Safety of diabetes drugs in patients with heart failure.

PubMed

Carrasco-Sánchez, F J; Ostos-Ruiz, A I; Soto-Martín, M

2018-03-01

Heart failure (HF) and diabetes mellitus are 2 clinical conditions that often coexist, particularly in patients older than 65 years. Diabetes mellitus promotes the development of HF and confers a poorer prognosis. Hypoglycaemic agents (either by their mechanism of action, hypoglycaemic action or adverse effects) can be potentially dangerous for patients with HF. In this study, we performed a review of the available evidence on the safety of diabetes drugs in HF, focused on the main observational and experimental studies. Recent studies on cardiovascular safety have evaluated, although as a secondary objective, the impact of new hypoglycaemic agents on HF, helping us understand the neutrality, risks and potential benefits of these agents. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

ANALYSIS OF SEQUENTIAL FAILURES FOR ASSESSMENT OF RELIABILITY AND SAFETY OF MANUFACTURING SYSTEMS. (R828541)

EPA Science Inventory

Assessment of reliability and safety of a manufacturing system with sequential failures is an important issue in industry, since the reliability and safety of the system depend not only on all failed states of system components, but also on the sequence of occurrences of those...

Failure-Avoidance: Parenting, the Achievement Environment of the Home and Strategies for Reduction

ERIC Educational Resources Information Center

Thompson, Ted

2004-01-01

This paper draws together the as yet nascent literature on the development of failure-avoidant patterns of behaviour. These are behaviours intended to minimise risk to self-worth in the event of failure, thereby avoiding the negative impact of poor performance in terms of damage to self-worth. Self-worth protection, self-handicapping, impostor…

Waste minimisation in a hard chromiun plating Small Medium Enterprise (SME).

PubMed

Viguri, J R; Andrés, A; Irabien, A

2002-01-01

The high potential of waste stream minimisation in the metal finishing sector justifies specific studies of Small and Medium Enterprises (SME). In this work, the minimisation options of the wastes generated in a hard chromium plating activity have been analysed. The study has been performed in a small job shop company, which works in batch mode with big pieces. A process flowsheet after connecting the unit operations and determining the process inputs (raw and secondary materials) and outputs (waste streams) has been carried out. The main properties, quantity and current management of the waste streams have been shown. The obvious lack of information has been identified and finally the waste minimisation options that could be adopted by the company have been recorded.

Overview of Threats and Failure Models for Safety-Relevant Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This document presents a high-level overview of the threats to safety-relevant computer-based systems, including (1) a description of the introduction and activation of physical and logical faults; (2) the propagation of their effects; and (3) function-level and component-level error and failure mode models. These models can be used in the definition of fault hypotheses (i.e., assumptions) for threat-risk mitigation strategies. This document is a contribution to a guide currently under development that is intended to provide a general technical foundation for designers and evaluators of safety-relevant systems.

Minimising losses to predation during microalgae cultivation.

PubMed

Flynn, Kevin J; Kenny, Philip; Mitra, Aditee

2017-01-01

We explore approaches to minimise impacts of zooplanktonic pests upon commercial microalgal crops using system dynamics models to describe algal growth controlled by light and nutrient availability and zooplankton growth controlled by crop abundance and nutritional quality. Losses of microalgal crops are minimised when their growth is fastest and, in contrast, also when growing slowly under conditions of nutrient exhaustion. In many culture systems, however, dwindling light availability due to self-shading in dense suspensions favours slow growth under nutrient sufficiency. Such a situation improves microalgal quality as prey, enhancing zooplankton growth, and leads to rapid crop collapse. Timing of pest entry is important; crop losses are least likely in established, nutrient-exhausted microalgal communities grown for high C-content (e.g. for biofuels). A potentially useful approach is to promote a low level of P-stress that does not adversely affect microalgal growth but which produces a crop that is suboptimal for zooplankton growth.

Attitudes and behaviour towards construction waste minimisation: a comparative analysis between China and the USA.

PubMed

Liu, Jingkuang; Gong, Enqin; Wang, Dong; Lai, XiaoHong; Zhu, Jian

2018-05-21

With the spread of the concept of sustainable development, people have gained awareness about the problem of massive illegal dumping of construction waste. In this research, a questionnaire survey was carried out in the USA and China. The results indicated the following. (1) Workers in both the countries had positive minimisation attitudes, and the attitude of Chinese construction workers was not significantly different from that of American construction workers. Furthermore, their average values were 3.9 and 4.07, respectively. (2) Business owners had a poor understanding of the obligations that should be fulfilled by contractors and construction workers, which greatly reduced (a) construction workers' and contractors' motivation to implement waste minimisation management and (b) the benefit-driven effect. (3) In terms of perceived behavioural control, Chinese construction workers had poorer minimisation technologies and knowledge than American construction workers, and it was very difficult for them to implement construction waste minimisation. The research conclusions and relevant suggestions may be used to improve the construction waste minimisation behaviour and awareness of Chinese people and promote China's construction waste minimisation management.

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

NASA Astrophysics Data System (ADS)

Buscarnera, G.; Lizarraga-Barrera, J.

2014-12-01

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

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

ERIC Educational Resources Information Center

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Quantifying Pilot Contribution to Flight Safety during Hydraulic Systems Failure

NASA Technical Reports Server (NTRS)

Kramer, Lynda J.; Etherington, Timothy J.; Bailey, Randall E.; Kennedy, Kellie D.

2017-01-01

Accident statistics cite the flight crew as a causal factor in over 60% of large transport aircraft fatal accidents. Yet, a well-trained and well-qualified pilot is acknowledged as the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system. The latter statement, while generally accepted, cannot be verified because little or no quantitative data exists on how and how many accidents/incidents are averted by crew actions. A joint NASA/FAA high-fidelity motion-base human-in-the-loop test was conducted using a Level D certified Boeing 737-800 simulator to evaluate the pilot's contribution to safety-of-flight during routine air carrier flight operations and in response to aircraft system failures. To quantify the human's contribution, crew complement (two-crew, reduced crew, single pilot) was used as the independent variable in a between-subjects design. This paper details the crew's actions, including decision-making, and responses while dealing with a hydraulic systems leak - one of 6 total non-normal events that were simulated in this experiment.

A Review of Recent Advances in Perioperative Patient Safety.

PubMed

Fowler, Alexander J

2013-01-01

Major complications in surgery affect up to 16% of surgical procedures. Over the past 50 years, many patient safety initiatives have attempted to reduce such complications. Since the formation of the National Patient Safety Agency in 2001, there have been major advances in patient safety. Most recently, the production and implementation of the Surgical Safety Checklist by the World Health Organisation (WHO), a checklist ensuring that certain 'never events' (wrong-site surgery, wrong operation etc.) do not occur, irrespective of healthcare allowance. In this review, a summary of recent advances in patient safety are considered - including improvements in communication, understanding of human factors that cause mistakes, and strategies developed to minimise these. Additionally, the synthesis of best medical practice and harm minimisation is examined, with particular emphasis on communication and appreciation of human factors in the operating theatre. This is based on the resource management systems developed in other high risk industries (e.g. nuclear), and has also been adopted for other high risk medical areas. The WHO global movement to reduce surgical mortality has been highly successful, especially in the healthcare systems of developing nations where mortality reductions of up to 50% have been observed, and reductions in patient complications of 4%. Incident reporting has long been a key component of patient safety and continues to be so; allowing reflection and improved guideline formation. All patients are placed at risk in the surgical environment. It is crucial that this risk is minimised, whilst optimising the patient's outcome. In this review, recent advances in perioperative patient safety are examined and placed in context.

[A contribution safety on using low molecular weight heparin in patients with renal failure].

PubMed

Gea Rodríguez, E; Barral Viñals, N; Manso Mardones, P; Indo Berges, O

2004-01-01

1. To promote safe and appropriate use of low molecular weight heparins in patients with renal failure. 2. To analyze results from a pharmaceutical intervention program. Data from a prospective, 16-month study are presented. The entire adult population of a general hospital with 41,792 stays/year is included. An intensive monitoring program for low molecular weight heparin prescriptions in patients with renal failure is implemented. This program identifies patients using a computerized unit dose system, and is aided by a software able to calculate creatinine clearance using the Cockroft-Gault formula from an interphase between laboratory, pharmacy and admissions data, and by an algorithm to establish a recommended pharmaceutical intervention according to renal failure severity and low molecular weight heparin indication, either with prophylactic or therapeutic purposes. In all, 221 patients were identified, corresponding to 2.9% of admitted patients and 25.5% of patients with renal failure. Answers were assessable for 128 patients (61%). Extent of program acceptance according to physician-accepted pharmaceutical interventions was proportional to renal failure severity and therapy intensiveness. An acceptance of 70% was obtained for treatments with clearance < 30 mL/min, of 41.8% for treatments with 30-60 mL/min, of 31.5% for prophylaxis, and of 21.4% for low-risk patients. 1. Program repercussions improve prescription safety. 2. Scarce literature and a belief in low molecular weight heparin safety account for responses regarding pharmaceutical intervention. 3. Integrated computerized systems are essential for the implementation of intensive pharmaceutical care programs.

Machine learning prediction for classification of outcomes in local minimisation

NASA Astrophysics Data System (ADS)

Das, Ritankar; Wales, David J.

2017-01-01

Machine learning schemes are employed to predict which local minimum will result from local energy minimisation of random starting configurations for a triatomic cluster. The input data consists of structural information at one or more of the configurations in optimisation sequences that converge to one of four distinct local minima. The ability to make reliable predictions, in terms of the energy or other properties of interest, could save significant computational resources in sampling procedures that involve systematic geometry optimisation. Results are compared for two energy minimisation schemes, and for neural network and quadratic functions of the inputs.

The Parable of the Boiled System Safety Professional: Drift to Failure

NASA Technical Reports Server (NTRS)

Shivers, C. Herbert

2011-01-01

Recall from the Parable of the Boiled Frog, that tossing a frog into boiling water causes the frog to jump out and hop away while placing a frog in suitable temperature water and slowly bringing the water to a boil results in the frog boiling due to not being aware of the slowly increasing danger, theoretically, of course. System safety professionals must guard against allowing dangers to creep unnoticed into their projects and be ever alert to notice signs of impending problems. People have used various phrases related to the idea, most notably, latent conditions, James Reason in Managing the Risks of Organizational Accidents (1, pp 10-11), Drift to Failure, Sydney Dekker (2, pp 82-86) in Resilience Engineering: Chronicling the Emergence of Confused Consensus in Resilience Engineering: Concepts and Precepts, Hollnagel, Woods and Leveson, and normalization of deviance, Diane Vaughan in The Challenger Launch Decision: Risky Technology, Culture, and Deviance at NASA (3). Reason also said, If eternal vigilance is the price of liberty, then chronic unease is the price of safety (1, p 37). Our challenge as system safety professionals is to be aware of the emergence of signals that warn us of slowly eroding safety margins. This paper will discuss how system safety professionals might better perform in that regard.

16 CFR 1115.5 - Reporting of failures to comply with a voluntary consumer product safety standard relied upon by...

Code of Federal Regulations, 2010 CFR

2010-01-01

... voluntary consumer product safety standard relied upon by the Commission under section 9 of the CPSA. 1115.5 Section 1115.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.5 Reporting of failures to comply...

Safety by design: effects of operating room floor marking on the position of surgical devices to promote clean air flow compliance and minimise infection risks.

PubMed

de Korne, Dirk F; van Wijngaarden, Jeroen D H; van Rooij, Jeroen; Wauben, Linda S G L; Hiddema, U Frans; Klazinga, Niek S

2012-09-01

To evaluate the use of floor marking on the positioning of surgical devices within the clean air flow in an operating room (OR) to minimise infection risk. Laminar flow clean air systems are important in preventing infection in ORs but, for optimal results, surgical devices must be correctly positioned. The authors evaluated floor marking in four ORs at an eye hospital using time series analysis. Through observations during 829 surgeries over a 20-month period, the positions of surgical devices were determined. Eight semistructured interviews with surgical staff were conducted to assess user experiences and team dynamics. Before marking, the instrument table was positioned completely within the laminar flow in only 6.1% of the cases. This increased to 36.1% and finally 53.8%. Mayo stands were increasingly positioned within the laminar flow: from 74.2% to 84.7%. The surgical lamp decreasingly obstructed flow: from 41.8% to 28.7%. At T3 (20 months), however, in 48.6% of the applicable cases the lamp was positioned in the flow again. Discussions and site visits between airside operators and surgical staff resulted in increasing awareness of specific risk areas in the OR. OR floor markings facilitated and stimulated safety awareness and resulted in significantly increased compliance with the positioning of surgical devices in the clean air flow. Safety and quality approaches in hospital care, therefore, should include a human factors approach that focuses on system design in addition to teaching clinical and non-technical skills.

Practical Implementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery

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

Younge, Kelly Cooper, E-mail: kyounge@med.umich.edu; Wang, Yizhen; Thompson, John

2015-04-01

Purpose: To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals. Methods and Materials: Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged. Results: A totalmore » of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes. Conclusions: FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.« less

Probability of loss of assured safety in systems with multiple time-dependent failure modes.

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

Helton, Jon Craig; Pilch, Martin.; Sallaberry, Cedric Jean-Marie.

2012-09-01

Weak link (WL)/strong link (SL) systems are important parts of the overall operational design of high-consequence systems. In such designs, the SL system is very robust and is intended to permit operation of the entire system under, and only under, intended conditions. In contrast, the WL system is intended to fail in a predictable and irreversible manner under accident conditions and render the entire system inoperable before an accidental operation of the SL system. The likelihood that the WL system will fail to deactivate the entire system before the SL system fails (i.e., degrades into a configuration that could allowmore » an accidental operation of the entire system) is referred to as probability of loss of assured safety (PLOAS). Representations for PLOAS for situations in which both link physical properties and link failure properties are time-dependent are derived and numerically evaluated for a variety of WL/SL configurations, including PLOAS defined by (i) failure of all SLs before failure of any WL, (ii) failure of any SL before failure of any WL, (iii) failure of all SLs before failure of all WLs, and (iv) failure of any SL before failure of all WLs. The effects of aleatory uncertainty and epistemic uncertainty in the definition and numerical evaluation of PLOAS are considered.« less

Prescription safety eyewear: impact studies of lens and frame failure.

PubMed

Vinger, P F; Woods, T A

2000-02-01

To determine if a plano lens could be the test lens for all prescription (Rx) lenses and to investigate why Rx lenses pop out of safety eyewear. Plano and Rx polycarbonate lenses (n = 641) with varying thickness and edge geometry, mounted on steel lens holders, and Rx safety eyewear (n = 128) placed on headforms were impacted with test objects of varying diameter and hardness. Impacts were studied with 500 to 2,000 frames-per-second motion analysis. Plano lenses were at least, or more, prone to failure (dislodgment, perforation, shatter, or crack) than -3.00 or +3.00 lenses of the same minimum thickness. More than 40% of safety frames with removable lenses broke or had lenses pop out when impacted with energies expected in industry and sports. Plano lenses can be used as the test lenses for all Rx lenses made of the same material with the same minimal thickness. The ANSI Z87.1-1989 industrial standard for Rx eyewear is inadequate for sports or other activities with high-impact potential. The best lens-retention system has, as a component, a frame with a bevel perpendicular to a frontal impact force.

Minimising the harm from nicotine use: finding the right regulatory framework.

PubMed

Borland, Ron

2013-05-01

The tobacco problem can be usefully conceptualised as two problems: eliminating the most harmful forms of nicotine use (certainly cigarettes, and probably all smoked tobacco), and minimising the use and/or harms from use of lower-harm, but addictive forms of nicotine. A possible target would be to effectively eliminate use of the most harmful forms of nicotine within the next decade and then turn our focus to a long-term strategy for the low-harm forms. This paper focuses on the administrative framework(s) needed to accomplish these twin tasks. For a phase-out taking a long time and/or for dealing with residually net harmful and addictive products, there are severe limitations to allowing for-profit marketing of tobacco because such an arrangement (the current one in most countries) can markedly slow down progress and because of the difficulty of constraining marketing in ways that minimise undesirable use. A harm reduction model where the marketing is under the control of a non-profit entity (a regulated market) is required to curtail the incredible power of for-profit marketing and to allow tobacco marketing to be done in ways that further the goal of minimising tobacco-related harm. Countries with a nationalised industry can move their industry onto a harm minimisation framework if they have the political will. Countries with a for-profit industry should consider whether the time and effort required to reconstruct the market may, in the longer term, facilitate achieving their policy goals.

Safety evaluation of driver cognitive failures and driving errors on right-turn filtering movement at signalized road intersections based on Fuzzy Cellular Automata (FCA) model.

PubMed

Chai, Chen; Wong, Yiik Diew; Wang, Xuesong

2017-07-01

This paper proposes a simulation-based approach to estimate safety impact of driver cognitive failures and driving errors. Fuzzy Logic, which involves linguistic terms and uncertainty, is incorporated with Cellular Automata model to simulate decision-making process of right-turn filtering movement at signalized intersections. Simulation experiments are conducted to estimate the relationships between cognitive failures and driving errors with safety performance. Simulation results show Different types of cognitive failures are found to have varied relationship with driving errors and safety performance. For right-turn filtering movement, cognitive failures are more likely to result in driving errors with denser conflicting traffic stream. Moreover, different driving errors are found to have different safety impacts. The study serves to provide a novel approach to linguistically assess cognitions and replicate decision-making procedures of the individual driver. Compare to crash analysis, the proposed FCA model allows quantitative estimation of particular cognitive failures, and the impact of cognitions on driving errors and safety performance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Random safety auditing, root cause analysis, failure mode and effects analysis.

PubMed

Ursprung, Robert; Gray, James

2010-03-01

Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

A Predictive Safety Management System Software Package Based on the Continuous Hazard Tracking and Failure Prediction Methodology

NASA Technical Reports Server (NTRS)

Quintana, Rolando

2003-01-01

The goal of this research was to integrate a previously validated and reliable safety model, called Continuous Hazard Tracking and Failure Prediction Methodology (CHTFPM), into a software application. This led to the development of a safety management information system (PSMIS). This means that the theory or principles of the CHTFPM were incorporated in a software package; hence, the PSMIS is referred to as CHTFPM management information system (CHTFPM MIS). The purpose of the PSMIS is to reduce the time and manpower required to perform predictive studies as well as to facilitate the handling of enormous quantities of information in this type of studies. The CHTFPM theory encompasses the philosophy of looking at the concept of safety engineering from a new perspective: from a proactive, than a reactive, viewpoint. That is, corrective measures are taken before a problem instead of after it happened. That is why the CHTFPM is a predictive safety because it foresees or anticipates accidents, system failures and unacceptable risks; therefore, corrective action can be taken in order to prevent all these unwanted issues. Consequently, safety and reliability of systems or processes can be further improved by taking proactive and timely corrective actions.

Minimising the harm from nicotine use: finding the right regulatory framework

PubMed Central

Borland, Ron

2013-01-01

The tobacco problem can be usefully conceptualised as two problems: eliminating the most harmful forms of nicotine use (certainly cigarettes, and probably all smoked tobacco), and minimising the use and/or harms from use of lower-harm, but addictive forms of nicotine. A possible target would be to effectively eliminate use of the most harmful forms of nicotine within the next decade and then turn our focus to a long-term strategy for the low-harm forms. This paper focuses on the administrative framework(s) needed to accomplish these twin tasks. For a phase-out taking a long time and/or for dealing with residually net harmful and addictive products, there are severe limitations to allowing for-profit marketing of tobacco because such an arrangement (the current one in most countries) can markedly slow down progress and because of the difficulty of constraining marketing in ways that minimise undesirable use. A harm reduction model where the marketing is under the control of a non-profit entity (a regulated market) is required to curtail the incredible power of for-profit marketing and to allow tobacco marketing to be done in ways that further the goal of minimising tobacco-related harm. Countries with a nationalised industry can move their industry onto a harm minimisation framework if they have the political will. Countries with a for-profit industry should consider whether the time and effort required to reconstruct the market may, in the longer term, facilitate achieving their policy goals. PMID:23591515

Conjugate gradient minimisation approach to generating holographic traps for ultracold atoms.

PubMed

Harte, Tiffany; Bruce, Graham D; Keeling, Jonathan; Cassettari, Donatella

2014-11-03

Direct minimisation of a cost function can in principle provide a versatile and highly controllable route to computational hologram generation. Here we show that the careful design of cost functions, combined with numerically efficient conjugate gradient minimisation, establishes a practical method for the generation of holograms for a wide range of target light distributions. This results in a guided optimisation process, with a crucial advantage illustrated by the ability to circumvent optical vortex formation during hologram calculation. We demonstrate the implementation of the conjugate gradient method for both discrete and continuous intensity distributions and discuss its applicability to optical trapping of ultracold atoms.

The Contribution of Equitation Science to Minimising Horse-Related Risks to Humans.

PubMed

Starling, Melissa; McLean, Andrew; McGreevy, Paul

2016-02-23

Equitation science is an evidence-based approach to horse training and riding that focuses on a thorough understanding of both equine ethology and learning theory. This combination leads to more effective horse training, but also plays a role in keeping horse riders and trainers safe around horses. Equitation science underpins ethical equitation, and recognises the limits of the horse's cognitive and physical abilities. Equitation is an ancient practice that has benefited from a rich tradition that sees it flourishing in contemporary sporting pursuits. Despite its history, horse-riding is an activity for which neither horses nor humans evolved, and it brings with it significant risks to the safety of both species. This review outlines the reasons horses may behave in ways that endanger humans and how training choices can exacerbate this. It then discusses the recently introduced 10 Principles of Equitation Science and explains how following these principles can minimise horse-related risk to humans and enhance horse welfare.

Margins Associated with Loss of Assured Safety for Systems with Multiple Time-Dependent Failure Modes.

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

Helton, Jon C.; Brooks, Dusty Marie; Sallaberry, Cedric Jean-Marie.

Representations for margins associated with loss of assured safety (LOAS) for weak link (WL)/strong link (SL) systems involving multiple time-dependent failure modes are developed. The following topics are described: (i) defining properties for WLs and SLs, (ii) background on cumulative distribution functions (CDFs) for link failure time, link property value at link failure, and time at which LOAS occurs, (iii) CDFs for failure time margins defined by (time at which SL system fails) – (time at which WL system fails), (iv) CDFs for SL system property values at LOAS, (v) CDFs for WL/SL property value margins defined by (property valuemore » at which SL system fails) – (property value at which WL system fails), and (vi) CDFs for SL property value margins defined by (property value of failing SL at time of SL system failure) – (property value of this SL at time of WL system failure). Included in this presentation is a demonstration of a verification strategy based on defining and approximating the indicated margin results with (i) procedures based on formal integral representations and associated quadrature approximations and (ii) procedures based on algorithms for sampling-based approximations.« less

The safety of sacubitril-valsartan for the treatment of chronic heart failure.

PubMed

Tyler, Jeffrey M; Teerlink, John R

2017-02-01

Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril. Areas covered: This review discusses the clinical efficacy and safety of angiotensin receptor neprilysin inhibitor sacubitril-valsartan in heart failure with reduced ejection fraction. Expert opinion: Based on the PARADIGM-HF trial, sacubitril-valsartan offers compelling reductions in meaningful clinical endpoints, independent of age or severity of disease. The rate of adverse events was comparable between the enalapril and sacubitril-valsartan groups, although the absolute rates are likely underestimated due to the entry criteria and run-in period. Future trials and post-market surveillance are critical to better understand the risk of angioedema in high risk populations, particularly African-Americans, as well as long-term theoretical risks including the potential for increased cerebral amyloid plaque deposition with possible development of neurocognitive disease. Current trials are underway to evaluate potential benefit in patients with heart failure with preserved ejection fraction.

Investigating the relationship between predictability and imbalance in minimisation: a simulation study

PubMed Central

2013-01-01

Background The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Methods Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Results Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. Conclusions In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design. PMID:23537389

Investigating the relationship between predictability and imbalance in minimisation: a simulation study.

PubMed

McPherson, Gladys C; Campbell, Marion K; Elbourne, Diana R

2013-03-27

The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design.

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy.

PubMed

Giardina, M; Castiglia, F; Tomarchio, E

2014-12-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events.

Probability of Loss of Assured Safety in Systems with Multiple Time-Dependent Failure Modes: Incorporation of Delayed Link Failure in the Presence of Aleatory Uncertainty.

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

Helton, Jon C.; Brooks, Dusty Marie; Sallaberry, Cedric Jean-Marie.

Probability of loss of assured safety (PLOAS) is modeled for weak link (WL)/strong link (SL) systems in which one or more WLs or SLs could potentially degrade into a precursor condition to link failure that will be followed by an actual failure after some amount of elapsed time. The following topics are considered: (i) Definition of precursor occurrence time cumulative distribution functions (CDFs) for individual WLs and SLs, (ii) Formal representation of PLOAS with constant delay times, (iii) Approximation and illustration of PLOAS with constant delay times, (iv) Formal representation of PLOAS with aleatory uncertainty in delay times, (v) Approximationmore » and illustration of PLOAS with aleatory uncertainty in delay times, (vi) Formal representation of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, (vii) Approximation and illustration of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, and (viii) Procedures for the verification of PLOAS calculations for the three indicated definitions of delayed link failure.« less

30 CFR 56.7010 - Power failures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Power failures. 56.7010 Section 56.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling § 56.7010 Power failures. In the event of power failure, drill controls shall be placed in the...

30 CFR 56.7010 - Power failures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Power failures. 56.7010 Section 56.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling § 56.7010 Power failures. In the event of power failure, drill controls shall be placed in the...

30 CFR 57.7010 - Power failures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Power failures. 57.7010 Section 57.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling-Surface Only § 57.7010 Power failures. In the event of power failure, drill controls shall be...

30 CFR 56.7010 - Power failures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Power failures. 56.7010 Section 56.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling § 56.7010 Power failures. In the event of power failure, drill controls shall be placed in the...

30 CFR 57.7010 - Power failures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Power failures. 57.7010 Section 57.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling-Surface Only § 57.7010 Power failures. In the event of power failure, drill controls shall be...

30 CFR 57.7010 - Power failures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Power failures. 57.7010 Section 57.7010 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND... Drilling-Surface Only § 57.7010 Power failures. In the event of power failure, drill controls shall be...

EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING USING FAILURE MODE AND EFFECTS ANALYSIS

PubMed Central

Ford, Eric C.; Gaudette, Ray; Myers, Lee; Vanderver, Bruce; Engineer, Lilly; Zellars, Richard; Song, Danny Y.; Wong, John; DeWeese, Theodore L.

2013-01-01

Purpose Failure mode and effects analysis (FMEA) is a widely used tool for prospectively evaluating safety and reliability. We report our experiences in applying FMEA in the setting of radiation oncology. Methods and Materials We performed an FMEA analysis for our external beam radiation therapy service, which consisted of the following tasks: (1) create a visual map of the process, (2) identify possible failure modes; assign risk probability numbers (RPN) to each failure mode based on tabulated scores for the severity, frequency of occurrence, and detectability, each on a scale of 1 to 10; and (3) identify improvements that are both feasible and effective. The RPN scores can span a range of 1 to 1000, with higher scores indicating the relative importance of a given failure mode. Results Our process map consisted of 269 different nodes. We identified 127 possible failure modes with RPN scores ranging from 2 to 160. Fifteen of the top-ranked failure modes were considered for process improvements, representing RPN scores of 75 and more. These specific improvement suggestions were incorporated into our practice with a review and implementation by each department team responsible for the process. Conclusions The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error. The FMEA framework can naturally incorporate further quantification and monitoring. A general-use system for incident and near miss reporting would be useful in this regard. PMID:19409731

Risky Business: condom failures as experienced by female sex workers in Mombasa, Kenya.

PubMed

Bradburn, Caitlyn K; Wanje, George; Pfeiffer, James; Jaoko, Walter; Kurth, Ann E; McClelland, R Scott

2017-03-01

Limited research exists about condom failure as experienced by female sex workers. We conducted a qualitative study to examine how female sex workers in Mombasa, Kenya contextualise and explain the occurrence of condom failure. In-depth, semi-structured interviews were conducted with thirty female sex workers to ascertain their condom failure experiences. We qualitatively analysed interview transcripts to determine how the women mitigate risk and cope with condom failure. Condom failure was not uncommon, but women mitigated the risk by learning about correct use, and by supplying and applying condoms themselves. Many female sex workers felt that men intentionally rupture condoms. Few women were aware of or felt empowered to prevent HIV, STIs, and pregnancy after condom failure. Interventions to equip female sex workers with strategies for minimising the risk of HIV, STIs, and pregnancy in the aftermath of a condom failure should be investigated.

A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials.

PubMed

Parikh, Asit; Stephens, Kristin; Major, Eugene; Fox, Irving; Milch, Catherine; Sankoh, Serap; Lev, Michael H; Provenzale, James M; Shick, Jesse; Patti, Mark; McAuliffe, Megan; Berger, Joseph R; Clifford, David B

2018-05-08

Over the past decade, the potential for drug-associated progressive multifocal leukoencephalopathy (PML) has become an increasingly important consideration in certain drug development programmes, particularly those of immunomodulatory biologics. Whether the risk of PML with an investigational agent is proven (e.g. extrapolated from relevant experience, such as a class effect) or merely theoretical, the serious consequences of acquiring PML require careful risk minimisation and assessment. No single standard for such risk minimisation exists. Vedolizumab is a recently developed monoclonal antibody to α4β7 integrin. Its clinical development necessitated a dedicated PML risk minimisation assessment as part of a global preapproval regulatory requirement. The aim of this study was to describe the multiple risk minimisation elements that were incorporated in vedolizumab clinical trials in inflammatory bowel disease patients as part of the risk assessment and minimisation of PML programme for vedolizumab. A case evaluation algorithm was developed for sequential screening and diagnostic evaluation of subjects who met criteria that indicated a clinical suspicion of PML. An Independent Adjudication Committee provided an independent, unbiased opinion regarding the likelihood of PML. Although no cases were detected, all suspected PML events were thoroughly reviewed and successfully adjudicated, making it unlikely that cases were missed. We suggest that this programme could serve as a model for pragmatic screening for PML during the clinical development of new drugs.

Key performance outcomes of patient safety curricula: root cause analysis, failure mode and effects analysis, and structured communications skills.

PubMed

Fassett, William E

2011-10-10

As colleges and schools of pharmacy develop core courses related to patient safety, course-level outcomes will need to include both knowledge and performance measures. Three key performance outcomes for patient safety coursework, measured at the course level, are the ability to perform root cause analyses and healthcare failure mode effects analyses, and the ability to generate effective safety communications using structured formats such as the Situation-Background-Assessment-Recommendation (SBAR) situational briefing model. Each of these skills is widely used in patient safety work and competence in their use is essential for a pharmacist's ability to contribute as a member of a patient safety team.

Deriving Function-failure Similarity Information for Failure-free Rotorcraft Component Design

NASA Technical Reports Server (NTRS)

Roberts, Rory A.; Stone, Robert B.; Tumer, Irem Y.; Clancy, Daniel (Technical Monitor)

2002-01-01

Performance and safety are the top concerns of high-risk aerospace applications at NASA. Eliminating or reducing performance and safety problems can be achieved with a thorough understanding of potential failure modes in the design that lead to these problems. The majority of techniques use prior knowledge and experience as well as Failure Modes and Effects as methods to determine potential failure modes of aircraft. The aircraft design needs to be passed through a general technique to ensure that every potential failure mode is considered, while avoiding spending time on improbable failure modes. In this work, this is accomplished by mapping failure modes to certain components, which are described by their functionality. In turn, the failure modes are then linked to the basic functions that are carried within the components of the aircraft. Using the technique proposed in this paper, designers can examine the basic functions, and select appropriate analyses to eliminate or design out the potential failure modes. This method was previously applied to a simple rotating machine test rig with basic functions that are common to a rotorcraft. In this paper, this technique is applied to the engine and power train of a rotorcraft, using failures and functions obtained from accident reports and engineering drawings.

Safety and feasibility of STAT RAD: Improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis.

PubMed

Jones, Ryan T; Handsfield, Lydia; Read, Paul W; Wilson, David D; Van Ausdal, Ray; Schlesinger, David J; Siebers, Jeffrey V; Chen, Quan

2015-01-01

The clinical challenge of radiation therapy (RT) for painful bone metastases requires clinicians to consider both treatment efficacy and patient prognosis when selecting a radiation therapy regimen. The traditional RT workflow requires several weeks for common palliative RT schedules of 30 Gy in 10 fractions or 20 Gy in 5 fractions. At our institution, we have created a new RT workflow termed "STAT RAD" that allows clinicians to perform computed tomographic (CT) simulation, planning, and highly conformal single fraction treatment delivery within 2 hours. In this study, we evaluate the safety and feasibility of the STAT RAD workflow. A failure mode and effects analysis (FMEA) was performed on the STAT RAD workflow, including development of a process map, identification of potential failure modes, description of the cause and effect, temporal occurrence, and team member involvement in each failure mode, and examination of existing safety controls. A risk probability number (RPN) was calculated for each failure mode. As necessary, workflow adjustments were then made to safeguard failure modes of significant RPN values. After workflow alterations, RPN numbers were again recomputed. A total of 72 potential failure modes were identified in the pre-FMEA STAT RAD workflow, of which 22 met the RPN threshold for clinical significance. Workflow adjustments included the addition of a team member checklist, changing simulation from megavoltage CT to kilovoltage CT, alteration of patient-specific quality assurance testing, and allocating increased time for critical workflow steps. After these modifications, only 1 failure mode maintained RPN significance; patient motion after alignment or during treatment. Performing the FMEA for the STAT RAD workflow before clinical implementation has significantly strengthened the safety and feasibility of STAT RAD. The FMEA proved a valuable evaluation tool, identifying potential problem areas so that we could create a safer workflow

Subsurface safety valves: safety asset or safety liability

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

Busch, J.M.; Llewelyn, D.C.G.; Policky, B.J.

1983-10-01

This paper summarizes the methods used to compare the risk of a blowout for a well completed with a subsurface safety valve (SSSV) vs. a completion without an SSSV. These methods, which could be applied to any field, include a combination of SSSV reliability and conventional risk analyses. The Kuparuk River Unit Working Interest Owners recently formed a group to examine the risks associated with installing and maintaining SSSV's in the Kuparuk field. The group was charged with answering the question: ''Assuming Kuparuk field operating conditions, are SSSV's a safety asset, or do numerous operating and maintenance procedures make themmore » a safety liability.'' The results indicate that for the Kuparuk River Unit, an SSSV becomes a safety liability when the mean time between SSSV failures is less than one year. Since current SSSV mean time to failure (MTTF) at Kuparuk is approximately 1000 days, they are considered a safety asset.« less

[Organisational responsibility versus individual responsibility: safety culture? About the relationship between patient safety and medical malpractice law].

PubMed

Hart, Dieter

2009-01-01

The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.

Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition.

PubMed

Arenas Villafranca, Jose Javier; Gómez Sánchez, Araceli; Nieto Guindo, Miriam; Faus Felipe, Vicente

2014-07-15

Failure mode and effects analysis (FMEA) was used to identify potential errors and to enable the implementation of measures to improve the safety of neonatal parenteral nutrition (PN). FMEA was used to analyze the preparation and dispensing of neonatal PN from the perspective of the pharmacy service in a general hospital. A process diagram was drafted, illustrating the different phases of the neonatal PN process. Next, the failures that could occur in each of these phases were compiled and cataloged, and a questionnaire was developed in which respondents were asked to rate the following aspects of each error: incidence, detectability, and severity. The highest scoring failures were considered high risk and identified as priority areas for improvements to be made. The evaluation process detected a total of 82 possible failures. Among the phases with the highest number of possible errors were transcription of the medical order, formulation of the PN, and preparation of material for the formulation. After the classification of these 82 possible failures and of their relative importance, a checklist was developed to achieve greater control in the error-detection process. FMEA demonstrated that use of the checklist reduced the level of risk and improved the detectability of errors. FMEA was useful for detecting medication errors in the PN preparation process and enabling corrective measures to be taken. A checklist was developed to reduce errors in the most critical aspects of the process. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

PubMed Central

Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis

2013-01-01

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074

Incidence of patient safety events and process-related human failures during intra-hospital transportation of patients: retrospective exploration from the institutional incident reporting system.

PubMed

Yang, Shu-Hui; Jerng, Jih-Shuin; Chen, Li-Chin; Li, Yu-Tsu; Huang, Hsiao-Fang; Wu, Chao-Ling; Chan, Jing-Yuan; Huang, Szu-Fen; Liang, Huey-Wen; Sun, Jui-Sheng

2017-11-03

Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited. To perform a retrospective analysis of IHT-related events, human failures and unsafe acts. A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan. All eligible IHT-related patient safety events between January 2010 to December 2015 were included. Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts. There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (p<0.001). Of the events with human failures (n=186), the most common related process step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, p<0.001) was associated with increased patient harm, whereas the presence of omission (OR 0.12, p<0.001) was associated with less patient harm. This study shows a need to reduce human failures to prevent patient harm during intra-hospital transportation. We suggest that the transportation team pay specific attention to the sub-process at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted. © Article author(s) (or their employer(s) unless otherwise stated in the

Minimising Stress for Patients in the Veterinary Hospital: Why It Is Important and What Can Be Done about It

PubMed Central

Lloyd, Janice K. F.

2017-01-01

Minimising stress for patients should always be a priority in the veterinary hospital. However, this is often overlooked. While a “no stress” environment is not possible, understanding how to create a “low stress” (sometimes called “fear-free”) environment and how to handle animals in a less stressful manner benefits patients, staff and the hospital alike. Many veterinary practitioners believe creating a low stress environment is too hard and too time consuming, but this need not be the case. With some simple approaches, minimising patient, and hence staff, stress is achievable in all veterinary practices. This article provides a background on why minimising stress is important and outlines some practical steps that can be taken by staff to minimise stress for presenting and hospitalised patients. Useful resources on recognising signs of stress in dogs and cats, handling, restraint, behaviour modification, medications, and hospital design are provided. PMID:29056681

A Multidisciplinary Investigation of Aquatic Pollution and How to Minimise It

ERIC Educational Resources Information Center

Vergnoux, A.; Allari, E.; Sassi, M.; Thimonier, J.; Hammond, C.; Clouzot, L.

2011-01-01

The impact of humans on aquatic systems is covered in French high schools in the "Premiere" level (ages 16 to 17) by students studying economics and social sciences. We designed experiments to teach critical thinking about water pollution and how citizens can act to minimise it. The experimental session, which lasts three consecutive…

Modelling of Safety Instrumented Systems by using Bernoulli trials: towards the notion of odds on for SIS failures analysis

NASA Astrophysics Data System (ADS)

Cauffriez, Laurent

2017-01-01

This paper deals with the modeling of a random failures process of a Safety Instrumented System (SIS). It aims to identify the expected number of failures for a SIS during its lifecycle. Indeed, the fact that the SIS is a system being tested periodically gives the idea to apply Bernoulli trials to characterize the random failure process of a SIS and thus to verify if the PFD (Probability of Failing Dangerously) experimentally obtained agrees with the theoretical one. Moreover, the notion of "odds on" found in Bernoulli theory allows engineers and scientists determining easily the ratio between “outcomes with success: failure of SIS” and “outcomes with unsuccess: no failure of SIS” and to confirm that SIS failures occur sporadically. A Stochastic P-temporised Petri net is proposed and serves as a reference model for describing the failure process of a 1oo1 SIS architecture. Simulations of this stochastic Petri net demonstrate that, during its lifecycle, the SIS is rarely in a state in which it cannot perform its mission. Experimental results are compared to Bernoulli trials in order to validate the powerfulness of Bernoulli trials for the modeling of the failures process of a SIS. The determination of the expected number of failures for a SIS during its lifecycle opens interesting research perspectives for engineers and scientists by completing the notion of PFD.

A Critical Review of the Harm-Minimisation Tools Available for Electronic Gambling.

PubMed

Harris, Andrew; Griffiths, Mark D

2017-03-01

The increasing sophistication of gambling products afforded by electronic technologies facilitates increased accessibility to gambling, as well as encouraging rapid and continuous play. This poses several challenges from a responsible gambling perspective, in terms of facilitating player self-awareness and self-control. The same technological advancements in gambling that may facilitate a loss of control may also be used to provide responsible gambling tools and solutions to reduce gambling-related harm. Indeed, several harm-minimisation strategies have been devised that aim to facilitate self-awareness and self-control within a gambling session. Such strategies include the use of breaks in play, 'pop-up' messaging, limit setting, and behavioural tracking. The present paper reviews the theoretical argument underpinning the application of specific harm-minimisation tools, as well as providing one of the first critical reviews of the empirical research assessing their efficacy, in terms of influencing gambling cognitions and behaviour.

Poster - Thur Eve - 05: Safety systems and failure modes and effects analysis for a magnetic resonance image guided radiation therapy system.

PubMed

Lamey, M; Carlone, M; Alasti, H; Bissonnette, J P; Borg, J; Breen, S; Coolens, C; Heaton, R; Islam, M; van Proojen, M; Sharpe, M; Stanescu, T; Jaffray, D

2012-07-01

An online Magnetic Resonance guided Radiation Therapy (MRgRT) system is under development. The system is comprised of an MRI with the capability of travel between and into HDR brachytherapy and external beam radiation therapy vaults. The system will provide on-line MR images immediately prior to radiation therapy. The MR images will be registered to a planning image and used for image guidance. With the intention of system safety we have performed a failure modes and effects analysis. A process tree of the facility function was developed. Using the process tree as well as an initial design of the facility as guidelines possible failure modes were identified, for each of these failure modes root causes were identified. For each possible failure the assignment of severity, detectability and occurrence scores was performed. Finally suggestions were developed to reduce the possibility of an event. The process tree consists of nine main inputs and each of these main inputs consisted of 5 - 10 sub inputs and tertiary inputs were also defined. The process tree ensures that the overall safety of the system has been considered. Several possible failure modes were identified and were relevant to the design, construction, commissioning and operating phases of the facility. The utility of the analysis can be seen in that it has spawned projects prior to installation and has lead to suggestions in the design of the facility. © 2012 American Association of Physicists in Medicine.

Workflow interruptions, cognitive failure and near-accidents in health care.

PubMed

Elfering, Achim; Grebner, Simone; Ebener, Corinne

2015-01-01

Errors are frequent in health care. A specific model was tested that affirms failure in cognitive action regulation to mediate the influence of nurses' workflow interruptions and safety conscientiousness on near-accidents in health care. One hundred and sixty-five nurses from seven Swiss hospitals participated in a questionnaire survey. Structural equation modelling confirmed the hypothesised mediation model. Cognitive failure in action regulation significantly mediated the influence of workflow interruptions on near-accidents (p < .05). An indirect path from conscientiousness to near-accidents via cognitive failure in action regulation was also significant (p < .05). Compliance with safety regulations was significantly related to cognitive failure and near-accidents; moreover, cognitive failure mediated the association between compliance and near-accidents (p < .05). Contrary to expectations, compliance with safety regulations was not related to workflow interruptions. Workflow interruptions caused by colleagues, patients and organisational constraints are likely to trigger errors in nursing. Work redesign is recommended to reduce cognitive failure and improve safety of nurses and patients.

Frequency Analysis of Failure Scenarios from Shale Gas Development.

PubMed

Abualfaraj, Noura; Gurian, Patrick L; Olson, Mira S

2018-04-29

This study identified and prioritized potential failure scenarios for natural gas drilling operations through an elicitation of people who work in the industry. A list of twelve failure scenarios of concern was developed focusing on specific events that may occur during the shale gas extraction process involving an operational failure or a violation of regulations. Participants prioritized the twelve scenarios based on their potential impact on the health and welfare of the general public, potential impact on worker safety, how well safety guidelines protect against their occurrence, and how frequently they occur. Illegal dumping of flowback water, while rated as the least frequently occurring scenario, was considered the scenario least protected by safety controls and the one of most concern to the general public. In terms of worker safety, the highest concern came from improper or inadequate use of personal protective equipment (PPE). While safety guidelines appear to be highly protective regarding PPE usage, inadequate PPE is the most directly witnessed failure scenario. Spills of flowback water due to equipment failure are of concern both with regards to the welfare of the general public and worker safety as they occur more frequently than any other scenario examined in this study.

Frequency Analysis of Failure Scenarios from Shale Gas Development

PubMed Central

Abualfaraj, Noura; Olson, Mira S.

