techniques and instrumentation, it is now possible to successfully treat staghorn calculi in children, with very limited safety concerns. Currently, while PCNL is recommended as the first-line surgical treatment, ESWL, open surgery and/or combined methods are valuable but secondary options in the treatment of paediatric staghorn calculi. PMID:26558045

Radiation safety standards and their application: international policies and current issues.

PubMed

González, Abel J

2004-09-01

This paper briefly describes the current policies of the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection and how these policies are converted into international radiation safety standards by the International Atomic Energy Agency, which is the only global organization-within the United Nations family of international agencies-with a statutory mandate not only to establish such standards but also to provide for their application. It also summarizes the current status of the established corpus of such international standards, and of it foreseeable evolution, as well as of legally binding undertakings by countries around the world that are linked to these standards. Moreover, this paper also reviews some major current global issues related to the application of international standards, including the following: strengthening of national infrastructures for radiation safety, including technical cooperation programs for assisting developing countries; occupational radiation safety challenges, including the protection of pregnant workers and their unborn children, dealing with working environments with high natural radiation levels, and occupational attributability of health effects (probability of occupational causation); restricting discharges of radioactive substances into the environment: reviewing current international policies vis-a-vis the growing concern on the radiation protection of the "environment;" radiological protection of patients undergoing radiodiagnostic and radiotherapeutic procedures: the current International Action Plan; safety and security of radiation sources: post-11 September developments; preparedness and response to radiation emergencies: enhancing the international network; safe transport of radioactive materials: new apprehensions; safety of radioactive waste management: concerns and connections with radiation protection; and radioactive residues remaining after the termination of activities: radiation protection response to the forthcoming wave of decommissioning of installations with radioactive materials. The ultimate aim of this paper is to encourage information exchange, cooperation, and collaboration within the radiation protection professional community. In particular, the paper tries to facilitate consolidation of the growing international regime on radiation safety, including the expansion of legally binding undertakings by countries, the strengthening of the current corpus of international radiation safety standards, and the development of international provisions for ensuring the proper worldwide application of these standards, such as a system of international appraisals by peer review.

Threats to the health care safety net.

PubMed

Taylor, T B

2001-11-01

The American health care safety net is threatened due to inadequate funding in the face of increasing demand for services by virtually every segment of our society. The safety net is vital to public safety because it is the sole provider for first-line emergency care, as well as for routine health care of last resort, through hospital emergency departments (ED), emergency medical services providers (EMS), and public/free clinics. Despite the perceived complexity, the causes and solutions for the current crisis reside in simple economics. During the last two decades health care funding has radically changed, yet the fundamental infrastructure of the safety net has change little. In 1986, the Emergency Medical Treatment and Active Labor Act established federally mandated safety net care that inadvertently encouraged reliance on hospital EDs as the principal safety net resource. At the same time, decreasing health care funding from both private and public sources resulted in declining availability of services necessary to support this shift in demand, including hospital inpatient beds, EDs, EMS providers, on-call specialists, hospital-based nurses, and public hospitals/clinics. The result has been ED/hospital crowding and resource shortages that at times limit the ability to provide even true emergency care and threaten the ability of the traditional safety net to protect public health and safety. This paper explores the composition of the American health care safety net, the root causes for its disintegration, and offers short- and long-term solutions. The solutions discussed include restructuring of disproportionate share funding; presumed (deemed) eligibility for Medicaid eligibility; restructuring of funding for emergency care; health care for foreign nationals; the nursing shortage; utilization of a "health care resources commission"; "episodic (periodic)" health care coverage; best practices and health care services coordination; and government and hospital providers' roles. There is a base amount of funding that must be available to the American health care safety net to maintain its infrastructure and provide appropriate growth, research, development, and expansion of services. Fall below this level and the infrastructure will eventually crumble. America must patch the safety net with short-term funding and repair it with long-term health care policy and environmental changes.

Nurses' Perceptions of Patient Safety Culture in Three Hospitals in Saudi Arabia.

