Applying usability heuristics to radiotherapy systems.

PubMed

Chan, Alvita J; Islam, Mohammad K; Rosewall, Tara; Jaffray, David A; Easty, Anthony C; Cafazzo, Joseph A

2012-01-01

Heuristic evaluations have been used to evaluate safety of medical devices by identifying and assessing usability issues. Since radiotherapy treatment delivery systems often consist of multiple complex user-interfaces, a heuristic evaluation was conducted to assess the potential safety issues of such a system. A heuristic evaluation was conducted to evaluate the treatment delivery system at Princess Margaret Hospital (Toronto, Canada). Two independent evaluators identified usability issues with the user-interfaces and rated the severity of each issue. The evaluators identified 75 usability issues in total. Eighteen of them were rated as high severity, indicating the potential to have a major impact on patient safety. A majority of issues were found on the record and verify system, and many were associated with the patient setup process. While the hospital has processes in place to ensure patient safety, recommendations were developed to further mitigate the risks of potential consequences. Heuristic evaluation is an efficient and inexpensive method that can be successfully applied to radiotherapy delivery systems to identify usability issues and improve patient safety. Although this study was conducted only at one site, the findings may have broad implications for the design of these systems. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Safety-related requirements for photovoltaic modules and arrays. Final report

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

Levins, A.

1984-03-01

Underwriters Laboratories has conducted a study to identify and develop safety requirements for photovoltaic module and panel designs and configurations for residential, intermediate, and large scale applications. Concepts for safety systems, where each system is a collection of subsystems which together address the total anticipated hazard situation, are described. Descriptions of hardware, and system usefulness and viability are included. This discussion of safety systems recognizes that there is little history on which to base the expected safety related performance of a photovoltaic system. A comparison of these systems, as against the provisions of the 1984 National Electrical Code covering photovoltaicmore » systems is made. A discussion of the UL investigation of the photovoltaic module evaluated to the provisions of the Proposed UL Standard for Flat-Plate Photovoltaic Modules and Panels is included. Grounding systems, their basis and nature, and the advantages and disadvantages of each are described. The meaning of frame grounding, circuit grounding, and the type of circuit ground are covered. The development of the Standard for Flat-Plate Photovoltaic Modules and Panels has continued, and with both industry comment and a product submittal and listing, the Standard has been refined to a viable document allowing an objective safety review of photovoltaic modules and panels. How this document, and other UL documents would cover investigations of certain other photovoltaic system components is described.« less

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, improved operational availability, and optimized maintenance and logistic support infrastructure. This paper discusses the role of R&M in a program acquisition phase and the potential impact of R&M on safety, mission success, operational availability, and affordability. This includes discussion of the R&M elements that need to be addressed and the R&M analyses that need to be performed in order to support a safe and affordable system design. The paper also provides some lessons learned from the Space Shuttle program on the impact of R&M on safety and affordability.

Reliability/safety analysis of a fly-by-wire system

NASA Technical Reports Server (NTRS)

Brock, L. D.; Goddman, H. A.

1980-01-01

An analysis technique has been developed to estimate the reliability of a very complex, safety-critical system by constructing a diagram of the reliability equations for the total system. This diagram has many of the characteristics of a fault-tree or success-path diagram, but is much easier to construct for complex redundant systems. The diagram provides insight into system failure characteristics and identifies the most likely failure modes. A computer program aids in the construction of the diagram and the computation of reliability. Analysis of the NASA F-8 Digital Fly-by-Wire Flight Control System is used to illustrate the technique.

Facilitated Nurse Medication-Related Event Reporting to Improve Medication Management Quality and Safety in Intensive Care Units.

PubMed

Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B

Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.

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...

Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

PubMed

Bergman, Lina M; Pettersson, Monica E; Chaboyer, Wendy P; Carlström, Eric D; Ringdal, Mona L

2017-10-01

To identify, classify, and describe safety hazards during the process of intrahospital transport of critically ill patients. A prospective observational study. Data from participant observations of the intrahospital transport process were collected over a period of 3 months. The study was undertaken at two ICUs in one university hospital. Critically ill patients transported within the hospital by critical care nurses, unlicensed nurses, and physicians. None. Content analysis was performed using deductive and inductive approaches. We detected a total of 365 safety hazards (median, 7; interquartile range, 4-10) during 51 intrahospital transports of critically ill patients, 80% of whom were mechanically ventilated. The majority of detected safety hazards were assessed as increasing the risk of harm, compromising patient safety (n = 204). Using the System Engineering Initiative for Patient Safety, we identified safety hazards related to the work system, as follows: team (n = 61), tasks (n = 83), tools and technologies (n = 124), environment (n = 48), and organization (n = 49). Inductive analysis provided an in-depth description of those safety hazards, contributing factors, and process-related outcomes. Findings suggest that intrahospital transport is a hazardous process for critically ill patients. We have identified several factors that may contribute to transport-related adverse events, which will provide the opportunity for the redesign of systems to enhance patient safety.

A review of models relevant to road safety.

PubMed

Hughes, B P; Newstead, S; Anund, A; Shu, C C; Falkmer, T

2015-01-01

It is estimated that more than 1.2 million people die worldwide as a result of road traffic crashes and some 50 million are injured per annum. At present some Western countries' road safety strategies and countermeasures claim to have developed into 'Safe Systems' models to address the effects of road related crashes. Well-constructed models encourage effective strategies to improve road safety. This review aimed to identify and summarise concise descriptions, or 'models' of safety. The review covers information from a wide variety of fields and contexts including transport, occupational safety, food industry, education, construction and health. The information from 2620 candidate references were selected and summarised in 121 examples of different types of model and contents. The language of safety models and systems was found to be inconsistent. Each model provided additional information regarding style, purpose, complexity and diversity. In total, seven types of models were identified. The categorisation of models was done on a high level with a variation of details in each group and without a complete, simple and rational description. The models identified in this review are likely to be adaptable to road safety and some of them have previously been used. None of systems theory, safety management systems, the risk management approach, or safety culture was commonly or thoroughly applied to road safety. It is concluded that these approaches have the potential to reduce road trauma. Copyright © 2014 Elsevier Ltd. All rights reserved.

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

Aderhold, J. R.; Gordon, G.; Scott, G. W.

1976-01-01

The economic, technical, and environmental implications of remotely piloted vehicles (RVP) are examined. The time frame is 1980-85. Representative uses are selected; detailed functional and performance requirements are derived for RPV systems; and conceptual system designs are devised. Total system cost comparisons are made with non-RPV alternatives. The potential market demand for RPV systems is estimated. Environmental and safety requirements are examined, and legal and regulatory concerns are identified. A potential demand for 2,000-11,000 RVP systems is estimated. Typical cost savings of 25 to 35% compared to non-RPV alternatives are determined. There appear to be no environmental problems, and the safety issue appears manageable.

Adherence to recommended electronic health record safety practices across eight health care organizations.

PubMed

Sittig, Dean F; Salimi, Mandana; Aiyagari, Ranjit; Banas, Colin; Clay, Brian; Gibson, Kathryn A; Goel, Ashutosh; Hines, Robert; Longhurst, Christopher A; Mishra, Vimal; Sirajuddin, Anwar M; Satterly, Tyler; Singh, Hardeep

2018-04-26

The Safety Assurance Factors for EHR Resilience (SAFER) guides were released in 2014 to help health systems conduct proactive risk assessment of electronic health record (EHR)- safety related policies, processes, procedures, and configurations. The extent to which SAFER recommendations are followed is unknown. We conducted risk assessments of 8 organizations of varying size, complexity, EHR, and EHR adoption maturity. Each organization self-assessed adherence to all 140 unique SAFER recommendations contained within 9 guides (range 10-29 recommendations per guide). In each guide, recommendations were organized into 3 broad domains: "safe health IT" (total 45 recommendations); "using health IT safely" (total 80 recommendations); and "monitoring health IT" (total 15 recommendations). The 8 sites fully implemented 25 of 140 (18%) SAFER recommendations. Mean number of "fully implemented" recommendations per guide ranged from 94% (System Interfaces-18 recommendations) to 63% (Clinical Communication-12 recommendations). Adherence was higher for "safe health IT" domain (82.1%) vs "using health IT safely" (72.5%) and "monitoring health IT" (67.3%). Despite availability of recommendations on how to improve use of EHRs, most recommendations were not fully implemented. New national policy initiatives are needed to stimulate implementation of these best practices.

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

Food safety systems in a small dairy factory: implementation, major challenges, and assessment of systems' performances.

PubMed

Cusato, Sueli; Gameiro, Augusto H; Corassin, Carlos H; Sant'ana, Anderson S; Cruz, Adriano G; Faria, José de Assis F; de Oliveira, Carlos Augusto F

2013-01-01

The present study describes the implementation of a food safety system in a dairy processing plant located in the State of São Paulo, Brazil, and the challenges found during the process. In addition, microbiological indicators have been used to assess system's implementation performance. The steps involved in the implementation of a food safety system included a diagnosis of the prerequisites, implementation of the good manufacturing practices (GMPs), sanitation standard operating procedures (SSOPs), training of the food handlers, and hazard analysis and critical control point (HACCP). In the initial diagnosis, conformity with 70.7% (n=106) of the items analyzed was observed. A total of 12 critical control points (CCPs) were identified: (1) reception of the raw milk, (2) storage of the raw milk, (3 and 4) reception of the ingredients and packaging, (5) milk pasteurization, (6 and 7) fermentation and cooling, (8) addition of ingredients, (9) filling, (10) storage of the finished product, (11) dispatching of the product, and (12) sanitization of the equipment. After implementation of the food safety system, a significant reduction in the yeast and mold count was observed (p<0.05). The main difficulties encountered for the implementation of food safety system were related to the implementation of actions established in the flow chart and to the need for constant training/adherence of the workers to the system. Despite this, the implementation of the food safety system was shown to be challenging, but feasible to be reached by small-scale food industries.

Minutes of the Explosives Safety Seminar (20th) Held at OMNI international Hotel, Norfolk, Virginia on 24-26 August 1982. Volume I

DTIC Science & Technology

1982-08-01

between one that provides for total protection of life and property and one that per- mits operators to conduct activities in a " laisse - faire " manner...Workers. AD-PO00 456 General Risk Analysis Methodological Implications to Explosives Risk Management Systems. AD-PO0O 457 Risk Analysis for Explosives...THE EFFECTS OF THE HEALTH AND SAFETY AT WORK ACT, 1974, ON MILITARY EXPLOSIVES SAFETY MANAGEMENT IN THE UNITED KINGDOM ........................ 7 Air

Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

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

Pugliese, S.M.

1977-02-01

In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

NASA Glenn 1-by 1-Foot Supersonic Wind Tunnel User Manual

NASA Technical Reports Server (NTRS)

Seablom, Kirk D.; Soeder, Ronald H.; Stark, David E.; Leone, John F. X.; Henry, Michael W.

1999-01-01

This manual describes the NASA Glenn Research Center's 1 - by 1 -Foot Supersonic Wind Tunnel and provides information for customers who wish to conduct experiments in this facility. Tunnel performance envelopes of total pressure, total temperature, and dynamic pressure as a function of test section Mach number are presented. For each Mach number, maps are presented of Reynolds number per foot as a function of the total air temperature at the test section inlet for constant total air pressure at the inlet. General support systems-such as the service air, combustion air, altitude exhaust system, auxiliary bleed system, model hydraulic system, schlieren system, model pressure-sensitive paint, and laser sheet system are discussed. In addition, instrumentation and data processing, acquisition systems are described, pretest meeting formats and schedules are outlined, and customer responsibilities and personnel safety are addressed.

LOGIC CIRCUIT

DOEpatents

Strong, G.H.; Faught, M.L.

1963-12-24

A device for safety rod counting in a nuclear reactor is described. A Wheatstone bridge circuit is adapted to prevent de-energizing the hopper coils of a ball backup system if safety rods, sufficient in total control effect, properly enter the reactor core to effect shut down. A plurality of resistances form one arm of the bridge, each resistance being associated with a particular safety rod and weighted in value according to the control effect of the particular safety rod. Switching means are used to switch each of the resistances in and out of the bridge circuit responsive to the presence of a particular safety rod in its effective position in the reactor core and responsive to the attainment of a predetermined velocity by a particular safety rod enroute to its effective position. The bridge is unbalanced in one direction during normal reactor operation prior to the generation of a scram signal and the switching means and resistances are adapted to unbalance the bridge in the opposite direction if the safety rods produce a predetermined amount of control effect in response to the scram signal. The bridge unbalance reversal is then utilized to prevent the actuation of the ball backup system, or, conversely, a failure of the safety rods to produce the predetermined effect produces no unbalance reversal and the ball backup system is actuated. (AEC)

Verification and Validation for Flight-Critical Systems (VVFCS)

NASA Technical Reports Server (NTRS)

Graves, Sharon S.; Jacobsen, Robert A.

2010-01-01

On March 31, 2009 a Request for Information (RFI) was issued by NASA s Aviation Safety Program to gather input on the subject of Verification and Validation (V & V) of Flight-Critical Systems. The responses were provided to NASA on or before April 24, 2009. The RFI asked for comments in three topic areas: Modeling and Validation of New Concepts for Vehicles and Operations; Verification of Complex Integrated and Distributed Systems; and Software Safety Assurance. There were a total of 34 responses to the RFI, representing a cross-section of academic (26%), small & large industry (47%) and government agency (27%).

Quality management in health care: a 20-year journey.

PubMed

Ruiz, Ulises

2004-01-01

In this article, the total quality programme in the Spanish healthcare system (1986-1992) and the subsequent quality improvement steps that have led to definition and implementation of such an integrated framework, seeking a quality management system and patient safety, are discussed.

Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

PubMed

Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

2006-11-01

Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P < .001) when compared to before implementation of the 3 patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

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.

Are automatic systems the future of motorcycle safety? A novel methodology to prioritize potential safety solutions based on their projected effectiveness.

PubMed

Gil, Gustavo; Savino, Giovanni; Piantini, Simone; Baldanzini, Niccolò; Happee, Riender; Pierini, Marco

2017-11-17

Motorcycle riders are involved in significantly more crashes per kilometer driven than passenger car drivers. Nonetheless, the development and implementation of motorcycle safety systems lags far behind that of passenger cars. This research addresses the identification of the most effective motorcycle safety solutions in the context of different countries. A knowledge-based system of motorcycle safety (KBMS) was developed to assess the potential for various safety solutions to mitigate or avoid motorcycle crashes. First, a set of 26 common crash scenarios was identified from the analysis of multiple crash databases. Second, the relative effectiveness of 10 safety solutions was assessed for the 26 crash scenarios by a panel of experts. Third, relevant information about crashes was used to weigh the importance of each crash scenario in the region studied. The KBMS method was applied with an Italian database, with a total of more than 1 million motorcycle crashes in the period 2000-2012. When applied to the Italian context, the KBMS suggested that automatic systems designed to compensate for riders' or drivers' errors of commission or omission are the potentially most effective safety solution. The KBMS method showed an effective way to compare the potential of various safety solutions, through a scored list with the expected effectiveness of each safety solution for the region to which the crash data belong. A comparison of our results with a previous study that attempted a systematic prioritization of safety systems for motorcycles (PISa project) showed an encouraging agreement. Current results revealed that automatic systems have the greatest potential to improve motorcycle safety. Accumulating and encoding expertise in crash analysis from a range of disciplines into a scalable and reusable analytical tool, as proposed with the use of KBMS, has the potential to guide research and development of effective safety systems. As the expert assessment of the crash scenarios is decoupled from the regional crash database, the expert assessment may be reutilized, thereby allowing rapid reanalysis when new crash data become available. In addition, the KBMS methodology has potential application to injury forecasting, driver/rider training strategies, and redesign of existing road infrastructure.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

A hierarchical factor analysis of a safety culture survey.

PubMed

Frazier, Christopher B; Ludwig, Timothy D; Whitaker, Brian; Roberts, D Steve

2013-06-01

Recent reviews of safety culture measures have revealed a host of potential factors that could make up a safety culture (Flin, Mearns, O'Connor, & Bryden, 2000; Guldenmund, 2000). However, there is still little consensus regarding what the core factors of safety culture are. The purpose of the current research was to determine the core factors, as well as the structure of those factors that make up a safety culture, and establish which factors add meaningful value by factor analyzing a widely used safety culture survey. A 92-item survey was constructed by subject matter experts and was administered to 25,574 workers across five multi-national organizations in five different industries. Exploratory and hierarchical confirmatory factor analyses were conducted revealing four second-order factors of a Safety Culture consisting of Management Concern, Personal Responsibility for Safety, Peer Support for Safety, and Safety Management Systems. Additionally, a total of 12 first-order factors were found: three on Management Concern, three on Personal Responsibility, two on Peer Support, and four on Safety Management Systems. The resulting safety culture model addresses gaps in the literature by indentifying the core constructs which make up a safety culture. This clarification of the major factors emerging in the measurement of safety cultures should impact the industry through a more accurate description, measurement, and tracking of safety cultures to reduce loss due to injury. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Restraint system usage in the traffic population. 1987 annual report

DOT National Transportation Integrated Search

1988-08-01

This study continued to monitor the use of occupant restraint systems and motorcycle/moped helmet usage in 19 U.S. cities during 1987. A total of 272,857 observations of automobile drivers indicated an overall driver safety belt usage rate of 42.3 pe...

Restraint system use in 19 U.S. cities 1989 annual report.

DOT National Transportation Integrated Search

1990-06-01

This study continued to monitor the use of occupant restraint systems and motorcycle/moped helmet use in 19 U.S. cities during 1989. A total of 69,232 observations of automobile drivers indicated an overall driver safety belt use rate of 46.3 percent...

Restraint system use in 19 U.S. cities. 1991 annual report

DOT National Transportation Integrated Search

1992-03-01

This study continued to monitor the use of occupant restraint systems and motorcycle/moped helmet use in 19 U.S. cities during 1991. A total of 256,907 observations of automobile drivers indicated an overall driver safety belt use rate of 51.1%. The ...

A risk-based decision support framework for selection of appropriate safety measure system for underground coal mines.

PubMed

Samantra, Chitrasen; Datta, Saurav; Mahapatra, Siba Sankar

2017-03-01

In the context of underground coal mining industry, the increased economic issues regarding implementation of additional safety measure systems, along with growing public awareness to ensure high level of workers safety, have put great pressure on the managers towards finding the best solution to ensure safe as well as economically viable alternative selection. Risk-based decision support system plays an important role in finding such solutions amongst candidate alternatives with respect to multiple decision criteria. Therefore, in this paper, a unified risk-based decision-making methodology has been proposed for selecting an appropriate safety measure system in relation to an underground coal mining industry with respect to multiple risk criteria such as financial risk, operating risk, and maintenance risk. The proposed methodology uses interval-valued fuzzy set theory for modelling vagueness and subjectivity in the estimates of fuzzy risk ratings for making appropriate decision. The methodology is based on the aggregative fuzzy risk analysis and multi-criteria decision making. The selection decisions are made within the context of understanding the total integrated risk that is likely to incur while adapting the particular safety system alternative. Effectiveness of the proposed methodology has been validated through a real-time case study. The result in the context of final priority ranking is seemed fairly consistent.

Towards a framework of human factors certification of complex human-machine systems

NASA Technical Reports Server (NTRS)

Bukasa, Birgit

1994-01-01

As far as total automation is not realized, the combination of technical and social components in man-machine systems demands not only contributions from engineers but at least to an equal extent from behavioral scientists. This has been neglected far too long. The psychological, social and cultural aspects of technological innovations were almost totally overlooked. Yet, along with expected safety improvements the institutionalization of human factors is on the way. The introduction of human factors certification of complex man-machine systems will be a milestone in this process.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

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

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 3: Nuclear Safety Analysis Document (NSAD)

NASA Technical Reports Server (NTRS)

1972-01-01

Nuclear safety analysis as applied to a space base mission is presented. The nuclear safety analysis document summarizes the mission and the credible accidents/events which may lead to nuclear hazards to the general public. The radiological effects and associated consequences of the hazards are discussed in detail. The probability of occurrence is combined with the potential number of individuals exposed to or above guideline values to provide a measure of accident and total mission risk. The overall mission risk has been determined to be low with the potential exposure to or above 25 rem limited to less than 4 individuals per every 1000 missions performed. No radiological risk to the general public occurs during the prelaunch phase at KSC. The most significant risks occur from prolonged exposure to reactor debris following land impact generally associated with the disposal phase of the mission where fission product inventories can be high.

Direct manipulation of tool-like masters for controlling a master-slave surgical robotic system.

PubMed

Zhang, Linan; Zhou, Ningxin; Wang, Shuxin

2014-12-01

Robotic-assisted minimally invasive surgery (MIS) can benefit both patients and surgeons. However, the learning curve for robotically assisted procedures can be long and the total system costs are high. Therefore, there is considerable interest in new methods and lower cost controllers for a surgical robotic system. In this study, a knife-master and a forceps-master, shaped similarly to a surgical knife and forceps, were developed as input devices for control of a master-slave surgical robotic system. In addition, a safety strategy was developed to eliminate the master-slave orientation difference and stabilize the surgical system. Master-slave tracking experiments and a ring-and-bar experiment showed that the safety tracking strategy could ensure that the robot system moved stably without any tremor in the tracking motion. Subjects could manipulate the surgical tool to achieve the master-slave operation with less training compared to a mechanical master. Direct manipulation of the small, light and low-cost surgical tools to control a robotic system is a possible operating mode. Surgeons can operate the robotic system in their own familiar way, without long training. The main potential safety issues can be solved by the proposed safety control strategy. Copyright © 2013 John Wiley & Sons, Ltd.

14 CFR 23.1585 - Operating procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... each operating condition in which the fuel system independence prescribed in § 23.953 is necessary for safety must be furnished, together with instructions for placing the fuel system in a configuration used... furnished. (i) Information on the total quantity of usable fuel for each fuel tank, and the effect on the...

[Quality management and safety culture in medicine: context and concepts].

PubMed

Wischet, Werner; Eitzinger, Claudia

2009-01-01

The publication of the IOM report "To err is human: building a safer health system" in 1999 put spotlight on the primacy of the principle of primum non nocere and made patient safety a central topic of quality management. A key conclusion of the report was the need for a well-developed safety culture. While concepts of quality management have evolved along the lines of ISO and Total Quality Management over the last decades patient safety still has not got the same amount of attention (PubMed). Evidence from other safety-critical areas but also from the field of medicine itself suggests that an efficient culture of safety is a conditio sine qua non for the sustainable improvement of patient safety. Considering these arguments the present paper aims at emphasizing the importance of an efficient culture of safety for patient safety and quality management in healthcare. In addition, key instruments of safety culture as well as their limitations will be presented.

Developing and Evaluating an Automated All-Cause Harm Trigger System.

PubMed

Sammer, Christine; Miller, Susanne; Jones, Cason; Nelson, Antoinette; Garrett, Paul; Classen, David; Stockwell, David

2017-04-01

From 2009 through 2012, the Adventist Health System Patient Safety Organization (AHS PSO) used the Global Trigger Tool method for harm identification and demonstrated harm reduction. Although the awareness of harm demonstrated opportunities for improvement across the system, leaders determined that the human and fiscal resources required to continue with a retrospective manual harm identification process were unsustainable. In addition, there was growing concern that the identification of harm after the patient's discharge did not allow for intervention during the hospital stay. Therefore, the AHS PSO decided to seek an alternative method for patient harm identification. The AHS PSO and another PSO jointly developed a novel automated all-cause harm trigger identification system that allowed for real-time bedside intervention, real-time trend analysis affecting patient safety, and continued learning about harm measurement. A sociotechnical approach of people, process, and technology was used at two pilot hospitals sharing the same electronic health record platform. Automated positive harm triggers and work-flow models were developed and evaluated. Combined data from the two hospitals in a period of 11 consecutive months indicated (1) a total of 2,696 harms (combined hospital-acquired and outside-acquired); (2) that hypoglycemia (blood glucose ≤ 40 mg/dL) was the most frequently identified harm; (3) 256 harms related to the Patient Safety Indicator 90 (PSI 90) Composite descriptions versus 77 harms reported to regulatory harm reduction programs; and (4) that almost one third (32%) of total harms were classified as outside-acquired. The automated harm trigger system revealed not only more harm but a broader scope of harm and led to a deeper understanding of patient safety vulnerabilities. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of the system to be built. Shortly thereafter, as the system requirements are being defined, the second iteration of hazard analyses takes place, the systems hazard analysis (SHA). During the systems requirements phase, decisions are made as to what functions of the system will be the responsibility of software. This is the most critical time to affect the safety of the software. From this point, software safety analyses as well as software engineering practices are the main focus for assuring safe software. While many of the steps proposed in this paper seem like just sound engineering practices, they are the best technical and most cost effective means to assure safe software within a safe system.

Security Systems Consideration: A Total Security Approach

NASA Astrophysics Data System (ADS)

Margariti, S. V.; Meletiou, G.; Stergiou, E.; Vasiliadis, D. C.; Rizos, G. E.

2007-12-01

The "safety" problem for protection systems is to determine in a given situation whether a subject can acquire a particular right to an object. Security and audit operation face the process of securing the application on computing and network environment; however, storage security has been somewhat overlooked due to other security solutions. This paper identifies issues for data security, threats and attacks, summarizes security concepts and relationships, and also describes storage security strategies. It concludes with recommended storage security plan for a total security solution.

The impact of safety organizing, trusted leadership, and care pathways on reported medication errors in hospital nursing units.

PubMed

Vogus, Timothy J; Sutcliffe, Kathleen M

2011-01-01

Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.

The occupational safety of health professionals working at community and family health centers.

PubMed

Ozturk, Havva; Babacan, Elif

2014-10-01

Healthcare professionals encounter many medical risks while providing healthcare services to individuals and the community. Thus, occupational safety studies are very important in health care organizations. They involve studies performed to establish legal, technical, and medical measures that must be taken to prevent employees from sustaining physical or mental damage because of work hazards. This study was conducted to determine if the occupational safety of health personnel at community and family health centers (CHC and FHC) has been achieved. The population of this cross-sectional study comprised 507 nurses, 199 physicians, and 237 other medical personnel working at a total of 18 family health centers (FHC) and community health centers (CHC) in Trabzon, Turkey. The sample consisted of a total of 418 nurses, 156 physicians, and 123 other medical personnel. Sampling method was not used, and the researchers tried to reach the whole population. Data were gathered with the Occupational Safety Scale (OSS) and a questionnaire regarding demographic characteristics and occupational safety. According to the evaluations of all the medical personnel, the mean ± SD of total score of the OSS was 3.57 ± 0.98; of the OSS's subscales, the mean ± SD of the health screening and registry systems was 2.76 ± 1.44, of occupational diseases and problems was 3.04 ± 1.3 and critical fields control was 3.12 ± 1.62. In addition, occupational safety was found more insufficient by nurses (F = 14.18; P < 0.001). All healthcare personnel, particularly nurses working in CHCs and FHCs found occupational safety to be insufficient as related to protective and supportive activities.

[Analysis of the patient safety culture in hospitals of the Spanish National Health System].

PubMed

Saturno, P J; Da Silva Gama, Z A; de Oliveira-Sousa, S L; Fonseca, Y A; de Souza-Oliveira, A C; Castillo, Carmen; López, M José; Ramón, Teresa; Carrillo, Andrés; Iranzo, M Dolores; Soria, Victor; Saturno, Pedro J; Parra, Pedro; Gomis, Rafael; Gascón, Juan José; Martinez, José; Arellano, Carmen; Gama, Zenewton A Da Silva; de Oliveira-Sousa, Silvana L; de Souza-Oliveira, Adriana C; Fonseca, Yadira A; Ferreira, Marta Sobral

2008-12-01

A safety culture is essential to minimize errors and adverse events. Its measurement is needed to design activities in order to improve it. This paper describes the methods and main results of a study on safety climate in a nation-wide representative sample of public hospitals of the Spanish NHS. The Hospital Survey on Patient Safety Culture questionnaire was distributed to a random sample of health professionals in a representative sample of 24 hospitals, proportionally stratified by hospital size. Results are analyzed to provide a description of safety climate, its strengths and weaknesses. Differences by hospital size, type of health professional and service are analyzed using ANOVA. A total of 2503 responses are analyzed (response rate: 40%, (93% from professionals with direct patient contact). A total of 50% gave patient safety a score from 6 to 8 (on a 10-point scale); 95% reported < 2 events last year. Dimensions "Teamwork within hospital units" (71.8 [1.8]) and "Supervisor/Manager expectations and actions promoting safety" (61.8 [1.7]) have the highest percentage of positive answers. "Staffing", "Teamwork across hospital units", "Overall perceptions of safety" and "Hospital management support for patient safety" could be identified as weaknesses. Significant differences by hospital size, type of professional and service suggest a generally more positive attitude in small hospitals and Pharmacy services, and a more negative one in physicians. Strengths and weaknesses of the safety climate in the hospitals of the Spanish NHS have been identified and they are used to design appropriate strategies for improvement.

Military Housing Inspection-Camp Buehring, Kuwait

DTIC Science & Technology

2016-09-30

General DPW Director Public Works FAS Fire Alarm System HVAC Heating, Ventilation, and Air Conditioning IAW In Accordance With ITM Inspection...safety policies and standards regarding electrical and fire protection systems . Findings We found significant deficiencies in electrical and fire...protection systems during the physical inspections of the U.S. military-occupied facilities at Camp Buehring. We identified a total of 538

[Topics from "Overseas Drug Safety Information" in the past five years].

PubMed

Amanuma, Kimiko

2013-01-01

The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

Microbiological performance of a food safety management system in a food service operation.

PubMed

Lahou, E; Jacxsens, L; Daelman, J; Van Landeghem, F; Uyttendaele, M

2012-04-01

The microbiological performance of a food safety management system in a food service operation was measured using a microbiological assessment scheme as a vertical sampling plan throughout the production process, from raw materials to final product. The assessment scheme can give insight into the microbiological contamination and the variability of a production process and pinpoint bottlenecks in the food safety management system. Three production processes were evaluated: a high-risk sandwich production process (involving raw meat preparation), a medium-risk hot meal production process (starting from undercooked raw materials), and a low-risk hot meal production process (reheating in a bag). Microbial quality parameters, hygiene indicators, and relevant pathogens (Listeria monocytogenes, Salmonella, Bacillus cereus, and Escherichia coli O157) were in accordance with legal criteria and/or microbiological guidelines, suggesting that the food safety management system was effective. High levels of total aerobic bacteria (>3.9 log CFU/50 cm(2)) were noted occasionally on gloves of food handlers and on food contact surfaces, especially in high contamination areas (e.g., during handling of raw material, preparation room). Core control activities such as hand hygiene of personnel and cleaning and disinfection (especially in highly contaminated areas) were considered points of attention. The present sampling plan was used to produce an overall microbiological profile (snapshot) to validate the food safety management system in place.

Laboratory safety and the WHO World Alliance for Patient Safety.

PubMed

McCay, Layla; Lemer, Claire; Wu, Albert W

2009-06-01

Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.

Implementation of a Surgical Safety Checklist: Impact on Surgical Team Perspectives

PubMed Central

Papaconstantinou, Harry T.; Jo, ChanHee; Reznik, Scott I.; Smythe, W. Roy; Wehbe-Janek, Hania

2013-01-01

Background The World Health Organization (WHO) surgical safety checklist has been shown to decrease mortality and complications and has been adopted worldwide. However, system flaws and human errors persist. Identifying provider perspectives of patient safety initiatives may identify strategies for improvement. The purpose of this study was to determine provider perspectives of surgical safety checklist implementation in an effort to improve initiatives that enhance surgical patients' safety. Methods In September 2010, a WHO-adapted surgical safety checklist was implemented at our institution. Surgical teams were invited to complete a checklist-focused questionnaire 1 month before and 1 year after implementation. Baseline and follow-up results were compared. Results A total of 437 surgical care providers responded to the survey: 45% of providers responded at baseline and 64% of providers responded at follow-up. Of the total respondents, 153 (35%) were nurses, 104 (24%) were anesthesia providers, and 180 (41%) were surgeons. Overall, we found an improvement in the awareness of patient safety and quality of care, with significant improvements in the perception of the value of and participation in the time-out process, in surgical team communication, and in the establishment and clarity of patient care needs. Some discordance was noted between surgeons and other surgical team members, indicating that barriers in communication still exist. Overall, approximately 65% of respondents perceived that the checklist improved patient safety and patient care; however, we found a strong negative perception of operating room efficiency. Conclusion Implementation of a surgical safety checklist improves perceptions of surgical safety. Barriers to implementation exist, but staff feedback may be used to enhance the sustainability and success of patient safety initiatives. PMID:24052757

BSE situation and establishment of Food Safety Commission in Japan

PubMed Central

Kim, Chi-Kyeong

2006-01-01

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

Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

PubMed

Makam, Raghavendra Charan P; Hoaglin, David C; McManus, David D; Wang, Victoria; Gore, Joel M; Spencer, Frederick A; Pradhan, Richeek; Tran, Hoang; Yu, Hong; Goldberg, Robert J

2018-01-01

Direct oral anticoagulants (DOACs) have emerged as promising alternatives to vitamin K antagonists (VKAs) for patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs. We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE. Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR) 0.76, 95% Confidence Interval (CI) (0.68-0.84)], any stroke (0.80, 0.73-0.88), systemic embolism (0.56, 0.34-0.93), and total mortality (0.89, 0.84-0.95). Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB). Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03), recurrent DVT (0.83, 0.66-1.05), recurrent non-fatal PE (0.97, 0.75-1.25), and total mortality (0.94, 0.79-1.12). Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB. Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

[Development and validation of the Korean patient safety culture scale for nursing homes].

PubMed

Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

2013-06-01

The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

The impact of using an intravenous workflow management system (IVWMS) on cost and patient safety.

PubMed

Lin, Alex C; Deng, Yihong; Thaibah, Hilal; Hingl, John; Penm, Jonathan; Ivey, Marianne F; Thomas, Mark

2018-07-01

The aim of this study was to determine the financial costs associated with wasted and missing doses before and after the implementation of an intravenous workflow management system (IVWMS) and to quantify the number and the rate of detected intravenous (IV) preparation errors. A retrospective analysis of the sample hospital information system database was conducted using three months of data before and after the implementation of an IVWMS System (DoseEdge ® ) which uses barcode scanning and photographic technologies to track and verify each step of the preparation process. The financial impact associated with wasted and missing >IV doses was determined by combining drug acquisition, labor, accessory, and disposal costs. The intercepted error reports and pharmacist detected error reports were drawn from the IVWMS to quantify the number of errors by defined error categories. The total number of IV doses prepared before and after the implementation of the IVWMS system were 110,963 and 101,765 doses, respectively. The adoption of the IVWMS significantly reduced the amount of wasted and missing IV doses by 14,176 and 2268 doses, respectively (p < 0.001). The overall cost savings of using the system was $144,019 over 3 months. The total number of errors detected was 1160 (1.14%) after using the IVWMS. The implementation of the IVWMS facilitated workflow changes that led to a positive impact on cost and patient safety. The implementation of the IVWMS increased patient safety by enforcing standard operating procedures and bar code verifications. Published by Elsevier B.V.

A probabilistic technique for the assessment of complex dynamic system resilience

NASA Astrophysics Data System (ADS)

Balchanos, Michael Gregory

In the presence of operational uncertainty, one of the greatest challenges in systems engineering is to ensure system effectiveness, mission capability and survivability for large scale, complex system architectures. Historic events such as the 2003 Northeastern Blackout, and the 2005 Hurricane Katrina, have underlined the great importance of system safety, and survivability. With safety management currently applied on a reactive basis to emerging incidents and risk challenges, there is a paradigm shift from passive, reactive and diagnosis-based approaches to the development of architectures that will autonomously manage safety and survivability through active, proactive and prognosis-based engineering solutions. The shift aims to bring safety considerations early in the engineering design process, in order to reduce retrofitting and additional safety certification costs, increase flexibility in risk management, and essentially make safety be "built-in" the design. As a possible enabling research direction, resilience engineering is an emerging discipline, pertinent to safety management, which offers alternative insights on the design of more safe and survivable system architectures. Conceptually, resilience engineering brings new perspectives on the understanding of system safety, accidents, failures, performance degradations and risk. A resilient system can "absorb" the impact of change due to unexpected disturbances, while it "adapts" to change, in order to maintain the system's physical integrity and capability to carry on with its mission. The leading hypothesis advocates that if a complex dynamic system is more resilient, then it would be more survivable, thus more effective, despite the unexpected disturbances that could affect its normal operating conditions. For investigating the impact of more resilient systems on survivability and safety, a framework for theoretical resilience estimations has been formulated. It constitutes the basis for quantitative techniques for total system resilience evaluation, based on scenario-based, dynamic system simulations. Physics-based Modeling and Simulation (M&S) is applied for dynamical system behavior analysis, which includes system performance, health monitoring, damage propagation and overall mission capability. For the development of the assessment framework and testing of a resilience assessment technique, a small-scale canonical problem has been formulated, involving a computational model of a degradable and reconfigurable spring-mass-damper SDOF system, in a multiple main and redundant spring configuration. A rule-based feedback controller is responsible for system performance recovery, through the application of different reconfiguration strategies and strategic activation of the necessary main or redundant springs. Uncertainty effects on system operation are introduced through disturbance factors, such as external forces with varying magnitude, input frequency, event duration and occurrence time. Such factors are the basis for scenario formulation, in support of a Monte Carlo simulation analysis. Case studies with varying levels of damping and different reconfiguration strategies, involve the investigation of operational uncertainty effects on system performance, mission capability, and system survivability. These studies furthermore explore uncertainty effects on resilience functions that describe the system's capacities on "restoring" mission capability, on "absorbing" the effects of changing conditions, and on "adapting" to the occurring change. The proposed resilience assessment technique or the Topological Investigation for Resilient and Effective Systems, through Increased Architecture Survivability (TIRESIAS) is then applied and demonstrated for a naval system application, in the form of a reduced scale, reconfigurable cooling network of a naval combatant. Uncertainty effects are modeled through combinations of different number of network fluid leaks. The TIRESIAS approach on the system baseline (32-control valve configuration) has allowed for the investigation of leak effects on survival times, mission capability degradations, as well as the resilience function capacities. As part of the technique demonstration, case studies were conducted for different architecture configurations, which have been generated for different total number of control valves and valve locations on the topology.

The development and application of electronic information system for safety administration of newborns in the rooming-in care.

PubMed

Wang, Fang; Dong, Jian-Cheng; Chen, Jian-Rong; Wu, Hui-Qun; Liu, Man-Hua; Xue, Li-Ly; Zhu, Xiang-Hua; Wang, Jian

2015-01-01

To independently research and develop an electronic information system for safety administration of newborns in the rooming-in care, and to investigate the effects of its clinical application. By VS 2010 SQL SERVER 2005 database and adopting Microsoft visual programming tool, an interactive mobile information system was established, with integrating data, information and knowledge with using information structures, information processes and information technology. From July 2011 to July 2012, totally 210 newborns from the rooming-in care of the Obstetrics Department of the Second Affiliated Hospital of Nantong University were chosen and randomly divided into two groups: the information system monitoring group (110 cases) and the regular monitoring group (100 cases). Incidence of abnormal events and degree of satisfaction were recorded and calculated. ① The wireless electronic information system has four main functions including risk scaling display, identity recognition display, nursing round notes board and health education board; ② statistically significant differences were found between the two groups both on the active or passive discovery rate of abnormal events occurred in the newborns (P<0.05) and the satisfaction degree of the mothers and their families (P<0.05); ③ the system was sensitive and reliable, and the wireless transmission of information was correct and safety. The system is with high practicability in the clinic and can ensure the safety for the newborns with improved satisfactions.

Measurable improvement in patient safety culture: A departmental experience with incident learning.

PubMed

Kusano, Aaron S; Nyflot, Matthew J; Zeng, Jing; Sponseller, Patricia A; Ermoian, Ralph; Jordan, Loucille; Carlson, Joshua; Novak, Avrey; Kane, Gabrielle; Ford, Eric C

2015-01-01

Rigorous use of departmental incident learning is integral to improving patient safety and quality of care. The goal of this study was to quantify the impact of a high-volume, departmental incident learning system on patient safety culture. A prospective, voluntary, electronic incident learning system was implemented in February 2012 with the intent of tracking near-miss/no-harm incidents. All incident reports were reviewed weekly by a multiprofessional team with regular department-wide feedback. Patient safety culture was measured at baseline with validated patient safety culture survey questions. A repeat survey was conducted after 1 and 2 years of departmental incident learning. Proportional changes were compared by χ(2) or Fisher exact test, where appropriate. Between 2012 and 2014, a total of 1897 error/near-miss incidents were reported, representing an average of 1 near-miss report per patient treated. Reports were filed by a cross section of staff, with the majority of incidents reported by therapists, dosimetrists, and physicists. Survey response rates at baseline and 1 and 2 years were 78%, 80%, and 80%, respectively. Statistically significant and sustained improvements were noted in several safety metrics, including belief that the department was openly discussing ways to improve safety, the sense that reports were being used for safety improvement, and the sense that changes were being evaluated for effectiveness. None of the surveyed dimensions of patient safety culture worsened. Fewer punitive concerns were noted, with statistically significant decreases in the worry of embarrassment in front of colleagues and fear of getting colleagues in trouble. A comprehensive incident learning system can identify many areas for improvement and is associated with significant and sustained improvements in patient safety culture. These data provide valuable guidance as incident learning systems become more widely used in radiation oncology. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Safety, reliability, maintainability and quality provisions for the Space Shuttle program

NASA Technical Reports Server (NTRS)

1990-01-01

This publication establishes common safety, reliability, maintainability and quality provisions for the Space Shuttle Program. NASA Centers shall use this publication both as the basis for negotiating safety, reliability, maintainability and quality requirements with Shuttle Program contractors and as the guideline for conduct of program safety, reliability, maintainability and quality activities at the Centers. Centers shall assure that applicable provisions of the publication are imposed in lower tier contracts. Centers shall give due regard to other Space Shuttle Program planning in order to provide an integrated total Space Shuttle Program activity. In the implementation of safety, reliability, maintainability and quality activities, consideration shall be given to hardware complexity, supplier experience, state of hardware development, unit cost, and hardware use. The approach and methods for contractor implementation shall be described in the contractors safety, reliability, maintainability and quality plans. This publication incorporates provisions of NASA documents: NHB 1700.1 'NASA Safety Manual, Vol. 1'; NHB 5300.4(IA), 'Reliability Program Provisions for Aeronautical and Space System Contractors'; and NHB 5300.4(1B), 'Quality Program Provisions for Aeronautical and Space System Contractors'. It has been tailored from the above documents based on experience in other programs. It is intended that this publication be reviewed and revised, as appropriate, to reflect new experience and to assure continuing viability.

Policy analysis of the budget used in training program for reducing lower back pain among heavy equipment operators in the construction industry: System dynamics approach

NASA Astrophysics Data System (ADS)

Vitharana, V. H. P.; Chinda, T.