2018-01-01

This study identified and prioritized potential failure scenarios for natural gas drilling operations through an elicitation of people who work in the industry. A list of twelve failure scenarios of concern was developed focusing on specific events that may occur during the shale gas extraction process involving an operational failure or a violation of regulations. Participants prioritized the twelve scenarios based on their potential impact on the health and welfare of the general public, potential impact on worker safety, how well safety guidelines protect against their occurrence, and how frequently they occur. Illegal dumping of flowback water, while rated as the least frequently occurring scenario, was considered the scenario least protected by safety controls and the one of most concern to the general public. In terms of worker safety, the highest concern came from improper or inadequate use of personal protective equipment (PPE). While safety guidelines appear to be highly protective regarding PPE usage, inadequate PPE is the most directly witnessed failure scenario. Spills of flowback water due to equipment failure are of concern both with regards to the welfare of the general public and worker safety as they occur more frequently than any other scenario examined in this study. PMID:29710821

Generic Sensor Failure Modeling for Cooperative Systems.

PubMed

Jäger, Georg; Zug, Sebastian; Casimiro, António

2018-03-20

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application's fault tolerance and thereby promises maintainability of such system's safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques.

Generic Sensor Failure Modeling for Cooperative Systems

PubMed Central

Jäger, Georg; Zug, Sebastian

2018-01-01

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application’s fault tolerance and thereby promises maintainability of such system’s safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques. PMID:29558435

A process evaluation of the 'Aware' and 'Supportive Communities' gambling harm-minimisation programmes in New Zealand.

PubMed

Kolandai-Matchett, Komathi; Bellringer, Maria; Landon, Jason; Abbott, Max

2018-04-01

The Gambling Act 2003 mandated a public health strategy for preventing and minimising gambling harm in New Zealand. Aware Communities and Supportive Communities are two public health programmes subsequently implemented nationwide. These programmes differed from common health promotion initiatives such as media or education campaigns as they were community-action based (requiring community involvement in programme planning and delivery). We carried out a process evaluation to determine their implementation effectiveness and inform improvement and future programme planning. Our qualitative dominant mixed methods design comprised analysis of over a hundred implementer progress reports (submitted July 2010 - June 2013), a staff survey and a staff focus group interview. The programmes demonstrated capacity to not only achieve expected outcomes (e.g. enhanced community awareness about harmful gambling), but also to enhance social sustainability at the community level (e.g. established trustful relationships) and achieve some programme sustainability (e.g. community ownership over ongoing programme delivery). The evaluation noted the potential for a sustainable gambling harm-minimisation model. Community-action based harm-minimisation programmes offer programme sustainability potential which in turn offers funding cost-effectiveness when there are continual public health outcomes beyond initial funding. Although resource intensive, the community-action based approach enables culturally appropriate public health programmes suitable for societies where specific ethnic groups have higher gambling risk. Recognition of such harm-minimisation programmes' contribution to social sustainability is important considering the potential for broader public health outcomes (e.g. better life quality, lesser social problems) within socially sustainable societies.

Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure

PubMed Central

Ness, Peter J.; Khaimi, Mahmoud A.; Feldman, Robert M.; Tabet, Rania; Sarkisian, Steven R.; Skuta, Gregory L.; Chuang, Alice Z.; Mankiewicz, Kimberly A.

2011-01-01

Purpose To determine the efficacy and safety of diode transscleral cyclophotocoagulation (TSCPC) after tube shunt failure. Patients and Methods The patient population consisted of 32 eyes of 31 patients with uncontrolled glaucoma. Each eye had a previously implanted aqueous tube shunt and was currently on maximally tolerated medication. Each eye also underwent TSCPC treatment using the Iridex (Mountain View, CA) diode laser with a maximum of 360 degrees of treatment. All 31 charts were reviewed for data pertaining to demographics, treatment, ocular history, and follow-up clinical examinations. Safety was evaluated by complication data. Efficacy was evaluated in terms of TSCPC treatment parameters (number of laser applications, laser power, application duration, and degrees of ciliary body treated), intraocular pressure (IOP), number of hypotensive medications, and any further treatment required. Results With a mean (SD) follow-up of 17.1 (16.3) (median = 11.7) months from the last treatment, the mean IOP decreased from 28.6 (10.2) mmHg to 16.8 (7.5) mmHg (35% reduction) at 3 months (n = 30, p < 0.0001) and to 14.7 (7.9) mmHg (43% reduction) at 1 year (n = 13, p < 0.0001). Complications included hypotony (n = 4), hyphema (n = 2), failed corneal transplant (n = 1), and loss of light perception (n = 5). Conclusions TSCPC has a significant ocular hypotensive effect on glaucoma refractory to both tube shunt and medical therapy. The safety of this intervention remains unclear in this high risk patient population and warrants further study. PMID:21336148

In vitro activity of minimised hammerhead ribozymes.

PubMed Central

Hendry, P; McCall, M J; Santiago, F S; Jennings, P A

1995-01-01

A number of minimised hammerhead ribozymes (minizymes) which lack stem II have been kinetically characterised. These minizymes display optimal cleavage activity at temperatures around 37 degrees C. The cleavage reactions of the minizymes are first order in hydroxide ion concentration up to around pH 9.3 above which the cleavage rate constants decline rapidly. The reactions show a biphasic dependence on magnesium-ion concentration; one of the interactions has an apparent dissociation constant of around 20 mM while the other appears to be very weak, showing no sign of saturation at 200 mM MgCl2. The minizymes are significantly less active than comparable, full-size ribozymes when cleaving short substrates. However, at a particular site in a transcribed TAT gene from HIV-1, minizymes are more effective than ribozymes. PMID:7479037

Shale Failure Mechanics and Intervention Measures in Underground Coal Mines: Results From 50 Years of Ground Control Safety Research

PubMed Central

2015-01-01

Ground control research in underground coal mines has been ongoing for over 50 years. One of the most problematic issues in underground coal mines is roof failures associated with weak shale. This paper will present a historical narrative on the research the National Institute for Occupational Safety and Health has conducted in relation to rock mechanics and shale. This paper begins by first discussing how shale is classified in relation to coal mining. Characterizing and planning for weak roof sequences is an important step in developing an engineering solution to prevent roof failures. Next, the failure mechanics associated with the weak characteristics of shale will be discussed. Understanding these failure mechanics also aids in applying the correct engineering solutions. The various solutions that have been implemented in the underground coal mining industry to control the different modes of failure will be summarized. Finally, a discussion on current and future research relating to rock mechanics and shale is presented. The overall goal of the paper is to share the collective ground control experience of controlling roof structures dominated by shale rock in underground coal mining. PMID:26549926

Shale Failure Mechanics and Intervention Measures in Underground Coal Mines: Results From 50 Years of Ground Control Safety Research.

PubMed

Murphy, M M

2016-02-01

Ground control research in underground coal mines has been ongoing for over 50 years. One of the most problematic issues in underground coal mines is roof failures associated with weak shale. This paper will present a historical narrative on the research the National Institute for Occupational Safety and Health has conducted in relation to rock mechanics and shale. This paper begins by first discussing how shale is classified in relation to coal mining. Characterizing and planning for weak roof sequences is an important step in developing an engineering solution to prevent roof failures. Next, the failure mechanics associated with the weak characteristics of shale will be discussed. Understanding these failure mechanics also aids in applying the correct engineering solutions. The various solutions that have been implemented in the underground coal mining industry to control the different modes of failure will be summarized. Finally, a discussion on current and future research relating to rock mechanics and shale is presented. The overall goal of the paper is to share the collective ground control experience of controlling roof structures dominated by shale rock in underground coal mining.

Shale Failure Mechanics and Intervention Measures in Underground Coal Mines: Results From 50 Years of Ground Control Safety Research

NASA Astrophysics Data System (ADS)

Murphy, M. M.

2016-02-01

Ground control research in underground coal mines has been ongoing for over 50 years. One of the most problematic issues in underground coal mines is roof failures associated with weak shale. This paper will present a historical narrative on the research the National Institute for Occupational Safety and Health has conducted in relation to rock mechanics and shale. This paper begins by first discussing how shale is classified in relation to coal mining. Characterizing and planning for weak roof sequences is an important step in developing an engineering solution to prevent roof failures. Next, the failure mechanics associated with the weak characteristics of shale will be discussed. Understanding these failure mechanics also aids in applying the correct engineering solutions. The various solutions that have been implemented in the underground coal mining industry to control the different modes of failure will be summarized. Finally, a discussion on current and future research relating to rock mechanics and shale is presented. The overall goal of the paper is to share the collective ground control experience of controlling roof structures dominated by shale rock in underground coal mining.

Use of failure mode, effect and criticality analysis to improve safety in the medication administration process.

PubMed

Rodriguez-Gonzalez, Carmen Guadalupe; Martin-Barbero, Maria Luisa; Herranz-Alonso, Ana; Durango-Limarquez, Maria Isabel; Hernandez-Sampelayo, Paloma; Sanjurjo-Saez, Maria

2015-08-01

To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index. This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized. Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility. FMECA is a useful approach that can improve the medication administration process. © 2015 John Wiley & Sons, Ltd.

Children and adults minimise activated muscle volume by selecting gait parameters that balance gross mechanical power and work demands.

PubMed

Hubel, Tatjana Y; Usherwood, James R

2015-09-01

Terrestrial locomotion on legs is energetically expensive. Compared with cycling, or with locomotion in swimming or flying animals, walking and running are highly uneconomical. Legged gaits that minimise mechanical work have previously been identified and broadly match walking and running at appropriate speeds. Furthermore, the 'cost of muscle force' approaches are effective in relating locomotion kinetics to metabolic cost. However, few accounts have been made for why animals deviate from either work-minimising or muscle-force-minimising strategies. Also, there is no current mechanistic account for the scaling of locomotion kinetics with animal size and speed. Here, we report measurements of ground reaction forces in walking children and adult humans, and their stance durations during running. We find that many aspects of gait kinetics and kinematics scale with speed and size in a manner that is consistent with minimising muscle activation required for the more demanding between mechanical work and power: spreading the duration of muscle action reduces activation requirements for power, at the cost of greater work demands. Mechanical work is relatively more demanding for larger bipeds--adult humans--accounting for their symmetrical M-shaped vertical force traces in walking, and relatively brief stance durations in running compared with smaller bipeds--children. The gaits of small children, and the greater deviation of their mechanics from work-minimising strategies, may be understood as appropriate for their scale, not merely as immature, incompletely developed and energetically sub-optimal versions of adult gaits. © 2015. Published by The Company of Biologists Ltd.

49 CFR 193.2515 - Investigations of failures.

Code of Federal Regulations, 2010 CFR

2010-10-01

....2515 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS Operations § 193.2515 Investigations of failures. (a) Each...

A cost minimisation analysis of a telepaediatric otolaryngology service.

PubMed

Xu, Cathy Q; Smith, Anthony C; Scuffham, Paul A; Wootton, Richard

2008-02-04

Paediatric ENT services in regional areas can be provided through telemedicine (tele-ENT) using videoconferencing or with a conventional outpatient department ENT service (OPD-ENT) in which patients travel to see the specialist. The objective of this study was to identify the least-cost approach to providing ENT services for paediatric outpatients. A cost-minimisation analysis was conducted comparing the annual costs of the two modes of service provided by the Royal Children's Hospital (RCH) in Brisbane. Activity records were reviewed to analyse volume of activity during a 12 month period in 2005, i.e. number of clinics, duration of clinics, number of consultations via telemedicine and in outpatient clinics, diagnoses, and travel related information. A sensitivity analysis was conducted using factors where there was some uncertainty or potential future variation. During the study period, 88 ENT consultations were conducted via videoconference for 70 patients at Bundaberg Base Hospital. 177 ENT consultations were conducted at the RCH for 117 patients who had travelled from the Bundaberg region to Brisbane. The variable cost of providing the tele-ENT service was A$108 per consultation, compared with A$155 per consultation for the conventional outpatient service. Telemedicine was cheaper when the workload exceeded 100 consultations per year. If all 265 consultations were conducted as tele-ENT consultations, the cost-savings would be $7,621. The cost-minimisation analysis demonstrated that under the circumstances described in this paper, the tele-ENT service was a more economical method for the health department of providing specialist ENT services.

49 CFR 192.617 - Investigation of failures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Investigation of failures. 192.617 Section 192.617... BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Operations § 192.617 Investigation of failures. Each operator shall establish procedures for analyzing accidents and failures, including the selection of...

49 CFR 192.617 - Investigation of failures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Investigation of failures. 192.617 Section 192.617... BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Operations § 192.617 Investigation of failures. Each operator shall establish procedures for analyzing accidents and failures, including the selection of...

49 CFR 192.617 - Investigation of failures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Investigation of failures. 192.617 Section 192.617... BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Operations § 192.617 Investigation of failures. Each operator shall establish procedures for analyzing accidents and failures, including the selection of...

49 CFR 192.617 - Investigation of failures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Operations § 192.617 Investigation of failures. Each...

Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

PubMed

Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

2017-07-11

The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

30 CFR 41.13 - Failure to notify.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Failure to notify. 41.13 Section 41.13 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.13 Failure to notify. Failure...

30 CFR 41.13 - Failure to notify.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Failure to notify. 41.13 Section 41.13 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.13 Failure to notify. Failure...

30 CFR 41.13 - Failure to notify.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Failure to notify. 41.13 Section 41.13 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR FILING AND OTHER ADMINISTRATIVE REQUIREMENTS NOTIFICATION OF LEGAL IDENTITY Notification of Legal Identity § 41.13 Failure to notify. Failure...

Retrieval medicine: a review and guide for UK practitioners. Part 2: safety in patient retrieval systems

PubMed Central

Hearns, S; Shirley, P J

2006-01-01

Retrieval and transfer of critically ill and injured patients is a high risk activity. Risk can be minimised with robust safety and clinical governance systems in place. This article describes the various governance systems that can be employed to optimise safety and efficiency in retrieval services. These include operating procedure development, equipment management, communications procedures, crew resource management, significant event analysis, audit and training. PMID:17130608

Fracture - An Unforgiving Failure Mode

NASA Technical Reports Server (NTRS)

Goodin, James Ronald

2006-01-01

During the 2005 Conference for the Advancement for Space Safety, after a typical presentation of safety tools, a Russian in the audience simply asked, "How does that affect the hardware?" Having participated in several International System Safety Conferences, I recalled that most attention is dedicated to safety tools and little, if any, to hardware. The intent of this paper on the hazard of fracture and failure modes associated with fracture is my attempt to draw attention to the grass roots of system safety - improving hardware robustness and resilience.

Failure Modes Effects and Criticality Analysis, an Underutilized Safety, Reliability, Project Management and Systems Engineering Tool

NASA Astrophysics Data System (ADS)

Mullin, Daniel Richard

2013-09-01

The majority of space programs whether manned or unmanned for science or exploration require that a Failure Modes Effects and Criticality Analysis (FMECA) be performed as part of their safety and reliability activities. This comes as no surprise given that FMECAs have been an integral part of the reliability engineer's toolkit since the 1950s. The reasons for performing a FMECA are well known including fleshing out system single point failures, system hazards and critical components and functions. However, in the author's ten years' experience as a space systems safety and reliability engineer, findings demonstrate that the FMECA is often performed as an afterthought, simply to meet contract deliverable requirements and is often started long after the system requirements allocation and preliminary design have been completed. There are also important qualitative and quantitative components often missing which can provide useful data to all of project stakeholders. These include; probability of occurrence, probability of detection, time to effect and time to detect and, finally, the Risk Priority Number. This is unfortunate as the FMECA is a powerful system design tool that when used effectively, can help optimize system function while minimizing the risk of failure. When performed as early as possible in conjunction with writing the top level system requirements, the FMECA can provide instant feedback on the viability of the requirements while providing a valuable sanity check early in the design process. It can indicate which areas of the system will require redundancy and which areas are inherently the most risky from the onset. Based on historical and practical examples, it is this author's contention that FMECAs are an immense source of important information for all involved stakeholders in a given project and can provide several benefits including, efficient project management with respect to cost and schedule, system engineering and requirements management

Toward early safety alert endpoints: exploring biomarkers suggestive of microbicide failure.

PubMed

Mauck, Christine K; Lai, Jaim Jou; Weiner, Debra H; Chandra, Neelima; Fichorova, Raina N; Dezzutti, Charlene S; Hillier, Sharon L; Archer, David F; Creinin, Mitchell D; Schwartz, Jill L; Callahan, Marianne M; Doncel, Gustavo F

2013-11-01

Several microbicides, including nonoxynol-9 (N-9) and cellulose sulfate (CS), looked promising during early trials but failed in efficacy trials. We aimed to identify Phase I mucosal safety endpoints that might explain that failure. In a blinded, randomized, parallel trial, 60 healthy premenopausal sexually abstinent women applied Universal HEC placebo, 6% CS or 4% N-9 gel twice daily for 13½ days. Endpoints included immune biomarkers in cervicovaginal lavage (CVL) and endocervical cytobrushes, inflammatory infiltrates in vaginal biopsies, epithelial integrity by naked eye, colposcopy, and histology, CVL anti-HIV activity, vaginal microflora, pH, and adverse events. Twenty women enrolled per group. Soluble/cellular markers were similar with CS and placebo, except secretory leukocyte protease inhibitor (SLPI) levels decreased in CVL, and CD3(+) and CD45(+) cells increased in biopsies after CS use. Increases in interleukin (IL)-8, IL-1, IL-1RA, and myeloperoxidase (MPO) and decreases in SLPI were significant with N-9. CVL anti-HIV activity was significantly higher during CS use compared to N-9 or placebo. CS users tended to have a higher prevalence of intermediate Nugent score, Escherichia coli, and Enterococcus and fewer gram-negative rods. Most Nugent scores diagnostic for bacterial vaginosis were in N-9 users. All cases of histological inflammation or deep epithelial disruption occurred in N-9 users. While the surfactant N-9 showed obvious biochemical and histological signs of inflammation, more subtle changes, including depression of SLPI, tissue influx of CD45(+) and CD3(+) cells, and subclinical microflora shifts were associated with CS use and may help to explain the clinical failure of nonsurfactant microbicides.

MAXimising Involvement in MUltiMorbidity (MAXIMUM) in primary care: protocol for an observation and interview study of patients, GPs and other care providers to identify ways of reducing patient safety failures

PubMed Central

Daker-White, Gavin; Hays, Rebecca; Esmail, Aneez; Minor, Brian; Barlow, Wendy; Brown, Benjamin; Blakeman, Thomas; Bower, Peter

2014-01-01

Introduction Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention. Methods and analysis We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors. Ethics and dissemination Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision

High-fidelity phase and amplitude control of phase-only computer generated holograms using conjugate gradient minimisation.

PubMed

Bowman, D; Harte, T L; Chardonnet, V; De Groot, C; Denny, S J; Le Goc, G; Anderson, M; Ireland, P; Cassettari, D; Bruce, G D

2017-05-15

We demonstrate simultaneous control of both the phase and amplitude of light using a conjugate gradient minimisation-based hologram calculation technique and a single phase-only spatial light modulator (SLM). A cost function, which incorporates the inner product of the light field with a chosen target field within a defined measure region, is efficiently minimised to create high fidelity patterns in the Fourier plane of the SLM. A fidelity of F = 0.999997 is achieved for a pattern resembling an LG10 mode with a calculated light-usage efficiency of 41.5%. Possible applications of our method in optical trapping and ultracold atoms are presented and we show uncorrected experimental realisation of our patterns with F = 0.97 and 7.8% light efficiency.

Heart failure.

PubMed

Metra, Marco; Teerlink, John R

2017-10-28

Heart failure is common in adults, accounting for substantial morbidity and mortality worldwide. Its prevalence is increasing because of ageing of the population and improved treatment of acute cardiovascular events, despite the efficacy of many therapies for patients with heart failure with reduced ejection fraction, such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), β blockers, and mineralocorticoid receptor antagonists, and advanced device therapies. Combined angiotensin receptor blocker neprilysin inhibitors (ARNIs) have been associated with improvements in hospital admissions and mortality from heart failure compared with enalapril, and guidelines now recommend substitution of ACE inhibitors or ARBs with ARNIs in appropriate patients. Improved safety of left ventricular assist devices means that these are becoming more commonly used in patients with severe symptoms. Antidiabetic therapies might further improve outcomes in patients with heart failure. New drugs with novel mechanisms of action, such as cardiac myosin activators, are under investigation for patients with heart failure with reduced left ventricular ejection fraction. Heart failure with preserved ejection fraction is a heterogeneous disorder that remains incompletely understood and will continue to increase in prevalence with the ageing population. Although some data suggest that spironolactone might improve outcomes in these patients, no therapy has conclusively shown a significant effect. Hopefully, future studies will address these unmet needs for patients with heart failure. Admissions for acute heart failure continue to increase but, to date, no new therapies have improved clinical outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of governance mechanisms on food safety in the supply chain: Evidence from the Lebanese dairy sector.

PubMed

Abebe, Gumataw K; Chalak, Ali; Abiad, Mohamad G

2017-07-01

Food safety is a key public health issue worldwide. This study aims to characterise existing governance mechanisms - governance structures (GSs) and food safety management systems (FSMSs) - and analyse the alignment thereof in detecting food safety hazards, based on empirical evidence from Lebanon. Firm-to-firm and public baseline are the dominant FSMSs applied in a large-scale, while chain-wide FSMSs are observed only in a small-scale. Most transactions involving farmers are relational and market-based in contrast to (large-scale) processors, which opt for hierarchical GSs. Large-scale processors use a combination of FSMSs and GSs to minimise food safety hazards albeit potential increase in coordination costs; this is an important feature of modern food supply chains. The econometric analysis reveals contract period, on-farm inspection and experience having significant effects in minimising food safety hazards. However, the potential to implement farm-level FSMS is influenced by formality of the contract, herd size, trading partner choice, and experience. Public baseline FSMSs appear effective in controlling food safety hazards; however, this may not be viable due to the scarcity of public resources. We suggest public policies to focus on long-lasting governance mechanisms by introducing incentive schemes and farm-level FSMSs by providing loans and education to farmers. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

49 CFR 193.2515 - Investigations of failures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Investigations of failures. 193.2515 Section 193.2515 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS... GAS FACILITIES: FEDERAL SAFETY STANDARDS Operations § 193.2515 Investigations of failures. (a) Each...

49 CFR 193.2515 - Investigations of failures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Investigations of failures. 193.2515 Section 193.2515 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS... GAS FACILITIES: FEDERAL SAFETY STANDARDS Operations § 193.2515 Investigations of failures. (a) Each...

49 CFR 193.2515 - Investigations of failures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Investigations of failures. 193.2515 Section 193.2515 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS... GAS FACILITIES: FEDERAL SAFETY STANDARDS Operations § 193.2515 Investigations of failures. (a) Each...

49 CFR 193.2515 - Investigations of failures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Investigations of failures. 193.2515 Section 193.2515 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS... GAS FACILITIES: FEDERAL SAFETY STANDARDS Operations § 193.2515 Investigations of failures. (a) Each...

Combining neuroendocrine inhibitors in heart failure: reflections on safety and efficacy.

PubMed

Jneid, Hani; Moukarbel, George V; Dawson, Bart; Hajjar, Roger J; Francis, Gary S

2007-12-01

Neuroendocrine activation in heart failure has become the major target of pharmacotherapy for this growing epidemic. Agents targeting the renin-angiotensin-aldosterone and sympathetic nervous systems have shown cardiovascular and survival benefits in clinical trials. Beta-blockers and angiotensin-converting enzyme (ACE) inhibitors remain the mainstream initial therapy. The benefits of aldosterone antagonists have been demonstrated in advanced heart failure (spironolactone) and after myocardial infarction complicated by left ventricular dysfunction and heart failure (eplerenone). Emerging clinical evidence demonstrated that angiotensin receptor blockers may be a reasonable alternative to ACE inhibitors in patients with heart failure (candesartan) and following myocardial infarction complicated by heart failure or left ventricular dysfunction (valsartan). Angiotensin receptor blockers (candesartan) also provided incremental benefits when added to ACE inhibitors in chronic heart failure. Thus, combining neuroendocrine inhibitors in heart failure appears both biologically plausible and evidence-based. However, this approach raised concerns about side effects, such as hypotension, renal insufficiency, hyperkalemia, and others. Close follow-up and implementation of evidence-based medicine (ie, using agents and doses proven beneficial in clinical trials) should therefore be undertaken when combining neuroendocrine inhibitors.

Reliability and Failure in NASA Missions: Blunders, Normal Accidents, High Reliability, Bad Luck

NASA Technical Reports Server (NTRS)

Jones, Harry W.

2015-01-01

NASA emphasizes crew safety and system reliability but several unfortunate failures have occurred. The Apollo 1 fire was mistakenly unanticipated. After that tragedy, the Apollo program gave much more attention to safety. The Challenger accident revealed that NASA had neglected safety and that management underestimated the high risk of shuttle. Probabilistic Risk Assessment was adopted to provide more accurate failure probabilities for shuttle and other missions. NASA's "faster, better, cheaper" initiative and government procurement reform led to deliberately dismantling traditional reliability engineering. The Columbia tragedy and Mars mission failures followed. Failures can be attributed to blunders, normal accidents, or bad luck. Achieving high reliability is difficult but possible.

[Clinical assessment of drug safety].

PubMed

Imbs, J-L; Welsch, M

2007-09-01

The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.

Evaluation and Customization of WHO Safety Checklist for Patient Safety in Otorhinolaryngology.

PubMed

Dabholkar, Yogesh; Velankar, Haritosh; Suryanarayan, Sneha; Dabholkar, Twinkle Y; Saberwal, Akanksha A; Verma, Bhavika

2018-03-01

The WHO has designed a safe surgery checklist to enhance communication and awareness of patient safety during surgery and to minimise complications. WHO recommends that the check-list be evaluated and customised by end users as a tool to promote safe surgery. The aim of present study was to evaluate the impact of WHO safety checklist on patient safety awareness in otorhinolaryngology and to customise it for the speciality. A prospective structured questionnaire based study was done in ENT operating room for duration of 1 month each for cases, before and after implementation of safe surgery checklist. The feedback from respondents (surgeons, nurses and anaesthetists) was used to arrive at a customised checklist for otolaryngology as per WHO guidelines. The checklist significantly improved team member's awareness of patient's identity (from 17 to 86%) and each other's identity and roles (from 46 to 94%) and improved team communication (from 73 to 92%) in operation theatre. There was a significant improvement in preoperative check of equipment and critical events were discussed more frequently. The checklist could be effectively customised to suit otolaryngology needs as per WHO guidelines. The modified checklist needs to be validated by otolaryngology associations. We conclude from our study that the WHO Surgical safety check-list has a favourable impact on patient safety awareness, team-work and communication of operating team and can be customised for otolaryngology setting.

Application of multi attribute failure mode analysis of milk production using analytical hierarchy process method

NASA Astrophysics Data System (ADS)

Rucitra, A. L.

2018-03-01

Pusat Koperasi Induk Susu (PKIS) Sekar Tanjung, East Java is one of the modern dairy industries producing Ultra High Temperature (UHT) milk. A problem that often occurs in the production process in PKIS Sekar Tanjung is a mismatch between the production process and the predetermined standard. The purpose of applying Analytical Hierarchy Process (AHP) was to identify the most potential cause of failure in the milk production process. Multi Attribute Failure Mode Analysis (MAFMA) method was used to eliminate or reduce the possibility of failure when viewed from the failure causes. This method integrates the severity, occurrence, detection, and expected cost criteria obtained from depth interview with the head of the production department as an expert. The AHP approach was used to formulate the priority ranking of the cause of failure in the milk production process. At level 1, the severity has the highest weight of 0.41 or 41% compared to other criteria. While at level 2, identifying failure in the UHT milk production process, the most potential cause was the average mixing temperature of more than 70 °C which was higher than the standard temperature (≤70 ° C). This failure cause has a contributes weight of 0.47 or 47% of all criteria Therefore, this study suggested the company to control the mixing temperature to minimise or eliminate the failure in this process.

JNCC guidelines for minimising the risk of injury and disturbance to marine mammals from seismic surveys: We can do better.

PubMed

Wright, Andrew J; Cosentino, A Mel

2015-11-15

The U.K.'s Joint Nature Conservation Committee 1998 guidelines for minimising acoustic impacts from seismic surveys on marine mammals were the first of their kind. Covering both planning and operations, they included various measures for reducing the potential for damaging hearing - an appropriate focus at the time. Since introduction, the guidelines have been criticised for, among other things: the arbitrarily-sized safety zones; the lack of shut-down provisions; the use of mitigation measures that introduce more noise into the environment (e.g., soft-starts); inadequate observer training; and the lack of standardised data collection protocols. Despite the concerns, the guidelines have remained largely unchanged. Moreover, increasing scientific recognition of the scope and magnitude of non-injurious impacts of sound on marine life has become much more widespread since the last revisions in 2010. Accordingly, here we present feasible and realistic recommendations for such improvements, in light of the current state of knowledge. Copyright © 2015 Elsevier Ltd. All rights reserved.

"Change Can Only Be a Good Thing:" Staff Views on the Introduction of a Harm Minimisation Policy in a Forensic Learning Disability Service

ERIC Educational Resources Information Center

Fish, Rebecca; Woodward, Sarah; Duperouzel, Helen

2012-01-01

Recent local research about personal experiences of self-injury and discussions about the use of harm minimisation with service users who self-injure were the motivation behind this study to glean staff opinions and advice about the introduction of a harm minimisation policy. An online survey was designed, and all staff were invited by email to…

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

PubMed

Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

CT fluoroscopy-guided renal tumour cutting needle biopsy: retrospective evaluation of diagnostic yield, safety, and risk factors for diagnostic failure.

PubMed

Iguchi, Toshihiro; Hiraki, Takao; Matsui, Yusuke; Fujiwara, Hiroyasu; Sakurai, Jun; Masaoka, Yoshihisa; Gobara, Hideo; Kanazawa, Susumu

2018-01-01

To evaluate retrospectively the diagnostic yield, safety, and risk factors for diagnostic failure of computed tomography (CT) fluoroscopy-guided renal tumour biopsy. Biopsies were performed for 208 tumours (mean diameter 2.3 cm; median diameter 2.1 cm; range 0.9-8.5 cm) in 199 patients. One hundred and ninety-nine tumours were ≤4 cm. All 208 initial procedures were divided into diagnostic success and failure groups. Multiple variables related to the patients, lesions, and procedures were assessed to determine the risk factors for diagnostic failure. After performing 208 initial and nine repeat biopsies, 180 malignancies and 15 benign tumours were pathologically diagnosed, whereas 13 were not diagnosed. In 117 procedures, 118 Grade I and one Grade IIIa adverse events (AEs) occurred. Neither Grade ≥IIIb AEs nor tumour seeding were observed within a median follow-up period of 13.7 months. Logistic regression analysis revealed only small tumour size (≤1.5 cm; odds ratio 3.750; 95% confidence interval 1.362-10.326; P = 0.011) to be a significant risk factor for diagnostic failure. CT fluoroscopy-guided renal tumour biopsy is a safe procedure with a high diagnostic yield. A small tumour size (≤1.5 cm) is a significant risk factor for diagnostic failure. • CT fluoroscopy-guided renal tumour biopsy has a high diagnostic yield. • CT fluoroscopy-guided renal tumour biopsy is safe. • Small tumour size (≤1.5 cm) is a risk factor for diagnostic failure.

Obstetric Safety and Quality.

PubMed

Pettker, Christian M; Grobman, William A

2015-07-01

Obstetric safety and quality is an emerging and important topic not only as a result of the pressures of patient and regulatory expectations, but also because of the genuine interest of caregivers to reduce harm, improve outcomes, and optimize care. Although each seeks to improve care by using scientific approaches beyond human physiology and pathophysiology, patient safety methodologies seek to avoid preventable adverse events, whereas health care quality projects aim to achieve the best possible outcomes. It is well-documented that an increasingly complex medical system controlled by human workers is a circumstance subject to recurrent failure. A safety culture encourages a proactive approach to mitigate failure before, during, and after it occurs. This article highlights the key concepts in health care safety and quality and reviews the background of the quality improvement sciences with particular emphasis on obstetric outcomes and quality measures.

Probabilistic safety analysis of earth retaining structures during earthquakes

NASA Astrophysics Data System (ADS)

Grivas, D. A.; Souflis, C.

1982-07-01

A procedure is presented for determining the probability of failure of Earth retaining structures under static or seismic conditions. Four possible modes of failure (overturning, base sliding, bearing capacity, and overall sliding) are examined and their combined effect is evaluated with the aid of combinatorial analysis. The probability of failure is shown to be a more adequate measure of safety than the customary factor of safety. As Earth retaining structures may fail in four distinct modes, a system analysis can provide a single estimate for the possibility of failure. A Bayesian formulation of the safety retaining walls is found to provide an improved measure for the predicted probability of failure under seismic loading. The presented Bayesian analysis can account for the damage incurred to a retaining wall during an earthquake to provide an improved estimate for its probability of failure during future seismic events.

(n, N) type maintenance policy for multi-component systems with failure interactions

NASA Astrophysics Data System (ADS)

Zhang, Zhuoqi; Wu, Su; Li, Binfeng; Lee, Seungchul

2015-04-01

This paper studies maintenance policies for multi-component systems in which failure interactions and opportunistic maintenance (OM) involve. This maintenance problem can be formulated as a Markov decision process (MDP). However, since an action set and state space in MDP exponentially expand as the number of components increase, traditional approaches are computationally intractable. To deal with curse of dimensionality, we decompose such a multi-component system into mutually influential single-component systems. Each single-component system is formulated as an MDP with the objective of minimising its long-run average maintenance cost. Under some reasonable assumptions, we prove the existence of the optimal (n, N) type policy for a single-component system. An algorithm to obtain the optimal (n, N) type policy is also proposed. Based on the proposed algorithm, we develop an iterative approximation algorithm to obtain an acceptable maintenance policy for a multi-component system. Numerical examples find that failure interactions and OM pose significant effects on a maintenance policy.

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

PubMed

Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

2017-09-11

The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development

The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.

PubMed

Holubarsch, Christian J F; Colucci, Wilson S; Meinertz, Thomas; Gaus, Wilhelm; Tendera, Michal

2008-12-01

Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed. To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS 1442 in patients with congestive heart failure. In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF< or =35%) were included and received 900 mg/day WS 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event. 2681 patients (WS 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF> or =25%, WS 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups. In this study, WS 1442 had no significant effect on the primary endpoint. WS 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.

Minimising barriers to dental care in older people

PubMed Central

Borreani, Elena; Wright, Desmond; Scambler, Sasha; Gallagher, Jennifer E

2008-01-01

Background Older people are increasingly retaining their natural teeth but at higher risk of oral disease with resultant impact on their quality of life. Socially deprived people are more at risk of oral disease and yet less likely to take up care. Health organisations in England and Wales are exploring new ways to commission and provide dental care services in general and for vulnerable groups in particular. This study was undertaken to investigate barriers to dental care perceived by older people in socially deprived inner city area where uptake of care was low and identify methods for minimising barriers in older people in support of oral health. Methods A qualitative dual-methodological approach, utilising both focus groups and individual interviews, was used in this research. Participants, older people and carers of older people, were recruited using purposive sampling through day centres and community groups in the inner city boroughs of Lambeth, Southwark and Lewisham in South London. A topic guide was utilised to guide qualitative data collection. Informants' views were recorded on tape and in field notes. The data were transcribed and analysed using Framework Methodology. Results Thirty-nine older people and/or their carers participated in focus groups. Active barriers to dental care in older people fell into five main categories: cost, fear, availability, accessibility and characteristics of the dentist. Lack of perception of a need for dental care was a common 'passive barrier' amongst denture wearers in particular. The cost of dental treatment, fear of care and perceived availability of dental services emerged to influence significantly dental attendance. Minimising barriers involves three levels of action to be taken: individual actions (such as persistence in finding available care following identification of need), system changes (including reducing costs, improving information, ensuring appropriate timing and location of care, and good patient

System safety in Stirling engine development

NASA Technical Reports Server (NTRS)

Bankaitis, H.

1981-01-01

The DOE/NASA Stirling Engine Project Office has required that contractors make safety considerations an integral part of all phases of the Stirling engine development program. As an integral part of each engine design subtask, analyses are evolved to determine possible modes of failure. The accepted system safety analysis techniques (Fault Tree, FMEA, Hazards Analysis, etc.) are applied in various degrees of extent at the system, subsystem and component levels. The primary objectives are to identify critical failure areas, to enable removal of susceptibility to such failures or their effects from the system and to minimize risk.

Beyond antidoping and harm minimisation: a stakeholder-corporate social responsibility approach to drug control for sport.

PubMed

Mazanov, Jason

2016-04-01

Debate about the ethics of drug control in sport has largely focused on arguing the relative merits of the existing antidoping policy or the adoption of a health-based harm minimisation approach. A number of ethical challenges arising from antidoping have been identified, and a number of, as yet, unanswered questions remain for the maturing ethics of applying harm minimisation principles to drug control for sport. This paper introduces a 'third approach' to the debate, examining some implications of applying a stakeholder theory of corporate social responsibility (CSR) to the issue of doping in sport. The introduction of the stakeholder-CSR model creates an opportunity to challenge the two dominant schools by enabling a different perspective to contribute to the development of an ethically robust drug control for sport. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Application of Function-Failure Similarity Method to Rotorcraft Component Design

NASA Technical Reports Server (NTRS)

Roberts, Rory A.; Stone, Robert E.; Tumer, Irem Y.; Clancy, Daniel (Technical Monitor)

2002-01-01

Performance and safety are the top concerns of high-risk aerospace applications at NASA. Eliminating or reducing performance and safety problems can be achieved with a thorough understanding of potential failure modes in the designs that lead to these problems. The majority of techniques use prior knowledge and experience as well as Failure Modes and Effects as methods to determine potential failure modes of aircraft. During the design of aircraft, a general technique is needed to ensure that every potential failure mode is considered, while avoiding spending time on improbable failure modes. In this work, this is accomplished by mapping failure modes to specific components, which are described by their functionality. The failure modes are then linked to the basic functions that are carried within the components of the aircraft. Using this technique, designers can examine the basic functions, and select appropriate analyses to eliminate or design out the potential failure modes. The fundamentals of this method were previously introduced for a simple rotating machine test rig with basic functions that are common to a rotorcraft. In this paper, this technique is applied to the engine and power train of a rotorcraft, using failures and functions obtained from accident reports and engineering drawings.

Effects of hospital safety-net burden and hospital volume on failure to rescue after open abdominal aortic surgery.

PubMed

Rosero, Eric B; Joshi, Girish P; Minhajuddin, Abu; Timaran, Carlos H; Modrall, J Gregory

2017-08-01

Failure to rescue (FTR) is defined as the inability to rescue a patient from major perioperative complications, resulting in operative mortality. FTR is a known contributor to operative mortality after open abdominal aortic surgery. Understanding the causes of FTR is essential to designing interventions to improve perioperative outcomes. The objective of this study was to determine the relative contributions of hospital volume and safety-net burden (the proportion of uninsured and Medicaid-insured patients) to FTR. The Nationwide Inpatient Sample (2001-2011) was analyzed to investigate variables associated with FTR after elective open abdominal aortic operations in the United States. FTR was defined as in-hospital death following postoperative complications. Mixed multivariate regression models were used to assess independent predictors of FTR, taking into account the clustered structure of the data (patients nested into hospitals). A total of 47,233 elective open abdominal aortic operations were performed in 1777 hospitals during the study period. The overall incidences of postoperative complications, in-hospital mortality, and FTR in the whole cohort were 32.7%, 3.2%, and 8.6%, respectively. After adjusting for demographics, comorbidities, and hospital characteristics, safety-net burden was significantly associated with increased likelihood of FTR (highest vs lowest quartile of safety-net burden, odds ratio, 1.59; 95% confidence interval, 1.32-1.91; P < .0001). In contrast, after adjusting for safety-net burden, procedure-specific hospital volume was not significantly associated with FTR (P = .897). After adjusting for patient- and hospital-level variables, including hospital volume, safety-net burden was an independent predictor of FTR after open aortic surgery. Future investigations should be aimed at better understanding the relationship between safety-net hospital burden and FTR to design interventions to improve outcomes after open abdominal aortic surgery

Why system safety programs can fail

NASA Technical Reports Server (NTRS)

Hammer, W.

1971-01-01

Factors that cause system safety programs to fail are discussed from the viewpoint that in general these programs have not achieved their intended aims. The one item which is considered to contribute most to failure of a system safety program is a poor statement of work which consists of ambiguity, lack of clear definition, use of obsolete requirements, and pure typographical errors. It is pointed out that unless safety requirements are stated clearly, and where they are readily apparent as firm requirements, some of them will be overlooked by designers and contractors. The lack of clarity is stated as being a major contributing factor in system safety program failure and usually evidenced in: (1) lack of clear requirements by the procuring activity, (2) lack of clear understanding of system safety by other managers, and (3) lack of clear methodology to be employed by system safety engineers.

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

49 CFR 192.617 - Investigation of failures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS... operator shall establish procedures for analyzing accidents and failures, including the selection of...

A streamlined failure mode and effects analysis

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

Ford, Eric C., E-mail: eford@uw.edu; Smith, Koren; Terezakis, Stephanie

Purpose: Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort. Methods: FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and usedmore » to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project. Results: Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes hadRPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator. Conclusions: Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.« less

A streamlined failure mode and effects analysis.

PubMed

Ford, Eric C; Smith, Koren; Terezakis, Stephanie; Croog, Victoria; Gollamudi, Smitha; Gage, Irene; Keck, Jordie; DeWeese, Theodore; Sibley, Greg

2014-06-01

Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort. FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project. Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator. Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.

Minimisation de l'influence de la témperature sur un capteur polarimétrique de position angulaire

NASA Astrophysics Data System (ADS)

Gaumont, Eric; Chakari, Ayoub; Clement, Michel; Meyrueis, Patrick

2018-04-01

This paper, "Minimisation de l'influence de la témperature sur un capteur polarimétrique de position angulaire," was presented as part of International Conference on Space Optics—ICSO 1997, held in Toulouse, France.

Seismic analysis for translational failure of landfills with retaining walls.

PubMed

Feng, Shi-Jin; Gao, Li-Ya

2010-11-01

In the seismic impact zone, seismic force can be a major triggering mechanism for translational failures of landfills. The scope of this paper is to develop a three-part wedge method for seismic analysis of translational failures of landfills with retaining walls. The approximate solution of the factor of safety can be calculated. Unlike previous conventional limit equilibrium methods, the new method is capable of revealing the effects of both the solid waste shear strength and the retaining wall on the translational failures of landfills during earthquake. Parameter studies of the developed method show that the factor of safety decreases with the increase of the seismic coefficient, while it increases quickly with the increase of the minimum friction angle beneath waste mass for various horizontal seismic coefficients. Increasing the minimum friction angle beneath the waste mass appears to be more effective than any other parameters for increasing the factor of safety under the considered condition. Thus, selecting liner materials with higher friction angle will considerably reduce the potential for translational failures of landfills during earthquake. The factor of safety gradually increases with the increase of the height of retaining wall for various horizontal seismic coefficients. A higher retaining wall is beneficial to the seismic stability of the landfill. Simply ignoring the retaining wall will lead to serious underestimation of the factor of safety. Besides, the approximate solution of the yield acceleration coefficient of the landfill is also presented based on the calculated method. Copyright © 2010 Elsevier Ltd. All rights reserved.

Functional Safety of Hybrid Laser Safety Systems - How can a Combination between Passive and Active Components Prevent Accidents?

NASA Astrophysics Data System (ADS)

Lugauer, F. P.; Stiehl, T. H.; Zaeh, M. F.

Modern laser systems are widely used in industry due to their excellent flexibility and high beam intensities. This leads to an increased hazard potential, because conventional laser safety barriers only offer a short protection time when illuminated with high laser powers. For that reason active systems are used more and more to prevent accidents with laser machines. These systems must fulfil the requirements of functional safety, e.g. according to IEC 61508, which causes high costs. The safety provided by common passive barriers is usually unconsidered in this context. In the presented approach, active and passive systems are evaluated from a holistic perspective. To assess the functional safety of hybrid safety systems, the failure probability of passive barriers is analysed and added to the failure probability of the active system.

Advances on the Failure Analysis of the Dam-Foundation Interface of Concrete Dams.