PubMed

Alquwez, Nahed; Cruz, Jonas Preposi; Almoghairi, Ahmed Mohammed; Al-Otaibi, Raid Salman; Almutairi, Khalid Obaid; Alicante, Jerico G; Colet, Paolo C

2018-05-14

To assess the present patient safety culture of three general hospitals in Saudi Arabia, as perceived by nurses. This study utilized a descriptive, cross-sectional design. A convenience sample of 351 nurses working in three general hospitals in the central region of Saudi Arabia was surveyed in this study using the Hospital Survey of Patients' Safety Culture (HSOPSC) from October 2016 to April 2017. From the 12 composites of the HSOPSC, the nurses perceived only the following two patient safety areas as strengths: teamwork within units and organizational learning-continuous improvement. Six areas of patient safety were identified as weaknesses, namely overall perception of patient safety, handoffs and transitions, communication openness, staffing, frequency of events reported, and nonpunitive response to errors. Nationality, educational attainment, hospital, length of service in the hospital, work area or unit, length of service in the current work area or unit, current position, and direct patient contact or interaction were significant predictors of the nurses' perceived patient safety culture. The findings in this study clarify the current status of patient safety culture in three hospitals in the Kingdom of Saudi Arabia. The present findings should be considered by policymakers, hospital leaders, and nurse executives in creating interventions aimed at improving the patient safety culture in hospitals. A multidimensional network intervention targeting the different dimensions of patient safety culture and involving different organizational levels should be implemented to improve patient safety. © 2018 Sigma Theta Tau International.

Discovery and preclinical development of dasabuvir for the treatment of hepatitis C infection.

PubMed

El Kassas, Mohamed; Elbaz, Tamer; Hafez, Enas; Wifi, Mohamed Naguib; Esmat, Gamal

2017-06-01

Hepatitis C virus (HCV) is a leading cause of liver-related morbidity and mortality. Positively, the introduction of new directly-acting antivirals (DAAs) have led to dramatic improvements in response rates to antiviral therapy. Furthermore, newer generations of DAAs have demonstrated better safety profiles as well as efficacy than older generations. Current treatment recommendations are based on different combinations of DAAs. Current combination therapies rely on agents that target the different steps of viral replication by using different molecules from various DAAs families. Areas covered: In this review, the authors summarize data from of one of the recently developed NS5B polymerase inhibitors, dasabuvir, formerly known as ABT-333. Herein, the authors discuss the drug discovery data for dasabuvir including data from preclinical, toxicological resistance studies. The authors also review dasabuvir's clinical efficacy across various clinical challenges, in addition to its limitations in clinical practice. Expert opinion: Dasabuvir represents an important medical advance when used as a combination therapy for HCV. Unfortunately, it does present limitations like low genotypic coverage and further research is still required to address some of the lingering issues.

Multi-interface level in oil tanks and applications of optical fiber sensors

NASA Astrophysics Data System (ADS)

Leal-Junior, Arnaldo G.; Marques, Carlos; Frizera, Anselmo; Pontes, Maria José

2018-01-01

On the oil production also involves the production of water, gas and suspended solids, which are separated from the oil on three-phase separators. However, the control strategies of an oil separator are limited due to unavailability of suitable multi-interface level sensors. This paper presents a description of the multi-phase level problem on the oil industry and a review of the current technologies for multi-interface level assessment. Since optical fiber sensors present chemical stability, intrinsic safety, electromagnetic immunity, lightweight and multiplexing capabilities, it can be an alternative for multi-interface level measurement that can overcome some of the limitations of the current technologies. For this reason, Fiber Bragg Gratings (FBGs) based optical fiber sensor system for multi-interface level assessment is proposed, simulated and experimentally assessed. The results show that the proposed sensor system is capable of measuring interface level with a relative error of only 2.38%. Furthermore, the proposed sensor system is also capable of measuring the oil density with an error of 0.8 kg/m3.

Negative Transference Numbers in Polymer Electrolytes

NASA Astrophysics Data System (ADS)

Pesko, Danielle; Timachova, Ksenia; Balsara, Nitash

Energy density and safety of conventional lithium-ion batteries is limited by the use of flammable organic liquids as a solvent for lithium salts. Polymer electrolytes have the potential to address both limitations. The poor performance of batteries with polymer electrolytes is generally attributed to low ionic conductivity. The purpose of our work is to show that another transport property, the cation transference number, t +, of polymer electrolytes is fundamentally different from that of conventional electrolytes. Our experimental approach, based on concentrated solution theory, indicates that t + of mixtures of poly(ethylene oxide) and LiTFSI salt are negative over most of the accessible concentration window. In contrast, approaches based on dilute solution theory suggest that t + in the same system is positive. In addition to presenting a new approach for determining t +, we also present data obtained from the steady-state current method, pulsed-field-gradient NMR, and the current-interrupt method. Discrepancies between different approaches are resolved. Our work implies that in the absence of concentration gradients, the net fluxes of both cations and anions are directed toward the positive electrode. Conventional liquid electrolytes do not suffer from this constraint.

