Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

Patient safety in primary care: a survey of general practitioners in The Netherlands.

PubMed

Gaal, Sander; Verstappen, Wim; Wensing, Michel

2010-01-21

Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

Application of an aviation model of incident reporting and investigation to the neurosurgical scenario: method and preliminary data.

PubMed

Ferroli, Paolo; Caldiroli, Dario; Acerbi, Francesco; Scholtze, Maurizio; Piro, Alfonso; Schiariti, Marco; Orena, Eleonora F; Castiglione, Melina; Broggi, Morgan; Perin, Alessandro; DiMeco, Francesco

2012-11-01

Incident reporting systems are universally recognized as important tools for quality improvement in all complex adaptive systems, including the operating room. Nevertheless, introducing a safety culture among neurosurgeons is a slow process, and few studies are available in the literature regarding the implementation of an incident reporting system within a neurosurgical department. The authors describe the institution of an aviation model of incident reporting and investigation in neurosurgery, focusing on the method they have used and presenting some preliminary results. In 2010, the Inpatient Safety On-Board project was developed through cooperation between a team of human factor and safety specialists with aviation backgrounds (DgSky team) and the general manager of the Fondazione Istituto Neurologico Carlo Besta. In 2011, after specific training in safety culture, the authors implemented an aviation-derived prototype of incident reporting within the Department of Neurosurgery. They then developed an experimental protocol to track, analyze, and categorize any near misses that happened in the operating room. This project officially started in January 2012, when a dedicated team of assessors was established. All members of the neurosurgical department were asked to report near misses on a voluntary, confidential, and protected form (Patient Incident Reporting System form, Besta Safety Management Programme). Reports were entered into an online database and analyzed by a dedicated team of assessors with the help of a facilitator, and an aviation-derived root cause analysis was performed. Since January 2012, 14 near misses were analyzed and classified. The near-miss contributing factors were mainly related to human factors (9 of 14 cases), technology (1 of 14 cases), organizational factors (3 of 14 cases), or procedural factors (1 of 14 cases). Implementing an incident reporting system is quite demanding; the process should involve all of the people who work within the environment under study. Persistence and strong commitment are required to enact the culture change essential in shifting from a paradigm of infallible operators to the philosophy of errare humanum est. For this paradigm shift to be successful, contributions from aviation and human factor experts are critical.

Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study

PubMed Central

2017-01-01

Purpose The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. Methods A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Results Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. Conclusion The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies. PMID:29284217

Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications.

PubMed

Diez-Domingo, Javier; de Martino, Maurizio; Lopez, Jose Garcia-Sicilia; Zuccotti, Gian Vincenzo; Icardi, Giancarlo; Villani, Alberto; Moreno-Perez, David; Hernández, María Méndez; Aldeán, Javier Álvarez; Mateen, Ahmed Abdul; Enweonye, Igwebuike; de Rooij, Richard; Chandra, Richa

2016-08-01

This descriptive, non-comparative, phase III study evaluated the safety and tolerability of cell culture-derived (TIVc) and egg-derived (TIV) seasonal influenza vaccines in children at risk of influenza-related complications. Four hundred and thirty subjects were randomized 2:1 to TIVc or TIV. Subjects aged 3 to <9 years received one dose (if previously vaccinated, n=89) or two doses (if not previously vaccinated, n=124) of the study vaccines; the 9 to <18-year-olds (n=213) received one dose. Reactogenicity was assessed for 7 days after vaccination; safety was monitored for 6 months. After any vaccination, the most frequently reported solicited local adverse event (AE) was tenderness/pain (TIVc 44%, 66%, 53% and TIV 56%, 51%, 65% in the age groups 3 to <6 years, 6 to <9 years, and 9 to <18 years, respectively) and the systemic AE was irritability (22% TIVc, 24% TIV) in 3 to <6-year-olds and headache in 6 to <9-year-olds (20% TIVc, 13% TIV) and 9 to <18-year-olds (21% TIVc, 26% TIV). There were no cases of severe fever (≥40°C). No vaccine-related serious AEs were noted. New onset of chronic disease was reported in ≤1% of subjects. TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477). Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Morinda citrifolia (Noni) fruit--phytochemistry, pharmacology, safety.

PubMed

Potterat, Olivier; Hamburger, Matthias

2007-03-01

Products derived from Noni fruit (Morinda citrifolia) have been commercialised in the USA since the 1990s and are increasingly distributed all over the world. A large number of beneficial effects have been claimed for Noni. Fruit juice of Noni has been approved as a Novel Food by the European Commission in 2003. This article reviews current knowledge on the phytochemistry, pharmacology, safety aspects of Noni fruit and Noni-derived products, and health-related claims and benefits. The knowledge on the chemical composition of Noni fruit has considerably increased over recent years. A number of in vitro and, to a certain extent, in vivo studies demonstrate a range of potentially beneficial effects. However, clinical data are essentially lacking. To what extent the findings from experimental pharmacological studies are of potential clinical relevance is not clear at present. Based on a toxicological assessment, Noni juice was considered as safe. Due to recent reports of cases of hepatotoxicity, the safety issue has been re-examined in Europe. While the European Food Safety Authority sees no link between adverse effects on liver and consumption of Noni juice, a continuing monitoring of the situation is desirable and some vigilance advised.

Medicinal and other products and human and animal transmissible spongiform encephalopathies: memorandum from a WHO meeting.

PubMed Central

1997-01-01

The report in March 1996 of 10 human cases of a novel from of Creutzfeldt-Jakob disease in the United Kingdom, and its possible link to the agent that causes bovine spongiform encephalopathy (BSE), raises many questions about the safety of animal-derived products and by-products entering the food chain or being used in medicine. This Memorandum updates the preventive measures put forward in 1991 to minimize the risks associated with the use of bovine-derived materials in medicinal products and medical devices. PMID:9509622

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

A methodology for developing and balancing quantitative design requirements for safety, reliability, and maintainability has been proposed. Conceived as the basis of a more rational approach to the design of spacecraft, the methodology would also be applicable to the design of automobiles, washing machines, television receivers, or almost any other commercial product. Heretofore, it has been common practice to start by determining the requirements for reliability of elements of a spacecraft or other system to ensure a given design life for the system. Next, safety requirements are determined by assessing the total reliability of the system and adding redundant components and subsystems necessary to attain safety goals. As thus described, common practice leaves the maintainability burden to fall to chance; therefore, there is no control of recurring costs or of the responsiveness of the system. The means that have been used in assessing maintainability have been oriented toward determining the logistical sparing of components so that the components are available when needed. The process established for developing and balancing quantitative requirements for safety (S), reliability (R), and maintainability (M) derives and integrates NASA s top-level safety requirements and the controls needed to obtain program key objectives for safety and recurring cost (see figure). Being quantitative, the process conveniently uses common mathematical models. Even though the process is shown as being worked from the top down, it can also be worked from the bottom up. This process uses three math models: (1) the binomial distribution (greaterthan- or-equal-to case), (2) reliability for a series system, and (3) the Poisson distribution (less-than-or-equal-to case). The zero-fail case for the binomial distribution approximates the commonly known exponential distribution or "constant failure rate" distribution. Either model can be used. The binomial distribution was selected for modeling flexibility because it conveniently addresses both the zero-fail and failure cases. The failure case is typically used for unmanned spacecraft as with missiles.

A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers.

PubMed

Jang, Hee-Chang; Kim, Choong Jong; Kim, Kye Hyoung; Lee, Kwang-Hee; Byun, Young-Ho; Seong, Baik-Lin; Saletti, Giulietta; Czerkinsky, Cecil; Park, Wan Beom; Park, Sang-Won; Kim, Hong-Bin; Kim, Nam Joong; Oh, Myoung-don

2010-08-16

A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, and to determine its minimum effective dose. The overall rates of cutaneous "take" reaction and humoral and cellular immunogenicity in CJ-50300 vaccinees were 100% (123/123), 99.2% (122/123), and 90.8% (109/120), respectively, and these rates did not differ significantly between the conventional-dose and the low-dose CJ-50300 (1.0x10(8) and 1.0x10(7) plaque-forming units/mL, respectively) (P>0.05 for each). No serious adverse reaction was observed. However, one case of possible generalized vaccinia occurred in the conventionally dosed group [ClinicalTrials.gov Identifier: NCT00607243].

The safety and regulation of natural products used as foods and food ingredients.

PubMed

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Integrating animal health and food safety surveillance data from slaughterhouse control.

PubMed

Lynch, J A; Silva, P

2013-08-01

Surveillance at the slaughterhouse level for animal health and food safety purposes encompasses examination for the presence of pathology, pathogens, drug residues, chemical contaminants and antimicrobial resistance. Government, industry and academia are the primary proponents of such surveillance. A variety of policies and policy instruments from voluntary to legislative may be applied to promote or obligate participation. Efforts to integrate data across such diverse organisations encounter significant legal, logistical and financial challenges. Enhancement of policies to encourage effective integration of animal health and food safety surveillance data from slaughterhouse control should promote: a long-term approach; collaboration among government, industry and academia; application of a risk-based scheme; and transparent public access to data, with generation of consumer-oriented communications derived from the data. A strong case can be made that the complementary pursuit of both sustainable animal health and food safety can continue to be aided by surveillance at the slaughterhouse level.

Optimum Use of Acute Treatments for Hereditary Angioedema: Evidence-Based Expert Consensus

PubMed Central

Longhurst, Hilary

2018-01-01

Acute treatment of hereditary angioedema due to C1 inhibitor deficiency has become available in the last 10 years and has greatly improved patients’ quality of life. Two plasma-derived C1 inhibitors (Berinert and Cinryze), a recombinant C1 inhibitor (Ruconest/Conestat alpha), a kallikrein inhibitor (Ecallantide), and a bradykinin B2 receptor inhibitor (Icatibant) are all effective. Durably good response is maintained over repeated treatments and several years. All currently available prophylactic agents are associated with breakthrough attacks, therefore an acute treatment plan is essential for every patient. Experience has shown that higher doses of C1 inhibitor than previously recommended may be desirable, although only recombinant C1 inhibitor has been subject to full dose–response evaluation. Treatment of early symptoms of an attack, with any licensed therapy, results in milder symptoms, more rapid resolution and shorter duration of attack, compared with later treatment. All therapies have been shown to be well-tolerated, with low risk of serious adverse events. Plasma-derived C1 inhibitors have a reassuring safety record regarding lack of transmission of virus or other infection. Thrombosis has been reported in association with plasma-derived C1 inhibitor in some case series. Ruconest was associated with anaphylaxis in a single rabbit-allergic volunteer, but no further anaphylaxis has been reported in those not allergic to rabbits despite, in a few cases, prior IgE sensitization to rabbit or milk protein. Icatibant is associated with high incidence of local reactions but not with systemic effects. Ecallantide may cause anaphylactoid reactions and is given under supervision. For children and pregnant women, plasma-derived C1 inhibitor has the best evidence of safety and currently remains first-line treatment. PMID:29594115

Optimum Use of Acute Treatments for Hereditary Angioedema: Evidence-Based Expert Consensus.

PubMed

Longhurst, Hilary

2017-01-01

Acute treatment of hereditary angioedema due to C1 inhibitor deficiency has become available in the last 10 years and has greatly improved patients' quality of life. Two plasma-derived C1 inhibitors (Berinert and Cinryze), a recombinant C1 inhibitor (Ruconest/Conestat alpha), a kallikrein inhibitor (Ecallantide), and a bradykinin B2 receptor inhibitor (Icatibant) are all effective. Durably good response is maintained over repeated treatments and several years. All currently available prophylactic agents are associated with breakthrough attacks, therefore an acute treatment plan is essential for every patient. Experience has shown that higher doses of C1 inhibitor than previously recommended may be desirable, although only recombinant C1 inhibitor has been subject to full dose-response evaluation. Treatment of early symptoms of an attack, with any licensed therapy, results in milder symptoms, more rapid resolution and shorter duration of attack, compared with later treatment. All therapies have been shown to be well-tolerated, with low risk of serious adverse events. Plasma-derived C1 inhibitors have a reassuring safety record regarding lack of transmission of virus or other infection. Thrombosis has been reported in association with plasma-derived C1 inhibitor in some case series. Ruconest was associated with anaphylaxis in a single rabbit-allergic volunteer, but no further anaphylaxis has been reported in those not allergic to rabbits despite, in a few cases, prior IgE sensitization to rabbit or milk protein. Icatibant is associated with high incidence of local reactions but not with systemic effects. Ecallantide may cause anaphylactoid reactions and is given under supervision. For children and pregnant women, plasma-derived C1 inhibitor has the best evidence of safety and currently remains first-line treatment.

A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle.

PubMed

Zhou, Cui; Wang, Jian Wu; Huang, Kun Lun; He, XiaoYun; Chen, Xiu Ping; Sun, Hong; Yu, Tian; Che, Hui Lian

2011-10-01

Transgenic cloned animals expressing beneficial human nutritional traits offer a new strategy for large-scale production of some kinds of functional substances. In some cases, the required safety testing for genetically modified (GM) foods do not seem appropriate for human food safety, though regulations do not seem to provide alternatives. A 90-day rat feeding study is the core study for the safety assessment of GM foods. The test material in this 90-day study was prepared nonfat milk powder containing recombinant human lactoferrin (rhLF), which was expressed in transgenic cloned cattle. Groups of 10 male and female Sprague-Dawley rats were given a nutritionally balanced purified diet containing 7.5, 15, or 30% transgenic or conventional milk powder for 90 days. A commercial AIN93G diet was used as an additional control group. Clinical, biological, and pathological parameters were compared between groups. The only significant effect of treatment was higher mean ferritin and Fe(+) concentrations for both male and female rats fed the transgenic milk powder diets, as compared to rats fed nontransgenic milk diets or the commercial diet. The results of the present study are consistent with previous research, which indicates that milk powder containing rhLF derived from healthy transgenic cloned cattle is as safe as conventional milk powder.

Managing risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE).

PubMed

Dourson, Michael L; Gadagbui, Bernard K; Thompson, Rod B; Pfau, Edward J; Lowe, John

2016-10-01

A method for determining a safety range for non-cancer risks is proposed, similar in concept to the range used for cancer in the management of waste sites. This safety range brings transparency to the chemical specific Reference Dose or Concentration by replacing their "order of magnitude" definitions with a scientifically-based range. EPA's multiple RfCs for trichloroethylene (TCE) were evaluated as a case study. For TCE, a multi-endpoint safety range was judged to be 3 μg/m(3) to 30 μg/m,(3) based on a review of kidney effects found in NTP (1988), thymus effects found in Keil et al. (2009) and cardiac effects found in the Johnson et al. (2003) study. This multi-endpoint safety range is derived from studies for which the appropriate averaging time corresponds to different exposure durations, and, therefore, can be applied to both long- and short-term exposures with appropriate consideration of exposure averaging times. For shorter-term exposures, averaging time should be based on the time of cardiac development in humans during fetal growth, an average of approximately 20-25 days. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

[Adipose-derived stromal cells (ASC) - basics and therapeutic approaches in otorhinolaryngology].

PubMed

Frölich, K; Hagen, R; Kleinsasser, N

2014-06-01

Adipose-derived Stromal Cells (ASC) - Basics and Therapeutic Approaches in Otorhinolaryngology Mesenchymal stem cells from adipose tissue can be easily harvested with less discomfort, low donor-site morbidity and high amount compared to bone marrow-derived stem cells. Due to their multilineage differentiation potential in various cell types, immunmodulatory properties and their capability to enhance wound healing, ASC are a promising cell source for tissue engineering approaches and regenerative medicine. They are characterized by the expression of specific surface marker proteins and their differentiation potential into the mesenchymal lineages. Whereas only preclinical studies are published for otorhinolaryngology-related therapeutic options using ASC, various diseases, for instance graft-versus-host disease, have already been treated with ASC in single cases or clinical trials. Safety and genomic stability of ASC as well as the risk of spontaneous malignant transformation are still disputed. This review summarizes the current literature on characterization and anatomic localization of ASC. In addition, beside the presentation of preclinical studies concerning therapeutic approaches in otorhinolaryngology as well as of current clinical applications, the issue of safety of ASC in human stem cell therapy is discussed. © Georg Thieme Verlag KG Stuttgart · New York.

Safety and efficacy of wavefront-guided myopic laser in situ keratomileusis using a new wavefront sensor technology: first 100 cases.

PubMed

Smadja, David; Santhiago, Marcony R; Tellouck, Joy; De Castro, Tania; Lecomte, Fanny; Mello, Glauco R; Touboul, David

2015-08-01

To evaluate the safety and efficacy of wavefront-guided laser in situ keratomileusis (LASIK) for the correction of low to high myopia and myopic astigmatism using data derived from a new-generation Hartmann-Shack aberrometer. Refractive Surgery Unit, Bordeaux Hospital University, France. Retrospective case series. This retrospective study analyzed the initial group of eyes treated with wavefront-guided LASIK for myopia and myopic astigmatism using the Visx S4IR excimer laser and wavefront data derived from a new Hartmann-Shack aberrometer (iDesign Advanced Wavescan aberrometer). Refractive (refraction and refractive accuracy) and visual outcomes (uncorrected [UDVA] and corrected [CDVA] distance visual acuities) were recorded 3 months postoperatively. The study included 100 eyes of 50 consecutively treated patients. The mean decimal UDVA improved from 0.1 ± 0.1 (SD) preoperatively to 1.1 ± 0.15 postoperatively (P < .01). A monocular UDVA of 20/16, 20/20, and 20/25 were achieved in 76.6%, 94.4%, and 96.6% of eyes, respectively. The postoperative manifest spherical equivalent was within ±0.5 diopter in all eyes. No eye lost 2 or more lines of CDVA, and 29.2% of the eyes gained 1 or more lines of CDVA. Wavefront-guided LASIK performed using data derived from the new Hartmann-Shack aberrometer was safe, effective, and predictable for treating myopia and myopic astigmatism. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts.

PubMed

Wallace, Louise M; Spurgeon, Peter; Benn, Jonathan; Koutantji, Maria; Vincent, Charles

2009-08-01

This paper describes practical implications and learning from a multi-method study of feedback from patient safety incident reporting systems. The study was performed using the Safety Action and Information Feedback from Incident Reporting model, a model of the requirements of the feedback element of a patient safety incident reporting and learning system, derived from a scoping review of research and expert advice from world leaders in safety in high-risk industries. We present the key findings of the studies conducted in the National Health Services (NHS) trusts in England and Wales in 2006. These were a survey completed by risk managers for 351 trusts in England and Wales, three case studies including interviews with staff concerning an example of good practice feedback and an audit of 90 trusts clinical risk staff newsletters. We draw on an Expert Workshop that included 71 experts from the NHS, from regulatory bodies in health care, Royal Colleges, Health and Safety Executive and safety agencies in health care and high-risk industries (commercial aviation, rail and maritime industries). We draw recommendations of enduring relevance to the UK NHS that can be used by trust staff to improve their systems. The recommendations will be of relevance in general terms to health services worldwide.

Recommendations for toxicological investigation of drug-impaired driving and motor vehicle fatalities.

PubMed

Logan, Barry K; Lowrie, Kayla J; Turri, Jennifer L; Yeakel, Jillian K; Limoges, Jennifer F; Miles, Amy K; Scarneo, Colleen E; Kerrigan, Sarah; Farrell, Laurel J

2013-10-01

This report describes the review and update of a set of minimum recommendations for the toxicological investigation of suspected alcohol and drug-impaired driving cases and motor vehicle fatalities involving drugs or alcohol. The recommendations have the goal of ensuring that a consistent set of data regarding the most frequently encountered drugs linked to driving impairment is collected for practical application in the investigation of these cases and to allow epidemiological monitoring and the development of evidence-based public policy on this important public safety issue. The recommendations are based on a survey of practices in US laboratories performing this kind of analysis, consideration of existing epidemiological crash and arrest data and practical considerations of widely available technology platforms in laboratories performing this work. The final recommendations were derived from a consensus meeting of experts recruited from survey respondents and the membership of the National Safety Council's Alcohol, Drug and Impairment Division (formerly known as the Committee on Alcohol and Other Drugs, CAOD).

A study on current risk assessments and guidelines on the use of food animal products derived from cloned animals.

PubMed

Hur, Sun Jin

2017-10-01

The author widely surveyed and analyzed the food safety issues, ethical issues, permits, and approval of animal products from animals cloned by somatic cell nuclear transfer worldwide. As a result of a 2-year survey, the author found that there is no evidence that meat and milk derived from cloned animals or their progeny pose a risk to food safety in terms of genotoxicity, adverse reproductive effects, or allergic reactions. Most countries have not approved meat and milk derived from cloned animals, and their progeny are entering the food supply. To establish the guidelines, the author suggests four principles of safety assessment for meat and milk derived from cloned animals. The four main principles for safety assessment are similarities of chemical composition, adverse reproductive effects, genotoxicity, and allergic reactions under the influence of meat and milk from cloned animals and noncloned counterparts. This principle means that meat and milk derived from a cloned animal are safe if there are no differences in the four safety assessments of meat and milk between cloned animal's progeny and noncloned counterparts. Copyright © 2017 Elsevier Ltd. All rights reserved.

Smeed's law and expected road fatality reduction: An assessment of the Italian case.

PubMed

Persia, Luca; Gigli, Roberto; Usami, Davide Shingo

2015-12-01

Smeed's law defines the functional relationship existing between the fatality rate and the motorization rate.While focusing on the Italian case and based on the Smeed's law, the study assesses the possibility for Italy of reaching the target of halving the number of road fatalities by 2020, in light of the evolving socioeconomic situation. A Smeed's model has been calibrated based on the recorded Italian data. The evolution of the two indicators, fatality and motorization rates, has been estimated using the predictions of the main parameters (population, fleet size and fatalities). Those trends have been compared with the natural decreasing trend derived from the Smeed's law. Nine scenarios have been developed showing the relationship between the fatality rate and the motorization rate. In case of a limited increase (logistic regression) of the vehicle fleet and according to the estimated evolution of the population, the path defined by motorization and fatality rate is very steep, diverging from the estimated confidence interval of the Smeed's model. In these scenarios the motorization rate is almost constant during the decade. In the actual economic context, a limited development of the vehicle fleet is more plausible. In these conditions the target achievement of halving the number of fatalities in Italy may occur only in case of a structural break (i.e., the introduction of highly effective road safety policies). Practical application: The proposed tools can be used both to evaluate retrospectively the effectiveness of road safety improvements and to assess if a relevant effort is needed to reach the established road safety targets.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Deep Borehole Disposal Safety Analysis.

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

Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

[Safety assessment of foods derived from genetically modified plants].

PubMed

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Applying Human Factors Principles to Mitigate Usability Issues Related to Embedded Assumptions in Health Information Technology Design

PubMed Central

Lowry, Svetlana Z; Patterson, Emily S

2014-01-01

Background There is growing recognition that design flaws in health information technology (HIT) lead to increased cognitive work, impact workflows, and produce other undesirable user experiences that contribute to usability issues and, in some cases, patient harm. These usability issues may in turn contribute to HIT utilization disparities and patient safety concerns, particularly among “non-typical” HIT users and their health care providers. Health care disparities are associated with poor health outcomes, premature death, and increased health care costs. HIT has the potential to reduce these disparate outcomes. In the computer science field, it has long been recognized that embedded cultural assumptions can reduce the usability, usefulness, and safety of HIT systems for populations whose characteristics differ from “stereotypical” users. Among these non-typical users, inappropriate embedded design assumptions may contribute to health care disparities. It is unclear how to address potentially inappropriate embedded HIT design assumptions once detected. Objective The objective of this paper is to explain HIT universal design principles derived from the human factors engineering literature that can help to overcome potential usability and/or patient safety issues that are associated with unrecognized, embedded assumptions about cultural groups when designing HIT systems. Methods Existing best practices, guidance, and standards in software usability and accessibility were subjected to a 5-step expert review process to identify and summarize those best practices, guidance, and standards that could help identify and/or address embedded design assumptions in HIT that could negatively impact patient safety, particularly for non-majority HIT user populations. An iterative consensus-based process was then used to derive evidence-based design principles from the data to address potentially inappropriate embedded cultural assumptions. Results Design principles that may help identify and address embedded HIT design assumptions are available in the existing literature. Conclusions Evidence-based HIT design principles derived from existing human factors and informatics literature can help HIT developers identify and address embedded cultural assumptions that may underlie HIT-associated usability and patient safety concerns as well as health care disparities. PMID:27025349

Applying Human Factors Principles to Mitigate Usability Issues Related to Embedded Assumptions in Health Information Technology Design.

PubMed

Gibbons, Michael C; Lowry, Svetlana Z; Patterson, Emily S

2014-12-18

There is growing recognition that design flaws in health information technology (HIT) lead to increased cognitive work, impact workflows, and produce other undesirable user experiences that contribute to usability issues and, in some cases, patient harm. These usability issues may in turn contribute to HIT utilization disparities and patient safety concerns, particularly among "non-typical" HIT users and their health care providers. Health care disparities are associated with poor health outcomes, premature death, and increased health care costs. HIT has the potential to reduce these disparate outcomes. In the computer science field, it has long been recognized that embedded cultural assumptions can reduce the usability, usefulness, and safety of HIT systems for populations whose characteristics differ from "stereotypical" users. Among these non-typical users, inappropriate embedded design assumptions may contribute to health care disparities. It is unclear how to address potentially inappropriate embedded HIT design assumptions once detected. The objective of this paper is to explain HIT universal design principles derived from the human factors engineering literature that can help to overcome potential usability and/or patient safety issues that are associated with unrecognized, embedded assumptions about cultural groups when designing HIT systems. Existing best practices, guidance, and standards in software usability and accessibility were subjected to a 5-step expert review process to identify and summarize those best practices, guidance, and standards that could help identify and/or address embedded design assumptions in HIT that could negatively impact patient safety, particularly for non-majority HIT user populations. An iterative consensus-based process was then used to derive evidence-based design principles from the data to address potentially inappropriate embedded cultural assumptions. Design principles that may help identify and address embedded HIT design assumptions are available in the existing literature. Evidence-based HIT design principles derived from existing human factors and informatics literature can help HIT developers identify and address embedded cultural assumptions that may underlie HIT-associated usability and patient safety concerns as well as health care disparities.

77 FR 29665 - International Conference on Harmonisation; Addendum to International Conference on Harmonisation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability AGENCY: Food and Drug... availability of a guidance entitled ``S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived... implementation of the ICH guidance [[Page 29666

Roy's safety-first portfolio principle in financial risk management of disastrous events.

PubMed

Chiu, Mei Choi; Wong, Hoi Ying; Li, Duan

2012-11-01

Roy pioneers the concept and practice of risk management of disastrous events via his safety-first principle for portfolio selection. More specifically, his safety-first principle advocates an optimal portfolio strategy generated from minimizing the disaster probability, while subject to the budget constraint and the mean constraint that the expected final wealth is not less than a preselected disaster level. This article studies the dynamic safety-first principle in continuous time and its application in asset and liability management. We reveal that the distortion resulting from dropping the mean constraint, as a common practice to approximate the original Roy's setting, either leads to a trivial case or changes the problem nature completely to a target-reaching problem, which produces a highly leveraged trading strategy. Recognizing the ill-posed nature of the corresponding Lagrangian method when retaining the mean constraint, we invoke a wisdom observed from a limited funding-level regulation of pension funds and modify the original safety-first formulation accordingly by imposing an upper bound on the funding level. This model revision enables us to solve completely the safety-first asset-liability problem by a martingale approach and to derive an optimal policy that follows faithfully the spirit of the safety-first principle and demonstrates a prominent nature of fighting for the best and preventing disaster from happening. © 2012 Society for Risk Analysis.

U. K. pressing campaign to improve offshore safety

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

Knott, D.

1994-02-14

The U.K. government is making progress in its campaign to improve the safety of personnel working offshore. The government's Health and Safety Executive (HSE) plans to assess and pass judgment on at lease one safety plan, called a safety case, from each U.K. North Sea operator as soon as possible. HSE has agreed with the industry on a list of 61 priority safety cases, known as exemplars. Feedback from exemplar assessment will help operators review safety management and assist in preparation or revision of future safety cases. It also will give HSE practice in assessing a range of case types.more » The requirement for a safety program is part of new U.K. offshore legislation designed to prevent another accident similar to the Piper Alpha platform fire and explosion of 1988. After the transition period it will be against the law to operate an oil and gas installation in British waters without an accepted safety case. Besides existing installations, safety cases are also required for new installations reaching design stage by May 31, 1993, the date safety case regulations went into force. The paper describes the Cullen report, companies' experiences with the new law, and the safety assessment progress so far.« less

The relevance of gene transfer to the safety of food and feed derived from genetically modified (GM) plants.

PubMed

van den Eede, G; Aarts, H; Buhk, H-J; Corthier, G; Flint, H J; Hammes, W; Jacobsen, B; Midtvedt, T; van der Vossen, J; von Wright, A; Wackernagel, W; Wilcks, A

2004-07-01

In 2000, the thematic network ENTRANSFOOD was launched to assess four different topics that are all related to the testing or assessment of food containing or produced from genetically modified organisms (GMOs). Each of the topics was linked to a European Commission (EC)-funded large shared cost action (see http://www.entransfood.com). Since the exchange of genetic information through horizontal (lateral) gene transfer (HGT) might play a more important role, in quantity and quality, than hitherto imagined, a working group dealing with HGT in the context of food and feed safety was established. This working group was linked to the GMOBILITY project (GMOBILITY, 2003) and the results of the deliberations are laid down in this review paper. HGT is reviewed in relation to the potential risks of consuming food or feed derived from transgenic crops. First, the mechanisms for obtaining transgenic crops are described. Next, HGT mechanisms and its possible evolutionary role are described. The use of marker genes is presented in detail as a special case for genes that may pose a risk. Furthermore, the exposure to GMOs and in particular to genetically modified (GM) deoxyribonucleic acid (DNA) is discussed as part of the total risk assessment. The review finishes off with a number of conclusions related to GM food and feed safety. The aim of this paper is to provide a comprehensive overview to assist risk assessors as well as regulators and the general public in understanding the safety issues related to these mechanisms. Copryright 2004 Elsevier Ltd.

Formal Foundations for Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2015-01-01

Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2010-01-01 2010-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2011-01-01 2011-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

Use of Fomepizole in Pediatric Methanol Exposure: The First Case Report in Taiwan and a Literature Review.

PubMed

Chen, Tzu-Hua; Kuo, Chang-Hung; Huang, Chia-Tsuan; Wang, Wei-Li

2016-08-01

Methanol poisoning is rare in the pediatric population, but a delay in diagnosis and intervention may cause severe morbidity and mortality. The current therapy for methanol poisoning is ethanol or fomepizole, which acts as a competitive inhibitor of hepatic alcohol dehydrogenase to inhibit the production of toxic metabolites derived from the oxidation of methanol. However, clinical experience in pediatric methanol poisoning is limited, and the safety profiles of the antidotes have not been established in children, especially in Asian populations. This is the first case to describe the use of fomepizole in a child with methanol exposure in Taiwan. Copyright © 2013. Published by Elsevier B.V.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk.

PubMed

Eyles, John; Heddle, Nancy; Webert, Kathryn; Arnold, Emmy; McCurdy, Bronwen

2011-08-24

Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk

PubMed Central

2011-01-01

Background Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Methods Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. Results While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Conclusions Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches. PMID:21864330

New safety rules challenge U. K. operators, regulators

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

Hudson, J.

1994-08-15

Offshore safety regulations based on lessons learned from the Piper Alpha blast of 1988 have been in operation in the U.K. for a year. The Offshore Installations (Safety Case) Regulations 1992 make operators of fixed and mobile installations (the duty holders'') responsible for producing a formal safety assessment, or safety case, for each installation. After the end of November 1995 it will be an offense to operate an installation without a safety case which has been approved by the government's Health and Safety Executive (HSE). Producing safety cases for installations is a major task for duty holder, while assessing themmore » is a huge under taking for HSE's Offshore Safety Division (OSD). This paper reviews how HSE has established management arrangements to handle safety cases, considers progress in assessment, highlights some of the important lessons learned, and look to the future.« 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.

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

PubMed

Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Safety Assessment of Panax spp Root-Derived Ingredients as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

48 CFR 923.7001 - Nuclear safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from the...

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

Correlation of genetic variability with safety of mumps vaccine Urabe AM9 strain.

PubMed

Amexis, G; Fineschi, N; Chumakov, K

2001-08-15

The Urabe AM9 strain of mumps vaccine live is known for its genetic instability and some vaccines derived from this strain were withdrawn from the market due to an excessive number of vaccine-associated parotitis and meningitis cases. To identify the molecular basis of this instability, we determined complete nucleotide sequences of several stocks of the Urabe strain used for vaccine production by different manufacturers and of two clinical isolates from cases of vaccine-associated meningitis. In contrast to previously published studies relating the Lys335 --> Glu mutation in the viral HN gene with neurovirulence of mumps virus, we could not confirm any association of this mutation with the safety of mumps vaccine. Each of the three vaccine stocks studied had its own characteristic profile of mutations that was identified by cDNA sequencing and quantitated by mutant analysis by PCR and restriction enzyme cleavage. Determination of the mutational profile of mumps vaccine lots could allow vaccine manufacturers to characterize seed viruses and monitor the consistency of vaccine production to prevent emergence of virulent revertants.

Collapse Mechanisms Of Masonry Structures

NASA Astrophysics Data System (ADS)

Zuccaro, G.; Rauci, M.

2008-07-01

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of one of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.

Collapse Mechanisms Of Masonry Structures

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

Zuccaro, G.; Rauci, M.

2008-07-08

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of onemore » of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.« less

Using Smart Pumps to Understand and Evaluate Clinician Practice Patterns to Ensure Patient Safety

PubMed Central

Mansfield, Jennifer; Jarrett, Steven

2013-01-01

Background: Safety software installed on intravenous (IV) infusion pumps has been shown to positively impact the quality of patient care through avoidance of medication errors. The data derived from the use of smart pumps are often overlooked, although these data provide helpful insight into the delivery of quality patient care. Objective: The objectives of this report are to describe the value of implementing IV infusion safety software and analyzing the data and reports generated by this system. Case study: Based on experience at the Carolinas HealthCare System (CHS), executive score cards provide an aggregate view of compliance rate, number of alerts, overrides, and edits. The report of serious errors averted (ie, critical catches) supplies the location, date, and time of the critical catch, thereby enabling management to pinpoint the end-user for educational purposes. By examining the number of critical catches, a return on investment may be calculated. Assuming 3,328 of these events each year, an estimated cost avoidance would be $29,120,000 per year for CHS. Other reports allow benchmarking between institutions. Conclusion: A review of the data about medication safety across CHS has helped garner support for a medication safety officer position with the goal of ultimately creating a safer environment for the patient. PMID:24474836

Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

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

Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.

Safety tests were conducted on fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800 °C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during 15 of these safety tests. Comparisons between PARFUME predictions and post-irradiation examination results of the safety tests were conducted on two types of AGR-1 compacts: compactsmore » containing only intact particles and compacts containing one or more particles whose SiC layers failed during safety testing. In both cases, PARFUME globally over-predicted the experimental release fractions by several orders of magnitude: more than three (intact) and two (failed SiC) orders of magnitude for silver, more than three and up to two orders of magnitude for strontium, and up to two and more than one orders of magnitude for krypton. The release of cesium from intact particles was also largely over-predicted (by up to five orders of magnitude) but its release from particles with failed SiC was only over-predicted by a factor of about 3. These over-predictions can be largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. The integral release nature of the data makes it difficult to estimate the individual over-estimations in the kernel or each coating layer. Nevertheless, a tentative assessment of correction factors to these diffusivities was performed to enable a better match between the modeling predictions and the safety testing results. The method could only be successfully applied to silver and cesium. In the case of strontium, correction factors could not be assessed because potential release during the safety tests could not be distinguished from matrix content released during irradiation. Furthermore, in the case of krypton, all the coating layers are partly retentive and the available data did not allow the level of retention in individual layers to be determined, hence preventing derivation of any correction factors.« less

Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

DOE PAGES

Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.; ...

2016-04-07

Safety tests were conducted on fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800 °C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during 15 of these safety tests. Comparisons between PARFUME predictions and post-irradiation examination results of the safety tests were conducted on two types of AGR-1 compacts: compactsmore » containing only intact particles and compacts containing one or more particles whose SiC layers failed during safety testing. In both cases, PARFUME globally over-predicted the experimental release fractions by several orders of magnitude: more than three (intact) and two (failed SiC) orders of magnitude for silver, more than three and up to two orders of magnitude for strontium, and up to two and more than one orders of magnitude for krypton. The release of cesium from intact particles was also largely over-predicted (by up to five orders of magnitude) but its release from particles with failed SiC was only over-predicted by a factor of about 3. These over-predictions can be largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. The integral release nature of the data makes it difficult to estimate the individual over-estimations in the kernel or each coating layer. Nevertheless, a tentative assessment of correction factors to these diffusivities was performed to enable a better match between the modeling predictions and the safety testing results. The method could only be successfully applied to silver and cesium. In the case of strontium, correction factors could not be assessed because potential release during the safety tests could not be distinguished from matrix content released during irradiation. Furthermore, in the case of krypton, all the coating layers are partly retentive and the available data did not allow the level of retention in individual layers to be determined, hence preventing derivation of any correction factors.« less

Deriving a no expected sensitization induction level for fragrance ingredients without animal testing: An integrated approach applied to specific case studies.

PubMed

Natsch, Andreas; Emter, Roger; Haupt, Tina; Ellis, Graham

2018-06-01

Cosmetic regulations prohibit animal testing for the purpose of safety assessment and recent REACH guidance states that the local lymph node assay (LLNA) in mice shall only be conducted if in vitro data cannot give sufficient information for classification and labelling. However, Quantitative Risk Assessment (QRA) for fragrance ingredients requires a NESIL, a dose not expected to cause induction of skin sensitization in humans. In absence of human data, this is derived from the LLNA and it remains a key challenge for risk assessors to derive this value from non-animal data. Here we present a workflow using structural information, reactivity data and KeratinoSens results to predict a LLNA result as a point of departure. Specific additional tests (metabolic activation, complementary reactivity tests) are applied in selected cases depending on the chemical domain of a molecule. Finally, in vitro and in vivo data on close analogues are used to estimate uncertainty of the prediction in the specific chemical domain. This approach was applied to three molecules which were subsequently tested in the LLNA and 22 molecules with available and sometimes discordant human and LLNA data. Four additional case studies illustrate how this approach is being applied to recently developed molecules in the absence of animal data. Estimation of uncertainty and how this can be applied to determine a final NESIL for risk assessment is discussed. We conclude that, in the data-rich domain of fragrance ingredients, sensitization risk assessment without animal testing is possible in most cases by this integrated approach.

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety.

PubMed

Li, Rongxia; Stewart, Brock; Weintraub, Eric

2016-01-01

The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. In this study, we derived the asymptotic relative efficiency (ARE) between these two methods to quantify this loss in power in the SCRI design. The equation is formulated as [Formula: see text] (a: control window-length ratio between SCRI and SCCS designs; b: ratio of risk window length and control window length in the SCCS design; and [Formula: see text]: relative risk of exposed window to control window). According to this equation, the relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk [Formula: see text]. We provide an example utilizing data from the Vaccine Safety Datalink (VSD) to study the potential elevated risk of febrile seizure following seasonal influenza vaccine in the 2010-2011 season.

Review Guidelines for Software Languages for use in Nuclear Power Plant Safety Systems

DTIC Science & Technology

1997-10-01

desirable to segregate base classes from derived classes. Review is facilitated and safety is enhanced if project-specific guidance is provided on the... Segregate base from derived classes. In C++, it is desirable to segregate base classes from derived classes. 4.4.1.8 Minimizing Use of Literals...memory utilization. At the lowest level are base attributes, i.e., attributes xv NUREG/CR-6463 Rev. 1 sufficiently specific to define guidelines. An

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Sulphur-Containing Heterocycles as Antimycobacterial Agents: Recent Advances in Thiophene and Thiadiazole Derivatives.

PubMed

Krátký, Martin; Vinsova, Jarmila

2016-01-01

The global tuberculosis epidemic and emergence of drug resistance call for intensive research on new antimycobacterial agents. Recent development is focused mainly on heterocyclic molecules. In many cases, introduction of sulphur has improved antimicrobial activity; many drugs feature a sulphur heterocycle. Thiophene derivatives and thiadiazoles including derived ortho-condensed heterocycles have been found to have a wide range of biological activities. This review highlights the recent progress in the field with a focus on whole-cell antimycobacterial activity of the agents as well as targeting of enzymes from Mycobacterium tuberculosis. Some of the compounds have exhibited high activity with submicromolar minimum inhibitory concentrations including activity against drug-resistant strains and/or IC50 values for a range of enzymes as their targets (InhA, dehydroquinase, Pks13, carbonic anhydrases, DprE1). Mechanisms of action, toxicity, and structure-activity relationships are also discussed. Several compounds have exhibited promising in vitro and in vivo activities and safety profiles, thus constituting novel, promising leads.

Tailoring in risk communication by linking risk profiles and communication preferences: The case of speeding of young car drivers.

PubMed

Geber, Sarah; Baumann, Eva; Klimmt, Christoph

2016-12-01

Speeding is one of the most relevant risk behaviors for serious and fatal accidents, particularly among young drivers. This study presents a tailoring strategy for anti-speeding communication. By referring to their motivational dispositions toward speeding derived from motivational models of health behavior, young car drivers were segmented into different risk groups. In order to ensure that risk communication efforts would actually be capable to target these groups, the linkage between the risk profiles and communication preferences were explored. The study was conducted on the basis of survey data of 1168 German car drivers aged between 17 and 24 years. The data reveal four types of risk drivers significantly differing in their motivational profiles. Moreover, the findings show significant differences in communication habits and media use between these risk groups. By linking the risk profiles and communication preferences, implications for tailoring strategies of road safety communication campaigns are derived. Promising segmentation and targeting strategies are discussed also beyond the current case of anti-speeding campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.

DISPELLING MYTHS AND MISCONCEPTIONS TO IMPLEMENT A SAFETY CULTURE

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

Potts, T. Todd; Smith, Ken; Hylko, James M.

2003-02-27

Industrial accidents are typically reported in terms of technological malfunctions, ignoring the human element in accident causation. However, over two-thirds of all accidents are attributable to human and organizational factors (e.g., planning, written procedures, job factors, training, communication, and teamwork), thereby affecting risk perception, behavior and attitudes. This paper reviews the development of WESKEM, LLC's Environmental, Safety, and Health (ES&H) Program that addresses human and organizational factors from a top-down, bottom-up approach. This approach is derived from the Department of Energy's Integrated Safety Management System. As a result, dispelling common myths and misconceptions about safety, while empowering employees to ''STOPmore » work'' if necessary, have contributed to reducing an unusually high number of vehicle, ergonomic and slip/trip/fall incidents successfully. Furthermore, the safety culture that has developed within WESKEM, LLC's workforce consists of three common characteristics: (1) all employees hold safety as a value; (2) each individual feels responsible for the safety of their co-workers as well as themselves; and (3) each individual is willing and able to ''go beyond the call of duty'' on behalf of the safety of others. WESKEM, LLC as a company, upholds the safety culture and continues to enhance its existing ES&H program by incorporating employee feedback and lessons learned collected from other high-stress industries, thereby protecting its most vital resource - the employees. The success of this program is evident by reduced accident and injury rates, as well as the number of safe work hours accrued while performing hands-on field activities. WESKEM, LLC (Paducah + Oak Ridge) achieved over 800,000 safe work hours through August 2002. WESKEM-Paducah has achieved over 665,000 safe work hours without a recordable injury or lost workday case since it started operations on February 28, 2000.« less

Longitudinal safety evaluation of electric vehicles with the partial wireless charging lane on freeways.

PubMed

Li, Ye; Wang, Wei; Xing, Lu; Fan, Qi; Wang, Hao

2018-02-01

As an environment friendly transportation mode, the electric vehicle (EV) has drawn an increasing amount of attention from governments, vehicle manufactories and researchers recently. One of the biggest issue impeding EV's popularization associates with the charging process. The wireless charging lane (WCL) has been proposed as a convenient charging facility for EVs. Due to the high costs, the application of WCL on the entire freeways is impractical in the near future, while the partial WCL (PWCL) may be a feasible solution. This study aims to evaluate longitudinal safety of EVs with PWCL on freeways based on simulations. The simulation experiments are firstly designed, including deployment of PWCL on freeways and distribution of state of charge (SOC) of EVs. Then, a vehicle behavior model for EVs is proposed based on the intelligent driver model (IDM). Two surrogate safety measures, derived from time-to-collision (TTC), are utilized as indicators for safety evaluations. Sensitivity analysis is also conducted for related factors. Results show that the distribution of EVs' SOC significantly affect longitudinal safety when the PWCL is utilized. The low SOC in traffic consisting of EVs has the negative effect on longitudinal safety. The randomness and incompliance of EV drivers worsens the safety performance. The sensitivity analysis indicates that the larger maximum deceleration rate results in the higher longitudinal crash risks of EVs, while the length of PWCL has no monotonous effect. Different TTC thresholds also show no impact on results. A case study shows the consistent results. Based on the findings, several suggestions are discussed for EVs' safety improvement. Results of this study provide useful information for freeway safety when EVs are applied in the future. Copyright © 2017 Elsevier Ltd. All rights reserved.

An Overview on Recent Progress in Electrochemical Biosensors for Antimicrobial Drug Residues in Animal-Derived Food

PubMed Central

Majdinasab, Marjan; Yaqub, Mustansara; Rahim, Abdur; Catanante, Gaelle; Hayat, Akhtar; Marty, Jean Louis

2017-01-01

Anti-microbial drugs are widely employed for the treatment and cure of diseases in animals, promotion of animal growth, and feed efficiency. However, the scientific literature has indicated the possible presence of antimicrobial drug residues in animal-derived food, making it one of the key public concerns for food safety. Therefore, it is highly desirable to design fast and accurate methodologies to monitor antimicrobial drug residues in animal-derived food. Legislation is in place in many countries to ensure antimicrobial drug residue quantities are less than the maximum residue limits (MRL) defined on the basis of food safety. In this context, the recent years have witnessed a special interest in the field of electrochemical biosensors for food safety, based on their unique analytical features. This review article is focused on the recent progress in the domain of electrochemical biosensors to monitor antimicrobial drug residues in animal-derived food. PMID:28837093

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

Strain Gage Load Calibration of the Wing Interface Fittings for the Adaptive Compliant Trailing Edge Flap Flight Test

NASA Technical Reports Server (NTRS)

Miller, Eric J.; Holguin, Andrew C.; Cruz, Josue; Lokos, William A.

2014-01-01

The safety-of-flight parameters for the Adaptive Compliant Trailing Edge (ACTE) flap experiment require that flap-to-wing interface loads be sensed and monitored in real time to ensure that the structural load limits of the wing are not exceeded. This paper discusses the strain gage load calibration testing and load equation derivation methodology for the ACTE interface fittings. Both the left and right wing flap interfaces were monitored; each contained four uniquely designed and instrumented flap interface fittings. The interface hardware design and instrumentation layout are discussed. Twenty-one applied test load cases were developed using the predicted in-flight loads. Pre-test predictions of strain gage responses were produced using finite element method models of the interface fittings. Predicted and measured test strains are presented. A load testing rig and three hydraulic jacks were used to apply combinations of shear, bending, and axial loads to the interface fittings. Hardware deflections under load were measured using photogrammetry and transducers. Due to deflections in the interface fitting hardware and test rig, finite element model techniques were used to calculate the reaction loads throughout the applied load range, taking into account the elastically-deformed geometry. The primary load equations were selected based on multiple calibration metrics. An independent set of validation cases was used to validate each derived equation. The 2-sigma residual errors for the shear loads were less than eight percent of the full-scale calibration load; the 2-sigma residual errors for the bending moment loads were less than three percent of the full-scale calibration load. The derived load equations for shear, bending, and axial loads are presented, with the calculated errors for both the calibration cases and the independent validation load cases.

The role of eye protection in work-related eye injuries.

PubMed

Fong, L P; Taouk, Y

1995-05-01

A recent survey of general hospitals by the Victorian Injury Surveillance System found that ocular trauma represented 15% of work-related injuries. As circumstances surrounding occupational eye injuries have been poorly documented previously, their associations to occupation, industry and work-safety practices, including safety eyewear use, need to be identified to develop appropriate preventive strategies for high-risk groups. From a prospective cross-sectional survey of all eye injuries treated at the Royal Victorian Eye and Ear Hospital, work-related cases were analysed for demographic, occupational and safety eye-wear information. Hospital-based data were supplemented by information from WorkCover Authorities and Labour Force statistics to derive incidence and cost estimates. There were 9390 eye injuries during the 18-month survey period; 42% (n=3923) of total and 29% (n=52) of penetrating ocular injuries occurred at work. The most frequently injured were metal, automotive and building trades workers grinding and drilling (41% of outpatients) and hammering (53% of penetrating eye injuries). Automotive workers had the highest frequency for penetrating injuries, and most were exposed to hammering and were also the least likely to wear safety eye-wear. Eye injuries are frequent (10% of work-related injuries) and highly preventable by the correct use of safety eye-wear, a cost-effective intervention that may result in cost savings of $59 million for work-type activities in the occupational and domestic settings in Australia each year.

Attributing foodborne salmonellosis in humans to animal reservoirs in the European Union using a multi-country stochastic model.