PubMed

Altarejos-García, Luis; Escuder-Bueno, Ignacio; Morales-Torres, Adrián

2015-12-02

Failure analysis of the dam-foundation interface in concrete dams is characterized by complexity, uncertainties on models and parameters, and a strong non-linear softening behavior. In practice, these uncertainties are dealt with a well-structured mixture of experience, best practices and prudent, conservative design approaches based on the safety factor concept. Yet, a sound, deep knowledge of some aspects of this failure mode remain unveiled, as they have been offset in practical applications by the use of this conservative approach. In this paper we show a strategy to analyse this failure mode under a reliability-based approach. The proposed methodology of analysis integrates epistemic uncertainty on spatial variability of strength parameters and data from dam monitoring. The purpose is to produce meaningful and useful information regarding the probability of occurrence of this failure mode that can be incorporated in risk-informed dam safety reviews. In addition, relationships between probability of failure and factors of safety are obtained. This research is supported by a more than a decade of intensive professional practice on real world cases and its final purpose is to bring some clarity, guidance and to contribute to the improvement of current knowledge and best practices on such an important dam safety concern.

Advances on the Failure Analysis of the Dam—Foundation Interface of Concrete Dams

PubMed Central

Altarejos-García, Luis; Escuder-Bueno, Ignacio; Morales-Torres, Adrián

2015-01-01

Failure analysis of the dam-foundation interface in concrete dams is characterized by complexity, uncertainties on models and parameters, and a strong non-linear softening behavior. In practice, these uncertainties are dealt with a well-structured mixture of experience, best practices and prudent, conservative design approaches based on the safety factor concept. Yet, a sound, deep knowledge of some aspects of this failure mode remain unveiled, as they have been offset in practical applications by the use of this conservative approach. In this paper we show a strategy to analyse this failure mode under a reliability-based approach. The proposed methodology of analysis integrates epistemic uncertainty on spatial variability of strength parameters and data from dam monitoring. The purpose is to produce meaningful and useful information regarding the probability of occurrence of this failure mode that can be incorporated in risk-informed dam safety reviews. In addition, relationships between probability of failure and factors of safety are obtained. This research is supported by a more than a decade of intensive professional practice on real world cases and its final purpose is to bring some clarity, guidance and to contribute to the improvement of current knowledge and best practices on such an important dam safety concern. PMID:28793709

33 CFR 164.82 - Maintenance, failure, and reporting.

Code of Federal Regulations, 2011 CFR

2011-07-01

... safety, such as propulsion machinery, steering gear, radar, gyrocompass, echo depth-sounding or other... repair within 96 hours an inoperative marine radar required by § 164.72(a) shall so notify the Captain of... navigational-safety equipment, including but not limited to failure of one of two installed radars, where each...

33 CFR 164.82 - Maintenance, failure, and reporting.

Code of Federal Regulations, 2013 CFR

2013-07-01

... safety, such as propulsion machinery, steering gear, radar, gyrocompass, echo depth-sounding or other... repair within 96 hours an inoperative marine radar required by § 164.72(a) shall so notify the Captain of... navigational-safety equipment, including but not limited to failure of one of two installed radars, where each...

33 CFR 164.82 - Maintenance, failure, and reporting.

Code of Federal Regulations, 2014 CFR

2014-07-01

... safety, such as propulsion machinery, steering gear, radar, gyrocompass, echo depth-sounding or other... repair within 96 hours an inoperative marine radar required by § 164.72(a) shall so notify the Captain of... navigational-safety equipment, including but not limited to failure of one of two installed radars, where each...

33 CFR 164.82 - Maintenance, failure, and reporting.

Code of Federal Regulations, 2012 CFR

2012-07-01

... safety, such as propulsion machinery, steering gear, radar, gyrocompass, echo depth-sounding or other... repair within 96 hours an inoperative marine radar required by § 164.72(a) shall so notify the Captain of... navigational-safety equipment, including but not limited to failure of one of two installed radars, where each...

Quantifying Safety Margin Using the Risk-Informed Safety Margin Characterization (RISMC)

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

Grabaskas, David; Bucknor, Matthew; Brunett, Acacia

2015-04-26

The Risk-Informed Safety Margin Characterization (RISMC), developed by Idaho National Laboratory as part of the Light-Water Reactor Sustainability Project, utilizes a probabilistic safety margin comparison between a load and capacity distribution, rather than a deterministic comparison between two values, as is usually done in best-estimate plus uncertainty analyses. The goal is to determine the failure probability, or in other words, the probability of the system load equaling or exceeding the system capacity. While this method has been used in pilot studies, there has been little work conducted investigating the statistical significance of the resulting failure probability. In particular, it ismore » difficult to determine how many simulations are necessary to properly characterize the failure probability. This work uses classical (frequentist) statistics and confidence intervals to examine the impact in statistical accuracy when the number of simulations is varied. Two methods are proposed to establish confidence intervals related to the failure probability established using a RISMC analysis. The confidence interval provides information about the statistical accuracy of the method utilized to explore the uncertainty space, and offers a quantitative method to gauge the increase in statistical accuracy due to performing additional simulations.« less

10 CFR 70.62 - Safety program and integrated safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... conclusion of each failure investigation of an item relied on for safety or management measure. (b) Process... methodology being used. (3) Requirements for existing licensees. Individuals holding an NRC license on...

Sensitivity to VSR failure: K pipe break accident

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

Meichle, R.H.

1969-09-12

Reactor effects of failure of a safety rod to scram can be considered in two major respects: The reduction in total safety system strength which will affect the amount of ``prompt drop`` and subsequent flux decay rate of the average neutron flux-level; and the change in local flux distribution due to the absence of the particular rod which fails to enter the reactor. The purpose of this memorandum is to describe the physical effects involved and to indicate the approximate magnitude of both reactor-wide and localized changes in event of failure of a VSR simultaneous with a K Reactor risermore » accident.« less

14 CFR 31.25 - Factor of safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... envelope stress. (c) A factor of safety of at least five must be used in the design of all fibrous or non... any single failure will not jeopardize safety of flight. (d) In applying factors of safety, the effect...

Constitutive behavior and progressive mechanical failure of electrodes in lithium-ion batteries

NASA Astrophysics Data System (ADS)

Zhang, Chao; Xu, Jun; Cao, Lei; Wu, Zenan; Santhanagopalan, Shriram

2017-07-01

The electrodes of lithium-ion batteries (LIB) are known to be brittle and to fail earlier than the separators during an external crush event. Thus, the understanding of mechanical failure mechanism for LIB electrodes (anode and cathode) is critical for the safety design of LIB cells. In this paper, we present experimental and numerical studies on the constitutive behavior and progression of failure in LIB electrodes. Mechanical tests were designed and conducted to evaluate the constitutive properties of porous electrodes. Constitutive models were developed to describe the stress-strain response of electrodes under uniaxial tensile and compressive loads. The failure criterion and a damage model were introduced to model their unique tensile and compressive failure behavior. The failure mechanism of LIB electrodes was studied using the blunt rod test on dry electrodes, and numerical models were built to simulate progressive failure. The different failure processes were examined and analyzed in detail numerically, and correlated with experimentally observed failure phenomena. The test results and models improve our understanding of failure behavior in LIB electrodes, and provide constructive insights on future development of physics-based safety design tools for battery structures under mechanical abuse.

Constitutive behavior and progressive mechanical failure of electrodes in lithium-ion batteries

DOE PAGES

Zhang, Chao; Xu, Jun; Cao, Lei; ...

2017-05-05

The electrodes of lithium-ion batteries (LIB) are known to be brittle and to fail earlier than the separators during an external crush event. Thus, the understanding of mechanical failure mechanism for LIB electrodes (anode and cathode) is critical for the safety design of LIB cells. In this paper, we present experimental and numerical studies on the constitutive behavior and progression of failure in LIB electrodes. Mechanical tests were designed and conducted to evaluate the constitutive properties of porous electrodes. Constitutive models were developed to describe the stress-strain response of electrodes under uniaxial tensile and compressive loads. The failure criterion andmore » a damage model were introduced to model their unique tensile and compressive failure behavior. The failure mechanism of LIB electrodes was studied using the blunt rod test on dry electrodes, and numerical models were built to simulate progressive failure. The different failure processes were examined and analyzed in detail numerically, and correlated with experimentally observed failure phenomena. Finally, the test results and models improve our understanding of failure behavior in LIB electrodes, and provide constructive insights on future development of physics-based safety design tools for battery structures under mechanical abuse.« less

Effects of unplanned treatment interruptions on HIV treatment failure - results from TAHOD.

PubMed

Jiamsakul, Awachana; Kerr, Stephen J; Ng, Oon Tek; Lee, Man Po; Chaiwarith, Romanee; Yunihastuti, Evy; Van Nguyen, Kinh; Pham, Thuy Thanh; Kiertiburanakul, Sasisopin; Ditangco, Rossana; Saphonn, Vonthanak; Sim, Benedict L H; Merati, Tuti Parwati; Wong, Wingwai; Kantipong, Pacharee; Zhang, Fujie; Choi, Jun Yong; Pujari, Sanjay; Kamarulzaman, Adeeba; Oka, Shinichi; Mustafa, Mahiran; Ratanasuwan, Winai; Petersen, Boondarika; Law, Matthew; Kumarasamy, Nagalingeswaran

2016-05-01

Treatment interruptions (TIs) of combination antiretroviral therapy (cART) are known to lead to unfavourable treatment outcomes but do still occur in resource-limited settings. We investigated the effects of TI associated with adverse events (AEs) and non-AE-related reasons, including their durations, on treatment failure after cART resumption in HIV-infected individuals in Asia. Patients initiating cART between 2006 and 2013 were included. TI was defined as stopping cART for >1 day. Treatment failure was defined as confirmed virological, immunological or clinical failure. Time to treatment failure during cART was analysed using Cox regression, not including periods off treatment. Covariables with P < 0.10 in univariable analyses were included in multivariable analyses, where P < 0.05 was considered statistically significant. Of 4549 patients from 13 countries in Asia, 3176 (69.8%) were male and the median age was 34 years. A total of 111 (2.4%) had TIs due to AEs and 135 (3.0%) had TIs for other reasons. Median interruption times were 22 days for AE and 148 days for non-AE TIs. In multivariable analyses, interruptions >30 days were associated with failure (31-180 days HR = 2.66, 95%CI (1.70-4.16); 181-365 days HR = 6.22, 95%CI (3.26-11.86); and >365 days HR = 9.10, 95% CI (4.27-19.38), all P < 0.001, compared to 0-14 days). Reasons for previous TI were not statistically significant (P = 0.158). Duration of interruptions of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure. If TI is unavoidable, its duration should be minimised to reduce the risk of failure after treatment resumption. © 2016 John Wiley & Sons Ltd.

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

PubMed

Bazant, Zdenĕk P; Pang, Sze-Dai

2006-06-20

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

Probabilistic analysis on the failure of reactivity control for the PWR

NASA Astrophysics Data System (ADS)

Sony Tjahyani, D. T.; Deswandri; Sunaryo, G. R.

2018-02-01

The fundamental safety function of the power reactor is to control reactivity, to remove heat from the reactor, and to confine radioactive material. The safety analysis is used to ensure that each parameter is fulfilled during the design and is done by deterministic and probabilistic method. The analysis of reactivity control is important to be done because it will affect the other of fundamental safety functions. The purpose of this research is to determine the failure probability of the reactivity control and its failure contribution on a PWR design. The analysis is carried out by determining intermediate events, which cause the failure of reactivity control. Furthermore, the basic event is determined by deductive method using the fault tree analysis. The AP1000 is used as the object of research. The probability data of component failure or human error, which is used in the analysis, is collected from IAEA, Westinghouse, NRC and other published documents. The results show that there are six intermediate events, which can cause the failure of the reactivity control. These intermediate events are uncontrolled rod bank withdrawal at low power or full power, malfunction of boron dilution, misalignment of control rod withdrawal, malfunction of improper position of fuel assembly and ejection of control rod. The failure probability of reactivity control is 1.49E-03 per year. The causes of failures which are affected by human factor are boron dilution, misalignment of control rod withdrawal and malfunction of improper position for fuel assembly. Based on the assessment, it is concluded that the failure probability of reactivity control on the PWR is still within the IAEA criteria.

Fault tree applications within the safety program of Idaho Nuclear Corporation

NASA Technical Reports Server (NTRS)

Vesely, W. E.

1971-01-01

Computerized fault tree analyses are used to obtain both qualitative and quantitative information about the safety and reliability of an electrical control system that shuts the reactor down when certain safety criteria are exceeded, in the design of a nuclear plant protection system, and in an investigation of a backup emergency system for reactor shutdown. The fault tree yields the modes by which the system failure or accident will occur, the most critical failure or accident causing areas, detailed failure probabilities, and the response of safety or reliability to design modifications and maintenance schemes.

[Failure mode effect analysis applied to preparation of intravenous cytostatics].

PubMed

Santos-Rubio, M D; Marín-Gil, R; Muñoz-de la Corte, R; Velázquez-López, M D; Gil-Navarro, M V; Bautista-Paloma, F J

2016-01-01

To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes. This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Destructive Single-Event Failures in Diodes

NASA Technical Reports Server (NTRS)

Casey, Megan C.; Gigliuto, Robert A.; Lauenstein, Jean-Marie; Wilcox, Edward P.; Kim, Hak; Chen, Dakai; Phan, Anthony M.; LaBel, Kenneth A.

2013-01-01

In this summary, we have shown that diodes are susceptible to destructive single-event effects, and that these failures occur along the guard ring. By determining the last passing voltages, a safe operating area can be derived. By derating off of those values, rather than by the rated voltage, like what is currently done with power MOSFETs, we can work to ensure the safety of future missions. However, there are still open questions about these failures. Are they limited to a single manufacturer, a small number, or all of them? Is there a threshold rated voltage that must be exceeded to see these failures? With future work, we hope to answer these questions. In the full paper, laser results will also be presented to verify that failures only occur along the guard ring.

A Taxonomy of Fallacies in System Safety Arguments

NASA Technical Reports Server (NTRS)

Greenwell, William S.; Knight, John C.; Holloway, C. Michael; Pease, Jacob J.

2006-01-01

Safety cases are gaining acceptance as assurance vehicles for safety-related systems. A safety case documents the evidence and argument that a system is safe to operate; however, logical fallacies in the underlying argument may undermine a system s safety claims. Removing these fallacies is essential to reduce the risk of safety-related system failure. We present a taxonomy of common fallacies in safety arguments that is intended to assist safety professionals in avoiding and detecting fallacious reasoning in the arguments they develop and review. The taxonomy derives from a survey of general argument fallacies and a separate survey of fallacies in real-world safety arguments. Our taxonomy is specific to safety argumentation, and it is targeted at professionals who work with safety arguments but may lack formal training in logic or argumentation. We discuss the rationale for the selection and categorization of fallacies in the taxonomy. In addition to its applications to the development and review of safety cases, our taxonomy could also support the analysis of system failures and promote the development of more robust safety case patterns.

Cell salvage for minimising perioperative allogeneic blood transfusion

PubMed Central

Carless, Paul A; Henry, David A; Moxey, Annette J; O’Connell, Dianne; Brown, Tamara; Fergusson, Dean A

2014-01-01

Background Concerns regarding the safety of transfused blood have prompted reconsideration of the use of allogeneic (from an unrelated donor) red blood cell (RBC) transfusion, and a range of techniques to minimise transfusion requirements. Objectives To examine the evidence for the efficacy of cell salvage in reducing allogeneic blood transfusion and the evidence for any effect on clinical outcomes. Search methods We identified studies by searching CENTRAL (The Cochrane Library 2009, Issue 2), MEDLINE (1950 to June 2009), EMBASE (1980 to June 2009), the internet (to August 2009) and bibliographies of published articles. Selection criteria Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to cell salvage (autotransfusion) or to a control group who did not receive the intervention. Data collection and analysis Data were independently extracted and the risk of bias assessed. Relative risks (RR) and weighted mean differences (WMD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random-effects model. The primary outcomes were the number of patients exposed to allogeneic red cell transfusion and the amount of blood transfused. Other clinical outcomes are detailed in the review. Main results A total of 75 trials were included. Overall, the use of cell salvage reduced the rate of exposure to allogeneic RBC transfusion by a relative 38% (RR 0.62; 95% CI 0.55 to 0.70). The absolute reduction in risk (ARR) of receiving an allogeneic RBC transfusion was 21% (95% CI 15% to 26%). In orthopaedic procedures the RR of exposure to RBC transfusion was 0.46 (95% CI 0.37 to 0.57) compared to 0.77 (95% CI 0.69 to 0.86) for cardiac procedures. The use of cell salvage resulted in an average saving of 0.68 units of allogeneic RBC per patient (WMD −0.68; 95% CI −0.88 to −0.49). Cell salvage did not appear to impact adversely on clinical outcomes. Authors’ conclusions

Failure to rescue in safety-net hospitals: availability of hospital resources and differences in performance.

PubMed

Wakeam, Elliot; Hevelone, Nathanael D; Maine, Rebecca; Swain, Jabaris; Lipsitz, Stuart A; Finlayson, Samuel R G; Ashley, Stanley W; Weissman, Joel S

2014-03-01

Failure to rescue (FTR), the mortality rate among surgical patients with complications, is an emerging quality indicator. Hospitals with a high safety-net burden, defined as the proportion of patients covered by Medicaid or uninsured, provide a disproportionate share of medical care to vulnerable populations. Given the financial strains on hospitals with a high safety-net burden, availability of clinical resources may have a role in outcome disparities. To assess the association between safety-net burden and FTR and to evaluate the effect of clinical resources on this relationship. A retrospective cohort of 46,519 patients who underwent high-risk inpatient surgery between January 1, 2007, and December 31, 2010, was assembled using the Nationwide Inpatient Sample. Hospitals were divided into the following 3 safety-net categories: high-burden hospitals (HBHs), moderate-burden hospitals (MBHs), and low-burden hospitals (LBHs). Bivariate and multivariate analyses controlling for patient, procedural, and hospital characteristics, as well as clinical resources, were used to evaluate the relationship between safety-net burden and FTR. FTR. Patients in HBHs were younger (mean age, 65.2 vs 68.2 years; P = .001), more likely to be of black race (11.3% vs 4.2%, P < .001), and less likely to undergo an elective procedure (39.3% vs 48.6%, P = .002) compared with patients in LBHs. The HBHs were more likely to be large, major teaching facilities and to have high levels of technology (8.6% vs 4.0%, P = .02), sophisticated internal medicine (7.7% vs 4.3%, P = .10), and high ratios of respiratory therapists to beds (39.7% vs 21.1%, P < .001). However, HBHs had lower proportions of registered nurses (27.9% vs 38.8%, P = .02) and were less likely to have a positron emission tomographic scanner (15.4% vs 22.0%, P = .03) and a fully implemented electronic medical record (12.6% vs 17.8%, P = .03). Multivariate analyses showed that HBHs (adjusted odds ratio, 1.35; 95% CI

Space engine safety system

NASA Technical Reports Server (NTRS)

Maul, William A.; Meyer, Claudia M.

1991-01-01

A rocket engine safety system was designed to initiate control procedures to minimize damage to the engine or vehicle or test stand in the event of an engine failure. The features and the implementation issues associated with rocket engine safety systems are discussed, as well as the specific concerns of safety systems applied to a space-based engine and long duration space missions. Examples of safety system features and architectures are given, based on recent safety monitoring investigations conducted for the Space Shuttle Main Engine and for future liquid rocket engines. Also, the general design and implementation process for rocket engine safety systems is presented.

Safety and feasibility of inpatient exercise training in pediatric heart failure: a preliminary report.

PubMed

McBride, Michael G; Binder, Tracy Jo; Paridon, Stephen M

2007-01-01

To determine the safety and feasibility of an inpatient exercise training program for a group of pediatric heart transplantation candidates on multiple inotropic support. Children with end-stage heart disease often require heart transplantation. Currently, no data exist on the safety and feasibility of an inpatient exercise training program in pediatric patients awaiting heart transplantation while on inotropic support. Twenty ambulatory patients (11 male; age, 13.6 +/- 3.2 years) were admitted, listed, and subsequently enrolled into an exercise training program while awaiting heart transplantation. Patient diagnoses consisted of dilated cardiomyopathy (n = 15), restrictive cardiomyopathy (n = 1), and failing single-ventricle physiology (n = 4). Inotropic support consisted of a combination of dobutamine, dopamine, or milrinone. Exercise sessions were scheduled three times a week lasting from 30 to 60 minutes and consisted of aerobic and musculoskeletal conditioning. Over 6.2 +/- 4.2 months, 1,251 of a possible 1,508 exercise training sessions were conducted, with a total of 615 hours (26.3 +/- 2.7 min/session) dedicated to low-intensity aerobic exercise. Reasons for noncompliance included a change in medical status, staffing, or patient cooperation. Two adverse episodes (seizures) occurred, neither of which resulted in termination from the program. No adverse episodes of hypotension or significant complex arrhythmias occurred. No complication of medication administration or loss of intravenous access occurred. Data from this study indicate that pediatric patients on inotropic support as a result of systemic ventricular or biventricular heart failure can safely participate in exercise training programs with relatively moderate to high compliance.

Efficacy and Safety of Renal Sympathetic Denervation on Dogs with Pressure Overload-Induced Heart Failure.

PubMed

Chen, Pingan; Leng, Shuilong; Luo, Yishan; Li, Shaonan; Huang, Zicheng; Liu, Zhenxi; Liu, Zhen; Wang, Jie; Lei, Xiaoming

2017-02-01

In dogs with heart failure (HF) induced by overload pressure, the role of renal sympathetic denervation (RSD) on heart failure and in the renal artery is unclear. Therefore, we investigated the efficacy and safety of RSD in dogs with pressure overload-induced heart failure. Twenty mongrel dogs were divided into a sham-operated group, an HF group and an HF + RSD group. In the sham-operated group, the abdominal aorta was located but was not constricted, in the HF group, the abdominal aorta was constricted without RSD, and the HF+RSD group underwent RSD with constriction of the abdominal aorta after 10 weeks. Blood sampling assays, echocardiography, intravascular ultrasound (IVUS) measurement and histopathological examination were performed. Renal sympathetic denervation caused a significant reduction in the levels of noradrenaline (166.62±6.84 vs. 183.48±13.66 pg/ml, P<0.05), plasma renin activity (1.93±0.12 vs. 2.10±0.13 ng/mlh, P<0.05) and B-type natriuretic peptide (71.14±3.86 vs. 83.15±5.73 pg/ml, P<0.05) at eight weeks after RSD in the HF+RSD group. Compared with the HF group at eight weeks, the left ventricular internal dimension at end-diastole and end-systole were lower and the left ventricular ejection fraction was higher (all P<0.05) at eight weeks after RSD in the HF+RSD group. Intravenous ultrasound images showed no changes in the renal artery lumen, and intimal hyperplasia and vascular lumen stenosis were not observed after RSD. Renal sympathetic denervation could improve cardiac function in dogs with HF induced by pressure overload; RSD had no adverse influence on the renal artery. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

10 CFR 36.37 - Power failures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Power failures. 36.37 Section 36.37 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... only when using an operable and calibrated radiation survey meter. ...

10 CFR 36.37 - Power failures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Power failures. 36.37 Section 36.37 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... only when using an operable and calibrated radiation survey meter. ...

10 CFR 36.37 - Power failures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Power failures. 36.37 Section 36.37 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... only when using an operable and calibrated radiation survey meter. ...

10 CFR 36.37 - Power failures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Power failures. 36.37 Section 36.37 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... only when using an operable and calibrated radiation survey meter. ...

10 CFR 36.37 - Power failures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Power failures. 36.37 Section 36.37 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... only when using an operable and calibrated radiation survey meter. ...

Albumin Dialysis for Liver Failure: A Systematic Review.

PubMed

Tsipotis, Evangelos; Shuja, Asim; Jaber, Bertrand L

2015-09-01

Albumin dialysis is the best-studied extracorporeal nonbiologic liver support system as a bridge or destination therapy for patients with liver failure awaiting liver transplantation or recovery of liver function. We performed a systematic review to examine the efficacy and safety of 3 albumin dialysis systems (molecular adsorbent recirculating system [MARS], fractionated plasma separation, adsorption and hemodialysis [Prometheus system], and single-pass albumin dialysis) in randomized trials for supportive treatment of liver failure. PubMed, Ovid, EMBASE, Cochrane's Library, and ClinicalTrials.gov were searched. Two authors independently screened citations and extracted data on patient characteristics, quality of reports, efficacy, and safety end points. Ten trials (7 of MARS and 3 of Prometheus) were identified (620 patients). By meta-analysis, albumin dialysis achieved a net decrease in serum total bilirubin level relative to standard medical therapy of 8.0 mg/dL (95% confidence interval [CI], -10.6 to -5.4) but not in serum ammonia or bile acids. Albumin dialysis achieved an improvement in hepatic encephalopathy relative to standard medical therapy with a risk ratio of 1.55 (95% CI, 1.16-2.08) but had no effect survival with a risk ratio of 0.95 (95% CI, 0.84-1.07). Because of inconsistency in the reporting of adverse events, the safety analysis was limited but did not demonstrate major safety concerns. Use of albumin dialysis as supportive treatment for liver failure is successful at removing albumin-bound molecules, such as bilirubin and at improving hepatic encephalopathy. Additional experience is required to guide its optimal use and address safety concerns. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Learning from failure in health care: frequent opportunities, pervasive barriers.

PubMed

Edmondson, A C

2004-12-01

The notion that hospitals and medical practices should learn from failures, both their own and others', has obvious appeal. Yet, healthcare organisations that systematically and effectively learn from the failures that occur in the care delivery process, especially from small mistakes and problems rather than from consequential adverse events, are rare. This article explores pervasive barriers embedded in healthcare's organisational systems that make shared or organisational learning from failure difficult and then recommends strategies for overcoming these barriers to learning from failure, emphasising the critical role of leadership. Firstly, leaders must create a compelling vision that motivates and communicates urgency for change; secondly, leaders must work to create an environment of psychological safety that fosters open reporting, active questioning, and frequent sharing of insights and concerns; and thirdly, case study research on one hospital's organisational learning initiative suggests that leaders can empower and support team learning throughout their organisations as a way of identifying, analysing, and removing hazards that threaten patient safety.

Learning from failure in health care: frequent opportunities, pervasive barriers

PubMed Central

Edmondson, A

2004-01-01

The notion that hospitals and medical practices should learn from failures, both their own and others', has obvious appeal. Yet, healthcare organisations that systematically and effectively learn from the failures that occur in the care delivery process, especially from small mistakes and problems rather than from consequential adverse events, are rare. This article explores pervasive barriers embedded in healthcare's organisational systems that make shared or organisational learning from failure difficult and then recommends strategies for overcoming these barriers to learning from failure, emphasising the critical role of leadership. Firstly, leaders must create a compelling vision that motivates and communicates urgency for change; secondly, leaders must work to create an environment of psychological safety that fosters open reporting, active questioning, and frequent sharing of insights and concerns; and thirdly, case study research on one hospital's organisational learning initiative suggests that leaders can empower and support team learning throughout their organisations as a way of identifying, analysing, and removing hazards that threaten patient safety. PMID:15576689

Failure modes and effects analysis automation

NASA Technical Reports Server (NTRS)

Kamhieh, Cynthia H.; Cutts, Dannie E.; Purves, R. Byron

1988-01-01

A failure modes and effects analysis (FMEA) assistant was implemented as a knowledge based system and will be used during design of the Space Station to aid engineers in performing the complex task of tracking failures throughout the entire design effort. The three major directions in which automation was pursued were the clerical components of the FMEA process, the knowledge acquisition aspects of FMEA, and the failure propagation/analysis portions of the FMEA task. The system is accessible to design, safety, and reliability engineers at single user workstations and, although not designed to replace conventional FMEA, it is expected to decrease by many man years the time required to perform the analysis.

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.

77 FR 28451 - Unsatisfactory Safety Rating; Revocation of Operating Authority Registration; Technical Amendments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... carrier for failure to comply with safety fitness requirements; if the Agency determines that a motor carrier is ``Unfit'' based on its Safety Fitness Determination procedures, the Agency must revoke the... failure to comply with safety fitness requirements. See 49 U.S.C. 13905(f)(1)(B) and (3). The implementing...

42 CFR 3.422 - Failure to request a hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.422 Failure to request a... Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail...

42 CFR 3.422 - Failure to request a hearing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.422 Failure to request a... Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail...

42 CFR 3.422 - Failure to request a hearing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.422 Failure to request a... Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail...

42 CFR 3.422 - Failure to request a hearing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.422 Failure to request a... Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail...

42 CFR 3.422 - Failure to request a hearing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.422 Failure to request a... Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail...

49 CFR 234.105 - Activation failure.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Activation failure. 234.105 Section 234.105 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SIGNAL SYSTEM SAFETY AND STATE ACTION PLANS Response to Reports...

49 CFR 234.105 - Activation failure.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Activation failure. 234.105 Section 234.105 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SIGNAL SYSTEM SAFETY AND STATE ACTION PLANS Response to Reports...

Efficacy and safety of crataegus extract WS 1442 in comparison with placebo in patients with chronic stable New York Heart Association class-III heart failure.

PubMed

Tauchert, Michael

2002-05-01

The purpose of this study was to investigate whether long-term therapy with crataegus extract WS 1442 is efficacious as add-on therapy to preexisting diuretic treatment in patients with heart failure with a more advanced stage of the disease (New York Heart Association [NYHA] class III), whether effects are dose dependent, and whether the treatment is safe and well tolerated. Exercise capacity was assessed by use of seated bicycle ergometry with incremental workloads. Scores for subjective symptoms and complaints made by the patients were analyzed. Efficacy and tolerability of the treatments were judged by both the patients and investigators. Safety was assessed by the documentation of adverse events and the safety laboratory. A total of 209 patients were randomized to treatment with 1800 mg of WS 1442, 900 mg of WS 1442, or with placebo. After 16 weeks of therapy with 1800 mg of WS 1442 per day, maximal tolerated workload during bicycle exercise showed a statistically significant increase in comparison with both placebo and 900 mg of WS 1442. Typical heart failure symptoms as rated by the patients were reduced to a greater extent by WS 1442 than by placebo. This difference was significant for both doses of WS 1442. Both efficacy and tolerability were rated best for the 1800 mg of WS 1442 group by patients and investigators alike. The incidence of adverse events was lowest in the 1800 mg of WS 1442 group, particularly with respect to dizziness and vertigo. The data from this study confirm that there is a dose-dependent effect of WS 1442 on the exercise capacity of patients with heart failure and on typical heart failure-related clinical signs and symptoms. The drug was shown to be well tolerated and safe.

49 CFR 191.12 - Distribution Systems: Mechanical Fitting Failure Reports

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Distribution Systems: Mechanical Fitting Failure Reports 191.12 Section 191.12 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER...

Neuromuscular transmission failure in myasthenia gravis: decrement of safety factor and susceptibility of extraocular muscles.

PubMed

Serra, Alessandro; Ruff, Robert L; Leigh, Richard John

2012-12-01

An appropriate density of acetylcholine receptors (AChRs) and Na(+) channels (NaChs) in the normal neuromuscular junction (NMJ) determines the magnitude of safety factor (SF) that guarantees fidelity of neuromuscular transmission. In myasthenia gravis (MG), an overall simplification of the postsynaptic folding secondary to NMJ destruction results in AChRs and NaChs depletion. Loss of AChRs and NaChs accounts, respectively, for 59% and 40% reduction of the SF at the endplate, which manifests as neuromuscular transmission failure. The extraocular muscles (EOM) have physiologically less developed postsynaptic folding, hence a lower baseline SF, which predisposes them to dysfunction in MG and development of fatigue during "high performance" eye movements, such as saccades. However, saccades in MG show stereotyped, conjugate initial components, similar to normal, which might reflect preserved neuromuscular transmission fidelity at the NMJ of the fast, pale global fibers, which have better developed postsynaptic folding than other extraocular fibers. © 2012 New York Academy of Sciences.

A Big Data Analysis Approach for Rail Failure Risk Assessment.

PubMed

Jamshidi, Ali; Faghih-Roohi, Shahrzad; Hajizadeh, Siamak; Núñez, Alfredo; Babuska, Robert; Dollevoet, Rolf; Li, Zili; De Schutter, Bart

2017-08-01

Railway infrastructure monitoring is a vital task to ensure rail transportation safety. A rail failure could result in not only a considerable impact on train delays and maintenance costs, but also on safety of passengers. In this article, the aim is to assess the risk of a rail failure by analyzing a type of rail surface defect called squats that are detected automatically among the huge number of records from video cameras. We propose an image processing approach for automatic detection of squats, especially severe types that are prone to rail breaks. We measure the visual length of the squats and use them to model the failure risk. For the assessment of the rail failure risk, we estimate the probability of rail failure based on the growth of squats. Moreover, we perform severity and crack growth analyses to consider the impact of rail traffic loads on defects in three different growth scenarios. The failure risk estimations are provided for several samples of squats with different crack growth lengths on a busy rail track of the Dutch railway network. The results illustrate the practicality and efficiency of the proposed approach. © 2017 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

Automated Mixed Traffic Vehicle (AMTV) technology and safety study

NASA Technical Reports Server (NTRS)

Johnston, A. R.; Peng, T. K. C.; Vivian, H. C.; Wang, P. K.

1978-01-01

Technology and safety related to the implementation of an Automated Mixed Traffic Vehicle (AMTV) system are discussed. System concepts and technology status were reviewed and areas where further development is needed are identified. Failure and hazard modes were also analyzed and methods for prevention were suggested. The results presented are intended as a guide for further efforts in AMTV system design and technology development for both near term and long term applications. The AMTV systems discussed include a low speed system, and a hybrid system consisting of low speed sections and high speed sections operating in a semi-guideway. The safety analysis identified hazards that may arise in a properly functioning AMTV system, as well as hardware failure modes. Safety related failure modes were emphasized. A risk assessment was performed in order to create a priority order and significant hazards and failure modes were summarized. Corrective measures were proposed for each hazard.

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

PubMed

Sorrentino, Patricia

2016-01-01

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Progress and prospect on failure mechanisms of solid-state lithium batteries

NASA Astrophysics Data System (ADS)

Ma, Jun; Chen, Bingbing; Wang, Longlong; Cui, Guanglei

2018-07-01

By replacing traditional liquid organic electrolyte with solid-state electrolyte, the solid-state lithium batteries powerfully come back to the energy storage field due to their eminent safety and energy density. In recent years, a variety of solid-state lithium batteries based on excellent solid-state electrolytes are developed. However, the performance degradation of solid-state lithium batteries during cycling and storing is still a serious challenge for practical application. Therefore, this review summarizes the research progress of solid-state lithium batteries from the perspectives of failure phenomena and failure mechanisms. Additionally, the development of methodologies on studying the failure mechanisms of solid-state lithium batteries is also reviewed. Moreover, some perspectives on the remaining questions for understanding the failure behaviors and achieving long cycle life, high safety and high energy density solid-state lithium batteries are presented. This review will help researchers to recognize the status of solid-state lithium batteries objectively and attract much more research interest in conquering the failure issues of solid-state lithium batteries.

Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial

PubMed Central

O’Connor, Christopher M.; Whellan, David J.; Lee, Kerry L.; Keteyian, Steven J.; Cooper, Lawton S.; Ellis, Stephen J.; Leifer, Eric S.; Kraus, William E.; Kitzman, Dalane W.; Blumenthal, James A.; Rendall, David S.; Miller, Nancy Houston; Fleg, Jerome L.; Schulman, Kevin A.; McKelvie, Robert S.; Zannad, Faiez; Piña, Ileana L.

2010-01-01

Context Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. Objective To test the efficacy and safety of exercise training among patients with heart failure. Design, Setting, and Patients Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. Interventions Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. Main Outcome Measures Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. Results The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Etiology was ischemic in 51%. Median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 (65%) patients in the exercise group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.84–1.02; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 [16%] in the exercise group vs 198 [17%] in the usual care group; HR, 0.96; 95% CI, 0.79–1.17; P = .70), cardiovascular mortality or cardiovascular hospitalization (632

Intramuscular diaphragmatic stimulation for patients with traumatic high cervical injuries and ventilator dependent respiratory failure: A systematic review of safety and effectiveness.

PubMed

Garara, Bhavin; Wood, Alasdair; Marcus, Hani J; Tsang, Kevin; Wilson, Mark H; Khan, Mansoor

2016-03-01

Intramuscular diaphragmatic stimulation using an abdominal laparoscopic approach has been proposed as a safer alternative to traditional phrenic nerve stimulation. It has also been suggested that early implementation of diaphragmatic pacing may prevent diaphragm atrophy and lead to earlier ventilator independence. The aim of this study was therefore to systematically review the safety and effectiveness of intramuscular diaphragmatic stimulators in the treatment of patients with traumatic high cervical injuries resulting in long-term ventilator dependence, with particular emphasis on the affect of timing of insertion of such stimulators. The Cochrane database and PubMed were searched between January 2000 and June 2015. Reference lists of selected papers were also reviewed. The inclusion criteria used to select from the pool of eligible studies were: (1) reported on adult patients with traumatic high cervical injury, who were ventilator-dependant, (2) patients underwent intramuscular diaphragmatic stimulation, and (3) commented on safety and/or effectiveness. 12 articles were included in the review. Reported safety issues post insertion of intramuscular electrodes included pneumothorax, infection, and interaction with pre-existing cardiac pacemaker. Only one procedural failure was reported. The percentage of patients reported as independent of ventilatory support post procedure ranged between 40% and 72.2%. The mean delay of insertion ranged from 40 days to 9.7 years; of note the study with the average shortest delay in insertion reported the greatest percentage of fully weaned patients. Although evidence for intramuscular diaphragmatic stimulation in patients with high cervical injuries and ventilator dependent respiratory failure is currently limited, the technique appears to be safe and effective. Earlier implantation of such devices does not appear to be associated with greater surgical risk, and may be more effective. Further high quality studies are warranted

Implantable Hemodynamic Monitoring for Heart Failure Patients.

PubMed

Abraham, William T; Perl, Leor

2017-07-18

Rates of heart failure hospitalization remain unacceptably high. Such hospitalizations are associated with substantial patient, caregiver, and economic costs. Randomized controlled trials of noninvasive telemedical systems have failed to demonstrate reduced rates of hospitalization. The failure of these technologies may be due to the limitations of the signals measured. Intracardiac and pulmonary artery pressure-guided management has become a focus of hospitalization reduction in heart failure. Early studies using implantable hemodynamic monitors demonstrated the potential of pressure-based heart failure management, whereas subsequent studies confirmed the clinical utility of this approach. One large pivotal trial proved the safety and efficacy of pulmonary artery pressure-guided heart failure management, showing a marked reduction in heart failure hospitalizations in patients randomized to active pressure-guided management. "Next-generation" implantable hemodynamic monitors are in development, and novel approaches for the use of this data promise to expand the use of pressure-guided heart failure management. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

High-Temperature Graphitization Failure of Primary Superheater Tube

NASA Astrophysics Data System (ADS)

Ghosh, D.; Ray, S.; Roy, H.; Mandal, N.; Shukla, A. K.

2015-12-01

Failure of boiler tubes is the main cause of unit outages of the plant, which further affects the reliability, availability and safety of the unit. So failure analysis of boiler tubes is absolutely essential to predict the root cause of the failure and the steps are taken for future remedial action to prevent the failure in near future. This paper investigates the probable cause/causes of failure of the primary superheater tube in a thermal power plant boiler. Visual inspection, dimensional measurement, chemical analysis, metallographic examination and hardness measurement are conducted as the part of the investigative studies. Apart from these tests, mechanical testing and fractographic analysis are also conducted as supplements. Finally, it is concluded that the superheater tube is failed due to graphitization for prolonged exposure of the tube at higher temperature.

Orion Burn Management, Nominal and Response to Failures

NASA Technical Reports Server (NTRS)

Odegard, Ryan; Goodman, John L.; Barrett, Charles P.; Pohlkamp, Kara; Robinson, Shane

2016-01-01

An approach for managing Orion on-orbit burn execution is described for nominal and failure response scenarios. The burn management strategy for Orion takes into account per-burn variations in targeting, timing, and execution; crew and ground operator intervention and overrides; defined burn failure triggers and responses; and corresponding on-board software sequencing functionality. Burn-to- burn variations are managed through the identification of specific parameters that may be updated for each progressive burn. Failure triggers and automatic responses during the burn timeframe are defined to provide safety for the crew in the case of vehicle failures, along with override capabilities to ensure operational control of the vehicle. On-board sequencing software provides the timeline coordination for performing the required activities related to targeting, burn execution, and responding to burn failures.

A cost-minimisation analysis comparing different antibiotic regimens used in treating all-cause bacterial pneumonia in Hong Kong.

PubMed

Lee, Kenneth K C; Wan, Matthew H S; Fan, Barry S K; Chau, Michelle W Y; Lee, Vivian W Y

2009-03-01

To find out the antibiotic treatment regimens with the lowest cost for all-cause bacterial pneumonia, a study to compare the costs of different antibiotic regimens in the treatment of patients diagnosed with all-cause bacterial pneumonia who required hospitalisation was carried out. This was a multicentre, retrospective study of patient medical records. The primary aim was to examine whether the initial choice of antibiotic had affected the total cost of treatment, while the secondary aim was to find out whether the initial choice of antibiotic had affected the initial treatment failure rates and death rates. A cost-minimisation analysis (CMA) from a public hospital perspective was employed. A total of 333 patient medical case notes were reviewed. The most commonly prescribed antibiotic regimen was amoxycillin-clavulanate (AC) followed by amoxycillin-clavulanate plus macrolide (ACM) and quinolone (Q). In the study population, no statistical significance could be detected between the mean cost of the three regimens. In the subgroup analysis of patients with a history of chronic obstructive pulmonary disease (COPD) and patients with a history of smoking, the Q regimen appeared to be the least expensive. In the study population, no significant difference could be identified between the mean cost of the three antibiotic regimens. In a special populations such as patients with a history of COPD and patients with a history of smoking, the Q regimen appeared to be superior. Further studies in these areas are needed.

Methods and Case Studies for Teaching and Learning about Failure and Safety.

ERIC Educational Resources Information Center

Bignell, Victor

1999-01-01

Discusses methods for analyzing case studies of failures of technological systems. Describes two distance learning courses that compare standard models of failure and success with the actuality of given scenarios. Provides teaching and learning materials and information sources for application to aspects of design, manufacture, inspection, use,…

Software system safety

NASA Technical Reports Server (NTRS)

Uber, James G.

1988-01-01

Software itself is not hazardous, but since software and hardware share common interfaces there is an opportunity for software to create hazards. Further, these software systems are complex, and proven methods for the design, analysis, and measurement of software safety are not yet available. Some past software failures, future NASA software trends, software engineering methods, and tools and techniques for various software safety analyses are reviewed. Recommendations to NASA are made based on this review.

Application of Failure Mode and Effects Analysis to Intraoperative Radiation Therapy Using Mobile Electron Linear Accelerators

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

Ciocca, Mario, E-mail: mario.ciocca@cnao.it; Cantone, Marie-Claire; Veronese, Ivan

2012-02-01

Purpose: Failure mode and effects analysis (FMEA) represents a prospective approach for risk assessment. A multidisciplinary working group of the Italian Association for Medical Physics applied FMEA to electron beam intraoperative radiation therapy (IORT) delivered using mobile linear accelerators, aiming at preventing accidental exposures to the patient. Methods and Materials: FMEA was applied to the IORT process, for the stages of the treatment delivery and verification, and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system,more » based on the product of three parameters (severity, frequency of occurrence and detectability, each ranging from 1 to 10); 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results: Twenty-four subprocesses were identified. Ten potential failure modes were found and scored, in terms of RPN, in the range of 42-216. The most critical failure modes consisted of internal shield misalignment, wrong Monitor Unit calculation and incorrect data entry at treatment console. Potential causes of failure included shield displacement, human errors, such as underestimation of CTV extension, mainly because of lack of adequate training and time pressures, failure in the communication between operators, and machine malfunctioning. The main effects of failure were represented by CTV underdose, wrong dose distribution and/or delivery, unintended normal tissue irradiation. As additional safety measures, the utilization of a dedicated staff for IORT, double-checking of MU calculation and data entry and finally implementation of in vivo dosimetry were suggested. Conclusions: FMEA appeared as a useful tool for prospective evaluation of patient safety in

Qualitative research in Spanish cannabis social clubs: "The moment you enter the door, you are minimising the risks".

