30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

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.

Predictors of nurses' acceptance of an intravenous catheter safety device.

PubMed

Rivers, Dianna Lipp; Aday, Lu Ann; Frankowski, Ralph F; Felknor, Sarah; White, Donna; Nichols, Brenda

2003-01-01

It is important to determine the factors that predict whether nurses accept and use a new intravenous (IV) safety device because there are approximately 800,000 needlesticks per year with the risk of contracting a life-threatening bloodborne disease such as HIV or hepatitis C. To determine the predictors of nurses' acceptance of the Protectiv Plus IV catheter safety needle device at a teaching hospital in Texas. A one-time cross-sectional survey of nurses (N = 742) was conducted using a 34-item questionnaire. A framework was developed identifying organizational and individual predictors of acceptance. The three principal dimensions of acceptance were (a) satisfaction with the device, (b) extent to which the device is always used, and (c) nurse recommendations over other safety devices. Measurements included developing summary subscales for the variables of safety climate and acceptance. Descriptive statistics and multiple linear and logistic regression models were computed. The findings showed widespread acceptance of the device. Nurses who had adequate training and a positive institutional safety climate were more accepting (p

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.

The Informatics Opportunities at the Intersection of Patient Safety and Clinical Informatics

PubMed Central

Kilbridge, Peter M.; Classen, David C.

2008-01-01

Health care providers have a basic responsibility to protect patients from accidental harm. At the institutional level, creating safe health care organizations necessitates a systematic approach. Effective use of informatics to enhance safety requires the establishment and use of standards for concept definitions and for data exchange, development of acceptable models for knowledge representation, incentives for adoption of electronic health records, support for adverse event detection and reporting, and greater investment in research at the intersection of informatics and patient safety. Leading organizations have demonstrated that health care informatics approaches can improve safety. Nevertheless, significant obstacles today limit optimal application of health informatics to safety within most provider environments. The authors offer a series of recommendations for addressing these challenges. PMID:18436896

30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false MSHA acceptance of equivalent non-MSHA product... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non...) [Reserved] (d) After MSHA has determined that non-MSHA product safety standards are equivalent and has...

30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non...) [Reserved] (d) After MSHA has determined that non-MSHA product safety standards are equivalent and has...

30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false MSHA acceptance of equivalent non-MSHA product... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non...) [Reserved] (d) After MSHA has determined that non-MSHA product safety standards are equivalent and has...

30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non...) [Reserved] (d) After MSHA has determined that non-MSHA product safety standards are equivalent and has...

30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA acceptance of equivalent non-MSHA product... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non...) [Reserved] (d) After MSHA has determined that non-MSHA product safety standards are equivalent and has...

The acceptability and safety of praziquantel alone and in combination with mebendazole in the treatment of Schistosoma mansoni and soil-transmitted helminthiasis in children aged 1-4 years in Uganda.

PubMed

Namwanje, Harriet; Kabatereine, Narcis B; Olsen, Annette

2011-10-01

There is limited information on the acceptability and safety of praziquantel for treatment of schistosomiasis in children below the age of four years. In addition, although mebendazole has been extensively used together with praziquantel against infections with schistosomiasis and soil-transmitted helminthiasis (STH) in school-aged children, no specific acceptability or safety studies have been published on this drug combination in younger children. A randomized clinical trial was conducted to determine the safety of praziquantel alone and in combination with mebendazole in the treatment of Schistosoma mansoni and STH in children aged 1 to 4 years. A total of 596 children from Bwondha fishing community in Mayuge district and Wang-Kado fishing community in Nebbi district were investigated using duplicate Kato-Katz thick smears of two stool samples and 130 (21·8%) were found infected with S. mansoni. Of these, 19·2% (25) had heavy intensity of infections. Of the infected children, 82 were included and randomised into praziquantel (40 mg/kg) + mebendazole (500 mg) or praziquantel (40 mg/kg) alone. Many symptoms were reported before treatment while very few were reported after treatment and all on treatment day. No serious adverse events were reported or observed after treatment. Praziquantel with or without mebendazole was well tolerated in small children in the study area.

Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes.

PubMed

Rohlman, Diane S; Parish, Megan; Elliot, Diane L; Hanson, Ginger; Perrin, Nancy

2016-08-10

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14-24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen's d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior.

Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes

PubMed Central

Rohlman, Diane S.; Parish, Megan; Elliot, Diane L.; Hanson, Ginger; Perrin, Nancy

2016-01-01

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14–24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior. PMID:27517968

[Risk assessment of manual handling of loads: the choice of reference values in light of Leg. 81/2008].

PubMed

Baracco, A; Coggiola, M; Discalzi, G; Perrelli, F; Romano, C

2009-01-01

Italian law on safety at work does not clarify specific levels of load for safe manual material handling. For this reason professionals appointed for safety need to define new target range value for the correct application of D.Lgs. 81/2008 law. Authors, discussing about indication of the national laws and international rules, suggest the assumption of a load of 25 and 20 kg as reference values for male and female adult and healthy workers. They also examine the graduation of the acceptable loads in relation to workers' age and the Lifting Index values to be adopted as action limit and exposure limit.

Tough To Reach, Tough To Teach: Students with Behavior Problems.

ERIC Educational Resources Information Center

Rockwell, Sylvia

This book on students with behavior disorders is intended to serve as a resource on intervention strategies for regular education teachers, administrators, and support personnel. After an introductory chapter, a chapter on classroom climate considers setting limits, safety, trust, acceptance, and sense of purpose. The next chapter, on scheduling,…

SRTC criticality safety technical review: Nuclear Criticality Safety Evaluation 93-04 enriched uranium receipt

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

Rathbun, R.

Review of NMP-NCS-930087, {open_quotes}Nuclear Criticality Safety Evaluation 93-04 Enriched Uranium Receipt (U), July 30, 1993, {close_quotes} was requested of SRTC (Savannah River Technology Center) Applied Physics Group. The NCSE is a criticality assessment to determine the mass limit for Engineered Low Level Trench (ELLT) waste uranium burial. The intent is to bury uranium in pits that would be separated by a specified amount of undisturbed soil. The scope of the technical review, documented in this report, consisted of (1) an independent check of the methods and models employed, (2) independent HRXN/KENO-V.a calculations of alternate configurations, (3) application of ANSI/ANS 8.1,more » and (4) verification of WSRC Nuclear Criticality Safety Manual procedures. The NCSE under review concludes that a 500 gram limit per burial position is acceptable to ensure the burial site remains in a critically safe configuration for all normal and single credible abnormal conditions. This reviewer agrees with that conclusion.« less

Quality and safety attributes of afghan raisins before and after processing

PubMed Central

McCoy, Stacy; Chang, Jun Won; McNamara, Kevin T; Oliver, Haley F; Deering, Amanda J

2015-01-01

Raisins are an important export commodity for Afghanistan; however, Afghan packers are unable to export to markets seeking high-quality products due to limited knowledge regarding their quality and safety. To evaluate this, Afghan raisin samples from pre-, semi-, and postprocessed raisins were obtained from a raisin packer in Kabul, Afghanistan. The raisins were analyzed and compared to U.S. standards for processed raisins. The samples tested did not meet U.S. industry standards for embedded sand and pieces of stem, total soluble solids, and titratable acidity. The Afghan raisins did meet or exceed U.S. Grade A standard for the number of cap-stems, percent damaged, crystallization levels, moisture content, and color. Following processing, the number of total aerobic bacteria, yeasts, molds, and total coliforms were within the acceptable limits. Although quality issues are present in the Afghan raisins, the process used to clean the raisins is suitable to maintain food safety standards. PMID:25650241

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

Medical innovation versus stem cell tourism.

PubMed

Lindvall, Olle; Hyun, Insoo

2009-06-26

Stem cell tourism is criticized on grounds of consumer fraud, blatant lack of scientific justification, and patient safety. However, the issues are complex because they invoke questions concerning the limits of acceptable medical innovation and medical travel. Here we discuss these issues and articulate conditions under which "unproven" therapies may be offered to patients outside of regular clinical trials.

The Morality and Economics of Safety in Defence Procurement

NASA Astrophysics Data System (ADS)

Clement, Tim

Ministry of Defence policy is to conform as closely as possible to UK health and safety legislation in all its operations. We consider the implications of the law and the guidance provided by the Health and Safety Executive for the arguments we need to make for the safety of defence procurements, and extract four general principles to help in answering the questions that arise when considering the safety of systems with complex behaviour. One of these principles is analysed further to identify how case law and the guidance interpret the requirement for risks to be reduced so far as is reasonably practicable. We then apply the principles to answer some questions that have arisen in our work as Independent Safety Auditors, including the limits to the tolerability of risk to armed forces personnel and civilians in wartime, and the acceptability of the transfer of risk from one group to another when controls on risk are introduced.

Moms growing together: Piloting action methods and expressive arts in a therapeutic group for teen mothers.

PubMed

SmithBattle, Lee; Chantamit-O-Pas, Chutima; Freed, Patricia; McLaughlin, Dorcas; Schneider, Joanne K

2017-05-01

The purpose of this pilot study was to test the safety, acceptability, feasibility, and effectiveness of Moms Growing Together (MGT), an intervention to prevent and reduce psychological distress in teen mothers. A mixed method design was used. The primary outcomes were reported satisfaction with MGT (acceptance); successful recruitment and retention of teen mothers (feasibility); and prevention or reduction of psychological distress (safety and effectiveness). Summary scores on each of three symptom measures operationally defined psychological distress. Sixteen African-American teen mothers participated in the study: eight in MGT and eight in a comparison group. MGT was considered safe and acceptable. MGT had a negative small effect (effect size [ES] = -0.028) on decreasing depression in participants and a moderate effect in reducing anxiety (ES = 0.395) and trauma symptoms (ES = 0.521-0.554) relative to the comparison group. Prolonged recruitment limited feasibility. Because psychological distress casts a long shadow on teen mothers' well-being, developing teen-friendly clinical programs that address their mental health is a high priority. © 2017 Wiley Periodicals, Inc.

75 FR 77675 - AREVA NP, Inc.; Confirmatory Order (Effective Immediately)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-13

..., appropriate notification of regulatory authorities, safety culture and safety conscious work environment...., outside the global AREVA organization), safety culture assessment in accordance with an accepted nuclear....e., outside the global AREVA organization), safety culture assessment in accordance with an accepted...

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

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

Schenkel, Roland

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is anmore » example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R and D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.« less

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

NASA Astrophysics Data System (ADS)

Schenkel, Roland

2012-06-01

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is an example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R&D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.

A brief, trauma-informed intervention increases safety behavior and reduces HIV risk for drug-involved women who trade sex.

PubMed

Decker, Michele R; Tomko, Catherine; Wingo, Erin; Sawyer, Anne; Peitzmeier, Sarah; Glass, Nancy; Sherman, Susan G

2017-08-01

Female sex workers (FSWs) are an important population for HIV acquisition and transmission. Their risks are shaped by behavioral, sexual network, and structural level factors. Violence is pervasive and associated with HIV risk behavior and infection, yet interventions to address the dual epidemics of violence and HIV among FSWs are limited. We used participatory methods to develop a brief, trauma-informed intervention, INSPIRE (Integrating Safety Promotion with HIV Risk Reduction), to improve safety and reduce HIV risk for FSWs. A quasi-experimental, single group pretest-posttest study evaluated intervention feasibility, acceptability and efficacy among FSWs in Baltimore, MD, most of whom were drug-involved (baseline n = 60; follow-up n = 39 [65%]; non-differential by demographics or outcomes). Qualitative data collected at follow-up contextualizes findings. Based on community partnership and FSW input, emergent goals included violence-related support, connection with services, and buffering against structural forces that blame FSWs for violence. Qualitative and quantitative results demonstrate feasibility and acceptability. At follow-up, improvements were seen in avoidance of client condom negotiation (p = 0.04), and frequency of sex trade under the influence of drugs or alcohol (p = 0.04). Women's safety behavior increased (p < 0.001). Participants improved knowledge and use of sexual violence support (p < 0.01) and use of intimate partner violence support (p < 0.01). By follow-up, most respondents (68.4%) knew at least one program to obtain assistance reporting violence to police. Over the short follow-up period, client violence increased. In reflecting on intervention acceptability, participants emphasized the value of a safe and supportive space to discuss violence. This brief, trauma-informed intervention was feasible and highly acceptable to FSWs. It prompted safety behavior, mitigated sex trade under the influence, and bolstered confidence in condom negotiation. INSPIRE influenced endpoints deemed valuable by community partners, specifically improving connection to support services and building confidence in the face of myths that falsely blame sex workers for violence. Violence persisted; prevention also requires targeting perpetrators, and longer follow-up durations as women acquire safety skills. This pilot study informs scalable interventions that address trauma and its impact on HIV acquisition and care trajectories for FSWs. Addressing violence in the context of HIV prevention is feasible, acceptable to FSWs, and can improve safety and reduce HIV risk, thus supporting FSW health and human rights.

Qualification of an Acceptable Alternative to Halon 1211 DOD Flightline Extinguishers

DTIC Science & Technology

2008-09-01

Minimum Performance Standard MSDS Material Safety Data Sheet NATO North Atlantic Treaty Organization NAWCAD Naval Air Warfare Center Aircraft...included chronic and acute occupational exposure limits and cardiotoxicity. Alternatives that were carcinogens or that had any adverse developmental...gear to fight the fires Does not exceed pain threshold for exposed skin Each unit tested met this performance objective 2. Firefighting

78 FR 46855 - Safety Zone; East End Maritime Foundation Fireworks Display, Greenport Harbor, Greenport, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

.... Deliveries accepted between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. The telephone.... and 5 p.m., Monday through Friday, except Federal holidays. 3. Privacy Act Anyone can search the.... This rule will be enforced for a limited period of time on September 21, 2013, with a rain date of...

77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Safety. Pursuant to section 106 of the Consumer Product Safety Improvement Act of 2008, ASTM F963-11 will... INFORMATION: On February 10, 2009, section 106(a) of the Consumer Product Safety Improvement Act of 2008... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory...

Effectiveness and acceptance of the intelligent speeding prediction system (ISPS).

PubMed

Zhao, Guozhen; Wu, Changxu

2013-03-01

The intelligent speeding prediction system (ISPS) is an in-vehicle speed assistance system developed to provide quantitative predictions of speeding. Although the ISPS's prediction of speeding has been validated, whether the ISPS can regulate a driver's speed behavior or whether a driver accepts the ISPS needs further investigation. Additionally, compared to the existing intelligent speed adaptation (ISA) system, whether the ISPS performs better in terms of reducing excessive speeds and improving driving safety needs more direct evidence. An experiment was conducted to assess and compare the effectiveness and acceptance of the ISPS and the ISA. We conducted a driving simulator study with 40 participants. System type served as a between-subjects variable with four levels: no speed assistance system, pre-warning system developed based on the ISPS, post-warning system ISA, and combined pre-warning and ISA system. Speeding criterion served as a within-subjects variable with two levels: lower (posted speed limit plus 1 mph) and higher (posted speed limit plus 5 mph) speed threshold. Several aspects of the participants' driving speed, speeding measures, lead vehicle response, and subjective measures were collected. Both pre-warning and combined systems led to greater minimum time-to-collision. The combined system resulted in slower driving speed, fewer speeding exceedances, shorter speeding duration, and smaller speeding magnitude. The results indicate that both pre-warning and combined systems have the potential to improve driving safety and performance. Copyright © 2012 Elsevier Ltd. All rights reserved.

49 CFR 193.2303 - Construction acceptance.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service...

49 CFR 193.2303 - Construction acceptance.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service...

16 CFR 1110.5 - Acceptable certificates.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Acceptable certificates. 1110.5 Section 1110.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CERTIFICATES OF COMPLIANCE § 1110.5 Acceptable certificates. A certificate that is in hard copy or electronic...

16 CFR 1110.5 - Acceptable certificates.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Acceptable certificates. 1110.5 Section 1110.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CERTIFICATES OF COMPLIANCE § 1110.5 Acceptable certificates. A certificate that is in hard copy or electronic...

16 CFR 1110.5 - Acceptable certificates.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Acceptable certificates. 1110.5 Section 1110.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CERTIFICATES OF COMPLIANCE § 1110.5 Acceptable certificates. A certificate that is in hard copy or electronic...

16 CFR 1110.5 - Acceptable certificates.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Acceptable certificates. 1110.5 Section 1110.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CERTIFICATES OF COMPLIANCE § 1110.5 Acceptable certificates. A certificate that is in hard copy or electronic...

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.

Comparison of veterinary drug residue results in animal tissues by ultrahigh-performance liquid chromatography coupled to triple quadrupole ... use of a commercial lipid removal product

USDA-ARS?s Scientific Manuscript database

Veterinary drug residues in animal-derived foods must be monitored to ensure food safety, verify proper veterinary practices, enforce legal limits in domestic and imported foods, and other purposes. A common goal in drug residue analysis in foods is to achieve acceptable monitoring results for as m...

16 CFR § 1110.5 - Acceptable certificates.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Acceptable certificates. § 1110.5 Section § 1110.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS CERTIFICATES OF COMPLIANCE § 1110.5 Acceptable certificates. A certificate that is in hard copy or electronic...

Electric fence standards comport with human data and AC limits.

PubMed

Kroll, Mark W; Perkins, Peter E; Panescu, Dorin

2015-08-01

The ubiquitous electric fence is essential to modern agriculture and has saved lives by reducing the number of livestock automobile collisions. Modern safety standards such as IEC 60335-2-76 and UL 69 have played a role in this positive result. However, these standards are essentially based on energy and power (RMS current), which have limited direct relationship to cardiac effects. We compared these standards to bioelectrically more relevant units of charge and average current in view of recent work on VF (ventricular fibrillation) induction and to existing IEC AC current limits. There are 3 limits for normal (low) pulsing rate: IEC energy limit, IEC current limit, and UL current limit. We then calculated the delivered charge allowed for each pulse duration for these limits and then compared them to a charge-based safety model derived from published human ventricular-fibrillation induction data. Both the IEC and UL also allow for rapid pulsing for up to 3 minutes. We calculated maximum outputs for various pulse durations assuming pulsing at 10, 20, and 30 pulses per second. These were then compared to standard utility power safety (AC) limits via the conversion factor of 7.4 to convert average current to RMS current for VF risk. The outputs of TASER electrical weapons (typically < 100 μC and ~100 μs duration) were also compared. The IEC and UL electric fence energizer normal rate standards are conservative in comparison with actual human laboratory experiments. The IEC and UL electric fence energizer rapid-pulsing standards are consistent with accepted IEC AC current limits for commercially used pulse durations.

NASA Safety Standard: Guidelines and Assessment Procedures for Limiting Orbital Debris

NASA Technical Reports Server (NTRS)

1995-01-01

Collision with orbital debris is a hazard of growing concern as historically accepted practices and procedures have allowed man-made objects to accumulate in orbit. To limit future debris generation, NASA Management Instruction (NMI) 1700.8, 'Policy to Limit Orbital Debris Generation,' was issued in April of 1993. The NMI requires each program to conduct a formal assessment of the potential to generate orbital debris. This document serves as a companion to NMI 1700.08 and provides each NASA program with specific guidelines and assessment methods to assure compliance with the NMI. Each main debris assessment issue (e.g., Post Mission Disposal) is developed in a separate chapter.

Thermostable Shelf Life Study

NASA Technical Reports Server (NTRS)

Perchonok, M. H.; Antonini, D. K.

2008-01-01

The objective of this project is to determine the shelf life end-point of various food items by means of actual measurement or mathematical projection. The primary goal of the Advanced Food Technology Project in these long duration exploratory missions is to provide the crew with a palatable, nutritious and safe food system while minimizing volume, mass, and waste. The Mars missions could be as long as 2.5 years with the potential of the food being positioned prior to the crew arrival. Therefore, it is anticipated that foods that are used during the Mars missions will require a 5 year shelf life. Shelf life criteria are safety, nutrition, and acceptability. Any of these criteria can be the limiting factor in determining the food's shelf life. Due to the heat sterilization process used for the thermostabilized food items, safety will be preserved as long as the integrity of the package is maintained. Nutrition and acceptability will change over time. Since the food can be the sole source of nutrition to the crew, a significant loss in nutrition may determine when the shelf life endpoint has occurred. Shelf life can be defined when the food item is no longer acceptable. Acceptability can be defined in terms of appearance, flavor, texture, or aroma. Results from shelf life studies of the thermostabilized food items suggest that the shelf life of the foods range from 0 months to 8 years, depending on formulation.

Thermostabilized Shelf Life Study

NASA Technical Reports Server (NTRS)

Perchonok, Michele H.; Catauro, Patricia M.

2009-01-01

The objective of this project is to determine the shelf life end-point of various food items by means of actual measurement or mathematical projection. The primary goal of the Advanced Food Technology Project in these long duration exploratory missions is to provide the crew with a palatable, nutritious and safe food system while minimizing volume, mass, and waste. The Mars missions could be as long as 2.5 years with the potential of the food being positioned prior to the crew arrival. Therefore, it is anticipated that foods that are used during the Mars missions will require a 5 year shelf life. Shelf life criteria are safety, nutrition, and acceptability. Any of these criteria can be the limiting factor in determining the food's shelf life. Due to the heat sterilization process used for the thermostabilized food items, safety will be preserved as long as the integrity of the package is maintained. Nutrition and acceptability will change over time. Since the food can be the sole source of nutrition to the crew, a significant loss in nutrition may determine when the shelf life endpoint has occurred. Shelf life can be defined when the food item is no longer acceptable. Acceptability can be defined in terms of appearance, flavor, texture, or aroma. Results from shelf life studies of the thermostabilized food items suggest that the shelf life of the foods range from 0 months to 8 years, depending on formulation.

You can't improve what you don't measure: Safety climate measures available in the German-speaking countries to support safety culture development in healthcare.

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

Safety climate measurement is a key input into safety culture development. The aim of this review is to provide an overview of the safety climate measures that have been evaluated for their psychometric properties in a German-speaking country and to make recommendations on how to use them in quality and patient safety improvement. A systematic search strategy was implemented to obtain relevant articles. PubMed and Web of Science databases were searched, and 128 abstracts were identified. After application of limits, 33 full texts were retrieved for subsequent evaluation. Studies were included on the basis of predetermined inclusion criteria and independent assessment by two reviewers. Publications were reviewed concerning healthcare setting, target group, safety culture dimensions covered and results of their psychometric evaluation. This review identified 11 instruments for safety climate assessment in different healthcare settings (i. e. hospitals, nursing homes, primary care, dental care and community pharmacy) for which acceptable to good internal consistency was reported. We observed wide variability concerning the number of dimensions (1 to 14; in some cases including outcome dimensions) and items (9 to 128) that the instruments were comprised of. Nevertheless, consistency with regard to the thematic areas covered was rather high. While there is clear evidence that we can assess safety climate in healthcare, the application of safety climate measures by quality and patient safety practitioners has so far been rather limited. This review bridges this gap between research and improvement practice by highlighting the central role of safety climate assessment in a mixed methods approach to inform safety culture development. Copyright © 2016. Published by Elsevier GmbH.

Promoting Adolescent Girls' Well-Being in Pakistan: a Mixed-Methods Study of Change Over Time, Feasibility, and Acceptability, of the COMPASS Program.

PubMed

Asghar, Khudejha; Mayevskaya, Yana; Sommer, Marni; Razzaque, Ayesha; Laird, Betsy; Khan, Yasmin; Qureshi, Shamsa; Falb, Kathryn; Stark, Lindsay

2018-04-10

Promoting resilience among displaced adolescent girls in northern Pakistan may buffer against developmental risks such as violence exposure and associated longer-term consequences for physical and mental well-being. However, girls' access to such programming may be limited by social norms restricting movement. A mixed-method evaluation examined change over time, feasibility, and acceptability of the COMPASS program in three districts of Khyber-Pakhtunkhwa province through a single-group within-participant pretest-posttest of adolescent girls aged 12-19 enrolled in the intervention (n = 78), and qualitative in-depth interviews with girls following posttest completion (n = 15). Primary outcomes included improvements in movement, safety, and comfort discussing life skills topics with caregivers, operationalized quantitatively as number of places visited in the previous month, number of spaces that girls felt safe visiting, and comfort discussing puberty, education, working outside the home, and marriage, respectively. Secondary outcomes included psychosocial well-being, gendered rites of passage, social support networks, perceptions of support for survivors of violence, and knowledge of services. Quantitative pretest-posttest findings included significant improvements in movement, psychosocial well-being, and some improvements in social support, knowledge of services, and gendered rites of passage; findings on safety and comfort discussing life skills topics were not significant. Qualitative findings illuminated themes related to definitions of safety and freedom of movement, perceptions and acceptability of program content, perceptions of social support, and perceptions of blame and support and knowledge of services in response to violence. Taken together, findings illustrate positive impacts of life skills programming, and the need for societal changes on gender norms to improve girls' safety in public spaces and access to resources.

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

49 CFR 232.505 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2013 CFR

2013-10-01

... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... principal test objectives shall be to demonstrate that the equipment meets the safety design and performance... 49 Transportation 4 2013-10-01 2013-10-01 false Pre-revenue service acceptance testing plan. 232...

49 CFR 232.505 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2012 CFR

2012-10-01

... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... principal test objectives shall be to demonstrate that the equipment meets the safety design and performance... 49 Transportation 4 2012-10-01 2012-10-01 false Pre-revenue service acceptance testing plan. 232...

49 CFR 232.505 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2014 CFR

2014-10-01

... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... principal test objectives shall be to demonstrate that the equipment meets the safety design and performance... 49 Transportation 4 2014-10-01 2014-10-01 false Pre-revenue service acceptance testing plan. 232...

49 CFR 232.505 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... principal test objectives shall be to demonstrate that the equipment meets the safety design and performance... 49 Transportation 4 2011-10-01 2011-10-01 false Pre-revenue service acceptance testing plan. 232...

Accepting managed aquifer recharge of urban storm water reuse: The role of policy-related factors

NASA Astrophysics Data System (ADS)

Mankad, Aditi; Walton, Andrea

2015-12-01

A between-groups experimental design examined public acceptance for managed aquifer recharge of storm water for indirect potable and nonpotable reuse; acceptance was based on five policy-related variables (fairness, effectiveness, trust, importance of safety assurances, and importance of communication activities). Results showed that public acceptance (N = 408) for managed aquifer recharge of storm water was higher for nonpotable applications, as was the importance of safety assurances. Analyses of variance also showed that perceptions of fairness and effectiveness were higher for a nonpotable scheme, but not trust. A three-step hierarchical regression (Step 1: age, gender, education, and income; Step 2: type of use; Step 3: fairness, effectiveness, trust, safety assurance, and communication activities) demonstrated that type of storm water use and the policy-related factors accounted for 73% of the variance in acceptance of storm water (R2 = 0.74, adjusted R2 = 0.74, F (10, 397) = 113.919, p < 0.001). Age, type of use, and three of the five policy-related factors were also significant individual predictors of acceptance. The most important predictors were perceptions of trust in water authorities, perceptions of effectiveness, and perceptions of fairness. Interestingly, while safety assurance was important in attitudinal acceptance of managed aquifer recharge based on type of use, safety assurance was not found to be significant predictor of acceptance. This research suggests that policy-makers should look to address matters of greater public importance and drive such as fairness, trust, and effectiveness of storm water programs and advocate these at the forefront of their policies, rather than solely on education campaigns.

The concurrent validity of the Amharic version of Screening of Activity Limitation and Safety Awareness (SALSA) in persons affected by leprosy.

PubMed

Wijk, Ulrika; Brandsma, J Wim; Dahlström, Orjan; Björk, Mathilda

2013-03-01

Leprosy is endemic in many countries and results in activity limitations. There is a need for assessment tools to guide professionals in their evaluation and choice of intervention in order to improve conditions for leprosy-affected people. The purpose of our study was to evaluate the concurrent validity of the Amharic version of Screening of Activity Limitation and Safety Awareness (SALSA-am) scale with Amharic version of Disability of the Arm, Shoulder and Hand (DASH-am) questionnaire. Thirty-eight individuals with nerve damage due to leprosy completed the SALSA-am and DASH-am questionnaires. Spearman's rank correlation was used to determine relationships between SALSA and DASH scores. Specificity, sensitivity and accuracy were calculated. There was a good correlation 0.87 (P < 0.001) between SALSA-am and DASH-am scores. Sensitivity, specificity and accuracy were calculated with acceptable results. SALSA-am is considered a useful questionnaire for determining activity limitations in persons affected by leprosy, and showed good correlation with DASH-am. The concurrent validity was considered good.

Improving eye safety in citrus harvest crews through the acceptance of personal protective equipment, community-based participatory research, social marketing, and community health workers.

PubMed

Tovar-Aguilar, J Antonio; Monaghan, Paul F; Bryant, Carol A; Esposito, Andrew; Wade, Mark; Ruiz, Omar; McDermott, Robert J

2014-01-01

For the last 10 years, the Partnership for Citrus Workers Health (PCWH) has been an evidence-based intervention program that promotes the adoption of protective eye safety equipment among Spanish-speaking farmworkers of Florida. At the root of this program is the systematic use of community-based preventive marketing (CBPM) and the training of community health workers (CHWs) among citrus harvester using popular education. CBPM is a model that combines the organizational system of community-based participatory research (CBPR) and the strategies of social marketing. This particular program relied on formative research data using a mixed-methods approach and a multilevel stakeholder analysis that allowed for rapid dissemination, effective increase of personal protective equipment (PPE) usage, and a subsequent impact on adoptive workers and companies. Focus groups, face-to-face interviews, surveys, participant observation, Greco-Latin square, and quasi-experimental tests were implemented. A 20-hour popular education training produced CHWs that translated results of the formative research to potential adopters and also provided first aid skills for eye injuries. Reduction of injuries is not limited to the use of safety glasses, but also to the adoption of timely intervention and regular eye hygiene. Limitations include adoption in only large companies, rapid decline of eye safety glasses without consistent intervention, technological limitations of glasses, and thorough cost-benefit analysis.

Assessment of the Physicochemical Quality of Drinking Water Resources in the Central Part of Iran.

PubMed

Nikaeen, Mahnaz; Shahryari, Ali; Hajiannejad, Mehdi; Saffari, Hossein; Kachuei, Zahra Moosavian; Hassanzadeh, Akbar

2016-01-01

The aim of the study described in this article was to assess the physicochemical quality of water resources in Isfahan province, located in the central part of Iran, from June to November 2012. Comparison of the results with the acceptable limits recommended by the World Health Organization (WHO) for drinking water showed that nitrate, chloride, iron, and fluoride concentrations exceeded the maximum acceptable level in 12.3%, 9.2%, 6.8%, and 1.5% of samples, respectively. Total dissolved solids (TDS) and turbidity values also exceeded the maximum acceptable level in 9.2% and 3.1% of samples, respectively. In general, the quality of drinking water resources in the central part of Iran at present is mostly acceptable and satisfactory. It may be deteriorated in the future, however, because water quantity and quality in arid and semiarid areas are highly variable over time. Therefore, continued monitoring of the water resources quality is extremely important to environmental safety.

Assessing contextual factors that influence acceptance of pedestrian alerts by a night vision system.

PubMed

Källhammer, Jan-Erik; Smith, Kip

2012-08-01

We investigated five contextual variables that we hypothesized would influence driver acceptance of alerts to pedestrians issued by a night vision active safety system to inform the specification of the system's alerting strategies. Driver acceptance of automotive active safety systems is a key factor to promote their use and implies a need to assess factors influencing driver acceptance. In a field operational test, 10 drivers drove instrumented vehicles equipped with a preproduction night vision system with pedestrian detection software. In a follow-up experiment, the 10 drivers and 25 additional volunteers without experience with the system watched 57 clips with pedestrian encounters gathered during the field operational test. They rated the acceptance of an alert to each pedestrian encounter. Levels of rating concordance were significant between drivers who experienced the encounters and participants who did not. Two contextual variables, pedestrian location and motion, were found to influence ratings. Alerts were more accepted when pedestrians were close to or moving toward the vehicle's path. The study demonstrates the utility of using subjective driver acceptance ratings to inform the design of active safety systems and to leverage expensive field operational test data within the confines of the laboratory. The design of alerting strategies for active safety systems needs to heed the driver's contextual sensitivity to issued alerts.

The effects, safety and acceptability of compact, pre-filled, autodisable injection devices when delivered by lay health workers.

PubMed

Glenton, Claire; Khanna, Rajesh; Morgan, Chris; Nilsen, Elin Strømme

2013-08-01

To systematically assess (i) the effects and safety and (ii) the acceptability of using lay health workers (LHWs) to deliver vaccines and medicines to mothers and children through compact pre-filled autodisable devices (CPADs). We searched electronic databases and grey literature. For the systematic review of effects and safety, we sought randomised and non-randomised controlled trials, controlled before-after studies and interrupted time series studies. For the systematic review of acceptability, we sought qualitative studies. Two researchers independently carried out data extraction, study quality assessment and thematic analysis of the qualitative data. No studies met our criteria for the review exploring the effects and safety of using LHWs to deliver CPADs. For the acceptability review, six qualitative studies assessed the acceptability of using LHWs to deliver hepatitis B vaccine, tetanus toxoid vaccine, gentamicin or oxytocin using Uniject™ devices. All studies took place in low- or middle-income countries and explored the perceptions of community members, LHWs, supervisors, health professionals or programme managers. Most of the studies were of low quality. Recipients generally accepted the intervention. Most health professionals were confident that LHWs could deliver the intervention with sufficient training and supervision, but some had problems delivering supervision. The LHWs perceived Uniject™ as effective and important and were motivated by positive responses from the community. However, some LHWs feared the consequences if harm should come to recipients. Evidence of the effects and safety of using CPADs delivered by LHWs is lacking. Evidence regarding acceptability suggests that this intervention may be acceptable although LHWs may feel vulnerable to blame. © 2013 John Wiley & Sons Ltd.

49 CFR 193.2303 - Construction acceptance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES...

Plutonium Critical Mass Curve Comparison to Mass at Upper Subcritical Limit (USL) Using Whisper

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

Alwin, Jennifer Louise; Zhang, Ning

Whisper is computational software designed to assist the nuclear criticality safety analyst with validation studies with the MCNP ® Monte Carlo radiation transport package. Standard approaches to validation rely on the selection of benchmarks based upon expert judgment. Whisper uses sensitivity/uncertainty (S/U) methods to select relevant benchmarks to a particular application or set of applications being analyzed. Using these benchmarks, Whisper computes a calculational margin. Whisper attempts to quantify the margin of subcriticality (MOS) from errors in software and uncertainties in nuclear data. The combination of the Whisper-derived calculational margin and MOS comprise the baseline upper subcritical limit (USL), tomore » which an additional margin may be applied by the nuclear criticality safety analyst as appropriate to ensure subcriticality. A series of critical mass curves for plutonium, similar to those found in Figure 31 of LA-10860-MS, have been generated using MCNP6.1.1 and the iterative parameter study software, WORM_Solver. The baseline USL for each of the data points of the curves was then computed using Whisper 1.1. The USL was then used to determine the equivalent mass for plutonium metal-water system. ANSI/ANS-8.1 states that it is acceptable to use handbook data, such as the data directly from the LA-10860-MS, as it is already considered validated (Section 4.3 4) “Use of subcritical limit data provided in ANSI/ANS standards or accepted reference publications does not require further validation.”). This paper attempts to take a novel approach to visualize traditional critical mass curves and allows comparison with the amount of mass for which the k eff is equal to the USL (calculational margin + margin of subcriticality). However, the intent is to plot the critical mass data along with USL, not to suggest that already accepted handbook data should have new and more rigorous requirements for validation.« less

[Economic analysis versus the principle of guaranteed safety in blood transfusion].

PubMed

Moatti, J P; Loubière, S; Rotily, M

2000-06-01

This article shows that policies aimed at reducing risks of infectious agents transmissible through blood unfortunately follow a law of 'diminishing returns': increasing marginal costs have to be devoted for limited reductions in the risks of contamination through blood donations. Therefore, the economic cost-effectiveness analysis is appropriate to identify screening strategies which may minimize costs to reach a certain level of safety. Moreover, economic analysis can contribute to public debates about the level of residual risk that society is willing to accept. Empirical results from French studies about screening for hepatitis C virus (HCV) in individuals who have received blood transfusions and in blood donations are presented to illustrate these points.

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

HPV self-sampling in Japanese women: A feasibility study in a population with limited experience of tampon use.

PubMed

Hanley, Sharon Jb; Fujita, Hiromasa; Yokoyama, Susumu; Kunisawa, Shiori; Tamakoshi, Akiko; Dong, Peixin; Kobayashi, Noriko; Watari, Hidemichi; Kudo, Masataka; Sakuragi, Noriaki

2016-09-01

Cervical cancer incidence and mortality is increasing in Japanese women under age 50. Screening uptake is low and proactive recommendations for human papillomavirus vaccination have been suspended. Other cervical cancer prevention initiatives are urgently needed. We assessed whether human papillomavirus self-sampling might be an acceptable alternative to physician-led screening, particularly in women with limited experience of tampon use. We also sought to identify any practical, logistical, or safety issues in women already attending for screening, before carrying out further large-scale studies in non-responders. In total, 203 women aged 20-49 attending their annual workplace healthcheck in Sapporo, northern Japan, performed unsupervised human papillomavirus self-sampling before undergoing a physician-led cervical smear and human papillomavirus test, and completing a measure of acceptability for both tests. Ninety per cent of participants stated they would use self-sampling again. They found instructions easy to follow and reported no issues with the usability of the self-sampling device. Compared with physician-led testing, women found self-sampling significantly less painful, less embarrassing and could relax more (p < 0.001), regardless of history of tampon use, which was associated with negative experiences in physician sampling (p = 0.034). Women lacked confidence the test had been performed correctly, despite no unsatisfactory samples. No safety issues were reported. Self-sampling was highly acceptable in this population of women. They could perform the test safely unsupervised, but lacked confidence the test has been carried out correctly. Japanese women need to be educated about the accuracy of human papillomavirus self-sampling and further large-scale studies are necessary in non-responders. © The Author(s) 2016.

Safety analysis of proposed data-driven physiologic alarm parameters for hospitalized children.

PubMed

Goel, Veena V; Poole, Sarah F; Longhurst, Christopher A; Platchek, Terry S; Pageler, Natalie M; Sharek, Paul J; Palma, Jonathan P

2016-12-01

Modification of alarm limits is one approach to mitigating alarm fatigue. We aimed to create and validate heart rate (HR) and respiratory rate (RR) percentiles for hospitalized children, and analyze the safety of replacing current vital sign reference ranges with proposed data-driven, age-stratified 5th and 95th percentile values. In this retrospective cross-sectional study, nurse-charted HR and RR data from a training set of 7202 hospitalized children were used to develop percentile tables. We compared 5th and 95th percentile values with currently accepted reference ranges in a validation set of 2287 patients. We analyzed 148 rapid response team (RRT) and cardiorespiratory arrest (CRA) events over a 12-month period, using HR and RR values in the 12 hours prior to the event, to determine the proportion of patients with out-of-range vitals based upon reference versus data-driven limits. There were 24,045 (55.6%) fewer out-of-range measurements using data-driven vital sign limits. Overall, 144/148 RRT and CRA patients had out-of-range HR or RR values preceding the event using current limits, and 138/148 were abnormal using data-driven limits. Chart review of RRT and CRA patients with abnormal HR and RR per current limits considered normal by data-driven limits revealed that clinical status change was identified by other vital sign abnormalities or clinical context. A large proportion of vital signs in hospitalized children are outside presently used norms. Safety evaluation of data-driven limits suggests they are as safe as those currently used. Implementation of these parameters in physiologic monitors may mitigate alarm fatigue. Journal of Hospital Medicine 2015;11:817-823. © 2015 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

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

What Is Known: Examining the Empirical Literature in Resident Work Hours Using 30 Influential Articles.

PubMed

Philibert, Ingrid

2016-12-01

Examining influential, highly cited articles can show the advancement of knowledge about the effect of resident physicians' long work hours, as well as the benefits and drawbacks of work hour limits. A narrative review of 30 articles, selected for their contribution to the literature, explored outcomes of interest in the research on work hours-including patient safety, learning, and resident well-being. Articles were selected from a comprehensive review. Citation volume, quality, and contribution to the evolving thinking on work hours and to the Accreditation Council for Graduate Medical Education standards were assessed. Duty hour limits are supported by the scientific literature, particularly limits on weekly hours and reducing the frequency of overnight call. The literature shows declining hours and call frequency over 4 decades of study, although the impact on patient safety, learning, and resident well-being is not clear. The review highlighted limitations of the scientific literature on resident hours, including small samples and reduced generalizability for intervention studies, and the inability to rule out confounders in large studies using administrative data. Key areas remain underinvestigated, and accepted methodology is challenged when assessing the impact of interventions on the multiple outcomes of interest. The influential literature, while showing the beneficial effect of work hour limits, does not answer all questions of interest in determining optimal limits on resident hours. Future research should use methods that permit a broader, collective examination of the multiple, often competing attributes of the learning environment that collectively promote patient safety and resident learning and well-being.

Allogeneic blood stem cell transplantation: considerations for donors.

PubMed

Anderlini, P; Körbling, M; Dale, D; Gratwohl, A; Schmitz, N; Stroncek, D; Howe, C; Leitman, S; Horowitz, M; Gluckman, E; Rowley, S; Przepiorka, D; Champlin, R

1997-08-01

Allogeneic transplantation of cytokine-mobilized peripheral blood stem cells (PBSCs) is now being increasingly performed, but safety considerations for hematologically normal PBSC donors have not been fully addressed. Progenitors are generally mobilized for collection from normal donors using recombinant human granulocyte colony-stimulating factor (rhG-CSF). Although the short-term safety profile of rhG-CSF seems acceptable, experience remains limited and its optimal dose and schedule have not been defined. Minimal data exist regarding long-term safety of rhG-CSF, primarily derived from experience in patients with chronic neutropenia or cancer. An "ad hoc" workshop was recently convened among a group of investigators actively involved in the field of allogeneic stem cell transplantation to discuss the safety issues pertaining to normal PBSC donors. There was agreement on the following points: (1) On the basis of available data, it appears that rhG-CSF treatment and PBSC collection have an acceptable short-term safety profile in normal donors. However, the need for continued safety monitoring was recognized. (2) rhG-CSF doses up to 10 microg/kg/d show a consistent dose-response relationship with the mobilization (and collection) of CD34+ progenitor cells, and this dose is acceptable for routine clinical use. Whether higher doses are superior (or cost effective) remains to be determined, and they may produce more severe side effects. The potential risks of marked leukocytosis (arbitrarily defined as a leukocyte count of more than 70 x 10(9)/L) have been a concern, and rhG-CSF dose reduction is performed by many centers to maintain leukocyte counts below this level. (3) Transient post donation cytopenias, involving granulocytes, lymphocytes, and platelets, may occur and are at least partly related to the leukapheresis procedure. These are generally asymptomatic and self-limited; follow-up blood counts are not necessarily required. Reinfusion of autologous platelet-rich plasma should be considered for donors with expected postdonation thrombocytopenia (platelet count < 80 to 100 x 10(9)/L). (4) Donors should meet the eligibility criteria which apply to donors of apheresis platelets, with the exception that pediatric donors may also be considered. Any deviation from these criteria should have supporting documentation. There is insufficient information at this time to clearly establish definite contraindications for PBSC collection in a hematologically normal donor. Potential contraindications include the presence of inflammatory, autoimmune, or rheumatologic disorders, as well as atherosclerotic or cerebrovascular disease. (5) The creation of an International PBSC Donor Registry is desirable to facilitate monitoring the long-term effects of the procedure. Individual institutions or donor centers are encouraged to establish their own PBSC donor follow-up system, preferably with a standardized approach to data collection.

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.

Concussion Knowledge and Communication Behaviors of Collegiate Wrestling Coaches.