Review article: practical current issues in perioperative patient safety.

PubMed

Eichhorn, John H

2013-02-01

This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.

Optimism about safety and group-serving interpretations of safety among pedestrians and cyclists in relation to road use in general and under low light conditions.

PubMed

King, M J; Wood, J M; Lacherez, P F; Marszalek, R P

2012-01-01

Drivers are known to be optimistic about their risk of crash involvement, believing that they are less likely to be involved in a crash than other drivers. However, little comparative research has been conducted among other road users. In addition, optimism about crash risk is conceptualised as applying only to an individual's assessment of his or her personal risk of crash involvement. The possibility that the self-serving nature of optimism about safety might be generalised to the group-level as a cyclist or a pedestrian, i.e., becoming group-serving rather than self-serving, has been overlooked in relation to road safety. This study analysed a subset of data collected as part of a larger research project on the visibility of pedestrians, cyclists and road workers, focusing on a set of questionnaire items administered to 406 pedestrians, 838 cyclists and 622 drivers. The items related to safety in various scenarios involving drivers, pedestrians and cyclists, allowing predictions to be derived about group differences in agreement with items based on the assumption that the results would exhibit group-serving bias. Analysis of the responses indicated that specific hypotheses about group-serving interpretations of safety and responsibility were supported in 22 of the 26 comparisons. When the nine comparisons relevant to low lighting conditions were considered separately, seven were found to be supported. The findings of the research have implications for public education and for the likely acceptance of messages which are inconsistent with current assumptions and expectations of pedestrians and cyclists. They also suggest that research into group-serving interpretations of safety, even for temporary roles rather than enduring groups, could be fruitful. Further, there is an implication that gains in safety can be made by better educating road users about the limitations of their visibility and the ramifications of this for their own road safety, particularly in low light. 2010 Elsevier Ltd. All rights reserved.

Efficacy and safety of selective glucocorticoid receptor modulators in comparison to glucocorticoids in arthritis, a systematic review.

PubMed

Safy, M; de Hair, M J H; Jacobs, J W G; Buttgereit, F; Kraan, M C; van Laar, J M

2017-01-01

Long-term treatment with glucocorticoids (GCs) plays an important role in the management of arthritis patients, although the efficacy/safety balance is unfavorable. Alternatives with less (severe) adverse effects but with good efficacy are needed. Selective GC receptor modulators (SGRMs) are designed to engage the GC receptor with dissociative characteristics: transactivation of genes, which is mainly responsible for unwanted effects, is less strong while trans-repression of genes, reducing inflammation, is maintained. It is expected that SGRMs thus have a better efficacy/safety balance than GCs. A systematic review providing an overview of the evidence in arthritis is lacking. To systematically review the current literature on efficacy and safety of oral SGRMs in comparison to GCs in arthritis. A search was performed in Medline, Embase and the Cochrane Library, from inception dates of databases until May 2017. Experimental studies involving animal arthritis models or human material of arthritis patients, as well as clinical studies in arthritis patients were included, provided they reported original data. All types of arthritis were included. Data was extracted on the SGRM studied and on the GC used as reference standard; the design or setting of the study was extracted as well as the efficacy and safety results. A total of 207 articles was retrieved of which 17 articles were eligible for our analysis. Two studies concerned randomized controlled trials (RCT), five studies were pre-clinical studies using human material, and 10 studies involved pre-clinical animal models (acute and/or chronic arthritis induced in mice or rats). PF-04171327, the only compound investigated in a clinical trial setting, had a better efficacy/safety balance compared to GCs: better clinical anti-inflammatory efficacy and similar safety. Studies assessing both efficacy and safety of SGRMs are scarce. There is limited evidence for dissociation of anti-inflammatory and metabolic effects of the SGRMs studied. Development of many SGRMs is haltered in a preclinical phase. One SGRM showed a better clinical efficacy/safety balance.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Putting Safety in the Frame: Nurses' Sensemaking at Work.