2018-04-01

Lower back pain (LBP), prevalence is high among the heavy equipment operators leading to high compensation cost in the construction industry. It is found that proper training program assists in reducing chances of having LBP. This study, therefore aims to examine different safety related budget available to support LBP related training program for different age group workers, utilizing system dynamics modeling approach. The simulation results show that at least 2.5% of the total budget must be allocated in the safety and health budget to reduce the chances of having LBP cases.

Comparative analysis of zonal systems for macro-level crash modeling.

PubMed

Cai, Qing; Abdel-Aty, Mohamed; Lee, Jaeyoung; Eluru, Naveen

2017-06-01

Macro-level traffic safety analysis has been undertaken at different spatial configurations. However, clear guidelines for the appropriate zonal system selection for safety analysis are unavailable. In this study, a comparative analysis was conducted to determine the optimal zonal system for macroscopic crash modeling considering census tracts (CTs), state-wide traffic analysis zones (STAZs), and a newly developed traffic-related zone system labeled traffic analysis districts (TADs). Poisson lognormal models for three crash types (i.e., total, severe, and non-motorized mode crashes) are developed based on the three zonal systems without and with consideration of spatial autocorrelation. The study proposes a method to compare the modeling performance of the three types of geographic units at different spatial configurations through a grid based framework. Specifically, the study region is partitioned to grids of various sizes and the model prediction accuracy of the various macro models is considered within these grids of various sizes. These model comparison results for all crash types indicated that the models based on TADs consistently offer a better performance compared to the others. Besides, the models considering spatial autocorrelation outperform the ones that do not consider it. Based on the modeling results and motivation for developing the different zonal systems, it is recommended using CTs for socio-demographic data collection, employing TAZs for transportation demand forecasting, and adopting TADs for transportation safety planning. The findings from this study can help practitioners select appropriate zonal systems for traffic crash modeling, which leads to develop more efficient policies to enhance transportation safety. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Public safety answering point readiness for wireless E-911 in New York State.

PubMed

Bailey, Bob W; Scott, Jay M; Brown, Lawrence H

2003-01-01

To determine the level of wireless enhanced 911 readiness among New York's primary public safety answering points. This descriptive study utilized a simple, single-page survey that was distributed in August 2001, with telephone follow-up concluding in January 2002. Surveys were distributed to directors of the primary public safety answering points in each of New York's 62 counties. Information was requested regarding current readiness for providing wireless enhanced 911 service, hardware and software needs for implementing the service, and the estimated costs for obtaining the necessary hardware and software. Two directors did not respond and could not be contacted by telephone; three declined participation; one did not operate an answering point; and seven provided incomplete responses, resulting in usable data from 49 (79%) of the state's public safety answering points. Only 27% of the responding public safety answering points were currently wireless enhanced 911 ready. Specific needs included obtaining or upgrading computer systems (16%), computer-aided dispatch systems (53%), mapping software (71%), telephone systems (27%), and local exchange carrier trunk lines (42%). The total estimated hardware and software costs for achieving wireless enhanced 911 readiness was between 16 million and 20 million dollars. New York's primary public safety answering points are not currently ready to provide wireless enhanced 911 service, and the cost for achieving readiness could be as high as 20 million dollars.

Reducing the risk of rear-end collisions with infrastructure-to-vehicle (I2V) integration of variable speed limit control and adaptive cruise control system.

PubMed

Li, Ye; Wang, Hao; Wang, Wei; Liu, Shanwen; Xiang, Yun

2016-08-17

Adaptive cruise control (ACC) has been investigated recently to explore ways to increase traffic capacity, stabilize traffic flow, and improve traffic safety. However, researchers seldom have studied the integration of ACC and roadside control methods such as the variable speed limit (VSL) to improve safety. The primary objective of this study was to develop an infrastructure-to-vehicle (I2V) integrated system that incorporated both ACC and VSL to reduce rear-end collision risks on freeways. The intelligent driver model was firstly modified to simulate ACC behavior and then the VSL strategy used in this article was introduced. Next, the I2V system was proposed to integrate the 2 advanced techniques, ACC and VSL. Four scenarios of no control, VSL only, ACC only, and the I2V system were tested in simulation experiments. Time exposed time to collision (TET) and time integrated time to collision (TIT), 2 surrogate safety measures derived from time to collision (TTC), were used to evaluate safety issues associated with rear-end collisions. The total travel times of each scenario were also compared. The simulation results indicated that both the VSL-only and ACC-only methods had a positive impact on reducing the TET and TIT values (reduced by 53.0 and 58.6% and 59.0 and 65.3%, respectively). The I2V system combined the advantages of both ACC and VSL to achieve the most safety benefits (reduced by 71.5 and 77.3%, respectively). Sensitivity analysis of the TTC threshold also showed that the I2V system obtained the largest safety benefits with all of the TTC threshold values. The impact of different market penetration rates of ACC vehicles in I2V system indicated that safety benefits increase with an increase in ACC proportions. Compared to VSL-only and ACC-only scenarios, this integrated I2V system is more effective in reducing rear-end collision risks. The findings of this study provide useful information for traffic agencies to implement novel techniques to improve safety on freeways.

NASA B737 flight test results of the total energy control system

NASA Technical Reports Server (NTRS)

Bruce, Kevin R.

1987-01-01

The Total Energy Control System (TECS) is an integrated autopilot/autothrottle developed by BCAC that was test flown on NASA Langley's Transport System Research Vehicle (i.e., a highly modified Boeing B737). This systems was developed using principles of total energy in which the total kinetic and potential energy of the airplane was controlled by the throttles, and the energy distribution controled by the elevator. TECS integrates all the control functions of a conventional pitch autopilot and autothrottle into a single generalized control concept. This integration provides decoupled flightpath and maneuver control, as well as a coordinated throttle response for all maneuvers. A mode hierarchy was established to preclude exceeding airplane safety and performance limits. The flight test of TECS took place as a series of five flights over a 33-week period during September 1985 at NASA Langley. Most of the original flight test plan was completed within the first three flights with the system not exhibiting any instabilities or design problems that required any gain adjustment during flight.

Safety of ultrashort-term sit with pollen allergoids adjuvanted by monophosphoryl lipid A: a prospective Italian survey.

PubMed

Crivellaro, M; Senna, G E; Pappacoda, A; Vanzelli, R; Spacal, B; Marchi, G; Recchia, G; Makatsori, M

2011-03-01

A 3-year prospective post marketing survey on the safety of the recently developed ultrashort pre-seasonal subcutaneous immunotherapy (uSCIT-MPL4) with pollen allergoids adjuvanted with monophosphoryl lipid A was performed. A total of 510 patients received uSCIT-MPL4, 61% for grass, 35.7% for birch, 13.2% for parietaria and 3% for other pollens (ragweed, mugwort, and olive). A total of 3308 injections were given and the mean duration of uSCIT-MPL-4 was 2.3 years. Overall, only 7 slight systemic reactions (SR) were observed in 510 patients (1.37%) and 2.11/1000 injections suggesting that this treatment is even safer than traditional depot injection SIT.

Using human factors engineering to improve patient safety in the cardiovascular operating room.

PubMed

Gurses, Ayse P; Martinez, Elizabeth A; Bauer, Laura; Kim, George; Lubomski, Lisa H; Marsteller, Jill A; Pennathur, Priyadarshini R; Goeschel, Chris; Pronovost, Peter J; Thompson, David

2012-01-01

Despite significant medical advances, cardiac surgery remains a high risk procedure. Sub-optimal work system design characteristics can contribute to the risks associated with cardiac surgery. However, hazards due to work system characteristics have not been identified in the cardiovascular operating room (CVOR) in sufficient detail to guide improvement efforts. The purpose of this study was to identify and categorize hazards (anything that has the potential to cause a preventable adverse patient safety event) in the CVOR. An interdisciplinary research team used prospective hazard identification methods including direct observations, contextual inquiry, and photographing to collect data in 5 hospitals for a total 22 cardiac surgeries. We performed thematic analysis of the qualitative data guided by a work system model. 60 categories of hazards such as practice variations, high workload, non-compliance with evidence-based guidelines, not including clinicians' in medical device purchasing decisions were found. Results indicated that hazards are common in cardiac surgery and should be eliminated or mitigated to improve patient safety. To improve patient safety in the CVOR, efforts should focus on creating a culture of safety, increasing compliance with evidence based infection control practices, improving communication and teamwork, and designing better tools and technologies through partnership among all stakeholders.

Research in fire prevention.

PubMed

Pearce, N

1985-10-01

This paper describes in broad terms, the fire testing programme we carried out on whole bed assemblies in 1984. It should be clear that the tests were carried out in a thoroughly rigorous scientific manner. As always there is more to be done. The immediate task of finding the so called 'safe' bed assembly is proceeding with the search this year for safer pillows. Softer barrier foams are now being produced and it may be that the NHS could use full depth foam mattresses rather than a barrier foam wrap. On the engineering side I have explained the false alarm problem, and I have reviewed some of the research we are doing to see that new technology is used to give us better systems in future. Life safety sprinkler systems give the possibility of truly active fire protection in patient areas. They will enhance fire safety but at the moment no trade-offs can be offered in other areas of fire protection--either active or passive. My final point is that although I have considered the Department's fire research by looking separately at specific projects, the fire safety of a hospital must always be considered as a total package. To be effective, individual components of fire safety must not be considered in isolation but as part of the overall fire safety system.

Effects on speed and safety of point-to-point speed enforcement systems: evaluation on the urban motorway A56 Tangenziale di Napoli.

PubMed

Montella, Alfonso; Imbriani, Lella Liana; Marzano, Vittorio; Mauriello, Filomena

2015-02-01

In this paper, we evaluated the effects on speed and safety of the point-to-point (P2P) speed enforcement system activated on the urban motorway A56 in Italy. The P2P speed enforcement is a relatively new approach to traffic law enforcement that involves the calculation of the average speed over a section. To evaluate the speed effects, we performed a before-after analysis of speed data investigating also effects on non-compliance to speed limits. To evaluate the safety effects, we carried out an empirical Bayes observational before-and-after study. The P2P system led to very positive effects on both speed and safety. As far as the effects on the section average travel speeds, the system yielded to a reduction in the mean speed, the 85th percentile speed, the standard deviation of speed, and the proportion of drivers exceeding the speed limits, exceeding the speed limits more than 10km/h, and exceeding the speed limits more than 20km/h. The best results were the decrease of the speed variability and the reduction of the excessive speeding behaviour. The decrease in the standard deviation of speed was 26% while the proportion of light and heavy vehicles exceeding the speed limits more than 20km/h was reduced respectively by 84 and 77%. As far as the safety effects, the P2P system yielded to a 32% reduction in the total crashes, with a lower 95% confidence limit of the estimate equal to 22%. The greatest crash reductions were in rainy weather (57%), on wet pavement (51%), on curves (49%), for single vehicle crashes (44%), and for injury crashes (37%). It is noteworthy that the system produced a statistically significant reduction of 21% in total crashes also in the part of the motorway where it was not activated, thus generating a significant spillover effect. The investigation of the effects of the P2P system on speed and safety over time allowed to develop crash modification functions where the relationship between crash modification factors and speed parameters (mean speed, 85th percentile speed, and standard deviation of speed) was expressed by a power function. Crash modification functions show that the effect of speed on safety is greater on curves and for injury crashes. Even though the study results show excellent outcomes, we must point out that the crash reduction effects decreased over time and speed, speed variability, and non-compliance to speed limits significantly increased over time. To maintain its effectiveness over time, P2P speed enforcement must be actively managed, i.e. constantly monitored and supported by appropriate sanctions. Copyright © 2014 Elsevier Ltd. All rights reserved.

From the traditional concept of safety management to safety integrated with quality.

PubMed

García Herrero, Susana; Mariscal Saldaña, Miguel Angel; Manzanedo del Campo, Miguel Angel; Ritzel, Dale O

2002-01-01

This editorial reviews the evolution of the concepts of safety and quality that have been used in the traditional workplace. The traditional programs of safety are explored showing strengths and weaknesses. The concept of quality management is also viewed. Safety management and quality management principles, stages, and measurement are highlighted. The concepts of quality and safety guarantee are assessed. Total Quality Management concepts are reviewed and applied to safety quality. Total safety management principles are discussed. Finally, an analysis of the relationship between quality and safety from data collected from a company in Spain is presented.

Increasing Patient Safety Event Reporting in an Emergency Medicine Residency.

PubMed

Steen, Sven; Jaeger, Cassie; Price, Lindsay; Griffen, David

2017-01-01

Patient safety event reporting is an important component for fostering a culture of safety. Our tertiary care hospital utilizes a computerized patient safety event reporting system that has been historically underutilized by residents and faculty, despite encouragement of its use. The objective of this quality project was to increase patient safety event reporting within our Emergency Medicine residency program. Knowledge of event reporting was evaluated with a survey. Eighteen residents and five faculty participated in a formal educational session on event reporting followed by feedback every two months on events reported and actions taken. The educational session included description of which events to report and the logistics of accessing the reporting system. Participants received a survey after the educational intervention to assess resident familiarity and comfort with using the system. The total number of events reported was obtained before and after the educational session. After the educational session, residents reported being more confident in knowing what to report as a patient safety event, knowing how to report events, how to access the reporting tool, and how to enter a patient safety event. In the 14 months preceding the educational session, an average of 0.4 events were reported per month from the residency. In the nine months following the educational session, an average of 3.7 events were reported per month by the residency. In addition, the reported events resulted in meaningful actions taken by the hospital to improve patient safety, which were shared with the residents. Improvement efforts including an educational session, feedback to the residency of events reported, and communication of improvements resulting from reported events successfully increased the frequency of safety event reporting in an Emergency Medicine residency.

Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study.

PubMed

Tsuru, Tomomi; Tanaka, Yoshiya; Kishimoto, Mitsumasa; Saito, Kazuyoshi; Yoshizawa, Seiji; Takasaki, Yoshinari; Miyamura, Tomoya; Niiro, Hiroaki; Morimoto, Shinji; Yamamoto, Junichi; Lledo-Garcia, Rocio; Shao, Jing; Tatematsu, Shuichiro; Togo, Osamu; Koike, Takao

2016-01-01

This 12-week, randomized, double-blind, placebo-controlled, multicenter phase 1/2 study (NCT01449071) assessed the safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus despite standard of care. Twenty patients were randomized 1:1:1:1:1 to placebo or one of four epratuzumab dose regimens (100 mg every other week [Q2W], 400 mg Q2W, 600 mg every week [QW], or 1200 mg Q2W) administered during an initial 4-week dosing period. Adverse events (AEs), pharmacokinetics and pharmacodynamics were assessed. Nineteen of 20 patients completed the study. All placebo patients and 13 of 16 epratuzumab patients reported ≥1 AE, 2 of 16 epratuzumab patients reported a serious AE. C(max) and AUC(τ) increased proportionally with dose after first and last infusion, t(1/2) was similar across groups (∼13 days). Epratuzumab treatment was associated with decreased CD22 mean fluorescence intensity in total B cells (CD19(+)CD22(+)) and unswitched memory B cells (CD19(+)IgD(+)CD27(+)). Small-to-moderate decreases were observed in total B cell (CD20(+)) count. Epratuzumab was well-tolerated, with no new safety signals identified. The pharmacokinetics appeared linear after first and last infusions. Treatment with epratuzumab was associated with CD22 downregulation and with small-to-moderate decreases in total B cell count.

Safety performance evaluation of cable median barriers on freeways in Florida.

PubMed

Alluri, Priyanka; Haleem, Kirolos; Gan, Albert; Mauthner, John

2016-07-03

This article aims to evaluate the safety performance of cable median barriers on freeways in Florida. The safety performance evaluation was based on the percentages of barrier and median crossovers by vehicle type, crash severity, and cable median barrier type (Trinity Cable Safety System [CASS] and Gibraltar system). Twenty-three locations with cable median barriers totaling about 101 miles were identified. Police reports of 6,524 crashes from years 2005-2010 at these locations were reviewed to verify and obtain detailed crash information. A total of 549 crashes were determined to be barrier related (i.e., crashes involving vehicles hitting the cable median barrier) and were reviewed in further detail to identify crossover crashes and the manner in which the vehicles crossed the barriers; that is, by either overriding, underriding, or penetrating the barriers. Overall, 2.6% of vehicles that hit the cable median barrier crossed the median and traversed into the opposite travel lane. Overall, 98.1% of cars and 95.5% of light trucks that hit the barrier were prevented from crossing the median. In other words, 1.9% of cars and 4.5% of light trucks that hit the barrier had crossed the median and encroached on the opposite travel lanes. There is no significant difference in the performance of cable median barrier for cars versus light trucks in terms of crossover crashes. In terms of severity, overrides were more severe compared to underrides and penetrations. The statistics showed that the CASS and Gibraltar systems performed similarly in terms of crossover crashes. However, the Gibraltar system experienced a higher proportion of penetrations compared to the CASS system. The CASS system resulted in a slightly higher percentage of moderate and minor injury crashes compared to the Gibraltar system. Cable median barriers are successful in preventing median crossover crashes; 97.4% of the cable median barrier crashes were prevented from crossing over the median. Of all of the vehicles that hit the barrier, 83.6% were either redirected or contained by the cable barrier system. Barrier crossover crashes were found to be more severe compared to barrier noncrossover crashes. In addition, overrides were found to be more severe compared to underrides and penetrations.

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

Nyflot, MJ; Kusano, AS; Zeng, J

Purpose: Interest in incident learning systems (ILS) for improving safety and quality in radiation oncology is growing, as evidenced by the upcoming release of the national ILS. However, an institution implementing such a system would benefit from quantitative metrics to evaluate performance and impact. We developed metrics to measure volume of reporting, severity of reported incidents, and changes in staff attitudes over time from implementation of our institutional ILS. Methods: We analyzed 2023 incidents from our departmental ILS from 2/2012–2/2014. Incidents were prospectively assigned a near-miss severity index (NMSI) at multidisciplinary review to evaluate the potential for error ranging frommore » 0 to 4 (no harm to critical). Total incidents reported, unique users reporting, and average NMSI were evaluated over time. Additionally, departmental safety attitudes were assessed through a 26 point survey adapted from the AHRQ Hospital Survey on Patient Safety Culture before, 12 months, and 24 months after implementation of the incident learning system. Results: Participation in the ILS increased as demonstrated by total reports (approximately 2.12 additional reports/month) and unique users reporting (0.51 additional users reporting/month). Also, the average NMSI of reports trended lower over time, significantly decreasing after 12 months of reporting (p<0.001) but with no significant change at months 18 or 24. In survey data significant improvements were noted in many dimensions, including perceived barriers to reporting incidents such as concern of embarrassment (37% to 18%; p=0.02) as well as knowledge of what incidents to report, how to report them, and confidence that these reports were used to improve safety processes. Conclusion: Over a two-year period, our departmental ILS was used more frequently, incidents became less severe, and staff confidence in the system improved. The metrics used here may be useful for other institutions seeking to create or evaluate their own incident learning systems.« less

User manual for NASA Lewis 10 by 10 foot supersonic wind tunnel. Revised

NASA Technical Reports Server (NTRS)

Soeder, Ronald H.

1995-01-01

This manual describes the 10- by 10-Foot Supersonic Wind Tunnel at the NASA Lewis Research Center and provides information for users who wish to conduct experiments in this facility. Tunnel performance operating envelopes of altitude, dynamic pressure, Reynolds number, total pressure, and total temperature as a function of test section Mach number are presented. Operating envelopes are shown for both the aerodynamic (closed) cycle and the propulsion (open) cycle. The tunnel test section Mach number range is 2.0 to 3.5. General support systems, such as air systems, hydraulic system, hydrogen system, fuel system, and Schlieren system, are described. Instrumentation and data processing and acquisition systems are also described. Pretest meeting formats and schedules are outlined. Tunnel user responsibility and personnel safety are also discussed.

[Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

PubMed

Yang, Wei; Xie, Yanming; Zhuang, Yan

2011-10-01

There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

PubMed

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

The appropriate and inappropriate use of child restraint seats in Manitoba.

PubMed

Blair, John; Perdios, Angeliki; Babul, Shelina; Young, Kevin; Beckles, Janice; Pike, Ian; Cripton, Peter; Sasges, Debbie; Mulpuri, Krishore; Desapriya, Ediriweera

2008-09-01

The objective of this research was to describe the use and incorrect use of child restraint systems in Manitoba, Canada. In 2004, a team of inspectors made up of Royal Canadian Mounted Police officers and trained car seat technicians from the Manitoba child seat coalition conducted a descriptive survey of types and frequency of child restraint systems' incorrect use. The setting was 10 roadside inspection sites located around the city of Winnipeg, Manitoba. The subjects were parents and primary caregivers of children using child restraint systems. The main outcome measured was the reported appropriate use rate as determined by the compliance to safety standards for correct installation and use of child restraints. A total of 340 child restraint systems were assessed. The overall rate of incorrect use was 70%. The errors present in stage III systems (booster seats) are much lower than the errors present in stage I systems (rear-facing child safety seats) and stage II systems (forward-facing child safety seats). The data presented illustrate that incorrect use of child restraint systems in the province of Manitoba is a large problem and must be dealt with immediately in order to ensure child safety now and in the future. Community-wide information and enhanced enforcement campaigns, consisting of activities such as mass media, information and publicity, child restraint systems displays and special enforcement strategies (check points, dedicated law enforcement officials, alternative penalties) should be used to increase the correct use of child restraint systems. Failure to use child restraint systems properly can contribute to serious injury or death of a child.

Causation mechanisms in car-to-vulnerable road user crashes: implications for active safety systems.

PubMed

Habibovic, Azra; Davidsson, Johan

2012-11-01

Vulnerable road users (VRUs), such as pedestrians and bicyclists, are often involved in crashes with passenger cars. One way to prevent these crashes is to deploy active safety systems that support the car drivers and/or VRUs. However, to develop such systems, a thorough understanding of crash causation mechanisms is required. The aim of this study is to identify crash causation mechanisms from the perspective of the VRUs, and to explore the implications of these mechanisms for the development of active safety systems. Data originate from the European project SafetyNet, where 995 crashes were in-depth investigated using the SafetyNet Accident Causation System (SNACS). To limit the scope, this study analyzed only intersection crashes involving VRUs. A total of 56 VRU crashes were aggregated. Results suggest that, while 30% of the VRUs did not see the conflict car due to visual obstructions in the traffic environment, 70% of the VRUs saw the car before the collision, but still misunderstood the traffic situation and/or made an inadequate plan of action. An important implication that follows from this is that, while detection of cars is clearly an issue that needs to be addressed, it is even more important to help the VRUs to correctly understand traffic situation (e.g., does the driver intend to slow down, and if s/he does, is it to let the VRU cross or for some other reason?). The former issue suggests a role for various cooperative active safety systems, as the obstacles are generally impenetrable with regular sensors. The latter issue is less straightforward. While various systems can be proposed, such as providing gap size estimation and reducing the car speed variability, the functional merits of each such a system need to be further investigated. Copyright © 2012 Elsevier Ltd. All rights reserved.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

NASA Lewis 8- by 6-foot supersonic wind tunnel user manual

NASA Technical Reports Server (NTRS)

Soeder, Ronald H.

1993-01-01

The 8- by 6-Foot Supersonic Wind Tunnel (SWT) at Lewis Research Center is available for use by qualified researchers. This manual contains tunnel performance maps which show the range of total temperature, total pressure, static pressure, dynamic pressure, altitude, Reynolds number, and mass flow as a function of test section Mach number. These maps are applicable for both the aerodynamic and propulsion cycle. The 8- by 6-Foot Supersonic Wind Tunnel is an atmospheric facility with a test section Mach number range from 0.36 to 2.0. General support systems (air systems, hydraulic system, hydrogen system, infrared system, laser system, laser sheet system, and schlieren system are also described as are instrumentation and data processing and acquisition systems. Pretest meeting formats are outlined. Tunnel user responsibility and personal safety requirements are also stated.

Health, safety, and environmental management system operation in contracting companies: A case study.

PubMed

Nassiri, Parvin; Yarahmadi, Rasoul; Gholami, Pari Shafaei; Hamidi, Abdolamir; Mirkazemi, Roksana

2016-05-03

Systematic and cooperative interactions among parent industry and contractors are necessary for a successful health, safety, and environmental management system (HSE-MS). This study was conducted to evaluate the HSE-MS performance in contracting companies in one of the petrochemical industries in Iran during 2013. Managers of parent and contracting companies participated in this study. The data collection forms included 7 elements of an integrated HSE-MS (leadership and commitment; policy and strategic objectives; organization, resources, and documentation; evaluation and risk management; planning; implementation and monitoring; auditing and reviewing). The results showed that mean percentage of the total scores in seven elements of HSE-MS was 85.7% and 87.0% based on self-report and report of parent company, respectively. In conclusion, this study showed that HSE-MS was desirably functioning; however, improvement to ensure health and safety of workers is still required.

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

PubMed

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

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

Using wide area differential GPS to improve total system error for precision flight operations

NASA Astrophysics Data System (ADS)

Alter, Keith Warren

Total System Error (TSE) refers to an aircraft's total deviation from the desired flight path. TSE can be divided into Navigational System Error (NSE), the error attributable to the aircraft's navigation system, and Flight Technical Error (FTE), the error attributable to pilot or autopilot control. Improvement in either NSE or FTE reduces TSE and leads to the capability to fly more precise flight trajectories. The Federal Aviation Administration's Wide Area Augmentation System (WAAS) became operational for non-safety critical applications in 2000 and will become operational for safety critical applications in 2002. This navigation service will provide precise 3-D positioning (demonstrated to better than 5 meters horizontal and vertical accuracy) for civil aircraft in the United States. Perhaps more importantly, this navigation system, which provides continuous operation across large regions, enables new flight instrumentation concepts which allow pilots to fly aircraft significantly more precisely, both for straight and curved flight paths. This research investigates the capabilities of some of these new concepts, including the Highway-In-The Sky (HITS) display, which not only improves FTE but also reduces pilot workload when compared to conventional flight instrumentation. Augmentation to the HITS display, including perspective terrain and terrain alerting, improves pilot situational awareness. Flight test results from demonstrations in Juneau, AK, and Lake Tahoe, CA, provide evidence of the overall feasibility of integrated, low-cost flight navigation systems based on these concepts. These systems, requiring no more computational power than current-generation low-end desktop computers, have immediate applicability to general aviation flight from Cessnas to business jets and can support safer and ultimately more economical flight operations. Commercial airlines may also, over time, benefit from these new technologies.

Assessing drivers' response during automated driver support system failures with non-driving tasks.

PubMed

Shen, Sijun; Neyens, David M

2017-06-01

With the increase in automated driver support systems, drivers are shifting from operating their vehicles to supervising their automation. As a result, it is important to understand how drivers interact with these automated systems and evaluate their effect on driver responses to safety critical events. This study aimed to identify how drivers responded when experiencing a safety critical event in automated vehicles while also engaged in non-driving tasks. In total 48 participants were included in this driving simulator study with two levels of automated driving: (a) driving with no automation and (b) driving with adaptive cruise control (ACC) and lane keeping (LK) systems engaged; and also two levels of a non-driving task (a) watching a movie or (b) no non-driving task. In addition to driving performance measures, non-driving task performance and the mean glance duration for the non-driving task were compared between the two levels of automated driving. Drivers using the automated systems responded worse than those manually driving in terms of reaction time, lane departure duration, and maximum steering wheel angle to an induced lane departure event. These results also found that non-driving tasks further impaired driver responses to a safety critical event in the automated system condition. In the automated driving condition, driver responses to the safety critical events were slower, especially when engaged in a non-driving task. Traditional driver performance variables may not necessarily effectively and accurately evaluate driver responses to events when supervising autonomous vehicle systems. Thus, it is important to develop and use appropriate variables to quantify drivers' performance under these conditions. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Practical Applications of Cosmic Ray Science: Spacecraft, Aircraft, Ground Based Computation and Control Systems and Human Health and Safety

NASA Technical Reports Server (NTRS)

Atwell, William; Koontz, Steve; Normand, Eugene

2012-01-01

In this paper we review the discovery of cosmic ray effects on the performance and reliability of microelectronic systems as well as on human health and safety, as well as the development of the engineering and health science tools used to evaluate and mitigate cosmic ray effects in earth surface, atmospheric flight, and space flight environments. Three twentieth century technological developments, 1) high altitude commercial and military aircraft; 2) manned and unmanned spacecraft; and 3) increasingly complex and sensitive solid state micro-electronics systems, have driven an ongoing evolution of basic cosmic ray science into a set of practical engineering tools (e.g. ground based test methods as well as high energy particle transport and reaction codes) needed to design, test, and verify the safety and reliability of modern complex electronic systems as well as effects on human health and safety. The effects of primary cosmic ray particles, and secondary particle showers produced by nuclear reactions with spacecraft materials, can determine the design and verification processes (as well as the total dollar cost) for manned and unmanned spacecraft avionics systems. Similar considerations apply to commercial and military aircraft operating at high latitudes and altitudes near the atmospheric Pfotzer maximum. Even ground based computational and controls systems can be negatively affected by secondary particle showers at the Earth's surface, especially if the net target area of the sensitive electronic system components is large. Accumulation of both primary cosmic ray and secondary cosmic ray induced particle shower radiation dose is an important health and safety consideration for commercial or military air crews operating at high altitude/latitude and is also one of the most important factors presently limiting manned space flight operations beyond low-Earth orbit (LEO).

Macroergonomic analysis and design for improved safety and quality performance.

PubMed

Kleiner, B M

1999-01-01

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

Civil Uses of Remotely Piloted Aircraft

NASA Technical Reports Server (NTRS)

Aderhold, J. R.; Gordon, G.; Scott, G. W.

1976-01-01

The technology effort is identified and assessed that is required to bring the civil uses of RPVs to fruition and to determine whether or not the potential market is real and economically practical, the technologies are within reach, the operational problems are manageable, and the benefits are worth the cost. To do so, the economic, technical, and environmental implications are examined. The time frame is 1980-85. Representative uses are selected; detailed functional and performance requirements are derived for RPV systems; and conceptual system designs are devised. Total system cost comparisons are made with non-RPV alternatives. The potential market demand for RPV systems is estimated. Environmental and safety requirements are examined, and legal and regulatory concerns are identified. A potential demand for 2,000-11,000 RPV systems is estimated. Typical cost savings of 25-35% compared to non-RPV alternatives are determined. There appear to be no environmental problems, and the safety issue appears manageable.

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

[European Union Network for Patient Safety and Quality of Care (PASQ). Development and preliminary results in Europe and in the Spanish National Health System].

PubMed

Agra-Varela, Y; Fernández-Maíllo, M; Rivera-Ariza, S; Sáiz-Martínez-Acitorez, I; Casal-Gómez, J; Palanca-Sánchez, I; Bacou, J

2015-01-01

The joint action, European Union Network for Patient Safety and Quality of Care: PaSQ, aims to promote patient safety (PS) in the European Union (EU) and to facilitate the exchange of experiences among Member States (MS) and stakeholders on issues related to quality of care, PS, and patient involvement. The development and preliminary results are presented here, especially as regards the Spanish National Health System (SNHS). PaSQ is developed through 7 work packages, primarily aimed at sharing good practices (GP), which were identified using specific questionnaires and selected by means of explicit criteria, as well as to implement safe clinical practices (SCP) of proven effectiveness and agreed among MS. A total of 482 GP (39% provided by Spanish professionals) were identified. The 34 events organised in the EU, 11 including Spanish participation, facilitate sharing these practices. A total of 194 Health Care centres (49% in Spain) are implementing SCP (hand hygiene, safe surgery, medication reconciliation, and paediatric early warning scores) ACHIEVEMENTS AND FUTURE PERSPECTIVES: PaSQ is making it possible to strengthen collaboration between organizations and professionals at EU and SNHS level regarding PS and quality of care. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

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

2018-06-01

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

Food safety regulations in Australia and New Zealand Food Standards.

PubMed

Ghosh, Dilip

2014-08-01

Citizens of Australia and New Zealand recognise that food security is a major global issue. Food security also affects Australia and New Zealand's status as premier food exporting nations and the health and wellbeing of the Australasian population. Australia is uniquely positioned to help build a resilient food value chain and support programs aimed at addressing existing and emerging food security challenges. The Australian food governance system is fragmented and less transparent, being largely in the hands of government and semi-governmental regulatory authorities. The high level of consumer trust in Australian food governance suggests that this may be habitual and taken for granted, arising from a lack of negative experiences of food safety. In New Zealand the Ministry of Primary Industries regulates food safety issues. To improve trade and food safety, New Zealand and Australia work together through Food Standards Australia New Zealand (FSANZ) and other co-operative agreements. Although the potential risks to the food supply are dynamic and constantly changing, the demand, requirement and supply for providing safe food remains firm. The Australasian food industry will need to continually develop its system that supports the food safety program with the help of scientific investigations that underpin the assurance of what is and is not safe. The incorporation of a comprehensive and validated food safety program is one of the total quality management systems that will ensure that all areas of potential problems are being addressed by industry. © 2014 Society of Chemical Industry.

Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus.

PubMed

Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F

2016-11-01

We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.

Evaluating the effectiveness of active vehicle safety systems.

PubMed

Jeong, Eunbi; Oh, Cheol

2017-03-01

Advanced vehicle safety systems have been widely introduced in transportation systems and are expected to enhance traffic safety. However, these technologies mainly focus on assisting individual vehicles that are equipped with them, and less effort has been made to identify the effect of vehicular technologies on the traffic stream. This study proposed a methodology to assess the effectiveness of active vehicle safety systems (AVSSs), which represent a promising technology to prevent traffic crashes and mitigate injury severity. The proposed AVSS consists of longitudinal and lateral vehicle control systems, which corresponds to the Level 2 vehicle automation presented by the National Highway Safety Administration (NHTSA). The effectiveness evaluation for the proposed technology was conducted in terms of crash potential reduction and congestion mitigation. A microscopic traffic simulator, VISSIM, was used to simulate freeway traffic stream and collect vehicle-maneuvering data. In addition, an external application program interface, VISSIM's COM-interface, was used to implement the AVSS. A surrogate safety assessment model (SSAM) was used to derive indirect safety measures to evaluate the effectiveness of the AVSS. A 16.7-km freeway stretch between the Nakdong and Seonsan interchanges on Korean freeway 45 was selected for the simulation experiments to evaluate the effectiveness of AVSS. A total of five simulation runs for each evaluation scenario were conducted. For the non-incident conditions, the rear-end and lane-change conflicts were reduced by 78.8% and 17.3%, respectively, under the level of service (LOS) D traffic conditions. In addition, the average delay was reduced by 55.5%. However, the system's effectiveness was weakened in the LOS A-C categories. Under incident traffic conditions, the number of rear-end conflicts was reduced by approximately 9.7%. Vehicle delays were reduced by approximately 43.9% with 100% of market penetration rate (MPR). These results imply that from the perspective of traffic operations and control to address the safety and congestion issues of a traffic stream, smarter management strategies that consider both traffic conditions and MPR are required to fully exploit the effectiveness of the AVSS in the field. Copyright © 2017 Elsevier Ltd. All rights reserved.

Addressing the Influence of Space Weather on Airline Navigation

NASA Technical Reports Server (NTRS)

Sparks, Lawrence

2012-01-01

The advent of satellite-based augmentation systems has made it possible to navigate aircraft safely using radio signals emitted by global navigation satellite systems (GNSS) such as the Global Positioning System. As a signal propagates through the earth's ionosphere, it suffers delay that is proportional to the total electron content encountered along the raypath. Since the magnitude of this total electron content is strongly influenced by space weather, the safety and reliability of GNSS for airline navigation requires continual monitoring of the state of the ionosphere and calibration of ionospheric delay. This paper examines the impact of space weather on GNSS-based navigation and provides an overview of how the Wide Area Augmentation System protects its users from positioning error due to ionospheric disturbances

Applying the WHO conceptual framework for the International Classification for Patient Safety to a surgical population

PubMed Central

McElroy, L. M.; Woods, D. M.; Yanes, A. F.; Skaro, A. I.; Daud, A.; Curtis, T.; Wymore, E.; Holl, J. L.; Abecassis, M. M.; Ladner, D. P.

2016-01-01

Objective Efforts to improve patient safety are challenged by the lack of universally agreed upon terms. The International Classification for Patient Safety (ICPS) was developed by the World Health Organization for this purpose. This study aimed to test the applicability of the ICPS to a surgical population. Design A web-based safety debriefing was sent to clinicians involved in surgical care of abdominal organ transplant patients. A multidisciplinary team of patient safety experts, surgeons and researchers used the data to develop a system of classification based on the ICPS. Disagreements were reconciled via consensus, and a codebook was developed for future use by researchers. Results A total of 320 debriefing responses were used for the initial review and codebook development. In total, the 320 debriefing responses contained 227 patient safety incidents (range: 0–7 per debriefing) and 156 contributing factors/hazards (0–5 per response). The most common severity classification was ‘reportable circumstance,’ followed by ‘near miss.’ The most common incident types were ‘resources/organizational management,’ followed by ‘medical device/equipment.’ Several aspects of surgical care were encompassed by more than one classification, including operating room scheduling, delays in care, trainee-related incidents, interruptions and handoffs. Conclusions This study demonstrates that a framework for patient safety can be applied to facilitate the organization and analysis of surgical safety data. Several unique aspects of surgical care require consideration, and by using a standardized framework for describing concepts, research findings can be compared and disseminated across surgical specialties. The codebook is intended for use as a framework for other specialties and institutions. PMID:26803539

Safe system approach to reducing serious injury risk in motorcyclist collisions with fixed hazards.

PubMed

Bambach, M R; Mitchell, R J

2015-01-01

Collisions with fixed objects in the roadway environment account for a substantial proportion of motorcyclist fatalities. Many studies have identified individual roadway environment and/or motorcyclist characteristics that are associated with the severity of the injury outcome, including the presence of roadside barriers, helmet use, alcohol use and speeding. However, no studies have reported the cumulative benefit of such characteristics on motorcycling safety. The safe system approach recognises that the system must work as a whole to reduce the net injury risk to road users to an acceptable level, including the four system cornerstone areas of roadways, speeds, vehicles and people. The aim of the present paper is to consider these cornerstone areas concomitantly, and quantitatively assess the serious injury risk of motorcyclists in fixed object collisions using this holistic approach. A total of 1006 Australian and 15,727 (weighted) United States motorcyclist-fixed object collisions were collected retrospectively, and the serious injury risks associated with roadside barriers, helmet use, alcohol use and speeding were assessed both individually and concomitantly. The results indicate that if safety efforts are made in each of the safe system cornerstone areas, the combined effect is to substantially reduce the serious injury risk of fixed hazards to motorcyclists. The holistic approach is shown to reduce the serious injury risk considerably more than each of the safety efforts considered individually. These results promote the use of a safe system approach to motorcycling safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents.

PubMed

Gemzell-Danielsson, Kristina; Buhling, Kai J; Dermout, Sylvia M; Lukkari-Lax, Eeva; Montegriffo, Elaine; Apter, Dan

2016-06-01

To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5mg (average approximate release rate 8μg/24h over the first year; LNG-IUS 8; Jaydess®) in adolescents. In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17years) received LNG-IUS 8 for 12months. The primary outcome was the incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included: serious TEAEs, adverse events of special interest, overall user satisfaction, discontinuation rate at 12months, and Pearl Index. LNG-IUS 8 placement was successful in 303/304 participants (99.7%). Overall, 82.6% of participants reported TEAEs, and serious TEAEs and serious study drug-related TEAEs were reported by 7.6% and 1.0% of participants, respectively. No cases of pelvic inflammatory disease, ectopic pregnancy, or uterine perforation were reported. No pregnancies were reported during the 12-month study. At Month 12/study end, the overall user satisfaction rate was 83.9%. Overall, 51 participants (16.8%) prematurely discontinued the study before 12months; 13.8% of participants discontinued owing to TEAEs. No new or unexpected safety events were associated with the low-dose LNG-IUS 8. The safety profile of LNG-IUS 8 in adolescents was consistent with that previously reported in adults. The high overall user-satisfaction rate at study end and the low discontinuation rate over 12months demonstrate that LNG-IUS 8 is a highly acceptable contraceptive method among adolescents. This study is the first to assess the low-dose levonorgestrel intrauterine system LNG-IUS 8 (average approximate release rate 8μg/24h over the first year and total content 13.5mg) specifically in females<18years of age and confirms the safety and efficacy of LNG-IUS 8 in an adolescent population. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

The Digital School Library: A World-Wide Development and a Fascinating Challenge.

ERIC Educational Resources Information Center

Loertscher, David

2003-01-01

Explores the academic environment of a total information system for school libraries based on the idea of a digital intranet. Discusses safety; customization; the core library collection; curriculum-specific collections; access to short-term resources; Internet access; personalized features; search engines; equity issues; and staffing. (LRW)

Investigating the influence on safety of retrofitting Italian motorways with barriers meeting a new EU standard.

PubMed

Cafiso, Salvatore; D'Agostino, Carmelo; Persaud, Bhagwant

2017-04-03

A new European Union (EU) regulation for safety barriers, which is based on performance, has encouraged road agencies to perform an upgrade of old barriers, with the expectation that there will be safety benefits at the retrofitted sites. The new class of barriers was designed and installed in compliance with the 1998 (European Norm) EN 1317 standards for road restraint systems, which lays down common requirements for the testing and certification of road restraint systems in all countries of the European Committee for Standardization (CEN). Both the older and new barriers are made of steel and are installed in such a way as to avoid vehicle intrusion, but the older ones are thought to be only effective at low speeds and large angles of impact. The new standard seeks to remedy this by providing better protection at higher speeds. This article seeks to quantify the effect on the frequency of fatal and injury crashes of retrofitting motorways with barriers meeting the new standards. The estimation of the crash modification was carried out by performing an empirical Bayes before-after analysis based on data from the A18 Messina-Catania motorway in Italy. The methodology has the great advantage to account for the regression to the mean effects. Besides, to account for time trend effects and dispersion of crash data, a modified calibration methodology of safety performance was used. This study, based on data collected on 76 km of motorway in the period 2000-2012, derived Crash Modification Factor point estimates that indicate reductions of 72% for run-off-road fatal and injury crashes and 38% in total fatal and injury crashes that could be expected by upgrading an old safety barrier by complying with new EU 1317 standards. The estimated benefit-cost ratio of 5.57 for total crashes indicates that the treatment is cost effective. The magnitude of this benefit indicates that the retrofits are cost-effective even for total crashes and should continue in any European country inasmuch as the estimated Crash Modification Factors are based on treatment sites that are reasonably representative of all European motorways.

Sociotechnical factors influencing unsafe use of hospital information systems: A qualitative study in Malaysian government hospitals.