PubMed

Belackova, Vendula; Tomkova, Alexandra; Zabransky, Tomas

2016-08-01

Cannabis social clubs (CSCs) in Spain are non-profit organisations that connect regular adult cannabis users. One of their functions is to supply cannabis to the closed circuit of members. The CSCs do not breach any international treaties. The aim of the paper is to present the findings of a qualitative study among Spanish CSCs in order to assess their potential for minimising the harm resulting from cannabis use (such as respiratory and mental health risks, the risk of dependence, and social risks). A convenience sample of 11 CSCs was selected from four regions of Spain - the Basque country, Catalonia, the Balearic Islands, and Galicia. 94 respondents took part in 14 focus groups (FGs). The number of participants in a FG ranged from two to 12. A semi-structured interview guide and a structured questionnaire were used in the FG. Members described a variety of risk minimising features of the CSCs: the availability of a quality product and mechanisms for its control, availability of different strains of cannabis and knowledge about their different psychoactive effects, increased control over personal cannabis use, informal information sharing and interaction, reduced stigma, and reduced criminal risks. The fact that the CSCs have no incentive to increase members' consumption means that they should be considered to be feasible spaces for the implementation of public health policies. Policy objectives could include a requirement that CSC members have control over the quality of cannabis, that different strains of cannabis are available together with information on their effects, that quantity of cannabis at intake is restricted and planned for each member, and that harm minimisation activities are both formally and informally implemented in the clubs. Copyright © 2016 Elsevier B.V. All rights reserved.

Good people who try their best can have problems: recognition of human factors and how to minimise error.

PubMed

Brennan, Peter A; Mitchell, David A; Holmes, Simon; Plint, Simon; Parry, David

2016-01-01

Human error is as old as humanity itself and is an appreciable cause of mistakes by both organisations and people. Much of the work related to human factors in causing error has originated from aviation where mistakes can be catastrophic not only for those who contribute to the error, but for passengers as well. The role of human error in medical and surgical incidents, which are often multifactorial, is becoming better understood, and includes both organisational issues (by the employer) and potential human factors (at a personal level). Mistakes as a result of individual human factors and surgical teams should be better recognised and emphasised. Attitudes and acceptance of preoperative briefing has improved since the introduction of the World Health Organization (WHO) surgical checklist. However, this does not address limitations or other safety concerns that are related to performance, such as stress and fatigue, emotional state, hunger, awareness of what is going on situational awareness, and other factors that could potentially lead to error. Here we attempt to raise awareness of these human factors, and highlight how they can lead to error, and how they can be minimised in our day-to-day practice. Can hospitals move from being "high risk industries" to "high reliability organisations"? Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Critical Review of Commercial Secondary Lithium-Ion Battery Safety Standards

NASA Astrophysics Data System (ADS)

Jones, Harry P.; Chapin, Thomas, J.; Tabaddor, Mahmod

2010-09-01

The development of Li-ion cells with greater energy density has lead to safety concerns that must be carefully assessed as Li-ion cells power a wide range of products from consumer electronics to electric vehicles to space applications. Documented field failures and product recalls for Li-ion cells, mostly for consumer electronic products, highlight the risk of fire, smoke, and even explosion. These failures have been attributed to the occurrence of internal short circuits and the subsequent thermal runaway that can lead to fire and explosion. As packaging for some applications include a large number of cells, the risk of failure is likely to be magnified. To address concerns about the safety of battery powered products, safety standards have been developed. This paper provides a review of various international safety standards specific to lithium-ion cells. This paper shows that though the standards are harmonized on a host of abuse conditions, most lack a test simulating internal short circuits. This paper describes some efforts to introduce internal short circuit tests into safety standards.

Application of failure mode and effect analysis in a radiology department.

PubMed

Thornton, Eavan; Brook, Olga R; Mendiratta-Lala, Mishal; Hallett, Donna T; Kruskal, Jonathan B

2011-01-01

With increasing deployment, complexity, and sophistication of equipment and related processes within the clinical imaging environment, system failures are more likely to occur. These failures may have varying effects on the patient, ranging from no harm to devastating harm. Failure mode and effect analysis (FMEA) is a tool that permits the proactive identification of possible failures in complex processes and provides a basis for continuous improvement. This overview of the basic principles and methodology of FMEA provides an explanation of how FMEA can be applied to clinical operations in a radiology department to reduce, predict, or prevent errors. The six sequential steps in the FMEA process are explained, and clinical magnetic resonance imaging services are used as an example for which FMEA is particularly applicable. A modified version of traditional FMEA called Healthcare Failure Mode and Effect Analysis, which was introduced by the U.S. Department of Veterans Affairs National Center for Patient Safety, is briefly reviewed. In conclusion, FMEA is an effective and reliable method to proactively examine complex processes in the radiology department. FMEA can be used to highlight the high-risk subprocesses and allows these to be targeted to minimize the future occurrence of failures, thus improving patient safety and streamlining the efficiency of the radiology department. RSNA, 2010

Common Cause Failure Modeling

NASA Technical Reports Server (NTRS)

Hark, Frank; Britton, Paul; Ring, Rob; Novack, Steven D.

2016-01-01

Common Cause Failures (CCFs) are a known and documented phenomenon that defeats system redundancy. CCFS are a set of dependent type of failures that can be caused by: system environments; manufacturing; transportation; storage; maintenance; and assembly, as examples. Since there are many factors that contribute to CCFs, the effects can be reduced, but they are difficult to eliminate entirely. Furthermore, failure databases sometimes fail to differentiate between independent and CCF (dependent) failure and data is limited, especially for launch vehicles. The Probabilistic Risk Assessment (PRA) of NASA's Safety and Mission Assurance Directorate at Marshal Space Flight Center (MFSC) is using generic data from the Nuclear Regulatory Commission's database of common cause failures at nuclear power plants to estimate CCF due to the lack of a more appropriate data source. There remains uncertainty in the actual magnitude of the common cause risk estimates for different systems at this stage of the design. Given the limited data about launch vehicle CCF and that launch vehicles are a highly redundant system by design, it is important to make design decisions to account for a range of values for independent and CCFs. When investigating the design of the one-out-of-two component redundant system for launch vehicles, a response surface was constructed to represent the impact of the independent failure rate versus a common cause beta factor effect on a system's failure probability. This presentation will define a CCF and review estimation calculations. It gives a summary of reduction methodologies and a review of examples of historical CCFs. Finally, it presents the response surface and discusses the results of the different CCFs on the reliability of a one-out-of-two system.

Common Cause Failure Modeling

NASA Technical Reports Server (NTRS)

Hark, Frank; Britton, Paul; Ring, Rob; Novack, Steven D.

2015-01-01

Common Cause Failures (CCFs) are a known and documented phenomenon that defeats system redundancy. CCFS are a set of dependent type of failures that can be caused by: system environments; manufacturing; transportation; storage; maintenance; and assembly, as examples. Since there are many factors that contribute to CCFs, the effects can be reduced, but they are difficult to eliminate entirely. Furthermore, failure databases sometimes fail to differentiate between independent and CCF (dependent) failure and data is limited, especially for launch vehicles. The Probabilistic Risk Assessment (PRA) of NASA's Safety and Mission Assurance Directorate at Marshall Space Flight Center (MFSC) is using generic data from the Nuclear Regulatory Commission's database of common cause failures at nuclear power plants to estimate CCF due to the lack of a more appropriate data source. There remains uncertainty in the actual magnitude of the common cause risk estimates for different systems at this stage of the design. Given the limited data about launch vehicle CCF and that launch vehicles are a highly redundant system by design, it is important to make design decisions to account for a range of values for independent and CCFs. When investigating the design of the one-out-of-two component redundant system for launch vehicles, a response surface was constructed to represent the impact of the independent failure rate versus a common cause beta factor effect on a system's failure probability. This presentation will define a CCF and review estimation calculations. It gives a summary of reduction methodologies and a review of examples of historical CCFs. Finally, it presents the response surface and discusses the results of the different CCFs on the reliability of a one-out-of-two system.

Evaluation of Safety, Quality and Productivity in Construction

NASA Astrophysics Data System (ADS)

Usmen, M. A.; Vilnitis, M.

2015-11-01

This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

Resilience Engineering in Critical Long Term Aerospace Software Systems: A New Approach to Spacecraft Software Safety

NASA Astrophysics Data System (ADS)

Dulo, D. A.

Safety critical software systems permeate spacecraft, and in a long term venture like a starship would be pervasive in every system of the spacecraft. Yet software failure today continues to plague both the systems and the organizations that develop them resulting in the loss of life, time, money, and valuable system platforms. A starship cannot afford this type of software failure in long journeys away from home. A single software failure could have catastrophic results for the spaceship and the crew onboard. This paper will offer a new approach to developing safe reliable software systems through focusing not on the traditional safety/reliability engineering paradigms but rather by focusing on a new paradigm: Resilience and Failure Obviation Engineering. The foremost objective of this approach is the obviation of failure, coupled with the ability of a software system to prevent or adapt to complex changing conditions in real time as a safety valve should failure occur to ensure safe system continuity. Through this approach, safety is ensured through foresight to anticipate failure and to adapt to risk in real time before failure occurs. In a starship, this type of software engineering is vital. Through software developed in a resilient manner, a starship would have reduced or eliminated software failure, and would have the ability to rapidly adapt should a software system become unstable or unsafe. As a result, long term software safety, reliability, and resilience would be present for a successful long term starship mission.

Achieving dietary recommendations and reducing greenhouse gas emissions: modelling diets to minimise the change from current intakes.

PubMed

Horgan, Graham W; Perrin, Amandine; Whybrow, Stephen; Macdiarmid, Jennie I

2016-04-07

Average population dietary intakes do not reflect the wide diversity of dietary patterns across the population. It is recognised that most people in the UK do not meet dietary recommendations and have diets with a high environmental impact, but changing dietary habits has proved very difficult. The purpose of this study was to investigate the diversity in dietary changes needed to achieve a healthy diet and a healthy diet with lower greenhouse gas emissions (GHGE) (referred to as a sustainable diet) by taking into account each individual's current diet and then minimising the changes they need to make. Linear programming was used to construct two new diets for each adult in the UK National Diet and Nutrition Survey (n = 1491) by minimising the changes to their current intake. Stepwise changes were applied until (i) dietary recommendations were achieved and (ii) dietary recommendations and a GHGE target were met. First, gradual changes (≤50%) were made to the amount of any foods currently eaten. Second, new foods were added to the diet. Third, greater reductions (≤75%) were made to the amount of any food currently eaten and finally, foods were removed from the diet. One person out of 1491 in the sample met all the dietary requirements based on their reported dietary intake. Only 7.5 and 4.6 % of people achieved a healthy diet and a sustainable diet, respectively, by changing the amount of any food they currently ate by up to 50 %. The majority required changes to the amount of each food eaten plus the addition of new foods. Fewer than 5 % had to remove foods they ate to meet recommendations. Sodium proved the most difficult nutrient recommendation to meet. The healthy diets and sustainable diets produced a 15 and 27 % reduction in greenhouse gas emissions respectively. Since healthy diets alone do not produce substantial reductions in greenhouse gas emissions, dietary guidelines need to include recommendations for environmental sustainability. Minimising the

Lifestyle modification with diet and exercise in obese patients with heart failure - A pilot study

USDA-ARS?s Scientific Manuscript database

There is a paucity of data regarding intentional weight loss in obese heart failure patients. This study sought to ascertain the safety and effectiveness of a lifestyle modification program in patients with systolic heart failure and metabolic syndrome. Patients (n=20) with systolic heart failure (e...

Nuclear Safety for Space Systems

NASA Astrophysics Data System (ADS)

Offiong, Etim

2010-09-01

It is trite, albeit a truism, to say that nuclear power can provide propulsion thrust needed to launch space vehicles and also, to provide electricity for powering on-board systems, especially for missions to the Moon, Mars and other deep space missions. Nuclear Power Sources(NPSs) are known to provide more capabilities than solar power, fuel cells and conventional chemical means. The worry has always been that of safety. The earliest superpowers(US and former Soviet Union) have designed and launched several nuclear-powered systems, with some failures. Nuclear failures and accidents, however little the number, could be far-reaching geographically, and are catastrophic to humans and the environment. Building on the numerous research works on nuclear power on Earth and in space, this paper seeks to bring to bear, issues relating to safety of space systems - spacecrafts, astronauts, Earth environment and extra terrestrial habitats - in the use and application of nuclear power sources. It also introduces a new formal training course in Space Systems Safety.

Improving patient safety through the systematic evaluation of patient outcomes

PubMed Central

Forster, Alan J.; Dervin, Geoff; Martin, Claude; Papp, Steven

2012-01-01

Despite increased advocacy for patient safety and several large-scale programs designed to reduce preventable harm, most notably surgical checklists, recent data evaluating entire health systems suggests that we are no further ahead in improving patient safety and that hospital complications are no less frequent now than in the 1990s. We suggest that the failure to systematically measure patient safety is the reason for our limited progress. In addition to defining patient safety outcomes and describing their financial and clinical impact, we argue why the failure to implement patient safety measurement systems has compromised the ability to move the agenda forward. We also present an overview of how patient safety can be assessed and the strengths and weaknesses of each method and comment on some of the consequences created by the absence of a systematic measurement system. PMID:23177520

Probability of loss of assured safety in temperature dependent systems with multiple weak and strong links.

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

Johnson, Jay Dean; Oberkampf, William Louis; Helton, Jon Craig

2004-12-01

Relationships to determine the probability that a weak link (WL)/strong link (SL) safety system will fail to function as intended in a fire environment are investigated. In the systems under study, failure of the WL system before failure of the SL system is intended to render the overall system inoperational and thus prevent the possible occurrence of accidents with potentially serious consequences. Formal developments of the probability that the WL system fails to deactivate the overall system before failure of the SL system (i.e., the probability of loss of assured safety, PLOAS) are presented for several WWSL configurations: (i) onemore » WL, one SL, (ii) multiple WLs, multiple SLs with failure of any SL before any WL constituting failure of the safety system, (iii) multiple WLs, multiple SLs with failure of all SLs before any WL constituting failure of the safety system, and (iv) multiple WLs, multiple SLs and multiple sublinks in each SL with failure of any sublink constituting failure of the associated SL and failure of all SLs before failure of any WL constituting failure of the safety system. The indicated probabilities derive from time-dependent temperatures in the WL/SL system and variability (i.e., aleatory uncertainty) in the temperatures at which the individual components of this system fail and are formally defined as multidimensional integrals. Numerical procedures based on quadrature (i.e., trapezoidal rule, Simpson's rule) and also on Monte Carlo techniques (i.e., simple random sampling, importance sampling) are described and illustrated for the evaluation of these integrals. Example uncertainty and sensitivity analyses for PLOAS involving the representation of uncertainty (i.e., epistemic uncertainty) with probability theory and also with evidence theory are presented.« less

Contributions of clinical disconnections and unresolved conflict to failures in intrapartum safety

PubMed Central

Lyndon, Audrey; Zlatnik, Marya G.; Maxfield, David G.; Lewis, Annie; McMillan, Chase; Kennedy, Holly Powell

2014-01-01

Objective To explore clinician perspectives on whether they experience difficulty resolving patient-related concerns or observe problems with the performance or behavior of colleagues involved in intrapartum care. Design Qualitative descriptive study of physician, nursing, and midwifery professional association members. Participants and Setting Participants (N=1932) were drawn from the membership lists of the Association of Women’s Health, Obstetric, and Neonatal Nurses (AWHONN), American College of Obstetricians and Gynecologists (ACOG), American College of Nurse Midwives (ACNM), and Society for Maternal-Fetal Medicine (SMFM). Methods Email survey with multiple choice and free text responses. Descriptive statistics and inductive thematic analysis were used to characterize the data. Results Forty-seven percent of participants reported experiencing situations in which patients were put at risk due to failure of team members to listen or respond to a concern. Thirty-seven percent reported unresolved concerns regarding another clinician’s performance. The overarching theme was clinical disconnection, which included disconnections between clinicians about patient needs and plans of care and disconnections between clinicians and administration about the support required to provide safe and appropriate clinical care. Lack of responsiveness to concerns by colleagues and administration contributed to resignation and defeatism among participants who had experienced such situations. Conclusion Despite encouraging progress in developing cultures of safety in individual centers and systems, significant work is needed to improve collaboration and reverse historic normalization of both systemic disrespect and overt disruptive behaviors in intrapartum care. PMID:24354506

Combustion Safety Simplified Test Protocol Field Study

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

Brand, L; Cautley, D.; Bohac, D.

2015-11-05

"9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies onmore » combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.« less

Lithium-Ion Battery Failure: Effects of State of Charge and Packing Configuration

DTIC Science & Technology

2016-08-22

Naval Research Laboratory Washington, DC 20375-5320 NRL/MR/6180--16-9689 Lithium - Ion Battery Failure: Effects of State of Charge and Packing...PAGES 17. LIMITATION OF ABSTRACT Lithium - Ion Battery Failure: Effects of State of Charge and Packing Configuration Neil S. Spinner,* Katherine M. Hinnant...Steven G. Tuttle (202) 404-3419 Lithium - ion battery safety remains a significant concern, as battery failure leads to ejection of hazardous materials

47 CFR 90.1420 - Failure to comply with the NSA or the Commission's rules.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Failure to comply with the NSA or the... § 90.1420 Failure to comply with the NSA or the Commission's rules. (a) Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the Public Safety Broadband License. The...

47 CFR 90.1420 - Failure to comply with the NSA or the Commission's rules.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Failure to comply with the NSA or the... § 90.1420 Failure to comply with the NSA or the Commission's rules. (a) Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the Public Safety Broadband License. The...

47 CFR 90.1420 - Failure to comply with the NSA or the Commission's rules.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Failure to comply with the NSA or the... § 90.1420 Failure to comply with the NSA or the Commission's rules. (a) Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the Public Safety Broadband License. The...

Failure to replicate the deleterious effects of safety behaviors in exposure therapy.

PubMed

Sy, Jennifer T; Dixon, Laura J; Lickel, James J; Nelson, Elizabeth A; Deacon, Brett J

2011-05-01

The current study attempted to replicate the finding obtained by Powers, Smits, and Telch (2004; Journal of Consulting and Clinical Psychology, 72, 448-545) that both the availability and utilization of safety behaviors interfere with the efficacy of exposure therapy. An additional goal of the study was to evaluate which explanatory theories about the detrimental effects of safety behaviors best account for this phenomenon. Undergraduate students (N=58) with high claustrophobic fear were assigned to one of three treatment conditions: (a) exposure only, (b) exposure with safety behavior availability, and (c) exposure with safety behavior utilization. Participants in each condition improved substantially, and there were no significant between-group differences in fear reduction. Unexpectedly, exposure with safety behavior utilization led to significantly greater improvement in self-efficacy and claustrophobic cognitions than exposure only. The extent to which participants inferred danger from the presence of safety aids during treatment was associated with significantly less improvement on all outcome measures. The findings call into question the hypothesized deleterious effects of safety behaviors on the outcome of exposure therapy and highlight a possible mechanism through which the mere presence of safety cues during exposure trials might affect treatment outcomes depending on participants' perceptions of the dangerousness of exposure stimuli. Published by Elsevier Ltd.

Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy

PubMed Central

Broggi, Sara; Cantone, Marie Claire; Chiara, Anna; Muzio, Nadia Di; Longobardi, Barbara; Mangili, Paola

2013-01-01

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety. PACS number: 87.55.Qr PMID:24036868

Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy.

PubMed

Broggi, Sara; Cantone, Marie Claire; Chiara, Anna; Di Muzio, Nadia; Longobardi, Barbara; Mangili, Paola; Veronese, Ivan

2013-09-06

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety.

Identification of priorities for medication safety in neonatal intensive care.

PubMed

Kunac, Desireé L; Reith, David M

2005-01-01

Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.

Long Term Safety Area Tracking (LT-SAT) with online failure detection and recovery for robotic minimally invasive surgery.

PubMed

Penza, Veronica; Du, Xiaofei; Stoyanov, Danail; Forgione, Antonello; Mattos, Leonardo S; De Momi, Elena

2018-04-01

Despite the benefits introduced by robotic systems in abdominal Minimally Invasive Surgery (MIS), major complications can still affect the outcome of the procedure, such as intra-operative bleeding. One of the causes is attributed to accidental damages to arteries or veins by the surgical tools, and some of the possible risk factors are related to the lack of sub-surface visibilty. Assistive tools guiding the surgical gestures to prevent these kind of injuries would represent a relevant step towards safer clinical procedures. However, it is still challenging to develop computer vision systems able to fulfill the main requirements: (i) long term robustness, (ii) adaptation to environment/object variation and (iii) real time processing. The purpose of this paper is to develop computer vision algorithms to robustly track soft tissue areas (Safety Area, SA), defined intra-operatively by the surgeon based on the real-time endoscopic images, or registered from a pre-operative surgical plan. We propose a framework to combine an optical flow algorithm with a tracking-by-detection approach in order to be robust against failures caused by: (i) partial occlusion, (ii) total occlusion, (iii) SA out of the field of view, (iv) deformation, (v) illumination changes, (vi) abrupt camera motion, (vii), blur and (viii) smoke. A Bayesian inference-based approach is used to detect the failure of the tracker, based on online context information. A Model Update Strategy (MUpS) is also proposed to improve the SA re-detection after failures, taking into account the changes of appearance of the SA model due to contact with instruments or image noise. The performance of the algorithm was assessed on two datasets, representing ex-vivo organs and in-vivo surgical scenarios. Results show that the proposed framework, enhanced with MUpS, is capable of maintain high tracking performance for extended periods of time ( ≃ 4 min - containing the aforementioned events) with high precision (0

Impact of Pharmacy-Led Dyslipidemia Interventions on Medication Safety and Therapeutic Failure in Patients

DTIC Science & Technology

2005-05-01

Center (PEC) guidelines on therapeutic failure. Such guidelines recommend atorvastatin as an alternative agent in patients who had a bona fide failure...on simvastatin. Failures requiring atorvastatin as an alternate agent were defined as (a) patients not at their LDL goal on maximal doses of...simvastatin 20 atorvastatin 20 med changed 3 (2%) simvastatin 10 atorvastatin 10 med changed 1 (0.7%) simvastatin 10 atorvastatin 20 med changed 5 (3.3

Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study.

PubMed

Del Trigo, Maria; Bergeron, Sebastien; Bernier, Mathieu; Amat-Santos, Ignacio J; Puri, Rishi; Campelo-Parada, Francisco; Altisent, Omar Abdul-Jawad; Regueiro, Ander; Eigler, Neal; Rozenfeld, Erez; Pibarot, Philippe; Abraham, William T; Rodés-Cabau, Josep

2016-03-26

In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. We did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 [SD 6·2] to 24·8 [12·9]; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 [SD 9·8] to 79·1 [13·0]; p=0·0001); and 6 min walk test distance (from a mean of 244 m [SD 112] to 318 m [134]; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10

Combining System Safety and Reliability to Ensure NASA CoNNeCT's Success

NASA Technical Reports Server (NTRS)

Havenhill, Maria; Fernandez, Rene; Zampino, Edward

2012-01-01

Hazard Analysis, Failure Modes and Effects Analysis (FMEA), the Limited-Life Items List (LLIL), and the Single Point Failure (SPF) List were applied by System Safety and Reliability engineers on NASA's Communications, Navigation, and Networking reConfigurable Testbed (CoNNeCT) Project. The integrated approach involving cross reviews of these reports by System Safety, Reliability, and Design engineers resulted in the mitigation of all identified hazards. The outcome was that the system met all the safety requirements it was required to meet.

Multi-objective ACO algorithms to minimise the makespan and the total rejection cost on BPMs with arbitrary job weights

NASA Astrophysics Data System (ADS)

Jia, Zhao-hong; Pei, Ming-li; Leung, Joseph Y.-T.

2017-12-01

In this paper, we investigate the batch-scheduling problem with rejection on parallel machines with non-identical job sizes and arbitrary job-rejected weights. If a job is rejected, the corresponding penalty has to be paid. Our objective is to minimise the makespan of the processed jobs and the total rejection cost of the rejected jobs. Based on the selected multi-objective optimisation approaches, two problems, P1 and P2, are considered. In P1, the two objectives are linearly combined into one single objective. In P2, the two objectives are simultaneously minimised and the Pareto non-dominated solution set is to be found. Based on the ant colony optimisation (ACO), two algorithms, called LACO and PACO, are proposed to address the two problems, respectively. Two different objective-oriented pheromone matrices and heuristic information are designed. Additionally, a local optimisation algorithm is adopted to improve the solution quality. Finally, simulated experiments are conducted, and the comparative results verify the effectiveness and efficiency of the proposed algorithms, especially on large-scale instances.

The Effects of Pop-up Harm Minimisation Messages on Electronic Gaming Machine Gambling Behaviour in New Zealand.

PubMed

Palmer du Preez, Katie; Landon, Jason; Bellringer, Maria; Garrett, Nick; Abbott, Max

2016-12-01

In New Zealand a simple pop-up message feature that provides gambling session information and forces a break in play is mandatory on all electronic gaming machines in all venues (EGMs). Previous research has demonstrated small effects of more sophisticated pop-up messages tested predominantly in laboratory environments. The present research examined gambler engagement with and views on the New Zealand pop-up messages and on the relationship between pop-up messages and EGM expenditure. A sample of gamblers was recruited at casino and non-casino (pub) EGM venues. Most participants were aware of pop-up messages (57 %) and many saw them often (38 %). Among gamblers who reported seeing pop-up messages, half read the message content, and a quarter believed that pop-up messages helped them control the amount of money they spend on gambling. Participants who reported being likely to stop gambling in response to pop-up messages spent significantly less money on gambling when variables that were independently associated with EGM expenditure were controlled for. A modest harm minimisation effect of the pop-up message feature that has been operating in New Zealand for 5 years was evident. Suggestions for improvement of the harm minimisation potential of the current pop-up message feature are discussed.

The influence of ship's stability on safety of navigation

NASA Astrophysics Data System (ADS)

Hanzu-Pazara, R.; Duse; Varsami, C.; Andrei, C.; Dumitrache, R.

2016-08-01

Ship's stability is one of the most important and complex concept about safety of ship and safety of navigation and it is governed by maritime law as well as maritime codes. The paper presents the importance of ship's intact stability as part of the general concept of ship's seaworthiness. There is always a correlation between ship’ stability and safety of ship and safety of navigation. Loss of ship's stability is presented as a threat to safety of navigation. We are going to present the causes that lead to ship stability failure and their impact on safety of navigation. A study of various ship stability casualties in heavy weather conditions are going to be presented, the causes are going to be analyzed and the possible ways of stability failures are assessed. Vessel's intact stability is a fundamental component of seaworthiness so it is in the interest of all owners/operators to learn about this topic and ensure that their vessel possesses a satisfactory level of stability in order to ensure its safety as well as that of the people on board the ship. Understanding ship's stability, trim, stress, and the basics of ship's construction is a key to keeping a ship seaworthy. The findings of this study can be beneficial to the maritime safety administrations to adopt decision-making on maritime safety management, but it is also important to carry out statistics and analysis of marine casualties to help to adopt proper safety management measures. Moreover, the study can be a useful guidance for masters and officers on board vessel in order to understand the factors that contribute to ship stability failure during the voyage not only in port during loading operations and to take preventive measures to avoid to put the ship in such a dangerous situations.

Teamwork and communication: an effective approach to patient safety.

PubMed

Mujumdar, Sandhya; Santos, Diana

2014-01-01

Teamwork and communication failures are leading causes of patient safety incidents in health care. Though health care providers must work in teams, they are not well-trained in teamwork and communication skills. Health care faces the problems of differences in communication styles, communication failures and poor teamwork. There is enough evidence in the literature to show that communication failure is detrimental to patient safety. It is estimated that 80% of serious medical errors worldwide take place because of miscommunication between medical providers. NUH recognizes that effective communication and teamwork are essential in the delivery of high quality safe patient care, especially in a complex organization. NUH is a good example, where there is a rich mix of nationalities and races, in staff and in patients, and there is a rapidly expanding care environment. NUH had to overcome these challenges by adopting a multi-pronged approach. The trials and tribulations of NUH in this journey were worthwhile as the patient safety climate survey scores improved over the years.

Evaluation of Gusset Plate Safety in Steel Truss Bridges

DOT National Transportation Integrated Search

2011-10-01

Failure of the I-35 truss bridge in Minneapolis has been attributed to failure of a gusset plate, necessitating : evaluation of gusset plate safety on bridges across the county. FHWA Publication IF-09-014 provides state : DOTs with important guidance...

Analyzing parameters optimisation in minimising warpage on side arm using response surface methodology (RSM)

NASA Astrophysics Data System (ADS)

Rayhana, N.; Fathullah, M.; Shayfull, Z.; Nasir, S. M.; Hazwan, M. H. M.

2017-09-01

This paper presents a systematic methodology to analyse the warpage of the side arm part using Autodesk Moldflow Insight software. Response Surface Methodology (RSM) was proposed to optimise the processing parameters that will result in optimal solutions by efficiently minimising the warpage of the side arm part. The variable parameters considered in this study was based on most significant parameters affecting warpage stated by previous researchers, that is melt temperature, mould temperature and packing pressure while adding packing time and cooling time as these is the commonly used parameters by researchers. The results show that warpage was improved by 10.15% and the most significant parameters affecting warpage are packing pressure.

Directory of aerospace safety specialized information sources

NASA Technical Reports Server (NTRS)

Fullerton, E. A.; Rubens, L. S.; Mandel, G.; Mckenna, P. J.

1974-01-01

Directory aids safety specialists in locating information sources and individual experts in engineering-related fields. Lists 170 organizations and approximately 300 individuals who can provide safety-related technical information in form of documentation, data, and consulting expertise. Information on hazard and failure cause identification, accident analysis, and materials characteristics are covered.

Dams and Levees: Safety Risks

NASA Astrophysics Data System (ADS)

Carter, N. T.

2017-12-01

The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

A review of wiring system safety in space power systems

NASA Technical Reports Server (NTRS)

Stavnes, Mark W.; Hammoud, Ahmad N.

1993-01-01

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

Guaranteeing safety in spatially situated agents

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

Kohout, R.C.; Hendler, J.A.; Musliner, D.J.

1996-12-31

{open_quote}Mission-critical{close_quotes} systems, which include such diverse applications as nuclear power plant controllers, {open_quotes}fly-by-wire{close_quotes} airplanes, medical care and monitoring systems, and autonomous mobile vehicles, are characterized by the fact that system failure is potentially catastrophic. The high cost of failure justifies the expenditure of considerable effort at design-time in order to guarantee the correctness of system behavior. This paper examines the problem of guaranteeing safety in a well studied class of robot motion problems known as the {open_quotes}asteroid avoidance problem.{close_quotes} We establish necessary and sufficient conditions for ensuring safety in the simple version of this problem which occurs most frequently inmore » the literature, as well as sufficient conditions for a more general and realistic case. In doing so, we establish functional relationships between the number, size and speed of obstacles, the robot`s maximum speed and the conditions which must be maintained in order to ensure safety.« less

A novel approach for evaluating the risk of health care failure modes.

PubMed

Chang, Dong Shang; Chung, Jenq Hann; Sun, Kuo Lung; Yang, Fu Chiang

2012-12-01

Failure mode and effects analysis (FMEA) can be employed to reduce medical errors by identifying the risk ranking of the health care failure modes and taking priority action for safety improvement. The purpose of this paper is to propose a novel approach of data analysis. The approach is to integrate FMEA and a mathematical tool-Data envelopment analysis (DEA) with "slack-based measure" (SBM), in the field of data analysis. The risk indexes (severity, occurrence, and detection) of FMEA are viewed as multiple inputs of DEA. The practicality and usefulness of the proposed approach is illustrated by one case of health care. Being a systematic approach for improving the service quality of health care, the approach can offer quantitative corrective information of risk indexes that thereafter reduce failure possibility. For safety improvement, these new targets of the risk indexes could be used for management by objectives. But FMEA cannot provide quantitative corrective information of risk indexes. The novel approach can surely overcome this chief shortcoming of FMEA. After combining DEA SBM model with FMEA, the two goals-increase of patient safety, medical cost reduction-can be together achieved.

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.

Failure Assessment of Stainless Steel and Titanium Brazed Joints

NASA Technical Reports Server (NTRS)

Flom, Yury A.

2012-01-01

Following successful application of Coulomb-Mohr and interaction equations for evaluation of safety margins in Albemet 162 brazed joints, two additional base metal/filler metal systems were investigated. Specimens consisting of stainless steel brazed with silver-base filler metal and titanium brazed with 1100 Al alloy were tested to failure under combined action of tensile, shear, bending and torsion loads. Finite Element Analysis (FEA), hand calculations and digital image comparison (DIC) techniques were used to estimate failure stresses and construct Failure Assessment Diagrams (FAD). This study confirms that interaction equation R(sub sigma) + R(sub tau) = 1, where R(sub sigma) and R(sub t u) are normal and shear stress ratios, can be used as conservative lower bound estimate of the failure criterion in stainless steel and titanium brazed joints.

Analytical Method to Evaluate Failure Potential During High-Risk Component Development

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Stone, Robert B.; Clancy, Daniel (Technical Monitor)

2001-01-01

Communicating failure mode information during design and manufacturing is a crucial task for failure prevention. Most processes use Failure Modes and Effects types of analyses, as well as prior knowledge and experience, to determine the potential modes of failures a product might encounter during its lifetime. When new products are being considered and designed, this knowledge and information is expanded upon to help designers extrapolate based on their similarity with existing products and the potential design tradeoffs. This paper makes use of similarities and tradeoffs that exist between different failure modes based on the functionality of each component/product. In this light, a function-failure method is developed to help the design of new products with solutions for functions that eliminate or reduce the potential of a failure mode. The method is applied to a simplified rotating machinery example in this paper, and is proposed as a means to account for helicopter failure modes during design and production, addressing stringent safety and performance requirements for NASA applications.

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion

PubMed Central

Henry, David A; Carless, Paul A; Moxey, Annette J; O’Connell, Dianne; Ker, Katharine; Fergusson, Dean A

2014-01-01

Background Public concerns regarding the safety of transfused blood have prompted reconsideration of the indications for the transfusion of allogeneic red cells (blood from an unrelated donor), and a range of techniques designed to minimise transfusion requirements. Objectives To examine the evidence for the efficacy of pre-operative autologous blood donation (PAD) in reducing the need for perioperative allogeneic red blood cell (RBC) transfusion. Search methods Articles were identified by searches of the electronic databases; MEDLINE (January 1950 to July 2009), EMBASE (January 1980 to Week 31, 2009), ISI Web of Science (inception to August 2009), The Cochrane Library 2009, Issue 3, and The Cochrane Injuries Group Specialised Register (searched August 7 2009). Reference lists in relevant publications were checked and authors were contacted to identify additional studies. The searches were updated in August 2009. Selection criteria Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to PAD, or to a control group who did not receive the intervention. Data collection and analysis Data were independently extracted and the risk of bias was assessed. Relative risks (RR) and mean differences (MD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random-effects model. The principal outcomes were the proportion of patients exposed to allogeneic red blood cells (RBCs) and the amount of blood transfused. Other clinical outcomes are detailed in the review. Main results Fourteen trials were included. Overall PAD reduced the risk of receiving an allogeneic blood transfusion by a relative 68% (RR 0.32; 95% CI 0.22 to 0.47). The absolute reduction in risk of allogeneic transfusion was 44% (risk difference (RD) −0.44; 95% CI −0.68 to −0.21). In contrast, the results show that the risk of receiving any blood transfusion (allogeneic and/or autologous) is increased by

Positive inotropes in heart failure: a review article

PubMed Central

Amin, Ahmad; Maleki, Majid

2012-01-01

Increasing myocardial contractility has long been considered a big help for patients with systolic heart failure, conferring an augmented haemodynamic profile in terms of higher cardiac output, lower cardiac filling pressure and better organ perfusion. Though concerns have been raised over the safety issues regarding the clinical trials of different inotropes in hearts with systolic dysfunction, they still stand as a main therapeutic strategy in many centres dealing with such patients. They must be used as short in duration, low in dose and stopped as early as possible. Evidence-based guidelines have provided clinicians with valuable data for better applying inotropes in heart failure patients. In this paper, the authors address clinical trials with different agents used for increasing cardiac contractility in heart failure patients. Furthermore, the authors focus on recent guidelines on making the most out of inotropes in heart failure patients. PMID:27326019

Failure propagation in multi-cell lithium ion batteries

DOE PAGES

Lamb, Joshua; Orendorff, Christopher J.; Steele, Leigh Anna M.; ...

2014-10-22

Traditionally, safety and impact of failure concerns of lithium ion batteries have dealt with the field failure of single cells. However, large and complex battery systems require the consideration of how a single cell failure will impact the system as a whole. Initial failure that leads to the thermal runaway of other cells within the system creates a much more serious condition than the failure of a single cell. This work examines the behavior of small modules of cylindrical and stacked pouch cells after thermal runaway is induced in a single cell through nail penetration trigger [1] within the module.more » Cylindrical cells are observed to be less prone to propagate, if failure propagates at all, owing to the limited contact between neighboring cells. However, the electrical connectivity is found to be impactful as the 10S1P cylindrical cell module did not show failure propagation through the module, while the 1S10P module had an energetic thermal runaway consuming the module minutes after the initiation failure trigger. Modules built using pouch cells conversely showed the impact of strong heat transfer between cells. In this case, a large surface area of the cells was in direct contact with its neighbors, allowing failure to propagate through the entire battery within 60-80 seconds for all configurations (parallel or series) tested. This work demonstrates the increased severity possible when a point failure impacts the surrounding battery system.« less

The safety of synthetic zeolites used in detergents.

PubMed

Fruijtier-Pölloth, Claudia

2009-01-01

Synthetic zeolites are replacing phosphates as builders in laundry detergents; workers and consumers may, therefore, increasingly be exposed to these materials and it is important to assess their safety. This article puts mechanistic, toxicological and exposure data into context for a safety assessment. Zeolites are hygroscopic compounds with ion-exchanging properties. They may partially decompose under acidic conditions such as in the stomach releasing sodium ions, silicic acid and aluminum salts. The intact molecule is not bioavailable after oral intake or exposure through the dermal and inhalational routes. Under current conditions of manufacture and use, no systemic toxicity is to be expected from neither the intact molecule nor the degradation products; a significant effect on the bioavailability of other compounds is not likely. Zeolites may cause local irritation. It is, therefore, important to minimise occupational exposure. The co-operation of detergent manufacturers with the manufacturers of washing machines is necessary to find the right balance between environmental aspects such as energy and water savings and the occurrence of detergent residues on textiles due to insufficient rinsing.

Procedure for Failure Mode, Effects, and Criticality Analysis (FMECA)

NASA Technical Reports Server (NTRS)

1966-01-01

This document provides guidelines for the accomplishment of Failure Mode, Effects, and Criticality Analysis (FMECA) on the Apollo program. It is a procedure for analysis of hardware items to determine those items contributing most to system unreliability and crew safety problems.

Ampoule failure sensor time response testing: Experiment 1

NASA Technical Reports Server (NTRS)

Johnson, M. L.; Watring, D. A.

1994-01-01

The response time of an ampoule failure sensor exposed to a liquid or vapor gallium-arsenide (GaAs) is investigated. The experimental configuration represents the sample/ampoule cartridge assembly used in NASA's Crystal Growth Furnace (CGF). The sensor is a chemical fuse made from a metal with which the semiconductor material reacts more rapidly than it does with the containing cartridge. For the III-IV compound of GaAs, a platinum metal was chosen based on the reaction of platinum and arsenic at elevated temperatures which forms a low melting eutectic. Ampoule failure is indicated by a step change in resistance of the failure sensor on the order of megohms. The sensors will increase the safety of crystal growth experiments by providing an indication that an ampoule has failed. Experimental results indicate that the response times (after a known ampoule failure) for the 0.003 and 0.010 inch ampoule failure sensors are 2.4 and 3.6 minutes, respectively. This ampoule failure sensor will be utilized in the CGF during the second United States Microgravity Laboratory Mission (USML-2) and is the subject of a NASA patent application.

Brazed Joints Design and Allowables: Discuss Margins of Safety in Critical Brazed Structures

NASA Technical Reports Server (NTRS)

FLom, Yury

2009-01-01

This slide presentation tutorial discusses margins of safety in critical brazed structures. It reviews: (1) the present situation (2) definition of strength (3) margins of safety (4) design allowables (5) mechanical testing (6) failure criteria (7) design flowchart (8) braze gap (9) residual stresses and (10) delayed failures. This presentation addresses the strength of the brazed joints, the methods of mechanical testing, and our ability to evaluate the margins of safety of the brazed joints as it applies to the design of critical and expensive brazed assemblies.

Abstracts of NASA-ASRDI publications relevant to aerospace safety research

NASA Technical Reports Server (NTRS)

Mandel, G.; Mckenna, P. J.

1973-01-01

Abstracts covering the following areas are presented: (1) oxygen technology; (2) fire safety; (3) accidents/incidents; (4) toxic spills; (5) aircraft safety; (6) structural failures; (7) nuclear systems; (8) fluid flow; and (9) zero gravity combustion.

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

Columbus safety and reliability

NASA Astrophysics Data System (ADS)

Longhurst, F.; Wessels, H.

1988-10-01

Analyses carried out to ensure Columbus reliability, availability, and maintainability, and operational and design safety are summarized. Failure modes/effects/criticality is the main qualitative tool used. The main aspects studied are fault tolerance, hazard consequence control, risk minimization, human error effects, restorability, and safe-life design.

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

PubMed

Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

2008-10-01

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

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

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

Darby, John L.

2011-05-01

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

Cost-minimisation analysis of subcutaneous methotrexate versus biologic therapy for the treatment of patients with rheumatoid arthritis who have had an insufficient response or intolerance to oral methotrexate.

PubMed

Fitzpatrick, Ray; Scott, David Gi; Keary, Ian

2013-11-01

This study aims to model the economic impact of subcutaneous methotrexate (SC MTX) or a biologic over a 12-month period using a hypothetical population of rheumatoid arthritis patients who failed to tolerate or respond to oral MTX and were suitable candidates for biologic therapy. A decision-based model was developed using current National Institute for Health and Clinical Excellence (NICE) guidance to determine the management of this hypothetical UK population. Published data on the continuation rates of SC MTX and biologics were used to compare the costs of the two treatment options. The economic model used a cost-minimisation methodology from a UK National Health Service (NHS) perspective, with the cost of all drugs and resources being estimated on this basis. Sensitivity analyses were also performed to determine the effects of changing key assumptions on the mean cost differences. The routine use of SC MTX following oral MTX failure has the potential to save an estimated £7,197 per patient in the first year of therapy and £9.3m per year nationally in new patients. Sensitivity analyses support the robustness of the results. The results of this study suggest that routine use of SC MTX following oral MTX failure has the potential to provide considerable savings to the NHS through optimised use of MTX first-line therapy. It is proposed, therefore, that patients should start on oral MTX with a subsequent switch to SC MTX in the case of an insufficient response or tolerability issues, before introducing a biologic agent.

Commonalities and Differences in Functional Safety Systems Between ISS Payloads and Industrial Applications

NASA Astrophysics Data System (ADS)

Malyshev, Mikhail; Kreimer, Johannes

2013-09-01

Safety analyses for electrical, electronic and/or programmable electronic (E/E/EP) safety-related systems used in payload applications on-board the International Space Station (ISS) are often based on failure modes, effects and criticality analysis (FMECA). For industrial applications of E/E/EP safety-related systems, comparable strategies exist and are defined in the IEC-61508 standard. This standard defines some quantitative criteria based on potential failure modes (for example, Safe Failure Fraction). These criteria can be calculated for an E/E/EP system or components to assess their compliance to requirements of a particular Safety Integrity Level (SIL). The standard defines several SILs depending on how much risk has to be mitigated by a safety-critical system. When a FMECA is available for an ISS payload or its subsystem, it may be possible to calculate the same or similar parameters as defined in the 61508 standard. One example of a payload that has a dedicated functional safety subsystem is the Electromagnetic Levitator (EML). This payload for the ISS is planned to be operated on-board starting 2014. The EML is a high-temperature materials processing facility. The dedicated subsystem "Hazard Control Electronics" (HCE) is implemented to ensure compliance to failure tolerance in limiting samples processing parameters to maintain generation of the potentially toxic by-products to safe limits in line with the requirements applied to the payloads by the ISS Program. The objective of this paper is to assess the implementation of the HCE in the EML against criteria for functional safety systems in the IEC-61508 standard and to evaluate commonalities and differences with respect to safety requirements levied on ISS Payloads. An attempt is made to assess a possibility of using commercially available components and systems certified for compliance to industrial functional safety standards in ISS payloads.