PubMed

DE Knegt, L V; Pires, S M; Hald, T

2015-04-01

A Bayesian modelling approach comparing the occurrence of Salmonella serovars in animals and humans was used to attribute salmonellosis cases to broilers, turkeys, pigs, laying hens, travel and outbreaks in 24 European Union countries. Salmonella data for animals and humans, covering the period from 2007 to 2009, were mainly obtained from studies and reports published by the European Food Safety Authority. Availability of food sources for consumption was derived from trade and production data from the European Statistical Office. Results showed layers as the most important reservoir of human salmonellosis in Europe, with 42·4% (7 903 000 cases, 95% credibility interval 4 181 000-14 510 000) of cases, 95·9% of which was caused by S. Enteritidis. In Finland and Sweden, most cases were travel-related, while in most other countries the main sources were related to the laying hen or pig reservoir, highlighting differences in the epidemiology of Salmonella, surveillance focus and eating habits across the European Union.

Radionuclide administration to nursing mothers: mathematically derived guidelines

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

Romney, B.M.; Nickoloff, E.L.; Esser, P.D.

We determined a formula to establish objective guidelines for the administration of radionuclides to nursing mothers. The formula is based on the maximum permissible dose to the infant's critical organ, serial measurements of breast milk activity, milk volume, and dose to the critical organ per microcurie in milk. Using worst-case assumptions, we believe that cessation of nursing for 24 hours after administration of technetium labeled radiopharmaceuticals is sufficient for safety. Longer-lived agents require greater delays. Iodine-123 radiopharmaceuticals are preferable to iodine-131 agents and should always be used when studying the unblocked thyroid.

A study of patient safety management in the framework of clinical governance according to the nurses working in the ICU of the hospitals in the East of Tehran.

PubMed

Sahebalzamani, Mohammad; Mohammady, Mohsen

2014-05-01

The improvement of patient safety conditions in the framework of clinical service governance is one of the most important concerns worldwide. The importance of this issue and its effects on the health of patients encouraged the researcher to conduct this study to evaluate patient safety management in the framework of clinical governance according to the nurses working in the intensive care units (ICUs) of the hospitals of the east of Tehran, Iran in 2012. This descriptive study, which was based on census method, was conducted on 250 nurses sampled from the hospitals located in the east of Tehran. For the collection of data, a researcher-made questionnaire in five categories, including culture, leadership, training, environment, and technology, as well as on safety items was used. To test the validity of the questionnaire, content validity test was conducted, and the reliability of the questionnaire was assessed by retest method, in which the value of alpha was equal to 91%. The results showed that safety culture was at a high level in 55% of cases, safety leadership was at a high level in 40% cases and at a low level in 2.04% cases, safety training was at a high level in 64.8% cases and at a low level in 4% cases, safety of environment and technology was at a high level in 56.8% cases and at a low level in 1.6% cases, and safety items of the patients in their reports were at a high level in approximately 44% cases and at a low level in 6.5% cases. The results of Student's t-test (P < 0.001) showed that the average score of all safety categories of the patients was significantly higher than the average points. Diligence of the management and personnel of the hospital is necessary for the improvement of safety management. For this purpose, the management of hospitals can show interest in safety, develop an events reporting system, enhance teamwork, and implement clinical governance plans.

Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Whiteside, Iain J.

2012-01-01

We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms.

PubMed

Constable, A; Jonas, D; Cockburn, A; Davi, A; Edwards, G; Hepburn, P; Herouet-Guicheney, C; Knowles, M; Moseley, B; Oberdörfer, R; Samuels, F

2007-12-01

Very few traditional foods that are consumed have been subjected to systematic toxicological and nutritional assessment, yet because of their long history and customary preparation and use and absence of evidence of harm, they are generally regarded as safe to eat. This 'history of safe use' of traditional foods forms the benchmark for the comparative safety assessment of novel foods, and of foods derived from genetically modified organisms. However, the concept is hard to define, since it relates to an existing body of information which describes the safety profile of a food, rather than a precise checklist of criteria. The term should be regarded as a working concept used to assist the safety assessment of a food product. Important factors in establishing a history of safe use include: the period over which the traditional food has been consumed; the way in which it has been prepared and used and at what intake levels; its composition and the results of animal studies and observations from human exposure. This paper is aimed to assist food safety professionals in the safety evaluation and regulation of novel foods and foods derived from genetically modified organisms, by describing the practical application and use of the concept of 'history of safe use'.

Recent Cases: Administrative Law--Occupational Safety and Health Act

ERIC Educational Resources Information Center

Harvard Law Review, 1976

1976-01-01

Implications of the Occupational Safety and Health Act of 1970 are described in two cases: Brennan v. Occupational Safety and Health Review Commission (Underhill Construction Corp.), and Anning-Johnson Co. v. United States Occupational Safety and Health Review Commission. (LBH)

An examination of some safety issues among commercial motorcyclists in Nigeria: a case study.

PubMed

Arosanyin, Godwin Tunde; Olowosulu, Adekunle Taiwo; Oyeyemi, Gafar Matanmi

2013-01-01

The reduction of road crashes and injuries among motorcyclists in Nigeria requires a system inquiry into some safety issues at pre-crash, crash and post-crash stages to guide action plans. This paper examines safety issues such as age restriction, motorcycle engine capacity, highway code awareness, licence holding, helmet usage, crash involvement, rescue and payment for treatment among commercial motorcyclists. The primary data derived from a structured questionnaire administered to 334 commercial motorcyclists in Samaru, Zaria were analysed using descriptive statistics and logistic regression technique. There was total compliance with age restriction and motorcycle engine capacity. About 41.8% of the operators were not aware of the existence of the highway code. The odds of licence holding increased with highway code awareness, education with above senior secondary as the reference category and earnings. The odds of crash involvement decreased with highway code awareness, earnings and mode of operation. About 84% of the motorcyclists did not use crash helmet, in spite of being aware of the benefit, and 65.4% of motorcycle crashes was found to be with other road users. The promotion of safety among motorcyclists therefore requires strict traffic law enforcement and modification of road design to segregate traffic and protect pedestrians.

International regulations on labour health and safety applied to fishing and maritime transport sectors. Are maritime workers under-protected.

PubMed

Rodríguez, Julio Louro; Portela, Rosa Mary de la Campa; Pardo, Guadalupe Martín

2012-01-01

The work activity developed on board is of great importance in our nearby environment, and it has a series of peculiarities that determine the service rendering of sea workers. On the other hand, work at sea is developed on an international basis. Nowadays such work becomes a completely globalised industrial sector in relation to the elements that make up the ship's operation, including manpower. For that reason several relevant international organisations have paid attention to this industrial sector and have adopted a broad regulation on this matter. In the case of the European Union, the Community procedure emphasises enormous interest in providing specific and comprehensive training to seafarers, as well as in regulating working time on board with the aim of minimising the safety problems caused by fatigue. In the present article a schematic presentation of regulations on workers' health and occupational safety protection derived from the European Union, the International Maritime Organisation, and the International Labour Organisation has been done. Also it shows what parts of these regulations are not applicable to the work on board, and it reveals how the workers of fishing and maritime transport sectors are under-protected with regard to the guarantee of their health and occupational safety compared to workers in other sectors.

Poisoning due to tutin in honey-a report of an outbreak in New Zealand.

PubMed

Beasley, Michael; Hood, Dell; Anderson, Philippa; Reeve, John; Slaughter, Robin J

2018-04-13

In autumn 2008, an outbreak of toxic honey poisoning was identified. The outbreak was not recognised initially until three cases from one family group presented to hospital, with a common factor of recent consumption of locally produced honey. The aim of this study was to investigate potential cases of this honey poisoning and determine which toxin was involved. The incident was investigated retrospectively by Waikato District Health Board's Population Health unit and the New Zealand Food Safety Authority (NZFSA). Identified patients were followed up by questionnaire to gather case information. HortResearch (now Plant and Food Research) tested honey samples for toxins. The causative agent was identified as tutin, which comes from the New Zealand native plant tutu (Coriaria arborea) which has long been known as a potential source of contamination of honey produced in the warmer parts of New Zealand. Retrospective case investigation identified a total of 22 possible or probable cases, based on a clinical case definition. The spectrum of toxic effects reported were broadly similar to those previously described for tutin, derived either directly from the plant itself or indirectly from honey. There were 13 samples of honey, linked to symptomatic individuals, which were available for testing. Of these, 10 were positive for tutin and its hydroxy metabolite hyenanchin (hydroxytutin) and one was positive for hyenanchin alone. Toxic honey production is a significant risk in parts of New Zealand. Beekeepers and health professionals need to be informed of this risk and know how best to manage it. Due to this poisoning incident, public and professional awareness of honey poisoning has been substantially enhanced. This incident led to development of new food safety standards for New Zealand honey.

A Safety Case Approach for Deep Geologic Disposal of DOE HLW and DOE SNF in Bedded Salt - 13350

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

Sevougian, S. David; MacKinnon, Robert J.; Leigh, Christi D.

2013-07-01

The primary objective of this study is to investigate the feasibility and utility of developing a defensible safety case for disposal of United States Department of Energy (U.S. DOE) high-level waste (HLW) and DOE spent nuclear fuel (SNF) in a conceptual deep geologic repository that is assumed to be located in a bedded salt formation of the Delaware Basin [1]. A safety case is a formal compilation of evidence, analyses, and arguments that substantiate and demonstrate the safety of a proposed or conceptual repository. We conclude that a strong initial safety case for potential licensing can be readily compiled bymore » capitalizing on the extensive technical basis that exists from prior work on the Waste Isolation Pilot Plant (WIPP), other U.S. repository development programs, and the work published through international efforts in salt repository programs such as in Germany. The potential benefits of developing a safety case include leveraging previous investments in WIPP to reduce future new repository costs, enhancing the ability to effectively plan for a repository and its licensing, and possibly expediting a schedule for a repository. A safety case will provide the necessary structure for organizing and synthesizing existing salt repository science and identifying any issues and gaps pertaining to safe disposal of DOE HLW and DOE SNF in bedded salt. The safety case synthesis will help DOE to plan its future R and D activities for investigating salt disposal using a risk-informed approach that prioritizes test activities that include laboratory, field, and underground investigations. It should be emphasized that the DOE has not made any decisions regarding the disposition of DOE HLW and DOE SNF. Furthermore, the safety case discussed herein is not intended to either site a repository in the Delaware Basin or preclude siting in other media at other locations. Rather, this study simply presents an approach for accelerated development of a safety case for a potential DOE HLW and DOE SNF repository using the currently available technical basis for bedded salt. This approach includes a summary of the regulatory environment relevant to disposal of DOE HLW and DOE SNF in a deep geologic repository, the key elements of a safety case, the evolution of the safety case through the successive phases of repository development and licensing, and the existing technical basis that could be used to substantiate the safety of a geologic repository if it were to be sited in the Delaware Basin. We also discuss the potential role of an underground research laboratory (URL). (authors)« less

Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

PubMed

Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

2008-07-01

The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

Skin Antiageing and Systemic Redox Effects of Supplementation with Marine Collagen Peptides and Plant-Derived Antioxidants: A Single-Blind Case-Control Clinical Study

PubMed Central

De Luca, Chiara; Mikhal'chik, Elena V.; Suprun, Maxim V.; Papacharalambous, Michael; Truhanov, Arseniy I.; Korkina, Liudmila G.

2016-01-01

Recently, development and research of nutraceuticals based on marine collagen peptides (MCPs) have been growing due to their high homology with human collagens, safety, bioavailability through gut, and numerous bioactivities. The major concern regarding safety of MCPs intake relates to increased risk of oxidative stress connected with collagen synthesis (likewise in fibrosis) and to ROS production by MCPs-stimulated phagocytes. In this clinical-laboratory study, fish skin MCPs combined with plant-derived skin-targeting antioxidants (AO) (coenzyme Q10 + grape-skin extract + luteolin + selenium) were administered to volunteers (n = 41). Skin properties (moisture, elasticity, sebum production, and biological age) and ultrasonic markers (epidermal/dermal thickness and acoustic density) were measured thrice (2 months before treatment and before and after cessation of 2-month oral intake). The supplementation remarkably improved skin elasticity, sebum production, and dermal ultrasonic markers. Metabolic data showed significant increase of plasma hydroxyproline and ATP storage in erythrocytes. Redox parameters, GSH/coenzyme Q10 content, and GPx/GST activities were unchanged, while NO and MDA were moderately increased within, however, normal range of values. Conclusions. A combination of MCPs with skin-targeting AOs could be effective and safe supplement to improve skin properties without risk of oxidative damage. PMID:26904164

BESAFE II: Accident safety analysis code for MFE reactor designs

NASA Astrophysics Data System (ADS)

Sevigny, Lawrence Michael

The viability of controlled thermonuclear fusion as an alternative energy source hinges on its desirability from an economic and an environmental and safety standpoint. It is the latter which is the focus of this thesis. For magnetic fusion energy (MFE) devices, the safety concerns equate to a design's behavior during a worst-case accident scenario which is the loss of coolant accident (LOCA). In this dissertation, we examine the behavior of MFE devices during a LOCA and how this behavior relates to the safety characteristics of the machine; in particular the acute, whole-body, early dose. In doing so, we have produced an accident safety code, BESAFE II, now available to the fusion reactor design community. The Appendix constitutes the User's Manual for BESAFE II. The theory behind early dose calculations including the mobilization of activation products is presented in Chapter 2. Since mobilization of activation products is a strong function of temperature, it becomes necessary to calculate the thermal response of a design during a LOCA in order to determine the fraction of the activation products which are mobilized and thus become the source for the dose. The code BESAFE II is designed to determine the temperature history of each region of a design and determine the resulting mobilization of activation products at each point in time during the LOCA. The BESAFE II methodology is discussed in Chapter 4, followed by demonstrations of its use for two reference design cases: a PCA-Li tokamak and a SiC-He tokamak. Of these two cases, it is shown that the SiC-He tokamak is a better design from an accident safety standpoint than the PCA-Li tokamak. It is also found that doses derived from temperature-dependent mobilization data are different than those predicted using set mobilization categories such as those that involve Piet fractions. This demonstrates the need for more experimental data on fusion materials. The possibility for future improvements and modifications to BESAFE II is discussed in Chapter 6, for example, by adding additional environmental indices such as a waste disposal index. The biggest improvement to BESAFE II would be an increase in the database of activation product mobilization for a larger spectrum of fusion reactor materials. The ultimate goal we have is for BESAFE II to become part of a systems design program which would include economic factors and allow both safety and the cost of electricity to influence design.

Dynamic Safety Cases for Through-Life Safety Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

2015-01-01

We describe dynamic safety cases, a novel operationalization of the concept of through-life safety assurance, whose goal is to enable proactive safety management. Using an example from the aviation systems domain, we motivate our approach, its underlying principles, and a lifecycle. We then identify the key elements required to move towards a formalization of the associated framework.

A classification tree based modeling approach for segment related crashes on multilane highways.

PubMed

Pande, Anurag; Abdel-Aty, Mohamed; Das, Abhishek

2010-10-01

This study presents a classification tree based alternative to crash frequency analysis for analyzing crashes on mid-block segments of multilane arterials. The traditional approach of modeling counts of crashes that occur over a period of time works well for intersection crashes where each intersection itself provides a well-defined unit over which to aggregate the crash data. However, in the case of mid-block segments the crash frequency based approach requires segmentation of the arterial corridor into segments of arbitrary lengths. In this study we have used random samples of time, day of week, and location (i.e., milepost) combinations and compared them with the sample of crashes from the same arterial corridor. For crash and non-crash cases, geometric design/roadside and traffic characteristics were derived based on their milepost locations. The variables used in the analysis are non-event specific and therefore more relevant for roadway safety feature improvement programs. First classification tree model is a model comparing all crashes with the non-crash data and then four groups of crashes (rear-end, lane-change related, pedestrian, and single-vehicle/off-road crashes) are separately compared to the non-crash cases. The classification tree models provide a list of significant variables as well as a measure to classify crash from non-crash cases. ADT along with time of day/day of week are significantly related to all crash types with different groups of crashes being more likely to occur at different times. From the classification performance of different models it was apparent that using non-event specific information may not be suitable for single vehicle/off-road crashes. The study provides the safety analysis community an additional tool to assess safety without having to aggregate the corridor crash data over arbitrary segment lengths. Copyright © 2010. Published by Elsevier Ltd.

An Elementary Algorithm for Autonomous Air Terminal Merging and Interval Management

NASA Technical Reports Server (NTRS)

White, Allan L.

2017-01-01

A central element of air traffic management is the safe merging and spacing of aircraft during the terminal area flight phase. This paper derives and examines an algorithm for the merging and interval managing problem for Standard Terminal Arrival Routes. It describes a factor analysis for performance based on the distribution of arrivals, the operating period of the terminal, and the topology of the arrival routes; then presents results from a performance analysis and from a safety analysis for a realistic topology based on typical routes for a runway at Phoenix International Airport. The heart of the safety analysis is a statistical derivation on how to conduct a safety analysis for a local simulation when the safety requirement is given for the entire airspace.

Determining animal drug combinations based on efficacy and safety.

PubMed

Kratzer, D D; Geng, S

1986-08-01

A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration.

PubMed

Taylor, Jennifer A; Gerwin, Daniel; Morlock, Laura; Miller, Marlene R

2011-12-01

To evaluate the need for triangulating case-finding tools in patient safety surveillance. This study applied four case-finding tools to error-associated patient safety events to identify and characterise the spectrum of events captured by these tools, using puncture or laceration as an example for in-depth analysis. Retrospective hospital discharge data were collected for calendar year 2005 (n=48,418) from a large, urban medical centre in the USA. The study design was cross-sectional and used data linkage to identify the cases captured by each of four case-finding tools. Three case-finding tools (International Classification of Diseases external (E) and nature (N) of injury codes, Patient Safety Indicators (PSI)) were applied to the administrative discharge data to identify potential patient safety events. The fourth tool was Patient Safety Net, a web-based voluntary patient safety event reporting system. The degree of mutual exclusion among detection methods was substantial. For example, when linking puncture or laceration on unique identifiers, out of 447 potential events, 118 were identical between PSI and E-codes, 152 were identical between N-codes and E-codes and 188 were identical between PSI and N-codes. Only 100 events that were identified by PSI, E-codes and N-codes were identical. Triangulation of multiple tools through data linkage captures potential patient safety events most comprehensively. Existing detection tools target patient safety domains differently, and consequently capture different occurrences, necessitating the integration of data from a combination of tools to fully estimate the total burden.

Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

PubMed

Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

2013-12-01

This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them.

Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

PubMed

Jones, Sarahjane

2016-10-01

The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

An assessment of traffic safety culture related to engagement in efforts to improve traffic safety : final report.

DOT National Transportation Integrated Search

2016-12-01

This final report summarizes the methods, results, conclusions, and recommendations derived from a survey conducted to understand values, beliefs, and attitudes regarding engagement in behaviors that impact the traffic safety of others. Results of th...

Safety of intrathecal autologous adipose-derived mesenchymal stromal cells in patients with ALS

PubMed Central

Madigan, Nicolas N.; Morris, Jonathan; Jentoft, Mark; Sorenson, Eric J.; Butler, Greg; Gastineau, Dennis; Dietz, Allan; Windebank, Anthony J.

2016-01-01

Objective: To determine the safety of intrathecal autologous adipose-derived mesenchymal stromal cell treatment for amyotrophic lateral sclerosis (ALS). Methods: Participants with ALS were enrolled and treated in this phase I dose-escalation safety trial, ranging from 1 × 107 (single dose) to 1 × 108 cells (2 monthly doses). After intrathecal treatments, participants underwent standardized follow-up, which included clinical examinations, revised ALS Functional Rating Scale (ALSFRS-R) questionnaire, blood and CSF sampling, and MRI of the neuroaxis. Results: Twenty-seven patients with ALS were enrolled and treated in this study. The safety profile was positive, with the most common side effects reported being temporary low back and radicular leg pain at the highest dose level. These clinical findings were associated with elevated CSF protein and nucleated cells with MRI of thickened lumbosacral nerve roots. Autopsies from 4 treated patients did not show evidence of tumor formation. Longitudinal ALSFRS-R questionnaires confirmed continued progression of disease in all treated patients. Conclusions: Intrathecal treatment of autologous adipose-derived mesenchymal stromal cells appears safe at the tested doses in ALS. These results warrant further exploration of efficacy in phase II trials. Classification of evidence: This phase I study provides Class IV evidence that in patient with ALS, intrathecal autologous adipose-derived mesenchymal stromal cell therapy is safe. PMID:27784774

The Safety Argumentation Schools of Thought

NASA Technical Reports Server (NTRS)

Graydon, Patrick John

2017-01-01

Safety cases have been produced and researched for decades. Definitions of `safety case' agree on both the need to generate suitable evidence and the central role of argument. But the relevant literature seems to exhibit multiple schools of thought that are largely unrecognized and somewhat at odds with each other. This paper presents preliminary results from research to identify and characterize the safety case schools of thought so as to reduce confusion and discord in research and practice.

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

PubMed Central

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

2017-01-01

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

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

PubMed Central

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

2013-01-01

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

A quantitative comparison of the safety margins in the european indicative occupational exposure limits and the derived no-effect levels for workers under REACH.

PubMed

Schenk, Linda; Johanson, Gunnar

2011-06-01

The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults.

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 § 1975.2 Basis... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution...

Determining the Applicability of Threshold of Toxicological Concern Approaches to Substances Found in Foods

PubMed Central

Canady, Richard; Lane, Richard; Paoli, Greg; Wilson, Margaret; Bialk, Heidi; Hermansky, Steven; Kobielush, Brent; Lee, Ji-Eun; Llewellyn, Craig; Scimeca, Joseph

2013-01-01

Threshold of Toxicological Concern (TTC) decision-support methods present a pragmatic approach to using data from well-characterized chemicals and protective estimates of exposure in a stepwise fashion to inform decisions regarding low-level exposures to chemicals for which few data exist. It is based on structural and functional categorizations of chemicals derived from decades of animal testing with a wide variety of chemicals. Expertise is required to use the TTC methods, and there are situations in which its use is clearly inappropriate or not currently supported. To facilitate proper use of the TTC, this paper describes issues to be considered by risk managers when faced with the situation of an unexpected substance in food. Case studies are provided to illustrate the implementation of these considerations, demonstrating the steps taken in deciding whether it would be appropriate to apply the TTC approach in each case. By appropriately applying the methods, employing the appropriate scientific expertise, and combining use with the conservative assumptions embedded within the derivation of the thresholds, the TTC can realize its potential to protect public health and to contribute to efficient use of resources in food safety risk management. PMID:24090142

A discussion of approaches to transforming care: contemporary strategies to improve patient safety.

PubMed

Burston, Sarah; Chaboyer, Wendy; Wallis, Marianne; Stanfield, Jane

2011-11-01

This article presents a discussion of three contemporary approaches to transforming care: Transforming Care at the Bedside, Releasing Time to Care: the Productive Ward and the work of the Studer Group(®). International studies of adverse events in hospitals have highlighted the need to focus on patient safety. The case for transformational change was identified and recently several approaches have been developed to effect this change. Despite limited evaluation, these approaches have spread and have been adopted outside their country of origin and contextual settings. Medline and CINAHL databases were searched for the years 1999-2009. Search terms included derivatives of 'transformation' combined with 'care', 'nursing', 'patient safety', 'Transforming Care at the Bedside', 'the Productive Ward' and 'Studer Group'. A comparison of the three approaches revealed similarities including: the foci of the approaches; interventions employed; and the outcomes measured. Key differences identified are the implementation models used, spread strategies and sustainability of the approaches. The approaches appear to be complementary and a hybrid of the approaches such as a blend of a top-down and bottom-up leadership strategy may offer more sustainable behavioural change. These approaches transform the way nurses do their work, how they work with others and how they view the care they provide to promote patient safety. All the approaches involve the implementation of multiple interventions occurring simultaneously to affect improvements in patient safety. The approaches are complementary and a hybrid approach may offer more sustainable outcomes. © 2011 Blackwell Publishing Ltd.

Making the invisible visible: a qualitative study of the values, attitudes and norms of radiologists relating to radiation safety.

PubMed

Fridell, Kent; Ekberg, Jessica

2016-06-01

Some shortcomings regarding safety have emerged in inspections by the Swedish Radiation Safety Authority of Swedish radiology departments which perform 5.4 million radiological examinations and 100 000 nuclear scans annually. To ensure safety in the healthcare system and to build a strong environment of radiation protection for patients (and for employees) there must be a strong culture of safety. To understand an organization's behaviour, decisions and actions it is important to study its cultural values. The aims of this study were to discuss how values, attitudes and norms affect radiologists' decisions as well as how they influence the implementation of various radiation protection measures. To investigate this, focus group interviews and in-depth individual interviews were performed in a sample from a number of radiology departments at hospitals in Sweden. The results show that the core value was derived from the patients' perspective with the focus on the knowledge that he or she has come to the healthcare system for a particular reason: to discover disease or, in the best case, to be declared healthy. The majority attitudes were based on experiences associated with aspects that the radiologist could not influence. This often concerns increased pressure on radiology investigations from clinics in the various operational units. Under the concept of norms, the radiologists in the study requested that the development of regulations and guidelines should be connected to issues of justification for various radiological queries.

Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

Cartilage Regeneration in Osteoarthritic Patients by a Composite of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells and Hyaluronate Hydrogel: Results from a Clinical Trial for Safety and Proof-of-Concept with 7 Years of Extended Follow-Up.

PubMed

Park, Yong-Beom; Ha, Chul-Won; Lee, Choong-Hee; Yoon, Young Cheol; Park, Yong-Geun

2017-02-01

Few methods are available to regenerate articular cartilage defects in patients with osteoarthritis. We aimed to assess the safety and efficacy of articular cartilage regeneration by a novel medicinal product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs). Patients with Kellgren-Lawrence grade 3 osteoarthritis and International Cartilage Repair Society (ICRS) grade 4 cartilage defects were enrolled in this clinical trial. The stem cell-based medicinal product (a composite of culture-expanded allogeneic hUCB-MSCs and hyaluronic acid hydrogel [Cartistem]) was applied to the lesion site. Safety was assessed by the World Health Organization common toxicity criteria. The primary efficacy outcome was ICRS cartilage repair assessed by arthroscopy at 12 weeks. The secondary efficacy outcome was visual analog scale (VAS) score for pain on walking. During a 7-year extended follow-up, we evaluated safety, VAS score, International Knee Documentation Committee (IKDC) subjective score, magnetic resonance imaging (MRI) findings, and histological evaluations. Seven participants were enrolled. Maturing repair tissue was observed at the 12-week arthroscopic evaluation. The VAS and IKDC scores were improved at 24 weeks. The improved clinical outcomes were stable over 7 years of follow-up. The histological findings at 1 year showed hyaline-like cartilage. MRI at 3 years showed persistence of the regenerated cartilage. Only five mild to moderate treatment-emergent adverse events were observed. There were no cases of osteogenesis or tumorigenesis over 7 years. The application of this novel stem cell-based medicinal product appears to be safe and effective for the regeneration of durable articular cartilage in osteoarthritic knees. Stem Cells Translational Medicine 2017;6:613-621. © 2016 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

Improving safety culture through the health and safety organization: a case study.

PubMed

Nielsen, Kent J

2014-02-01

International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

A Review of the Efficacy, Safety, and Clinical Implications of Naturally Derived Dietary Supplements for Dyslipidemia.

PubMed

Thaipitakwong, Thanchanit; Aramwit, Pornanong

2017-02-01

Dyslipidemia is recognized as a major cause of cardiovascular disease. A number of evidence-based guidelines recommend conventional synthetic drugs as standard therapy for dyslipidemia in clinical practice. However, antihyperlipidemic drugs have some serious side effects. Naturally derived dietary supplements are becoming attractive as an alternative strategy because of their high efficacy and safety, as supported by numerous data. Moreover, they could be considered an initial treatment for dyslipidemia. The aims of this literature review were to demonstrate the efficacy, safety, and clinical implications of dietary supplements for treating dyslipidemia. We reviewed the literature, including data from in vitro, in vivo, and human studies, and clinical guideline recommendations. We classified dietary supplements by their proposed mechanisms of action on lipid metabolism and also collected daily dosage recommendations, interactions with concurrent drugs and/or foods, dosage forms, and examples of commercially available products. Various types of naturally derived dietary supplements exhibit lipid-improving properties. Efficacy and safety are acceptable; however, their use in clinical practice will require further well-designed investigations and the support of scientific data.

Introduction of Exogenous HSV-TK Suicide Gene Increases Safety of Keratinocyte-Derived Induced Pluripotent Stem Cells by Providing Genetic "Emergency Exit" Switch.

PubMed

Sułkowski, Maciej; Konieczny, Paweł; Chlebanowska, Paula; Majka, Marcin

2018-01-09

Since their invention in 2006, induced Pluripotent Stem (iPS) cells remain a great promise for regenerative medicine circumventing the ethical issues linked to Embryonic Stem (ES) cell research. iPS cells can be generated in a patient-specific manner as an unlimited source of various cell types for in vitro drug screening, developmental biology studies and regenerative use. Having the capacity of differentiating into the cells of all three primary germ layers, iPS cells have high potential to form teratoma tumors. This remains their main disadvantage and hazard which, until resolved, prevents utilization of iPS cells in clinic. Here, we present an approach for increasing iPS cells safety by introducing genetic modification-exogenous suicide gene Herpes Simplex Virus Thymidine Kinase ( HSV-TK ). Its expression results in specific vulnerability of genetically modified cells to prodrug-ganciclovir (GCV). We show that HSV-TK expressing cells can be eradicated both in vitro and in vivo with high specificity and efficiency with low doses of GCV. Described strategy increases iPS cells safety for future clinical applications by generating "emergency exit" switch allowing eradication of transplanted cells in case of their malfunction.

The development of an inherent safety approach to the prevention of domino accidents.

PubMed

Cozzani, Valerio; Tugnoli, Alessandro; Salzano, Ernesto

2009-11-01

The severity of industrial accidents in which a domino effect takes place is well known in the chemical and process industry. The application of an inherent safety approach for the prevention of escalation events leading to domino accidents was explored in the present study. Reference primary scenarios were analyzed and escalation vectors were defined. Inherent safety distances were defined and proposed as a metric to express the intensity of the escalation vectors. Simple rules of thumb were presented for a preliminary screening of these distances. Swift reference indices for layout screening with respect to escalation hazard were also defined. Two case studies derived from existing layouts of oil refineries were selected to understand the potentialities coming from the application in the methodology. The results evidenced that the approach allows a first comparative assessment of the actual domino hazard in a layout, and the identification of critical primary units with respect to escalation events. The methodology developed also represents a useful screening tool to identify were to dedicate major efforts in the design of add-on measures, optimizing conventional passive and active measures for the prevention of severe domino accidents.

Using in situ simulation to identify and resolve latent environmental threats to patient safety: case study involving operational changes in a labor and delivery ward.

PubMed

Hamman, William R; Beaudin-Seiler, Beth M; Beaubien, Jeffrey M; Gullickson, Amy M; Orizondo-Korotko, Krystyna; Gross, Amy C; Fuqua, Wayne; Lammers, Richard

2010-01-01

Since the publication of "To Err Is Human" in 1999, health care professionals have looked to high-reliability industries such as aviation for guidance on improving system safety. One of the most widely adopted aviation-derived approaches is simulation-based team training, also known as crew resource management training. In the health care domain, crew resource management training often takes place in custom-built simulation laboratories that are designed to replicate operating rooms or labor and delivery rooms. Unlike these traditional crew resource management training programs, "in situ simulation" occurs on actual patient care units, involves actual health care team members, and uses actual organization processes to train and assess team performance. During the past 24 months, our research team has conducted nearly 40 in situ simulations. In this article, we present the results from 1 such simulation: a patient who experienced a difficult labor that resulted in an emergency caesarian section and hysterectomy. During the simulation, a number of latent environmental threats to safety were identified. This article presents the latent threats and the steps that the hospital has taken to remedy them.

Focus on patient safety all day, every day.

PubMed

2015-06-01

Case managers may think their job doesn't involve patient safety, but they promote safety by ensuring a safe discharge and are in a position to see safety breaches and mistakes all over the hospital. CMS includes discharge planning in its worksheets for surveyors to use to assess a hospital's compliance with Medicare Conditions of Participation. Because they work with patients from admission to discharge, case managers know which clinicians are competent, those who are not, and may observe safety breaches like failure to wash hands and leaving the catheter in too long. Case managers should spend enough time with their patients to know their situations at home and their support systems and use the information to create workable and safe discharge plans. Hospitals should create an environment and a culture where case managers and other clinicians feel comfortable speaking up when they see safety breaches.

A Review of Aspects of Oxidative Hair Dye Chemistry with Special Reference to N-Nitrosamine Formation

PubMed Central

Lewis, David; Mama, John; Hawkes, Jamie

2013-01-01

This review discusses a new aspect to the safety profile of oxidative hair dyes using data already in the public domain. These dyes contain secondary amines that are capable of forming potentially carcinogenic nitrosamine derivatives when exposed to atmospheric pollution. Numerous scientific articles confirm the existence of secondary amines in hair dyes (and their intermediates), the possibility of nitrosation by atmospheric NOx of secondary amines to give the N-nitrosamines, and the significant safety risks on N-nitrosamines. It is believed that such nitrosamine derivatives should be investigated more fully in the interests of consumer safety. PMID:28809322

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.

Synergistic relationships between Analytical Chemistry and written standards.

PubMed

Valcárcel, Miguel; Lucena, Rafael

2013-07-25

This paper describes the mutual impact of Analytical Chemistry and several international written standards (norms and guides) related to knowledge management (CEN-CWA 14924:2004), social responsibility (ISO 26000:2010), management of occupational health and safety (OHSAS 18001/2), environmental management (ISO 14001:2004), quality management systems (ISO 9001:2008) and requirements of the competence of testing and calibration laboratories (ISO 17025:2004). The intensity of this impact, based on a two-way influence, is quite different depending on the standard considered. In any case, a new and fruitful approach to Analytical Chemistry based on these relationships can be derived. Copyright © 2013 Elsevier B.V. All rights reserved.

Time Safety Margin: Theory and Practice

DTIC Science & Technology

2016-09-01

Basic Dive Recovery Terminology The Simplest Definition of TSM: Time Safety Margin is the time to directly travel from the worst-case vector to an...Safety Margin (TSM). TSM is defined as the time in seconds to directly travel from the worst case vector (i.e. worst case combination of parameters...invoked by this AFI, base recovery planning and risk management upon the calculated TSM. TSM is the time in seconds to di- rectly travel from the worst case

Safety analysts training

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

Bolton, P.

The purpose of this task was to support ESH-3 in providing Airborne Release Fraction and Respirable Fraction training to safety analysts at LANL who perform accident analysis, hazard analysis, safety analysis, and/or risk assessments at nuclear facilities. The task included preparation of materials for and the conduct of two 3-day training courses covering the following topics: safety analysis process; calculation model; aerosol physic concepts for safety analysis; and overview of empirically derived airborne release fractions and respirable fractions.

Landslide hazard analysis for pipelines: The case of the Simonette river crossing

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

Grivas, D.A.; Schultz, B.C.; O`Neil, G.

1995-12-31

The overall objective of this study is to develop a probabilistic methodology to analyze landslide hazards and their effects on the safety of buried pipelines. The methodology incorporates a range of models that can accommodate differences in the ground movement modes and the amount and type of information available at various site locations. Two movement modes are considered, namely (a) instantaneous (catastrophic) slides, and (b) gradual ground movement which may result in cumulative displacements over the pipeline design life (30--40 years) that are in excess of allowable values. Probabilistic analysis is applied in each case to address the uncertainties associatedmore » with important factors that control slope stability. Availability of information ranges from relatively well studied, instrumented installations to cases where data is limited to what can be derived from topographic and geologic maps. The methodology distinguishes between procedures applied where there is little information and those that can be used when relatively extensive data is available. important aspects of the methodology are illustrated in a case study involving a pipeline located in Northern Alberta, Canada, in the Simonette river valley.« less

Sustainable and safe design of footwear integrating ecological footprint and risk criteria.

PubMed

Herva, Marta; Álvarez, Antonio; Roca, Enrique

2011-09-15

The ecodesign of a product implies that different potential environmental impacts of diverse nature must be taken into account considering its whole life cycle, apart from the general design criteria (i.e. technical, functional, ergonomic, aesthetic or economic). In this sense, a sustainability assessment methodology, ecological footprint (EF), and environmental risk assessment (ERA), were combined for the first time to derive complementary criteria for the ecodesign of footwear. Four models of children's shoes were analyzed and compared. The synthetic shoes obtained a smaller EF (6.5 gm(2)) when compared to the leather shoes (11.1 gm(2)). However, high concentrations of hazardous substances were detected in the former, even making the Hazard Quotient (HQ) and the Cancer Risk (CR) exceed the recommended safety limits for one of the synthetic models analyzed. Risk criteria were prioritized in this case and, consequently, the design proposal was discarded. For the other cases, the perspective provided by the indicators of different nature was balanced to accomplish a fairest evaluation. The selection of fibers produced under sustainable criteria and the reduction of the materials consumption was recommended, since the area requirements would be minimized and the absence of hazardous compounds would ensure safety conditions during the use stage. Copyright © 2011 Elsevier B.V. All rights reserved.

Soy formulas and nonbovine milk.

PubMed

Muraro, Maria Antonella; Giampietro, Paolo G; Galli, Elena

2002-12-01

Cow's milk allergy is frequently observed during the first year of life when nutritional requirements are critical. In those cases where breast-feeding is not available, a safe and adequate substitute to cow's milk should be offered. The primary aim of this review is to evaluate the clinical use of milk derived from vegetable proteins, such as soy, or from animals such as goat, mare, or donkey, or elemental diet in children with cow's milk allergy. MEDLINE searches were conducted with key words such as soy, goat's milk, donkey's milk, mare's milk, and elemental diet. Additional articles were identified from references in books or articles. Original research papers and review articles from peer-reviewed journals were chosen. Soy formulas are nutritionally adequate and can be used in children with immunoglobulin E-mediated nongastrointestinal manifestations of cow's milk allergy. Goat's milk is as allergenic as cow's milk. Mare's milk and donkey's milk may be used in selected cases of cow's milk allergy after appropriate modification to make them suitable for human infants. Elemental diets are usually restricted to the most severe cases of cow's milk allergy (ie, sensitivity to extensively hydrolyzed protein formulas). Vegetable formulas obtained from soy and milk derived from other mammals, such as mare or donkey, homemade preparations, and elemental diet may represent valid alternatives for children with cow's milk allergy. Extensive clinical trials are needed on the safety profile of any alternative mammal-derived milk. The choice of alternative milk should take into account the clinical profile of the child allergic to cow's milk, particularly as concerns age, severity of symptoms, degree of sensitivity to cow's milk proteins, and any multiple food allergies.

Clinical safety issues of measles, mumps and rubella vaccines.

PubMed Central

Afzal, M. A.; Minor, P. D.; Schild, G. C.

2000-01-01

The clinical safety of measles and measles-mumps-rubella vaccines has been questioned in recent reports that propose a possible link between measles virus or measles vaccines and the occurrence of juvenile Crohn disease and autism. This article reviews the outcomes of several laboratory investigations which were carried out independently to identify the presence or absence of measles virus in the intestinal tissues derived from cases of inflammatory bowel disease. One research group reported the presence of measles virus particles and genomic RNA in inflammatory bowel disease tissues, but this could not be confirmed by other groups, despite use of techniques that are highly specific and sensitive for the detection of measles virus nucleic acid in clinical specimens down to the molecular level. Based on the published data reviewed here, it can be concluded that there is no direct association between measles virus or measles vaccines and the development of Crohn disease, a conclusion which is supported by most epidemiological findings. PMID:10743285

Update on Vaccine-Derived Polioviruses - Worldwide, January 2016-June 2017.

PubMed

Jorba, Jaume; Diop, Ousmane M; Iber, Jane; Henderson, Elizabeth; Sutter, Roland W; Wassilak, Steven G F; Burns, Cara C

2017-11-03

In 1988, the World Health Assembly launched the Global Polio Eradication Initiative (GPEI) (1). Among the three wild poliovirus (WPV) serotypes, only type 1 (WPV1) has been detected since 2012. Since 2014, detection of WPV1 has been limited to three countries, with 37 cases in 2016 and 11 cases in 2017 as of September 27. The >99.99% decline worldwide in polio cases since the launch of the GPEI is attributable to the extensive use of the live, attenuated oral poliovirus vaccine (OPV) in mass vaccination campaigns and comprehensive national routine immunization programs. Despite its well-established safety record, OPV use can be associated with rare emergence of genetically divergent vaccine-derived polioviruses (VDPVs) whose genetic drift from the parental OPV strains indicates prolonged replication or circulation (2). VDPVs can also emerge among persons with primary immunodeficiencies (PIDs). Immunodeficiency-associated VDPVs (iVDPVs) can replicate for years in some persons with PIDs. In addition, circulating vaccine-derived polioviruses (cVDPVs) can emerge very rarely among immunologically normal vaccine recipients and their contacts in areas with inadequate OPV coverage and can cause outbreaks of paralytic polio. This report updates previous summaries regarding VDPVs (3). During January 2016-June 2017, new cVDPV outbreaks were identified, including two in the Democratic Republic of the Congo (DRC) (eight cases), and another in Syria (35 cases), whereas the circulation of cVDPV type 2 (cVDPV2) in Nigeria resulted in cVDPV2 detection linked to a previous emergence. The last confirmed case from the 2015-2016 cVDPV type 1 (cVDPV1) outbreak in Laos occurred in January 2016. Fourteen newly identified persons in 10 countries were found to excrete iVDPVs, and three previously reported patients in the United Kingdom and Iran (3) were still excreting type 2 iVDPV (iVDPV2) during the reporting period. Ambiguous VDPVs (aVDPVs), isolates that cannot be classified definitively, were found among immunocompetent persons and environmental samples in 10 countries. Cessation of all OPV use after certification of polio eradication will eliminate the risk for new VDPV infections.

MANAGING UNCERTAINTIES ASSOCIATED WITH RADIOACTIVE WASTE DISPOSAL: TASK GROUP 4 OF THE IAEA PRISM PROJECT

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

Seitz, R.

2011-03-02

It is widely recognized that the results of safety assessment calculations provide an important contribution to the safety arguments for a disposal facility, but cannot in themselves adequately demonstrate the safety of the disposal system. The safety assessment and a broader range of arguments and activities need to be considered holistically to justify radioactive waste disposal at any particular site. Many programs are therefore moving towards the production of what has become known as a Safety Case, which includes all of the different activities that are conducted to demonstrate the safety of a disposal concept. Recognizing the growing interest inmore » the concept of a Safety Case, the International Atomic Energy Agency (IAEA) is undertaking an intercomparison and harmonization project called PRISM (Practical Illustration and use of the Safety Case Concept in the Management of Near-surface Disposal). The PRISM project is organized into four Task Groups that address key aspects of the Safety Case concept: Task Group 1 - Understanding the Safety Case; Task Group 2 - Disposal facility design; Task Group 3 - Managing waste acceptance; and Task Group 4 - Managing uncertainty. This paper addresses the work of Task Group 4, which is investigating approaches for managing the uncertainties associated with near-surface disposal of radioactive waste and their consideration in the context of the Safety Case. Emphasis is placed on identifying a wide variety of approaches that can and have been used to manage different types of uncertainties, especially non-quantitative approaches that have not received as much attention in previous IAEA projects. This paper includes discussions of the current results of work on the task on managing uncertainty, including: the different circumstances being considered, the sources/types of uncertainties being addressed and some initial proposals for approaches that can be used to manage different types of uncertainties.« less

Natural Product-Derived Treatments for Attention-Deficit/Hyperactivity Disorder: Safety, Efficacy, and Therapeutic Potential of Combination Therapy

PubMed Central

Ahn, James; Ahn, Hyung Seok; Cheong, Jae Hoon; dela Peña, Ike

2016-01-01

Typical treatment plans for attention-deficit/hyperactivity disorder (ADHD) utilize nonpharmacological (behavioral/psychosocial) and/or pharmacological interventions. Limited accessibility to behavioral therapies and concerns over adverse effects of pharmacological treatments prompted research for alternative ADHD therapies such as natural product-derived treatments and nutritional supplements. In this study, we reviewed the herbal preparations and nutritional supplements evaluated in clinical studies as potential ADHD treatments and discussed their performance with regard to safety and efficacy in clinical trials. We also discussed some evidence suggesting that adjunct treatment of these agents (with another botanical agent or pharmacological ADHD treatments) may be a promising approach to treat ADHD. The analysis indicated mixed findings with regard to efficacy of natural product-derived ADHD interventions. Nevertheless, these treatments were considered as a “safer” approach than conventional ADHD medications. More comprehensive and appropriately controlled clinical studies are required to fully ascertain efficacy and safety of natural product-derived ADHD treatments. Studies that replicate encouraging findings on the efficacy of combining botanical agents and nutritional supplements with other natural product-derived therapies and widely used ADHD medications are also warranted. In conclusion, the risk-benefit balance of natural product-derived ADHD treatments should be carefully monitored when used as standalone treatment or when combined with other conventional ADHD treatments. PMID:26966583

Surrogate safety measures from traffic simulation models

DOT National Transportation Integrated Search

2003-01-01

This project investigates the potential for deriving surrogate measures of safety from existing microscopic traffic simulation models for intersections. The process of computing the measures in the simulation, extracting the required data, and summar...

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

PubMed

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

Adipose-Derived Stem Cells in Novel Approaches to Breast Reconstruction: Their Suitability for Tissue Engineering and Oncological Safety.

PubMed

O'Halloran, Niamh; Courtney, Donald; Kerin, Michael J; Lowery, Aoife J

2017-01-01

Adipose-derived stem cells (ADSCs) are rapidly becoming the gold standard cell source for tissue engineering strategies and hold great potential for novel breast reconstruction strategies. However, their use in patients with breast cancer is controversial and their oncological safety, particularly in relation to local disease recurrence, has been questioned. In vitro, in vivo, and clinical studies using ADSCs report conflicting data on their suitability for adipose tissue regeneration in patients with cancer. This review aims to provide an overview of the potential role for ADSCs in breast reconstruction and to examine the evidence relating to the oncologic safety of their use in patients with breast cancer.

75 FR 15485 - Pipeline Safety: Workshop on Guidelines for Integrity Assessment of Cased Pipe

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID...: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of workshop. SUMMARY... ``Guidelines for Integrity Assessment of Cased Pipe in Gas Transmission Pipelines'' and related Frequently...

Towards Measurement of Confidence in Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Paim Ganesh J.; Habli, Ibrahim

2011-01-01

Arguments in safety cases are predominantly qualitative. This is partly attributed to the lack of sufficient design and operational data necessary to measure the achievement of high-dependability targets, particularly for safety-critical functions implemented in software. The subjective nature of many forms of evidence, such as expert judgment and process maturity, also contributes to the overwhelming dependence on qualitative arguments. However, where data for quantitative measurements is systematically collected, quantitative arguments provide far more benefits over qualitative arguments, in assessing confidence in the safety case. In this paper, we propose a basis for developing and evaluating integrated qualitative and quantitative safety arguments based on the Goal Structuring Notation (GSN) and Bayesian Networks (BN). The approach we propose identifies structures within GSN-based arguments where uncertainties can be quantified. BN are then used to provide a means to reason about confidence in a probabilistic way. We illustrate our approach using a fragment of a safety case for an unmanned aerial system and conclude with some preliminary observations

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

Automatic Analysis of Critical Incident Reports: Requirements and Use Cases.

PubMed

Denecke, Kerstin

2016-01-01

Increasingly, critical incident reports are used as a means to increase patient safety and quality of care. The entire potential of these sources of experiential knowledge remains often unconsidered since retrieval and analysis is difficult and time-consuming, and the reporting systems often do not provide support for these tasks. The objective of this paper is to identify potential use cases for automatic methods that analyse critical incident reports. In more detail, we will describe how faceted search could offer an intuitive retrieval of critical incident reports and how text mining could support in analysing relations among events. To realise an automated analysis, natural language processing needs to be applied. Therefore, we analyse the language of critical incident reports and derive requirements towards automatic processing methods. We learned that there is a huge potential for an automatic analysis of incident reports, but there are still challenges to be solved.

Human exposure standards in the frequency range 1 Hz To 100 kHz: the case for adoption of the IEEE standard.

PubMed

Patrick Reilly, J

2014-10-01

Differences between IEEE C95 Standards (C95.6-2002 and C95.1-2005) in the low-frequency (1 Hz-100 kHz) and the ICNIRP-2010 guidelines appear across the frequency spectrum. Factors accounting for lack of convergence include: differences between the IEEE standards and the ICNIRP guidelines with respect to biological induction models, stated objectives, data trail from experimentally derived thresholds through physical and biological principles, selection and justification of safety/reduction factors, use of probability models, compliance standards for the limbs as distinct from the whole body, defined population categories, strategies for central nervous system protection below 20 Hz, and correspondence of environmental electric field limits with contact currents. This paper discusses these factors and makes the case for adoption of the limits in the IEEE standards.

Defining Occupational and Consumer Exposure Limits for Nanomaterials - First Experiences from REACH Registrations

NASA Astrophysics Data System (ADS)

Aschberger, K.; Klöslova, Z.; Falck, G.; Christensen, F. M.