PubMed

Salahuddin, Lizawati; Ismail, Zuraini; Hashim, Ummi Rabaah; Raja Ikram, Raja Rina; Ismail, Nor Haslinda; Naim Mohayat, Mohd Hariz

2018-03-01

The objective of this study is to identify factors influencing unsafe use of hospital information systems in Malaysian government hospitals. Semi-structured interviews with 31 medical doctors in three Malaysian government hospitals implementing total hospital information systems were conducted between March and May 2015. A thematic qualitative analysis was performed on the resultant data to deduce the relevant themes. A total of five themes emerged as the factors influencing unsafe use of a hospital information system: (1) knowledge, (2) system quality, (3) task stressor, (4) organization resources, and (5) teamwork. These qualitative findings highlight that factors influencing unsafe use of a hospital information system originate from multidimensional sociotechnical aspects. Unsafe use of a hospital information system could possibly lead to the incidence of errors and thus raises safety risks to the patients. Hence, multiple interventions (e.g. technology systems and teamwork) are required in shaping high-quality hospital information system use.

Fire Safety Analysis of the Polar Icebreaker Replacement Design. Volume 2

DTIC Science & Technology

1987-10-01

report. ; iote : At t tne -3f incident only five or sx men were aboard: therefore, they could not atterrot to attack a fire of this intensmtp t hemse I...fire extinguisher (PKP) AUTOMATIC: A1301 Halon 1301 total flooding system - remotely actuated AF AFFF (3%) sprinkler system - remotely actuated AFM...simulate wind effects, we have found that its judicious use along with the vent and shaft routines allows for the modelling of simple HVAC systems

Seniors managing multiple medications: using mixed methods to view the home care safety lens.

PubMed

Lang, Ariella; Macdonald, Marilyn; Marck, Patricia; Toon, Lynn; Griffin, Melissa; Easty, Tony; Fraser, Kimberly; MacKinnon, Neil; Mitchell, Jonathan; Lang, Eddy; Goodwin, Sharon

2015-12-12

Patient safety is a national and international priority with medication safety earmarked as both a prevalent and high-risk area of concern. To date, medication safety research has focused overwhelmingly on institutional based care provided by paid healthcare professionals, which often has little applicability to the home care setting. This critical gap in our current understanding of medication safety in the home care sector is particularly evident with the elderly who often manage more than one chronic illness and a complex palette of medications, along with other care needs. This study addresses the medication management issues faced by seniors with chronic illnesses, their family, caregivers, and paid providers within Canadian publicly funded home care programs in Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS). Informed by a socio-ecological perspective, this study utilized Interpretive Description (ID) methodology and participatory photographic methods to capture and analyze a range of visual and textual data. Three successive phases of data collection and analysis were conducted in a concurrent, iterative fashion in eight urban and/or rural households in each province. A total of 94 participants (i.e., seniors receiving home care services, their family/caregivers, and paid providers) were interviewed individually. In addition, 69 providers took part in focus groups. Analysis was iterative and concurrent with data collection in that each interview was compared with subsequent interviews for converging as well as diverging patterns. Six patterns were identified that provide a rich portrayal of the complexity of medication management safety in home care: vulnerabilities that impact the safe management and storage of medication, sustaining adequate supports, degrees of shared accountability for care, systems of variable effectiveness, poly-literacy required to navigate the system, and systemic challenges to maintaining medication safety in the home. There is a need for policy makers, health system leaders, care providers, researchers, and educators to work with home care clients and caregivers on three key messages for improvement: adapt care delivery models to the home care landscape; develop a palette of user-centered tools to support medication safety in the home; and strengthen health systems integration.

The effect of touch-key size on the usability of In-Vehicle Information Systems and driving safety during simulated driving.

PubMed

Kim, Heejin; Kwon, Sunghyuk; Heo, Jiyoon; Lee, Hojin; Chung, Min K

2014-05-01

Investigating the effect of touch-key size on usability of In-Vehicle Information Systems (IVISs) is one of the most important research issues since it is closely related to safety issues besides its usability. This study investigated the effects of the touch-key size of IVISs with respect to safety issues (the standard deviation of lane position, the speed variation, the total glance time, the mean glance time, the mean time between glances, and the mean number of glances) and the usability of IVISs (the task completion time, error rate, subjective preference, and NASA-TLX) through a driving simulation. A total of 30 drivers participated in the task of entering 5-digit numbers with various touch-key sizes while performing simulated driving. The size of the touch-key was 7.5 mm, 12.5 mm, 17.5 mm, 22.5 mm and 27.5 mm, and the speed of driving was set to 0 km/h (stationary state), 50 km/h and 100 km/h. As a result, both the driving safety and the usability of the IVISs increased as the touch-key size increased up to a certain size (17.5 mm in this study), at which they reached asymptotes. We performed Fitts' law analysis of our data, and this revealed that the data from the dual task experiment did not follow Fitts' law. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Wireless Laser Range Finder System for Vertical Displacement Monitoring of Mega-Trusses during Construction

PubMed Central

Park, Hyo Seon; Son, Sewook; Choi, Se Woon; Kim, Yousok

2013-01-01

As buildings become increasingly complex, construction monitoring using various sensors is urgently needed for both more systematic and accurate safety management and high-quality productivity in construction. In this study, a monitoring system that is composed of a laser displacement sensor (LDS) and a wireless sensor node was proposed and applied to an irregular building under construction. The subject building consists of large cross-sectional members, such as mega-columns, mega-trusses, and edge truss, which secured the large spaces. The mega-trusses and edge truss that support this large space are of the cantilever type. The vertical displacement occurring at the free end of these members was directly measured using an LDS. To validate the accuracy and reliability of the deflection data measured from the LDS, a total station was also employed as a sensor for comparison with the LDS. In addition, the numerical simulation result was compared with the deflection obtained from the LDS and total station. Based on these investigations, the proposed wireless displacement monitoring system was able to improve the construction quality by monitoring the real-time behavior of the structure, and the applicability of the proposed system to buildings under construction for the evaluation of structural safety was confirmed. PMID:23648650

[The INSuLa Project: the survey of training needs in the SPSAL(Service for Prevention and Safety in the Work Environment)].

PubMed

Martini, Agnese; Iavicoli, Sergio; Bonafede, Michela; Corso, Luca; Iosuel, Michela; Isolani, Lucia; Di Leone, Giorgio; Di Marzio, Davide; Bertazzi, Pier Alberto

2014-01-01

According to Italian Legislative Decree 81/2008 and subsequent modifications the Regions and Autonomous Provinces have a innovative and complex role: 1) to regulate and coordinate the total prevention system and 2) to develop interventions/initiatives through regional/local occupational safety and health (OSH) department using not only inspections and controls but education, training and support. Recommendations also include consolidating the role of actors involved in preventing risks to occupational health throughout occupational safety and health education and training, keys for a successful process to improve prevention system. As result of changing world of work and OSH legislation the INSuLa project has creating a national survey involving of all Italian prevention system actors, in order to evaluate implementation and impact of the actual regulations. According to overall objective of the INSuLA project, for the first time in Italy, we studied about operators in regional/local OSH department. The purpose of this paper is to show and recognize the individual learning paths, the perception of adequacy education degree, the exploring criticalities andthe training needs.

Occupational health and safety in China: the case of state-managed enterprises.

PubMed

Chen, Meei-Shia; Chan, Anita

2010-01-01

The widely held image, inside and outside China, of the total absence of an occupational health and safety (OHS) system in that country is not an accurate picture. This article argues that the unsafe working conditions and prevalent occupational diseases and injuries widely reported in the Chinese and foreign media occur mostly in private mines and in the Asian foreign-funded and domestic private manufacturing sectors. In contrast, the capital-intensive, larger state-owned enterprises and enterprises that have been transformed from state enterprises generally have better OHS systems. An in-depth study of two such enterprises reveals viable OHS systems, worker-management OHS committees, regular health and safety inspections, and trade unions' and workers congresses' oversight and supervision. Above all, there is an enterprise culture that regards accidents as avoidable, and both workers and management feel distressed and guilty when accidents happen. The authors believe it is important to acknowledge and champion these positive examples of "best practices" that can be emulated in workplaces throughout China, which is under great pressure from competitive domestic and global forces to relax its OHS standards.

Performability evaluation of the SIFT computer

NASA Technical Reports Server (NTRS)

Meyer, J. F.; Furchtgott, D. G.; Wu, L. T.

1979-01-01

Performability modeling and evaluation techniques are applied to the SIFT computer as it might operate in the computational evironment of an air transport mission. User-visible performance of the total system (SIFT plus its environment) is modeled as a random variable taking values in a set of levels of accomplishment. These levels are defined in terms of four attributes of total system behavior: safety, no change in mission profile, no operational penalties, and no economic process whose states describe the internal structure of SIFT as well as relavant conditions of the environment. Base model state trajectories are related to accomplishment levels via a capability function which is formulated in terms of a 3-level model hierarchy. Performability evaluation algorithms are then applied to determine the performability of the total system for various choices of computer and environment parameter values. Numerical results of those evaluations are presented and, in conclusion, some implications of this effort are discussed.

Shielded Metal Arc Welding. Welding Module 4. Instructor's Guide.

ERIC Educational Resources Information Center

Missouri Univ., Columbia. Instructional Materials Lab.

This guide is intended to assist vocational educators in teaching an eight-unit module in shielded metal arc welding. The module is part of a welding curriculum that has been designed to be totally integrated with Missouri's Vocational Instruction Management System. The following topics are covered in the module: safety; theory, power sources, and…

Basic Welding Skills. Welding Module 1. Instructor's Guide.

ERIC Educational Resources Information Center

Missouri Univ., Columbia. Instructional Materials Lab.

This guide is intended to assist vocational educators in teaching a six-unit module in basic welding skills. The module is part of a welding curriculum that has been designed to be totally integrated with Missouri's Vocational Instruction Management System. The following topics are covered in the module: the welding profession, personal safety,…

Effect of the implementation of HACCP on the microbiological quality of meals at a university restaurant.

PubMed

Cenci-Goga, B T; Ortenzi, R; Bartocci, E; Codega de Oliveira, A; Clementi, F; Vizzani, A

2005-01-01

A study was conducted to evaluate the microbiological quality, including total mesophilic counts and markers of bacteriological hygiene, as indicator of food safety of three categories of the most consumed meals in a university restaurant, before and after implementation of the HACCP system and personnel training. Cold gastronomy products, cooked warm-served products, and cooked cold-served products were tested for bacterial contamination. Throughout the experiment, 894 samples were examined for total counts of aerobic bacteria, counts of indicator organisms (coliform organisms and Escherichia coli) and pathogens (Staphylococcus aureus, Bacillus cereus, Salmonella spp., and Listeria monocytogenes). Implementation of the HACCP system, together with training in personnel hygiene, good manufacturing practices, and cleaning and sanitation procedures, resulted in lower aerobic plate counts and a lower incidence of S. aureus, coliform organisms, E. coli, and B. cereus, whereas Salmonella spp. and L. monocytogenes were not found in all samples studied. The microbial results of this study demonstrate that personnel training together with HACCP application contributed to improve the food safety of meals served in the restaurant studied.

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

PubMed

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.

[Implementation of a form for adverse effect notification: results for the 1st year].

PubMed

Pérez Blanco, Verónica; Rubio Gómez, Isabel; Alarcón Gascueña, Piedad; Mateos Rubio, José; Herradón Cano, Matilde; Delgado García, Amadeo

2009-02-01

To describe the introduction of an incident monitoring system by electronic reporting in the Complejo Hospitalario de Toledo (CHT) and to analyse the initial results. CHT is a public hospital with 750 beds, 59 for critical patients, an ambulatory surgery unit and three outpatient clinics. Access to the electronic reporting system is on the main screen of the hospital intranet. The reporting system is voluntary and confidential. It was introduced at the same time as setting up website on clinical safety and the provision of specific training on the subject. A total of 62 reports were received on the electronic system over a period of 12 months (December 2006 to December 2007), of which 74.5% were reported by nursing staff. The service from where it was reported most often was Geriatrics (43.1%). Most of the incidents were classified by the notifiers themselves as "no injury" (64.7%) and as "avoidable" 92.2%. A total of 56.9% were related to care. Some reports led to the issuing of three documents of recommendations by the Quality Unit and the Pharmacy Department. Most of the notifications were incidents related to care and were reported by nurses. The reporting system can complement other tools in promoting a clinical safety culture and defining the risk profile of a health organisation.

Use of car crashes resulting in fatal and serious injuries to analyze a safe road transport system model and to identify system weaknesses.

PubMed

Stigson, Helena; Hill, Julian

2009-10-01

The objective of this study was to evaluate a model for a safe road transport system, based on some safety performance indicators regarding the road user, the vehicle, and the road, by using crashes with fatally and seriously injured car occupants. The study also aimed to evaluate whether the model could be used to identify system weaknesses and components (road user, vehicles, and road) where improvements would yield the highest potential for further reductions in serious injuries. Real-life car crashes with serious injury outcomes (Maximum Abbreviated Injury Scale 2+) were classified according to the vehicle's safety rating by Euro NCAP (European New Car Assessment Programme) and whether the vehicle was fitted with ESC (Electronic Stability Control). For each crash, the road was also classified according to EuroRAP (European Road Assessment Programme) criteria, and human behavior in terms of speeding, seat belt use, and driving under the influence of alcohol/drugs. Each crash was compared and classified according to the model criteria. Crashes where the safety criteria were not met in more than one of the 3 components were reclassified to identify whether all the components were correlated to the injury outcome. In-depth crash injury data collected by the UK On The Spot (OTS) accident investigation project was used in this study. All crashes in the OTS database occurring between 2000 and 2005 with a car occupant with injury rated MAIS2+ were included, for a total of 101 crashes with 120 occupants. It was possible to classify 90 percent of the crashes according to the model. Eighty-six percent of the occupants were injured when more than one of the 3 components were noncompliant with the safety criteria. These cases were reclassified to identify whether all of the components were correlated to the injury outcome. In 39 of the total 108 cases, at least two components were still seen to interact. The remaining cases were only related to one of the safety criteria, namely, the road user (26), the vehicle (19), and the road (24). The criteria for the road and the vehicle did not address multiple event crashes, rear-end crashes, hitting stationary/parked vehicles, or trailers. The model for a safe road transport system was found useful to classify fatal and serious road vehicle crashes. It was possible to classify 90 percent of the crashes according to the safety road transport model. For all these cases it was possible to identify weaknesses and parts of the road transport system with the highest potential to prevent fatal and serious injuries. Injury outcomes were mostly related to an interaction between the 3 components: the road, the vehicle, and the road user.

Safety, tolerability, and systemic absorption of dapivirine vaginal microbicide gel in healthy, HIV-negative women.

PubMed

Nel, Annalene M; Coplan, Paul; van de Wijgert, Janneke H; Kapiga, Saidi H; von Mollendorf, Claire; Geubbels, Eveline; Vyankandondera, Joseph; Rees, Helen V; Masenga, Gileard; Kiwelu, Ireen; Moyes, Jocelyn; Smythe, Shanique C

2009-07-31

To assess the local and systemic safety of dapivirine vaginal gel vs. placebo gel as well as the systemic absorption of dapivirine in healthy, HIV-negative women. Two prospective, randomized, double-blind, placebo-controlled phase I/II studies were conducted at five research centers, four in Africa and one in Belgium. A total of 119 women used dapivirine gel (concentrations of 0.001, 0.002, 0.005, or 0.02%), and 28 used placebo gel twice daily for 42 days. The primary endpoints were colposcopic findings, adverse events, Division of AIDS grade 3 or grade 4 laboratory values, and plasma levels of dapivirine. Safety data were similar for the dapivirine and placebo gels. None of the adverse events with incidence more than 5% occurred with greater frequency in the dapivirine than placebo groups. Similar percentages of placebo and dapivirine gel users had adverse events that were considered by the investigator to be related to study gel. A total of five serious adverse events occurred in the two studies, and none was assessed as related to study gel. Mean plasma concentrations of dapivirine were approximately dose proportional, and, within each dose group, mean concentrations were similar on days 7, 28, and 42. The maximum observed mean concentration was 474 pg/ml in the 0.02% gel group on day 28. Two weeks after the final application of study gel, mean concentrations decreased to 5 pg/ml or less. Twice daily administration of dapivirine vaginal gel for 42 days was safe and well tolerated with low systemic absorption in healthy, HIV-negative women suggesting that continued development is warranted.

Water Safety Plan on cruise ships: a promising tool to prevent waterborne diseases.

PubMed

Mouchtouri, Varvara A; Bartlett, Christopher L R; Diskin, Arthur; Hadjichristodoulou, Christos

2012-07-01

Legionella spp. and other waterborne pathogens have been isolated from various water systems on land based premises as well as on ships and cases of Legionnaires' disease have been associated with both sites. Peculiarities of cruise ships water systems make the risk management a challenging process. The World Health Organization suggests a Water Safety Plan (WSP) as the best approach to mitigate risks and hazards such as Legionella spp. and others. To develop WSP on a cruise ship and discuss challenges, perspectives and key issues to success. Hazards and hazardous events were identified and risk assessment was conducted of the ship water system. Ship company management, policies and procedures were reviewed, site visits were conducted, findings and observations were recorded and discussed with engineers and key crew members were interviewed. A total of 53 hazards and hazardous events were taken into consideration for the risk assessment and additional essential barriers were established when needed. Most of them concerned control measures for biofilm development and Legionella spp. contamination. A total of 29 operational limits were defined. Supplementary verification and supportive programs were established. Application of the WSP to ship water systems, including potable water, recreational water facilities and decorative water features and fountains, is expected to improve water management on ships. The success of a WSP depends on support from senior management, commitment of the Captain and crew members, correct execution of all steps of a risk assessment and practicality and applicability in routine operation. The WSP provides to shipping industry a new approach and a move toward evidence based water safety policy. Copyright © 2012 Elsevier B.V. All rights reserved.

Nanotechnology and textiles engineered by carbon nanotubes for the realization of advanced personal protective equipments

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

Andretta, Antonio, E-mail: Antonio-Andretta@klopman.com; Terranova, Maria Letizia; Lavecchia, Teresa

2014-06-19

Carbon nanotubes (CNT) and CNT-based active materials have been used to assemble the gas sensing unit of innovative platforms able to detect toxic atmospheres developing in confined workplaces. The main goal of the project was to realize a full-featured, operator-friendly safety detection and monitoring system based on multifunctional textiles nanotechnologies. The fabricated sensing platform consists of a multiple gas detector coupled with a specifically designed telecommunication infrastructure. The portable device, totally integrated in the workwear, offers several advantages over the conventional safety tools employed in industrial work activities.

Nanotechnology and textiles engineered by carbon nanotubes for the realization of advanced personal protective equipments

NASA Astrophysics Data System (ADS)

Andretta, Antonio; Terranova, Maria Letizia; Lavecchia, Teresa; Gay, Stefano; Picano, Alfredo; Mascioletti, Alessandro; Stirpe, Daniele; Cucchiella, Cristian; Pascucci, Eddy; Dugnani, Giovanni; Gatti, Davide; Laria, Giuseppe; Codenotti, Barbara; Maldini, Giorgio; Roth, Siegmar; Passeri, Daniele; Rossi, Marco; Tamburri, Emanuela

2014-06-01

Carbon nanotubes (CNT) and CNT-based active materials have been used to assemble the gas sensing unit of innovative platforms able to detect toxic atmospheres developing in confined workplaces. The main goal of the project was to realize a full-featured, operator-friendly safety detection and monitoring system based on multifunctional textiles nanotechnologies. The fabricated sensing platform consists of a multiple gas detector coupled with a specifically designed telecommunication infrastructure. The portable device, totally integrated in the workwear, offers several advantages over the conventional safety tools employed in industrial work activities.

Patient Safety Leadership WalkRounds.

PubMed

Frankel, Allan; Graydon-Baker, Erin; Neppl, Camilla; Simmonds, Terri; Gustafson, Michael; Gandhi, Tejal K

2003-01-01

In the WalkRounds concept, a core group, which includes the senior executives and/or vice presidents, conducts weekly visits to different areas of the hospital. The group, joined by one or two nurses in the area and other available staff, asks specific questions about adverse events or near misses and about the factors or systems issues that led to these events. ANALYSIS OF EVENTS: Events in the Walkrounds are entered into a database and classified according to the contributing factors. The data are aggregated by contributing factors and priority scores to highlight the root issues. The priority scores are used to determine QI pilots and make best use of limited resources. Executives are surveyed quarterly about actions they have taken as a direct result of WalkRounds and are asked what they have learned from the rounds. As of September 2002, 47 Patient Safety Leadership WalkRounds visited a total of 48 different areas of the hospital, with 432 individual comments. The WalkRounds require not only knowledgeable and invested senior leadership but also a well-organized support structure. Quality and safety personnel are needed to collect data and maintain a database of confidential information, evaluate the data from a systems approach, and delineate systems-based actions to improve care delivery. Comments of frontline clinicians and executives suggested that WalkRounds helps educate leadership and frontline staff in patient safety concepts and will lead to cultural changes, as manifested in more open discussion of adverse events and an improved rate of safety-based changes.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

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

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

PubMed Central

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient. PMID:26345628

Relative Ball 3X-VSR reactivity strength DR reactor. Interim Report of PT IP-126-C

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

Simpson, D.E.

1959-06-01

Prior to this experiment, no measurements of Ball 3X effectiveness had been performed for any of the older 2004-tube Hanford piles, and calculations concerning total control requirements were made assuming the vertical safety system strength equal to the strength of the B, D, F vertical safety rods. With current and projected enrichment loadings, the vertical control system was calculated to be inadequate to satisfy the total control criteria at all times, resulting in the necessity to provide supplementary control in the form of horizontal rods or temporary process tube poison. Because of the larger ball channels at DR, the Ballmore » 3X system is stronger than at the other 29-VSR piles. Therefore, the potential relaxation of total control limits was greater for DR should an experiment show the Ball 3X strength to be significantly greater than the B, D, F VSR strength. PT-IP-126-C authorized an experiment to determine the Ball 3X effectiveness at DR Pile by measurement of the relative strength of a VSR and a column of 3X balls in the same channel. The experiment was performed in March, 1958, and on the strength of favorable results a supplement to the PT was prepared to authorize the same test at one of the other 29-VSR piles. This supplement has not been approved; therefore, the results of the DR test are being reported separately in this document.« less

Causal Factors and Adverse Events of Aviation Accidents and Incidents Related to Integrated Vehicle Health Management

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Briggs, Jeffrey L.; Evans, Joni K.; Jones, Sharon M.; Kurtoglu, Tolga; Leone, Karen M.; Sandifer, Carl E.

2011-01-01

Causal factors in aviation accidents and incidents related to system/component failure/malfunction (SCFM) were examined for Federal Aviation Regulation Parts 121 and 135 operations to establish future requirements for the NASA Aviation Safety Program s Integrated Vehicle Health Management (IVHM) Project. Data analyzed includes National Transportation Safety Board (NSTB) accident data (1988 to 2003), Federal Aviation Administration (FAA) incident data (1988 to 2003), and Aviation Safety Reporting System (ASRS) incident data (1993 to 2008). Failure modes and effects analyses were examined to identify possible modes of SCFM. A table of potential adverse conditions was developed to help evaluate IVHM research technologies. Tables present details of specific SCFM for the incidents and accidents. Of the 370 NTSB accidents affected by SCFM, 48 percent involved the engine or fuel system, and 31 percent involved landing gear or hydraulic failure and malfunctions. A total of 35 percent of all SCFM accidents were caused by improper maintenance. Of the 7732 FAA database incidents affected by SCFM, 33 percent involved landing gear or hydraulics, and 33 percent involved the engine and fuel system. The most frequent SCFM found in ASRS were turbine engine, pressurization system, hydraulic main system, flight management system/flight management computer, and engine. Because the IVHM Project does not address maintenance issues, and landing gear and hydraulic systems accidents are usually not fatal, the focus of research should be those SCFMs that occur in the engine/fuel and flight control/structures systems as well as power systems.

GLM Post Launch Testing and Airborne Science Field Campaign

NASA Astrophysics Data System (ADS)

Goodman, S. J.; Padula, F.; Koshak, W. J.; Blakeslee, R. J.

2017-12-01

The Geostationary Operational Environmental Satellite (GOES-R) series provides the continuity for the existing GOES system currently operating over the Western Hemisphere. The Geostationary Lightning Mapper (GLM) is a wholly new instrument that provides a capability for total lightning detection (cloud and cloud-to-ground flashes). The first satellite in the GOES-R series, now GOES-16, was launched in November 2016 followed by in-orbit post launch testing for approximately 12 months before being placed into operations replacing the GOES-E satellite in December. The GLM will map total lightning continuously throughout day and night with near-uniform spatial resolution of 8 km with a product latency of less than 20 sec over the Americas and adjacent oceanic regions. The total lightning is very useful for identifying hazardous and severe thunderstorms, monitoring storm intensification and tracking evolution. Used in tandem with radar, satellite imagery, and surface observations, total lightning data has great potential to increase lead time for severe storm warnings, improve aviation safety and efficiency, and increase public safety. In this paper we present initial results from the post-launch in-orbit performance testing, airborne science field campaign conducted March-May, 2017 and assessments of the GLM instrument and science products.

Preliminary stochastic model for managing Vibrio parahaemolyticus and total viable bacterial counts in a Pacific oyster (Crassostrea gigas) supply chain.

PubMed

Fernandez-Piquer, Judith; Bowman, John P; Ross, Tom; Estrada-Flores, Silvia; Tamplin, Mark L

2013-07-01

Vibrio parahaemolyticus can accumulate and grow in oysters stored without refrigeration, representing a potential food safety risk. High temperatures during oyster storage can lead to an increase in total viable bacteria counts, decreasing product shelf life. Therefore, a predictive tool that allows the estimation of both V. parahaemolyticus populations and total viable bacteria counts in parallel is needed. A stochastic model was developed to quantitatively assess the populations of V. parahaemolyticus and total viable bacteria in Pacific oysters for six different supply chain scenarios. The stochastic model encompassed operations from oyster farms through consumers and was built using risk analysis software. Probabilistic distributions and predictions for the percentage of Pacific oysters containing V. parahaemolyticus and high levels of viable bacteria at the point of consumption were generated for each simulated scenario. This tool can provide valuable information about V. parahaemolyticus exposure and potential control measures and can help oyster companies and regulatory agencies evaluate the impact of product quality and safety during cold chain management. If coupled with suitable monitoring systems, such models could enable preemptive action to be taken to counteract unfavorable supply chain conditions.

[Assessing the economic impact of adverse events in Spanish hospitals by using administrative data].

PubMed

Allué, Natalia; Chiarello, Pietro; Bernal Delgado, Enrique; Castells, Xavier; Giraldo, Priscila; Martínez, Natalia; Sarsanedas, Eugenia; Cots, Francesc

2014-01-01

To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010. A retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. This study included 245,320 episodes with a total cost of 1,308,791,871€. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between €5,260 and €11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was € 88,268,906, amounting to an additional 6.7% of total health expenditure. Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System. Copyright © 2013 SESPAS. Published by Elsevier Espana. All rights reserved.

Frontline worker perceptions of medication safety in India

PubMed Central

Sharma, Sangeeta; Tabassum, Fauzia; Khurana, Sarbjeet; Kapoor, Kaveri

2016-01-01

Background: To explore interprofessionals’ perceptions about patient safety, particularly medication safety and associated factors and barriers. Methods: A total of 389 respondents were recruited using convenience sample in the cross sectional survey. Results: Medication safety was perceived as somewhat safe (60%). One-third of respondents witnessed 3–4 or more medication errors (MEs) within the past 1 year. Out of that, one quarter were reportedly, sentinel events. More sentinel events were witnessed in public hospitals and solo practice clinics compared with corporate hospitals and nursing homes (p < 0.02). No difference was observed in the occurrence of sentinel events in accredited and nonaccredited facilities (p = 0.30). Younger respondents witnessed more MEs, whereas accredited hospitals (mostly corporate hospitals) witnessed significantly fewer MEs and graded overall safety as ‘better’. However, most MEs go unreported particularly in solo practice clinics (88%) followed by nursing homes (67%), public hospitals (54%), and corporate hospitals (42%). Error identification and subsequent disclosure was inhibited by several system factors: fear of punitive action and lack of reporting systems. General surgical (46%), medical (42%), and paediatric units (36%), were the most error-prone places. Documentation diverted all healthcare workers from direct patient care. Many doctors and pharmacists from nursing homes, solo clinics and public hospitals reported working overtime. Staff shortages and poor training were overwhelming concerns to all healthcare workers and in public hospitals. Solo clinics and nursing homes perceived more barriers; lack of reporting systems, standard protocol, and resources for patient safety and unfamiliarity with prescribed medications was their overwhelming concern. Other factors threatening MEs were a lack of team approach and openness in interdisciplinary communications, illegible medical orders, and medicines prescribed by brand names. Conclusions: Immediate interventions to improve medication safety include enforcement of legible/printed medical orders in generic names, workforce development, developing standard protocols, and a corresponding change in organizational culture. Accreditation can serve as a driver for improving patient safety. PMID:27904743

[Risk management in anesthesia and critical care medicine].

PubMed

Eisold, C; Heller, A R

2017-03-01

Throughout its history, anesthesia and critical care medicine has experienced vast improvements to increase patient safety. Consequently, anesthesia has never been performed on such a high level as it is being performed today. As a result, we do not always fully perceive the risks involved in our daily activity. A survey performed in Swiss hospitals identified a total of 169 hot spots which endanger patient safety. It turned out that there is a complex variety of possible errors that can only be tackled through consistent implementation of a safety culture. The key elements to reduce complications are continuing staff education, algorithms and standard operating procedures (SOP), working according to the principles of crisis resource management (CRM) and last but not least the continuous work-up of mistakes identified by critical incident reporting systems.

Facing the Recession: How Did Safety-Net Hospitals Fare Financially Compared with Their Peers?

PubMed Central

Reiter, Kristin L; Jiang, H Joanna; Wang, Jia

2014-01-01

Objective To examine the effect of the recession on the financial performance of safety-net versus non-safety-net hospitals. Data Sources/Study Setting Agency for Healthcare Research and Quality Hospital Cost and Utilization Project State Inpatient Databases, Medicare Cost Reports, American Hospital Association Annual Survey, InterStudy, and Area Health Resource File. Study Design Retrospective, longitudinal panel of hospitals, 2007–2011. Safety-net hospitals were identified using percentage of patients who were Medicaid or uninsured. Generalized estimating equations were used to estimate average effects of the recession on hospital operating and total margins, revenues and expenses in each year, 2008–2011, comparing safety-net with non-safety-net hospitals. Data Collection/Extraction Methods 1,453 urban, nonfederal, general acute hospitals in 32 states with complete data. Principal Findings Safety-net hospitals, as identified in 2007, had lower operating and total margins. The gap in operating margin between safety-net and non-safety-net hospitals was sustained throughout the recession; however, total margin was more negatively affected for non-safety-net hospitals in 2008. Higher percentages of Medicaid and uninsured patients were associated with lower revenue in private hospitals in all years, and lower revenue and expenses in public hospitals in 2011. Conclusions Safety-net hospitals may not be disproportionately vulnerable to macro-economic fluctuations, but their significantly lower margins leave less financial cushion to weather sustained financial pressure. PMID:25220012

Economic analysis of an internet-based depression prevention intervention.

PubMed

Ruby, Alexander; Marko-Holguin, Monika; Fogel, Joshua; Van Voorhees, Benjamin W

2013-09-01

The transition through adolescence places adolescents at increased risk of depression, yet care-seeking in this population is low, and treatment is often ineffective. In response, we developed an Internet-based depression prevention intervention (CATCH-IT) targeting at-risk adolescents. We explore CATCH-IT program costs, especially safety costs, in the context of an Accountable Care Organization as well as the perceived value of the Internet program. Total and per-patient costs of development were calculated using an assumed cohort of a 5,000-patient Accountable Care Organization. Total and per-patient costs of implementation were calculated from grant data and the Medicare Resource-Based Relative Value Scale (RBRVS) and were compared to the willingness-to-pay for CATCH-IT and to the cost of current treatment options. The cost effectiveness of the safety protocol was assessed using the number of safety calls placed and the percentage of patients receiving at least one safety call. The willingness-to-pay for CATCH-IT, a measure of its perceived value, was assessed using post-study questionnaires and was compared to the development cost for a break-even point. We found the total cost of developing the intervention to be USD 138,683.03. Of the total, 54% was devoted to content development with per patient cost of USD 27.74. The total cost of implementation was found to be USD 49,592.25, with per patient cost of USD 597.50. Safety costs accounted for 35% of the total cost of implementation. For comparison, the cost of a 15-session group cognitive behavioral therapy (CBT) intervention aimed at at-risk adolescents was USD 1,632 per patient. Safety calls were successfully placed to 96.4% of the study participants. The cost per call was USD 40.51 with a cost per participant of USD 197.99. The willingness-to-pay for the Internet portion of CATCH-IT had a median of USD 40. The break-even point to offset the cost of development was 3,468 individuals. Developing Internet-based interventions like CATCH-IT appears economically viable in the context of an Accountable Care Organization. Furthermore, while the cost of implementing an effective safety protocol is proportionally high for this intervention, CATCH-IT is still significantly cheaper to implement than current treatment options. Limitations of this research included diminished participation in follow-up surveys assessing willingness-to-pay. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE AND HEALTH POLICIES: This research emphasizes that preventive interventions have the potential to be cheaper to implement than treatment protocols, even before taking into account lost productivity due to illness. Research such as this business application analysis of the CATCH-IT program highlights the importance of supporting preventive medical interventions as the healthcare system already does for treatment interventions. This research is the first to analyze the economic costs of an Internet-based intervention. Further research into the costs and outcomes of such interventions is certainly warranted before they are widely adopted. Furthermore, more research regarding the safety of Internet-based programs will likely need to be conducted before they are broadly accepted.

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

PubMed Central

2014-01-01

Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection.

PubMed

Xu, Rong; Wang, QuanQiu

2014-01-15

Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

Gas Metal Arc Welding. Welding Module 5. Instructor's Guide.

ERIC Educational Resources Information Center

Missouri Univ., Columbia. Instructional Materials Lab.

This guide is intended to assist vocational educators in teaching an eight-unit module in gas metal arc welding. The module is part of a welding curriculum that has been designed to be totally integrated with Missouri's Vocational Instruction Management System. The following topics are covered in the module: safety and testing, gas metal arc…

Anthropometry of Infants, Children, and Youths to Age 18 for Product Safety Design. Final Report.

ERIC Educational Resources Information Center

Snyder, Richard G.; And Others

A total of 87 traditional and functional body measurements were taken on a sample of 4,127 infants, children, and youths representing the U.S. population aged two weeks through 18 years. Measurements were taken throughout the United States by two teams of anthropometrists using an automated anthropometric data acquisition system. Standard…

Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial.

PubMed

Nelson, Anita; Apter, Dan; Hauck, Brian; Schmelter, Thomas; Rybowski, Sarah; Rosen, Kimberly; Gemzell-Danielsson, Kristina

2013-12-01

To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems. Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems: 13.5 mg total content or 19.5 mg total content. The primary outcome was the pregnancy rate, calculated as the Pearl Index. Overall, 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups, respectively, had a placement attempted and were included in the full analysis set to evaluate efficacy and safety. Mean (standard deviation) age was 27.1 (4.8) years; 39.2% were nulliparous. Over the 3-year study period, 0.33 pregnancies per 100 women-years (95% confidence interval [CI] 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI 0.15-0.57) with the 19.5 mg intrauterine contraceptive system. Kaplan-Meier estimates for that period were 0.009 and 0.010, respectively. At least partial expulsions occurred in 4.56% and 3.58% and discontinuation rates resulting from a reported adverse event occurred in 21.9% and 19.1%, respectively. Ten of the 20 pregnancies were ectopic. Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation. Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00528112. : I.

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.

Perceptions of health care professionals on the safety and security at Odi District Hospital, Gauteng, South Africa

PubMed Central

Okeke, Sunday O.

2017-01-01

Background For optimum delivery of service, an establishment needs to ensure a safe and secure environment. In 2011, the South African government promulgated the National Core Standards for Health Establishments for safety and security for all employees in all establishments. Little is known about whether these standards are being complied to. Aim and setting: To assess the perceptions of health care professionals (HCPs) on safety and security at Odi District Hospital. Methodology A sample of 181 out of a total of 341 HCPs was drawn through a systematic sampling method from each HCP category. Data were collected through a self-administered questionnaire. The SPSS® statistical software version 22 was used for data analysis. The level of statistical significance was set at < 0.05. Results There were more female respondents than male respondents (136; 75.10%). The dominant age group was 28–47 years (114; 57.46%). Perceptions on security personnel, their efficiency and the security system were significantly affirmed (p = 0.0001). The hospital infrastructure, surroundings and plan in emergencies were perceived to be safe (p < 0.0001). The hospital lighting system was perceived as inadequate (p = 0.0041). Only 36 (20.2%) HCPs perceived that hospital authorities were concerned about employees’ safety (p < 0.0001). Conclusion HCPs had positive perceptions regarding the hospital’s security system. Except for the negative perceptions of the lighting system and the perceived lack of hospital authorities’ concern for staff safety, perceptions of the HCPs on the hospital working environment were positive. The hospital authorities need to establish the basis of negative perceptions and enforce remedial measures to redress them. PMID:29113444

Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

PubMed

Qureshi, Zaina P; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Stevenson, Kurt B; Szeinbach, Sheryl L

2011-07-01

Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal. There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals). Approximately one in seven approved NMEs were discontinued from the market in the period of 1980-2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society. Copyright © 2011 John Wiley & Sons, Ltd.

The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

PubMed

Pratesi, Giovanni; Pratesi, Carlo; Chiesa, Roberto; Coppi, Gioacchino; Scheinert, Dierk; Brunkwall, Jan S; van der Meulen, Stefaan; Torsello, Giovanni

2017-10-01

This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.

System cost/performance analysis (study 2.3). Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

Kazangey, T.

1973-01-01

The relationships between performance, safety, cost, and schedule parameters were identified and quantified in support of an overall effort to generate program models and methodology that provide insight into a total space vehicle program. A specific space vehicle system, the attitude control system (ACS), was used, and a modeling methodology was selected that develops a consistent set of quantitative relationships among performance, safety, cost, and schedule, based on the characteristics of the components utilized in candidate mechanisms. These descriptive equations were developed for a three-axis, earth-pointing, mass expulsion ACS. A data base describing typical candidate ACS components was implemented, along with a computer program to perform sample calculations. This approach, implemented on a computer, is capable of determining the effect of a change in functional requirements to the ACS mechanization and the resulting cost and schedule. By a simple extension of this modeling methodology to the other systems in a space vehicle, a complete space vehicle model can be developed. Study results and recommendations are presented.

Efficacy and safety of the remOVE System for OTSC® and FTRD® clip removal: data from a PMCF analysis.

PubMed

Caputo, Antonio; Schmidt, Arthur; Caca, Karel; Bauerfeind, Peter; Schostek, Sebastian; Ho, Chi-Nghia; Gottwald, Thomas; Schurr, Marc O

2018-06-01

The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system. A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip. Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%). Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.

Westinghouse Hanford Company health and safety performance report. Fourth quarter calendar year 1994

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

Lansing, K.A.

1995-03-01

Detailed information pertaining to As Low As Reasonably Achievable/Contamination Control Improvement Project (ALARA/CCIP) activities are outlined. Improved commitment to the WHC ALARA/CCIP Program was experienced throughout FY 1994. During CY 1994, 17 of 19 sitewide ALARA performance goals were completed on or ahead of schedule. Estimated total exposure by facility for CY 1994 is listed in tables by organization code for each dosimeter frequency. Facilities/areas continue to utilize the capabilities of the RPR tracking system in conjunction with the present site management action-tracking system to manage deficiencies, trend performance, and develop improved preventive efforts. Detailed information pertaining to occupational injuries/illnessesmore » are provided. The Industrial Safety and Hygiene programs are described which have generated several key initiatives that are believed responsible for improved safety performance. A breakdown of CY 1994 occupational injuries/illnesses by type, affected body group, cause, job type, age/gender, and facility is provided. The contributing experience of each WHC division/department in attaining this significant improvement is described along with tables charting specific trends. The Radiological Control Program is on schedule to meet all RL Site Management System milestones and program commitments.« less

Accuracy and safety of ward based pleural ultrasound in the Australian healthcare system.

PubMed

Hammerschlag, Gary; Denton, Matthew; Wallbridge, Peter; Irving, Louis; Hew, Mark; Steinfort, Daniel

2017-04-01

Ultrasound has been shown to improve the accuracy and safety of pleural procedures. Studies to date have been performed in large, specialized units, where pleural procedures are performed by a small number of highly specialized physicians. There are no studies examining the safety and accuracy of ultrasound in the Australian healthcare system where procedures are performed by junior doctors with a high staff turnover. We performed a retrospective review of the ultrasound database in the Respiratory Department at the Royal Melbourne Hospital to determine accuracy and complications associated pleural procedures. A total of 357 ultrasounds were performed between October 2010 and June 2013. Accuracy of pleural procedures was 350 of 356 (98.3%). Aspiration of pleural fluid was successful in 121 of 126 (96%) of patients. Two (0.9%) patients required chest tube insertion for management of pneumothorax. There were no recorded pleural infections, haemorrhage or viscera puncture. Ward-based ultrasound for pleural procedures is safe and accurate when performed by appropriately trained and supported junior medical officers. Our findings support this model of pleural service care in the Australian healthcare system. © 2016 Asian Pacific Society of Respirology.

A drive through Web 2.0: an exploration of driving safety promotion on Facebook™.

PubMed

Apatu, Emma J I; Alperin, Melissa; Miner, Kathleen R; Wiljer, David

2013-01-01

This study explored Facebook™ to capture the prevalence of driving safety promotion user groups, obtain user demographic information, to understand if Facebook™ user groups influence reported driving behaviors, and to gather a sense of perceived effectiveness of Facebook™ for driving safety promotion targeted to young adults. In total, 96 driving safety Facebook™ groups (DSFGs) were identified with a total of 33,368 members, 168 administrators, 156 officers, 1,598 wall posts representing 12 countries. A total of 85 individuals participated in the survey. Demographic findings of this study suggest that driving safety promotion can be targeted to young and older adults. Respondents' ages ranged from 18 to 66 years. A total of 62% of respondents aged ≤ 24 years and 57.8% of respondents aged ≥ 25 years reported changing their driving-related behaviors as a result of reading information on the DSFGs to which they belonged. A higher proportion of respondents ≥ 25 years were significantly more likely to report Facebook™ and YouTube™ as an effective technology for driving safety promotion. This preliminary study indicates that DSFGs may be effective tools for driving safety promotion among young adults. More research is needed to understand the cognition of Facebook™ users as it relates to adopting safe driving behavior. The findings from this study present descriptive data to guide public health practitioners for future health promotion activities on Facebook™.

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

[Process orientation as a tool of strategic approaches to corporate governance and integrated management systems].