PubMed

O'Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

2015-01-01

Current patient safety policy focuses nursing on patient care goals, often overriding nurses' safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used "frames" built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses' decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses' frames question current policy and practice by challenging how nurses' safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management.

Putting Safety in the Frame

PubMed Central

O’Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

2015-01-01

Current patient safety policy focuses nursing on patient care goals, often overriding nurses’ safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used “frames” built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses’ decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses’ frames question current policy and practice by challenging how nurses’ safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management. PMID:28462311

Mobile phones, mobile phone base stations and cancer: a review.

PubMed

Moulder, J E; Foster, K R; Erdreich, L S; McNamee, J P

2005-03-01

There have been reports in the media and claims in the courts that radiofrequency (RF) emissions from mobile phones are a cause of cancer, and there have been numerous public objections to the siting of mobile phone base antennas because of a fear of cancer. This review summarizes the current state of evidence concerning whether the RF energy used for wireless communication might be carcinogenic. Relevant studies were identified by searching MedLine with a combination of exposure and endpoint terms. This was supplemented by a review of the over 1700 citations assembled by the Institute of Electrical and Electronics Engineers (IEEE) International Committee on Electromagnetic Safety as part of their updating of the IEEE C95.1 RF energy safety guidelines. Where there were multiple studies, preference was given to recent reports, to positive reports of effects and to attempts to confirm such positive reports. Biophysical considerations indicate that there is little theoretical basis for anticipating that RF energy would have significant biological effects at the power levels used by modern mobile phones and their base station antennas. The epidemiological evidence for a causal association between cancer and RF energy is weak and limited. Animal studies have provided no consistent evidence that exposure to RF energy at non-thermal intensities causes or promotes cancer. Extensive in vitro studies have found no consistent evidence of genotoxic potential, but in vitro studies assessing the epigenetic potential of RF energy are limited. Overall, a weight-of-evidence evaluation shows that the current evidence for a causal association between cancer and exposure to RF energy is weak and unconvincing. However, the existing epidemiology is limited and the possibility of epigenetic effects has not been thoroughly evaluated, so that additional research in those areas will be required for a more thorough assessment of the possibility of a causal connection between cancer and the RF energy from mobile telecommunications.

Opportunities for biotechnology and policy regarding mycotoxin issues in international trade.

PubMed

Kendra, David F; Dyer, Rex B

2007-10-20

Despite being introduced more than a decade ago, agricultural biotechnology still remains framed in controversy impacting both the global economy and international regulations. Controversies surrounding agricultural biotechnology produced crops and foods commonly focus on human and environmental safety, intellectual property rights, consumer choice, ethics, food security, poverty reduction and environmental conservation. Originally, some consumers were reluctant to accept the first generation agricultural biotechnology products because they appeared to primarily benefit agricultural producers; however, it is clear from continued evaluations that these technologies also improved both the safety and wholesomeness of food and helped improve the environment. Plants engineered to resist insect pests and tolerate less toxic pesticides resulted in improved yields thereby enabling farmers to produce more food per acre while reducing the need for herbicides, pesticides, and water and tilling. An indirect benefit of reduced pest damage in transgenic corn expressing genes to control insect pests is lower levels of mycotoxins, most notably those caused by the genus Fusarium. Mycotoxins are an important regulatory issue globally because of their toxic and carcinogenic potential to humans and animals. Complicating this issue is the fact that toxicological databases for mycotoxins are relatively incomplete compared to other food contaminants. Current debates about agricultural biotechnology and mycotoxins reveal significant differences in perception of associated risks and benefits. When faced with uncertainty, regulators tend to set limits as low as possible. Additionally, some regulators invoke the "Precautionary Principle" when limited information is available or disputes over interpretation exist for possible contaminants, including mycotoxins. A major concern regarding use of the "Precautionary Principle" is the appearance that regulators can justify setting any limit on the basis of inconclusive or unknown potential hazards of a contaminant which may significantly impact global trade because mycotoxin residues vary widely between countries. This paper describes the current economic and heath impact of these regulations and their impact on international trade.