PubMed

Kroshus, Emily; Kerr, Zachary Y; DeFreese, J D; Parsons, John T

2017-08-01

Sport coaches can play an important role in shaping a team's approach to concussion safety through their communication with team members. However, across all sports, there is limited knowledge about factors that make coaches more or less likely to engage in safety-supportive communication. The objectives of this study were to assess the concussion-related knowledge and attitudes of wrestling coaches, as well as the extent to which they engage in autonomy-supportive coaching practices, and to determine how these factors are related to communication with athletes in support of concussion safety. Data were collected through an online survey of head coaches of National Collegiate Athletic Association (NCAA) wrestling teams (n = 89, 40.5% response rate). On average, coaches answered five out of a possible nine knowledge questions correctly and were significantly more likely to think it was acceptable for an athlete to continue playing after sustaining a concussion during a national qualifying competition as compared to during an early-season competition. Engaging in autonomy-supportive coaching behaviors was the coach factor explaining the largest percentage of variability in communication. Findings suggest that while knowledge deficits and attitudes about the acceptability of continued play while symptomatic during more consequential competitive matches should be addressed in educational programming for collegiate wrestling coaches, these changes alone may not be a sufficient for adequately increasing concussion safety communication. Targeting more distal factors such as autonomy-supportive approaches to coaching may hold promise for intervention design and should be explored in future prospective research.

Commercial grade item (CGI) dedication of generators for nuclear safety related applications

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

Das, R.K.; Hajos, L.G.

1993-03-01

The number of nuclear safety related equipment suppliers and the availability of spare and replacement parts designed specifically for nuclear safety related application are shrinking rapidly. These have made it necessary for utilities to apply commercial grade spare and replacement parts in nuclear safety related applications after implementing proper acceptance and dedication process to verify that such items conform with the requirements of their use in nuclear safety related application. The general guidelines for the commercial grade item (CGI) acceptance and dedication are provided in US Nuclear Regulatory Commission (NRC) Generic Letters and Electric Power Research Institute (EPRI) Report NP-5652,more » Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications. This paper presents an application of these generic guidelines for procurement, acceptance, and dedication of a commercial grade generator for use as a standby generator at Salem Generating Station Units 1 and 2. The paper identifies the critical characteristics of the generator which once verified, will provide reasonable assurance that the generator will perform its intended safety function. The paper also delineates the method of verification of the critical characteristics through tests and provide acceptance criteria for the test results. The methodology presented in this paper may be used as specific guidelines for reliable and cost effective procurement and dedication of commercial grade generators for use as standby generators at nuclear power plants.« less

Handling and safety enhancement of race cars using active aerodynamic systems

NASA Astrophysics Data System (ADS)

Diba, Fereydoon; Barari, Ahmad; Esmailzadeh, Ebrahim

2014-09-01

A methodology is presented in this work that employs the active inverted wings to enhance the road holding by increasing the downward force on the tyres. In the proposed active system, the angles of attack of the vehicle's wings are adjusted by using a real-time controller to increase the road holding and hence improve the vehicle handling. The handling of the race car and safety of the driver are two important concerns in the design of race cars. The handling of a vehicle depends on the dynamic capabilities of the vehicle and also the pneumatic tyres' limitations. The vehicle side-slip angle, as a measure of the vehicle dynamic safety, should be narrowed into an acceptable range. This paper demonstrates that active inverted wings can provide noteworthy dynamic capabilities and enhance the safety features of race cars. Detailed analytical study and formulations of the race car nonlinear model with the airfoils are presented. Computer simulations are carried out to evaluate the performance of the proposed active aerodynamic system.

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

Dietitians employed by health care facilities preferred a HACCP system over irradiation or chemical rinses for reducing risk of foodborne disease.

PubMed

Giamalva, J N; Redfern, M; Bailey, W C

1998-08-01

To survey dietitians in health care facilities about the acceptability of alternative meat and poultry processing methods designed to reduce the risk of foodborne disease and their willingness to pay for these processes. A geographically representative sample of 600 members of The American Dietetic Association who work in health care facilities. The response rate was 250 completed questionnaires from 592 eligible subjects (42%). A mail survey was used to gather information on the acceptability of a Hazard Analysis and Critical Control Point (HACCP) system, chemical rinses, and irradiation for increasing the safety of food. Discrete choice contingent valuation was used to determine the acceptability at current prices and at 5, 10, and 25 cents per pound above current prices. Logistic regression was used to estimate mean willingness to pay (the maximum amount respondents are willing to pay) for each process. A simultaneous equations regression model was used to estimate the effects of other variables on acceptability. Respondents expressed a high level of concern for food safety in health care facilities. The estimated mean willingness to pay was highest for a HACCP system and lowest for chemical rinses. The successful adoption of alternative methods to increase food safety depends on their acceptance by foodservice professionals. The professionals sampled were most accepting of a HACCP system, somewhat less accepting of irradiation, and least accepting of new chemical rinses. Poultry and beef processors and government agencies concerned with food safety may want to take into account the attitudes of foodservice professionals.

Study design and analysis of automobile bumper for pedestrian safety

NASA Astrophysics Data System (ADS)

Kulkarni, Akash; Vora, Rushabh; Ravi, K.

2017-11-01

This paper aims to design and analyse the bumper beam structure, in order to ensure the protection of the pedestrians along with the occupants inside the vehicle. The concern shown towards the pedestrian safety is because, each year about 2,70,000 pedestrians are killed in road accidents that accounts to 22% of the total deaths. From the literature review, it was inferred that the mounting position of bumper and material selection play a crucial role in maximising the pedestrian safety. Hence in this paper, the effects of bumper mounting position and the bumper beam material have been studied, with reference to an explicit dynamic collision involving with a dummy human lower leg set-up. The acceptance of a particular mounting position/material was based on the fact that the maximum stress and deformation induced were less than the yield limits of the human leg form structure (representing the skin, femur and tibia).

75 FR 44046 - Noise Exposure Map Acceptance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-27

... Airport (PHL) under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise Abatement Act... June 1, 2010. Under 49 U.S.C. Section 47503 of the Aviation Safety and Noise Abatement Act (hereinafter... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Noise Exposure Map Acceptance ACTION...

76 FR 6453 - Raynor Marketing, Ltd., Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. 11-C0003] Raynor Marketing, Ltd., Provisional...(e). Published below is a provisionally-accepted Settlement Agreement with Raynor Marketing, Ltd..., Raynor Marketing, Ltd. and the staff (``Staff'') of the United States Consumer Product Safety Commission...

[Food additives and healthiness].

PubMed

Heinonen, Marina

2014-01-01

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

An exploration of complementary feeding of infants and young children in the rural area of Muhoroni, Nyanza province, Kenya: a descriptive study.

PubMed

Harvey, Sophie; Callaby, Jo; Roberts, Lesley

2017-08-01

Inappropriate infant and young child feeding practices contribute to malnutrition, infection and long-term development limitation. To explore complementary feeding and food safety in Muhoroni District, Nyanza Province in rural Kenya. To compare practices with the Infant and Young Child Feeding (IYCF) guidelines, and identify associations with inappropriate practices. Between January and April 2014, a questionnaire completed by primary caregivers of children aged 6-23 months asked about foods the child had received in the previous 24 hours, the introduction of complementary foods, and the food hygiene practices undertaken by the caregiver. The most recent World Health Organization IYCF core indicators (continued breastfeeding at 1 year; minimum dietary diversity; minimum meal frequency; minimum acceptable diet) were determined for 400 children. These indicators were compared with demographic indicators in multivariate analyses to identify associations with appropriate complementary feeding practices. A total of 55.2% of children aged 12-15 months continued to be breastfed at the time of questioning. Of the study population, 61.5% achieved minimum dietary diversity, 70.8% achieved minimum meal frequency and 43.0% achieved minimum acceptable diet. Older children were more likely to achieve minimum dietary diversity and minimum acceptable diet; however, they were also less likely to achieve minimum meal frequency. High levels of hygiene practices were reported in all areas of food safety. Complementary feeding indicators were higher than nationally, although less than half of children (43.0%) were receiving a minimum acceptable diet. Further work should explore the potential relationship between age and adequate infant feeding.

Integration of safety technologies into rheumatology and orthopedics practices: a randomized, controlled trial.

PubMed

Moorjani, Gautam R; Bedrick, Edward J; Michael, Adrian A; Peisajovich, Andres; Sibbitt, Wilmer L; Bankhurst, Arthur D

2008-07-01

To identify and integrate new safety technologies into outpatient musculoskeletal procedures and measure the effect on outcome, including pain. Using national resources for patient safety and literature review, the following safety technologies were identified: a safety needle to reduce inadvertent needlesticks to heath care workers, and the reciprocating procedure device (RPD) to improve patient safety and reduce pain. Five hundred sixty-six musculoskeletal procedures involving syringes and needles were randomized to either an RPD group or a conventional syringe group, and pain, quality, safety, and physician acceptance were measured. During 566 procedures, no accidental needlesticks occurred with safety needles. Use of the RPD resulted in a 35.4% reduction (95% confidence interval [95% CI] 24-46%) in patient-assessed pain (mean +/- SD scores on a visual analog pain scale [VAPS] 3.12 +/- 2.23 for the RPD and 4.83 +/- 3.22 for the conventional syringe; P < 0.001) and a 49.5% reduction (95% CI 34-64%) in patient-assessed significant pain (VAPS score > or =5) (P < 0.001). Physician acceptance of the RPD combined with a safety needle was excellent. As mandated by the Joint Commission and the Occupational Safety and Health Administration, safety technologies and the use of pain scales can be successfully integrated into rheumatologic and orthopedic procedures. The combination of a safety needle to reduce needlestick injuries to health care workers and the RPD to improve safety and outcome of patients is effective and well accepted by physicians.

Feasibility, safety, acceptability, and preliminary efficacy of measurement-based care depression treatment for HIV patients in Bamenda, Cameroon.

PubMed

Pence, Brian W; Gaynes, Bradley N; Atashili, Julius; O'Donnell, Julie K; Kats, Dmitry; Whetten, Kathryn; Njamnshi, Alfred K; Mbu, Tabenyang; Kefie, Charles; Asanji, Shantal; Ndumbe, Peter

2014-06-01

Depression affects 18-30 % of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. We enrolled 55 participants; all started amitriptyline 25-50 mg daily at baseline. By 12 weeks, most remained at 50 mg daily (range 25-125 mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87 % achieved depression remission (PHQ-9 <5) by 12 weeks. Intervention fidelity was high: HIV providers followed MBC recommendations at 96 % of encounters. Most divergences reflected a failure to increase dose when indicated. No serious and few bothersome side effects were reported. Most suicidality (prevalence 62 % at baseline; 8 % at 12 weeks) was either passive or low-risk. Participant satisfaction was high (100 %), and most participants (89 %) indicated willingness to pay for medications if MBC were implemented in routine care. The adapted MBC intervention demonstrated high feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting.

The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

PubMed

Chawla, Anita; Carls, Ginger; Deng, Edmund; Tuttle, Edward

2015-07-01

Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

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.

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

Test load verification through strain data analysis

NASA Technical Reports Server (NTRS)

Verderaime, V.; Harrington, F.

1995-01-01

A traditional binding acceptance criterion on polycrystalline structures is the experimental verification of the ultimate factor of safety. At fracture, the induced strain is inelastic and about an order-of-magnitude greater than designed for maximum expected operational limit. At this extreme strained condition, the structure may rotate and displace at the applied verification load such as to unknowingly distort the load transfer into the static test article. Test may result in erroneously accepting a submarginal design or rejecting a reliable one. A technique was developed to identify, monitor, and assess the load transmission error through two back-to-back surface-measured strain data. The technique is programmed for expediency and convenience. Though the method was developed to support affordable aerostructures, the method is also applicable for most high-performance air and surface transportation structural systems.

Glucose determination in human aqueous humor with Raman spectroscopy

NASA Technical Reports Server (NTRS)

Lambert, James L.; Pelletier, Christine C.; Borchert, Mark

2005-01-01

It has been suggested that spectroscopic analysis of the aqueous humor of the eye could be used to indirectly predict blood glucose levels in diabetics noninvasively. We have been investigating this potential using Raman spectroscopy in combination with partial least squares (PLS) analysis. We have determined that glucose at clinically relevant concentrations can be accurately predicted in human aqueous humor in vitro using a PLS model based on artificial aqueous humor. We have further determined that with proper instrument design, the light energy necessary to achieve clinically acceptable prediction of glucose does not damage the retinas of rabbits and can be delivered at powers below internationally acceptable safety limits. Herein we summarize our current results and address our strategies to improve instrument design. 2005 Society of Photo-Optical Instrumentation Engineers.

Health-risk based approach to setting drinking water standards for long-term space missions

NASA Technical Reports Server (NTRS)

Macler, Bruce A.; Dunsky, Elizabeth C.

1992-01-01

In order to develop plausible and appropriate drinking water contaminant standards for longer-term NASA space missions, such as those planned for the Space Exploration Initiative, a human health risk characterization was performed using toxicological and exposure values typical of space operations and crew. This risk characterization showed that the greatest acute waterborne health concern was from microbial infection leading to incapacitating gastrointestinal illness. Ingestion exposure pathways for toxic materials yielded de minimus acute health risks unlikely to affect SEI space missions. Risks of chronic health problems were within acceptable public health limits. Our analysis indicates that current Space Station Freedom maximum contamination levels may be unnecessarily strict. We propose alternative environmental contaminant values consistent with both acceptable short and long-term crew health safety.

Assessing the safety culture of care homes: a multimethod evaluation of the adaptation, face validity and feasibility of the Manchester Patient Safety Framework.

PubMed

Marshall, Martin; Cruickshank, Lesley; Shand, Jenny; Perry, Sarah; Anderson, James; Wei, Li; Parker, Dianne; de Silva, Debra

2017-09-01

Understanding the cultural characteristics of healthcare organisations is widely recognised to be an important component of patient safety. A growing number of vulnerable older people are living in care homes but little attention has been paid to safety culture in this sector. In this study, we aimed to adapt the Manchester Patient Safety Framework (MaPSaF), a commonly used tool in the health sector, for use in care homes and then to test its face validity and preliminary feasibility as a tool for developing a better understanding of safety culture in the sector. As part of a wider improvement programme to reduce the prevalence of common safety incidents among residents in 90 care homes in England, we adapted MaPSaF and carried out a multimethod participatory evaluation of its face validity and feasibility for care home staff. Data were collected using participant observation, interviews, documentary analysis and a survey, and were analysed thematically. MaPSaF required considerable adaptation in terms of its length, language and content in order for it to be perceived to be acceptable and useful to care home staff. The changes made reflected differences between the health and care home sectors in terms of the local context and wider policy environment, and the expectations, capacity and capabilities of the staff. Based on this preliminary study, the adapted tool, renamed 'Culture is Key', appears to have reasonable face validity and, with adequate facilitation, it is usable by front-line staff and useful in raising their awareness about safety issues. 'Culture is Key' is a new tool which appears to have acceptable face validity and feasibility to be used by care home staff to deepen their understanding of the safety culture of their organisations and therefore has potential to contribute to improving care for vulnerable older people. 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/.

41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

Code of Federal Regulations, 2014 CFR

2014-01-01

... departments or other local authorities for use in developing pre-fire plans. ... Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the...

41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

Code of Federal Regulations, 2012 CFR

2012-01-01

... departments or other local authorities for use in developing pre-fire plans. ... Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the...

41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

Code of Federal Regulations, 2013 CFR

2013-07-01

... departments or other local authorities for use in developing pre-fire plans. ... Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the...

41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

Code of Federal Regulations, 2011 CFR

2011-01-01

... departments or other local authorities for use in developing pre-fire plans. ... Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the...

41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

Code of Federal Regulations, 2010 CFR

2010-07-01

... departments or other local authorities for use in developing pre-fire plans. ... Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the...

Occupational Therapy and Sensory Integration for Children with Autism: A Feasibility, Safety, Acceptability and Fidelity Study

ERIC Educational Resources Information Center

Schaaf, Roseann C.; Benevides, Teal W.; Kelly, Donna; Mailloux-Maggio, Zoe

2012-01-01

Objective: To examine the feasibility, safety, and acceptability of a manualized protocol of occupational therapy using sensory integration principles for children with autism. Methods: Ten children diagnosed with autism spectrum disorder ages 4-8 years received intensive occupational therapy intervention using sensory integration principles…

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.

Changing drivers' intentions and behaviours using fear-based driver fatigue advertisements.

PubMed

Tay, Richard; Watson, Barry

2002-01-01

This paper examines the effects of fear arousal and perceived efficacy on the acceptance and rejection of road safety advertising messages that are typical in Australia and New Zealand. Our results suggest that the level of fear arousal could be lowered without a significant effect on the message acceptance rates but could result in a lower rate of message rejection. Our results also suggest that the inclusion of explicit coping strategies in the road safety advertisements has a significant positive effect on message acceptance.

Development of a Cost-Effective Educational Tool to Promote Acceptance of the HPV Vaccination by Hispanic Mothers.

PubMed

Brueggmann, Doerthe; Opper, Neisha; Felix, Juan; Groneberg, David A; Mishell, Daniel R; Jaque, Jenny M

2016-06-01

Although vaccination against the Human Papilloma Virus (HPV) reduces the risk of related morbidities, the vaccine uptake remains low in adolescents. This has been attributed to limited parental knowledge and misconceptions. In this cross sectional study, we assessed the (1) clarity of educational material informing Hispanic mothers about HPV, cervical cancer and the HPV vaccine, (2) determined vaccination acceptability and (3) identified predictors of vaccine acceptance in an underserved health setting. 418 Hispanic mothers received the educational material and completed an anonymous survey. 91 % of participants understood most or all of the information provided. 77 % of participants reported vaccine acceptance for their children; this increased to 84 % when only those with children eligible to receive vaccination were included. Significant positive predictors of maternal acceptance of the HPV vaccine for their children were understanding most or all of the provided information, older age and acceptance of the HPV vaccine for themselves. Concerns about safety and general dislike of vaccines were negatively associated with HPV vaccine acceptance. Prior knowledge, level of education, previous relevant gynecologic history, general willingness to vaccinate and other general beliefs about vaccines were not significantly associated with HPV vaccine acceptance. The majority of participants reported understanding of the provided educational material. Vaccine acceptability was fairly high, but was even higher among those who understood the information. This study documents a cost-effective way to provide Hispanic mothers with easy-to-understand HPV-related information that could increase parental vaccine acceptability and future vaccine uptake among their children.

Public acceptability of highway safety countermeasures : volume IV, pedestrian measures.

DOT National Transportation Integrated Search

1981-06-01

This volume is part of a larger study providing information about public attitudes : towards proposed highway safety countermeasures in three program areas: alcohol : and drugs, unsafe driving behaviors, and pedestrian safety. Pedestrian safety : cou...

Risk of Performance Decrement and Crew Illness Due to an Inadequate Food System

NASA Technical Reports Server (NTRS)

Douglas, Grace L.; Cooper, Maya; Bermudez-Aguirre, Daniela; Sirmons, Takiyah

2016-01-01

NASA is preparing for long duration manned missions beyond low-Earth orbit that will be challenged in several ways, including long-term exposure to the space environment, impacts to crew physiological and psychological health, limited resources, and no resupply. The food system is one of the most significant daily factors that can be altered to improve human health, and performance during space exploration. Therefore, the paramount importance of determining the methods, technologies, and requirements to provide a safe, nutritious, and acceptable food system that promotes crew health and performance cannot be underestimated. The processed and prepackaged food system is the main source of nutrition to the crew, therefore significant losses in nutrition, either through degradation of nutrients during processing and storage or inadequate food intake due to low acceptability, variety, or usability, may significantly compromise the crew's health and performance. Shelf life studies indicate that key nutrients and quality factors in many space foods degrade to concerning levels within three years, suggesting that food system will not meet the nutrition and acceptability requirements of a long duration mission beyond low-Earth orbit. Likewise, mass and volume evaluations indicate that the current food system is a significant resource burden. Alternative provisioning strategies, such as inclusion of bioregenerative foods, are challenged with resource requirements, and food safety and scarcity concerns. Ensuring provisioning of an adequate food system relies not only upon determining technologies, and requirements for nutrition, quality, and safety, but upon establishing a food system that will support nutritional adequacy, even with individual crew preference and self-selection. In short, the space food system is challenged to maintain safety, nutrition, and acceptability for all phases of an exploration mission within resource constraints. This document presents the evidence for the Risk of Performance Decrement and Crew Illness Due to an Inadequate Food System and the gaps in relation to exploration, as identified by the NASA Human Research Program (HRP). The research reviewed here indicates strategies to establish methods, technologies, and requirements that increase food stability, support adequate nutrition, quality, and variety, enable supplementation with grow-pick-and-eat salad crops, ensure safety, and reduce resource use. Obtaining the evidence to establish an adequate food system is essential, as the resources allocated to the food system may be defined based on the data relating nutritional stability and food quality requirements to crew performance and health.

Acceptability of text messages for safety netting patients with low-risk cancer symptoms: a qualitative study.

PubMed

Hirst, Yasemin; Lim, Anita Wey Wey

2018-05-01

Safety netting is an important diagnostic strategy for patients presenting to primary care with potential (low-risk) cancer symptoms. Typically, this involves asking patients to return if symptoms persist. However, this relies on patients re-appraising their symptoms and making follow-up appointments, which could contribute to delays in diagnosis. Text messaging is increasingly used in primary care to communicate with patients, and could be used to improve safety netting. To explore the acceptability and feasibility of using text messages to safety net patients presenting with low-risk cancer symptoms in GP primary care (txt-netting). Qualitative focus group and interview study with London-based GPs. Participants were identified using convenience sampling methods. Five focus groups and two interviews were conducted with 22 GPs between August and December 2016. Sessions were audiorecorded, transcribed verbatim, and analysed using thematic analysis. GPs were amenable to the concept of using text messages in cancer safety netting, identifying it as an additional tool that could help manage patients and promote symptom awareness. There was wide variation in GP preferences for text message content, and a number of important potential barriers to txt-netting were identified. Concerns were raised about the difficulties of conveying complex safety netting advice within the constraints of a text message, and about confidentiality, widening inequalities, and workload implications. Text messages were perceived to be an acceptable potential strategy for safety netting patients with low-risk cancer symptoms. Further work is needed to ensure it is cost-effective, user friendly, confidential, and acceptable to patients. © British Journal of General Practice 2018.

Comparative evaluation of different medication safety measures for the emergency department: physicians' usage and acceptance of training, poster, checklist and computerized decision support.

PubMed

Sedlmayr, Brita; Patapovas, Andrius; Kirchner, Melanie; Sonst, Anja; Müller, Fabian; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Vogler, Renate; Criegee-Rieck, Manfred; Prokosch, Hans-Ulrich; Dormann, Harald; Maas, Renke; Bürkle, Thomas

2013-07-29

Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively "critical" orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

PubMed Central

2013-01-01

Background Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. Methods A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. Results During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Conclusions Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment. PMID:23890121

Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).

PubMed

Matsuzaki, Masunori; Hori, Masatsugu; Izumi, Tohru; Fukunami, Masatake

2011-12-01

Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients. A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days. Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects. Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).

76 FR 5494 - Pipeline Safety: Mechanical Fitting Failure Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Safety: Mechanical Fitting Failure Reporting Requirements AGENCY: Pipeline and Hazardous Materials Safety... tightening. A widely accepted industry guidance document, Gas Pipeline Technical Committee (GPTC) Guide, does...

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Evaluation of a Broad-Spectrum Partially Automated Adverse Event Surveillance System: A Potential Tool for Patient Safety Improvement in Hospitals With Limited Resources.

PubMed

Saikali, Melody; Tanios, Alain; Saab, Antoine

2017-11-21

The aim of the study was to evaluate the sensitivity and resource efficiency of a partially automated adverse event (AE) surveillance system for routine patient safety efforts in hospitals with limited resources. Twenty-eight automated triggers from the hospital information system's clinical and administrative databases identified cases that were then filtered by exclusion criteria per trigger and then reviewed by an interdisciplinary team. The system, developed and implemented using in-house resources, was applied for 45 days of surveillance, for all hospital inpatient admissions (N = 1107). Each trigger was evaluated for its positive predictive value (PPV). Furthermore, the sensitivity of the surveillance system (overall and by AE category) was estimated relative to incidence ranges in the literature. The surveillance system identified a total of 123 AEs among 283 reviewed medical records, yielding an overall PPV of 52%. The tool showed variable levels of sensitivity across and within AE categories when compared with the literature, with a relatively low overall sensitivity estimated between 21% and 44%. Adverse events were detected in 23 of the 36 AE categories defined by an established harm classification system. Furthermore, none of the detected AEs were voluntarily reported. The surveillance system showed variable sensitivity levels across a broad range of AE categories with an acceptable PPV, overcoming certain limitations associated with other harm detection methods. The number of cases captured was substantial, and none had been previously detected or voluntarily reported. For hospitals with limited resources, this methodology provides valuable safety information from which interventions for quality improvement can be formulated.

Nuclear regulation: an evaluative study. [Monograph

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

Wood, W.C.

This paper gives an overview of nuclear regulation, followed by an account of the legislative rationale and the economic rationale for safety regulation of nuclear technology. It goes on to review the structure and safety programs of the Nuclear Regulatory Commission (NRC) and to show how many of the NRC's problems are unlike those facing other regulatory agencies. In assessing the results of nuclear regulation, it examines whether regulation has produced an acceptable level of safety and the nature of the evidence on acceptability. It concludes that the existing level of safety achievement is not cost-effective, and identifies some sourcesmore » of regulatory failure as a failure to make hard decisions on risk, diffuse responsibility for safety, and economic dissincentives to cost-effective safety. Recommendations for reforming NRC are to separate technical issues from social ones and to correct the incentives for safety. 153 references, 6 figures, 4 tables.« less

CT colonography: accuracy, acceptance, safety and position in organised population screening.

PubMed

de Haan, Margriet C; Pickhardt, Perry J; Stoker, Jaap

2015-02-01

Colorectal cancer (CRC) is the second most common cancer and second most common cause of cancer-related deaths in Europe. The introduction of CRC screening programmes using stool tests and flexible sigmoidoscopy, have been shown to reduce CRC-related mortality substantially. In several European countries, population-based CRC screening programmes are ongoing or being rolled out. Stool tests like faecal occult blood testing are non-invasive and simple to perform, but are primarily designed to detect early invasive cancer. More invasive tests like colonoscopy and CT colonography (CTC) aim at accurately detecting both CRC and cancer precursors, thus providing for cancer prevention. This review focuses on the accuracy, acceptance and safety of CTC as a CRC screening technique and on the current position of CTC in organised population screening. Based on the detection characteristics and acceptability of CTC screening, it might be a viable screening test. The potential disadvantage of radiation exposure is probably overemphasised, especially with newer technology. At this time-point, it is not entirely clear whether the detection of extracolonic findings at CTC is of net benefit and is cost effective, but with responsible handling, this may be the case. Future efforts will seek to further improve the technique, refine appropriate diagnostic algorithms and study cost-effectiveness. 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.

Expert opinions on the acceptance of alternative methods in food safety evaluations: Formulating recommendations to increase acceptance of non-animal methods for kinetics.

PubMed

Punt, Ans; Bouwmeester, Hans; Schiffelers, Marie-Jeanne W A; Peijnenburg, Ad A C M

2018-02-01

Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Management methodology for pressure equipment

NASA Astrophysics Data System (ADS)

Bletchly, P. J.

Pressure equipment constitutes a significant investment in capital and a major proportion of potential high-risk plant in many operations and this is particularly so in an alumina refinery. In many jurisdictions pressure equipment is also subject to statutory regulation that imposes obligations on Owners of the equipment with respect to workplace safety. Most modern technical standards and industry codes of practice employ a risk-based approach to support better decision making with respect to pressure equipment. For a management system to be effective it must demonstrate that risk is being managed within acceptable limits.

Cognitive and Emotion Regulation Change Processes in Cognitive Behavioural Therapy for Social Anxiety Disorder.

PubMed

O'Toole, Mia S; Mennin, Douglas S; Hougaard, Esben; Zachariae, Robert; Rosenberg, Nicole K

2015-01-01

The objective of the study was to investigate variables, derived from both cognitive and emotion regulation conceptualizations of social anxiety disorder (SAD), as possible change processes in cognitive behaviour therapy (CBT) for SAD. Several proposed change processes were investigated: estimated probability, estimated cost, safety behaviours, acceptance of emotions, cognitive reappraisal and expressive suppression. Participants were 50 patients with SAD, receiving a standard manualized CBT program, conducted in groups or individually. All variables were measured pre-therapy, mid-therapy and post-therapy. Lower level mediation models revealed that while a change in most process measures significantly predicted clinical improvement, only changes in estimated probability and cost and acceptance of emotions showed significant indirect effects of CBT for SAD. The results are in accordance with previous studies supporting the mediating role of changes in cognitive distortions in CBT for SAD. In addition, acceptance of emotions may also be a critical component to clinical improvement in SAD during CBT, although more research is needed on which elements of acceptance are most helpful for individuals with SAD. The study's lack of a control condition limits any conclusion regarding the specificity of the findings to CBT. Change in estimated probability and cost, and acceptance of emotions showed an indirect effect of CBT for SAD. Cognitive distortions appear relevant to target with cognitive restructuring techniques. Finding acceptance to have an indirect effect could be interpreted as support for contemporary CBT approaches that include acceptance-based strategies. Copyright © 2014 John Wiley & Sons, Ltd.

Creatine and creatine forms intended for sports nutrition.

PubMed

Andres, Susanne; Ziegenhagen, Rainer; Trefflich, Iris; Pevny, Sophie; Schultrich, Katharina; Braun, Hans; Schänzer, Wilhelm; Hirsch-Ernst, Karen Ildico; Schäfer, Bernd; Lampen, Alfonso

2017-06-01

Creatine is a popular ergogenic supplement in sports nutrition. Yet, supplementation of creatine occasionally caused adverse effects such as gastrointestinal complaints, muscle cramps and an increase in body weight. Creatine monohydrate has already been evaluated by different competent authorities and several have come to the conclusion that a daily intake of 3 g creatine per person is unlikely to pose safety concerns, focusing on healthy adults with exclusion of pregnant and breastfeeding women. Possible vulnerable subgroups were also discussed in relation to the safety of creatine. The present review provides an up-to-date overview of the relevant information with special focus on human studies regarding the safety of creatine monohydrate and other marketed creatine forms, in particular creatine pyruvate, creatine citrate, creatine malate, creatine taurinate, creatine phosphate, creatine orotate, creatine ethyl ester, creatine pyroglutamate, creatine gluconate, and magnesium creatine chelate. Limited data are available with regard to the safety of the latter creatine forms. Considering an acceptable creatine intake of 3 g per day, most of the evaluated creatine forms are unlikely to pose safety concerns, however some safety concerns regarding a supplementary intake of creatine orotate, creatine phosphate, and magnesium creatine chelate are discussed here. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Consumer acceptance of irradiated food: theory and reality

NASA Astrophysics Data System (ADS)

Bruhn, Christine M.

1998-06-01

For years most consumers have expressed less concern about food irradiation than other food processing technologies. Attitude studies have demonstrated that when given science-based information, from 60% to 90% of consumers prefer the advantages irradiation processing provides. When information is accompanied by samples, acceptance may increase to 99%. Information on irradiation should include product benefits, safety and wholesomeness, address environmental safety issues, and include endorsements by recognized health authorities. Educational and marketing programs should now be directed toward retailers and processors. Given the opportunity, consumers will buy high quality, safety-enhanced irradiated food.

Determinants of debit cards acceptance: An empirical investigation

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

Ismail, Shafinar; Adnan, Azimah; Azizi, Amsyar

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300more » respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.« less

Determinants of debit cards acceptance: An empirical investigation

NASA Astrophysics Data System (ADS)

Ismail, Shafinar; Bakri, Mohamed Hariri; Zulkepli, Jafri; Adnan, Azimah; Azizi, Amsyar

2014-12-01

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300 respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 2: Accident Model Document (AMD)

NASA Technical Reports Server (NTRS)

1972-01-01

The Accident Model Document is one of three documents of the Preliminary Safety Analysis Report (PSAR) - Reactor System as applied to a Space Base Program. Potential terrestrial nuclear hazards involving the zirconium hydride reactor-Brayton power module are identified for all phases of the Space Base program. The accidents/events that give rise to the hazards are defined and abort sequence trees are developed to determine the sequence of events leading to the hazard and the associated probabilities of occurence. Source terms are calculated to determine the magnitude of the hazards. The above data is used in the mission accident analysis to determine the most probable and significant accidents/events in each mission phase. The only significant hazards during the prelaunch and launch ascent phases of the mission are those which arise form criticality accidents. Fission product inventories during this time period were found to be very low due to very limited low power acceptance testing.

Mindfulness Meditation-Based Intervention Is Feasible, Acceptable, and Safe for Chronic Low Back Pain Requiring Long-Term Daily Opioid Therapy

PubMed Central

Burzinski, Cindy A.; Cox, Jennifer; Kloke, John; Singles, Janice; Mirgain, Shilagh; Stegner, Aaron; Cook, Dane B.; Bačkonja, Miroslav

2016-01-01

Abstract Objective: Although mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy. Design: 26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone. Setting: Outpatient. Patients: Adults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer. Interventions: Targeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. “Usual care” for opioid-treated CLBP was provided to participants by their regular clinicians. Outcome measures: Feasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants. Results: Thirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants. Conclusions: MM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP. PMID:27267151

Of Acceptable Risk: Science and the Determination of Safety.

ERIC Educational Resources Information Center

Lowrance, William W.

This book looks at the problems of determination of safety and the underlying concept of safety itself. It is believed that if certain pervasive themes are properly appreciated, the whole field of safety will be better understood. The first chapter of the book sketches the general nature of safety decisions, defining safety as a measure of the…

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual basis but to consider measures of aggregate safety risk and to ensure wherever possible that there be quantitative measures for evaluating how effective the controls are in reducing these aggregate risks. The term aggregate risk, when used in this handbook, refers to the accumulation of risks from individual scenarios that lead to a shortfall in safety performance at a high level: e.g., an excessively high probability of loss of crew, loss of mission, planetary contamination, etc. Without aggregated quantitative measures such as these, it is not reasonable to expect that safety has been optimized with respect to other technical and programmatic objectives. At the same time, it is fully recognized that not all sources of risk are amenable to precise quantitative analysis and that the use of qualitative approaches and bounding estimates may be appropriate for those risk sources. Second, the handbook stresses the necessity of developing confidence that the controls derived for the purpose of achieving system safety not only handle risks that have been identified and properly characterized but also provide a general, more holistic means for protecting against unidentified or uncharacterized risks. For example, while it is not possible to be assured that all credible causes of risk have been identified, there are defenses that can provide protection against broad categories of risks and thereby increase the chances that individual causes are contained. Third, the handbook strives at all times to treat uncertainties as an integral aspect of risk and as a part of making decisions. The term "uncertainty" here does not refer to an actuarial type of data analysis, but rather to a characterization of our state of knowledge regarding results from logical and physical models that approximate reality. Uncertainty analysis finds how the output parameters of the models are related to plausible variations in the input parameters and in the modeling assumptions. The evaluation of unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that derive from the safety objectives of the organization. The safety claims are developed from a hierarchy of safety objectives and are therefore hierarchical themselves. Assurance that all the claims are true within acceptable risk tolerance limits implies that all of the safety objectives have been satisfied, and therefore that the system is safe. The acceptable risk tolerance limits are provided by the authority who must make the decision whether or not to proceed to the next step in the life cycle. These tolerances are therefore referred to as the decision maker's risk tolerances. In general, the safety claims address two fundamental facets of safety: 1) whether required safety thresholds or goals have been achieved, and 2) whether the safety risk is as low as possible within reasonable impacts on cost, schedule, and performance. The latter facet includes consideration of controls that are collective in nature (i.e., apply generically to broad categories of risks) and thereby provide protection against unidentified or uncharacterized risks.

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2014 CFR

2014-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2011 CFR

2011-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2012 CFR

2012-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2013 CFR

2013-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

In the Shadow of the Arch: Safety and Acceptance of Lesbian, Gay, Bisexual, Transgender and Queer Students at the University of Georgia.

ERIC Educational Resources Information Center

Hill, Robert J.; Childers, JoEllen; Childs, Adrian P.; Cowie, Gail; Hatton, Annette; Lewis, Jamie B.; MacNair, Nancy; Oswalt, Sara; Perez, Ruperto M.; Valentine, Thomas

The Campus Climate Research Group at the University of Georgia conducted a survey to explore safety and acceptance issues for lesbian, gay, transgender, and queer (LGBTQ) students at the university. The findings are based on 82 questionnaires returned form 223 surveys distributed to the LGBTQ community in fall 2001. The research results indicate…

47 CFR 87.39 - Equipment acceptable for licensing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment acceptable for licensing. 87.39 Section 87.39 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Applications and Licenses § 87.39 Equipment acceptable for licensing...

47 CFR 87.39 - Equipment acceptable for licensing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment acceptable for licensing. 87.39 Section 87.39 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Applications and Licenses § 87.39 Equipment acceptable for licensing...

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

Poet, Torka S.; Timchalk, Chuck

A large number of volatile chemicals have been identified in the headspaces of tanks used to store mixed chemical and radioactive waste at the U.S. Department of Energy (DOE) Hanford Site, and there is concern that vapor releases from the tanks may be hazardous to workers. Contractually established occupational exposure limits (OELs) established by the Occupational Safety and Health Administration (OSHA) and American Conference of Governmental Industrial Hygienists (ACGIH) do not exist for all chemicals of interest. To address the need for worker exposure guidelines for those chemicals that lack OSHA or ACGIH OELs, a procedure for assigning Acceptable Occupationalmore » Exposure Limits (AOELs) for Hanford Site tank farm workers has been developed and applied to a selected group of 57 headspace chemicals.« less

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.

Revisiting phage therapy: new applications for old resources.

PubMed

Nobrega, Franklin L; Costa, Ana Rita; Kluskens, Leon D; Azeredo, Joana

2015-04-01

The success of phage therapy is dependent on the development of strategies able to overcome the limitations of bacteriophages as therapeutic agents, the creation of an adequate regulatory framework, the implementation of safety protocols, and acceptance by the general public. Many approaches have been proposed to circumvent phages' intrinsic limitations but none have proved to be completely satisfactory. In this review we present the major hurdles of phage therapy and the solutions proposed to circumvent them. A thorough discussion of the advantages and drawbacks of these solutions is provided and special attention is given to the genetic modification of phages as an achievable strategy to shape bacteriophages to exhibit desirable biological properties. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population.

PubMed

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population

PubMed Central

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

Background The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Methods Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Results Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Conclusion Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding. PMID:28553116

Feasibility of a Video-Based Advance Care Planning Website to Facilitate Group Visits among Diverse Adults from a Safety-Net Health System.

PubMed

Zapata, Carly; Lum, Hillary D; Wistar, Emily; Horton, Claire; Sudore, Rebecca L

2018-02-20

Primary care providers in safety-net settings often do not have time to discuss advance care planning (ACP). Group visits (GV) may be an efficient means to provide ACP education. To assess the feasibility and impact of a video-based website to facilitate GVs to engage diverse adults in ACP. Feasibility pilot among patients who were ≥55 years of age from two primary care clinics in a Northern California safety-net setting. Participants attended two 90-minute GVs and viewed the five steps of the movie version of the PREPARE website ( www.prepareforyourcare.org ) concerning surrogates, values, and discussing wishes in video format. Two clinician facilitators were available to encourage participation. We assessed pre-to-post ACP knowledge, whether participants designated a surrogate or completed an advance directive (AD), and acceptability of GVs and PREPARE materials. We conducted two GVs with 22 participants. Mean age was 64 years (±7), 55% were women, 73% nonwhite, and 55% had limited literacy. Knowledge improved about surrogate designation (46% correct pre vs. 85% post, p = 0.01) and discussing decisions with others (59% vs. 90%, p = 0.01). Surrogate designation increased (48% vs. 85%, p = 0.01) and there was a trend toward AD completion (9% vs. 24%, p = 0.21). Participants rated the GVs and PREPARE materials a mean of 8 (±3.1) on a 10-point acceptability scale. Using the PREPARE movie to facilitate ACP GVs for diverse adults in safety net, primary care settings is feasible and shows potential for increasing ACP engagement.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views

PubMed Central

McDonald, R; Waring, J; Harrison, S; Walshe, K; Boaden, R

2005-01-01

Background: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. Methods: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. Results: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. Conclusions: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate. PMID:16076795

Safety in Outdoor Adventure Programs. S.O.A.P. Safety Policy.

ERIC Educational Resources Information Center

MacDonald, Wayne, Comp.; And Others

Drafted in 1978 as a working document for Safety in Outdoor Adventure Programs (S.O.A.P.) by a council of outdoor adventure programmers, checklists outline standard accepted safety policy for Outdoor Adventure Programs and Wilderness Adventure Programs conducted through public or private agencies in California. Safety policy emphasizes: the…

Acceptability and preferences for safer conception HIV prevention strategies: A qualitative study

PubMed Central

Schwartz, Sheree; West, Nora; Phofa, Rebecca; Yende, Nompumelelo; Sanne, Ian; Bassett, Jean; Van Rie, Annelies

2016-01-01

Safer conception strategies to reduce HIV transmission risk include antiretroviral therapy (ART) for HIV-positive partners, pre-exposure prophylaxis (PrEP) for HIV-negative partners, condomless sex limited to fertile periods, and home-based self-insemination. Resistance to taking treatment or cultural concerns may limit uptake of strategies and intervention success. Understanding the acceptability and preferences between different approaches is important to optimize service delivery. Between February-July 2013, 42 adults (21 HIV-positive and 21 HIV-negative) receiving primary care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, participated in focus group discussions or in-depth interviews. Themes were analyzed using a grounded theory approach. Acceptability of antiretroviral-based (ARV) strategies varied. Concerns over side effects, ARV treatment duration, and beliefs that treatment is only for the sick were common barriers, however desperation for a child was noted as a facilitator for uptake. HIV-negative men and HIV-positive women had favorable attitudes towards self-insemination, though paternity and safety concerns were raised. Self-insemination was generally preferred over PrEP by HIV-negative men, and ARV-based strategies were preferred by couples with HIV-negative female partners, despite concerns raised about condomless sex while virally suppressed. Knowledge about the fertile window was low. A strong counselling component will be required for effective uptake and adherence to safer conception services. PMID:26384950

Acceptability and preferences for safer conception HIV prevention strategies: a qualitative study.

PubMed

Schwartz, Sheree R; West, Nora; Phofa, Rebecca; Yende, Nompumelelo; Sanne, Ian; Bassett, Jean; Van Rie, Annelies

2016-10-01

Safer conception strategies to reduce the HIV transmission risk include antiretroviral therapy for HIV-positive partners, pre-exposure prophylaxis for HIV-negative partners, condomless sex limited to fertile periods, and home-based self-insemination. Resistance to taking treatment or cultural concerns may limit uptake of strategies and intervention success. Understanding the acceptability and preferences between different approaches is important to optimise service delivery. Between February and July 2013, 42 adults (21 HIV-positive and 21 HIV-negative) receiving primary care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, participated in focus group discussions or in-depth interviews. Themes were analysed using a grounded theory approach. Acceptability of antiretroviral-based strategies varied. Concerns over side effects, antiretroviral treatment duration and beliefs that treatment is only for the sick were common barriers; however, desperation for a child was noted as a facilitator for uptake. HIV-negative men and HIV-positive women had favourable attitudes towards self-insemination, though paternity and safety concerns were raised. Self-insemination was generally preferred over pre-exposure prophylaxis by HIV-negative men, and antiretroviral-based strategies were preferred by couples with HIV-negative female partners, despite concerns raised about condomless sex while virally suppressed. Knowledge about the fertile window was low. A strong counselling component will be required for effective uptake and adherence to safer conception services. © The Author(s) 2016.

The NTF Inlet Guide Vanes Thermal Gradient Problem and Its Mitigation

NASA Technical Reports Server (NTRS)

Venkat, Venki S.; Paryz, Roman W.; Bissett, Owen W.; Kilgore, W.