PubMed

Sens, Brigitte

2010-01-01

The concept of general process orientation as an instrument of organisation development is the core principle of quality management philosophy, i.e. the learning organisation. Accordingly, prestigious quality awards and certification systems focus on process configuration and continual improvement. In German health care organisations, particularly in hospitals, this general process orientation has not been widely implemented yet - despite enormous change dynamics and the requirements of both quality and economic efficiency of health care processes. But based on a consistent process architecture that considers key processes as well as management and support processes, the strategy of excellent health service provision including quality, safety and transparency can be realised in daily operative work. The core elements of quality (e.g., evidence-based medicine), patient safety and risk management, environmental management, health and safety at work can be embedded in daily health care processes as an integrated management system (the "all in one system" principle). Sustainable advantages and benefits for patients, staff, and the organisation will result: stable, high-quality, efficient, and indicator-based health care processes. Hospitals with their broad variety of complex health care procedures should now exploit the full potential of total process orientation. Copyright © 2010. Published by Elsevier GmbH.

Safety Precautions for Total Release Foggers

EPA Pesticide Factsheets

Total release foggers, also known as bug bombs, are pesticide products containing aerosol propellants that release their contents at once to fumigate an area. They can pose a hazard if used incorrectly. Find safety information and videos on this page.

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

The Italian National Health Service expenditure on workplace prevention and safety (2006-2013): a national-level analysis.

PubMed

Signorelli, C; Riccò, M; Odone, A

2016-01-01

The World Health Organization (WHO) stated that countries' health policies should give high priority to primary prevention of occupational health hazards. Scant data are available on health expenditure on workplace prevention and safety services and on its impact on occupational health outcomes in Italy and in other European countries. objective of the present study was to systematically retrieve, analyse and critically appraise the available national-level data on public health expenditure on workplace prevention and safety services as well as to correlate them with occupational health outcomes. National-level data on total public health expenditure on prevention services, its share spent on workplace prevention and safety services as well as on number of workers receiving appropriate health surveillance were derived from the national public health expenditure monitoring system over a 8-year study period (2006-2013). An analytic approach was adopted to explore the association between health expenditure and occupational health services supply. The Italian National Health Service spends almost € 5 billion per year on preventive care, of which 13.3% are spent on workplace prevention and safety programmes (€ 645 million, € 10.6 per capita). There is wide heterogeneity between Italian regions. Our findings are useful for health systems and policies analysis, national and international comparisons as well as for health policy makers to plan, implement and monitor occupational health prevention programmes.

Improving homogeneity by dynamic speed limit systems.

PubMed

van Nes, Nicole; Brandenburg, Stefan; Twisk, Divera

2010-05-01

Homogeneity of driving speeds is an important variable in determining road safety; more homogeneous driving speeds increase road safety. This study investigates the effect of introducing dynamic speed limit systems on homogeneity of driving speeds. A total of 46 subjects twice drove a route along 12 road sections in a driving simulator. The speed limit system (static-dynamic), the sophistication of the dynamic speed limit system (basic roadside, advanced roadside, and advanced in-car) and the situational condition (dangerous-non-dangerous) were varied. The homogeneity of driving speed, the rated credibility of the posted speed limit and the acceptance of the different dynamic speed limit systems were assessed. The results show that the homogeneity of individual speeds, defined as the variation in driving speed for an individual subject along a particular road section, was higher with the dynamic speed limit system than with the static speed limit system. The more sophisticated dynamic speed limit system tested within this study led to higher homogeneity than the less sophisticated systems. The acceptance of the dynamic speed limit systems used in this study was positive, they were perceived as quite useful and rather satisfactory. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

Evaluating the road safety effects of a fuel cost increase measure by means of zonal crash prediction modeling.

PubMed

Pirdavani, Ali; Brijs, Tom; Bellemans, Tom; Kochan, Bruno; Wets, Geert

2013-01-01

Travel demand management (TDM) consists of a variety of policy measures that affect the transportation system's effectiveness by changing travel behavior. The primary objective to implement such TDM strategies is not to improve traffic safety, although their impact on traffic safety should not be neglected. The main purpose of this study is to evaluate the traffic safety impact of conducting a fuel-cost increase scenario (i.e. increasing the fuel price by 20%) in Flanders, Belgium. Since TDM strategies are usually conducted at an aggregate level, crash prediction models (CPMs) should also be developed at a geographically aggregated level. Therefore zonal crash prediction models (ZCPMs) are considered to present the association between observed crashes in each zone and a set of predictor variables. To this end, an activity-based transportation model framework is applied to produce exposure metrics which will be used in prediction models. This allows us to conduct a more detailed and reliable assessment while TDM strategies are inherently modeled in the activity-based models unlike traditional models in which the impact of TDM strategies are assumed. The crash data used in this study consist of fatal and injury crashes observed between 2004 and 2007. The network and socio-demographic variables are also collected from other sources. In this study, different ZCPMs are developed to predict the number of injury crashes (NOCs) (disaggregated by different severity levels and crash types) for both the null and the fuel-cost increase scenario. The results show a considerable traffic safety benefit of conducting the fuel-cost increase scenario apart from its impact on the reduction of the total vehicle kilometers traveled (VKT). A 20% increase in fuel price is predicted to reduce the annual VKT by 5.02 billion (11.57% of the total annual VKT in Flanders), which causes the total NOCs to decline by 2.83%. Copyright © 2012 Elsevier Ltd. All rights reserved.

The magnetic navigation system allows safety and high efficacy for ablation of arrhythmias.

PubMed

Bauernfeind, Tamas; Akca, Ferdi; Schwagten, Bruno; de Groot, Natasja; Van Belle, Yves; Valk, Suzanne; Ujvari, Barbara; Jordaens, Luc; Szili-Torok, Tamas

2011-07-01

We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities. In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15±9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P=0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P=0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P=ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P<0.05). Less fluoroscopy was used in group MNS (30±20 vs. 35±25 min, P<0.01). There were no differences in procedure times and recurrence rates for the overall groups (168±67 vs. 159±75 min, P=ns; 14 vs. 11%, P=ns; respectively). Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs.

Serving up food safety: who wants a piece of the pie?

PubMed

Schmidt, C W

2001-07-01

A total of 12 federal agencies, plus their state counterparts, contribute to the regulatory snarl that governs the safety of the American food supply. With so much federal oversight, one might expect U.S. foods to be virtually risk-free. But this is hardly the case; contaminated food is responsible for 75 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. Recent reports from the General Accounting Office and the National Research Council claim that creation of a single agency with centralized authority is the best solution to U.S. food safety problems. Some experts agree that regulatory gaps in food safety highlight the need for centralized leadership, and that more money is necessary to fund the number of inspectors needed to adequately inspect the food supply before it reaches consumers. The single-agency concept has garnered congressional, industry, and scientific support, but the idea isn't without its skeptics, who believe that consolidating food safety under a single agency eliminates checks and balances offered by the current system and, more importantly, runs the risk of politicizing the agency.

Intelligent Engine Systems: Thermal Management and Advanced Cooling

NASA Technical Reports Server (NTRS)

Bergholz, Robert

2008-01-01

The objective is to provide turbine-cooling technologies to meet Propulsion 21 goals related to engine fuel burn, emissions, safety, and reliability. Specifically, the GE Aviation (GEA) Advanced Turbine Cooling and Thermal Management program seeks to develop advanced cooling and flow distribution methods for HP turbines, while achieving a substantial reduction in total cooling flow and assuring acceptable turbine component safety and reliability. Enhanced cooling techniques, such as fluidic devices, controlled-vortex cooling, and directed impingement jets, offer the opportunity to incorporate both active and passive schemes. Coolant heat transfer enhancement also can be achieved from advanced designs that incorporate multi-disciplinary optimization of external film and internal cooling passage geometry.

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

Formal Verification of Safety Buffers for Sate-Based Conflict Detection and Resolution

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Jeannin, Jean-Baptiste; Munoz, Cesar A.

2010-01-01

The information provided by global positioning systems is never totally exact, and there are always errors when measuring position and velocity of moving objects such as aircraft. This paper studies the effects of these errors in the actual separation of aircraft in the context of state-based conflict detection and resolution. Assuming that the state information is uncertain but that bounds on the errors are known, this paper provides an analytical definition of a safety buffer and sufficient conditions under which this buffer guarantees that actual conflicts are detected and solved. The results are presented as theorems, which were formally proven using a mechanical theorem prover.

Economic comparison of conventional maintenance and electrochemical oxidation to warrant water safety in dental unit water lines.

PubMed

Fischer, Sebastian; Meyer, Georg; Kramer, Axel

2012-01-01

In preparation for implementation of a central water processing system at a dental department, we analyzed the costs of conventional decentralized disinfection of dental units against a central water treatment concept based on electrochemical disinfection. The cost evaluation included only the costs of annually required antimicrobial consumables and additional water usage of a decentralize conventional maintenance system for dental water lines build in the respective dental units and the central electrochemical water disinfection system, BLUE SAFETY™ Technologies. In total, analysis of costs of 6 dental departments reviled additional annual costs for hygienic preventive measures of € 4,448.37. For the BLUE SAFETY™ Technology, the additional annual total agent consumption costs were € 2.18, accounting for approximately 0.05% of the annual total agent consumption costs of the conventional maintenance system. For both water processing concepts, the additional costs for energy could not be calculated, since the required data was not obtainable from the manufacturers. For both concepts, the investment and maintenance costs were not calculated due to lack of manufacturer's data. Therefore, the results indicate the difference of costs for the required consumables only. Aside of the significantly lower annual costs for required consumables and disinfectants; a second advantage for the BLUE SAFETY™ Technology is its constant and automatic operation, which does not require additional staff resources. This not only safety human resources, but add additionally to cost saving. Since the antimicrobial disinfection capacity of the BLUE SAFETY™ was demonstrated previously and is well known, this technology, which is comparable or even superior in its non-corrosive effect, may be regarded as method of choice for continuous disinfection and prevention of biofilm formation in dental units' water lines.

Economic comparison of conventional maintenance and electrochemical oxidation to warrant water safety in dental unit water lines

PubMed Central

Fischer, Sebastian; Meyer, Georg; Kramer, Axel

2012-01-01

Background: In preparation for implementation of a central water processing system at a dental department, we analyzed the costs of conventional decentralized disinfection of dental units against a central water treatment concept based on electrochemical disinfection. Methods: The cost evaluation included only the costs of annually required antimicrobial consumables and additional water usage of a decentralize conventional maintenance system for dental water lines build in the respective dental units and the central electrochemical water disinfection system, BLUE SAFETY™ Technologies. Results: In total, analysis of costs of 6 dental departments reviled additional annual costs for hygienic preventive measures of € 4,448.37. For the BLUE SAFETY™ Technology, the additional annual total agent consumption costs were € 2.18, accounting for approximately 0.05% of the annual total agent consumption costs of the conventional maintenance system. For both water processing concepts, the additional costs for energy could not be calculated, since the required data was not obtainable from the manufacturers. Discussion: For both concepts, the investment and maintenance costs were not calculated due to lack of manufacturer's data. Therefore, the results indicate the difference of costs for the required consumables only. Aside of the significantly lower annual costs for required consumables and disinfectants; a second advantage for the BLUE SAFETY™ Technology is its constant and automatic operation, which does not require additional staff resources. This not only safety human resources, but add additionally to cost saving. Conclusion: Since the antimicrobial disinfection capacity of the BLUE SAFETY™ was demonstrated previously and is well known, this technology, which is comparable or even superior in its non-corrosive effect, may be regarded as method of choice for continuous disinfection and prevention of biofilm formation in dental units’ water lines. PMID:22558042

Advancing Well-Being Through Total Worker Health®.

PubMed

Schill, Anita L

2017-04-01

Total Worker Health® (TWH) is a paradigm-shifting approach to safety, health, and well-being in the workplace. It is defined as policies, programs, and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. The most current TWH concepts are presented, including a description of issues relevant to TWH and introduction of a hierarchy of controls applied to TWH. Total Worker Health advocates for a foundation of safety and health through which work can contribute to higher levels of well-being.

Comparing the Affordable Care Act's Financial Impact on Safety-Net Hospitals in States That Expanded Medicaid and Those That Did Not.

PubMed

Dobson, Allen; DaVanzo, Joan E; Haught, Randy; Phap-Hoa, Luu

2017-11-01

Safety-net hospitals play a vital role in delivering health care to Medicaid enrollees, the uninsured, and other vulnerable patients. By reducing the number of uninsured Americans, the Affordable Care Act (ACA) was also expected to lower these hospitals’ significant uncompensated care costs and shore up their financial stability. To examine how the ACA’s Medicaid expansion affected the financial status of safety-net hospitals in states that expanded Medicaid and in states that did not. Using Medicare hospital cost reports for federal fiscal years 2012 and 2015, the authors compared changes in Medicaid inpatient days as a percentage of total inpatient days, Medicaid revenues as a percentage of total net patient revenues, uncompensated care costs as a percentage of total operating costs, and hospital operating margins. Medicaid expansion had a significant, favorable financial impact on safety-net hospitals. From 2012 to 2015, safety-net hospitals in expansion states, compared to those in nonexpansion states, experienced larger increases in Medicaid inpatient days and Medicaid revenues as well as reduced uncompensated care costs. These changes improved operating margins for safety-net hospitals in expansion states. Margins for safety-net hospitals in nonexpansion states, meanwhile, declined.

The influence of total flight time, recent flight time and age on pilot accident rates

DOT National Transportation Integrated Search

1983-06-30

This paper presents initial finding from a research effort conducted for the Safety Analysis Dvision, Office of Aviation Safety, Federal Aviation Administration (FAA). The analysis considers the influence of recent pilot flight time, total pilot flig...

Integration of Active and Passive Safety Technologies--A Method to Study and Estimate Field Capability.

PubMed

Hu, Jingwen; Flannagan, Carol A; Bao, Shan; McCoy, Robert W; Siasoco, Kevin M; Barbat, Saeed

2015-11-01

The objective of this study is to develop a method that uses a combination of field data analysis, naturalistic driving data analysis, and computational simulations to explore the potential injury reduction capabilities of integrating passive and active safety systems in frontal impact conditions. For the purposes of this study, the active safety system is actually a driver assist (DA) feature that has the potential to reduce delta-V prior to a crash, in frontal or other crash scenarios. A field data analysis was first conducted to estimate the delta-V distribution change based on an assumption of 20% crash avoidance resulting from a pre-crash braking DA feature. Analysis of changes in driver head location during 470 hard braking events in a naturalistic driving study found that drivers' head positions were mostly in the center position before the braking onset, while the percentage of time drivers leaning forward or backward increased significantly after the braking onset. Parametric studies with a total of 4800 MADYMO simulations showed that both delta-V and occupant pre-crash posture had pronounced effects on occupant injury risks and on the optimal restraint designs. By combining the results for the delta-V and head position distribution changes, a weighted average of injury risk reduction of 17% and 48% was predicted by the 50th percentile Anthropomorphic Test Device (ATD) model and human body model, respectively, with the assumption that the restraint system can adapt to the specific delta-V and pre-crash posture. This study demonstrated the potential for further reducing occupant injury risk in frontal crashes by the integration of a passive safety system with a DA feature. Future analyses considering more vehicle models, various crash conditions, and variations of occupant characteristics, such as age, gender, weight, and height, are necessary to further investigate the potential capability of integrating passive and DA or active safety systems.

Analysis of National Major Work Safety Accidents in China, 2003–2012

PubMed Central

YE, Yunfeng; ZHANG, Siheng; RAO, Jiaming; WANG, Haiqing; LI, Yang; WANG, Shengyong; DONG, Xiaomei

2016-01-01

Background: This study provides a national profile of major work safety accidents in China, which cause more than 10 fatalities per accident, intended to provide scientific basis for prevention measures and strategies to reduce major work safety accidents and deaths. Methods: Data from 2003–2012 Census of major work safety accidents were collected from State Administration of Work Safety System (SAWS). Published literature and statistical yearbook were also included to implement information. We analyzed the frequency of accidents and deaths, trend, geographic distribution and injury types. Additionally, we discussed the severity and urgency of emergency rescue by types of accidents. Results: A total of 877 major work safety accidents were reported, resulting in 16,795 deaths and 9,183 injuries. The numbers of accidents and deaths, mortality rate and incidence of major accidents have declined in recent years. The mortality rate and incidence was 0.71 and 1.20 per 106 populations in 2012, respectively. Transportation and mining contributed to the highest number of major accidents and deaths. Major aviation and railway accidents caused more casualties per incident, while collapse, machinery, electrical shock accidents and tailing dam accidents were the most severe situation that resulted in bigger proportion of death. Conclusion: Ten years’ major work safety accident data indicate that the frequency of accidents and number of eaths was declined and several safety concerns persist in some segments. PMID:27057515

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

PubMed Central

Zhao, Wenle; Pauls, Keith

2015-01-01

Background Centralized outcome adjudication has been used widely in multi-center clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network’s data management center within a homegrown clinical trial management system. In this paper, the system design strategy and database structure are presented. Methods A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. Results By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer one or two days. A total of 7,336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. Conclusions A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. PMID:26464429

Comparison of the Safety of Seven Iodinated Contrast Media

PubMed Central

Seong, Jong-Mi; Choi, Nam-Kyong; Lee, Joongyub; Chang, Yoosoo; Kim, Ye-Jee; Yang, Bo Ram; Jin, Xue-Mei; Kim, Ju-Young

2013-01-01

We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety. PMID:24339697

Assessment of heavy metals exposure, noise and thermal safety in the ambiance of a vacuum metallurgy separation system for recycling heavy metals from crushed e-wastes.

PubMed

Zhan, Lu; Xu, Zhenming

2014-12-01

Vacuum metallurgy separation (VMS) is a technically feasible method to recover Pb, Cd and other heavy metals from crushed e-wastes. To further determine the environmental impacts and safety of this method, heavy metals exposure, noise and thermal safety in the ambiance of a vacuum metallurgy separation system are evaluated in this article. The mass concentrations of total suspended particulate (TSP) and PM10 are 0.1503 and 0.0973 mg m(-3) near the facilities. The concentrations of Pb, Cd and Sn in TSP samples are 0.0104, 0.1283 and 0.0961 μg m(-3), respectively. Health risk assessments show that the hazard index of Pb is 3.25 × 10(-1) and that of Cd is 1.09 × 10(-1). Carcinogenic risk of Cd through inhalation is 1.08 × 10(-5). The values of the hazard index and risk indicate that Pb and Cd will not cause non-cancerous effects or carcinogenic risk on workers. The noise sources are mainly the mechanical vacuum pump and the water cooling pump. Both of them have the noise levels below 80 dB (A). The thermal safety assessment shows that the temperatures of the vacuum metallurgy separation system surface are all below 303 K after adopting the circulated water cooling and heat insulation measures. This study provides the environmental information of the vacuum metallurgy separation system, which is of assistance to promote the industrialisation of vacuum metallurgy separation for recovering heavy metals from e-wastes. © The Author(s) 2014.

Mindful Application of Aviation Practices in Healthcare.

PubMed

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

2017-12-01

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

An Index For Rating the Total Secondary Safety of Vehicles from Real World Crash Data

PubMed Central

Newstead, S.; Watson, L.; Cameron, M.

2007-01-01

This study proposes a total secondary safety index for light passenger vehicles that rates the relative performance of vehicles in protecting both their own occupants and other road users in the full range of real world crash circumstances. The index estimates the risk of death or serious injury to key road users in crashes involving light passenger vehicles across the full range of crash types. The proposed index has been estimated from real world crash data from Australasia and was able to identify vehicles that have superior or inferior total secondary safety characteristics compared with the average vehicle. PMID:18184497

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

An empirical survey of the benefits of implementing pay for safety scheme (PFSS) in the Hong Kong construction industry.

PubMed

Chan, Daniel W M; Chan, Albert P C; Choi, Tracy N Y

2010-10-01

The Government of the Hong Kong Special Administrative Region (SAR) has implemented different safety initiatives to improve the safety performance of the construction industry over the past decades. The Pay for Safety Scheme (PFSS), which is one of the effective safety measures launched by the government in 1996, has been widely adopted in the public works contracts. Both the accident rate and fatality rate of public sector projects have decreased noticeably over this period. This paper aims to review the current state of application of PFSS in Hong Kong, and attempts to identify and analyze the perceived benefits of PFSS in construction via an industry-wide empirical questionnaire survey. A total of 145 project participants who have gained abundant hands-on experience with the PFSS construction projects were requested to complete a survey questionnaire to indicate the relative importance of those benefits identified in relation to PFSS. The perceived benefits were measured and ranked from the perspectives of the client and contractor for crosscomparison. The survey findings suggested the most significant benefits derived from adopting PFSS were: (a) Increased safety training; (b) Enhanced safety awareness; (c) Encouragement of developing safety management system; and (d) Improved safety commitment. A wider application of PFSS should be advocated so as to achieve better safety performance within the construction industry. It is recommended that a similar scheme to the PFSS currently adopted in Hong Kong may be developed for implementation in other regions or countries for international comparisons. Copyright © 2010 Elsevier Ltd and National Safety Council. All rights reserved.

Systemic safety project selection tool.

DOT National Transportation Integrated Search

2013-07-01

"The Systemic Safety Project Selection Tool presents a process for incorporating systemic safety planning into traditional safety management processes. The Systemic Tool provides a step-by-step process for conducting systemic safety analysis; conside...

The comparative efficacy and safety of topical and intravenous tranexamic acid for reducing perioperative blood loss in Total knee arthroplasty- A randomized controlled non-inferiority trial.

PubMed

George, Jefferson; Eachempati, Krishna Kiran; Subramanyam, Koushik Narayan; Gurava Reddy, A V

2018-01-01

Total Knee Arthroplasty (TKA) can be associated with significant perioperative blood loss and blood transfusions. This is a prospective randomised non-inferiority trial comparing intraarticular (IA) and intravenous (IV) routes of administering Tranexamic acid (TXA) with regard to efficacy and safety. A total of 113 patients who underwent primary unilateral TKA from January to June 2017 randomly received either 1.5g TXA in 100mL normal saline solution (IA group, n=58) or 10mg/kg TXA (IV group, n=55) at 10min before the tourniquet inflation and at tourniquet release. Haemoglobin (Hb) drop on third day (primary outcome), visible blood loss (VBL), hidden blood loss (HBL), total blood loss (TBL), transfusion requirement, incidence of deep vein thrombosis (DVT), wound complications and renal function derangement (secondary outcomes) were recorded. The mean difference in haemoglobin drop between both groups was 0.25g/dL with 90% CI of -0.07 to 0.58. Since the lower bound of 90% CI was above equivalence margin of -0.35, IA group was found to be non-inferior to IV group in terms of Hb drop. The mean difference between both groups of VBL, HBL and TBL were 0.85mL (p value 0.90), -7.9mL (p value 0.90) and -6.2mL (p value 0.93) respectively. Transfusions and wound complications were statistically insignificant. None of the patients had DVT or renal function derangement. IA TXA is not inferior to IV TXA with regard to efficacy and safety and may be preferred considering ease of administration and lack of systemic absorption. Copyright © 2017 Elsevier B.V. All rights reserved.

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

PubMed

Saikali, Melody; Tanios, Alain; Saab, Antoine

2017-11-21

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

Macroeconomic fluctuations and motorcycle fatalities in the U.S.

PubMed

French, Michael T; Gumus, Gulcin

2014-03-01

The effects of business cycles on health outcomes in general, and on traffic fatalities in particular, have received much attention recently. In this paper, we focus on motorcycle safety and examine the impact of changing levels of economic activity on fatal crashes by motorcyclists in the United States. We analyze state-level longitudinal data with 1,104 state/year observations from the 1988-2010 Fatality Analysis Reporting System (FARS). Using the extensive motorcycle crash characteristics available in FARS, we examine not only total fatality rates but also rates decomposed by crash type, day, time, and the level of the motorcycle operator's blood alcohol content. Our results are consistent with much of the existing literature showing that traffic fatality rates are pro-cyclical. The estimates suggest that a 10% increase in real income per capita is associated with a 10.4% rise in the total motorcycle fatality rate. Along with potential mechanisms, policymakers and public health officials should consider the effects of business cycles on motorcycle safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The safety management system must document the responsible person's— (1) Safety and pollution prevention...

Pupils' Perceptions of Safety at School

ERIC Educational Resources Information Center

Cowie, Helen; Oztug, Ozhan

2008-01-01

The research reported in this article was carried out in four secondary schools, two with a peer support system (PS) and two without (NPS) and involved a total of 931 pupils, (49.5 per cent males, and 50.5 per cent females). Participants were aged between 11 and 15 years of age, mean age 12.8 years. The aim was to compare the perceptions of safety…

Advanced Life Support System Value Metric

NASA Technical Reports Server (NTRS)

Jones, Harry W.; Arnold, James O. (Technical Monitor)

1999-01-01

The NASA Advanced Life Support (ALS) Program is required to provide a performance metric to measure its progress in system development. Extensive discussions within the ALS program have reached a consensus. The Equivalent System Mass (ESM) metric has been traditionally used and provides a good summary of the weight, size, and power cost factors of space life support equipment. But ESM assumes that all the systems being traded off exactly meet a fixed performance requirement, so that the value and benefit (readiness, performance, safety, etc.) of all the different systems designs are exactly equal. This is too simplistic. Actual system design concepts are selected using many cost and benefit factors and the system specification is then set accordingly. The ALS program needs a multi-parameter metric including both the ESM and a System Value Metric (SVM). The SVM would include safety, maintainability, reliability, performance, use of cross cutting technology, and commercialization potential. Another major factor in system selection is technology readiness level (TRL), a familiar metric in ALS. The overall ALS system metric that is suggested is a benefit/cost ratio, [SVM + TRL]/ESM, with appropriate weighting and scaling. The total value is the sum of SVM and TRL. Cost is represented by ESM. The paper provides a detailed description and example application of the suggested System Value Metric.

Development of a low risk augmentation system for an energy efficient transport having relaxed static stability

NASA Technical Reports Server (NTRS)

Sizlo, T. R.; Berg, R. A.; Gilles, D. L.

1979-01-01

An augmentation system for a 230 passenger, twin engine aircraft designed with a relaxation of conventional longitudinal static stability was developed. The design criteria are established and candidate augmentation system control laws and hardware architectures are formulated and evaluated with respect to reliability, flying qualities, and flight path tracking performance. The selected systems are shown to satisfy the interpreted regulatory safety and reliability requirements while maintaining the present DC 10 (study baseline) level of maintainability and reliability for the total flight control system. The impact of certification of the relaxed static stability augmentation concept is also estimated with regard to affected federal regulations, system validation plan, and typical development/installation costs.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

[Evaluation of the risk of delayed adverse effects of chronic combined exposure to radiation and chemical factors with the purpose to ensure safety in orbital and exploration space missions].

PubMed

Shafirkin, A V; Mukhamedieva, L N; Tatarkin, S V; Barantseva, M Iu

2012-01-01

The work had the aim to anatomize the existing issues with providing safety in extended orbital and exploration missions for ensuing estimation of actual values of the total radiation risk for the crew, and risks of other delayed effects of simultaneous exposure to ionizing radiation and chemical pollutants in cabin air, and a number of other stressful factors inevitable in space flight. The flow of chronic experiments for separate and combined studies with reproduction of air makeup and radiation doses in actual orbital and predicted exploration missions is outlined. To set safety limits, new approaches should be applied to the description of gradual norm degradation to pathologies in addition to several generalized quantitative indices of adaptation and straining of the regulatory systems, as well as of effectiveness of the compensatory body reserve against separate and combined exposure.

Compliance of middle school-aged babysitters in central Pennsylvania with national recommendations for emergency preparedness and safety practices.

PubMed

Hackman, Nicole M; Cass, Katie; Olympia, Robert P

2012-06-01

To determine the compliance of middle school-aged babysitters with national recommendations for emergency preparedness and safety practices. A prospective, self-administered questionnaire-based study was conducted at 3 middle schools in central Pennsylvania. A total of 1364 questionnaires were available for analysis. Responding babysitters (n = 890) reported previous training that included babysitter (21%), first aid (64%), and cardiopulmonary resuscitation (59%) training. Reported unsafe babysitter practices were leaving a child unattended (36%) and opening the door to a stranger (24%). The most common emergency experience encountered by responding babysitters included cut or scrape (83%), burns (28%), and choking (14%). Ten percent of responding babysitters have activated the 911 system. Middle school-aged babysitters will likely encounter common household emergencies and therefore benefit from first aid training; however, very little difference in safety knowledge was found between trained and untrained babysitters, suggesting modifications in babysitter training programs may be required.

The structure and emerging trends of construction safety management research: a bibliometric review.

PubMed

Liang, Huakang; Zhang, Shoujian; Su, Yikun

2018-03-29

Recently, construction safety management (CSM) practices and systems have become important topics for stakeholders to take care of human resources. However, few studies have attempted to map the global research on CSM. A comprehensive bibliometric review was conducted in this study based on multiple methods. In total, 1172 CSM-related papers from the Web of Science Core Collection database were examined. The analyses focused on publication year, country-institute, publication source, author and research topics. The results indicated that the USA, China, Australia and the UK took leading positions in CSM research. Two branches of journals were identified, namely the branch of engineering science and that of safety science and social science. Additionally, seven themes together with 28 specific topics were detected to allow researchers to track the main structure and temporal evolution of CSM research. Finally, the main research trends and potential research directions were discussed to guide the future research.

Upgrading the fuel-handling machine of the Novovoronezh nuclear power plant unit no. 5

NASA Astrophysics Data System (ADS)

Terekhov, D. V.; Dunaev, V. I.

2014-02-01

The calculation of safety parameters was carried out in the process of upgrading the fuel-handling machine (FHM) of the Novovoronezh nuclear power plant (NPP) unit no. 5 based on the results of quantitative safety analysis of nuclear fuel transfer operations using a dynamic logical-and-probabilistic model of the processing procedure. Specific engineering and design concepts that made it possible to reduce the probability of damaging the fuel assemblies (FAs) when performing various technological operations by an order of magnitude and introduce more flexible algorithms into the modernized FHM control system were developed. The results of pilot operation during two refueling campaigns prove that the total reactor shutdown time is lowered.

16 CFR 1209.8 - Procedure for calibration of radiation instrumentation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard § 1209.8 Procedure... radiation pyrometer. Repeat for each temperature. (b) Total heat flux meter. The total flux meter shall be... meter. This latter calibration shall make use of the radiant panel tester as the heat source...

16 CFR 1209.8 - Procedure for calibration of radiation instrumentation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard § 1209.8 Procedure... radiation pyrometer. Repeat for each temperature. (b) Total heat flux meter. The total flux meter shall be... meter. This latter calibration shall make use of the radiant panel tester as the heat source...

16 CFR 1209.8 - Procedure for calibration of radiation instrumentation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard § 1209.8 Procedure... radiation pyrometer. Repeat for each temperature. (b) Total heat flux meter. The total flux meter shall be... meter. This latter calibration shall make use of the radiant panel tester as the heat source...

16 CFR 1209.8 - Procedure for calibration of radiation instrumentation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard § 1209.8 Procedure... radiation pyrometer. Repeat for each temperature. (b) Total heat flux meter. The total flux meter shall be... meter. This latter calibration shall make use of the radiant panel tester as the heat source...

Safety Alerts: An Observational Study in Portugal.

PubMed

Soares, Sara; Roque, Fátima; Teixeira Rodrigues, António; Figueiras, Adolfo; Herdeiro, Maria Teresa

2015-09-01

The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

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

ERIC Educational Resources Information Center

Garner, Ana C.

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

Commentary: Status of road safety in Asia.

PubMed

Wismans, Jac; Skogsmo, Ingrid; Nilsson-Ehle, Anna; Lie, Anders; Thynell, Marie; Lindberg, Gunnar

2016-01-01

The objective of this article is to assess the status of road safety in Asia and present accident and injury prevention strategies based on global road safety improvement experiences and discuss the way forward by indicating opportunities and countermeasures that could be implemented to achieve a new level of safety in Asia. This study provides a review and analyses of data in the literature, including from the World Health Organization (WHO) and World Bank, and a review of lessons learned from best practices in high-income countries. In addition, an estimation of costs due to road transport injuries in Asia and review of future trends in road transport is provided. Data on the global and Asian road safety problem and status of prevention strategies in Asia as well as recommendations for future actions are discussed. The total number of deaths due to road accidents in the 24 Asian countries, encompassing 56% of the total world population, is 750,000 per year (statistics 2010). The total number of injuries is more than 50 million, of which 12% are hospital admissions. The loss to the economy in the 24 Asian countries is estimated to around US$800 billion or 3.6% of the gross domestic product (GDP). This article clearly shows that road safety is causing large problems and high costs in Asia, with an enormous impact on the well-being of people, economy, and productivity. In many Asian low- and middle-income countries, the yearly number of fatalities and injuries is increasing. Vulnerable road users (pedestrians, cyclists, and motorcyclists combined) are particularly at risk. Road safety in Asia should be given rightful attention, including taking powerful, effective actions. This review stresses the need for reliable accident data, because there is considerable underreporting in the official statistics. Reliable accident data are imperative to determine evidence-based intervention strategies and monitor the success of these interventions and analyses. On the other hand, lack of good high-quality accident data should not be an excuse to postpone interventions. There are many opportunities for evidence-based transport safety improvements, including measures concerning the 5 key risk factors: speed, drunk driving, not wearing motorcycle helmets, not wearing seat belts, and not using child restraints in cars, as specified in the Decade of Action for Road Safety 2011-2020. In this commentary, a number of additional measures are proposed that are not covered in the Decade of Action Plan. These new measures include separate roads or lanes for pedestrians and cyclists; helmet wearing for e-bike riders; special attention to elderly persons in public transportation; introduction of emerging collision avoidance technologies, in particular automatic emergency braking (AEB) and alcohol locks; improved truck safety focusing on the other road user (including blind spot detection technology; underride protection at the front, rear, and side; and energy-absorbing fronts); and improvements in motorcycle safety concerning protective clothing, requirements for advanced braking systems, improved visibility of motorcycles by using daytime running lights, and better guardrails.

Safer Systems: A NextGen Aviation Safety Strategic Goal

NASA Technical Reports Server (NTRS)

Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

2008-01-01

The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

Radio Frequency Identification (RFID) technology and patient safety

PubMed Central

Ajami, Sima; Rajabzadeh, Ahmad

2013-01-01

Background: Radio frequency identification (RFID) systems have been successfully applied in areas of manufacturing, supply chain, agriculture, transportation, healthcare, and services to name a few. However, the different advantages and disadvantages expressed in various studies of the challenges facing the technology of the use of the RFID technology have been met with skepticism by managers of healthcare organizations. The aim of this study was to express and display the role of RFID technology in improving patient safety and increasing the impact of it in healthcare. Materials and Methods: This study was non-systematical review, which the literature search was conducted with the help of libraries, books, conference proceedings, PubMed databases and also search engines available at Google, Google scholar in which published between 2004 and 2013 during Febuary 2013. We employed the following keywords and their combinations; RFID, healthcare, patient safety, medical errors, and medication errors in the searching areas of title, keywords, abstract, and full text. Results: The preliminary search resulted in 68 articles. After a careful analysis of the content of each paper, a total of 33 papers was selected based on their relevancy. Conclusion: We should integrate RFID with hospital information systems (HIS) and electronic health records (EHRs) and support it by clinical decision support systems (CDSS), it facilitates processes and reduce medical, medication and diagnosis errors. PMID:24381626

Radio Frequency Identification (RFID) technology and patient safety.

PubMed

Ajami, Sima; Rajabzadeh, Ahmad

2013-09-01

Radio frequency identification (RFID) systems have been successfully applied in areas of manufacturing, supply chain, agriculture, transportation, healthcare, and services to name a few. However, the different advantages and disadvantages expressed in various studies of the challenges facing the technology of the use of the RFID technology have been met with skepticism by managers of healthcare organizations. The aim of this study was to express and display the role of RFID technology in improving patient safety and increasing the impact of it in healthcare. This study was non-systematical review, which the literature search was conducted with the help of libraries, books, conference proceedings, PubMed databases and also search engines available at Google, Google scholar in which published between 2004 and 2013 during Febuary 2013. We employed the following keywords and their combinations; RFID, healthcare, patient safety, medical errors, and medication errors in the searching areas of title, keywords, abstract, and full text. The preliminary search resulted in 68 articles. After a careful analysis of the content of each paper, a total of 33 papers was selected based on their relevancy. We should integrate RFID with hospital information systems (HIS) and electronic health records (EHRs) and support it by clinical decision support systems (CDSS), it facilitates processes and reduce medical, medication and diagnosis errors.

Performance and safety aspects of the XV-15 tilt rotor research aircraft

NASA Technical Reports Server (NTRS)

Wernicke, K. G.

1977-01-01

Aircraft performance is presented illustrating the flexibility and capability of the XV-15 to conduct its planned proof-of-concept flight research in the areas of dynamics, stability and control, and aerodynamics. Additionally, the aircraft will demonstrate mission-type performance typical of future operational aircraft. The aircraft design is described and discussed with emphasis on the safety and fail-operate features of the aircraft and its systems. Two or more levels of redundancy are provided in the dc and ac electrical systems, hydraulics, conversion, flaps, landing gear extension, SCAS, and force-feel. RPM is maintained by a hydro-electrical blade pitch governor that consists of a primary and standby governor with a cockpit wheel control for manual backup. The two engines are interconnected for operation on a single engine. In the event of total loss of power, the aircraft can enter autorotation starting from the airplane as well as the helicopter mode of flight.

Method for Identification of Results of Dynamic Overloads in Assessment of Safety Use of the Mine Auxiliary Transportation System

NASA Astrophysics Data System (ADS)

Tokarczyk, Jarosław

2016-12-01

Method for identification the effects of dynamic overload affecting the people, which may occur in the emergency state of suspended monorail is presented in the paper. The braking curve using MBS (Multi-Body System) simulation was determined. For this purpose a computational model (MBS) of suspended monorail was developed and two different variants of numerical calculations were carried out. An algorithm of conducting numerical simulations to assess the effects of dynamic overload acting on the suspended monorails' users is also posted in the paper. An example of computational model FEM (Finite Element Method) composed of technical mean and the anthropometrical model ATB (Articulated Total Body) is shown. The simulation results are presented: graph of HIC (Head Injury Criterion) parameter and successive phases of dislocation of ATB model. Generator of computational models for safety criterion, which enables preparation of input data and remote starting the simulation, is proposed.

A combined methodology using electrical resistivity tomography, ordinary kriging and porosimetry for quantifying total C trapped in carbonate formations associated with natural analogues for CO2 leakage

NASA Astrophysics Data System (ADS)

Prado-Pérez, A. J.; Aracil, E.; Pérez del Villar, L.

2014-06-01

Currently, carbon deep geological storage is one of the most accepted methods for CO2 sequestration, being the long-term behaviour assessment of these artificial systems absolutely essential to guarantee the safety of the CO2 storage. In this sense, hydrogeochemical modelling is being used for evaluating any artificial CO2 deep geological storage as a potential CO2 sinkhole and to assess the leakage processes that are usually associated with these engineered systems. Carbonate precipitation, as travertines or speleothems, is a common feature in the CO2 leakage scenarios and, therefore, is of the utmost importance to quantify the total C content trapped as a stable mineral phase in these carbonate formations. A methodology combining three classical techniques such as: electrical resistivity tomography, geostatistical analysis and mercury porosimetry is described in this work, which was developed for calculating the total amount of C trapped as CaCO3 associated with the CO2 leakages in Alicún de las Torres natural analogue (Granada, Spain). The proposed methodology has allowed estimating the amount of C trapped as calcite, as more than 1.7 Mt. This last parameter, focussed on an artificial CO2 deep geological storage, is essential for hydrogeochemical modellers when evaluating whether CO2 storages constitute or not CO2 sinkholes. This finding is extremely important when assessing the long-term behaviour and safety of any artificial CO2 deep geological storage.

Modelling safety of multistate systems with ageing components

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

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

Results of European post-marketing surveillance of bosentan in pulmonary hypertension.

PubMed

Humbert, M; Segal, E S; Kiely, D G; Carlsen, J; Schwierin, B; Hoeper, M M

2007-08-01

After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.

A Global Perspective on Drinking-Water and Sanitation Classification: An Evaluation of Census Content

PubMed Central

Yu, Weiyu; Wardrop, Nicola A.; Bain, Robert E. S.; Lin, Yanzhao; Zhang, Ce; Wright, Jim A.

2016-01-01

Following the recent expiry of the United Nations’ 2015 Millennium Development Goals (MDGs), new international development agenda covering 2030 water, sanitation and hygiene (WASH) targets have been proposed, which imply new demands on data sources for monitoring relevant progress. This study evaluates drinking-water and sanitation classification systems from national census questionnaire content, based upon the most recent international policy changes, to examine national population census’s ability to capture drinking-water and sanitation availability, safety, accessibility, and sustainability. In total, 247 censuses from 83 low income and lower-middle income countries were assessed using a scoring system, intended to assess harmonised water supply and sanitation classification systems for each census relative to the typology needed to monitor the proposed post-2015 indicators of WASH targets. The results signal a lack of international harmonisation and standardisation in census categorisation systems, especially concerning safety, accessibility, and sustainability of services in current census content. This suggests further refinements and harmonisation of future census content may be necessary to reflect ambitions for post-2015 monitoring. PMID:26986472

Active heat exchange system development for latent heat thermal energy storage

NASA Technical Reports Server (NTRS)

Lefrois, R. T.; Knowles, G. R.; Mathur, A. K.; Budimir, J.

1979-01-01

Active heat exchange concepts for use with thermal energy storage systems in the temperature range of 250 C to 350 C, using the heat of fusion of molten salts for storing thermal energy are described. Salt mixtures that freeze and melt in appropriate ranges are identified and are evaluated for physico-chemical, economic, corrosive and safety characteristics. Eight active heat exchange concepts for heat transfer during solidification are conceived and conceptually designed for use with selected storage media. The concepts are analyzed for their scalability, maintenance, safety, technological development and costs. A model for estimating and scaling storage system costs is developed and is used for economic evaluation of salt mixtures and heat exchange concepts for a large scale application. The importance of comparing salts and heat exchange concepts on a total system cost basis, rather than the component cost basis alone, is pointed out. The heat exchange concepts were sized and compared for 6.5 MPa/281 C steam conditions and a 1000 MW(t) heat rate for six hours. A cost sensitivity analysis for other design conditions is also carried out.

Application and validation of the TTI based chill chain management system SMAS (Safety Monitoring and Assurance System) on shelf life optimization of vacuum packed chilled tuna.