2013-04-01

By 1 December 2010 substances manufactured or imported in the EU >= 1000 t (as well as certain other substances) had to be registered under the REACH Regulation 1907/2006. The Joint Research Centre (JRC) in close cooperation with the European Chemicals Agency (ECHA) carried out an analysis and assessment of what type of information on nanomaterials was provided in the received registrations. The aim of the assessment was to develop options for an adaptation of the REACH regulation to ensure proper information generation and reporting and an appropriate risk/safety assessment of nanomaterials (Nano Support project). It should be noted that this analysis and assessment was not a compliance check of the dossiers. From 26000 submitted registration dossiers covering 4700 substances finally 25 dossiers (19 substances) were identified to cover nanomaterials or nanoforms of a substance. It is possible that other dossiers are considered to cover nanomaterials or nanoforms by the registrants, however such dossiers could not be identified to address nanoforms given the information contained in those dossiers. The identified 25 dossiers were subject to a detailed analysis and assessment of information provided for all endpoints including substance identity, physico-chemical properties, human health, environmental fate & behaviour, ecotoxicity, PBT6 assessment, Classification and Labelling as well as the attached Chemical Safety Report documenting the Chemical Risk/Safety Assessment. In order to evaluate how the safety of workers and consumers was ensured, it was appropriate to check how the "Derived No (Minimum) Effect Levels" (DN(M)ELs) were established for substances, covering nanomaterials or nanoforms. DNELs were established mainly for long term inhalation exposure of workers. Half of the assessed dossiers included an oral long term DNEL for the general population. DNELs were usually not specific for nanosized forms and, in the few cases where they were calculated for nanosized materials, they were not derived from hazard data for the nanoform. Different methods for deriving the DNELs were applied and few dossiers derived DNELs by applying the default assessment factors in the REACH guidance. Several DNELs were based on available Occupational Exposure Limits (OELs) for inhalable and respirable dust or the nuisance dust levels, which have not been established for nanosized materials. In general lower (i.e. less strict) assessment factors were applied with different types of justification. All DNELs were expressed in the mass metrics. It is important to note that submission, identification and selection of the dossiers addressed in this study was done before the adoption of the EC recommendation (2011/696/EU) on a definition of nanomaterial and before the publication of the revised ECHA guidance documents that include recommendations for nanomaterials.

Additional nuclear criticality safety calculations for small-diameter containers

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

Hone, M.J.

This report documents additional criticality safety analysis calculations for small diameter containers, which were originally documented in Reference 1. The results in Reference 1 indicated that some of the small diameter containers did not meet the criteria established for criticality safety at the Portsmouth facility (K{sub eff} +2{sigma}<.95) when modeled under various contingency assumptions of reflection and moderation. The calculations performed in this report reexamine those cases which did not meet the criticality safety criteria. In some cases, unnecessary conservatism is removed, and in other cases mass or assay limits are established for use with the respective containers.

Derivation of an occupational exposure limit (OEL) for methylene chloride based on acute CNS effects and relative potency analysis.

PubMed

Storm, J E; Rozman, K K

1998-06-01

The Occupational Safety and Health Administration (OSHA) methylene chloride Permissible Exposure Level (PEL) or 25 ppm is quantitatively derived from mouse tumor results observed in a high-exposure National Toxicology Program bioassay. Because this approach depends on controversial interspecies and low-dose extrapolations, the PEL itself has stimulated heated debate. Here, an alternative safety assessment for methylene chloride is presented. It is based on an acute human lowest-observed-adverse-effect level (LOAEL) of 200 ppm for subtle central nervous system (CNS) depression. Steep, parallel exposure-response curves for anesthetic and subanesthetic CNS effects associated with compounds mechanistically and structurally related to methylene chloride are shown to support a safety factor of two to account for inter-individual variability in response. LOAEL/no-observed-adverse-effect ratios for subtle CNS effects associated with structurally related solvents are shown to support a safety factor range of two to four to account for uncertainty in identifying a subthreshold exposure level. Anesthetic relative potencies and anesthetic/subanesthetic effect level ratios are shown to be constant for the compounds evaluated, demonstrating that subanesthetic relative potencies are also constant. Relative potencies among similarly derived occupational exposure limits (OELs) for solvents structurally related to methylene chloride are therefore used to validate the derived methylene chloride OEL range of 25-50 ppm. Because this safety assessment is based on human (rather than rodent) data and empirical (rather than theoretical) exposure-response relationships and is supported by relative potency analysis, it is a defensible alternative to to the OSHA risk assessment and should positively contribute to the debate regarding the appropriate basis and value for a methylene chloride PEL.

An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.

PubMed

Booth, Nancy L; Kruger, Claire L; Wallace Hayes, A; Clemens, Roger

2012-09-01

Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves. Copyright © 2012. Published by Elsevier Ltd.

Blood safety--a focus on plasma derivatives in Mainland China.

PubMed

Zhu, Y M

2007-01-01

Plasma derivative production in Mainland China can be encapsulated by two figures: 50 years of history and 5000 tons of annually processed source plasma. Demands for albumin, immunoglobulinin and main clotting factors can barely be met, despite a relatively low average usage among China's population of 1.3 billion. The tragedy of contamination among plasma donors in Henan province in the early 1990's has left shadows on the safety of the plasma derivative industry. However, during the last ten years the Chinese government has made great strides forward. The regulation of the entire operation has been strengthened, from law and standard setting and upholding to stricter licensing regulations for plasma centers and fractionators. Public concerns in blood safety are gradually being relieved, and confidence is returning. Nevertheless, the plasma donors and hemophilia patients infected a decade ago by infected blood or plasma products represent a set of severe social and medical problems that the government and society must still deal with.

Assessment of biochar safety via its leachate characterization using physicochemical and biological assays

NASA Astrophysics Data System (ADS)

Dailianis, Stefanos; Tsouloufa, Argyro; Antonopoulou, Maria; Konstantinou, Ioannis; Karapanagioti, Hrissi K.; Manariotis, Ioannis D.

2016-04-01

The present study investigates the physicochemical composition of water aliquots derived from biochars produced from the pyrolysis of malt spent rootlets, in combination with the concomitant toxicological profile in each case. Specifically, physicochemical parameters and heavy metal ions were determined in aliquots of six (6) serial washes of biochar (1.5 g of solid was added in column and washed 6 times with 40 mL of distilled water per wash). The chemical analysis of each aliquot showed increased levels of PO4-3, Cl-, NO3-, SO4-2, F- and Br- in the first wash aliquot, followed by a significant decrease over washes. Non-detectable concentrations were observed after 3 washes in almost all cases. Similarly, the increased levels of Zn, Be, Cs, Mn, V and Se determined in the first wash aliquot were eliminated followed successive washes. In parallel, the toxic potency of each wash aliquot was recorded by (a) a multi-well test plate bioassay, using instars II-III larvae of the fairy shrimp Thamnocephalus platyurus, hatched from cysts derived from Screening Toxicity test supplied by MicroBio Tests Inc. (Thamnotoxkit FTM) and (b) the Microtox bioassay, using bioluminescent bacteria Vibrio fischeri. According to the results, first and second wash aliquots were toxic for T. platyurus (LC50 values of 22.12 and 68.28% v/v, respectively), followed by a significant elimination of toxicity after further washes in all cases. Similarly, the Microtox bioassay showed a significant inhibition of Vibrio luminescence after treatment for a period of 5-90 min (98-100% inhibition of luminescence) with the first wash aliquot (EC50 ≤ 0.01 % v/v), with no toxicity to be observed after successive washes. According to the results, at least one wash of biochar is prerequisite for improving its safety for further use. Moreover, the removal of both inorganic and organic, such as metal ions, substances commonly washed by the biochar, could be a crucial step for its sustainable use and final application, thus avoiding the induction of adverse effects on biota.

Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib.

PubMed

Curtis, Jeffrey R; Zhang, Richard; Krishnaswami, Sriram; Anisfeld, Andrew; Chen, Yan; Strengholt, Sander; Chen, Connie; Geier, Jamie

2017-03-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To characterise the relative safety profile of tofacitinib to biologic disease-modifying antirheumatic drugs (bDMARDs), the accrued patient-years (pt-yrs) of exposure needed in an RA clinical trial programme to detect a potential increase in risk of specific adverse events (AEs) was determined. This case study/framework was constructed on the pt-yrs' accrual within pooled phase (P)1, P2 and P3, as well as long-term extension, studies of tofacitinib in RA (March 2015 data-cut) and published AE incidence rates for bDMARDs. Sample size calculations were based on a Poisson distribution to estimate pt-yrs' exposure required for 90 % probability that the lower bound of the 95 % confidence interval for tofacitinib/bDMARD would be >1, assuming that tofacitinib rates were 1.2×/1.5×/2.0× greater than comparator rates. AE rates for bDMARDs were derived from sources intended to optimise similarity with the tofacitinib database in terms of baseline characteristics, study duration and follow-up. Based on the tofacitinib exposure accrued (19,406 pt-yrs), data were sufficient (90 % probability) to detect potential differences over external bDMARD comparator rates in serious infections (≥1.2×), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, major adverse cardiovascular events (MACE) and lymphoma (each ≥1.5×), as well as opportunistic infections and gastrointestinal perforations (≥2×), should they exist. This risk characterisation approach can support the comparative safety of new RA medications. To date, tofacitinib safety appears similar to approved published data from bDMARDs with respect to serious infections, malignancies (excluding NMSC), NMSC, MACE, lymphoma, opportunistic infections and gastrointestinal perforations.

Case-control analysis in highway safety: Accounting for sites with multiple crashes.

PubMed

Gross, Frank

2013-12-01

There is an increased interest in the use of epidemiological methods in highway safety analysis. The case-control and cohort methods are commonly used in the epidemiological field to identify risk factors and quantify the risk or odds of disease given certain characteristics and factors related to an individual. This same concept can be applied to highway safety where the entity of interest is a roadway segment or intersection (rather than a person) and the risk factors of interest are the operational and geometric characteristics of a given roadway. One criticism of the use of these methods in highway safety is that they have not accounted for the difference between sites with single and multiple crashes. In the medical field, a disease either occurs or it does not; multiple occurrences are generally not an issue. In the highway safety field, it is necessary to evaluate the safety of a given site while accounting for multiple crashes. Otherwise, the analysis may underestimate the safety effects of a given factor. This paper explores the use of the case-control method in highway safety and two variations to account for sites with multiple crashes. Specifically, the paper presents two alternative methods for defining cases in a case-control study and compares the results in a case study. The first alternative defines a separate case for each crash in a given study period, thereby increasing the weight of the associated roadway characteristics in the analysis. The second alternative defines entire crash categories as cases (sites with one crash, sites with two crashes, etc.) and analyzes each group separately in comparison to sites with no crashes. The results are also compared to a "typical" case-control application, where the cases are simply defined as any entity that experiences at least one crash and controls are those entities without a crash in a given period. In a "typical" case-control design, the attributes associated with single-crash segments are weighted the same as the attributes of segments with multiple crashes. The results support the hypothesis that the "typical" case-control design may underestimate the safety effects of a given factor compared to methods that account for sites with multiple crashes. Compared to the first alternative case definition (where multiple crash segments represent multiple cases) the results from the "typical" case-control design are less pronounced (i.e., closer to unity). The second alternative (where case definitions are constructed for various crash categories and analyzed separately) provides further evidence that sites with single and multiple crashes should not be grouped together in a case-control analysis. This paper indicates a clear need to differentiate sites with single and multiple crashes in a case-control analysis. While the results suggest that sites with multiple crashes can be accounted for using a case-control design, further research is needed to determine the optimal method for addressing this issue. This paper provides a starting point for that research. Copyright © 2012 Elsevier Ltd. All rights reserved.

A generalized concept for cost-effective structural design. [Statistical Decision Theory applied to aerospace systems

NASA Technical Reports Server (NTRS)

Thomas, J. M.; Hawk, J. D.

1975-01-01

A generalized concept for cost-effective structural design is introduced. It is assumed that decisions affecting the cost effectiveness of aerospace structures fall into three basic categories: design, verification, and operation. Within these basic categories, certain decisions concerning items such as design configuration, safety factors, testing methods, and operational constraints are to be made. All or some of the variables affecting these decisions may be treated probabilistically. Bayesian statistical decision theory is used as the tool for determining the cost optimum decisions. A special case of the general problem is derived herein, and some very useful parametric curves are developed and applied to several sample structures.

Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

PubMed

Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

2017-07-01

Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

The dread factor: how hazards and safety training influence learning and performance.

PubMed

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

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

19 CFR 122.187 - Revocation or suspension of access.

Code of Federal Regulations, 2010 CFR

2010-04-01

... that continued access might pose an unacceptable risk to public health, interest or safety, national security, aviation safety, the revenue, or the security of the area. In this case the port director will... health, safety, or security is involved and, in such a case, a final notice of revocation or suspension...

76 FR 14641 - Defense Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS Case 2010-D022... contract clause that clearly identifies any items being purchased that are critical safety items so that.... SUPPLEMENTARY INFORMATION: I. Background This DFARS case was initiated at the request of the Defense Contract...

Hard and Soft Safety Verifications

NASA Technical Reports Server (NTRS)

Wetherholt, Jon; Anderson, Brenda

2012-01-01

The purpose of this paper is to examine the differences between and the effects of hard and soft safety verifications. Initially, the terminology should be defined and clarified. A hard safety verification is datum which demonstrates how a safety control is enacted. An example of this is relief valve testing. A soft safety verification is something which is usually described as nice to have but it is not necessary to prove safe operation. An example of a soft verification is the loss of the Solid Rocket Booster (SRB) casings from Shuttle flight, STS-4. When the main parachutes failed, the casings impacted the water and sank. In the nose cap of the SRBs, video cameras recorded the release of the parachutes to determine safe operation and to provide information for potential anomaly resolution. Generally, examination of the casings and nozzles contributed to understanding of the newly developed boosters and their operation. Safety verification of SRB operation was demonstrated by examination for erosion or wear of the casings and nozzle. Loss of the SRBs and associated data did not delay the launch of the next Shuttle flight.

Narrative Practice and the Signs of Safety Approach: Engaging Adolescents in Building Rigorous Safety Plans

ERIC Educational Resources Information Center

Gibson, Matthew

2014-01-01

The Signs of Safety approach to child protection has been gaining prominence around the world and this approach has developed through learning from good practice. Generally, examples of good practice are derived from adults who pose a risk to children, while this paper outlines an example of good practice that engages an adolescent in building a…

Key aspects in managing safety when working with multiple contractors: A case study.

PubMed

Drupsteen, Linda; Rasmussen, Hanna B; Ustailieva, Erika; van Kampen, Jakko

2015-01-01

Working with multiple contractors in a shared workplace can introduce and increase safety risks due to complexity. The aim of this study was to explore how safety issues are recognized in a specific case and to identify whether clients and contractors perceive problems similarly. The safety issues are explored through a brief survey and a workshop in the maintenance department of a logistics company. The results indicate that culture and behavior are recognized differently by clients and by contractors. The contractors and client had different perceptions of involvement of contractors by the client. The contractors complained on lack of involvement, which was not fully recognized by the client. The case study used a practical approach to show differences in perception of safety within a project. The study illustrates the need for more applied studies and interventions on contractor safety.

Towards a Formal Basis for Modular Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

Adequacy of the default values for skin surface area used for risk assessment and French anthropometric data by a probabilistic approach.

PubMed

Dornic, N; Ficheux, A S; Bernard, A; Roudot, A C

2017-08-01

The notes of guidance for the testing of cosmetic ingredients and their safety evaluation by the Scientific Committee on Consumer Safety (SCCS) is a document dedicated to ensuring the safety of European consumers. This contains useful data for risk assessment such as default values for Skin Surface Area (SSA). A more in-depth study of anthropometric data across Europe reveals considerable variations. The default SSA value was derived from a study on the Dutch population, which is known to be one of the tallest nations in the World. This value could be inadequate for shorter populations of Europe. Data were collected in a survey on cosmetic consumption in France. Probabilistic treatment of these data and analysis of the case of methylisothiazolinone, a sensitizer recently evaluated by a deterministic approach submitted to SCCS, suggest that the default value for SSA used in the quantitative risk assessment might not be relevant for a significant share of the French female population. Others female populations of Southern Europe may also be excluded. This is of importance given that some studies show an increasing risk of developping skin sensitization among women. The disparities in anthropometric data across Europe should be taken into consideration. Copyright © 2017 Elsevier Ltd. All rights reserved.

Is the chronic Tier-1 effect assessment approach for insecticides protective for aquatic ecosystems?

PubMed

Brock, Theo Cm; Bhatta, Ranjana; van Wijngaarden, René Pa; Rico, Andreu

2016-10-01

We investigated the appropriateness of several methods, including those recommended in the Aquatic Guidance Document of the European Food Safety Authority (EFSA), for the derivation of chronic Tier-1 regulatory acceptable concentrations (RACs) for insecticides and aquatic organisms. The insecticides represented different chemical classes (organophosphates, pyrethroids, benzoylureas, insect growth regulators, biopesticides, carbamates, neonicotinoids, and miscellaneous). Chronic Tier-1 RACs derived using toxicity data for the standard species Daphnia magna, Chironomus spp., and/or Americamysis bahia, were compared with Tier-3 RACs derived from micro- and mesocosm studies on basis of the ecological threshold option (ETO-RACs). ETO-RACs could be derived for 31 insecticides applied to micro- and mesocosms in single or multiple applications, yielding a total number of 36 cases for comparison. The chronic Tier-1 RACs calculated according to the EFSA approach resulted in a sufficient protection level, except for 1 neonicotinoid (slightly underprotective) and for several pyrethroids if toxicity data for A. bahia were not included. This latter observation can be explained by 1) the fact that A. bahia is the most sensitive standard test species for pyrethroids, 2) the hydrophobic properties of pyrethroids, and 3) the fact that long-term effects observed in (epi) benthic arthropods may be better explained by exposure via the sediment than via overlying water. Besides including toxicity data for A. bahia, the protection level for pyrethroids can be improved by selecting both D. magna and Chironomus spp. as standard test species for chronic Tier-1 derivation. Although protective in the majority of cases, the conservativeness of the recommended chronic Tier-1 RACs appears to be less than an order of magnitude for a relatively large proportion of insecticides when compared with their Tier-3 ETO-RACs. This may leave limited options for refinement of the chronic effect assessment using laboratory toxicity data for additional species. Integr Environ Assess Manag 2016;12:747-758. © 2015 SETAC. © 2015 SETAC.

Macroergonomic analysis and design for improved safety and quality performance.

PubMed

Kleiner, B M

1999-01-01

Macroergonomics, which emerged historically after sociotechnical systems theory, quality management, and ergonomics, is presented as the basis for a needed integrative methodology. A macroergonomics methodology was presented in some detail to demonstrate how aspects of microergonomics, total quality management (TQM), and sociotechnical systems (STS) can be triangulated in a common approach. In the context of this methodology, quality and safety were presented as 2 of several important performance criteria. To demonstrate aspects of the methodology, 2 case studies were summarized with safety and quality performance results where available. The first case manipulated both personnel and technical factors to achieve a "safety culture" at a nuclear site. The concept of safety culture is defined in INSAG-4 (International Atomic Energy Agency, 1991). as "that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance." The second case described a tire manufacturing intervention to improve quality (as defined by Sink and Tuttle, 1989) through joint consideration of technical and social factors. It was suggested that macroergonomics can yield greater performance than can be achieved through ergonomic intervention alone. Whereas case studies help to make the case, more rigorous formative and summative research is needed to refine and validate the proposed methodology respectively.

[An investigative report concerning safety and management in the magnetic resonance environment: there are more accidents than expected].

PubMed

Doi, Tsukasa; Yamatani, Yuya; Ueyama, Tsuyoshi; Nishiki, Shigeo; Ogura, Akio; Kawamitsu, Hideaki; Tsuchihashi, Toshio; Okuaki, Tomoyuki; Matsuda, Tsuyoshi; Kumashiro, Masayuki

2011-01-01

Using a questionnaire, we surveyed 2,500 facilities in Japan to clarify medical accidents concerning the magnetic resonance device and its environment. Data derived from 1,319 valid responses (52.8%), allowed us to analyze the situation of (or the reason for) the occurrence of the accidents and their environmental factors. Five hundred and nine facilities (39% of all facilities) had the experience of magnetically induced displacement of the large ferromagnetic material. Intravenous (I.V.) drip stands were involved the largest number of them: 31% (228 cases). Oxygen bottles had the second largest number of incidents: 20%. There were also many incidents involving various materials brought in by non-medical staff (e.g. stepladder for construction). About 20% of the accidents occurred outside of working hours. Patients in 12% of the facilities (154 facilities) experienced burns. In 39 of the cases, burns were received to the inside of the thighs. In 38 of the cases, patients received burns from an electrical cable touching the skin. There were also frequent incidents of burning regarding the boa. We received reports of burns and pain from the halo vest even though it's required to be worn for MR safety. Regarding incidents of contraindications, 280 patients with pacemakers were brought into the magnetic resonance (MR) inspection room. Twelve percent of the facilities experienced natural quench. Lack of training for the staff who introduce and operate high magnetic field devices are considered involving frequently occurring accidents of attractions and burns at hospitals with over 500 beds caused by carrying in materials.

Biological safety concepts of genetically modified live bacterial vaccines.

PubMed

Frey, Joachim

2007-07-26

Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated immunity as well as antibody-mediated immunity, which is particularly beneficial in inducing mucosal immune responses, is obtained by the vaccine-strain's ability to colonize and multiply in the host without causing disease. For this reason, live vaccines require attenuation of virulence of the bacterium to which immunity must be induced. Traditionally attenuation was achieved simply by multiple passages of the microorganism on growth medium, in animals, eggs or cell cultures or by chemical or physical mutagenesis, which resulted in random mutations that lead to attenuation. In contrast, novel molecular methods enable the development of genetically modified organisms (GMOs) targeted to specific genes that are particularly suited to induce attenuation or to reduce undesirable effects in the tissue in which the vaccine strains can multiply and survive. Since live vaccine strains (attenuated by natural selection or genetic engineering) are potentially released into the environment by the vaccinees, safety issues concerning the medical as well as environmental aspects must be considered. These involve (i) changes in cell, tissue and host tropism, (ii) virulence of the carrier through the incorporation of foreign genes, (iii) reversion to virulence by acquisition of complementation genes, (iv) exchange of genetic information with other vaccine or wild-type strains of the carrier organism and (v) spread of undesired genes such as antibiotic resistance genes. Before live vaccines are applied, the safety issues must be thoroughly evaluated case-by-case. Safety assessment includes knowledge of the precise function and genetic location of the genes to be mutated, their genetic stability, potential reversion mechanisms, possible recombination events with dormant genes, gene transfer to other organisms as well as gene acquisition from other organisms by phage transduction, transposition or plasmid transfer and cis- or trans-complementation. For this, GMOs that are constructed with modern techniques of genetic engineering display a significant advantage over random mutagenesis derived live organisms. The selection of suitable GMO candidate strains can be made under in vitro conditions using basic knowledge on molecular mechanisms of pathogenicity of the corresponding bacterial species rather than by in vivo testing of large numbers of random mutants. This leads to a more targeted safety testing on volunteers and to a reduction in the use of animal experimentation.

Chromosomal aberrations and deoxyribonucleic acid single-strand breaks in adipose-derived stem cells during long-term expansion in vitro.

PubMed

Froelich, Katrin; Mickler, Johannes; Steusloff, Gudrun; Technau, Antje; Ramos Tirado, Mario; Scherzed, Agmal; Hackenberg, Stephan; Radeloff, Andreas; Hagen, Rudolf; Kleinsasser, Norbert

2013-07-01

Adipose-derived stem cells (ASCs) are a promising mesenchymal cell source for tissue engineering approaches. To obtain an adequate cell amount, in vitro expansion of the cells may be required in some cases. To monitor potential contraindications for therapeutic applications in humans, DNA strand breaks and chromosomal aberrations in ASCs during in vitro expansion were examined. After isolation of ASC from human lipoaspirates of seven patients, in vitro expansion over 10 passages was performed. Cells from passages 1, 2, 3, 5 and 10 were used for the alkaline single-cell microgel electrophoresis (comet) assay to detect DNA single-strand breaks and alkali labile as well as incomplete excision repair sites. Chromosomal changes were examined by means of the chromosomal aberration test. During in vitro expansion, ASC showed no DNA single-strand breaks in the comet assay. With the chromosomal aberration test, however, a significant increase in chromosomal aberrations were detected. The study showed that although no DNA fragmentation could be determined, the safety of ASC cannot be ensured with respect to chromosome stability during in vitro expansion. Thus, reliable analyses for detecting ASC populations, which accumulate chromosomal aberrations or even undergo malignant transformation during extensive in vitro expansion, must be implemented as part of the safety evaluation of these cells for stem cell-based therapy. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Reconciling quality and cost: A case study in interventional radiology.

PubMed

Zhang, Li; Domröse, Sascha; Mahnken, Andreas

2015-10-01

To provide a method to calculate delay cost and examine the relationship between quality and total cost. The total cost including capacity, supply and delay cost for running an interventional radiology suite was calculated. The capacity cost, consisting of labour, lease and overhead costs, was derived based on expenses per unit time. The supply cost was calculated according to actual procedural material use. The delay cost and marginal delay cost derived from queueing models was calculated based on waiting times of inpatients for their procedures. Quality improvement increased patient safety and maintained the outcome. The average daily delay costs were reduced from 1275 € to 294 €, and marginal delay costs from approximately 2000 € to 500 €, respectively. The one-time annual cost saved from the transfer of surgical to radiological procedures was approximately 130,500 €. The yearly delay cost saved was approximately 150,000 €. With increased revenue of 10,000 € in project phase 2, the yearly total cost saved was approximately 290,000 €. Optimal daily capacity of 4.2 procedures was determined. An approach for calculating delay cost toward optimal capacity allocation was presented. An overall quality improvement was achieved at reduced costs. • Improving quality in terms of safety, outcome, efficiency and timeliness reduces cost. • Mismatch of demand and capacity is detrimental to quality and cost. • Full system utilization with random demand results in long waiting periods and increased cost.

Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis.

PubMed

Katzka, David A; Geno, Debra M; Ravi, Anupama; Smyrk, Thomas C; Lao-Sirieix, Pierre; Miremadi, Ahmed; Miramedi, Ahmed; Debiram, Irene; O'Donovan, Maria; Kita, Hirohito; Kephart, Gail M; Kryzer, Lori A; Camilleri, Michael; Alexander, Jeffrey A; Fitzgerald, Rebecca C

2015-01-01

Management of eosinophilic esophagitis (EoE) requires repeated endoscopic collection of mucosal samples to assess disease activity and response to therapy. An easier and less expensive means of monitoring of EoE is required. We compared the accuracy, safety, and tolerability of sample collection via Cytosponge (an ingestible gelatin capsule comprising compressed mesh attached to a string) with those of endoscopy for assessment of EoE. Esophageal tissues were collected from 20 patients with EoE (all with dysphagia, 15 with stricture, 13 with active EoE) via Cytosponge and then by endoscopy. Number of eosinophils/high-power field and levels of eosinophil-derived neurotoxin were determined; hematoxylin-eosin staining was performed. We compared the adequacy, diagnostic accuracy, safety, and patient preference for sample collection via Cytosponge vs endoscopy procedures. All 20 samples collected by Cytosponge were adequate for analysis. By using a cutoff value of 15 eosinophils/high power field, analysis of samples collected by Cytosponge identified 11 of the 13 individuals with active EoE (83%); additional features such as abscesses were also identified. Numbers of eosinophils in samples collected by Cytosponge correlated with those in samples collected by endoscopy (r = 0.50, P = .025). Analysis of tissues collected by Cytosponge identified 4 of the 7 patients without active EoE (57% specificity), as well as 3 cases of active EoE not identified by analysis of endoscopy samples. Including information on level of eosinophil-derived neurotoxin did not increase the accuracy of diagnosis. No complications occurred during the Cytosponge procedure, which was preferred by all patients, compared with endoscopy. In a feasibility study, the Cytosponge is a safe and well-tolerated method for collecting near mucosal specimens. Analysis of numbers of eosinophils/high-power field identified patients with active EoE with 83% sensitivity. Larger studies are needed to establish the efficacy and safety of this method of esophageal tissue collection. ClinicalTrials.gov number: NCT01585103. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

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

PubMed

Gürtler, R

2010-06-01

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

Evaluating performance of risk identification methods through a large-scale simulation of observational data.

PubMed

Ryan, Patrick B; Schuemie, Martijn J

2013-10-01

There has been only limited evaluation of statistical methods for identifying safety risks of drug exposure in observational healthcare data. Simulations can support empirical evaluation, but have not been shown to adequately model the real-world phenomena that challenge observational analyses. To design and evaluate a probabilistic framework (OSIM2) for generating simulated observational healthcare data, and to use this data for evaluating the performance of methods in identifying associations between drug exposure and health outcomes of interest. Seven observational designs, including case-control, cohort, self-controlled case series, and self-controlled cohort design were applied to 399 drug-outcome scenarios in 6 simulated datasets with no effect and injected relative risks of 1.25, 1.5, 2, 4, and 10, respectively. Longitudinal data for 10 million simulated patients were generated using a model derived from an administrative claims database, with associated demographics, periods of drug exposure derived from pharmacy dispensings, and medical conditions derived from diagnoses on medical claims. Simulation validation was performed through descriptive comparison with real source data. Method performance was evaluated using Area Under ROC Curve (AUC), bias, and mean squared error. OSIM2 replicates prevalence and types of confounding observed in real claims data. When simulated data are injected with relative risks (RR) ≥ 2, all designs have good predictive accuracy (AUC > 0.90), but when RR < 2, no methods achieve 100 % predictions. Each method exhibits a different bias profile, which changes with the effect size. OSIM2 can support methodological research. Results from simulation suggest method operating characteristics are far from nominal properties.

System Safety in Early Manned Space Program: A Case Study of NASA and Project Mercury

NASA Technical Reports Server (NTRS)

Hansen, Frederick D.; Pitts, Donald

2005-01-01

This case study provides a review of National Aeronautics and Space Administration s (NASA's) involvement in system safety during research and evolution from air breathing to exo-atmospheric capable flight systems culminating in the successful Project Mercury. Although NASA has been philosophically committed to the principals of system safety, this case study points out that budget and manpower constraints-as well as a variety of internal and external pressures can jeopardize even a well-designed system safety program. This study begins with a review of the evolution and early years of NASA's rise as a project lead agency and ends with the lessons learned from Project Mercury.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

? Click Here! Resources for MSD Safety MSD Safety MSD's Integrated Safety Management Plan [PDF] Safety culture and policies at MSD MSD0010: Integrated Safety Management: Principles and Case Studies Calendar for MSD classes on Integrated Safety Management MSD0015 Handout - Waste Briefing Document [PDF] Waste

Making a Case for Organizational Change in Patient Safety Initiatives

DTIC Science & Technology

2005-05-01

or medical staff could be required to directly observe patient care processes. Such firsthand encounters with process flaws are particularly...can actually make patient safety worse. Take, for example, the previously described situation where nurses stopped reporting when the medication ...455 Making a Case for Organizational Change in Patient Safety Initiatives Rangaraj Ramanujam, Donna J. Keyser, Carl A. Sirio Abstract

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Stephen B.

2010-01-01

Software plays an increasingly larger role in all aspects of NASA's science missions. This has been extended to the identification, management and control of faults which affect safety-critical functions and by default, the overall success of the mission. Traditionally, the analysis of fault identification, management and control are hardware based. Due to the increasing complexity of system, there has been a corresponding increase in the complexity in fault management software. The NASA Independent Validation & Verification (IV&V) program is creating processes and procedures to identify, and incorporate safety-critical software requirements along with corresponding software faults so that potential hazards may be mitigated. This Specific to Generic ... A Case for Reuse paper describes the phases of a dependability and safety study which identifies a new, process to create a foundation for reusable assets. These assets support the identification and management of specific software faults and, their transformation from specific to generic software faults. This approach also has applications to other systems outside of the NASA environment. This paper addresses how a mission specific dependability and safety case is being transformed to a generic dependability and safety case which can be reused for any type of space mission with an emphasis on software fault conditions.

Evaluating chemical safety: ToxCast, Tipping Points and Virtual Tissues (Tamburro Symposium)

EPA Science Inventory

This presentation provides an overview of high-throughput toxicology at the NCCT using high-content imaging and computational models for analyzing chemical safety. In In particular, this work outlines the derivation of toxicological "tipping points" from in vitro concentration- a...

Deriving freshwater safety thresholds for hexabromocyclododecane and comparison of toxicity of brominated flame retardants.

PubMed

Dong, Liang; Zheng, Lei; Yang, Suwen; Yan, Zhenguang; Jin, Weidong; Yan, Yuhong

2017-05-01

Hexabromocyclododecane (HBCD) is a brominated flame retardant used throughout the world. It has been detected in various environmental media and has been shown toxic to aquatic life. The toxic effects of HBCD to aquatic organisms in Chinese freshwater ecosystems are discussed here. Experiments were conducted with nine types of acute toxicity testing and three types of chronic toxicity testing. After comparing a range of species sensitivity distribution models, the optimal model of Bull III was used to derive the safety thresholds for HBCD. The acute safety threshold and the chronic safety threshold of HBCD for Chinese freshwater organisms were found to be 2.32mg/L and 0.128mg/L, respectively. Both values were verified by the methods of the Netherlands and the United States. HBCD was found to be less toxic compared to other widely used brominated flame retardants. The present results provide valuable information for revision of the water quality standard of HBCD in China. Copyright © 2017 Elsevier Inc. All rights reserved.

Novel Stem Cell Therapies for Applications to Wound Healing and Tissue Repair.

PubMed

Grada, Ayman; Falanga, Vincent

2016-10-26

The number of individuals with chronic cutaneous wounds has been increasing worldwide due to an aging population, diabetes, obesity, and cardiovascular disease. In the United States, almost seven million Americans have chronic skin ulcers. Many therapeutic approaches have been used. However, the treatment outcomes are not always ideal because of failure to achieve complete wound closure in around 60% of cases, scarring, and high rate of recurrence. Therefore, there is a need for more effective therapies. Stem cells offer promising possibilities. Pre-clinical studies have shown that bone- or adipose tissue-derived mesenchymal stem cells (MSCs) have a competitive advantage over other types of stem cells due to their better defined multipotent differentiating potential, paracrine effects, immunomodulatory properties, and safety. However, large controlled clinical trials are needed to examine the capabilities of MSCs in humans and to assess their safety profile. In this review, we highlight emerging treatments in tissue regeneration and repair and provide some perspectives on how to translate current knowledge about stem cells-both multipotent and pluripotent-into viable clinical approaches for treating patients with difficult to heal wounds.

Safety Education and Science.

ERIC Educational Resources Information Center

Ralph, Richard

1980-01-01

Safety education in the science classroom is discussed, including the beginning of safe management, attitudes toward safety education, laboratory assistants, chemical and health regulation, safety aids, and a case study of a high school science laboratory. Suggestions for safety codes for science teachers, student behavior, and laboratory…

Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey.

PubMed

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-10-01

To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's alpha coefficients ranged from 0.50 to 0.89. It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes.

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective.

PubMed

Xu, Xiao Ping; Deng, Dong Ning; Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong's patient safety strategies in the context of Mainland China. A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff's patient safety culture mind-set, to realize a "bottom-up" approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety.

Use of a safety climate questionnaire in UK health care: factor structure, reliability and usability.

PubMed

Hutchinson, A; Cooper, K L; Dean, J E; McIntosh, A; Patterson, M; Stride, C B; Laurence, B E; Smith, C M

2006-10-01

To explore the factor structure, reliability, and potential usefulness of a patient safety climate questionnaire in UK health care. Four acute hospital trusts and nine primary care trusts in England. The questionnaire used was the 27 item Teamwork and Safety Climate Survey. Thirty three healthcare staff commented on the wording and relevance. The questionnaire was then sent to 3650 staff within the 13 NHS trusts, seeking to achieve at least 600 responses as the basis for the factor analysis. 1307 questionnaires were returned (36% response). Factor analyses and reliability analyses were carried out on 897 responses from staff involved in direct patient care, to explore how consistently the questions measured the underlying constructs of safety climate and teamwork. Some questionnaire items related to multiple factors or did not relate strongly to any factor. Five items were discarded. Two teamwork factors were derived from the remaining 11 teamwork items and three safety climate factors were derived from the remaining 11 safety items. Internal consistency reliabilities were satisfactory to good (Cronbach's alpha > or =0.69 for all five factors). This is one of the few studies to undertake a detailed evaluation of a patient safety climate questionnaire in UK health care and possibly the first to do so in primary as well as secondary care. The results indicate that a 22 item version of this safety climate questionnaire is useable as a research instrument in both settings, but also demonstrates a more general need for thorough validation of safety climate questionnaires before widespread usage.

Determining the safety of enzymes used in animal feed.

PubMed

Pariza, Michael W; Cook, Mark

2010-04-01

The purpose of this paper is to provide guidance for evaluating the safety of enzyme preparations used in animal feed. Feed enzymes are typically added to animal feed to increase nutrient bioavailability by acting on feed components prior to or after consumption, i.e., within the gastrointestinal tract. In contrast, food processing enzymes are generally used during processing and then inactivated or removed prior to consumption. The enzymes used in both applications are almost always impure mixtures of active enzyme and other metabolites from the production strain, hence similar safety evaluation procedures for both are warranted. We propose that the primary consideration should be the safety of the production strain and that the decision tree mechanism developed previously for food processing enzymes (Pariza and Johnson, 2001) is appropriate for determining the safety of feed enzymes. Thoroughly characterized non-pathogenic, non-toxigenic microbial strains with a history of safe use in enzyme manufacture are also logical candidates for generating safe strain lineages, from which additional strains may be derived via genetic modification by traditional and non-traditional strategies. For new feed enzyme products derived from a safe strain lineage, it is important to ensure a sufficiently high safety margin for the intended use, and that the product complies with appropriate specifications for chemical and microbial contamination. Copyright 2009 Elsevier Inc. All rights reserved.

Safety management by walking around (SMBWA): a safety intervention program based on both peer and manager participation.

PubMed

Luria, Gil; Morag, Ido

2012-03-01

"Management by walking around" (MBWA) is a practice that has aroused much interest in management science and practice. The purpose of this study is to demonstrate adaptation of this practice to safety management. We describe a three-year long case study that collected empirical data in which a modified MBWA was practiced in order to improve safety in a semiconductor fabrication facility. The main modification involved integrating an information system with the MBWA in order to create a practice that would generate safety leadership development and an organizational safety learning mechanism, while promoting employee safety participation. The results of the case study demonstrate that the SMBWA practice facilitated thousands of tours in which safety leadership behaviors were practiced by managers and by employees (employees performed five times as many tours as managers). The information system collected information about safety behaviors and safety conditions that could not otherwise be obtained. Thus, this study presents a new organizational safety practice SMBWA, and demonstrates the ways in which SMBWA may improve safety in organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

Safety Case Notations: Alternatives for the Non-Graphically Inclined?

NASA Technical Reports Server (NTRS)

Holloway, C. M.

2008-01-01

This working paper presents preliminary ideas of five possible text-based notations for representing safety cases, which may be easier for non-graphically inclined people to use and understand than the currently popular graphics-based representations.

Criticality Safety Evaluation for Small Sample Preparation and Non-Destructive Assay (NDA) Operations in Wing 7 Basement of the CMR Facility

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

Kunkle, Paige Elizabeth; Zhang, Ning

Nuclear Criticality Safety (NCS) has reviewed the fissionable material small sample preparation and NDA operations in Wing 7 Basement of the CMR Facility. This is a Level-1 evaluation conducted in accordance with NCS-AP-004 [Reference 1], formerly NCS-GUIDE-01, and the guidance set forth on use of the Standard Criticality Safety Requirements (SCSRs) [Reference 2]. As stated in Reference 2, the criticality safety evaluation consists of both the SCSR CSED and the SCSR Application CSED. The SCSR CSED is a Level-3 CSED [Reference 3]. This Level-1 CSED is the SCSR Application CSED. This SCSR Application (Level-1) evaluation does not derive controls, itmore » simply applies controls derived from the SCSR CSED (Level-3) for the application of operations conducted here. The controls derived in the SCSR CSED (Level-3) were evaluated via the process described in Section 6.6.5 of SD-130 (also reproduced in Section 4.3.5 of NCS-AP-004 [Reference 1]) and were determined to not meet the requirements for consideration of elevation into the safety basis documentation for CMR. According to the guidance set forth on use of the SCSRs [Reference 2], the SCSR CSED (Level-3) is also applicable to the CMR Facility because the process and the normal and credible abnormal conditions in question are bounded by those that are described in the SCSR CSED. The controls derived in the SCSR CSED include allowances for solid materials and solution operations. Based on the operations conducted at this location, there are less-than-accountable (LTA) amounts of 233U. Based on the evaluation documented herein, the normal and credible abnormal conditions that might arise during the execution of this process will remain subcritical with the following recommended controls.« less

Strain Gage Load Calibration of the Wing Interface Fittings for the Adaptive Compliant Trailing Edge Flap Flight Test

NASA Technical Reports Server (NTRS)

Miller, Eric J.; Holguin, Andrew C.; Cruz, Josue; Lokos, William A.

2014-01-01

This is the presentation to follow conference paper of the same name. The adaptive compliant trailing edge (ACTE) flap experiment safety of flight requires that the flap to wing interface loads be sensed and monitored in real time to ensure that the wing structural load limits are not exceeded. This paper discusses the strain gage load calibration testing and load equation derivation methodology for the ACTE interface fittings. Both the left and right wing flap interfaces will be monitored and each contains four uniquely designed and instrumented flap interface fittings. The interface hardware design and instrumentation layout are discussed. Twenty one applied test load cases were developed using the predicted in-flight loads for the ACTE experiment.

Quality, Safety, Value: From Theory to Practice Management What Should We Measure?

PubMed

Shore, Benjamin J; Murphy, Robert F; Hogue, Grant D

2015-01-01

Over the past 35 years the health care community and in particular orthopaedic surgery, has undergone a transformation from retrospective case-series-based expert opinion to randomized prospective clinical trials. During this transition, orthopaedic surgeons have become very skilled in the measurement of physician-derived outcomes (radiographic angles, complications, recurrences, and mortality); however, these are not patient-centered outcomes and they are of little importance to our patients' satisfaction. Moving forward outcome measurement needs to be restructured to focus more on patient-reported outcomes. This paper outlines why outcome measurement is important, reviews outcome strategies that have been used historically, introduces a new outcome measurement tool and identifies strategies for future implementation and measurement of health care quality and value within pediatric orthopaedics.

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Lessons learned from measuring safety culture: an Australian case study.

PubMed

Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

2010-10-01

adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture. Undertaking research in this way requires local engagement, commitment and capacity from the study site. The absence of these factors is likely to limit the practicality of this approach in the clinical setting. the use of safety culture surveys as the only method of assessing safety culture is of limited value in identifying strategies to potentially improve the safety culture. Copyright © 2010 Elsevier Ltd. All rights reserved.

Generalized implementation of software safety policies

NASA Technical Reports Server (NTRS)

Knight, John C.; Wika, Kevin G.

1994-01-01

As part of a research program in the engineering of software for safety-critical systems, we are performing two case studies. The first case study, which is well underway, is a safety-critical medical application. The second, which is just starting, is a digital control system for a nuclear research reactor. Our goal is to use these case studies to permit us to obtain a better understanding of the issues facing developers of safety-critical systems, and to provide a vehicle for the assessment of research ideas. The case studies are not based on the analysis of existing software development by others. Instead, we are attempting to create software for new and novel systems in a process that ultimately will involve all phases of the software lifecycle. In this abstract, we summarize our results to date in a small part of this project, namely the determination and classification of policies related to software safety that must be enforced to ensure safe operation. We hypothesize that this classification will permit a general approach to the implementation of a policy enforcement mechanism.

Loosely Coupled GPS-Aided Inertial Navigation System for Range Safety

NASA Technical Reports Server (NTRS)

Heatwole, Scott; Lanzi, Raymond J.

2010-01-01

The Autonomous Flight Safety System (AFSS) aims to replace the human element of range safety operations, as well as reduce reliance on expensive, downrange assets for launches of expendable launch vehicles (ELVs). The system consists of multiple navigation sensors and flight computers that provide a highly reliable platform. It is designed to ensure that single-event failures in a flight computer or sensor will not bring down the whole system. The flight computer uses a rules-based structure derived from range safety requirements to make decisions whether or not to destroy the rocket.

ESA Human rating Requirements:Status

NASA Astrophysics Data System (ADS)

Trujillo, M.; Sgobba, T.

2012-01-01

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

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Development and Evaluation of a Multi-Institutional Case Studies-Based Course in Food Safety

ERIC Educational Resources Information Center

Pleitner, Aaron M.; Chapin, Travis K.; Hammons, Susan R.; Stelten, Anna Van; Nightingale, Kendra K.; Wiedmann, Martin; Johnston, Lynette M.; Oliver, Haley F.

2015-01-01

Developing novel, engaging courses in food safety is necessary to train professionals in this discipline. Courses that are interactive and case-based encourage development of critical thinking skills necessary for identifying and preventing foodborne disease outbreaks. The purpose of this study was to assess the efficacy of a case study…

40 CFR 721.3560 - Derivative of tetra-chloro-ethy-lene.

Code of Federal Regulations, 2010 CFR

2010-07-01

... according to procedures established by the Occupational Safety and Health Administration and Mine Safety and Health Administration regulations and set forth at 29 CFR 1910.134, and 30 CFR part 11, respectively, and... including the duration of exposure, associated chemical substances, chemical and mechanical stresses, and...

Iatrogenic Baclofen Neurotoxicity in ESRD: Recognition and Management

PubMed Central

Roberts, John K.; Westphal, Scott; Sparks, Matthew A.

2016-01-01

Baclofen is an oral derivative of gamma-aminobutyric acid (GABA) used to treat muscular spasticity from disorders of the central nervous system. However, it is also being used for a variety of other conditions such as musculoskeletal pain, myoclonus, and alcohol withdrawal. The elimination of baclofen is heavily dependent on intact renal function, and the contraindication for use in patients with insufficient renal function is not well recognized by healthcare providers. Here, the authors report a series of mild to severe cases of baclofen intoxication in patients with end-stage renal disease. In all cases, baclofen was initiated by either inpatient or outpatient healthcare providers and the patients generally presented with altered mentation, somnolence, and/or respiratory depression. All patients were treated with aggressive hemodialysis and made a full recovery. This paper will briefly review the literature regarding baclofen intoxication, safety of baclofen use in renal disease, and efficacy of extra-corporeal therapy in the treatment of baclofen intoxication. PMID:26096760

Iatrogenic Baclofen Neurotoxicity in ESRD: Recognition and Management.

PubMed

Roberts, John K; Westphal, Scott; Sparks, Matthew A

2015-01-01

Baclofen is an oral derivative of gamma-aminobutyric acid (GABA) used to treat muscular spasticity from disorders of the central nervous system. However, it is also being used for a variety of other conditions such as musculoskeletal pain, myoclonus, and alcohol withdrawal. The elimination of baclofen is heavily dependent on intact renal function, and the contraindication for use in patients with insufficient renal function is not well recognized by healthcare providers. Here, the authors report a series of mild to severe cases of baclofen intoxication in patients with end-stage renal disease. In all cases, baclofen was initiated by either inpatient or outpatient healthcare providers and the patients generally presented with altered mentation, somnolence, and/or respiratory depression. All patients were treated with aggressive hemodialysis and made a full recovery. This paper will briefly review the literature regarding baclofen intoxication, safety of baclofen use in renal disease, and efficacy of extracorporeal therapy in the treatment of baclofen intoxication. © 2015 Wiley Periodicals, Inc.

Coccidioidomycosis, immunoglobulin deficiency: safety challenges with CAR T cells therapy for relapsed lymphoma.

PubMed

Zahid, Umar; Shaukat, Al-Aman; Hassan, Nida; Anwer, Faiz

2017-10-01

Treatment of patients with relapsed or refractory lymphoma may require allogenic hematopoietic stem cell transplant (HSCT), but treatment of post-transplant relapse disease remains very challenging. Donor lymphocyte infusion and blinatumomab have been used with limited success for the treatment of relapse. Initial data on donor-derived CAR T cells has shown this modality to be safe and highly effective in various hematological malignancies. We present a case of a patient with highly refractory, transformed follicular lymphoma who failed both autologous and allogenic HSCT. Patient achieved long-lasting complete remission with the use of donor origin CD19 CAR T-cell therapy, without any evidence of graft-versus-host disease flare. Our patient later developed disseminated coccidioidomycosis and persistent hypogammaglobulinemia. Immunotherapy using CD19 CAR T cells can be a highly effective salvage modality, especially in cases of focal lymphoma relapse. Long-term immunosuppression secondary to B cell lymphopenia, hypogammaglobulinemia, immunoglobulin subclass deficiency, fungal infections and other infectious complications need to be monitored and promptly treated as indicated.

ASIL determination for motorbike's Electronics Throttle Control System (ETCS) mulfunction

NASA Astrophysics Data System (ADS)

Zaman Rokhani, Fakhrul; Rahman, Muhammad Taqiuddin Abdul; Ain Kamsani, Noor; Sidek, Roslina Mohd; Saripan, M. Iqbal; Samsudin, Khairulmizam; Khair Hassan, Mohd

2017-11-01

Electronics Throttle Control System (ETCS) is the principal electronic unit in all fuel injection engine motorbike, augmenting the engine performance efficiency in comparison to the conventional carburetor based engine. ETCS is regarded as a safety-critical component, whereby ETCS malfunction can cause unintended acceleration or deceleration event, which can be hazardous to riders. In this study, Hazard Analysis and Risk Assessment, an ISO26262 functional safety standard analysis has been applied on motorbike's ETCS to determine the required automotive safety integrity level. Based on the analysis, the established automotive safety integrity level can help to derive technical and functional safety measures for ETCS development.

A World Health Organization field trial assessing a proposed ICD-11 framework for classifying patient safety events.