2013-01-01

The National Transonic Facility (NTF) utilizes Inlet Guide Vanes (IGV) to provide precise, quick response Mach number control for the tunnel. During cryogenic operations, the massive IGV structure can experience large thermal gradients, measured as "Delta T or (Delta)T", between the IGV ring and its support structure called the transfer case. If these temperature gradients are too large, the IGV structure can be stressed beyond its safety limit and cease operation. In recent years, (Delta)T readings exceeding the prescribed safety limits were observed frequently during cryogenic operations, particularly during model access. The tactical operation methods of the tunnel to minimize (Delta)T did not always succeed. One obvious option to remedy this condition is to warm up the IGV structure by disabling the main drive operation, but this "natural" warm up method can takes days in some cases, resulting in productivity loss. This paper documents the thermal gradient problem associated with the IGV structure during cryogenic operation and how the facility has recently achieved an acceptable mitigation which has resulted in improved efficiency of operations.

Bibliography on contaminants and solubility of organic compounds in oxygen

NASA Technical Reports Server (NTRS)

Ordin, P. M. (Compiler)

1975-01-01

A compilation of a number of document citations is presented which contains information on contaminants in oxygen. Topics covered include contaminants and solubility of organic compounds in oxygen, reaction characteristics of organic compounds with oxygen, and sampling and detection limits of impurities. Each citation in the data bank contains many items of information about the document. Some of the items are title, author, abstract, corporate source, description of figures pertinent to hazards or safety, key references, and descriptors (keywords) by which the document can be retrieved. Each citation includes an evaluation of the technical contents as to being good/excellent, acceptable, or poor. The descriptors used to define the contents of the documents and subsequently used in the computerized search operations were developed for the cryogenic fluid safety by experts in the cryogenics field.

An Ai Chi-based aquatic group improves balance and reduces falls in community-dwelling adults: A pilot observational cohort study.

PubMed

Skinner, Elizabeth H; Dinh, Tammy; Hewitt, Melissa; Piper, Ross; Thwaites, Claire

2016-11-01

Falls are associated with morbidity, loss of independence, and mortality. While land-based group exercise and Tai Chi programs reduce the risk of falls, aquatic therapy may allow patients to complete balance exercises with less pain and fear of falling; however, limited data exist. The objective of the study was to pilot the implementation of an aquatic group based on Ai Chi principles (Aquabalance) and to evaluate the safety, intervention acceptability, and intervention effect sizes. Pilot observational cohort study. Forty-two outpatients underwent a single 45-minute weekly group aquatic Ai Chi-based session for eight weeks (Aquabalance). Safety was monitored using organizational reporting systems. Patient attendance, satisfaction, and self-reported falls were also recorded. Balance measures included the Timed Up and Go (TUG) test, the Four Square Step Test (FSST), and the unilateral Step Tests. Forty-two patients completed the program. It was feasible to deliver Aquabalance, as evidenced by the median (IQR) attendance rate of 8.0 (7.8, 8.0) out of 8. No adverse events occurred and participants reported high satisfaction levels. Improvements were noted on the TUG, 10-meter walk test, the Functional Reach Test, the FSST, and the unilateral step tests (p < 0.05). The proportion of patients defined as high falls risk reduced from 38% to 21%. The study was limited by its small sample size, single-center nature, and the absence of a control group. Aquabalance was safe, well-attended, and acceptable to participants. A randomized controlled assessor-blinded trial is required.

Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution.

PubMed

Komenaka, Ian K; Nodora, Jesse N; Madlensky, Lisa; Winton, Lisa M; Heberer, Meredith A; Schwab, Richard B; Weitzel, Jeffrey N; Martinez, Maria Elena

2016-07-01

Some communities and populations lack access to genetic cancer risk assessment (GCRA) and testing. This is particularly evident in safety-net institutions, which serve a large segment of low-income, uninsured individuals. We describe the experience of a safety-net clinic with limited resources in providing GCRA and BRCA1/2 testing. We compared the proportion and characteristics of high-risk women who were offered and underwent GCRA and genetic testing. We also provide a description of the mutation profile for affected women. All 125 patients who were offered GCRA accepted to undergo GCRA. Of these, 72 % had a breast cancer diagnosis, 70 % were Hispanic, 52.8 % were non-English speakers, and 66 % did not have health insurance. Eighty four (67 %) were offered genetic testing and 81 (96 %) agreed. Hispanic women, those with no medical insurance, and those with a family history of breast cancer were significantly more likely to undergo testing (p > 0.01). Twelve of 81 (15 %) patients were found to have deleterious mutations, seven BRCA1, and five BRCA2. Our experience shows that it is possible to offer GCRA and genetic testing even in the setting of limited resources for these services. This is important given that a large majority of the low-income women in our study agreed to undergo counseling and testing. Our experience could serve as a model for similar low-resource safety-net health settings.

Public acceptability of highway safety countermeasures. Volume 1, Background of study and methodology

DOT National Transportation Integrated Search

1981-06-01

This study provides information about public attitudes towards proposed highway safety countermeasures in three program areas: alcohol and drugs, unsafe driving behaviors, and pedestrian safety. This volume describes the three research methodologies ...

Acceptability and validity of older driver screening with the DrivingHealth Inventory.

PubMed

Edwards, Jerri D; Leonard, Kathleen M; Lunsman, Melissa; Dodson, Joan; Bradley, Stacy; Myers, Charlsie A; Hubble, Bridgette

2008-05-01

Research has indicated that technology can be effectively used to identify high-risk older drivers. However, adaptation of such technology has been limited. Researchers debate whether older drivers represent a safety problem as well as whether they should be screened for driving fitness. The present study examined how drivers feel regarding technological screening and mandatory state testing. The validity and acceptability of a new technological screening battery for identifying high-risk drivers, the DrivingHealth Inventory (DHI), was also evaluated. In a sample of 258 Alabama drivers aged 18-87, older drivers performed significantly worse than younger drivers on sensory, cognitive, and physical subtests of the DHI, and older drivers with a crash history performed worse than older drivers without crashes. Regardless of age, 90% of participants supported states requiring screening for older drivers' license renewal. The majority of the participants (72%) supported use of technological screening batteries such as the DHI as a driver screening tool. Considering the acceptability and potential efficacy of the DHI, it may be a useful tool in evaluating driving fitness among older adults.

Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years

PubMed Central

Zhu, Fengcai; Li, Juan; Hu, Yuemei; Zhang, Xiang; Yang, Xiaoping; Zhao, Hui; Wang, Junzhi; Yang, Jianguo; Xia, Guodong; Dai, Qinyong; Tang, Haiwen; V Suryakiran, Pemmaraju; Datta, Sanjoy K; Descamps, Dominique; Bi, Dan; Struyf, Frank

2014-01-01

Immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in healthy Chinese females aged 9–45 years in 2 phase IIIB, randomized, controlled trials. Girls aged 9–17 years (ClinicalTrials.gov, NCT00996125) received vaccine (n = 374) or control (n = 376) and women aged 26–45 years (NCT01277042) received vaccine (n = 606) or control (n = 606) at months 0, 1, and 6. The primary objective was to show non-inferiority of anti-HPV-16 and -18 immune responses in initially seronegative subjects at month 7, compared with Chinese women aged 18–25 years enrolled in a separate phase II/III trial (NCT00779766). Secondary objectives were to describe the anti-HPV-16 and -18 immune response, reactogenicity and safety. At month 7, immune responses were non-inferior for girls (9–17 years) vs. young women (18–25 years): the upper limit of the 95% confidence interval (CI) for the geometric mean titer (GMT) ratio (women/girls) was below the limit of 2 for both anti-HPV-16 (0.37 [95% CI: 0.32, 0.43]) and anti-HPV-18 (0.42 [0.36, 0.49]). Immune responses at month 7 were also non-inferior for 26–45 year-old women vs. 18–25 year-old women: the upper limit of the 95% CI for the difference in seroconversion (18–25 minus 26–45) was below the limit of 5% for both anti-HPV-16 (0.00% [–1.53, 1.10]) and anti-HPV-18 (0.21% [–1.36, 1.68]). GMTs were 2- to 3-fold higher in girls (9–17 years) as compared with young women (18–25 years). The HPV-16/18 AS04-adjuvanted vaccine had an acceptable safety profile when administered to healthy Chinese females aged 9–45 years. PMID:25424785

Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years.

PubMed

Zhu, Fengcai; Li, Juan; Hu, Yuemei; Zhang, Xiang; Yang, Xiaoping; Zhao, Hui; Wang, Junzhi; Yang, Jianguo; Xia, Guodong; Dai, Qinyong; Tang, Haiwen; Suryakiran, Pemmaraju; Datta, Sanjoy K; Descamps, Dominique; Bi, Dan; Struyf, Frank

2014-01-01

Immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in healthy Chinese females aged 9-45 years in 2 phase IIIB, randomized, controlled trials. Girls aged 9-17 years (ClinicalTrials.gov, NCT00996125) received vaccine (n = 374) or control (n = 376) and women aged 26-45 years (NCT01277042) received vaccine (n = 606) or control (n = 606) at months 0, 1, and 6. The primary objective was to show non-inferiority of anti-HPV-16 and -18 immune responses in initially seronegative subjects at month 7, compared with Chinese women aged 18-25 years enrolled in a separate phase II/III trial (NCT00779766). Secondary objectives were to describe the anti-HPV-16 and -18 immune response, reactogenicity and safety. At month 7, immune responses were non-inferior for girls (9-17 years) vs. young women (18-25 years): the upper limit of the 95% confidence interval (CI) for the geometric mean titer (GMT) ratio (women/girls) was below the limit of 2 for both anti-HPV-16 (0.37 [95% CI: 0.32, 0.43]) and anti-HPV-18 (0.42 [0.36, 0.49]). Immune responses at month 7 were also non-inferior for 26-45 year-old women vs. 18-25 year-old women: the upper limit of the 95% CI for the difference in seroconversion (18-25 minus 26-45) was below the limit of 5% for both anti-HPV-16 (0.00% [-1.53, 1.10]) and anti-HPV-18 (0.21% [-1.36, 1.68]). GMTs were 2- to 3-fold higher in girls (9-17 years) as compared with young women (18-25 years). The HPV-16/18 AS04-adjuvanted vaccine had an acceptable safety profile when administered to healthy Chinese females aged 9-45 years.

The attitude of Canadian university students toward a behavior-based blood donor health assessment questionnaire.

PubMed

Go, Stephanie L; Lam, Cindy T Y; Lin, Yahui T; Wong, Deborah J; Lazo-Langner, Alejandro; Chin-Yee, Ian

2011-04-01

In Canada, all men who have sex with men (MSM) are indefinitely deferred from donating blood. The purpose of this study was to determine the acceptability of an alternative behavior-based donor health questionnaire among Canadian university students. Further we sought to determine the perception of blood safety associated with specific risk behaviors. Questions found on the Canadian Blood Services' donor health assessment questionnaire as well as from studies assessing high-risk behavior for human immunodeficiency virus infection were included. For each question participants were asked to rate the acceptability, comfort in answering, perceived effect on blood safety, and whether the question would deter them from donating blood. Data were analyzed using nonparametric tests. A total of 741 students participated in the study. Questions regarding sexual practices of the donor were rated less important for blood safety compared to those assessing for sexually transmitted infections, sex for money, and injection drug use (30%-62% vs. 69%-95% unsafe). A total of 24.4% of students rated both questions on MSM status and a behavior-based alternative as equally unacceptable. We found an inverse correlation between perception of safety and acceptability of questions. Our findings suggest that a behavior-based screening modification is unlikely to change opinions or satisfy those who object to the MSM current policy in place. Acceptability of these questions might be related to a poor understanding of the effect of sexual practices on blood supply safety. © 2010 American Association of Blood Banks.

Public acceptability of highway safety countermeasures. Volume 3, Alcohol and drug research

DOT National Transportation Integrated Search

1981-06-01

This volume, part of a larger study on public attitudes towards proposed highway safety countermeasures for alcohol and drugs, unsafe driving behaviors, and pedestrian safety, discusses reactions to breath testers, drunk-driving deterrence techniques...

A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems.

PubMed

Phansalkar, Shobha; Edworthy, Judy; Hellier, Elizabeth; Seger, Diane L; Schedlbauer, Angela; Avery, Anthony J; Bates, David W

2010-01-01

The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design.

Sunscreens with Titanium Dioxide (TiO2) Nano-Particles: A Societal Experiment

PubMed Central

van de Poel, Ibo; Osseweijer, Patricia

2010-01-01

The risks of novel technologies, such as nano(bio)technology cannot be fully assessed due to the existing uncertainties surrounding their introduction into society. Consequently, the introduction of innovative technologies can be conceptualised as a societal experiment, which is a helpful approach to evaluate moral acceptability. This approach is illustrated with the marketing of sunscreens containing nano-sized titanium dioxide (TiO2) particles. We argue that the marketing of this TiO2 nanomaterial in UV protective cosmetics is ethically undesirable, since it violates four reasonable moral conditions for societal experimentation (absence of alternatives, controllability, limited informed consent, and continuing evaluation). To remedy the current way nano-sized TiO2 containing sunscreens are utilised, we suggest five complementing actions (closing the gap, setup monitoring tools, continuing review, designing for safety, and regulative improvements) so that its marketing can become more acceptable. PMID:20835397

Department of Defense picture archiving and communication system acceptance testing: results and identification of problem components.

PubMed

Allison, Scott A; Sweet, Clifford F; Beall, Douglas P; Lewis, Thomas E; Monroe, Thomas

2005-09-01

The PACS implementation process is complicated requiring a tremendous amount of time, resources, and planning. The Department of Defense (DOD) has significant experience in developing and refining PACS acceptance testing (AT) protocols that assure contract compliance, clinical safety, and functionality. The DOD's AT experience under the initial Medical Diagnostic Imaging Support System contract led to the current Digital Imaging Network-Picture Archiving and Communications Systems (DIN-PACS) contract AT protocol. To identify the most common system and component deficiencies under the current DIN-PACS AT protocol, 14 tri-service sites were evaluated during 1998-2000. Sixteen system deficiency citations with 154 separate types of limitations were noted with problems involving the workstation, interfaces, and the Radiology Information System comprising more than 50% of the citations. Larger PACS deployments were associated with a higher number of deficiencies. The most commonly cited systems deficiencies were among the most expensive components of the PACS.

Clinical feasibility of interactive motion-controlled games for stroke rehabilitation.

PubMed

Bower, Kelly J; Louie, Julie; Landesrocha, Yoseph; Seedy, Paul; Gorelik, Alexandra; Bernhardt, Julie

2015-08-02

Active gaming technologies, including the Nintendo Wii and Xbox Kinect, have become increasingly popular for use in stroke rehabilitation. However, these systems are not specifically designed for this purpose and have limitations. The aim of this study was to investigate the feasibility of using a suite of motion-controlled games in individuals with stroke undergoing rehabilitation. Four games, which utilised a depth-sensing camera (PrimeSense), were developed and tested. The games could be played in a seated or standing position. Three games were controlled by movement of the torso and one by upper limb movement. Phase 1 involved consecutive recruitment of 40 individuals with stroke who were able to sit unsupported. Participants were randomly assigned to trial one game during a single session. Sixteen individuals from Phase 1 were recruited to Phase 2. These participants were randomly assigned to an intervention or control group. Intervention participants performed an additional eight sessions over four weeks using all four game activities. Feasibility was assessed by examining recruitment, adherence, acceptability and safety in both phases of the study. Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and improvements over time were seen in several functional outcome measures. There were no serious adverse safety events reported in either phase of the study; however, a number of participants reported minor increases in pain. A post-stroke intervention using interactive motion-controlled games shows promise as a feasible and potentially effective treatment approach. This paper presents important recommendations for future game development and research to further explore long-term adherence, acceptability, safety and efficacy. Australian and New Zealand Clinical Trials Registry ( ACTRN12613000220763 ).

Acceptability of Health Care-Related Risks: A Literature Review.

PubMed

Quintard, Bruno; Roberts, Tamara; Nitaro, Léa; Quenon, Jean-Luc; Michel, Philippe

2016-03-01

Risk management aims at reducing risks associated with hospital care to an acceptable level, both in their frequency and their impact on health. The social acceptability of risk on the part of the general population and of the health-care professionals, faced with regular information about adverse events, is undoubtedly evolving rapidly.In contrast to risk acceptability, the concept of risk perception is of limited interest to risk managers because it does not inform on the behaviors and actions resulting from these perceptions. The aim of this work was to define the concept of social acceptability of risk through an in-depth examination of a wide-ranging and multidisciplinary literature. A 1990-2010 English and French literature review was carried out in medical, epidemiological, and human and social sciences online databases, gray literature, and books. Of the 5931 references retrieved, 203 met the inclusion criteria. We identified contributions from 5 major research fields: economic, sociocognitive, psychometric, sociological/anthropological, and interactionist. When assessing risks, individuals use a variety of psychological and social processes that include their perception not only of a given risk but also of their own personal and social resources. This global perception has a direct impact on the responses and actual behavior of individuals and groups, enabling them to cope with the risk and/or manage it. Social acceptability includes perceptions related to risks and the stated intentions of individual behavior. This concept may therefore be relevant for defining local and national patient safety priorities.

Magnetic resonance imaging - A troubleshooter in obstetric emergencies: A pictorial review

PubMed Central

Gupta, Rohini; Bajaj, Sunil Kumar; Kumar, Nishith; Chandra, Ranjan; Misra, Ritu Nair; Malik, Amita; Thukral, Brij Bhushan

2016-01-01

The application of magnetic resonance imaging (MRI) in pregnancy faced initial skepticism of physicians because of fetal safety concerns. The perceived fetal risk has been found to be unwarranted and of late, the modality has attained acceptability. Its role in diagnosing fetal anomalies is well recognized and following its safety certification in pregnancy, it is finding increasing utilization during pregnancy and puerperium. However, the use of MRI in maternal emergency obstetric conditions is relatively limited as it is still evolving. In early gestation, ectopic implantation is one of the major life-threatening conditions that are frequently encountered. Although ultrasound (USG) is the accepted mainstay modality, the diagnostic predicament persists in many cases. MRI has a role where USG is indeterminate, particularly in the extratubal ectopic pregnancy. Later in gestation, MRI can be a useful adjunct in placental disorders like previa, abruption, and adhesion. It is a good problem-solving tool in adnexal masses such as ovarian torsion and degenerated fibroid, which have a higher incidence during pregnancy. Catastrophic conditions like uterine rupture can also be preoperatively and timely diagnosed. MRI has a definite role to play in postpartum and post-abortion life-threatening conditions, e.g., retained products of conception, and gestational trophoblastic disease, especially when USG is inconclusive or inadequate. PMID:27081223

Public acceptability of highway safety countermeasures. Volume 2, Safe driving conformance research

DOT National Transportation Integrated Search

1981-06-01

This volume is part of a larger study providing information about public attitudes towards proposed highway safety countermeasures in three program areas: alcohol and drugs, unsafe driving behaviors, and pedestrian safety. Topic areas discussed in th...

In Vitro Evaluation of Sunscreen Safety: Effects of the Vehicle and Repeated Applications on Skin Permeation from Topical Formulations

PubMed Central

Parenti, Carmela

2018-01-01

The evaluation of UV-filter in vitro percutaneous absorption allows the estimation of the systemic exposure dose (SED) and the margin of safety (MoS) of sunscreen products. As both the vehicle and pattern of application may affect sunscreen safety and efficacy, we evaluated in vitro release and skin permeation of two widely used UV-filters, octylmethoxycinnamate (OMC) and butylmethoxydibenzoylmethane (BMBM) from topical formulations with different features (oil in water (O/W) emulsions with different viscosity, water in oil (W/O) emulsion, oils with different lipophilicity). To mimic in-use conditions, we carried out experiments repeating sunscreen application on the skin surface for three consecutive days. BMBM release from all these vehicles was very low, thus leading to poor skin permeation. The vehicle composition significantly affected OMC release and skin permeation, and slight increases of OMC permeation were observed after repeated applications. From skin permeation data, SED and MoS values of BMBM and OMC were calculated for all the investigated formulations after a single application and repeated applications. While MoS values of BMBM were always well beyond the accepted safety limit, the safety of sunscreen formulations containing OMC may depend on the vehicle composition and the application pattern. PMID:29495452

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians.

PubMed

Nappi, Rossella E; Kaunitz, Andrew M; Bitzer, Johannes

2016-01-01

The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices.

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

PubMed Central

Nappi, Rossella E.; Kaunitz, Andrew M.; Bitzer, Johannes

2016-01-01

ABSTRACT Objectives: The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. Methods: We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. Results: The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Conclusions: Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices. PMID:26572318

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

Safety and pharmacokinetics of paclitaxel and the oral mTOR inhibitor everolimus in advanced solid tumours

PubMed Central

Campone, M; Levy, V; Bourbouloux, E; Berton Rigaud, D; Bootle, D; Dutreix, C; Zoellner, U; Shand, N; Calvo, F; Raymond, E

2009-01-01

Everolimus displays antiproliferative effects on cancer cells, yields antiangiogenic activity in established tumours, and shows synergistic activity with paclitaxel in preclinical models. This study assessed the safety and the pharmacokinetic interactions of everolimus and paclitaxel in patients with advanced malignancies. Everolimus was dose escalated from 15 to 30 mg and administered with paclitaxel 80 mg m−2 on days 1, 8, and 15 every 28 days. Safety was assessed weekly, and dose-limiting toxicity (DLT) was evaluated in cycle 1. A total of 16 patients (median age 54.5 years, range 33–69) were entered; 11 had prior taxane therapy for breast (n=5), ovarian (n=3), and vaginal cancer (n=1) or angiosarcoma (n=2). Grade 3 neutropenia in six patients met the criteria for DLT in two patients receiving everolimus 30 mg weekly. Other drug-related grade 3 toxicities were leucopenia, anaemia, thrombocytopenia, stomatitis, asthenia, and increased liver enzymes. Tumour stabilisation reported in 11 patients exceeded 6 months in 2 patients with breast cancer. Everolimus showed an acceptable safety profile at the dose of 30 mg when combined with weekly paclitaxel 80 mg m−2, warranting further clinical investigation. PMID:19127256

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.

Timing analysis by model checking

NASA Technical Reports Server (NTRS)

Naydich, Dimitri; Guaspari, David

2000-01-01

The safety of modern avionics relies on high integrity software that can be verified to meet hard real-time requirements. The limits of verification technology therefore determine acceptable engineering practice. To simplify verification problems, safety-critical systems are commonly implemented under the severe constraints of a cyclic executive, which make design an expensive trial-and-error process highly intolerant of change. Important advances in analysis techniques, such as rate monotonic analysis (RMA), have provided a theoretical and practical basis for easing these onerous restrictions. But RMA and its kindred have two limitations: they apply only to verifying the requirement of schedulability (that tasks meet their deadlines) and they cannot be applied to many common programming paradigms. We address both these limitations by applying model checking, a technique with successful industrial applications in hardware design. Model checking algorithms analyze finite state machines, either by explicit state enumeration or by symbolic manipulation. Since quantitative timing properties involve a potentially unbounded state variable (a clock), our first problem is to construct a finite approximation that is conservative for the properties being analyzed-if the approximation satisfies the properties of interest, so does the infinite model. To reduce the potential for state space explosion we must further optimize this finite model. Experiments with some simple optimizations have yielded a hundred-fold efficiency improvement over published techniques.

Flight test summary of modified fuel systems

NASA Technical Reports Server (NTRS)

Barrett, B. G.

1976-01-01

Two different aircraft designs, each with two modified fuel control systems, were evaluated. Each aircraft was evaluated in a given series of defined ground and flight conditions while quantitative and qualitative observations were made. During this program, some ten flights were completed, and a total of about 13 hours of engine run time was accumulated by the two airplanes. The results of these evaluations with emphasis on the operational and safety aspects were analyzed. Ground tests of the engine alone were not able to predict acceptable limiting lean mixture settings for the flight envelopes of the Cessna Models 150 and T337.

77 FR 45282 - NRC Position on the Relationship Between General Design Criteria and Technical Specification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

..., are described in the final safety analysis report (FSAR). The staff safety evaluation documents the acceptability of these analyses, and it is the combination of the FSAR analyses and the staff safety evaluation... analysis, maintain their capability to perform their safety functions. Technical Specification Operability...

Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer.

PubMed

Lousberg, Laurence; Jerusalem, Guy

2016-01-01

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus-exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer

PubMed Central

Lousberg, Laurence; Jerusalem, Guy

2016-01-01

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus–exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile. PMID:28096680

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.

Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies.

PubMed

Giovannoni, Gavin; Kappos, Ludwig; Gold, Ralf; Khatri, Bhupendra O; Selmaj, Krzysztof; Umans, Kimberly; Greenberg, Steven J; Sweetser, Marianne; Elkins, Jacob; McCroskery, Peter

2016-09-01

Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis. Cumulative incidence of treatment-emergent adverse events (AEs) was the primary endpoint. This analysis included 2236 patients with 5214 patient-years of exposure to daclizumab. The cumulative incidence of any AE was 84% and of any serious AE excluding MS relapse was 16%. The incidences of AEs when evaluated by 6-month intervals remained stable over the 6.5 years of maximum follow-up. Most AEs were mild or moderate in severity. An important safety concern associated with daclizumab therapy involved hepatic AEs (16%) and serum transaminase elevations at least three times the upper limit of normal (10%), most of which were asymptomatic, self-limiting, and non-recurring. Cumulative incidences of cutaneous, infectious, and gastrointestinal AEs were 33%, 59%, and 25%, respectively; most events either resolved spontaneously or were treated successfully with standard medical interventions and did not result in discontinuation of treatment. This integrated analysis demonstrates that treatment of RRMS with daclizumab for periods of up to 6.5 years is associated with an acceptable safety profile with no evidence of cumulative toxicity over time. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

40 CFR 68.48 - Safety information.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

40 CFR 68.48 - Safety information.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

40 CFR 68.48 - Safety information.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

40 CFR 68.48 - Safety information.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

46 CFR 28.275 - Acceptance criteria for instructors and course curricula.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 1 2011-10-01 2011-10-01 false Acceptance criteria for instructors and course curricula... the Aleutian Trade § 28.275 Acceptance criteria for instructors and course curricula. (a) A Fishing Vessel Safety Instructor shall submit a detailed course curriculum that relates directly to the...

46 CFR 28.275 - Acceptance criteria for instructors and course curricula.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Acceptance criteria for instructors and course curricula... the Aleutian Trade § 28.275 Acceptance criteria for instructors and course curricula. (a) A Fishing Vessel Safety Instructor shall submit a detailed course curriculum that relates directly to the...

33 CFR 175.130 - Visual distress signals accepted.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Visual distress signals accepted... (CONTINUED) BOATING SAFETY EQUIPMENT REQUIREMENTS Visual Distress Signals § 175.130 Visual distress signals accepted. (a) Any of the following signals, when carried in the number required, can be used to meet the...

33 CFR 175.130 - Visual distress signals accepted.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Visual distress signals accepted... (CONTINUED) BOATING SAFETY EQUIPMENT REQUIREMENTS Visual Distress Signals § 175.130 Visual distress signals accepted. (a) Any of the following signals, when carried in the number required, can be used to meet the...

33 CFR 175.130 - Visual distress signals accepted.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Visual distress signals accepted... (CONTINUED) BOATING SAFETY EQUIPMENT REQUIREMENTS Visual Distress Signals § 175.130 Visual distress signals accepted. (a) Any of the following signals, when carried in the number required, can be used to meet the...

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

A cloud medication safety support system using QR code and Web services for elderly outpatients.

PubMed

Tseng, Ming-Hseng; Wu, Hui-Ching

2014-01-01

Drug is an important part of disease treatment, but medication errors happen frequently and have significant clinical and financial consequences. The prevalence of prescription medication use among the ambulatory adult population increases with advancing age. Because of the global aging society, outpatients need to improve medication safety more than inpatients. The elderly with multiple chronic conditions face the complex task of medication management. To reduce the medication errors for the elder outpatients with chronic diseases, a cloud medication safety supporting system is designed, demonstrated and evaluated. The proposed system is composed of a three-tier architecture: the front-end tier, the mobile tier and the cloud tier. The mobile tier will host the personalized medication safety supporting application on Android platforms that provides some primary functions including reminders for medication, assistance with pill-dispensing, recording of medications, position of medications and notices of forgotten medications for elderly outpatients. Finally, the hybrid technology acceptance model is employed to understand the intention and satisfaction level of the potential users to use this mobile medication safety support application system. The result of the system acceptance testing indicates that this developed system, implementing patient-centered services, is highly accepted by the elderly. This proposed M-health system could assist elderly outpatients' homecare in preventing medication errors and improving their medication safety.

Drivers' safety needs, behavioural adaptations and acceptance of new driving support systems.

PubMed

Saad, Farida; Van Elslande, Pierre

2012-01-01

The aim of this paper is to discuss the contribution of two complementary approaches for designing and evaluating new driver support systems likely to improve the operation and safety of the road traffic system. The first approach is based on detailed analyses of traffic crashes so as to estimate drivers' needs for assistance and the situational constraints that safety functions should address to be efficient. The second approach is based on in depth-analyses of behavioral adaptations induced by the usage of new driver support systems in regular driving situations and on drivers' acceptance of the assistance provided by the systems.

Facts about Mumps for Adults

MedlinePlus

... containing vaccine or have other acceptable evidence of immunity to the disease. College and university students, healthcare ... MMR vaccine or have other acceptable evidence of immunity to ensure adequate protection. Vaccine safety The MMR ...

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.

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

PubMed

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

2011-06-01

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

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.

Assessing the Groundwater Quality at a Saudi Arabian Agricultural Site and the Occurrence of Opportunistic Pathogens on Irrigated Food Produce.

PubMed

Alsalah, Dhafer; Al-Jassim, Nada; Timraz, Kenda; Hong, Pei-Ying

2015-10-05

This study examines the groundwater quality in wells situated near agricultural fields in Saudi Arabia. Fruits (e.g., tomato and green pepper) irrigated with groundwater were also assessed for the occurrence of opportunistic pathogens to determine if food safety was compromised by the groundwater. The amount of total nitrogen in most of the groundwater samples exceeded the 15 mg/L permissible limit for agricultural irrigation. Fecal coliforms in densities > 12 MPN/100 mL were detected in three of the groundwater wells that were in close proximity to a chicken farm. These findings, coupled with qPCR-based fecal source tracking, show that groundwater in wells D and E, which were nearest to the chicken farm, had compromised quality. Anthropogenic contamination resulted in a shift in the predominant bacterial phyla within the groundwater microbial communities. For example, there was an elevated presence of Proteobacteria and Cyanobacteria in wells D and E but a lower overall microbial richness in the groundwater perturbed by anthropogenic contamination. In the remaining wells, the genus Acinetobacter was detected at high relative abundance ranging from 1.5% to 48% of the total groundwater microbial community. However, culture-based analysis did not recover any antibiotic-resistant bacteria or opportunistic pathogens from these groundwater samples. In contrast, opportunistic pathogenic Enterococcus faecalis and Pseudomonas aeruginosa were isolated from the fruits irrigated with the groundwater from wells B and F. Although the groundwater was compromised, quantitative microbial risk assessment suggests that the annual risk incurred from accidental consumption of E. faecalis on these fruits was within the acceptable limit of 10(-4). However, the annual risk arising from P. aeruginosa was 9.55 × 10(-4), slightly above the acceptable limit. Our findings highlight that the groundwater quality at this agricultural site in western Saudi Arabia is not pristine and that better agricultural management practices are needed alongside groundwater treatment strategies to improve food safety.

Assessing the Groundwater Quality at a Saudi Arabian Agricultural Site and the Occurrence of Opportunistic Pathogens on Irrigated Food Produce

PubMed Central

Alsalah, Dhafer; Al-Jassim, Nada; Timraz, Kenda; Hong, Pei-Ying

2015-01-01

This study examines the groundwater quality in wells situated near agricultural fields in Saudi Arabia. Fruits (e.g., tomato and green pepper) irrigated with groundwater were also assessed for the occurrence of opportunistic pathogens to determine if food safety was compromised by the groundwater. The amount of total nitrogen in most of the groundwater samples exceeded the 15 mg/L permissible limit for agricultural irrigation. Fecal coliforms in densities > 12 MPN/100 mL were detected in three of the groundwater wells that were in close proximity to a chicken farm. These findings, coupled with qPCR-based fecal source tracking, show that groundwater in wells D and E, which were nearest to the chicken farm, had compromised quality. Anthropogenic contamination resulted in a shift in the predominant bacterial phyla within the groundwater microbial communities. For example, there was an elevated presence of Proteobacteria and Cyanobacteria in wells D and E but a lower overall microbial richness in the groundwater perturbed by anthropogenic contamination. In the remaining wells, the genus Acinetobacter was detected at high relative abundance ranging from 1.5% to 48% of the total groundwater microbial community. However, culture-based analysis did not recover any antibiotic-resistant bacteria or opportunistic pathogens from these groundwater samples. In contrast, opportunistic pathogenic Enterococcus faecalis and Pseudomonas aeruginosa were isolated from the fruits irrigated with the groundwater from wells B and F. Although the groundwater was compromised, quantitative microbial risk assessment suggests that the annual risk incurred from accidental consumption of E. faecalis on these fruits was within the acceptable limit of 10−4. However, the annual risk arising from P. aeruginosa was 9.55 × 10−4, slightly above the acceptable limit. Our findings highlight that the groundwater quality at this agricultural site in western Saudi Arabia is not pristine and that better agricultural management practices are needed alongside groundwater treatment strategies to improve food safety. PMID:26445052

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.

A simple approach to industrial laser safety.

PubMed

Lewandowski, Michael A; Hinz, Michael W

2005-02-01

Industrial applications of lasers include marking, welding, cutting, and other material processing. Lasers used in these ways have significant power output but are generally designed to limit operator exposure to direct or scattered laser radiation to harmless levels in order to meet the Federal Laser Product Performance Standard (21CFR1040) for Class 1 laser products. Interesting challenges occur when companies integrate high power lasers into manufacturing or process control equipment. A significant part of the integration process is developing engineering and administrative controls to produce an acceptable level of laser safety while balancing production, maintenance, and service requirements. 3M Company uses a large number of high power lasers in numerous manufacturing processes. Whether the laser is purchased as a Class 1 laser product or whether it is purchased as a Class 4 laser and then integrated into a manufacturing application, 3M Company has developed an industrial laser safety program that maintains a high degree of laser safety while facilitating the rapid and economical integration of laser technology into the manufacturing workplace. This laser safety program is based on the requirements and recommendations contained in the American National Standard for Safe Use of Lasers, ANSI Z136.1. The fundamental components of the 3M program include hazard evaluation, engineering, administrative, and procedural controls, protective equipment, signs and labels, training, and re-evaluation upon change. This program is implemented in manufacturing facilities and has resulted in an excellent history of laser safety and an effective and efficient use of laser safety resources.

Food safety objectives for Listeria monocytogenes in Spanish food sampled in cafeterias and restaurants.

PubMed

Doménech, E; Amorós, J A; Escriche, I

2011-09-01

To gain more insight into the context of food safety management by public administrations, food safety objectives must be studied. The Valencian administration quantified the prevalence of Listeria monocytogenes in cafeterias and restaurants in this region of Spain between 2002 and 2010. The results obtained from this survey are presented here for 2,262 samples of fish, salad, egg, cold meat, and mayonnaise dishes. Microbiological criteria defined for L. monocytogenes were used to differentiate acceptable and unacceptable samples; more than 99.9% of the samples were acceptable. These findings indicate that established food safety objectives are achievable, consumer health at the time of consumption can be safeguarded, and food safety management systems such as hazard analysis critical control point plans or good manufacturing practices implemented in food establishments are effective. Monitoring of foods and food safety is an important task that must continue to reduce the current L. monocytogenes prevalence of 0.1% in restaurant or cafeteria dishes, which could adversely affect consumer health.

76 FR 77561 - Atomic Safety and Licensing Board; In the Matter of Progress Energy Florida, Inc.; (Levy County...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

...] Atomic Safety and Licensing Board; In the Matter of Progress Energy Florida, Inc.; (Levy County Nuclear... Statements) This Atomic Safety and Licensing Board hereby gives notice that it will accept oral or written..., Inc.; Establishment of Atomic Safety and Licensing Board, 74 FR 9113 (Mar. 2, 2009) (ADAMS Accession...

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.

A Quantitative Assessment of the Factors that Influence Technology Acceptance in Emergency Response

ERIC Educational Resources Information Center

Seiter, Thomas C.

2012-01-01

Traditional models for studying user acceptance and adoption of technology focused on the factors that identify and tested the relationships forged between the user and the technology in question. In emergency response, implementing technology without user acceptance may affect the safety of the responders and citizenry. Integrating the factors…

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.

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.

The scavenging of volatile anesthetic agents in the cardiovascular intensive care unit environment: a technical report.

PubMed

Pickworth, Thomas; Jerath, Angela; DeVine, Rita; Kherani, Nazmin; Wąsowicz, Marcin

2013-01-01

The use of volatile-based sedation within critical care environments has been limited by difficulties of drug administration and safety concerns over environment pollution and staff exposure in an intensive care unit (ICU) with no scavenging. The aim of this study was to develop a simple scavenging system to be used with the Anesthesia Conserving Device (AnaConDa(®)) and to determine whether or not ambient concentrations of residual anesthetic are within current acceptable limits. The scavenging system consists of two Deltasorb(®) canisters attached to the ICU ventilator in series. AnaConDa is a miniature vaporizer designed to provide volatile-based sedation within an ICU. The first ten patients recruited into a larger randomized trial assessing outcomes after elective coronary graft bypass surgery were sedated within the cardiac ICU using either isoflurane or sevoflurane. Sedation was guided by the Sedation Agitation Scale, resulting in an end-tidal minimum anesthetic concentration of volatile agent ranging from 0.1-0.3. At one hour post ICU admission, infrared photometric analysis was used to assess environmental contamination at four points along the ventilator circuit and scavenging system and around the patient's head. All measurements taken within the patient's room were below 1 part per million, which satisfies criteria for occupational exposure. This study shows that volatile agents can be administered safely within critical care settings using a simple scavenging system. Our scavenging system used in conjunction with the AnaConDa device reduced the concentration of environmental contamination to a level that is acceptable to Canadian standards and standards in most Western countries and thus conforms to international safety standards. The related clinical trial was registered at www.clinicaltrials.gov (NCT01151254).

75 FR 27734 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... Glatz, Division of Policy and Planning, Office of Information Technology, Consumer Product Safety... appropriate, and other forms of information technology. Title: Safety Standard for Bicycle Helmets--16 CFR... and process for Commission acceptance of accreditation of third party conformity assessment bodies for...

Science and Safety: 'Acceptable' Risk

ERIC Educational Resources Information Center

Science News, 1976

1976-01-01

Stresses ways to answer questions related to widespread publicity - are nuclear reactors safe, will dangerous research in genetic manipulation be banned? - with emphasis on true meaning of safety as related to risks. (EB)

Using default methodologies to derive an acceptable daily exposure (ADE).

PubMed

Faria, Ellen C; Bercu, Joel P; Dolan, David G; Morinello, Eric J; Pecquet, Alison M; Seaman, Christopher; Sehner, Claudia; Weideman, Patricia A

2016-08-01

This manuscript discusses the different historical and more recent default approaches that have been used to derive an acceptable daily exposure (ADE). While it is preferable to derive a health-based ADE based on a complete nonclinical and clinical data package, this is not always possible. For instance, for drug candidates in early development there may be no or limited nonclinical or clinical trial data. Alternative approaches that can support decision making with less complete data packages represent a variety of methods that rely on default assumptions or data inputs where chemical-specific data on health effects are lacking. A variety of default approaches are used including those based on certain toxicity estimates, a fraction of the therapeutic dose, cleaning-based limits, the threshold of toxicological concern (TTC), and application of hazard banding tools such as occupational exposure banding (OEB). Each of these default approaches is discussed in this manuscript, including their derivation, application, strengths, and limitations. In order to ensure patient safety when faced with toxicological and clinical data-gaps, default ADE methods should be purposefully as or more protective than ADEs derived from full data packages. Reliance on the subset of default approaches (e.g., TTC or OEB) that are based on toxicological data is preferred over other methods for establishing ADEs in early development while toxicology and clinical data are still being collected. Copyright © 2016. Published by Elsevier Inc.

Assessing the utility of TAM, TPB, and UTAUT for advanced driver assistance systems.

PubMed

Rahman, Md Mahmudur; Lesch, Mary F; Horrey, William J; Strawderman, Lesley

2017-11-01

Advanced Driver Assistance Systems (ADAS) are intended to enhance driver performance and improve transportation safety. The potential benefits of these technologies, such as reduction in number of crashes, enhancing driver comfort or convenience, decreasing environmental impact, etc., have been acknowledged by transportation safety researchers and federal transportation agencies. Although these systems afford safety advantages, they may also challenge the traditional role of drivers in operating vehicles. Driver acceptance, therefore, is essential for the implementation of these systems into the transportation system. Recognizing the need for research into the factors affecting driver acceptance, this study assessed the utility of the Technology Acceptance Model (TAM), the Theory of Planned Behavior (TPB), and the Unified Theory of Acceptance and Use of Technology (UTAUT) for modelling driver acceptance in terms of Behavioral Intention to use an ADAS. Each of these models propose a set of factors that influence acceptance of a technology. Data collection was done using two approaches: a driving simulator approach and an online survey approach. In both approaches, participants interacted with either a fatigue monitoring system or an adaptive cruise control system combined with a lane-keeping system. Based on their experience, participants responded to several survey questions to indicate their attitude toward using the ADAS and their perception of its usefulness, usability, etc. A sample of 430 surveys were collected for this study. Results found that all the models (TAM, TPB, and UTAUT) can explain driver acceptance with their proposed sets of factors, each explaining 71% or more of the variability in Behavioral Intention. Among the models, TAM was found to perform the best in modelling driver acceptance followed by TPB. The findings of this study confirm that these models can be applied to ADAS technologies and that they provide a basis for understanding driver acceptance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Perception of drinking water safety and factors influencing acceptance and sustainability of a water quality intervention in rural southern India.

PubMed

Francis, Mark Rohit; Nagarajan, Guru; Sarkar, Rajiv; Mohan, Venkata Raghava; Kang, Gagandeep; Balraj, Vinohar

2015-07-30

Acceptance and long-term sustainability of water quality interventions are pivotal to realizing continued health benefits. However, there is limited research attempting to understand the factors that influence compliance to or adoption of such interventions. Eight focus group discussions with parents of young children--including compliant and not compliant households participating in an intervention study, and three key-informant interviews with village headmen were conducted between April and May 2014 to understand perceptions on the effects of unsafe water on health, household drinking water treatment practices, and the factors influencing acceptance and sustainability of an ongoing water quality intervention in a rural population of southern India. The ability to recognize health benefits from the intervention, ease of access to water distribution centers and the willingness to pay for intervention maintenance were factors facilitating acceptance and sustainability of the water quality intervention. On the other hand, faulty perceptions on water treatment, lack of knowledge about health hazards associated with drinking unsafe water, false sense of protection from locally available water, resistance to change in taste or odor of water and a lack of support from male members of the household were important factors impeding acceptance and long term use of the intervention. This study highlights the need to effectively involve communities at important stages of implementation for long term success of water quality interventions. Timely research on the factors influencing uptake of water quality interventions prior to implementation will ensure greater acceptance and sustainability of such interventions in low income settings.

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data.

PubMed

Moffa, Adriano H; Brunoni, André R; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M; Daskalakis, Zafiris J; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K

2017-10-15

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD. Copyright © 2017. Published by Elsevier B.V.

Space Station crew safety alternatives study. Volume 5: Space Station safety plan

NASA Technical Reports Server (NTRS)

Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.

1985-01-01

The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.