PubMed

Tsironi, Theofania; Gogou, Eleni; Velliou, Eirini; Taoukis, Petros S

2008-11-30

The objective of the study was to establish a validated kinetic model for growth of spoilage bacteria on vacuum packed tuna slices in the temperature range of 0 to 15 degrees C and to evaluate the applicability of the TTI (Time Temperature Integrators) based SMAS (Safety Monitoring and Assurance System) system to improve tuna product quality at the time of consumption in comparison to the conventional First In First Out (FIFO) approach. The overall measurements of total flora and lactic acid bacteria (LAB) on the tuna samples used in a laboratory simulated field test were in close agreement with the predictions of the developed kinetic model. The spoilage profile of the TTI bearing products, handled with SMAS, was improved. Three out of the thirty products that were handled randomly, according to the FIFO approach, were already spoiled at the time of consumption (logN(LAB)>6.5) compared to no spoiled products when handled with the SMAS approach.

A Global Perspective on Drinking-Water and Sanitation Classification: An Evaluation of Census Content.

PubMed

Yu, Weiyu; Wardrop, Nicola A; Bain, Robert E S; Lin, Yanzhao; Zhang, Ce; Wright, Jim A

2016-01-01

Following the recent expiry of the United Nations' 2015 Millennium Development Goals (MDGs), new international development agenda covering 2030 water, sanitation and hygiene (WASH) targets have been proposed, which imply new demands on data sources for monitoring relevant progress. This study evaluates drinking-water and sanitation classification systems from national census questionnaire content, based upon the most recent international policy changes, to examine national population census's ability to capture drinking-water and sanitation availability, safety, accessibility, and sustainability. In total, 247 censuses from 83 low income and lower-middle income countries were assessed using a scoring system, intended to assess harmonised water supply and sanitation classification systems for each census relative to the typology needed to monitor the proposed post-2015 indicators of WASH targets. The results signal a lack of international harmonisation and standardisation in census categorisation systems, especially concerning safety, accessibility, and sustainability of services in current census content. This suggests further refinements and harmonisation of future census content may be necessary to reflect ambitions for post-2015 monitoring.

A resident conference for systems-based practice and practice-based learning.

PubMed

Sultana, Carmen J; Baxter, Jason K

2011-02-01

Improving patient safety and quality of care is part of systems-based practice and practice-based learning for residents. We expanded our obstetrics and gynecology department's regularly scheduled morbidity and mortality conferences to teach quality assurance concepts based on patient care on obstetrics and gynecology fourth-year resident rotations. Obstetrics and gynecology fourth-year residents on one of the two rotations each presented and analyzed a systems-based problem they encountered during patient care. They used an online learning module and proposed solutions, many of which were effectively implemented. Over 5 years, case presentations from 33 conferences were available with problems identified in emergency preparedness, coordination of care, scheduling and supervision, communication, medical practice, documentation, and lack of equipment or facilities. Twenty-two of the suggested solutions were partially or totally implemented. Barriers to implementation were identified. In conclusion, a conference presentation by fourth-year residents can identify patient safety problems, aid in their resolution, and suggest changes to patient care while teaching the principles of systems-based practice and practice-based learning.

Evaluation and review of the safety management system implementation in the Royal Thai Air Force

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

16 CFR § 1209.8 - Procedure for calibration of radiation instrumentation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard § 1209.8... radiation pyrometer. Repeat for each temperature. (b) Total heat flux meter. The total flux meter shall be... meter. This latter calibration shall make use of the radiant panel tester as the heat source...

Development and Assessment of a Medication Safety Measurement Program in a Long-Term Care Pharmacy.

PubMed

Hertig, John B; Hultgren, Kyle E; Parks, Scott; Rondinelli, Rick

2016-02-01

Medication errors continue to be a major issue in the health care system, including in long-term care facilities. While many hospitals and health systems have developed methods to identify, track, and prevent these errors, long-term care facilities historically have not invested in these error-prevention strategies. The objective of this study was two-fold: 1) to develop a set of medication-safety process measures for dispensing in a long-term care pharmacy, and 2) to analyze the data from those measures to determine the relative safety of the process. The study was conducted at In Touch Pharmaceuticals in Valparaiso, Indiana. To assess the safety of the medication-use system, each step was documented using a comprehensive flowchart (process flow map) tool. Once completed and validated, the flowchart was used to complete a "failure modes and effects analysis" (FMEA) identifying ways a process may fail. Operational gaps found during FMEA were used to identify points of measurement. The research identified a set of eight measures as potential areas of failure; data were then collected on each one of these. More than 133,000 medication doses (opportunities for errors) were included in the study during the research time frame (April 1, 2014, and ended on June 4, 2014). Overall, there was an approximate order-entry error rate of 15.26%, with intravenous errors at 0.37%. A total of 21 errors migrated through the entire medication-use system. These 21 errors in 133,000 opportunities resulted in a final check error rate of 0.015%. A comprehensive medication-safety measurement program was designed and assessed. This study demonstrated the ability to detect medication errors in a long-term pharmacy setting, thereby making process improvements measureable. Future, larger, multi-site studies should be completed to test this measurement program.

Space nuclear power applied to electric propulsion

NASA Technical Reports Server (NTRS)

Vicente, F. A.; Karras, T.; Darooka, D.; Isenberg, L.

1989-01-01

Space reactor power systems with characteristics ideal for advanced spacecraft systems applications are discussed. These characteristics are: high power-to-weight ratio (15 to 33 W/kg); high volume density (high ballistic coefficient); no preferential orientation in orbit; long operational life; high reliability; and total launch and operational safety. These characteristics allow the use of electric propulsion to raise spacecraft from low earth parking orbits to operational orbits, greatly increasing the useful orbit payload for a given launch vehicle by eliminating the need for a separation injection stage. A proposed demonstration mission is described.

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

Use of Atorvastatin in Systemic Lupus Erythematosus in Children and Adolescents

PubMed Central

Schanberg, L. E.; Sandborg, C.; Barnhart, H. X.; Ardoin, S. P.; Yow, E.; Evans, G. W.; Mieszkalski, K. L.; Ilowite, N. T.; Eberhard, A.; Imundo, L. F.; Kimura, Y.; von Scheven, E.; Silverman, E.; Bowyer, S. L.; Punaro, M.; Singer, N. G.; Sherry, D. D.; McCurdy, D.; Klein-Gitelman, M.; Wallace, C.; Silver, R.; Wagner-Weiner, L.; Higgins, G. C.; Brunner, H. I.; Jung, L.; Soep, J. B.; Reed, A. M.; Provenzale, J.; Thompson, S. D.

2014-01-01

Objective Statins reduce atherosclerosis and cardiovascular morbidity in the general population, but their efficacy and safety in children and adolescents with systemic lupus erythematosus (SLE) are unknown. This study was undertaken to determine the 3-year efficacy and safety of atorvastatin in preventing subclinical atherosclerosis progression in pediatric-onset SLE. Methods A total of 221 participants with pediatric SLE (ages 10–21 years) from 21 North American sites were enrolled in the Atherosclerosis Prevention in Pediatric Lupus Erythematosus study, a randomized double-blind, placebo-controlled clinical trial, between August 2003 and November 2006 with 36-month followup. Participants were randomized to receive atorvastatin (n = 113) or placebo (n = 108) at 10 or 20 mg/day depending on weight, in addition to usual care. The primary end point was progression of mean-mean common carotid intima-media thickening (CIMT) measured by ultrasound. Secondary end points included other segment/wall-specific CIMT measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) level, and SLE disease activity and damage outcomes. Results Progression of mean-mean common CIMT did not differ significantly between treatment groups (0.0010 mm/year for atorvastatin versus 0.0024 mm/year for placebo; P = 0.24). The atorvastatin group achieved lower hsCRP (P = 0.04), total cholesterol (P < 0.001), and low-density lipoprotein (P < 0.001) levels compared with placebo. In the placebo group, CIMT progressed significantly across all CIMT outcomes (0.0023–0.0144 mm/year; P < 0.05). Serious adverse events and critical safety measures did not differ between groups. Conclusion Our results indicate that routine statin use over 3 years has no significant effect on subclinical atherosclerosis progression in young SLE patients; however, further analyses may suggest subgroups that would benefit from targeted statin therapy. Atorvastatin was well tolerated without safety concerns. PMID:22031171

A spin-recovery parachute system for light general-aviation airplanes

NASA Technical Reports Server (NTRS)

Bradshaw, C.

1980-01-01

A tail mounted spin recovery parachute system was designed and developed for use on light general aviation airplanes. The system was designed for use on typical airplane configurations, including low wing, high wing, single engine and twin engine designs. A mechanically triggered pyrotechnic slug gun is used to forcibly deploy a pilot parachute which extracts a bag that deploys a ring slot spin recovery parachute. The total system weighs 8.2 kg. System design factors included airplane wake effects on parachute deployment, prevention of premature parachute deployment, positive parachute jettison, compact size, low weight, system reliability, and pilot and ground crew safety. Extensive ground tests were conducted to qualify the system. The recovery parachute was used successfully in flight 17 times.

Children's and Adults' Comfort Experience of Extra Seat Belts When Riding in the Rear Seat of a Passenger Car.

PubMed

Osvalder, Anna-Lisa; Hansson, Ida; Bohman, Katarina

2015-01-01

The objective of this study was to explore passengers' comfort experience of extra seat belts during on-road driving in the rear seat of a passenger car and to investigate how the use of extra belts affects children's and adults' attitudes to the product. Two different seat belt systems were tested, criss-cross (CC) and backpack (BP), consisting of the standard 3-point belt together with an additional 2-point belt. In total, 32 participants (15 children aged 6-10, 6 youths aged 11-15, and 11 adults aged 20-79, who differed considerably in size, shape, and proportions) traveled for one hour with each system, including city traffic and highway driving. Four video cameras monitored the test subject during the drive. Subjective data regarding emotions and perceived discomfort were collected in questionnaires every 20 min. A semistructured interview was held afterwards. All participant groups accepted the new products and especially the increased feeling of safety (P <.01); 56% preferred CC and 44% preferred BP but the difference was not significant. In total, 81% wanted to have extra seat belts in their family car. CC was appreciated for its symmetry, comfort, and the perceived feeling of safety. Some participants found CC unpleasant because the belts tended to slip close to the neck, described as a strangling feeling. BP was simpler to use and did not cause annoyance to the neck in the way CC did. Instead, it felt asymmetric and to some extent less safe than CC. Body size and shape affected seat belt fit to a great extent, which in turn affected the experience of comfort, both initially and over time. Perceived safety benefit and experienced comfort were the most determinant factors for the attitude toward the extra seat belts. The extra seat belts were perceived as being better than the participants had expected before the test, and they became more used to them over time. This exploratory study provided valuable knowledge from a user perspective for further development of new seat belt systems in cars. In addition to an increased feeling of safety, seat belt fit and comfort are supplementary influencing factors when it comes to gaining acceptance of new seat belt systems.

The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

PubMed

Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

2015-05-01

Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Implementation of a critical incident reporting system in a neurosurgical department.

PubMed

Kantelhardt, P; Müller, M; Giese, A; Rohde, V; Kantelhardt, S R

2011-02-01

Critical incident monitoring is an important tool for quality improvement and the maintenance of high safety standards. It was developed for aviation safety and is now widely accepted as a useful tool to reduce medical care-related morbidity and mortality. Despite this widespread acceptance, the literature has no reports on any neurosurgical applications of critical incident monitoring. We describe the introduction of a mono-institutional critical incident reporting system in a neurosurgical department. Furthermore, we have developed a formula to assess possible counterstrategies. All staff members of a neurosurgical department were advised to report critical incidents. The anonymous reporting form contained a box for the description of the incident, several multiple-choice questions on specific risk factors, place and reason for occurrence of the incident, severity of the consequences and suggested counterstrategies. The incident data was entered into an online documentation system (ADKA DokuPik) and evaluated by an external specialist. For data analysis we applied a modified assessment scheme initially designed for flight safety. Data collection was started in September 2008. The average number of reported incidents was 18 per month (currently 216 in total). Most incidents occurred on the neurosurgical ward (64%). Human error was involved in 86% of the reported incidents. The largest group of incidents consisted of medication-related problems. Accordingly, counterstrategies were developed, resulting in a decrease in the relative number of reported medication-related incidents from 42% (March 09) to 30% (September 09). Implementation of the critical incident reporting system presented no technical problems. The reporting rate was high compared to that reported in the current literature. The formulation, evaluation and introduction of specific counterstrategies to guard against selected groups of incidents may improve patient safety in neurosurgical departments. © Georg Thieme Verlag KG Stuttgart · New York.

Statistical classification of drug incidents due to look-alike sound-alike mix-ups.

PubMed

Wong, Zoie Shui Yee

2016-06-01

It has been recognised that medication names that look or sound similar are a cause of medication errors. This study builds statistical classifiers for identifying medication incidents due to look-alike sound-alike mix-ups. A total of 227 patient safety incident advisories related to medication were obtained from the Canadian Patient Safety Institute's Global Patient Safety Alerts system. Eight feature selection strategies based on frequent terms, frequent drug terms and constituent terms were performed. Statistical text classifiers based on logistic regression, support vector machines with linear, polynomial, radial-basis and sigmoid kernels and decision tree were trained and tested. The models developed achieved an average accuracy of above 0.8 across all the model settings. The receiver operating characteristic curves indicated the classifiers performed reasonably well. The results obtained in this study suggest that statistical text classification can be a feasible method for identifying medication incidents due to look-alike sound-alike mix-ups based on a database of advisories from Global Patient Safety Alerts. © The Author(s) 2014.

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

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

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

System safety education focused on flight safety

NASA Technical Reports Server (NTRS)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

Effect of STOP technique on safety climate in a construction company.

PubMed

Darvishi, Ebrahim; Maleki, Afshin; Dehestaniathar, Saeed; Ebrahemzadih, Mehrzad

2015-01-01

Safety programs are a core part of safety management in workplaces that can reduce incidents and injuries. The aim of this study was to investigate the influence of Safety Training Observation Program (STOP) technique as a behavior modification program on safety climate in a construction company. This cross-sectional study was carried out on workers of the Petrochemical Construction Company, western Iran. In order to improve safety climate, an unsafe behavior modification program entitled STOP was launched among workers of project during 12 months from April 2013 and April 2014. The STOP technique effectiveness in creating a positive safety climate was evaluated using the Safety Climate Assessment Toolkit. 76.78% of total behaviors were unsafe. 54.76% of total unsafe acts/ at-risk behaviors were related to the fall hazard. The most cause of unsafe behaviors was associated with habit and unavailability of safety equipment. After 12 month of continuous implementation the STOP technique, 55.8% of unsafe behaviors reduced among workers. The average score of safety climate evaluated using of the Toolkit, before and after the implementation of the STOP technique was 5.77 and 7.24, respectively. The STOP technique can be considered as effective approach for eliminating at-risk behavior, reinforcing safe work practices, and creating a positive safety climate in order to reduction incidents/injuries.

A system of safety management practices and worker engagement for reducing and preventing accidents: an empirical and theoretical investigation.

PubMed

Wachter, Jan K; Yorio, Patrick L

2014-07-01

The overall research objective was to theoretically and empirically develop the ideas around a system of safety management practices (ten practices were elaborated), to test their relationship with objective safety statistics (such as accident rates), and to explore how these practices work to achieve positive safety results (accident prevention) through worker engagement. Data were collected using safety manager, supervisor and employee surveys designed to assess and link safety management system practices, employee perceptions resulting from existing practices, and safety performance outcomes. Results indicate the following: there is a significant negative relationship between the presence of ten individual safety management practices, as well as the composite of these practices, with accident rates; there is a significant negative relationship between the level of safety-focused worker emotional and cognitive engagement with accident rates; safety management systems and worker engagement levels can be used individually to predict accident rates; safety management systems can be used to predict worker engagement levels; and worker engagement levels act as mediators between the safety management system and safety performance outcomes (such as accident rates). Even though the presence of safety management system practices is linked with incident reduction and may represent a necessary first-step in accident prevention, safety performance may also depend on mediation by safety-focused cognitive and emotional engagement by workers. Thus, when organizations invest in a safety management system approach to reducing/preventing accidents and improving safety performance, they should also be concerned about winning over the minds and hearts of their workers through human performance-based safety management systems designed to promote and enhance worker engagement. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Systems simulation for an airport trailing vortex warning system

NASA Technical Reports Server (NTRS)

Jeffreys, H. B.

1972-01-01

The approach, development, and limited system studies associated with a system simulation for an Airport Trailing Vortex Warning System are documented. The usefulness is shown of a systems engineering approach to the problem of developing a system, as dictated by aircraft vortices, which will increase air-traffic flow in the takeoff/landing corridors of busy airports while maintaining the required safety factor for each operation. The simulation program has been developed in a modular form which permits new, more sophisticated component models, when they become available and are required, to be incorporated into the program with a minimum of program modifications. This report documents a limited system study that has been performed using this Total System Simulation Model. The resulting preliminary system requirements, conclusions, and recommendations are given.

Racial/ethnic differences in obesity and comorbidities between safety-net- and non safety-net integrated health systems

PubMed Central

Balasubramanian, Bijal A.; Garcia, Michael P.; Corley, Douglas A.; Doubeni, Chyke A.; Haas, Jennifer S.; Kamineni, Aruna; Quinn, Virginia P.; Wernli, Karen; Zheng, Yingye; Skinner, Celette Sugg

2017-01-01

Abstract Previous research shows that patients in integrated health systems experience fewer racial disparities compared with more traditional healthcare systems. Little is known about patterns of racial/ethnic disparities between safety-net and non safety-net integrated health systems. We evaluated racial/ethnic differences in body mass index (BMI) and the Charlson comorbidity index from 3 non safety-net- and 1 safety-net integrated health systems in a cross-sectional study. Multinomial logistic regression modeled comorbidity and BMI on race/ethnicity and health care system type adjusting for age, sex, insurance, and zip-code-level income The study included 1.38 million patients. Higher proportions of safety-net versus non safety-net patients had comorbidity score of 3+ (11.1% vs. 5.0%) and BMI ≥35 (27.7% vs. 15.8%). In both types of systems, blacks and Hispanics were more likely than whites to have higher BMIs. Whites were more likely than blacks or Hispanics to have higher comorbidity scores in a safety net system, but less likely to have higher scores in the non safety-nets. The odds of comorbidity score 3+ and BMI 35+ in blacks relative to whites were significantly lower in safety-net than in non safety-net settings. Racial/ethnic differences were present within both safety-net and non safety-net integrated health systems, but patterns differed. Understanding patterns of racial/ethnic differences in health outcomes in safety-net and non safety-net integrated health systems is important to tailor interventions to eliminate racial/ethnic disparities in health and health care. PMID:28296752

A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

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

Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.

Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entriesmore » in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care.« less

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices.

PubMed

Vernick, J S; O'Brien, M; Hepburn, L M; Johnson, S B; Webster, D W; Hargarten, S W

2003-12-01

To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Information about all unintentional and undetermined firearm deaths from 1991-98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0-17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year.

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

PubMed

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

2011-12-01

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

Safety comparison of four types of rabies vaccines in patients with WHO category II animal exposure

PubMed Central

Peng, Jun; Lu, Sha; Zhu, Zhenggang; Zhang, Man; Hu, Quan; Fang, Yuan

2016-01-01

Abstract To evaluate the safeties of 4 types of rabies vaccines for patients with WHO category II animal exposure, especially in different age groups. A total of 4000 patients with WHO category II animal exposure were randomly divided into 4 vaccine groups, and were respectively given with Vaccines A, B, C, and D. And subjects in each vaccine group were divided into 4 age groups (≤5, 5–18, 19–60, and ≥60-year-old groups). Then adverse events (including local and systemic ones) were recorded and compared. Consequently, except for Vaccine B, patients under the age of 5 in Groups A, C, and D suffered from more adverse reactions than those in other age groups. Furthermore, for the children aged less than 5 years, incidence of adverse events following administration of Vaccine B, with the dose of 0.5 mL and production of bioreactor systems, was significantly lower than Vaccines A and D. Our data showed that rabies vaccines with smaller doses and more advanced processing techniques are of relatively high safety for the patients, especially for the young children. PMID:27893654

Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments.

PubMed

ElAgouri, Ghada; ElAmrawy, Fatema; ElYazbi, Ahmed; Eshra, Ahmed; Nounou, Mohamed I

2015-08-15

The global market is invaded by male enhancement nutraceuticals claimed to be of natural origin sold with a major therapeutic claim. Most of these products have been reported by international systems like the Food and Drug Administration (FDA). We hypothesize that these products could represent a major threat to the health of the consumers. In this paper, pharmaceutical evaluation of some of these nutraceutical products sold in Egypt under the therapeutic claim of treating erectile dysfunction, are discussed along with pharmacological evaluation to investigate their safety and efficacy parameters. Samples were analyzed utterly using conventional methods, i.e.: HPLC, HPTLC, NIR, content uniformity and weight variation and friability. The SeDeM system was used for quality assessment. On the basis of the results of this research, the sampled products are adulterated and totally heterogeneous in their adulterant drug content and pharmaceutical quality. These products represent a major safety threat for the consumers in Egypt and the Middle East, especially; the target audience is mostly affected with heart and blood pressure problems seeking natural and safe alternatives to the well-established Phosphodiesterase 5 Inhibitors (PDE-5Is). Copyright © 2015 Elsevier B.V. All rights reserved.

Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

PubMed

Chrischilles, Elizabeth A; Gagne, Joshua J; Fireman, Bruce; Nelson, Jennifer; Toh, Sengwee; Shoaibi, Azadeh; Reichman, Marsha E; Wang, Shirley; Nguyen, Michael; Zhang, Rongmei; Izem, Rima; Goulding, Margie R; Southworth, Mary Ross; Graham, David J; Fuller, Candace; Katcoff, Hannah; Woodworth, Tiffany; Rogers, Catherine; Saliga, Ryan; Lin, Nancy D; McMahill-Walraven, Cheryl N; Nair, Vinit P; Haynes, Kevin; Carnahan, Ryan M

2018-03-01

The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71). This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety. Copyright © 2018 John Wiley & Sons, Ltd.

The magnetic navigation system allows safety and high efficacy for ablation of arrhythmias

PubMed Central

Bauernfeind, Tamas; Akca, Ferdi; Schwagten, Bruno; de Groot, Natasja; Van Belle, Yves; Valk, Suzanne; Ujvari, Barbara; Jordaens, Luc; Szili-Torok, Tamas

2011-01-01

Aims We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities. Methods and results In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15 ± 9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P = 0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P = 0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P = ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P < 0.05). Less fluoroscopy was used in group MNS (30 ± 20 vs. 35 ± 25 min, P < 0.01). There were no differences in procedure times and recurrence rates for the overall groups (168 ± 67 vs. 159 ± 75 min, P = ns; 14 vs. 11%, P = ns; respectively). Conclusions Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs. PMID:21508006

Safety and Efficacy of Transvenous Lead Extraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience.

PubMed

Sharma, Saumya; Ekeruo, Ijeoma A; Nand, Nikita P; Sundara Raman, Ajay; Zhang, Xu; Reddy, Sunil K; Hariharan, Ramesh

2018-02-01

The goal of this study is to assess the safety and efficacy of mechanical lead extraction utilizing the Evolution system. Compared with other techniques commonly used for lead extraction, data regarding the safety and efficacy of mechanical lead extraction using the Evolution system is limited and needs further evaluation. Between June 1, 2009 and September 30, 2016, we retrospectively analyzed 400 consecutive patients who exclusively underwent mechanical lead extraction utilizing the Evolution system. A total of 400 patients underwent mechanical lead extraction of 683 leads. Mean age of extracted leads was 6.77 ± 4.42 years (range 1 to 31 years). The extracted device system was an implantable cardioverter-defibrillator in 274 patients (68.5%) and a pacemaker system in 126 patients (31.5%). Complete lead removal rate was 97% with a clinical success rate of 99.75%. Incomplete lead removal with <4-cm remnant was associated with older leads (lead age >8 years). Failure to achieve clinical success was noted in 1 patient (0.25%). Cardiac papillary avulsion, system-related infection, and cardiac tamponade were the major complications noted in 6 patients (1.5%). Minor complications were encountered in 24 patients (6%), of which hematoma requiring evacuation was the most common minor complication. There were no patient deaths. In our single-center study, lead extractions utilizing the Evolution mechanical lead extraction system were safe and effective and resulted in high clinical and procedural success, with low complication rates and no fatalities. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Investigation of Stability of Precise Geodetic Instruments Used in Deformation Monitoring

NASA Astrophysics Data System (ADS)

Woźniak, Marek; Odziemczyk, Waldemar

2017-12-01

Monitoring systems using automated electronic total stations are an important element of safety control of many engineering objects. In order to ensure the appropriate credibility of acquired data, it is necessary that instruments (total stations in most of the cases) used for measurements meet requirements of measurement accuracy, as well as the stability of instrument axis system geometry. With regards to the above, it is expedient to conduct quality control of data acquired using electronic total stations in the context of performed measurement procedures. This paper presents results of research conducted at the Faculty of Geodesy and Cartography at Warsaw University of Technology investigating the stability of "basic" error values (collimation, zero location for V circle, inclination), for two types of automatic total stations: TDA 5005 and TCRP 1201+. Research provided also information concerning the influence of temperature changes upon the stability of investigated instrument's optical parameters. Results are presented in graphical analytic technique. Final conclusions propose methods, which allow avoiding negative results of measuring tool-set geometry changes during conducting precise deformation monitoring measurements.

Comparative evaluation of user interfaces for robot-assisted laser phonomicrosurgery.

PubMed

Dagnino, Giulio; Mattos, Leonardo S; Becattini, Gabriele; Dellepiane, Massimo; Caldwell, Darwin G

2011-01-01

This research investigates the impact of three different control devices and two visualization methods on the precision, safety and ergonomics of a new medical robotic system prototype for assistive laser phonomicrosurgery. This system allows the user to remotely control the surgical laser beam using either a flight simulator type joystick, a joypad, or a pen display system in order to improve the traditional surgical setup composed by a mechanical micromanipulator coupled with a surgical microscope. The experimental setup and protocol followed to obtain quantitative performance data from the control devices tested are fully described here. This includes sets of path following evaluation experiments conducted with ten subjects with different skills, for a total of 700 trials. The data analysis method and experimental results are also presented, demonstrating an average 45% error reduction when using the joypad and up to 60% error reduction when using the pen display system versus the standard phonomicrosurgery setup. These results demonstrate the new system can provide important improvements in terms of surgical precision, ergonomics and safety. In addition, the evaluation method presented here is shown to support an objective selection of control devices for this application.

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.

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals

PubMed Central

Shaw, Charles D.; Groene, Oliver; Botje, Daan; Sunol, Rosa; Kutryba, Basia; Klazinga, Niek; Bruneau, Charles; Hammer, Antje; Wang, Aolin; Arah, Onyebuchi A.; Wagner, Cordula; Klazinga, N; Kringos, DS; Lombarts, K; Plochg, T; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Garel, P; Hanslik, K; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Franca, M; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; Chow, A; DerSarkissian, M; Thompson, C; Wang, A; Thompson, A

2014-01-01

Objective To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. Design A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. Setting and Participants Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Main Outcome Measure Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. Results Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). Conclusions Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes. PMID:24615598

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals.

PubMed

Shaw, Charles D; Groene, Oliver; Botje, Daan; Sunol, Rosa; Kutryba, Basia; Klazinga, Niek; Bruneau, Charles; Hammer, Antje; Wang, Aolin; Arah, Onyebuchi A; Wagner, Cordula

2014-04-01

To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

Advanced Life Support System Value Metric

NASA Technical Reports Server (NTRS)

Jones, Harry W.; Rasky, Daniel J. (Technical Monitor)

1999-01-01

The NASA Advanced Life Support (ALS) Program is required to provide a performance metric to measure its progress in system development. Extensive discussions within the ALS program have led to the following approach. The Equivalent System Mass (ESM) metric has been traditionally used and provides a good summary of the weight, size, and power cost factors of space life support equipment. But ESM assumes that all the systems being traded off exactly meet a fixed performance requirement, so that the value and benefit (readiness, performance, safety, etc.) of all the different systems designs are considered to be exactly equal. This is too simplistic. Actual system design concepts are selected using many cost and benefit factors and the system specification is defined after many trade-offs. The ALS program needs a multi-parameter metric including both the ESM and a System Value Metric (SVM). The SVM would include safety, maintainability, reliability, performance, use of cross cutting technology, and commercialization potential. Another major factor in system selection is technology readiness level (TRL), a familiar metric in ALS. The overall ALS system metric that is suggested is a benefit/cost ratio, SVM/[ESM + function (TRL)], with appropriate weighting and scaling. The total value is given by SVM. Cost is represented by higher ESM and lower TRL. The paper provides a detailed description and example application of a suggested System Value Metric and an overall ALS system metric.

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 climate and culture: Integrating psychological and systems perspectives.

PubMed

Casey, Tristan; Griffin, Mark A; Flatau Harrison, Huw; Neal, Andrew

2017-07-01

Safety climate research has reached a mature stage of development, with a number of meta-analyses demonstrating the link between safety climate and safety outcomes. More recently, there has been interest from systems theorists in integrating the concept of safety culture and to a lesser extent, safety climate into systems-based models of organizational safety. Such models represent a theoretical and practical development of the safety climate concept by positioning climate as part of a dynamic work system in which perceptions of safety act to constrain and shape employee behavior. We propose safety climate and safety culture constitute part of the enabling capitals through which organizations build safety capability. We discuss how organizations can deploy different configurations of enabling capital to exert control over work systems and maintain safe and productive performance. We outline 4 key strategies through which organizations to reconcile the system control problems of promotion versus prevention, and stability versus flexibility. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Consensus statement: patient safety, healthcare-associated infections and hospital environmental surfaces.

PubMed

Roques, Christine; Al Mousa, Haifaa; Duse, Adriano; Gallagher, Rose; Koburger, Torsten; Lingaas, Egil; Petrosillo, Nicola; Škrlin, Jasenka

2015-01-01

Healthcare-associated infections have serious implications for both patients and hospitals. Environmental surface contamination is the key to transmission of nosocomial pathogens. Routine manual cleaning and disinfection eliminates visible soil and reduces environmental bioburden and risk of transmission, but may not address some surface contamination. Automated area decontamination technologies achieve more consistent and pervasive disinfection than manual methods, but it is challenging to demonstrate their efficacy within a randomized trial of the multiple interventions required to reduce healthcare-associated infection rates. Until data from multicenter observational studies are available, automated area decontamination technologies should be an adjunct to manual cleaning and disinfection within a total, multi-layered system and risk-based approach designed to control environmental pathogens and promote patient safety.

The role of total laboratory automation in a consolidated laboratory network.

PubMed

Seaberg, R S; Stallone, R O; Statland, B E

2000-05-01

In an effort to reduce overall laboratory costs and improve overall laboratory efficiencies at all of its network hospitals, the North Shore-Long Island Health System recently established a Consolidated Laboratory Network with a Core Laboratory at its center. We established and implemented a centralized Core Laboratory designed around the Roche/Hitachi CLAS Total Laboratory Automation system to perform the general and esoteric laboratory testing throughout the system in a timely and cost-effective fashion. All remaining STAT testing will be performed within the Rapid Response Laboratories (RRLs) at each of the system's hospitals. Results for this laboratory consolidation and implementation effort demonstrated a decrease in labor costs and improved turnaround time (TAT) at the core laboratory. Anticipated system savings are approximately $2.7 million. TATs averaged 1.3 h within the Core Laboratory and less than 30 min in the RRLs. When properly implemented, automation systems can reduce overall laboratory expenses, enhance patient services, and address the overall concerns facing the laboratory today: job satisfaction, decreased length of stay, and safety. The financial savings realized are primarily a result of labor reductions.

National Safety Council

MedlinePlus

... Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the Journey What ... Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the Journey What ...

The use of synthetic ligaments in the design of an enhanced stability total knee joint replacement.

PubMed

Stokes, Michael D; Greene, Brendan C; Pietrykowski, Luke W; Gambon, Taylor M; Bales, Caroline E; DesJardins, John D

2018-03-01

Current total knee replacement designs work to address clinically desired knee stability and range of motion through a balance of retained anatomy and added implant geometry. However, simplified implant geometries such as bearing surfaces, posts, and cams are often used to replace complex ligamentous constraints that are sacrificed during most total knee replacement procedures. This article evaluates a novel total knee replacement design that incorporates synthetic ligaments to enhance the stability of the total knee replacement system. It was hypothesized that by incorporating artificial cruciate ligaments into a total knee replacement design at specific locations and lengths, the stability of the total knee replacement could be significantly altered while maintaining active ranges of motion. The ligament attachment mechanisms used in the design were evaluated using a tensile test, and determined to have a safety factor of three with respect to expected ligamentous loading in vivo. Following initial computational modeling of possible ligament orientations, a physical prototype was constructed to verify the function of the design by performing anterior/posterior drawer tests under physiologic load. Synthetic ligament configurations were found to increase total knee replacement stability up to 94% compared to the no-ligament case, while maintaining total knee replacement flexion range of motion between 0° and 120°, indicating that a total knee replacement that incorporates synthetic ligaments with calibrated location and lengths should be able to significantly enhance and control the kinematic performance of a total knee replacement system.

International perspectives on food safety and regulations - a need for harmonized regulations: perspectives in China.

PubMed

Liu, Xiumei

2014-08-01

Food safety is a major livelihood issue and a priority concern in China. Since the Food Safety Law of the People's Republic of China was issued in 2009, the food safety control system has been strengthened through, inter alia, the Food Safety Risk Surveillance System, the Food Safety Risk Assessment System and the Food Safety Standards System. In accordance with the Food Safety Law and regulations for implementation, the Ministry of Health released the 'Twelfth Five-year Plan' of Food Safety Standards. The existing 5000 food-related standards will be integrated. Notwithstanding, the supervision system in China needs to be further improved and strengthened. © 2014 Society of Chemical Industry.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

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

BIS-Guided Total Intravenous Anesthesia for Orchiopexy and Circumcision in a Child with Severe Autism: A Case Report

PubMed Central

Okur, Selçuk; Arıkan, Müge; Temel, Gülşen; Temel, Volkan

2012-01-01

Autistic children are very difficult to manage in the hospital setting because they react badly to any change in routine. We describe a case of 10-year-old male patient with severe autism undergoing orchidopexy and circumcision. Following premedication, anesthesia was induced with remifentanil, propofol, atracurium, and maintained with total intravenous anesthesia (propofol and remifentanil). The Bispectral Index System was monitored for determination of the depth of anesthesia. After surgery, all infusions were discontinued. The patient was then transferred to the postanesthetic care unit. There were no adverse events observed during the anesthetic management. The patient was discharged from the hospital on the second postoperative day. Bispectral Index System-guided Total Intravenous Anesthesia can provide some advantages for patient with autism, such as hemodynamic stability, early and easy recovery, to facilitate faster discharge, to optimize the delivery of anesthetic agents, to minimize its adverse effects, and to maximize its safety. PMID:23227368

Surgical checklists: a systematic review of impacts and implementation

PubMed Central

Treadwell, Jonathan R; Lucas, Scott; Tsou, Amy Y

2014-01-01

Background Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety. Methods A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication). Results We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information. Conclusions Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings. PMID:23922403

A scientific operations plan for the NASA space telescope. [ground support systems, project planning

NASA Technical Reports Server (NTRS)

West, D. K.; Costa, S. R.

1975-01-01

A ground system is described which is compatible with the operational requirements of the space telescope. The goal of the ground system is to minimize the cost of post launch operations without seriously compromising the quality and total throughput of space telescope science, or jeopardizing the safety of the space telescope in orbit. The resulting system is able to accomplish this goal through optimum use of existing and planned resources and institutional facilities. Cost is also reduced and efficiency in operation increased by drawing on existing experience in interfacing guest astronomers with spacecraft as well as mission control experience obtained in the operation of present astronomical spacecraft.

International Space Station (ISS) Orbital Replaceable Unit (ORU) Wet Storage Risk Assessment

NASA Technical Reports Server (NTRS)

Squire, Michael D.; Rotter, Henry A.; Lee, Jason; Packham, Nigel; Brady, Timothy K.; Kelly, Robert; Ott, C. Mark

2014-01-01

The International Space Station (ISS) Program requested the NASA Engineering and Safety Center (NESC) to evaluate the risks posed by the practice of long-term wet storage of ISS Environmental Control and Life Support (ECLS) regeneration system orbital replacement units (ORUs). The ISS ECLS regeneration system removes water from urine and humidity condensate and converts it into potable water and oxygen. A total of 29 ORUs are in the ECLS system, each designed to be replaced by the ISS crew when necessary. The NESC assembled a team to review the ISS ECLS regeneration system and evaluate the potential for biofouling and corrosion. This document contains the outcome of the evaluation.

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.

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

....35-50. Note: Safety control systems include automatic and manual safety trip controls and automatic... engines. (e) Automatic safety trip control systems must— (1) Be provided where there is an immediate... 46 Shipping 2 2011-10-01 2011-10-01 false Safety control systems. 62.25-15 Section 62.25-15...

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...

49 CFR 191.27 - Filing offshore pipeline condition reports.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE; ANNUAL REPORTS, INCIDENT REPORTS, AND SAFETY-RELATED..., job title, and business telephone number of person submitting the report. (4) Total length of pipeline...

Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system).

PubMed

Arenas Jiménez, María Dolores; Ferre, Gabriel; Álvarez-Ude, Fernando

Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

Advancing a sociotechnical systems approach to workplace safety – developing the conceptual framework

PubMed Central

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Practitioner Summary: Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels. PMID:25831959

Advancing a sociotechnical systems approach to workplace safety--developing the conceptual framework.

PubMed

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels.

Comparison between autologous blood transfusion drainage and closed-suction drainage/no drainage in total knee arthroplasty: a meta-analysis.

PubMed

Hong, Kun-Hao; Pan, Jian-Ke; Yang, Wei-Yi; Luo, Ming-Hui; Xu, Shu-Chai; Liu, Jun

2016-08-01

Autologous blood transfusion (ABT) drainage system is a new unwashed salvaged blood retransfusion system for total knee replacement (TKA). However, whether to use ABT drainage, closed-suction (CS) drainage or no drainage in TKA surgery remains controversial. This is the first meta-analysis to assess the clinical efficiency, safety and potential advantages regarding the use of ABT drains compared with closed-suction/no drainage. PubMed, Embase, and the Cochrane Library were comprehensively searched in March 2015. Fifteen randomized controlled trials (RCTs) were identified and pooled for statistical analysis. The primary outcome evaluated was homologous blood transfusion rate. The secondary outcomes were post-operative haemoglobin on days 3-5, length of hospital stay and wound infections after TKA surgery. The pooled data included 1,721 patients and showed that patients in the ABT drainage group might benefit from lower blood transfusion rates (16.59 % and 37.47 %, OR: 0.28 [0.14, 0.55]; 13.05 % and 16.91 %, OR: 0.73 [0.47,1.13], respectively). Autologous blood transfusion drainage and closed-suction drainage/no drainage have similar clinical efficacy and safety with regard to post-operative haemoglobin on days 3-5, length of hospital stay and wound infections. Autologous blood transfusion drainage offers a safe and efficient alternative to CS/no drainage with a lower blood transfusion rate. Future large-volume high-quality RCTs with extensive follow-up will affirm and update this system review.

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

In-Office Endoscopic Laryngeal Laser Procedures: A Patient Safety Initiative.

PubMed

Anderson, Jennifer; Bensoussan, Yael; Townsley, Richard; Kell, Erika

2018-05-01

Objective To review complications of in-office endoscopic laryngeal laser procedures after implementation of standardized safety protocol. Methods A retrospective review was conducted of the first 2 years of in-office laser procedures at St Michaels Hospital after the introduction of a standardized safety protocol. The protocol included patient screening, procedure checklist with standardized reporting of processes, medications, and complications. Primary outcomes measured were complication rates of in-office laryngeal laser procedures. Secondary outcomes included hemodynamic changes, local anesthetic dose, laser settings, total laser/procedure time, and incidence of sedation. Results A total of 145 in-office KTP procedures performed on 65 patients were reviewed. In 98% of cases, the safety protocol was fully implemented. The overall complication rate was 4.8%. No major complications were encountered. Minor complications included vasovagal episodes and patient intolerance. The rate of patient intolerance resulting early termination of anticipated procedure was 13.1%. Total local anesthetic dose averaged 172.9 mg lidocaine per procedure. The mean amount of laser energy dispersed was 261.2 J, with mean total procedure time of 48.3 minutes. Sixteen percent of patients had preprocedure sedation. Vital signs were found to vary modestly. Systolic blood pressure was lower postprocedure in 13.8% and symptomatic in 4.1%. Discussion The review of our standardized safety protocol has revealed that in-office laser treatment for laryngeal pathology has extremely low complication rates with safe patient outcomes. Implications for Practice The trend of shifting procedures out of the operating room into the office/clinic setting requires new processes designed to promote patient safety.

Cohort study comparing prostate photovaporisation with XPS 180W and HPS 120W laser.

PubMed

López, B; Capitán, C; Hernández, V; de la Peña, E; Jiménez-Valladolid, I; Guijarro, A; Pérez-Fernández, E; Llorente, C

2016-01-01

Prostate photovaporisation with Greenlight laser for the surgical treatment of benign prostate hyperplasia has rapidly evolve to the new XPS 180W. We have previously demonstrated the safety and efficacy of the HPS 120W. The aim of this study was to assess the functional and safety results, with a year of follow-up, of photovaporisation using the XPS 180W laser compared with its predecessor. A cohort study was conducted with a series of 191 consecutive patients who underwent photovaporisation between 1/2008 and 5/2013. The inclusion criteria were an international prostate symptom score (IPSS) >15 after medical failure, a prostate volume <80 cm(3) and a maximum flow <15 mL/s. We assessed preoperative and intraoperative variables (energy used, laser time and total surgical time), complications, catheter hours, length of stay and functional results (maximum flow, IPSS, prostate-specific antigen and prostate volume) at 3, 6 and 12 months. We analysed the homogeneity in preoperative characteristics of the 2 groups through univariate analysis techniques. The postoperative functional results were assessed through an analysis of variance of repeated measures with mixed models. A total of 109 (57.1%) procedures were performed using HPS 120W, and 82 (42.9%) were performed using XPS. There were no differences between the preoperative characteristics. We observed significant differences both in the surgical time and effective laser time in favour of the XPS system. This advantage was 11% (48 ± 15.7 vs. 53.8 ± 16.2, p<.05) and 9% (32.8 ± 11.7 vs. 36 ± 11.6, p<.05), respectively. There were no statistically significant differences in the rest of the analysed parameters. The technical improvements in the XPS 180W system help reduce surgical time, maintaining the safety and efficacy profile offered by the HPS 120W system, with completely superimposable results at 1 year of follow-up. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

[Nursing professionals and health care assistants' perception of patient safety culture in the operating room].