PubMed

Forster, Alan J; Bernard, Burnand; Drösler, Saskia E; Gurevich, Yana; Harrison, James; Januel, Jean-Marie; Romano, Patrick S; Southern, Danielle A; Sundararajan, Vijaya; Quan, Hude; Vanderloo, Saskia E; Pincus, Harold A; Ghali, William A

2017-08-01

To assess the utility of the proposed World Health Organization (WHO)'s International Classification of Disease (ICD) framework for classifying patient safety events. Independent classification of 45 clinical vignettes using a web-based platform. The WHO's multi-disciplinary Quality and Safety Topic Advisory Group. The framework consists of three concepts: harm, cause and mode. We defined a concept as 'classifiable' if more than half of the raters could assign an ICD-11 code for the case. We evaluated reasons why cases were nonclassifiable using a qualitative approach. Harm was classifiable in 31 of 45 cases (69%). Of these, only 20 could be classified according to cause and mode. Classifiable cases were those in which a clear cause and effect relationship existed (e.g. medication administration error). Nonclassifiable cases were those without clear causal attribution (e.g. pressure ulcer). Of the 14 cases in which harm was not evident (31%), only 5 could be classified according to cause and mode and represented potential adverse events. Overall, nine cases (20%) were nonclassifiable using the three-part patient safety framework and contained significant ambiguity in the relationship between healthcare outcome and putative cause. The proposed framework enabled classification of the majority of patient safety events. Cases in which potentially harmful events did not cause harm were not classifiable; additional code categories within the ICD-11 are one proposal to address this concern. Cases with ambiguity in cause and effect relationship between healthcare processes and outcomes remain difficult to classify. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

HSE's safety assessment principles for criticality safety.

PubMed

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-06-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

Prevalence of Post-tonsillectomy Bleeding as Day-case Surgery with Combination Method; Cold Dissection Tonsillectomy and Bipolar Diathermy Hemostasis

PubMed Central

Faramarzi, Abolahassan; Heydari, Seyed Taghi

2010-01-01

Objective Post-tonsillectomy hemorrhage remains an important factor in determining the safety of performing tonsillectomy as a day case procedure. The aim of this study was to determine the safety of day case tonsillectomy by using combination method, cold dissection tonsillectomy and bipolar diathermy hemostasis. Methods A prospective randomized clinical study conducted on the patients who had undergone day case tonsillectomy (DCT). There were two groups (DCT and control group) each group consisting of 150 cases. Tonsillectomy was performed by using combination method; cold dissection and hemostasis was achieved by ligation of vessels with bipolar electerocautery. Findings We found 3 cases of post-tonsillectomy bleeding in DCT group and 4 cases in the control group. There was no statistically significant difference in the rate of post-operative hemorrhage between the two groups. Conclusion The findings suggest the safety of the combination of cold dissection tonsillectomy and bipolar diathermy hemostasis as day case tonsillectomy. PMID:23056702

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

PubMed

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

2014-06-03

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

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

PubMed Central

Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

Increasing use of pyrethroids in Canadian households: should we be concerned?

PubMed

van Balen, Erna C; Wolansky, Marcelo J; Kosatsky, Tom

2012-11-07

Pyrethroids are a class of plant-derived insecticides and their man-made analogues that are increasingly applied in Canada as first choice for pest control in many agricultural and residential settings. Their popularity is partly due to their alleged safety compared to the older organochlorine and organophosphate insecticides. Application of pyrethroids is expanding because of recent increases in the level of pest infestations--such as bed bugs--and the decreased susceptibility of target species to many pest control products. Pyrethroid residues have been documented in homes, child care centres and food. While pyrethroids are considered of low health risk for humans, their increased use is of concern. Our current understanding of the adverse effects of pyrethroids derives mainly from studies of short-term effects in laboratory animals, case reports of self- and accidental poisonings, and high-dose occupational exposures, for which the levels and formulations of pyrethroid products differ from those relevant for long-term exposure in the general population. The available data suggest that the reproductive and nervous systems, endocrine signalling pathways, and early childhood development may be targets for adverse effects in the case of repeated exposure to pyrethroid formulations. Given uncertainty about the existence of long-term health effects of exposure to pyrethroids, particularly under realistic scenarios, we should be cautious when promoting pyrethroid products as safe methods for pest control.

The JRC-ITU approach to the safety of advanced nuclear fuel cycles

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

Fanghaenel, T.; Rondinella, V.V.; Somers, J.

2013-07-01

The JRC-ITU safety studies of advanced fuels and cycles adopt two main axes. First the full exploitation of still available and highly relevant knowledge and samples from past fuel preparation and irradiation campaigns (complementing the limited number of ongoing programmes). Secondly, the shift of focus from simple property measurement towards the understanding of basic mechanisms determining property evolution and behaviour of fuel compounds during normal, off-normal and accident conditions. The final objective of the second axis is the determination of predictive tools applicable to systems and conditions different from those from which they were derived. State of the art experimentalmore » facilities, extensive networks of partnerships and collaboration with other organizations worldwide, and a developing programme for training and education are essential in this approach. This strategy has been implemented through various programs and projects. The SUPERFACT programme constitutes the main body of existing knowledge on the behavior in-pile of MOX fuel containing minor actinides. It encompassed all steps of a closed fuel cycle. Another international project investigating the safety of a closed cycle is METAPHIX. In this case a U-Pu19-Zr10 metal alloy containing Np, Am and Cm constitutes the fuel. 9 test pins have been prepared and irradiated. In addition to the PIE (Post Irradiation Examination), pyrometallurgical separation of the irradiated fuel has been performed, to demonstrate all the steps of a multiple recycling closed cycle and characterize their safety relevant aspects. Basic studies like thermodynamic fuel properties, fuel-cladding-coolant interactions have also been carried out at JRC-ITU.« less

Assuring Ground-Based Detect and Avoid for UAS Operations

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

2014-01-01

One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

Food safety of milk and dairy product of dairy cattle from heavy metal contamination

NASA Astrophysics Data System (ADS)

Harlia, E.; Rahmah, KN; Suryanto, D.

2018-01-01

Food safety of milk and dairy products is a prerequisite for consumption, which must be free from physical, biological and chemical contamination. Chemical contamination of heavy metals Pb (Plumbum/Lead) and Cd (Cadmium) is generally derived from the environment such as from water, grass, feed additives, medicines and farm equipment. The contamination of milk and dairy products can affect quality and food safety for human consumption. The aim of this research is to investigate contamination of heavy metals Pb and Cd on fresh milk, pasteurized milk, and dodol milk compared with the Maximum Residue Limits (MRL). The methods of this researched was through case study and data obtained analyzed descriptively. Milk samples were obtained from Bandung and surrounding areas. The number of samples used was 30 samples for each product: 30 samples of fresh milk directly obtained from dairy farm, 30 samples of pasteurized milk obtained from street vendors and 30 samples of dodol milk obtained from home industry. Parameters observed were heavy metal residues of Pb and Cd. The results showed that: 1) approximately 83% of fresh milk samples were contaminated by Pb which 57% samples were above MRL and 90% samples were contaminated by Cd above MRL; 2) 67% of pasteurized milk samples were contaminated by Pb below MRL; 3) 60% of dodol milk samples were contaminated by Pb and Cd above MRL.

Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China.

PubMed

Ma, Shan; Pang, Guang Li; Shao, Yu Juan; Hongo-Hirasaki, Tomoko; Shang, Meng Xian; Inouye, Marcus; Jian, Chang Yong; Zhu, Meng Zhao; Yang, Hu Hu; Gao, Jian Feng; Xi, Zhi Ying; Song, Dian Wei

2018-03-01

There is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters: transmembrane pressure, temperature, protein concentration, and prefiltration methods. The developed procedure was based on filtering undiluted process solution (50.0 g/l IVIG) under constant transmembrane pressure filtration at 294 kPa and 25 °C following prefiltration with a 0.1 μm MILLEX VV filter. The recovery of IgG was approximately 98%, and no substantial changes in biochemical characteristics were observed before and after nanofiltration in scaled-up production. A viral clearance validation study with parvovirus under worst-case conditions performed at the National Institutes for Food and Drug Control of China (NIFDC) showed PPV logarithmic reduction value (LRV) > 4. Improved viral safety of IVIG can be assured by implementing a Planova BioEX nanofiltration step to ensure effective parvovirus clearance under conditions providing excellent protein recovery and no detectable impact on product biochemical properties. This plasma-derived IVIG product is the first to be certified for parvovirus safety by the NIFDC in China. Copyright © 2018 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Evaluating oversight systems for emerging technologies: a case study of genetically engineered organisms.

PubMed

Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel

2009-01-01

The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.

A Case History Introducing the Oregon Ag Seminar Series-Keys to Program and Research-to-Practice Success.

PubMed

Harrington, Marcy J; Lloyd, Kirk

2017-01-01

This case history of Oregon state's Ag Seminar Series is consistent with the Socio-Ecological Model, demonstrating how policy at a state level can influence an organizational approach with impacts that ultimately influence safety practices on the farm. From modest beginnings, the Ag Seminar Series, offered through a workers compensation insurance company, now serves over 2,300 Oregon farmers annually in English and Spanish. This case offers unique but also replicable methods for educators, insurers, and researchers in safety education, safety motivators, and research-to-practice (r2p).

Federal and tribal lands road safety audits : case studies

DOT National Transportation Integrated Search

2009-12-01

A road safety audit (RSA) is a formal safety performance examination by an independent, multidisciplinary team. RSAs are an effective tool for proactively improving the safety performance of a road project during the planning and design stages, and f...

A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

PubMed

Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

2015-10-01

Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

Study of a safety margin system for powered-lift STOL aircraft

NASA Technical Reports Server (NTRS)

Heffley, R. K.; Jewell, W. F.

1978-01-01

A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

Workforce Perceptions of Hospital Safety Culture: Development and Validation of the Patient Safety Climate in Healthcare Organizations Survey

PubMed Central

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-01-01

Objective To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Data Sources/Study Setting Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Study Design Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. Data Collection We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). Principal Findings We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's α coefficients ranged from 0.50 to 0.89. Conclusions It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes. PMID:17850530

The Shirts on Our Backs: Teleological Perspectives on Factory Safety in Bangladesh

ERIC Educational Resources Information Center

Dhooge, Lucien J.

2016-01-01

This case study addresses the issue of factory safety in the garment industry through an examination of two recent catastrophic failures in Bangladesh. The case study was designed for students in Business Ethics in the MBA curriculum at the Scheller College of Business at the Georgia Institute of Technology. The case study has also been adapted…

Closed medical negligence claims can drive patient safety and reduce litigation.

PubMed

Pegalis, Steven E; Bal, B Sonny

2012-05-01

Medical liability reform is viewed by many physician groups as a means of reducing medical malpractice litigation and lowering healthcare costs. However, alternative approaches such as closed medical negligence claims data may also achieve these goals. We asked whether information gleaned from closed claims related to medical negligence could promote patient safety and reduce costs related to medical liability. Specifically, we investigated whether physician groups have examined such data to identify error patterns and to then institute specific patient treatment protocols. We searched for medical societies that have systematically examined closed medical negligence claims in their specialty to develop specific standards of physician conduct. We then searched the medical literature for published evidence of the efficacy, if any, related to the patient safety measures thus developed. Anesthesia and obstetric physician societies have successfully targeted costs and related concerns arising from medical malpractice lawsuits by using data from closed claims to develop patient safety and treatment guidelines. In both specialties, after institution of safety measures derived from closed medical negligence claims, the incidence and costs related to medical malpractice decreased and physician satisfaction improved. Tort reform, in the form of legislatively prescribed limits on damages arising from lawsuits, is not the only means of addressing the incidence and costs related to medical malpractice litigation. As the experience of anesthesia and obstetric physicians has demonstrated, safety guidelines derived from analyzing past medical malpractice litigation can achieve the same goals while also promoting patient safety.

Intrathecal Pump Exposure to Electromagnetic Interference: A Report of Device Interrogation following Multiple ECT Sessions.

PubMed

Bicket, Mark C; Hanna, George M

2016-02-01

Intrathecal drug delivery systems represent an increasingly common treatment modality for patients with a variety of conditions, including chronic pain and spasticity. Pumps rely on electronic programming to properly control and administer highly concentrated medications. Electromagnetic interference (EMI) is a known exposure that may cause a potential patient safety issue stemming from direct patient injury, pump damage, or changes to pump operation or flow rate. The objective of our case report was to describe an approach to evaluating a patient with a pump prior to and following exposure to EMI from electroconvulsive therapy (ECT), as well as to document findings from device interrogations associated with this event. Case report. Academic university-based pain management center. We present the case of a patient with an intrathecal pump who underwent multiple exposures to EMI in the form of 42 ECT sessions. Interrogation of the intrathecal drug delivery system revealed no safety issues following ECT sessions. At no time were error messages, unintentional changes in event logs, unintentional changes in pump settings, or evidence of pump stall or over-infusion noted. Communication with multiple entities (patient, family, consulting physicians, and device manufacturer) and maintaining vigilance through device interrogation both before and after EMI exposure are appropriate safeguards to mitigate the risk and detect potential adverse events of EMI with intrathecal drug delivery systems. Given the infrequent reports of device exposure to ECT, best practices may be derived from experience with EMI exposure from magnetic resonance imaging (MRI). Although routine EMI exposure to intrathecal drug delivery systems should be avoided, we describe one patient with repeated exposure to ECT without apparent complication.

Deriving Case, Agreement and Voice Phenomena in Syntax

ERIC Educational Resources Information Center

Sigurdsson, Einar Freyr

2017-01-01

This dissertation places case, agreement and Voice phenomena in syntax. It argues that the derivation is driven by so-called derivational features, that is, structure-building features (Merge) and probe features (Agree) (Heck and Muller 2007 and Muller 2010; see also Chomsky 2000, 2001). Both types are essential in deriving case and agreement in…

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

Detection of animal-derived proteins in feedstuffs in Italy: a reproducibility study.

PubMed

Ingravalle, Francesco; Abete, Maria Cesarina; Crescio, Maria Ines; Ru, Giuseppe

2007-04-01

Bovine spongiform encephalopathy is a prion disease of ruminants that was first recognized in 1986 in the United Kingdom. Early in the epidemic, it became obvious that the presence of meat and bone meal in feed rations was a common factor in all bovine spongiform encephalopathy cases. The first ban of derived animal proteins in feed was enforced in Europe in 1994 and implemented by Regulation 999/2001 that prohibited the feeding of animal-derived protein to farm animals. The only official method currently accepted by the European Union Commission for test for the presence of animal-derived proteins in feedstuffs is feed microscopy. In Italy, monitoring of feedstuff safety is provided by both the Ministry of Health and the Ministry of Agriculture. The quality of official control, usually assessed by verifying the reproducibility and the accuracy of the testing method, is of fundamental importance for all laboratories and institutions using these results for comparative purposes. The aims of this study were to assess the reproducibility of the official method over all the Italian surveillance network and to provide a model for evaluating the performance of the monitoring system. The accuracy of the identification of the animal class of derived protein detected (avian, mammalian, or aquatic organism) was assessed. The interlaboratory agreement within the overall network reached 0.97 (95% confidence interval of 0.95 to 0.98) for determining the presence or absence of animal-derived proteins (e.g., for mammalian, avian, or aquatic species), and specificity of the identification of the animal class indicated that fish proteins are more easily recognized than are avian or mammalian proteins.

Inactivation of Zika virus by solvent/detergent treatment of human plasma and other plasma-derived products and pasteurization of human serum albumin.

PubMed

Kühnel, Denis; Müller, Sebastian; Pichotta, Alexander; Radomski, Kai Uwe; Volk, Andreas; Schmidt, Torben

2017-03-01

In 2016 the World Health Organization declared the mosquito-borne Zika virus (ZIKV) a "public health emergency of international concern." ZIKV is a blood-borne pathogen, which therefore causes concerns regarding the safety of human plasma-derived products due to potential contamination of the blood supply. This study investigated the effectiveness of viral inactivation steps used during the routine manufacturing of various plasma-derived products to reduce ZIKV infectivity. Human plasma and intermediates from the production of various plasma-derived products were spiked with ZIKV and subjected to virus inactivation using the identical techniques (either solvent/detergent [S/D] treatment or pasteurization) and conditions used for the actual production of the respective products. Samples were taken and the viral loads measured before and after inactivation. After S/D treatment of spiked intermediates of the plasma-derived products Octaplas(LG), Octagam, and Octanate, the viral loads were below the limit of detection in all cases. The mean log reduction factor (LRF) was at least 6.78 log for Octaplas(LG), at least 7.00 log for Octagam, and at least 6.18 log for Octanate after 60, 240, and 480 minutes of S/D treatment, respectively. For 25% human serum albumin (HSA), the mean LRF for ZIKV was at least 7.48 log after pasteurization at 60°C for 120 minutes. These results demonstrate that the commonly used virus inactivation processes utilized during the production of human plasma and plasma-derived products, namely, S/D treatment or pasteurization, are effective for inactivation of ZIKV. © 2016 The Authors Transfusion published by Wiley Periodicals, Inc. on behalf of AABB.

Deriving and Validating a Road Safety Performance Indicator for Vehicle Fleet Passive Safety

PubMed Central

Page, Marianne; Rackliff, Lucy

2006-01-01

Road safety performance indicators (RSPI) are policy tools which describe the extent of insecure operational safety conditions within traffic systems. This study describes the production of an RSPI which represents the presence within a country’s vehicle fleet, of vehicles that may not effectively protect an occupant in a collision. This work is highly original, as it uses the entire vehicle database of European Union Member States in order to estimate the average level of passive safety offered by the entire fleet in each country. The EuroNCAP safety ratings and vehicle age of each vehicle in each fleet have been obtained to calculate the RSPI. The methodology used could be adopted as an international standard. PMID:16968645

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements.

PubMed

Schilter, B; Andersson, C; Anton, R; Constable, A; Kleiner, J; O'Brien, J; Renwick, A G; Korver, O; Smit, F; Walker, R

2003-12-01

There is a growing interest by both consumers and industry for the development of food products with 'functional' properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are given by particular ingredients, and in many cases these are derived from botanicals. The variety of plants providing these functions is large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components. The present report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in vitro, animal, and/or human studies, depends on the adequacy of this information. A decision tree is presented as an aid to determine the extent of data requirements based on product comparison. The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected than for food ingredients or additives where no physiological effects are intended. In rare cases, post launch monitoring programmes may be envisaged to confirm expected exposures and adequacy of the safety margin. This guidance document was elaborated by an expert group of the Natural Toxin Task Force of the European Branch of the International Life Sciences Institute--ILSI Europe and discussed with a wider audience of scientists at a workshop held on 13-15 May 2002 in Marseille, France.

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

Regenerative medicine for the treatment of Teno-desmic injuries of the equine. A series of 150 horses treated with platelet-derived growth factors.

PubMed

Scala, Marco; Lenarduzzi, Silvia; Spagnolo, Francesco; Trapasso, Maria; Ottonello, Chiara; Muraglia, Anita; Barla, Annalisa; Squillario, Margherita; Strada, Paolo

2014-01-01

The aim of the present study was to evaluate the safety and the clinical outcome of platelet-rich plasma for the treatment of teno-desmic injures in competition horses. From January 2009 to December 2011, 150 sport horses suffering from teno-desmic injuries were treated with no-gelled platelet-concentrate. No horse showed any major adverse reaction as a result of the procedure. Full healing was obtained for 81% of the horses. Twelve percent had clinical improvement and only 7% a failure. Eight percent of cases of relapse were observed. No statistically significant correlation existed between clinical outcome and the area of the lesion. A statistically significant correlation existed between the clinical outcome and the age of the horse. Treatment with platelet-derived growth factors leads to the formation of a tendon with normal morphology and functionality, which translate in the resumption of the agonistic activity for the horses we treated. Copyright © 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Mesenchymal Stem Cell Transplantation in Multiple Sclerosis

PubMed Central

Cohen, Jeffrey A.

2013-01-01

Mesenchymal stem cells (MSCs) are a pluripotent non-hematopoietic precursor cells that can be isolated from bone marrow and numerous other tissues, culture-expanded to purity, and induced to differentiate in vitro and in vivo into mesodermal derivatives. MSCs exhibit many phenotypic and functional similarities to pericytes. The immunomodulatory, tissue protective, and repair-promoting properties of MSCs demonstrated both in vitro and in animal models make them an attractive potential therapy for MS and other conditions characterized by inflammation and/or tissue injury. Other potential advantages of MSCs as a therapeutic include the relative ease of culture expansion, relative immunoprivilege allowing allogeneic transplantation, and their ability to traffic from blood to areas of tissue allowing intravascular administration. The overall published experience with MSC transplantation in MS is modest, but several small case series and preliminary studies yielded promising results. Several groups, including us, recently initiated formal studies of autologous, culture-expanded, bone-marrow-derived MSC transplantation in MS. Although there are several potential safety concerns, to date, the procedure has been well tolerated. Future studies that more definitively assess efficacy also will need to address several technical issues. PMID:23294498

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen.

PubMed

Soriano, Rachelle A; Ramos-Soriano, Asuncion G

2017-01-01

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is particularly troublesome for pediatric patients, as current therapeutic options consist of biologic agents and steroids which alter the immune response and have the harmful side effect of leaving the patient more susceptible to opportunistic infections and eventual surgery. Another option for therapy exists in the form of serum-derived bovine immunoglobulin/protein isolate (SBI), the key ingredient in a medical food, EnteraGam®. The FDA has reviewed the safety of SBI and issued a no challenge letter to the generally recognized as safe (GRAS) findings for this medical food. The product also has no known food or drug interactions, no significant adverse effects, and no contraindications, save for beef allergy. SBI has been shown to induce clinical remission in adult populations and to decrease markers of inflammation in pediatric patients. Here, we present a detailed case of pediatric UC, including documentation of mucosal healing and decrease in pediatric UC activity index in a difficult to treat pediatric patient, after the addition of SBI to this patient's treatment regimen.

Efficacy and safety of a porcine collagen sponge for cranial neurosurgery: a prospective case-control study.

PubMed

Brandão, Rafael Augusto Castro Santiago; Costa, Bruno Silva; Dellaretti, Marcos Antonio; de Carvalho, Gervásio Teles C; Faria, Marcello Penholate; de Sousa, Atos Alves

2013-01-01

The use of dural grafts is very useful when primary dural closure cannot be achieved. Our primary objective was to study the incidence of postoperative cerebrospinal fluid leak, including fistula and pseudomeningocele, and postoperative infection by comparing autologous material and a new collagen graft. A prospective nonrandomized study with a new collagen-based product derived from porcine cells (Peridry) was performed. It was used for dural replacement in 50 patients who underwent a variety of neurosurgical procedures requiring the use of a dural graft. These results were compared with a control group of 50 patients who were treated with autologous duraplasty material. The follow-up period was 3 months. Postoperative overall cerebrospinal fluid fistula occurred in 6% of both groups. No patient in the collagen group developed any sort of infection. One patient in the control developed osteomyelitis in the bone flap. The new collagen-based product derived from porcine cells (Peridry), compared with an autologous tissue, is safe, effective, easy to use, as well as time saving in cranial neurosurgery. Copyright © 2013 Elsevier Inc. All rights reserved.

Development of a Comprehensive Database System for Safety Analyst

PubMed Central

Paz, Alexander; Veeramisti, Naveen; Khanal, Indira; Baker, Justin

2015-01-01

This study addressed barriers associated with the use of Safety Analyst, a state-of-the-art tool that has been developed to assist during the entire Traffic Safety Management process but that is not widely used due to a number of challenges as described in this paper. As part of this study, a comprehensive database system and tools to provide data to multiple traffic safety applications, with a focus on Safety Analyst, were developed. A number of data management tools were developed to extract, collect, transform, integrate, and load the data. The system includes consistency-checking capabilities to ensure the adequate insertion and update of data into the database. This system focused on data from roadways, ramps, intersections, and traffic characteristics for Safety Analyst. To test the proposed system and tools, data from Clark County, which is the largest county in Nevada and includes the cities of Las Vegas, Henderson, Boulder City, and North Las Vegas, was used. The database and Safety Analyst together help identify the sites with the potential for safety improvements. Specifically, this study examined the results from two case studies. The first case study, which identified sites having a potential for safety improvements with respect to fatal and all injury crashes, included all roadway elements and used default and calibrated Safety Performance Functions (SPFs). The second case study identified sites having a potential for safety improvements with respect to fatal and all injury crashes, specifically regarding intersections; it used default and calibrated SPFs as well. Conclusions were developed for the calibration of safety performance functions and the classification of site subtypes. Guidelines were provided about the selection of a particular network screening type or performance measure for network screening. PMID:26167531

Finite mixture modeling approach for developing crash modification factors in highway safety analysis.

PubMed

Park, Byung-Jung; Lord, Dominique; Wu, Lingtao

2016-10-28

This study aimed to investigate the relative performance of two models (negative binomial (NB) model and two-component finite mixture of negative binomial models (FMNB-2)) in terms of developing crash modification factors (CMFs). Crash data on rural multilane divided highways in California and Texas were modeled with the two models, and crash modification functions (CMFunctions) were derived. The resultant CMFunction estimated from the FMNB-2 model showed several good properties over that from the NB model. First, the safety effect of a covariate was better reflected by the CMFunction developed using the FMNB-2 model, since the model takes into account the differential responsiveness of crash frequency to the covariate. Second, the CMFunction derived from the FMNB-2 model is able to capture nonlinear relationships between covariate and safety. Finally, following the same concept as those for NB models, the combined CMFs of multiple treatments were estimated using the FMNB-2 model. The results indicated that they are not the simple multiplicative of single ones (i.e., their safety effects are not independent under FMNB-2 models). Adjustment Factors (AFs) were then developed. It is revealed that current Highway Safety Manual's method could over- or under-estimate the combined CMFs under particular combination of covariates. Safety analysts are encouraged to consider using the FMNB-2 models for developing CMFs and AFs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Chinese plasma-derived products supply under the lot release management system in 2007-2011.

PubMed

Zhang, Xuejun; Ye, Shengliang; Du, Xi; Yuan, Jing; Zhao, Chaoming; Li, Changqing

2013-11-01

In 2007, the Chinese State Food and Drug Administration (SFDA) implemented a management system for lot release of all plasma-derived products. Since then, there have been only a few systematic studies of the blood supply, which is a concern when considering the small amount of plasma collected per capita (approximately 3 L/1000 people). As a result, there may be a threat to the safety of the available blood supply. In this study, we examined the characteristics of the supply of Chinese plasma-derived products. We investigated the reports of lot-released biological products derived from all 8 national or regional regulatory authorities in China from 2007 to 2011. The market supply characteristics of Chinese plasma-derived products were analyzed by reviewing the changes in supply varieties, the batches of lot-released plasma-derived products and the actual supply. As a result, the national regulatory authorities can more accurately develop a specific understanding of the production and quality management information provided by Chinese plasma product manufacturers. The implementation of the lot release system further ensures the clinical validity of the plasma-derived products in China and improves the safety of using plasma-derived products. This work provides an assessment of the future Chinese market supply of plasma-derived products and can function as a theoretical basis for the establishment of hemovigilance. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Research Update - Intervention Technologies for Enhancing the Safety and Security of Fresh and Minimally Processed Produce and Solid Plant-Derived Foods

USDA-ARS?s Scientific Manuscript database

The produce safety research objectives of Research Project 1935-41420-011 are to 1) understand pathogen microbial ecology and its effects on decontamination efficacy; 2) develop biological-based intervention strategies for pathogen reduction; and 3) develop new effective chemical and physical decont...

The isoflavone content of two new alfalfa-derived products for instant beverage preparation.

PubMed

Soto-Zarazúa, M Guadalupe; Rodrigues, Francisca; Pimentel, Filipa B; Bah, M M; Oliveira, M Beatriz P P

2016-01-01

The frequent use of plant-based products to promote health leads to the search for scientific information related to efficacy and safety of those products for human consumption. Two alfalfa-derived products (ADP), freeze-dried juice (FDJ) and dehydrated powder (DP), from alfalfa harvested in Mexico, are being developed as new possible nutraceuticals. To the best of our knowledge, any study reports the real composition of such products used to prepare instant beverages in what concerns isoflavone contents. Seven isoflavones (glycitein, formononetin, biochanin A, daidzein, genistein, daidzin and genistin) were assessed by HPLC-DAD analysis as well as its variation in five different batches of these products. Different solvents were tested in order to choose the best one to extract isoflavones. The results showed the presence of daidzein, genistein, genistin and daidzin in most samples while glycitein, formononetin and biochanin A were not detected. Significant differences between isoflavone contents were found with different solvent systems. Water was the best option to extract daidzein (0.40-1.08 mg per unit and 1.30-4.90 mg per unit for DP and FDJ, respectively) whereas the water-methanol-formic acid mixture was efficient to extract genistein (0.19-0.43 mg per unit and 0.15-0.72 mg per unit for DP and FDJ, respectively). In all cases, the total isoflavone content was higher in freeze-dried juices than in dehydrated powders. Genistein and daidzein were the more abundant isoflavones quantified. Further physiological and nutritional studies are needed to complete the validation of effectiveness and safety of these products.

International Approaches for Nuclear Waste Disposal in Geological Formations: Report on Fifth Worldwide Review

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

Faybishenko, Boris; Birkholzer, Jens; Persoff, Peter

2016-09-01

The goal of the Fifth Worldwide Review is to document evolution in the state-of-the-art of approaches for nuclear waste disposal in geological formations since the Fourth Worldwide Review that was released in 2006. The last ten years since the previous Worldwide Review has seen major developments in a number of nations throughout the world pursuing geological disposal programs, both in preparing and reviewing safety cases for the operational and long-term safety of proposed and operating repositories. The countries that are approaching implementation of geological disposal will increasingly focus on the feasibility of safely constructing and operating their repositories in short-more » and long terms on the basis existing regulations. The WWR-5 will also address a number of specific technical issues in safety case development along with the interplay among stakeholder concerns, technical feasibility, engineering design issues, and operational and post-closure safety. Preparation and publication of the Fifth Worldwide Review on nuclear waste disposal facilitates assessing the lessons learned and developing future cooperation between the countries. The Report provides scientific and technical experiences on preparing for and developing scientific and technical bases for nuclear waste disposal in deep geologic repositories in terms of requirements, societal expectations and the adequacy of cases for long-term repository safety. The Chapters include potential issues that may arise as repository programs mature, and identify techniques that demonstrate the safety cases and aid in promoting and gaining societal confidence. The report will also be used to exchange experience with other fields of industry and technology, in which concepts similar to the design and safety cases are applied, as well to facilitate the public perception and understanding of the safety of the disposal approaches relative to risks that may increase over long times frames in the absence of a successful implementation of final dispositioning.« less

Potential chemical and microbiological risks on human health from urban wastewater reuse in agriculture. Case study of wastewater effluents in Spain.

PubMed

Muñoz, Ivan; Tomàs, Núria; Mas, Jordi; García-Reyes, Juan Fracisco; Molina-Díaz, Antonio; Fernández-Alba, Amadeo R

2010-05-01

Potential health risks derived from wastewater reuse in agriculture have been evaluated with Risk Assessment modelling techniques, in a case study involving the effluents of two Spanish wastewater treatment plants. One of the plants applies primary and secondary treatment, and the other one applies an additional tertiary treatment. Health risks were assessed on the basis of ingesting contaminated food, due to exposure to: (i) 22 chemical pollutants, namely pharmaceuticals and personal care products (PPCPs), and priority pollutants included in the European Framework Directive, and (ii) microorganisms, namely enterovirus. Chemical Risk Assessment has been carried out following the European Commission's technical guidelines, while risks from exposure to viruses have been evaluated by means of Quantitative Microbial Risk Assessment, assuming a virus to coliform ratio of 1:10(5). The results of the chemical assessment show that there is a margin of safety above 100 for all substances, with the exception of gemfibrozil, for which the mean margin of safety (MOS) is above 100, but the lower bound of MOS with a 95 % confidence interval lies in the 3-4 range. A MOS under 100 was also found for 2,3,7,8-TCDD in one of the effluents. The assessment of risks from viruses shows a very low probability of infection. The overall results show that risks are lower for the plant applying tertiary treatment, especially concerning microbiological parameters.

[Genetically modified plants and food safety. State of the art and discussion in the European Union].

PubMed

Schauzu, M

2004-09-01

Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

Risk assessment strategies as a tool in the application of the Appropriate Level of Protection (ALOP) and Food Safety Objective (FSO) by risk managers.

PubMed

Gkogka, E; Reij, M W; Gorris, L G M; Zwietering, M H

2013-10-01

In the course of the last decade, the Appropriate Level of Protection (ALOP), the Food Safety Objective (FSO) and their associated metrics have been proposed by the World Trade Organization and Codex Alimentarius as a means for competent authorities to ultimately translate governmental public health policy regarding food safety into risk-based targets for the food industry. The industry needs to meet these targets through the effective choice of control measures that are part of its operational food safety management system. The aim of this study was to put the practical application of ALOP and FSO to the test in the case of Salmonella in chicken meat in the Netherlands. Two different risk assessment approaches were applied to derive potential ALOP and FSO values, a 'top-down' approach based on epidemiological data and a 'bottom-up' approach based on food supply chain data. To this end, two stochastic models specific to the Dutch situation were built. Comparisons between 23 countries in Europe were also made using the top-down model. The mean estimated current Level Of Protection values were similar for the two approaches applied, with the bottom-up model yielding 87 cases per 100,000 inhabitants per year (95% CI: 0.03, 904) and the top-down model 71 (95% CI: 9.9, 155). The estimated FSO values on the other hand were considerably different with the mean 'top down' FSO being -4.6 log CFU/g (95% CI: -5.4, -4.1) and the mean 'bottom-up' FSO -6.0 log CFU/g (95% CI: -8.1, -2.9) reflecting major differences in the output distributions of this parameter obtained with the two approaches. Significant differences were observed between current LOP values for different EU countries, although it was not clear whether this was due to actual differences in the factors influencing the risk of salmonellosis or due to the quality of the available data. Copyright © 2013 Elsevier B.V. All rights reserved.

How to reduce your inventory: a real world case study.

PubMed

Mack, J A; Jordan, H H

1994-08-01

This case study describes the use of a performance analysis system at the Safety Products Division of Mine Safety Appliances Company, which contributed to the reduction of excess inventories by more than $8,000,000 during the first two years of implementation.

TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.

PubMed

Weld, Lancaster R; Stringer, Matthew T; Ebertowski, James S; Baumgartner, Timothy S; Kasprenski, Matthew C; Kelley, Jeremy C; Cho, Doug S; Tieva, Erwin A; Novak, Thomas E

2016-09-01

The objective was to evaluate the effect of TeamSTEPPS on operating room efficiency and patient safety. TeamSTEPPS consisted of briefings attended by all health care personnel assigned to the specific operating room to discuss issues unique to each case scheduled for that day. The operative times, on-time start rates, and turnover times of all cases performed by the urology service during the initial year with TeamSTEPPS were compared to the prior year. Patient safety issues identified during postoperative briefings were analyzed. The mean case time was 12.7 minutes less with TeamSTEPPS (P < .001). The on-time first-start rate improved by 21% with TeamSTEPPS (P < .001). The mean room turnover time did not change. Patient safety issues declined from an initial rate of 16% to 6% at midyear and remained stable (P < 0.001). TeamSTEPPS was associated with improved operating room efficiency and diminished patient safety issues in the operating room. © The Author(s) 2015.

Maintenance and Safety Practices of Escalator in Commercial Buildings

NASA Astrophysics Data System (ADS)

Afida Isnaini Janipha, Nurul; Nur Aina Syed Alwee, Sharifah; Ariff, Raihan Mohd; Ismail, Faridah

2018-02-01

The escalator is very crucial to transport a person from one place to another. Nevertheless, there are many cases recorded the accidents in relation to escalator. These may occur due to lack of maintenance which leads to systems breakdown, poor safety practices, wear and tear, users’ negligence and others. Thus, proper maintenance systems need to be improvised to prevent and reduce escalator accident in future. This research was aimed to determine the escalator maintenance activities and safety practices in a commercial building. Three case studies were selected within Selangor area. Semi-structured interviews were conducted for collecting data from these three case studies. To achieve the aim of this research, the study was carried out on the maintenance activities, safety practices and cost related to escalator maintenance. As one of the important means of access in building, it is very crucial to increase effectiveness of escalator particularly in commercial building. It is expected that readers will get clear information on the maintenance activities and safety practices of escalator in commercial building.

Car Safety Seat Usage and Selection Among Families Attending University Hospital Limerick.

PubMed

Scully, P; Finner, N; Letshwiti, J B; O'Gorman, C

2016-05-10

The safest way for children to travel within a car is by provision of a weight-appropriate safety-seat. To investigate this, we conducted a cross-sectional study of adult parents who had children under 12 years, and collected information related to: car use, safety-seat legislation, and type of safety-seat employed. Data were reviewed on 120 children from 60 respondents. Ninety-eight (81.7%) children were transported daily by car. Forty-eight (81.4%) respondents were aware that current safety-seat legislation is based on the weight of the child. One hundred and seven (89.9%) children were restrained during travel using a car safety-seat. One hundred and two (96.2%) safety seats were newly purchased, installed in 82.3% (88) cases by family members with installation instructions fully read in 58 (55.2%) cases. Ninety-nine (83.2%) children were restrained using an appropriate safety-seat for their weight. The results show that four out of five families are employing the most appropriate safety-seat for their child, so providing an effective mechanism to reduce car-related injury. However, the majority of safety-seats are installed by family members, which may have child safety consequences.

Understanding safety culture in long-term care: a case study.

PubMed

Halligan, Michelle H; Zecevic, Aleksandra; Kothari, Anita R; Salmoni, Alan W; Orchard, Treena

2014-12-01

This case study aimed to understand safety culture in a high-risk secured unit for cognitively impaired residents in a long-term care (LTC) facility. Specific objectives included the following: diagnosing the present level of safety culture maturity using the Patient Safety Culture Improvement Tool (PSCIT), examining the barriers to a positive safety culture, and identifying actions for improvement. A mixed methods design was used within a secured unit for cognitively impaired residents in a Canadian nonprofit LTC facility. Semistructured interviews, a focus group, and the Modified Stanford Patient Safety Culture Survey Instrument were used to explore this topic. Data were synthesized to situate safety maturity of the unit within the PSCIT adapted for LTC. Results indicated a reactive culture, where safety systems were piecemeal and developed only in response to adverse events and/or regulatory requirements. A punitive regulatory environment, inadequate resources, heavy workloads, poor interdisciplinary collaboration, and resident safety training capacity were major barriers to improving safety. This study highlights the importance of understanding a unit's safety culture and identifies the PSCIT as a useful framework for planning future improvements to safety culture maturity. Incorporating mixed methods in the study of health care safety culture provided a good model that can be recommended for future use in research and LTC practice.

The Unexpected Education: What We Can Learn from Disaster News Stories.

ERIC Educational Resources Information Center

Garner, Ana C.

A study explored the safety education provided by six newspapers, using the 1988 crash of Delta Flight 1141 as a case study. A total of 351 "Delta 1141" news stories were analyzed for five key areas: overall story category, passenger safety theme, flight personnel safety theme, plane safety theme, and rescue safety. Of the stories…

Epidemiological designs for vaccine safety assessment: methods and pitfalls.

PubMed

Andrews, Nick

2012-09-01

Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Monitoring road safety development at regional level: A case study in the ASEAN region.

PubMed

Chen, Faan; Wang, Jianjun; Wu, Jiaorong; Chen, Xiaohong; Zegras, P Christopher

2017-09-01

Persistent monitoring of progress, evaluating the results of interventions and recalibrating to achieve continuous improvement over time is widely recognized as being crucial towards the successful development of road safety. In the ASEAN (Association of Southeast Asian Nations) region there is a lack of well-resourced teams that contain multidisciplinary safety professionals, and specialists in individual countries, who are able to carry out this work effectively. In this context, not only must the monitoring framework be effective, it must also be easy to use and adapt. This paper provides a case study that can be easily reproduced; based on an updated and refined Road Safety Development Index (RSDI), by means of the RSR (Rank-sum ratio)-based model, for monitoring/reporting road safety development at regional level. The case study was focused on the road safety achievements in eleven Southeast Asian countries; identifying the areas of poor performance, potential problems and delays. These countries are finally grouped into several classes based on an overview of their progress and achievements regarding to road safety. The results allow the policymakers to better understand their own road safety progress toward their desired impact; more importantly, these results enable necessary interventions to be made in a quick and timely manner. Keeping action plans on schedule if things are not progressing as desired. This would avoid 'reinventing the wheel' and trial and error approaches to road safety, making the implementation of action plans more effective. Copyright © 2017 Elsevier Ltd. All rights reserved.

Acute And Long-Term Bioeffects And Lamp Safety

NASA Astrophysics Data System (ADS)

Andersen, F. Alan

1980-10-01

Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

Safety Training--A Special Case?

ERIC Educational Resources Information Center

Cooper, Mark; Cotton, David

2000-01-01

Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

Nutritional and safety assessment of foods and feeds nutritionally improved through biotechnology--case studies by the International Food Biotechnology Committee of ILSI.

PubMed

Glenn, Kevin C

2008-01-01

During the last two decades, the public and private sectors have made substantial research progress internationally toward improving the nutritional value of a wide range of food and feed crops. Nevertheless, significant numbers of people still suffer from the effects of undernutrition. As newly developed crops with nutritionally improved traits come closer to being available to producers and consumers, scientifically sound and efficient processes are needed to assess the safety and nutritional quality of these crops. In 2004, a Task Force of international scientific experts, convened by the International Food Biotechnology Committee (IFBiC) of ILSI, published recommendations for the safety and nutritional assessment of foods and feeds nutritionally improved through modern biotechnology (J. Food Science, 2004, 69:CRH62-CRH68). The comparative safety assessment process is a basic principle in this publication and is the starting point, not the conclusion, of the analysis. Significant differences in composition are expected to be observed in the case of nutritionally enhanced crops and must be assessed on a case-by-case basis. The Golden Rice 2 case study will be presented as an example of a food crop nutritionally enhanced through the application of modern biotechnology (i.e., recombinant DNA techniques) to illustrate how the 2004 recommendations provide a robust paradigm for the safety assessment of "real world" examples of improved nutrition crops.

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.

PubMed

Reisinger, Keith S; Block, Stanley L; Izu, Allen; Groth, Nicola; Holmes, Sandra J

2009-09-15

This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

New horizons in microbiological food safety: Photodynamic Decontamination based on a curcumin derivative.

PubMed

Glueck, Michael; Schamberger, Barbara; Eckl, Peter; Plaetzer, Kristjan

2017-12-06

Outbreaks of foodborne diseases are regularly reported worldwide. In particular, uncooked plant food is considered risky in terms of microbiological safety. Food is also the most important transmission route for resistant microorganisms from animals to humans. Photodynamic Decontamination (PDc) of foodstuff was recently introduced as a novel approach for increasing microbiological food safety. We investigated the efficiency of PDc on plant food with different geometries (flat, spherical and complex) using a two-dimensional LED array as a light source (435 nm, 33.8 J cm -2 ) and the cationic curcumin derivative SACUR-3 as a photosensitiser. A photoantibacterial effect (>3 log 10 CFU reduction) was achieved on all flat substrates (slices of cucumber, tomato and lettuce) with 10 μM, 50 μM or 100 μM SACUR-3. The maximal photokilling with a relative inactivation of 5.6 log 10 was measured on lettuce using 50 μM of the photoactive compound. Phototreatment of non-germinated fenugreek seeds and mung beans was successful if the spherical objects were rotated while under illumination (antibacterial effect at 100 μM SACUR-3). The decontamination of mung bean germlings with a more complex geometry using the PDc approach was ineffective with the two-dimensional light source. In conclusion, PDc based on the cationic curcumin derivative SACUR-3 is very effective at improving the microbiological safety of plant food with a flat or spherical geometry. More complex objects will require the development of novel illumination devices.

Illustrated structural application of universal first-order reliability method

NASA Technical Reports Server (NTRS)

Verderaime, V.

1994-01-01

The general application of the proposed first-order reliability method was achieved through the universal normalization of engineering probability distribution data. The method superimposes prevailing deterministic techniques and practices on the first-order reliability method to surmount deficiencies of the deterministic method and provide benefits of reliability techniques and predictions. A reliability design factor is derived from the reliability criterion to satisfy a specified reliability and is analogous to the deterministic safety factor. Its application is numerically illustrated on several practical structural design and verification cases with interesting results and insights. Two concepts of reliability selection criteria are suggested. Though the method was developed to support affordable structures for access to space, the method should also be applicable for most high-performance air and surface transportation systems.

A journey from basic stem cell discovery to clinical application: the case of adventitial progenitor cells.

PubMed

Spencer, Helen L; Slater, Sadie C; Rowlinson, Jonathan; Morgan, Tom; Culliford, Lucy A; Guttridge, Martin; Emanueli, Costanza; Angelini, Gianni; Madeddu, Paolo

2015-01-01

Ischemia is a leading cause of death in the western world. Regenerative medicine aims to improve healing of ischemic injury by complementing pharmacologic/interventional treatments. Navigating regenerative therapies from 'bench-to-bedside' is a multistep time-consuming process, balancing cell expansion, purity, safety and efficacy while complying with regulatory guidelines. Studies started in academic laboratories unused to long-term planning often fail because of poor strategy design, lack of contingency plans or funding. We provide a strategic insight into our translation of saphenous vein-derived adventitial progenitor cells into a clinical grade product to treat angina. We discuss discovery phases, introduction of standard operating procedures and upgrade to clinical standards. We also examine contractual aspects of transferring to GMP-accredited facilities for clinical production and unexpected hurdles.

Ocular Injury in Cosmetic Laser Treatments of the Face.

PubMed

Huang, Amy; Phillips, Arianna; Adar, Tony; Hui, Andrea

2018-02-01

BACKGROUND: The eye is a vulnerable and commonly injured organ in cosmetic laser procedures of the face. Treatment of the eyelids and periorbital areas increases this risk, especially when ocular protection devices are not used or are removed during the procedure. A study has shown that injury from laser epilation of the periocular areas is one of the most common causes of litigation in cutaneous laser surgery. OBJECTIVE: The goal of this review is to determine the causes of ocular injury in cosmetic laser procedures and derive lessons on critical safety elements to prevent future injury. METHODS: We conducted a review of the current literature through a PubMed search on case reports of ocular injury in cosmetic laser treatments of the face. Twenty-one cases are examined. RESULTS: In more than 62 percent of cases, ocular protection was not used or protection was used but removed during the procedure to treat areas close to the eye. However, despite the proper use of intraocular corneal shields and wavelength-specific goggles, accidents occurred in 33 percent of cases. CONCLUSION: Ocular protection devices are essential to prevent most cases of laser-induced eye injury. Use of high fluence and long wavelength lasers increases the risk of ocular injury due to deeper penetration of the organ by radiation. Inadequate cooling between pulses also predisposes to injury by cosmetic lasers.

Ocular Injury in Cosmetic Laser Treatments of the Face

PubMed Central

Huang, Amy; Phillips, Arianna; Adar, Tony

2018-01-01

BACKGROUND: The eye is a vulnerable and commonly injured organ in cosmetic laser procedures of the face. Treatment of the eyelids and periorbital areas increases this risk, especially when ocular protection devices are not used or are removed during the procedure. A study has shown that injury from laser epilation of the periocular areas is one of the most common causes of litigation in cutaneous laser surgery. OBJECTIVE: The goal of this review is to determine the causes of ocular injury in cosmetic laser procedures and derive lessons on critical safety elements to prevent future injury. METHODS: We conducted a review of the current literature through a PubMed search on case reports of ocular injury in cosmetic laser treatments of the face. Twenty-one cases are examined. RESULTS: In more than 62 percent of cases, ocular protection was not used or protection was used but removed during the procedure to treat areas close to the eye. However, despite the proper use of intraocular corneal shields and wavelength-specific goggles, accidents occurred in 33 percent of cases. CONCLUSION: Ocular protection devices are essential to prevent most cases of laser-induced eye injury. Use of high fluence and long wavelength lasers increases the risk of ocular injury due to deeper penetration of the organ by radiation. Inadequate cooling between pulses also predisposes to injury by cosmetic lasers. PMID:29552271

A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

PubMed

Hoffman, Keith B; Dimbil, Mo; Kyle, Robert F; Tatonetti, Nicholas P; Erdman, Colin B; Demakas, Andrea; Chen, Dingguo; Overstreet, Brian M

2015-12-01

Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations. To develop a drug safety statistic that estimates downstream medical costs associated with serious adverse events (AEs) and unfavorable patient outcomes associated with the use of 706 FDA-approved drugs. All primary suspect case reports for each drug were collected from the FDA's Adverse Event Reporting System database (FAERS) from 2010-2014. The Medical Dictionary for Regulatory Activities (MedDRA) was used to code serious AEs and outcomes, which were tallied for each case report. Medical costs associated with AEs and poor patient outcomes were derived from Agency for Healthcare Research and Quality (AHRQ) survey data, and their corresponding ICD-9-CM codes were mapped to MedDRA terms. Nonserious AEs and outcomes were not included. For each case report, either the highest AE cost or, if no eligible AE was listed, the highest outcome cost was used. All costed cases were aggregated for each drug and divided by the number of patients exposed to obtain a downstream estimated direct medical cost burden per exposure. Each drug was assigned a corresponding 1-100 point total. The 706 drugs showed an exponential distribution of downstream costs, and the data were transformed using the natural log to approximate a normal distribution. The minimum score was 8.29, and the maximum score was 99.25, with a mean of 44.32. Drugs with the highest individual scores tended to be kinase inhibitors, thalidomide analogs, and endothelin receptor antagonists. When scores were analyzed across Established Pharmacologic Class (EPC), the kinase inhibitor and endothelin receptor antagonist classes had the highest total. However, other EPCs with median scores of 75 and above included hepatitis C virus NS3/4A protease inhibitor, recombinant human interferon beta, vascular endothelial growth factor-directed antibody, and tumor necrosis factor blocker. When Anatomical Therapeutic Chemical classifications were analyzed, antineoplastic drugs were outliers with approximately 80% of their individual scores 60 and above, while approximately 20%-30% of blood and anti-infective drugs had scores of 60 and above. Within-drug class results served to differentiate similar drugs. For example, 6 serotonin reuptake inhibitors had a score range of 35 to 53. This scoring system is based on estimated direct medical costs associated with postmarketing AEs and poor patient outcomes and thereby helps fill a large information gap regarding drug safety in real-world patient populations.