14 CFR 189.3 - Kinds of messages accepted or relayed.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

78 FR 54280 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... safety-related batteries would remain operable if all the inter-cell and terminal connections were at the... new acceptance criteria for total battery connection resistance to ensure that the safety-related batteries can perform their specified safety function. Basis for proposed no significant hazards...

75 FR 15484 - Railroad Safety Technology Program Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... governments for projects that have a public benefit of improved railroad safety and efficiency. The program... State and local governments for projects * * * that have a public benefit of improved safety and network... minimum 20 percent grantee cost share (cash or in-kind) match requirement. DATES: FRA will begin accepting...

Simulating Geriatric Home Safety Assessments in a Three-Dimensional Virtual World

ERIC Educational Resources Information Center

Andrade, Allen D.; Cifuentes, Pedro; Mintzer, Michael J.; Roos, Bernard A.; Anam, Ramanakumar; Ruiz, Jorge G.

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with…

The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review

PubMed Central

Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy

2017-01-01

Objectives This study reviews the current state of the published peer-reviewed literature related to physician burnout and two quality of care dimensions. The purpose of this systematic literature review is to address the question, ‘How does physician burnout affect the quality of healthcare related to the dimensions of acceptability and safety?’ Design Using a multiphase screening process, this systematic literature review is based on publically available peer-reviewed studies published between 2002 and 2017. Six electronic databases were searched: (1) MEDLINE Current, (2) MEDLINE In-process, (3) MEDLINE Epub Ahead of Print, (4) PsycINFO, (5) Embase and (6) Web of Science. Setting Physicians practicing in civilian settings. Participants Practicing physicians who have completed training. Primary and secondary outcome measures Quality of healthcare related to acceptability (ie, patient satisfaction, physician communication and physician attitudes) and safety (ie, minimising risks or harm to patients). Results 4114 unique citations were identified. Of these, 12 articles were included in the review. Two studies were rated as having high risk of bias and 10 as having moderate risk. Four studies were conducted in North America, four in Europe, one in the Middle East and three in East Asia. Results of this systematic literature review suggest there is moderate evidence that burnout is associated with safety-related quality of care. Because of the variability in the way patient acceptability-related quality of care was measured and the inconsistency in study findings, the evidence supporting the relationship between burnout and patient acceptability-related quality of care is less strong. Conclusions The focus on direct care-related quality highlights additional ways that physician burnout affects the healthcare system. These studies can help to inform decisions about how to improve patient care by addressing physician burnout. Continued work looking at the relationship between dimensions of acceptability-related quality of care measures and burnout is needed to advance the field. PMID:28637730

Acceptability of donated breast milk in a resource limited South African setting.

PubMed

Coutsoudis, Irene; Petrites, Alissa; Coutsoudis, Anna

2011-02-22

The importance of breast milk for infants' growth, development and overall health is widely recognized. In situations where women are not able to provide their infants with sufficient amounts of their own breast milk, donor breast milk is the next preferred option. Although there is considerable research on the safety and scientific aspects of donor milk, and the motivations and experiences of donors, there is limited research addressing the attitudes and experiences of the women and families whose infants receive this milk. This study therefore examined attitudes towards donated breast milk among mothers, families and healthcare providers of potential recipient infants. The study was conducted at a public hospital and nearby clinic in Durban, South Africa. The qualitative data was derived from eight focus group discussions which included four groups with mothers; one with male partners; and one with grandmothers, investigating attitudes towards receiving donated breast milk for infants. There was also one group each with nurses and doctors about their attitudes towards donated breast milk and its use in the hospital. The focus groups were conducted in September and October 2009 and each group had between four and eleven participants, leading to a total of 48 participants. Although breast milk was seen as important to child health there were concerns about undermining of breast milk because of concerns about HIV and marketing and promotion of formula milks. In addition there were concerns about the safety of donor breast milk and discomfort about using another mother's milk. Participants believed that education on the importance of breast milk and transparency on the processes involved in sourcing and preparing donor milk would improve the acceptability. This study has shown that there are obstacles to the acceptability of donor milk, mainly stemming from lack of awareness/familiarity with the processes around donor breast milk and that these could be readily addressed through education. Even the more psychological concerns would also likely be reduced over time as these educational efforts progress. With government and health care worker endorsement and commitment, breast milk donation could have a promising role in improving child health.

Risk-based Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

1992-01-01

Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

49 CFR 180.511 - Acceptable results of inspections and tests.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) Safety system inspection. A tank car successfully passes the safety system inspection when each thermal..., distortion, excessive permanent expansion, or other evidence of weakness that might render the tank car...

Once and for All.

ERIC Educational Resources Information Center

Wright, Dorothy

1984-01-01

A Connecticut district's stringent asbestos removal and testing program is described, which applies a modified National Institute of Occupational Safety and Health-Occupational Safety and Health Administration (NIOSH-OSHA) test as a standard of acceptable removal. (MJL)

HEU Holdup Measurements on 321-M A-Lathe

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

Dewberry, R.A.

The Analytical Development Section of SRTC was requested by the Facilities Disposition Division (FDD) of the Savannah River Site to determine the holdup of enriched uranium in the 321-M facility as part of an overall deactivation project of the facility. The 321-M facility was used to fabricate enriched uranium fuel assemblies, lithium-aluminum target tubes, neptunium assemblies, and miscellaneous components for the production reactors. The results of the holdup assays are essential for determining compliance with the solid waste Waste Acceptance Criteria, Material Control and Accountability, and to meet criticality safety controls. Three measurement systems were used to determine highly enrichedmore » uranium (HEU) holdup. This report covers holdup measurements on the A-Lathe that was used to machine uranium-aluminum-alloy (U-Al). Our results indicated that the lathe contained more than the limits stated in the Waste Acceptance Criteria (WAC) for the solid waste E-Area Vaults. Thus the lathe was decontaminated three times and assayed four times in order to bring the amounts of uranium to an acceptable content. This report will discuss the methodology, Non-Destructive Assay (NDA) measurements, and results of the U-235 holdup on the lathe.« less

What determines the acceptability of genetically modified food that can improve human nutrition?

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

Purchase, Iain F.H.

It has been predicted that by 2025 there will be an annual shortfall of cereals for feeding the human population of 68.5 million tonnes. One possible solution is the use of genetically modified (GM) crops, which are already grown extensively (59 million ha of GM crops were planted in 2002) in the USA, South America, Africa and China. Nevertheless, there is considerable disagreement about the advisability of using such crops, particularly in Europe. Obviously, the safety of the food derived from the GM crops is a primary consideration. Safety assessment relies on establishing that the food is substantially equivalent tomore » its non-GM counterpart and specific testing for allergenicity of proteins and toxicity of metabolites and the whole food. There appears to be international agreement on the principles of safety assessment. Safety to the environment is equally important, but will not be covered in this presentation. The public's perception of the risk of new technology is critical to its acceptance. Perception of risk, in turn, depends on the credibility of the source of the information and trust in the regulatory process. In many countries, the public appears to have lost its trust in the scientists and government dealing with GM food, making the acceptability of GM crops uncertain. Of equal importance are the socio-economic factors that impinge on the viability of GM produce. These include intellectual property protection, trade liberalisation (through subsidy and tariff barriers in developed countries) and the intensity of bio safety regulations. The socio-economic interests of developed and developing countries may diverge and may even be contradictory in any one country. Acceptance of GM crops will thus depend on detailed issues surrounding particular crops and economies.« less

What determines the acceptability of genetically modified food that can improve human nutrition?

PubMed

Purchase, Iain F H

2005-09-01

It has been predicted that by 2025 there will be an annual shortfall of cereals for feeding the human population of 68.5 million tones. One possible solution is the use of genetically modified (GM) crops, which are already grown extensively (59 million ha of GM crops were planted in 2002) in the USA, South America, Africa and China. Nevertheless, there is considerable disagreement about the advisability of using such crops, particularly in Europe. Obviously, the safety of the food derived from the GM crops is a primary consideration. Safety assessment relies on establishing that the food is substantially equivalent to its non-GM counterpart and specific testing for allergenicity of proteins and toxicity of metabolites and the whole food. There appears to be international agreement on the principles of safety assessment. Safety to the environment is equally important, but will not be covered in this presentation. The public's perception of the risk of new technology is critical to its acceptance. Perception of risk, in turn, depends on the credibility of the source of the information and trust in the regulatory process. In many countries, the public appears to have lost its trust in the scientists and government dealing with GM food, making the acceptability of GM crops uncertain. Of equal importance are the socio-economic factors that impinge on the viability of GM produce. These include intellectual property protection, trade liberalization (through subsidy and tariff barriers in developed countries) and the intensity of bio safety regulations. The socio-economic interests of developed and developing countries may diverge and may even be contradictory in any one country. Acceptance of GM crops will thus depend on detailed issues surrounding particular crops and economies.

The relationship between resident burnout and safety-related and acceptability-related quality of healthcare: a systematic literature review.

PubMed

Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy; Rea, Margaret

2017-11-09

There has been increasing interest in examining the relationship between physician wellbeing and quality of patient care. However, few reviews have specifically focused on resident burnout and quality of patient care. The purpose of this systematic literature review of the current scientific literature is to address the question, "How does resident burnout affect the quality of healthcare related to the dimensions of acceptability and safety?" This systematic literature review uses a multi-step screening process of publicly available peer-reviewed studies from five electronic databases: (1) Medline Current, (2) Medline In-process, (3) PsycINFO, (4) Embase, and (5) Web of Science. The electronic literature search resulted in the identification of 4638 unique citations. Of these, 10 articles were included in the review. Studies were assessed for risk of bias. Of the 10 studies that met the inclusion criteria, eight were conducted in the US, one in The Netherlands, and one in Mexico. Eight of the 10 studies focused on patient safety. The results of these included studies suggest there is moderate evidence that burnout is associated with patient safety (i.e., resident self-perceived medical errors and sub-optimal care). There is less evidence that specific dimensions of burnout are related to acceptability (i.e., quality of care, communication with patients). The results of this systematic literature review suggest a relationship between patient safety and burnout. These results potentially have important implications for the medical training milieu because residents are still in training and at the same time are asked to teach students. The results also indicate a need for more evidence-based interventions that support continued research examining quality of care measures, especially as they relate to acceptability.

Second-stage labor: how long is too long?

PubMed

Leveno, Kenneth J; Nelson, David B; McIntire, Donald D

2016-04-01

The management of labor has come under increased scrutiny due to the rapid escalation of cesarean delivery in the United States. A workshop of the Society for Maternal-Fetal Medicine, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the American Congress of Obstetricians and Gynecologists was convened to address the rising cesarean delivery rates and one of their recommendations was that the accepted upper limit of the second stage of labor should be increased to ≥4 hours in nulliparous women with epidural analgesia and to ≥3 hours in parous women with epidural. This led to the inaugural Obstetric Care Consensus series document, "Safe Prevention of the Primary Cesarean Delivery," wherein the workshop recommendations on second-stage labor were promulgated nationally. The result is that the now acceptable maximum length of the second stage of labor exceeds the obstetric precepts that have been in use for >50 years. In this Clinical Opinion, we review the evidence on infant safety, vis-à-vis length of the second stage of labor. Our examination of the evidence begins at the outset of the 20th century and culminates in the very recent (2014) recommendation to abandon the long accepted obstetric paradigm that second-stage labor >3 hours in nulliparous women with labor epidural is unsafe for the unborn infant. We conclude that the currently available evidence fails to support the Obstetric Care Consensus position that longer second-stage labor is safe for the unborn infant. Indeed, the evidence suggests quite the opposite. We suggest that when infant safety is at stake the evidence should be robust before a new clinical road is taken. The evidence is not robust. Copyright © 2016 Elsevier Inc. All rights reserved.

Acceptability of Family-Centered Advanced Care Planning for Adolescents With HIV

PubMed Central

Kimmel, Allison; Wilkins, Megan L.; Rana, Sohail; Garcia, Ana; Cheng, Yao I.; Wang, Jichuan; Lyon, Maureen E.

2016-01-01

BACKGROUND AND OBJECTIVE: Small pilot studies support the appropriateness of engaging adolescents with chronic or life-limiting illnesses in pediatric advance care planning (pACP). We do not yet know if pACP is acceptable, feasible, and worthwhile, even if emotionally intense, in a fully powered randomized controlled trial. METHODS: We conducted a prospective 2-arm randomized controlled trial at 6 US urban hospitals. Adolescent/family member dyads were randomized to receive the 1-session-a-week 3-session FAmily-CEntered Advance Care Planning (FACE) pACP intervention (1, ACP Survey; 2, Goals of Care Conversation/Treatment Preferences; 3, Completion of Advance Directive) or active comparator (1, Developmental History; 2, Safety Tips; 3, Nutrition/Exercise). The Satisfaction Questionnaire was administered to participants independently after each session by a blinded research assistant. RESULTS: We enrolled 53% of eligible participants and intervened with 97 adolescent/family dyads. Adolescents ranged in age from 14 to 21 years; 54% were male individuals; 93% African American; and 73% perinatally infected. Attendance was 99% for all 3 sessions in each arm. At session 3, FACE adolescents and family dyad members, respectively, found the session useful (98%, 98%) and helpful (98%, 100%), despite feelings of sadness (25%, 17%). FACE adolescents’ improvement in the total subscale A score (useful, helpful, like a load off my mind, satisfied, something I needed to do, courageous, worthwhile) was better than control adolescents at session 3 (β = 1.16, P = .02). There were no adverse events. CONCLUSIONS: FACE enabled worthwhile conversations, while simultaneously eliciting intense emotions. No participants withdrew, 99% of those enrolled completed each session, and there were no adverse events, evidence of pACP’s feasibility, acceptability, and safety. PMID:27940700

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

Insecticide residues in stored grains in Sonora, Mexico: quantification and toxicity testing.

PubMed

Aldana-Madrid, M L; Valdez-Hurtado, S; Vargas-Valdez, N D; Salazar-Lopez, N J; Silveira-Gramont, M I; Loarca-Piña, F G; Rodríguez-Olibarria, G; Wong-Corral, F J; Borboa-Flores, J; Burgos-Hernández, A

2008-02-01

Food safety has acquired great attention by food importer and exporters. Food rejection or acceptance across international borders is based on the compliance with international food regulations. Due to the lack of recent data on pesticide residues in Mexican grains, this study focused on detecting and quantifying insecticide residues in stored wheat, corn, chickpeas, and beans, as well as to determine their mutagenic potential. Grains were sampled from primary storage sites in Sonora, Mexico. Malathion, chlorpyrifos, deltamethrin, cypermethrin, 4,4-DDE, 4,4-DDD and 4,4-DDT were analyzed in 135 samples. Grain samples were not mutagenic and most pesticide levels were within regulation limits.

Alternative food safety intervention technologies

USDA-ARS?s Scientific Manuscript database

Alternative nonthermal and thermal food safety interventions are gaining acceptance by the food processing industry and consumers. These technologies include high pressure processing, ultraviolet and pulsed light, ionizing radiation, pulsed and radiofrequency electric fields, cold atmospheric plasm...

76 FR 77329 - Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-12

... lifetime for a non- medical reason. Id. at 89. While observing that the yearly estimates ``may remain... FDA approval as the sine qua non of the ``currently accepted medical use'' and ``accepted safety for...

Administrative goals and safety standards for hazard control on forested recreation sites

Treesearch

Lee A. Paine

1973-01-01

For efficient control of tree hazard on recreation sites, a specific administrative goal must be selected. A safety standard designed to achieve the selected goal and a uniform hazard-rating procedure will then promote a consistent level of safety at an acceptable cost. Safety standards can be established with the aid of data for past years, and dollar evaluations are...

Romanian Experience for Enhancing Safety and Security in Transport of Radioactive Material - 12223

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

Vieru, Gheorghe

2012-07-01

The transport of Dangerous Goods-Class no.7 Radioactive Material (RAM), is an important part of the Romanian Radioactive Material Management. The overall aim of this activity is for enhancing operational safety and security measures during the transport of the radioactive materials, in order to ensure the protection of the people and the environment. The paper will present an overall of the safety and security measures recommended and implemented during transportation of RAM in Romania. Some aspects on the potential threat environment will be also approached with special referring to the low level radioactive material (waste) and NORM transportation either by roadmore » or by rail. A special attention is given to the assessment and evaluation of the possible radiological consequences due to RAM transportation. The paper is a part of the IAEA's Vienna Scientific Research Contract on the State Management of Nuclear Security Regime (Framework) concluded with the Institute for Nuclear Research, Romania, where the author is the CSI (Chief Scientific Investigator). The transport of RAM in Romania is a very sensible and complex problem taking into consideration the importance and the need of the security and safety for such activities. The Romanian Nuclear Regulatory Body set up strictly regulation and procedures according to the Recommendation of the IAEA Vienna and other international organizations. There were implemented the adequate regulation and procedures in order to keep the environmental impacts and the radiological consequences at the lower possible level and to assure the effectiveness of state nuclear security regime due to possible malicious acts in carrying out these activities including transport and the disposal site at the acceptable international levels. The levels of the estimated doses and risk expectation values for transport and disposal are within the acceptable limits provided by national and international regulations and recommendations but can increase, significantly during potential malicious acts. (authors)« less

Anticipating and addressing workplace static magnetic field effects at levels <0.5 mT.

PubMed

Emery, R J; Hopkins, J R; Charlton, M A

2000-11-01

Magnetic resonance, once a research tool limited to the basic sciences, has experienced an increase in popularity due to its unique ability to analyze certain living systems in vivo. Expanding applications in the biomedical sciences have resulted in magnetic sources being located in research institutions nationally. Space and resource limitations sometimes necessitate siting magnetic resonance units in proximity to other institutional operations. For magnetic field shielding and personnel protection considerations, the generally accepted 0.5 mT (milliTesla) limit for implanted cardiac devices is commonly used as the conservative basis for decisions. But the effects of magnetic fields on equipment can be easily observed at levels far below 0.5 mT, often resulting in concern and apprehension on the part of personnel in the surrounding areas. Responding to recurrent worker concerns spawned by noticeable effects on equipment at exposure levels <0.5 mT can strain finite radiation safety program resources. To enhance the ability to anticipate possible facility incompatibility issues associated with the installation of magnetic sources, a literature review was conducted to summarize documented equipment effects. Various types of equipment were found to be impacted at levels ranging down to perhaps 0.001 mT. Armed with this information, practicing radiation safety professionals can better anticipate facility incompatibility issues and improve their responses to worker concerns initiated by observed effects on equipment.

Oakland County Science Safety Series: Reference Guide for Elementary Science.

ERIC Educational Resources Information Center

Crowder, Betty Pogue; And Others

This reference guide is designed to organize and suggest acceptable practices and procedures for dealing with safety in elementary science instruction. It is intended as a reference for teachers, administrators, and other school staff in planning for science activities and in making daily safety decisions. Topics covered in the guide include: (1)…

Oakland County Science Safety Series: Reference Guide for Biology.

ERIC Educational Resources Information Center

Bury, Dan; And Others

This reference guide is designed to organize and suggest acceptable practices and procedures for dealing with safety in the area of biology instruction. It is intended as a reference for teachers, administrators, and other school staff in planning for science activities and in making daily safety decisions. Discussions deal with responsibility for…

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2011 CFR

2011-01-01

... for the design and construction of a new DOE nuclear facility or a major modification to an existing... acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a... mitigate hazards to workers, the public, or the environment. They include (1) physical, design, structural...

75 FR 24710 - Determination That BREVIBLOC (Esmolol Hydrochloride) Injection, 250 Milligrams/Milliliter, 10...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

..., Was Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration... from sale for reasons of safety or effectiveness. This determination means the agency will not accept... of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for...

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

Further safety enhancement of a specialized power assisted tricycle for a child with osteogenesis imperfecta type III and design of an adjustble hand power tricycle.

PubMed

Geu, Matthew; Madsen, Robert; Weber, Erica; Burnett, Michael; Barrett, Steven

2006-01-01

Several tricycles, one a customized power assisted tricycle, and the second a hand powered tricycle were developed, which offered a unique opportunity to serve multiple purposes in several children's development throughout Wyoming. In Both cases these tricycles provide the children with the opportunity to gain muscle mass, strength, coordination, and confidence. The power assisted tricycle was completed as a senior design project in 2002, and over time safety enhancements have been completed to make the tricycle safer for operation. Unfortunately, the safety system enhancements were not acceptable for it to be released for use. For this reason the tricycle was further redesigned to include more redundant safety systems which will allow the tricycle to be safe for the child's use. The second tricycle was designed to allow for a group of children who have limited use of their legs, to be able to use the same tricycle to give them more upper body strength. A gear system using multiple gear sprockets was adapted to a preexisting tricycle to provide hand power rather than foot power. Without these improvements, the children would not have the opportunity to use these tricycles to help with their development.

Solar disinfection of water for diarrhoeal prevention in southern India.

PubMed

Rose, A; Roy, S; Abraham, V; Holmgren, G; George, K; Balraj, V; Abraham, S; Muliyil, J; Joseph, A; Kang, G

2006-02-01

To evaluate the efficacy and acceptability of solar irradiation in the prevention of diarrhoeal morbidity in children under 5 years of age, in an urban slum in Vellore, Tamil Nadu. A total of 100 children were assigned to receive drinking water that had been subjected to solar disinfection in polyethylene terephthalate bottles. One hundred age and sex matched controls were also selected. Both groups were followed by weekly home visits for a period of six months for any diarrhoeal morbidity. At the end of the follow up period, the acceptability of the intervention was assessed by interviews, questionnaires, and focus group discussions. There was significant reduction in the incidence, duration, and severity of diarrhoea in children receiving solar disinfected water, despite 86% of the children drinking water other than that treated by the intervention. The incidence of diarrhoea in the intervention group was 1.7 per child-year, and among controls 2.7 per child-year, with an incidence rate ratio of 0.64 (95% CI -0.48 to 0.86). The risk of diarrhoea was reduced by 40% by using solar disinfection. In qualitative evaluation of acceptability, most women felt that solar disinfection was a feasible and sustainable method of disinfecting water. Solar disinfection of water is an inexpensive, effective, and acceptable method of increasing water safety in a resource limited environment, and can significantly decrease diarrhoeal morbidity in children.

Nintedanib: evidence for its therapeutic potential in idiopathic pulmonary fibrosis

PubMed Central

Inomata, Minoru; Nishioka, Yasuhiko; Azuma, Arata

2015-01-01

Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor prognosis. The molecular mechanisms involved in the progression of IPF are not fully understood; however, the platelet-derived growth factor (PDGF)/PDGF receptor pathway is thought to play a critical role in fibrogenesis of the lungs. Other growth factors, including fibroblast growth factor and vascular endothelial growth factor, are also thought to contribute to the pathogenesis of pulmonary fibrosis. Nintedanib is an inhibitor of multiple tyrosine kinases, including receptors for PDGF, fibroblast growth factor, and vascular endothelial growth factor. In the Phase II TOMORROW trial, treatment with 150 mg of nintedanib twice daily showed a trend to slow the decline in lung function and significantly decrease acute exacerbations in patients with IPF, while showing an acceptable safety profile. The Phase III INPULSIS trials demonstrated a significant decrease in the annual rate of decline in forced vital capacity in IPF patients treated with 150 mg nintedanib twice daily. In the INPULSIS-2 trial, the time to the first acute exacerbation significantly increased in IPF patients who were treated with 150 mg of nintedanib twice daily. Pirfenidone, another antifibrotic drug, was shown to limit the decline in pulmonary function in patients with IPF in the ASCEND trial. Combination therapy with nintedanib and pirfenidone is anticipated, although further evaluation of its long-term safety is needed. There is limited evidence for the safety of the combination therapy although a Phase II trial conducted in Japan demonstrated that combination therapy with nintedanib and pirfenidone was tolerable for 1 month. Available antifibrotic agents (ie, pirfenidone and N-acetylcysteine) have limited efficacy as single therapies for IPF; therefore, further study of combination therapy with antifibrotic agents is needed. PMID:26346347

Prevention of postpartum hemorrhage at home birth in Afghanistan.

PubMed

Sanghvi, Harshadkumar; Ansari, Nasratullah; Prata, Ndola J V; Gibson, Hannah; Ehsan, Aftab T; Smith, Jeffrey M

2010-03-01

To test the safety, acceptability, feasibility, and effectiveness of community-based education and distribution of misoprostol for prevention of postpartum hemorrhage at home birth in Afghanistan. A nonrandomized experimental control design in rural Afghanistan. A total of 3187 women participated: 2039 in the intervention group and 1148 in the control group. Of the 1421 women in the intervention group who took misoprostol, 100% correctly took it after birth, including 20 women with twin pregnancies. Adverse effect rates were unexpectedly lower in the intervention group than in the comparison group. Among women in the intervention group, 92% said they would use misoprostol in their next pregnancy. In the intervention area where community-based distribution of misoprostol was introduced, near-universal uterotonic coverage (92%) was achieved compared with 25% coverage in the control areas. In Afghanistan, community-based education and distribution of misoprostol is safe, acceptable, feasible, and effective. This strategy should be considered for other countries where access to skilled attendance is limited.

Implementing human factors in clinical practice.

PubMed

Timmons, Stephen; Baxendale, Bryn; Buttery, Andrew; Miles, Giulia; Roe, Bridget; Browes, Simon

2015-05-01

To understand whether aviation-derived human factors training is acceptable and useful to healthcare professionals. To understand whether and how healthcare professionals have been able to implement human factors approaches to patient safety in their own area of clinical practice. Qualitative, longitudinal study using semi-structured interviews and focus groups, of a multiprofessional group of UK NHS staff (from the emergency department and operating theatres) who have received aviation-derived human factors training. The human factors training was evaluated positively, and thought to be both acceptable and relevant to practice. However, the staff found it harder to implement what they had learned in their own clinical areas, and this was principally attributed to features of the informal organisational cultures. In order to successfully apply human factors approaches in hospital, careful consideration needs to be given to the local context and informal culture of clinical practice. 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.

Developing acceptance limits for measured bearing wear of the Space Shuttle Main Engine high pressure oxidizer turbopump

NASA Technical Reports Server (NTRS)

Genge, Gary G.

1991-01-01

The probabilistic design approach currently receiving attention for structural failure modes has been adapted for obtaining measured bearing wear limits in the Space Shuttle Main Engine high-pressure oxidizer turbopump. With the development of the shaft microtravel measurements to determine bearing health, an acceptance limit was neeed that protects against all known faiure modes yet is not overly conservative. This acceptance criteria limit has been successfully determined using probabilistic descriptions of preflight hardware geometry, empirical bearing wear data, mission requirements, and measurement tool precision as an input for a Monte Carlo simulation. The result of the simulation is a frequency distribution of failures as a function of preflight acceptance limits. When the distribution is converted into a reliability curve, a conscious risk management decision is made concerning the acceptance limit.

78 FR 24817 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction on motor vehicle safety due to drivers' use of electronic devices. Consequently, NHTSA is issuing nonbinding, voluntary Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice announces the issuance of the final version of the first phase of the NHTSA Guidelines. This first phase applies to original equipment (OE) in-vehicle electronic devices used by the driver to perform secondary tasks (communications, entertainment, information gathering, navigation tasks, etc. are considered secondary tasks) through visual-manual means (i.e., the driver looks at a device, manipulates a device-related control with his or her hand, and/or watches for visual feedback). The NHTSA Guidelines list certain secondary tasks believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The NHTSA Guidelines recommend that in-vehicle devices be designed so that they cannot be used by the driver to perform these inherently distracting secondary tasks while driving. For all other visual-manual secondary tasks, the NHTSA Guidelines specify a test method for measuring eye glance behavior during those tasks. Eye glance metrics are compared to acceptance criteria to evaluate whether a task interferes too much with driver attention, rendering it unsuitable for a driver to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that the task be made inaccessible for performance by the driver while driving. In addition, the NHTSA Guidelines contain several recommendations to limit and reduce the potential for distraction associated with the use of OE in-vehicle electronic devices.

Preclinical, Clinical, and Over-the-Counter Postmarketing Experience with a New Vaginal Cup: Menstrual Collection

PubMed Central

North, Barbara B.

2011-01-01

Abstract Background Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Methods Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. Results No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. Conclusions These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services. PMID:21194348

Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection.

PubMed

North, Barbara B; Oldham, Michael J

2011-02-01

Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services.

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

Are Limits of Concern a useful concept to improve the environmental risk assessment of GM plants?

PubMed

Dolezel, Marion; Miklau, Marianne; Heissenberger, Andreas; Reichenbecher, Wolfram

2017-01-01

The European Food Safety Authority (EFSA) has introduced a concept for the environmental risk assessment of genetically modified (GM) plants which foresees the definition of ecological threshold values defining acceptable adverse effects of the GM plant on the environment (Limits of Concern, LoC). We analysed the LoC concept by scrutinising its feasibility with regard to important aspects of the environmental risk assessment. We then considered its relationship with protection goals, the comparative safety assessment and the stepwise testing approach. We finally discussed its usefulness for assessing long-term effects, effects on non-target organisms and species of conservation concern. The LoC concept is a possible approach to introduce ecological thresholds into environmental risk assessment in order to evaluate environmental harm. However, the concept leaves many important aspects open. Thresholds for environmental harm for protection goals need spatial and temporal differentiation from LoCs used for ERA indicators. Regionalisation of LoCs must be provided for as biodiversity levels and protection goals vary across the EU. Further guidance is needed with respect to the consequences, in case LoCs are exceeded and a link needs to be established between environmentally relevant results from the comparative safety assessment and the LoC concept. LoCs for long-term effects have to be evaluated by long-term monitoring. LoCs for non-target organisms need to be discriminated according to the species and parameters assessed. The overall LoC concept is considered useful if LoCs are further specified and differentiated. Although LoCs will finally be determined by political decisions, they should be based on scientific grounds in order to increase confidence in the conclusions on the safety of GM plants.

Mindful Application of Aviation Practices in Healthcare.

PubMed

Powell-Dunford, Nicole; Brennan, Peter A; Peerally, Mohammad Farhad; Kapur, Narinder; Hynes, Jonny M; Hodkinson, Peter D

2017-12-01

Evidence supports the efficacy of incorporating select recognized aviation practices and procedures into healthcare. Incident analysis, debrief, safety brief, and crew resource management (CRM) have all been assessed for implementation within the UK healthcare system, a world leader in aviation-based patient safety initiatives. Mindful application, in which aviation practices are specifically tailored to the unique healthcare setting, show promise in terms of acceptance and long-term sustainment. In order to establish British healthcare applications of aviation practices, a PubMed search of UK authored manuscripts published between 2005-2016 was undertaken using search terms 'aviation,' 'healthcare,' 'checklist,' and 'CRM.' A convenience sample of UK-authored aviation medical conference presentations and UK-authored patient safety manuscripts were also reviewed. A total of 11 of 94 papers with UK academic affiliations published between 2005-2016 and relevant to aviation modeled healthcare delivery were found. The debrief process, incident analysis, and CRM are the primary practices incorporated into UK healthcare, with success dependent on cultural acceptance and mindful application. CRM training has gained significant acceptance in UK healthcare environments. Aviation modeled incident analysis, debrief, safety brief, and CRM training are increasingly undertaken within the UK healthcare system. Nuanced application, in which the unique aspects of the healthcare setting are addressed as part of a comprehensive safety approach, shows promise for long-term success. The patient safety brief and aviation modeled incident analysis are in earlier phases of implementation, and warrant further analysis.Powell-Dunford N, Brennan PA, Peerally MF, Kapur N, Hynes JM, Hodkinson PD. Mindful application of aviation practices in healthcare. Aerosp Med Hum Perform. 2017; 88(12):1107-1116.

Semi-Markov Approach to the Shipping Safety Modelling

NASA Astrophysics Data System (ADS)

Guze, Sambor; Smolarek, Leszek

2012-02-01

In the paper the navigational safety model of a ship on the open area has been studied under conditions of incomplete information. Moreover the structure of semi-Markov processes is used to analyse the stochastic ship safety according to the subjective acceptance of risk by the navigator. In addition, the navigator’s behaviour can be analysed by using the numerical simulation to estimate the probability of collision in the safety model.

Connected vehicle pilot - privacy white paper.

DOT National Transportation Integrated Search

2016-09-21

Connected Vehicle (CV) technologies is beneficial when users feel safe in broadcasting their Basic Safety Message and trust in their safety and mobility applications. Users must also accept and have a right to know how their privacy is impacted by be...

Alternative food safety intervention technologies: flash pasteurization of finfish

USDA-ARS?s Scientific Manuscript database

Alternative nonthermal and thermal food safety interventions are gaining acceptance by the food processing industry and consumers. These technologies include high pressure processing, ultraviolet and pulsed light, ionizing radiation, pulsed and radiofrequency electric fields, cold atmospheric plasm...

Human papillomavirus vaccine awareness, acceptability, and decision-making factors among Chinese college students.

PubMed

Wang, Shao-Ming; Zhang, Shao-Kai; Pan, Xiong-Fei; Ren, Ze-Fang; Yang, Chun-Xia; Wang, Zeng-Zhen; Gao, Xiao-Hong; Li, Man; Zheng, Quan-Qing; Ma, Wei; Zhao, Fang-Hui; Qiao, You-Lin; Sivasubramaniam, Priya

2014-01-01

College students are recommended as the target groups for catch-up human papillomavirus (HPV) vaccination. Systematical exploration of awareness, acceptability, and decision-making factors of HPV vaccination among Chinese college students has been limited. A multi-center survey was conducted in mainland China between November 2011 and May 2012. College students aged 18-22 years were stratified by their grade, gender, and major for sampling. Socio-demographic and HPV-related information such as knowledge, perceptions, acceptability, and attitudes were collected through a questionnaire. A total of 3,497 undergraduates completed the questionnaire, among which 1,686 were males. The acceptability of the HPV vaccine was high (70.8%). Undergraduates from high-level universities, at lower grade, or with greater prior knowledge of HPV vaccines showed higher acceptability of HPV vaccination (ptrend <0.001). Additionally, undergraduates with vaccination experience outside the National Expanded Program on Immunization (OR=1.29; 95%CI: 1.10-1.51) or fear of HPV-related diseases (OR=2.79; 95%CI: 2.28-3.41) were more willing to accept HPV vaccination. General knowledge of HPV vaccine was low among undergraduates, and safety was a major concern (71.05%). The majority of students wished to pay less than 300RMB for HPV vaccine and chose the Chinese Center for Disease Control and Prevention as the most appropriate venue for vaccination. Although most undergraduates demonstrate positive attitudes towards HPV vaccination, challenges pertaining to introduction exist in China. Corresponding proactive education and governmental subsidy to do so are urgently needed by this age-group population. Suggestions and potential strategies indicated may help shape the future HPV vaccination program in China.

Robust control of burst suppression for medical coma

NASA Astrophysics Data System (ADS)

Westover, M. Brandon; Kim, Seong-Eun; Ching, ShiNung; Purdon, Patrick L.; Brown, Emery N.

2015-08-01

Objective. Medical coma is an anesthetic-induced state of brain inactivation, manifest in the electroencephalogram by burst suppression. Feedback control can be used to regulate burst suppression, however, previous designs have not been robust. Robust control design is critical under real-world operating conditions, subject to substantial pharmacokinetic and pharmacodynamic parameter uncertainty and unpredictable external disturbances. We sought to develop a robust closed-loop anesthesia delivery (CLAD) system to control medical coma. Approach. We developed a robust CLAD system to control the burst suppression probability (BSP). We developed a novel BSP tracking algorithm based on realistic models of propofol pharmacokinetics and pharmacodynamics. We also developed a practical method for estimating patient-specific pharmacodynamics parameters. Finally, we synthesized a robust proportional integral controller. Using a factorial design spanning patient age, mass, height, and gender, we tested whether the system performed within clinically acceptable limits. Throughout all experiments we subjected the system to disturbances, simulating treatment of refractory status epilepticus in a real-world intensive care unit environment. Main results. In 5400 simulations, CLAD behavior remained within specifications. Transient behavior after a step in target BSP from 0.2 to 0.8 exhibited a rise time (the median (min, max)) of 1.4 [1.1, 1.9] min; settling time, 7.8 [4.2, 9.0] min; and percent overshoot of 9.6 [2.3, 10.8]%. Under steady state conditions the CLAD system exhibited a median error of 0.1 [-0.5, 0.9]%; inaccuracy of 1.8 [0.9, 3.4]%; oscillation index of 1.8 [0.9, 3.4]%; and maximum instantaneous propofol dose of 4.3 [2.1, 10.5] mg kg-1. The maximum hourly propofol dose was 4.3 [2.1, 10.3] mg kg-1 h-1. Performance fell within clinically acceptable limits for all measures. Significance. A CLAD system designed using robust control theory achieves clinically acceptable performance in the presence of realistic unmodeled disturbances and in spite of realistic model uncertainty, while maintaining infusion rates within acceptable safety limits.

Robust control of burst suppression for medical coma

PubMed Central

Westover, M Brandon; Kim, Seong-Eun; Ching, ShiNung; Purdon, Patrick L; Brown, Emery N

2015-01-01

Objective Medical coma is an anesthetic-induced state of brain inactivation, manifest in the electroencephalogram by burst suppression. Feedback control can be used to regulate burst suppression, however, previous designs have not been robust. Robust control design is critical under real-world operating conditions, subject to substantial pharmacokinetic and pharmacodynamic parameter uncertainty and unpredictable external disturbances. We sought to develop a robust closed-loop anesthesia delivery (CLAD) system to control medical coma. Approach We developed a robust CLAD system to control the burst suppression probability (BSP). We developed a novel BSP tracking algorithm based on realistic models of propofol pharmacokinetics and pharmacodynamics. We also developed a practical method for estimating patient-specific pharmacodynamics parameters. Finally, we synthesized a robust proportional integral controller. Using a factorial design spanning patient age, mass, height, and gender, we tested whether the system performed within clinically acceptable limits. Throughout all experiments we subjected the system to disturbances, simulating treatment of refractory status epilepticus in a real-world intensive care unit environment. Main results In 5400 simulations, CLAD behavior remained within specifications. Transient behavior after a step in target BSP from 0.2 to 0.8 exhibited a rise time (the median (min, max)) of 1.4 [1.1, 1.9] min; settling time, 7.8 [4.2, 9.0] min; and percent overshoot of 9.6 [2.3, 10.8]%. Under steady state conditions the CLAD system exhibited a median error of 0.1 [−0.5, 0.9]%; inaccuracy of 1.8 [0.9, 3.4]%; oscillation index of 1.8 [0.9, 3.4]%; and maximum instantaneous propofol dose of 4.3 [2.1, 10.5] mg kg−1. The maximum hourly propofol dose was 4.3 [2.1, 10.3] mg kg−1 h−1. Performance fell within clinically acceptable limits for all measures. Significance A CLAD system designed using robust control theory achieves clinically acceptable performance in the presence of realistic unmodeled disturbances and in spite of realistic model uncertainty, while maintaining infusion rates within acceptable safety limits. PMID:26020243

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system.

PubMed

Held, Jeremia P; Ferrer, Begoña; Mainetti, Renato; Steblin, Alexander; Hertler, Benjamin; Moreno-Conde, Alberto; Dueñas, Alvaro; Pajaro, Marta; L-Parra-Calderón, Carlos; Vargiu, Eloisa; Zarco, Maria J; Barrera, Maria; Echevarria, Carmen; Jódar-Sánchez, Francisco; Luft, Andreas R; Borghese, Nunzio A

2017-09-25

New technologies, such as telerehabilitation and gaming devices offer the possibility for patients to train at home. This opens the challenge of safety for the patient as he is called to exercise neither with a therapist on the patients' side nor with a therapist linked remotely to supervise the sessions. To study the safety, usability and patient acceptance of an autonomous telerehabilitation system for balance and gait (the REWIRE platform) in the patients home. Cohort study. Community, in the stroke patients' home. 15 participants with first-ever stroke, with a mild to moderate residual deficit of the lower extremities. Autonomous rehabilitation based on virtual rehabilitation was provided at the participants' home for twelve weeks. The primary outcome was compliance (the ratio between days of actual and scheduled training), analysed with the two-tailed Wilcoxon Mann- Whitney test. Furthermore safety is defined by adverse events. The secondary endpoint was the acceptance of the system measured with the Technology Acceptance Model. Additionally, the cumulative duration of weekly training was analysed. During the study there were no adverse events related to the therapy. Patients performed on average 71% (range 39 to 92%) of the scheduled sessions. The Technology Acceptance Model Questionnaire showed excellent values for stroke patients after the training. The average training duration per week was 99 ±53min. Autonomous telerehabilitation for balance and gait training with the REWIRE-system is safe, feasible and can help to intensive rehabilitative therapy at home. Telerehabilitation enables safe training in home environment and supports of the standard rehabilitation therapy.

Development of a patient safety climate survey for Chinese hospitals: cross-national adaptation and psychometric evaluation.

PubMed

Zhu, Junya; Li, Liping; Zhao, Hailei; Han, Guangshu; Wu, Albert W; Weingart, Saul N

2014-10-01

Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries. To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals. Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety. The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items. The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals. 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.

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

Field test of a motorcycle safety education course for novice riders

DOT National Transportation Integrated Search

1982-07-01

The purpose of this study was to subject the Motorcycle Safety Foundation's Motorcycle Rider Course (MRC) to a large-scale field test designed to evaluate the following aspects of the course: (1) Instructional Effectiveness, (2) User Acceptance, and ...

Guidelines for the acceptance of peroxide-containing oral hygiene products. American Dental Association Council on Dental Therapeutics.

PubMed

1994-08-01

Safety and efficacy criteria are defined for oral products containing various forms of peroxides. The guidelines ask for safety and efficacy studies plus observation criteria that include long-term follow-up.

Analysis of existing work-zone devices with MASH safety performance criteria.

DOT National Transportation Integrated Search

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

40 CFR 68.65 - Process safety information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... data; (4) Reactivity data: (5) Corrosivity data; (6) Thermal and chemical stability data; and (7... operator shall document that equipment complies with recognized and generally accepted good engineering...

Development and validation of nonthermal and advanced thermal food safety intervention technologies

USDA-ARS?s Scientific Manuscript database

Alternative nonthermal and thermal food safety interventions are gaining acceptance by the food processing industry and consumers. These technologies include high pressure processing, ultraviolet and pulsed light, ionizing radiation, pulsed and radiofrequency electric fields, cold atmospheric plasm...

47 CFR 80.43 - Equipment acceptable for licensing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment acceptable for licensing. 80.43 Section 80.43 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... are used on vessels in the Maritime Security Fleet and are deemed to satisfy all Commission equipment...

47 CFR 80.43 - Equipment acceptable for licensing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment acceptable for licensing. 80.43 Section 80.43 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... are used on vessels in the Maritime Security Fleet and are deemed to satisfy all Commission equipment...

Safety and Acceptability of Couples HIV Testing and Counseling for US Men Who Have Sex with Men: A Randomized Prevention Study

PubMed Central

Sullivan, Patrick S.; White, Darcy; Rosenberg, Eli S.; Barnes, Jasper; Jones, Jeb; Dasgupta, Sharoda; O’Hara, Brandon; Scales, Lamont; Salazar, Laura F.; Wingood, Gina; DiClemente, Ralph; Wall, Kristin M.; Hoff, Colleen; Gratzer, Beau; Allen, Susan; Stephenson, Rob

2013-01-01

We tested a couples HIV testing and counseling (CHTC) intervention with male couples in Atlanta by randomizing eligible couples to receive either CHTC or separate individual voluntary HIV counseling and testing (iVCT). To evaluate the acceptability and safety of CHTC, main outcomes were satisfaction with the intervention and the proportions of couples reporting intimate partner violence (IPV) and relationship dissolution after the service. The results indicated that the service was very acceptable to men (median 7-item index of satisfaction was 34 for CHTC and 35 for iVCT, P = .4). There was no difference in either incident IPV (22% versus 17% for CHTC and iVCT, respectively, P = .6) or relationship dissolution (42% versus 51% for CHTC and iVCT, respectively, P = .5). Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners. PMID:23995295

Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers

PubMed Central

Yin, Ren-Cheng

2018-01-01

The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building. PMID:29734736

Safety and efficacy of intravitreal bevacizumab followed by pegaptanib maintenance as a treatment regimen for age-related macular degeneration.