PubMed

Bernalte-Martí, Vicente; Orts-Cortés, María Isabel; Maciá-Soler, Loreto

2015-01-01

To assess nursing professionals and health care assistants' perceptions, opinions and behaviours on patient safety culture in the operating room of a public hospital of the Spanish National Health Service. To describe strengths and weaknesses or opportunities for improvement according to the Agency for Healthcare Research and Quality criteria, as well as to determine the number of events reported. A descriptive, cross-sectional study was conducted using the Spanish version of the questionnaire Hospital Survey on Patient Safety Culture. The sample consisted of nursing professionals, who agreed to participate voluntarily in this study and met the selection criteria. A descriptive and inferential analysis was performed depending on the nature of the variables and the application conditions of statistical tests. Significance if p < .05. In total, 74 nursing professionals responded (63.2%). No strengths were found in the operating theatre, and improvements are needed concerning staffing (64.0%), and hospital management support for patient safety (52.9%). A total of 52.3% (n = 65) gave patient safety a score from 7 to 8.99 (on a 10 point scale); 79.7% (n = 72) reported no events last year. The total variance explained by the regression model was 0.56 for "Frequency of incident reporting" and 0.26 for "Overall perception of safety". There was a more positive perception of patient safety culture at unit level. Weaknesses have been identified, and they can be used to design specific intervention activities to improve patient safety culture in other nearby operating theatres. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

The Role of Safety Culture in Influencing Provider Perceptions of Patient Safety.

PubMed

Bishop, Andrea C; Boyle, Todd A

2016-12-01

To determine how provider perceptions of safety culture influence their involvement in patient safety practices. Health-care providers were surveyed in 2 tertiary hospitals located in Atlantic Canada, composed of 4 units in total. The partial least squares (PLS) approach to structural equation modeling was used to analyze the data. Latent variables provider PLS model encompassed the hypothesized relationships between provider characteristics, safety culture, perceptions of patient safety practices, and actual performance of patient safety practices, using the Health Belief Model (HBM) as a guide. Data analysis was conducted using SmartPLS. A total of 113 health-care providers completed a survey out of an eligible 318, representing a response rate of 35.5%. The final PLS model showed acceptable internal consistency with all four latent variables having a composite reliability score above the recommended 0.70 cutoff value (safety culture = 0.86, threat = 0.76, expectations = 0.83, PS practices = 0.75). Discriminant validity was established, and all path coefficients were found to be significant at the α = 0.05 level using nonparametric bootstrapping. The survey results show that safety culture accounted for 34% of the variance in perceptions of threat and 42% of the variance in expectations. This research supports the role that safety culture plays in the promotion and maintenance of patient safety activities for health-care providers. As such, it is recommended that the introduction of new patient safety strategies follow a thorough exploration of an organization's safety culture.

Pirate Mother Ship Warning and Reporting System (PMSW&RS)

DTIC Science & Technology

2011-09-01

1958 Geneva Convention and the 1982 Safety of Life At Sea (SOLAS) Convention both direct nations to cooperate in suppression of piracy on the high... seas (Department of the Navy & Department of Homeland Security, 2007). Countering the piracy threat requires a multifaceted approach with all...Pirate attacks on the world’s seas totaled 266 in the first six months of 2011, up from 196 incidents in the same period last year” (International

Research on Building Education & Workforce Capacity in Systems Engineering

DTIC Science & Technology

2011-10-31

product or prototype that addresses a real DoD need. Implemented as pilot courses in eight civilian and six military universities affiliated with...Engineering 1 1.1 Computer Engineering 1 1.1 Operations Research 1 1.1 Product Architecture 1 1.1 Total 93 100.0 Table 7: Breakdown of Student... product specifications, inattention to budget limits and safety issues, inattention to product life cycle, poor implementation of risk management plans

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed

Shu, Qin; Cai, Miao; Tao, Hong-Bing; Cheng, Zhao-Hui; Chen, Jing; Hu, Yin-Huan; Li, Gang

2015-07-01

The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation.A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured.A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The "overall perceptions of safety" (48.1% vs 40.4%, P < 0.001) and "frequency of events reported" (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess "patient safety grade" to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events.Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital.

A Clinical Tool for Reducing Central Nervous System Depression among Neonates Exposed to Codeine through Breast Milk

PubMed Central

Kelly, Lauren E.; Chaudhry, Shahnaz A.; Rieder, Michael J.; ‘t Jong, Geert; Moretti, Myla E.; Lausman, Andrea; Ross, Colin; Berger, Howard; Carleton, Bruce; Hayden, Michael R.; Madadi, Parvaz; Koren, Gideon

2013-01-01

Background Neonates are commonly exposed to maternal codeine through breast milk. Central Nervous System (CNS) depression has been reported in up to 24% of nurslings following codeine exposure. In 2009, we developed guidelines to improve the safety of codeine use during breastfeeding based on previously established pharmacogenetic and clinical risk factors. The primary objective of this study was to prospectively evaluate the effectiveness of these guidelines in ensuring neonatal safety. Methods and Findings Women taking codeine for pain following caesarean section were given safety guidelines, including advice to use the lowest codeine dose for no longer than four days and to switch to a non-opioid when possible. Mothers provided a saliva sample for analysis of genes involved in opioid disposition, metabolism and response. A total of 238 consenting women participated. Neonatal sedation was reported in 2.1% (5/238) of breastfeeding women taking codeine according to our safety guidelines. This rate was eight fold lower than that reported in previous prospective studies. Women reporting sedated infants were taking codeine for a significantly longer period of time (4.80±2.59 days vs. 2.52±1.58 days, p = 0.0018). While following the codeine safety guidelines, mothers were less likely to supplement with formula, reported lower rates of sedation in themselves and breastfed more frequently throughout the day when compared to previously reported rates. Genotyping analysis of cytochrome p450 2D6 (CYP2D6), uridine-diphosphate glucuronosyltransferase (UGT) 2B7, p-glycoprotein (ABCB1), the mu-opioid receptor (OPRM1) and catechol-o-demethyltransferase (COMT) did not predict codeine response in breastfeeding mother/infant pairs when following the safety guidelines. Conclusions The only cases of CNS depression occurred when the length of codeine use exceeded the guideline recommendations. Neonatal safety of codeine can be improved using evidence-based guidelines, even in those deemed by genetics to be at high risk for toxicity. PMID:23922910

Associations between safety culture and employee engagement over time: a retrospective analysis.

PubMed

Daugherty Biddison, Elizabeth Lee; Paine, Lori; Murakami, Peter; Herzke, Carrie; Weaver, Sallie J

2016-01-01

With the growth of the patient safety movement and development of methods to measure workforce health and success have come multiple modes of assessing healthcare worker opinions and attitudes about work and the workplace. Safety culture, a group-level measure of patient safety-related norms and behaviours, has been proposed to influence a variety of patient safety outcomes. Employee engagement, conceptualised as a positive, work-related mindset including feelings of vigour, dedication and absorption in one's work, has also demonstrated an association with a number of important worker outcomes in healthcare. To date, the relationship between responses to these two commonly used measures has been poorly characterised. Our study used secondary data analysis to assess the relationship between safety culture and employee engagement over time in a sample of >50 inpatient hospital units in a large US academic health system. With >2000 respondents in each of three time periods assessed, we found moderate to strong positive correlations (r=0.43-0.69) between employee engagement and four Safety Attitudes Questionnaire domains. Independent collection of these two assessments may have limited our analysis in that minimally different inclusion criteria resulted in some differences in the total respondents to the two instruments. Our findings, nevertheless, suggest a key area in which healthcare quality improvement efforts might be streamlined. 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/

Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

PubMed

Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

2010-12-01

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

Method for selection of optimal road safety composite index with examples from DEA and TOPSIS method.

PubMed

Rosić, Miroslav; Pešić, Dalibor; Kukić, Dragoslav; Antić, Boris; Božović, Milan

2017-01-01

Concept of composite road safety index is a popular and relatively new concept among road safety experts around the world. As there is a constant need for comparison among different units (countries, municipalities, roads, etc.) there is need to choose an adequate method which will make comparison fair to all compared units. Usually comparisons using one specific indicator (parameter which describes safety or unsafety) can end up with totally different ranking of compared units which is quite complicated for decision maker to determine "real best performers". Need for composite road safety index is becoming dominant since road safety presents a complex system where more and more indicators are constantly being developed to describe it. Among wide variety of models and developed composite indexes, a decision maker can come to even bigger dilemma than choosing one adequate risk measure. As DEA and TOPSIS are well-known mathematical models and have recently been increasingly used for risk evaluation in road safety, we used efficiencies (composite indexes) obtained by different models, based on DEA and TOPSIS, to present PROMETHEE-RS model for selection of optimal method for composite index. Method for selection of optimal composite index is based on three parameters (average correlation, average rank variation and average cluster variation) inserted into a PROMETHEE MCDM method in order to choose the optimal one. The model is tested by comparing 27 police departments in Serbia. Copyright © 2016 Elsevier Ltd. All rights reserved.

14 CFR 415.131 - Flight safety system crew data.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight safety system crew data. 415.131... Launch Vehicle From a Non-Federal Launch Site § 415.131 Flight safety system crew data. (a) An applicant's safety review document must identify each flight safety system crew position and the role of that...

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false What makes up a safety management... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The...

A Mathematical Model for Railway Control Systems

NASA Technical Reports Server (NTRS)

Hoover, D. N.

1996-01-01

We present a general method for modeling safety aspects of railway control systems. Using our modeling method, one can progressively refine an abstract railway safety model, sucessively adding layers of detail about how a real system actually operates, while maintaining a safety property that refines the original abstract safety property. This method supports a top-down approach to specification of railway control systems and to proof of a variety of safety-related properties. We demonstrate our method by proving safety of the classical block control system.

A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

PubMed

Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

2016-05-01

To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. Randomized model-based simulation study. University medical center. A total of 33 third-year medical students. Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. Significant differences exist between safety mechanisms of winged blood collection needles.

Recent Development of Augmented Reality in Surgery: A Review.

PubMed

Vávra, P; Roman, J; Zonča, P; Ihnát, P; Němec, M; Kumar, J; Habib, N; El-Gendi, A

2017-01-01

The development augmented reality devices allow physicians to incorporate data visualization into diagnostic and treatment procedures to improve work efficiency, safety, and cost and to enhance surgical training. However, the awareness of possibilities of augmented reality is generally low. This review evaluates whether augmented reality can presently improve the results of surgical procedures. We performed a review of available literature dating from 2010 to November 2016 by searching PubMed and Scopus using the terms "augmented reality" and "surgery." Results . The initial search yielded 808 studies. After removing duplicates and including only journal articles, a total of 417 studies were identified. By reading of abstracts, 91 relevant studies were chosen to be included. 11 references were gathered by cross-referencing. A total of 102 studies were included in this review. The present literature suggest an increasing interest of surgeons regarding employing augmented reality into surgery leading to improved safety and efficacy of surgical procedures. Many studies showed that the performance of newly devised augmented reality systems is comparable to traditional techniques. However, several problems need to be addressed before augmented reality is implemented into the routine practice.

77 FR 70409 - System Safety Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

...-0060, Notice No. 2] 2130-AC31 System Safety Program AGENCY: Federal Railroad Administration (FRA... passenger railroads to develop and implement a system safety program (SSP) to improve the safety of their... Division, U.S. Department of Transportation, Federal Railroad Administration, Office of Railroad Safety...

An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study.

PubMed

Arnaud, Mickael; Bégaud, Bernard; Thiessard, Frantz; Jarrion, Quentin; Bezin, Julien; Pariente, Antoine; Salvo, Francesco

2018-04-01

Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered. Noninsulin glucose-lowering drugs (NIGLDs) were selected as a case study, and hospitalization data were used to select important medical events (IME). Signal detection was performed quarterly from 2008 to 2015 using sequence symmetry analysis. NIGLD/IME associations were screened if one or more exposed case was identified in the quarter, and three or more exposed cases were identified in the population at the date of screening. Detected signals were prioritized using the Longitudinal-SNIP (L-SNIP) algorithm based on strength (S), novelty (N), and potential impact of signal (I), and pattern of drug use (P). Signals scored in the top 10% were identified as of high priority. A reference set was built based on NIGLD summaries of product characteristics (SPCs) to compute the performance of the developed system. A total of 815 associations were screened and 241 (29.6%) were detected as signals; among these, 58 (24.1%) were prioritized. The performance for signal detection was sensitivity = 47%; specificity = 80%; positive predictive value (PPV) 33%; negative predictive value = 82%. The use of the L-SNIP algorithm increased the early identification of positive controls, restricted to those mentioned in the SPCs after 2008: PPV = 100% versus PPV = 14% with its non-use. The system revealed a strong new signal with dipeptidylpeptidase-4 inhibitors and venous thromboembolism. The developed system seems promising for the routine use of healthcare data for safety surveillance of drugs used in chronic diseases.

Financial Effect of a Drug Distribution Model Change on a Health System.

PubMed

Turingan, Erin M; Mekoba, Bijan C; Eberwein, Samuel M; Roberts, Patricia A; Pappas, Ashley L; Cruz, Jennifer L; Amerine, Lindsey B

2017-06-01

Background: Drug manufacturers change distribution models based on patient safety and product integrity needs. These model changes can limit health-system access to medications, and the financial impact on health systems can be significant. Objective: The primary aim of this study was to determine the health-system financial impact of a manufacturer's change from open to limited distribution for bevacizumab (Avastin), rituximab (Rituxan), and trastuzumab (Herceptin). The secondary aim was to identify opportunities to shift administration to outpatient settings to support formulary change. Methods: To assess the financial impact on the health system, the cost minus discount was applied to total drug expenditure during a 1-year period after the distribution model change. The opportunity analysis was conducted for three institutions within the health system through chart review of each inpatient administration. Opportunity cost was the sum of the inpatient administration cost and outpatient administration margin. Results: The total drug expenditure for the study period was $26 427 263. By applying the cost minus discount, the financial effect of the distribution model change was $1 393 606. A total of 387 administrations were determined to be opportunities to be shifted to the outpatient setting. During the study period, the total opportunity cost was $1 766 049. Conclusion: Drug expenditure increased for the health system due to the drug distribution model change and loss of cost minus discount. The opportunity cost of shifting inpatient administrations could offset the increase in expenditure. It is recommended to restrict bevacizumab, rituximab, and trastuzumab through Pharmacy & Therapeutics Committees to outpatient use where clinically appropriate.

System safety education focused on industrial engineering

NASA Technical Reports Server (NTRS)

Johnston, W. L.; Morris, R. S.

1971-01-01

An educational program, designed to train students with the specific skills needed to become safety specialists, is described. The discussion concentrates on application, selection, and utilization of various system safety analytical approaches. Emphasis is also placed on the management of a system safety program, its relationship with other disciplines, and new developments and applications of system safety techniques.

Analyzing Software Requirements Errors in Safety-Critical, Embedded Systems

NASA Technical Reports Server (NTRS)

Lutz, Robyn R.

1993-01-01

This paper analyzes the root causes of safety-related software errors in safety-critical, embedded systems. The results show that software errors identified as potentially hazardous to the system tend to be produced by different error mechanisms than non- safety-related software errors. Safety-related software errors are shown to arise most commonly from (1) discrepancies between the documented requirements specifications and the requirements needed for correct functioning of the system and (2) misunderstandings of the software's interface with the rest of the system. The paper uses these results to identify methods by which requirements errors can be prevented. The goal is to reduce safety-related software errors and to enhance the safety of complex, embedded systems.

Teleretinal screening for diabetic retinopathy in six Los Angeles urban safety-net clinics: initial findings.

PubMed

Ogunyemi, Omolola; Terrien, Elizabeth; Eccles, Alicia; Patty, Lauren; George, Sheba; Fish, Allison; Teklehaimanot, Senait; Ilapakurthi, Ramarao; Aimiuwu, Otaren; Baker, Richard

2011-01-01

Diabetic retinopathy is a leading cause of blindness in US adults. This paper presents initial results of a teleretinal screening project for diabetic retinopathy involving six Los Angeles safety net clinics. A total of 1,943 patients have been screened for diabetic retinopathy by three ophthalmologist readers, with 416 receiving a recommendation for referral to specialty care. Of the cases recommended for referral, 24 had proliferative diabetic retinopathy, 62 had severe non-proliferative diabetic retinopathy (NPDR), 60 had moderate NPDR, 19 had mild NPDR, 138 had a non-diabetic condition, such as glaucoma, 63 had clinically significant macular edema without retinopathy and 50 had non-gradable images. Between 3% and 12.2% of retinal images taken at the clinics were assessed by readers as inadequate for any interpretation. The study shows the feasibility and challenges of teleretinal screening for diabetic retinopathy in urban areas facing specialist shortages and an overburdened, under-resourced safety net care-delivery system.

Teleretinal Screening for Diabetic Retinopathy in Six Los Angeles Urban Safety-Net Clinics: Initial Findings

PubMed Central

Ogunyemi, Omolola; Terrien, Elizabeth; Eccles, Alicia; Patty, Lauren; George, Sheba; Fish, Allison; Teklehaimanot, Senait; Ilapakurthi, Ramarao; Aimiuwu, Otaren; Baker, Richard

2011-01-01

Diabetic retinopathy is a leading cause of blindness in US adults. This paper presents initial results of a teleretinal screening project for diabetic retinopathy involving six Los Angeles safety net clinics. A total of 1,943 patients have been screened for diabetic retinopathy by three ophthalmologist readers, with 416 receiving a recommendation for referral to specialty care. Of the cases recommended for referral, 24 had proliferative diabetic retinopathy, 62 had severe non-proliferative diabetic retinopathy (NPDR), 60 had moderate NPDR, 19 had mild NPDR, 138 had a non-diabetic condition, such as glaucoma, 63 had clinically significant macular edema without retinopathy and 50 had non-gradable images. Between 3% and 12.2% of retinal images taken at the clinics were assessed by readers as inadequate for any interpretation. The study shows the feasibility and challenges of teleretinal screening for diabetic retinopathy in urban areas facing specialist shortages and an overburdened, under-resourced safety net care-delivery system. PMID:22195163

Improving Patient Safety With Error Identification in Chemotherapy Orders by Verification Nurses.

PubMed

Baldwin, Abigail; Rodriguez, Elizabeth S

2016-02-01

The prevalence of medication errors associated with chemotherapy administration is not precisely known. Little evidence exists concerning the extent or nature of errors; however, some evidence demonstrates that errors are related to prescribing. This article demonstrates how the review of chemotherapy orders by a designated nurse known as a verification nurse (VN) at a National Cancer Institute-designated comprehensive cancer center helps to identify prescribing errors that may prevent chemotherapy administration mistakes and improve patient safety in outpatient infusion units. This article will describe the role of the VN and details of the verification process. To identify benefits of the VN role, a retrospective review and analysis of chemotherapy near-miss events from 2009-2014 was performed. A total of 4,282 events related to chemotherapy were entered into the Reporting to Improve Safety and Quality system. A majority of the events were categorized as near-miss events, or those that, because of chance, did not result in patient injury, and were identified at the point of prescribing.

The Coast Guard Proceedings of the Marine Safety and Security Council: Spring 2016

DTIC Science & Technology

2016-04-01

PROCEEDINGS Spring 2016 Vol. 73, Number 1 Safety Management System Objectives 6 Safety Management Facilitates Safe Vessel Operation Vessel systems...crew, and operations. by LCDR Aaron W. Demo 9 Safety Management Systems to Prevent Pollution from Ships Standard procedures protect the environment...by LCDR Michael Lendvay 11 Dead Reckoning by Safety Management ? Check your course. by LCDR Corydon F. Heard IV Safety Management Systems and the Outer

Safety Education in Driving. 2nd Revision.

ERIC Educational Resources Information Center

Ohio State Univ., Columbus. Vocational Instructional Materials Lab.

Intended for driving instruction students, this publication contains instructional materials for safety education. It contains six sections on facts and figures; defensive driving; safety devices; restraints; emergency situations; and other highway users. Each section consists of reading material followed by an activity or activities. A total of…

Safety System Design for Technology Education. A Safety Guide for Technology Education Courses K-12.

ERIC Educational Resources Information Center

North Carolina State Dept. of Public Instruction, Raleigh. Div. of Vocational Education.

This manual is designed to involve both teachers and students in planning and controlling a safety system for technology education classrooms. The safety program involves students in the design and maintenance of the system by including them in the analysis of the classroom environment, job safety analysis, safety inspection, and machine safety…

Flight test summary of modified fuel systems

NASA Technical Reports Server (NTRS)

Barrett, B. G.

1976-01-01

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

Integrated autopilot/autothrottle for the NASA TSRV B-737 aircraft: Design and verification by nonlinear simulation

NASA Technical Reports Server (NTRS)

Bruce, Kevin R.

1989-01-01

An integrated autopilot/autothrottle was designed for flight test on the NASA TSRV B-737 aircraft. The system was designed using a total energy concept and is attended to achieve the following: (1) fuel efficiency by minimizing throttle activity; (2) low development and implementation costs by designing the control modes around a fixed inner loop design; and (3) maximum safety by preventing stall and engine overboost. The control law was designed initially using linear analysis; the system was developed using nonlinear simulations. All primary design requirements were satisfied.

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

Transportation systems safety hazard analysis tool (SafetyHAT) user guide (version 1.0)

DOT National Transportation Integrated Search

2014-03-24

This is a user guide for the transportation system Safety Hazard Analysis Tool (SafetyHAT) Version 1.0. SafetyHAT is a software tool that facilitates System Theoretic Process Analysis (STPA.) This user guide provides instructions on how to download, ...

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices

PubMed Central

Vernick, J; O'Brien, M; Hepburn, L; Johnson, S; Webster, D; Hargarten, S

2003-01-01

Objective: To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Design: Information about all unintentional and undetermined firearm deaths from 1991–98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. Results: There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0–17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Conclusion: Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year. PMID:14693889

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.

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed Central

Shu, Qin; Cai, Miao; Tao, Hong-bing; Cheng, Zhao-hui; Chen, Jing; Hu, Yin-huan; Li, Gang

2015-01-01

Abstract The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation. A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured. A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The “overall perceptions of safety” (48.1% vs 40.4%, P < 0.001) and “frequency of events reported” (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess “patient safety grade” to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events. Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital. PMID:26166083

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

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

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

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

Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials.

PubMed

Gottenberg, Jacques-Eric; Dörner, Thomas; Bootsma, Hendrika; Devauchelle-Pensec, Valérie; Bowman, Simon J; Mariette, Xavier; Bartz, Holger; Oortgiesen, Marga; Shock, Anthony; Koetse, Willem; Galateanu, Catrinel; Bongardt, Sabine; Wegener, William A; Goldenberg, David M; Meno-Tetang, Guy; Kosutic, Gordana; Gordon, Caroline

2018-05-01

EMBODY 1 (ClinicalTrials.gov identifier: NCT01262365) and EMBODY 2 (ClinicalTrials.gov identifier: NCT01261793) investigated the efficacy and safety of epratuzumab, a CD22-targeted humanized monoclonal IgG antibody, in patients with systemic lupus erythematosus (SLE). The studies showed no significant difference from placebo in primary or secondary clinical outcome measures but did demonstrate B cell-specific immunologic activity. The aim of this post hoc analysis was to determine whether epratuzumab had a different clinical efficacy profile in SLE patients with versus those without an associated diagnosis of Sjögren's syndrome (SS). The efficacy and safety of epratuzumab were compared between 2 patient subpopulations randomized in EMBODY 1 and 2: SLE patients with and those without a diagnosis of associated SS. British Isles Lupus Assessment Group (BILAG) total score, BILAG-based Combined Lupus Assessment (BICLA) clinical response to treatment, biologic markers (including B cells, IgG, IgM, and IgA), and safety were assessed. A total of 1,584 patients were randomized in the EMBODY 1 and EMBODY 2 trials; 113 patients were anti-SSA positive and had a diagnosis of associated SS, and 1,375 patients (86.8%) had no diagnosis of associated SS (918 patients were randomized to receive epratuzumab and 457 to receive placebo). For patients with associated SS, but not those without associated SS, a higher proportion of patients receiving epratuzumab achieved a BICLA response and a reduction from baseline in BILAG total score. B cell reduction was faster in patients with associated SS. The sensitivity of B cells to epratuzumab as measured by the mean concentration producing 50% of the maximum B cell count depletion was lower for patients with associated SS (9.5 μg/ml) versus the total EMBODY population (87.1 μg/ml). No difference in the frequency of adverse events in those receiving placebo was reported. Patients with SLE and associated SS treated with epratuzumab showed improvement in SLE disease activity, which was associated with bioactivity, such as decreases in B cell number and IgM level. © 2018 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Improving Patient Safety in Public Hospitals: Developing Standard Measures to Track Medical Errors and Process Breakdowns.

PubMed

Ackerman, Sara L; Gourley, Gato; Le, Gem; Williams, Pamela; Yazdany, Jinoos; Sarkar, Urmimala

2018-03-14

The aim of the study was to develop standards for tracking patient safety gaps in ambulatory care in safety net health systems. Leaders from five California safety net health systems were invited to participate in a modified Delphi process sponsored by the Safety Promotion Action Research and Knowledge Network (SPARKNet) and the California Safety Net Institute in 2016. During each of the three Delphi rounds, the feasibility and validity of 13 proposed patient safety measures were discussed and prioritized. Surveys and transcripts from the meetings were analyzed to understand the decision-making process. The Delphi process included eight panelists. Consensus was reached to adopt 9 of 13 proposed measures. All 9 measures were unanimously considered valid, but concern was expressed about the feasibility of implementing several of the measures. Although safety net health systems face high barriers to standardized measurement, our study demonstrates that consensus can be reached on acceptable and feasible methods for tracking patient safety gaps in safety net health systems. If accompanied by the active participation key stakeholder groups, including patients, clinicians, staff, data system professionals, and health system leaders, the consensus measures reported here represent one step toward improving ambulatory patient safety in safety net health systems.

Safety and tolerability of intrathecal liposomal cytarabine as central nervous system prophylaxis in patients with acute lymphoblastic leukemia.

PubMed

Valentin, Angelika; Troppan, Katharina; Pfeilstöcker, Michael; Nösslinger, Thomas; Linkesch, Werner; Neumeister, Peter

2014-08-01

Central nervous system recurrence in acute lymphoblastic leukemia (ALL) occurs in up to 15% of patients and is frequently associated with poor outcome. The purpose of our study was to evaluate the efficacy and safety of a slow-release liposomal formulation of cytarabine for intrathecal (IT) meningeal prophylaxis in patients suffering from ALL. Forty patients aged 20-77 years (median 36) were preventively treated with a total of 96 (range 1-6) single doses containing 50 mg of liposomal cytarabine on a compassionate use basis. After a median observation period of 23 months (range 2-118) only two patients experienced a combined medullary-leptomeningeal disease recurrence after primary diagnosis. Except for headache grade 2 in two patients, no specific toxicity attributable to IT liposomal cytarabine application was noted. Long-term neurological side effects were not observed. IT liposomal cytarabine therapy with concomitant dexamethasone appears to be feasible and well tolerated.

Study report recommendations for the next generation Range Safety System (RSS) Integrated Receiver/Decoder (IRD)

NASA Technical Reports Server (NTRS)

Crosby, Robert H.

1992-01-01

The Integrated Receiver/Decoder (IRD) currently used on the Space Shuttle was designed in the 1980 and prior time frame. Over the past 12 years, several parts have become obsolete or difficult to obtain. As directed by the Marshall Space Flight Center, a primary objective is to investigate updating the IRD design using the latest technology subsystems. To take advantage of experience with the current designs, an analysis of failures and a review of discrepancy reports, material review board actions, scrap, etc. are given. A recommended new design designated as the Advanced Receiver/Decoder (ARD) is presented. This design uses the latest technology components to simplify circuits, improve performance, reduce size and cost, and improve reliability. A self-test command is recommended that can improve and simplify operational procedures. Here, the new design is contrasted with the old. Possible simplification of the total Range Safety System is discussed, as is a single-step crypto technique that can improve and simplify operational procedures.

The Art World's Concept of Negative Space Applied to System Safety Management

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

Tools from several different disciplines can improve system safety management. This paper relates the Art World with our system safety world, showing useful art schools of thought applied to system safety management, developing an art theory-system safety bridge. This bridge is then used to demonstrate relations with risk management, the legal system, personnel management and basic management (establishing priorities). One goal of this presentation/paper is simply to be a fun diversion from the many technical topics presented during the conference.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

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

49 CFR 350.105 - What definitions are used in this part?

Code of Federal Regulations, 2011 CFR

2011-10-01

... governments, and other persons carrying out programs, activities, and projects relating to CMV safety and... percent of total MCSAP funds are available for these activities. Commercial motor vehicle (CMV) means a... vehicle safety plan (CVSP) means the document outlining the State's CMV safety objectives, strategies...

Let's Teach Safety. A Directory of Classroom Resources.

ERIC Educational Resources Information Center

American Vocational Association, Arlington, VA.

Intended for use by vocational education teachers, this directory contains listings of such classroom resources as films, pamphlets, charts, and transparencies useful for teaching safety awareness and safety habits in seven vocational occupation areas. A total of fifty-one resources relating to agricultural occupations are listed. The section on…

Water quality, compliance, and health outcomes among utilities implementing Water Safety Plans in France and Spain.

PubMed

Setty, Karen E; Kayser, Georgia L; Bowling, Michael; Enault, Jerome; Loret, Jean-Francois; Serra, Claudia Puigdomenech; Alonso, Jordi Martin; Mateu, Arnau Pla; Bartram, Jamie

2017-05-01

Water Safety Plans (WSPs), recommended by the World Health Organization since 2004, seek to proactively identify potential risks to drinking water supplies and implement preventive barriers that improve safety. To evaluate the outcomes of WSP application in large drinking water systems in France and Spain, we undertook analysis of water quality and compliance indicators between 2003 and 2015, in conjunction with an observational retrospective cohort study of acute gastroenteritis incidence, before and after WSPs were implemented at five locations. Measured water quality indicators included bacteria (E. coli, fecal streptococci, total coliform, heterotrophic plate count), disinfectants (residual free and total chlorine), disinfection by-products (trihalomethanes, bromate), aluminum, pH, turbidity, and total organic carbon, comprising about 240K manual samples and 1.2M automated sensor readings. We used multiple, Poisson, or Tobit regression models to evaluate water quality before and after the WSP intervention. The compliance assessment analyzed exceedances of regulated, recommended, or operational water quality thresholds using chi-squared or Fisher's exact tests. Poisson regression was used to examine acute gastroenteritis incidence rates in WSP-affected drinking water service areas relative to a comparison area. Implementation of a WSP generally resulted in unchanged or improved water quality, while compliance improved at most locations. Evidence for reduced acute gastroenteritis incidence following WSP implementation was found at only one of the three locations examined. Outcomes of WSPs should be expected to vary across large water utilities in developed nations, as the intervention itself is adapted to the needs of each location. The approach may translate to diverse water quality, compliance, and health outcomes. Copyright © 2017 Elsevier GmbH. All rights reserved.

Efficacy and safety of nifedipine GITS in Asians with hypertension: results of a post-marketing surveillance study in China.

PubMed

Runlin, Gao; Junren, Zhu; Guozhang, Liu; Weizhong, Zhang; Tingjie, Zhang; Ningling, Sun; Landen, Harald

2007-01-01

This post-marketing surveillance study assessed the efficacy, safety and tolerability of treatment with nifedipine GITS (gastrointestinal therapeutic system) in hypertensive patients with different risk profiles under normal daily practice conditions in China. A total of 7395 patients were included in 564 outpatient clinics. Patients received 30mg or 60mg of nifedipine GITS, which could be up- and down-titrated if necessary. Efficacy, safety and tolerability data were collected at up to three follow-up visits. Patient documentation was completed using standardised and barcoded case report forms. Descriptive and explorative analyses of the data were performed. At endpoint, 93% of patients were receiving 30mg of nifedipine GITS and 7% were taking 60mg of nifedipine GITS. The mean observation period was 9 +/- 7 weeks. At endpoint, the mean BP reduction was 27.7/14.8mm Hg; 43% of patients had a systolic BP <140mm Hg, and 58% had a diastolic BP <90mm Hg. BP control as recommended by international guidelines was achieved in 43.5% of all patients. A total of 3163 patients (42.8%) received additional antihypertensive medication, of which ACE inhibitors were most commonly used (40.7%), followed by beta-adrenoceptor antagonists (25.8%).Twenty-nine patients (0.4%) experienced a total of 39 adverse events. Subjective physicians' assessments of efficacy, tolerability and patient acceptance of nifedipine GITS treatment returned ratings of 'very good' and 'good' in 91-95% of each category. Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 7395 Chinese patients under normal daily practice conditions. The results confirm the findings and experience of previously performed clinical studies.

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

2006-01-01

The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

14 CFR 417.311 - Flight safety crew roles and qualifications.

Code of Federal Regulations, 2012 CFR

2012-01-01

... crew roles and qualifications. (a) A flight safety crew must operate the flight safety system hardware... the knowledge, skills, and abilities needed to operate the flight safety system hardware in accordance... rules. (3) An individual who operates flight safety support systems must have knowledge of and be...

14 CFR 417.311 - Flight safety crew roles and qualifications.

Code of Federal Regulations, 2013 CFR

2013-01-01

... crew roles and qualifications. (a) A flight safety crew must operate the flight safety system hardware... the knowledge, skills, and abilities needed to operate the flight safety system hardware in accordance... rules. (3) An individual who operates flight safety support systems must have knowledge of and be...

14 CFR 417.311 - Flight safety crew roles and qualifications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... crew roles and qualifications. (a) A flight safety crew must operate the flight safety system hardware... the knowledge, skills, and abilities needed to operate the flight safety system hardware in accordance... rules. (3) An individual who operates flight safety support systems must have knowledge of and be...

HYGIENE PRACTICES IN URBAN RESTAURANTS AND CHALLENGES TO IMPLEMENTING FOOD SAFETY AND HAZARD ANALYSIS CRITICAL CONTROL POINTS (HACCP) PROGRAMMES IN THIKA TOWN, KENYA.

PubMed

Muinde, R K; Kiinyukia, C; Rombo, G O; Muoki, M A

2012-12-01

To determine the microbial load in food, examination of safety measures and possibility of implementing an Hazard Analysis Critical Control Points (HACCP) system. The target population for this study consisted of restaurants owners in Thika. Municipality (n = 30). Simple randomsamples of restaurantswere selected on a systematic sampling method of microbial analysis in cooked, non-cooked, raw food and water sanitation in the selected restaurants. Two hundred and ninety eight restaurants within Thika Municipality were selected. Of these, 30 were sampled for microbiological testing. From the study, 221 (74%) of the restaurants were ready to eat establishments where food was prepared early enough to hold and only 77(26%) of the total restaurants, customers made an order of food they wanted. 118(63%) of the restaurant operators/staff had knowledge on quality control on food safety measures, 24 (8%) of the restaurants applied these knowledge while 256 (86%) of the restaurants staff showed that food contains ingredients that were hazard if poorly handled. 238 (80%) of the resultants used weighing and sorting of food materials, 45 (15%) used preservation methods and the rest used dry foods as critical control points on food safety measures. The study showed that there was need for implementation of Hazard Analysis Critical Control Points (HACCP) system to enhance food safety. Knowledge of HACCP was very low with 89 (30%) of the restaurants applying some of quality measures to the food production process systems. There was contamination with Coliforms, Escherichia coli and Staphylococcus aureus microbial though at very low level. The means of Coliforms, Escherichia coli and Staphylococcus aureas microbial in sampled food were 9.7 x 103CFU/gm, 8.2 x 103 CFU/gm and 5.4 x 103 CFU/gm respectively with Coliforms taking the highest mean.

Evaluation Of The Vehicle Radar Safety Systems Rashid Radar Safety Brake Collision Warning System, Final Report

DOT National Transportation Integrated Search

1988-02-01

THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...

Mechanisms of slow-pitch softball injuries reported to the HQ Air Force Safety Center a 10-year descriptive study, 1993-2002.

PubMed

Burnham, Bruce R; Copley, G Bruce; Shim, Matthew J; Kemp, Philip A; Jones, Bruce H

2010-01-01

Softball is a popular sport in civilian and military populations and results in a large number of lost-workday injuries. The purpose of this study is to describe the mechanisms associated with softball injuries occurring among active duty U.S. Air Force (USAF) personnel to better identify potentially effective countermeasures. Data derived from safety reports were obtained from the USAF Ground Safety Automated System in 2003. Softball injuries for the years 1993-2002 that resulted in at least one lost workday were included in the study. Narrative data were systematically reviewed and coded in order to categorize and summarize mechanisms associated with these injuries. This report documents a total of 1181 softball-related mishap reports, involving 1171 active duty USAF members who sustained one lost-workday injury while playing softball. Eight independent mechanisms were identified. Three specific scenarios (sliding, being hit by a ball, and colliding with a player) accounted for 60% of reported softball injuries. Mechanisms of injury for activities such as playing softball, necessary for prevention planning, can be identified using the detailed information found in safety reports. This information should also be used to develop better sports injury coding systems. Within the USAF and U.S. softball community, interventions to reduce injuries related to the most common mechanisms (sliding, being hit by a ball, and colliding with a player) should be developed, implemented, and evaluated. Published by Elsevier Inc.

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

PubMed

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

Housing system and laying hen strain impacts on egg microbiology.

PubMed

Jones, D R; Anderson, K E

2013-08-01

Alternative hen housing is becoming more commonplace in the egg market. However, a complete understanding of the implications for alternative housing systems on egg safety has not been achieved. The current study examines the impact of housing Hy-Line Brown, Hy-Line Silver Brown, and Barred Plymouth Rock hens in conventional cage, cage-free, and free range egg production systems on shell microbiology. Eggs were collected at 4 sampling periods. Egg shell emulsion pools were formed and enumerated for total aerobic organisms, Enterobacteriaceae, and yeast and mold counts. Hy-Line Brown and Hy-Line Silver Brown hens produced eggs with significantly (P < 0.05 and 0.001, respectively) different levels of aerobic organisms dependent on housing system. Eggs from conventional cages had significantly different (P < 0.05) levels of aerobic contamination in relation to hen strain with Hy-Line Silver Brown having the greatest (4.57 log cfu/mL). Hy-Line Brown and Barred Plymouth Rock hens produced eggs with significantly different (P < 0.01) levels of Enterobacteriaceae among housing systems with conventional caged eggs having the lowest level of contamination for the hen strains. There were no differences within each strain among housing systems for yeast and mold contamination. The study shows that hen strain has an effect on egg microbial levels for various housing systems, and egg safety should be considered when making hen strain selections for each housing system.

Mines Systems Safety Improvement Using an Integrated Event Tree and Fault Tree Analysis

NASA Astrophysics Data System (ADS)

Kumar, Ranjan; Ghosh, Achyuta Krishna

2017-04-01

Mines systems such as ventilation system, strata support system, flame proof safety equipment, are exposed to dynamic operational conditions such as stress, humidity, dust, temperature, etc., and safety improvement of such systems can be done preferably during planning and design stage. However, the existing safety analysis methods do not handle the accident initiation and progression of mine systems explicitly. To bridge this gap, this paper presents an integrated Event Tree (ET) and Fault Tree (FT) approach for safety analysis and improvement of mine systems design. This approach includes ET and FT modeling coupled with redundancy allocation technique. In this method, a concept of top hazard probability is introduced for identifying system failure probability and redundancy is allocated to the system either at component or system level. A case study on mine methane explosion safety with two initiating events is performed. The results demonstrate that the presented method can reveal the accident scenarios and improve the safety of complex mine systems simultaneously.

Potentials for Platooning in U.S. Highway Freight Transport: Preprint

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

Muratori, Matteo; Holden, Jacob; Lammert, Michael

2017-03-15

Smart technologies enabling connection among vehicles and between vehicles and infrastructure as well as vehicle automation to assist human operators are receiving significant attention as means for improving road transportation systems by reducing fuel consumption - and related emissions - while also providing additional benefits through improving overall traffic safety and efficiency. For truck applications, currently responsible for nearly three-quarters of the total U.S. freight energy use and greenhouse gas (GHG) emissions, platooning has been identified as an early feature for connected and automated vehicles (CAVs) that could provide significant fuel savings and improved traffic safety and efficiency without radicalmore » design or technology changes compared to existing vehicles. A statistical analysis was performed based on a large collection of real-world U.S. truck usage data to estimate the fraction of total miles that are technically suitable for platooning. In particular, our analysis focuses on estimating 'platoonable' mileage based on overall highway vehicle use and prolonged high-velocity traveling, establishing that about 65% of the total miles driven by combination trucks could be driven in platoon formation, leading to a 4% reduction in total truck fuel consumption. This technical potential for 'platoonable' miles in the U.S. provides an upper bound for scenario analysis considering fleet willingness to platoon as an estimate of overall benefits of early adoption of CAV technologies. A benefit analysis is proposed to assess the overall potential for energy savings and emissions mitigation by widespread implementation of highway platooning for trucks.« less

Safe summers: Adapting evidence-based injury prevention into a summer curriculum.

PubMed

Schaeffer, Melody; Cioni, Claire; Kozma, Nicole; Rains, Catherine; Todd, Greta

2017-11-01

Unintentional injury is the leading cause of death for those aged 0 years to 19 years. St. Louis Children's Hospital created Safety Land, a comprehensive injury prevention intervention which is provided during summer months. This program uses a life-size board game to teach safety education to children in ages 5 years to 11 years. The purpose of this study was to evaluate the effect of Safety Land on safety knowledge in children that participated in the intervention. St. Louis Children's Hospital identified ZIP codes with the highest use of the emergency room for injury. Daycares and summer camps within these ZIP codes were targeted for the Safety Land intervention. A multiple choice pretest and posttest survey was designed to measure knowledge change within program participants. Students were selected for testing based on site availably. Within these sites, a convenience sample of children was selected for pretesting and posttesting. Safety Land staff conducted the pretest a week before the intervention, and the posttest was administered the week after the intervention. A total knowledge score was calculated to determine overall knowledge change. Descriptive statistics and independent-samples t tests were conducted to determine statistical significance of change in knowledge (p < 0.05) for each question. Between May 2014 and August 2016, 3,866 children participated in Safety Land. A total of 310 children completed the pretest and 274 completed the posttest. Mean test scores increased from 66.7% to 85.1% and independent-samples t test of the total knowledge score was significant (p < 0.05) between pretest and posttest values. Findings suggest that this intervention is effective in increasing the knowledge of safety behaviors for children receiving the curriculum during the summer months. Further research should focus on long-term behavior changes in these youth.

[Injury patterns and typical stress situations in paragliding].

PubMed

Bohnsack, M; Schröter, E

2005-05-01

Paragliding is known as a high risk sport with a substantial rate of severe and fatal injuries. Analysis of typical injury mechanisms and statistics showed that the total rate of paragliding injuries has decreased in recent years for an increasing number of pilots. In 2003, the rate of severe and fatal injuries in paragliding was less than that of other air sports and motorcycling. Through the introduction of a spine protector system in Germany and Austria, the number of vertebral fractures decreased significantly between 2000 and 2003. Most other injuries, especially of the lower extremities, could be avoided by adequate and farsighted flight behavior. Qualified instruction with regular training, standardized development of safety equipment and consequent analysis of paragliding injuries will help to improve the safety status in paragliding.