Preliminary Failure Modes and Effects Analysis of the US DCLL Test Blanket Module

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

Lee C. Cadwallader

2010-06-01

This report presents the results of a preliminary failure modes and effects analysis (FMEA) of a small tritium-breeding test blanket module design for the International Thermonuclear Experimental Reactor. The FMEA was quantified with “generic” component failure rate data, and the failure events are binned into postulated initiating event families and frequency categories for safety assessment. An appendix to this report contains repair time data to support an occupational radiation exposure assessment for test blanket module maintenance.

Preliminary Failure Modes and Effects Analysis of the US DCLL Test Blanket Module

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

Lee C. Cadwallader

2007-08-01

This report presents the results of a preliminary failure modes and effects analysis (FMEA) of a small tritium-breeding test blanket module design for the International Thermonuclear Experimental Reactor. The FMEA was quantified with “generic” component failure rate data, and the failure events are binned into postulated initiating event families and frequency categories for safety assessment. An appendix to this report contains repair time data to support an occupational radiation exposure assessment for test blanket module maintenance.

A new approach to tag design in dolphin telemetry: Computer simulations to minimise deleterious effects

NASA Astrophysics Data System (ADS)

Pavlov, V. V.; Wilson, R. P.; Lucke, K.

2007-02-01

Remote-sensors and transmitters are powerful devices for studying cetaceans at sea. However, despite substantial progress in microelectronics and miniaturisation of systems, dolphin tags are imperfectly designed; additional drag from tags increases swim costs, compromises swimming capacity and manoeuvrability, and leads to extra loads on the animal's tissue. We propose a new approach to tag design, elaborating basic principles and incorporating design stages to minimise device effects by using computer-aided design. Initially, the operational conditions of the device are defined by quantifying the shape, hydrodynamics and range of the natural deformation of the dolphin body at the tag attachment site (such as close to the dorsal fin). Then, parametric models of both of the dorsal fin and a tag are created using the derived data. The link between parameters of the fin and a tag model allows redesign of tag models according to expected changes of fin geometry (difference in fin shape related with species, sex, and age peculiarities, simulation of the bend of the fin during manoeuvres). A final virtual modelling stage uses iterative improvement of a tag model in a computer fluid dynamics (CFD) environment to enhance tag performance. This new method is considered as a suitable tool of tag design before creation of the physical model of a tag and testing with conventional wind/water tunnel technique. Ultimately, tag materials are selected to conform to the conditions identified by the modelling process and thus help create a physical model of a tag, which should minimise its impact on the animal carrier and thus increase the reliability and quality of the data obtained.

16 CFR 1702.5 - Failure to supply adverse information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Failure to supply adverse information. 1702.5 Section 1702.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

16 CFR 1702.5 - Failure to supply adverse information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Failure to supply adverse information. 1702.5 Section 1702.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

16 CFR 1702.5 - Failure to supply adverse information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Failure to supply adverse information. 1702.5 Section 1702.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

16 CFR 1702.5 - Failure to supply adverse information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Failure to supply adverse information. 1702.5 Section 1702.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

How to make the most of failure mode and effect analysis.

PubMed

Stalhandske, Erik; DeRosier, Joseph; Patail, Bryanne; Gosbee, John

2003-01-01

Current accreditation standards issued by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) require hospitals to carry out a proactive risk assessment on at least 1 high-risk activity each year for each accredited program. Because hospital risk managers and patient safety managers generally do not have the knowledge or level of comfort for conducting a proactive risk assessment, they will appreciate the expertise offered by biomedical equipment technicians (BMETs), occupational safety and health professionals, and others. The skills that have been developed by BMETs and others while conducting job safety analyses or failure mode effect analysis can now be applied to a health care proactive analysis. This article touches on the Health Care Failure Mode and Effect Analysis (HFMEA) model that the Department of Veterans Affairs (VA) National Center for Patient Safety developed for proactive risk assessment within the health care community. The goal of this article is to enlighten BMETs and others on the growth of proactive risk assessment within health care and also on the support documents and materials produced by the VA. For additional information on HFMEA, visit the VA website at www.patientsafety.gov/HFMEA.html.

Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy

PubMed Central

2013-01-01

Background A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient. Methods FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of

Minimising toxicity of cadmium in plants--role of plant growth regulators.

PubMed

Asgher, Mohd; Khan, M Iqbal R; Anjum, Naser A; Khan, Nafees A

2015-03-01

A range of man-made activities promote the enrichment of world-wide agricultural soils with a myriad of chemical pollutants including cadmium (Cd). Owing to its significant toxic consequences in plants, Cd has been one of extensively studied metals. However, sustainable strategies for minimising Cd impacts in plants have been little explored. Plant growth regulators (PGRs) are known for their role in the regulation of numerous developmental processes. Among major PGRs, plant hormones (such as auxins, gibberellins, cytokinins, abscisic acid, jasmonic acid, ethylene and salicylic acid), nitric oxide (a gaseous signalling molecule), brassinosteroids (steroidal phytohormones) and polyamines (group of phytohormone-like aliphatic amine natural compounds with aliphatic nitrogen structure) have gained attention by agronomist and physiologist as a sustainable media to induce tolerance in abiotic-stressed plants. Considering recent literature, this paper: (a) overviews Cd status in soil and its toxicity in plants, (b) introduces major PGRs and overviews their signalling in Cd-exposed plants, (c) appraises mechanisms potentially involved in PGR-mediated enhanced plant tolerance to Cd and (d) highlights key aspects so far unexplored in the subject area.

System safety management: A new discipline

NASA Technical Reports Server (NTRS)

Pope, W. C.

1971-01-01

The systems theory is discussed in relation to safety management. It is suggested that systems safety management, as a new discipline, holds great promise for reducing operating errors, conserving labor resources, avoiding operating costs due to mistakes, and for improving managerial techniques. It is pointed out that managerial failures or system breakdowns are the basic reasons for human errors and condition defects. In this respect, a recommendation is made that safety engineers stop visualizing the problem only with the individual (supervisor or employee) and see the problem from the systems point of view.

Safety belt promotion: theory and practice.

PubMed

Nelson, G D; Moffit, P B

1988-02-01

The purpose of this paper is to provide practitioners a rationale and description of selected theoretically based approaches to safety belt promotion. Theory failure is a threat to the integrity and effectiveness of safety belt promotion. The absence of theory driven programs designed to promote safety belt use is a concern of this paper. Six theoretical models from the social and behavioral sciences are reviewed with suggestions for application to promoting safety belt use and include Theory of Reasoned Action, the Health Belief Model, Fear Arousal, Operant Learning, Social Learning Theory, and Diffusion of Innovations. Guidelines for the selection and utilization of theory are discussed.

20 CFR 410.475 - Failure to submit evidence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Failure to submit evidence. 410.475 Section 410.475 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.475...

20 CFR 410.475 - Failure to submit evidence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Failure to submit evidence. 410.475 Section 410.475 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.475...

49 CFR 510.12 - Remedies for failure to comply with compulsory process.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION INFORMATION GATHERING POWERS... failure to comply, NHTSA may take appropriate action pursuant to the authority conferred by the National...

Certification Processes for Safety-Critical and Mission-Critical Aerospace Software

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2003-01-01

This document is a quick reference guide with an overview of the processes required to certify safety-critical and mission-critical flight software at selected NASA centers and the FAA. Researchers and software developers can use this guide to jumpstart their understanding of how to get new or enhanced software onboard an aircraft or spacecraft. The introduction contains aerospace industry definitions of safety and safety-critical software, as well as, the current rationale for certification of safety-critical software. The Standards for Safety-Critical Aerospace Software section lists and describes current standards including NASA standards and RTCA DO-178B. The Mission-Critical versus Safety-Critical software section explains the difference between two important classes of software: safety-critical software involving the potential for loss of life due to software failure and mission-critical software involving the potential for aborting a mission due to software failure. The DO-178B Safety-critical Certification Requirements section describes special processes and methods required to obtain a safety-critical certification for aerospace software flying on vehicles under auspices of the FAA. The final two sections give an overview of the certification process used at Dryden Flight Research Center and the approval process at the Jet Propulsion Lab (JPL).

Development Testing and Subsequent Failure Investigation of a Spring Strut Mechanism

NASA Technical Reports Server (NTRS)

Dervan, Jared; Robertson, Brandan; Staab, Lucas; Culberson, Michael; Pellicciotti, Joseph

2014-01-01

The NASA Engineering and Safety Center (NESC) and Lockheed Martin (LM) performed random vibration testing on a single spring strut development unit to assess its ability to withstand qualification level random vibration environments. Failure of the strut while exposed to random vibration resulted in a follow-on failure investigation, design changes, and additional development tests. This paper focuses on the results of the failure investigations referenced in detail in the NESC final report [1] including identified lessons learned to aid in future design iterations of the spring strut and to help other mechanism developers avoid similar pitfalls.

Development Testing and Subsequent Failure Investigation of a Spring Strut Mechanism

NASA Technical Reports Server (NTRS)

Dervan, Jared; Robertson, Brandon; Staab, Lucas; Culberson, Michael; Pellicciotti, Joseph

2014-01-01

The NASA Engineering and Safety Center (NESC) and Lockheed Martin (LM) performed random vibration testing on a single spring strut development unit to assess its ability to withstand qualification level random vibration environments. Failure of the strut while exposed to random vibration resulted in a follow-on failure investigation, design changes, and additional development tests. This paper focuses on the results of the failure investigations referenced in detail in the NESC final report including identified lessons learned to aid in future design iterations of the spring strut and to help other mechanism developers avoid similar pitfalls.

Selected classes of minimised hammerhead ribozyme have very high cleavage rates at low Mg2+ concentration.

PubMed Central

Conaty, J; Hendry, P; Lockett, T

1999-01-01

In vitro selection was used to enrich for highly efficient RNA phosphodiesterases within a size-constrained (18 nt) ribonucleotide domain. The starting population (g0) was directed in trans against an RNA oligonucleotide substrate immobilised to an avidin-magnetic phase. Four rounds of selection were conducted using 20 mM Mg2+to fractionate the population on the basis of divalent metal ion-dependent phosphodiesterase activity. The resulting generation 4 (g4) RNA was then directed through a further two rounds of selection using low concentrations of Mg2+. Generation 6 (g6) was composed of sets of active, trans cleaving minimised ribozymes, containing recognised hammerhead motifs in the conserved nucleotides, but with highly variable linker domains (loop II-L.1-L.4). Cleavage rate constants in the g6 population ranged from 0.004 to 1.3 min-1at 1 mM Mg2+(pH 8.0, 37 degrees C). Selection was further used to define conserved positions between G(10.1) and C(11.1) required for high cleavage activity at low Mg2+concentration. At 10 mM MgCl2the kinetic phenotype of these molecules was comparable to a hammerhead ribozyme with 4 bp in helix II. At low Mg2+concentration, the disparity in cleavage rate constants increases in favour of the minimised ribozymes. Favourable kinetic traits appeared to be a general property for specific selected linker sequences, as the high rates of catalysis were transferable to a different substrate system. PMID:10325431

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.

Sophisticated Calculation of the 1oo4-architecture for Safety-related Systems Conforming to IEC61508

NASA Astrophysics Data System (ADS)

Hayek, A.; Bokhaiti, M. Al; Schwarz, M. H.; Boercsoek, J.

2012-05-01

With the publication and enforcement of the standard IEC 61508 of safety related systems, recent system architectures have been presented and evaluated. Among a number of techniques and measures to the evaluation of safety integrity level (SIL) for safety-related systems, several measures such as reliability block diagrams and Markov models are used to analyze the probability of failure on demand (PFD) and mean time to failure (MTTF) which conform to IEC 61508. The current paper deals with the quantitative analysis of the novel 1oo4-architecture (one out of four) presented in recent work. Therefore sophisticated calculations for the required parameters are introduced. The provided 1oo4-architecture represents an advanced safety architecture based on on-chip redundancy, which is 3-failure safe. This means that at least one of the four channels have to work correctly in order to trigger the safety function.

Evaluation of the safety performance of highway alignments based on fault tree analysis and safety boundaries.

PubMed

Chen, Yikai; Wang, Kai; Xu, Chengcheng; Shi, Qin; He, Jie; Li, Peiqing; Shi, Ting

2018-05-19

To overcome the limitations of previous highway alignment safety evaluation methods, this article presents a highway alignment safety evaluation method based on fault tree analysis (FTA) and the characteristics of vehicle safety boundaries, within the framework of dynamic modeling of the driver-vehicle-road system. Approaches for categorizing the vehicle failure modes while driving on highways and the corresponding safety boundaries were comprehensively investigated based on vehicle system dynamics theory. Then, an overall crash probability model was formulated based on FTA considering the risks of 3 failure modes: losing steering capability, losing track-holding capability, and rear-end collision. The proposed method was implemented on a highway segment between Bengbu and Nanjing in China. A driver-vehicle-road multibody dynamics model was developed based on the 3D alignments of the Bengbu to Nanjing section of Ning-Luo expressway using Carsim, and the dynamics indices, such as sideslip angle and, yaw rate were obtained. Then, the average crash probability of each road section was calculated with a fixed-length method. Finally, the average crash probability was validated against the crash frequency per kilometer to demonstrate the accuracy of the proposed method. The results of the regression analysis and correlation analysis indicated good consistency between the results of the safety evaluation and the crash data and that it outperformed the safety evaluation methods used in previous studies. The proposed method has the potential to be used in practical engineering applications to identify crash-prone locations and alignment deficiencies on highways in the planning and design phases, as well as those in service.

Glovebox and Experiment Safety

NASA Astrophysics Data System (ADS)

Maas, Gerard

2005-12-01

Human spaceflight hardware and operations must comply with NSTS 1700.7. This paper discusses how a glovebox can help.A short layout is given on the process according NSTS/ISS 13830, explaining the responsibility of the payload organization, the approval authority of the PSRP and the defined review phases (0 till III).Amongst others, the following requirement has to be met:"200.1 Design to Tolerate Failures. Failure tolerance is the basic safety requirement that shall be used to control most payload hazards. The payload must tolerate a minimum number of credible failures and/or operator errors determined by the hazard level. This criterion applies when the loss of a function or the inadvertent occurrence of a function results in a hazardous event.200.1a Critical Hazards. Critical hazards shall be controlled such that no single failure or operator error can result in damage to STS/ISS equipment, a nondisabling personnel injury, or the use of unscheduled safing procedures that affect operations of the Orbiter/ISS or another payload.200.1b Catastrophic Hazards. Catastrophic hazards shall be controlled such that no combination of two failures or operator errors can result in the potential for a disabling or fatal personnel injury or loss of the Orbiter/ISS, ground facilities or STS/ISS equipment."For experiments in material science, biological science and life science that require real time operator manipulation, the above requirement may be hard or impossible to meet. Especially if the experiment contains substances that are considered hazardous when released into the habitable environment. In this case operation of the experiment in a glovebox can help to comply.A glovebox provides containment of the experiment and at the same time allows manipulation and visibility to the experiment.The containment inside the glovebox provides failure tolerance because the glovebox uses a negative pressure inside the working volume (WV). The level of failure tolerance is dependent of

Efficient direct yaw moment control: tyre slip power loss minimisation for four-independent wheel drive vehicle

NASA Astrophysics Data System (ADS)

Kobayashi, Takao; Katsuyama, Etsuo; Sugiura, Hideki; Ono, Eiichi; Yamamoto, Masaki

2018-05-01

This paper proposes an efficient direct yaw moment control (DYC) capable of minimising tyre slip power loss on contact patches for a four-independent wheel drive vehicle. Simulations identified a significant power loss reduction with a direct yaw moment due to a change in steer characteristics during acceleration or deceleration while turning. Simultaneously, the vehicle motion can be stabilised. As a result, the proposed control method can ensure compatibility between vehicle dynamics performance and energy efficiency. This paper also describes the results of a full-vehicle simulation that was conducted to examine the effectiveness of the proposed DYC.

Determination of UAV pre-flight Checklist for flight test purpose using qualitative failure analysis

NASA Astrophysics Data System (ADS)

Hendarko; Indriyanto, T.; Syardianto; Maulana, F. A.

2018-05-01

Safety aspects are of paramount importance in flight, especially in flight test phase. Before performing any flight tests of either manned or unmanned aircraft, one should include pre-flight checklists as a required safety document in the flight test plan. This paper reports on the development of a new approach for determination of pre-flight checklists for UAV flight test based on aircraft’s failure analysis. The Lapan’s LSA (Light Surveillance Aircraft) is used as a study case, assuming this aircraft has been transformed into the unmanned version. Failure analysis is performed on LSA using fault tree analysis (FTA) method. Analysis is focused on propulsion system and flight control system, which fail of these systems will lead to catastrophic events. Pre-flight checklist of the UAV is then constructed based on the basic causes obtained from failure analysis.

Operations analysis (study 2.1). Contingency analysis. [of failure modes anticipated during space shuttle upper stage planning

NASA Technical Reports Server (NTRS)

1974-01-01

Future operational concepts for the space transportation system were studied in terms of space shuttle upper stage failure contingencies possible during deployment, retrieval, or space servicing of automated satellite programs. Problems anticipated during mission planning were isolated using a modified 'fault tree' technique, normally used in safety analyses. A comprehensive space servicing hazard analysis is presented which classifies possible failure modes under the catagories of catastrophic collision, failure to rendezvous and dock, servicing failure, and failure to undock. The failure contingencies defined are to be taken into account during design of the upper stage.

Reliability and Maintainability Engineering - A Major Driver for Safety and Affordability

NASA Technical Reports Server (NTRS)

Safie, Fayssal M.

2011-01-01

The United States National Aeronautics and Space Administration (NASA) is in the midst of an effort to design and build a safe and affordable heavy lift vehicle to go to the moon and beyond. To achieve that, NASA is seeking more innovative and efficient approaches to reduce cost while maintaining an acceptable level of safety and mission success. One area that has the potential to contribute significantly to achieving NASA safety and affordability goals is Reliability and Maintainability (R&M) engineering. Inadequate reliability or failure of critical safety items may directly jeopardize the safety of the user(s) and result in a loss of life. Inadequate reliability of equipment may directly jeopardize mission success. Systems designed to be more reliable (fewer failures) and maintainable (fewer resources needed) can lower the total life cycle cost. The Department of Defense (DOD) and industry experience has shown that optimized and adequate levels of R&M are critical for achieving a high level of safety and mission success, and low sustainment cost. Also, lessons learned from the Space Shuttle program clearly demonstrated the importance of R&M engineering in designing and operating safe and affordable launch systems. The Challenger and Columbia accidents are examples of the severe impact of design unreliability and process induced failures on system safety and mission success. These accidents demonstrated the criticality of reliability engineering in understanding component failure mechanisms and integrated system failures across the system elements interfaces. Experience from the shuttle program also shows that insufficient Reliability, Maintainability, and Supportability (RMS) engineering analyses upfront in the design phase can significantly increase the sustainment cost and, thereby, the total life cycle cost. Emphasis on RMS during the design phase is critical for identifying the design features and characteristics needed for time efficient processing

Black swans, cognition, and the power of learning from failure.

PubMed

Catalano, Allison S; Redford, Kent; Margoluis, Richard; Knight, Andrew T

2018-06-01

Failure carries undeniable stigma and is difficult to confront for individuals, teams, and organizations. Disciplines such as commercial and military aviation, medicine, and business have long histories of grappling with it, beginning with the recognition that failure is inevitable in every human endeavor. Although conservation may arguably be more complex, conservation professionals can draw on the research and experience of these other disciplines to institutionalize activities and attitudes that foster learning from failure, whether they are minor setbacks or major disasters. Understanding the role of individual cognitive biases, team psychological safety, and organizational willingness to support critical self-examination all contribute to creating a cultural shift in conservation to one that is open to the learning opportunity that failure provides. This new approach to managing failure is a necessary next step in the evolution of conservation effectiveness. © 2017 The Authors. Conservation Biology published by Wiley Periodicals, Inc. on behalf of Society for Conservation Biology.

Risk Management Plans: are they a tool for improving drug safety?

PubMed

Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

2010-08-01

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

Oestradiol supplement minimises coronary occlusion-induced myocardial infarction and ventricular dysfunction in oophorectomised female rats.

PubMed

Zheng, Xiao-Pu; Ma, Ai-Qun; Dong, An-Ping; Wang, Shun; Jiang, Wen-Hui; Wang, Ting-Zhong; Fan, Fen-Ling; Ling, Shanhong

2011-09-15

Endogenous oestrogen deficiency after menopause is associated with high risk of acute cardiac events and the protection of exogenous oestrogen supplements remains uncertain. This study investigates whether oestrogen therapy protects the heart from ischemic injury in oophorectomised rats. Sexually mature female Sprague-Dawley rats (6 for each group) with bilateral oophorectomy underwent selective ligation (occlusion) of left coronary artery for 4 weeks. 17β-oestradiol (E2) supplements (10 μg, i.m., every other day) were started before (preventive-therapeutic supplement) or after coronary occlusion (therapeutic supplement). In oophorectomised rats plasma levels of E2 declined from 1301 ± 80 to 196 ± 48 pmol/L (p<0.01) and cardiac expression of oestrogen receptors (ER) decreased by ∼60%. E2 supplements recovered the ER expression. Selective ligation of left coronary led myocardial infarction in the left ventricle, with an increase in plasma cardiac troponin I (cTn-I), decrease in systolic blood pressure (SBP), and reduction of left ventricular pressures. Preventive-therapeutic but not therapeutic E2 supplement reduced cTn-I levels (from 21.9 ± 2.0 to 6.0 ± 0.3 ng/mL, p<0.01), minimised infarction (from 37.0 ± 1.2% to 18.1 ± 2.3%, p<0.05), increased SBP (from 82 ± 4.2 to 97 ± 4.4mm Hg, p<0.05), and improved left ventricular end pressures in the oophorectomised rats following coronary occlusion. Postmenopausal (ooporectomised) oestrogen supplement commenced before establishment of myocardial ischemia minimises myocardial infarction and ventricular dysfunction following the coronary artery occlusion. Cellular and molecular mechanisms underlying the cardiac protection of oestrogen therapy remain unclear, in which activation of cardiac ER expression and increasing in circulating CD90(+) stem cells may be involved. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis.

PubMed

Zheng, Yuanshui; Johnson, Randall; Larson, Gary

2016-06-01

Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authors estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

2006-01-01

System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

The Parable of the Boiled Safety Professional

NASA Technical Reports Server (NTRS)

Shivers, Charles H.

2011-01-01

Common and unique issues contribute to system failures. This paper touches on the concept of drift to failure as a cautionary message. Managers and leaders, design team members, fabricators and assemblers, analysis and assurance personnel, and others associated with operating and maintaining systems, need to pay attention to identify the manifestation of individual and collective behaviors that might indicate slips in rigor or focus or decisions that might eat away at safety margins as our system drifts to failure. Corrections to drift made during design and development phases may efficiently prevent or mitigate drift problems occurring in the operational phase.

Understanding and Minimising Occupational Radiation in the Catheterisation Laboratory with PISAX and the ACIST CVi® Contrast Delivery System

PubMed Central

Bar, Olivier

2013-01-01

This paper provides an overview of radiation exposure and its associated risks in the cardiac catheterisation laboratory (cath lab), as well as strategies to minimise radiation exposure for operators, cath lab staff and patients. The benefits of using a mobile 2 mm lead equivalent radiation shield (PISAX) and adoption of an automated contrast injection system (the ACIST CVi® Contrast Delivery System) are discussed, and the potential advantages of their combination are reviewed. PMID:29588748

Influenza infection and heart failure-vaccination may change heart failure prognosis?

PubMed

Kadoglou, Nikolaos P E; Bracke, Frank; Simmers, Tim; Tsiodras, Sotirios; Parissis, John

2017-05-01

The interaction of influenza infection with the pathogenesis of acute heart failure (AHF) and the worsening of chronic heart failure (CHF) is rather complex. The deleterious effects of influenza infection on AHF/CHF can be attenuated by specific immunization. Our review aimed to summarize the efficacy, effectiveness, safety, and dosage of anti-influenza vaccination in HF. In this literature review, we searched MEDLINE and EMBASE from January 1st 1966 to December 31st, 2016, for studies examining the association between AHF/CHF, influenza infections, and anti-influenza immunizations. We used broad criteria to increase the sensitivity of the search. HF was a prerequisite for our search. The search fields used included "heart failure," "vaccination," "influenza," "immunization" along with variants of these terms. No restrictions on the type of study design were applied. The most common clinical scenario is exacerbation of pre-existing CHF by influenza infection. Scarce evidence supports a potential positive association of influenza infection with AHF. Vaccinated patients with pre-existing CHF have reduced all-cause morbidity and mortality, but effects are not consistently documented. Immunization with higher antigen quantity may confer additional protection, but such aggressive approach has not been generally advocated. Further studies are needed to delineate the role of influenza infection on AHF/CHF pathogenesis and maintenance. Annual anti-influenza vaccination appears to be an effective measure for secondary prevention in HF. Better immunization strategies and more efficacious vaccines are urgently necessary.

The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management

PubMed Central

Patel, Teresa; Fisher, Stanley P.

2016-01-01

Objective This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. Methods The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. Results Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest‐ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. Conclusions The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success. PMID:27477689

Importance of teamwork, communication and culture on failure-to-rescue in the elderly.

PubMed

Ghaferi, A A; Dimick, J B

2016-01-01

Surgical mortality increases significantly with age. Wide variations in mortality rates across hospitals suggest potential levers for improvement. Failure-to-rescue has been posited as a potential mechanism underlying these differences. A review was undertaken of the literature evaluating surgery, mortality, failure-to-rescue and the elderly. This was followed by a review of ongoing studies and unpublished work aiming to understand better the mechanisms underlying variations in surgical mortality in elderly patients. Multiple hospital macro-system factors, such as nurse staffing, available hospital technology and teaching status, are associated with differences in failure-to-rescue rates. There is emerging literature regarding important micro-system factors associated with failure-to-rescue. These are grouped into three broad categories: hospital resources, attitudes and behaviours. Ongoing work to produce interventions to reduce variations in failure-to-rescue rates include a focus on teamwork, communication and safety culture. Researchers are using novel mixed-methods approaches and theories adapted from organizational studies in high-reliability organizations in an effort to improve the care of elderly surgical patients. Although elderly surgical patients experience failure-to-rescue events at much higher rates than their younger counterparts, patient-level effects do not sufficiently explain these differences. Increased attention to the role of organizational dynamics in hospitals' ability to rescue these high-risk patients will establish high-yield interventions aimed at improving patient safety. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

Fatigue failure of the cephalomedullary nail: revision options, outcomes and review of the literature.

PubMed

Tucker, Adam; Warnock, Michael; McDonald, Sinead; Cusick, Laurence; Foster, Andrew P

2018-04-01

Cephalomedullary nail (CMN) failure is a rare entity following hip fracture treatment. However, it poses significant challenges for revision surgery, both mechanically and biologically. Nail failure rates have been reported at < 2%; however, no published studies have reported revision surgery procedures and their respective outcomes. We present a regional experience, with outcomes, of the revision options. We identified 20 fatigued CMNs that underwent four different revision procedures. Mean age was 73 ± 15.24 years, with a 3:1 female preponderance, and a median ASA grade of 3. Post-operative CMN radiographs demonstrated a significant number of fractures were fixed in varus, with reductions in neck-shaft angles post-operatively. A "poor" quality of reduction resulted in significantly earlier nail failure, compared to "adequate" and "good" (p = 0.027). Tip-Apex Distance (TAD) mean was 23.2 ± 8.3 mm, and an adequate TAD with three-point fixation was seen in only 35% of cases. Mean time to failure was 401.0 ± 237.2 days, with mean age at failure of 74.0 ± 14.8 years. Options after failure included revision CMN nail, proximal femoral locking plate (PFLP), long-stem or restoration arthroplasty, or femoral endoprosthesis. Barthel Functional Index scores showed no significant difference at 3 and 12 months post-operatively, nor any difference between treatment groups. Mean 12-month mortality was 30%, akin to a primary hip fracture mortality risk according to NICE guidelines. Mortality rates were lowest in revision nails. Subsequent revision rates were higher in the PFLP group. There is no reported evidence on the best surgical technique for managing the failed CMN, with no clear functional benefit in the options above. Good surgical technique at the time of primary CMN surgery is critical in minimising fatigue failure. After revision, overall mortality rates were equivalent to reported primary hip fracture mortality rates. Further multicentre

Probabilistic Design Analysis (PDA) Approach to Determine the Probability of Cross-System Failures for a Space Launch Vehicle

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Lo, Yunnhon; Ward, Natalie C.

2010-01-01

Quantifying the probability of significant launch vehicle failure scenarios for a given design, while still in the design process, is critical to mission success and to the safety of the astronauts. Probabilistic risk assessment (PRA) is chosen from many system safety and reliability tools to verify the loss of mission (LOM) and loss of crew (LOC) requirements set by the NASA Program Office. To support the integrated vehicle PRA, probabilistic design analysis (PDA) models are developed by using vehicle design and operation data to better quantify failure probabilities and to better understand the characteristics of a failure and its outcome. This PDA approach uses a physics-based model to describe the system behavior and response for a given failure scenario. Each driving parameter in the model is treated as a random variable with a distribution function. Monte Carlo simulation is used to perform probabilistic calculations to statistically obtain the failure probability. Sensitivity analyses are performed to show how input parameters affect the predicted failure probability, providing insight for potential design improvements to mitigate the risk. The paper discusses the application of the PDA approach in determining the probability of failure for two scenarios from the NASA Ares I project

Efficiency and Safety of Prolonged Levosimendan Infusion in Patients with Acute Heart Failure

PubMed Central

Aidonidis, Georgios; Kanonidis, Ioannis; Koutsimanis, Vasileios; Neumann, Till; Erbel, Raimund; Sakadamis, Georgios

2011-01-01

Background. Levosimendan is an inotropic drug with unique pharmacological advantages in patients with acute heart failure. Scope of this study is to determine whether longer infusion patterns without the hypotension-inducing loading dose could justify an effective and safe alternative approach. Methods. 70 patients admitted to the emergencies with decompensated chronic heart failure received intravenously levosimendan without a loading dose up to 72 hours. Clinical parameters, BNP (Brain Natriuretic Peptide) and signal-averaged-ECG data (SAECG) were recorded up to 72 hours. Results. The 48-hour group demonstrated a statistically significant BNP decrease (P < .001) after 48 hours, which also maintained after 72 hours. The 72-hour group demonstrated a bordeline decrease of BNP after 48 hours (P = .039), necessitating an additional 24-hour infusion to achieve significant reduction after 72 hours (P < .004). SAECG data demonstrated a statistically significant decrease after 72 hours (P < .04). Apart from two deaths due to advanced heart failure, no major complications were observed. Conclusion. Prolonged infusion of levosimendan without a loading dose is associated with an acceptable clinical and neurohumoral response. PMID:21559263

Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

PubMed

Bartunek, Jozef; Davison, Beth; Sherman, Warren; Povsic, Thomas; Henry, Timothy D; Gersh, Bernard; Metra, Marco; Filippatos, Gerasimos; Hajjar, Roger; Behfar, Atta; Homsy, Christian; Cotter, Gad; Wijns, William; Tendera, Michal; Terzic, Andre

2016-02-01

Cardiopoiesis is a conditioning programme that aims to upgrade the cardioregenerative aptitude of patient-derived stem cells through lineage specification. Cardiopoietic stem cells tested initially for feasibility and safety exhibited signs of clinical benefit in patients with ischaemic heart failure (HF) warranting definitive evaluation. Accordingly, CHART-1 is designed as a large randomized, sham-controlled multicentre study aimed to validate cardiopoietic stem cell therapy. Patients (n = 240) with chronic HF secondary to ischaemic heart disease, reduced LVEF (<35%), and at high risk for recurrent HF-related events, despite optimal medical therapy, will be randomized 1:1 to receive 600 × 10(6) bone marrow-derived and lineage-directed autologous cardiopoietic stem cells administered via a retention-enhanced intramyocardial injection catheter or a sham procedure. The primary efficacy endpoint is a hierarchical composite of mortality, worsening HF, Minnesota Living with Heart Failure Questionnaire score, 6 min walk test, LV end-systolic volume, and LVEF at 9 months. The secondary efficacy endpoint is the time to cardiovascular death or worsening HF at 12 months. Safety endpoints include mortality, readmissions, aborted sudden deaths, and serious adverse events at 12 and 24 months. The CHART-1 clinical trial is powered to examine the therapeutic impact of lineage-directed stem cells as a strategy to achieve cardiac regeneration in HF populations. On completion, CHART-1 will offer a definitive evaluation of the efficacy and safety of cardiopoietic stem cells in the treatment of chronic ischaemic HF. NCT01768702. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Minimising visitor impacts to protected areas: The efficacy of low impact education programmes

USGS Publications Warehouse

Marion, J.L.; Reid, S.E.

2007-01-01

Protected area managers, tourism providers, and other organisations commonly employ education programmes to address visitation-related impairment of natural and cultural resources, social conditions, and neighbouring communities. These programmes have different names (Leave No Trace, Codes of Conduct, Environmental Guidelines for Tourists) but share common objectives: to sustain opportunities for high quality visitor experiences while avoiding or minimising associated negative impacts to protected area resources, visitor experiences, and park neighbours. Theoretical and empirical research studies in the United States are reviewed to evaluate the efficacy of educational efforts that seek to encourage adoption of low impact behaviours. Findings reveal that most of the visitor education efforts evaluated did effectively alter visitor knowledge, behaviour and/or resource and social conditions in the intended direction. These findings, including discussions of message content, delivery, audience characteristics and theoretical grounding, provide insights for improving the efficacy of future educational efforts.

[Failure mode and effects analysis to improve quality in clinical trials].

PubMed

Mañes-Sevilla, M; Marzal-Alfaro, M B; Romero Jiménez, R; Herranz-Alonso, A; Sanchez Fresneda, M N; Benedi Gonzalez, J; Sanjurjo-Sáez, M

The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

30 CFR 100.4 - Unwarrantable failure and immediate notification.

Code of Federal Regulations, 2014 CFR

2014-07-01

... CIVIL PENALTIES FOR VIOLATIONS OF THE FEDERAL MINE SAFETY AND HEALTH ACT OF 1977 CRITERIA AND PROCEDURES FOR PROPOSED ASSESSMENT OF CIVIL PENALTIES § 100.4 Unwarrantable failure and immediate notification. (a) The minimum penalty for any citation or order issued under section 104(d)(1) of the Mine Act...

30 CFR 100.4 - Unwarrantable failure and immediate notification.

Code of Federal Regulations, 2013 CFR

2013-07-01

... CIVIL PENALTIES FOR VIOLATIONS OF THE FEDERAL MINE SAFETY AND HEALTH ACT OF 1977 CRITERIA AND PROCEDURES FOR PROPOSED ASSESSMENT OF CIVIL PENALTIES § 100.4 Unwarrantable failure and immediate notification. (a) The minimum penalty for any citation or order issued under section 104(d)(1) of the Mine Act...

30 CFR 100.4 - Unwarrantable failure and immediate notification.

Code of Federal Regulations, 2011 CFR

2011-07-01

... CIVIL PENALTIES FOR VIOLATIONS OF THE FEDERAL MINE SAFETY AND HEALTH ACT OF 1977 CRITERIA AND PROCEDURES FOR PROPOSED ASSESSMENT OF CIVIL PENALTIES § 100.4 Unwarrantable failure and immediate notification. (a) The minimum penalty for any citation or order issued under section 104(d)(1) of the Mine Act...

30 CFR 100.4 - Unwarrantable failure and immediate notification.

Code of Federal Regulations, 2012 CFR

2012-07-01

... CIVIL PENALTIES FOR VIOLATIONS OF THE FEDERAL MINE SAFETY AND HEALTH ACT OF 1977 CRITERIA AND PROCEDURES FOR PROPOSED ASSESSMENT OF CIVIL PENALTIES § 100.4 Unwarrantable failure and immediate notification. (a) The minimum penalty for any citation or order issued under section 104(d)(1) of the Mine Act...

Safety Management of a Clinical Process Using Failure Mode and Effect Analysis: Continuous Renal Replacement Therapies in Intensive Care Unit Patients.

PubMed

Sanchez-Izquierdo-Riera, Jose Angel; Molano-Alvarez, Esteban; Saez-de la Fuente, Ignacio; Maynar-Moliner, Javier; Marín-Mateos, Helena; Chacón-Alves, Silvia

2016-01-01

The failure mode and effect analysis (FMEA) may improve the safety of the continuous renal replacement therapies (CRRT) in the intensive care unit. We use this tool in three phases: 1) Retrospective observational study. 2) A process FMEA, with implementation of the improvement measures identified. 3) Cohort study after FMEA. We included 54 patients in the pre-FMEA group and 72 patients in the post-FMEA group. Comparing the risks frequencies per patient in both groups, we got less cases of under 24 hours of filter survival time in the post-FMEA group (31 patients 57.4% vs. 21 patients 29.6%; p < 0.05); less patients suffered circuit coagulation with inability to return the blood to the patient (25 patients [46.3%] vs. 16 patients [22.2%]; p < 0.05); 54 patients (100%) versus 5 (6.94%) did not get phosphorus levels monitoring (p < 0.05); in 14 patients (25.9%) versus 0 (0%), the CRRT prescription did not appear on medical orders. As a measure of improvement, we adopt a dynamic dosage management. After the process FMEA, there were several improvements in the management of intensive care unit patients receiving CRRT, and we consider it a useful tool for improving the safety of critically ill patients.

Utility of Failure Mode and Effect Analysis to Improve Safety in Suctioning by Orotracheal Tube.

PubMed

Vázquez-Valencia, Agustín; Santiago-Sáez, Andrés; Perea-Pérez, Bernardo; Labajo-González, Elena; Albarrán-Juan, Maria Elena

2017-02-01

The objective of the study was to use the Failure Mode and Effect Analysis (FMEA) tool to analyze the technique of secretion suctioning on patients with an endotracheal tube who were admitted into an intensive care unit. Brainstorming was carried out within the service to determine the potential errors most frequent in the process. After this, the FMEA was applied, including its stages, prioritizing risk in accordance with the risk prioritization number (RPN), selecting improvement actions in which they have an RPN of more than 300. We obtained 32 failure modes, of which 13 surpassed an RPN of 300. After our result, 21 improvement actions were proposed for those failure modes with RPN scores above 300. FMEA allows us to ascertain possible failures so as to later propose improvement actions for those which have an RPN of more than 300. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Failure Modes and Effects Analysis of bilateral same-day cataract surgery

PubMed Central

Shorstein, Neal H.; Lucido, Carol; Carolan, James; Liu, Liyan; Slean, Geraldine; Herrinton, Lisa J.

2017-01-01

PURPOSE To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN Retrospective cohort study. METHODS Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding error of intracameral antibiotic that could lead to endophthalmitis or TASS and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence intervals [CI] 0.1–12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using a FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards. PMID:28410711

Automatisms in EMIR instrument to improve operation, safety and maintenance

NASA Astrophysics Data System (ADS)

Fernández Izquierdo, Patricia; Núñez Cagigal, Miguel; Barreto Rodríguez, Roberto; Martínez Rey, Noelia; Santana Tschudi, Samuel; Barreto Cabrera, Maria; Patrón Recio, Jesús; Garzón López, Francisco

2014-08-01

EMIR is the NIR imager and multiobject spectrograph being built as a common user instrument for the 10-m class GTC. Big cryogenic instruments demand a reliable design and a specific hardware and software to increase its safety and productivity. EMIR vacuum, cooling and heating systems are monitored and partially controlled by a Programmable Logic Controller (PLC) in industrial format with a touch screen. The PLC aids the instrument operator in the maintenance tasks recovering autonomously vacuum if required or proposing preventive maintenance actions. The PLC and its associated hardware improve EMIR safety having immediate reactions against eventual failure modes in the instrument or in external supplies, including hardware failures during the heating procedure or failure in the PLC itself. EMIR PLC provides detailed information periodically about status and alarms of vacuum and cooling components or external supplies.

Efficacy and safety of icotinib in Chinese patients with advanced non-small cell lung cancer after failure of chemotherapy.

PubMed

Shao, Lan; Zhang, Beibei; He, Chunxiao; Lin, Baochai; Song, Zhengbo; Lou, Guangyuan; Yu, Xinmin; Zhang, Yiping

2014-01-01

The preclinical experiments and several clinical studies showed icotinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in Chinese patients with advanced non-small cell lung cancer (NSCLC) who failed previous chemotherapy. We performed a retrospective study of the efficacy and safety of icotinib monotherapy in a different and more recent sample of Chinese patients. The clinical data of 149 patients with advanced NSCLC who were admitted to Zhejiang Cancer Hospital from August 1, 2011 to July 31, 2012 were retrospectively analyzed. All patients were given icotinib treatment after the failure of previous chemotherapy. Univariate and multivariate analyses were conducted based on the Kaplan Meier method and Cox proportional hazards model. The objective response rate was 33/149 and disease control rate was 105/149. No complete response occurred. Median progression free survival (PFS) with icotinib treatment was 5.03 months (95% CI: 3.51 to 6.55). Median overall survival was 12.3 months (95% CI: 10.68 to 13.92). Multivariate analysis showed that the mutation of EGFR and one regimen of prior chemotherapy were significantly associated with longer PFS. At least one drug related adverse event was observed in 65.8% (98/149) of patients, but mostly grade 1 or 2 and reversible and none grade 4 toxicity. Icotinib monotherapy is an effective and well tolerated regimen for Chinese patients with NSCLC after the failure of chemotherapy. It is a promising agent and further study with icotinib in properly conducted trials with larger patient samples and other ethnic groups is warranted.

Professional failure to thrive: a threat to high-quality care?

PubMed

Stamler, Lynnette Leeseberg; Gabriel, Aaron M

2010-03-01

The term professional failure to thrive arose from descriptions of non-organic failure to thrive in infants and observations of nurses' behaviours. First coined by Stamler in 1997, subsequent unrelated research results have supported the theoretical construct. In an era when patient safety and high-quality care have never been more important, and nursing retention has reached heretofore unknown levels of global concern, critical examination of factors that may alleviate professional issues and support high-quality healthcare is especially useful. In this paper, we suggest theoretical causes for professional failure to thrive (PFTT) and associated behaviours exhibited by nurses, and draw links to current research to support the theory. Given the theoretical support, PFTT represents an additional avenue that should be considered and explored through research studies.

Understanding situation awareness and its importance in patient safety.

PubMed

Gluyas, Heather; Harris, Sarah-Jane

2016-04-20

Situation awareness describes an individual's perception, comprehension and subsequent projection of what is going on in the environment around them. The concept of situation awareness sits within the group of non-technical skills that include teamwork, communication and managing hierarchical lines of communication. The importance of non-technical skills has been recognised in safety-critical industries such as aviation, the military, nuclear, and oil and gas. However, health care has been slow to embrace the role of non-technical skills such as situation awareness in improving outcomes and minimising the risk of error. This article explores the concept of situation awareness and the cognitive processes involved in maintaining it. In addition, factors that lead to a loss of situation awareness and strategies to improve situation awareness are discussed.

Control of large commercial vehicle accidents caused by front tire failures.

DOT National Transportation Integrated Search

1975-08-01

The Federal Highway Administration of the u.s. Department of Transportation is concerned with the loss of life, injury, and property damage that result from front tire failure on heavyduty trucks. The Bureau of Motor Carrier Safety contracted with Ul...