PubMed

Hughes, Mark S; Sang, Delia N

2006-01-01

Vascular endothelial growth factor (VEGF)-A, both necessary and sufficient in promoting ocular neovascularization, is an attractive therapeutic target. Combining nonselective and selective VEGF blockade may provide clinical benefit with minimal risks in the treatment of neovascular age-related macular degeneration (AMD). Twenty patients with all subtypes of neovascular AMD and a broad range of baseline vision were treated with intravitreal bevacizumab followed by pegaptanib sodium for 54 weeks. Visual acuity measurements, biomicroscopy, funduscopy, fluorescein angiography, optical coherence tomography, and adverse event assessments were performed. Mean visual acuity improved from approximately 20/200 at baseline to 20/80. All patients experienced an improvement in retinal thickness, ranging from -47 to -297 microns. Adverse events were limited to transient irritation or redness. No significant elevation in intraocular pressure occurred following either bevacizumab or pegaptanib injections. Nonselective VEGF blockade with bevacizumab induction and selective VEGF165 blockade with pegaptanib as maintenance therapies may offer clinically meaningful outcomes with acceptable safety profiles in patients with AMD.

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

Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers.

PubMed

Hsu, Ting-Yu; Yin, Ren-Cheng; Wu, Yih-Min

2018-05-05

The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building.

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

PubMed

Würtzen, G

1993-01-01

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

Occupational noise exposure of nightclub bar employees in Ireland.

PubMed

Kelly, Aoife C; Boyd, Sara M; Henehan, Gary T M; Chambers, Gordon

2012-01-01

Due to the transposition of the EU Directive 2003/10/EC into Irish Law, the entertainment sector was obligated to comply with the requirements of the Safety, Health and Welfare at Work (General Application) Regulations 2007, Chapter 1 Part 5: Control of Noise at Work since February 2008. Compliance with the Noise Regulations was examined in 9 nightclubs in Ireland. The typical daily noise exposure of 19 bar employees was measured using 2 logging dosimeters and a Type 1 fixed position sound level meter. Physical site inspections identified nightclub noise control measures. Interviews and questionnaires were used to assess the managers and employees awareness of the noise legislation. The average bar employee daily noise exposure (L(EX, 8h)) was 92 dBA, almost 4 times more than the accepted legal limit. None of the venues examined were fully compliant with the requirements of the 2007 Noise Regulations, and awareness of this legislation was limited.

Noise Control in Space Shuttle Orbiter

NASA Technical Reports Server (NTRS)

Goodman, Jerry R.

2009-01-01

Acoustic limits in habitable space enclosures are required to ensure crew safety, comfort, and habitability. Noise control is implemented to ensure compliance with the acoustic requirements. The purpose of this paper is to describe problems with establishing acoustic requirements and noise control efforts, and present examples of noise control treatments and design applications used in the Space Shuttle Orbiter. Included is the need to implement the design discipline of acoustics early in the design process, and noise control throughout a program to ensure that limits are met. The use of dedicated personnel to provide expertise and oversight of acoustic requirements and noise control implementation has shown to be of value in the Space Shuttle Orbiter program. It is concluded that to achieve acceptable and safe noise levels in the crew habitable space, early resolution of acoustic requirements and implementation of effective noise control efforts are needed. Management support of established acoustic requirements and noise control efforts is essential.

Determination and evaluation of acceptable force limits in single-digit tasks.

PubMed

Nussbaum, Maury A; Johnson, Hope

2002-01-01

Acceptable limits derived from psychophysical methodologies have been proposed, measured, and employed in a range of applications. There is little existing work, however, on such limits for single-digit exertions and relatively limited evidence on several fundamental issues related to data collection and processing of a sequence of self-regulated exertion levels. An experimental study was conducted using 14 male and 10 female participants (age range 18-31 years) from whom maximal voluntary exertions and maximal acceptable limits (MALs) were obtained using the index finger and thumb. Moderate to high levels of consistency were found for both measures between sessions separated by one day. Single MAL values, determined from a time series of exertions, were equivalent across three divergent processing methods and between values obtained from 5- and 25-min samples. A critical interpretation of these and earlier results supports continued use of acceptable limits but also suggests that they should be used with some caution and not equated with safe limits. This research can be applied toward future development of exertion limits based on perceived acceptability.

Food Safety Education Using an Interactive Multimedia Kiosk in a WIC Setting: Correlates of Client Satisfaction and Practical Issues

ERIC Educational Resources Information Center

Trepka, Mary Jo; Newman, Frederick L.; Huffman, Fatma G.; Dixon, Zisca

2010-01-01

Objective: To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Methods: Female clients or caregivers (n = 176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk.…

77 FR 24992 - OSHA Strategic Partnership Program for Worker Safety and Health (OSPP); Extension of the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

... Strategic Partnership Program for Worker Safety and Health (OSPP); Extension of the Office of Management and... specified in the OSHAs Strategic Partnership Program for Worker Safety and Health (OSPP). DATES: Comments... accepted during the Department of Labor's and Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m...

Nurses' experiences and perspectives on medication safety practices: an explorative qualitative study.

PubMed

Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester

2014-04-01

To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.

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

Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods.

PubMed

Dibari, Filippo; Bahwere, Paluku; Huerga, Helena; Irena, Abel Hailu; Owino, Victor; Collins, Steve; Seal, Andrew

2013-01-01

To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m(-2), 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. Copyright © 2013 Elsevier Inc. All rights reserved.

75 FR 7934 - Airworthiness Directives; McCauley Propeller Systems 1A103/TCM Series Propellers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... with cracks that do not meet acceptable limits, and rework of propellers with cracks that meet..., replacement of propellers with cracks that do not meet acceptable limits, and rework of propellers with cracks... propeller hub, removal from service of propellers with cracks that do not meet acceptable limits, and rework...

Electrochemical aptasensor for detecting tetracycline in milk

NASA Astrophysics Data System (ADS)

Hanh Le, Thi; Phuc Pham, Van; Huyen La, Thi; Binh Phan, Thi; Huan Le, Quang

2016-03-01

A rapid, simple and sensitive biosensor system for tetracycline detection is very important in food safety. In this paper we developed a label-free aptasensor for electrochemical detection of tetracycline. According to the electrochemical impendence spectroscopy (EIS) analysis, there was a linear relationship between the concentration of tetracycline and the electron transfer resistance from 10 to 3000 ng ml-1 of the tetracycline concentration. The detection limit was 10 ng ml-1 in 15 min detection duration. The prepared aptasensor showed a good reproducibility with an acceptable stability in tetracycline detection. The recoveries of tetracycline in spiked milk samples were in the range of 88.1%-94.2%. The aptasensor has sensitivity 98% and specificity of 100%.

Informed consent in blood transfusion: knowledge and administrative issues in Uganda hospitals.

PubMed

Kajja, Isaac; Bimenya, Gabriel S; Smit Sibinga, Cees Th

2011-02-01

Blood as a transplant is not free of risks. Clinicians and patients ought to know the parameters of a transfusion informed consent. A mixed methodology to explore patients' and clinicians' knowledge and opinions of administration and strategies to improve the transfusion informed consent process was conducted. The clinicians' level of knowledge was limited to provision of information about and the right to consent to a transfusion. They disagreed on administrative issues but had acceptable opinions on improving the process. Patients perceived this process as a way of assurance of blood safety. This process is important and should not be omitted. Copyright © 2010 Elsevier Ltd. All rights reserved.

An integrated approach for improving occupational health and safety management: the voluntary protection program in Taiwan.

PubMed

Su, Teh-Sheng; Tsai, Way-Yi; Yu, Yi-Chun

2005-05-01

A voluntary compliance program for occupational health and safety management, Voluntary Protection Programs (VPP), was implemented with a strategy of cooperation and encouragement in Taiwan. Due to limitations on increasing the human forces of inspection, a regulatory-based guideline addressing the essence of Occupational Health and Safety Management Systems (OHSMS) was promulgated, which combined the resources of third parties and insurance providers to accredit a self-improving worksite with the benefits of waived general inspection and a merit contributing to insurance premium payment reduction. A designated institute accepts enterprise's applications, performs document review and organizes the onsite inspection. A final review committee of Council of Labor Affairs (CLA) confers a two-year certificate on an approved site. After ten years, the efforts have shown a dramatic reduction of occupational injuries and illness in the total number of 724 worksites granted certification. VPP worksites, in comparison with all industries, had 49% lower frequency rate in the past three years. The severity rate reduction was 80% in the same period. The characteristics of Taiwan VPP program and international occupational safety and health management programs are provided. A Plan-Do-Check-Act management cycle was employed for pursuing continual improvements to the culture fostered. The use of a quantitative measurement for assessing the performance of enterprises' occupational safety and health management showed the efficiency of the rating. The results demonstrate that an employer voluntary protection program is a promising strategy for a developing country.

75 FR 43495 - Sunshine Act Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Sunshine Act Notice AGENCY: Defense Nuclear Facilities..., structures, and components, and (5) safety-related design aspects of new facilities or modifications of existing facilities needed to deliver high-level waste feed. The Board will be prepared to accept any other...

14 CFR 415.35 - Acceptable flight risk.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Acceptable flight risk. 415.35 Section 415.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval, an...

14 CFR 415.35 - Acceptable flight risk.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Acceptable flight risk. 415.35 Section 415.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval, an...

14 CFR 415.35 - Acceptable flight risk.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Acceptable flight risk. 415.35 Section 415.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval, an...

14 CFR 415.35 - Acceptable flight risk.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Acceptable flight risk. 415.35 Section 415.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval, an...

37 CFR 1.803 - Acceptable depository.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Biological Material § 1.803 Acceptable depository. (a) A deposit shall be recognized for the purposes of... depository must: (i) Have a continuous existence; (ii) Exist independent of the control of the depositor... safety measures to minimize the risk of losing biological material deposited with it; (v) Be impartial...

37 CFR 1.803 - Acceptable depository.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Biological Material § 1.803 Acceptable depository. (a) A deposit shall be recognized for the purposes of... depository must: (i) Have a continuous existence; (ii) Exist independent of the control of the depositor... safety measures to minimize the risk of losing biological material deposited with it; (v) Be impartial...

37 CFR 1.803 - Acceptable depository.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Biological Material § 1.803 Acceptable depository. (a) A deposit shall be recognized for the purposes of... depository must: (i) Have a continuous existence; (ii) Exist independent of the control of the depositor... safety measures to minimize the risk of losing biological material deposited with it; (v) Be impartial...

76 FR 49751 - Perfect Fitness, Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

... CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. 11-C0009] Perfect Fitness, Provisional...(e). Published below is a provisionally-accepted Settlement Agreement with Perfect Fitness... accordance with 16 CFR 1118.20, Perfect Fitness and staff (``Staff'') of the United States Consumer Product...

14 CFR 415.35 - Acceptable flight risk.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Acceptable flight risk. 415.35 Section 415.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval, an...

Dynamic residual pattern of azoxystrobin in Swiss chard with contribution to safety evaluation.

PubMed

Farha, Waziha; Abd El-Aty, A M; Rahman, Md Musfiqur; Kabir, Md Humayun; Chung, Hyung Suk; Lee, Han Sol; Jeon, Jong-Sup; Wang, Jing; Chang, Byung-Joon; Shin, Ho-Chul; Shim, Jae-Han

2018-02-01

This study aimed at quantifying the residual amount of azoxystrobin in Swiss chard samples grown under greenhouse conditions at two different locations (Gwangju and Naju, Republic of Korea). Samples were extracted with acetonitrile, separated by salting out, and subjected to purification by using solid-phase extraction. The analyte was identified using liquid chromatography-ultraviolet detection. The linearity of the calibration range was excellent with coefficient of determination 1.00. Recovery at three different spiking levels (0.1, 0.5, and 4 mg/kg) ranged between 82.89 and 109.46% with relative standard deviation <3. The limit of quantification, 0.01 mg/kg, was considerably much lower than the maximum residue limit (50 mg/kg) set by the Korean Ministry of Food and Drug Safety. The developed methodology was successfully used for field-treated leaves, which were collected randomly at 0-14 days following azoxystrobin application. The rate of disappearance in/on Swiss chard was ascribed to first-order kinetics with a half-life of 8 and 5 days, in leaves grown in Gwangju and Naju greenhouses, respectively. Risk assessments revealed that the acceptable daily intake percentage is substantially below the risk level of consumption at day 0 (in both areas), thus encouraging its safe consumption. Copyright © 2017 John Wiley & Sons, Ltd.

Soft Regulation with Crowd Recommendation: Coordinating Self-Interested Agents in Sociotechnical Systems under Imperfect Information.

PubMed

Luo, Yu; Iyengar, Garud; Venkatasubramanian, Venkat

2016-01-01

Regulating emerging industries is challenging, even controversial at times. Under-regulation can result in safety threats to plant personnel, surrounding communities, and the environment. Over-regulation may hinder innovation, progress, and economic growth. Since one typically has limited understanding of, and experience with, the novel technology in practice, it is difficult to accomplish a properly balanced regulation. In this work, we propose a control and coordination policy called soft regulation that attempts to strike the right balance and create a collective learning environment. In soft regulation mechanism, individual agents can accept, reject, or partially accept the regulator's recommendation. This non-intrusive coordination does not interrupt normal operations. The extent to which an agent accepts the recommendation is mediated by a confidence level (from 0 to 100%). Among all possible recommendation methods, we investigate two in particular: the best recommendation wherein the regulator is completely informed and the crowd recommendation wherein the regulator collects the crowd's average and recommends that value. We show by analysis and simulations that soft regulation with crowd recommendation performs well. It converges to optimum, and is as good as the best recommendation for a wide range of confidence levels. This work sheds a new theoretical perspective on the concept of the wisdom of crowds.

Soft Regulation with Crowd Recommendation: Coordinating Self-Interested Agents in Sociotechnical Systems under Imperfect Information

PubMed Central

2016-01-01

Regulating emerging industries is challenging, even controversial at times. Under-regulation can result in safety threats to plant personnel, surrounding communities, and the environment. Over-regulation may hinder innovation, progress, and economic growth. Since one typically has limited understanding of, and experience with, the novel technology in practice, it is difficult to accomplish a properly balanced regulation. In this work, we propose a control and coordination policy called soft regulation that attempts to strike the right balance and create a collective learning environment. In soft regulation mechanism, individual agents can accept, reject, or partially accept the regulator’s recommendation. This non-intrusive coordination does not interrupt normal operations. The extent to which an agent accepts the recommendation is mediated by a confidence level (from 0 to 100%). Among all possible recommendation methods, we investigate two in particular: the best recommendation wherein the regulator is completely informed and the crowd recommendation wherein the regulator collects the crowd’s average and recommends that value. We show by analysis and simulations that soft regulation with crowd recommendation performs well. It converges to optimum, and is as good as the best recommendation for a wide range of confidence levels. This work sheds a new theoretical perspective on the concept of the wisdom of crowds. PMID:26977699

Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa.

PubMed

Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

2016-01-01

This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women. ClinicalTrials.gov NCT01071174.

Engineering in an age of anxiety

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

Weinberg, A.M.

Public fears of nuclear or chemical accidents should challenge engineers to build systems that are inherently safe. Much of our national anxiety focuses on modern technology. This anxiety places constraints on our technologies. Probabilistic risk assessment (PBA) has become an accepted tool for determining the safety of a device. Although PBA is widely accepted by engineers, it will not allay the public's anxieties. To concede that a technology has the potential for causing a major disaster, even if the probability of occurrence is minute, is unacceptable in the age of anxiety. The search for inherent safety concepts, that - informedmore » skeptics - and the public will accept, continues. The greenhouse effect may be decisive in spurring the demand for inherently safe nuclear technology. Ultimately what the public requires by way of assurance may well depend on the alternatives available. 11 refs.« less

An Assessment of Software Safety as Applied to the Department of Defense Software Development Process

DTIC Science & Technology

1992-12-01

provide program 5 managers some level of confidence that their software will operate at an acceptable level of risk. A number of structured safety...safety within the constraints of operational effectiveness, schedule, and cost through timely application of system safety management and engineering...Master of Science in Software Systems Management Peter W. Colan, B.S.E. Robert W. Prouhet, B.S. Captain, USAF Captain, USAF December 1992 Approved for

An Example of an INPRO Assessment of an INS in the Area of Waste Management

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

Allan, C.; Busurin, Y.; Depisch, F.

2006-07-01

Following a resolution of the General Conference of the IAEA in the year 2000 the International Project on Innovative Nuclear Reactors and Fuel Cycles, referred to as INPRO, was initiated. INPRO has defined requirements organized in a hierarchy of Basic Principles, User Requirements and Criteria (consisting of an indicator and an acceptance limit) to be met by innovative nuclear reactor systems (INS) in six areas, namely: economics, safety, waste management, environment, proliferation resistance, and infrastructure. If an INS meets all requirements in all areas it represents a sustainable system for the supply of energy, capable of making a significant contributionmore » to meeting the energy needs of the 21. century. Draft manuals have been developed, for each INPRO area, to provide guidance for performing an assessment of whether an INS meets the INPRO requirements in a given area. The manuals set out the information that needs to be assembled to perform an assessment and provide guidance on selecting the acceptance limits and, for a given INS, for determining the value of the indicators for comparison with the associated acceptance limits. Each manual also includes an example of a specific assessment to illustrate the guidance. This paper discusses the example presented in the manual for performing an INPRO assessment in the area of waste management. The example, chosen solely for the purpose of illustrating the INPRO methodology, describes an assessment of an INS based on the DUPIC fuel cycle. It is assumed that uranium is mined, milled, converted, enriched, and fabricated into LWR fuel in Canada. The LWR fuel is assumed to be leased to a utility in the USA. The spent LWR fuel is assumed to be returned to Canada where it is processed into CANDU DUPIC fuel, which is then burned in CANDU reactors. The assessment steps and the results are presented in detail in the paper. The example illustrates an assessment performed for an INS at an early stage of development. (authors)« less

7 CFR 42.143 - Operating Characteristic (OC) curves for on-line sampling and inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

...=Number of sample units in a subgroup. T=Subgroup tolerance.L=Acceptance limit.S=Starting value. EC02SE91... ng=Number of sample units in a subgroup. T=Subgroup tolerance. L=Acceptance limit. S=Starting value... of sample units in a subgroup. T=Subgroup tolerance. L=Acceptance limit. S=Starting value. EC02SE91...

Light duty utility arm phase 2 qualification test procedure

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

Barnes, G.A.

1997-01-16

This Acceptance Test Procedure (ATP) will test and verify that the Exhauster meets the specified functional requirements, safety requirements, operating requirements, and provide a record of the functional test results. The system/functions that will be tested are listed in the scope section of the Acceptance Test Procedure.

49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance with...

30 CFR 18.16 - Withdrawal of approval, certification, or acceptance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Withdrawal of approval, certification, or acceptance. 18.16 Section 18.16 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES...

49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance with...

49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance with...

49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance with...

49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance with...

Sex differences in principal farm operators' tractor driving safety beliefs and behaviors.

PubMed

Cole, H P; Westneat, S C; Browning, S R; Piercy, L R; Struttmann, T

2000-01-01

To examine the widely accepted hypothesis that farm women are more concerned with safety issues and behaviors than their male counterparts are. A telephone survey was administered to a random sample of Kentucky principal farm operators, 90 of whom were women. Participants were questioned about their tractor safety beliefs and practices. No significant sex differences in tractor safety perceptions and behavior were observed. Socialization of women to the role of principal farm operator may override their typically greater sensitivity to safety issues, an important consideration when designing safety campaigns for this population.

Child Safety Programs: Implications Affecting Use of Child Restraints.

ERIC Educational Resources Information Center

Hoadley, Michael R.; And Others

1981-01-01

A study identified behavioral and attitudinal factors influencing the use of child restraints in automobiles. The data suggest that the focus of safety education needs to be aimed at both child and parent acceptance and understanding of the importance of restraint use. (JN)

Solar disinfection of water for diarrhoeal prevention in southern India

PubMed Central

Rose, A; Roy, S; Abraham, V; Holmgren, G; George, K; Balraj, V; Abraham, S; Muliyil, J; Joseph, A; Kang, G

2006-01-01

Aims To evaluate the efficacy and acceptability of solar irradiation in the prevention of diarrhoeal morbidity in children under 5 years of age, in an urban slum in Vellore, Tamil Nadu. Methods A total of 100 children were assigned to receive drinking water that had been subjected to solar disinfection in polyethylene terephthalate bottles. One hundred age and sex matched controls were also selected. Both groups were followed by weekly home visits for a period of six months for any diarrhoeal morbidity. At the end of the follow up period, the acceptability of the intervention was assessed by interviews, questionnaires, and focus group discussions. Results There was significant reduction in the incidence, duration, and severity of diarrhoea in children receiving solar disinfected water, despite 86% of the children drinking water other than that treated by the intervention. The incidence of diarrhoea in the intervention group was 1.7 per child‐year, and among controls 2.7 per child‐year, with an incidence rate ratio of 0.64 (95% CI −0.48 to 0.86). The risk of diarrhoea was reduced by 40% by using solar disinfection. In qualitative evaluation of acceptability, most women felt that solar disinfection was a feasible and sustainable method of disinfecting water. Conclusions Solar disinfection of water is an inexpensive, effective, and acceptable method of increasing water safety in a resource limited environment, and can significantly decrease diarrhoeal morbidity in children. PMID:16403847

Probabilistic Requirements (Partial) Verification Methods Best Practices Improvement. Variables Acceptance Sampling Calculators: Empirical Testing. Volume 2

NASA Technical Reports Server (NTRS)

Johnson, Kenneth L.; White, K. Preston, Jr.

2012-01-01

The NASA Engineering and Safety Center was requested to improve on the Best Practices document produced for the NESC assessment, Verification of Probabilistic Requirements for the Constellation Program, by giving a recommended procedure for using acceptance sampling by variables techniques as an alternative to the potentially resource-intensive acceptance sampling by attributes method given in the document. In this paper, the results of empirical tests intended to assess the accuracy of acceptance sampling plan calculators implemented for six variable distributions are presented.

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.

Geotechnical approach for occupational safety risk analysis of critical slope in open pit mining as implication for earthquake hazard

NASA Astrophysics Data System (ADS)

Munirwansyah; Irsyam, Masyhur; Munirwan, Reza P.; Yunita, Halida; Zulfan Usrina, M.

2018-05-01

Occupational safety and health (OSH) is a planned effort to prevent accidents and diseases caused by work. In conducting mining activities often occur work accidents caused by unsafe field conditions. In open mine area, there is often a slump due to unstable slopes, which can disrupt the activities and productivity of mining companies. Based on research on stability of open pit slopes conducted by Febrianti [8], the Meureubo coal mine located in Aceh Barat district, on the slope of mine was indicated unsafe slope conditions, it will be continued research on OSH for landslide which is to understand the stability of the excavation slope and the shape of the slope collapse. Plaxis software was used for this research. After analyzing the slope stability and the effect of landslide on OSH with Job Safety Analysis (JSA) method, to identify the hazard to work safety, risk management analysis will be conducted to classified hazard level and its handling technique. This research aim is to know the level of risk of work accident at the company and its prevention effort. The result of risk analysis research is very high-risk value that is > 350 then the activity must be stopped until the risk can be reduced to reach the risk value limit < 20 which is allowed or accepted.

Fatal exposure to methylene chloride among bathtub refinishers - United States, 2000-2011.

PubMed

2012-02-24

In 2010, the Michigan Fatality Assessment and Control Evaluation program conducted an investigation into the death of a bathtub refinisher who used a methylene chloride-based paint stripping product marketed for use in aircraft maintenance. The program identified two earlier, similar deaths in Michigan. Program staff members notified CDC's National Institute for Occupational Safety and Health (NIOSH), which in turn notified the Occupational Safety and Health Administration (OSHA). In addition to the three deaths, OSHA identified 10 other bathtub refinisher fatalities associated with methylene chloride stripping agents that had been investigated in nine states during 2000-2011. Each death occurred in a residential bathroom with inadequate ventilation. Protective equipment, including a respirator, either was not used or was inadequate to protect against methylene chloride vapor, which has been recognized as potentially fatal to furniture strippers and factory workers but has not been reported previously as a cause of death among bathtub refinishers. Worker safety agencies, public health agencies, methylene chloride-based stripper manufacturers, and trade organizations should communicate the extreme hazards of using methylene chloride-based stripping products in bathtub refinishing to employers, workers, and consumers. Employers should strongly consider alternative methods of bathtub stripping and always ensure worker safety protections that reduce the risk for health hazards to acceptable levels. Employers choosing to use methylene chloride-based stripping products must comply with OSHA's standard to limit methylene chloride exposures to safe levels.

E-cigarette versus nicotine inhaler: comparing the perceptions and experiences of inhaled nicotine devices.

PubMed

Steinberg, Michael B; Zimmermann, Mia Hanos; Delnevo, Cristine D; Lewis, M Jane; Shukla, Parth; Coups, Elliot J; Foulds, Jonathan

2014-11-01

Novel nicotine delivery products, such as electronic cigarettes (e-cigarettes), have dramatically grown in popularity despite limited data on safety and benefit. In contrast, the similar U.S. Food and Drug Administration (FDA)-approved nicotine inhaler is rarely utilized by smokers. Understanding this paradox could be helpful to determine the potential for e-cigarettes as an alternative to tobacco smoking. To compare the e-cigarette with the nicotine inhaler in terms of perceived benefits, harms, appeal, and role in assisting with smoking cessation. A cross-over trial was conducted from 2012 to 2013 PARTICIPANTS/INTERVENTIONS: Forty-one current smokers age 18 and older used the e-cigarette and nicotine inhaler each for 3 days, in random order, with a washout period in between. Thirty-eight participants provided data on product use, perceptions, and experiences. The Modified Cigarette Evaluation Questionnaire (mCEQ) measured satisfaction, reward, and aversion. Subjects were also asked about each product's helpfulness, similarity to cigarettes, acceptability, image, and effectiveness in quitting smoking. Cigarette use was also recorded during the product-use periods. The e-cigarette had a higher total satisfaction score (13.9 vs. 6.8 [p < 0.001]; range for responses 3-21) and higher reward score (15.8 vs. 8.7 [p < 0.001]; range for responses 5-35) than the inhaler. The e-cigarette received higher ratings for helpfulness, acceptability, and "coolness." More subjects would use the e-cigarette to make a quit attempt (76 %) than the inhaler (24 %) (p < 0.001). Eighteen percent (7/38) of subjects abstained from smoking during the 3-day periods using the e-cigarette vs. 10 % (4/38) using the inhaler (p = 0.18). The e-cigarette was more acceptable, provided more satisfaction, and had higher perceived benefit than the inhaler during this trial. E-cigarettes have the potential to be important nicotine delivery products owing to their high acceptance and perceived benefit, but more data are needed to evaluate their actual efficacy and safety. Providers should be aware of these issues, as patients will increasingly inquire about them.

The safety and efficacy of using a concentrated intranasal midazolam formulation for paediatric dental sedation.

PubMed

Wood, Michael

2011-01-01

To add to the evidence base for safe and effective paediatric conscious sedation techniques in primary dental care. To consider the safety and effectiveness of an alternative sedation technique for facilitating dental treatment in anxious children, thereby avoiding dental general anaesthetic. Leagrave Dental Sedation Clinic. A primary care-based general and referral clinic for anxious patients, special care dentistry and oral surgery. This is a prospective service evaluation of 114 selected anxious children requiring invasive dental treatment. Each child was administered 0.25 mg/kg intranasal midazolam using a concentrated 40 mg/ml midazolam (INM) in 2% lignocaine solution. Successful completion of intended dental treatment with a child who is co-operative and who meets the UK accepted definition of conscious sedation. 57% of the children found the administration of the new formulation acceptable. Of the 114 patients who received INM, 104 completed the treatment (91%). The 10 children who could not complete the treatment with INM were converted to intravenous sedation and treatment was completed successfully at the same appointment. During treatment there was no desaturation and only one patient desaturated briefly in the recovery area. Parents rated the technique acceptable in 76% of cases and would have the procedure repeated in 83% of cases. Parents rated this technique as having 8.3 out of 10 with only 5 parents awarding a score of less than 7 out of 10. Side effects included blurred vision, sneezing, headaches, restlessness with one patient having post-operative nausea and vomiting. In selected cases intranasal sedation provides a safe and effective alternative for dental GA in short invasive procedures limited to one or two quadrants in children. Other techniques, e.g., oral and intravenous sedation, appear to have a much higher acceptability of administration. This technique may be useful if inhalation sedation, oral sedation or intravenous sedation is considered and the child is still unco-operative, either as a technique on its own or to facilitate cannulation for intravenous sedation. It is recommended that this technique should only be used by dentists skilled in intravenous paediatric sedation with midazolam with the appropriate staff training and equipment at their disposal.

Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review.

PubMed

Berry, Natalie; Lobban, Fiona; Emsley, Richard; Bucci, Sandra

2016-05-31

Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed.

Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review

PubMed Central

Lobban, Fiona; Emsley, Richard; Bucci, Sandra

2016-01-01

Background Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. Objective This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. Methods We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. Results The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. Conclusions This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed. PMID:27245693

[Comics for traffic education: evaluation of a traffic safety campaign].

PubMed

Bonfadelli, H

1989-01-01

Traffic safety campaigns often are ineffective to change driving behavior because they don't reach the target group or are recognized only by people who are already interested or concerned. The evaluation of a traffic safety campaign called "Leo Lässig", addressed to young new drivers, shows that recognition and acceptance by the target group were stimulated by the age-conform means of comic-strips.

Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

PubMed

Crandall, Phil; Van Loo, Ellen J; O'Bryan, Corliss A; Mauromoustakos, Andy; Yiannas, Frank; Dyenson, Natalie; Berdnik, Irina

2012-09-01

International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required improved company food safety practices and increased employee training. Adoption of a GFSI benchmarked scheme resulted in fewer audits, i.e., one less per year. An educational opportunity exists to acquaint retailers and suppliers worldwide with the benefits of having an internationally recognized certification program such as that recognized by the GFSI.

Evaluation of Nurses' Acceptance of Screen Display Methods with Temporarily Non-Display for Privacy Protection.

PubMed

Niimi, Yukari; Ota, Katsumasa; Ikegami, Chikako

2018-01-01

The purpose of this study was to explore nurses' acceptance of a screen display method that temporarily hides patient information for privacy protection. Using a questionnaire, we asked nurses to evaluate the display method from the viewpoints of safety and efficiency with respect to 22 personal information items. The nurses were favorably interested in introducing the display method into their hospital system; however, their acceptance varied.

[Weighing use and safety of therapeutic agents and feed additives (author's transl)].

PubMed

van der Wal, P

1982-02-01

(1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable.

76 FR 7853 - Patient Safety Organizations: Voluntary Delisting From Apollo Publishing, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... Organizations: Voluntary Delisting From Apollo Publishing, Inc. AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: Apollo Publishing, Inc.: AHRQ has accepted a notification of voluntary relinquishment from Apollo Publishing, Inc., of its status as a Patient Safety...

Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe.

PubMed

Brown, A Ross; Whale, Graham; Jackson, Mathew; Marshall, Stuart; Hamer, Mick; Solga, Andreas; Kabouw, Patrick; Galay-Burgos, Malyka; Woods, Richard; Nadzialek, Stephanie; Maltby, Lorraine

2017-01-01

This critical review examines the definition and implementation of environmental protection goals for chemicals in current European Union (EU) legislation, guidelines, and international agreements to which EU countries are party. The European chemical industry is highly regulated, and prospective environmental risk assessments (ERAs) are tailored for different classes of chemical, according to their specific hazards, uses, and environmental exposure profiles. However, environmental protection goals are often highly generic, requiring the prevention of "unacceptable" or "adverse" impacts on "biodiversity" and "ecosystems" or the "environment as a whole." This review aims to highlight working examples, challenges, solutions, and best practices for defining specific protection goals (SPGs), which are seen to be essential for refining and improving ERA. Specific protection goals hinge on discerning acceptable versus unacceptable adverse effects on the key attributes of relevant, sensitive ecological entities (ranging from organisms to ecosystems). Some isolated examples of SPGs for terrestrial and aquatic biota can be found in prospective ERA guidance for plant protection products (PPPs). However, SPGs are generally limited to environmental or nature legislation that requires environmental monitoring and retrospective ERA. This limitation is due mainly to the availability of baselines, which define acceptable versus unacceptable environmental effects on the key attributes of sentinel species, populations and/or communities, such as reproductive status, abundance, or diversity. Nevertheless, very few regulatory case examples exist in which SPGs incorporate effect magnitude, spatial extent, and temporal duration. We conclude that more holistic approaches are needed for defining SPGs, particularly with respect to protecting population sustainability, ecosystem function, and integrity, which are implicit in generic protection goals and explicit in the International Programme for Chemical Safety (IPCS) definition of "adverse effect." A possible solution, which the chemical industry is currently assessing, is wider application of the ecosystem services approach proposed by the European Food Safety Authority (EFSA) for the risk assessment of PPPs. Integr Environ Assess Manag 2017;13:17-37. © 2016 SETAC. © 2016 SETAC.

Left lobe living donor liver transplantation in adults: What is the safety limit?

PubMed

Ikegami, Toru; Yoshizumi, Tomoharu; Sakata, Kazuhito; Uchiyama, Hideaki; Harimoto, Norifumi; Harada, Noboru; Itoh, Shinji; Nagatsu, Akihisa; Soejima, Yuji; Maehara, Yoshihiko

2016-12-01

Small-for-size syndrome (SFSS) is the most significant cause of graft loss after living donor liver transplantation (LDLT), especially after left lobe (LL) LDLT in adults. The safety limit of applying LL-LDLT in adults without severe SFSS with a high rate of lethality needs to be determined. A total of 207 LL-LDLTs in adults since September 2005 were evaluated to analyze the risk factors for severe SFSS, defined as a serum total bilirubin concentration of ≥20.0 mg/dL after LDLT. Although there were no significant differences in cumulative graft survival after LDLT between medium grafts (graft volume [GV] to standard liver volume [SLV] ratio ≥ 40.0%), small grafts (35.0% ≤ GV/SLV < 40.0%), and extra small grafts (GV/SLV < 35.0%), patients with severe SFSS showed a significantly lower 5-year graft survival rate than those without (42.9% versus 94.3%, respectively; P < 0.001). Multivariate analysis for severe SFSS after LL-LDLT showed that donor age of ≥48 years (P = 0.01), Model for End-Stage Liver Disease (MELD) score of ≥ 19 (P < 0.01), and end portal venous pressure of ≥19 mm Hg (P = 0.04) were the significant and independent factors for severe SFSS after LL-LDLT. Within such high-risk subgroups of patients with a donor age of ≥48 years or MELD score of ≥ 19 before LDLT, operative blood loss volume of ≥8.0 L was a risk factor for severe SFSS. LL-LDLT in adults could be indicated and provide acceptable outcomes for the combinations of donors aged < 48 years and recipients with a MELD score of <19. Smaller grafts might yield acceptable outcomes in appropriately selected donor-recipient combinations. Liver Transplantation 22 1666-1675 2016 AASLD. © 2016 by the American Association for the Study of Liver Diseases.

VPP Star recognition

NASA Image and Video Library

2011-06-09

Stennis Space Center Deputy Director Rick Gilbrech (right) accepts a plaque designating the test facility as a Voluntary Protection Program Star site. Presenting the plaque is Clyde Payne, area director for the Occupational Safety and Health Administration in Jackson, Miss. OSHA established VPP in 1982 as a proactive safety management model to recognize excellence in safety and health. Since then, more than 2,000 organizations have been designated VPP Star sites. To reach that goal, an organization must demonstrate comprehensive and successful safety and health management programs in the workplace.

Safety analysis report for the Waste Storage Facility. Revision 2

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

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

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.

Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China.

PubMed

Jia, P L; Zhang, L H; Zhang, M M; Zhang, L L; Zhang, C; Qin, S F; Li, X L; Liu, K X

2014-06-30

To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC. Cross-sectional study. Data were obtained from 20 hospital pharmacies in the southwest part of China. We performed χ(2) test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test-retest was performed to assess reproducibility of the items. A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions ('Teamwork', 'Staff Training and Skills' and 'Staffing, Work Pressure and Pace') was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (p<0.05). There was a statistical difference in the perception of patient safety culture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89). The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable. 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.

World Trade Organization, ILO conventions, and workers' compensation.

PubMed

LaDou, Joseph

2005-01-01

The World Trade Organization, the World Bank, and the International Monetary Fund can assist in the implementation of ILO Conventions relating to occupational safety and health in developing countries. Most countries that seek to trade globally receive permission to do so from the WTO. If the WTO required member countries to accept the core ILO Conventions relating to occupational safety and health and workers' compensation, it could accomplish something that has eluded international organizations for decades. International workers' compensation standards are seldom discussed, but may at this time be feasible. Acceptance of a minimum workers' compensation insurance system could be a requirement imposed on applicant nations by WTO member states.

Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability

PubMed Central

Abrouk, Michael; Levin, Ethan; Brodsky, Merrick; Gandy, Jessica R; Nakamura, Mio; Zhu, Tian Hao; Farahnik, Benjamin; Koo, John; Bhutani, Tina

2016-01-01

Introduction The 308 nm excimer laser is a widely used device throughout the field of dermatology for many diseases including psoriasis. Although the laser has demonstrated clinical efficacy, there is a lack of literature outlining the safety, efficacy, and patient acceptability of the excimer laser. Methods A literature search on PubMed was used with combinations of the terms “excimer”, “excimer laser”, “308 nm”, “psoriasis”, “protocol”, “safety”, “efficacy”, acceptability”, “side effects”, and “dose”. The search results were included if they contained information pertaining to excimer laser and psoriasis treatment and description of the safety, efficacy, and patient acceptability of the treatment. Results The 308 nm excimer laser is generally safe and well tolerated with minimal side effects including erythema, blistering, and pigmentary changes. It has a range of efficacies depending on the protocol used with several different treatment protocols, including the induration protocol, the minimal erythema dose protocol, and the newer minimal blistering dose protocol. Conclusion Although the excimer laser is not a first-line treatment, it remains an excellent treatment option for psoriasis patients and has been demonstrated to be an effective treatment with little to no side effects. PMID:29387603

Effectiveness and driver acceptance of a semi-autonomous forward obstacle collision avoidance system.

PubMed

Itoh, Makoto; Horikome, Tatsuya; Inagaki, Toshiyuki

2013-09-01

This paper proposes a semi-autonomous collision avoidance system for the prevention of collisions between vehicles and pedestrians and objects on a road. The system is designed to be compatible with the human-centered automation principle, i.e., the decision to perform a maneuver to avoid a collision is made by the driver. However, the system is partly autonomous in that it turns the steering wheel independently when the driver only applies the brake, indicating his or her intent to avoid the obstacle. With a medium-fidelity driving simulator, we conducted an experiment to investigate the effectiveness of this system for improving safety in emergency situations, as well as its acceptance by drivers. The results indicate that the system effectively improves safety in emergency situations, and the semi-autonomous characteristic of the system was found to be acceptable to drivers. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.

9 CFR 351.14 - Processes to be supervised; extent of examinations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... examinations. 351.14 Section 351.14 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT... be at least once a month if the plant consistently handles only raw materials acceptable under § 351... consistently handles some raw materials that are acceptable, and some that are unacceptable, under § 351.3, for...

75 FR 76405 - Winter Bee, Inc., Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

... CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. 11-C0002] Winter Bee, Inc., Provisional...(e).\\1\\ Published below is a provisionally-accepted Settlement Agreement with Winter Bee, Inc... 1. In accordance with 16 CFR 1118.20, Winter Bee, Inc. (``Winter Bee'') and the staff (``Staff'') of...

42 CFR 484.18 - Condition of participation: Acceptance of patients, plan of care, and medical supervision.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., and medical supervision. Patients are accepted for treatment on the basis of a reasonable expectation... a doctor of medicine, osteopathy, or podiatric medicine. (a) Standard: Plan of care. The plan of... treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and...

Noninvasive pH monitoring of platelet concentrates: a large field test.

PubMed

Gkoumassi, Effimia; Klein-Bosgoed, Christa; Dijkstra-Tiekstra, Margriet J; de Korte, Dirk; de Wildt-Eggen, Janny

2013-10-01

Developing new quality control methods for platelet concentrates (PCs) can contribute to increasing transfusion safety and efficiency. The aim of this study was to investigate in a large field test the quality of expired PCs and whether 100% noninvasive pH monitoring can be used to predict PC quality. The pH of 13,693 PCs produced for transfusion was monitored daily using Blood Storage, Inc.'s pH sterile, automated fluoroscopic evaluation technology. Upon indication of compromised quality or expiration, PCs were returned and in vitro tests were performed. A total of 998 PCs were returned, of which 962 outdated, 26 had a positive BacT/ALERT reaction, seven had aggregates, one was without swirl, one had low pH, and one had high pH. BacT/ALERT was faster in identifying bacterial contamination than pH measurements. The pH at the end of the storage period was significantly lower than at the beginning. In vitro tests indicated that while the PC quality was acceptable upon expiration, it rapidly declined after expiration. In this setting where the vast majority of PCs were of good quality and within acceptable pH limits, daily, noninvasive routine pH measurement has limited added value in identifying quality-compromised PCs. © 2013 Sanquin Research. Transfusion © 2013 American Association of Blood Banks.

Fuzzy Logic Controller Stability Analysis Using a Satisfiability Modulo Theories Approach

NASA Technical Reports Server (NTRS)

Arnett, Timothy; Cook, Brandon; Clark, Matthew A.; Rattan, Kuldip

2017-01-01

While many widely accepted methods and techniques exist for validation and verification of traditional controllers, at this time no solutions have been accepted for Fuzzy Logic Controllers (FLCs). Due to the highly nonlinear nature of such systems, and the fact that developing a valid FLC does not require a mathematical model of the system, it is quite difficult to use conventional techniques to prove controller stability. Since safety-critical systems must be tested and verified to work as expected for all possible circumstances, the fact that FLC controllers cannot be tested to achieve such requirements poses limitations on the applications for such technology. Therefore, alternative methods for verification and validation of FLCs needs to be explored. In this study, a novel approach using formal verification methods to ensure the stability of a FLC is proposed. Main research challenges include specification of requirements for a complex system, conversion of a traditional FLC to a piecewise polynomial representation, and using a formal verification tool in a nonlinear solution space. Using the proposed architecture, the Fuzzy Logic Controller was found to always generate negative feedback, but inconclusive for Lyapunov stability.

Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms

PubMed Central

Lopez, Felipe L; Ernest, Terry B; Tuleu, Catherine; Gul, Mine Orlu

2015-01-01

Introduction: Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability. Areas covered: The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems. Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery. PMID:26165848

Architectural and Behavioral Systems Design Methodology and Analysis for Optimal Habitation in a Volume-Limited Spacecraft for Long Duration Flights

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.; Lewis, Ruthan; Toups, Larry; Howard, Robert; Whitmire, Alexandra; Smitherman, David; Howe, Scott

2016-01-01

As our human spaceflight missions change as we reach towards Mars, the risk of an adverse behavioral outcome increases, and requirements for crew health, safety, and performance, and the internal architecture, will need to change to accommodate unprecedented mission demands. Evidence shows that architectural arrangement and habitability elements impact behavior. Net habitable volume is the volume available to the crew after accounting for elements that decrease the functional volume of the spacecraft. Determination of minimum acceptable net habitable volume and associated architectural design elements, as mission duration and environment varies, is key to enabling, maintaining, andor enhancing human performance and psychological and behavioral health. Current NASA efforts to derive minimum acceptable net habitable volumes and study the interaction of covariates and stressors, such as sensory stimulation, communication, autonomy, and privacy, and application to internal architecture design layouts, attributes, and use of advanced accommodations will be presented. Furthermore, implications of crew adaptation to available volume as they transfer from Earth accommodations, to deep space travel, to planetary surface habitats, and return, will be discussed.