77 FR 75443 - Draft Safety Culture Policy Statement: Request for Public Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... personal and organizational characteristics are present in a positive safety culture. A characteristic, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal...

Influences on Young Children's Knowledge: The Case of Road Safety Education.

ERIC Educational Resources Information Center

Cullen, Joy

1998-01-01

Argues that effective road safety education for young children needs to incorporate constructivist and socio-cultural perspectives on learning. Excerpts interviews with young children highlighting the variety of influences affecting children's road safety knowledge and examination of a road safety curriculum to illustrate the value of a dual…

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.3 - Actions for which Safety Integration Plan is required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false Actions for which Safety Integration Plan is... TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.3 Actions for which Safety Integration Plan is required. A SIP...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

EPA Pesticide Factsheets

EPA News Release: IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

Using the electronic health record to build a culture of practice safety: evaluating the implementation of trigger tools in one general practice.

PubMed

Margham, Tom; Symes, Natalie; Hull, Sally A

2018-04-01

Identifying patients at risk of harm in general practice is challenging for busy clinicians. In UK primary care, trigger tools and case note reviews are mainly used to identify rates of harm in sample populations. This study explores how adaptions to existing trigger tool methodology can identify patient safety events and engage clinicians in ongoing reflective work around safety. Mixed-method quantitative and narrative evaluation using thematic analysis in a single East London training practice. The project team developed and tested five trigger searches, supported by Excel worksheets to guide the case review process. Project evaluation included summary statistics of completed worksheets and a qualitative review focused on ease of use, barriers to implementation, and perception of value to clinicians. Trigger searches identified 204 patients for GP review. Overall, 117 (57%) of cases were reviewed and 62 (53%) of these cases had patient safety events identified. These were usually incidents of omission, including failure to monitor or review. Key themes from interviews with practice members included the fact that GPs' work is generally reactive and GPs welcomed an approach that identified patients who were 'under the radar' of safety. All GPs expressed concern that the tool might identify too many patients at risk of harm, placing further demands on their time. Electronic trigger tools can identify patients for review in domains of clinical risk for primary care. The high yield of safety events engaged clinicians and provided validation of the need for routine safety checks. © British Journal of General Practice 2018.

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

Implementation Procedure for STS Payloads, System Safety Requirements

NASA Technical Reports Server (NTRS)

1979-01-01

Guidelines and instructions for the implementation of the SP&R system safety requirements applicable to STS payloads are provided. The initial contact meeting with the payload organization and the subsequent safety reviews necessary to comply with the system safety requirements of the SP&R document are described. Waiver instructions are included for the cases in which a safety requirement cannot be met.

[Results of a post-marketing surveillance of meropenem for febrile neutropenia].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-08-01

The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

The reduction of a ""safety catastrophic'' potential hazard: A case history

NASA Technical Reports Server (NTRS)

Jones, J. P.

1971-01-01

A worst case analysis is reported on the safety of time watch movements for triggering explosive packages on the lunar surface in an experiment to investigate physical lunar structural characteristics through induced seismic energy waves. Considered are the combined effects of low pressure, low temperature, lunar gravity, gear train error, and position. Control measures constitute a seal control cavity and design requirements to prevent overbanking in the mainspring torque curve. Thus, the potential hazard is reduced to safety negligible.

Nutritional composition and safety aspects of edible insects.

PubMed

Rumpold, Birgit A; Schlüter, Oliver K

2013-05-01

Insects, a traditional food in many parts of the world, are highly nutritious and especially rich in proteins and thus represent a potential food and protein source. A compilation of 236 nutrient compositions in addition to amino acid spectra and fatty acid compositions as well as mineral and vitamin contents of various edible insects as derived from literature is given and the risks and benefits of entomophagy are discussed. Although the data were subject to a large variation, it could be concluded that many edible insects provide satisfactorily with energy and protein, meet amino acid requirements for humans, are high in MUFA and/or PUFA, and rich in several micronutrients such as copper, iron, magnesium, manganese, phosphorous, selenium, and zinc as well as riboflavin, pantothenic acid, biotin, and in some cases folic acid. Liabilities of entomophagy include the possible content of allergenic and toxic substances as well as antinutrients and the presence of pathogens. More data are required for a thorough assessment of the nutritional potential of edible insects and proper processing and decontamination methods have to be developed to ensure food safety. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Pediatric melanoma: incidence, treatment, and prognosis

PubMed Central

Saiyed, Faiez K; Hamilton, Emma C; Austin, Mary T

2017-01-01

The purpose of this review is to outline recent advancements in diagnosis, treatment, and prevention of pediatric melanoma. Despite the recent decline in incidence, it continues to be the deadliest form of skin cancer in children and adolescents. Pediatric melanoma presents differently from adult melanoma; thus, the traditional asymmetry, border irregularity, color variegation, diameter >6 mm, and evolution (ABCDE) criteria have been modified to include features unique to pediatric melanoma (amelanotic, bleeding/bump, color uniformity, de novo/any diameter, evolution of mole). Surgical and medical management of pediatric melanoma continues to derive guidelines from adult melanoma treatment. However, more drug trials are being conducted to determine the specific impact of drug combinations on pediatric patients. Alongside medical and surgical treatment, prevention is a central component of battling the incidence, as ultraviolet (UV)-related mutations play a central role in the vast majority of pediatric melanoma cases. Aggressive prevention measures targeting sun safety and tanning bed usage have shown positive sun-safety behavior trends, as well as the potential to decrease melanomas that manifest later in life. As research into the field of pediatric melanoma continues to expand, a prevention paradigm needs to continue on a community-wide level. PMID:29388632

Anthraquinone Content in Noni (Morinda citrifolia L.).

PubMed

Bussmann, Rainer W; Hennig, Lothar; Giannis, Athanassios; Ortwein, Jutta; Kutchan, Toni M; Feng, Xi

2013-01-01

Noni has been used in traditional medicine and as food for thousands of years. While the fruits serve as food and internal medicine, leaves were traditionally used only topically. In recent years, concern regarding the possible content of anthraquinones in noni has led to scrutiny by the European Food Safety Authority. Little research existed on the content of anthraquinones in different noni preparations, with no information about the potential effect of harvest and preparation methods. Our research focused on lucidin, alizarin, and rubiadin, the most important anthraquinones from a health perspective. We found that the production process (fermentation/juice production versus drying/lyophilization) has no effect on the anthraquinone content. The source product, however, does have implications: noni fruit puree from which seeds had been removed as well as consumer products produced from such puree had no detectable amounts of any anthraquinones. Products that did contain seed or leaf material in all cases did contain partly significant amounts of anthraquinones. To alleviate safety concerns, we suggest that noni products, whether fermented or unfermented juice or powder, should be derived only from fully ripe noni fruits, and that any seed material needs to be removed during the production process.

Anthraquinone Content in Noni (Morinda citrifolia L.)

PubMed Central

Bussmann, Rainer W.; Hennig, Lothar; Giannis, Athanassios; Ortwein, Jutta; Kutchan, Toni M.; Feng, Xi

2013-01-01

Noni has been used in traditional medicine and as food for thousands of years. While the fruits serve as food and internal medicine, leaves were traditionally used only topically. In recent years, concern regarding the possible content of anthraquinones in noni has led to scrutiny by the European Food Safety Authority. Little research existed on the content of anthraquinones in different noni preparations, with no information about the potential effect of harvest and preparation methods. Our research focused on lucidin, alizarin, and rubiadin, the most important anthraquinones from a health perspective. We found that the production process (fermentation/juice production versus drying/lyophilization) has no effect on the anthraquinone content. The source product, however, does have implications: noni fruit puree from which seeds had been removed as well as consumer products produced from such puree had no detectable amounts of any anthraquinones. Products that did contain seed or leaf material in all cases did contain partly significant amounts of anthraquinones. To alleviate safety concerns, we suggest that noni products, whether fermented or unfermented juice or powder, should be derived only from fully ripe noni fruits, and that any seed material needs to be removed during the production process. PMID:24062780

Stem cells in clinical trials for treatment of retinal degeneration.

PubMed

Klassen, Henry

2016-01-01

After decades of basic science research involving the testing of regenerative strategies in animal models of retinal degenerative diseases, a number of clinical trials are now underway, with additional trials set to begin shortly. These efforts will evaluate the safety and preliminary efficacy of cell-based products in the eyes of patients with a number of retinal conditions, notably including age-related macular degeneration, retinitis pigmentosa and Stargardt's disease. This review considers the scientific work and early trials with fetal cells and tissues that set the stage for the current clinical investigatory work, as well the trials themselves, specifically those either now completed, underway or close to initiation. The cells of interest include retinal pigment epithelial cells derived from embryonic stem or induced pluripotent stem cells, undifferentiated neural or retinal progenitors or cells from the vascular/bone marrow compartment or umbilical cord tissue. Degenerative diseases of the retina represent a popular target for emerging cell-based therapeutics and initial data from early stage clinical trials suggest that short-term safety objectives can be met in at least some cases. The question of efficacy will require additional time and testing to be adequately resolved.

A Big-Data-based platform of workers' behavior: Observations from the field.

PubMed

Guo, S Y; Ding, L Y; Luo, H B; Jiang, X Y

2016-08-01

Behavior-Based Safety (BBS) has been used in construction to observe, analyze and modify workers' behavior. However, studies have identified that BBS has several limitations, which have hindered its effective implementation. To mitigate the negative impact of BBS, this paper uses a case study approach to develop a Big-Data-based platform to classify, collect and store data about workers' unsafe behavior that is derived from a metro construction project. In developing the platform, three processes were undertaken: (1) a behavioral risk knowledge base was established; (2) images reflecting workers' unsafe behavior were collected from intelligent video surveillance and mobile application; and (3) images with semantic information were stored via a Hadoop Distributed File System (HDFS). The platform was implemented during the construction of the metro-system and it is demonstrated that it can effectively analyze semantic information contained in images, automatically extract workers' unsafe behavior and quickly retrieve on HDFS as well. The research presented in this paper can enable construction organizations with the ability to visualize unsafe acts in real-time and further identify patterns of behavior that can jeopardize safety outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.

The safety of available treatments of male hypogonadism in organic and functional hypogonadism.

PubMed

Corona, G; Rastrelli, G; Reisman, Y; Sforza, A; Maggi, M

2018-03-01

In the case of primary male hypogonadism (HG), only testosterone (T) replacement therapy (TRT) is possible whereas when the problem is secondary to a pituitary or hypothalamus alteration both T production and fertility can be, theoretically, restored. We here systematically reviewed and discussed the advantages and limits of medications formally approved for the treatment of HG. Areas covered: Data derived from available meta-analyses of placebo controlled randomized trials (RCTs) were considered and analyzed. Gonadotropins are well-toleratedand their use is mainly limited by higher costs and a more cumbersome treatment schedule than TRT. Available RCTs on TRT suggest that cardiovascular (CV) and venous thromboembolism risk is not a major issue and that prostate safety is guaranteed. The risk of increased hematocrit is mainly limited to the use of short terminjectable preparations. Expert opinion: In the last few years the concept of 'organic' irreversible HG and 'functional' or age- and comorbidity-related HG has been introduced. This definition is not evidence-based. The majority of RCTs enrolled patients with 'functional' HG. Considering the significant improvement in body composition, glucose metabolism and sexual activity, TRT should not be limited to 'organic' HG, but also offered for 'functional'.

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

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

2001-01-01

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

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

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

[Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

PubMed

Axelsen, Karina Rahbek; Nafei, Hanne; Jakobsen, Stine Finne; Gandrup, Per; Knudsen, Janne Lehmann

2014-10-13

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the function and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been narrowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

Use of human and porcine dermal-derived bioprostheses in complex abdominal wall reconstructions: a literature review and case report.

PubMed

Baillie, Daniel R; Stawicki, S Peter; Eustance, Nicole; Warsaw, David; Desai, Darius

2007-05-01

The goal of abdominal wall reconstruction is to restore and maintain abdominal domain. A PubMed(R) review of the literature (including "old" MEDLINE through February 2007) suggests that bioprosthetic materials are increasingly used to facilitate complex abdominal wall reconstruction. Reported results (eight case reports/series involving 137 patients) are encouraging. The most commonly reported complications are wound seroma (18 patients, 13%), skin dehiscence with graft exposure without herniation (six, 4.4%), superficial and deep wound infections (five, 3.6%), hernia recurrence (four, 2.9%), graft failure with dehiscence (two), hematoma (two), enterocutaneous fistula (one), and flap necrosis (one). Two recent cases are reported herein. In one, a 46-year-old woman required open abdominal management after gastric remnant perforation following a Roux-en-Y gastric bypass procedure. Porcine dermal collagen combined with cutaneous flaps was used for definitive abdominal wall reconstruction. The patient's condition improved postoperatively and she was well 5 months after discharge from the hospital. In the second, a 54-year-old woman underwent repair of an abdominal wall defect following resection of a large leiomyosarcoma. Human acellular dermis combined with myocutaneous flaps was used to reconstruct the abdominal wall defect. The patient's recovery was uncomplicated and 20 weeks following surgery she was doing well with no evidence of recurrence or hernia. The results reported to date and the outcomes presented here suggest that bioprosthetic materials are safe and effective for repair of large abdominal wall defects. Prospective, randomized, controlled studies are needed to compare the safety and efficacy of other reconstructive techniques as well as human and porcine dermal-derived bioprostheses.

Safety and Convergence Analysis of Intersecting Aircraft Flows Under Decentralized Collision Avoidance

NASA Astrophysics Data System (ADS)

Dallal, Ahmed H.

Safety is an essential requirement for air traffic management and control systems. Aircraft are not allowed to get closer to each other than a specified safety distance, to avoid any conflicts and collisions between aircraft. Forecast analysis predicts a tremendous increase in the number of flights. Subsequently, automated tools are needed to help air traffic controllers resolve air born conflicts. In this dissertation, we consider the problem of conflict resolution of aircraft flows with the assumption that aircraft are flowing through a fixed specified control volume at a constant speed. In this regard, several centralized and decentralized resolution rules have been proposed for path planning and conflict avoidance. For the case of two intersecting flows, we introduce the concept of conflict touches, and a collaborative decentralized conflict resolution rule is then proposed and analyzed for two intersecting flows. The proposed rule is also able to resolved airborne conflicts that resulted from resolving another conflict via the domino effect. We study the safety conditions under the proposed conflict resolution and collision avoidance rule. Then, we use Lyapunov analysis to analytically prove the convergence of conflict resolution dynamics under the proposed rule. The analysis show that, under the proposed conflict resolution rule, the system of intersecting aircraft flows is guaranteed to converge to safe, conflict free, trajectories within a bounded time. Simulations are provided to verify the analytically derived conclusions and study the convergence of the conflict resolution dynamics at different encounter angles. Simulation results show that lateral deviations taken by aircraft in each flow, to resolve conflicts, are bounded, and aircraft converged to safe and conflict free trajectories, within a finite time.

Cannabinoids in treatment-resistant epilepsy: A review.

PubMed

O'Connell, Brooke K; Gloss, David; Devinsky, Orrin

2017-05-01

Treatment-resistant epilepsy (TRE) affects 30% of epilepsy patients and is associated with severe morbidity and increased mortality. Cannabis-based therapies have been used to treat epilepsy for millennia, but only in the last few years have we begun to collect data from adequately powered placebo-controlled, randomized trials (RCTs) with cannabidiol (CBD), a cannabis derivative. Previously, information was limited to case reports, small series, and surveys reporting on the use of CBD and diverse medical marijuana (MMJ) preparations containing: tetrahydrocannabinol (THC), CBD, and many other cannabinoids in differing combinations. These RCTs have studied the safety and explored the potential efficacy of CBD use in children with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). The role of the placebo response is of paramount importance in studying medical cannabis products given the intense social and traditional media attention, as well as the strong beliefs held by many parents and patients that a natural product is safer and more effective than FDA-approved pharmaceutical agents. We lack valid data on the safety, efficacy, and dosing of artisanal preparations available from dispensaries in the 25 states and District of Columbia with MMJ programs and online sources of CBD and other cannabinoids. On the other hand, open-label studies with 100mg/ml CBD (Epidiolex®, GW Pharmaceuticals) have provided additional evidence of its efficacy along with an adequate safety profile (including certain drug interactions) in children and young adults with a spectrum of TREs. Further, Phase 3 RCTs with Epidiolex support efficacy and adequate safety profiles for children with DS and LGS at doses of 10- and 20-mg/kg/day. This article is part of a Special Issue titled "Cannabinoids and Epilepsy". Copyright © 2016 Elsevier Inc. All rights reserved.

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

Toward an understanding of the impact of production pressure on safety performance in construction operations.

PubMed

Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

2014-07-01

It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. Copyright © 2013 Elsevier Ltd. All rights reserved.

Prevalence and test characteristics of national health safety network ventilator-associated events.

PubMed

Lilly, Craig M; Landry, Karen E; Sood, Rahul N; Dunnington, Cheryl H; Ellison, Richard T; Bagley, Peter H; Baker, Stephen P; Cody, Shawn; Irwin, Richard S

2014-09-01

The primary aim of the study was to measure the test characteristics of the National Health Safety Network ventilator-associated event/ventilator-associated condition constructs for detecting ventilator-associated pneumonia. Its secondary aims were to report the clinical features of patients with National Health Safety Network ventilator-associated event/ventilator-associated condition, measure costs of surveillance, and its susceptibility to manipulation. Prospective cohort study. Two inpatient campuses of an academic medical center. Eight thousand four hundred eight mechanically ventilated adults discharged from an ICU. None. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs detected less than a third of ventilator-associated pneumonia cases with a sensitivity of 0.325 and a positive predictive value of 0.07. Most National Health Safety Network ventilator-associated event/ventilator-associated condition cases (93%) did not have ventilator-associated pneumonia or other hospital-acquired complications; 71% met the definition for acute respiratory distress syndrome. Similarly, most patients with National Health Safety Network probable ventilator-associated pneumonia did not have ventilator-associated pneumonia because radiographic criteria were not met. National Health Safety Network ventilator-associated event/ventilator-associated condition rates were reduced 93% by an unsophisticated manipulation of ventilator management protocols. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs failed to detect many patients who had ventilator-associated pneumonia, detected many cases that did not have a hospital complication, and were susceptible to manipulation. National Health Safety Network ventilator-associated event/ventilator-associated condition surveillance did not perform as well as ventilator-associated pneumonia surveillance and had several undesirable characteristics.

[Review: Patient safety as a national health goal: current state and essential fields of action for the German healthcare system].

PubMed

Hölscher, Uvo M; Gausmann, Peter; Haindl, Hans; Heidecke, Claus-Dieter; Hübner, Nils-Olaf; Lauer, Wolfgang; Lauterberg, Jörg; Skorning, Max; Thürmann, Petra A

2014-01-01

For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system. Copyright © 2014. Published by Elsevier GmbH.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of complete EHS0470, General Employee Radiation Safety (on-line course). Escort is required for visitors who Safety (on-line course) ii. EHS0348 Chemical Hygiene and Safety (on-line course) iii. EHS0470 General

Exploring the Effects of Cultural Variables in the Implementation of Behavior-Based Safety in Two Organizations

ERIC Educational Resources Information Center

Bumstead, Alaina; Boyce, Thomas E.

2005-01-01

The present case study examines how culture can influence behavior-based safety in different organizational settings and how behavior-based safety can impact different organizational cultures. Behavior-based safety processes implemented in two culturally diverse work settings are described. Specifically, despite identical implementation plans,…

Occupational Safety and Health Programs in Career Education.

ERIC Educational Resources Information Center

DiCarlo, Robert D.; And Others

This resource guide was developed in response to the Occupational Safety and Health Act of 1970 and is intended to assist teachers in implementing courses in occupational safety and health as part of a career education program. The material is a synthesis of films, programed instruction, slides and narration, case studies, safety pamphlets,…

A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

PubMed

Goh, Yang Miang; Askar Ali, Mohamed Jawad

2016-08-01

One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

30 CFR 56.4530 - Exits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control... a sufficient number of exits to permit prompt escape in case of fire. ...

Product Differences in Intra-articular Hyaluronic Acids for Osteoarthritis of the Knee.

PubMed

Altman, Roy D; Bedi, Asheesh; Karlsson, Jon; Sancheti, Parag; Schemitsch, Emil

2016-08-01

Knee osteoarthritis (OA) is a common and often disabling joint disorder among adults that may result in impaired activity and daily function. A variety of treatment options are currently available and prescribed for knee OA depending on the severity of the disorder and physician preference. Intra-articular hyaluronic acid (IA-HA) injection is a treatment for knee OA that reportedly provides numerous biochemical and biological benefits, including shock absorption, chondroprotection, and anti-inflammatory effects within the knee. Clarity is needed as to whether the available IA-HA products should be considered for therapy as a group or whether there are significant differences in the products that need to be considered in treatment of OA of the knee. To determine whether there are differences in efficacy and safety with respect to intrinsic properties of available IA-HA injections for knee OA. Meta-analysis. A comprehensive literature search of the Medline, EMBASE, and PubMed databases was conducted for all existing randomized trials of IA-HA. The primary outcome measure analyzed was the mean pain score at the reported follow-up nearest to 26 weeks after injection. Pooled efficacy and safety results were recorded for subgroupings of HA product characteristics. A total of 68 studies were included for analysis. Products with an average molecular weight ≥3000 kDa provided favorable efficacy results when compared with products of an average molecular weight <3000 kDa. Products with a molecular weight ≥3000 kDa demonstrated significantly fewer discontinuations due to treatment-related adverse events than did ≤1500 kDa counterparts, while trial discontinuation rates were similar between biological fermentation-derived HA products and avian-derived HA. The results did not demonstrate a significant difference in the occurrence of effusion across molecular weight subgroups. Additionally, biological fermentation-derived HA had a significantly smaller incidence of effusion than did avian-derived HA. Biological fermentation-derived HA demonstrated fewer acute flare-ups at the injection site than did avian-derived HA products, while high-molecular-weight products demonstrated the highest rate of injection site flare-up. Despite similarities, IA-HA products should not be treated as a group, as there are differences in IA-HA products that influence both efficacy and safety. In the available literature, IA-HA products with a molecular weight ≥3000 kDa and those derived from biological fermentation relate to superior efficacy and safety-factors that may influence selection an IA-HA product for OA of the knee. © 2015 The Author(s).

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2014 CFR

2014-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2012 CFR

2012-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

Violence and School Safety. Case Citations, 2002.

ERIC Educational Resources Information Center

Russo, Charles J., Ed.; Mawdsley, Ralph D., Ed.

This publication highlights and explains some 400 court cases from 2002 involving issues of school violence and safety. It is divided into four sections, or topics: (1) "The Fourth Amendment: Search and Seizure" (R. Mawdsley); (2) "Negligence" (W. Evans, Jr.); (3) "Assault on School Personnel" (M. Yates); and (4) "Drugs and Weapons in Schools" (M.…

A Team, Case-based Examination and Its Impact on Student Performance in a Patient Safety and Informatics Course

PubMed Central

Etheridge, Kierstan; DeLellis, Teresa

2017-01-01

Objective. To describe the redesigned assessment plan for a patient safety and informatics course and assess student pharmacist performance and perceptions. Methods. The final examination of a patient safety course was redesigned from traditional multiple choice and short answer to team-based, open-ended, and case-based. Faculty for each class session developed higher level activities, focused on developing key skills or attitudes deemed essential for practice, for a progressive patient case consisting of nine activities. Student performance and perceptions were analyzed with pre- and post-surveys using 5-point scales. Results. Mean performance on the examination was 93.6%; median scores for each assessed course outcome ranged from 90% to 100%. Eighty-five percent of students completed both surveys. Confidence performing skills and demonstrating attitudes improved for each item on post-survey compared with pre-survey. Eighty-one percent of students indicated the experience of taking the examination was beneficial for their professional development. Conclusion. A team, case-based examination was associated with high student performance and improved self-confidence in performing medication safety-related skills. PMID:28970618

Integrating evidence-based practices for increasing cancer screenings in safety net health systems: a multiple case study using the Consolidated Framework for Implementation Research.

PubMed

Liang, Shuting; Kegler, Michelle C; Cotter, Megan; Emily, Phillips; Beasley, Derrick; Hermstad, April; Morton, Rentonia; Martinez, Jeremy; Riehman, Kara

2016-08-02

Implementing evidence-based practices (EBPs) to increase cancer screenings in safety net primary care systems has great potential for reducing cancer disparities. Yet there is a gap in understanding the factors and mechanisms that influence EBP implementation within these high-priority systems. Guided by the Consolidated Framework for Implementation Research (CFIR), our study aims to fill this gap with a multiple case study of health care safety net systems that were funded by an American Cancer Society (ACS) grants program to increase breast and colorectal cancer screening rates. The initiative funded 68 safety net systems to increase cancer screening through implementation of evidence-based provider and client-oriented strategies. Data are from a mixed-methods evaluation with nine purposively selected safety net systems. Fifty-two interviews were conducted with project leaders, implementers, and ACS staff. Funded safety net systems were categorized into high-, medium-, and low-performing cases based on the level of EBP implementation. Within- and cross-case analyses were performed to identify CFIR constructs that influenced level of EBP implementation. Of 39 CFIR constructs examined, six distinguished levels of implementation. Two constructs were from the intervention characteristics domain: adaptability and trialability. Three were from the inner setting domain: leadership engagement, tension for change, and access to information and knowledge. Engaging formally appointed internal implementation leaders, from the process domain, also distinguished level of implementation. No constructs from the outer setting or individual characteristics domain differentiated systems by level of implementation. Our study identified a number of influential CFIR constructs and illustrated how they impacted EBP implementation across a variety of safety net systems. Findings may inform future dissemination efforts of EBPs for increasing cancer screening in similar settings. Moreover, our analytic approach is similar to previous case studies using CFIR and hence could facilitate comparisons across studies.

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

GEN-IV Benchmarking of Triso Fuel Performance Models under accident conditions modeling input data

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

Collin, Blaise Paul

This document presents the benchmark plan for the calculation of particle fuel performance on safety testing experiments that are representative of operational accidental transients. The benchmark is dedicated to the modeling of fission product release under accident conditions by fuel performance codes from around the world, and the subsequent comparison to post-irradiation experiment (PIE) data from the modeled heating tests. The accident condition benchmark is divided into three parts: • The modeling of a simplified benchmark problem to assess potential numerical calculation issues at low fission product release. • The modeling of the AGR-1 and HFR-EU1bis safety testing experiments. •more » The comparison of the AGR-1 and HFR-EU1bis modeling results with PIE data. The simplified benchmark case, thereafter named NCC (Numerical Calculation Case), is derived from “Case 5” of the International Atomic Energy Agency (IAEA) Coordinated Research Program (CRP) on coated particle fuel technology [IAEA 2012]. It is included so participants can evaluate their codes at low fission product release. “Case 5” of the IAEA CRP-6 showed large code-to-code discrepancies in the release of fission products, which were attributed to “effects of the numerical calculation method rather than the physical model” [IAEA 2012]. The NCC is therefore intended to check if these numerical effects subsist. The first two steps imply the involvement of the benchmark participants with a modeling effort following the guidelines and recommendations provided by this document. The third step involves the collection of the modeling results by Idaho National Laboratory (INL) and the comparison of these results with the available PIE data. The objective of this document is to provide all necessary input data to model the benchmark cases, and to give some methodology guidelines and recommendations in order to make all results suitable for comparison with each other. The participants should read this document thoroughly to make sure all the data needed for their calculations is provided in the document. Missing data will be added to a revision of the document if necessary. 09/2016: Tables 6 and 8 updated. AGR-2 input data added« less

Generation IV benchmarking of TRISO fuel performance models under accident conditions: Modeling input data

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

Collin, Blaise P.

2014-09-01

This document presents the benchmark plan for the calculation of particle fuel performance on safety testing experiments that are representative of operational accidental transients. The benchmark is dedicated to the modeling of fission product release under accident conditions by fuel performance codes from around the world, and the subsequent comparison to post-irradiation experiment (PIE) data from the modeled heating tests. The accident condition benchmark is divided into three parts: the modeling of a simplified benchmark problem to assess potential numerical calculation issues at low fission product release; the modeling of the AGR-1 and HFR-EU1bis safety testing experiments; and, the comparisonmore » of the AGR-1 and HFR-EU1bis modeling results with PIE data. The simplified benchmark case, thereafter named NCC (Numerical Calculation Case), is derived from ''Case 5'' of the International Atomic Energy Agency (IAEA) Coordinated Research Program (CRP) on coated particle fuel technology [IAEA 2012]. It is included so participants can evaluate their codes at low fission product release. ''Case 5'' of the IAEA CRP-6 showed large code-to-code discrepancies in the release of fission products, which were attributed to ''effects of the numerical calculation method rather than the physical model''[IAEA 2012]. The NCC is therefore intended to check if these numerical effects subsist. The first two steps imply the involvement of the benchmark participants with a modeling effort following the guidelines and recommendations provided by this document. The third step involves the collection of the modeling results by Idaho National Laboratory (INL) and the comparison of these results with the available PIE data. The objective of this document is to provide all necessary input data to model the benchmark cases, and to give some methodology guidelines and recommendations in order to make all results suitable for comparison with each other. The participants should read this document thoroughly to make sure all the data needed for their calculations is provided in the document. Missing data will be added to a revision of the document if necessary.« less

Viability of single balloon enteroscopy performed under endoscopist-directed sedation.

PubMed

López Rosés, Leopoldo; Álvarez, Beatriz; González Ramírez, Abel; López Baz, Alina; Fernández López, Alexia; Alonso, Sara; Dacal, Andrés; Martí, Eva; Albines, Gino; Fernández Molina, Julieta; Lancho, Ángel

2018-04-01

there is a lot of controversy with regard to who should be responsible for sedation during digestive endoscopy, particularly in advanced procedures that require deep sedation such as enteroscopy. The aim of this study was to evaluate the endoscopist-directed sedation viability during single balloon enteroscopy. this was a prospective, observational study of a series of consecutive enteroscopies. The clinical staff included an endoscopist, scrub nurse and a nurse in charge of monitoring and sedative administration. The following parameters were monitored: pulse oximetry, blood pressure (every five minutes), electrocardiogram and respiratory rate. There was continuous supplemental oxygen and CO2 insufflation. The patient was in the left lateral decubitus position and a fluoroscopic control was used. forty-four explorations were performed in 39 patients, 24 were male and 15 female. The median age was 74 (18-89) and the ASA score was I in 12 cases, II in 23 cases and III in nine cases. Comorbidities were present in 68% of cases. The drugs used included propofol in 23 cases, propofol and midazolam in ten cases, propofol/midazolam/fentanyl in two cases, propofol and fentanyl in two cases, and midazolam/fentanyl in seven cases. All procedures were complete. The length of the procedure was 52 minutes (20-120). There were diagnostic findings in 65.9% of cases and therapeutic measures in 47.7%. There were no severe complications and the rate of complications derived from sedation was 22.7%. endoscopist-directed sedation is effective and safe for single balloon enteroscopy. Multi-center and wider studies are needed in order to better assess the efficacy, safety and efficiency of sedation controlled by a non-anesthetist during advanced endoscopy in this field.

A review of three stand-alone topical thrombins for surgical hemostasis.

PubMed

Cheng, Christine M; Meyer-Massetti, Carla; Kayser, Steven R

2009-01-01

Topical thrombins are active hemostatic agents that can be used to minimize blood loss during surgery. Before 2007, the only topical thrombins available were derived from bovine plasma. Antibody formation to bovine thrombin and/or factor V, with subsequent risk of cross-reactivity with human factor V, and hemorrhagic complications associated with human factor-V deficiencies have been described in case reports of surgeries in which bovine thrombins were used. This risk is now included in the boxed warning section of the bovine thrombin prescribing information. In 2007 and 2008, 2 new topical thrombins from nonbovine sources received approval for use from the US Food and Drug Administration. The 3 active topical thrombins that are currently marketed are bovine plasma-derived thrombin, human plasma-derived thrombin, and human recombinant thrombin. The purpose of this review was to evaluate the literature on the efficacy and safety of topical thrombins and discuss the pharmacoeconomic considerations associated with their use. PubMed, EMBASE, and International Pharmaceutical Abstracts were searched for relevant papers published in English through October 10,2008, using the terms thrombin, human recombinant thrombin, bovine thrombin, plasma derived thrombin, and topical thrombin. Manufacturer-provided materials were also reviewed. Abstracts and unpublished data, as well as evaluations of sealants, adhesives, glues, and other hemostats that contain thrombin mixed with fibrinogen and other clotting factors, were excluded. Four randomized, double-blind studies involving the active, stand-alone topical thrombins were found. The bovine thrombin involved in these studies was the predecessor to the currently marketed, highly purified bovine formulation. No studies comparing the human products, studies involving the highly purified bovine preparation, or placebo-controlled studies involving bovine thrombin were found. In a Phase III comparison of human recombinant thrombin and bovine thrombin, the percentages of patients who achieved hemostasis within 10 minutes of topical thrombin application were 95.4% and 95.1%, respectively (95% CI, -3.7 to 5.0). The incidence of hemostasis within 10 minutes was also similar in a Phase III comparison of human plasma-derived thrombin and bovine thrombin (both, 97.4% [95% CI, 0.96 to 1.05]). In the study that compared human recombinant and bovine thrombin, the incidence of antiproduct antibody formation was 21.5% (43/200) in the bovine thrombin group and 1.5% (3/198) in the human recombinant thrombin group (P < 0.001); patients with antibodies to bovine thrombin had numerically higher incidences of bleeding or thromboembolic events than did patients without these antibodies (19% vs 13%; P value not reported). Human plasma-derived thrombin is available as a frozen sterile solution that must be thawed before application, whereas the human recombinant and bovine plasma-derived products are supplied as unrefrigerated sterile powders that must be reconstituted before use. The human thrombins are more costly than bovine thrombin on a per-vial basis. The average wholesale prices (US $, 2008) for 5000-IU vials of bovine thrombin and human recombinant thrombin were $87.85 and $103.20, respectively; the average wholesale price for a 4000- to 6000-IU vial of human plasma-derived thrombin was $96.00. Topical thrombins vary in the ways in which they are manufactured and their safety profiles, storage requirements, and costs. Human recombinant thrombin and human plasma-derived thrombin have each been shown to have hemostatic efficacy comparable to that of bovine thrombin. Bovine thrombin carries the risk of formation of cross-reactive antibodies to bovine thrombin, factor V, and other impurities that may be present in these formulations. Immunogenicity data for the currently marketed, highly purified bovine thrombin relative to older formulations of bovine thrombin could not be found. Whether the potential safety advantage justifies the added cost of the human products remains to be established.

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

PubMed

2008-03-01

In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The general principles for the risk assessment of GM plants and derived food and feed are followed, as described in the EFSA guidance document of the EFSA Scientific Panel on Genetically Modified Organisms. In Section 1 the mandate, scope and general principles for risk assessment of GM plant derived food and feed are discussed. Products under consideration are food and feed derived from GM plants, such as maize, soybeans, oilseed rape and cotton, modified through the introduction of one or more genes coding for agronomic input traits like herbicide tolerance and/or insect resistance. Furthermore GM plant derived food and feed, which have been obtained through extensive genetic modifications targeted at specific alterations of metabolic pathways leading to improved nutritional and/or health characteristics, such as rice containing beta-carotene, soybeans with enhanced oleic acid content, or tomato with increased concentration of flavonoids, are considered. The safety assessment of GM plants and derived food and feed follows a comparative approach, i.e. the food and feed are compared with their non-GM counterparts in order to identify intended and unintended (unexpected) differences which subsequently are assessed with respect to their potential impact on the environment, safety for humans and animals, and nutritional quality. Key elements of the assessment procedure are the molecular, compositional, phenotypic and agronomic analysis in order to identify similarities and differences between the GM plant and its near isogenic counterpart. The safety assessment is focussed on (i) the presence and characteristics of newly expressed proteins and other new constituents and possible changes in the level of natural constituents beyond normal variation, and on the characteristics of the GM food and feed, and (ii) the possible occurrence of unintended (unexpected) effects in GM plants due to genetic modification. In order to identify these effects a comparative phenotypic and molecular analysis of the GM plant and its near isogenic counterpart is carried out, in parallel with a targeted analysis of single specific compounds, which represent important metabolic pathways in the plant like macro and micro nutrients, known anti-nutrients and toxins. Significant differences may be indicative of the occurrence of unintended effects, which require further investigation. Section 2 provides an overview of studies performed for the safety and nutritional assessment of whole food and feed. Extensive experience has been built up in recent decades from the safety and nutritional testing in animals of irradiated foods, novel foods and fruit and vegetables. These approaches are also relevant for the safety and nutritional testing of whole GM food and feed. Many feeding trials have been reported in which GM foods like maize, potatoes, rice, soybeans and tomatoes have been fed to rats or mice for prolonged periods, and parameters such as body weight, feed consumption, blood chemistry, organ weights, histopathology etc have been measured. The food and feed under investigation were derived from GM plants with improved agronomic characteristics like herbicide tolerance and/or insect resistance. The majority of these experiments did not indicate clinical effects or histopathological abnormalities in organs or tissues of exposed animals. In some cases adverse effects were noted, which were difficult to interpret due to shortcomings in the studies. Many studies have also been carried out with feed derived from GM plants with agronomic input traits in target animal species to assess the nutritive value of the feed and their performance potential. Studies in sheep, pigs, broilers, lactating dairy cows, and fish, comparing the in vivo bioavailability of nutrients from a range of GM plants with their near isogenic counterpart and commercial varieties, showed that they were comparable with those for near isogenic non-GM lines and commercial varieties. In Section 3 toxicological in vivo, in silico, and in vitro test methods are discussed which may be applied for the safety and nutritional assessment of specific compounds present in food and feed or of whole food and feed derived from GM plants. Moreover the purpose, potential and limitations of the 90-day rodent feeding trial for the safety and nutritional testing of whole food and feed have been examined. Methods for single and repeated dose toxicity testing, reproductive and developmental toxicity testing and immunotoxicity testing, as described in OECD guideline tests for single well-defined chemicals are discussed and considered to be adequate for the safety testing of single substances including new products in GM food and feed. Various in silico and in vitro methods may contribute to the safety assessment of GM plant derived food and feed and components thereof, like (i) in silico searches for sequence homology and/or structural similarity of novel proteins or their degradation products to known toxic or allergenic proteins, (ii) simulated gastric and intestinal fluids in order to study the digestive stability of newly expressed proteins and in vitro systems for analysis of the stability of the novel protein under heat or other processing conditions, and (iii) in vitro genotoxicity test methods that screen for point mutations, chromosomal aberrations and DNA damage/repair. The current performance of the safety assessment of whole foods is mainly based on the protocols for low-molecular-weight chemicals such as pharmaceuticals, industrial chemicals, pesticides, food additives and contaminants. However without adaptation, these protocols have limitations for testing of whole food and feed. This primarily results from the fact that defined single substances can be dosed to laboratory animals at very large multiples of the expected human exposure, thus giving a large margin of safety. In contrast foodstuffs are bulky, lead to satiation and can only be included in the diet at much lower multiples of expected human intakes. When testing whole foods, the possible highest concentration of the GM food and feed in the laboratory animal diet may be limited because of nutritional imbalance of the diet, or by the presence of compounds with a known toxicological profile. The aim of the 90-days rodent feeding study with the whole GM food and feed is to assess potential unintended effects of toxicological and/or nutritional relevance and to establish whether the GM food and feed is as safe and nutritious as its traditional comparator rather than determining qualitative and quantitative intrinsic toxicity of defined food constituents. The design of the study should be adapted from the OECD 90-day rodent toxicity study. The precise study design has to take into account the nature of the food and feed and the characteristics of the new trait(s) and their intended role in the GM food and feed. A 90-day animal feeding trial has a large capacity (sensitivity and specificity) to detect potential toxicological effects of single well defined compounds. This can be concluded from data reported on the toxicology of a wide range of industrial chemicals, pharmaceuticals, food substances, environmental, and agricultural chemicals. It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients, toxicants or secondary metabolites. With respect to the detection of potential unintended effects in whole GM food and feed, it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable (unintended) effects in a 90-day rodent feeding study, as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels. Laboratory animal feeding studies of 90-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure. This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 3-month subchronic studies in rodents, by comparing findings at 3 and 24 months for a range of different chemicals. The 90-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology. Analyses of available data indicate that, for a wide range of substances, reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests. Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed, then these tests should be considered. By relating the estimated daily intake, or theoretical maximum daily intake per capita for a given whole food (or the sum of its individual commercial constituents) to that consumed on average per rat per day in the subchronic 90-day feeding study, it is possible to establish the margin of exposure (safety margin) for consumers. Results obtained from testing GM food and feed in rodents indicate that large (at least 100-fold) 'safety' margins exist between animal exposure levels without observed adverse effects and estimated human daily intake. Results of feeding studies with feed derived from GM plants with improved agronomic properties, carried out in a wide range of livestock species, are discussed. The studies did not show any biologically relevant differences in the parameters tested between control and test animals. (ABSTRACT TRUNCATED)

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Bioterrorism Preparedness for Infectious Disease (BTPID) Proposal

DTIC Science & Technology

2007-01-01

approximately $210,000/ year x 5 years. (Pending) Safety, Tolerability and Immunogenicity of ACAM3000 Modified Vaccinia Ankara (MVA) Small Pox ...Hospital. • (Pending) Safety, Tolerability and Immunogenicity of ACAM3000 Modified Vaccinia Ankara (MVA) Small Pox Vaccine in HIV-Seropositive...choosing optimal pox virus derived vectors as vaccines in terms of reducing clinical reactogenicity and inducing dendritic cell (DC) aturation. 2006 Elsevier

Sequence analysis of CVI988-based vaccine, pCVI988-699-2-RV that has undergone a reversion to virulence

USDA-ARS?s Scientific Manuscript database

In our safety evaluation of CVI988-699-2delta, a vaccine derived from a bacterial artificial chromosome (BAC)-based infectious clone of low passage CVI988, we found that the virus reverted to virulence during a safety trial using specific pathogen free (SPF) leghorn chickens. To determine changes i...

A Validation Study of the Revised Personal Safety Decision Scale

ERIC Educational Resources Information Center

Kim, HaeJung; Hopkins, Karen M.

2017-01-01

Objective: The purpose of this study is to examine the reliability and validity of an 11-item Personal Safety Decision Scale (PSDS) in a sample of child welfare workers. Methods: Data were derived from a larger cross-sectional online survey to a random stratified sample of 477 public child welfare workers in a mid-Atlantic State. An exploratory…

Derivation of improved load transformation matrices for launchers-spacecraft coupled analysis, and direct computation of margins of safety

NASA Technical Reports Server (NTRS)

Klein, M.; Reynolds, J.; Ricks, E.

1989-01-01

Load and stress recovery from transient dynamic studies are improved upon using an extended acceleration vector in the modal acceleration technique applied to structural analysis. Extension of the normal LTM (load transformation matrices) stress recovery to automatically compute margins of safety is presented with an application to the Hubble space telescope.

Public recreation and neighborhood sense of community: an exploration of a hypothesized relationship

Treesearch

Svetoslav D. Gueorguiev; Edwin Gomez; Eddie Hill

2008-01-01

This study explores the relationship between park attributes (perceived safety and perceived benefits) and their relationship to sense of community in urban neighborhoods. The study finds that the perception of benefits derived from park use has a direct relationship with sense of community, and that park safety is indirectly related to sense of community, with the...

Risk and protective factors for falls from furniture in young children: multicenter case-control study.

PubMed

Kendrick, Denise; Maula, Asiya; Reading, Richard; Hindmarch, Paul; Coupland, Carol; Watson, Michael; Hayes, Mike; Deave, Toity

2015-02-01

Falls from furniture are common in young children but there is little evidence on protective factors for these falls. To estimate associations for risk and protective factors for falls from furniture in children aged 0 to 4 years. Multicenter case-control study at hospitals, minor injury units, and general practices in and around 4 UK study centers. Recruitment commenced June 14, 2010, and ended April 27, 2012. Participants included 672 children with falls from furniture and 2648 control participants matched on age, sex, calendar time, and study center. Thirty-five percent of cases and 33% of control individuals agreed to participate. The mean age was 1.74 years for cases and 1.91 years for control participants. Fifty-four percent of cases and 56% of control participants were male. Exposures included safety practices, safety equipment use, and home hazards. Falls from furniture occurring at the child's home resulting in attendance at an emergency department, minor injury unit, or hospital admission. Compared with parents of control participants, parents of cases were significantly more likely not to use safety gates in the home (adjusted odds ratio [AOR], 1.65; 95% CI, 1.29-2.12) and not to have taught their children rules about climbing on kitchen objects (AOR, 1.58; 95% CI, 1.16-2.15). Cases aged 0 to 12 months were significantly more likely to have been left on raised surfaces (AOR, 5.62; 95% CI, 3.62-8.72), had their diapers changed on raised surfaces (AOR, 1.89; 95% CI, 1.24-2.88), and been put in car/bouncing seats on raised surfaces (AOR, 2.05; 95% CI, 1.29-3.27). Cases 3 years and older were significantly more likely to have played or climbed on furniture (AOR, 9.25; 95% CI, 1.22-70.07). Cases were significantly less likely to have played or climbed on garden furniture (AOR, 0.74; 95% CI, 0.56-0.97). If estimated associations are causal, some falls from furniture may be prevented by incorporating advice into child health contacts, personal child health records, and home safety assessments about use of safety gates; not leaving children, changing diapers, or putting children in car/bouncing seats on raised surfaces; allowing children to play or climb on furniture; and teaching children safety rules about climbing on objects.

Abused women's experiences of a primary care identification and referral intervention: a case study analysis.

PubMed

Bradbury-Jones, Caroline; Clark, Maria; Taylor, Julie

2017-12-01

The aim of this study was to report the findings of a qualitative case study that investigated abused women's experiences of an identification and referral intervention and to discuss the implications for nurses, specifically those working in primary and community care. Domestic violence and abuse is a significant public health issue globally but it is a hidden problem that is under-reported. In the UK, Identification and Referral to Improve Safety is a primary care-based intervention that has been found to increase referral rates of abused women to support and safety services. This paper reports on the findings of an evaluation study of two sites in England. Qualitative study with a case study design. In line with case study design, the entire evaluation study employed multiple data collection methods. We report on the qualitative interviews with women referred through the programme. The aim was to elicit their experiences of the three aspects of the intervention: identification; referral; safety. Data collection took place March 2016. Ten women took part. Eight had exited the abusive relationship but two remained with the partner who had perpetrated the abuse. Women were overwhelmingly positive about the programme and irrespective of whether they had remained or exited the relationship all reported perceptions of increased safety and improved health. Nurses have an important role to play in identifying domestic violence and abuse and in referral and safety planning. As part of a portfolio of domestic violence and abuse interventions, those that empower women to take control of their safety (such as Identification and Referral to Improve Safety) are important. © 2017 John Wiley & Sons Ltd.

Total Quality Management and the System Safety Secretary

NASA Technical Reports Server (NTRS)

Elliott, Suzan E.

1993-01-01

The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

Next generation safety performance monitoring at signalized intersections using connected vehicle technology.

DOT National Transportation Integrated Search

2014-08-01

Crash-based safety evaluation is often hampered by randomness, lack of timeliness, and rarity of crash : occurrences. This is particularly the case for technology-driven safety improvement projects that are : frequently updated or replaced by newer o...

An open-label dose escalation study to evaluate the safety of administration of nonviral stromal cell-derived factor-1 plasmid to treat symptomatic ischemic heart failure.

PubMed

Penn, Marc S; Mendelsohn, Farrell O; Schaer, Gary L; Sherman, Warren; Farr, Maryjane; Pastore, Joseph; Rouy, Didier; Clemens, Ruth; Aras, Rahul; Losordo, Douglas W

2013-03-01

Preclinical studies indicate that adult stem cells induce tissue repair by activating endogenous stem cells through the stromal cell-derived factor-1:chemokine receptor type 4 axis. JVS-100 is a DNA plasmid encoding human stromal cell-derived factor-1. We tested in a phase 1, open-label, dose-escalation study with 12 months of follow-up in subjects with ischemic cardiomyopathy to see if JVS-100 improves clinical parameters. Seventeen subjects with ischemic cardiomyopathy, New York Heart Association class III heart failure, with an ejection fraction ≤40% on stable medical therapy, were enrolled to receive 5, 15, or 30 mg of JVS-100 via endomyocardial injection. The primary end points for safety and efficacy were at 1 and 4 months, respectively. The primary safety end point was a major adverse cardiac event. Efficacy end points were change in quality of life, New York Heart Association class, 6-minute walk distance, single photon emission computed tomography, N-terminal pro-brain natruretic peptide, and echocardiography at 4 and 12 months. The primary safety end point was met. At 4 months, all of the cohorts demonstrated improvements in 6-minute walk distance, quality of life, and New York Heart Association class. Subjects in the 15- and 30-mg dose groups exhibited improvements in 6-minute walk distance (15 mg: median [range]: 41 minutes [3-61 minutes]; 30 mg: 31 minutes [22-74 minutes]) and quality of life (15 mg: -16 points [+1 to -32 points]; 30 mg: -24 points [+17 to -38 points]) over baseline. At 12 months, improvements in symptoms were maintained. These data highlight the importance of defining the molecular mechanisms of stem cell-based tissue repair and suggest that overexpression of stromal cell-derived factor-1 via gene therapy is a strategy for improving heart failure symptoms in patients with ischemic cardiomyopathy.