16 CFR § 1702.5 - Failure to supply adverse information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Failure to supply adverse information. § 1702.5 Section § 1702.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those

In-Flight Validation of a Pilot Rating Scale for Evaluating Failure Transients in Electronic Flight Control Systems

NASA Technical Reports Server (NTRS)

Kalinowski, Kevin F.; Tucker, George E.; Moralez, Ernesto, III

2006-01-01

Engineering development and qualification of a Research Flight Control System (RFCS) for the Rotorcraft Aircrew Systems Concepts Airborne Laboratory (RASCAL) JUH-60A has motivated the development of a pilot rating scale for evaluating failure transients in fly-by-wire flight control systems. The RASCAL RFCS includes a highly-reliable, dual-channel Servo Control Unit (SCU) to command and monitor the performance of the fly-by-wire actuators and protect against the effects of erroneous commands from the flexible, but single-thread Flight Control Computer. During the design phase of the RFCS, two piloted simulations were conducted on the Ames Research Center Vertical Motion Simulator (VMS) to help define the required performance characteristics of the safety monitoring algorithms in the SCU. Simulated failures, including hard-over and slow-over commands, were injected into the command path, and the aircraft response and safety monitor performance were evaluated. A subjective Failure/Recovery Rating (F/RR) scale was developed as a means of quantifying the effects of the injected failures on the aircraft state and the degree of pilot effort required to safely recover the aircraft. A brief evaluation of the rating scale was also conducted on the Army/NASA CH-47B variable stability helicopter to confirm that the rating scale was likely to be equally applicable to in-flight evaluations. Following the initial research flight qualification of the RFCS in 2002, a flight test effort was begun to validate the performance of the safety monitors and to validate their design for the safe conduct of research flight testing. Simulated failures were injected into the SCU, and the F/RR scale was applied to assess the results. The results validate the performance of the monitors, and indicate that the Failure/Recovery Rating scale is a very useful tool for evaluating failure transients in fly-by-wire flight control systems.

Sensor Failure Detection of FASSIP System using Principal Component Analysis

NASA Astrophysics Data System (ADS)

Sudarno; Juarsa, Mulya; Santosa, Kussigit; Deswandri; Sunaryo, Geni Rina

2018-02-01

In the nuclear reactor accident of Fukushima Daiichi in Japan, the damages of core and pressure vessel were caused by the failure of its active cooling system (diesel generator was inundated by tsunami). Thus researches on passive cooling system for Nuclear Power Plant are performed to improve the safety aspects of nuclear reactors. The FASSIP system (Passive System Simulation Facility) is an installation used to study the characteristics of passive cooling systems at nuclear power plants. The accuracy of sensor measurement of FASSIP system is essential, because as the basis for determining the characteristics of a passive cooling system. In this research, a sensor failure detection method for FASSIP system is developed, so the indication of sensor failures can be detected early. The method used is Principal Component Analysis (PCA) to reduce the dimension of the sensor, with the Squarred Prediction Error (SPE) and statistic Hotteling criteria for detecting sensor failure indication. The results shows that PCA method is capable to detect the occurrence of a failure at any sensor.

Phase I/II Trial of Adeno-Associated Virus–Mediated Alpha-Glucosidase Gene Therapy to the Diaphragm for Chronic Respiratory Failure in Pompe Disease: Initial Safety and Ventilatory Outcomes

PubMed Central

Smith, Barbara K.; Collins, Shelley W.; Conlon, Thomas J.; Mah, Cathryn S.; Lawson, Lee Ann; Martin, Anatole D.; Fuller, David D.; Cleaver, Brian D.; Clément, Nathalie; Phillips, Dawn; Islam, Saleem; Dobjia, Nicole

2013-01-01

Abstract Pompe disease is an inherited neuromuscular disease caused by deficiency of lysosomal acid alpha-glucosidase (GAA) leading to glycogen accumulation in muscle and motoneurons. Cardiopulmonary failure in infancy leads to early mortality, and GAA enzyme replacement therapy (ERT) results in improved survival, reduction of cardiac hypertrophy, and developmental gains. However, many children have progressive ventilatory insufficiency and need additional support. Preclinical work shows that gene transfer restores phrenic neural activity and corrects ventilatory deficits. Here we present 180-day safety and ventilatory outcomes for five ventilator-dependent children in a phase I/II clinical trial of AAV-mediated GAA gene therapy (rAAV1-hGAA) following intradiaphragmatic delivery. We assessed whether rAAV1-hGAA results in acceptable safety outcomes and detectable functional changes, using general safety measures, immunological studies, and pulmonary functional testing. All subjects required chronic, full-time mechanical ventilation because of respiratory failure that was unresponsive to both ERT and preoperative muscle-conditioning exercises. After receiving a dose of either 1×1012 vg (n=3) or 5×1012 vg (n=2) of rAAV1-hGAA, the subjects' unassisted tidal volume was significantly larger (median [interquartile range] 28.8% increase [15.2–35.2], p<0.05). Further, most patients tolerated appreciably longer periods of unassisted breathing (425% increase [103–851], p=0.08). Gene transfer did not improve maximal inspiratory pressure. Expected levels of circulating antibodies and no T-cell-mediated immune responses to the vector (capsids) were observed. One subject demonstrated a slight increase in anti-GAA antibody that was not considered clinically significant. These results indicate that rAAV1-hGAA was safe and may lead to modest improvements in volitional ventilatory performance measures. Evaluation of the next five patients will determine whether earlier

Improving patient safety: patient-focused, high-reliability team training.

PubMed

McKeon, Leslie M; Cunningham, Patricia D; Oswaks, Jill S Detty

2009-01-01

Healthcare systems are recognizing "human factor" flaws that result in adverse outcomes. Nurses work around system failures, although increasing healthcare complexity makes this harder to do without risk of error. Aviation and military organizations achieve ultrasafe outcomes through high-reliability practice. We describe how reliability principles were used to teach nurses to improve patient safety at the front line of care. Outcomes include safety-oriented, teamwork communication competency; reflections on safety culture and clinical leadership are discussed.

The nuts and bolts of pills and portions: the functions of a drug safety working group.

PubMed

Nath, Noleen S; Jones, Ellen H; Stride, Peter; Premaratne, Manuja; Thaker, Darshit; Lim, Ivan

2011-11-01

Hospitalised patients commonly experience adverse drug events (ADEs) and medication errors. Runciman reported that ADEs in hospitals account for 20% of reported adverse events and contribute to 27% of deaths where death followed an adverse event. Hughes recommends multidisciplinary hospital drug committees to assess performance and raise standards. The new Code of Conduct of the Medical Board of Australia recommends participation in systems for surveillance and monitoring of adverse events, and to improve patient safety. We describe the functions and role of a Drug Safety Working Group (DSWG) in a suburban hospital, which aims to audit and promote a culture of prescribing and medication administration that is prudent and cautious to minimise the risk of harm to patients. We believe that regular prescription monitoring and feedback to Resident Medical Officers (RMOs) improves medication management in our hospital.

Compendium of traffic safety research projects : 1987-1997

DOT National Transportation Integrated Search

1997-09-01

The National Highway Traffic Safety Administration's (NHTSA) Research and Evaluation Division, Office of Research and Traffic Records, conducts research and evaluation projects dealing with human attitudes, behaviors, and failures (motor vehicle cras...

Radiation safety education reduces the incidence of adult fingers on neonatal chest radiographs.

PubMed

Sahota, N; Burbridge, B E; Duncan, M D

2014-06-01

A previous audit revealed a high frequency of adult fingers visualised on neonatal intensive care unit (NICU) chest radiographs-representing an example of inappropriate occupational radiation exposure. Radiation safety education was provided to staff and we hypothesised that the education would reduce the frequency of adult fingers visualised on NICU chest radiographs. Two cross-sectional samples taken before and after the administration of the education were compared. We examined fingers visualised directly in the beam, fingers in the direct beam but eliminated by technologists editing the image, and fingers under the cones of the portable x-ray machine. There was a 46.2% reduction in fingers directly in the beam, 50.0% reduction in fingers directly in the beam but cropped out, and 68.4% reduction in fingers in the coned area. There was a 57.1% overall reduction in adult fingers visualised, which was statistically significant (Z value - 7.48, P < 0.0001). This study supports radiation safety education in minimising inappropriate occupational radiation exposure.

Value of Telemonitoring and Telemedicine in Heart Failure Management.

PubMed

Gensini, Gian Franco; Alderighi, Camilla; Rasoini, Raffaele; Mazzanti, Marco; Casolo, Giancarlo

2017-11-01

The use of telemonitoring and telemedicine is a relatively new but quickly developing area in medicine. As new digital tools and applications are being created and used to manage medical conditions such as heart failure, many implications require close consideration and further study, including the effectiveness and safety of these telemonitoring tools in diagnosing, treating and managing heart failure compared to traditional face-to-face doctor-patient interaction. When compared to multidisciplinary intervention programs which are frequently hindered by economic, geographic and bureaucratic barriers, non-invasive remote monitoring could be a solution to support and promote the care of patients over time. Therefore it is crucial to identify the most relevant biological parameters to monitor, which heart failure sub-populations may gain real benefits from telehealth interventions and in which specific healthcare subsets these interventions should be implemented in order to maximise value.

Safety modelling and testing of lithium-ion batteries in electrified vehicles

NASA Astrophysics Data System (ADS)

Deng, Jie; Bae, Chulheung; Marcicki, James; Masias, Alvaro; Miller, Theodore

2018-04-01

To optimize the safety of batteries, it is important to understand their behaviours when subjected to abuse conditions. Most early efforts in battery safety modelling focused on either one battery cell or a single field of interest such as mechanical or thermal failure. These efforts may not completely reflect the failure of batteries in automotive applications, where various physical processes can take place in a large number of cells simultaneously. In this Perspective, we review modelling and testing approaches for battery safety under abuse conditions. We then propose a general framework for large-scale multi-physics modelling and experimental work to address safety issues of automotive batteries in real-world applications. In particular, we consider modelling coupled mechanical, electrical, electrochemical and thermal behaviours of batteries, and explore strategies to extend simulations to the battery module and pack level. Moreover, we evaluate safety test approaches for an entire range of automotive hardware sets from cell to pack. We also discuss challenges in building this framework and directions for its future development.

29 CFR 1903.18 - Failure to correct a violation for which a citation has been issued.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES... Compliance Safety and Health Officer of such failure and of the additional penalty proposed under section 17... citation has been issued shall not begin to run until the entry of a final order of the Review Commission...

29 CFR 1903.18 - Failure to correct a violation for which a citation has been issued.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR INSPECTIONS, CITATIONS AND PROPOSED PENALTIES... Compliance Safety and Health Officer of such failure and of the additional penalty proposed under section 17... citation has been issued shall not begin to run until the entry of a final order of the Review Commission...

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and software system safety as part of the pre-revenue service testing of the equipment. (d)(1... safely by initiating a full service brake application in the event of a hardware or software failure that... 49 Transportation 4 2010-10-01 2010-10-01 false Train electronic hardware and software safety. 238...

Global left atrial failure in heart failure.

PubMed

Triposkiadis, Filippos; Pieske, Burkert; Butler, Javed; Parissis, John; Giamouzis, Gregory; Skoularigis, John; Brutsaert, Dirk; Boudoulas, Harisios

2016-11-01

The left atrium plays an important role in the maintenance of cardiovascular and neurohumoral homeostasis in heart failure. However, with progressive left ventricular dysfunction, left atrial (LA) dilation and mechanical failure develop, which frequently culminate in atrial fibrillation. Moreover, LA mechanical failure is accompanied by LA endocrine failure [deficient atrial natriuretic peptide (ANP) processing-synthesis/development of ANP resistance) and LA regulatory failure (dominance of sympathetic nervous system excitatory mechanisms, excessive vasopressin release) contributing to neurohumoral overactivity, vasoconstriction, and volume overload (global LA failure). The purpose of the present review is to describe the characteristics and emphasize the clinical significance of global LA failure in patients with heart failure. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

Extracorporeal Ultrafiltration for Fluid Overload in Heart Failure

PubMed Central

Costanzo, Maria Rosa; Ronco, Claudio; Abraham, William T.; Agostoni, Piergiuseppe; Barasch, Jonathan; Fonarow, Gregg C.; Gottlieb, Stephen S.; Jaski, Brian E.; Kazory, Amir; Levin, Allison P.; Levin, Howard R.; Marenzi, Giancarlo; Mullens, Wilfried; Negoianu, Dan; Redfield, Margaret M.; Tang, W.H. Wilson; Testani, Jeffrey M.; Voors, Adriaan A.

2017-01-01

More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients’ vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration. PMID:28494980

30 CFR 57.22206 - Main ventilation failure (I-A, II-A, III, and V-A mines).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Main ventilation failure (I-A, II-A, III, and V-A mines). 57.22206 Section 57.22206 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Main ventilation failure (I-A, II-A, III, and V-A mines). (a) When there has been a main ventilation...

Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study).

PubMed

Kinugawa, Koichiro; Inomata, Takayuki; Sato, Naoki; Yasuda, Moriyoshi; Shimakawa, Toshiyuki; Bando, Kosuke; Mizuguchi, Kazuki

2015-01-01

The vasopressin receptor 2 (V2) receptor antagonist tolvaptan is an aquaretic agent that has been found to improve symptoms in patients with congestive heart failure. In this study (SMILE study), we administered tolvaptan to patients aged ≥ 80 years with heart failure accompanied by congestive symptoms and compared its effectiveness and safety profiles in this group with those in patients < 80 years (U-80). The results showed that the effectiveness of tolvaptan in the aged patients was similar to that in U-80 patients. In the safety profile, the incidence rate of thirst was lower in the aged patients than that in U-80 patients (9.6% versus 11.6%, P = 0.0023). Furthermore, the incidence of hypernatremia, defined as ≥ 150 mEq/L in aged patients, was comparable with that in U-80 patients (2.9% versus 3.6%, respectively, P = 0.3657). Based on these findings, tolvaptan has similar effectiveness and safety profiles in aged patients compared with U-80 patients. In addition, we found that a higher starting dose of tolvaptan was markedly associated with the occurrence of hypernatremia exclusively in the aged population; therefore, we recommend that tolvaptan should be started at lower doses in aged patients.

CRYOGENIC UPPER STAGE SYSTEM SAFETY

NASA Technical Reports Server (NTRS)

Smith, R. Kenneth; French, James V.; LaRue, Peter F.; Taylor, James L.; Pollard, Kathy (Technical Monitor)

2005-01-01

NASA s Exploration Initiative will require development of many new systems or systems of systems. One specific example is that safe, affordable, and reliable upper stage systems to place cargo and crew in stable low earth orbit are urgently required. In this paper, we examine the failure history of previous upper stages with liquid oxygen (LOX)/liquid hydrogen (LH2) propulsion systems. Launch data from 1964 until midyear 2005 are analyzed and presented. This data analysis covers upper stage systems from the Ariane, Centaur, H-IIA, Saturn, and Atlas in addition to other vehicles. Upper stage propulsion system elements have the highest impact on reliability. This paper discusses failure occurrence in all aspects of the operational phases (Le., initial burn, coast, restarts, and trends in failure rates over time). In an effort to understand the likelihood of future failures in flight, we present timelines of engine system failures relevant to initial flight histories. Some evidence suggests that propulsion system failures as a result of design problems occur shortly after initial development of the propulsion system; whereas failures because of manufacturing or assembly processing errors may occur during any phase of the system builds process, This paper also explores the detectability of historical failures. Observations from this review are used to ascertain the potential for increased upper stage reliability given investments in integrated system health management. Based on a clear understanding of the failure and success history of previous efforts by multiple space hardware development groups, the paper will investigate potential improvements that can be realized through application of system safety principles.

Electrical safety for high voltage arrays

NASA Technical Reports Server (NTRS)

Marshall, N. A.

1983-01-01

A number of key electrical safety requirements for the high voltage arrays of central station photovoltaic power systems are explored. The suitability of representative industrial DC power switchgear for control and fault protection was evaluated. Included were AC/DC circuit breakers, electromechanical contactors and relays, load interruptors, cold disconnect devices, sectionalizing switches, and high voltage DC fuses. As appropriate, steady state and transient characteristics were analyzed. Failure modes impacting upon operation and maintenance safety were also identified, as were the voltage withstand and current interruption levels.

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis

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

Zheng, Yuanshui, E-mail: yuanshui.zheng@okc.procure.com; Johnson, Randall; Larson, Gary

Purpose: Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. Methods: The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authorsmore » estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. Results: In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. Conclusions: The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at

Light Water Reactor Sustainability Program: Risk-Informed Safety Margins Characterization (RISMC) Pathway Technical Program Plan

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

Smith, Curtis; Rabiti, Cristian; Martineau, Richard

Safety is central to the design, licensing, operation, and economics of Nuclear Power Plants (NPPs). As the current Light Water Reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of Systems, Structures, and Components (SSCs) degradations or failures that initiate safety-significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very high degreemore » of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated, primarily based on “engineering judgment.”« less

Patient safety: honoring advanced directives.

PubMed

Tice, Martha A

2007-02-01

Healthcare providers typically think of patient safety in the context of preventing iatrogenic injury. Prevention of falls and medication or treatment errors is the typical focus of adverse event analyses. If healthcare providers are committed to honoring the wishes of patients, then perhaps failures to honor advanced directives should be viewed as reportable medical errors.

Safety and feasibility of chronic transvenous phrenic nerve stimulation for treatment of central sleep apnea in heart failure patients.

PubMed

Zhang, Xilong; Ding, Ning; Ni, Buqing; Yang, Bing; Wang, Hong; Zhang, Shi-Jiang

2017-03-01

Central sleep apnea (CSA) is common in patients with heart failure (HF) and is associated with poor quality of life and prognosis. Early acute studies using transvenous phrenic nerve stimulation (PNS) to treat CSA in HF have shown a significantly reduction of CSA and improvement of key polysomnographic parameters. In this study, we evaluated the safety of and efficiency chronic transvenous PNS with an implanted neurostimulator in HF patients with CSA. This study was a prospective, nonrandomized evaluation of unilateral transvenous PNS in eight HF patients with CSA. The stimulation lead, which connected to a proprietary neurostimulator, was positioned in either the left pericardiophrenic or right brachiocephalic vein. Monitoring during implantation and 6-monthly follow-ups were performed. Six of the implanted eight patients completed the study (one was lost to follow-up; one died from pneumonia). Neither side effects nor adverse events related to stimulation occurred. During the 6-monthly follow-ups, one patient had a lead dislodgement in the first month and the lead was subsequently repositioned. No additional lead dislodgements occurred. There were no significant changes in sleep habits, appetite, bleeding or infections. Compared with the parameters before stimulator implantation, there were significant improvement in apnea-hypopnea index, central apnea index, left ventricular ejection fraction and 6-min walk distance (all P < 0.01). Use of chronic transvenous PNS appears to be safe and feasible in HF patients with CSA. Large multicenter studies are needed to confirm safety and efficacy in this population. © 2015 John Wiley & Sons Ltd.

Evaluation of a Multi-Axial, Temperature, and Time Dependent (MATT) Failure Model

NASA Technical Reports Server (NTRS)

Richardson, D. E.; Anderson, G. L.; Macon, D. J.; Rudolphi, Michael (Technical Monitor)

2002-01-01

To obtain a better understanding the response of the structural adhesives used in the Space Shuttle's Reusable Solid Rocket Motor (RSRM) nozzle, an extensive effort has been conducted to characterize in detail the failure properties of these adhesives. This effort involved the development of a failure model that includes the effects of multi-axial loading, temperature, and time. An understanding of the effects of these parameters on the failure of the adhesive is crucial to the understanding and prediction of the safety of the RSRM nozzle. This paper documents the use of this newly developed multi-axial, temperature, and time (MATT) dependent failure model for modeling failure for the adhesives TIGA 321, EA913NA, and EA946. The development of the mathematical failure model using constant load rate normal and shear test data is presented. Verification of the accuracy of the failure model is shown through comparisons between predictions and measured creep and multi-axial failure data. The verification indicates that the failure model performs well for a wide range of conditions (loading, temperature, and time) for the three adhesives. The failure criterion is shown to be accurate through the glass transition for the adhesive EA946. Though this failure model has been developed and evaluated with adhesives, the concepts are applicable for other isotropic materials.

Application of modified extended method in CREAM for safety inspector in coal mines

NASA Astrophysics Data System (ADS)

Wang, Jinhe; Zhang, Xiaohong; Zeng, Jianchao

2018-01-01

Safety inspector often performs duties in circumstances contributes to the oc currence of human failures. Therefore, the paper aims at quantifying human failure pro bability (HFP) of safety inspector during the coal mine operation with cognitive reliabi lity and error analysis method (CREAM). Whereas, some shortcomings of this approa ch that lacking considering the applicability of the common performance condition (C PC), and the subjective of evaluating CPC level which weaken the accuracy of the qua ntitative prediction results. A modified extended method in CREAM which is able to a ddress these difficulties with a CPC framework table is proposed, and the proposed me thodology is demonstrated by the virtue of a coal-mine accident example. The results a re expected to be useful in predicting HFP of safety inspector and contribute to the enh ancement of coal mine safety.

Health and safety programs for art and theater schools.

PubMed

McCann, M

2001-01-01

A wide variety of health and safety hazards exist in schools and colleges of art and theater due to a lack of formal health and safety programs and a failure to include health and safety concerns during planning of new facilities and renovation of existing facilities. This chapter discusses the elements of a health and safety program as well as safety-related structural and equipment needs that should be in the plans for any school of art or theater. These elements include curriculum content, ventilation, storage, housekeeping, waste management, fire and explosion prevention, machine and tool safety, electrical safety, noise, heat stress, and life safety and emergency procedures and equipment. Ideally, these elements should be incorporated into the plans for any new facilities, but ongoing programs can also benefit from a review of existing health and safety programs.

Energetics of lithium ion battery failure.

PubMed

Lyon, Richard E; Walters, Richard N

2016-11-15

The energy released by failure of rechargeable 18-mm diameter by 65-mm long cylindrical (18650) lithium ion cells/batteries was measured in a bomb calorimeter for 4 different commercial cathode chemistries over the full range of charge using a method developed for this purpose. Thermal runaway was induced by electrical resistance (Joule) heating of the cell in the nitrogen-filled pressure vessel (bomb) to preclude combustion. The total energy released by cell failure, ΔHf, was assumed to be comprised of the stored electrical energy E (cell potential×charge) and the chemical energy of mixing, reaction and thermal decomposition of the cell components, ΔUrxn. The contribution of E and ΔUrxn to ΔHf was determined and the mass of volatile, combustible thermal decomposition products was measured in an effort to characterize the fire safety hazard of rechargeable lithium ion cells. Published by Elsevier B.V.

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).

PubMed

Veronese, Ivan; De Martin, Elena; Martinotti, Anna Stefania; Fumagalli, Maria Luisa; Vite, Cristina; Redaelli, Irene; Malatesta, Tiziana; Mancosu, Pietro; Beltramo, Giancarlo; Fariselli, Laura; Cantone, Marie Claire

2015-06-13

A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres. The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

Minimising compassion fatigue in obstetrics/gynaecology doctors: exploring an intervention for an occupational hazard.

PubMed

Allen, Rosemary; Watt, Felice; Jansen, Brendan; Coghlan, Edwina; Nathan, Elizabeth A

2017-08-01

To explore the indicators of occupational stress in a group of obstetrics and gynaecology doctors and to investigate the impact of work-focused discussion groups over a 6 month period. The ProQOL questionnaire was used to measure the efficacy of monthly psychiatrist-led Balint style discussion groups on minimising Compassion Fatigue (consisting of Secondary Traumatic Stress and Burnout). The 25 doctors were given the given the ProQOL questionnaire to complete: (a) at the initiation of the intervention in July 2015, (b) in October 2015, and (c) in December 2015. Significantly decreased levels of Secondary Traumatic Stress ( p=0.008), Burnout ( p=0.010), as well as significantly increased rates of Compassion Satisfaction ( p=0.035) were recorded. Participants requested that the groups be continued. Psychiatrist-led work focused discussion groups were associated with improved rates of Secondary Traumatic Stress, Burnout, and Compassion Satisfaction in this sample group.

Value of Telemonitoring and Telemedicine in Heart Failure Management

PubMed Central

Alderighi, Camilla; Rasoini, Raffaele; Mazzanti, Marco; Casolo, Giancarlo

2017-01-01

The use of telemonitoring and telemedicine is a relatively new but quickly developing area in medicine. As new digital tools and applications are being created and used to manage medical conditions such as heart failure, many implications require close consideration and further study, including the effectiveness and safety of these telemonitoring tools in diagnosing, treating and managing heart failure compared to traditional face-to-face doctor–patient interaction. When compared to multidisciplinary intervention programs which are frequently hindered by economic, geographic and bureaucratic barriers, non-invasive remote monitoring could be a solution to support and promote the care of patients over time. Therefore it is crucial to identify the most relevant biological parameters to monitor, which heart failure sub-populations may gain real benefits from telehealth interventions and in which specific healthcare subsets these interventions should be implemented in order to maximise value. PMID:29387464

Quality and Safety Matter

NASA Astrophysics Data System (ADS)

Manha, William D.

2010-09-01

One to the expressions for the most demanding quality was made by a well-known rocket scientist, for which this center was named, Dr. Wernher Von Braun in the Foreword of a book about the design of rocket engines that was first published by NASA in 1967: “Success in space demands perfection. Many of the brilliant achievements made in this vast, austere environment seem almost miraculous. Behind each apparent miracle, however, stands the flawless performance of numerous highly complex systems. All are important. The failure of only one portion of a launch vehicle or spacecraft may cause failure of an entire mission. But the first to feel this awesome imperative for perfection are the propulsion systems, especially the engines. Unless they operate flawlessly first, none of the other systems will get a chance to perform in space. Perfection begins in the design of space hardware. This book emphasizes quality and reliability in the design of propulsion and engine systems. It draws deeply from the vast know-how and experience which have been the essence of several well-designed, reliable systems of the past and present. And, with a thoroughness and completeness not previously available, it tells how the present high state of reliability, gained through years of research and testing, can be maintained, and perhaps improved, in engines of the future. As man ventures deeper into space to explore the planets, the search for perfection in the design of propulsion systems will continue.” Some catastrophes with losses of life will be compared to show lapses in quality and safety and contrasted with a catastrophe without loss of life because of compliance with safety requirements. 1. October 24, 1960,(USSR) Nedelin Catastrophe, Death on the Steppes, 124 deaths 2. October 25, 1966,(USA) North American Rockwell, Apollo Block I Service Module Service(SM) Propulsion System fuel tank explosion/fire and destruction of SM and test cell, test engineer/conductor/author, Bill Manha

Causes and prevention of splitting/bursting failure of concrete crossties: a computational study

DOT National Transportation Integrated Search

2017-09-17

Concrete splitting/bursting is a well-known failure mode of concrete crossties that can compromise the crosstie integrity and raise railroad maintenance and track safety concerns. This paper presents a computational study aimed at better understandin...

Natriuretic peptide-guided management in heart failure.

PubMed

Chioncel, Ovidiu; Collins, Sean P; Greene, Stephen J; Ambrosy, Andrew P; Vaduganathan, Muthiah; Macarie, Cezar; Butler, Javed; Gheorghiade, Mihai

2016-08-01

Heart failure is a clinical syndrome that manifests from various cardiac and noncardiac abnormalities. Accordingly, rapid and readily accessible methods for diagnosis and risk stratification are invaluable for providing clinical care, deciding allocation of scare resources, and designing selection criteria for clinical trials. Natriuretic peptides represent one of the most important diagnostic and prognostic tools available for the care of heart failure patients. Natriuretic peptide testing has the distinct advantage of objectivity, reproducibility, and widespread availability.The concept of tailoring heart failure management to achieve a target value of natriuretic peptides has been tested in various clinical trials and may be considered as an effective method for longitudinal biomonitoring and guiding escalation of heart failure therapies with overall favorable results.Although heart failure trials support efficacy and safety of natriuretic peptide-guided therapy as compared with usual care, the relationship between natriuretic peptide trajectory and clinical benefit has not been uniform across the trials, and certain subgroups have not shown robust benefit. Furthermore, the precise natriuretic peptide value ranges and time intervals of testing are still under investigation. If natriuretic peptides fail to decrease following intensification of therapy, further work is needed to clarify the optimal pharmacologic approach. Despite decreasing natriuretic peptide levels, some patients may present with other high-risk features (e.g. elevated troponin). A multimarker panel investigating multiple pathological processes will likely be an optimal alternative, but this will require prospective validation.Future research will be needed to clarify the type and magnitude of the target natriuretic peptide therapeutic response, as well as the duration of natriuretic peptide-guided therapy in heart failure patients.

The procedure safety system

NASA Technical Reports Server (NTRS)

Obrien, Maureen E.

1990-01-01

Telerobotic operations, whether under autonomous or teleoperated control, require a much more sophisticated safety system than that needed for most industrial applications. Industrial robots generally perform very repetitive tasks in a controlled, static environment. The safety system in that case can be as simple as shutting down the robot if a human enters the work area, or even simply building a cage around the work space. Telerobotic operations, however, will take place in a dynamic, sometimes unpredictable environment, and will involve complicated and perhaps unrehearsed manipulations. This creates a much greater potential for damage to the robot or objects in its vicinity. The Procedural Safety System (PSS) collects data from external sensors and the robot, then processes it through an expert system shell to determine whether an unsafe condition or potential unsafe condition exists. Unsafe conditions could include exceeding velocity, acceleration, torque, or joint limits, imminent collision, exceeding temperature limits, and robot or sensor component failure. If a threat to safety exists, the operator is warned. If the threat is serious enough, the robot is halted. The PSS, therefore, uses expert system technology to enhance safety thus reducing operator work load, allowing him/her to focus on performing the task at hand without the distraction of worrying about violating safety criteria.

Failure Assessment of Brazed Structures

NASA Technical Reports Server (NTRS)

Flom, Yuri

2012-01-01

Despite the great advances in analytical methods available to structural engineers, designers of brazed structures have great difficulties in addressing fundamental questions related to the loadcarrying capabilities of brazed assemblies. In this chapter we will review why such common engineering tools as Finite Element Analysis (FEA) as well as many well-established theories (Tresca, von Mises, Highest Principal Stress, etc) don't work well for the brazed joints. This chapter will show how the classic approach of using interaction equations and the less known Coulomb-Mohr failure criterion can be employed to estimate Margins of Safety (MS) in brazed joints.

Single wheel hub motor failures and their impact on vehicle and driver behaviour

NASA Astrophysics Data System (ADS)

Wanner, Daniel; Kreußlein, Maria; Augusto, Bruno; Drugge, Lars; Stensson Trigell, Annika

2016-10-01

This research work studies the impact of single wheel hub motor failures on the dynamic behaviour of electric vehicles and the corresponding driver reactions. An experimental study in a moving-base driving simulator is conducted to analyse the influence of single wheel hub motor failures for motorway speeds. Driver reaction times are derived from the measured data and discussed in their experimental context. The failure is rated objectively on the dynamic behaviour of the vehicle and compared to the subjective evaluation. Findings indicate that critical traffic situations impairing traffic safety can occur for motorway speeds. Clear counteractions by the drivers had to be taken.

3D visualization of membrane failures in fuel cells

NASA Astrophysics Data System (ADS)

Singh, Yadvinder; Orfino, Francesco P.; Dutta, Monica; Kjeang, Erik

2017-03-01

Durability issues in fuel cells, due to chemical and mechanical degradation, are potential impediments in their commercialization. Hydrogen leak development across degraded fuel cell membranes is deemed a lifetime-limiting failure mode and potential safety issue that requires thorough characterization for devising effective mitigation strategies. The scope and depth of failure analysis has, however, been limited by the 2D nature of conventional imaging. In the present work, X-ray computed tomography is introduced as a novel, non-destructive technique for 3D failure analysis. Its capability to acquire true 3D images of membrane damage is demonstrated for the very first time. This approach has enabled unique and in-depth analysis resulting in novel findings regarding the membrane degradation mechanism; these are: significant, exclusive membrane fracture development independent of catalyst layers, localized thinning at crack sites, and demonstration of the critical impact of cracks on fuel cell durability. Evidence of crack initiation within the membrane is demonstrated, and a possible new failure mode different from typical mechanical crack development is identified. X-ray computed tomography is hereby established as a breakthrough approach for comprehensive 3D characterization and reliable failure analysis of fuel cell membranes, and could readily be extended to electrolyzers and flow batteries having similar structure.

CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure.

PubMed

Peek, Giles J; Clemens, Felicity; Elbourne, Diana; Firmin, Richard; Hardy, Pollyanna; Hibbert, Clare; Killer, Hilliary; Mugford, Miranda; Thalanany, Mariamma; Tiruvoipati, Ravin; Truesdale, Ann; Wilson, Andrew

2006-12-23

An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising. The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR) is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress') by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18-65 years) with severe, but potentially reversible, respiratory failure (Murray score >/= 3.0 or hypercapnea with pH < 7.2) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital, Leicester or continuing conventional care in a centre providing a high standard of conventional treatment. The central randomisation service will minimise by type of conventional treatment centre, age, duration of high pressure ventilation, hypoxia/hypercapnea, diagnosis and number of organs failed, to ensure balance in key prognostic variables. Extracorporeal membrane oxygenation

Primary battery design and safety guidelines handbook

NASA Technical Reports Server (NTRS)

Bragg, Bobby J.; Casey, John E.; Trout, J. Barry

1994-01-01

This handbook provides engineers and safety personnel with guidelines for the safe design or selection and use of primary batteries in spaceflight programs. Types of primary batteries described are silver oxide zinc alkaline, carbon-zinc, zinc-air alkaline, manganese dioxide-zionc alkaline, mercuric oxide-zinc alkaline, and lithium anode cells. Along with typical applications, the discussions of the individual battery types include electrochemistry, construction, capacities and configurations, and appropriate safety measures. A chapter on general battery safety covers hazard sources and controls applicable to all battery types. Guidelines are given for qualification and acceptance testing that should precede space applications. Permissible failure levels for NASA applications are discussed.

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single propeller elements (for example...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

Compendium of research and evaluations in traffic safety published

DOT National Transportation Integrated Search

1996-05-01

The National Highway Traffic Safety Administration's (NHTSA's) Office of Program Development and Evaluation (OPDE) conducts research projects that investigate human attitudes, behaviors, and failures as they relate to motor vehicle crashes. OPDE focu...

Failure Mode and Effect Analysis for Delivery of Lung Stereotactic Body Radiation Therapy

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

Perks, Julian R., E-mail: julian.perks@ucdmc.ucdavis.edu; Stanic, Sinisa; Stern, Robin L.

2012-07-15

Purpose: To improve the quality and safety of our practice of stereotactic body radiation therapy (SBRT), we analyzed the process following the failure mode and effects analysis (FMEA) method. Methods: The FMEA was performed by a multidisciplinary team. For each step in the SBRT delivery process, a potential failure occurrence was derived and three factors were assessed: the probability of each occurrence, the severity if the event occurs, and the probability of detection by the treatment team. A rank of 1 to 10 was assigned to each factor, and then the multiplied ranks yielded the relative risks (risk priority numbers).more » The failure modes with the highest risk priority numbers were then considered to implement process improvement measures. Results: A total of 28 occurrences were derived, of which nine events scored with significantly high risk priority numbers. The risk priority numbers of the highest ranked events ranged from 20 to 80. These included transcription errors of the stereotactic coordinates and machine failures. Conclusion: Several areas of our SBRT delivery were reconsidered in terms of process improvement, and safety measures, including treatment checklists and a surgical time-out, were added for our practice of gantry-based image-guided SBRT. This study serves as a guide for other users of SBRT to perform FMEA of their own practice.« less

The Range Safety Debris Catalog Analysis in Preparation for the Pad Abort One Flight Test

NASA Technical Reports Server (NTRS)

Kutty, Prasad; Pratt, William

2010-01-01

With each flight test a Range Safety Data Package is assembled to understand the potential consequences of various failure scenarios. Debris catalog analysis considers an overpressure failure of the Abort Motor and the resulting debris field created 1. Characterize debris fragments generated by failure: weight, shape, and area 2. Compute fragment ballistic coefficients 3. Compute fragment ejection velocities.

A randomised crossover trial of minimising medical terminology in secondary care correspondence in patients with chronic health conditions: impact on understanding and patient reported outcomes.

PubMed

Wernick, M; Hale, P; Anticich, N; Busch, S; Merriman, L; King, B; Pegg, T

2016-05-01

There is little existing research on the role that secondary care letters have in ensuring patient understanding of chronic health conditions. To determine whether minimising the use of medical terminology in medical correspondence improved patient understanding and anxiety/depression scores. A single-centre, non-blinded, randomised crossover design assessed health literacy, EQ-5D scores and the impact of the 'translated' letter on the doctor's professionalism, the patient's relationship with their general practitioner (GP) and their perceived impact on chronic disease management. Patients were crossed over between their 'translated' and original letter. Sixty patients were recruited. Use of a 'translated' letter reduced mean terms not understood from 7.78 to 1.76 (t(58) = 4.706, P < 0.001). Most patients (78.0%) preferred the 'translated' letter, with 69.5% patients perceiving an enhancement in their doctor's professionalism (z = 2.864, P = 0.004), 69.0% reporting a positive influence on relationship with their GP (z = 2.943, P = 0.003) and 79.7% reporting an increase in perceived ability to manage their chronic health condition with the 'translated' letter (z = 4.601, P < 0.001). There was no effect on EQ-5D depression/anxiety scores. Minimising the use of medical terminology in medical correspondence significantly improved patient understanding and perception of their ability to manage their chronic health condition. Although there was no impact on EQ-5D depression/anxiety scores, overwhelming patient preference for the 'translated' letter indicates a need for minimisation of medical terminology in medical correspondence for patients with chronic health conditions. © 2016 Royal Australasian College of Physicians.

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

PubMed

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

2011-12-01

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

Minimising Backbreak at the Dewan Cement Limestone Quarry Using an Artificial Neural Network

NASA Astrophysics Data System (ADS)

Muhammad, Khan; Shah, Akram

2017-12-01

Backbreak, defined as excessive breakage behind the last row of blastholes in blasting operations at a quarry, causes destabilisation of rock slopes, improper fragmentation, minimises drilling efficiency. In this paper an artificial neural network (ANN) is applied to predict backbreak, using 12 input parameters representing various controllable factors, such as the characteristics of explosives and geometrical blast design, at the Dewan Cement limestone quarry in Hattar, Pakistan. This ANN was trained with several model architectures. The 12-2-1 ANN model was selected as the simplest model yielding the best result, with a reported correlation coefficient of 0.98 and 0.97 in the training and validation phases, respectively. Sensitivity analysis of the model suggested that backbreak can be reduced most effectively by reducing powder factor, blasthole inclination, and burden. Field tests were subsequently carried out in which these sensitive parameters were varied accordingly; as a result, backbreak was controlled and reduced from 8 m to less than a metre. The resulting reduction in powder factor (kg of explosives used per m3 of blasted material) also reduced blasting costs.

Prescriber barriers and enablers to minimising potentially inappropriate medications in adults: a systematic review and thematic synthesis.

PubMed

Anderson, Kristen; Stowasser, Danielle; Freeman, Christopher; Scott, Ian

2014-12-08

To synthesise qualitative studies that explore prescribers' perceived barriers and enablers to minimising potentially inappropriate medications (PIMs) chronically prescribed in adults. A qualitative systematic review was undertaken by searching PubMed, EMBASE, Scopus, PsycINFO, CINAHL and INFORMIT from inception to March 2014, combined with an extensive manual search of reference lists and related citations. A quality checklist was used to assess the transparency of the reporting of included studies and the potential for bias. Thematic synthesis identified common subthemes and descriptive themes across studies from which an analytical construct was developed. Study characteristics were examined to explain differences in findings. All healthcare settings. Medical and non-medical prescribers of medicines to adults. Prescribers' perspectives on factors which shape their behaviour towards continuing or discontinuing PIMs in adults. 21 studies were included; most explored primary care physicians' perspectives on managing older, community-based adults. Barriers and enablers to minimising PIMs emerged within four analytical themes: problem awareness; inertia secondary to lower perceived value proposition for ceasing versus continuing PIMs; self-efficacy in regard to personal ability to alter prescribing; and feasibility of altering prescribing in routine care environments given external constraints. The first three themes are intrinsic to the prescriber (eg, beliefs, attitudes, knowledge, skills, behaviour) and the fourth is extrinsic (eg, patient, work setting, health system and cultural factors). The PIMs examined and practice setting influenced the themes reported. A multitude of highly interdependent factors shape prescribers' behaviour towards continuing or discontinuing PIMs. A full understanding of prescriber barriers and enablers to changing prescribing behaviour is critical to the development of targeted interventions aimed at deprescribing PIMs and reducing the

Directionality and Orientation Effects on the Resistance to Propagating Shear Failure

NASA Astrophysics Data System (ADS)

Leis, B. N.; Barbaro, F. J.; Gray, J. M.

Hydrocarbon pipelines transporting compressible products like methane or high-vapor-pressure (HVP) liquids under supercritical conditions can be susceptible to long-propagating failures. As the unplanned release of such hydrocarbons can lead to significant pollution and/or the horrific potential of explosion and/or a very large fire, design criteria to preclude such failures were essential to environmental and public safety. Thus, technology was developed to establish the minimum arrest requirements to avoid such failures shortly after this design concern was evident. Soon after this technology emerged in the early 1970sit became evident that its predictions were increasinglynon-conservative as the toughness of line-pipe steel increased. A second potentially critical factor for what was a one-dimensional technology was that changes in steel processing led to directional dependence in both the flow and fracture properties. While recognized, this dependence was tacitly ignored in quantifying arrest, as were early observations that indicated propagating shear failure was controlled by plastic collapse rather than by fracture processes.

Minimising the effect of nanoparticle deformation in intermittent contact amplitude modulation atomic force microscopy measurements

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

Babic, Bakir, E-mail: bakir.babic@measurement.gov.au; Lawn, Malcolm A.; Coleman, Victoria A.

The results of systematic height measurements of polystyrene (PS) nanoparticles using intermittent contact amplitude modulation atomic force microscopy (IC-AM-AFM) are presented. The experimental findings demonstrate that PS nanoparticles deform during AFM imaging, as indicated by a reduction in the measured particle height. This deformation depends on the IC-AM-AFM imaging parameters, material composition, and dimensional properties of the nanoparticles. A model for nanoparticle deformation occurring during IC-AM-AFM imaging is developed as a function of the peak force which can be calculated for a particular set of experimental conditions. The undeformed nanoparticle height can be estimated from the model by extrapolation tomore » zero peak force. A procedure is proposed to quantify and minimise nanoparticle deformation during IC-AM-AFM imaging, based on appropriate adjustments of the experimental control parameters.« less

Minimisation of the LCOE for the hybrid power supply system with the lead-acid battery

NASA Astrophysics Data System (ADS)

Kasprzyk, Leszek; Tomczewski, Andrzej; Bednarek, Karol; Bugała, Artur

2017-10-01

The paper presents the methodology of minimisation of the unit cost of production of energy generated in the hybrid system compatible with the lead-acid battery, and used to power a load with the known daily load curve. For this purpose, the objective function in the form of the LCOE and the genetic algorithm method were used. Simulation tests for three types of load with set daily load characteristics were performed. By taking advantage of the legal regulations applicable in the territory of Poland, regarding the energy storing in the power system, the optimal structure of the prosumer solar-wind system including the lead-acid battery, which meets the condition of maximum rated power, was established. An assumption was made that the whole solar energy supplied to the load would be generated in the optimised system.

Model-OA wind turbine generator - Failure modes and effects analysis

NASA Technical Reports Server (NTRS)

Klein, William E.; Lali, Vincent R.

1990-01-01

The results failure modes and effects analysis (FMEA) conducted for wind-turbine generators are presented. The FMEA was performed for the functional modes of each system, subsystem, or component. The single-point failures were eliminated for most of the systems. The blade system was the only exception. The qualitative probability of a blade separating was estimated at level D-remote. Many changes were made to the hardware as a result of this analysis. The most significant change was the addition of the safety system. Operational experience and need to improve machine availability have resulted in subsequent changes to the various systems, which are also reflected in this FMEA.

Fatigue failure of metal components as a factor in civil aircraft accidents

NASA Technical Reports Server (NTRS)

Holshouser, W. L.; Mayner, R. D.

1972-01-01

A review of records maintained by the National Transportation Safety Board showed that 16,054 civil aviation accidents occurred in the United States during the 3-year period ending December 31, 1969. Material failure was an important factor in the cause of 942 of these accidents. Fatigue was identified as the mode of the material failures associated with the cause of 155 accidents and in many other accidents the records indicated that fatigue failures might have been involved. There were 27 fatal accidents and 157 fatalities in accidents in which fatigue failures of metal components were definitely identified. Fatigue failures associated with accidents occurred most frequently in landing-gear components, followed in order by powerplant, propeller, and structural components in fixed-wing aircraft and tail-rotor and main-rotor components in rotorcraft. In a study of 230 laboratory reports on failed components associated with the cause of accidents, fatigue was identified as the mode of failure in more than 60 percent of the failed components. The most frequently identified cause of fatigue, as well as most other types of material failures, was improper maintenance (including inadequate inspection). Fabrication defects, design deficiencies, defective material, and abnormal service damage also caused many fatigue failures. Four case histories of major accidents are included in the paper as illustrations of some of the factors invovled in fatigue failures of aircraft components.