Child Safety: It's No Accident. An Issue Statement.

ERIC Educational Resources Information Center

Virginia State Div. for Children, Richmond.

The three major causes of injury and mortality among children in the state of Virginia are, in order of frequency, automobile-related accidents, poison ingestion, and suicide. With respect to injuries sustained in automobile accidents, adults traveling with children by car must accept responsibility for the safety of child passengers. Acute…

Managing pedestrian safety II : A case-control study of collision locations on state routes in King County and Seattle, Washington

DOT National Transportation Integrated Search

2008-01-01

The safety of non-motorized transportation systems is essential to the public acceptance and overall success of Washington State's and local jurisdictions' efforts to reduce congestion. The State's and the jurisdictions' goals to increase non-SOV (si...

Evaluation of interactive highway safety design model crash prediction tools for two-lane rural roads on Kansas Department of Transportation projects.

DOT National Transportation Integrated Search

2014-01-01

Historically, project-level decisions for the selection of highway features to promote safety were : based on either engineering judgment or adherence to accepted national guidance. These tools have allowed : highway designers to produce facilities t...

Evaluation of interactive highway safety design model crash prediction tools for two-lane rural roads on Kansas Department of Transportation projects : [technical summary].

DOT National Transportation Integrated Search

2014-01-01

Historically, project-level decisions for the selection of highway features to promote safety were based on either engineering judgment or adherence to accepted national guidance. These tools have allowed highway designers to produce facilities that ...

49 CFR Appendix B to Part 385 - Explanation of Safety Rating Process

Code of Federal Regulations, 2011 CFR

2011-10-01

...-employment controlled substance test result (critical). § 382.303(a)Failing to conduct post accident testing... controls in place that function effectively to ensure acceptable compliance with the applicable safety... are those identified as such where noncompliance relates to management and/or operational controls...

49 CFR Appendix B to Part 385 - Explanation of Safety Rating Process

Code of Federal Regulations, 2010 CFR

2010-10-01

...-employment controlled substance test result (critical). § 382.303(a)Failing to conduct post accident testing... controls in place that function effectively to ensure acceptable compliance with the applicable safety... are those identified as such where noncompliance relates to management and/or operational controls...

30 CFR 6.10 - Use of independent laboratories.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PRODUCT SAFETY STANDARDS § 6.10 Use of independent laboratories. (a) MSHA will accept testing and... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Use of independent laboratories. 6.10 Section 6.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION...

42 CFR 37.42 - Approval of roentgenographic facilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Roentgenology, Radium Therapy and Nuclear Medicine,” Vol. 117, No. 4, April 1973. (c) Each roentgenographic.... The form shall include: (1) The date of the last radiation safety inspection by an appropriate...; and (4) the date of acquisition of the X-ray unit. To be acceptable, the radiation safety inspection...

Designing with Traffic Safety in Mind.

ERIC Educational Resources Information Center

Matthews, John

1998-01-01

Provides an example of how one county public school system was able to minimize traffic accidents and increase safety around its schools. Illustrations are provided of safer bus loading zones, pedestrian walkways and sidewalks, staff parking, and acceptable methods for staging buses. A checklist for school driveway design concludes the article.…

Infusing Some Queer into Teacher Education

ERIC Educational Resources Information Center

Turnbull, Miles; Hilton, Tom

2010-01-01

Publically-funded schools in North America are often scary and dangerous places for gay, lesbian, bisexual, transgendered, and questioning (GBLTQ) youth, and many teens suggest that the adults charged with ensuring their safety and learning often do little to promote their acceptance and safety among their peers. Educators need preparation to…

Communicating for Safety's Sake

ERIC Educational Resources Information Center

Wiesner, Robert

2005-01-01

No community is safe until every member takes responsibility for the community's collective safety. College communities are no different from families, towns and businesses in that respect. Getting everyone to accept responsibility is a challenge and skilled communication is an important component of the solution. As part of the front line,…

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.

Validation of the French version of the Hospital Survey on Patient Safety Culture questionnaire.

PubMed

Occelli, P; Quenon, J-L; Kret, M; Domecq, S; Delaperche, F; Claverie, O; Castets-Fontaine, B; Amalberti, R; Auroy, Y; Parneix, P; Michel, P

2013-09-01

To assess the psychometric properties of the French version of the Hospital Survey on Patient Safety Culture questionnaire (HSOPSC) and study the hierarchical structure of the measured dimensions. Cross-sectional survey of the safety culture. 18 acute care units of seven hospitals in South-western France. Full- and part-time healthcare providers who worked in the units. None. Item responses measured with 5-point agreement or frequency scales. Data analyses A principal component analysis was used to identify the emerging components. Two structural equation modeling methods [LInear Structural RELations (LISREL) and Partial Least Square (PLS)] were used to verify the model and to study the relative importance of the dimensions. Internal consistency of the retained dimensions was studied. A test-retest was performed to assess reproducibility of the items. Overall response rate was 77% (n = 401). A structure in 40 items grouped in 10 dimensions was proposed. The LISREL approach showed acceptable data fit of the proposed structure. The PLS approach indicated that three dimensions had the most impact on the safety culture: 'Supervisor/manager expectations & actions promoting safety' 'Organizational learning-continuous improvement' and 'Overall perceptions of safety'. Internal consistency was above 0.70 for six dimensions. Reproducibility was considered good for four items. The French HSOPSC questionnaire showed acceptable psychometric properties. Classification of the dimensions should guide future development of safety culture improving action plans.

Consumer acceptance of ozone-treated whole shell eggs.

PubMed

Kamotani, Setsuko; Hooker, Neal; Smith, Stephanie; Lee, Ken

2010-03-01

Ozone-based processing is a novel technology with potentially fewer adverse effects than in-shell thermal pasteurization of eggs. There are no consumer acceptance studies published on ozone-treated eggs. This study examines consumers' ability to detect changes between ozone-treated, thermal-treated, and fresh untreated eggs. Consumers (n = 111) evaluated visual attributes of uncooked eggs and a separate group of consumers (n = 132) evaluated acceptability of cooked eggs. Consumers evaluated attribute intensity of the eggs. The yolks and albumens of the thermal-treated and ozone-treated eggs were perceived to be significantly cloudier than the untreated control, while the ozone-treated eggs were more similar to control (P < 0.05). The yolks of ozone-treated eggs were perceived to have significantly lower heights and greater spreads than the others (P < 0.05). Despite these perceptions, overall visual appeal of ozone-treated eggs was not significantly different from control eggs. A separate set of consumers used hedonic scales to evaluate overall liking, appearance, aroma, flavor, and texture of cooked eggs. Just-about-right (JAR) scales were used to rate the color, moistness, and texture. There were no differences on any attribute scores between the treatments, except thermal-treated and ozone-treated were perceived as less moist than the control. There were no adverse effects on consumer acceptance of eggs, treated with ozone, with acceptance the same as an untreated control. These findings are useful as ozone pasteurization can enhance the safety of fresh shell eggs to meet the goals of the U.S. Egg Safety Action Plan. The U.S. Egg Safety Action Plan requires all shell eggs to be pasteurized to prevent foodborne illness. Heat pasteurization partially cooks the egg, so an alternative process uses ozone with less heat. This study shows the ozone pasteurization has no detectable sensory defects.

SLUDGE TREATMENT PROJECT KOP DISPOSITION - THERMAL AND GAS ANALYSIS FOR THE COLD VACUUM DRYING FACILITY

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

SWENSON JA; CROWE RD; APTHORPE R

2010-03-09

The purpose of this document is to present conceptual design phase thermal process calculations that support the process design and process safety basis for the cold vacuum drying of K Basin KOP material. This document is intended to demonstrate that the conceptual approach: (1) Represents a workable process design that is suitable for development in preliminary design; and (2) Will support formal safety documentation to be prepared during the definitive design phase to establish an acceptable safety basis. The Sludge Treatment Project (STP) is responsible for the disposition of Knock Out Pot (KOP) sludge within the 105-K West (KW) Basin.more » KOP sludge consists of size segregated material (primarily canister particulate) from the fuel and scrap cleaning process used in the Spent Nuclear Fuel process at K Basin. The KOP sludge will be pre-treated to remove fines and some of the constituents containing chemically bound water, after which it is referred to as KOP material. The KOP material will then be loaded into a Multi-Canister Overpack (MCO), dried at the Cold Vacuum Drying Facility (CVDF) and stored in the Canister Storage Building (CSB). This process is patterned after the successful drying of 2100 metric tons of spent fuel, and uses the same facilities and much of the same equipment that was used for drying fuel and scrap. Table ES-l present similarities and differences between KOP material and fuel and between MCOs loaded with these materials. The potential content of bound water bearing constituents limits the mass ofKOP material in an MCO load to a fraction of that in an MCO containing fuel and scrap; however, the small particle size of the KOP material causes the surface area to be significantly higher. This relatively large reactive surface area represents an input to the KOP thermal calculations that is significantly different from the calculations for fuel MCOs. The conceptual design provides for a copper insert block that limits the volume available to receive KOP material, enhances heat conduction, and functions as a heat source and sink during drying operations. This use of the copper insert represents a significant change to the thermal model compared to that used for the fuel calculations. A number of cases were run representing a spectrum of normal and upset conditions for the drying process. Dozens of cases have been run on cold vacuum drying of fuel MCOs. Analysis of these previous calculations identified four cases that provide a solid basis for judgments on the behavior of MCO in drying operations. These four cases are: (1) Normal Process; (2) Degraded vacuum pumping; (3) Open MCO with loss of annulus water; and (4) Cool down after vacuum drying. The four cases were run for two sets of input parameters for KOP MCOs: (1) a set of parameters drawn from safety basis values from the technical data book and (2) a sensitivity set using parameters selected to evaluate the impact of lower void volume and smaller particle size on MCO behavior. Results of the calculations for the drying phase cases are shown in Table ES-2. Cases using data book safety basis values showed dry out in 9.7 hours and heat rejection sufficient to hold temperature rise to less than 25 C. Sensitivity cases which included unrealistically small particle sizes and corresponding high reactive surface area showed higher temperature increases that were limited by water consumption. In this document and in the attachment (Apthorpe, R. and M.G. Plys, 2010) cases using Technical Databook safety basis values are referred to as nominal cases. In future calculations such cases will be called safety basis cases. Also in these documents cases using parameters that are less favorable to acceptable performance than databook safety values are referred to as safety cases. In future calculations such cases will be called sensitivity cases or sensitivity evaluations Calculations to be performed in support of the detailed design and formal safety basis documentation will expand the calculations presented in this document to include: additional features of the drying cycle, more realistic treatment of uranium metal consumption during oxidation, larger water inventory, longer time scales, and graphing of results of hydrogen gas concentration.« less

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

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...

Acceptability of the 6-PACK falls prevention program: A pre-implementation study in hospitals participating in a cluster randomized controlled trial

PubMed Central

Hill, Keith D.; Brand, Caroline A.; Livingston, Patricia M.; Botti, Mari

2017-01-01

There is limited evidence to support the effectiveness of falls prevention interventions in the acute hospital setting. The 6-PACK falls prevention program includes a fall-risk tool; ‘falls alert’ signs; supervision of patients in the bathroom; ensuring patients’ walking aids are within reach; toileting regimes; low-low beds; and bed/chair alarms. This study explored the acceptability of the 6-PACK program from the perspective of nurses and senior staff prior to its implementation in a randomised controlled trial. A mixed-methods approach was applied involving 24 acute wards from six Australian hospitals. Participants were nurses working on participating wards and senior hospital staff including: Nurse Unit Managers; senior physicians; Directors of Nursing; and senior personnel involved in quality and safety or falls prevention. Information on program acceptability (suitability, practicality and benefits) was obtained by surveys, focus groups and interviews. Survey data were analysed descriptively, and focus group and interview data thematically. The survey response rate was 60%. Twelve focus groups (n = 96 nurses) and 24 interviews with senior staff were conducted. Falls were identified as a priority patient safety issue and nurses as key players in falls prevention. The 6-PACK program was perceived to offer practical benefits compared to current practice. Nurses agreed fall-risk tools, low-low beds and alert signs were useful for preventing falls (>70%). Views were mixed regarding positioning patients’ walking aid within reach. Practical issues raised included access to equipment; and risk of staff injury with low-low bed use. Bathroom supervision was seen to be beneficial, however not always practical. Views on the program appropriateness and benefits were consistent across nurses and senior staff. Staff perceived the 6-PACK program as suitable, practical and beneficial, and were open to adopting the program. Some practical concerns were raised highlighting issues to be addressed by the implementation plan. PMID:28199376

Multi-discipline Waste Acceptance Process at the Nevada National Security Site - 13573

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

Carilli, Jhon T.; Krenzien, Susan K.

2013-07-01

The Nevada National Security Site low-level radioactive waste disposal facility acceptance process requires multiple disciplines to ensure the protection of workers, the public, and the environment. These disciplines, which include waste acceptance, nuclear criticality, safety, permitting, operations, and performance assessment, combine into the overall waste acceptance process to assess low-level radioactive waste streams for disposal at the Area 5 Radioactive Waste Management Site. Four waste streams recently highlighted the integration of these disciplines: the Oak Ridge Radioisotope Thermoelectric Generators and Consolidated Edison Uranium Solidification Project material, West Valley Melter, and classified waste. (authors)

Inspection Score and Grading System for Food Services in Brazil: The Results of a Food Safety Strategy to Reduce the Risk of Foodborne Diseases during the 2014 FIFA World Cup.

PubMed

da Cunha, Diogo T; Saccol, Ana L de Freitas; Tondo, Eduardo C; de Oliveira, Ana B A; Ginani, Veronica C; Araújo, Carolina V; Lima, Thalita A S; de Castro, Angela K F; Stedefeldt, Elke

2016-01-01

In 2014, Brazil hosted one of the most popular sport competitions in the world, the FIFA World Cup. Concerned about the intense migration of tourists, the Brazilian government decided to deploy a food safety strategy based on inspection scores and a grading system applied to food services. The present study aimed to evaluate the results of the food safety strategy deployed during the 2014 FIFA World Cup in Brazil. To assess food safety, an evaluation instrument was applied twice in 1927 food service establishments from 26 cities before the start of the competition. This instrument generated a food safety score for each establishment that ranged from 0.0 (no flaws observed) to 2565.95, with four possible grades: A (0.0-13.2); B (13.3-502.6); C (502.7-1152.2); and pending (more than 1152.3). Each food service received a stamp with the grade of the second evaluation. After the end of the World Cup, a study was conducted with different groups of the public to evaluate the acceptance of the strategy. To this end, 221 consumers, 998 food service owners or managers, 150 health surveillance auditors, and 27 health surveillance coordinators were enrolled. These participants completed a survey with positive and negative responses about the inspection score system through a 5-point Likert scale. A reduction in violation scores from 393.1 to 224.4 (p < 0.001) was observed between the first and second evaluation cycles. Of the food services evaluated, 38.7% received the A stamp, 41.4% the B stamp, and 13.9% the C stamp. All positive responses on "system reliability" presented a mean of 4.0 or more, indicating that the public believed this strategy is reliable for communicating risks and promoting food safety. The strategy showed positive results regarding food safety and public acceptance. The deployed strategy promoted improvements in the food safety of food services. The implementation of a permanent policy may be well accepted by the public and may greatly contribute to a reduction in foodborne diseases (FBDs).

Organizing uninsured safety-net access to specialist physician services.

PubMed

Hall, Mark A

2013-05-01

Arranging referrals for specialist services is often the greatest difficulty that safety-net access programs face in attempting to provide fairly comprehensive services for the uninsured. When office-based community specialists are asked to care for uninsured patients, they cite the following barriers: difficulty determining which patients merit charity care, having to arrange for services patients need from other providers, and concerns about liability for providing inadequate care. Solutions to these barriers to specialist access can be found in the same institutional arrangements that support primary care and hospital services for the uninsured. These safety-net organization structures can be extended to include specialist physician care by funding community health centers to contract for specialist referrals, using free-standing referral programs to subsidize community specialists who accept uninsured patients at discounted rates, and encouraging hospitals through tax exemption or disproportionate share funding to require specialists on their medical staffs to accept an allocation of uninsured office-based referrals.

Vibration safety limits for magnetic resonance elastography.

PubMed

Ehman, E C; Rossman, P J; Kruse, S A; Sahakian, A V; Glaser, K J

2008-02-21

Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.

Vibration safety limits for magnetic resonance elastography

PubMed Central

Ehman, E C; Rossman, P J; Kruse, S A; Sahakian, A V; Glaser, K J

2010-01-01

Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure, and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast, and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values, and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans. PMID:18263949

Risks of carcinogenesis from electromagnetic radiation of mobile telephony devices.

PubMed

Yakymenko, I; Sidorik, E

2010-07-01

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

Organic solvents in the pharmaceutical industry.

PubMed

Grodowska, Katarzyna; Parczewski, Andrzej

2010-01-01

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation.

PubMed

McNamee, Pauline; Hibatallah, Jalila; Costabel-Farkas, Margit; Goebel, Carsten; Araki, Daisuke; Dufour, Eric; Hewitt, Nicola J; Jones, Penny; Kirst, Annette; Le Varlet, Béatrice; Macfarlane, Martin; Marrec-Fairley, Monique; Rowland, Joanna; Schellauf, Florian; Scheel, Julia

2009-07-01

The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.

Safety, tolerability and pharmacokinetics of a novel phosphodiesterase inhibitor, E6005 ointment, in healthy volunteers and in patients with atopic dermatitis.

PubMed

Ohba, Fuminori; Nomoto, Maiko; Hojo, Seiichiro; Akama, Hideto

2016-01-01

The purpose of the present studies was to assess the safety, tolerability and pharmacokinetics of topical application of a novel phosphodiesterase inhibitor, E6005, in healthy volunteers and in patients with atopic dermatitis (AD). In two randomized, investigator-blind, vehicle-controlled studies, we evaluated the topical application of E6005 ointment at concentrations ranging from 0.01% to 0.2% in healthy volunteers (Study 001) and in patients with AD (Study 101). Thirty-six subjects were enrolled in Study 001 and 40 in Study 101. Neither skin irritation nor photosensitization was observed with application of E6005 in Study 001. Four subjects receiving E6005 in Study 001 experienced a treatment-emergent adverse event (application site edema, increased alanine aminotransferase or erythema); three of these subjects discontinued the study. Two subjects receiving E6005 in Study 101 experienced an adverse event (gout or enterocolitis); one discontinued the study. Plasma concentrations of E6005 were below the limit of quantification (1 ng/ml) in both studies. E6005 ointment exhibited acceptable safety and tolerability. Topical application of E6005 ointment resulted in very low systemic exposure to E6005 in healthy volunteers and in patients with AD.

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.

Evaluation of 39 medical implants at 7.0 T

PubMed Central

Feng, David X; McCauley, Joseph P; Morgan–Curtis, Fea K; Salam, Redoan A; Pennell, David R; Loveless, Mary E

2015-01-01

Objective: With increased signal to noise ratios, 7.0-T MRI has the potential to contribute unique information regarding anatomy and pathophysiology of a disease. However, concerns for the safety of subjects with metallic medical implants have hindered advancement in this field. The purpose of the present research was to evaluate the MRI safety for 39 commonly used medical implants at 7.0 T. Methods: Selected metallic implants were tested for magnetic field interactions, radiofrequency-induced heating and artefacts using standardized testing techniques. Results: 5 of the 39 implants tested may be unsafe for subjects undergoing MRI at 7.0 T. Conclusion: Implants were deemed either “MR Conditional” or “MR Unsafe” for the 7.0-T MRI environment. Further research is needed to expand the existing database categorizing implants that are acceptable for patients referred for MRI examinations at 7.0 T. Advances in knowledge: Lack of MRI testing for common metallic medical implants limits the translational potential of 7.0-T MRI. For safety reasons, patients with metallic implants are not allowed to undergo a 7.0-T MRI scan, precluding part of the population that can benefit from the detailed resolution of ultra-high-field MRIs. This investigation provides necessary MRI testing of common medical implants at 7.0 T. PMID:26481696

Advances in In Vitro and In Silico Tools for Toxicokinetic Dose ...

EPA Pesticide Factsheets

Recent advances in vitro assays, in silico tools, and systems biology approaches provide opportunities for refined mechanistic understanding for chemical safety assessment that will ultimately lead to reduced reliance on animal-based methods. With the U.S. commercial chemical landscape encompassing thousands of chemicals with limited data, safety assessment strategies that reliably predict in vivo systemic exposures and subsequent in vivo effects efficiently are a priority. Quantitative in vitro-in vivo extrapolation (QIVIVE) is a methodology that facilitates the explicit and quantitative application of in vitro experimental data and in silico modeling to predict in vivo system behaviors and can be applied to predict chemical toxicokinetics, toxicodynamics and also population variability. Tiered strategies that incorporate sufficient information to reliably inform the relevant decision context will facilitate acceptance of these alternative data streams for safety assessments. This abstract does not necessarily reflect U.S. EPA policy. This talk will provide an update to an international audience on the state of science being conducted within the EPA’s Office of Research and Development to develop and refine approaches that estimate internal chemical concentrations following a given exposure, known as toxicokinetics. Toxicokinetic approaches hold great potential in their ability to link in vitro activities or toxicities identified during high-throughput screen

Enhancing safety and aroma appealing of fresh-cut fruits and vegetables using the antimicrobial and aromatic power of essential oils.

PubMed

Ayala-Zavala, J Fernando; González-Aguilar, Gustavo A; del-Toro-Sánchez, L

2009-09-01

Microbial and aroma attributes are within the most decisive factors limiting safety and sensory appealing of fresh-cut fruits and vegetables. Alternatively, several plant essential oils (EOs) are constituted of several volatile active compounds and most of them present antimicrobial potential and had different aroma profile. Considering these premises, this hypothesis article states that safety and aroma appealing of fresh-cut produce could be improved with EO treatment. EOs could prevent fresh-cut fruit decay; however, their volatile constituents could be sorbed by the produce, and according to the aroma notes of the antimicrobial oil, sensorial appealing of odor, and flavor of the treated produce might be affected positively or negatively. Specifically, garlic oil is a natural antimicrobial constituted by sulfur compounds, which are responsible for its odor and antimicrobial properties. Besides, fresh-cut tomato is a highly perishable product that needs antimicrobial agents to preserve its quality and safety for a longer period of time. From the sensorial point of view, aroma combination of garlic and tomato is a common seasoning practice in Europe and America and well accepted by consumers. Once the right combination of flavors between the EOs and the fresh-cut produce has been selected, safety and quality of the treated fruit could be improved by adding antimicrobial protection and extra aroma. Therefore, other combinations between EOs and fresh-cut produce are discussed. This approximation could reinforce the trends of natural food preservation, accomplishing the demands of the increasing sector of consumers demanding tasty and convenient fresh-cut produce, containing only natural ingredients.

Empowering people to help speak up about safety in primary care: Using codesign to involve patients and professionals in developing new interventions for patients with multimorbidity.

PubMed

Knowles, Sarah; Hays, Rebecca; Senra, Hugo; Bower, Peter; Locock, Louise; Protheroe, Jo; Sanders, Caroline; Daker-White, Gavin

2018-04-01

Multimorbidity, defined as the presence of two or more long-term conditions, is increasingly common in primary care, and patients with multimorbidity may face particular barriers to quality of care and increased safety risks due to the complexity of managing multiple conditions. Consistent with calls to directly involve service users in improving care, we aimed to use design materials to codesign new interventions to improve safety in primary care. We drew on two established methods-accelerated experience-based codesign and the future workshop approach. We synthesized design materials based on research into the patient experience of safety and multimorbidity in primary care to enable both patients, service users and carers, and primary health-care professionals to propose interventions to improve care. Both patients and professionals prioritized polypharmacy as a threat to safety. Their recommendations for supportive interventions were consistent with Burden of Treatment theory, emphasizing the limited capacity of patients with multimorbidity and the need for services to proactively offer support to reduce the burden of managing complex treatment regimes. The process was feasible and acceptable to participants, who valued the opportunity to jointly propose new interventions. The iterative workshop approach enabled the research team to better explore and refine the suggestions of attendees. Final recommendations included the need for accessible reminders to support medication adherence and medication reviews for particularly vulnerable patients conducted with pharmacists within GP practices. © 2017 The Authors. Health Expectations published by John Wiley & Sons Ltd.

Running to Safety: Analysis of Disaster Susceptibility of Neighborhoods and Proximity of Safety Facilities in Silay City, Philippines

NASA Astrophysics Data System (ADS)

Patiño, C. L.; Saripada, N. A.; Olavides, R. D.; Sinogaya, J.

2016-06-01

Going on foot is the most viable option when emergency responders fail to show up in disaster zones at the quickest and most reasonable time. In the Philippines, the efficacy of disaster management offices is hampered by factors such as, but not limited to, lack of equipment and personnel, distance, and/or poor road networks and traffic systems. In several instances, emergency response times exceed acceptable norms. This study explores the hazard susceptibility, particularly to fire, flood, and landslides, of neighborhoods vis-à-vis their proximity to safety facilities in Silay City, Philippines. Imbang River exposes communities in the city to flooding while the mountainous terrain makes the city landslide prone. Building extraction was done to get the possible human settlements in the city. The building structures were extracted through image processing using a ruleset-based approach in the process of segmentation and classification of LiDAR derivatives and ortho-photos. Neighborhoods were then identified whether they have low to high susceptibility to disaster risks in terms of floods and landslides based on the hazards maps obtained from the Philippines' Mines and Geosciences Bureau (MGB). Service area analyses were performed to determine the safety facilities available to different neighborhoods at varying running times. Locations which are inaccessible or are difficult to run to because of distance and corresponding hazards were determined. Recommendations are given in the form of infrastructure installation, relocation of facilities, safety equipment and vehicle procurement, and policy changes for specific areas in Silay City.

Probabilistic Requirements (Partial) Verification Methods Best Practices Improvement. Variables Acceptance Sampling Calculators: Derivations and Verification of Plans. Volume 1

NASA Technical Reports Server (NTRS)

Johnson, Kenneth L.; White, K, Preston, Jr.

2012-01-01

The NASA Engineering and Safety Center was requested to improve on the Best Practices document produced for the NESC assessment, Verification of Probabilistic Requirements for the Constellation Program, by giving a recommended procedure for using acceptance sampling by variables techniques. This recommended procedure would be used as an alternative to the potentially resource-intensive acceptance sampling by attributes method given in the document. This document contains the outcome of the assessment.

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

PubMed

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

2018-01-01

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

Evolution of a holistic systems approach to planning and managing road safety: the Victorian case study, 1970-2015.

PubMed

Muir, Carlyn; Johnston, Ian R; Howard, Eric

2018-06-01

The Victorian Safe System approach to road safety slowly evolved from a combination of the Swedish Vision Zero philosophy and the Sustainable Safety model developed by the Dutch. The Safe System approach reframes the way in which road safety is viewed and managed. This paper presents a case study of the institutional change required to underpin the transformation to a holistic approach to planning and managing road safety in Victoria, Australia. The adoption and implementation of a Safe System approach require strong institutional leadership and close cooperation among all the key agencies involved, and Victoria was fortunate in that it had a long history of strong interagency mechanisms in place. However, the challenges in the implementation of the Safe System strategy in Victoria are generally neither technical nor scientific; they are predominantly social and political. While many governments purport to develop strategies based on Safe System thinking, on-the-ground action still very much depends on what politicians perceive to be publicly acceptable, and Victoria is no exception. This is a case study of the complexity of institutional change and is presented in the hope that the lessons may prove useful for others seeking to adopt more holistic planning and management of road safety. There is still much work to be done in Victoria, but the institutional cultural shift has taken root. Ongoing efforts must be continued to achieve alert and compliant road users; however, major underpinning benefits will be achieved through focusing on road network safety improvements (achieving forgiving infrastructure, such as wire rope barriers) in conjunction with reviews of posted speed limits (to be set in response to the level of protection offered by the road infrastructure) and by the progressive introduction into the fleet of modern vehicle safety features. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed Central

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

2018-01-01

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

Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women

PubMed Central

Cranston, Ross D.; Mayer, Kenneth H.; Febo, Irma; Duffill, Kathryn; Siegel, Aaron; Engstrom, Jarret C.; Nikiforov, Alexyi; Park, Seo-Young; Brand, Rhonda M.; Jacobson, Cindy; Giguere, Rebecca; Dolezal, Curtis; Frasca, Timothy; Leu, Cheng-Shiun; Schwartz, Jill L.; Carballo-Diéguez, Alex

2016-01-01

Objectives The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. Methods MSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. Results 248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. Conclusions In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population. Trial Registration ClinicalTrials.gov NCT01283360 PMID:27362788

Moving social work norms via theater for senior farmers.

PubMed

Reed, Deborah B; Claunch, Deborah T

2017-02-01

Senior farmers have a 2.6-fold risk of fatal injury compared to their younger counterparts. Usual educational interventions have resulted in limited success in reducing injury. An innovative strategy, didactic readers theater, was piloted. Farmers' stories provided the foundation for the scripts. The approach incorporated adult learning strategies based on Ajzen's Theory of Planned Behavior. The intervention was marketed as a "dinner theater" to farm couples. Three short socio-novels (plays) were presented by local farmers who served as actors. Following each play participants completed a reaction form and participated in a short discussion about the play's content. One week later a phone survey was completed that tapped further reaction to the content and behavior changes. Thirty-three farm household individuals (including 16 couples) participated. Participants expressed favorable reaction to the intervention. Within one week post intervention, 42% had made safety changes and 67% were "thinking about/intending" to make changes. The use of real stories contributed to the success of this intervention. Farmers identified with the stories and began to think and talk about the impact that aging exerts on their health and safety. Interaction among the group identified work modifications which empowered the farmers to make positive changes in their own work behavior. Educational interventions with farmers have met with limited success in reducing farm-related injuries. Moreover, few interventions have utilized the family unit. This novel program, incorporating local organizations and using limited financial resources, resulted in swift behavior changes. Total Worker Health includes not only the worker, but also the family. Interventions that include family units should be considered when possible. This format is effective, easily adapted to local issues, can be delivered using existing infrastructure, and is acceptable to the farm community. It is currently being tested on a larger scale. Copyright © 2016 National Safety Council and Elsevier Ltd. All rights reserved.

Driver acceptance of commercial vehicle operations (CVO) technology in the motor carrier environment. Executive summary, Critical issues relating to acceptance of technology by interstate truck and bus drivers

DOT National Transportation Integrated Search

2000-05-01

The California database incorporated in the Highway Safety Information System (HSIS) is derived from the California TASAS (Traffic Accident Surveillance and Analysis System). The system, maintained by the Traffic Operations Office of Caltrans, is a m...

Perceived safety climate, job demands, and coworker support among union and nonunion injured construction workers.

PubMed

Gillen, Marion; Baltz, Davis; Gassel, Margy; Kirsch, Luz; Vaccaro, Diane

2002-01-01

This study evaluated injured construction workers' perceptions of workplace safety climate, psychological job demands, decision latitude, and coworker support, and the relationship of these variables to the injury severity sustained by the workers. Injury severity was assessed using the Health Assessment Questionnaire (HAQ), which evaluates functional limitations. Worker perceptions of workplace variables were determined by two instruments: (a) the Safety Climate Measure for Construction Sites and (b) the Job Content Questionnaire (JCQ). The overall model explained 23% of the variance in injury severity, with unique contributions provided by union status, the Safety Climate Score, and Psychological Job Demands. A positive significant correlation was found between injury severity and the Safety Climate Scores (r = .183, P = .003), and between the Safety Climate Scores and union status (r = .225, P < .001). There were statistically significant differences between union and nonunion workers' responses regarding perceived safety climate on 5 of the 10 safety climate items. Union workers were more likely than nonunion workers to: (a) perceive their supervisors as caring about their safety; (b) be made aware of dangerous work practices; (c) have received safety instructions when hired; (d) have regular job safety meetings; and (e) perceive that taking risks was not a part of their job. However, with regard to the 49-item JCQ, which includes Coworker Support, the responses between union and nonunion workers were very similar, indicating an overall high degree of job satisfaction. However, workers who experienced their workplace as more safe also perceived the level of management (r = -.55, P < .001) and coworker (r = -.31, P < .001) support as being higher. The findings of this study underscore the critical need for construction managers to alert workers to dangerous work practices and conditions more frequently, and express concern and praise workers for safe work in a manner that is culturally acceptable in this industry. Workplace interventions that decrease the incidence and severity of injuries, but that are flexible enough to meet a variety of potentially competing imperatives, such as production deadlines and client demands, need to be identified.

10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acceptable for processing, the Director of New Reactors or the Director of Nuclear Reactor Regulation will... 10 Energy 1 2013-01-01 2013-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION AGENCY RULES OF PRACTICE AND PROCEDURE...

76 FR 53494 - In the Matter of United States Enrichment Corporation; Paducah Gaseous Enrichment Plant...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... removable contamination, unless otherwise authorized by Health Physics. USEC- Paducah is required by... Section V are acceptable and necessary and conclude that with these commitments the public health and safety are reasonably assured. In view of the foregoing, I have determined that public health and safety...

76 FR 17487 - Protection of Stratospheric Ozone: New Substitute in the Motor Vehicle Air Conditioning Sector...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

... and to disapprove substitutes that present overall risks to human health and the environment more.... Acceptability Decision B. Use Conditions C. Environmental Impacts D. Health and Safety Impacts E. Retrofit Usage...: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions That...

14 CFR 415.129 - Flight safety system test data.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., acceptance, age surveillance, and preflight testing of a flight safety system and its subsystems and..., subsystem, and component testing requirements of part 417 of this chapter and appendix E to part 417 of this... demonstrate similarity by performing the analysis required by appendix E of part 417 of this chapter. The...

14 CFR 415.129 - Flight safety system test data.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., acceptance, age surveillance, and preflight testing of a flight safety system and its subsystems and..., subsystem, and component testing requirements of part 417 of this chapter and appendix E to part 417 of this... demonstrate similarity by performing the analysis required by appendix E of part 417 of this chapter. The...

14 CFR 415.129 - Flight safety system test data.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., acceptance, age surveillance, and preflight testing of a flight safety system and its subsystems and..., subsystem, and component testing requirements of part 417 of this chapter and appendix E to part 417 of this... demonstrate similarity by performing the analysis required by appendix E of part 417 of this chapter. The...

14 CFR 415.129 - Flight safety system test data.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., acceptance, age surveillance, and preflight testing of a flight safety system and its subsystems and..., subsystem, and component testing requirements of part 417 of this chapter and appendix E to part 417 of this... demonstrate similarity by performing the analysis required by appendix E of part 417 of this chapter. The...

14 CFR 415.129 - Flight safety system test data.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., acceptance, age surveillance, and preflight testing of a flight safety system and its subsystems and..., subsystem, and component testing requirements of part 417 of this chapter and appendix E to part 417 of this... demonstrate similarity by performing the analysis required by appendix E of part 417 of this chapter. The...

75 FR 9196 - Letter From Secretary of Energy Accepting Defense Nuclear Facilities Safety Board (Board...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... capability for non- vital laboratory room electrical loads that provides an engineered control to reduce..., approximately two orders of magnitude higher than our evaluation guideline for selecting safety class controls. Approval of the DSA included recognition of weaknesses in the facility's control set and the need to...

Food safety education using an interactive multimedia kiosk in a WIC setting: correlates of client satisfaction and practical issues.

PubMed

Trepka, Mary Jo; Newman, Frederick L; Huffman, Fatma G; Dixon, Zisca

2010-01-01

To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Female clients or caregivers (n=176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk. Satisfaction with program, participant demographics, and change in food-handling behavior were assessed by univariate analyses. Over 90% of the participants enjoyed the kiosk, and most (87.5%) reported using computers a lot. Compared with participants with education beyond high school, participants with less education were more likely to report enjoying the kiosk (98.2% vs 88.1%, P = .007), preferred learning with the kiosk (91.7% vs 79.1%, P = .02), and would like to learn about other topics using IMM (95.4% vs 86.6%, P = .04). Food safety education delivered by IMM was well accepted by inner-city WIC clinic clients, including those with less education. Copyright 2010 Society for Nutrition Education. Published by Elsevier Inc. All rights reserved.

Guideline for the utilization of commercial grade items in nuclear safety related applications: Final report. [Contains Glossary

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

Tulay, M.P.; Yurich, F.J.; Schremser, F.M. Jr.

1988-06-01

This guideline provides direction for the procurement and use of Commercial Grade Items (CGI)in safety-related applications. It is divided into five major sections. A glossary of terms and definitions, an acronym listing, and seven appendices have been included. The glossary defines terms used in this guideline. In certain instances, the definitions may be unique to this guideline. Identification of acronyms utilized in this guideline is also provided. Section 1 provides a background of the commercial grade item issues facing the nuclear industry. It provides a historical perspective of commercial grade item issues. Section 2 discusses the generic process for themore » acceptance of a commercial grade item for safety-related use. Section 3 defines the four distinct methods used to accept commercial grade items for safety-related applications. Section 4 lists specific references that are identified in this guideline. Section 5 is a bibliography of documents that were considered in developed this guideline, but were not directly referenced in the document.« less

Basis for Interim Operation for Fuel Supply Shutdown Facility

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

BENECKE, M.W.

2003-02-03

This document establishes the Basis for Interim Operation (BIO) for the Fuel Supply Shutdown Facility (FSS) as managed by the 300 Area Deactivation Project (300 ADP) organization in accordance with the requirements of the Project Hanford Management Contract procedure (PHMC) HNF-PRO-700, ''Safety Analysis and Technical Safety Requirements''. A hazard classification (Benecke 2003a) has been prepared for the facility in accordance with DOE-STD-1027-92 resulting in the assignment of Hazard Category 3 for FSS Facility buildings that store N Reactor fuel materials (303-B, 3712, and 3716). All others are designated Industrial buildings. It is concluded that the risks associated with the currentmore » and planned operational mode of the FSS Facility (uranium storage, uranium repackaging and shipment, cleanup, and transition activities, etc.) are acceptable. The potential radiological dose and toxicological consequences for a range of credible uranium storage building have been analyzed using Hanford accepted methods. Risk Class designations are summarized for representative events in Table 1.6-1. Mitigation was not considered for any event except the random fire event that exceeds predicted consequences based on existing source and combustible loading because of an inadvertent increase in combustible loading. For that event, a housekeeping program to manage transient combustibles is credited to reduce the probability. An additional administrative control is established to protect assumptions regarding source term by limiting inventories of fuel and combustible materials. Another is established to maintain the criticality safety program. Additional defense-in-depth controls are established to perform fire protection system testing, inspection, and maintenance to ensure predicted availability of those systems, and to maintain the radiological control program. It is also concluded that because an accidental nuclear criticality is not credible based on the low uranium enrichment, the form of the uranium, and the required controls, a Criticality Alarm System (CAS) is not required as allowed by DOE Order 420.1 (DOE 2000).« less

Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON(®)-TB Gold (+) Kenyan adults without evidence of tuberculosis.

PubMed

Walsh, Douglas S; Owira, Victorine; Polhemus, Mark; Otieno, Lucas; Andagalu, Ben; Ogutu, Bernhards; Waitumbi, John; Hawkridge, Anthony; Shepherd, Barbara; Pau, Maria Grazia; Sadoff, Jerald; Douoguih, Macaya; McClain, J Bruce

2016-05-05

In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON(®)-TB Gold In-Tube test (QFT-G)(-) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(-) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(-) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects. Published by Elsevier Ltd.

Task 2 - Limits for High-Frequency Conducted Susceptibility Testing - CS114 (NRC-HQ-60-14-D-0015)

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

Wood, Richard Thomas; Ewing, Paul D.; Moses, Rebecca J.

2015-09-01

A principal focus of Task 2 under this project was for ORNL to evaluate the basis for susceptibility testing against high-frequency conducted interference and to establish recommendations to resolve concerns about the severity of test limits for the conducted susceptibility (CS) test, CS114, from MIL-STD-461. The primary concern about the test limit has been characterized by the EPRI EMI Working Group in the following terms: Demonstrating compliance with the CS114 test limits recommended in TR-102323 has proven to be problematic, even for components that have been tested to commercial standards and demonstrated proper operation in industrial applications [6]. Specifically, EPRImore » notes that the CS114 limits approved in regulatory documents are significantly higher than those invoked by the US military and similar commercial standards in the frequency range below 200 kHz. For this task, ORNL evaluated the original approach to establishing the test limit, EPRI technical findings from a review of the limit, and the regulatory basis through which the currently approved limits were accepted. Based on this analysis, strategies have been developed regarding changes to the CS114 limit that can resolve the technical concerns raised by the industry. Guided by the principles that reasonable assurance of safety must not be compromised but excessive conservatism should be reduced, recommendations on a suitable basis for a revised limit have been developed and can be incorporated into the planned Revision 2 of RG 1.180.« less

Buyer beware: personnel selling nail guns know little about dangerous tools.

PubMed

Lipscomb, Hester J; Nolan, James; Patterson, Dennis; Fullen, Mark; Takacs, Brandon C; Pompeii, Lisa A

2011-08-01

Nail gun use is ubiquitous in wood frame construction. Accessibility and decreasing costs have extended associated occupational hazards to consumers. Compelling evidence documents decreased injury risk among trained users and those with tools with sequential triggers. To prevent inadvertent discharge of nails, this safer trigger requires the nose be depressed before the trigger is pulled to fire. The sequential trigger is not required by the Consumer Product Safety Commission (CPSC) or the Occupational Safety and Health Administration (OSHA) nor are there any guidelines for training. We collected data from personnel at 217 points of sale/rental of framing nail guns in four areas of the country. Sales personnel had little understanding of risks associated with use of framing nail guns. Individuals who had used the tool and those working in construction outlets were more likely to be knowledgeable; even so, less than half understood differences in trigger/actuation systems. Consumers, including contractors purchasing for workers, cannot count on receiving accurate information from sales personnel regarding risks associated with use of these tools. The attitudes and limited knowledge of some sales personnel regarding these potentially deadly tools likely contributes to a culture accepting of injury. The findings demonstrate how influences on the culture of construction are not limited to workers, employers, or the places construction gets done. Copyright © 2011 Wiley-Liss, Inc.

Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

PubMed Central

Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

2016-01-01

Background This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. Methods 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. Results No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. Conclusions The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women. Trial Registration ClinicalTrials.gov NCT01071174 PMID:26963505

Comparison of Removable and Irremovable Walking Boot to Total Contact Casting in Offloading the Neuropathic Diabetic Foot Ulceration.

PubMed

Piaggesi, Alberto; Goretti, Chiara; Iacopi, Elisabetta; Clerici, Giacomo; Romagnoli, Fabio; Toscanella, Fabrizia; Vermigli, Cristiana

2016-08-01

Despite its efficacy in healing neuropathic diabetic foot ulcers (DFUs), total contact cast (TCC) is often underused because of technical limitations and poor patient acceptance. We compared TCC to irremovable and removable commercially available walking boots for DFU offloading. We prospectively studied 60 patients with DFUs, randomly assigned to 3 different offloading modalities: TCC (group A), walking boot rendered irremovable (i-RWD; group B), and removable walking boot (RWD; group C). Patients were followed up weekly for 90 days or up to complete re-epithelization; ulcer survival, healing time, and ulcer size reduction (USR) were considered for efficacy, whereas number of adverse events was considered for safety. Patients' acceptance and costs were also evaluated. Mean healing time in the 3 groups did not differ (P = .5579), and survival analysis showed no difference between the groups (logrank test P = .8270). USR from baseline to the end of follow-up was significant (P < .01) in all groups without differences between the groups. Seven patients in group A (35%), 2 in group B (10%), and 1 in group C (5%) (Fisher exact test P = .0436 group A vs group C) reported nonsevere adverse events. Patients' acceptance and costs were significantly better in group C (P < .05). Our results suggest that a walking boot was as effective and safe as TCC in offloading the neuropathic DFUs, irrespective of removability. The better acceptability and lesser costs of a removable device may actually extend the possibilities of providing adequate offloading. Level II, prospective comparative study. © The Author(s) 2016.