Structural Deterministic Safety Factors Selection Criteria and Verification

NASA Technical Reports Server (NTRS)

Verderaime, V.

1992-01-01

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

Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections.

PubMed

Song, Yang; Du, Hui; Dai, Chengxiang; Zhang, Li; Li, Suke; Hunter, David J; Lu, Liangjing; Bao, Chunde

2018-04-01

This study aimed to evaluate the safety and therapeutic potential of autologous human adipose-derived mesenchymal stem cells (haMSCs) in patients with osteoarthritis. Safety and efficacy of haMSCs were preclinically assessed in vitro and in BALB/c-nu nude mice. 18 patients were enrolled and divided into three dose groups: the low-dose, mid-dose and high-dose group (1 × 10 7 , 2 × 10 7 and 5 × 10 7 cells, respectively), provided three injections and followed up for 96 weeks. The preclinical study established the safety and efficacy of haMSCs. Intra-articular injections of haMSCs were safe and improved pain, function and cartilage volume of the knee joint, rendering them a promising novel treatment for knee osteoarthritis. The dosage of 5 × 10 7 haMSCs exhibited the highest improvement (ClinicalTrials.gov Identifier: NCT01809769).

Safety of nicergoline as an agent for management of cognitive function disorders.

PubMed

Saletu, Bernd; Garg, Amit; Shoeb, Ahsan

2014-01-01

Nicergoline is a semisynthetic ergot derivative and has a selective alpha-1A adrenergic receptor blocking property and also other additional mechanisms of actions, both in the brain and in the periphery. It is in clinical use for over three decades in over fifty countries for conditions such as cerebral infarction, acute and chronic peripheral circulation disorders, vascular dementia, and Alzheimer's disease and has been found to be beneficial in a variety of other conditions. However, concerns about its safety have been raised, especially after the European medicines agency's (EMEA's) restriction in the use of all ergot derivatives including nicergoline. But, most of the available literature and data suggest that the adverse events with nicergoline are mild and transient. Further, none of the available treatment options for cognitive disorders afford definitive resolution of symptoms. In this backdrop, we discuss the pharmacology of nicergoline with special emphasis on the safety of this compound, especially when used in patients suffering from cognitive function disorders.

Safety of Nicergoline as an Agent for Management of Cognitive Function Disorders

PubMed Central

2014-01-01

Nicergoline is a semisynthetic ergot derivative and has a selective alpha-1A adrenergic receptor blocking property and also other additional mechanisms of actions, both in the brain and in the periphery. It is in clinical use for over three decades in over fifty countries for conditions such as cerebral infarction, acute and chronic peripheral circulation disorders, vascular dementia, and Alzheimer's disease and has been found to be beneficial in a variety of other conditions. However, concerns about its safety have been raised, especially after the European medicines agency's (EMEA's) restriction in the use of all ergot derivatives including nicergoline. But, most of the available literature and data suggest that the adverse events with nicergoline are mild and transient. Further, none of the available treatment options for cognitive disorders afford definitive resolution of symptoms. In this backdrop, we discuss the pharmacology of nicergoline with special emphasis on the safety of this compound, especially when used in patients suffering from cognitive function disorders. PMID:25243157

AdvoCATE - User Guide

NASA Technical Reports Server (NTRS)

Denney, Ewen W.

2015-01-01

The basic vision of AdvoCATE is to automate the creation, manipulation, and management of large-scale assurance cases based on a formal theory of argument structures. Its main purposes are for creating and manipulating argument structures for safety assurance cases using the Goal Structuring Notation (GSN), and as a test bed and proof-of-concept for the formal theory of argument structures. AdvoCATE is available for Windows 7, Macintosh OSX, and Linux. Eventually, AdvoCATE will serve as a dashboard for safety related information and provide an infrastructure for safety decisions and management.

The business case for patient safety.

PubMed

Hwang, Raymond W; Herndon, James H

2007-04-01

Recent trends have focused attention on improving patient safety in the United States healthcare system. Lapses in patient safety create undue, often preventable, morbidity. These include adverse drug events, adverse surgical events and nosocomial infections. From an organizational perspective, these events are both inefficient and expensive. Many safe practices and quality enhancing improvements, such as computer provider order entry, proper infection surveillance, telemedicine intensive care, and registered nurse staffing are in fact cost-effective. However, in order to fully achieve higher quality, better adverse event reporting and a culture of safety must first be developed. Increased provider recognition, models of success, public awareness and consumer demand are propelling improvements. As we will outline in this review of the current literature, the business case for patient safety is a compelling one, offering substantial economic incentives for achieving the necessary goal of improved patient outcomes.

The Immunogenicity and Immune Tolerance of Pluripotent Stem Cell Derivatives

PubMed Central

Liu, Xin; Li, Wenjuan; Fu, Xuemei; Xu, Yang

2017-01-01

Human embryonic stem cells (hESCs) can undergo unlimited self-renewal and differentiate into all cell types in human body, and therefore hold great potential for cell therapy of currently incurable diseases including neural degenerative diseases, heart failure, and macular degeneration. This potential is further underscored by the promising safety and efficacy data from the ongoing clinical trials of hESC-based therapy of macular degeneration. However, one main challenge for the clinical application of hESC-based therapy is the allogeneic immune rejection of hESC-derived cells by the recipient. The breakthrough of the technology to generate autologous-induced pluripotent stem cells (iPSCs) by nuclear reprogramming of patient’s somatic cells raised the possibility that autologous iPSC-derived cells can be transplanted into the patients without the concern of immune rejection. However, accumulating data indicate that certain iPSC-derived cells can be immunogenic. In addition, the genomic instability associated with iPSCs raises additional safety concern to use iPSC-derived cells in human cell therapy. In this review, we will discuss the mechanism underlying the immunogenicity of the pluripotent stem cells and recent progress in developing immune tolerance strategies of human pluripotent stem cell (hPSC)-derived allografts. The successful development of safe and effective immune tolerance strategy will greatly facilitate the clinical development of hPSC-based cell therapy. PMID:28626459

Relative safety of pooled whole blood-derived versus single-donor (apheresis) platelets in the United States: a systematic review of disparate risks.

PubMed

Vamvakas, Eleftherios C

2009-12-01

Risks of transfusion-transmitted infections (TTIs), transfusion-associated sepsis (TAS), and transfusion-related acute lung injury (TRALI) were compared between pooled whole blood-derived (PWBD) and single-donor platelets (PLTs) transfused in the United States. The literature was searched for estimates of the risk of TTIs and TAS and of the effect on bacterial contamination of PLTs of process improvements, bacterial culture, and surrogate methods to detect bacteria. Seven studies published between January 2005 and December 2008 and comparing bacterial contamination frequency between PWBD and single-donor PLTs after implementing bacterial culture testing of both components were subjected to meta-analysis. The three retrieved studies diagnosing TRALI based on the 2004 consensus definition in settings transfusing both PWBD and single-donor PLTs were not amenable to meta-analysis and were assessed qualitatively. Under a best-case scenario, if 100% (from the current 12.5%) of PLT doses were provided as PWBD PLTs, the number of additional transmissions of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, bacteria, or a novel pathogen annually could be 1.2, 1.3, 9.0, 105.3, or 69.2 to 252.6, respectively. Compared with single-donor PLTs, US PLT pools of five concentrates have a 5.6-fold higher risk of bacterial contamination (summary odds ratio, 5.58; 95% confidence interval, 2.60-11.98; p < 0.05). The three studies that diagnosed TRALI based on the consensus definition did not demonstrate a difference in risk between PWBD and single-donor PLTs. TTIs and TAS determine the relative safety of PWBD versus single-donor PLTs. The available limited data do not support a higher risk of TRALI from single-donor (compared with PWBD) PLTs.

Epidemiology of human immunodeficiency virus infection in blood donations in Europe and Italy

PubMed Central

Suligoi, Barbara; Raimondo, Mariangela; Regine, Vincenza; Salfa, Maria Cristina; Camoni, Laura

2010-01-01

Background The safety of blood with regards to transmission of infectious diseases is guaranteed by European laws that regulate both the selection of donors through pre-donation questionnaires and serological screening. However, variability in the epidemiology of human immunodeficiency virus (HIV) infection in different countries and some differences in the selection of donors can influence the efficacy (with regards to the safety of blood) of these processes. In this study we compared the prevalence of HIV in blood donations in the three macro-areas of Europe and in various western European countries, analysed the criteria of selection and rewarding of donors in western European countries, and studied the trend in the prevalence of HIV in Italy from to 1995 and 2006. Methods European data were derived from the European Centre for the Surveillance of HIV; Italian data were obtained from the Transfusion-Transmitted Infections Surveillance System and National and Regional Register of blood and plasma. The information on eligibility criteria and rewarding offered to donors was derived from international sources. Results The prevalence of HIV in blood donations was highest in eastern Europe, followed by central Europe and western Europe. Among the western European countries, Spain, Italy and Israel had the highest prevalences; the prevalence was noted to be higher in countries which did not offer any rewarding to the donor. In Italy the prevalence of HIV was 3.8 cases per 100,000 donations in 2006 and increased between 1995 and 2006, both among donations from repeat donors and first time donors. Conclusions The data highlight the need to continue improving the selection of donors and the coverage of the surveillance systems for HIV infection in transfusion services. PMID:20671878

Epidemiology of human immunodeficiency virus infection in blood donations in Europe and Italy.

PubMed

Suligoi, Barbara; Raimondo, Mariangela; Regine, Vincenza; Salfa, Maria Cristina; Camoni, Laura

2010-07-01

The safety of blood with regards to transmission of infectious diseases is guaranteed by European laws that regulate both the selection of donors through pre-donation questionnaires and serological screening. However, variability in the epidemiology of human immunodeficiency virus (HIV) infection in different countries and some differences in the selection of donors can influence the efficacy (with regards to the safety of blood) of these processes. In this study we compared the prevalence of HIV in blood donations in the three macro-areas of Europe and in various western European countries, analysed the criteria of selection and rewarding of donors in western European countries, and studied the trend in the prevalence of HIV in Italy from to 1995 and 2006. European data were derived from the European Centre for the Surveillance of HIV; Italian data were obtained from the Transfusion-Transmitted Infections Surveillance System and National and Regional Register of blood and plasma. The information on eligibility criteria and rewarding offered to donors was derived from international sources. The prevalence of HIV in blood donations was highest in eastern Europe, followed by central Europe and western Europe. Among the western European countries, Spain, Italy and Israel had the highest prevalences; the prevalence was noted to be higher in countries which did not offer any rewarding to the donor. In Italy the prevalence of HIV was 3.8 cases per 100,000 donations in 2006 and increased between 1995 and 2006, both among donations from repeat donors and first time donors. The data highlight the need to continue improving the selection of donors and the coverage of the surveillance systems for HIV infection in transfusion services.

Ciguatera: a public health perspective.

PubMed

Dickey, Robert W; Plakas, Steven M

2010-08-15

Ciguatera fish poisoning is a seafood-borne illness caused by consumption of fish that have accumulated lipid-soluble ciguatoxins. In the United States, ciguatera is responsible for the highest reported incidence of food-borne illness outbreaks attributed to finfish, and it is reported to hold this distinction globally. Ciguatoxins traverse the marine food web from primary producers, Gambierdiscus spp., to commonly consumed fish in tropical and subtropical regions of the world. Ciguatoxins comprise 12 known congeners among Caribbean and tropical Atlantic fish and 29 reported congeners among Pacific fish. Expanding trade in fisheries from ciguatera-endemic regions contributes to wider distribution and increasing frequency of disease among seafood consumers in non-endemic regions. Ciguatoxins produce a complex array of gastrointestinal, neurological and cardiological symptoms. Treatment options are very limited and supportive in nature. Information derived from the study of ciguatera outbreaks has improved clinical recognition, confirmation, and timely treatment. Such studies are equally important for the differentiation of ciguatoxin profiles in fish from one region to the next, the determination of toxicity thresholds in humans, and the formulation of safety limits. Analytical information from case and outbreak investigations was used to derive Pacific and Caribbean ciguatoxin threshold contamination rates for adverse effects in seafood consumers. To these threshold estimates 10-fold safety factors were applied to address individual human risk factors; uncertainty in the amount of fish consumed; and analytical accuracy. The studies may serve as the basis for industry and consumer advisory levels of 0.10ppb C-CTX-1 equivalent toxicity in fish from the tropical Atlantic, Gulf of Mexico, Caribbean, and 0.01ppb P-CTX-1 equivalent toxicity in fish from Pacific regions. Published by Elsevier Ltd.

Myocardial regeneration potential of adipose tissue-derived stem cells

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

Bai, Xiaowen, E-mail: baixw01@yahoo.com; Alt, Eckhard, E-mail: ealt@mdanderson.org

Research highlights: {yields} Various tissue resident stem cells are receiving tremendous attention from basic scientists and clinicians and hold great promise for myocardial regeneration. {yields} For practical reasons, human adipose tissue-derived stem cells are attractive stem cells for future clinical application in repairing damaged myocardium. {yields} This review summarizes the characteristics of cultured and freshly isolated stem cells obtained from adipose tissue, their myocardial regeneration potential and the, underlying mechanisms, and safety issues. -- Abstract: Various tissue resident stem cells are receiving attention from basic scientists and clinicians as they hold promise for myocardial regeneration. For practical reasons, adipose tissue-derivedmore » stem cells (ASCs) are attractive cells for clinical application in repairing damaged myocardium based on the following advantages: abundant adipose tissue in most patients and easy accessibility with minimally invasive lipoaspiration procedure. Several recent studies have demonstrated that both cultured and freshly isolated ASCs could improve cardiac function in animal model of myocardial infarction. The mechanisms underlying the beneficial effect of ASCs on myocardial regeneration are not fully understood. Growing evidence indicates that transplantation of ASCs improve cardiac function via the differentiation into cardiomyocytes and vascular cells, and through paracrine pathways. Paracrine factors secreted by injected ASCs enhance angiogenesis, reduce cell apoptosis rates, and promote neuron sprouts in damaged myocardium. In addition, Injection of ASCs increases electrical stability of the injured heart. Furthermore, there are no reported cases of arrhythmia or tumorigenesis in any studies regarding myocardial regeneration with ASCs. This review summarizes the characteristics of both cultured and freshly isolated stem cells obtained from adipose tissue, their myocardial regeneration potential, and the underlying mechanisms for beneficial effect on cardiac function, and safety issues.« less

Simulation of Hydrogen Distribution in Ignalina NPP ALS Compartments During BDBA

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

Babilas, Egidijus; Urbonavicius, Egidijus; Rimkevicius, Sigitas

2006-07-01

Accident Localisation System (ALS) of Ignalina NPP is a 'pressure suppression' type confinement, which protects the population, employees and environment from the radiation hazards. According to the Safety Analysis Report for Ignalina NPP {approx}110 m{sup 3} of hydrogen is released to ALS compartments during the Maximum Design Basis Accident. However in case of beyond design basis accident, when the oxidation of zirconium starts, the amount of generated hydrogen could be significantly higher. If the volume concentration of hydrogen in the compartment reaches 4%, there is a possibility for a combustible mixture to appear. To prevent the possible hydrogen accumulation inmore » the ALS of the Ignalina NPP during an accident the H{sub 2} control system is installed. The results of the performed analysis derived the places of the possible H{sub 2} accumulation in the ALS compartments during the transient processes and assessed the mixture combustibility in these places for a beyond design basis accident scenario. Such analysis of H{sub 2} distribution in the ALS of Ignalina NPP in case of BDBA was not performed before. (authors)« less

Consumer's Fresh Produce Food Safety Practices: Outcomes of a Fresh Produce Safety Education Program

ERIC Educational Resources Information Center

Scott, Amanda R.; Pope, Paul E.; Thompson, Britta M.

2009-01-01

The Centers for Disease Control and Prevention estimate that there are 76 million cases of foodborne disease annually. Foodborne disease is usually associated with beef, poultry, and seafood. However, there is an increasing number of foodborne disease cases related to fresh produce. Consumers may not associate fresh produce with foodborne disease…

[Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

PubMed

Axelsen, Karina Rahbek; Nafei, Hanne; Jakobsen, Stine Finne; Gandrup, Per; Knudsen, Janne Lehmann

2015-06-08

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the func­tion and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been nar­rowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

Implications of case managers' perceptions and attitude on safety of home-delivered care.

PubMed

Jones, Sarahjane

2015-12-01

Perceptions on safety in community care have been relatively unexplored. A project that sought to understand the multiple perspectives on safety in the NHS case-management programme was carried out in relation to the structure, process, and outcome of care. This article presents a component of the nursing perspective that highlights an important element in the structure of nursing care that could potentially impede the nurses' ability to be fully effective and safe. A single case study of the case-management programme was undertaken. Three primary care organisations from three strategic health authorities participated, and three focus groups were conducted (one within each organisation). In total, 17 case management nurses participated. Data were audiotaped and transcribed verbatim and subjected to framework analysis. Nursing staff attitudes were identified as a structure of care that influence safety outcomes, particularly their perceptions of the care setting and the implications it has on their role and patient behaviour. Greater understanding of the expected role of the community nurse is necessary, and relevant training is required for nurses to be successful in empowering patients to perform more safely. In addition, efforts need to be made to improve patients' trust in the health-care system to prevent harm and promote more effective utilisation of resources.

Application of stem cell-derived retinal pigmented epithelium in retinal degenerative diseases: present and future.

PubMed

Luo, Mingyue; Chen, Youxin

2018-01-01

As a constituent of blood-retinal barrier and retinal outer segment (ROS) scavenger, retinal pigmented epithelium (RPE) is fundamental to normal function of retina. Malfunctioning of RPE contributes to the onset and advance of retinal degenerative diseases. Up to date, RPE replacement therapy is the only possible method to completely reverse retinal degeneration. Transplantation of human RPE stem cell-derived RPE (hRPESC-RPE) has shown some good results in animal models. With promising results in terms of safety and visual improvement, human embryonic stem cell-derived RPE (hESC-RPE) can be expected in clinical settings in the near future. Despite twists and turns, induced pluripotent stem cell-derived RPE (iPSC-RPE) is now being intensely investigated to overcome genetic and epigenetic instability. By far, only one patient has received iPSC-RPE transplant, which is a hallmark of iPSC technology development. During follow-up, no major complications such as immunogenicity or tumorigenesis have been observed. Future trials should keep focusing on the safety of stem cell-derived RPE (SC-RPE) especially in long period, and better understanding of the nature of stem cell and the molecular events in the process to generate SC-RPE is necessary to the prosperity of SC-RPE clinical application.

Impact of biomarker development on drug safety assessment

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

Marrer, Estelle, E-mail: estelle.marrer@novartis.co; Dieterle, Frank

2010-03-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative andmore » 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.« less

Intranet-based safety documentation in management of major hazards and occupational health and safety.

PubMed

Leino, Antti

2002-01-01

In the European Union, Council Directive 96/82/EC requires operators producing, using, or handling significant amounts of dangerous substances to improve their safety management systems in order to better manage the major accident potentials deriving from human error. A new safety management system for the Viikinmäki wastewater treatment plant in Helsinki, Finland, was implemented in this study. The system was designed to comply with both the new safety liabilities and the requirements of OHSAS 18001 (British Standards Institute, 1999). During the implementation phase experiences were gathered from the development processes in this small organisation. The complete documentation was placed in the intranet of the plant. Hyperlinks between documents were created to ensure convenience of use. Documentation was made accessible for all workers from every workstation.

An injury prevention strategy for teen restaurant workers. Washington State's ProSafety project.

PubMed

Ward, Julie A; de Castro, A B; Tsai, Jenny Hsin-Chun; Linker, Darren; Hildahl, Lyle; Miller, Mary E

2010-02-01

High levels of youth employment, workplace hazards, and characteristics unique to adolescents contribute to a relatively high incidence of injuries among teens in the restaurant industry. This article discusses the ProSafety model of injury prevention among teen restaurant workers. Through integration with an existing career and technical education program, the ProSafety project seeks to prevent occupational injuries among the teen worker population through classroom safety education and internship skills reinforcement. ProSafety is the product of an innovative collaboration with occupational health nurses, business professionals, educators, and government. Its approach is derived from Social Cognitive Theory, is consistent with key values and strategies of occupational health nurses, and provides lessons for practitioners seeking to reduce occupational injuries in food service or among other populations of adolescent workers.

Safety assessment of sandalwood oil (Santalum album L.).

PubMed

Burdock, George A; Carabin, Ioana G

2008-02-01

Sandalwood (Santalum album L.) is a fragrant wood from which oil is derived for use in food and cosmetics. Sandalwood oil is used in the food industry as a flavor ingredient with a daily consumption of 0.0074 mg/kg. Over 100 constituents have been identified in sandalwood oil with the major constituent being alpha-santalol. Sandalwood oil and its major constituent have low acute oral and dermal toxicity in laboratory animals. Sandalwood oil was not mutagenic in spore Rec assay and was found to have anticarcinogenic, antiviral and bactericidal activity. Occasional cases of irritation or sensitization reactions to sandalwood oil in humans are reported in the literature. Although the available information on toxicity of sandalwood oil is limited, it has a long history of oral use without any reported adverse effects and is considered safe at present use levels.

Dynamic Pressure Distribution due to Horizontal Acceleration in Spherical LNG Tank with Cylindrical Central Part

NASA Astrophysics Data System (ADS)

Ko, Dae-Eun; Shin, Sang-Hoon

2017-11-01

Spherical LNG tanks having many advantages such as structural safety are used as a cargo containment system of LNG carriers. However, it is practically difficult to fabricate perfectly spherical tanks of different sizes in the yard. The most effective method of manufacturing LNG tanks of various capacities is to insert a cylindrical part at the center of existing spherical tanks. While a simplified high-precision analysis method for the initial design of the spherical tanks has been developed for both static and dynamic loads, in the case of spherical tanks with a cylindrical central part, the analysis method available only considers static loads. The purpose of the present study is to derive the dynamic pressure distribution due to horizontal acceleration, which is essential for developing an analysis method that considers dynamic loads as well.

Centralized or decentralized perinatal surgical care for rural women: a realist review of the evidence on safety.

PubMed

Kornelsen, Jude; McCartney, Kevin; Williams, Kim

2016-08-13

The precipitous closure of rural maternity services in British Columbia (BC), Canada, and internationally has demanded a reevaluation of how to meet the perinatal surgical needs of rural women in accordance with the Triple Aim objectives of safety, cost-effectiveness, and satisfaction of all key stakeholders. There is emerging international evidence that General Practitioners with Enhanced Surgical Skills (GPESS) are a well-positioned health service solution due to their generalist nature in low-volume settings. A realist review was undertaken to evaluate international evidence on efficacious models of perinatal surgical care. This article presents findings of the safety of such practice, one discrete part of the full realist review. This paper was derived from a larger review, which used a realist review methodology to guide the approach, and adhered to the RAMESES quality standard for realist reviews. Seven academic databases were searched in December 2013, using year (1990) and language (English) limiters in keeping with a rapid review approach. Mining of bibliographies in addition to consultation with international experts led to further inclusion of academic and grey literature up to March 2014. Two hundred fifty-four articles were originally identified; 119 articles were removed from consideration for lack of fit, resulting in the review of 191 articles from the peer reviewed and grey literature. Of these, 53 pertained to safety and are considered herein. Evidence on the safety of GPESS was consistent in the literature cited. Clinical, case study, and qualitative evidence demonstrates that perinatal surgical care is equally safe when provided by GPESS and specialist physicians. Findings allow health planners to confidently build perinatal surgical services around the contribution of GPs with enhanced surgical skills and focus on educational, regulatory, and continuing professional development mechanisms to ensure their sustainability. Volume-to-outcomes associations are variable and inconclusive with regards to safety, suggesting the need for more evidence. These findings, and the attendant health services planning directions, are reassuring as they suggest the viability of local models of care where feasible.

Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children.

PubMed

Halperin, Scott A; Smith, Bruce; Mabrouk, Taoufik; Germain, Marc; Trépanier, Pierre; Hassell, Thomas; Treanor, John; Gauthier, Richard; Mills, Elaine L

2002-01-15

We performed randomized, double-blind, controlled trials to assess the safety and immunogenicity of an inactivated, Madin Darby Canine Kidney (MDCK)-derived cell line produced influenza vaccine in healthy adults (19-50 years), children (3-12 years) and the elderly (> or =65 years). We studied three lots of cell culture-derived vaccine and one lot of licensed egg-derived vaccine in healthy adults (n=462), two lots of cell culture-derived vaccine and one lot of egg-derived vaccine in seniors (n=269), and one lot of each vaccine in children (n=209). Adverse events were collected during the first 3 days post-immunization; serum was collected before and 1 month after immunization. Rates of local and systemic adverse reactions were similar with both vaccines. An injection site adverse event rated at least moderate severity was reported by 21.9% of children who received the egg-derived vaccine and 25.0% of those who received the cell culture-derived vaccine. In healthy adults the proportions were 12.1 and 15.3%, respectively and 6.7 and 6.3%, respectively in seniors. Systemic events of at least moderate severity were 12.4 and 12.5% in children, 19.8 and 13.6% in healthy adults, and 14.1 and 9.7% in seniors; none of these differences were statistically significant. The antibody response against all three viruses was similar between the two vaccines. From 83 to 100% of children, healthy adults and seniors achieved hemagglutination inhibition titers in excess of 40 post-immunization. We conclude that the cell culture-derived vaccine was safe and immunogenic in children, healthy adults and seniors.

Fire safety concerns in space operations

NASA Technical Reports Server (NTRS)

Friedman, Robert

1987-01-01

This paper reviews the state-of-the-art in fire control techniques and identifies important issues for continuing research, technology, and standards. For the future permanent orbiting facility, the space station, fire prevention and control calls for not only more stringent fire safety due to the long-term and complex missions, but also for simplified and flexible safety rules to accommodate the variety of users. Future research must address a better understanding of the microgravity space environment as it influences fire propagation and extinction and the application of the technology of fire detection, extinguishment, and material assessment. Spacecraft fire safety should also consider the adaptation of methods and concepts derived from aircraft and undersea experience.

Origin and Subsequent Modifications of Explosive Safety Quantity- Distance (ESQD) Standards for Mass Detonating Explosives with Special Reference to Naval Vessels. Volume 2. Appendices

DTIC Science & Technology

1978-05-01

quite heated’ discussion; further, some individuals may be in conflict with one another and speaking only to their own momentary self -interest or...Explosives Safety Board has a charter with resposibilities derived from Acts of Congress and from DoD Directives. Specifically in the area of travel fund

Neighbourhood safety and leisure-time physical activity among Dutch adults: a multilevel perspective.

PubMed

Kramer, Daniëlle; Maas, Jolanda; Wingen, Marleen; Kunst, Anton E

2013-01-28

Several neighbourhood elements have been found to be related to leisure-time walking and cycling. However, the association with neighbourhood safety remains unclear. This study aimed to assess the association of neighbourhood-level safety with leisure-time walking and cycling among Dutch adults. Data were derived from the national health survey (POLS) 2006-2009, with valid data on 20046 respondents residing in 2127 neighbourhoods. Multilevel logistic regression models were used to examine the association between neighbourhood-level safety (general safety and specific safety components: physical disorder, social disorder, crime-related fear, traffic safety) and residents' engagement in outdoor leisure-time walking and cycling for at least 30 minutes per week. An increase in neighbourhood safety (both general safety and each of the safety components) was significantly associated with an increase in leisure-time cycling participation. Associations were strongest for general safety and among older women. In the general population, neighbourhood safety was not significantly associated with leisure-time walking. However, among younger and older adult men and lower educated individuals, an increase in general safety was associated with a decrease in leisure-time walking participation. In the Netherlands, neighbourhood safety appears to be related to leisure-time cycling but not to walking. Leisure-time cycling may best be encouraged by improving different safety components at once, rather than focusing on one safety aspect such as traffic safety. Special attention is needed for older women.

76 FR 81761 - Mine Safety Disclosure

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... inspections pursuant to miners' complaints.\\18\\ If violations of safety or health standards are found, MSHA... appropriateness of proposed penalties. Other types of cases include miners' complaints of safety- or health-related discrimination and miners' applications for compensation after a mine has been idled by a closure...

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

Assuring the safety of genetically modified (GM) foods: the importance of an holistic, integrative approach.

PubMed

Cockburn, Andrew

2002-09-11

Genes change continuously by natural mutation and recombination enabling man to select and breed crops having the most desirable traits such as yield or flavour. Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops, very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a rigorous safety testing paradigm has been developed for GM crops, which utilises a systematic, stepwise and holistic approach. The resultant science based process, focuses on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness of the transformed crop. In addition, detailed consideration is given to the history and safe use of the parent crop as well as that of the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator which has a known history of safe use. By building a detailed profile on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the significance from a safety perspective, of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop, derived food or feed is as safe as its traditional counterpart. Using this approach in the evaluation of more than 50 GM crops which have been approved worldwide, the conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops. The lack of any adverse effects resulting from the production and consumption of GM crops grown on more than 300 million cumulative acres over the last 5 years supports these safety conclusions.

Gastroprotective Efficacy and Safety Evaluation of Scoparone Derivatives on Experimentally Induced Gastric Lesions in Rodents

PubMed Central

Son, Dong Ju; Lee, Gyung Rak; Oh, Sungil; Lee, Sung Eun; Choi, Won Sik

2015-01-01

This study investigated the gastroprotective efficacy of synthesized scoparone derivatives on experimentally induced gastritis and their toxicological safety. Six scoparone derivatives were synthesized and screened for gastroprotective activities against HCl/ethanol- and indomethacin-induced gastric ulcers in rats. Among these compounds, 5,6,7-trimethoxycoumarin and 6,7,8-trimethoxycoumarin were found to have gastroprotective activity greater than the standard drug rebamipide; 6-methoxy-7,8-methylenedioxycoumarin, 6-methoxy-7,8-(1-methoxy)-methylenedioxycoumarin, 6,7-methylenedioxycoumarin, and 6,7-(1-methoxy)-methylenedioxycoumarin were found to be equipotent or less potent that of rebamipide. Pharmacological studies suggest that the presence of a methoxy group at position C-5 or C-8 of the scoparone’s phenyl ring significantly improves gastroprotective activity, whereas the presence of a dioxolane ring at C-6, C-7, or C-8 was found to have decreased activity. In order to assess toxicological safety, two of the potent gastroprotective scoparone derivatives—5,6,7-trimethoxycoumarin and 6,7,8-trimethoxycoumarin—were examined for their acute toxicity in mice as well as their effect on cytochrome P450 (CYP) enzyme activity. These two compounds showed low acute oral toxicity in adult male and female mice, and caused minimal changes to CYP3A4 and CYP2C9 enzyme activity. These results indicate that compared to other scoparone derivatives, 5,6,7-trimethoxycoumarin and 6,7,8-trimethoxycoumarin can improve gastroprotective effects, and they have low toxicity and minimal effects on drug-metabolizing enzymes. PMID:25781220

76 FR 56242 - Duke Energy Carolinas, LLC; Southern Nuclear Operating Company; Establishment of Atomic Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972... 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... Task Force Report. The contested proceedings in both cases had been terminated at the Atomic Safety and...

[Poliovirus vaccine].

PubMed

Shimizu, Hiroyuki

2012-06-01

To avoid the risk of vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to circulating vaccine-derived polioviruses, an inactivated poliovirus vaccine (IPV) was introduced for routine immunization in a number of countries with a low risk of polio outbreaks. Currently, production and marketing of a standalone conventional IPV and two diphtheria-pertussis-tetanus-IPV (Sabin-derived IPV; sIPV) products have been submitted, and it is expected that the IPV products will be introduced in Japan in the autumn of 2012. At the same time, a decline in the OPV immunization rate became apparent in Japan due to serious public concerns about a remaining risk of VAPP and introduction of IPV in the near future. Therefore, the recent development of polio immunity gaps should be carefully monitored, and surveillance of suspected polio cases and laboratory diagnosis of polioviruses have to be intensified for the transition period from OPV to IPV in Japan. The development of sIPV is one of the most realistic options to introduce affordable IPV to developing countries. In this regard, further clinical studies on its efficacy, safety, and interchangeability of sIPV will be needed after the introduction of the sIPV products, which will be licensed in Japan for the first time in the world.

Development of an encapsulated stem cell-based therapy for diabetes.

PubMed

Tomei, Alice Anna; Villa, Chiara; Ricordi, Camillo

2015-01-01

Islet transplantation can treat the most severe cases of type 1 diabetes but it currently requires deceased donor pancreata as an islet source and chronic immunosuppression to prevent rejection and recurrence of autoimmunity. Stem cell-derived insulin-producing cells may address the shortage of organ donors, whereas cell encapsulation may reduce or eliminate the requirement for immunosuppression, minimizing the risks associated with the islet transplantation procedure, and potentially prolonging graft survival. This review focuses on the design principles for immunoisolation devices and on stem cell differentiation into insulin-producing cell products. The reader will gain understanding of the different types of immunoisolation devices and the key parameters that affect the outcome of the encapsulated graft. Progresses in stem cell differentiation towards mature endocrine islet cells, including the most recent clinical trials and the challenges associated with the application of immunoisolation devices designed for primary islets to stem-cell products, are also discussed. Recent advancements in the field of stem cell-derived islet cell products and immunoisolation strategies hold great promise for type 1 diabetes. However, a combination product including both cells and an immunoisolation strategy still needs to be optimized and tested for safety and efficacy.

Toxicological database of soil and derived products (BDT).

PubMed

Uricchio, Vito Felice

2008-01-01

The Toxicological database of soil and derived products is a project firstly proposed by the Regional Environmental Authority of Apulia. Such a project aims to provide comprehensive and updated information on the regional environmental characteristics, on the pollution state of the regional soil, on the main pollutants and on the reclaim techniques to be used in case of both non-point (agricultural activities) and point (industrial activities) sources of pollution. The project's focus is on the soil pollution because of the fundamental role played by the soil in supporting the biological cycle. Furthermore, the reasons for the project are related both to the reduction of human health risks due to toxic substances ingestion (these substances are present in some ring of the eating chain), and to the recognition of the importance of the groundwater quality safety (primary source of fresh water in many Mediterranean Regions). The essential requirements of a data entry are the following: speed and simplicity of the data entry; reliability and stability of the database structures; speed, easiness and pliability of the queries. Free consultation of the database represents one of the most remarkable advantages coming from the use of an "open" system.

Thesis - keeping the management system {open_quotes}live{close_quotes} and reaching the workforce

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

Primrose, M.J.; Bentley, P.D.; Graaf, G.C. van der

1996-12-31

Previous papers given to SPE conferences have described the Shell Group approach to Safety Management Systems and to Safety Cases. Their extension to HSE MS and to HSE Cases has also been addressed. Since 1984 the Enhanced Safety Management (ESM) programme within Shell companies has led to a significant improvement in the management of safety but it was only when structured management systems (based upon an understanding of the business processes) were introduced that true integration of HSE as a line responsibility became a reality. This paper describes the THESIS software package and the way that management systems have beenmore » made {open_quote}live{close_quote} and how workforce involvement can be demonstrated.« less

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

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

Seitz, Roger; Kumano, Yumiko; Bailey, Lucy

2014-01-09

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

Model-Driven Development of Safety Architectures

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2017-01-01

We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

Pathological classification of human iPSC-derived neural stem/progenitor cells towards safety assessment of transplantation therapy for CNS diseases.

PubMed

Sugai, Keiko; Fukuzawa, Ryuji; Shofuda, Tomoko; Fukusumi, Hayato; Kawabata, Soya; Nishiyama, Yuichiro; Higuchi, Yuichiro; Kawai, Kenji; Isoda, Miho; Kanematsu, Daisuke; Hashimoto-Tamaoki, Tomoko; Kohyama, Jun; Iwanami, Akio; Suemizu, Hiroshi; Ikeda, Eiji; Matsumoto, Morio; Kanemura, Yonehiro; Nakamura, Masaya; Okano, Hideyuki

2016-09-19

The risk of tumorigenicity is a hurdle for regenerative medicine using induced pluripotent stem cells (iPSCs). Although teratoma formation is readily distinguishable, the malignant transformation of iPSC derivatives has not been clearly defined due to insufficient analysis of histology and phenotype. In the present study, we evaluated the histology of neural stem/progenitor cells (NSPCs) generated from integration-free human peripheral blood mononuclear cell (PBMC)-derived iPSCs (iPSC-NSPCs) following transplantation into central nervous system (CNS) of immunodeficient mice. We found that transplanted iPSC-NSPCs produced differentiation patterns resembling those in embryonic CNS development, and that the microenvironment of the final site of migration affected their maturational stage. Genomic instability of iPSCs correlated with increased proliferation of transplants, although no carcinogenesis was evident. The histological classifications presented here may provide cues for addressing potential safety issues confronting regenerative medicine involving iPSCs.

Towards a Three-Dimensional Near-Real Time Cloud Product for Aviation Safety and Weather Diagnoses

NASA Technical Reports Server (NTRS)

Minnis, Patrick; Nguyen, Louis; Palikonda, Rabindra; Spangeberg, Douglas; Nordeen, Michele L.; Yi, Yu-Hong; Ayers, J. Kirk

2004-01-01

Satellite data have long been used for determining the extent of cloud cover and for estimating the properties at the cloud tops. The derived properties can also be used to estimate aircraft icing potential to improve the safety of air traffic in the region. Currently, cloud properties and icing potential are derived in near-real time over the United States of America (USA) from the Geostationary Operational Environmental Satellite GOES) imagers at 75 W and 135 W. Traditionally, the results have been given in two dimensions because of the lack of knowledge about the vertical extent of clouds and the occurrence of overlapping clouds. Aircraft fly in a three-dimensional space and require vertical as well as horizontal information about clouds, their intensity, and their potential for icing. To improve the vertical component of the derived cloud and icing parameters, this paper explores various methods and datasets for filling in the three-dimensional space over the USA with cloud water.

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

Relational Safety and Liberating Training Spaces: An Application with a Focus on Sexual Orientation Issues

ERIC Educational Resources Information Center

Hernandez, Pilar; Rankin, Pressley, IV

2008-01-01

This article describes and discusses a teaching case of a clinical training situation involving a gay marriage and family therapy student working with a same-sex affectional couple. The conceptual pillars of this teaching case, relational safety and liberating spaces, are advanced as illustrations of how the student developed his voice in the…

ELECTRO CONVULSIVE THERAPY IN PRE-PUBERTAL CATATONIA: A CASE STUDY

PubMed Central

Thakur, Anupam; Dutta, S.; Jagadheesan, K.; Sinha, Vinod Kumar

2001-01-01

Depression in prepubertal age group is a relatively rare condition. The presence of life threatening catatonic features call for aggressive treatment. Electro convulsive therapy (ECT) has been described to be effective in these circumstances; however, doubts have been raised about its safety profile. This present case study illustrates the efficacy and safety of ECT in prepubertal catatonia. PMID:21407888

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

Interventional cardiology live case presentations: regulatory considerations.

PubMed

Farb, Andrew; Brown, Sheila A; Wolf, Deborah A; Zuckerman, Bram

2010-10-01

Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. © 2010 Wiley-Liss, Inc.

Interventional cardiology live case presentations regulatory considerations.

PubMed

Farb, Andrew; Brown, Sheila A; Wolf, Deborah A; Zuckerman, Bram

2010-10-01

Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. Copyright © 2010. Published by Elsevier Inc.

Mycotoxin food and feed regulation and the specific case of ochratoxin A: a review of the worldwide status.

PubMed

Duarte, S C; Lino, C M; Pena, A

2010-10-01

Mycotoxins are naturally occurring contaminants whose presence in food- and feedstuffs cannot be completely avoided. The safety and economic impact arising from the commercialization of mycotoxin-contaminated food and feed supply chain is considerable and acknowledged. To protect consumers from mycotoxin-derived health risks, many countries have adopted regulations or guidelines to limit exposure. Similar to regulation for other mycotoxins, the regulatory status of ochratoxin A (OTA) lacks consensus. Although this was one of the first fungal toxins to be subjected to compliance control due to its toxic properties, the conflict between the prime objective of consumer health safeguard and the economic interests of producers and traders remains. One of the key challenges facing policymakers is to balance these conflicting demands and reach consensual regulatory actions or limits. The noteworthy transboundary implications are recognized, both in the case of absence as the unsubstantiated tightening of regulatory limits. This paper scrutinizes the rationales and implications of mycotoxin regulation, with special attention devoted to OTA. In view of the ongoing debate concerning this complex issue, a review of the arguments and suggested strategies proposed by different parties is also made. The specific case of OTA regulation in food and feed is updated and analysed at a European Union and global level.

Are your employees sick of hearing about safety? Ways to improve how safety is communicated at your company

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

Pollari, Roger A.

2008-06-02

Companies that care about their employees care about their employees’ safety and will go to great lengths to communicate the importance of working safely. Monthly safety meetings, creative safety contests, safety websites, sharing lessons learned—safety communicators tend to use a variety of methods to distribute procedures and critical safety information to help employees plan and perform work. However, the safety message falls on deaf ears in some cases, especially when employees feel they’re being overloaded with safety information to the point where they are sick of hearing about it. This poses a conundrum for safety communicators: Should they keep pouringmore » on the safety, or should they lighten up? How much is the right amount?« less

A Review of Research on Procedures for Teaching Safety Skills to Persons with Developmental Disabilities

ERIC Educational Resources Information Center

Dixon, Dennis R.; Bergstrom, Ryan; Smith, Marlena N.; Tarbox, Jonathan

2010-01-01

Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire. A number of studies…

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

29 CFR 1902.31 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR STATE... indicates otherwise: Act means the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq... Secretary of Labor for Occupational Safety and Health. Commencement of a case under section 18(e) of the Act...

10 CFR 50.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... radium-226 to the public health and safety or the common defense and security; and (ii) Before, on, or... as to affect the protection of health and safety against radiation. Cost of service regulation means... waterway, in case of emergency, to protect the public health and safety. Residence within the exclusion...

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of Materials Safety Bulletins Archive September 2016 - Hazardous Waste [PDF] July 2016 - When Should You Report - Include Safety Training in On-The-Job Training [PDF] July 2009 - Eye Injury from Corrosive Organic Solvent

Electrical Safety: Safety and Health for Electrical Trades. Student Manual.

ERIC Educational Resources Information Center

Fowler, Thaddeus W.; Miles, Karen K.

This document is designed to teach learners in secondary and postsecondary electrical trades courses to recognize, evaluate, and control hazards associated with electrical work, The manual's eight sections each include some or all of the following components: instructional text; definitions; case studies illustrating key safety considerations;…

National Transportation Safety Board Safety Study: Safety At Passive Grade Crossings. Volume 2: Case Summaries

DOT National Transportation Integrated Search

1998-07-07

More than 4,000 accidents have occurred at the nation's active and passive grade crossings each year from 1991 through 1996. Many of the accidents at active crossings have involved highway vehicle drivers who did not comply with train-activated warni...

Repurposing historical control clinical trial data to provide safety context.

PubMed

Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

2016-02-01

Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

Boundary conditions for developing a safety concept for an exothermal reaction.

PubMed

Hauptmanns, Ulrich

2007-09-05

Kinetic calculations for an example exothermal chemical process, the production of TCB, are carried out. They address both parameter uncertainties and random failures of the cooling system. In this way, they enable one to establish comprehensive boundary conditions for a safety system in terms of unavailability, the quantities of the undesired by-product (TCDD) produced and the times available before a required intervention, if a pre-determined quantity of TCDD is tolerated. It is shown that accounting for stochastic effects and uncertainties derived from insufficient knowledge provides a broader and more realistic knowledge base for devising a viable safety concept.

Fatal hypersensitivity reaction to an oral spray of flurbiprofen: a case report.

PubMed

Calapai, G; Imbesi, S; Cafeo, V; Ventura Spagnolo, E; Minciullo, P L; Caputi, A P; Gangemi, S; Milone, L

2013-08-01

Safety of the anti-inflammatory drug flurbiprofen is comparable with that of other non-steroidal anti-inflammatory drugs of the propionic acid class, which are commonly associated with gastrointestinal and renal side effects. Here we report a case of a fatal hypersensitivity reaction to an oral spray of flurbiprofen taken for sore throat. A 29-year-old man came to the emergency care unit reporting sore throat with an intense burning sensation associated with fever. Pharyngotonsillitis was diagnosed, and local treatment with oral flurbiprofen spray was prescribed. Immediately after using the spray, the patient experienced a severe reaction characterized by serious dyspnoea, followed by death. The cause of death was heart failure with acute asphyxia from oedema of the glottis. The cause of death was concluded to be hypersensitivity to flurbiprofen spray. Oral propionic acid derivatives have been associated with a relatively high frequency of allergic reactions. However, allergy to flurbiprofen has rarely been documented. Scientific literature reports two relevant cases of hypersensitivity reaction to flurbiprofen: in one case, a patient presented with a maculopapular rash 48 h after having taken oral flurbiprofen followed by angio-oedema and hypotension. In another case, a single oral dose of flurbiprofen caused itching and swelling around the eyes, redness and increased lacrimation. We describe, for the first time, a fatal case of hypersensitivity reaction to flurbiprofen oral spray. Hypersensitivity reactions to flurbiprofen are infrequent; however, health professionals should be aware of potential adverse reactions, even during topical administration as oral spray. © 2013 John Wiley & Sons Ltd.

Balancing Ethical Pros and Cons of Stem Cell Derived Gametes.

PubMed

Segers, Seppe; Mertes, Heidi; de Wert, Guido; Dondorp, Wybo; Pennings, Guido

2017-07-01

In this review we aim to provide an overview of the most important ethical pros and cons of stem cell derived gametes (SCD-gametes), as a contribution to the debate about reproductive tissue engineering. Derivation of gametes from stem cells holds promising applications both for research and for clinical use in assisted reproduction. We explore the ethical issues connected to gametes derived from embryonic stem cells (both patient specific and non-patient specific) as well as those related to gametes derived from induced pluripotent stem cells. The technology of SCD-gametes raises moral concerns of how reproductive autonomy relates to issues of embryo destruction, safety, access, and applications beyond clinical infertility.

Safety Studies for Use of Adipose Tissue‐Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial

PubMed Central

Riester, Scott M.; Denbeigh, Janet M.; Lin, Yang; Jones, Dakota L.; de Mooij, Tristan; Lewallen, Eric A.; Nie, Hai; Paradise, Christopher R.; Radel, Darcie J.; Dudakovic, Amel; Camilleri, Emily T.; Larson, Dirk R.; Qu, Wenchun; Krych, Aaron J.; Frick, Matthew A.; Im, Hee‐Jeong; Dietz, Allan B.; Smith, Jay

2016-01-01

Abstract Adipose‐derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra‐articular joint space. Culture‐expanded human AMSCs grown in human platelet‐lysate were delivered via intra‐articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x‐ray, magnetic resonance imaging, and histopathology. Intra‐articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra‐articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910–922 PMID:28297568

Self-sufficiency, free trade and safety.

PubMed

Rautonen, Jukka

2010-01-01

The relationship between free trade, self-sufficiency and safety of blood and blood components has been a perennial discussion topic in the blood service community. Traditionally, national self-sufficiency has been perceived as the ultimate goal that would also maximize safety. However, very few countries are, or can be, truly self-sufficient when self-sufficiency is understood correctly to encompass the whole value chain from the blood donor to the finished product. This is most striking when plasma derived medicines are considered. Free trade of blood products, or competition, as such can have a negative or positive effect on blood safety. Further, free trade of equipment and reagents and several plasma medicines is actually necessary to meet the domestic demand for blood and blood derivatives in most countries. Opposing free trade due to dogmatic reasons is not in the best interest of any country and will be especially harmful for the developing world. Competition between blood services in the USA has been present for decades. The more than threefold differences in blood product prices between European blood services indicate that competition is long overdue in Europe, too. This competition should be welcomed but carefully and proactively regulated to avoid putting safe and secure blood supply at risk. Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

The role of production and teamwork practices in construction safety: a cognitive model and an empirical case study.

PubMed

Mitropoulos, Panagiotis Takis; Cupido, Gerardo

2009-01-01

In construction, the challenge for researchers and practitioners is to develop work systems (production processes and teams) that can achieve high productivity and high safety at the same time. However, construction accident causation models ignore the role of work practices and teamwork. This study investigates the mechanisms by which production and teamwork practices affect the likelihood of accidents. The paper synthesizes a new model for construction safety based on the cognitive perspective (Fuller's Task-Demand-Capability Interface model, 2005) and then presents an exploratory case study. The case study investigates and compares the work practices of two residential framing crews: a 'High Reliability Crew' (HRC)--that is, a crew with exceptional productivity and safety over several years, and an average performing crew from the same company. The model explains how the production and teamwork practices generate the work situations that workers face (the task demands) and affect the workers ability to cope (capabilities). The case study indicates that the work practices of the HRC directly influence the task demands and match them with the applied capabilities. These practices were guided by the 'principle' of avoiding errors and rework and included work planning and preparation, work distribution, managing the production pressures, and quality and behavior monitoring. The Task Demand-Capability model links construction research to a cognitive model of accident causation and provides a new way to conceptualize safety as an emergent property of the production practices and teamwork processes. The empirical evidence indicates that the crews' work practices and team processes strongly affect the task demands, the applied capabilities, and the match between demands and capabilities. The proposed model and the exploratory case study will guide further discovery of work practices and teamwork processes that can increase both productivity and safety in construction operations. Such understanding will enable training of construction foremen and crews in these practices to systematically develop high reliability crews.

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

Neurovirulence safety testing of mumps vaccines--historical perspective and current status.