Safety Guided Design of Crew Return Vehicle in Concept Design Phase Using STAMP/STPA

NASA Astrophysics Data System (ADS)

Nakao, H.; Katahira, M.; Miyamoto, Y.; Leveson, N.

2012-01-01

In the concept development and design phase of a new space system, such as a Crew Vehicle, designers tend to focus on how to implement new technology. Designers also consider the difficulty of using the new technology and trade off several system design candidates. Then they choose an optimal design from the candidates. Safety should be a key aspect driving optimal concept design. However, in past concept design activities, safety analysis such as FTA has not used to drive the design because such analysis techniques focus on component failure and component failure cannot be considered in the concept design phase. The solution to these problems is to apply a new hazard analysis technique, called STAMP/STPA. STAMP/STPA defines safety as a control problem rather than a failure problem and identifies hazardous scenarios and their causes. Defining control flow is the essential in concept design phase. Therefore STAMP/STPA could be a useful tool to assess the safety of system candidates and to be part of the rationale for choosing a design as the baseline of the system. In this paper, we explain our case study of safety guided concept design using STPA, the new hazard analysis technique, and model-based specification technique on Crew Return Vehicle design and evaluate benefits of using STAMP/STPA in concept development phase.

Independent Review Support for Phoenix Mars Mission Robotic Arm Brush Motor Failure

NASA Technical Reports Server (NTRS)

McManamen, John P.; Pellicciotti, Joseph; DeKramer, Cornelis; Dube, Michael J.; Peeler, Deborah; Muirhead, Brian K.; Sevilla, Donald R.; Sabahi, Dara; Knopp, Michael D.

2007-01-01

The Phoenix Project requested the NASA Engineering and Safety Center (NESC) perform an independent peer review of the Robotic Arm (RA) Direct Current (DC) motor brush anomalies that originated during the Mars Exploration Rover (MER) Project and recurred during the Phoenix Project. The request was to evaluate the Phoenix Project investigation efforts and provide an independent risk assessment. This includes a recommendation for additional work and assessment of the flight worthiness of the RA DC motors. Based on the investigation and findings contained within this report, the IRT concurs with the risk assessment Failure Cause / Corrective Action (FC/CA) by the project, "Failure Effect Rating "3"; Major Degradation or Total Loss of Function, Failure Cause/Corrective Action Rating Currently "4"; Unknown Cause, Uncertainty in Corrective Action."

48 CFR 952.223-77 - Conditional payment of fee or profit-protection of worker safety and health.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approved contractor Integrated Safety Management System (ISMS). The degrees of performance failure under... 100% of the total fee or profit earned for a first degree performance failure, not less than 11% nor greater than 25% for a second degree performance failure, and up to 10% for a third degree performance...

48 CFR 52.223-3 - Hazardous Material Identification and Material Safety Data.

Code of Federal Regulations, 2010 CFR

2010-10-01

... offeror is the actual manufacturer of these items. Failure to submit the Material Safety Data Sheet prior... data. (f) Neither the requirements of this clause nor any act or failure to act by the Government shall... resistant envelope. [56 FR 55375, Oct. 25, 1991, as amended at 60 FR 34740, July 3, 1995; 62 FR 238, Jan. 2...

Proposed system safety design and test requirements for the microlaser ordnance system

NASA Technical Reports Server (NTRS)

Stoltz, Barb A.; Waldo, Dale F.

1993-01-01

Safety for pyrotechnic ignition systems is becoming a major concern for the military. In the past twenty years, stray electromagnetic fields have steadily increased during peacetime training missions and have dramatically increased during battlefield missions. Almost all of the ordnance systems in use today depend on an electrical bridgewire for ignition. Unfortunately, the bridgewire is the cause of the majority of failure modes. The common failure modes include the following: broken bridgewires; transient RF power, which induces bridgewire heating; and cold temperatures, which contracts the explosive mix away from the bridgewire. Finding solutions for these failure modes is driving the costs of pyrotechnic systems up. For example, analyses are performed to verify that the system in the environment will not see more energy than 20 dB below the 'No-fire' level. Range surveys are performed to determine the operational, storage, and transportation RF environments. Cryogenic tests are performed to verify the bridgewire to mix interface. System requirements call for 'last minute installation,' 'continuity checks after installation,' and rotating safety devices to 'interrupt the explosive train.' As an alternative, MDESC has developed a new approach based upon our enabling laser diode technology. We believe that Microlaser initiated ordnance offers a unique solution to the bridgewire safety concerns. For this presentation, we will address, from a system safety viewpoint, the safety design and the test requirements for a Microlaser ordnance system. We will also review how this system could be compliant to MIL-STD-1576 and DOD-83578A and the additional necessary requirements.

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

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

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

Measuring and improving patient safety through health information technology: The Health IT Safety Framework

PubMed Central

Singh, Hardeep

2016-01-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

Questioning the Role of Requirements Engineering in the Causes of Safety-Critical Software Failures

NASA Technical Reports Server (NTRS)

Johnson, C. W.; Holloway, C. M.

2006-01-01

Many software failures stem from inadequate requirements engineering. This view has been supported both by detailed accident investigations and by a number of empirical studies; however, such investigations can be misleading. It is often difficult to distinguish between failures in requirements engineering and problems elsewhere in the software development lifecycle. Further pitfalls arise from the assumption that inadequate requirements engineering is a cause of all software related accidents for which the system fails to meet its requirements. This paper identifies some of the problems that have arisen from an undue focus on the role of requirements engineering in the causes of major accidents. The intention is to provoke further debate within the emerging field of forensic software engineering.

Analysis on Dangerous Source of Large Safety Accident in Storage Tank Area

NASA Astrophysics Data System (ADS)

Wang, Tong; Li, Ying; Xie, Tiansheng; Liu, Yu; Zhu, Xueyuan

2018-01-01

The difference between a large safety accident and a general accident is that the consequences of a large safety accident are particularly serious. To study the tank area which factors directly or indirectly lead to the occurrence of large-sized safety accidents. According to the three kinds of hazard source theory and the consequence cause analysis of the super safety accident, this paper analyzes the dangerous source of the super safety accident in the tank area from four aspects, such as energy source, large-sized safety accident reason, management missing, environmental impact Based on the analysis of three kinds of hazard sources and environmental analysis to derive the main risk factors and the AHP evaluation model is established, and after rigorous and scientific calculation, the weights of the related factors in four kinds of risk factors and each type of risk factors are obtained. The result of analytic hierarchy process shows that management reasons is the most important one, and then the environmental factors and the direct cause and Energy source. It should be noted that although the direct cause is relatively low overall importance, the direct cause of Failure of emergency measures and Failure of prevention and control facilities in greater weight.

Compendium of Traffic Safety Research Projects: 1985-1995 and Beyond

DOT National Transportation Integrated Search

1996-03-01

The National Highway Traffic Safety Administration's Office of Program : Development and Evaluation (OPDE) conducts research and evaluation projects : dealing with human attitudes, behaviors and failures (motor vehicle crashes). : OPDE's focus is on ...

Decreasing handoff-related care failures in children's hospitals.

PubMed

Bigham, Michael T; Logsdon, Tina R; Manicone, Paul E; Landrigan, Christopher P; Hayes, Leslie W; Randall, Kelly H; Grover, Purva; Collins, Susan B; Ramirez, Dana E; O'Guin, Crystal D; Williams, Catherine I; Warnick, Robin J; Sharek, Paul J

2014-08-01

Patient handoffs in health care require transfer of information, responsibility, and authority between providers. Suboptimal patient handoffs pose a serious safety risk. Studies demonstrating the impact of improved patient handoffs on care failures are lacking. The primary objective of this study was to evaluate the effect of a multihospital collaborative designed to decrease handoff-related care failures. Twenty-three children's hospitals participated in a quality improvement collaborative aimed at reducing handoff-related care failures. The improvement was guided by evidence-based recommendations regarding handoff intent and content, standardized handoff tools/methods, and clear transition of responsibility. Hospitals tailored handoff elements to locally important handoff types. Handoff-related care failures were compared between baseline and 3 intervention periods. Secondary outcomes measured compliance to specific change package elements and balancing measure of staff satisfaction. Twenty-three children's hospitals evaluated 7864 handoffs over the 12-month study period. Handoff-related care failures decreased from baseline (25.8%) to the final intervention period (7.9%) (P < .05). Significant improvement was observed in every handoff type studied. Compliance to change package elements improved (achieving a common understanding about the patient from 86% to 96% [P < .05]; clear transition of responsibility from 92% to 96% [P < .05]; and minimized interruptions and distractions from 84% to 90% [P < .05]) as did overall satisfaction with the handoff (from 55% to 70% [P < .05]). Implementation of a standardized evidence-based handoff process across 23 children's hospitals resulted in a significant decrease in handoff-related care failures, observed over all handoff types. Compliance to critical components of the handoff process improved, as did provider satisfaction. Copyright © 2014 by the American Academy of Pediatrics.

Decomposition-Based Failure Mode Identification Method for Risk-Free Design of Large Systems

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Stone, Robert B.; Roberts, Rory A.; Clancy, Daniel (Technical Monitor)

2002-01-01

When designing products, it is crucial to assure failure and risk-free operation in the intended operating environment. Failures are typically studied and eliminated as much as possible during the early stages of design. The few failures that go undetected result in unacceptable damage and losses in high-risk applications where public safety is of concern. Published NASA and NTSB accident reports point to a variety of components identified as sources of failures in the reported cases. In previous work, data from these reports were processed and placed in matrix form for all the system components and failure modes encountered, and then manipulated using matrix methods to determine similarities between the different components and failure modes. In this paper, these matrices are represented in the form of a linear combination of failures modes, mathematically formed using Principal Components Analysis (PCA) decomposition. The PCA decomposition results in a low-dimensionality representation of all failure modes and components of interest, represented in a transformed coordinate system. Such a representation opens the way for efficient pattern analysis and prediction of failure modes with highest potential risks on the final product, rather than making decisions based on the large space of component and failure mode data. The mathematics of the proposed method are explained first using a simple example problem. The method is then applied to component failure data gathered from helicopter, accident reports to demonstrate its potential.

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder.

PubMed

Agyemang, Elaine; Bailey, Lorna; Talbot, John

2017-01-01

Additional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system. The aim of this study was to examine how aRMMs are implemented and how effectiveness is assessed in the European Union (EU) using practical examples from Roche Products Limited in the United Kingdom (UK) (referred to as the 'Company'). Three centrally authorised products were selected from the Company's portfolio, each of which had aRMMs to address important safety concerns; specifically, teratogenicity, medication error and infections. The implementation of EU aRMMs, effectiveness checks and specific UK activities were analysed. Hard copy folders and electronic sites for Company aRMMs were used to assess process indicators. Periodic benefit-risk evaluation reports for specified time intervals and the Company safety database was used in checking safety outcomes for the selected products. For each product, the effectiveness of aRMMs was analysed based on specific process indicators and the subsequent safety outcomes. Literature searches were performed on scientific databases for the purposes of the broader study. The main process indicators in measuring effectiveness of Company aRMMs were distribution metrics for educational materials, assessment of awareness and clinical actions among healthcare professionals (HCPs). Case reports of pregnancy, medication errors and progressive multifocal leukoencephalopathy (PML) were the outcome indicators for Erivedge ® ▼, Kadcyla ® ▼ and MabThera ® (the latter specifically in autoimmune indications: rheumatoid arthritis, granulomatosis with polyangiitis and

Safety shield for vacuum/pressure chamber viewing port

NASA Technical Reports Server (NTRS)

Shimansky, R. A.; Spencer, R. S. (Inventor)

1981-01-01

Observers are protected from flying debris resulting from a failure of a vacuum or pressure chamber viewing port following an implosion or explosion by an optically clear shatter resistant safety shield which spaced apart from the viewing port on the outer surface of the chamber.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Evaluation of Brazed Joints Using Failure Assessment Diagram

NASA Technical Reports Server (NTRS)

Flom, Yury

2012-01-01

Fitness-for service approach was used to perform structural analysis of the brazed joints consisting of several base metal / filler metal combinations. Failure Assessment Diagrams (FADs) based on tensile and shear stress ratios were constructed and experimentally validated. It was shown that such FADs can provide a conservative estimate of safe combinations of stresses in the brazed joints. Based on this approach, Margins of Safety (MS) of the brazed joints subjected to multi-axial loading conditions can be evaluated..

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to

Food safety considerations for innovative nutrition solutions.

PubMed

Byrd-Bredbenner, Carol; Cohn, Marjorie Nolan; Farber, Jeffrey M; Harris, Linda J; Roberts, Tanya; Salin, Victoria; Singh, Manpreet; Jaferi, Azra; Sperber, William H

2015-07-01

Failure to secure safe and affordable food to the growing global population leads far too often to disastrous consequences. Among specialists and other individuals, food scientists have a key responsibility to improve and use science-based tools to address risk and advise food handlers and manufacturers with best-practice recommendations. With collaboration from production agriculture, food processors, state and federal agencies, and consumers, it is critical to implement science-based strategies that address food safety and that have been evaluated for effectiveness in controlling and/or eliminating hazards. It is an open question whether future food safety concerns will shift in priority given the imperatives to supply sufficient food. This report brings together leading food safety experts to address these issues with a focus on three areas: economic, social, and policy aspects of food safety; production and postharvest technology for safe food; and innovative public communication for food safety and nutrition. © 2015 New York Academy of Sciences.

The Financial Benefits of Various Catastrophic Failure Prevention Strategies in a Wind Farm: Two market studies (UK-Spain)

NASA Astrophysics Data System (ADS)

Yürüşen, N. Y.; Tautz-Weinert, J.; Watson, S. J.; Melero, J. J.

2017-11-01

Operation of wind farms is driven by the overall aim of minimising costs while maximising energy sales. However, in certain circumstances investments are required to guarantee safe operation and survival of an asset. In this paper, we discuss the merits of various catastrophic failure prevention strategies in a Spanish wind farm. The wind farm operator was required to replace blades in two phases: temporary and final repair. We analyse the power performance of the turbine in the different states and investigate four scenarios with different timing of temporary and final repair during one year. The financial consequences of the scenarios are compared with a baseline by using a discounted cash flow analysis that considers the wholesale electricity market selling prices and interest rates. A comparison with the UK electricity market is conducted to highlight differences in the rate of return in the two countries.

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.

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2015-01-01

The Aviation Safety Program (AvSP) System-Wide Safety and Assurance Technologies (SSAT) Project asked the AvSP Systems and Portfolio Analysis Team to identify SSAT-related trends. SSAT had four technical challenges: advance safety assurance to enable deployment of NextGen systems; automated discovery of precursors to aviation safety incidents; increasing safety of human-automation interaction by incorporating human performance, and prognostic algorithm design for safety assurance. This report reviews incident data from the NASA Aviation Safety Reporting System (ASRS) for system-component-failure- or-malfunction- (SCFM-) related and human-factor-related incidents for commercial or cargo air carriers (Part 121), commuter airlines (Part 135), and general aviation (Part 91). The data was analyzed by Federal Aviation Regulations (FAR) part, phase of flight, SCFM category, human factor category, and a variety of anomalies and results. There were 38 894 SCFM-related incidents and 83 478 human-factorrelated incidents analyzed between January 1993 and April 2011.

Hemodynamic effect and safety of intermittent sequential pneumatic compression leg sleeves in patients with congestive heart failure.

PubMed

Bickel, Amitai; Shturman, Alexander; Sergeiev, Michael; Ivry, Shimon; Eitan, Arieh; Atar, Shaul

2014-10-01

Pneumatic leg sleeves are widely used after prolonged operations for prevention of venous stasis. In healthy volunteers they increase cardiac function. We evaluated the hemodynamic effects and safety of intermittent sequential pneumatic compression (ISPC) leg sleeves in patients with chronic congestive heart failure (CHF). We studied 19 patients with systolic left ventricular dysfunction and CHF. ISPC leg sleeves, each with 10 air cells, were operated by a computerized compressor, exerting 2 cycles/min. Hemodynamic and echocardiographic parameters were measured before, during, and after ISPC activation. The baseline mean left ventricular ejection fraction was 29 ± 9.2%, median 32%, range 10%-40%. Cardiac output (from 4.26 to 4.83 L/min; P = .008) and stroke volume (from 56.1 to 63.5 mL; P = .029) increased significantly after ISPC activation, without a reciprocal increase in heart rate, and declined after sleeve deactivation. Systemic vascular resistance (SVR) decreased significantly (from 1,520 to 1,216 dyne-s/cm5; P = .0005), and remained lower than the baseline level throughout the study. There was no detrimental effect on diastolic function and no adverse clinical events, despite increased pulmonary venous return. ISPC leg sleeves in patients with chronic CHF do not exacerbate symptoms and transiently improve cardiac output through an increase in stroke volume and a reduction in SVR. Copyright © 2014 Elsevier Inc. All rights reserved.

Predicting remaining life by fusing the physics of failure modeling with diagnostics

NASA Astrophysics Data System (ADS)

Kacprzynski, G. J.; Sarlashkar, A.; Roemer, M. J.; Hess, A.; Hardman, B.

2004-03-01

Technology that enables failure prediction of critical machine components (prognostics) has the potential to significantly reduce maintenance costs and increase availability and safety. This article summarizes a research effort funded through the U.S. Defense Advanced Research Projects Agency and Naval Air System Command aimed at enhancing prognostic accuracy through more advanced physics-of-failure modeling and intelligent utilization of relevant diagnostic information. H-60 helicopter gear is used as a case study to introduce both stochastic sub-zone crack initiation and three-dimensional fracture mechanics lifing models along with adaptive model updating techniques for tuning key failure mode variables at a local material/damage site based on fused vibration features. The overall prognostic scheme is aimed at minimizing inherent modeling and operational uncertainties via sensed system measurements that evolve as damage progresses.

Failure of dissimilar material bonded joints

NASA Astrophysics Data System (ADS)

Konstantakopoulou, M.; Deligianni, A.; Kotsikos, G.

2016-03-01

Joining of materials in structural design has always been a challenge for engineers. Bolting and riveting has been used for many years, until the emergence of fusion welding which revolutionised construction in areas such as shipbuilding, automotive, infrastructure and consumer goods. Extensive research in the past 50 years has resulted in better understanding of the process and minimised the occurrence of failures associated with fusion welding such as, residual stress cracking, stress corrosion and corrosion fatigue cracking, localised reduction in mechanical properties due to microstructural changes (heat affected zone) etc. Bonding has been a technique that has been proposed as an alternative because it eliminates several of the problems associated with fusion welding. But, despite some applications it has not seen wide use. There is however a renewed interest in adhesively bonded joints, as designers look for ever more efficient structures which inevitably leads to the use and consequently joining of combinations of lightweight materials, often with fundamentally different mechanical and physical properties. This chapter provides a review of adhesively bonded joints and reports on improvements to bonded joint strength through the introduction of carbon nanotubes at the bond interface. Results from various workers in the field are reported as well as the findings of the authors in this area of research. It is obvious that there are several challenges that need to be addressed to further enhance the strength of bonded joints and worldwide research is currently underway to address those shortcomings and build confidence in the implementation of these new techniques.

Walter Bouldin Dam failure and reconstruction

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

None

1978-09-01

Walter Bouldin is one of several hydroelectric developments of Alabama Power Company. On February 10, 1975, an earth embankment section of Walter Bouldin Dam was breached, causing total evacuation of the forebay reservoir and rendering the 225-MW power plant inoperable. The Federal Power Commission instituted an investigation of the dam failure, and a report on the investigation was published in February 1976. Subsequently, an evidentiary hearing was held before an administrative law judge who issued his initial decision on August 19, 1976. The Commission, on April 21, 1977, issued its Opinion No. 795 in which it adopted the initial decisionmore » with modifications and terminated the investigation of failure of Walter Bouldin Dam. Opinion No. 795 directs the staff of the Bureau of Power to prepare, for the future guidance of the Commission, a report on the deficiencies which were found in its investigation, together with advice as to how such deficiencies have been and should be remedied. Also, it directs the staff of the Bureau of Power to address certain general recommendations included in the initial decision. This report was prepared in response to that directive and summaries information on the dam failure and its investigation; the evidentiary hearing; the judge's recommendations, the reconstruction of the Bouldin Dam; and the evalution and status of the Federal Energy Regulatory Commission Dam safety program. (LCL)« less

Compressed natural gas bus safety: a quantitative risk assessment.

PubMed

Chamberlain, Samuel; Modarres, Mohammad

2005-04-01

This study assesses the fire safety risks associated with compressed natural gas (CNG) vehicle systems, comprising primarily a typical school bus and supporting fuel infrastructure. The study determines the sensitivity of the results to variations in component failure rates and consequences of fire events. The components and subsystems that contribute most to fire safety risk are determined. Finally, the results are compared to fire risks of the present generation of diesel-fueled school buses. Direct computation of the safety risks associated with diesel-powered vehicles is possible because these are mature technologies for which historical performance data are available. Because of limited experience, fatal accident data for CNG bus fleets are minimal. Therefore, this study uses the probabilistic risk assessment (PRA) approach to model and predict fire safety risk of CNG buses. Generic failure data, engineering judgments, and assumptions are used in this study. This study predicts the mean fire fatality risk for typical CNG buses as approximately 0.23 fatalities per 100-million miles for all people involved, including bus passengers. The study estimates mean values of 0.16 fatalities per 100-million miles for bus passengers only. Based on historical data, diesel school bus mean fire fatality risk is 0.091 and 0.0007 per 100-million miles for all people and bus passengers, respectively. One can therefore conclude that CNG buses are more prone to fire fatality risk by 2.5 times that of diesel buses, with the bus passengers being more at risk by over two orders of magnitude. The study estimates a mean fire risk frequency of 2.2 x 10(-5) fatalities/bus per year. The 5% and 95% uncertainty bounds are 9.1 x 10(-6) and 4.0 x 10(-5), respectively. The risk result was found to be affected most by failure rates of pressure relief valves, CNG cylinders, and fuel piping.

The failure of earthquake failure models

USGS Publications Warehouse

Gomberg, J.

2001-01-01

In this study I show that simple heuristic models and numerical calculations suggest that an entire class of commonly invoked models of earthquake failure processes cannot explain triggering of seismicity by transient or "dynamic" stress changes, such as stress changes associated with passing seismic waves. The models of this class have the common feature that the physical property characterizing failure increases at an accelerating rate when a fault is loaded (stressed) at a constant rate. Examples include models that invoke rate state friction or subcritical crack growth, in which the properties characterizing failure are slip or crack length, respectively. Failure occurs when the rate at which these grow accelerates to values exceeding some critical threshold. These accelerating failure models do not predict the finite durations of dynamically triggered earthquake sequences (e.g., at aftershock or remote distances). Some of the failure models belonging to this class have been used to explain static stress triggering of aftershocks. This may imply that the physical processes underlying dynamic triggering differs or that currently applied models of static triggering require modification. If the former is the case, we might appeal to physical mechanisms relying on oscillatory deformations such as compaction of saturated fault gouge leading to pore pressure increase, or cyclic fatigue. However, if dynamic and static triggering mechanisms differ, one still needs to ask why static triggering models that neglect these dynamic mechanisms appear to explain many observations. If the static and dynamic triggering mechanisms are the same, perhaps assumptions about accelerating failure and/or that triggering advances the failure times of a population of inevitable earthquakes are incorrect.

Minimisation of costs by using disintegration at a full-scale anaerobic digestion plant.

PubMed

Winter, A

2002-01-01

Various half-scale and lab-scale investigations have already shown that the disintegration of excess sludge is a possible pre-treatment to optimise anaerobic digestion. To control these results different methods of disintegration were investigated at a full-scale plant. Two stirred ball mills and a plant for oxidation with ozone were applied. A positive influence of disintegration on the anaerobic biodegradability can be established with application of a stirred ball mill. Biogas production as well as the degree of degradation were increased by about 20%. Laboratory investigations also validate that disintegration increases the polymer demand and leads to a lower solid content after dewatering. A higher pollution level of process water after dewatering even with ammonia and COD corroborates the results of the anaerobic degradation. Capital costs for the stirred ball mill, costs for energy, manpower and maintenance can be covered if the specific costs for disposal are high. If the development of costs in future and the current discussion about sludge disposal are taken into account sewage sludge disintegration can be a suitable technique to minimise costs at waste water treatment plants.

A cost minimisation and Bayesian inference model predicts startle reflex modulation across species.

PubMed

Bach, Dominik R

2015-04-07

In many species, rapid defensive reflexes are paramount to escaping acute danger. These reflexes are modulated by the state of the environment. This is exemplified in fear-potentiated startle, a more vigorous startle response during conditioned anticipation of an unrelated threatening event. Extant explanations of this phenomenon build on descriptive models of underlying psychological states, or neural processes. Yet, they fail to predict invigorated startle during reward anticipation and instructed attention, and do not explain why startle reflex modulation evolved. Here, we fill this lacuna by developing a normative cost minimisation model based on Bayesian optimality principles. This model predicts the observed pattern of startle modification by rewards, punishments, instructed attention, and several other states. Moreover, the mathematical formalism furnishes predictions that can be tested experimentally. Comparing the model with existing data suggests a specific neural implementation of the underlying computations which yields close approximations to the optimal solution under most circumstances. This analysis puts startle modification into the framework of Bayesian decision theory and predictive coding, and illustrates the importance of an adaptive perspective to interpret defensive behaviour across species. Copyright © 2015 The Author. Published by Elsevier Ltd.. All rights reserved.

Is Patient Safety Improving? National Trends in Patient Safety Indicators: 1998–2007

PubMed Central

Downey, John R; Hernandez-Boussard, Tina; Banka, Gaurav; Morton, John M

2012-01-01

Context Emphasis has been placed on quality and patient safety in medicine; however, little is known about whether quality over time has actually improved in areas such as patient safety indicators (PSIs). Objective To determine whether national trends for hospital PSIs have improved from 1998 to 2007. Design, Setting, and Participants Using PSI criteria from the Agency for Healthcare Research and Quality, PSIs were identified in the Nationwide Inpatient Sample (NIS) for all eligible inpatient admissions between 1998 and 2007. Joinpoint regression was used to estimate annual percentage changes (APCs) for PSIs. Main Outcome Measure Annual percent change for PSIs. Results From 1998 to 2007, 7.6 million PSI events occurred for over 69 million hospitalizations. A total of 14 PSIs showed statistically significant trends. Seven PSIs had increasing APC: postoperative pulmonary embolism or deep vein thrombosis (8.94), postoperative physiological or metabolic derangement (7.67), postoperative sepsis (7.17), selected infections due to medical care (4.05), decubitus ulcer (3.05), accidental puncture or laceration (2.64), and postoperative respiratory failure (1.46). Seven PSIs showed decreasing APCs: birth trauma injury to neonate (−17.79), failure to rescue (−6.05), postoperative hip fracture (−5.86), obstetric trauma–vaginal without instrument (−5.69), obstetric trauma–vaginal with instrument (−4.11), iatrogenic pneumothorax (−2.5), and postoperative wound dehiscence (−1.8). Conclusion This is the first study to establish national trends of PSIs during the past decade indicating areas for potential quality improvement prioritization. While many factors influence these trends, the results indicate opportunities for either emulation or elimination of current patient safety trends. PMID:22150789

Kidney Failure

MedlinePlus

... store Donate Now Give Monthly Give In Honor Kidney Failure (ESRD) Causes, Symptoms, & Treatments www.kidneyfund.org > ... Disaster preparedness Kidney failure/ESRD diet What causes kidney failure? In most cases, kidney failure is caused ...

Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion

PubMed Central

Henry, David A; Carless, Paul A; Moxey, Annette J; O’Connell, Dianne; Stokes, Barrie J; Fergusson, Dean A; Ker, Katharine

2014-01-01

Background Concerns regarding the safety of transfused blood have led to the development of a range of interventions to minimise blood loss during major surgery. Anti-fibrinolytic drugs are widely used, particularly in cardiac surgery, and previous reviews have found them to be effective in reducing blood loss, the need for transfusion, and the need for re-operation due to continued or recurrent bleeding. In the last few years questions have been raised regarding the comparative performance of the drugs. The safety of the most popular agent, aprotinin, has been challenged, and it was withdrawn from world markets in May 2008 because of concerns that it increased the risk of cardiovascular complications and death. Objectives To assess the comparative effects of the anti-fibrinolytic drugs aprotinin, tranexamic acid (TXA), and epsilon aminocaproic acid (EACA) on blood loss during surgery, the need for red blood cell (RBC) transfusion, and adverse events, particularly vascular occlusion, renal dysfunction, and death. Search methods We searched: the Cochrane Injuries Group’s Specialised Register (July 2010), Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 3), MEDLINE (Ovid SP) 1950 to July 2010, EMBASE (Ovid SP) 1980 to July 2010. References in identified trials and review articles were checked and trial authors were contacted to identify any additional studies. The searches were last updated in July 2010. Selection criteria Randomised controlled trials (RCTs) of anti-fibrinolytic drugs in adults scheduled for non-urgent surgery. Eligible trials compared anti-fibrinolytic drugs with placebo (or no treatment), or with each other. Data collection and analysis Two authors independently assessed trial quality and extracted data. This version of the review includes a sensitivity analysis excluding trials authored by Prof. Joachim Boldt. Main results This review summarises data from 252 RCTs that recruited over 25,000 participants. Data from

Ending on a positive: Examining the role of safety leadership decisions, behaviours and actions in a safety critical situation.

PubMed

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

2018-01-01

Safety leadership is an important factor in supporting safe performance in the workplace. The present case study examined the role of safety leadership during the Bingham Canyon Mine high-wall failure, a significant mining incident in which no fatalities or injuries were incurred. The Critical Decision Method (CDM) was used in conjunction with a self-reporting approach to examine safety leadership in terms of decisions, behaviours and actions that contributed to the incidents' safe outcome. Mapping the analysis onto Rasmussen's Risk Management Framework (Rasmussen, 1997), the findings demonstrate clear links between safety leadership decisions, and emergent behaviours and actions across the work system. Communication and engagement based decisions featured most prominently, and were linked to different leadership practices across the work system. Further, a core sub-set of CDM decision elements were linked to the open flow and exchange of information across the work system, which was critical to supporting the safe outcome. The findings provide practical implications for the development of safety leadership capability to support safety within the mining industry. Copyright © 2017 Elsevier Ltd. All rights reserved.

Decrease the Number of Glovebox Glove Breaches and Failures

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

Hurtle, Jackie C.

2013-12-24

Los Alamos National Laboratory (LANL) is committed to the protection of the workers, public, and environment while performing work and uses gloveboxes as engineered controls to protect workers from exposure to hazardous materials while performing plutonium operations. Glovebox gloves are a weak link in the engineered controls and are a major cause of radiation contamination events which can result in potential worker exposure and localized contamination making operational areas off-limits and putting programmatic work on hold. Each day of lost opportunity at Technical Area (TA) 55, Plutonium Facility (PF) 4 is estimated at $1.36 million. Between July 2011 and Junemore » 2013, TA-55-PF-4 had 65 glovebox glove breaches and failures with an average of 2.7 per month. The glovebox work follows the five step safety process promoted at LANL with a decision diamond interjected for whether or not a glove breach or failure event occurred in the course of performing glovebox work. In the event that no glove breach or failure is detected, there is an additional decision for whether or not contamination is detected. In the event that contamination is detected, the possibility for a glove breach or failure event is revisited.« less

A red-flag-based approach to risk management of EHR-related safety concerns.

PubMed

Sittig, Dean F; Singh, Hardeep

2013-01-01

Although electronic health records (EHRs) have a significant potential to improve patient safety, EHR-related safety concerns have begun to emerge. Based on 369 responses to a survey sent to the memberships of the American Society for Healthcare Risk Management and the American Health Lawyers Association and supplemented by our previous work in EHR-related patient safety, we identified the following common EHR-related safety concerns: (1) incorrect patient identification; (2) extended EHR unavailability (either planned or unplanned); (3) failure to heed a computer-generated warning or alert; (4) system-to-system interface errors; (5) failure to identify, find, or use the most recent patient data; (6) misunderstandings about time; (7) incorrect item selected from a list of items; and (8) open or incomplete orders. In this article, we present a "red-flag"-based approach that can be used by risk managers to identify potential EHR safety concerns in their institutions. An organization that routinely conducts EHR-related surveillance activities, such as the ones proposed here, can significantly reduce risks associated with EHR implementation and use. © 2013 American Society for Healthcare Risk Management of the American Hospital Association.

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.

Fusion Safety Program annual report, fiscal year 1994

NASA Astrophysics Data System (ADS)

Longhurst, Glen R.; Cadwallader, Lee C.; Dolan, Thomas J.; Herring, J. Stephen; McCarthy, Kathryn A.; Merrill, Brad J.; Motloch, Chester C.; Petti, David A.

1995-03-01

This report summarizes the major activities of the Fusion Safety Program in fiscal year 1994. The Idaho National Engineering Laboratory (INEL) is the designated lead laboratory and Lockheed Idaho Technologies Company is the prime contractor for this program. The Fusion Safety Program was initiated in 1979. Activities are conducted at the INEL, at other DOE laboratories, and at other institutions, including the University of Wisconsin. The technical areas covered in this report include tritium safety, beryllium safety, chemical reactions and activation product release, safety aspects of fusion magnet systems, plasma disruptions, risk assessment failure rate data base development, and thermalhydraulics code development and their application to fusion safety issues. Much of this work has been done in support of the International Thermonuclear Experimental Reactor (ITER). Also included in the report are summaries of the safety and environmental studies performed by the Fusion Safety Program for the Tokamak Physics Experiment and the Tokamak Fusion Test Reactor and of the technical support for commercial fusion facility conceptual design studies. A major activity this year has been work to develop a DOE Technical Standard for the safety of fusion test facilities.

Rationale and design of the Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure (AVOID-HF) trial.

PubMed

Costanzo, Maria Rosa; Negoianu, Daniel; Fonarow, Gregg C; Jaski, Brian E; Bart, Bradley A; Heywood, J Thomas; Nabut, Jose L; Schollmeyer, Michael P

2015-09-01

In patients hospitalized with acutely decompensated heart failure, unresolved signs and symptoms of fluid overload have been consistently associated with poor outcomes. Regardless of dosing and type of administration, intravenous loop diuretics have not reduced heart failure events or mortality in patients with acutely decompensated heart failure. The results of trials comparing intravenous loop diuretics to mechanical fluid removal by isolated venovenous ultrafiltration have yielded conflicting results. Studies evaluating early decongestive strategies have shown that ultrafiltration removed more fluid and was associated with fewer heart failure-related rehospitalization than intravenous loop diuretics. In contrast, when used in the setting of worsening renal function, ultrafiltration was associated with poorer renal outcomes and no reduction in heart failure events. The AVOID-HF trial seeks to determine if an early strategy of ultrafiltration in patients with acutely decompensated heart failure is associated with fewer heart failure events at 90 days compared with a strategy based on intravenous loop diuretics. Study subjects from 40 highly experienced institutions are randomized to either early ultrafiltration or intravenous loop diuretics. In both treatment arms, fluid removal therapies are adjusted according to the patients' hemodynamic condition and renal function. The study was unilaterally terminated by the sponsor in the absence of futility and safety concerns after the enrollment of 221 subjects, or 27% of the originally planned sample size of 810 patients. The AVOID-HF trial's principal aim is to compare the safety and efficacy of ultrafiltration vs that of intravenous loop diuretics in patients hospitalized with acutely decompensated heart failure. Because stepped treatment approaches are applied in both ultrafiltration and intravenous loop diuretics groups and the primary end point is time to first heart failure event within 90 days, it is hoped that

Nitrates as a Treatment of Acute Heart Failure

PubMed Central

Alzahri, Mohammad S; Rohra, Anita

2016-01-01

The purpose of this article is to review the clinical efficacy and safety of nitrates in acute heart failure (AHF) by examining various trials on nitrates in AHF. Management of AHF can be challenging due to the lack of objective clinical evidence guiding optimal management. There have been many articles suggesting that, despite a benefit, nitrates are underused in clinical practice. Nitrates, when appropriately dosed, have a favourable effect on symptoms, blood pressure, intubation rates, mortality and other parameters. PMID:28785453

Identifying the necessary and sufficient number of risk factors for predicting academic failure.

PubMed

Lucio, Robert; Hunt, Elizabeth; Bornovalova, Marina

2012-03-01

Identifying the point at which individuals become at risk for academic failure (grade point average [GPA] < 2.0) involves an understanding of which and how many factors contribute to poor outcomes. School-related factors appear to be among the many factors that significantly impact academic success or failure. This study focused on 12 school-related factors. Using a thorough 5-step process, we identified which unique risk factors place one at risk for academic failure. Academic engagement, academic expectations, academic self-efficacy, homework completion, school relevance, school safety, teacher relationships (positive relationship), grade retention, school mobility, and school misbehaviors (negative relationship) were uniquely related to GPA even after controlling for all relevant covariates. Next, a receiver operating characteristic curve was used to determine a cutoff point for determining how many risk factors predict academic failure (GPA < 2.0). Results yielded a cutoff point of 2 risk factors for predicting academic failure, which provides a way for early identification of individuals who are at risk. Further implications of these findings are discussed. PsycINFO Database Record (c) 2012 APA, all rights reserved.

Effect of DGPS failures on dynamic positioning of mobile drilling units in the North Sea.

PubMed

Chen, Haibo; Moan, Torgeir; Verhoeven, Harry

2009-11-01

Basic features of differential global positioning system (DGPS), and its operational configuration on dynamically positioned (DP) mobile offshore drilling units in the North Sea are described. Generic failure modes of DGPS are discussed, and a critical DGPS failure which has the potential to cause drive-off for mobile drilling units is identified. It is the simultaneous erroneous position data from two DGPS's. Barrier method is used to analyze this critical DGPS failure. Barrier elements to prevent this failure are identified. Deficiencies of each barrier element are revealed based on the incidents and operational experiences in the North Sea. Recommendations to strengthen these barrier elements, i.e. to prevent erroneous position data from DGPS, are proposed. These recommendations contribute to the safety of DP operations of mobile offshore drilling units.

Malfunction and failure of robotic systems during general surgical procedures.

PubMed

Agcaoglu, Orhan; Aliyev, Shamil; Taskin, Halit Eren; Chalikonda, Sricharan; Walsh, Matthew; Costedio, Meagan M; Kroh, Matthew; Rogula, Tomasz; Chand, Bipan; Gorgun, Emre; Siperstein, Allan; Berber, Eren

2012-12-01

There has been recent interest in using robots for general surgical procedures. This shift in technique raises the issue of patient safety with automated instrumentation. Although the safety of robotics has been established for urologic procedures, there are scant data on its use in general surgical procedures. The aim of this study is to analyze the incidence of robotic malfunction and its consequences for general surgical procedures. All robotic general surgical procedures performed at a tertiary center between 2008 and 2011 were reviewed from institutional review board (IRB)-approved prospective databases. A total of 223 cases were done robotically, including 102 endocrine, 83 hepatopancreaticobiliary, 17 upper gastrointestinal, and 21 lower gastrointestinal colorectal procedures. There were 10 cases of robotic malfunction (4.5%). These failures were related to robotic instruments (n = 4), optical system (n = 3), robotic arms (n = 2), and robotic console (n = 1). None of these failures led to adverse patient consequences or conversion to open. Six (2.7%) cases were converted to open due to bleeding (n = 3), difficult dissection plane (n = 1), invasion of tumor to surrounding structures (n = 1), and intolerance of pneumoperitoneum due to CO(2) retention (n = 1). There was no mortality, and morbidity was 1% (n = 2). To our knowledge, this is the largest North American report to date on robotic general surgical procedures. Our results show that robotic malfunction occurs in a minority of cases, with no adverse consequences. We believe that awareness of these failures and knowing how to troubleshoot are important to maintain the efficiency of these procedures.

[Design of a plan for patient safety in pediatric surgery service].

PubMed

Paredes Esteban, R M; Castillo Fernández, A L; Miñarro del Moral, R; Garrido Pérez, J I; Granero Cendón, R; Gómez Beltrán, O; Berenguer Garcia, M J; Tejedor Fernández, M

2014-10-01

Patient safety is a key priority in quality management for healthcare services providers. Every patient is entitled to receive safe and effective healthcare. The aim of this study was to design a patient safety plan for a Paediatric Surgery Department. We carried out a literature review and we established a work group that included healthcare professionals from the Paediatric Surgery Department and the Quality and Medical Records Department. The group identified potential adverse events, failures and causes and established a rating using Failure Mode Effects Analysis. Potential risks were mapped out and a plan was designed establishing actions to reduce risks. We designated leaders to ensure the effective implementation of the plan. A total of 58 adverse events were identified in the Paediatric Surgery Department. We detected 128 failures that were produced by 211 different causes. The group developed a proposal with 424 specific measures to carry out preventive and/or remedial actions that were then narrowed down to 322. The group designed a plan to apply the programme, which is currently being implemented. The methodology used enabled obtaining key information for improvement of patient safety and developing preventive and/or remedial actions. These measures are applicable in practice, as they were designed using proposals and agreements with professionals that take active part in the care of children with surgical conditions.

Preventing blood transfusion failures: FMEA, an effective assessment method.

PubMed

Najafpour, Zhila; Hasoumi, Mojtaba; Behzadi, Faranak; Mohamadi, Efat; Jafary, Mohamadreza; Saeedi, Morteza

2017-06-30

Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. A structured FMEA was recruited in our study performed in 2014, and corrective actions were implemented and re-evaluated after 6 months. Sixteen 2-h sessions were held to perform FMEA in the blood transfusion process, including five steps: establishing the context, selecting team members, analysis of the processes, hazard analysis, and developing a risk reduction protocol for blood transfusion. Failure modes with the highest risk priority numbers (RPNs) were identified. The overall RPN scores ranged from 5 to 100 among which, four failure modes were associated with RPNs over 75. The data analysis indicated that failures with the highest RPNs were: labelling (RPN: 100), transfusion of blood or the component (RPN: 100), patient identification (RPN: 80) and sampling (RPN: 75). The results demonstrated that mis-transfusion of blood or blood component is the most important error, which can lead to serious morbidity or mortality. Provision of training to the personnel on blood transfusion, knowledge raising on hazards and appropriate preventative measures, as well as developing standard safety guidelines are essential, and must be implemented during all steps of blood and blood component transfusion.

Efficacy and safety of tolvaptan in heart failure patients with sustained volume overload despite the use of conventional diuretics: a phase III open-label study.

PubMed

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

2011-12-01

Volume overload is a common complication associated with heart failure (HF) and is recommended to be treated with loop or thiazide diuretics. However, use of diuretics can cause serum electrolyte imbalances and diuretic resistance. Tolvaptan, a selective, oral, non-peptide vasopressin V2-receptor antagonist, offers a new option for treating volume overload in HF patients. The aim of this study was to investigate the efficacy and safety of tolvaptan in Japanese HF patients with volume overload. Fifty-one HF patients with volume overload, despite using conventional diuretics, were treated with 15 mg/day tolvaptan for 7 days. If the response was insufficient at Day 7, tolvaptan was continued for a further 7 days at either 15 mg/day or 30 mg/day. Outcomes included changes in body weight, symptoms and safety parameters. Thirty-six patients discontinued treatment within 7 days, therefore 15 patients entered the second phase of treatment. In two patients, tolvaptan was increased to 30 mg/day after 7 days. Body weight was reduced on Day 7 (-1.95 ± 1.98 kg; n = 41) and Day 14 (-2.35 ± 1.44 kg; n = 11, 15 mg/day). Symptoms of volume overload, including lower limb edema, pulmonary congestion, jugular venous distention and hepatomegaly, were improved by tolvaptan treatment for 7 or 14 days. Neither tolvaptan increased the incidence of severe or serious adverse events when administered for 7-14 days. This study confirms the efficacy and safety of 15 mg/day tolvaptan for 7-14 days in Japanese HF patients with volume overload despite conventional diuretics.