33 CFR 165.1198 - Safety zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Safety zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA. 165.1198 Section 165.1198... Limited Access Areas Eleventh Coast Guard District § 165.1198 Safety zone; Military Ocean Terminal Concord...

33 CFR 165.1198 - Safety zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA. 165.1198 Section 165.1198... Limited Access Areas Eleventh Coast Guard District § 165.1198 Safety zone; Military Ocean Terminal Concord...

The U.S. Commercial Air Tour Industry: A Review of Aviation Safety Concerns

PubMed Central

Ballard, Sarah-Blythe

2016-01-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as “flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing.” The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators. PMID:24597160

The U.S. commercial air tour industry: a review of aviation safety concerns.

PubMed

Ballard, Sarah-Blythe

2014-02-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

PubMed

McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

2017-08-01

To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

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

PubMed

Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

2003-01-01

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

Evaluating the Impact of Radio Frequency Identification Retained Surgical Instruments Tracking on Patient Safety: Literature Review.

PubMed

Schnock, Kumiko O; Biggs, Bonnie; Fladger, Anne; Bates, David W; Rozenblum, Ronen

2017-02-22

Retained surgical instruments (RSI) are one of the most serious preventable complications in operating room settings, potentially leading to profound adverse effects for patients, as well as costly legal and financial consequences for hospitals. Safety measures to eliminate RSIs have been widely adopted in the United States and abroad, but despite widespread efforts, medical errors with RSI have not been eliminated. Through a systematic review of recent studies, we aimed to identify the impact of radio frequency identification (RFID) technology on reducing RSI errors and improving patient safety. A literature search on the effects of RFID technology on RSI error reduction was conducted in PubMed and CINAHL (2000-2016). Relevant articles were selected and reviewed by 4 researchers. After the literature search, 385 articles were identified and the full texts of the 88 articles were assessed for eligibility. Of these, 5 articles were included to evaluate the benefits and drawbacks of using RFID for preventing RSI-related errors. The use of RFID resulted in rapid detection of RSI through body tissue with high accuracy rates, reducing risk of counting errors and improving workflow. Based on the existing literature, RFID technology seems to have the potential to substantially improve patient safety by reducing RSI errors, although the body of evidence is currently limited. Better designed research studies are needed to get a clear understanding of this domain and to find new opportunities to use this technology and improve patient safety.

Complementary and alternative medical therapies for attention-deficit/hyperactivity disorder and autism.

PubMed

Weber, Wendy; Newmark, Sanford

2007-12-01

Complementary and alternative medical (CAM) therapies are commonly used by parents for their children who have attention deficit hyperactivity disorder (ADHD) or autism spectrum disorders. The use of these therapies is well documented, yet the evidence of the safety and efficacy of these treatments in children is limited. This article describes the current evidence-based CAM therapies for ADHD and autism, focusing on nutritional interventions; natural health products, including essential fatty acids, vitamins, minerals, and other health supplements; biofeedback; and reducing environmental toxins. The CAM evidence in ADHD is addressed, as is the CAM literature in autism.

Final Report: Sensorpedia Phases 1 and 2

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

Gorman, Bryan L; Resseguie, David R

2010-08-01

Over the past several years, ORNL has been actively involved in research to formalize the engineering principles and best practices behind emerging social media and social networking concepts to solve real-time data sharing problems for national security and defense, public health and safety, environmental and infrastructure awareness, and disaster preparedness and response. Sensorpedia, an ORNL web site, is a practical application of several key social media principles. Dubbed the Wikipedia for sensors, Sensorpedia is currently in limited BETA testing and was selected in 2009 by Federal Computer Week as one of the government s top 10 social networking sites.

Hospital Decontamination: What Nurses Need to Know.

PubMed

Cox, Brent

2016-12-01

Incidents involving the release of hazardous materials challenge medical providers with safely, quickly, and correctly removing contaminants from the victim. While doing so, the safety of the first receiver, current patients, bystanders, as well as the victim all have to be considered. Key challenges with hospital decontamination include, but are not limited to, selection of team members, training protocols, employee turnover, and funding. Best practices, based on the available literature and evidence, include administration buy-in and support; strong policy and procedure documentation; equipment maintenance programs; and team member recruitment, retention, and education. Copyright © 2016 Elsevier Inc. All rights reserved.