Impact of contextual factors and substance characteristics on perspectives toward cognitive enhancement.

PubMed

Sattler, Sebastian; Forlini, Cynthia; Racine, Eric; Sauer, Carsten

2013-01-01

Enhancing cognitive performance with substances--especially prescription drugs--is a fiercely debated topic among scholars and in the media. The empirical basis for these discussions is limited, given that the actual nature of factors that influence the acceptability of and willingness to use cognitive enhancement substances remains unclear. In an online factorial survey, contextual and substance-specific characteristics of substances that improve academic performance were varied experimentally and presented to respondents. Students in four German universities rated their willingness to use and moral acceptance of different substances for cognitive enhancement. We found that the overall willingness to use performance enhancing substances is low. Most respondents considered the use of these substances as morally unacceptable. Situational influences such as peer pressure, policies concerning substance use, relative performance level of peers, but also characteristics of the substance, such as perceptions of substance safety, shape the willingness and acceptability of using a substance to enhance academic performance. Among the findings is evidence of a contagion effect meaning that the willingness was higher when the respondents have more CE drug users in their social network. We also found deterrence effects from strong side effects of using the substance, as well as from policy regulations and sanctions. Regulations might activate social norms against usage and sanctions can be seen as costly to users. Moreover, enhancement substances seem to be most tempting to low performers to catch up with others compared to high performers. By identifying contextual factors and substance characteristics influencing the willingness and acceptability of cognitive enhancers, policy approaches could consider these insights to better manage the use of such substances.

Perioperative nurses' attitudes toward the electronic health record.

PubMed

Yontz, Laura S; Zinn, Jennifer L; Schumacher, Edward J

2015-02-01

The adoption of an electronic health record (EHR) is mandated under current health care legislation reform. The EHR provides data that are patient centered and improves patient safety. There are limited data; however, regarding the attitudes of perioperative nurses toward the use of the EHR. The purpose of this project was to identify perioperative nurses' attitudes toward the use of the EHR. Quantitative descriptive survey was used to determine attitudes toward the electronic health record. Perioperative nurses in a southeastern health system completed an online survey to determine their attitudes toward the EHR in providing patient care. Overall, respondents felt the EHR was beneficial, did not add to the workload, improved documentation, and would not eliminate any nursing jobs. Nursing acceptance and the utilization of the EHR are necessary for the successful integration of an EHR and to support the goal of patient-centered care. Identification of attitudes and potential barriers of perioperative nurses in using the EHR will improve patient safety, communication, reduce costs, and empower those who implement an EHR. Copyright © 2015 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

A Review of Information for Managing Aging in Nuclear Power Plants

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

WC Morgan; JV Livingston

1995-09-01

Age related degradation effects in safety related systems of nuclear power plants should be managed to prevent safety margins from eroding below the acceptable limits provided in plant design bases. The Nuclear Plant Aging Research (NPAR) Pro- gram, conducted under the auspices of the U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research, and other related aging management programs are developing technical information on managing aging. The aging management process central to these efforts consists of three key elements: 1) selecting structures, systems, and components (SSCs) in which aging should be controlled; 2) understanding the mechanisms and rates ofmore » degradation in these SSCs; and 3) managing degradation through effective inspection, surveillance, condition monitoring, trending, record keeping, mainten- ance, refurbishment, replacement, and adjustments in the operating environment and service conditions. This document concisely reviews and integrates information developed under the NPAR Program and other aging management studies and other available information related to understanding and managing age-related degradation effects and provides specific refer- ences to more comprehensive information on the same subjects.« less

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

NASA Astrophysics Data System (ADS)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance.

PubMed

LaPointe, Nancy M Allen; Pamer, Carol A; Kramer, Judith M

2003-10-01

To determine how well dofetilide and Betapace AF (sotalol, approved solely for atrial fibrillation and atrial flutter), with their detailed dosing and monitoring guidelines for safety, were accepted into clinical practice during the 2 calendar years after their introduction. We reviewed the number of new, refill, and total prescriptions of all antiarrhythmic agents in the United States from April 2000-December 2001 to assess use of dofetilide and Betapace AF in the drug market. Both were prescribed very infrequently throughout the study period. In addition, the infrequent reported use of these drugs for patients with atrial fibrillation and flutter indicated poor acceptance of these agents by prescribing physicians. We speculated that the restricted distribution and required educational program for dofetilide, as well as the availability of generic sotalol products, may have discouraged physicians from prescribing both dofetilide and Betapace AE CONCLUSION: A common goal for both the dofetilide risk-management program and the creation of a sotalol product indicated solely for atrial fibrillation and atrial flutter was to provide safer treatment for patients with these arrhythmias. Unfortunately, limited penetration of dofetilide and Betapace AF into the U.S. market suggests that drugs without a risk-management program or detailed dosing guidelines were more likely than dofetilide or Betapace AF to be selected for treatment of atrial fibrillation and atrial flutter.

Critical review of public health regulations of titanium dioxide, a human food additive.

PubMed

Jovanović, Boris

2015-01-01

From 1916 to 2011, an estimated total of 165050000 metric tons of titanium dioxide (TiO2 ) pigment were produced worldwide. Current safety regulations on the usage of the TiO2 pigment as an inactive ingredient additive in human food are based on legislation from 1969 and are arguably outdated. This article compiles new research results to provide fresh data for potential risk reassessment. However, even after 45 years, few scientific research reports have provided truly reliable data. For example, administration of very high doses of TiO2 is not relevant to daily human uptake. Nevertheless, because dose makes the poison, the literature provides a valuable source for understanding potential TiO2 toxicity after oral ingestion. Numerous scientific articles have observed that TiO2 can pass and be absorbed by the mammalian gastrointestinal tract; can bioconcentrate, bioaccumulate, and biomagnify in the tissues of mammals and other vertebrates; has a very limited elimination rate; and can cause histopathological and physiological changes in various organs of animals. Such action is contrary to the 1969 decision to approve the use of TiO2 as an inactive ingredient in human food without an established acceptable daily intake, stating that neither significant absorption nor tissue storage following ingestion of TiO2 was possible. Thus, relevant governmental agencies should reassess the safety of TiO2 as an additive in human food and consider establishing an acceptable maximum daily intake as a precautionary measure. © 2014 The Author. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of SETAC.

Sitagliptin/Simvastatin: a first combination tablet to treat type 2 diabetes and hypercholesterolemia – a review of its characteristics

PubMed Central

Ramadan, Wijdan H; Kabbara, Wissam K

2015-01-01

Background The purpose of this study was to review the current literature and information on the combination product Juvisync™ (sitagliptin + simvastatin), which was approved by the US Food and Drug Administration in October 2011. Methods PubMed (2001–2014) was searched for primary and review articles on sitagliptin, simvastatin, or the combination product. Drug manufacturing data and product labeling were also used. Studies of simvastatin, sitagliptin, or the combination were screened and analyzed to include relevant and recent papers. Selected English language trials were limited to those with human subjects and included both safety and efficacy outcomes. Results When compared with glipizide as add-on therapy to metformin, sitagliptin was noninferior but had lower rates of hypoglycemia and weight gain. In addition, when compared with insulin glargine, sitagliptin was less effective in decreasing glycosylated hemoglobin, but was associated with significantly lower rates of hypoglycemia. Further, trials have shown a beneficial effect of using statins in patients with diabetes mellitus with regard to decreasing cardiovascular risk, regardless of baseline lipid levels or the presence of a cardiac disease. Both medications have also demonstrated an acceptable side effect profile. However, caution is needed when coadministering with any drug that may increase simvastatin levels to reduce the risk of myopathy and rhabdomyolysis. Conclusion Juvisync should be used in patients requiring both sitagliptin and simvastatin. Both agents have shown good efficacy and acceptable safety profiles. Sitagliptin is a good option for diabetic patients to improve glycemic control with a lower risk of hypoglycemia and weight gain. PMID:25709467

Stability and compatibility assessment techniques for total parenteral nutrition admixtures: setting the bar according to pharmacopeial standards.

PubMed

Driscoll, David F

2005-05-01

The stability and compatibility of total parenteral nutrition mixtures compounded for patients requiring nutritional support is paramount to their safety on intravenous infusion. The most significant pharmaceutical issues associated with mixing total parenteral nutrition formulations affecting their safety involve the stability of lipid-injectable emulsions and the compatibility of calcium and phosphate salts. Methods of analysis for stability and compatibility have varied, and the assessments have mostly been largely qualitative. Although pharmacopeial standards have been primarily applicable to pharmaceutical manufacturers, recent efforts by the United States Pharmacopeia have been directed at standardizing pharmacy practices involved in the safe mixing of compounded sterile preparations. The adoption of chapter 797 entitled 'Pharmaceutical compounding - sterile preparations' on 1 January 2004 has had a dramatic impact on pharmacy practice in the United States. More recently, the United States Pharmacopeia has also proposed a new chapter 729 entitled 'Globule size distribution in lipid-injectable emulsions', setting specific limits on the sizes and concentrations of lipid droplets in the formulation, which may have implications for all-in-one mixtures. Finally, new efforts are under way to establish limits on the level of acceptable amounts of particulates intrinsically introduced by the manufacturer, and thus may have ramifications for particulates extrinsically introduced or initiated during compounding by the pharmacist. With careful monitoring and the development of appropriate pharmacopeial-based specifications that limit the size and concentration of large-diameter fat globules and eliminate the possibility of dibasic calcium phosphate precipitates, improved patient outcomes may be achieved.

Immunogenicity of therapeutics: a matter of efficacy and safety.

PubMed

Nechansky, Andreas; Kircheis, Ralf

2010-11-01

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

Human and animal health risk assessment of metal contamination in soil and plants from Ait Ammar abandoned iron mine, Morocco.

PubMed

Nouri, Mohamed; Haddioui, Abdelmajid

2016-01-01

The goal of this paper is to investigate metal pollution in food chain and assess the resulting health risks to native citizens in Ait Ammar village. The results showed that cadmium (Cd), lead (Pb), and copper (Cu) concentrations in animal organs were above the metal concentration safety limit. Nevertheless, soils and plants from mining area were contaminated with iron (Fe), chromium (Cr), zinc (Zn), and Cr, Cu, Zn respectively. Cd concentrations in almost animal organs were higher than the acceptable daily upper limit, suggesting human consumption of this livestock meat and offal may pose a health risk. The estimated intake of Pb and Cd for Ait Ammar population could be a cause of concern because it exceeded the Provisional Tolerable Weekly Intake (PTWI) proposed by Joint Expert Committee on Food Additives (JECFA) in this area. Thus, conducting regular periodic studies to assess the dietary intake of mentioned elements are recommended.

Potential for improvement of population diet through reformulation of commonly eaten foods.

PubMed

van Raaij, Joop; Hendriksen, Marieke; Verhagen, Hans

2009-03-01

FOOD REFORMULATION: Reformulation of foods is considered one of the key options to achieve population nutrient goals. The compositions of many foods are modified to assist the consumer bring his or her daily diet more in line with dietary recommendations. INITIATIVES ON FOOD REFORMULATION: Over the past few years the number of reformulated foods introduced on the European market has increased enormously and it is expected that this trend will continue for the coming years. LIMITS TO FOOD REFORMULATION: Limitations to food reformulation in terms of choice of foods appropriate for reformulation and level of feasible reformulation relate mainly to consumer acceptance, safety aspects, technological challenges and food legislation. IMPACT ON KEY NUTRIENT INTAKE AND HEALTH: The potential impact of reformulated foods on key nutrient intake and health is obvious. Evaluation of the actual impact requires not only regular food consumption surveys, but also regular updates of the food composition table including the compositions of newly launched reformulated foods.

Regulatory Science in Professional Education.

PubMed

Akiyama, Hiroshi

2017-01-01

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

Organic food: buying more safety or just peace of mind? A critical review of the literature.

PubMed

Magkos, Faidon; Arvaniti, Fotini; Zampelas, Antonis

2006-01-01

Consumer concern over the quality and safety of conventional food has intensified in recent years, and primarily drives the increasing demand for organically grown food, which is perceived as healthier and safer. Relevant scientific evidence, however, is scarce, while anecdotal reports abound. Although there is an urgent need for information related to health benefits and/or hazards of food products of both origins, generalized conclusions remain tentative in the absence of adequate comparative data. Organic fruits and vegetables can be expected to contain fewer agrochemical residues than conventionally grown alternatives; yet, the significance of this difference is questionable, inasmuch as actual levels of contamination in both types of food are generally well below acceptable limits. Also, some leafy, root, and tuber organic vegetables appear to have lower nitrate content compared with conventional ones, but whether or not dietary nitrate indeed constitutes a threat to human health is a matter of debate. On the other hand, no differences can be identified for environmental contaminants (e.g. cadmium and other heavy metals), which are likely to be present in food from both origins. With respect to other food hazards, such as endogenous plant toxins, biological pesticides and pathogenic microorganisms, available evidence is extremely limited preventing generalized statements. Also, results for mycotoxin contamination in cereal crops are variable and inconclusive; hence, no clear picture emerges. It is difficult, therefore, to weigh the risks, but what should be made clear is that 'organic' does not automatically equal 'safe.' Additional studies in this area of research are warranted. At our present state of knowledge, other factors rather than safety aspects seem to speak in favor of organic food.

Very low risk of light-induced retinal damage during Boston keratoprosthesis surgery: a rabbit study.

PubMed

Salvador-Culla, Borja; Behlau, Irmgard; Sayegh, Rony R; Stacy, Rebecca C; Dohlman, Claes H; Delori, François

2014-02-01

The aim of this study was to assess the possibility of light damage to the retina by a surgical microscope during implantation of a Boston Keratoprosthesis (B-KPro) in rabbits. The retinal irradiance from a Zeiss OPMI Lumera S7 operating microscope was measured at the working distance (16.5 cm). Light transmittance through an isolated B-KPro was measured. A B-KPro was implanted into 1 eye of 12 rabbits with the optic covered during the procedure. The operated eyes were then continuously exposed to a fixed light intensity under the microscope for 1 hour. Fluorescein angiography was carried out on days 2 and 9 postsurgery, after which the animals were euthanized. Further, we compared the potential of these retinal exposures to well-accepted light safety guidelines applicable to humans. Light transmittance of B-KPro revealed a blockage of short wavelengths (<390 nm) and of long wavelengths (1660-1750 nm) of light. In addition, the surgical microscope filtered a part of the blue, ultraviolet, and infrared wavelengths. Neither fluorescein angiography nor a histological examination showed any morphological retinal changes in our rabbits. Moreover, the retinal exposures were well below the safety limits. Modern surgical microscopes have filters incorporated in them that block the most damaging wavelengths of light. The B-KPro is made of 100% poly(methyl methacrylate), which makes it in itself a blocker of short wavelengths of light. No damage could be demonstrated in the animal study, and the retinal exposures were well below the safety limits. Together, these results suggest that light exposures during B-KPro surgery present a low risk of photochemical damage to the retina.

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.

49 CFR 396.12 - Procedures for intermodal equipment providers to accept reports required by § 390.42(b) of this...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Procedures for intermodal equipment providers to accept reports required by § 390.42(b) of this chapter. 396.12 Section 396.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER...

Efficacy, acceptability and safety of guided imagery/hypnosis in fibromyalgia - A systematic review and meta-analysis of randomized controlled trials.

PubMed

Zech, N; Hansen, E; Bernardy, K; Häuser, W

2017-02-01

This systematic review aimed at evaluating the efficacy, acceptability and safety of guided imagery/hypnosis (GI/H) in fibromyalgia. Cochrane Library, MEDLINE, PsycINFO and SCOPUS were screened through February 2016. Randomized controlled trials (RCTs) comparing GI/H with controls were analysed. Primary outcomes were ≥50% pain relief, ≥20% improvement of health-related quality of life, psychological distress, disability, acceptability and safety at end of therapy and 3-month follow-up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI).Seven RCTs with 387 subjects were included into a comparison of GI/H versus controls. There was a clinically relevant benefit of GI/H compared to controls on ≥50% pain relief [RD 0.18 (95% CI 0.02, 0.35)] and psychological distress [SMD -0.40 (95% CI -0.70, -0.11)] at the end of therapy. Acceptability at the end of treatment for GI/H was not significantly different to the control. Two RCTs with 95 subjects were included in the comparison of hypnosis combined with cognitive behavioural therapy (CBT) versus CBT alone. Combined therapy was superior to CBT alone in reducing psychological distress at the end of therapy [SMD -0.50 (95% CI -0.91, -0.09)]. There were no statistically significant differences between combined therapy and CBT alone in other primary outcomes at the end of treatment and follow-up. No study reported on safety. GI/H hold promise in a multicomponent management of fibromyalgia. We provide a systematic review with meta-analysis on guided imagery and hypnosis for fibromyalgia. Current analyses endorse the efficacy and tolerability of guided imagery/hypnosis and of the combination of hypnosis with cognitive-behavioural therapy in reducing key symptoms of fibromyalgia. © 2016 European Pain Federation - EFIC®.

Development of a Home Food Safety Questionnaire Based on the PRECEDE Model: Targeting Iranian Women.

PubMed

Esfarjani, Fatemeh; Hosseini, Hedayat; Mohammadi-Nasrabadi, Fatemeh; Abadi, Alireza; Roustaee, Roshanak; Alikhanian, Haleh; Khalafi, Marjan; Kiaee, Mohammad Farhad; Khaksar, Ramin

2016-12-01

Food safety is an essential public health issue for all countries. This study was the first attempt to design and develop a home food safety questionnaire (HFSQ), in the conceptual framework of the PRECEDE (predisposing, reinforcing, and enabling constructs in educational diagnosis and evaluation) model, and to assess its validity and reliability. The HFSQ was developed by reviewing electronic databases and 12 focus group discussions with 96 women volunteers. Ten panel members reviewed the questionnaire, and the content validity ratio and content validity index were computed. Twenty women completed the HFSQ, and face validity was assessed. Women who were responsible for food handling in their households (n =320) were selected randomly from 10 health centers and completed the HFSQ based on the PRECEDE model. To examine the construct validity, a principal components factor analysis with varimax rotation was used. Internal consistency was determined with Cronbach's α. Reproducibility was checked by Kendall's τ after 4 weeks with 30 women. The developed HSFQ was considered acceptable with a content validity index of 0.88. Face validity revealed that 95% of the participants understood the questions and found them easy to answer, and 90% confirmed the appearance of the HFSQ and declared the layout acceptable. Principal component factor analysis revealed that the HFSQ could explain 33.7, 55.3, 34.8, and 60.0% of the total variance of the predisposing, reinforcing, practice, and enabling components, respectively. Cronbach's α was acceptable at 0.73. For Kendall's τ c , r = 0.89, with a 95% confidence interval of 0.85 to 0.93. The HFSQ developed based on the PRECEDE model met the standards of acceptable reliability and validity, which can be generalized to a wider population. These results can provide information for the development of effective communication strategies to promote home food safety.

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...

Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination.

PubMed

Díez-Domingo, Javier; Baldó, José-María; Planelles-Catarino, Maria Victoria; Garcés-Sánchez, María; Ubeda, Isabel; Jubert-Rosich, Angels; Marès, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

2015-03-01

An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3-9 years. In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3-9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4(+) T cells with a TH 1 profile were observed. Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. © 2014 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

75 FR 53985 - Arizona Public Service Company, et al., Palo Verde Nuclear Generating Station, Unit 3; Temporary...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... are authorized by law, will not present an undue risk to public health or safety, and are consistent... Public Health and Safety The underlying purpose of 10 CFR 50.46 is to establish acceptance criteria for... (LOCA) and non-LOCA criteria, mechanical design, thermal hydraulics, seismic, core physics, and...

Children's Acceptance of Safety Guidelines after Exposure to Televised Dramas Depicting Accidents.

ERIC Educational Resources Information Center

Cantor, Joanne; Omdahl, Becky L.

1999-01-01

Presents a study where grade-school children were exposed to a scene from a movie involving one of two activities (either fire- or water-related activities) and involving one of two outcomes (fatal accidents or neutral events). Finds that watching the dramatized accidents increased students' estimated importance of adopting safety guidelines and…

Detection of errant laser beams

NASA Astrophysics Data System (ADS)

Taylor, Arthur F. D. S.; Edwards, Stanley A.; Barrett, J. A.; Bandle, Anthony M.

1990-10-01

The new generation of automated laser machine tools poses problems for those responsible for setting safety standards. While traditional safeguarding will frustrate full exploitation of this hybrid technology, wholesale abandonment of effective containment in favour of safety monitoring and control systems is unlikely to be acceptable. Long term, quantitative risk assessment will resolve this dilemma. Short term, guide lines will have to be derived from practical considerations of the laser facility design, materials, primary safety devices and procedures. Earlier risk assessments are reviewed relative to the emerging perspective of high average power laser installations. Aspects of extended beam delivery systems and equipment utilization and maintenance are examined to assess possible interaction with operational safety and in particular the potential to adversely influence errant laser beam occurrances (ELBO). To satisfy international safety standards for a laser enclosure which offers flexibility and is cost effective a detection system is described which continuously surveys the inside of the enclosure. Extensive trials have been carried out with high average power lasers (up to 10kW) where a range of engineering materials has been exposed to a laser beam. It is shown that the ratio of detection and shut down time to the burn through time can be an acceptable risk and thus indicate which materials will prove adequate.

Comparative efficacy, acceptability, and safety of medicinal, cognitive-behavioral therapy, and placebo treatments for acute major depressive disorder in children and adolescents: a multiple-treatments meta-analysis.

PubMed

Ma, Dongfeng; Zhang, Zhijun; Zhang, Xiangrong; Li, Lingjiang

2014-06-01

New generation antidepressant therapies, including serotonin-norepinephrine reuptake inhibitor (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) were introduced in the late 1980s; however, few comprehensive studies compared the benefits and risks of various contemporary treatments for major depressive disorder (MDD) in pediatric patients. Multiple-treatments meta-analysis (MTM) was conducted to assess efficacy, acceptability, and safety of contemporary interventions in children and adolescents with MDD. Cochrane Library, AMED, CINAHL, EMBASE, LiLACS, MEDLINE, PSYCINFO, PSYNDEX, and Journal of Medicine and Pharmacy databases were searched for randomized controlled trials (RCTs) comparing medicinal interventions (citalopram, escitalopram, fluoxetine, mirtazapine, paroxetine, sertraline, venlafaxine), cognitive behavioral therapy (CBT), combined fluoxetine with CBT, and placebo treatment for acute MDD from January 1988 to March 2013. Treatment success, dropout rate, and suicidal ideation/attempt outcomes were measured. Bayesian methods were used to conduct a MTM including age and funding subgroups. A total of 21 RCTs (4969 participants) were identified. Combined fluoxetine/CBT exhibited the highest efficacy, with fluoxetine alone superior to CBT, paroxetine, sertraline, citalopram, escitalopram, and placebo treatment. Sertraline, paroxetine, escitalopram, and venlafaxine showed superior acceptability to fluoxetine and combined fluoxetine/CBT. Combined fluoxetine/CBT combination was less safe, though CBT was safer than fluoxetine alone. Combined fluoxetine/CBT, fluoxetine, and mirtazapine exhibited the highest efficacy; sertraline, escitalopram, venlafaxine, and paroxetine were the best tolerated; and mirtazapine and venlafaxine were the safest. Sertraline and mirtazapine exhibited optimally balanced efficacy, acceptability, and safety for first-line acute treatment of child and adolescent MDD.

Cervical cancer prevention: safety, acceptability, and feasibility of a single-visit approach in Accra, Ghana.

PubMed

Blumenthal, Paul D; Gaffikin, Lynne; Deganus, Sylvia; Lewis, Robbyn; Emerson, Mark; Adadevoh, Sydney

2007-04-01

The purpose of this study was to assess the safety and acceptability of a single-visit approach to cervical cancer prevention combining visual inspection of the cervix with acetic acid wash (VIA) and cryotherapy. The study was observational. Nine clinicians were trained in VIA and cryotherapy. Over 18 months 3665 women were VIA-tested. If positive and eligible, cryotherapy was offered immediately. Treated women were followed-up at 3 months and 1 year. The test-positive rate was 13.2%. Of those eligible, 70.2% and 21% received immediate or delayed treatment, respectively. No major complications were recorded, and 5.6% presented for a perceived problem post-cryotherapy. Among those treated over 90% expressed satisfaction with their experience, and 96% had an indentifiable squamo-columnar junction. Only 2.6% (6/232) were test positive, 1-year posttreatment. A single-visit approach using VIA and cryotherapy proved to be safe, acceptable, and feasible in an urban African setting.

Nutritional characterisation of Zambian Moringa oleifera: acceptability and safety of short-term daily supplementation in a group of malnourished girls.

PubMed

Barichella, Michela; Pezzoli, Gianni; Faierman, Samanta A; Raspini, Benedetta; Rimoldi, Martina; Cassani, Erica; Bertoli, Simona; Battezzati, Alberto; Leone, Alessandro; Iorio, Laura; Ferri, Valentina; Pinelli, Giovanna; Pusani, Chiara; Bolliri, Carlotta; Cilia, Roberto; Caronni, Serena; De Marco, Patrizia; Cereda, Emanuele

2018-05-24

In Zambia, chronic malnutrition still is one of the most common problem among children. To fight against malnutrition, the easiest short-term solution could be to combine specific types of food with affordable local plants. A large variety of natural food resources grow in Zambia, such as Moringa oleifera (MO), whose leaves are known for their health benefits, but are not consumed much by local populations. We analysed Zambian MO powder obtained from dried leaves and found that it contains large amounts of protein, minerals and vitamins, such as iron, calcium and carotenoids. These characteristics make MO a good and sustainable complementary solution to malnutrition. We also evaluated the acceptability and the safety of dietary supplementation with MO powder in malnourished children for 30 days. A daily dose of 14 g daily was safe and well accepted. Its regular use in the menu of local populations may be viable proposition.

10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING... Construct Certain Utilization Facilities; and Advance Issuance of Limited Work Authorizations Phased...

The perceived feasibility and acceptability of a conceptually challenging exercise training program in older adults.

PubMed

Miller, Clint T; Teychenne, Megan; Maple, Jaimie-Lee

2018-01-01

Exercise training is an essential component of falls prevention strategies, but they do not fully address components of physical function that leads to falls. The training approaches to achieve this may not be perceived as appropriate or even feasible in older adults. This study aims to assess the perceived feasibility and acceptability of novel exercise training approaches not usually prescribed to older adults. Fourteen adults were exposed to conceptually and physically demanding exercises. Interviews were then conducted to determine perceptions and acceptability of individual exercise tasks. Qualitative thematic analysis was used to identify themes. Safety and confidence, acceptability, and population participation were the key themes identified. Staff knowledge, presence, program design, and overt safety equipment were important for alleviating initial apprehension. Although physically demanding, participants expressed satisfaction when challenged. Prior disposition, understanding the value, and the appeal of novel exercises were perceived to influence program engagement. Given the evidence for acceptability, this type of training is feasible and may be appropriate as part of an exercise training program for older adults. Further research should be conducted to confirm that the physical adaptations to exercise training approaches as presented in this study occur in a similar manner to that observed in younger adults, and to also determine whether these adaptations lead to prolonged independence and reduced falls in older adults compared to usual care.

Evaluation of Head-Worn Display Concepts for Commercial Aircraft Taxi Operations

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Arthur, Jarvis J., III; Prinzel, Lawrence J., III; Kramer, Lynda J.

2007-01-01

Previous research has demonstrated that a Head-Up Display (HUD) can be used to enable more capacity and safer aircraft surface operations. This previous research also noted that the HUD exhibited two major limitations which hindered the full potential of the display concept: 1) the monochrome HUD format; and, 2) a limited, fixed field of regard. Full-color Head Worn Displays (HWDs) with very small sizes and weights are emerging to the extent that this technology may be practical for commercial and business aircraft operations. By coupling the HWD with a head tracker, full-color, out-the-window display concepts with an unlimited field-of-regard may be realized to improve efficiency and safety in surface operations. A ground simulation experiment was conducted at NASA Langley to evaluate the efficacy of head-worn display applications which may directly address the limitations of the HUD while retaining all of its advantages in surface operations. The simulation experiment used airline crews to evaluate various displays (HUD, HWD) and display concepts in an operationally realistic environment by using a Chicago, O Hare airport database. The results pertaining to the implications of HWDs for commercial business and transport aviation applications are presented herein. Overall HWD system latency was measured and found to be acceptable, but not necessarily optimal. A few occurrences of simulator sickness were noted while wearing the HWD, but overall there appears to be commercial pilot acceptability and usability to the concept. Many issues were identified which need to be addressed in future research including continued reduction in user encumbrance due to the HWD, and improvement in image alignment, accuracy, and boresighting.

Department of Energy Construction Safety Reference Guide

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

Not Available

1993-09-01

DOE has adopted the Occupational Safety and Health Administration (OSHA) regulations Title 29 Code of Federal Regulations (CFR) 1926 ``Safety and Health Regulations for Construction,`` and related parts of 29 CFR 1910, ``Occupational Safety and Health Standards.`` This nonmandatory reference guide is based on these OSHA regulations and, where appropriate, incorporates additional standards, codes, directives, and work practices that are recognized and accepted by DOE and the construction industry. It covers excavation, scaffolding, electricity, fire, signs/barricades, cranes/hoists/conveyors, hand and power tools, concrete/masonry, stairways/ladders, welding/cutting, motor vehicles/mechanical equipment, demolition, materials, blasting, steel erection, etc.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Aviation Safety Simulation Model

NASA Technical Reports Server (NTRS)

Houser, Scott; Yackovetsky, Robert (Technical Monitor)

2001-01-01

The Aviation Safety Simulation Model is a software tool that enables users to configure a terrain, a flight path, and an aircraft and simulate the aircraft's flight along the path. The simulation monitors the aircraft's proximity to terrain obstructions, and reports when the aircraft violates accepted minimum distances from an obstruction. This model design facilitates future enhancements to address other flight safety issues, particularly air and runway traffic scenarios. This report shows the user how to build a simulation scenario and run it. It also explains the model's output.

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

Dillon, C.

Over the past few years, numerous Accreditation Bodies, Regulatory Agencies, and State Regulations have implemented requirements for Radiation Safety Surveys following installation or modification to x-ray rooms. The objective of this session is to review best practices in performing radiation safety surveys for both Therapy and Diagnostic installations, as well as a review of appropriate survey instruments. This session will be appropriate for both therapy and imaging physicists who are looking to increase their working knowledge of radiation safety surveys. Learning Objectives: Identify Appropriate Survey Meters for Radiation Safety Surveys Develop best practices for Radiation Safety Surveys for Therapy unitsmore » that include common areas of concern. Develop best practices for Radiation Safety Surveys of Diagnostic and Nuclear Medicine rooms. Identify acceptable dose levels and the factors that affect the calculations associated with performing Radiation Safety Surveys.« less

SAFETY ANALYSIS REPORT FOR PACKAGING, MODEL 9977, ADDENDUM 3, JUSTIFICATION FOR SMALL GRAM QUANTITY CONTENTS

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

Abramczyk, G.

2011-10-31

This Addendum establishes a new family of content envelopes consisting of small quantities of radioactive materials. These content envelopes and specific packing configurations are shown to be subcritical. However, the dose rates of some payloads must be measured and shown to comply with applicable radiation limits. Authorization for shipment of the content envelop requires acceptance of this Addendum by the DOE-HQ certifying official as a supplement to the 9977 SARP Revision 2 and DOE-HQ's subsequent revision of the CoC Revision 10 (which is based on SARP Addendum 2 and SARP Addendum 4) to authorize the additional content envelope. The Smallmore » Gram Quantity Content Envelopes and packing configurations will be incorporated in the next revision of the 9977 SARP.« less

Optimization of airport security process

NASA Astrophysics Data System (ADS)

Wei, Jianan

2017-05-01

In order to facilitate passenger travel, on the basis of ensuring public safety, the airport security process and scheduling to optimize. The stochastic Petri net is used to simulate the single channel security process, draw the reachable graph, construct the homogeneous Markov chain to realize the performance analysis of the security process network, and find the bottleneck to limit the passenger throughput. Curve changes in the flow of passengers to open a security channel for the initial state. When the passenger arrives at a rate that exceeds the processing capacity of the security channel, it is queued. The passenger reaches the acceptable threshold of the queuing time as the time to open or close the next channel, simulate the number of dynamic security channel scheduling to reduce the passenger queuing time.

Recommendations for safety testing with the in vivo comet assay.

PubMed

Vasquez, Marie Z

2012-08-30

While the in vivo comet assay increases its role in regulatory safety testing, deliberations about the interpretation of comet data continue. Concerns can arise regarding comet assay publications with limited data from non-blind testing of positive control compounds and using protocols (e.g. dose concentrations, sample times, and tissues) known to give an expected effect. There may be a tendency towards bias when the validation or interpretation of comet assay data is based on results generated by widely accepted but non-validated assays. The greatest advantages of the comet assay are its sensitivity and its ability to detect genotoxicity in tissues and at sample times that could not previously be evaluated. Guidelines for its use and interpretation in safety testing should take these factors into account. Guidelines should be derived from objective review of data generated by blind testing of unknown compounds dosed at non-toxic concentrations and evaluated in a true safety-testing environment, where the experimental design and conclusions must be defensible. However, positive in vivo comet findings with such compounds are rarely submitted to regulatory agencies and this data is typically unavailable for publication due to its proprietary nature. To enhance the development of guidelines for safety testing with the comet assay, and with the permission of several sponsors, this paper presents and discusses relevant data from multiple GLP comet studies conducted blind, with unknown pharmaceuticals and consumer products. Based on these data and the lessons we have learned through the course of conducting these studies, I suggest significant adjustments to the current conventions, and I provide recommendations for interpreting in vivo comet assay results in situations where risk must be evaluated in the absence of carcinogenicity or clinical data. Copyright © 2012 Elsevier B.V. All rights reserved.

Immunogenicity and Safety of a Booster Injection of DTap-IPV//Hib (Pentaxim) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers 15-18 Months of Age in Mexico: A Randomized Trial.

PubMed

Melo, Flor Irene Rodriguez; Morales, José Juan Renteria; De Los Santos, Abiel Homero Mascareñas; Rivas, Enrique; Vigne, Claire; Noriega, Fernando

2017-06-01

The live, attenuated, tetravalent dengue vaccine (CYD-TDV) is licensed in a number of dengue endemic countries for individuals ≥9 years of age. Before the integration of any vaccine into childhood vaccination schedules, a lack of immune interference and acceptable safety when coadministered with other recommended vaccines should be demonstrated. This randomized, multi-center phase III trial was conducted in Mexico. Healthy toddlers (n = 732) received a booster dose of a licensed pentavalent combination vaccine [diphtheria, tetanus, acellular pertussis, inactivated polio vaccine and Haemophilus influenzae type b (DTaP-IPV//Hib)] either concomitantly or sequentially, with the second dose of CYD-TDV administered as a 3-dose schedule. Antibody titers against diphtheria toxoid, tetanus toxoid and pertussis antigens were measured by enzyme-linked immunosorbent assay. Antibodies against poliovirus and dengue serotypes were measured using a plaque reduction neutralization test. Noninferiority was demonstrated for each of the DTaP-IPV//Hib antigens if the lower limit of the 2-sided 95% confidence interval of the difference in seroconversion rates between the 2 groups (CYD-TDV and placebo) was ≥10%. Safety of both vaccines was assessed. Noninferiority in immune response was demonstrated for all DTaP-IPV//Hib antigens. After 3 doses of CYD-TDV, no difference was observed in the immune response for CYD-TDV between groups. There were no safety concerns during the study. Coadministration of the DTaP-IPV//Hib booster vaccine with CYD-TDV has no observed impact on the immunogenicity or safety profile of the DTaP-IPV//Hib booster vaccine. No difference was observed on the CYD-TDV profile when administered concomitantly or sequentially with the DTaP-IPV//Hib booster vaccine.

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

Development of an effective risk management system in a teaching hospital.

PubMed

Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

2012-09-21

Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

The Technology Acceptance Model for Resource-Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to Low-Literacy End-Users in Resource-Limited Settings.

PubMed

Campbell, Jeffrey I; Aturinda, Isaac; Mwesigwa, Evans; Burns, Bridget; Santorino, Data; Haberer, Jessica E; Bangsberg, David R; Holden, Richard J; Ware, Norma C; Siedner, Mark J

2017-11-01

Although mobile health (mHealth) technologies have shown promise in improving clinical care in resource-limited settings (RLS), they are infrequently brought to scale. One limitation to the success of many mHealth interventions is inattention to end-user acceptability, which is an important predictor of technology adoption. We conducted in-depth interviews with 43 people living with HIV in rural Uganda who had participated in a clinical trial of a short messaging system (SMS)-based intervention designed to prompt return to clinic after an abnormal laboratory test. Interviews focused on established features of technology acceptance models, including perceived ease of use and perceived usefulness, and included open-ended questions to gain insight into unexplored issues related to the intervention's acceptability. We used conventional (inductive) and direct content analysis to derive categories describing use behaviors and acceptability. Interviews guided development of a proposed conceptual framework, the technology acceptance model for resource-limited settings (TAM-RLS). This framework incorporates both classic technology acceptance model categories as well as novel factors affecting use in this setting. Participants described how SMS message language, phone characteristics, and experience with similar technologies contributed to the system's ease of use. Perceived usefulness was shaped by the perception that the system led to augmented HIV care services and improved access to social support from family and colleagues. Emergent themes specifically related to mHealth acceptance among PLWH in Uganda included (1) the importance of confidentiality, disclosure, and stigma, and (2) the barriers and facilitators downstream from the intervention that impacted achievement of the system's target outcome. The TAM-RLS is a proposed model of mHealth technology acceptance based upon end-user experiences in rural Uganda. Although the proposed model requires validation, the TAM-RLS may serve as a useful tool to guide design and implementation of mHealth interventions.

49 CFR Appendix C to Part 238 - Suspension System Safety Performance Standards

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Suspension System Safety Performance Standards C... industry standard acceptable to FRA is developed and approved under the procedures provided in § 238.21. (a... as follows: ER12MY99.005 where: δ=flange angle (deg). μ=coefficient of friction of 0.5. (2) The net...

49 CFR Appendix C to Part 238 - Suspension System Safety Performance Standards

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Suspension System Safety Performance Standards C... industry standard acceptable to FRA is developed and approved under the procedures provided in § 238.21. (a... as follows: ER12MY99.005 where: δ=flange angle (deg). μ=coefficient of friction of 0.5. (2) The net...

The NATO Unmanned Aircraft System Human Systems Integration Guidebook

DTIC Science & Technology

2012-11-01

Stakeholders HSI Management Activity Goals Project SMEs HCR Acceptance Methods & Criteria Figure 2. Overarching HSI Goal Structure ...88ABW Clear 10/21/2013; 88ABW-2013-4442 55 N NATO North Atlantic Treaty Organisation NTSB National Transportation Safety Board S SME Subject...support the organisation Personnel trained to support safety Operational Concepts HSI Technical Activity Goals Allocation of Functions

75 FR 34360 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... certification provisions of section 14 of the Consumer Product Safety Act (CPSA) as amended by section 102 of..., the certification must be based on a test of each product or a reasonable testing program. For children's products, the certification must be based on testing conducted by a CPSC-accepted third party...

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

Generation III reactors safety requirements and the design solutions

NASA Astrophysics Data System (ADS)

Felten, P.

2009-03-01

Nuclear energy's public acceptance, and hence its development, depends on its safety. As a reactor designer, we will first briefly remind the basic safety principles of nuclear reactors' design. We will then show how the industry, and in particular Areva with its EPR, made design evolution in the wake of the Three Miles Island accident in 1979. In particular, for this new generation of reactors, severe accidents are taken into account beyond the standard design basis accidents. Today, Areva's EPR meets all so-called "generation III" safety requirements and was licensed by several nuclear safety authorities in the world. Many innovative solutions are integrated in the EPR, some of which will be introduced here.

Regulating the risk of tuberculosis transmission among health care workers.

PubMed

Nicas, M

2000-01-01

The 1994 Centers for Disease Control and Prevention guidelines on preventing tuberculosis (TB) transmission among health care workers (HCWs), and the 1997 Occupational Safety and Health Administration (OSHA) proposed TB standard, do not address the issue of acceptable risk. Further, many infection control personnel oppose OSHA's promulgating a standard because they believe most TB infections among HCWs are nonoccupational in origin. This article examines the relationship between TB infection and disease rates, and introduces a probability framework to apportion infection risk between occupational and nonoccupational exposure. It is argued that most TB infections among HCWs are work-related. A 0.2% overall annual risk of TB infection (accounting for both workplace and community exposure) is proposed as acceptable, because in the context of an infection surveillance program it limits an HCW's cumulative disease risk close to the value for the general United States population. Based on the probability framework, an estimate of the background community infection rate, and the traditional Wells-Riley risk model, it is shown that a target workplace infection risk value can be derived and expressed in terms of an expected pulmonary dose. The latter target dose informs risk management decision-making.

Treatment of facial telangiectasias with a diode-pumped Nd:YAG laser at 532 nm

NASA Astrophysics Data System (ADS)

Cassuto, Daniel A.; Ancona, Deborah M.; Emanuelli, Guglielmo

2000-06-01

Facial telangiectasias are a common cause of cosmetic concern. Current treatment modalities present various effects and limits. The pulsed dye laser has been considered the golden standard in efficacy and safety. Unfortunately it causes postoperative intracutaneous hematomata that discourage many patients form undergoing this treatment. Several other vascular lasers are disadvantaged by the risk of hypopigmented and atrophic scars. We assessed a recent powerful version of the potassium titanyl phosphate 532 nm laser, that can deliver sufficient energy in single pulses lasting 10-50 msec. Collateral damage is reduced while the heating of the vessel is slow enough to avoid explosive photothermolysis with its associated purpura. Sixty-six patients with facial telangiectasias were treated. In 62/66 patients, we achieved a 75 percent-100 percent clearance of the lesions, while two treatments were needed to reach an acceptable clearance in the remaining 4/66 patients. The overall need for more sessions was well tolerated, because the acceptable postoperative appearance allowed patients to continue normal business and social activities between treatments. No permanent complications or undesired effects were noted. The KTP/532nm laser is also being tested in combined laser-sclerotherapy of fine leg capillary telangiectasias with encouraging results.

Psychophysically determined forces of dynamic pushing for female industrial workers: Comparison of two apparatuses.

PubMed

Ciriello, Vincent M; Maikala, Rammohan V; Dempsey, Patrick G; O'Brien, Niall V

2010-01-01

Using psychophysics, the maximum acceptable forces for pushing have been previously developed using a magnetic particle brake (MPB) treadmill at the Liberty Mutual Research Institute for Safety. The objective of this study was to investigate the reproducibility of maximum acceptable initial and sustained forces while performing a pushing task at a frequency of 1min(-1) both on a MPB treadmill and on a high-inertia pushcart. This is important because our pushing guidelines are used extensively as a ergonomic redesign strategy and we would like the information to be as applicable as possible to cart pushing. On two separate days, nineteen female industrial workers performed a 40-min MPB treadmill pushing task and a 2-hr pushcart task, in the context of a larger experiment. During pushing, the subjects were asked to select a workload they could sustain for 8h without "straining themselves or without becoming unusually tired, weakened, overheated or out of breath." The results demonstrated that maximum acceptable initial and sustained forces of pushing determined on the high inertia pushcart were 0.8% and 2.5% lower than the MPB treadmill. The results also show that the maximum acceptable sustained force of the MPB treadmill task was 0.5% higher than the maximum acceptable sustained force of Snook and Ciriello (1991). Overall, the findings confirm that the existing pushing data developed by the Liberty Mutual Research Institute for Safety still provides an accurate estimate of maximal acceptable forces for the selected combination of distance and frequency of push for female industrial workers.