Environmental, health, and safety issues of sodium-sulfur batteries for electric and hybrid vehicles. Volume 1, Cell and battery safety

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

Ohi, J M

1992-09-01

This report is the first of four volumes that identify and assess the environmental, health, and safety issues involved in using sodium-sulfur (Na/S) battery technology as the energy source in electric and hybrid vehicles that may affect the commercialization of Na/S batteries. This and the other reports on recycling, shipping, and vehicle safety are intended to help the Electric and Hybrid Propulsion Division of the Office of Transportation Technologies in the US Department of Energy (DOE/EHP) determine the direction of its research, development, and demonstration (RD&D) program for Na/S battery technology. The reports review the status of Na/S battery RD&Dmore » and identify potential hazards and risks that may require additional research or that may affect the design and use of Na/S batteries. This volume covers cell design and engineering as the basis of safety for Na/S batteries and describes and assesses the potential chemical, electrical, and thermal hazards and risks of Na/S cells and batteries as well as the RD&D performed, under way, or to address these hazards and risks. The report is based on a review of the literature and on discussions with experts at DOE, national laboratories and agencies, universities, and private industry. Subsequent volumes will address environmental, health, and safety issues involved in shipping cells and batteries, using batteries to propel electric vehicles, and recycling and disposing of spent batteries. The remainder of this volume is divided into two major sections on safety at the cell and battery levels. The section on Na/S cells describes major component and potential failure modes, design, life testing and failure testing, thermal cycling, and the safety status of Na/S cells. The section on batteries describes battery design, testing, and safety status. Additional EH&S information on Na/S batteries is provided in the appendices.« less

Directory of aerospace safety specialized information sources

NASA Technical Reports Server (NTRS)

Fullerton, E. A.; Rubens, L. S.

1973-01-01

A directory is presented to make available to the aerospace safety community a handbook of organizations and experts in specific, well-defined areas of safety technology. It is designed for the safety specialist as an aid for locating both information sources and individual points of contact (experts) in engineering related fields. The file covers sources of data in aerospace design, tests, as well as information in hazard and failure cause identification, accident analysis, materials characteristics, and other related subject areas. These 171 organizations and their staff members, hopefully, should provide technical information in the form of documentation, data and consulting expertise. These will be sources that have assembled and collated their information, so that it will be useful in the solution of engineering problems. One of the goals of the project in the United States that have and are willing to share data of value to the aerospace safety community.

A Daily Diary Approach to the Examination of Chronic Stress, Daily Hassles and Safety Perceptions in Hospital Nursing.

PubMed

Louch, Gemma; O'Hara, Jane; Gardner, Peter; O'Connor, Daryl B

2017-12-01

Stress is a significant concern for individuals and organisations. Few studies have explored stress, burnout and patient safety in hospital nursing on a daily basis at the individual level. This study aimed to examine the effects of chronic stress and daily hassles on safety perceptions, the effect of chronic stress on daily hassles experienced and chronic stress as a potential moderator. Utilising a daily diary design, 83 UK hospital nurses completed three end-of-shift diaries, yielding 324 person days. Hassles, safety perceptions and workplace cognitive failure were measured daily, and a baseline questionnaire included a measure of chronic stress. Hierarchical multivariate linear modelling was used to analyse the data. Higher chronic stress was associated with more daily hassles, poorer perceptions of safety and being less able to practise safely, but not more workplace cognitive failure. Reporting more daily hassles was associated with poorer perceptions of safety, being less able to practise safely and more workplace cognitive failure. Chronic stress did not moderate daily associations. The hassles reported illustrate the wide-ranging hassles nurses experienced. The findings demonstrate, in addition to chronic stress, the importance of daily hassles for nurses' perceptions of safety and the hassles experienced by hospital nurses on a daily basis. Nurses perceive chronic stress and daily hassles to contribute to their perceptions of safety. Measuring the number of daily hassles experienced could proactively highlight when patient safety threats may arise, and as a result, interventions could usefully focus on the management of daily hassles.

Integrating Safety and Mission Assurance in Design

NASA Technical Reports Server (NTRS)

Cianciola, Chris; Crane, Kenneth

2008-01-01

This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safety and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.

Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis.

PubMed

Woehrle, Holger; Cowie, Martin R; Eulenburg, Christine; Suling, Anna; Angermann, Christiane; d'Ortho, Marie-Pia; Erdmann, Erland; Levy, Patrick; Simonds, Anita K; Somers, Virend K; Zannad, Faiez; Teschler, Helmut; Wegscheider, Karl

2017-08-01

This on-treatment analysis was conducted to facilitate understanding of mechanisms underlying the increased risk of all-cause and cardiovascular mortality in heart failure patients with reduced ejection fraction and predominant central sleep apnoea randomised to adaptive servo ventilation versus the control group in the SERVE-HF trial.Time-dependent on-treatment analyses were conducted (unadjusted and adjusted for predictive covariates). A comprehensive, time-dependent model was developed to correct for asymmetric selection effects (to minimise bias).The comprehensive model showed increased cardiovascular death hazard ratios during adaptive servo ventilation usage periods, slightly lower than those in the SERVE-HF intention-to-treat analysis. Self-selection bias was evident. Patients randomised to adaptive servo ventilation who crossed over to the control group were at higher risk of cardiovascular death than controls, while control patients with crossover to adaptive servo ventilation showed a trend towards lower risk of cardiovascular death than patients randomised to adaptive servo ventilation. Cardiovascular risk did not increase as nightly adaptive servo ventilation usage increased.On-treatment analysis showed similar results to the SERVE-HF intention-to-treat analysis, with an increased risk of cardiovascular death in heart failure with reduced ejection fraction patients with predominant central sleep apnoea treated with adaptive servo ventilation. Bias is inevitable and needs to be taken into account in any kind of on-treatment analysis in positive airway pressure studies. Copyright ©ERS 2017.

Safety assessment of Cracked K-joint Structure Based on Fracture Mechanics

NASA Astrophysics Data System (ADS)

Wang, Xin; Pengyu, Yan; Jianwei, Du; Fuhai, Cai

2017-05-01

The K-joint is the main bearing structure of lattice jib crane. During frequent operation of the crane, surface cracks often occur at its weld toe, and then continue to expand until failure. The safety of the weak structure K-joint of the crane jib can be evaluated by BS7910 failure assessment standard in order to improve its utilization. The finite element model of K-joint structure with cracks is established, and its mechanical properties is analyzed by ABAQUS software, the results show that the crack depth has a great influence on the bearing capacity of the structure compared with the crack length. It is assumed that the K-joint with the semi-elliptical surface crack under the action of the tension propagate stably under the condition that the c/a (ratio of short axis to long axis of ellipse) is about 0.3. The safety assessment of K-joint with different lengths crack is presented according to the 2A failure assessment diagram of BS7910, and the critical crack of K-joint under different loads can be obtained.

Evaluating the Performance of the NASA LaRC CMF Motion Base Safety Devices

NASA Technical Reports Server (NTRS)

Gupton, Lawrence E.; Bryant, Richard B., Jr.; Carrelli, David J.

2006-01-01

This paper describes the initial measured performance results of the previously documented NASA Langley Research Center (LaRC) Cockpit Motion Facility (CMF) motion base hardware safety devices. These safety systems are required to prevent excessive accelerations that could injure personnel and damage simulator cockpits or the motion base structure. Excessive accelerations may be caused by erroneous commands or hardware failures driving an actuator to the end of its travel at high velocity, stepping a servo valve, or instantly reversing servo direction. Such commands may result from single order failures of electrical or hydraulic components within the control system itself, or from aggressive or improper cueing commands from the host simulation computer. The safety systems must mitigate these high acceleration events while minimizing the negative performance impacts. The system accomplishes this by controlling the rate of change of valve signals to limit excessive commanded accelerations. It also aids hydraulic cushion performance by limiting valve command authority as the actuator approaches its end of travel. The design takes advantage of inherent motion base hydraulic characteristics to implement all safety features using hardware only solutions.

[Failure mode and effects analysis (FMEA) of insulin in a mother-child university-affiliated health center].

PubMed

Berruyer, M; Atkinson, S; Lebel, D; Bussières, J-F

2016-01-01

Insulin is a high-alert drug. The main objective of this descriptive cross-sectional study was to evaluate the risks associated with insulin use in healthcare centers. The secondary objective was to propose corrective measures to reduce the main risks associated with the most critical failure modes in the analysis. We conducted a failure mode and effects analysis (FMEA) in obstetrics-gynecology, neonatology and pediatrics. Five multidisciplinary meetings occurred in August 2013. A total of 44 out of 49 failure modes were analyzed. Nine out of 44 (20%) failure modes were deemed critical, with a criticality score ranging from 540 to 720. Following the multidisciplinary meetings, everybody agreed that an FMEA was a useful tool to identify failure modes and their relative importance. This approach identified many corrective measures. This shared experience increased awareness of safety issues with insulin in our mother-child center. This study identified the main failure modes and associated corrective measures. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Ares-I-X Vehicle Preliminary Range Safety Malfunction Turn Analysis

NASA Technical Reports Server (NTRS)

Beaty, James R.; Starr, Brett R.; Gowan, John W., Jr.

2008-01-01

Ares-I-X is the designation given to the flight test version of the Ares-I rocket (also known as the Crew Launch Vehicle - CLV) being developed by NASA. As part of the preliminary flight plan approval process for the test vehicle, a range safety malfunction turn analysis was performed to support the launch area risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could cause the vehicle trajectory to deviate from its normal flight path, and the effects of these failures were evaluated with an Ares-I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version 2 (POST2) simulation framework. The Ares-I-X simulation analysis provides output files containing vehicle state information, which are used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at Kennedy Space Center (KSC), and to develop the vehicle destruct criteria used by the flight test range safety officer. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study, and preliminary results are presented, determined by analysis of the trajectory deviation of the failure cases, compared with the expected vehicle trajectory.

Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

PubMed

Singh, Hardeep; Sittig, Dean F

2016-04-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

Failures in communication through documents and documentation across the perioperative pathway.

PubMed

Braaf, Sandra; Riley, Robin; Manias, Elizabeth

2015-07-01

To explore how communication failures occur in documents and documentations across the perioperative pathway in nurses' interactions with other nurses, surgeons and anaesthetists. Documents and documentation are used to communicate vital patient and procedural information among nurses, and in nurses' interactions with surgeons and anaesthetists, across the perioperative pathway. Previous research indicates that communication failure regularly occurs in the perioperative setting. A qualitative study was undertaken. The study was conducted over three hospitals in Melbourne, Australia. One hundred and twenty-five healthcare professionals from the disciplines of surgery, anaesthesia and nursing participated in the study. Data collection commenced in January 2010 and concluded in October 2010. Data were generated through 350 hours of observation, two focus groups and 20 semi-structured interviews. A detailed thematic analysis was undertaken. Communication failure occurred owing to a reliance on documents and documentation to transfer information at patient transition points, poor quality documents and documentation, and problematic access to information. Institutional ruling practices of professional practice, efficiency and productivity, and fiscal constraint dominated the coordination of nurses', surgeons' and anaesthetists' communication through documents and documentation. These governing practices configured communication to be incongruous with reliably meeting safety and quality objectives. Communication failure occurred because important information was sometimes buried in documents, insufficient, inaccurate, out-of-date or not verbally reinforced. Furthermore, busy nurses were not always able to access information they required in a timely manner. Patient safety was affected, which led to delays in treatment and at times inadequate care. Organisational support needs to be provided to nurses, surgeons and anaesthetists so they have sufficient time to complete

Early initiation of beta blockade in heart failure: issues and evidence.

PubMed

Williams, Randall E

2005-09-01

Despite clinical trials demonstrating that inhibitors of the renin-angiotensin and sympathetic nervous systems can reduce the mortality and morbidity risk associated with heart failure, these drugs have remained underutilized in general clinical practice. In particular, many patients with heart failure due to left ventricular systolic dysfunction fail to receive beta blockers, although this class of drugs, as well as other antihypertensive agents such as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, are recommended as part of routine heart failure therapy by national expert consensus guidelines. In-hospital initiation of beta-blocker therapy may improve long-term utilization by physicians and compliance by patients through obviating many of the misperceived dangers associated with beta blockade. The following review of the clinical trial data from the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) trial, the Metoprolol Controlled-Release Randomized Intervention Trial in Heart Failure (MERIT-HF), the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial, and the Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) trial on the efficacy, safety, and tolerability of beta blockers indicates that early initiation can be safely achieved and can improve patient outcomes.

Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study.

PubMed

Friedman, Diana C W; Lendvay, Thomas S; Hannaford, Blake

2013-05-01

Our goal was to analyze reported instances of the da Vinci robotic surgical system instrument failures using the FDA's MAUDE (Manufacturer and User Facility Device Experience) database. From these data we identified some root causes of failures as well as trends that may assist surgeons and users of the robotic technology. We conducted a survey of the MAUDE database and tallied robotic instrument failures that occurred between January 2009 and December 2010. We categorized failures into five main groups (cautery, shaft, wrist or tool tip, cable, and control housing) based on technical differences in instrument design and function. A total of 565 instrument failures were documented through 528 reports. The majority of failures (285) were of the instrument's wrist or tool tip. Cautery problems comprised 174 failures, 76 were shaft failures, 29 were cable failures, and 7 were control housing failures. Of the reports, 10 had no discernible failure mode and 49 exhibited multiple failures. The data show that a number of robotic instrument failures occurred in a short period of time. In reality, many instrument failures may go unreported, thus a true failure rate cannot be determined from these data. However, education of hospital administrators, operating room staff, surgeons, and patients should be incorporated into discussions regarding the introduction and utilization of robotic technology. We recommend institutions incorporate standard failure reporting policies so that the community of robotic surgery companies and surgeons can improve on existing technologies for optimal patient safety and outcomes.

Laboratory and 3-D-distinct element analysis of failure mechanism of slope under external surcharge

NASA Astrophysics Data System (ADS)

Li, N.; Cheng, Y. M.

2014-09-01

Landslide is a major disaster resulting in considerable loss of human lives and property damages in hilly terrain in Hong Kong, China and many other countries. The factor of safety and the critical slip surface for slope stabilization are the main considerations for slope stability analysis in the past, while the detailed post-failure conditions of the slopes have not been considered in sufficient details. There are however increasing interest on the consequences after the initiation of failure which includes the development and propagation of the failure surfaces, the amount of failed mass and runoff and the affected region. To assess the development of slope failure in more details and to consider the potential danger of slopes after failure has initiated, the slope stability problem under external surcharge is analyzed by the distinct element method (DEM) and laboratory model test in the present research. A more refined study about the development of failure, microcosmic failure mechanism and the post-failure mechanism of slope will be carried out. The numerical modeling method and the various findings from the present work can provide an alternate method of analysis of slope failure which can give additional information not available from the classical methods of analysis.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1989-01-01

This report provides findings, conclusions and recommendations regarding the National Space Transportation System (NSTS), the Space Station Freedom Program (SSFP), aeronautical projects and other areas of NASA activities. The main focus of the Aerospace Safety Advisory Panel (ASAP) during 1988 has been monitoring and advising NASA and its contractors on the Space Transportation System (STS) recovery program. NASA efforts have restored the flight program with a much better management organization, safety and quality assurance organizations, and management communication system. The NASA National Space Transportation System (NSTS) organization in conjunction with its prime contractors should be encouraged to continue development and incorporation of appropriate design and operational improvements which will further reduce risk. The data from each Shuttle flight should be used to determine if affordable design and/or operational improvements could further increase safety. The review of Critical Items (CILs), Failure Mode Effects and Analyses (FMEAs) and Hazard Analyses (HAs) after the Challenger accident has given the program a massive data base with which to establish a formal program with prioritized changes.

Role of Hyperkalemia in Heart Failure and the Therapeutic Use of Potassium Binders.

PubMed

Sarwar, Chaudhry M S; Bhagat, Aditi A; Anker, Stefan D; Butler, Javed

2017-01-01

Hyperkalemia can be a life-threatening disorder, especially for at-risk patients with heart failure, chronic kidney disease, with diabetes, and patients on certain drugs like renin-angiotensin-aldosterone system antagonists and mineralocorticoid receptor antagonists. There are limited therapeutic options available for hyperkalemia, and they have narrow effectiveness because of their unfavorable side effects profile in long-term and high cost utilization requiring inpatient care. Patiromersorbitex calcium and sodium zirconium cyclosilicate are novel potassium-lowering compounds for the treatment and prevention of hyperkalemia in at-risk population. These therapeutic agents have shown encouraging results in early phase II and phase III clinical trials. However, there is need to further study their efficacy and safety in heart failure population in order to establish their clinical use. The focus of this chapter will be to promote better understanding of potassium homeostasis in heart failure patients and the mechanistic overview of novel drugs, with emphasis on heart failure population.

Minimising Immunohistochemical False Negative ER Classification Using a Complementary 23 Gene Expression Signature of ER Status

PubMed Central

Li, Qiyuan; Eklund, Aron C.; Juul, Nicolai; Haibe-Kains, Benjamin; Workman, Christopher T.; Richardson, Andrea L.; Szallasi, Zoltan; Swanton, Charles

2010-01-01

Background Expression of the oestrogen receptor (ER) in breast cancer predicts benefit from endocrine therapy. Minimising the frequency of false negative ER status classification is essential to identify all patients with ER positive breast cancers who should be offered endocrine therapies in order to improve clinical outcome. In routine oncological practice ER status is determined by semi-quantitative methods such as immunohistochemistry (IHC) or other immunoassays in which the ER expression level is compared to an empirical threshold[1], [2]. The clinical relevance of gene expression-based ER subtypes as compared to IHC-based determination has not been systematically evaluated. Here we attempt to reduce the frequency of false negative ER status classification using two gene expression approaches and compare these methods to IHC based ER status in terms of predictive and prognostic concordance with clinical outcome. Methodology/Principal Findings Firstly, ER status was discriminated by fitting the bimodal expression of ESR1 to a mixed Gaussian model. The discriminative power of ESR1 suggested bimodal expression as an efficient way to stratify breast cancer; therefore we identified a set of genes whose expression was both strongly bimodal, mimicking ESR expression status, and highly expressed in breast epithelial cell lines, to derive a 23-gene ER expression signature-based classifier. We assessed our classifiers in seven published breast cancer cohorts by comparing the gene expression-based ER status to IHC-based ER status as a predictor of clinical outcome in both untreated and tamoxifen treated cohorts. In untreated breast cancer cohorts, the 23 gene signature-based ER status provided significantly improved prognostic power compared to IHC-based ER status (P = 0.006). In tamoxifen-treated cohorts, the 23 gene ER expression signature predicted clinical outcome (HR = 2.20, P = 0.00035). These complementary ER signature-based strategies estimated that

Minimising methodological biases to improve the accuracy of partitioning soil respiration using natural abundance 13C.

PubMed

Snell, Helen S K; Robinson, David; Midwood, Andrew J

2014-11-15

Microbial degradation of soil organic matter (heterotrophic respiration) is a key determinant of net ecosystem exchange of carbon, but it is difficult to measure because the CO2 efflux from the soil surface is derived not only from heterotrophic respiration, but also from plant root and rhizosphere respiration (autotrophic). Partitioning total CO2 efflux can be achieved using the different natural abundance stable isotope ratios (δ(13)C) of root and soil CO2. Successful partitioning requires very accurate measurements of total soil efflux δ(13)CO2 and the δ(13)CO2 of the autotrophic and heterotrophic sources, which typically differ by just 2-8‰. In Scottish moorland and grass mesocosm studies we systematically tested some of the most commonly used techniques in order to identify and minimise methodological errors. Typical partitioning methods are to sample the total soil-surface CO2 efflux using a chamber, then to sample CO2 from incubated soil-free roots and root-free soil. We investigated the effect of collar depth on chamber measurements of surface efflux δ(13)CO2 and the effect of incubation time on estimates of end-member δ(13)CO2. (1) a 5 cm increase in collar depth affects the measurement of surface efflux δ(13)CO2 by -1.5‰ and there are fundamental inconsistencies between modelled and measured biases; (2) the heterotrophic δ(13)CO2 changes by up to -4‰ within minutes of sampling; we recommend using regression to estimate the in situ δ(13)CO2 values; (3) autotrophic δ(13)CO2 measurements are reliable if root CO2 is sampled within an hour of excavation; (4) correction factors should be used to account for instrument drift of up to 3‰ and concentration-dependent non-linearity of CRDS (cavity ringdown spectroscopy) analysis. Methodological biases can lead to large inaccuracies in partitioning estimates. The utility of stable isotope partitioning of soil CO2 efflux will be enhanced by consensus on the optimum measurement protocols and by

Food-poisoning and commercial air travel.

PubMed

McMullan, R; Edwards, P J; Kelly, M J; Millar, B C; Rooney, P J; Moore, J E

2007-09-01

With the introduction of budget airlines and greater competitiveness amongst all airlines, air travel has now become an extremely popular form of travel, presenting its own unique set of risks from food poisoning. Foodborne illness associated with air travel is quite uncommon in the modern era. However, when it occurs, it may have serious implications for passengers and when crew are affected, has the potential to threaten safety. Quality, safe, in-flight catering relies on high standards of food preparation and storage; this applies at the airport kitchens (or at subcontractors' facilities), on the aircraft and in the transportation vehicles which carry the food from the ground source to the aircraft. This is especially challenging in certain countries. Several foodborne outbreaks have been recorded by the airline industry as a result of a number of different failures of these systems. These have provided an opportunity to learn from past mistakes and current practice has, therefore, reached such a standard so as to minimise risk of failures of this kind. This review examines: (i) the origin of food safety in modern commercial aviation; (ii) outbreaks which have occurred previously relating to aviation travel; (iii) the microbiological quality of food and water on board commercial aircraft; and (iv) how Hazard Analysis Critical Control Points may be employed to maintain food safety in aviation travel.

Predicting Time Series Outputs and Time-to-Failure for an Aircraft Controller Using Bayesian Modeling

NASA Technical Reports Server (NTRS)

He, Yuning

2015-01-01

Safety of unmanned aerial systems (UAS) is paramount, but the large number of dynamically changing controller parameters makes it hard to determine if the system is currently stable, and the time before loss of control if not. We propose a hierarchical statistical model using Treed Gaussian Processes to predict (i) whether a flight will be stable (success) or become unstable (failure), (ii) the time-to-failure if unstable, and (iii) time series outputs for flight variables. We first classify the current flight input into success or failure types, and then use separate models for each class to predict the time-to-failure and time series outputs. As different inputs may cause failures at different times, we have to model variable length output curves. We use a basis representation for curves and learn the mappings from input to basis coefficients. We demonstrate the effectiveness of our prediction methods on a NASA neuro-adaptive flight control system.

Neprilysin inhibition with sacubitril/valsartan in the treatment of heart failure: mortality bang for your buck.

PubMed

Ansara, A J; Kolanczyk, D M; Koehler, J M

2016-04-01

Heart failure remains a leading cause of morbidity and mortality worldwide. Advanced therapies have prolonged survival in patients with advanced heart failure, but pharmacotherapeutic optimization remains the mainstay of treatment. It has been over 10 years since the last mortality-reducing medication has been approved by the Food and Drug Administration. This article reviews the background, current knowledge and data supporting the use of sacubitril/valsartan (Entresto(®) ), the newly FDA-approved medication that dually inhibits angiotensin and neprilysin, in the treatment of heart failure. A literature search was performed (January 1980 to August 2015) using PubMed and the search terms were as follows: neprilysin inhibitor, heart failure, endopeptidase, natriuretic peptides, angiotensin, omapatrilat, LCZ696, valsartan and sacubitril. Peer-reviewed, published clinical trials, review articles, relevant treatment guidelines and prescribing information documents were identified and reviewed for relevance. Additionally, reference citations from publications identified were reviewed. The inhibition of endopeptidases has been an area of extensive study for the treatment of heart failure. Previously published literature with the endopeptidase inhibitor omapatrilat failed to demonstrate a sufficient balance between clinical efficacy and safety to justify its approval. Omapatrilat blocked three pathways that break down bradykinin, leading to high rates of angioedema. Sacubitril, on the other hand, is metabolized to a form that is highly selective for neprilysin without possessing activity for the other two peptidases, ACE and APP. The combination of sacubitril with valsartan in a single formulation offers the benefit of concurrent blockade of the renin angiotensin aldosterone system and the inhibition of neprilysin while minimizing angioedema risk. When compared to ACE inhibitor therapy in systolic heart failure patients, sacubitril/valsartan demonstrated reductions in

Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy.

PubMed

Zile, Michael R; Abraham, William T; Weaver, Fred A; Butter, Christian; Ducharme, Anique; Halbach, Marcel; Klug, Didier; Lovett, Eric G; Müller-Ehmsen, Jochen; Schafer, Jill E; Senni, Michele; Swarup, Vijay; Wachter, Rolf; Little, William C

2015-10-01

Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs. those without CRT. New York Heart Association (NYHA) Class III patients with an ejection fraction (EF) ≤35% were randomized (1 : 1) to ongoing guideline-directed medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety endpoint was system-/procedure-related major adverse neurological and cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations were significantly improved in BAT patients compared with controls. Changes in efficacy endpoints in the CRT group favoured BAT; however, the improvements were less than in the no-CRT group and were not statistically different from control. BAT is safe and significantly improved QoL, exercise capacity, NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF patients. These effects were most pronounced in patients not treated with CRT. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Integrated failure detection and management for the Space Station Freedom external active thermal control system

NASA Technical Reports Server (NTRS)

Mesloh, Nick; Hill, Tim; Kosyk, Kathy

1993-01-01

This paper presents the integrated approach toward failure detection, isolation, and recovery/reconfiguration to be used for the Space Station Freedom External Active Thermal Control System (EATCS). The on-board and on-ground diagnostic capabilities of the EATCS are discussed. Time and safety critical features, as well as noncritical failures, and the detection coverage for each provided by existing capabilities are reviewed. The allocation of responsibility between on-board software and ground-based systems, to be shown during ground testing at the Johnson Space Center, is described. Failure isolation capabilities allocated to the ground include some functionality originally found on orbit but moved to the ground to reduce on-board resource requirements. Complex failures requiring the analysis of multiple external variables, such as environmental conditions, heat loads, or station attitude, are also allocated to ground personnel.

Innovative safety valve selection techniques and data.

PubMed

Miller, Curt; Bredemyer, Lindsey

2007-04-11

The new valve data resources and modeling tools that are available today are instrumental in verifying that that safety levels are being met in both current installations and project designs. If the new ISA 84 functional safety practices are followed closely, good industry validated data used, and a user's maintenance integrity program strictly enforced, plants should feel confident that their design has been quantitatively reinforced. After 2 years of exhaustive reliability studies, there are now techniques and data available to support this safety system component deficiency. Everyone who has gone through the process of safety integrity level (SIL) verification (i.e. reliability math) will appreciate the progress made in this area. The benefits of these advancements are improved safety with lower lifecycle costs such as lower capital investment and/or longer testing intervals. This discussion will start with a review of the different valve, actuator, and solenoid/positioner combinations that can be used and their associated application restraints. Failure rate reliability studies (i.e. FMEDA) and data associated with the final combinations will then discussed. Finally, the impact of the selections on each safety system's SIL verification will be reviewed.

Kidney (Renal) Failure

MedlinePlus

... News Physician Resources Professions Site Index A-Z Kidney Failure Kidney failure, also known as renal failure, ... evaluated? How is kidney failure treated? What is kidney (renal) failure? The kidneys are designed to maintain ...

Safety control circuit for a neutronic reactor

DOEpatents

Ellsworth, Howard C.

2004-04-27

A neutronic reactor comprising an active portion containing material fissionable by neutrons of thermal energy, means to control a neutronic chain reaction within the reactor comprising a safety device and a regulating device, a safety device including means defining a vertical channel extending into the reactor from an aperture in the upper surface of the reactor, a rod containing neutron-absorbing materials slidably disposed within the channel, means for maintaining the safety rod in a withdrawn position relative to the active portion of the reactor including means for releasing said rod on actuation thereof, a hopper mounted above the active portion of the reactor having a door disposed at the bottom of the hopper opening into the vertical channel, a plurality of bodies of neutron-absorbing materials disposed within the hopper, and means responsive to the failure of the safety rod on actuation thereof to enter the active portion of the reactor for opening the door in the hopper.

Directory of aerospace safety specialized information sources, volume 2

NASA Technical Reports Server (NTRS)

Rubinstein, R. I.; Pinto, J. J.; Meschkow, S. Z.

1976-01-01

A handbook of organizations and experts in specific and well-defined areas of safety technology is presented. It is designed for the safety specialist as an aid for locating both information sources and individual points of contact (experts) in engineering related fields. The file covers sources of data in aerospace design, tests, and operations, as well as information on hazard and failure cause identification, accident analysis, and materials characteristics. Other related areas include the handling and transportation of hazardous chemicals, radioactive isotopes, and liquified natural gases.

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

DTIC Science & Technology

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES).

PubMed

Pieske, Burkert; Butler, Javed; Filippatos, Gerasimos; Lam, Carolyn; Maggioni, Aldo Pietro; Ponikowski, Piotr; Shah, Sanjiv; Solomon, Scott; Kraigher-Krainer, Elisabeth; Samano, Eliana Tibana; Scalise, Andrea Viviana; Müller, Katharina; Roessig, Lothar; Gheorghiade, Mihai

2014-09-01

The clinical outcomes for patients with worsening chronic heart failure (WCHF) remain exceedingly poor despite contemporary evidence-based therapies, and effective therapies are urgently needed. Accumulating evidence supports augmentation of cyclic guanosine monophosphate (cGMP) signalling as a potential therapeutic strategy for HF with reduced or preserved ejection fraction (HFrEF and HFpEF, respectively). Direct soluble guanylate cyclase (sGC) stimulators target reduced cGMP generation due to insufficient sGC stimulation and represent a promising method for cGMP enhancement. The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study (SOCRATES) programme consists of two randomized, parallel-group, placebo-controlled, double-blind, multicentre studies, SOCRATES-REDUCED (in patients with LVEF <45%) and SOCRATES-PRESERVED (in those with LVEF ≥ 45%), that will explore the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the once-daily oral sGC stimulator vericiguat (BAY 1021189) over 12 weeks compared with placebo. These studies will enrol patients stabilized during hospitalization for HF at the time of discharge or within 4 weeks thereafter. The primary endpoint in SOCRATES-REDUCED is change in NT-proBNP at 12 weeks. The primary endpoints in SOCRATES-PRESERVED are change in NT-proBNP and left atrial volume at 12 weeks. SOCRATES will be the first programme to enrol specifically both inpatients and outpatients with WCHF and patients with reduced or preserved ejection fraction. Results will inform the benefits of pursuing subsequent event-driven clinical outcome trials with sGC stimulators in this patient population. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

Identifying the latent failures underpinning medication administration errors: an exploratory study.

PubMed

Lawton, Rebecca; Carruthers, Sam; Gardner, Peter; Wright, John; McEachan, Rosie R C

2012-08-01

The primary aim of this article was to identify the latent failures that are perceived to underpin medication errors. The study was conducted within three medical wards in a hospital in the United Kingdom. The study employed a cross-sectional qualitative design. Interviews were conducted with 12 nurses and eight managers. Interviews were transcribed and subject to thematic content analysis. A two-step inter-rater comparison tested the reliability of the themes. Ten latent failures were identified based on the analysis of the interviews. These were ward climate, local working environment, workload, human resources, team communication, routine procedures, bed management, written policies and procedures, supervision and leadership, and training. The discussion focuses on ward climate, the most prevalent theme, which is conceptualized here as interacting with failures in the nine other organizational structures and processes. This study is the first of its kind to identify the latent failures perceived to underpin medication errors in a systematic way. The findings can be used as a platform for researchers to test the impact of organization-level patient safety interventions and to design proactive error management tools and incident reporting systems in hospitals. © Health Research and Educational Trust.

Lithium Battery Safety/Cell-to-Cell Failure Project FY14 Progress Report

DTIC Science & Technology

2015-03-06

Delacourt, “Thermal modeling of a cylindrical LiFePO4 /graphite lithium-ion battery.” J. Power Sources 195 (2010) 2961- 2968. 18. T. B. Bandhauer, S...Ren, J. Xie, H. He and F. Xu, “Failure study of commercial LiFePO4 cells in over-discharge conditions using electrochemical impedance spectroscopy...graphite/ LiFePO4 cell.” J. Power Sources 208 (2012) 296-305. 61. N. S. Spinner, C. T. Love, S. G. Tuttle, K. Swider-Lyons and S. L. Rose-Pehrsson

Dialysis Facility Safety: Processes and Opportunities.

PubMed

Garrick, Renee; Morey, Rishikesh

2015-01-01

Unintentional human errors are the source of most safety breaches in complex, high-risk environments. The environment of dialysis care is extremely complex. Dialysis patients have unique and changing physiology, and the processes required for their routine care involve numerous open-ended interfaces between providers and an assortment of technologically advanced equipment. Communication errors, both within the dialysis facility and during care transitions, and lapses in compliance with policies and procedures are frequent areas of safety risk. Some events, such as air emboli and needle dislodgments occur infrequently, but are serious risks. Other adverse events include medication errors, patient falls, catheter and access-related infections, access infiltrations and prolonged bleeding. A robust safety system should evaluate how multiple, sequential errors might align to cause harm. Systems of care can be improved by sharing the results of root cause analyses, and "good catches." Failure mode effects and analyses can be used to proactively identify and mitigate areas of highest risk, and methods drawn from cognitive psychology, simulation training, and human factor engineering can be used to advance facility safety. © 2015 Wiley Periodicals, Inc.

Failure analysis in the identification of synergies between cleaning monitoring methods.

PubMed

Whiteley, Greg S; Derry, Chris; Glasbey, Trevor

2015-02-01

The 4 monitoring methods used to manage the quality assurance of cleaning outcomes within health care settings are visual inspection, microbial recovery, fluorescent marker assessment, and rapid ATP bioluminometry. These methods each generate different types of information, presenting a challenge to the successful integration of monitoring results. A systematic approach to safety and quality control can be used to interrogate the known qualities of cleaning monitoring methods and provide a prospective management tool for infection control professionals. We investigated the use of failure mode and effects analysis (FMEA) for measuring failure risk arising through each cleaning monitoring method. FMEA uses existing data in a structured risk assessment tool that identifies weaknesses in products or processes. Our FMEA approach used the literature and a small experienced team to construct a series of analyses to investigate the cleaning monitoring methods in a way that minimized identified failure risks. FMEA applied to each of the cleaning monitoring methods revealed failure modes for each. The combined use of cleaning monitoring methods in sequence is preferable to their use in isolation. When these 4 cleaning monitoring methods are used in combination in a logical sequence, the failure modes noted for any 1 can be complemented by the strengths of the alternatives, thereby circumventing the risk of failure of any individual cleaning monitoring method. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Effects of national culture on human failures in container shipping: the moderating role of Confucian dynamism.

PubMed

Lu, Chin-Shan; Lai, Kee-hung; Lun, Y H Venus; Cheng, T C E

2012-11-01

Recent reports on work safety in container shipping operations highlight high frequencies of human failures. In this study, we empirically examine the effects of seafarers' perceptions of national culture on the occurrence of human failures affecting work safety in shipping operations. We develop a model adopting Hofstede's national culture construct, which comprises five dimensions, namely power distance, collectivism/individualism, uncertainty avoidance, masculinity/femininity, and Confucian dynamism. We then formulate research hypotheses from theory and test the hypotheses using survey data collected from 608 seafarers who work on global container carriers. Using a point scale for evaluating seafarers' perception of the five national culture dimensions, we find that Filipino seafarers score highest on collectivism, whereas Chinese and Taiwanese seafarers score highest on Confucian dynamism, followed by collectivism, masculinity, power distance, and uncertainty avoidance. The results also indicate that Taiwanese seafarers have a propensity for uncertainty avoidance and masculinity, whereas Filipino seafarers lean more towards power distance, masculinity, and collectivism, which are consistent with the findings of Hofstede and Bond (1988). The results suggest that there will be fewer human failures in container shipping operations when power distance is low, and collectivism and uncertainty avoidance are high. Specifically, this study finds that Confucian dynamism plays an important moderating role as it affects the strength of associations between some national culture dimensions and human failures. Finally, we discuss our findings' contribution to the development of national culture theory and their managerial implications for reducing the occurrence of human failures in shipping operations. Copyright © 2012 Elsevier Ltd. All rights reserved.

A Focus Group Exploration of Automated Case-Finders to Identify High-Risk Heart Failure Patients Within an Urban Safety Net Hospital.

PubMed

Patterson, Mark E; Miranda, Derick; Schuman, Greg; Eaton, Christopher; Smith, Andrew; Silver, Brad

2016-01-01

Leveraging "big data" as a means of informing cost-effective care holds potential in triaging high-risk heart failure (HF) patients for interventions within hospitals seeking to reduce 30-day readmissions. Explore provider's beliefs and perceptions about using an electronic health record (EHR)-based tool that uses unstructured clinical notes to risk-stratify high-risk heart failure patients. Six providers from an inpatient HF clinic within an urban safety net hospital were recruited to participate in a semistructured focus group. A facilitator led a discussion on the feasibility and value of using an EHR tool driven by unstructured clinical notes to help identify high-risk patients. Data collected from transcripts were analyzed using a thematic analysis that facilitated drawing conclusions clustered around categories and themes. From six categories emerged two themes: (1) challenges of finding valid and accurate results, and (2) strategies used to overcome these challenges. Although employing a tool that uses electronic medical record (EMR) unstructured text as the benchmark by which to identify high-risk patients is efficient, choosing appropriate benchmark groups could be challenging given the multiple causes of readmission. Strategies to mitigate these challenges include establishing clear selection criteria to guide benchmark group composition, and quality outcome goals for the hospital. Prior to implementing into practice an innovative EMR-based case-finder driven by unstructured clinical notes, providers are advised to do the following: (1) define patient quality outcome goals, (2) establish criteria by which to guide benchmark selection, and (3) verify the tool's validity and reliability. Achieving consensus on these issues would be necessary for this innovative EHR-based tool to effectively improve clinical decision-making and in turn, decrease readmissions for high-risk patients.

Cardiac AAV9-S100A1 gene therapy rescues postischemic heart failure in a preclinical large animal model

PubMed Central

Pleger, Sven T.; Shan, Changguang; Ksienzyk, Jan; Bekeredjian, Raffi; Boekstegers, Peter; Hinkel, Rabea; Schinkel, Stefanie; Leuchs, Barbara; Ludwig, Jochen; Qiu, Gang; Weber, Christophe; Kleinschmidt, Jürgen A.; Raake, Philip; Koch, Walter J.; Katus, Hugo A.; Müller, Oliver J.; Most, Patrick

2014-01-01

As a prerequisite to clinical application, we determined the long-term therapeutic effectiveness and safety of adeno-associated viral (AAV) S100A1 gene therapy in a preclinical, large animal model of heart failure. S100A1, a positive inotropic regulator of myocardial contractility, becomes depleted in failing cardiomyocytes in humans and various animal models, and myocardial-targeted S100A1 gene transfer rescues cardiac contractile function by restoring sarcoplasmic reticulum calcium Ca2+ handling in acutely and chronically failing hearts in small animal models. We induced heart failure in domestic pigs by balloon-occlusion of the left circumflex coronary artery, resulting in myocardial infarction. After 2 weeks, when the pigs displayed significant left ventricular contractile dysfunction, we administered through retrograde coronary venous delivery, AAV9-S100A1 to the left ventricular non-infarcted myocardium. AAV9-luciferase and saline treatment served as control. At 14 weeks, both control groups showed significantly decreased myocardial S100A1 protein expression along with progressive deterioration of cardiac performance and left ventricular remodeling. AAV9-S100A1 treatment prevented and reversed this phenotype by restoring cardiac S100A1 protein levels. S100A1 treatment normalized cardiomyocyte Ca2+ cycling, sarcoplasmic reticulum calcium handling and energy homeostasis. Transgene expression was restricted to cardiac tissue and extra-cardiac organ function was uncompromised indicating a favorable safety profile. This translational study shows the pre-clinical feasibility, long-term therapeutic effectiveness and a favorable safety profile of cardiac AAV9-S100A1 gene therapy in a preclinical model of heart failure. Our study presents a strong rational for a clinical trial of S100A1 gene therapy for human heart failure that could potentially complement current strategies to treat end-stage heart failure. PMID:21775667

Transtibial prosthesis suspension failure during skydiving freefall: a case report.

PubMed

Gordon, Assaf T; Land, Rebekah M

2009-01-01

This report describes the unusual case of an everyday-use prosthesis suspension system failure during the freefall phase of a skydiving jump. The case individual was a 53-year-old male with a left transtibial amputation secondary to trauma. He used his everyday prosthesis, a transtibial endoskeleton with push-button, plunger-releasing, pin-locking silicon liner suction suspension and a neoprene knee suspension sleeve, for a standard recreational tandem skydive. Within seconds of exiting the plane, the suspension systems failed, resulting in the complete prosthesis floating away. Several factors may have led to suspension system failure, including an inadequate seal and material design of the knee suspension sleeve and liner, lack of auxiliary suspension mechanisms, and lack of a safety cover overlying the push-button release mechanism. This is the first report, to our knowledge, to discuss prosthetic issues specifically related to skydiving. While amputees are to be encouraged to participate in this extreme sport, special modifications to everyday components may be necessary to reduce the possibility of prosthesis failure during freefall, parachute deployment, and landing.

A bioprosthetic total artificial heart for end-stage heart failure: Results from a pilot study.

PubMed

Latrémouille, Christian; Carpentier, Alain; Leprince, Pascal; Roussel, Jean-Christian; Cholley, Bernard; Boissier, Elodie; Epailly, Eric; Capel, Antoine; Jansen, Piet; Smadja, David M

2018-01-01

The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study. Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

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

PubMed

Niklas, K J

2000-04-01

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

Respiratory Failure

MedlinePlus

... of oxygen in the blood, it's called hypoxemic (HI-pok-SE-mik) respiratory failure. When respiratory failure ... carbon dioxide in the blood, it's called hypercapnic (HI-per-KAP-nik) respiratory failure. Causes Diseases and ...

Bone Marrow Failure Secondary to Cytokinesis Failure

DTIC Science & Technology

2015-12-01

SUPPLEMENTARY NOTES 14. ABSTRACT Fanconi anemia (FA) is a human genetic disease characterized by a progressive bone marrow failure and heightened...Fanconi anemia (FA) is the most commonly inherited bone marrow failure syndrome. FA patients develop bone marrow failure during the first decade of...experiments proposed in specific aims 1- 3 (Tasks 1-3). Task 1: To determine whether HSCs from Fanconi anemia mouse models have increased cytokinesis

Reliability enhancement of APR + diverse protection system regarding common cause failures

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

Oh, Y. G.; Kim, Y. M.; Yim, H. S.

2012-07-01

The Advanced Power Reactor Plus (APR +) nuclear power plant design has been developed on the basis of the APR1400 (Advanced Power Reactor 1400 MWe) to further enhance safety and economics. For the mitigation of Anticipated Transients Without Scram (ATWS) as well as Common Cause Failures (CCF) within the Plant Protection System (PPS) and the Emergency Safety Feature - Component Control System (ESF-CCS), several design improvement features have been implemented for the Diverse Protection System (DPS) of the APR + plant. As compared to the APR1400 DPS design, the APR + DPS has been designed to provide the Safety Injectionmore » Actuation Signal (SIAS) considering a large break LOCA accident concurrent with the CCF. Additionally several design improvement features, such as channel structure with redundant processing modules, and changes of system communication methods and auto-system test methods, are introduced to enhance the functional reliability of the DPS. Therefore, it is expected that the APR + DPS can provide an enhanced safety and reliability regarding possible CCF in the safety-grade I and C systems as well as the DPS itself. (authors)« less

Automating Nuclear-Safety-Related SQA Procedures with Custom Applications

DOE PAGES

Freels, James D.

2016-01-01

Nuclear safety-related procedures are rigorous for good reason. Small design mistakes can quickly turn into unwanted failures. Researchers at Oak Ridge National Laboratory worked with COMSOL to define a simulation app that automates the software quality assurance (SQA) verification process and provides results in less than 24 hours.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

PubMed

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

Findings From the National Machine Guarding Program-A Small Business Intervention: Machine Safety.

PubMed

Parker, David L; Yamin, Samuel C; Xi, Min; Brosseau, Lisa M; Gordon, Robert; Most, Ivan G; Stanley, Rodney

2016-09-01

The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 to 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of Occupational Safety and Health Administration (OSHA) citations and may result in serious traumatic injury. Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10% point increase in business-level machine scores (P < 0.0001) and a 33% point increase in LOTO program scores (P < 0.0001). Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees.

Safety assessment in the urban park environment in Alborz Province, Iran.

PubMed

Oostakhan, Morteza; Babaei, Aliakbar

2013-01-01