PubMed

Rubin, S A; Afzal, M A

2011-04-05

Many live, attenuated viral vaccines are derived from wild type viruses with known neurovirulent properties. To assure the absence of residual neurotoxicity, pre-clinical neurovirulence safety testing of candidate vaccines is performed. For mumps virus, a highly neurotropic virus, neurovirulence safety testing is performed in monkeys. However, laboratory studies suggest an inability of this test to correctly discern among virus strains of varying neurovirulence potential in man, and, further, some vaccines found to be neuroattenuated in monkeys were later found to be neurovirulent in humans when administered in large numbers. Over the past decade, concerted efforts have been made to replace monkey-based neurovirulence safety testing with more informative, alternative methods. This review summarizes the current status of mumps vaccine neurovirulence safety testing and insights into models currently approved and those under development. Published by Elsevier Ltd.

Stories from the Sharp End: Case Studies in Safety Improvement

PubMed Central

McCarthy, Douglas; Blumenthal, David

2006-01-01

Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

PubMed

Balka, Ellen; Tolar, Marianne; Coates, Shannon; Whitehouse, Sandra

2013-12-01

Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Behavior-based safety on construction sites: a case study.

PubMed

Choudhry, Rafiq M

2014-09-01

This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in unsafe behaviors and significant increases in safe behaviors. The results of this case study showed that an approach based on goal setting, feedback, and an effective measure of safety behavior if properly applied by committed management, can improve safety performance significantly in construction site environments. The results proved that the BBS management technique can be applied to any country's culture, showing that it would be a good approach for improving the safety of front-line workers and that it has industry wide application for ongoing construction projects. Copyright © 2014 Elsevier Ltd. All rights reserved.

Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

PubMed

Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

2014-01-01

A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

Safety, efficacy and efficiency of laser-assisted IVF in subfertile mutant mouse strains

PubMed Central

Li, Ming-Wen; Kinchen, Kristy L; Vallelunga, Jadine M; Young, Diana L; Wright, Kaleb D K; Gorano, Lisa N; Wasson, Katherine; Lloyd, K C Kent

2013-01-01

In the present report we studied the safety, efficacy and efficiency of using an infrared laser to facilitate IVF by assessing fertilization, development and birth rates after laser-zona drilling (LZD) in 30 subfertile genetically modified (GM) mouse lines. We determined that LZD increased the fertilization rate four to ten times that of regular IVF, thus facilitating the derivation of 26 of 30 (86.7%) GM mouse lines. Cryopreserved two-cell stage embryos derived by LZD-assisted IVF were recovered and developed to blastocysts in vitro at the same rate as frozen–thawed embryos derived by regular IVF. Surprisingly after surgical transfer to pseudopregnant recipients the birth rate of embryos derived by LZD-assisted IVF was significantly lower than that of embryos derived by regular IVF. However this result could be completely mitigated by the addition of 0.25 M sucrose to the culture medium during LZD which caused the oocyte to shrink in volume relative to the perivitelline space. By increasing the distance from the laser target site on the zona pellucida, we hypothesize that the hyperosmotic effect of sucrose reduced the potential for laser-induced cytotoxic thermal damage to the underlying oocytes. With appropriate preparation and cautious application, our results indicate that LZD-assisted IVF is a safe, efficacious and efficient assisted reproductive technology for deriving mutant mouse lines with male factor infertility and subfertility caused by sperm–zona penetration defects. PMID:23315689

Development of a Reality-Based Multimedia Case Study Teaching Method and Its Effect on Students' Planned Food Safety Behaviors

ERIC Educational Resources Information Center

Alberts, Caitlin M.; Stevenson, Clinton D.

2017-01-01

There is opportunity to decrease the frequency of foodborne illnesses by improving food safety competencies and planned behaviors of college students before they begin careers in the food industry. The objectives of this study were to (1) develop a multimedia case study teaching method that provides real world context for food science education;…

Vaccination of metastatic melanoma patients with autologous dendritic cell (DC) derived-exosomes: results of thefirst phase I clinical trial

PubMed Central

Escudier, Bernard; Dorval, Thierry; Chaput, Nathalie; André, Fabrice; Caby, Marie-Pierre; Novault, Sophie; Flament, Caroline; Leboulaire, Christophe; Borg, Christophe; Amigorena, Sebastian; Boccaccio, Catherine; Bonnerot, Christian; Dhellin, Olivier; Movassagh, Mojgan; Piperno, Sophie; Robert, Caroline; Serra, Vincent; Valente, Nancy; Le Pecq, Jean-Bernard; Spatz, Alain; Lantz, Olivier; Tursz, Thomas; Angevin, Eric; Zitvogel, Laurence

2005-01-01

Background DC derived-exosomes are nanomeric vesicles harboring functional MHC/peptide complexes capable of promoting T cell immune responses and tumor rejection. Here we report the feasability and safety of the first Phase I clinical trial using autologous exosomes pulsed with MAGE 3 peptides for the immunization of stage III/IV melanoma patients. Secondary endpoints were the monitoring of T cell responses and the clinical outcome. Patients and methods Exosomes were purified from day 7 autologous monocyte derived-DC cultures. Fifteen patients fullfilling the inclusion criteria (stage IIIB and IV, HLA-A1+, or -B35+ and HLA-DPO4+ leukocyte phenotype, tumor expressing MAGE3 antigen) were enrolled from 2000 to 2002 and received four exosome vaccinations. Two dose levels of either MHC class II molecules (0.13 versus 0.40 × 1014 molecules) or peptides (10 versus 100 μg/ml) were tested. Evaluations were performed before and 2 weeks after immunization. A continuation treatment was performed in 4 cases of non progression. Results The GMP process allowed to harvest about 5 × 1014 exosomal MHC class II molecules allowing inclusion of all 15 patients. There was no grade II toxicity and the maximal tolerated dose was not achieved. One patient exhibited a partial response according to the RECIST criteria. This HLA-B35+/A2+ patient vaccinated with A1/B35 defined CTL epitopes developed halo of depigmentation around naevi, a MART1-specific HLA-A2 restricted T cell response in the tumor bed associated with progressive loss of HLA-A2 and HLA-BC molecules on tumor cells during therapy with exosomes. In addition, one minor, two stable and one mixed responses were observed in skin and lymph node sites. MAGE3 specific CD4+ and CD8+ T cell responses could not be detected in peripheral blood. Conclusion The first exosome Phase I trial highlighted the feasibility of large scale exosome production and the safety of exosome administration. PMID:15740633

Improvements in medical quality and patient safety through implementation of a case bundle management strategy in a large outpatient blood collection center.

PubMed

Zhao, Shuzhen; He, Lujia; Feng, Chenchen; He, Xiaoli

2018-06-01

Laboratory errors in blood collection center (BCC) are most common in the preanalytical phase. It is, therefore, of vital importance for administrators to take measures to improve healthcare quality and patient safety.In 2015, a case bundle management strategy was applied in a large outpatient BCC to improve its medical quality and patient safety.Unqualified blood sampling, complications, patient waiting time, largest number of patients waiting during peak hours, patient complaints, and patient satisfaction were compared over the period from 2014 to 2016.The strategy reduced unqualified blood sampling, complications, patient waiting time, largest number of patients waiting during peak hours, and patient complaints, while improving patient satisfaction.This strategy was effective in improving BCC healthcare quality and patient safety.

Neighbourhood safety and leisure-time physical activity among Dutch adults: a multilevel perspective

PubMed Central

2013-01-01

Background Several neighbourhood elements have been found to be related to leisure-time walking and cycling. However, the association with neighbourhood safety remains unclear. This study aimed to assess the association of neighbourhood-level safety with leisure-time walking and cycling among Dutch adults. Methods Data were derived from the national health survey (POLS) 2006–2009, with valid data on 20046 respondents residing in 2127 neighbourhoods. Multilevel logistic regression models were used to examine the association between neighbourhood-level safety (general safety and specific safety components: physical disorder, social disorder, crime-related fear, traffic safety) and residents’ engagement in outdoor leisure-time walking and cycling for at least 30 minutes per week. Results An increase in neighbourhood safety (both general safety and each of the safety components) was significantly associated with an increase in leisure-time cycling participation. Associations were strongest for general safety and among older women. In the general population, neighbourhood safety was not significantly associated with leisure-time walking. However, among younger and older adult men and lower educated individuals, an increase in general safety was associated with a decrease in leisure-time walking participation. Conclusions In the Netherlands, neighbourhood safety appears to be related to leisure-time cycling but not to walking. Leisure-time cycling may best be encouraged by improving different safety components at once, rather than focusing on one safety aspect such as traffic safety. Special attention is needed for older women. PMID:23356476

[Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-10-01

The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.

Explicit Nonlinear Finite Element Geometric Analysis of Parabolic Leaf Springs under Various Loads

PubMed Central

Kong, Y. S.; Omar, M. Z.; Chua, L. B.; Abdullah, S.

2013-01-01

This study describes the effects of bounce, brake, and roll behavior of a bus toward its leaf spring suspension systems. Parabolic leaf springs are designed based on vertical deflection and stress; however, loads are practically derived from various modes especially under harsh road drives or emergency braking. Parabolic leaf springs must sustain these loads without failing to ensure bus and passenger safety. In this study, the explicit nonlinear dynamic finite element (FE) method is implemented because of the complexity of experimental testing A series of load cases; namely, vertical push, wind-up, and suspension roll are introduced for the simulations. The vertical stiffness of the parabolic leaf springs is related to the vehicle load-carrying capability, whereas the wind-up stiffness is associated with vehicle braking. The roll stiffness of the parabolic leaf springs is correlated with the vehicle roll stability. To obtain a better bus performance, two new parabolic leaf spring designs are proposed and simulated. The stress level during the loadings is observed and compared with its design limit. Results indicate that the newly designed high vertical stiffness parabolic spring provides the bus a greater roll stability and a lower stress value compared with the original design. Bus safety and stability is promoted, as well as the load carrying capability. PMID:24298209

Requirements Flowdown for Prognostics and Health Management

NASA Technical Reports Server (NTRS)

Goebel, Kai; Saxena, Abhinav; Roychoudhury, Indranil; Celaya, Jose R.; Saha, Bhaskar; Saha, Sankalita

2012-01-01

Prognostics and Health Management (PHM) principles have considerable promise to change the game of lifecycle cost of engineering systems at high safety levels by providing a reliable estimate of future system states. This estimate is a key for planning and decision making in an operational setting. While technology solutions have made considerable advances, the tie-in into the systems engineering process is lagging behind, which delays fielding of PHM-enabled systems. The derivation of specifications from high level requirements for algorithm performance to ensure quality predictions is not well developed. From an engineering perspective some key parameters driving the requirements for prognostics performance include: (1) maximum allowable Probability of Failure (PoF) of the prognostic system to bound the risk of losing an asset, (2) tolerable limits on proactive maintenance to minimize missed opportunity of asset usage, (3) lead time to specify the amount of advanced warning needed for actionable decisions, and (4) required confidence to specify when prognosis is sufficiently good to be used. This paper takes a systems engineering view towards the requirements specification process and presents a method for the flowdown process. A case study based on an electric Unmanned Aerial Vehicle (e-UAV) scenario demonstrates how top level requirements for performance, cost, and safety flow down to the health management level and specify quantitative requirements for prognostic algorithm performance.

Explicit nonlinear finite element geometric analysis of parabolic leaf springs under various loads.

PubMed

Kong, Y S; Omar, M Z; Chua, L B; Abdullah, S

2013-01-01

This study describes the effects of bounce, brake, and roll behavior of a bus toward its leaf spring suspension systems. Parabolic leaf springs are designed based on vertical deflection and stress; however, loads are practically derived from various modes especially under harsh road drives or emergency braking. Parabolic leaf springs must sustain these loads without failing to ensure bus and passenger safety. In this study, the explicit nonlinear dynamic finite element (FE) method is implemented because of the complexity of experimental testing A series of load cases; namely, vertical push, wind-up, and suspension roll are introduced for the simulations. The vertical stiffness of the parabolic leaf springs is related to the vehicle load-carrying capability, whereas the wind-up stiffness is associated with vehicle braking. The roll stiffness of the parabolic leaf springs is correlated with the vehicle roll stability. To obtain a better bus performance, two new parabolic leaf spring designs are proposed and simulated. The stress level during the loadings is observed and compared with its design limit. Results indicate that the newly designed high vertical stiffness parabolic spring provides the bus a greater roll stability and a lower stress value compared with the original design. Bus safety and stability is promoted, as well as the load carrying capability.

Prediction and optimization of the recovery rate in centrifugal separation of platelet-rich plasma (PRP)

NASA Astrophysics Data System (ADS)

Piao, Linfeng; Park, Hyungmin; Jo, Chris

2016-11-01

We present a theoretical model of the recovery rate of platelet and white blood cell in the process of centrifugal separation of platelet-rich plasma (PRP). For the practically used conditions in the field, the separation process is modeled as a one-dimensional particle sedimentation; a quasi-linear partial differential equation is derived based on the kinematic-wave theory. This is solved to determine the interface positions between supernatant-suspension and suspension-sediment, used to estimate the recovery rate of the plasma. While correcting the Brown's hypothesis (1989) claiming that the platelet recovery is linearly proportional to that of plasma, we propose a new correlation model for prediction of the platelet recovery, which is a function of the volume of whole blood, centrifugal acceleration and time. For a range of practical parameters, such as hematocrit, volume of whole blood and centrifugation (time and acceleration), the predicted recovery rate shows a good agreement with available clinical data. We propose that this model is further used to optimize the preparation method of PRP that satisfies the customized case. Supported by a Grant (MPSS-CG-2016-02) through the Disaster and Safety Management Institute funded by Ministry of Public Safety and Security of Korean government.

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

Infrastructure stability surveillance with high resolution InSAR

NASA Astrophysics Data System (ADS)

Balz, Timo; Düring, Ralf

2017-02-01

The construction of new infrastructure in largely unknown and difficult environments, as it is necessary for the construction of the New Silk Road, can lead to a decreased stability along the construction site, leading to an increase in landslide risk and deformation caused by surface motion. This generally requires a thorough pre-analysis and consecutive surveillance of the deformation patterns to ensure the stability and safety of the infrastructure projects. Interferometric SAR (InSAR) and the derived techniques of multi-baseline InSAR are very powerful tools for a large area observation of surface deformation patterns. With InSAR and deriver techniques, the topographic height and the surface motion can be estimated for large areas, making it an ideal tool for supporting the planning, construction, and safety surveillance of new infrastructure elements in remote areas.

Differentiation and Characterization of Dopaminergic Neurons From Baboon Induced Pluripotent Stem Cells.

PubMed

Grow, Douglas A; Simmons, DeNard V; Gomez, Jorge A; Wanat, Matthew J; McCarrey, John R; Paladini, Carlos A; Navara, Christopher S

2016-09-01

: The progressive death of dopamine producing neurons in the substantia nigra pars compacta is the principal cause of symptoms of Parkinson's disease (PD). Stem cells have potential therapeutic use in replacing these cells and restoring function. To facilitate development of this approach, we sought to establish a preclinical model based on a large nonhuman primate for testing the efficacy and safety of stem cell-based transplantation. To this end, we differentiated baboon fibroblast-derived induced pluripotent stem cells (biPSCs) into dopaminergic neurons with the application of specific morphogens and growth factors. We confirmed that biPSC-derived dopaminergic neurons resemble those found in the human midbrain based on cell type-specific expression of dopamine markers TH and GIRK2. Using the reverse transcriptase quantitative polymerase chain reaction, we also showed that biPSC-derived dopaminergic neurons express PAX6, FOXA2, LMX1A, NURR1, and TH genes characteristic of this cell type in vivo. We used perforated patch-clamp electrophysiology to demonstrate that biPSC-derived dopaminergic neurons fired spontaneous rhythmic action potentials and high-frequency action potentials with spike frequency adaption upon injection of depolarizing current. Finally, we showed that biPSC-derived neurons released catecholamines in response to electrical stimulation. These results demonstrate the utility of the baboon model for testing and optimizing the efficacy and safety of stem cell-based therapeutic approaches for the treatment of PD. Functional dopamine neurons were produced from baboon induced pluripotent stem cells, and their properties were compared to baboon midbrain cells in vivo. The baboon has advantages as a clinically relevant model in which to optimize the efficacy and safety of stem cell-based therapies for neurodegenerative diseases, such as Parkinson's disease. Baboons possess crucial neuroanatomical and immunological similarities to humans, and baboon pluripotent stem cells can be differentiated into functional neurons that mimic those in the human brain, thus laying the foundation for the utility of the baboon model for evaluating stem cell therapies. ©AlphaMed Press.

Continuous Improvement and the Safety Case for the Waste Isolation Pilot Plant Geologic Repository - 13467

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

Van Luik, Abraham; Patterson, Russell; Nelson, Roger

2013-07-01

The Waste Isolation Pilot Plant (WIPP) is a geologic repository 2150 feet (650 m) below the surface of the Chihuahuan desert near Carlsbad, New Mexico. WIPP permanently disposes of transuranic waste from national defense programs. Every five years, the U.S. Department of Energy (DOE) submits an application to the U.S. Environmental Protection Agency (EPA) to request regulatory-compliance re-certification of the facility for another five years. Every ten years, DOE submits an application to the New Mexico Environment Department (NMED) for the renewal of its hazardous waste disposal permit. The content of the applications made by DOE to the EPA formore » re-certification, and to the NMED for permit-renewal, reflect any optimization changes made to the facility, with regulatory concurrence if warranted by the nature of the change. DOE points to such changes as evidence for its having taken seriously its 'continuous improvement' operations and management philosophy. Another opportunity for continuous improvement is to look at any delta that may exist between the re-certification and re-permitting cases for system safety and the consensus advice on the nature and content of a safety case as being developed and published by the Nuclear Energy Agency's Integration Group for the Safety Case (IGSC) expert group. DOE at WIPP, with the aid of its Science Advisor and teammate, Sandia National Laboratories, is in the process of discerning what can be done, in a reasonably paced and cost-conscious manner, to continually improve the case for repository safety that is being made to the two primary regulators on a recurring basis. This paper will discuss some aspects of that delta and potential paths forward to addressing them. (authors)« less

Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis.

PubMed

Xue, Fei; Ma, Haijun; Stehman-Breen, Catherine; Haller, Christine; Katz, Leonid; Wagman, Rachel B; Critchlow, Cathy W

2013-10-01

To describe the rationale and methods for a prospective, open-cohort study assessing the long-term safety of Prolia(®) for treatment of postmenopausal osteoporosis (PMO) in postmarketing settings. Data will be derived from United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) national registries. Observation will begin on the date of first Prolia(®) regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic fracture, or osteoporosis treatment. Exposure to Prolia(®) and bisphosphonates will be updated during follow-up; exposure cohorts will be defined based on patient-years during which patients are on- or post-treatment. Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy. Medical review will confirm selected potential cases of ONJ and AFF. Incidence rates (IRs) of AEs will be described overall and for exposure cohorts; multivariate Cox proportional hazard regression models will compare IRs of AEs across exposure cohorts. Utilization patterns of Prolia(®) for approved, and unapproved indications will be described. This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population. The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time. © 2013 Amgen Inc. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Concerns of Quality and Safety in Public Domain Surgical Education Videos: An Assessment of the Critical View of Safety in Frequently Used Laparoscopic Cholecystectomy Videos.

PubMed

Deal, Shanley B; Alseidi, Adnan A

2017-12-01

Online videos are among the most common resources for case preparation. Using crowd sourcing, we evaluated the relationship between operative quality and viewing characteristics of online laparoscopic cholecystectomy videos. We edited 160 online videos of laparoscopic cholecystectomy to 60 seconds or less. Crowd workers (CW) rated videos using Global Objective Assessment of Laparoscopic Skills (GOALS), the critical view of safety (CVS) criteria, and assigned overall pass/fail ratings if CVS was achieved; linear mixed effects models derived average ratings. Views, likes, dislikes, subscribers, and country were recorded for subset analysis of YouTube videos. Spearman correlation coefficient (SCC) assessed correlation between performance measures. One video (0.06%) achieved a passing CVS score of ≥5; 23%, ≥4; 44%, ≥3; 79%, ≥2; and 100% ≥1. Pass/fail ratings correlated to CVS, SCC 0.95 (p < 0.001) and to GOALS, SCC 0.79 (p < 0.001). YouTube videos (n = 139) with higher views, likes, or subscribers did not correlate with better quality. The average CVS and GOALS scores were no different for videos with >20,000 views (22%) compared with those with <20,000 (78%). There is an incredibly low frequency of CVS and average GOALS technical performance in frequently used online surgical videos of LC. Favorable characteristics, such as number of views or likes, do not translate to higher quality. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

PubMed

Campbell, Emma Jean; Turpin, Merrill June

2010-12-01

Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

Verification and Validation in a Rapid Software Development Process

NASA Technical Reports Server (NTRS)

Callahan, John R.; Easterbrook, Steve M.

1997-01-01

The high cost of software production is driving development organizations to adopt more automated design and analysis methods such as rapid prototyping, computer-aided software engineering (CASE) tools, and high-level code generators. Even developers of safety-critical software system have adopted many of these new methods while striving to achieve high levels Of quality and reliability. While these new methods may enhance productivity and quality in many cases, we examine some of the risks involved in the use of new methods in safety-critical contexts. We examine a case study involving the use of a CASE tool that automatically generates code from high-level system designs. We show that while high-level testing on the system structure is highly desirable, significant risks exist in the automatically generated code and in re-validating releases of the generated code after subsequent design changes. We identify these risks and suggest process improvements that retain the advantages of rapid, automated development methods within the quality and reliability contexts of safety-critical projects.

Implementing Stakeholders' Access to Expertise: Experimenting on Nuclear Installations' Safety Cases - 12160

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

Gilli, Ludivine; Charron, Sylvie

2012-07-01

In 2009 and 2010, the Institute for Nuclear Safety and Radiation Protection (IRSN) led two pilot actions dealing with nuclear installations' safety cases. One concerned the periodical review of the French 900 MWe nuclear reactors, the other concerned the decommissioning of a workshop located on the site of Areva's La Hague fuel-reprocessing plant site in Northwestern France. The purpose of both these programs was to test ways for IRSN and a small number of stakeholders (Non-Governmental Organizations (NGOs) members, local elected officials, etc.) to engage in technical discussions. The discussions were intended to enable the stakeholders to review future applicationsmore » and provide valuable input. The test cases confirmed there is a definite challenge in successfully opening a meaningful dialogue to discuss technical issues, in particular the fact that most expertise reports were not public and the conflict that exists between the contrary demands of transparency and confidentiality of information. The test case also confirmed there are ways to further improvement of stakeholders' involvement. (authors)« less

Modeling the effects of AADT on predicting multiple-vehicle crashes at urban and suburban signalized intersections.

PubMed

Chen, Chen; Xie, Yuanchang

2016-06-01

Annual Average Daily Traffic (AADT) is often considered as a main covariate for predicting crash frequencies at urban and suburban intersections. A linear functional form is typically assumed for the Safety Performance Function (SPF) to describe the relationship between the natural logarithm of expected crash frequency and covariates derived from AADTs. Such a linearity assumption has been questioned by many researchers. This study applies Generalized Additive Models (GAMs) and Piecewise Linear Negative Binomial (PLNB) regression models to fit intersection crash data. Various covariates derived from minor-and major-approach AADTs are considered. Three different dependent variables are modeled, which are total multiple-vehicle crashes, rear-end crashes, and angle crashes. The modeling results suggest that a nonlinear functional form may be more appropriate. Also, the results show that it is important to take into consideration the joint safety effects of multiple covariates. Additionally, it is found that the ratio of minor to major-approach AADT has a varying impact on intersection safety and deserves further investigations. Copyright © 2016 Elsevier Ltd. All rights reserved.

Synthetic virus seeds for improved vaccine safety: Genetic reconstruction of poliovirus seeds for a PER.C6 cell based inactivated poliovirus vaccine.

PubMed

Sanders, Barbara P; Edo-Matas, Diana; Papic, Natasa; Schuitemaker, Hanneke; Custers, Jerome H H V

2015-10-13

Safety of vaccines can be compromised by contamination with adventitious agents. One potential source of adventitious agents is a vaccine seed, typically derived from historic clinical isolates with poorly defined origins. Here we generated synthetic poliovirus seeds derived from chemically synthesized DNA plasmids encoding the sequence of wild-type poliovirus strains used in marketed inactivated poliovirus vaccines. The synthetic strains were phenotypically identical to wild-type polioviruses as shown by equivalent infectious titers in culture supernatant and antigenic content, even when infection cultures are scaled up to 10-25L bioreactors. Moreover, the synthetic seeds were genetically stable upon extended passaging on the PER.C6 cell culture platform. Use of synthetic seeds produced on the serum-free PER.C6 cell platform ensures a perfectly documented seed history and maximum control over starting materials. It provides an opportunity to maximize vaccine safety which increases the prospect of a vaccine end product that is free from adventitious agents. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

PubMed

Bauer, Kristen; Esquilin, Ines O; Cornier, Alberto Santiago; Thomas, Stephen J; Quintero Del Rio, Ana I; Bertran-Pasarell, Jorge; Morales Ramirez, Javier O; Diaz, Clemente; Carlo, Simon; Eckels, Kenneth H; Tournay, Elodie; Toussaint, Jean-Francois; De La Barrera, Rafael; Fernandez, Stefan; Lyons, Arthur; Sun, Wellington; Innis, Bruce L

2015-09-01

This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858. © The American Society of Tropical Medicine and Hygiene.

Reliability considerations for the total strain range version of strainrange partitioning

NASA Technical Reports Server (NTRS)

Wirsching, P. H.; Wu, Y. T.

1984-01-01

A proposed total strainrange version of strainrange partitioning (SRP) to enhance the manner in which SRP is applied to life prediction is considered with emphasis on how advanced reliability technology can be applied to perform risk analysis and to derive safety check expressions. Uncertainties existing in the design factors associated with life prediction of a component which experiences the combined effects of creep and fatigue can be identified. Examples illustrate how reliability analyses of such a component can be performed when all design factors in the SRP model are random variables reflecting these uncertainties. The Rackwitz-Fiessler and Wu algorithms are used and estimates of the safety index and the probablity of failure are demonstrated for a SRP problem. Methods of analysis of creep-fatigue data with emphasis on procedures for producing synoptic statistics are presented. An attempt to demonstrate the importance of the contribution of the uncertainties associated with small sample sizes (fatique data) to risk estimates is discussed. The procedure for deriving a safety check expression for possible use in a design criteria document is presented.

Treatment of toxicity from amphetamines, related derivatives, and analogues: a systematic clinical review.

PubMed

Richards, John R; Albertson, Timothy E; Derlet, Robert W; Lange, Richard A; Olson, Kent R; Horowitz, B Zane

2015-05-01

Overdose of amphetamine, related derivatives, and analogues (ARDA) continues to be a serious worldwide health problem. Patients frequently present to the hospital and require treatment for agitation, psychosis, and hyperadrenegic symptoms leading to pathologic sequelae and mortality. To review the pharmacologic treatment of agitation, psychosis, and the hyperadrenergic state resulting from ARDA toxicity. MEDLINE, PsycINFO, and the Cochrane Library were searched from inception to September 2014. Articles on pharmacologic treatment of ARDA-induced agitation, psychosis, and hyperadrenergic symptoms were selected. Evidence was graded using Oxford CEBM. Treatment recommendations were compared to current ACCF/AHA guidelines. The search resulted in 6082 articles with 81 eligible treatment involving 835 human subjects. There were 6 high-quality studies supporting the use of antipsychotics and benzodiazepines for control of agitation and psychosis. There were several case reports detailing the successful use of dexmedetomidine for this indication. There were 9 high-quality studies reporting the overall safety and efficacy of β-blockers for control of hypertension and tachycardia associated with ARDA. There were 3 high-quality studies of calcium channel blockers. There were 2 level I studies of α-blockers and a small number of case reports for nitric oxide-mediated vasodilators. High-quality evidence for pharmacologic treatment of overdose from ARDA is limited but can help guide management of acute agitation, psychosis, tachycardia, and hypertension. The use of butyrophenone and later-generation antipsychotics, benzodiazepines, and β-blockers is recommended based on existing evidence. Future randomized prospective trials are needed to evaluate new agents and further define treatment of these patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Learning Road Safety Skills in the Classroom

ERIC Educational Resources Information Center

Brown, Freddy Jackson; Gillard, Duncan

2009-01-01

This case study demonstrates the effectiveness of a classroom based learning programme in the acquisition of road safety skills. The participant, a child with severe learning disabilities, was taught road safety behaviours in the classroom with the aid of photograph cards. When he had mastered these skills in the classroom, he returned to the…

Safety in the Elementary Science Classroom.

ERIC Educational Resources Information Center

National Science Teachers Association, Arlington, VA.

This guide gives elementary school teachers suggestions for providing a safe environment for their students and covers general safety concerns in the science classroom. Information is printed in a flip chart format for easy reference. Safety areas covered include: (1) In Case of Accident; (2) Eye Protection; (3) Plants in the Classroom; (4) First…

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of ? Click Here! Personnel Safety Personnel MSD EH&S Manager Martin Neitzel 66-242 ext. 6169 MLNeitzel Schwartz 66-250E ext. 4957 nischwartz@lbl.gov Lab Safety Advisory Committee Rep Robert Kaindl 2-354 ext

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of ? Click Here! Commitment to Safety at MSD In the Materials Sciences Division, our mission is to do world -class science in a safe environment. We proudly support a strong safety culture in which all staff and

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

Chemical plant innovative safety investments decision-support methodology.

PubMed

Reniers, G L L; Audenaert, A

2009-01-01

This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

Injuries Associated With Hazards Involving Motor Vehicle Batteries

DOT National Transportation Integrated Search

1997-07-01

National Highway Traffic Safety Administration's (NHTSA) National Center for : Statistics recently examined data from the Consumer Product Safety Commission's : (CPSC) National Electronic Injury Surveillance (NEISS) on cases involving : injuries burn...

Progress toward polio eradication--Worldwide, 2013-2014.

PubMed

Moturi, Edna K; Porter, Kimberly A; Wassilak, Steven G F; Tangermann, Rudolf H; Diop, Ousmane M; Burns, Cara C; Jafari, Hamid

2014-05-30

In 1988, the World Health Assembly of the World Health Organization (WHO) resolved to interrupt wild poliovirus (WPV) transmission worldwide, and in 2012, the World Health Assembly declared the completion of global polio eradication a programmatic emergency for public health. By 2013, the annual number of WPV cases had decreased by >99% since 1988, and only three countries remained that had never interrupted WPV transmission: Afghanistan, Nigeria, and Pakistan. This report summarizes global progress toward polio eradication during 2013-2014 and updates previous reports. In 2013, a total of 416 WPV cases were reported globally from eight countries, an 86% increase from the 223 WPV cases reported from five countries in 2012. This upsurge in 2013 was caused by a 60% increase in WPV cases detected in Pakistan, and by outbreaks in five previously polio-free countries resulting from international spread of WPV. In 2014, as of May 20, a total of 82 WPV cases had been reported worldwide, compared with 34 cases during the same period in 2013. Polio cases caused by circulating vaccine-derived poliovirus (cVDPV) were detected in eight countries in 2013 and in two countries so far in 2014. To achieve polio eradication in the near future, further efforts are needed to 1) address health worker safety concerns in areas of armed conflict in priority countries, 2) to prevent further spread of WPV and new outbreaks after importation into polio-free countries, and 3) to strengthen surveillance globally. Based on the international spread of WPV to date in 2014, the WHO Director General has issued temporary recommendations to reduce further international exportation of WPV through vaccination of persons traveling from currently polio-affected countries.

[Case-non case studies: Principles, methods, bias and interpretation].

PubMed

Faillie, Jean-Luc

2017-10-31

Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals. This article describes the principle of the case-non case study, the method of calculating the ROR and its confidence interval, the different modalities of analysis and how to interpret its results with regard to the advantages and limitations of this design. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Issues in Software System Safety: Polly Ann Smith Co. versus Ned I. Ludd

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2002-01-01

This paper is a work of fiction, but it is fiction with a very real purpose: to stimulate careful thought and friendly discussion about some questions for which thought is often careless and discussion is often unfriendly. To accomplish this purpose, the paper creates a fictional legal case. The most important issue in this fictional case is whether certain proffered expert testimony about software engineering for safety critical systems should be admitted. Resolving this issue requires deciding the extent to which current practices and research in software engineering, especially for safety-critical systems, can rightly be considered based on knowledge, rather than opinion.

Safety of Silicone Oil Removal in Cases of Gunshot Perforating Eye Injuries.

PubMed

Ghoraba, Hammouda Hamdy; Elgouhary, Sameh Mohamed; Mansour, Hosam Osman; Abdel-Fattah, Hitham Mamoun; Heikal, Mohamed Amin; Elgemaey, Emad Mohamed

2017-03-01

To evaluate the feasibility and safety of silicone oil (SO) removal in cases of gunshot perforating eye injuries (PEI). A retrospective, consecutive, interventional study from medical records regarding cases of gunshot PEI during the periods of Egyptian political instability (January 2011 until December 2013). The main outcomes were to evaluate the feasibility of SO removal in cases of gunshot PEI and management of retinal detachment (RD) after SO removal in such cases. One hundred ninety-six eyes of 193 patients were reviewed. SO was removed in 72 eyes of 70 patients (36.7%). After SO removal, five eyes (6.9%) developed RD. One case refused any other intervention. RD in the remaining four cases was treated with revision surgery and SO reinjection. The retina remained stable throughout follow-up. None of the eyes developed phthisis bulbi after SO removal. Mean follow-up after SO removal was 10.86 months (range: 3 months to 30 months). Mean follow-up after management of RD after SO removal was 17.7 months (range: 13 months to 21 months). Patients aged younger than 20 years were associated with extensive fibrous proliferation, which might affect the safety profile of SO removal in cases of gunshot PEI. Rate of RD after SO removal in cases of apparent retinal stability and localized fibrous proliferation was 6.9%. Retinal detachment after SO removal in such cases can be treated with revision surgery and SO reinjection. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:242-250.]. Copyright 2017, SLACK Incorporated.

Acute acalculous cholecystitis: A new safety risk for patients with MS treated with alemtuzumab.

PubMed

Croteau, David; Flowers, Charlene; Kulick, Corrinne G; Brinker, Allen; Kortepeter, Cindy M

2018-05-01

To evaluate acute acalculous cholecystitis (AAC) as a potential safety risk for patients treated with alemtuzumab. The Food and Drug Administration Adverse Event Reporting System and the medical literature were searched for cases of AAC in conjunction with alemtuzumab for all clinical indications. Eight spontaneously reported cases meeting the case definition of AAC in close temporal association with alemtuzumab use were identified. Based on established criteria within the Food and Drug Administration Division of Pharmacovigilance for causality assessment, 4 cases were assessed as probable while 4 were possible. All cases occurred in patients with relapsing-remitting multiple sclerosis. Seven of the 8 cases presented with AAC during or shortly after alemtuzumab treatment, thereby suggesting an acute cytokine release syndrome as a putative pathogenic mechanism. The cases identified in this review differ from the typical AAC cases described in the medical literature based on female preponderance, lack of concurrent critical illnesses, inconsistent presence of other risk factors, and resolution with conservative treatment in the majority of cases. AAC represents a new and potentially life-threatening adverse event associated with alemtuzumab use in relapsing-remitting multiple sclerosis. In cases seen to date, early and conservative treatment resulted in good clinical outcome, although the natural history of AAC in this population without critical illness is not well defined. Awareness of this safety risk by general and specialty neurologists is important for prompt recognition and optimal management. © 2018 American Academy of Neurology.

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

Safety distance assessment of industrial toxic releases based on frequency and consequence: a case study in Shanghai, China.

PubMed

Yu, Q; Zhang, Y; Wang, X; Ma, W C; Chen, L M

2009-09-15

A case study on the safety distance assessment of a chemical industry park in Shanghai, China, is presented in this paper. Toxic releases were taken into consideration. A safety criterion based on frequency and consequence of major hazard accidents was set up for consequence analysis. The exposure limits for the accidents with the frequency of more than 10(-4), 10(-5)-10(-4) and 10(-6)-10(-5) per year were mortalities of 1% (or SLOT), 50% (SLOD) and 75% (twice of SLOD) respectively. Accidents with the frequency of less than 10(-6) per year were considered incredible and ignored in the consequence analysis. Taking the safety distance of all the hazard installations in a chemical plant into consideration, the results based on the new criterion were almost smaller than those based on LC50 or SLOD. The combination of the consequence and risk based results indicated that the hazard installations in two of the chemical plants may be dangerous to the protection targets and measurements had to be taken to reduce the risk. The case study showed that taking account of the frequency of occurrence in the consequence analysis would give more feasible safety distances for major hazard accidents and the results were more comparable to those calculated by risk assessment.

Transdifferentiation and reprogramming: Overview of the processes, their similarities and differences.

PubMed

Cieślar-Pobuda, Artur; Knoflach, Viktoria; Ringh, Mikael V; Stark, Joachim; Likus, Wirginia; Siemianowicz, Krzysztof; Ghavami, Saeid; Hudecki, Andrzej; Green, Jason L; Łos, Marek J

2017-07-01

Reprogramming, or generation of induced pluripotent stem (iPS) cells (functionally similar to embryonic stem cells or ES cells) by the use of transcription factors (typically: Oct3/4, Sox2, c-Myc, Klf4) called "Yamanaka factors" (OSKM), has revolutionized regenerative medicine. However, factors used to induce stemness are also overexpressed in cancer. Both, ES cells and iPS cells cause teratoma formation when injected to tissues. This raises a safety concern for therapies based on iPS derivates. Transdifferentiation (lineage reprogramming, or -conversion), is a process in which one mature, specialized cell type changes into another without entering a pluripotent state. This process involves an ectopic expression of transcription factors and/or other stimuli. Unlike in the case of reprogramming, tissues obtained by this method do not carry the risk of subsequent teratomagenesis. Copyright © 2017 Elsevier B.V. All rights reserved.

Natural gas operations: considerations on process transients, design, and control.

PubMed

Manenti, Flavio

2012-03-01

This manuscript highlights tangible benefits deriving from the dynamic simulation and control of operational transients of natural gas processing plants. Relevant improvements in safety, controllability, operability, and flexibility are obtained not only within the traditional applications, i.e. plant start-up and shutdown, but also in certain fields apparently time-independent such as the feasibility studies of gas processing plant layout and the process design of processes. Specifically, this paper enhances the myopic steady-state approach and its main shortcomings with respect to the more detailed studies that take into consideration the non-steady state behaviors. A portion of a gas processing facility is considered as case study. Process transients, design, and control solutions apparently more appealing from a steady-state approach are compared to the corresponding dynamic simulation solutions. Copyright © 2011 ISA. Published by Elsevier Ltd. All rights reserved.

The nexus between OSH and subcontracting.

PubMed

Nunes, Isabel L

2012-01-01

Subcontracting of specialized functions to external companies (e.g. cleaning or maintenance) is actually very common within several industries. These external companies' are called contractors and their contracting is often designated as outsourcing. Frequently contractors involve other companies (the sub-contractors) to assist them in fulfilling the contract, resulting in a complex chain of organizations focused on interchange of work - the contracting chain. Therefore in the same work site can coexist workers form the client-company and workers from the contractors and/or subcontractors. Since contractors perform their job in client's facilities, they can be exposed to hazards that are unknown to them. On other hand, workers of the client company can also be exposed to hazardous situations derived from the work performed by the contractors. The paper discusses how adequate occupational safety and health conditions can be assured when dealing with this kind of dynamic labor networks. Two case-studies and several examples coming from international literature will be presented.

Clinical Aspects of Aconitum Preparations.

PubMed

Tai, Chi-Jung; El-Shazly, Mohamed; Wu, Tung-Ying; Lee, Kun-Tai; Csupor, Dezső; Hohmann, Judit; Chang, Fang-Rong; Wu, Yang-Chang

2015-08-01

Aconite species have played an important role in human history. Aconitum species have been used worldwide as poisons as well as remedies. Their potential in targeting several ailments such as pain, rheumatism, and lethargy has been recognized by Western, Chinese, and Indian health care practitioners. Aconite use in herbal preparations has declined, especially in Europe and the United States, in the first half of the twentieth century due to several reported toxicity cases. The situation has changed with the application of new technologies for the accurate analysis of its toxic components and the development of efficient detoxification protocols. Some Asian countries started small clinical trials to evaluate the potency and safety of different marketed aconite preparations. The current review summarizes therapeutic uses of aconite preparations in China, Taiwan, India, and Japan. It also highlights clinical trial results with special emphasis on their limitations. Modern drugs and pharmacopoeial preparations derived from aconite are also discussed. Georg Thieme Verlag KG Stuttgart · New York.

Effects of introducing energy recovery processes to the municipal solid waste management system in Ulaanbaatar, Mongolia.

PubMed

Toshiki, Kosuke; Giang, Pham Quy; Serrona, Kevin Roy B; Sekikawa, Takahiro; Yu, Jeoung-soo; Choijil, Baasandash; Kunikane, Shoichi

2015-02-01

Currently, most developing countries have not set up municipal solid waste management systems with a view of recovering energy from waste or reducing greenhouse gas emissions. In this article, we have studied the possible effects of introducing three energy recovery processes either as a single or combination approach, refuse derived fuel production, incineration and waste power generation, and methane gas recovery from landfill and power generation in Ulaanbaatar, Mongolia, as a case study. We concluded that incineration process is the most suitable as first introduction of energy recovery. To operate it efficiently, 3Rs strategies need to be promoted. And then, RDF production which is made of waste papers and plastics in high level of sorting may be considered as the second step of energy recovery. However, safety control and marketability of RDF will be required at that moment. Copyright © 2014. Published by Elsevier B.V.

Adjuvants and Inactivated Polio Vaccine: A Systematic Review

PubMed Central

Hawken, Jennifer; Troy, Stephanie B.

2012-01-01

Poliomyelitis is nearing universal eradication; in 2011, there were 650 cases reported globally. When wild polio is eradicated, global oral polio vaccine (OPV) cessation followed by universal use of inactivated polio vaccine (IPV) is believed to be the safest vaccination strategy as IPV does not mutate or run the risk of vaccine derived outbreaks that OPV does. However, IPV is significantly more expensive than OPV. One strategy to make IPV more affordable is to reduce the dose by adding adjuvants, compounds that augment the immune response to the vaccine. No adjuvants are currently utilized in stand-alone IPV; however, several have been explored over the past six decades. From aluminum, used in many licensed vaccines, to newer and more experimental adjuvants such as synthetic DNA, a diverse group of compounds has been assessed with varying strengths and weaknesses. This review summarizes the studies to date evaluating the efficacy and safety of adjuvants used with IPV. PMID:23041122

A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

2013-08-30

In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd.

Beyond the cold hit: measuring the impact of the national DNA data bank on public safety at the city and county level.

PubMed

Gabriel, Matthew; Boland, Cherisse; Holt, Cydne

2010-01-01

Over the past decade, the Combined DNA Index System (CODIS) has increased solvability of violent crimes by linking evidence DNA profiles to known offenders. At present, an in-depth analysis of the United States National DNA Data Bank effort has not assessed the success of this national public safety endeavor. Critics of this effort often focus on laboratory and police investigators unable to provide timely investigative support as a root cause(s) of CODIS' failure to increase public safety. By studying a group of nearly 200 DNA cold hits obtained in SFPD criminal investigations from 2001-2006, three key performance metrics (Significance of Cold Hits, Case Progression & Judicial Resolution, and Potential Reduction of Future Criminal Activity) provide a proper context in which to define the impact of CODIS at the City and County level. Further, the analysis of a recidivist group of cold hit offenders and their past interaction with law enforcement established five noteworthy criminal case resolution trends; these trends signify challenges to CODIS in achieving meaningful case resolutions. CODIS' effectiveness and critical activities to support case resolutions are the responsibility of all criminal justice partners in order to achieve long-lasting public safety within the United States.

Regulatory considerations for pluripotent stem cell therapies.

PubMed

Carpenter, Melissa K

2017-01-01

The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products. © 2017 Elsevier B.V. All rights reserved.

Safety and IVHM

NASA Technical Reports Server (NTRS)

Goebel, Kai

2012-01-01

When we address safety in a book on the business case for IVHM, the question arises whether safety isn t inherently in conflict with the need of operators to run their systems as efficiently (and as cost effectively) as possible. The answer may be that the system needs to be just as safe as needed, but not significantly more. That begs the next question: How safe is safe enough? Several regulatory bodies provide guidelines for operational safety, but irrespective of that, operators do not want their systems to be known as lacking safety. We illuminate the role of safety within the context of IVHM.

Computer-based training for safety: comparing methods with older and younger workers.

PubMed

Wallen, Erik S; Mulloy, Karen B

2006-01-01

Computer-based safety training is becoming more common and is being delivered to an increasingly aging workforce. Aging results in a number of changes that make it more difficult to learn from certain types of computer-based training. Instructional designs derived from cognitive learning theories may overcome some of these difficulties. Three versions of computer-based respiratory safety training were shown to older and younger workers who then took a high and a low level learning test. Younger workers did better overall. Both older and younger workers did best with the version containing text with pictures and audio narration. Computer-based training with pictures and audio narration may be beneficial for workers over 45 years of age. Computer-based safety training has advantages but workers of different ages may benefit differently. Computer-based safety programs should be designed and selected based on their ability to effectively train older as well as younger learners.

Identification of Behavior Based Safety by Using Traffic Light Analysis to Reduce Accidents

NASA Astrophysics Data System (ADS)

Mansur, A.; Nasution, M. I.

2016-01-01

This work present the safety assessment of a case study and describes an important area within the field production in oil and gas industry, namely behavior based safety (BBS). The company set a rigorous BBS and its intervention program that implemented and deployed continually. In this case, observers requested to have discussion and spread a number of determined questions related with work behavior to the workers during observation. Appraisal of Traffic Light Analysis (TLA) as one tools of risk assessment used to determine the estimated score of BBS questionnaire. Standardization of TLA appraisal in this study are based on Regulation of Minister of Labor and Occupational Safety and Health No:PER.05/MEN/1996. The result shown that there are some points under 84%, which categorized in yellow category and should corrected immediately by company to prevent existing bad behavior of workers. The application of BBS expected to increase the safety performance at work time-by-time and effective in reducing accidents.

Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.

PubMed

Wild, Claudia; Erdös, Judit; Zechmeister, Ingrid

2014-11-04

European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices. Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA. 10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices. Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.

Umbilical cord mesenchymal stromal cell transplantations: A systemic analysis of clinical trials.

PubMed

Can, Alp; Celikkan, Ferda Topal; Cinar, Ozgur

2017-12-01

The advances and success of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in experimental disease animal models have fueled the development of targeted therapies in humans. The therapeutic potential of allogeneic transplantation of UC-MSCs has been under examination since 2009. The purpose of this systematic analysis was to review the published results, limitations and obstacles for UC-MSC transplantation. An extensive search strategy was applied to the published literature, 93 peer-reviewed full-text articles and abstracts were found published by early August 2017 that investigated the safety, efficacy and feasibility of UC-MSCs in 2001 patients with 53 distinct pathologies including many systemic/local, acute/chronic conditions. Few data were extracted from the abstracts and/or Chinese-written articles (n = 7, 8%). Importantly, no long-term adverse effects, tumor formation or cell rejection were reported. All studies noted certain degrees of therapeutic benefit as evidenced by clinical symptoms and/or laboratory findings. Thirty-seven percent (n = 34) of studies were found published as a single case (n = 10; 11%) or 2-10 case reports (n = 24; 26%) with no control group. Due to the nature of many stem cell-based studies, the majority of patients also received conventional therapy regimens, which obscured the pure efficacy of the cells transplanted. Randomized, blind, phase 1/2 trials with control groups (placebo-controlled) showed more plausible results. Given that most UC-MSC trials are early phase, the internationally recognized cell isolation and preparation standards should be extended to future phase 2/3 trials to reach more convincing conclusions regarding the safety and efficacy of UC-MSC therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Experimental validation of a damage detection approach on a full-scale highway sign support truss

NASA Astrophysics Data System (ADS)

Yan, Guirong; Dyke, Shirley J.; Irfanoglu, Ayhan

2012-04-01

Highway sign support structures enhance traffic safety by allowing messages to be delivered to motorists related to directions and warning of hazards ahead, and facilitating the monitoring of traffic speed and flow. These structures are exposed to adverse environmental conditions while in service. Strong wind and vibration accelerate their deterioration. Typical damage to this type of structure includes local fatigue fractures and partial loosening of bolted connections. The occurrence of these types of damage can lead to a failure in large portions of the structure, jeopardizing the safety of passing traffic. Therefore, it is important to have effective damage detection approaches to ensure the integrity of these structures. In this study, an extension of the Angle-between-String-and-Horizon (ASH) flexibility-based approach [32] is applied to locate damage in sign support truss structures at bay level. Ambient excitations (e.g. wind) can be considered as a significant source of vibration in these structures. Considering that ambient excitation is immeasurable, a pseudo ASH flexibility matrix constructed from output-only derived operational deflection shapes is proposed. A damage detection method based on the use of pseudo flexibility matrices is proposed to address several of the challenges posed in real-world applications. Tests are conducted on a 17.5-m long full-scale sign support truss structure to validate the effectiveness of the proposed method. Damage cases associated with loosened bolts and weld failures are considered. These cases are realistic for this type of structure. The results successfully demonstrate the efficacy of the proposed method to locate the two common forms of damage on sign support truss structures instrumented with a few accelerometers.

Discussion on the Criterion for the Safety Certification Basis Compilation - Brazilian Space Program Case

NASA Astrophysics Data System (ADS)

Niwa, M.; Alves, N. C.; Caetano, A. O.; Andrade, N. S. O.