Food safety knowledge, attitude and practices of meat handler in abattoir and retail meat shops of Jigjiga Town, Ethiopia.

PubMed

Tegegne, H A; Phyo, H W W

2017-12-01

A cross-sectional survey was carried out among 91 meat handlers by using structured questionnaire to determine the food safety knowledge, attitude and practices in abattoir and retail meat shops of Jigjiga Town. The result shows that majority of the meat handlers were illiterate (30.8%) and primary school leaver (52.7%), and no one went through any food safety training except one meat inspector. The food-handlers' knowledge and safety practices were below acceptable level with the mean score of 13.12 ± 2.33 and 7.7 ± 2.1 respectively. Only few respondents knew about Staphylococcus aureus (3.3% correct answer), hepatitis A virus (19.8% correct answer), and E. coli (5.5% correct answer) as food borne pathogens. About 64% of meat handlers have good attitude about safety of food with mean of total score 14.4 ± 2. All respondents answer correctly questions about proper meat handling and hand washing but they did not translate into strict food hygiene practices. Chi2 analysis testing for the association between knowledge, attitude and practices did not show any significant association. It may be due to meat handlers' below acceptable level safety practices regardless of sociodemographic characteristics, knowledge and attitude. However, there was strong association between level of education and knowledge, and knowledge and hand washing (p < 0.05). There was also association between age and knowledge though it was not statistically significant. Thus, continuous education and hands on training for meat handlers that can enhance good safety practices through better understanding and positive attitude.

Food safety knowledge, attitude and practices of meat handler in abattoir and retail meat shops of Jigjiga Town, Ethiopia

PubMed Central

TEGEGNE, H.A.; PHYO, H.W.W.

2017-01-01

Summary A cross-sectional survey was carried out among 91 meat handlers by using structured questionnaire to determine the food safety knowledge, attitude and practices in abattoir and retail meat shops of Jigjiga Town. The result shows that majority of the meat handlers were illiterate (30.8%) and primary school leaver (52.7%), and no one went through any food safety training except one meat inspector. The food-handlers’ knowledge and safety practices were below acceptable level with the mean score of 13.12 ± 2.33 and 7.7 ± 2.1 respectively. Only few respondents knew about Staphylococcus aureus (3.3% correct answer), hepatitis A virus (19.8% correct answer), and E. coli (5.5% correct answer) as food borne pathogens. About 64% of meat handlers have good attitude about safety of food with mean of total score 14.4 ± 2. All respondents answer correctly questions about proper meat handling and hand washing but they did not translate into strict food hygiene practices. Chi2 analysis testing for the association between knowledge, attitude and practices did not show any significant association. It may be due to meat handlers’ below acceptable level safety practices regardless of sociodemographic characteristics, knowledge and attitude. However, there was strong association between level of education and knowledge, and knowledge and hand washing (p < 0.05). There was also association between age and knowledge though it was not statistically significant. Thus, continuous education and hands on training for meat handlers that can enhance good safety practices through better understanding and positive attitude. PMID:29707664

Interim analysis of post-marketing surveillance of eculizumab for paroxysmal nocturnal hemoglobinuria in Japan.

PubMed

Ninomiya, Haruhiko; Obara, Naoshi; Chiba, Shigeru; Usuki, Kensuke; Nishiwaki, Kaichi; Matsumura, Itaru; Shichishima, Tsutomu; Okamoto, Shinichiro; Nishimura, Jun-Ichi; Ohyashiki, Kazuma; Nakao, Shinji; Ando, Kiyoshi; Kanda, Yoshinobu; Kawaguchi, Tatsuya; Nakakuma, Hideki; Harada, Daisuke; Akiyama, Hirozumi; Kinoshita, Taroh; Ozawa, Keiya; Omine, Mitsuhiro; Kanakura, Yuzuru

2016-11-01

Data characterizing the safety and effectiveness of eculizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) are limited. We describe the safety and effectiveness of eculizumab in PNH patients enrolled in a post-marketing surveillance study. Types and frequencies of observed adverse events were similar to those reported in previous clinical trials and no meningococcal infection was reported. Effectiveness outcomes included the reduction of intravascular hemolysis, the change in hemoglobin (Hb) level, the withdrawal of transfusion and corticosteroids, the change of renal function, and overall survival. The effect of eculizumab on intravascular hemolysis was demonstrated by a reduction in lactate dehydrogenase levels at all measurements after baseline. Significant increases in Hb levels from baseline were also observed after 1 month's treatment with eculizumab (p < 0.01). Of those who were transfusion-dependent at baseline, the median number of transfusions decreased significantly from 18 to 0 unit/year after 1 year of treatment with eculizumab (p < 0.001). An increase in Hb and a high rate of transfusion independence were observed, especially in patients with platelet count ≥150 × 10 9 /L. Approximately 97 % of patients showed maintenance or improvement of renal function. Overall survival rate was about 90 % (median follow-up 1.9 years). These results suggest an acceptable safety profile and favorable prognosis after eculizumab intervention.

Safety and tolerability of ibrutinib monotherapy in Japanese patients with relapsed/refractory B cell malignancies.

PubMed

Tobinai, Kensei; Ogura, Michinori; Ishizawa, Kenichi; Suzuki, Tatsuya; Munakata, Wataru; Uchida, Toshiki; Aoki, Tomohiro; Morishita, Takanobu; Ushijima, Yoko; Takahara, Satoko

2016-01-01

In this phase I dose-escalation study we evaluated the safety, tolerability, pharmacokinetics, and antitumor activity of ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK, in Japanese patients with relapsed/refractory B cell malignancies (RRBCM). Fifteen patients aged 42-78 years were enrolled to one of three cohorts. Cohort 1 (n = 3) consisted of two phases, a single-dose (140 and 280 mg) phase and a multiple-dose (420 mg) phase of ibrutinib; cohort 2 (n = 6) included multiple doses of ibrutinib 560 mg; and cohort 3 (n = 6) included only patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) dosed at ibrutinib 420 mg. One patient (CLL/SLL cohort) experienced grade 3 pneumonia and sepsis, which were considered dose-limiting toxicities. No deaths were reported. The most common (≥ 20% patients) adverse events were neutropenia, anemia, nasopharyngitis, increased bilirubin, and rash. Dose-dependent increase in maximum plasma concentration and area under the concentration from 0 to the last quantifiable time was observed, while time to reach maximum plasma concentration and elimination half-life was similar between doses. The overall response rate was 73.3% (11/15) for all cohorts combined. Overall, ibrutinib (420 and 560 mg) was tolerable with acceptable safety profiles and effective for Japanese patients with RRBCM including CLL/SLL. NCT01704963.

Assessment of limited chest x-ray technique in postcardiac surgery management.

PubMed

Salehi, Mehrdad; Saberi, Kianoush; Rahmanian, Mehrzad; Bakhshandeh, Ali Reza; Sharifi, Shahnaz

2017-01-01

The objective of this study is to investigate the safety of elimination of chest radiography in the postcardiac surgery Intensive Care Unit (ICU). We compared patients in two different groups of routine CXR (RCXR) and limited CXR (LCXR) and their diagnostic and therapeutic outcome in a University hospital-based single center from 2014 to 2016. 3 CXR in the RCXR group and 1 CXR in the limited group was performed, in addition to on-demand criteria. A total of 978 samples were acceptable for analysis which 55.21% of RCXR and 59.50% of LCXR were male patients. In total, 523 abnormalities in RCXR group and 154 occasions in LCXR group resulted in 26.73% diagnostic efficacy for RCXRs and 28.57% for LCXR. From 1956 CXR that was taken in RCXR group, 72 occasions required intervention (3.68%) and 84 cases out of 539 (15.58%) LCXR needed an action to therapy. This means a 14.40% in RCXRs' abnormalities and 56.00% of LCXRs' abnormalities were accompanied with some interventions. Abolishing routine CXR in the ICUs would not be harmful for the patients, and it can be managed based on their clinical status and other safer imaging techniques.

Impact of Contextual Factors and Substance Characteristics on Perspectives toward Cognitive Enhancement

PubMed Central

Sattler, Sebastian; Forlini, Cynthia; Racine, Éric; Sauer, Carsten

2013-01-01

Enhancing cognitive performance with substances–especially prescription drugs–is a fiercely debated topic among scholars and in the media. The empirical basis for these discussions is limited, given that the actual nature of factors that influence the acceptability of and willingness to use cognitive enhancement substances remains unclear. In an online factorial survey, contextual and substance-specific characteristics of substances that improve academic performance were varied experimentally and presented to respondents. Students in four German universities rated their willingness to use and moral acceptance of different substances for cognitive enhancement. We found that the overall willingness to use performance enhancing substances is low. Most respondents considered the use of these substances as morally unacceptable. Situational influences such as peer pressure, policies concerning substance use, relative performance level of peers, but also characteristics of the substance, such as perceptions of substance safety, shape the willingness and acceptability of using a substance to enhance academic performance. Among the findings is evidence of a contagion effect meaning that the willingness was higher when the respondents have more CE drug users in their social network. We also found deterrence effects from strong side effects of using the substance, as well as from policy regulations and sanctions. Regulations might activate social norms against usage and sanctions can be seen as costly to users. Moreover, enhancement substances seem to be most tempting to low performers to catch up with others compared to high performers. By identifying contextual factors and substance characteristics influencing the willingness and acceptability of cognitive enhancers, policy approaches could consider these insights to better manage the use of such substances. PMID:23940757

Overcoming Language and Literacy Barriers in Safety and Health Training of Agricultural Workers

PubMed Central

Arcury, Thomas A.; Estrada, Jorge M.; Quandt, Sara A.

2010-01-01

The workforce in all areas of United States agriculture and forestry is becoming increasingly diverse in language, culture, and education. Many agricultural workers are immigrants who have limited English language skills and limited educational attainment. Providing safety and health training to this large, diverse, dispersed, and often transient population of workers is challenging. This review, prepared for the 2010 Agricultural Safety and Health Council of America/National Institute for Occupational Safety and Health conference, “Be Safe, Be Profitable: Protecting Workers in Agriculture,” is divided into five sections. First, we describe the occupational and demographic characteristics of agricultural workers in the US to highlight their safety and health training needs. Second, we summarize current research on the social and cultural attributes of agricultural workers and agricultural employers that affect the provision of safety and health training. Worker and employer attributes include language, literacy, financial limitations, work beliefs, and health beliefs. Third, we review current initiatives addressing safety and health training for agricultural workers that consider worker language and literacy. These initiatives are limited to a few specific topics (e.g., pesticides, heat stress); they do not provide general programs of safety training that would help establish a culture of workplace safety. However, several innovative approaches to health and safety training are being implemented, including the use of community-based participatory approaches and lay health promoter programs. Fourth, the limited industry response for safety training with this linguistically diverse and educationally limited workforce is summarized. Finally, gaps in knowledge and practice are summarized and recommendations to develop educationally, culturally, and linguistically appropriate safety and health training are presented. PMID:20665309

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.

20 CFR 404.780 - Evidence of “good cause” for exceeding time limits on accepting proof of support or application...

Code of Federal Regulations, 2010 CFR

2010-04-01

... accepting proof of support or application for a lump-sum death payment. (a) When evidence of good cause is... death payment. You may be asked for evidence of good cause for these delays if— (1) You are the insured... limits on accepting proof of support or application for a lump-sum death payment. 404.780 Section 404.780...

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Safety, effectiveness and comparability of professional skin cleansers.

PubMed

Terhaer, Flora K; Bock, Meike; Fartasch, Manigé; Gabard, Bernard; Elsner, Peter; Kleesz, Peter; Landeck, Lilla; Pohrt, Ute; Seyfarth, Florian; Schliemann, Sibylle; Diepgen, Thomas L; Zagrodnik, Fred; John, Swen Malte

2010-10-01

There are no widely-accepted methodical specifications with which to objectify cleansing effectiveness and skin compatibility of occuptional skin cleansing products in Europe. Therefore the German Social Insurance Agency (DGUV) initiated a study with the goal to evaluate such products in view of the potency and the safety of hand cleansers. A market analysis was a part of the project. The product descriptions and safety data sheets of 120 products (5-20/manufacturer) of 11 manufacturers were evaluated between 02/2008 and 04/2008. The manufacturers used mainly ingredients of low irritancy. The declaration of the applied ingredients was in the majority of the cases correctly labeled according to the INCI Declaration. Although there was documentation of skin tolerability for most products, the manufacturers used widely differing tests of skin compatibility. Evidences for cleansing effectiveness were not declared or have not been provided. One manufacturer even promised medical effects of its products. There was no uniform general classification of products making it difficult to identify characteristics of cleansers and choose between them. Presently, there are no commonly accepted criteria to classify products in view of cleansing effectiveness und skin compatibility. Generally accepted criteria and test methods are needed for the evaluation of hand cleansers in order to provide the possibility of transparency and comparability. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

WE-F-209-02: Radiation Safety Surveys of Linear Accelerators

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

Martin, M.

2016-06-15

Over the past few years, numerous Accreditation Bodies, Regulatory Agencies, and State Regulations have implemented requirements for Radiation Safety Surveys following installation or modification to x-ray rooms. The objective of this session is to review best practices in performing radiation safety surveys for both Therapy and Diagnostic installations, as well as a review of appropriate survey instruments. This session will be appropriate for both therapy and imaging physicists who are looking to increase their working knowledge of radiation safety surveys. Learning Objectives: Identify Appropriate Survey Meters for Radiation Safety Surveys Develop best practices for Radiation Safety Surveys for Therapy unitsmore » that include common areas of concern. Develop best practices for Radiation Safety Surveys of Diagnostic and Nuclear Medicine rooms. Identify acceptable dose levels and the factors that affect the calculations associated with performing Radiation Safety Surveys.« less

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

PubMed

Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

2013-09-01

In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

The patient reporting and action for a safe environment (PRASE) intervention: a feasibility study.

PubMed

O'Hara, Jane K; Lawton, Rebecca J; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Cocks, Kim; McEachan, Rosie R C; Reynolds, Caroline; Watt, Ian; Wright, John

2016-11-28

There is growing interest in the role of patients in improving patient safety. One such role is providing feedback on the safety of their care. Here we describe the development and feasibility testing of an intervention that collects patient feedback on patient safety, brings together staff to consider this feedback and to plan improvement strategies. We address two research questions: i) to explore the feasibility of the process of systematically collecting feedback from patients about the safety of care as part of the PRASE intervention; and, ii) to explore the feasibility and acceptability of the PRASE intervention for staff, and to understand more about how staff use the patient feedback for service improvement. We conducted a feasibility study using a wait-list controlled design across six wards within an acute teaching hospital. Intervention wards were asked to participate in two cycles of the PRASE (Patient Reporting & Action for a Safe Environment) intervention across a six-month period. Participants were patients on participating wards. To explore the acceptability of the intervention for staff, observations of action planning meetings, interviews with a lead person for the intervention on each ward and recorded researcher reflections were analysed thematically and synthesised. Recruitment of patients using computer tablets at their bedside was straightforward, with the majority of patients willing and able to provide feedback. Randomisation of the intervention was acceptable to staff, with no evidence of differential response rates between intervention and control groups. In general, ward staff were positive about the use of patient feedback for service improvement and were able to use the feedback as a basis for action planning, although engagement with the process was variable. Gathering a multidisciplinary team together for action planning was found to be challenging, and implementing action plans was sometimes hindered by the need to co-ordinate action across multiple services. The PRASE intervention was found to be acceptable to staff and patients. However, before proceeding to a full cluster randomised controlled trial, the intervention requires adaptation to account for the difficulties in implementing action plans within three months, the need for a facilitator to support the action planning meetings, and the provision of training and senior management support for participating ward teams. The PRASE intervention represents a promising method for the systematic collection of patient feedback about the safety of hospital care.

Plasma Hazards and Acceptance for International Space Station Extravehicular Activities

NASA Astrophysics Data System (ADS)

Patton, Thomas

2010-09-01

Extravehicular activity(EVA) is accepted by NASA and other space faring agencies as a necessary risk in order to build and maintain a safe and efficient laboratory in space. EVAs are used for standard construction and as contingency operations to repair critical equipment for vehicle sustainability and safety of the entire crew in the habitable volume. There are many hazards that are assessed for even the most mundane EVA for astronauts, and the vast majority of these are adequately controlled per the rules of the International Space Station Program. The need for EVA repair and construction has driven acceptance of a possible catastrophic hazard to the EVA crewmember which cannot currently be controlled adequately. That hazard is electrical shock from the very environment in which they work. This paper describes the environment, causes and contributors to the shock of EVA crewmembers attributed to the ionospheric plasma environment in low Earth orbit. It will detail the hazard history, and acceptance process for the risk associated with these hazards that give assurance to a safe EVA. In addition to the hazard acceptance process this paper will explore other factors that go into the decision to accept a risk including criticality of task, hardware design and capability, and the probability of hazard occurrence. Also included will be the required interaction between organizations at NASA(EVA Office, Environments, Engineering, Mission Operations, Safety) in order to build and eventually gain adequate acceptance rationale for a hazard of this kind. During the course of the discussion, all current methods of mitigating the hazard will be identified. This paper will capture the history of the plasma hazard analysis and processes used by the International Space Station Program to formally assess and qualify the risk. The paper will discuss steps that have been taken to identify and perform required analysis of the floating potential shock hazard from the ISS environment which eventually led to its status as an accepted risk for ISS EVAs.

Phase I/II evaluation of RV1001, a novel PI3Kδ inhibitor, in spontaneous canine lymphoma.

PubMed

Gardner, Heather L; Rippy, Sarah B; Bear, Misty D; Cronin, Kim L; Heeb, Heather; Burr, Holly; Cannon, Claire M; Penmetsa, Kumar V; Viswanadha, Srikant; Vakkalanka, Swaroop; London, Cheryl A

2018-01-01

RV1001 is a novel, potent, and selective PI3Kδ inhibitor. The purpose of this study was to evaluate the safety and efficacy of RV1001 in canine Non-Hodgkin lymphoma (NHL). Inhibition of endogenous pAKT by RV1001 in primary canine NHL cells was determined by Western blotting. A phase I study of RV1001 was performed in 21 dogs with naïve and drug resistant T and B-cell NHL to assess safety, pharmacokinetic profile, and response to therapy. The objective response rate was 62% (complete response (CR) n = 3; partial response (PR) n = 10), and responses were observed in both naïve and chemotherapy-resistant B and T cell NHL. This study provided the recommended starting dose for a phase II, non-pivotal, exploratory, open label multi-centered clinical trial in 35 dogs with naïve and drug resistant T and B-cell NHL, to further define the efficacy and safety profile of RV1001. The objective response rate in the phase II study was 77% (CR n = 1; PR n = 26). Clinical toxicities were primarily hepatobiliary and gastrointestinal, and were responsive to dose modifications and/or temporary drug discontinuation. Hepatotoxicity was the primary dose limiting toxicity. RV1001 exhibits good oral bioavailability, an acceptable safety profile, and biologic activity with associated inhibition of pAKT in dogs with B and T cell NHL. Data from these studies can be leveraged to help inform the design of future studies involving isoform-selective PI3K inhibitors in humans.

[Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients].

PubMed

Portillo Canizalez, Ligia Marcela; Blanco Rodriguez, Gerardo; Teyssier Morales, Gustavo; Penchyna Grub, Jaime; Trauernicht Mendieta, Sean; Zurita-Cruz, Jessie Nallely

Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2g/kg/day) + bisacodyl in pediatric patients. A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ 2 for qualitative variables. There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4g/kg/day). Copyright © 2017 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

3-T MRI safety assessments of magnetic dental attachments and castable magnetic alloys

PubMed Central

Miyata, K; Abe, Y; Ishii, T; Ishigami, T; Ohtani, K; Nagai, E; Ohyama, T; Umekawa, Y; Nakabayashi, S

2015-01-01

Objectives: To assess the safety of different magnetic dental attachments during 3-T MRI according to the American Society for Testing and Materials F2182-09 and F2052-06e1 standard testing methods and to develop a method to determine MRI compatibility by measuring magnetically induced torque. Methods: The temperature elevations, magnetically induced forces and torques of a ferromagnetic stainless steel keeper, a coping comprising a keeper and a cast magnetic alloy coping were measured on MRI systems. Results: The coping comprising a keeper demonstrated the maximum temperature increase (1.42 °C) for the whole-body-averaged specific absorption rate and was calculated as 2.1 W kg−1 with the saline phantom. All deflection angles exceeded 45°. The cast magnetic alloy coping had the greatest deflection force (0.33 N) during 3-T MRI and torque (1.015 mN m) during 0.3-T MRI. Conclusions: The tested devices showed minimal radiofrequency (RF)-induced heating in a 3-T MR environment, but the cast magnetic alloy coping showed a magnetically induced deflection force and torque approximately eight times that of the keepers. For safety, magnetic dental attachments should be inspected before and after MRI and large prostheses containing cast magnetic alloy should be removed. Although magnetic dental attachments may pose no great risk of RF-induced heating or magnetically induced torque during 3-T MRI, their magnetically induced deflection forces tended to exceed acceptable limits. Therefore, the inspection of such devices before and after MRI is important for patient safety. PMID:25785821

Critical Review of Public Health Regulations of Titanium Dioxide, a Human Food Additive

PubMed Central

Jovanović, Boris

2015-01-01

From 1916 to 2011, an estimated total of 165 050 000 metric tons of titanium dioxide (TiO2) pigment were produced worldwide. Current safety regulations on the usage of the TiO2 pigment as an inactive ingredient additive in human food are based on legislation from 1969 and are arguably outdated. This article compiles new research results to provide fresh data for potential risk reassessment. However, even after 45 years, few scientific research reports have provided truly reliable data. For example, administration of very high doses of TiO2 is not relevant to daily human uptake. Nevertheless, because dose makes the poison, the literature provides a valuable source for understanding potential TiO2 toxicity after oral ingestion. Numerous scientific articles have observed that TiO2 can pass and be absorbed by the mammalian gastrointestinal tract; can bioconcentrate, bioaccumulate, and biomagnify in the tissues of mammals and other vertebrates; has a very limited elimination rate; and can cause histopathological and physiological changes in various organs of animals. Such action is contrary to the 1969 decision to approve the use of TiO2 as an inactive ingredient in human food without an established acceptable daily intake, stating that neither significant absorption nor tissue storage following ingestion of TiO2 was possible. Thus, relevant governmental agencies should reassess the safety of TiO2 as an additive in human food and consider establishing an acceptable maximum daily intake as a precautionary measure. Integr Environ Assess Manag 2015;11:10–20. © 2014 The Author. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of SETAC. PMID:25091211

Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease.

PubMed

Shelygin, Yuri; Krivokapic, Zoran; Frolov, S A; Kostarev, I V; Astashov, V L; Vasiliev, S V; Lakhin, A V; Rodoman, G V; Soloviev, A O; Stoyko, Y M; Khitaryan, A G; Nechay, I A

2016-11-01

To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids. MPFF is an established treatment for hemorrhoidal disease. This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively). Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); -2.37 cm MPFF 1000 mg (P < 0.001) and -2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction -2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg. After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets. Key limitations: Safety study.

A pilot survey of the U.S. medical waste industry to determine training needs for safely handling highly infectious waste.

PubMed

Le, Aurora B; Hoboy, Selin; Germain, Anne; Miller, Hal; Thompson, Richard; Herstein, Jocelyn J; Jelden, Katelyn C; Beam, Elizabeth L; Gibbs, Shawn G; Lowe, John J

2018-02-01

The recent Ebola outbreak led to the development of Ebola virus disease (EVD) best practices in clinical settings. However, after the care of EVD patients, proper medical waste management and disposal was identified as a crucial component to containing the virus. Category A waste-contaminated with EVD and other highly infectious pathogens-is strictly regulated by governmental agencies, and led to only several facilities willing to accept the waste. A pilot survey was administered to determine if U.S. medical waste facilities are prepared to handle or transport category A waste, and to determine waste workers' current extent of training to handle highly infectious waste. Sixty-eight percent of survey respondents indicated they had not determined if their facility would accept category A waste. Of those that had acquired a special permit, 67% had yet to modify their permit since the EVD outbreak. This pilot survey underscores gaps in the medical waste industry to handle and respond to category A waste. Furthermore, this study affirms reports a limited number of processing facilities are capable or willing to accept category A waste. Developing the proper management of infectious disease materials is essential to close the gaps identified so that states and governmental entities can act accordingly based on the regulations and guidance developed, and to ensure public safety. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. The FemCap Investigators' Group.

PubMed

Mauck, C; Callahan, M; Weiner, D H; Dominik, R

1999-08-01

The FemCap is a new silicone rubber barrier contraceptive shaped like a sailor's hat, with a dome that covers the cervix, a rim that fits into the fornices, and a brim that conforms to the vaginal walls around the cervix. It was designed to result in fewer dislodgments and less pressure on the urethra than the cervical cap and diaphragm, respectively, and to require less clinician time for fitting. This was a phase II/III, multicenter, randomized, open-label, parallel group study of 841 women at risk for pregnancy. A subset of 42 women at one site underwent colposcopy. Women were randomized to use the FemCap or Ortho All-Flex contraceptive diaphragm, both with 2% nonoxynol-9 spermicide, for 28 weeks. The objectives were to compare the two devices with regard to their safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse than that of the diaphragm (meaning not more than 6 percentage points higher). The 6-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01. Clinical equivalence (noninferiority) of the FemCap compared with the diaphragm, as defined in this study, would mean that the true risk of pregnancy among FemCap users was no more than 1.73 times the pregnancy risk of diaphragm users. Because the observed upper 95% confidence limit (and even the point estimate) exceeded 1.73, the probability of pregnancy among FemCap users, compared with that among diaphragm users, did not meet the definition of clinical equivalence used in this study. The FemCap was believed to be safe and was associated with significantly fewer urinary tract infections. More women reported problems with the FemCap with regard to insertion, dislodgement, and especially removal, although their general assessments were positive. The two devices were comparable with regard to safety and acceptability, but a 6-point difference in the true 6-month pregnancy probabilities of the two devices could not be ruled out. Further studies are needed to determine whether design modifications can simplify insertion and removal.

HS-GC-MS method for the analysis of fragrance allergens in complex cosmetic matrices.

PubMed

Desmedt, B; Canfyn, M; Pype, M; Baudewyns, S; Hanot, V; Courselle, P; De Beer, J O; Rogiers, V; De Paepe, K; Deconinck, E

2015-01-01

Potential allergenic fragrances are part of the Cosmetic Regulation with labelling and concentration restrictions. This means that they have to be declared on the ingredients list, when their concentration exceeds the labelling limit of 10 ppm or 100 ppm for leave-on or rinse-off cosmetics, respectively. Labelling is important regarding consumer safety. In this way, sensitised people towards fragrances might select their products based on the ingredients list to prevent elicitation of an allergic reaction. It is therefore important to quantify potential allergenic ingredients in cosmetic products. An easy to perform liquid extraction was developed, combined with a new headspace GC-MS method. The latter was capable of analysing 24 volatile allergenic fragrances in complex cosmetic formulations, such as hydrophilic (O/W) and lipophilic (W/O) creams, lotions and gels. This method was successfully validated using the total error approach. The trueness deviations for all components were smaller than 8%, and the expectation tolerance limits did not exceed the acceptance limits of ± 20% at the labelling limit. The current methodology was used to analyse 18 cosmetic samples that were already identified as being illegal on the EU market for containing forbidden skin whitening substances. Our results showed that these cosmetic products also contained undeclared fragrances above the limit value for labelling, which imposes an additional health risk for the consumer. Copyright © 2014 Elsevier B.V. All rights reserved.

First-in-Human Trial of MIV-150 and Zinc Acetate Coformulated in a Carrageenan Gel: Safety, Pharmacokinetics, Acceptability, Adherence, and Pharmacodynamics

PubMed Central

Hoesley, Craig J.; Plagianos, Marlena; Hoskin, Elena; Zhang, Shimin; Teleshova, Natalia; Alami, Mohcine; Novak, Lea; Kleinbeck, Kyle R.; Katzen, Lauren L.; Zydowsky, Thomas M.; Fernández-Romero, José A.; Creasy, George W.

2016-01-01

Objective: To evaluate the safety and pharmacokinetics of MIV-150 and zinc acetate in a carrageenan gel (PC-1005). Acceptability, adherence, and pharmacodynamics were also explored. Design: A 3-day open-label safety run-in (n = 5) preceded a placebo-controlled, double-blind trial in healthy, HIV-negative, abstinent women randomized (4:1) to vaginally apply 4 mL of PC-1005 or placebo once daily for 14 days. Methods: Assessments included physical examinations, safety labs, colposcopy, biopsies, cervicovaginal lavages (CVLs), and behavioral questionnaires. MIV-150 (plasma, CVL, tissue), zinc (plasma, CVL), and carrageenan (CVL) concentrations were determined with LC-MS/MS, ICP-MS, and ELISA, respectively. CVL antiviral activity was measured using cell-based assays. Safety, acceptability, and adherence were analyzed descriptively. Pharmacokinetic parameters were calculated using noncompartmental techniques and actual sampling times. CVL antiviral EC50 values were calculated using a dose–response inhibition analysis. Results: Participants (n = 20) ranged from 19–44 years old; 52% were black or African American. Among those completing the trial (13/17, PC-1005; 3/3, placebo), 11/17 reported liking the gel overall; 7 recommended reducing the volume. Adverse events, which were primarily mild and/or unrelated, were comparable between groups. Low systemic MIV-150 levels were observed, without accumulation. Plasma zinc levels were unchanged from baseline. Seven of seven CVLs collected 4-hour postdose demonstrated antiviral (HIV, human papillomavirus) activity. High baseline CVL anti–herpes-simplex virus type-2 (HSV-2) activity precluded assessment of postdose activity. Conclusions: PC-1005 used vaginally for 14 days was well tolerated. Low systemic levels of MIV-150 were observed. Plasma zinc levels were unchanged. Postdose CVLs had anti-HIV and anti–human papillomavirus activity. These data warrant further development of PC-1005 for HIV and sexually transmitted infection prevention. PMID:27437826

Safety analysis, risk assessment, and risk acceptance criteria

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

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

Comprehensibility of traffic signs among urban drivers in Turkey.

PubMed

Kirmizioglu, Erkut; Tuydes-Yaman, Hediye

2012-03-01

Traffic signs are commonly used traffic safety tools, mainly developed to provide crucial information in a short time to support safe drive; but the success depends on their comprehensibility by the drivers. Also, a sudden change in the traditionally used and accepted signs can cause significant safety problem, as in the case of cancellation of red oblique bars in 2004 as a part of the European Union Harmonization Process of Turkey. Having a severe traffic safety problem in Turkey, a need to assess both the comprehensibility of internationally accepted traffic signs and current level of driver education, was the main motivation behind this study. A paper-based survey study in 2009 that reached a sample of 1478 urban drivers in the City of Ankara, focused on the determination of comprehensibility of 30 selected traffic signs, which are commonly used and critical for safety, including two recently changed signs. The meaning of each sign is sought using an open-ended question format to capture different levels and types of comprehensions, which enabled the detection of "opposite" and "partially correct" answers besides "wrong" and "correct" ones. High comprehensibility of 9 control group signs shows the validity of the study. The recently changed signs are among the oppositely associated ones proving the increased risk in traffic safety and need for more aggressive campaigning to publicize them. Copyright © 2011 Elsevier Ltd. All rights reserved.

Risks and benefits of commonly used herbal medicines in Mexico.

PubMed

Rodriguez-Fragoso, Lourdes; Reyes-Esparza, Jorge; Burchiel, Scott W; Herrera-Ruiz, Dea; Torres, Eliseo

2008-02-15

In Mexico, local empirical knowledge about medicinal properties of plants is the basis for their use as home remedies. It is generally accepted by many people in Mexico and elsewhere in the world that beneficial medicinal effects can be obtained by ingesting plant products. In this review, we focus on the potential pharmacologic bases for herbal plant efficacy, but we also raise concerns about the safety of these agents, which have not been fully assessed. Although numerous randomized clinical trials of herbal medicines have been published and systematic reviews and meta-analyses of these studies are available, generalizations about the efficacy and safety of herbal medicines are clearly not possible. Recent publications have also highlighted the unintended consequences of herbal product use, including morbidity and mortality. It has been found that many phytochemicals have pharmacokinetic or pharmacodynamic interactions with drugs. The present review is limited to some herbal medicines that are native or cultivated in Mexico and that have significant use. We discuss the cultural uses, phytochemistry, pharmacological, and toxicological properties of the following plant species: nopal (Opuntia ficus), peppermint (Mentha piperita), chaparral (Larrea divaricata), dandlion (Taraxacum officinale), mullein (Verbascum densiflorum), chamomile (Matricaria recutita), nettle or stinging nettle (Urtica dioica), passionflower (Passiflora incarnata), linden flower (Tilia europea), and aloe (Aloe vera). We conclude that our knowledge of the therapeutic benefits and risks of some herbal medicines used in Mexico is still limited and efforts to elucidate them should be intensified.

Risks and benefits of commonly used herbal medicines in Mexico

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

Rodriguez-Fragoso, Lourdes; Reyes-Esparza, Jorge; Burchiel, Scott W.

In Mexico, local empirical knowledge about medicinal properties of plants is the basis for their use as home remedies. It is generally accepted by many people in Mexico and elsewhere in the world that beneficial medicinal effects can be obtained by ingesting plant products. In this review, we focus on the potential pharmacologic bases for herbal plant efficacy, but we also raise concerns about the safety of these agents, which have not been fully assessed. Although numerous randomized clinical trials of herbal medicines have been published and systematic reviews and meta-analyses of these studies are available, generalizations about the efficacymore » and safety of herbal medicines are clearly not possible. Recent publications have also highlighted the unintended consequences of herbal product use, including morbidity and mortality. It has been found that many phytochemicals have pharmacokinetic or pharmacodynamic interactions with drugs. The present review is limited to some herbal medicines that are native or cultivated in Mexico and that have significant use. We discuss the cultural uses, phytochemistry, pharmacological, and toxicological properties of the following plant species: nopal (Opuntia ficus), peppermint (Mentha piperita), chaparral (Larrea divaricata), dandlion (Taraxacum officinale), mullein (Verbascum densiflorum), chamomile (Matricaria recutita), nettle or stinging nettle (Urtica dioica), passionflower (Passiflora incarnata), linden flower (Tilia europea), and aloe (Aloe vera). We conclude that our knowledge of the therapeutic benefits and risks of some herbal medicines used in Mexico is still limited and efforts to elucidate them should be intensified.« less

Risks and Benefits of Commonly used Herbal Medicines in México

PubMed Central

Rodriguez-Fragoso, Lourdes; Reyes-Esparza, Jorge; Burchiel, Scott; Herrera-Ruiz, Dea; Torres, Eliseo

2008-01-01

In Mexico, local empirical knowledge about medicinal properties of plants is the basis for their use as home remedies. It is generally accepted by many people in Mexico and elsewhere in the world that beneficial medicinal effects can be obtained by ingesting plant products. In this review, we focus on the potential pharmacologic bases for herbal plant efficacy, but we also raise concerns about the safety of these agents, which have not been fully assessed. Although numerous randomized clinical trials of herbal medicines have been published and systematic reviews and meta-analyses of these studies are available, generalizations about the efficacy and safety of herbal medicines are clearly not possible. Recent publications have also highlighted the unintended consequences of herbal product use, including morbidity and mortality. It has been found that many phytochemicals have pharmacokinetic or pharmacodynamic interactions with drugs. The present review is limited to some herbal medicine that are native or cultivated in Mexico and that have significant use. We discuss the cultural uses, phytochemistry, pharmacological and toxicological properties of the following following plant species: Nopal (Opuntia ficus), Peppermint (Mentha piperita), Chaparral (Larrea divaricata), Dandlion (Taraxacum officinale), Mullein (Verbascum densiflorum), Chamomile (Matricaria recutita), Nettle or Stinging Nettle (Urtica dioica), Passionflower (Passiflora incarmata), Linden Flower (Tilia europea), and Aloa (Aloa vera). We conclude that our knowledge of the therapeutic benefits and risks of some herbal medicines used in Mexico is still limited and efforts to elucidate them should be intensified. PMID:18037151

[Application of root cause analysis in healthcare].

PubMed

Hsu, Tsung-Fu

2007-12-01

The main purpose of this study was to explore various aspects of root cause analysis (RCA), including its definition, rationale concept, main objective, implementation procedures, most common analysis methodology (fault tree analysis, FTA), and advantages and methodologic limitations in regard to healthcare. Several adverse events that occurred at a certain hospital were also analyzed by the author using FTA as part of this study. RCA is a process employed to identify basic and contributing causal factors underlying performance variations associated with adverse events. The rationale concept of RCA offers a systemic approach to improving patient safety that does not assign blame or liability to individuals. The four-step process involved in conducting an RCA includes: RCA preparation, proximate cause identification, root cause identification, and recommendation generation and implementation. FTA is a logical, structured process that can help identify potential causes of system failure before actual failures occur. Some advantages and significant methodologic limitations of RCA were discussed. Finally, we emphasized that errors stem principally from faults attributable to system design, practice guidelines, work conditions, and other human factors, which induce health professionals to make negligence or mistakes with regard to healthcare. We must explore the root causes of medical errors to eliminate potential RCA system failure factors. Also, a systemic approach is needed to resolve medical errors and move beyond a current culture centered on assigning fault to individuals. In constructing a real environment of patient-centered safety healthcare, we can help encourage clients to accept state-of-the-art healthcare services.

Primary battery design and safety guidelines handbook

NASA Technical Reports Server (NTRS)

Bragg, Bobby J.; Casey, John E.; Trout, J. Barry

1994-01-01

This handbook provides engineers and safety personnel with guidelines for the safe design or selection and use of primary batteries in spaceflight programs. Types of primary batteries described are silver oxide zinc alkaline, carbon-zinc, zinc-air alkaline, manganese dioxide-zionc alkaline, mercuric oxide-zinc alkaline, and lithium anode cells. Along with typical applications, the discussions of the individual battery types include electrochemistry, construction, capacities and configurations, and appropriate safety measures. A chapter on general battery safety covers hazard sources and controls applicable to all battery types. Guidelines are given for qualification and acceptance testing that should precede space applications. Permissible failure levels for NASA applications are discussed.

Combustion and fires in low gravity

NASA Technical Reports Server (NTRS)

Friedman, Robert

1994-01-01

Fire safety always receives priority attention in NASA mission designs and operations, with emphasis on fire prevention and material acceptance standards. Recently, interest in spacecraft fire-safety research and development has increased because improved understanding of the significant differences between low-gravity and normal-gravity combustion suggests that present fire-safety techniques may be inadequate or, at best, non-optimal; and the complex and permanent orbital operations in Space Station Freedom demand a higher level of safety standards and practices. This presentation outlines current practices and problems in fire prevention and detection for spacecraft, specifically the Space Station Freedom's fire protection. Also addressed are current practices and problems in fire extinguishment for spacecraft.

A Human Mixture Risk Assessment for Neurodevelopmental Toxicity Associated with Polybrominated Diphenyl Ethers Used as Flame Retardants

PubMed Central

Martin, Olwenn V.; Evans, Richard M.; Faust, Michael

2017-01-01

Background: The European Food Safety Authority recently concluded that the exposure of small children (1–3 y old) to brominated diphenyl ether (BDE)-99 may exceed acceptable levels defined in relation to neurodevelopmental toxicity in rodents. The flame retardant BDE-209 may release BDE-99 and other lower brominated BDEs through biotic and abiotic degradation, and all age groups are exposed not only to BDE-209 and -99 but also to a cocktail of BDE congeners with evidence of neurodevelopmental toxicity. The possible risks from combined exposures to these substances have not been evaluated. Objectives: We performed a congener-specific mixture risk assessment (MRA) of human exposure to combinations of BDE-209 and other BDEs based on estimated exposures via diet and dust intake and on measured levels in biologic samples. Methods: We employed the Hazard Index (HI) method by using BDE congener-specific reference doses for neurodevelopmental toxicity. Results: Our HI analysis suggests that combined exposures to polybrominated diphenyl ethers (PBDEs) may exceed acceptable levels in breastfeeding infants (0–3 mo old) and in small children (1–3 y old), even for moderate (vs. high) exposure scenarios. Our estimates also suggest that acceptable levels of combined PBDEs may be exceeded in adults whose diets are high in fish. Small children had the highest combined exposures, with some estimated body burdens that were similar to body burdens associated with developmental neurotoxicity in rodents. Conclusions: Our estimates corroborate reports from several recent epidemiological studies of associations between PBDE exposures and neurobehavioral outcomes, and they support the inclusion of BDE-209 in the persistent organic pollutant (POP) convention as well as the need for strategies to reduce exposures to PBDE mixtures, including maximum residue limits for PBDEs in food and measures for limiting the release of PBDEs from consumer waste. https://doi.org/10.1289/EHP826 PMID:28886598

Shelf life extension of minimally processed cabbage and cucumber through gamma irradiation.

PubMed

Khattak, Amal Badshah; Bibi, Nizakat; Chaudry, Muhammad Ashraf; Khan, Misal; Khan, Maazullah; Qureshi, Muhammad Jamil

2005-01-01

The influence of irradiation of minimally processed cabbage and cucumber on microbial safety, texture, and sensory quality was investigated. Minimally processed, polyethylene-packed, and irradiated cabbage and cucumber were stored at refrigeration temperature (5 degrees C) for 2 weeks. The firmness values ranged from 3.23 kg (control) to 2.82 kg (3.0-kGy irradiated samples) for cucumbers, with a gradual decrease in firmness with increasing radiation dose (0 to 3 kGy). Cucumbers softened just after irradiation with a dose of 3.0 kGy and after 14 days storage, whereas the texture remained within acceptable limits up to a radiation dose of 2.5 kGy. The radiation treatment had no effect on the appearance scores of cabbage; however, scores decreased from 7.0 to 6.7 during storage. The appearance and flavor scores of cucumbers decreased with increasing radiation dose, and overall acceptability was better after radiation doses of 2.5 and 3.0 kGy. The aerobic plate counts per gram for cabbage increased from 3 to 5 log CFU (control), from 1.85 to 2.93 log CFU (2.5 kGy), and from a few colonies to 2.6 log CFU (3.0 kGy) after 14 days of storage at 5 degrees C. A similar trend was noted for cucumber samples. No coliform bacteria were detected at radiation doses greater than 2.0 kGy in either cabbage or cucumber samples. Total fungal counts per gram of sample were within acceptable limits for cucumbers irradiated at 3.0 kGy, and for cabbage no fungi were detected after 2.0-kGy irradiation. The D-values for Escherichia coli in cucumber and cabbage were 0.19 and 0.17 kGy, and those for Salmonella Paratyphi A were 0.25 and 0.29 kGy for cucumber and cabbage, respectively.

49 CFR 41.120 - Acceptable model codes.

Code of Federal Regulations, 2011 CFR

2011-10-01

... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake Hazards Reduction Program (NEHRP) Recommended Provisions (Copies are available from the Office of Earthquakes and...

49 CFR 41.120 - Acceptable model codes.

Code of Federal Regulations, 2013 CFR

2013-10-01

... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake Hazards Reduction Program (NEHRP) Recommended Provisions (Copies are available from the Office of Earthquakes and...

49 CFR 41.120 - Acceptable model codes.

Code of Federal Regulations, 2010 CFR

2010-10-01

... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake Hazards Reduction Program (NEHRP) Recommended Provisions (Copies are available from the Office of Earthquakes and...

49 CFR 41.120 - Acceptable model codes.

Code of Federal Regulations, 2014 CFR

2014-10-01

... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake Hazards Reduction Program (NEHRP) Recommended Provisions (Copies are available from the Office of Earthquakes and...

49 CFR 41.120 - Acceptable model codes.

Code of Federal Regulations, 2012 CFR

2012-10-01

... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake Hazards Reduction Program (NEHRP) Recommended Provisions (Copies are available from the Office of Earthquakes and...