European Workshop Industrical Computer Science Systems approach to design for safety

NASA Technical Reports Server (NTRS)

Zalewski, Janusz

1992-01-01

This paper presents guidelines on designing systems for safety, developed by the Technical Committee 7 on Reliability and Safety of the European Workshop on Industrial Computer Systems. The focus is on complementing the traditional development process by adding the following four steps: (1) overall safety analysis; (2) analysis of the functional specifications; (3) designing for safety; (4) validation of design. Quantitative assessment of safety is possible by means of a modular questionnaire covering various aspects of the major stages of system development.

IMPLEMENTATION OF DEFENSE NUCLEAR FACILITY SAFETY BOARD RECOMMENDATION 2000-2 AT WIPP

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

Jackson, K.; Wu, C.

2002-02-26

The Defense Nuclear Safeties Board (DNFSB) issued Recommendation 2000-2 on March 8, 2000, concerning the degrading conditions of vital safety systems, or systems important to nuclear safety, at DOE sites across the nation. The Board recommended that the DOE take action to assess the condition of its nuclear systems to ensure continued operational readiness of vital safety systems that are important for safely accomplishing the DOE's mission. To verify the readiness of vital safety systems, a two-phased approach was established. Phase I consisted of a qualitative assessment to approved criteria of the defined vital safety systems by operating contractor personnel,more » overseen by Federal field office personnel. Based on Phase I Assessment results, vital safety systems with significant deficiencies would be further assessed in Phase II, a more extensive quantitative assessment, by a contractor and Federal team, using a second set of criteria. In addition, Defense Nuclear Facility Safety Board Recommendation 2000-2 concluded that the degradation of confinement ventilation systems was of major concern, and issued a separate set of criteria to perform a Phase II Assessment on confinement ventilation systems.« less

49 CFR 659.15 - System safety program standard.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.15 System safety program standard. (a) General requirement. Each state...

Corrections of clinical chemistry test results in a laboratory information system.

PubMed

Wang, Sihe; Ho, Virginia

2004-08-01

The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

Neutron radiation effects on Fabry-Perot fiber optic sensors

NASA Astrophysics Data System (ADS)

Liu, Hanying; Talnagi, Joseph; Miller, Don W.

2003-07-01

Nuclear Power Plant operators and Generation IV plant designers are considering advanced data transmission and measurement systems to improve system economics and safety, while concurrently addressing the issue of obsolescence of instrumentation and control systems. Fiber optic sensors have advantages over traditional sensors such as immunity to electromagnetic interference or radio frequency interference, higher sensitivity and accuracy, smaller size and less weight, higher bandwidth and multiplexing capability. A Fabry-Perot fiber optic sensor utilizes a unique interferometric mechanism and data processing technique, and has potential applications in nuclear radiation environments. Three sensors with different gamma irradiation history were irradiated in a mixed neutron/gamma irradiation field, in which the total neutron fluence was 2.6×10 16 neutrons/cm 2 and the total gamma dose was 1.09 MGy. All of them experienced a temperature shift of about 34°F but responded linearly to temperature changes. An annealing phenomenon was observed as the environmental temperature increased, which reduced the offset by approximately 63%.

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.

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. Copyright © 2013 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.

Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

NASA Technical Reports Server (NTRS)

1972-01-01

A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

Regulatory Concerns on the In-Containment Water Storage System of the Korean Next Generation Reactor

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

Ahn, Hyung-Joon; Lee, Jae-Hun; Bang, Young-Seok

2002-07-15

The in-containment water storage system (IWSS) is a newly adopted system in the design of the Korean Next Generation Reactor (KNGR). It consists of the in-containment refueling water storage tank, holdup volume tank, and cavity flooding system (CFS). The IWSS has the function of steam condensation and heat sink for the steam release from the pressurizer and provides cooling water to the safety injection system and containment spray system in an accident condition and to the CFS in a severe accident condition. With the progress of the KNGR design, the Korea Institute of Nuclear Safety has been developing Safety andmore » Regulatory Requirements and Guidances for safety review of the KNGR. In this paper, regarding the IWSS of the KNGR, the major contents of the General Safety Criteria, Specific Safety Requirements, Safety Regulatory Guides, and Safety Review Procedures were introduced, and the safety review items that have to be reviewed in-depth from the regulatory viewpoint were also identified.« less

Mechanical code comparator

DOEpatents

Peter, Frank J.; Dalton, Larry J.; Plummer, David W.

2002-01-01

A new class of mechanical code comparators is described which have broad potential for application in safety, surety, and security applications. These devices can be implemented as micro-scale electromechanical systems that isolate a secure or otherwise controlled device until an access code is entered. This access code is converted into a series of mechanical inputs to the mechanical code comparator, which compares the access code to a pre-input combination, entered previously into the mechanical code comparator by an operator at the system security control point. These devices provide extremely high levels of robust security. Being totally mechanical in operation, an access control system properly based on such devices cannot be circumvented by software attack alone.

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

PubMed

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

2014-08-01

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

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

Pharmacokinetics and safety of imiquimod 5% cream in the treatment of actinic keratoses of the face, scalp, or hands and arms.

PubMed

Harrison, Lester I; Skinner, Shari L; Marbury, Thomas C; Owens, Mary L; Kurup, Sarala; McKane, Scott; Greene, Robert J

2004-06-01

The safety and efficacy of imiquimod 5% cream is being evaluated for the treatment of dysplastic lesions of the epidermis (actinic keratoses, AK). The objective of this clinical study was to describe the pharmacokinetics and safety of topical imiquimod during multiple dosing of AK subjects. A total of 58 adult subjects with 5 to 20 AK lesions at the treatment site applied imiquimod cream three times per week for up to 16 weeks as follows: 12 males and 11 females applied 12.5 mg imiquimod to the face; 11 males applied 25 mg to the entire balding area of the scalp; and 12 males and 12 females applied 75 mg to both hands and forearms. Pharmacokinetics and safety were assessed after the first and last doses, as well as biweekly. Imiquimod and its metabolites were measured in the serum and urine using sensitive liquid chromatography/mass spectrometry methods. Less than 0.6% of the applied doses was recovered in the urine of all subjects. Serum imiquimod levels were low, reflecting minimal dermal absorption, and increased with dose, although not proportionally. Peak levels at the end of dosing were 0.1, 0.2, and 1.6 ng/ml for the face, scalp, and hands/arms groups, respectively. A two- to fourfold accumulation was seen at the end of dosing. Local application site reactions were the most common adverse event, reported by approximately 50% of the subjects in each treatment group. The small number of systemic adverse events, including 'flu-like symptoms, were mostly mild and did not show a dose response. Thus, minimal systemic absorption and good safety margins for topical imiquimod were seen in AK subjects with doses as high as 75 mg three times per week for 16 weeks.

A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005–2010)

PubMed Central

Cousins, David H; Gerrett, David; Warner, Bruce

2012-01-01

A review of all medication incidents reported to the National Reporting and Learning System (NRLS) in England in Wales between 1 January 2005 and 31 December 2010 was undertaken. The 526 186 medication incident reports represented 9.68% of all patient safety incidents. Medication incidents from acute general hospitals (394 951) represented 75% of reports. There were relatively smaller numbers of medication incident reports (44 952) from primary care, representing 8.5% of the total. Of 86 821 (16%) medication incidents reporting actual patient harm, 822 (0.9%) resulted in death or severe harm. The incidents involving medicine administration (263 228; 50%) and prescribing (97 097; 18%) were the process steps with the largest number of reports. Omitted and delayed medicine (82 028; 16%) and wrong dose (80 170; 15%) represented the largest error categories. Thirteen medicines or therapeutic groups accounted for 377 (46%) of the incidents with outcomes of death or severe harm. The National Patient Safety Agency (NPSA) has issued guidance to help minimize incidents with many of these medicines. Many recent incidents could have been prevented if the NPSA guidance had been better implemented. It is recommended that healthcare organizations in all sectors establish an effective infrastructure to oversee and promote safe medication practice, including an annual medication safety report. In the future, preventable harms from medication incidents can be further minimized by; the continued use of the NRLS to identify and prioritize important actions to improve medication safety, a central organization continuing to issue medication safety guidance to the service and better methods to ensure that the National Health Service has implemented this guidance. PMID:22188210

75 FR 68224 - Safety Management Systems for Part 121 Certificate Holders

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... the general framework for an organization-wide safety management approach to air carrier operations... System? An SMS is an organization-wide approach to managing safety risk and assuring the effectiveness of... under 14 CFR part 121 to develop and implement a safety management system (SMS) to improve the safety of...

[Analysis of accidents for magnetically induced displacement of the large ferromagnetic material in magnetic resonance systems].

PubMed

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

2013-01-01

To improve magnetic resonance (MR) safety, we surveyed the accidents caused by large ferromagnetic materials brought into MR systems accidentally. We sent a questionnaire to 700 Japanese medical institutions and received 405 valid responses (58%). A total of 97 accidents in 77 institutions were observed and we analyzed them regarding incidental rate, the detail situation and environmental factors. The mean accident rate of each institute was 0.7/100,000 examinations, which was widely distributed (0-25.6/100,000) depending on the institute. In this survey, relatively small institutes with less than 500 beds tend to have these accidents more frequently (p<0.01). The institutes in which daily MR examination counts are more than 10 patients have fewer accidents than those with less than 10 daily examinations. The institutes with 6-10 MR examinations daily have significantly more accidents than that with more than 10 daily MR examinations (p<0.01). The main mental factors of the accidents were considered to be "prejudice" and "carelessness" but some advocate "ignorance." Though we could not find significant reduction in the institutes that have lectures and training for MR safety, we should continue lectures and training for MR safety to reduce accidents due to "ignorance."

Evaluation of seven in vitro alternatives for ocular safety testing.

PubMed

Bruner, L H; Kain, D J; Roberts, D A; Parker, R D

1991-07-01

Seven in vitro assays were evaluated to determine if any were useful as screening procedures in ocular safety assessment. Seventeen test materials (chemicals, household cleaners, hand soaps, dishwashing liquids, shampoos, and liquid laundry detergents) were tested in each assay. In vivo ocular irritation scores for the materials were obtained from existing rabbit low volume eye test (LVET) data. The seven assays evaluated included the silicon microphysiometer (SM), luminescent bacteria toxicity test (LBT), neutral red assay (NR), total protein assay (TP), Tetrahymena thermophila motility assay (TTMA), bovine eye/chorioallantoic membrane assay (BE/CAM), and the EYTEX system (ETS). For the seventeen materials used in this study there was a significant correlation between the in vivo irritant potential and in vitro data for all the tests except the EYTEX System (SM, r = -0.87; LBT, r = -0.91; NR, r = -0.85; TTMA, r = 0.78; TP, r = -0.86; ETS, r = 0.29). The irritation classifications provided by the BE/CAM also did not correspond with the actual in vivo irritancy potential of the test materials. The result of this study suggested it may be possible to classify materials into broad irritancy categories with some of the assays. This would allow their use as screens prior to limited in vivo confirmation in the ocular safety assessment process.

49 CFR 659.15 - System safety program standard.

Code of Federal Regulations, 2011 CFR

2011-10-01

... included in the affected rail transit agency's system safety program plan relating to the hazard management... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the...

30 CFR 250.804 - Production safety-system testing and records.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Production safety-system testing and records... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection... devices operating at temperatures which could ignite a methane-air mixture shall not be used. All...

30 CFR 250.804 - Production safety-system testing and records.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Production safety-system testing and records... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection... devices operating at temperatures which could ignite a methane-air mixture shall not be used. All...

30 CFR 250.804 - Production safety-system testing and records.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Production safety-system testing and records... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection... devices operating at temperatures which could ignite a methane-air mixture shall not be used. All...

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Safety management system document and data maintenance (1) Procedures which establish and maintain control of all documents and data relevant to the safety management system. (2) Documents are available at... safety management system have? 96.250 Section 96.250 Navigation and Navigable Waters COAST GUARD...

33 CFR 96.240 - What functional requirements must a safety management system meet?

Code of Federal Regulations, 2010 CFR

2010-07-01

... a safety management system meet? 96.240 Section 96.240 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.240 What functional...

33 CFR 96.230 - What objectives must a safety management system meet?

Code of Federal Regulations, 2010 CFR

2010-07-01

... management system meet? 96.230 Section 96.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.230 What objectives must a safety...

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2012-10-01 2012-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2013-10-01 2013-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2014-10-01 2014-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

Photovoltaic system criteria documents. Volume 5: Safety criteria for photovoltaic applications

NASA Technical Reports Server (NTRS)

Koenig, John C.; Billitti, Joseph W.; Tallon, John M.

1979-01-01

Methodology is described for determining potential safety hazards involved in the construction and operation of photovoltaic power systems and provides guidelines for the implementation of safety considerations in the specification, design and operation of photovoltaic systems. Safety verification procedures for use in solar photovoltaic systems are established.

49 CFR 659.27 - Internal safety and security reviews.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the..., indicating that the rail transit agency is in compliance with its system safety program plan and system... security reviews indicate that the rail transit agency is not in compliance with its system safety program...

Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

NASA Astrophysics Data System (ADS)

Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

2014-11-01

All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

Implementation of a timed, electronic, assessment-driven potassium-replacement protocol.

PubMed

Zielenski, Christopher; Crabtree, Adam; Le, Tien; Marlatt, Alyse; Ng, Dana; Tran, Alan

2017-06-15

The adherence to and effectiveness and safety of a timed, electronic, assessment-driven potassium-replacement protocol (TARP) were compared with an electronic nurse-driven replacement protocol (NRP) are reported. A retrospective observational study was conducted in a community hospital evaluating protocol adherence, effectiveness, and safety for 2 potassium-replacement protocols. All adults on medical units with an order for potassium replacement per protocol during the 3-month trial periods were reviewed. All patients requiring potassium replacement per protocol were included in the analysis. Adherence to the protocol was assessed by evaluating the dose of potassium administered and performance of reassessments. Effectiveness of the protocol was assessed by evaluating the time to achieve target potassium levels. Safety was assessed by evaluating the route of administration and occurrence of hyperkalemia. A total of 300 patients treated using potassium-replacement protocols required potassium replacement during the study period, with 148 patients in the NRP group requiring 491 instances of potassium replacement. In the TARP group a total of 564 instances requiring potassium replacement corresponded to 152 patients. Of the 491 instances requiring replacement in the NRP group, the correct dose was administered and reassessment performed 117 times (23.8%). Overall adherence ( p < 0.05), correct dose given ( p < 0.05), average time from blood draw to potassium replacement ( p < 0.0001), use of oral replacement ( p < 0.05), and time to achieve target potassium level within 12 hours ( p < 0.05) were significantly improved in the TARP group. The TARP improved the effectiveness and safety of potassium-replacement therapy over the traditional NRP without negatively affecting timeliness of care. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Catheter radiofrequency ablation for arrhythmias under the guidance of the Carto 3 three-dimensional mapping system in an operating room without digital subtraction angiography.

PubMed

Huang, Xingfu; Chen, Yanjia; Huang, Zheng; He, Liwei; Liu, Shenrong; Deng, Xiaojiang; Wang, Yongsheng; Li, Rucheng; Xu, Dingli; Peng, Jian

2018-06-01

Several studies have reported the efficacy of a zero-fluoroscopy approach for catheter radiofrequency ablation of arrhythmias in a digital subtraction angiography (DSA) room. However, no reports are available on the ablation of arrhythmias in the absence of DSA in the operating room. To investigate the efficacy and safety of catheter radiofrequency ablation for arrhythmias under the guidance of a Carto 3 three-dimensional (3D) mapping system in an operating room without DSA. Patients were enrolled according to the type of arrhythmia. The Carto 3 mapping system was used to reconstruct heart models and guide the electrophysiologic examination, mapping, and ablation. The total procedure, reconstruction, electrophysiologic examination, and mapping times were recorded. Furthermore, immediate success rates and complications were also recorded. A total of 20 patients were enrolled, including 12 males. The average age was 51.3 ± 17.2 (19-76) years. Nine cases of atrioventricular nodal re-entrant tachycardia, 7 cases of frequent ventricular premature contractions, 3 cases of Wolff-Parkinson-White syndrome, and 1 case of typical atrial flutter were included. All arrhythmias were successfully ablated. The procedure time was 127.0 ± 21.0 (99-177) minutes, the reconstruction time was 6.5 ± 2.9 (3-14) minutes, the electrophysiologic study time was 10.4 ± 3.4 (6-20) minutes, and the mapping time was 11.7 ± 8.3 (3-36) minutes. No complications occurred. Radiofrequency ablation of arrhythmias without DSA is effective and feasible under the guidance of the Carto 3 mapping system. However, the electrophysiology physician must have sufficient experience, and related emergency measures must be present to ensure safety.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

Severe brachial plexopathy after an ultrasound-guided single-injection nerve block for total shoulder arthroplasty in a patient with multiple sclerosis.

PubMed

Koff, Matthew D; Cohen, Jeffrey A; McIntyre, John J; Carr, Charles F; Sites, Brian D

2008-02-01

DESPITE the known benefits of regional anesthesia for patients undergoing joint arthroplasty, the performance of peripheral nerve blocks in patients with multiple sclerosis (MS) remains controversial. MS has traditionally been described as an isolated disease of the central nervous system, without involvement of the peripheral nerves, and peripheral nerve blockade has been suggested to be safe. However, careful review of the literature suggests that MS may also be associated with involvement of the peripheral nervous system, challenging traditional teachings. There is a paucity of evidence with regard to safety in using peripheral nerve regional anesthesia in these patients. This makes it difficult to provide adequate "informed consent" to these patients. This case report describes a patient with MS who sustained a severe brachial plexopathy after a total shoulder arthroplasty during combined general anesthesia and interscalene nerve block.

Should gun safety be taught in schools? Perspectives of teachers.

PubMed

Obeng, Cecilia

2010-08-01

Gun-related injuries and deaths among children occur at disproportionately high rates in the United States. Children who live in homes with guns are the most likely victims. This study describes teachers' views on whether gun safety should be taught to children in the preschool and elementary years. A total of 150 survey questionnaires were distributed to public and private school teachers in preschools and elementary schools in 2 counties of a Midwestern state. In total, 62% of the 102 respondents indicated that they favored the teaching of gun safety, while 13% disapproved and 25% had no opinion. Overall, 28.4% of the respondents supported the teaching of gun safety in grades pre-K (pre-kindergarten) through first grade. About 54% indicated that police or trained military personnel should do the teaching of this subject in schools, while 6.9% suggested that teachers should do the teaching. With a majority of the teachers in favor of teaching gun safety in the schools, a larger study should be conducted that explores the introduction of gun safety into the curriculum in preschool through grade 6. Such a study should evaluate the efficacy of teaching gun safety as a measure to prevent gun violence and injuries involving guns.

Safety assessment of the biogenic amines in fermented soya beans and fermented bean curd.

PubMed

Yang, Juan; Ding, Xiaowen; Qin, Yingrui; Zeng, Yitao

2014-08-06

To evaluate the safety of biogenic amines, high performance liquid chromatography (HPLC) was used to evaluate the levels of biogenic amines in fermented soya beans and fermented bean curd. In fermented soya beans, the total biogenic amines content was in a relatively safe range in many samples, although the concentration of histamine, tyramine, and β-phenethylamine was high enough in some samples to cause a possible safety threat, and 8 of the 30 samples were deemed unsafe. In fermented bean curd, the total biogenic amines content was more than 900 mg/kg in 19 white sufu amples, a level that has been determined to pose a safety hazard; putrescine was the only one detected in all samples and also had the highest concentration, which made samples a safety hazard; the content of tryptamine, β-phenethylamine, tyramine, and histamine had reached the level of threat to human health in some white and green sufu samples, and that may imply another potential safety risk; and 25 of the 33 samples were unsafe. In conclusion, the content of biogenic amines in all fermented soya bean products should be studied and appropriate limits determined to ensure the safety of eating these foods.

The Quality and Food Safety of Dry Smoke Garfish (Hemirhamphus far) Product From Maluku

NASA Astrophysics Data System (ADS)

Marthina Tapotubun, Alfonsina; Reiuwpassa, Fredrik; Apituley, Yolanda M. T. N.; Nanlohy, Hellen; Matrutty, Theodora E. A. A.

2017-10-01

Dry garfish is product of smoked process of “ikan julung” (Hemirhamphus far) and slowly the product getting dry, stiff and its colour become gold yellow-brown. The aim of this study is to find out quality and food safety of dry smoked “julung” from Maluku. The sample of this study is taken from production Keffing village, East Seram Regency, Maluku. Parameters to be analyzed are degrees of protein, fat, water, ash, TPC, Escherichia coli, Salmonella, Vibrio and total Staphylococcus aureus used standard analysis method for proximate (AOAC. 2005), sensosy parameters (BSN.2009) and food safety (BSN. 2006). Spreadsheet Ms Excel (Microsoft Inc., USA) is used for data processing; data is being analyzed descriptively to be interpreted in the research report. Dry smoked “julung” Keffing village, Maluku meet the good quality and food safety, that are ingredient degrees of water content 12.43%, protein 61.55%, fat 12.58%, ash 9.3%, TPC [6,8] × 101 CFU, total Staphylococcus sp [1,7] × 102, total E.coli 6.4 APM/g. and negatively for Salmonella and Vibrio.

Integrating system safety into the basic systems engineering process

NASA Technical Reports Server (NTRS)

Griswold, J. W.

1971-01-01

The basic elements of a systems engineering process are given along with a detailed description of what the safety system requires from the systems engineering process. Also discussed is the safety that the system provides to other subfunctions of systems engineering.

A Total Management Measurement Model for the Naval Weapons Center

DTIC Science & Technology

1991-02-01

Efficiency Productivity Public safety Employee safety Safety’Sccurity Customer safety Product security _ Quality of worklife Corporate Concern for...3 Corporate-ievel measures should represent a balance of in-house expertise; types of customers; and issues that surpass the customers’ I expertise...consideration. Examining the balance of distribution of these resources is also important. Addressing these issues would link the best potential to the most

In-Class Simulation of Pooling Safety Stock

ERIC Educational Resources Information Center

Bandy, D. Brent

2005-01-01

In managing business process flows, safety stock can be used to protect against stockouts due to demand variability. When more than one location is involved, the concept of aggregation enables the pooling of demands and associated inventories, resulting in improved service levels without increasing the total level of safety stock. This pooling of…

Blood alcohol test results of motor vehicle deaths as an evaluation method for the Fairfax Alcohol Safety Action Project.

DOT National Transportation Integrated Search

1973-01-01

The Fairfax Alcohol Safety Action Project (ASAP) was started following the June 1971 approval of the proposal and working plan submitted to the Department of Transportation by the Highway Safety Division of Virginia. A total of $2,123,000 was allocat...

77 FR 26045 - Agency Information Collection Activities; Proposed Collection; Comments Requested: Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... Secure Gun Storage or Safety Devices ACTION: 30-Day Notice of information collection. The Department of... approved collection. (2) Title of the Form/Collection: Certification of Secure Gun Storage or Safety... to the availability of secure gun storage or safety devices. (5) An estimate of the total number of...

77 FR 10559 - Agency Information Collection Activities: Proposed collection; comments requested: Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Secure Gun Storage or Safety Devices ACTION: 60-Day notice of information collection. The Department of...) Title of the Form/Collection: Certification of Secure Gun Storage or Safety Devices. (3) Agency form... gun storage or safety devices. (5) An estimate of the total number of respondents and the amount of...

20 CFR 718.1 - Statutory provisions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... AND SAFETY ACT OF 1969, AS AMENDED STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY OR DEATH... Mine Health and Safety Act of 1969, as amended by the Black Lung Benefits Act of 1972, the Federal Mine Safety and Health Amendments Act of 1977, the Black Lung Benefits Reform Act of 1977, the Black Lung...

20 CFR 718.1 - Statutory provisions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... AND SAFETY ACT OF 1969, AS AMENDED STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY OR DEATH... Mine Health and Safety Act of 1969, as amended by the Black Lung Benefits Act of 1972, the Federal Mine Safety and Health Amendments Act of 1977, the Black Lung Benefits Reform Act of 1977, the Black Lung...

20 CFR 718.1 - Statutory provisions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND SAFETY ACT OF 1969, AS AMENDED STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY OR DEATH... Mine Health and Safety Act of 1969, as amended by the Black Lung Benefits Act of 1972, the Federal Mine Safety and Health Amendments Act of 1977, the Black Lung Benefits Reform Act of 1977, the Black Lung...

20 CFR 718.1 - Statutory provisions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SAFETY ACT OF 1969, AS AMENDED STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY OR DEATH DUE TO... Safety Act of 1969, as amended by the Black Lung Benefits Act of 1972, the Federal Mine Safety and Health Amendments Act of 1977, the Black Lung Benefits Reform Act of 1977, the Black Lung Benefits Revenue Act of...

Safety Specialist Manpower, Manpower Resources. Volumes II and III.

ERIC Educational Resources Information Center

Booz Allen and Hamilton, Inc., Washington, DC.

These second and third volumes of a four-volume study of manpower in state highway safety programs over the next decade estimate manpower resources by state and in national aggregate and describe present and planned training programs for safety specialists. For each educational level, both total manpower and manpower actually available for…

Calibration of the Highway Safety Manual and development of new safety performance functions for rural multilane highways in Kansas : technical summary.

DOT National Transportation Integrated Search

2016-10-01

Rural roads account for 90.3% of the 140,476 total centerline miles of roadways : in Kansas. In recent years, rural fatal crashes have accounted for about 66% : of all fatal crashes. The Highway Safety Manual (HSM) provides models and : methodologies...

Health and safety management systems: liability or asset?

PubMed

Bennett, David

2002-01-01

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Telemetry and control system for interplatform crude loading at the Statfjord field

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

Malmin, P.C.; Lassa, P.

1988-04-01

A control system for crude loading to tankers at Statfjord field has been designed to allow tanker loading to the place at all times to prevent production shutdowns caused by loading-buoy problems. This paper discusses how the control system was designed to maximize the flexibility of loading operations and to meet all safety and regulatory requirements. The experience gained from more than 4 years of operation of the system is reviewed. The system has allowed maximum use of total field crude oil storage capacity while loading to 125,000-DWT (127 000-Mg) tankers nearly every day throughout the year. It has beenmore » possible to maintain a high production rate even through the periods of difficult weather conditions experienced in the northern North Sea.« less

Human factors systems approach to healthcare quality and patient safety

PubMed Central

Carayon, Pascale; Wetterneck, Tosha B.; Rivera-Rodriguez, A. Joy; Hundt, Ann Schoofs; Hoonakker, Peter; Holden, Richard; Gurses, Ayse P.

2013-01-01

Human factors systems approaches are critical for improving healthcare quality and patient safety. The SEIPS (Systems Engineering Initiative for Patient Safety) model of work system and patient safety is a human factors systems approach that has been successfully applied in healthcare research and practice. Several research and practical applications of the SEIPS model are described. Important implications of the SEIPS model for healthcare system and process redesign are highlighted. Principles for redesigning healthcare systems using the SEIPS model are described. Balancing the work system and encouraging the active and adaptive role of workers are key principles for improving healthcare quality and patient safety. PMID:23845724

Manned space flight nuclear system safety. Volume 5: Nuclear System safety guidelines. Part 1: Space base nuclear safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space base nuclear system safety are presented. Guidelines and requirements are presented for the space base subsystems, nuclear hardware (reactor, isotope sources, dynamic generator equipment), experiments, interfacing vehicles, ground support systems, range safety and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone; BW PIONEER Floating... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is in...

76 FR 12300 - Safety Management System for Certificated Airports; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-07

...-0997; Notice No. 10-14] RIN 2120-AJ38 Safety Management System for Certificated Airports; Extension of...: Background On October 7, 2010, the FAA published Notice No. 10-14, entitled ``Safety Management System for... conclusions from the safety management systems proof of concept. The FAA anticipates making this report...

Teams communicating through STEPPS.

PubMed

Stead, Karen; Kumar, Saravana; Schultz, Timothy J; Tiver, Sue; Pirone, Christy J; Adams, Robert J; Wareham, Conrad A

2009-06-01

To evaluate the effectiveness of the implementation of a TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) program at an Australian mental health facility. TeamSTEPPS is an evidence-based teamwork training system developed in the United States. Five health care sites in South Australia implemented TeamSTEPPS using a train-the-trainer model over an 8-month intervention period commencing January 2008 and concluding September 2008. A team of senior clinical staff was formed at each site to drive the improvement process. Independent researchers used direct observation and questionnaire surveys to evaluate the effectiveness of the implementation in three outcome areas: observed team behaviours; staff attitudes and opinions; and clinical performance and outcome. The results reported here focus on one site, an inpatient mental health facility. Team knowledge, skills and attitudes; patient safety culture; incident reporting rates; seclusion rates; observation for the frequency of use of TeamSTEPPS tools. Outcomes included restructuring of multidisciplinary meetings and the introduction of structured communication tools. The evaluation of patient safety culture and of staff knowledge, skills and attitudes (KSA) to teamwork and communication indicated a significant improvement in two dimensions of patient safety culture (frequency of event reporting, and organisational learning) and a 6.8% increase in the total KSA score. Clinical outcomes included reduced rates of seclusion. TeamSTEPPS implementation had a substantial impact on patient safety culture, teamwork and communication at an Australian mental health facility. It encouraged a culture of learning from patient safety incidents and making continuous improvements.

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital.

PubMed

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-05-01

This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA.

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital

PubMed Central

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-01-01

INTRODUCTION This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). METHODS This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. RESULTS A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. CONCLUSION As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA. PMID:24862747

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

NASA Astrophysics Data System (ADS)

Guo, Jingjing

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

Safety Analysis and Protection Measures of the Control System of the Pulsed High Magnetic Field Facility in WHMFC

NASA Astrophysics Data System (ADS)

Shi, J. T.; Han, X. T.; Xie, J. F.; Yao, L.; Huang, L. T.; Li, L.

2013-03-01

A Pulsed High Magnetic Field Facility (PHMFF) has been established in Wuhan National High Magnetic Field Center (WHMFC) and various protection measures are applied in its control system. In order to improve the reliability and robustness of the control system, the safety analysis of the PHMFF is carried out based on Fault Tree Analysis (FTA) technique. The function and realization of 5 protection systems, which include sequence experiment operation system, safety assistant system, emergency stop system, fault detecting and processing system and accident isolating protection system, are given. The tests and operation indicate that these measures improve the safety of the facility and ensure the safety of people.

Initial experience of intraoperative three-dimensional navigation for liver resection using real-time virtual sonography.

PubMed

Satou, Shouichi; Aoki, Taku; Kaneko, Junichi; Sakamoto, Yoshihiro; Hasegawa, Kiyoshi; Sugawara, Yasuhiko; Arai, Osamu; Mitake, Tsuyoshi; Miura, Koui; Kokudo, Norihiro

2014-02-01

Real-time virtual sonography is an innovative imaging technology that detects the spatial position of an ultrasound probe and immediately reconstructs a section of computed tomography (CT) and/or magnetic resonance in accordance with the ultrasound image, thereby allowing a real-time comparison of those modalities. A novel intraoperative navigation system for liver resection using real-time virtual sonography has been devised for the detection of tumors and navigation of the resection plane. Sixteen patients with hepatic malignancies (26 tumors in total) were involved in this study, and the system was used intraoperatively. The tumor size ranged 2 to 140 mm (23 mm in median). By the navigation system, operators could refer intraoperative ultrasound image displayed on the television monitor side-by-side with corresponding images of CT and/or magnetic resonance. In addition, the system overlaid preoperative simulation on the CT image and highlighted the extent of resection so as to navigate the resection plane. Because the system used electromagnetic power in the operation room, the feasibility and safety of the system was investigated as well as its validity. The system could be used uneventfully in each operation. All of the 26 tumors scheduled to be resected were detected by the navigation system. The weight of the resected specimen correlated with the preoperatively simulated volume (R = 0.995, P < .0001). The feasibility and safety of the navigation system were confirmed. The system should be helpful for intraoperative tumor detection and navigation of liver resection.

Identifying behaviour patterns of construction safety using system archetypes.

PubMed

Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

2015-07-01

Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. Copyright © 2015 Elsevier Ltd. All rights reserved.

Microbiological performance of dairy processing plants is influenced by scale of production and the implemented food safety management system: a case study.

PubMed

Opiyo, Beatrice Atieno; Wangoh, John; Njage, Patrick Murigu Kamau

2013-06-01

The effects of existing food safety management systems and size of the production facility on microbiological quality in the dairy industry in Kenya were studied. A microbial assessment scheme was used to evaluate 14 dairies in Nairobi and its environs, and their performance was compared based on their size and on whether they were implementing hazard analysis critical control point (HACCP) systems and International Organization for Standardization (ISO) 22000 recommendations. Environmental samples from critical sampling locations, i.e., workers' hands and food contact surfaces, and from end products were analyzed for microbial quality, including hygiene indicators and pathogens. Microbial safety level profiles (MSLPs) were constructed from the microbiological data to obtain an overview of contamination. The maximum MSLP score for environmental samples was 18 (six microbiological parameters, each with a maximum MSLP score of 3) and that for end products was 15 (five microbiological parameters). Three dairies (two large scale and one medium scale; 21% of total) achieved the maximum MSLP scores of 18 for environmental samples and 15 for the end product. Escherichia coli was detected on food contact surfaces in three dairies, all of which were small scale dairies, and the microorganism was also present in end product samples from two of these dairies, an indication of cross-contamination. Microbial quality was poorest in small scale dairies. Most operations in these dairies were manual, with minimal system documentation. Noncompliance with hygienic practices such as hand washing and cleaning and disinfection procedures, which is common in small dairies, directly affects the microbial quality of the end products. Dairies implementing HACCP systems or ISO 22000 recommendations achieved maximum MSLP scores and hence produced safer products.

[External therapy of plasma cell mastitis by jiuyi powder using partial least-squares discriminant analysis: a safety analysis].

PubMed

Ye, Mei-na; Yang, Ming; Cheng, Yi-qin; Wang, Bing; Zhu, Ying; Xia, Ya-ru; Meng, Tian; Chen, Hao; Chen, Li-ying; Cheng, Hong-feng

2015-04-01

To evaluate the safety and the clinical value of external use of jiuyi Powder (JP) in treating plasma cell mastitis using partial least-squares discriminant analysis (PLSDA). Totally 50 patients with plasma cell mastitis treated by external use of JP were observed and biochemical examinations of blood and urine detected before application, at day 4 after application, at day 1 and 14 after discontinuation. Blood mercury and urinary mercury were detected before application, at day 1, 4, and 7 after application, at day 1 and 14 after discontinuation. Urinary mercury was also detected at 28 after discontinuation and 3 months after discontinuation. The information of wound, days of external application and the total dosage of external application were recorded before application, at day 1, 4, and 7 after application, as well as at day 1 after discontinuation. Then a discriminant model covering potential safety factors was set up by PLSDA after screening safety indices with important effects. The applicability of the model was assessed using area under ROC curve. Potential safety factors were assessed using variable importance in the projection (VIP). Urinary β2-microglobulin (β2-MG), urinary N-acetyl-β-D-glucosaminidase (NAG), 24 h urinary protein, and urinary α1-microglobulin (α1-MG) were greatly affected by external use of JP in treating plasma cell mastitis. The accuracy rate of PLSDA discriminate model was 74. 00%. The sensitivity, specificity, and the area under ROC curve was 0. 7826, 0. 7037, and 0. 8084, respectively. Three factors with greater effect on the potential safety were screened as follows: pre-application volume of the sore cavity, days of external application, and the total dosage of external application. PLSDA method could be used in analyzing bioinformation of clinical Chinese medicine. Urinary β2-MG and urinary NAG were two main safety monitoring indices. Days of external application and the total dosage of external application were main factors influencing blood mercury and urine mercury. A safety classification simulation model of treating plasma cell mastitis by external therapy of JP was established by the two factors, which could be used to assess the safety of external application of JP to some extent.

Fire safety evaluation system for NASA office/laboratory buildings

NASA Astrophysics Data System (ADS)

Nelson, H. E.

1986-11-01

A fire safety evaluation system for office/laboratory buildings is developed. The system is a life safety grading system. The system scores building construction, hazardous areas, vertical openings, sprinklers, detectors, alarms, interior finish, smoke control, exit systems, compartmentation, and emergency preparedness.

Microbiological Status and Food Safety Compliance of Commercial Basil Production Systems.

PubMed

de Bruin, Willeke; Otto, Denise; Korsten, Lise

2016-01-01

Basil has been implicated in a number of microbe-associated foodborne illnesses across the world, and the source of contamination has often been traced back to the production and/or processing stages of the supply chain. The aim of this study was to evaluate the microbiological quality of fresh basil from the point of production to the retail outlet in the Gauteng and Northwest Provinces of South Africa. A total of 463 samples were collected over a 3-month period from two large-scale commercial herb producing and processing companies and three retail outlets. The microbiological quality of the samples was assessed based on the presence or absence of Escherichia coli O157:H7 and Salmonella Typhimurium and the levels of the indicator bacteria E. coli and total coliforms. Salmonella Typhimurium was detected on four basil samples (0.9%) arriving at the processing facility and at dispatch, but no E. coli O157:H7 was detected throughout the study. Total coliform counts were 0.4 to 4.1 CFU/g for basil, 1.9 to 3.4 log CFU/ml for water, and 0.2 to 1.7 log CFU/cm(2) for contact surfaces, whereas E. coli was detected in the water samples and only once on basil. The Colilert-18 and membrane filter methods were used to analyze water samples, and a comparison of results revealed that the Colilert-18 method was more sensitive. Strong evidence suggests that high numbers of coliforms do not necessarily indicate the presence of Salmonella Typhimurium. The study results highlight the importance of effective implementation of food safety management systems in the fresh produce industry.

Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

PubMed

Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

2016-05-27

23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

Patient safety culture: finding meaning in patient experiences.

PubMed

Bishop, Andrea C; Cregan, Brianna R

2015-01-01

The purpose of this paper is to determine what patient and family stories can tell us about patient safety culture within health care organizations and how patients experience patient safety culture. A total of 11 patient and family stories of adverse event experiences were examined in September 2013 using publicly available videos on the Canadian Patient Safety Insitute web site. Videos were transcribed verbatim and collated as one complete data set. Thematic analysis was used to perform qualitative inquiry. All qualitative analysis was done using NVivo 10 software. A total of three themes were identified: first, Being Passed Around; second, Not Having the Conversation; and third, the Person Behind the Patient. Results from this research also suggest that while health care organizations and providers might expect patients to play a larger role in managing their health, there may be underlying reasons as to why patients are not doing so. The findings indicate that patient experiences and narratives are useful sources of information to better understand organizational safety culture and patient experiences of safety while hospitalized. Greater inclusion and analysis of patient safety narratives is important in understanding the needs of patients and how patient safety culture interventions can be improved to ensure translation of patient safety strategies at the frontlines of care. Greater acknowledgement of the patient and family experience provides organizations with an integral perspective to assist in defining and addressing deficiencies within their patient safety culture and to identify opportunities for improvement.

A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol

PubMed Central

Klimek, L; Uhlig, J; Mösges, R; Rettig, K; Pfaar, O

2014-01-01

Background Cluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval. In this study, the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized, double-blind, placebo-controlled, multicenter study. Methods In total, 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1 : 1 to verum or placebo group. A short cluster up-dosing schedule of only 1 week was applied to achieve the maintenance dose which was administered monthly during the study period of 1 year. Total combined symptom and medication score (TCS) was defined as primary outcome parameter. Secondary outcome parameters were individual symptom and medication scores, ‘well days,’ global improvement as well as immunological effects and nasal allergen challenge. The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system. Results Significant reduction in the verum compared to the placebo group (intention-to-treat, population, verum: n = 55; placebo: n = 47) was found regarding TCS (P = 0.005), rhinoconjunctivitis total symptom score (RTSS, P = 0.006), and total rescue medication score (TRMS, P = 0.002). Additionally, secondary outcomes such as ‘well days,’ nasal challenge results, and increase of specific IgG4 were in favor of the active treatment. All systemic adverse reactions (0.8% of all injections in the verum group) were of mild intensity. No severe reactions related to the study medication were observed. Conclusion Cluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients. PMID:25130503

Influence of Cracks in Cementitious Engineered Barriers in a Near-Surface Disposal System: Assessment Analysis of the Belgian Case

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

Perko, Janez; Seetharam, Suresh C.; Jacques, Diederik

2013-07-01

In large cement-based structures such as a near surface disposal facility for radioactive waste voids and cracks are inevitable. However, the pattern and nature of cracks are very difficult to predict reliably. Cracks facilitate preferential water flow through the facility because their saturated hydraulic conductivity is generally higher than the conductivity of the cementitious matrix. Moreover, sorption within the crack is expected to be lower than in the matrix and hence cracks in engineered barriers can act as a bypass for radionuclides. Consequently, understanding the effects of crack characteristics on contaminant fluxes from the facility is of utmost importance inmore » a safety assessment. In this paper we numerically studied radionuclide leaching from a crack-containing cementitious containment system. First, the effect of cracks on radionuclide fluxes is assessed for a single repository component which contains a radionuclide source (i.e. conditioned radwaste). These analyses reveal the influence of cracks on radionuclide release from the source. The second set of calculations deals with the safety assessment results for the planned near-surface disposal facility for low-level radioactive waste in Dessel (Belgium); our focus is on the analysis of total system behaviour in regards to release of radionuclide fluxes from the facility. Simulation results are interpreted through a complementary safety indicator (radiotoxicity flux). We discuss the possible consequences from different scenarios of cracks and voids. (authors)« less

When a checklist is not enough: How to improve them and what else is needed.

PubMed

Raman, Jaishankar; Leveson, Nancy; Samost, Aubrey Lynn; Dobrilovic, Nikola; Oldham, Maggie; Dekker, Sidney; Finkelstein, Stan

2016-08-01

Checklists are being introduced to enhance patient safety, but the results have been mixed. The goal of this research is to understand why time-outs and checklists are sometimes not effective in preventing surgical adverse events and to identify additional measures needed to reduce these events. A total of 380 consecutive patients underwent complex cardiac surgery over a 24-month period between November 2011 and November 2013 at an academic medical center, out of a total of 529 cardiac cases. Elective isolated aortic valve replacements, mitral valve repairs, and coronary artery bypass graft surgical procedures (N = 149) were excluded. A time-out was conducted in a standard fashion in all patients in accordance with the World Health Organization surgical checklist protocol. Adverse events were classified as anything that resulted in an operative delay, nonavailability of equipment, failure of drug administration, or unexpected adverse clinical outcome. These events and their details were collected every week and analyzed using a systemic causal analysis technique using a technique called CAST (causal analysis based on systems theory). This analytic technique evaluated the sociotechnical system to identify the set of causal factors involved in the adverse events and the causal factors explored to identify reasons. Recommendations were made for the improvement of checklists and the use of system design changes that could prevent such events in the future. Thirty events were identified. The causal analysis of these 30 adverse events was carried out and actionable events classified. There were important limitations in the use of standard checklists as a stand-alone patient safety measure in the operating room setting, because of multiple factors. Major categories included miscommunication between staff, medication errors, missing instrumentation, missing implants, and improper handling of equipment or instruments. An average of 3.9 recommendations were generated for each adverse event scenario. Time-outs and checklists can prevent some types of adverse events, but they need to be carefully designed. Additional interventions aimed at improving safety controls in the system design are needed to augment the use of checklists. Customization of checklists for specialized surgical procedures may reduce adverse events. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Safety Characteristics in System Application Software for Human Rated Exploration

NASA Technical Reports Server (NTRS)

Mango, E. J.