2012-01-01

The recent advent of the commercial launch and re- entry activities, for promoting the expansion of human access to space for tourism and hypersonic travel, in the already complex ambience of the global space activities, brought additional difficulties over the development of a harmonized framework of international safety rules. In the present work, with the purpose of providing some complementary elements for global safety rule development, the certification-related activities conducted in the Brazilian space program are depicted and discussed, focusing mainly on the criterion for certification basis compilation. The results suggest that the composition of a certification basis with the preferential use of internationally-recognized standards, as is the case of ISO standards, can be a first step toward the development of an international safety regulation for commercial space activities.

An investigation of safety climate in OHSAS 18001-certified and non-certified organizations.

PubMed

Ghahramani, Abolfazl

2016-09-01

Many organizations worldwide have implemented Occupational Health and Safety Assessment Series (OHSAS) 18001 in their premises because of the assumed positive effects of this standard on safety. Few studies have analyzed the effect of the safety climate in OHSAS 18001-certified organizations. This case-control study used a new safety climate questionnaire to evaluate three OHSAS 18001-certified and three non-certified manufacturing companies in Iran. Hierarchical regression indicated that the safety climate was influenced by OHSAS implementation and by safety training. Employees who received safety training had better perceptions of the safety climate and its dimensions than other respondents within the certified companies. This study found that the implementation of OHSAS 18001 does not guarantee improvement of the safety climate. This study also emphasizes the need for high-quality safety training for employees of the certified companies to improve the safety climate.

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

Safety Awareness and Preparedness in Secondary Schools in Kenya: A Case of Turkana District

ERIC Educational Resources Information Center

Kipngeno, Ronoh Richard; Benjamin, Kyalo Wambua

2009-01-01

Safety for students and staff from hazards that can be created by unsafe conditions, behaviour, disasters or emergencies in schools cannot be guaranteed. This is because of inadequate preparedness and awareness programs for safety needs. This study investigated the adequacy of procedures, precautions and infrastructure to respond to fire outbreaks…

76 FR 56243 - Southern Nuclear Operating Co., PPL Bell Bend, L.L.C., Luminant Generation Company LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... Generation Company LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over this.... The contested proceedings in these cases had been terminated at the Atomic Safety and Licensing Board...

Indicators of Faculty and Staff Perceptions of Campus Safety: A Case Study

ERIC Educational Resources Information Center

Woolfolk, Willie A.

2013-01-01

The study addressed the problem of a critical increase in campus crime between 1999 and 2009, a period during which overall crime in the United States declined. Further the research explored the perceptions of campus safety among faculty and staff at an institution where campus safety initiatives are nationally ranked as exemplary and incidents of…

Professional and Personal Qualities of the Teacher in the Context of the Psychological Safety of Educational Environment

ERIC Educational Resources Information Center

Kulikova, Tatyana I.; Maliy, Dmitriy V.

2017-01-01

The article deals with the phenomenon of psychological safety of the educational environment (PSEE) in the modern school. Indicators of the educational process participants' psychological safety are revealed. The notion of the teacher's preparedness for the designing activity is defined. The authors have conducted a case study revealing integrated…

A Comprehensive Approach to Managing School Safety: Case Studies in Catalonia, Spain

ERIC Educational Resources Information Center

Díaz-Vicario, Anna; Gairín Sallán, Joaquín

2017-01-01

Background: Schools should be safe spaces for students, teaching staff and non-teaching staff. For the concept of "safety" to be meaningful, it must be interpreted broadly to encompass well-being in its widest sense. A common challenge for schools and educational authorities is, therefore, to manage school safety appropriately not only…

Lift truck safety review

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

Cadwallader, L.C.

1997-03-01

This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

Fire safety: A case study of technology transfer

NASA Technical Reports Server (NTRS)

Heins, C. F.

1975-01-01

Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

Wheelbarrow tire explosion causing trauma to the forearm and hand: a case report

PubMed Central

2009-01-01

Introduction Tire explosion injuries are rare, but they may result in a severe injury pattern. Case reports and statistics from injuries caused by exploded truck tires during servicing are established, but trauma from exploded small tires seems to be unknown. Case presentation A 47-year-old german man inflated a wheelbarrow tire. The tire exploded during inflation and caused an open, multiple forearm and hand injury. Conclusion Even small tires can cause severe injury patterns in the case of an explosion. High inflating pressures and low safety distances are the main factors responsible for this occurrence. Broad safety information and suitable filling devices are indispensable for preventing these occurrences. PMID:19946543

Enhanced inactivation of foodborne pathogenic and spoilage bacteria by FD&C Red no. 3 and other xanthene derivatives during ultrahigh pressure processing.

PubMed

Waite, Joy G; Yousef, Ahmed E

2008-09-01

Variability among microorganisms in barotolerance has been demonstrated at genus, species, and strain levels. Identification of conditions and additives that enhance the efficacy of ultrahigh pressure (UHP) against important foodborne microorganisms is crucial for maximizing product safety and stability. Preliminary work indicated that FD&C Red No. 3 (Red 3), a xanthene derivative, was bactericidal and acted synergistically with UHP against Lactobacillus spp. The objective of this study was to determine the antimicrobial efficacy of Red 3 and other xanthene derivatives, alone and combined with UHP, against spoilage and pathogenic bacteria in citrate-phosphate buffer (pH 7.0). Xanthene derivatives tested were fluorescein, Eosin Y, Erythrosin B, Phloxine B, Red 3, and Rose Bengal. Halogenated xanthene derivatives (10 ppm) were effective at reducing Listeria monocytogenes survivors but ineffective against Escherichia coli O157:H7. When combined with UHP (400 MPa, 3 min), the presence of derivatives enhanced inactivation. Because Red 3 was the only xanthene derivative to produce synergistic inactivation of both pathogens, further studies using this colorant were warranted. Efficacy of Red 3 against gram-positive bacteria (Lactobacillus plantarum and L. monocytogenes) was concentration dependent (1 to 10 ppm). E. coi O157: H7 strains were resistant to Red 3 concentrations up to 300 ppm. When Red 3 was combined with UHP, the lethality against gram-positive and gram-negative bacteria was dose dependent, with synergy being significant for most strains at > or = 3 ppm. Additional gram-positive and gram-negative bacteria showed lethalities similar to those observed for L. plantarum or L. monocytogenes, and E. coli O157:H7, respectively. Red 3 is a potentially useful additive to enhance the safety and stability of UHP-treated food products.

Building clinical and organizational resilience to reconcile safety threats, tensions and trade-offs: insights from theory and evidence.

PubMed

Jeffs, Lianne; Tregunno, Deborah; MacMillan, Kathleen; Espin, Sherry

2009-01-01

Healthcare delivery settings are complex adaptive and tightly coupled, interrelated systems. Within the larger healthcare system, a key subsystem is the "clinical microsystem" level. It is at this level that clinicians are faced with high levels of uncertainty in their daily work - uncertainty that impacts the quality and safety of care that patients receive. The first aim of this paper is to enhance healthcare leaders' understanding of what is currently known about safety threats and strategies to manage the inherent tensions and trade-offs that occur in everyday practice. The second aim is to inform strategies that build clinical and organizational resilience through a multi-level framework derived from the collective theoretical and empirical work. Together, this information can strengthen safety practices throughout healthcare organizations.

An Injury Prevention Strategy for Teen Restaurant Workers

PubMed Central

Ward, Julie A.; de Castro, A. B.; Tsai, Jenny Hsin-Chun; Linker, Darren; Hildahl, Lyle; Miller, Mary E.

2011-01-01

High levels of youth employment, workplace hazards, and characteristics unique to adolescents contribute to a relatively high incidence of injuries among teens in the restaurant industry. This article discusses the ProSafety model of injury prevention among teen restaurant workers. Through integration with an existing career and technical education program, the ProSafety project seeks to prevent occupational injuries among the teen worker population through classroom safety education and internship skills reinforcement. ProSafety is the product of an innovative collaboration with occupational health nurses, business professionals, educators, and government. Its approach is derived from Social Cognitive Theory, is consistent with key values and strategies of occupational health nurses, and provides lessons for practitioners seeking to reduce occupational injuries in food service or among other populations of adolescent workers. PMID:20180503

Establishment of novel detection system for embryonic stem cell-derived hepatocyte-like cells based on nongenetic manipulation with indocyanine green.

PubMed

Yoshie, Susumu; Ito, Jun; Shirasawa, Sakiko; Yokoyama, Tadayuki; Fujimura, Yuu; Takeda, Kazuo; Mizuguchi, Masahiro; Matsumoto, Ken; Tomotsune, Daihachiro; Sasaki, Katsunori

2012-01-01

Hepatocytes derived from embryonic stem cells (ESCs) are expected to be useful for basic research and clinical applications. However, in several studies, genetic methods used to detect and obtain them are difficult and pose major safety problems. Therefore, in this study, we established a novel detection system for hepatocytes by using indocyanine green (ICG), which is selectively taken up by hepatocytes, based on nongenetic manipulation. ICG has maximum light absorption near 780 nm, and it fluoresces between 800 and 900 nm. Making use of these properties, we developed flow cytometry equipped with an excitation lazer of 785 nm and specific bandpass filters and successfully detected ESC-derived ICG-positive cells that were periodic acid-Schiff positive and expressed hepatocyte phenotypic mRNAs. These results demonstrate that this detection system based on nongenetic manipulation with ICG will lead to isolate hepatocytes generated from ESCs and provide the appropriate levels of stability, quality, and safety required for cell source for cell-based therapy and pharmaceutical studies such as toxicology.

Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

PubMed

Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

2013-12-01

In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is recommended.

Genetic modification of hematopoietic cells using retroviral and lentiviral vectors: safety considerations for vector design and delivery into target cells.

PubMed

Dropulic, Boro

2005-07-01

The recent development of leukemia in three patients following retroviral vector gene transfer in hematopoietic stem cells, resulting in the death of one patient, has raised safety concerns for the use of integrating gene transfer vectors for human gene therapy. This review discusses these serious adverse events from the perspective of whether restrictions on vector design and vector-modified target cells are warranted at this time. A case is made against presently establishing specific restrictions for vector design and transduced cells; rather, their safety should be ascertained by empiric evaluation in appropriate preclinical models on a case-by-case basis. Such preclinical data, coupled with proper informed patient consent and a risk-benefit ratio analysis, provide the best available prospective evaluation of gene transfer vectors prior to their translation into the clinic.

GMP-compliant human adipose tissue-derived mesenchymal stem cells for cellular therapy.

PubMed

Aghayan, Hamid-Reza; Goodarzi, Parisa; Arjmand, Babak

2015-01-01

Stem cells, which can be derived from different sources, demonstrate promising therapeutic evidences for cellular therapies. Among various types of stem cell, mesenchymal stem cells are one of the most common stem cells that are used in cellular therapy. Human subcutaneous adipose tissue provides an easy accessible source of mesenchymal stem cells with some considerable advantages. Accordingly, various preclinical and clinical investigations have shown enormous potential of adipose-derived stromal cells in regenerative medicine. Consequently, increasing clinical applications of these cells has elucidated the importance of safety concerns regarding clinical transplantation. Therefore, clinical-grade preparation of adipose-derived stromal cells in accordance with current good manufacturing practice guidelines is an essential part of their clinical applications to ensure the safety, quality, characteristics, and identity of cell products. Additionally, GMP-compliant cell manufacturing involves several issues to provide a quality assurance system during translation from the basic stem cell sciences into clinical investigations and applications. On the other hand, advanced cellular therapy requires extensive validation, process control, and documentation. It also evidently elucidates the critical importance of production methods and probable risks. Therefore, implementation of a quality management and assurance system in accordance with GMP guidelines can greatly reduce these risks particularly in the higher-risk category or "more than minimally manipulated" products.

Cassava (Manihot esculenta Crantz) and Yam (Dioscorea spp.) Crops and Their Derived Foodstuffs: Safety, Security and Nutritional Value.

PubMed

Ferraro, Vincenza; Piccirillo, Clara; Tomlins, Keith; Pintado, Manuela E

2016-12-09

Cassava (Manihot esculenta Crantz) and yam (Dioscorea spp.) are tropical crops consumed by ca. 2 billion people and represent the main source of carbohydrate and energy for the approximately 700 million people living in the tropical and sub-tropical areas. They are a guarantee of food security for developing countries. The production of these crops and the transformation into food-derived commodities is increasing, it represents a profitable business and farmers generate substantial income from their market. However, there are some important concerns related to the food safety and food security. The high post-harvest losses, mainly for yam, the contamination by endogenous toxic compounds, mainly for cassava, and the contamination by external agents (such as micotoxins, pesticides, and heavy metal) represent a depletion of economic value and income. The loss in the raw crops or the impossibility to market the derived foodstuffs, due to incompliance with food regulations, can seriously limit all yam tubers and the cassava roots processors, from farmers to household, from small-medium to large enterprises. One of the greatest challenges to overcome those concerns is the transformation of traditional or indigenous processing methods into modern industrial operations, from the crop storage to the adequate package of each derived foodstuff.

How Safe Is Control Software

NASA Technical Reports Server (NTRS)

Dunn, William R.; Corliss, Lloyd D.

1991-01-01

Paper examines issue of software safety. Presents four case histories of software-safety analysis. Concludes that, to be safe, software, for all practical purposes, must be free of errors. Backup systems still needed to prevent catastrophic software failures.

A new approach to identify, classify and count drugrelated events

PubMed Central

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

2013-01-01

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

Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Document: are they sufficiently protective for insecticides?

PubMed

van Wijngaarden, René P A; Maltby, Lorraine; Brock, Theo C M

2015-08-01

The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides. The tier-1 and tier-2 RACs were compared with RACs based on threshold concentrations from micro/mesocosm studies (ETO-RAC). A lower-tier RAC was considered as sufficiently protective, if less than the corresponding ETO-RAC. ETO-RACs were calculated for repeated (n = 13) and/or single pulsed applications (n = 17) of 26 insecticides to micro/mesocosms, giving a maximum of 30 insecticide × application combinations (i.e. cases) for comparison. Acute tier-1 RACs (for 24 insecticides) were lower than the corresponding ETO-RACs in 27 out of 29 cases, while tier-2 Geom-RACs (for 23 insecticides) were lower in 24 out of 26 cases. The tier-2 SSD-RAC (for 21 insecticides) using HC5 /3 was lower than the ETO-RAC in 23 out of 27 cases, whereas the tier-2 SSD-RAC using HC5 /6 was protective in 25 out of 27 cases. The tier-1 and tier-2 approaches proposed by EFSA for acute effect assessment are sufficiently protective for the majority of insecticides evaluated. Further evaluation may be needed for insecticides with more novel chemistries (neonicotinoids, biopesticides) and compounds that show delayed effects (insect growth regulators). © 2014 Society of Chemical Industry.

Impact of the time-out process on safety attitude in a tertiary neurosurgical department.

PubMed

McLaughlin, Nancy; Winograd, Deborah; Chung, Hallie R; Van de Wiele, Barbara; Martin, Neil A

2014-11-01

In July 2011, the UCLA Health System released its current time-out process protocol used across the Health System. Numerous interventions were performed to improve checklist completion and time-out process observance. This study assessed the impact of the current protocol for the time-out on healthcare providers' safety attitude and operating room safety climate. All members involved in neurosurgical procedures in the main operating room of the Ronald Reagan UCLA Medical Center were asked to anonymously complete an online survey on their overall perception of the time-out process. The survey was completed by 93 of 128 members of the surgical team. Overall, 98.9% felt that performing a pre-incision time-out improves patient safety. The majority of respondents (97.8%) felt that the team member introductions helped to promote a team spirit during the case. In addition, 93.5% felt that performing a time-out helped to ensure all team members were comfortable to voice safety concerns throughout the case. All respondents felt that the attending surgeon should be present during the time-out and 76.3% felt that he/she should lead the time-out. Unanimously, it was felt that the review of anticipated critical elements by the attending surgeon was helpful to respondents' role during the case. Responses revealed that although the time-out brings the team together physically, it does not necessarily reinforce teamwork. The time-out process favorably impacted team members' safety attitudes and perception as well as overall safety climate in neurosurgical ORs. Survey responses identified leadership training and teamwork training as two avenues for future improvement. Copyright © 2014 Elsevier Inc. All rights reserved.

Spatial patterns of recorded mastitis incidence and somatic cell counts in Swedish dairy cows: implications for surveillance.

PubMed

Wolff, Cecilia; Stevenson, Mark; Emanuelson, Ulf; Egenvall, Agneta; Lindberg, Ann

2011-11-01

Clinical mastitis (CM) is the most common veterinary treated disease in Swedish dairy cattle. To investigate if the distribution of veterinary registered cases of CM in Sweden follows that of the spatial distribution of cows with high somatic cell counts (SCCs), the spatial distribution of CM odds was estimated from available records and compared with udder health measures based on measurements of SCC derived from official milk recording. The study revealed areas with significantly lower odds for CM but with a high proportion of cows with a poor udder health score, suggesting an under-reporting of CM. We also found areas of significantly higher odds for CM despite a low proportion of cows with a poor udder health score, suggestive of over-treatment of mastitis. The results should enable targeted studies of reasons for discrepancies, e.g. farmers' and veterinarians' attitudes to mastitis treatment and disease recording in areas with a deficit or excess of registered CM cases. High quality disease records for dairy cattle are of interest not only for the dairy management but also for disease surveillance, monitoring of use of antibiotics and food safety purposes.

Perspectives on communicating risks of chemicals.

PubMed

Armbrust, Kevin; Burns, Mitchell; Crossan, Angus N; Fischhoff, David A; Hammond, Larry E; Johnston, John J; Kennedy, Ivan; Rose, Michael T; Seiber, James N; Solomon, Keith

2013-05-22

The Agrochemicals Division symposium "Perfecting Communication of Chemical Risk", held at the 244th National Meeting and Exposition of the American Chemical Society in Philadelphia, PA, August 19-23, 2012, is summarized. The symposium, organized by James Seiber, Kevin Armbrust, John Johnston, Ivan Kennedy, Thomas Potter, and Keith Solomon, included discussion of better techniques for communicating risks, lessons from past experiences, and case studies, together with proposals to improve these techniques and their communication to the public as effective information. The case studies included risks of agricultural biotechnology, an organoarsenical (Roxarsone) in animal feed, petroleum spill-derived contamination of seafood, role of biomonitoring and other exposure assessment techniques, soil fumigants, implications of listing endosulfan as a persistant organic pollutant (POP), and diuron herbicide in runoff, including use of catchment basins to limit runoff to coastal ecozones and the Great Barrier Reef. The symposium attracted chemical risk managers including ecotoxicologists, environmental chemists, agrochemists, ecosystem managers, and regulators needing better techniques that could feed into better communication of chemical risks. Policy issues related to regulation of chemical safety as well as the role of international conventions were also presented. The symposium was broadcast via webinar to an audience outside the ACS Meeting venue.

Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China.

PubMed

Li, Rongcheng; Li, Chang Gui; Li, Yanping; Liu, Youping; Zhao, Hong; Chen, Xiaoling; Kuriyakose, Sherine; Van Der Meeren, Olivier; Hardt, Karin; Hezareh, Marjan; Roy-Ghanta, Sumita

2016-03-14

Replacing live-attenuated oral poliovirus vaccines (OPV) with inactivated poliovirus vaccines (IPV) is part of the global strategy to eradicate poliomyelitis. China was declared polio-free in 2000 but continues to record cases of vaccine-associated-poliomyelitis and vaccine-derived-poliovirus outbreaks. Two pilot safety studies and two larger immunogenicity trials evaluated the non-inferiority of IPV (Poliorix™, GSK Vaccines, Belgium) versus OPV in infants and booster vaccination in toddlers primed with either IPV or OPV in China. In pilot safety studies, 25 infants received 3-dose IPV primary vaccination (Study A, www.clinicaltrial.gov NCT00937404) and 25 received an IPV booster after priming with three OPV doses (Study B, NCT01021293). In the randomised, controlled immunogenicity and safety trial (Study C, NCT00920439), infants received 3-dose primary vaccination with IPV (N=541) or OPV (N=535) at 2,3,4 months of age, and a booster IPV dose at 18-24 months (N=470, Study D, NCT01323647: extension of study C). Blood samples were collected before and one month post-dose-3 and booster. Reactogenicity was assessed using diary cards. Serious adverse events (SAEs) were captured throughout each study. Study A and B showed that IPV priming and IPV boosting (after OPV) was safe. Study C: One month post-dose-3, all IPV and ≥ 98.3% OPV recipients had seroprotective antibody titres towards each poliovirus type. The immune response elicited by IPV was non-inferior to Chinese OPV. Seroprotective antibody titres persisted in ≥ 94.7% IPV and ≥ 96.1% OPV recipients at 18-24 months (Study D). IPV had a clinically acceptable safety profile in all studies. Grade 3 local and systemic reactions were uncommon. No SAEs were related to IPV administration. Trivalent IPV is non-inferior to OPV in terms of seroprotection (in the Chinese vaccination schedule) in infant and toddlers, with a clinically acceptable safety profile. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Brilliant Blue G double staining enhances successful internal limiting membrane peeling with minimal adverse effect by low cellular permeability into live cells.

PubMed

Hisatomi, Toshio; Notomi, Shoji; Tachibana, Takashi; Oishi, Seiichiro; Asato, Ryo; Yamashita, Takehiro; Murakami, Yusuke; Ikeda, Yasuhiro; Enaida, Hiroshi; Sakamoto, Taiji; Ishibashi, Tatsuro

2015-02-01

Brilliant Blue G is used as a surgical adjuvant for retinal surgery. Although BBG double or multiple staining was reported, the effectiveness and safety of repeated staining is still elusive. To further examine the effectiveness and safety, we examined BBG in clinical cases in vivo, primary cell culture in vitro, and surgically resected specimen ex vivo. A retrospective interventional case series with in vitro and ex vivo studies were performed. Vitrectomy was performed in 28 cases of epiretinal membrane with BBG single to multiple staining. The surgically resected membranes were stained by BBG with or without cellular fixation. Primary cell cultures were examined with BBG and live/death cell markers, such as Calcein AM and TUNEL. Single staining provided satisfactory staining in seven cases. Double or multiple staining substantially visualized internal limiting membrane (21 cases), especially the edges of remaining internal limiting membrane (11 cases). Adverse retinal staining was not noted and the final visual acuity showed no difference with multiple staining. The live cells barely stained with BBG, while some dead cells were stained. Brilliant Blue G multiple staining substantially enhanced the visualization of internal limiting membrane. The absence of abnormal staining supports the safety of repeated BBG staining.

In-depth genome analyses of viruses from vaccine-derived rabies cases and corresponding live-attenuated oral rabies vaccines.

PubMed

Pfaff, Florian; Müller, Thomas; Freuling, Conrad M; Fehlner-Gardiner, Christine; Nadin-Davis, Susan; Robardet, Emmanuelle; Cliquet, Florence; Vuta, Vlad; Hostnik, Peter; Mettenleiter, Thomas C; Beer, Martin; Höper, Dirk

2018-02-10

Live-attenuated rabies virus strains such as those derived from the field isolate Street Alabama Dufferin (SAD) have been used extensively and very effectively as oral rabies vaccines for the control of fox rabies in both Europe and Canada. Although these vaccines are safe, some cases of vaccine-derived rabies have been detected during rabies surveillance accompanying these campaigns. In recent analysis it was shown that some commercial SAD vaccines consist of diverse viral populations, rather than clonal genotypes. For cases of vaccine-derived rabies, only consensus sequence data have been available to date and information concerning their population diversity was thus lacking. In our study, we used high-throughput sequencing to analyze 11 cases of vaccine-derived rabies, and compared their viral population diversity to the related oral rabies vaccines using pairwise Manhattan distances. This extensive deep sequencing analysis of vaccine-derived rabies cases observed during oral vaccination programs provided deeper insights into the effect of accidental in vivo replication of genetically diverse vaccine strains in the central nervous system of target and non-target species under field conditions. The viral population in vaccine-derived cases appeared to be clonal in contrast to their parental vaccines. The change from a state of high population diversity present in the vaccine batches to a clonal genotype in the affected animal may indicate the presence of a strong bottleneck during infection. In conclusion, it is very likely that these few cases are the consequence of host factors and not the result of the selection of a more virulent genotype. Furthermore, this type of vaccine-derived rabies leads to the selection of clonal genotypes and the selected variants were genetically very similar to potent SAD vaccines that have undergone a history of in vitro selection. Copyright © 2018. Published by Elsevier Ltd.

Surveillance of adverse events following vaccination in the French armed forces, 2011-2012.

PubMed

Mayet, A; Duron, S; Meynard, J-B; Koeck, J-L; Deparis, X; Migliani, R

2015-06-01

French military personnel are subject to a compulsory vaccination schedule. The aim of this study was to present the results of surveillance of vaccine adverse events (VAEs) reported from 2011 to 2012 in the French armed forces. VAEs were surveyed among all French armed forces from 2011 to 2012 by the epidemiological departments of the military health service. For each case, a notification form providing patient and clinical information was provided. Case definitions were derived from the French drug safety guidelines. Three types of VAE were considered: non-serious, serious and unexpected. Incidence rates were calculated by relating VAEs to the number of vaccine doses delivered. In total, 161 VAE cases were reported. The overall VAE reporting rate was 24.6 VAEs per 100,000 doses, and the serious VAE rate was 1.3 per 100,000 doses (nine cases). The serious VAEs included two cases of Guillain-Barré syndrome, one case of optic neuritis, one case of a meningeal-like syndrome, one case of rheumatoid purpura, one case of acute asthma and three cases of fainting. The highest rates of VAE were observed with the Bacille Calmette-Guérin vaccine (BCG) (482.3 per 100,000 doses), inactivated diphtheria-tetanus-poliovirus with acellular pertussis vaccine (dTap-IPV) (106.1 per 100,000 doses) and meningococcal quadrivalent glycoconjugate vaccine (MenACWY-CRM) (39.3 per 100,000 doses). The global rates of VAE observed in 2011 and 2012 confirm the increase that has been observed since 2009 in the French armed forces, which could reflect improved practitioner awareness about VAEs and the use of certain vaccines added to the vaccination schedule recently (dTap-IPV in 2008 and MenACWY-CRM in 2010). VAEs appear to be relatively rare, particularly serious VAEs, which indicates acceptable tolerance of vaccines. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Deep Sequencing of Plant and Animal DNA Contained within Traditional Chinese Medicines Reveals Legality Issues and Health Safety Concerns

PubMed Central

Coghlan, Megan L.; Haile, James; Houston, Jayne; Murray, Dáithí C.; White, Nicole E.; Moolhuijzen, Paula; Bellgard, Matthew I.; Bunce, Michael

2012-01-01

Traditional Chinese medicine (TCM) has been practiced for thousands of years, but only within the last few decades has its use become more widespread outside of Asia. Concerns continue to be raised about the efficacy, legality, and safety of many popular complementary alternative medicines, including TCMs. Ingredients of some TCMs are known to include derivatives of endangered, trade-restricted species of plants and animals, and therefore contravene the Convention on International Trade in Endangered Species (CITES) legislation. Chromatographic studies have detected the presence of heavy metals and plant toxins within some TCMs, and there are numerous cases of adverse reactions. It is in the interests of both biodiversity conservation and public safety that techniques are developed to screen medicinals like TCMs. Targeting both the p-loop region of the plastid trnL gene and the mitochondrial 16S ribosomal RNA gene, over 49,000 amplicon sequence reads were generated from 15 TCM samples presented in the form of powders, tablets, capsules, bile flakes, and herbal teas. Here we show that second-generation, high-throughput sequencing (HTS) of DNA represents an effective means to genetically audit organic ingredients within complex TCMs. Comparison of DNA sequence data to reference databases revealed the presence of 68 different plant families and included genera, such as Ephedra and Asarum, that are potentially toxic. Similarly, animal families were identified that include genera that are classified as vulnerable, endangered, or critically endangered, including Asiatic black bear (Ursus thibetanus) and Saiga antelope (Saiga tatarica). Bovidae, Cervidae, and Bufonidae DNA were also detected in many of the TCM samples and were rarely declared on the product packaging. This study demonstrates that deep sequencing via HTS is an efficient and cost-effective way to audit highly processed TCM products and will assist in monitoring their legality and safety especially when plant reference databases become better established. PMID:22511890

Current food safety management systems in fish-exporting companies require further improvements to adequately cope with contextual pressure: case study.

PubMed

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

2014-10-01

Fish-processing plants still face food safety (FS) challenges worldwide despite the existence of several quality assurance standards and food safety management systems/s (FSMSs). This study assessed performance of FSMS in fish exporting sector considering pressure from the context in which they operate. A FSMS diagnostic tool with checklist was used to assess the context, FSMS, and FS output in 9 Kenyan fish exporting companies. Majority (67%) companies operated at moderate- to high-risk context but with an average performance in control and assurance activities. This situation could be insufficient to deal with ambiguity, uncertainty, and vulnerability issues in the context characteristics. Contextual risk posed by product characteristics (nature of raw materials) and chain environment characteristics was high. Risk posed by the chain environment characteristics, low power in supplier relationships, and low degree of authority in customer relationships was high. Lack of authority in relationship with suppliers would lead to high raw material risk situation. Even though cooling facilities, a key control activity, was at an advanced level, there was inadequate packaging intervention equipment which coupled with inadequate physical intervention equipment could lead to further weakened FSMS performance. For the fish companies to improve their FSMS to higher level and enhance predictability, they should base their FSMS on scientific information sources, historical results, and own experimental trials in their preventive, intervention, and monitoring systems. Specific suggestions are derived for improvements toward higher FSMS activity levels or lower risk levels in context characteristics. Weak areas in performance of control and assurance activities in export fish-processing sector already implementing current quality assurance guidelines and standards were studied taking into consideration contextual pressure wherein the companies operate. Important mitigation measures toward improved contextual risk, core assurance, and control activities irrespective of applied food safety management systems in fish industries were suggested. © 2014 Institute of Food Technologists®

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

PubMed

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

2016-01-01

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

Allopurinol use in pregnancy in three women with inflammatory bowel disease: safety and outcomes: a case series

PubMed Central

2013-01-01

Background Allopurinol is a frequently prescribed drug. In inflammatory bowel disease patients who shunt thiopurine metabolism towards more toxic and less desirable pathways, allopurinol is proving to be an effective add on therapy with good resultant disease control and less treatment side effects. As many such patients are young, the potential for pregnant women to be exposed to allopurinol is increasing. The safety of allopurinol in pregnancy is not known however. Case presentation We report three cases of safe use of allopurinol in pregnancy for women with inflammatory bowel disease. This included 2 patients with ulcerative colitis and 1 patient with fistulising Crohn’s disease. Allopurinol was used throughout pregnancy in all patients. All 3 pregnancies resulted in normal healthy babies born at term by Caesarean section. Conclusion It is important to evaluate and document the safety of allopurinol during pregnancy, as it is finding new roles in young patients. These three cases add significantly to the very limited data on allopurinol use in pregnancy. We encourage reporting of all cases of allopurinol use in pregnant patients and suggest an allopurinol pregnancy registry to document drug exposures and outcomes. PMID:24345189

New Safety and Technical Challenges and Operational Experience on the JET First Trace Tritium Experiment

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

Pearce, R.J.H.; Bell, A.C.; Brennan, D.

'Trace Tritium Experiments' (TTE) were successfully performed on JET in 2003. The Campaign marked the first use of tritium in JET plasmas since the Deuterium-Tritium Experiment (DTE1) Campaign in 1997, and was the first use of tritium in experiments under the EFDA organisation with the UKAEA as JET Operator. The safety and regulatory preparations for the experiment were extensive. Since JET has been operated by the UKAEA the operations have followed the model of a licensed nuclear site. The safe operation of the JET torus is demonstrated in a safety case. Key Safety Management Requirement (KSMR) and Key Safety Relatedmore » Equipment (KSRE) are identified in the Safety Case for DT operation. The safe operation of the torus is within the bounds of, and under the control of, an Authority to Operate (ATO). New technical challenges were presented by the need to inject and account for small quantities of tritium in very short pulses ({approx}80ms), with an accurate time stamp. The safety and operational management of the campaign are described. Valuable lessons were learned which would help in running future experiments. It is concluded that JET is in a strong position to run future trace tritium and full DT discharges.« less

Modeling level-of-safety for bus stops in China.

PubMed

Ye, Zhirui; Wang, Chao; Yu, Yongbo; Shi, Xiaomeng; Wang, Wei

2016-08-17

Safety performance at bus stops is generally evaluated by using historical traffic crash data or traffic conflict data. However, in China, it is quite difficult to obtain such data mainly due to the lack of traffic data management and organizational issues. In light of this, the primary objective of this study is to develop a quantitative approach to evaluate bus stop safety performance. The concept of level-of-safety for bus stops is introduced and corresponding models are proposed to quantify safety levels, which consider conflict points, traffic factors, geometric characteristics, traffic signs and markings, pavement conditions, and lighting conditions. Principal component analysis and k-means clustering methods were used to model and quantify safety levels for bus stops. A case study was conducted to show the applicability of the proposed model with data collected from 46 samples for the 7 most common types of bus stops in China, using 32 of the samples for modeling and 14 samples for illustration. Based on the case study, 6 levels of safety for bus stops were defined. Finally, a linear regression analysis between safety levels and the number of traffic conflicts showed that they had a strong relationship (R(2) value of 0.908). The results indicated that the method was well validated and could be practically used for the analysis and evaluation of bus stop safety in China. The proposed model was relatively easy to implement without the requirement of traffic crash data and/or traffic conflict data. In addition, with the proposed method, it was feasible to evaluate countermeasures to improve bus stop safety (e.g., exclusive bus lanes).

The patient safety climate in healthcare organizations (PSCHO) survey: Short-form development.

PubMed

Benzer, Justin K; Meterko, Mark; Singer, Sara J

2017-08-01

Measures of safety climate are increasingly used to guide safety improvement initiatives. However, cost and respondent burden may limit the use of safety climate surveys. The purpose of this study was to develop a 15- to 20-item safety climate survey based on the Patient Safety Climate in Healthcare Organizations survey, a well-validated 38-item measure of safety climate. The Patient Safety Climate in Healthcare Organizations was administered to all senior managers, all physicians, and a 10% random sample of all other hospital personnel in 69 private sector hospitals and 30 Veterans Health Administration hospitals. Both samples were randomly divided into a derivation sample to identify a short-form subset and a confirmation sample to assess the psychometric properties of the proposed short form. The short form consists of 15 items represented 3 overarching domains in the long-form scale-organization, work unit, and interpersonal. The proposed short form efficiently captures 3 important sources of variance in safety climate: organizational, work-unit, and interpersonal. The short-form development process was a practical method that can be applied to other safety climate surveys. This safety climate short form may increase response rates in studies that involve busy clinicians or repeated measures. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

PubMed Central

Nomura, Kaori; Takahashi, Kunihiko; Hinomura, Yasushi; Kawaguchi, Genta; Matsushita, Yasuyuki; Marui, Hiroko; Anzai, Tatsuhiko; Hashiguchi, Masayuki; Mochizuki, Mayumi

2015-01-01

Background The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection. Methods Two AE data sources from 2010 were examined, ie, JADER cases (JP) and Japanese cases extracted from the FAERS (FAERS-JP). Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS), were used on drug-event combinations for three substances frequently recorded in both systems. Results The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37) in the JP and 3.3±3.5 (maximum 62) in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and paroxetine. Signals identified by GPS for the JP and FAERS-JP, as referenced by Japanese labeling, showed higher positive sensitivity than was expected. Conclusion The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data. PMID:26109846

Comparative Case Studies Of Corridor Safety Improvement Efforts

DOT National Transportation Integrated Search

1999-12-01

In 1988, following a series of fatal crashes on U.S. Route 322, Pennsylvania's governor directed Pennsylvania's secretary of transportation to develop immediate, short-term measures to improve safety on the roadway. In response, the Pennsylvania Depa...

Indian reservation safety improvement program : a methodology and case study.

DOT National Transportation Integrated Search

2015-11-01

Improving roadway safety on Indian reservations requires a comprehensive approach. Limited : resources, lack of crash data, and few cross-jurisdictions coordination has made it difficult for : Native American communities to address their roadway safe...

Inherent Safety Characteristics of Advanced Fast Reactors

NASA Astrophysics Data System (ADS)

Bochkarev, A. S.; Korsun, A. S.; Kharitonov, V. S.; Alekseev, P. N.

2017-01-01

The study presents SFR transient performance for ULOF events initiated by pump trip and pump seizure with simultaneous failure of all shutdown systems in both cases. The most severe cases leading to the pin cladding rupture and possible sodium boiling are demonstrated. The impact of various features on SFR inherent safety performance for ULOF events was analysed. The decrease in hydraulic resistance of primary loop and increase in primary pump coast down time were investigated. Performing analysis resulted in a set of recommendations to varying parameters for the purpose of enhancing the inherent safety performance of SFR. In order to prevent the safety barrier rupture for ULOF events the set of thermal hydraulic criteria defining the ULOF transient processes dynamics and requirements to these criteria were recommended based on achieved results: primary sodium flow dip under the natural circulation asymptotic level and natural circulation rise time.

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

Science, safety, and trust: the case of transgenic food.

PubMed

Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

2013-02-01

Genetically modified (GM) food is discussed as an example of the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. On the whole, peer-reviewed studies on GM food safety do not note significant health risks, with a few exceptions, like the most renowned "Pusztai affair" and the recent "Seralini case." These latter studies have been disregarded by the scientific community, based on incorrect experimental designs and statistic analysis. Such contradictory results show the complexity of risk evaluation, and raise concerns in the citizen-consumers against the GM food. A thoughtful consideration by scientific community and decision makers of the moral values that are present in risk evaluation and risk management should be the most trustable answer to citizen-consumers to their claim for clear and definitive answers concerning safety/un-safety of GM food.

Risk Assessment in Underground Coalmines Using Fuzzy Logic in the Presence of Uncertainty

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Ala, Charan Kumar

2018-04-01

Fatal accidents are occurring every year as regular events in Indian coal mining industry. To increase the safety conditions, it has become a prerequisite to performing a risk assessment of various operations in mines. However, due to uncertain accident data, it is hard to conduct a risk assessment in mines. The object of this study is to present a method to assess safety risks in underground coalmines. The assessment of safety risks is based on the fuzzy reasoning approach. Mamdani fuzzy logic model is developed in the fuzzy logic toolbox of MATLAB. A case study is used to demonstrate the applicability of the developed model. The summary of risk evaluation in case study mine indicated that mine fire has the highest risk level among all the hazard factors. This study could help the mine management to prepare safety measures based on the risk rankings obtained.

Best practices for health and safety technology transfer in construction.

PubMed

Welch, Laura S; Russell, Dustin; Weinstock, Deborah; Betit, Eileen

2015-08-01

Construction continues to be a dangerous industry, yet solutions that would prevent injury and illness do exist. Prevention of injury and illness among construction workers requires dissemination, adoption, and implementation of these effective interventions, or "research to practice" (r2p). CPWR recruited participants with experience and insight into effective methods for diffusion of health and safety technologies in this industry for a symposium with 3 group sessions and 3 breakout groups. The organizers reviewed session notes and identified 141 recommendations, which were then assigned to 13 over-arching themes. Recommendations included a guide for researchers on patenting and licensing, a business case model, and in-depth case studies including development, testing, manufacturing, marketing, and diffusion. A more comprehensive understanding of the health and safety technology transfer landscape, the various actors, and their motivators and goals will help to foster the successful commercialization and diffusion of health and safety innovations. © 2015 Wiley Periodicals, Inc.

Occurrence of patulin in organic and conventional apple-based food marketed in Catalonia and exposure assessment.

PubMed

Piqué, Ester; Vargas-Murga, Liliana; Gómez-Catalán, Jesús; Lapuente, Joaquin de; Llobet, Joan Maria

2013-10-01

In the last years, consumption of organic foods has become increasingly popular. Nevertheless, safety of organic foods is still unclear, and needs to be thoroughly evaluated. Patulin is a mycotoxin mainly present in rotten apples and apple-based products. The aim of this study is to analyse the content of patulin in apple juices and purees derived from organic and conventional production systems, in order to assess the risk to consumers, particularly in children. A total of 93 apple-based products marketed in Catalonia were analysed, 49 of which were derived from conventional and 44 from organic farming. The results showed higher incidence of positive samples and higher concentration of patulin in organic apple purees when comparing with conventional ones. In the case of juices, significant differences were found between conventional and organic samples, but applying a multivariate analysis the type of agriculture did not seem to have a relevant contribution to patulin occurrence, being cloudiness the main factor involved. The estimated daily intake of patulin for infants and young children (0-3 years old), children (4-18 years old) and adults (19-66 years old), were below the provisional maximum tolerable daily intake (PMTDI) of 0.4 μg/kg bw in all scenarios considered. Copyright © 2013 Elsevier Ltd. All rights reserved.

77 FR 11353 - Defense Federal Acquisition Regulation Supplement: Award Fee Reduction or Denial for Health or...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... Denial for Health or Safety Issues (DFARS Case 2011-D033) AGENCY: Defense Acquisition Regulations System... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government...

The Impact of Patient Safety Training on Oral and Maxillofacial Surgery Residents' Attitudes and Knowledge: A Mixed Method Case Study

ERIC Educational Resources Information Center

Buhrow, Suzanne

2013-01-01

It is estimated that in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Patient safety experts and graduate medical education accreditation leaders recognize that medical education reform must include the integration of safety training focused on error causation, system engineering, and…

Fire safety of ground-based space facilities on the spaceport ;Vostochny;

NASA Astrophysics Data System (ADS)

Artamonov, Vladimir S.; Gordienko, Denis M.; Melikhov, Anatoly S.

2017-06-01

The facilities of the spaceport ;Vostochny; and the innovative technologies for fire safety to be implemented are considered. The planned approaches and prospects for fire safety ensuring at the facilities of the spaceport ;Vostochny; are presented herein, based on the study of emergency situations having resulted in fire accidents and explosion cases at the facilities supporting space vehicles operation.

Building Safer Secondary Schools in Uganda through Collective Commitment to Health and Safety Compliance

ERIC Educational Resources Information Center

Sekiwu, Denis; Kabanda, Milly

2014-01-01

The area of safety and accident prevention is of great concern to managers, because of the increasing number of deaths and accidents at work places. Using a case of Wakiso district, the study sought to investigate the relationship between collective commitment and management of health and safety in Ugandan secondary schools. The study employed a…

76 FR 73007 - Goodyear Tire and Rubber Company, Grant of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... measurable effect on the safety of the tire retread, repair, and recycling industries. The use of steel cord... true measure of inconsequentiality to motor vehicle safety in this case is that there is no effect of... safety of people working in the tire retread, repair, and recycling industries must also be considered...

Safe laser application requires more than laser safety

NASA Astrophysics Data System (ADS)

Frevel, A.; Steffensen, B.; Vassie, L.

1995-02-01

An overview is presented concerning aspects of laser safety in European industrial laser use. Surveys indicate that there is a large variation in the safety strategies amongst industrial laser users. Some key problem areas are highlighted. Emission of hazardous substances is a major problem for users of laser material processing systems where the majority of the particulate is of a sub-micrometre size, presenting a respiratory hazard. Studies show that in many cases emissions are not frequently monitored in factories and uncertainty exists over the hazards. Operators of laser machines do not receive adequate job training or safety training. The problem is compounded by a plethora of regulations and standards which are difficult to interpret and implement, and inspectors who are not conversant with the technology or the issues. A case is demonstrated for a more integrated approach to laser safety, taking into account the development of laser applications, organizational and personnel development, in addition to environmental and occupational health and safety aspects. It is necessary to achieve a harmonization between these elements in any organization involved in laser technology. This might be achieved through establishing technology transfer centres in laser technology.

Adverse outcomes in maternity care for women with a low risk profile in The Netherlands: a case series analysis

PubMed Central

2013-01-01

Background This study aimed to perform a structural analysis of determinants of risk of critical incidents in care for women with a low risk profile at the start of pregnancy with a view on improving patient safety. Methods We included 71 critical incidents in primary midwifery care and subsequent hospital care in case of referral after 36 weeks of pregnancy that were related to substandard care and for that reason were reported to the Health Care Inspectorate in The Netherlands in 36 months (n = 357). We performed a case-by-case analysis, using a previously validated instrument which covered five broad domains: healthcare organization, communication between healthcare providers, patient risk factors, clinical management, and clinical outcomes. Results Determinants that were associated with risk concerned healthcare organization (n = 20 incidents), communication about treatment procedures (n = 39), referral processes (n = 19), risk assessment by telephone triage (n = 10), and clinical management in an out of hours setting (n = 19). The 71 critical incidents included three cases of maternal death, eight cases of severe maternal morbidity, 42 perinatal deaths and 12 critical incidents with severe morbidity for the child. Suboptimal prenatal risk assessment, a delay in availability of health care providers in urgent situations, miscommunication about treatment between care providers, and miscommunication with patients in situations with a language barrier were associated with safety risks. Conclusions Systematic analysis of critical incidents improves insight in determinants of safety risk. The wide variety of determinants of risk of critical incidents implies that there is no single intervention to improve patient safety in the care for pregnant women with initially a low risk profile. PMID:24286376

Lessons learnt from Dental Patient Safety Case Reports

PubMed Central

Obadan, Enihomo M.; Ramoni, Rachel B.; Kalenderian, Elsbeth

2015-01-01

Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety. PMID:25925524

Elucidating the mechanisms of paternal non-disjunction of chromosome 21 in humans.

PubMed

Savage, A R; Petersen, M B; Pettay, D; Taft, L; Allran, K; Freeman, S B; Karadima, G; Avramopoulos, D; Torfs, C; Mikkelsen, M; Hassold, T J; Sherman, S L

1998-08-01

Paternal non-disjunction of chromosome 21 accounts for 5-10% of Down syndrome cases, therefore, relative to the maternally derived cases, little is known about paternally derived trisomy 21. We present the first analysis of recombination and non-disjunction for a large paternally derived population of free trisomy 21 conceptuses ( n = 67). Unlike maternal cases where the ratio of meiosis I (MI) to meiosis II (MII) errors is 3:1, a near 1:1 ratio exists among paternal cases, with a slight excess of MII errors. We found no paternal age effect for the overall population nor when classifying cases according to stage of non-disjunction error. Among 22 MI cases, only five had an observable recombinant event. This differs significantly from the 11 expected events ( P < 0.02, Fisher's exact), suggesting reduced recombination along the non-disjoined chromosomes 21 involved in paternal MI non-disjunction. No difference in recombination was detected among 27 paternal MII cases as compared with controls. However, cases exhibited a slight increase in the frequency of proximal and medial exchange when compared with controls (0.37 versus 0.28, respectively). Lastly, this study confirmed previous reports of excess male probands among paternally derived trisomy 21 cases. However, we report evidence suggesting an MII stage-specific sex ratio disturbance where 2.5 male probands were found for each female proband. Classification of MII cases based on the position of the exchange event suggested that the proband sex ratio disturbance was restricted to non-telomeric exchange cases. Based on these findings, we propose new models to explain the association between paternally derived trisomy 21 and excessive male probands.

Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations

PubMed Central

Lai, Huafang; Chen, Qiang

2012-01-01

Despite the success in expressing a variety of subunit vaccine proteins in plants and the recent stride in improving vaccine accumulation levels by transient expression systems, there is still no plant-derived vaccine that has been licensed for human use. The lack of commercial success of plant-made vaccines lies in several technical and regulatory barriers that remain to be overcome. These challenges include the lack of scalable downstream processing procedures, the uncertainty of regulatory compliance of production processes, and the lack of demonstration of plant-derived products that meet the required standards of regulatory agencies in identity, purity, potency and safety. In this study, we addressed these remaining challenges and successfully demonstrate the ability of using plants to produce a pharmaceutical grade Norwalk virus (NV) vaccine under current Good Manufacture Practice (cGMP) guidelines at multiple gram scales. Our results demonstrate that an efficient and scalable extraction and purification scheme can established for processing virus-like particles (VLP) of NV capsid protein (NVCP). We successfully operated the upstream and downstream NVCP production processes under cGMP regulations. Furthermore, plant-derived NVCP VLP demonstrates the identity, purity, potency and safety that meet the preset release specifications. This material is being tested in a Phase I human clinical trial. This research provides the first report of producing a plant-derived vaccine at scale under cGMP regulations in an academic setting and an important step for plant-produced vaccines to become a commercial reality. PMID:22134876

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.

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

PubMed

Lower, Tony; Pollock, Kirrily

2017-01-01

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

The medico-legal aspects of road traffic deaths in children under 5 years of age.

PubMed

Terranova, Claudio

2015-11-01

The family tragedy that results from a child who dies in a road traffic accident may be exacerbated by judicial consequences for the adult/parent driving the vehicle, carrying the child, or responsible for properly immobilising the child in the safety device that was used. The author presents two court cases of the road traffic accident deaths of two children under the age of five years. The two cases are presented using a methodological approach, which integrates competencies in other fields into the medico-legal aspects. An analysis of the two cases provides the opportunity to discuss the driver's responsibility to properly use child safety seat and to analyse and evaluate the efficacy and limits of child restraint systems. In the two cases, the responsibility for the application of a child safety device was excluded. It was confirmed that child protective devices are not always sufficient to avoid lesions or death in road accidents that occur with significant speed or other specific dynamics. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Relational safety and liberating training spaces: an application with a focus on sexual orientation issues.

PubMed

Hernández, Pilar; Rankin, Pressley

2008-04-01

This article describes and discusses a teaching case of a clinical training situation involving a gay marriage and family therapy student working with a same-sex affectional couple. The conceptual pillars of this teaching case, relational safety and liberating spaces, are advanced as illustrations of how the student developed his voice in the training process. Pivotal moments in this process are discussed, as are implications for training and personal and professional growth.