2016-01-01

NASA and its industry and international partners are embarking on a bold and inspiring development effort to design and build an exploration class space system. The space system is made up of the Orion system, the Space Launch System (SLS) and the Ground Systems Development and Operations (GSDO) system. All are highly coupled together and dependent on each other for the combined safety of the space system. A key area of system safety focus needs to be in the ground and flight application software system (GFAS). In the development, certification and operations of GFAS, there are a series of safety characteristics that define the approach to ensure mission success. This paper will explore and examine the safety characteristics of the GFAS development.

Condition Survey and Paver Implementation Davis-Monthan Air Force Base, Arizona

DTIC Science & Technology

1991-02-01

questiotns that the program asks, and then analysis results are produced based on those responses. The analysis reports can only be generated using the...09/01/89 PCI- 36 RATING- POOR CONDITION- RIDING- SAFETY - DRAINAGE- SHOULDERS- OVERALL- TOTAL NUMBER OF SAMPLES IN SECTION- 4 NUMBER OF SAMPLES...CONDITION- RIDING- SAFETY - DRAINAGE- SHOULDERS- OVERALL- TOTAL NUMBER OF SAMPLES IN SECTION- 17 NUMBER OF SAMPLES SURVEYED- 5 RECOMMENDED SAMPLES TO BE

Implementation Procedure for STS Payloads, System Safety Requirements

NASA Technical Reports Server (NTRS)

1979-01-01

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

Quality and safety attributes of afghan raisins before and after processing

PubMed Central

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

2015-01-01

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

Keeping patients safe in healthcare organizations: a structuration theory of safety culture.

PubMed

Groves, Patricia S; Meisenbach, Rebecca J; Scott-Cawiezell, Jill

2011-08-01

This paper presents a discussion of the use of structuration theory to facilitate understanding and improvement of safety culture in healthcare organizations. Patient safety in healthcare organizations is an important problem worldwide. Safety culture has been proposed as a means to keep patients safe. However, lack of appropriate theory limits understanding and improvement of safety culture. The proposed structuration theory of safety culture was based on a critique of available English-language literature, resulting in literature published from 1983 to mid-2009. CINAHL, Communication and Mass Media Complete, ABI/Inform and Google Scholar databases were searched using the following terms: nursing, safety, organizational culture and safety culture. When viewed through the lens of structuration theory, safety culture is a system involving both individual actions and organizational structures. Healthcare organization members, particularly nurses, share these values through communication and enact them in practice, (re)producing an organizational safety culture system that reciprocally constrains and enables the actions of the members in terms of patient safety. This structurational viewpoint illuminates multiple opportunities for safety culture improvement. Nurse leaders should be cognizant of competing value-based culture systems in the organization and attend to nursing agency and all forms of communication when attempting to create or strengthen a safety culture. Applying structuration theory to the concept of safety culture reveals a dynamic system of individual action and organizational structure constraining and enabling safety practice. Nurses are central to the (re)production of this safety culture system. © 2011 Blackwell Publishing Ltd.

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Safety and pharmacodynamics of venetoclax (ABT-199) in a randomized single and multiple ascending dose study in women with systemic lupus erythematosus.

PubMed

Lu, P; Fleischmann, R; Curtis, C; Ignatenko, S; Clarke, S H; Desai, M; Wong, S L; Grebe, K M; Black, K; Zeng, J; Stolzenbach, J; Medema, J K

2018-02-01

Objective The anti-apoptotic protein B-cell lymphoma 2 (Bcl-2) may contribute to the pathogenesis of systemic lupus erythematosus. The safety, tolerability, and pharmacodynamics of the selective Bcl-2 inhibitor venetoclax (ABT-199) were assessed in women with systemic lupus erythematosus. Methods A phase 1, double-blind, randomized, placebo controlled study evaluated single ascending doses (10, 30, 90, 180, 300, and 500 mg) and multiple ascending doses (2 cycles; 30, 60, 120, 240, 400, and 600 mg for 1 week, and then 3 weeks off per cycle) of orally administered venetoclax. Eligible participants were aged 18-65 years with a diagnosis of systemic lupus erythematosus for 6 months or more receiving stable therapy for systemic lupus erythematosus (which could have included corticosteroids and/or stable antimalarials). Results All patients (48/48) completed the single ascending dose, 25 continued into the multiple ascending dose, and 44/50 completed the multiple ascending dose; two of the withdrawals (venetoclax 60 mg and 600 mg cohorts) were due to adverse events. Adverse event incidences were slightly higher in the venetoclax groups compared with the placebo groups, with no dose dependence. There were no serious adverse events with venetoclax. The most common adverse events were headache, nausea, and fatigue. Venetoclax 600 mg multiple ascending dose treatment depleted total lymphocytes and B cells by approximately 50% and 80%, respectively. Naive, switched memory, and memory B-cell subsets enriched in autoreactive B cells exhibited dose-dependent reduction of up to approximately 80%. There were no consistent or marked changes in neutrophils, natural killer cells, hemoglobin, or platelets. Conclusions Venetoclax was generally well tolerated in women with systemic lupus erythematosus and reduced total lymphocytes and disease-relevant subsets of antigen-experienced B cells. Registration ClinicalTrials.gov: NCT01686555.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

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

14 CFR 417.233 - Analysis for an unguided suborbital launch vehicle flown with a wind weighting safety system.

Code of Federal Regulations, 2012 CFR

2012-01-01

... vehicle flown with a wind weighting safety system. 417.233 Section 417.233 Aeronautics and Space... with a wind weighting safety system. For each launch of an unguided suborbital launch vehicle flown with a wind weighting safety system, in addition to the other requirements in this subpart outlined in...

14 CFR 417.233 - Analysis for an unguided suborbital launch vehicle flown with a wind weighting safety system.

Code of Federal Regulations, 2013 CFR

2013-01-01

... vehicle flown with a wind weighting safety system. 417.233 Section 417.233 Aeronautics and Space... with a wind weighting safety system. For each launch of an unguided suborbital launch vehicle flown with a wind weighting safety system, in addition to the other requirements in this subpart outlined in...

14 CFR 417.233 - Analysis for an unguided suborbital launch vehicle flown with a wind weighting safety system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... vehicle flown with a wind weighting safety system. 417.233 Section 417.233 Aeronautics and Space... with a wind weighting safety system. For each launch of an unguided suborbital launch vehicle flown with a wind weighting safety system, in addition to the other requirements in this subpart outlined in...

14 CFR 417.233 - Analysis for an unguided suborbital launch vehicle flown with a wind weighting safety system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... vehicle flown with a wind weighting safety system. 417.233 Section 417.233 Aeronautics and Space... with a wind weighting safety system. For each launch of an unguided suborbital launch vehicle flown with a wind weighting safety system, in addition to the other requirements in this subpart outlined in...

14 CFR 417.233 - Analysis for an unguided suborbital launch vehicle flown with a wind weighting safety system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... vehicle flown with a wind weighting safety system. 417.233 Section 417.233 Aeronautics and Space... with a wind weighting safety system. For each launch of an unguided suborbital launch vehicle flown with a wind weighting safety system, in addition to the other requirements in this subpart outlined in...

Total energy food plant 21 million gallon ethanol facility

NASA Astrophysics Data System (ADS)

1981-10-01

The Phase I Engineering study includes the following: process description, waste water treatment plant, material summary, energy chart, capital cost estimate, equipment list, personnel requirements, drawings list, specifications list, and project schedule. The economic and financial feasibility of the technical process, and environmental, health, safety, and socio-economic assessments for the project are reported. The costs for extending the following utilities to the property line of the selected site are presented: potable water, sewer system, electricity, roads for truck traffic, and rail service.

Feasibility Study of Coal Gasification/Fuel Cell/Cogeneration Project. Fort Hood, Texas Site. Project Description,

DTIC Science & Technology

1985-07-01

and Operation 132 6.7.5 Safety 135 6.7.6 System Control Description 136 6.7.6.1 Coal Gasification 136 6.7.6.2 Gas Cooling, Cleaning and Compression...the hydrogen content. The gas is then desulfurized and heated before final polishing and feeding to the fuel cell. Receiving compressed fuel gas and...4 CO Shift 1 Stretford Desulfurizer 3 Gas Compressors 3 Material Handling(3) 3 Subtotal 39 Scheduled Shutdown 14 Total Annual Shutdown 53

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

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

PubMed

Fong, L P; Taouk, Y

1995-05-01

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

Identifying primary care patient safety research priorities in the UK: a James Lind Alliance Priority Setting Partnership

PubMed Central

Stocks, Susan Jill; Alam, Rahul; Taylor, Sian; Rolfe, Carly; Glover, Steven William; Whitcombe, Joanne; Campbell, Stephen M

2018-01-01

Objectives To identify the top 10 unanswered research questions for primary care patient safety research. Design A modified nominal group technique. Setting UK. Participants Anyone with experience of primary care including: patients, carers and healthcare professionals. 341 patients and 86 healthcare professionals submitted questions. Main outcomes A top 10, and top 30, future research questions for primary care patient safety. Results 443 research questions were submitted by 341 patients and 86 healthcare professionals, through a national survey. After checking for relevance and rephrasing, a total of 173 questions were collated into themes. The themes were largely focused on communication, team and system working, interfaces across primary and secondary care, medication, self-management support and technology. The questions were then prioritised through a national survey, the top 30 questions were taken forward to the final prioritisation workshop. The top 10 research questions focused on the most vulnerable in society, holistic whole-person care, safer communication and coordination between care providers, work intensity, continuity of care, suicide risk, complex care at home and confidentiality. Conclusions This study was the first national prioritisation exercise to identify patient and healthcare professional priorities for primary care patient safety research. The research priorities identified a range of important gaps in the existing evidence to inform everyday practice to address primary care patient safety. PMID:29490970

Research on public participant urban infrastructure safety monitoring system using smartphone

NASA Astrophysics Data System (ADS)

Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu

2017-04-01

Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.

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

NASA Technical Reports Server (NTRS)

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

1978-01-01

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

Implementation and implication of total quality management on client- contractor relationship in residential projects

NASA Astrophysics Data System (ADS)

Murali, Swetha; Ponmalar, V.

2017-07-01

To make innovation and continuous improvement as a norm, some traditional practices must become unlearnt. Change for growth and competitiveness are required for sustainability for any profitable business such as the construction industry. The leading companies are willing to implement Total Quality Management (TQM) principles, to realise potential advantages and improve growth and efficiency. Ironically, researches recollected quality as the most significant provider for competitive advantage in industrial leadership. The two objectives of this paper are 1) Identify TQM effectiveness in residential projects and 2) Identify the client satisfaction/dissatisfaction areas using Analytical Hierarchy Process (AHP) and suggest effective mitigate measures. Using statistical survey techniques like set of questionnaire survey, it is observed that total quality management was applied in some leading successful organization to an extent. The main attributes for quality achievement can be defined as teamwork and better communication with single agreed goal between client and contractor. Onsite safety is a paramount attribute in the identifying quality within the residential projects. It was noticed that the process based quality methods such as onsite safe working condition; safe management system and modern engineering process safety controls etc. as interlinked functions. Training and effective communication with all stakeholders on quality management principles is essential for effective quality work. Late Only through effective TQM principles companies can avoid some contract litigations with an increased client satisfaction Index.

Total hemispherical emissivity of very high temperature reactor (VHTR) candidate materials: Hastelloy X, Haynes 230, and Alloy 617

NASA Astrophysics Data System (ADS)

Maynard, Raymond K.

An experimental system was constructed in accordance with the standard ASTM C835-06 to measure the total hemispherical emissivity of structural materials of interest in Very High Temperature Reactor (VHTR) systems. The system was tested with304 stainless steel as well as for oxidized and un-oxidized nickel, and good reproducibility and agreement with the literature data was found. Emissivity of Hastelloy X was measured under different conditions that included: (i) "as received" (original sample) from the supplier; (ii) with increased surface roughness; (iii) oxidized, and; (iv) graphite coated. Measurements were made over a wide range of temperatures. Hastelloy X, as received from the supplier, was cleaned before additional roughening of the surface and coating with graphite. The emissivity of the original samples (cleaned after received) varied from around 0.18 to 0.28 in the temperature range of 473 K to 1498 K. The apparent emissivity increased only slightly as the roughness of the surface increased (without corrections for the increased surface area due to the increased surface roughness). When Hastelloy X was coated with graphite or oxidized however, its emissivity was observed to increase substantially. With a deposited graphite layer on the Hastelloy, emissivity increased from 0.2 to 0.53 at 473 K and from 0.25 to 0.6 at 1473 K; a finding that has strong favorable safety implications in terms of decay heat removal in post-accident VHTR environments. Although initial oxidation of Hastelloy X increased the emissivity prolonged oxidation did not significantly increase emissivity. However as there is some oxidation of Hastelloy X used in the construction of VHTRs, this represents an essentially neutral finding in terms of the safety implications in post-accident VHTR environments. The total hemispherical emissivity of Haynes 230 alloy, which is regarded as a leading candidate material for heat exchangers in VHTR systems, was measured under various surface conditions. The emissivity increased from 0.178 at 600 K to 0.235 at 1375 K for Haynes 230 as received sample. The emissivity increased significantly when its surface roughness was increased, or was oxidized in air, or coated with graphite dust, as compared to the as received material. The total hemispherical emissivity of Alloy 617 was measured as a function of temperature. The total emissivity increased from about 0.2 at 600 K to about 0.35 at 1275 K.

Calibration of the highway safety manual and development of new safety performance functions for rural multilane highways in Kansas : final report.

DOT National Transportation Integrated Search

2016-10-01

Rural roads account for 90.3% of the 140,476 total centerline miles of roadways in Kansas. In recent years, rural fatal crashes have accounted for about 66% of all fatal crashes. The Highway Safety Manual (HSM) provides models and methodologies for a...

77 FR 16805 - Notice of Request for Extension and Revision of a Currently Approved Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... availability is limited. To facilitate the scheduling of the Food Safety Mobile's visits when it is available... regarding its electronic Food Safety Mobile questionnaire. FSIS is planning to increase the total annual... selected food safety news and information. This service is available at http://www.fsis.usda.gov/news_and...

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.

14 CFR 415.127 - Flight safety system design and operation data.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Expendable Launch Vehicle From a Non-Federal Launch Site § 415.127 Flight safety system design and operation...: flight termination system; command control system; tracking; telemetry; communications; flight safety... control system. (7) Flight termination system component storage, operating, and service life. A listing of...

[Notification of incidents related to patient safety in hospitals in Catalonia, Spain during the period 2010-2013].

PubMed

Oliva, Glòria; Alava, Fernando; Navarro, Laura; Esquerra, Miquel; Lushchenkova, Oksana; Davins, Josep; Vallès, Roser

2014-07-01

The aim of this paper is to discover the aggregated results of a general notification system for incidents related to patient safety implemented in Catalan hospitals from 2010 to 2013. Observational study describing the incidents notified from January 2010 to December 2013 from all hospitals in Catalonia forming part of the project to create operational patient safety management units. The Patient Safety Notification and Learning System (SiNASP) was used. This makes it possible to classify incidents depending on the area where they occur, the type of incident notified, the consequences, the seriousness according to the Severity Assessment Code (SAC) and the profession of the notifying party, as the principal variables. The system was accessed via the Internet (SiNASP portal). Access was voluntary and anonymous or with a name given and later removed. During the study period, notification of a total of 5,948 incidents came from 22-29 hospitals. 5,244 of the incidents were handled by the centres and these are the ones analysed in the study. 64% (3,380) affected patients, 18% (950) created a situation capable of causing an incident and 18% (914) did not affect patients. 26% of incidents that affected patients (864) caused some kind of harm. Most incidents occurred during hospitalisation (54%) and in casualty (15%), followed by the ICU (9%) and the surgical block (8%). The most frequent notifying parties were nurses (71%) followed by doctors (15%) and pharmacists (9%). In terms of severity, most incidents were classified as low-risk (37%) or incidents that did not affect the patient (36%). However, 40 cases (0.76%) of extreme risk should be highlighted. In terms of the types of incident notified, most were due to a medication error (26.8%), followed by falls (16.3%) and patient identification (10.6%). The majority of notifications were incidents that affected patients and, of these, 26% caused harm. In general, they occurred in hospitalisation units and notification was mostly given by nurses. The incident notification system is a tool that complements others for promoting a patient safety culture and defining the risk profile of a health organisation. The opportunity for learning from experience is the reason for the existence of the notification system. Copyright © 2014. Published by Elsevier Espana.

Statewide analysis of bicycle crashes.

DOT National Transportation Integrated Search

2017-05-01

Bicycle crashes are a major traffic safety concern in Florida. In 2014, Florida led the nation with 139 bicyclist fatalities, representing approximately 20% of the nations total. This project aims to improve bicycle safety on Floridas state roa...

Extended time-to-collision measures for road traffic safety assessment.

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

Psychological safety: The key to high performance in high stress, potentially traumatic environments

Treesearch

James Saveland

2011-01-01

Safety is typically talked about in a context of the absence of injury. The field of resilience engineering has been advocating that we think about safety differently, by taking a systems view and begin to see how people create safety in unsafe systems by managing risk. There is growing recognition that safety is an emergent behavior of our complex system of human...

Cushion System for Multi-Use Child Safety Seat

NASA Technical Reports Server (NTRS)

Dabney, Richard W. (Inventor); Elrod, Susan V. (Inventor)

2007-01-01

A cushion system for use with a child safety seat has a plurality of bladders assembled to form a seat cushion that cooperates with the seat's safety harness. One or more sensors coupled to the safety harness sense tension therein and generate a signal indicative of the tension. Each of the bladders is individually pressurized by a pressurization system to define a support configuration of the seat cushion. The pressurization system is disabled when tension in the safety harness has attained a threshold level.

Cushion system for multi-use child safety seat

NASA Technical Reports Server (NTRS)

Elrod, Susan V. (Inventor); Dabney, Richard W. (Inventor)

2007-01-01

A cushion system for use with a child safety seat has a plurality of bladders assembled to form a seat cushion that cooperates with the seat's safety harness. One or more sensors coupled to the safety harness sense tension therein and generate a signal indicative of the tension. Each of the bladders is individually pressurized by a pressurization system to define a support configuration of the seat cushion. The pressurization system is disabled when tension in the safety harness has attained a threshold level.

Striving for safety: communicating and deciding in sociotechnical systems

PubMed Central

Flach, John M.; Carroll, John S.; Dainoff, Marvin J.; Hamilton, W. Ian

2015-01-01

How do communications and decisions impact the safety of sociotechnical systems? This paper frames this question in the context of a dynamic system of nested sub-systems. Communications are related to the construct of observability (i.e. how components integrate information to assess the state with respect to local and global constraints). Decisions are related to the construct of controllability (i.e. how component sub-systems act to meet local and global safety goals). The safety dynamics of sociotechnical systems are evaluated as a function of the coupling between observability and controllability across multiple closed-loop components. Two very different domains (nuclear power and the limited service food industry) provide examples to illustrate how this framework might be applied. While the dynamical systems framework does not offer simple prescriptions for achieving safety, it does provide guides for exploring specific systems to consider the potential fit between organisational structures and work demands, and for generalising across different systems regarding how safety can be managed. Practitioner Summary: While offering no simple prescriptions about how to achieve safety in sociotechnical systems, this paper develops a theoretical framework based on dynamical systems theory as a practical guide for generalising from basic research to work domains and for generalising across alternative work domains to better understand how patterns of communication and decision-making impact system safety. PMID:25761155

The carrier safety measurement system (CSMS) effectiveness test by behavior analysis and safety improvement categories (BASICs)

DOT National Transportation Integrated Search

2014-01-24

The Carrier Safety Measurement System (CSMS) is the Federal Motor Carrier Safety Administrations (FMCSA's) workload prioritization tool. This tool is used to identify carriers with potential safety issues so that they are subject to interventions ...

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

Identification of Crew-Systems Interactions and Decision Related Trends

NASA Technical Reports Server (NTRS)

Jones, Sharon Monica; Evans, Joni K.; Reveley, Mary S.; Withrow, Colleen A.; Ancel, Ersin; Barr, Lawrence

2013-01-01

NASA Vehicle System Safety Technology (VSST) project management uses systems analysis to identify key issues and maintain a portfolio of research leading to potential solutions to its three identified technical challenges. Statistical data and published safety priority lists from academic, industry and other government agencies were reviewed and analyzed by NASA Aviation Safety Program (AvSP) systems analysis personnel to identify issues and future research needs related to one of VSST's technical challenges, Crew Decision Making (CDM). The data examined in the study were obtained from the National Transportation Safety Board (NTSB) Aviation Accident and Incident Data System, Federal Aviation Administration (FAA) Accident/Incident Data System and the NASA Aviation Safety Reporting System (ASRS). In addition, this report contains the results of a review of safety priority lists, information databases and other documented references pertaining to aviation crew systems issues and future research needs. The specific sources examined were: Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementation (SERFIs), Flight Deck Automation Issues (FDAI) and NTSB Most Wanted List and Open Recommendations. Various automation issues taxonomies and priority lists pertaining to human factors, automation and flight design were combined to create a list of automation issues related to CDM.

Contributions of microgravity test results to the design of spacecraft fire-safety systems

NASA Technical Reports Server (NTRS)

Friedman, Robert; Urban, David L.

1993-01-01

Experiments conducted in spacecraft and drop towers show that thin-sheet materials have reduced flammability ranges and flame-spread rates under quiescent low-gravity environments (microgravity) compared to normal gravity. Furthermore, low-gravity flames may be suppressed more easily by atmospheric dilution or decreasing atmospheric total pressure than their normal-gravity counterparts. The addition of a ventilating air flow to the low-gravity flame zone, however, can greatly enhance the flammability range and flame spread. These results, along with observations of flame and smoke characteristics useful for microgravity fire-detection 'signatures', promise to be of considerable value to spacecraft fire-safety designs. The paper summarizes the fire detection and suppression techniques proposed for the Space Station Freedom and discusses both the application of low-gravity combustion knowledge to improve fire protection and the critical needs for further research.

How a health and safety management training program may improve the working environment in small- and medium-sized companies.

PubMed

Torp, Steffen

2008-03-01

The objective of this controlled intervention study was to investigate the effects of a 2-year training program in health and safety (H&S) management for managers at small- and medium-sized companies. A total of 113 managers of motor vehicle repair garages participated in the training and another 113 garage managers served as a comparison group. The effects were measured using questionnaires sent before and after the intervention to the managers and blue-collar workers at the garages. The intervention group managers reported significantly greater improvement of their H&S management system than the managers in the comparison group. The results also indicate that the management training positively affected how the workers regarded their supportive working environment. H&S management training may positively affect measures at both garage and individual levels.

78 FR 59082 - Privacy Act of 1974; Department of Transportation, Federal Motor Carrier Safety Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

... Carrier Management Information System (MCMIS) System of Records AGENCY: Federal Motor Carrier Safety... Administration DOT/FMCSA 001 Motor Carrier Management Information System System of Records.'' This system of... Federal Motor Carrier Safety Administration--DOT/FMCSA 001 Motor Carrier Management Information System...

77 FR 69899 - Public Conference on Geographic Information Systems (GIS) in Transportation Safety

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-21

... NATIONAL TRANSPORTATION SAFETY BOARD Public Conference on Geographic Information Systems (GIS) in... Geographic Information Systems (GIS) in transportation safety on December 4-5, 2012. GIS is a rapidly... visualization of data. The meeting will bring researchers and practitioners in transportation safety and GIS...

76 FR 14592 - Safety Management System; Withdrawal

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

...-06A] RIN 2120-AJ15 Safety Management System; Withdrawal AGENCY: Federal Aviation Administration (FAA... (``product/ service providers'') to develop a Safety Management System (SMS). The FAA is withdrawing the... management with a set of robust decision-making tools to use to improve safety. The FAA received 89 comments...

78 FR 9623 - Federal Motor Vehicle Safety Standards; Air Brake Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... [Docket No. NHTSA-2013-0011] RIN 2127-AL11 Federal Motor Vehicle Safety Standards; Air Brake Systems... rule that amended the Federal motor vehicle safety standard for air brake systems by requiring... published a final rule in the Federal Register amending Federal Motor Vehicle Safety Standard (FMVSS) No...

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

PubMed

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

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

TenHaken, Ron; Daniels, B.; Becker, M.; Barnes, Zack; Donovan, Shawn; Manley, Brenda

2007-01-01

Throughout 2006, Range Safety was involved in a number of exciting and challenging activities and events, from developing, implementing, and supporting Range Safety policies and procedures-such as the Space Shuttle Launch and Landing Plans, the Range Safety Variance Process, and the Expendable Launch Vehicle Safety Program procedures-to evaluating new technologies. Range Safety training development is almost complete with the last course scheduled to go on line in mid-2007. Range Safety representatives took part in a number of panels and councils, including the newly formed Launch Constellation Range Safety Panel, the Range Commanders Council and its subgroups, the Space Shuttle Range Safety Panel, and the unmanned aircraft systems working group. Space based range safety demonstration and certification (formerly STARS) and the autonomous flight safety system were successfully tested. The enhanced flight termination system will be tested in early 2007 and the joint advanced range safety system mission analysis software tool is nearing operational status. New technologies being evaluated included a processor for real-time compensation in long range imaging, automated range surveillance using radio interferometry, and a space based range command and telemetry processor. Next year holds great promise as we continue ensuring safety while pursuing our quest beyond the Moon to Mars.

Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

DOT National Transportation Integrated Search

2010-12-01

This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

In vitro and in vivo testing of a totally implantable left ventricular assist system.

PubMed

Jassawalla, J S; Daniel, M A; Chen, H; Lee, J; LaForge, D; Billich, J; Ramasamy, N; Miller, P J; Oyer, P E; Portner, P M

1988-01-01

The totally implantable Novacor LVAS is being tested under NIH auspices to demonstrate safety and efficacy before clinical trials. Twelve complete systems (submerged in saline at 37 degrees C) are being tested, with an NIH goal of demonstrating 80% reliability for 2 year operation with a 60% confidence level. The systems, which are continuously monitored, are diurnally cycled between two output levels by automatically varying preload and afterload. Currently, 14.3 years of failure-free operation have been accumulated, with a mean duration of 14 months. Using an exponential failure distribution model, the mean time to failure (MTTF) is greater than 8.8 years, corresponding to a demonstrated reliability (for a 2 year mission time) of 80% (80% confidence level). Recent ovine experiments with VAS subsystems include a 767 day volume compensator implant, a 279 day pump/drive unit implant and a 1,448 day BST implant. The last 12 chronic pump/drive unit experiments had a mean duration of 153 days (excluding early postoperative complications). This compares favorably with the NIH goals for complete systems (5 month mean duration). Complete system experiments are currently underway.

A review of agricultural pesticide incidents in man in England and Wales, 1952-71

PubMed Central

Hearn, C. E. D.

1973-01-01

Hearn, C. E. D. (1973).British Journal of Industrial Medicine,30, 253-258. A review of agricultural pesticide incidents in man in England and Wales, 1952-71. An analysis was carried out of the poisoning incidents attributed to pesticides in England and Wales investigated by the Safety Inspectorate of the Pesticides Branch of the Ministry of Agriculture, Fisheries, and Food from 1952 to 1971. All poisoning incidents attributed to pesticides which are reported to the Safety Inspectorate are recorded and separated into reported and confirmed incidents. The confirmed incidents are classified into fatal and non-fatal. The non-fatal incidents are subdivided into four categories, systemic poisoning, eye injuries, dermatitis, and chemical burns. There were nine fatal cases of poisoning due to pesticides between 1952 and 1971, of which only three were occupational in origin. The remaining six were non-occupational but were investigated by the Safety Inspectorate only because the incident happened to arise on, or in connection with, a farm. The details of all the cases are recorded. There were 222 non-fatal confirmed incidents during the period, affecting a total of 296 persons. There has been an increased frequency of incidents since 1966 largely attributable to more complete and comprehensive recording by the Safety Inspectorate. Out of a total of 250 recorded pesticide effects, 121 (48·5%) were systemic poisoning, 57 (22·8%) were eye injuries, 54 (21·6%) were dermatitis, and 18 (7·1%) were chemical burns. Of the 121 incidents of non-fatal systemic poisoning, usually of a mild character, 34 were due to organophosphates, 26 to a single incident involving chloropicrin, 15 to arsenites, eight to dinitro compounds, three to nicotine, two to fungicides, one to cyanide, and one to an organomercury compound. Thirty-one incidents were not classified because the symptoms were non-specific in character and the worker had been exposed to a large number of different chemicals. In some instances the relationship of the symptoms to previous exposure to pesticides was extremely uncertain. Eye injuries and dermatitis were attributable to a wide variety of different chemicals and in the majority of instances were mild. Sulphuric acid, used for potato haulm destruction, was the commonest recorded cause of chemical burns. The main problems in the use of pesticides in England and Wales today are (1) the illicit decanting of concentrate from the manufacturer's labelled containers, (2) the hoarding of incompletely used containers, (3) the disposal of empty containers, and (4) the importation of pesticides in inadequately labelled containers. These defined practical problems of safety in application and accident control are perhaps of greater importance than the long-term theoretical toxicological effects of pesticides which may be attracting too much attention today. PMID:4737427

Occupational aviation fatalities--Alaska, 2000-2010.

PubMed

2011-07-01

Aircraft crashes are the second leading cause of occupational deaths in Alaska; during the 1990s, a total of 108 fatal aviation crashes resulted in 155 occupational fatalities. To update data and identify risk factors for occupational death from aircraft crashes, CDC reviewed data from the National Transportation Safety Board (NTSB) and the Alaska Occupational Injury Surveillance System. During 2000--2010, a total of 90 occupational fatalities occurred as a result of 54 crashes, an average of five fatal aircraft crashes and eight fatalities per year. Among those crashes, 21 (39%) were associated with intended takeoffs or landings at landing sites not registered with the Federal Aviation Administration (FAA). Fifteen crashes (28%) were associated with weather, including poor visibility, wind, and turbulence. In addition, 11 crashes (20%) resulted from pilots' loss of aircraft control; nine (17%) from pilots' failure to maintain clearance from terrain, water, or objects; and seven (13%) from engine, structure, or component failure. To reduce occupational fatalities resulting from aircraft crashes in the state, safety interventions should focus on providing weather and other flight information to increase pilots' situational awareness, maintaining pilot proficiency and decision-making abilities, and expanding the infrastructure used by pilots to fly by instruments.

Evaluation of the efficacy, tolerability, and safety of an over-the-counter acne regimen containing benzoyl peroxide and salicylic acid in subjects with acne.

PubMed

Kircik, Leon H; Gwazdauskas, Jennifer; Butners, Victoria; Eastern, Joseph; Green, Lawrence J

2013-03-01

Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. MaxClarity™ is an OTC acne treatment system comprising BPO and SA in an aqueous foam delivery vehicle, VersaFoam AF™. This paper describes 2 open-label, single-arm studies conducted to assess the efficacy, safety, tolerability, and patient preference of MaxClarity in the treatment of mild, moderate, and severe acne. Subjects applied MaxClarity twice daily for 8 weeks in study 402 and for 12 weeks in study 405. Reductions in all lesion types were seen throughout both studies. At week 8 (study 402), there was a mean reduction from baseline of -56.9 ± 32.7% in total lesions in subjects with mild, moderate, or severe acne. At week 12 (study 405), there was a reduction from baseline of -61.6 ± 22.0% in total lesions in subjects with moderate or severe acne. Overall, both studies demonstrated that MaxClarity is a generally well tolerated and effective treatment for mild, moderate, and severe acne.

Recent Development of Augmented Reality in Surgery: A Review

PubMed Central

Vávra, P.; Zonča, P.; Ihnát, P.; El-Gendi, A.

2017-01-01

Introduction The development augmented reality devices allow physicians to incorporate data visualization into diagnostic and treatment procedures to improve work efficiency, safety, and cost and to enhance surgical training. However, the awareness of possibilities of augmented reality is generally low. This review evaluates whether augmented reality can presently improve the results of surgical procedures. Methods We performed a review of available literature dating from 2010 to November 2016 by searching PubMed and Scopus using the terms “augmented reality” and “surgery.” Results. The initial search yielded 808 studies. After removing duplicates and including only journal articles, a total of 417 studies were identified. By reading of abstracts, 91 relevant studies were chosen to be included. 11 references were gathered by cross-referencing. A total of 102 studies were included in this review. Conclusions The present literature suggest an increasing interest of surgeons regarding employing augmented reality into surgery leading to improved safety and efficacy of surgical procedures. Many studies showed that the performance of newly devised augmented reality systems is comparable to traditional techniques. However, several problems need to be addressed before augmented reality is implemented into the routine practice. PMID:29065604

Manganese phytate dotted polyaniline shell enwrapped carbon nanotube: Towards the reinforcements in fire safety and mechanical property of polymer.

PubMed

Wang, Junling; Zhan, Jing; Mu, Xiaowei; Jin, Xin; Chu, Fukai; Kan, Yongchun; Xing, Weiyi

2018-06-19

High fire hazard of epoxy resin (EP) has been an unavoidable obstruction on its wide application. Here, a manganese phytate dotted polyaniline shell enwrapped carbon nanotube (MPCNT) is facilely constructed and employed as flame retardant for EP. By adding 4.0 wt% MPCNT, the peak heat release rate, total heat release values, peak CO yields and total CO yields are decreased by 27.2, 12.3, 44.8, and 23.3%, respectively. The decreased absorbance intensity of toxic aromatic volatiles is also observed. Then, a tripartite cooperative flame retardant mechanism (a continuous barrier network, catalytic charring function of phytate, and catalytic activity of MnP/C system) is proposed. Furthermore, the storage modulus of EP composites with 2.0 and 4.0 wt% MPCNT are increased by 23.0 and 25.8% at 40 °C, respectively. Thus, the simultaneous reinforcements in fire safety and mechanical performance of EP are successfully achieved. This work may represent a significant step forward in the facile construction of functionalized carbon materials for achieving their whole potentials in polymer-matrix composite. Copyright © 2018. Published by Elsevier Inc.

Design an optimum safety policy for personnel safety management - A system dynamic approach

NASA Astrophysics Data System (ADS)

Balaji, P.

2014-10-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration (NASA) Space-Based Telemetry and Range Safety (STARS) study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety [global positioning system (GPS) metric tracking data, flight termination command and range safety data relay] and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California, USA) using the NASA Tracking and Data Relay Satellite System (TDRSS) as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit (RSU) provided real-time video for three days during the historic Global Flyer (Scaled Composites, Mojave, California, USA) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This paper discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety (global positioning system metric tracking data, flight termination command and range safety data relay) and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California) using the NASA Tracking and Data Relay Satellite System as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit provided real-time video for three days during the historic GlobalFlyer (Scaled Composites, Mojave, California) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This report discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

Analysis of Aviation Safety Reporting System Incident Data Associated With the Technical Challenges of the Vehicle Systems Safety Technology Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2014-01-01

This analysis was conducted to support the Vehicle Systems Safety Technology (VSST) Project of the Aviation Safety Program (AVsP) milestone VSST4.2.1.01, "Identification of VSST-Related Trends." In particular, this is a review of incident data from the NASA Aviation Safety Reporting System (ASRS). The following three VSST-related technical challenges (TCs) were the focus of the incidents searched in the ASRS database: (1) Vechicle health assurance, (2) Effective crew-system interactions and decisions in all conditions; and (3) Aircraft loss of control prevention, mitigation, and recovery.

Less than severe worst case accidents

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

Sanders, G.A.

1996-08-01

Many systems can provide tremendous benefit if operating correctly, produce only an inconvenience if they fail to operate, but have extreme consequences if they are only partially disabled such that they operate erratically or prematurely. In order to assure safety, systems are often tested against the most severe environments and accidents that are considered possible to ensure either safe operation or safe failure. However, it is often the less severe environments which result in the ``worst case accident`` since these are the conditions in which part of the system may be exposed or rendered unpredictable prior to total system failure.more » Some examples of less severe mechanical, thermal, and electrical environments which may actually be worst case are described as cautions for others in industries with high consequence operations or products.« less

Influences on the adoption of patient safety innovation in primary care: a qualitative exploration of staff perspectives.

PubMed

Litchfield, Ian; Gill, Paramjit; Avery, Tony; Campbell, Stephen; Perryman, Katherine; Marsden, Kate; Greenfield, Sheila

2018-05-22

Primary care is changing rapidly to meet the needs of an ageing and chronically ill population. New ways of working are called for yet the introduction of innovative service interventions is complicated by organisational challenges arising from its scale and diversity and the growing complexity of patients and their care. One such intervention is the multi-strand, single platform, Patient Safety Toolkit developed to help practices provide safer care in this dynamic and pressured environment where the likelihood of adverse incidents is increasing. Here we describe the attitudes of staff toward these tools and how their implementation was shaped by a number of contextual factors specific to each practice. The Patient Safety Toolkit comprised six tools; a system of rapid note review, an online staff survey, a patient safety questionnaire, prescribing safety indicators, a medicines reconciliation tool, and a safe systems checklist. We implemented these tools at practices across the Midlands, the North West, and the South Coast of England and conducted semi-structured interviews to determine staff perspectives on their effectiveness and applicability. The Toolkit was used in 46 practices and a total of 39 follow-up interviews were conducted. Three key influences emerged on the implementation of the Toolkit these related to their ease of use and the novelty of the information they provide; whether their implementation required additional staff training or practice resource; and finally factors specific to the practice's local environment such as overlapping initiatives orchestrated by their CCG. The concept of a balanced toolkit to address a range of safety issues proved popular. A number of barriers and facilitators emerged in particular those tools that provided relevant information with a minimum impact on practice resource were favoured. Individual practice circumstances also played a role. Practices with IT aware staff were at an advantage and those previously utilising patient safety initiatives were less likely to adopt additional tools with overlapping outputs. By acknowledging these influences we can better interpret reaction to and adoption of individual elements of the toolkit and optimise future implementation.

Safe Detection System for Hydrogen Leaks

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

Lieberman, Robert A.; Beshay, Manal

2012-02-29

Hydrogen is an "environmentally friendly" fuel for future transportation and other applications, since it produces only pure ("distilled") water when it is consumed. Thus, hydrogen-powered vehicles are beginning to proliferate, with the total number of such vehicles expected to rise to nearly 100,000 within the next few years. However, hydrogen is also an odorless, colorless, highly flammable gas. Because of this, there is an important need for hydrogen safety monitors that can warn of hazardous conditions in vehicles, storage facilities, and hydrogen production plants. To address this need, IOS has developed a unique intrinsically safe optical hydrogen sensing technology, andmore » has embodied it in detector systems specifically developed for safety applications. The challenge of using light to detect a colorless substance was met by creating chemically-sensitized optical materials whose color changes in the presence of hydrogen. This reversible reaction provides a sensitive, reliable, way of detecting hydrogen and measuring its concentration using light from low-cost LEDs. Hydrogen sensors based on this material were developed in three completely different optical formats: point sensors ("optrodes"), integrated optic sensors ("optical chips"), and optical fibers ("distributed sensors") whose entire length responds to hydrogen. After comparing performance, cost, time-to-market, and relative market need for these sensor types, the project focused on designing a compact optrode-based single-point hydrogen safety monitor. The project ended with the fabrication of fifteen prototype units, and the selection of two specific markets: fuel cell enclosure monitoring, and refueling/storage safety. Final testing and development of control software for these markets await future support.« less

Evaluation of child safety seat enforcement strategies

DOT National Transportation Integrated Search

1989-09-01

Nine community programs designed to increase child safety seat (CSS) use through public information and education (PI&E) and enforcement were evaluated. An administrative evaluation documented each site's PI&E and enforcement activties. A total of 5,...

Total Diet Studies as a Tool for Ensuring Food Safety

PubMed Central

Lee, Joon-Goo; Kim, Sheen-Hee; Kim, Hae-Jung

2015-01-01

With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety. PMID:26483881

Safety features of subcritical fluid fueled systems

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

Bell, C.R.

1995-10-01

Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitativemore » in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.« less

Potentials for Platooning in U.S. Highway Freight Transport

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

Muratori, Matteo; Holden, Jacob; Lammert, Michael

2017-03-28

Smart technologies enabling connection among vehicles and between vehicles and infrastructure as well as vehicle automation to assist human operators are receiving significant attention as a means for improving road transportation systems by reducing fuel consumption - and related emissions - while also providing additional benefits through improving overall traffic safety and efficiency. For truck applications, which are currently responsible for nearly three-quarters of the total U.S. freight energy use and greenhouse gas (GHG) emissions, platooning has been identified as an early feature for connected and automated vehicles (CAVs) that could provide significant fuel savings and improved traffic safety andmore » efficiency without radical design or technology changes compared to existing vehicles. A statistical analysis was performed based on a large collection of real-world U.S. truck usage data to estimate the fraction of total miles that are technically suitable for platooning. In particular, our analysis focuses on estimating 'platoonable' mileage based on overall highway vehicle use and prolonged high-velocity traveling, and established that about 65% of the total miles driven by combination trucks from this data sample could be driven in platoon formation, leading to a 4% reduction in total truck fuel consumption. This technical potential for 'platoonable' miles in the United States provides an upper bound for scenario analysis considering fleet willingness and convenience to platoon as an estimate of overall benefits of early adoption of connected and automated vehicle technologies. A benefit analysis is proposed to assess the overall potential for energy savings and emissions mitigation by widespread implementation of highway platooning for trucks.« less

20 CFR 410.426 - Determining total disability: Age, education, and work experience criteria.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.426 Determining total disability: Age, education, and work...

Risk management for the Space Exploration Initiative

NASA Technical Reports Server (NTRS)

Buchbinder, Ben

1993-01-01

Probabilistic Risk Assessment (PRA) is a quantitative engineering process that provides the analytic structure and decision-making framework for total programmatic risk management. Ideally, it is initiated in the conceptual design phase and used throughout the program life cycle. Although PRA was developed for assessment of safety, reliability, and availability risk, it has far greater application. Throughout the design phase, PRA can guide trade-off studies among system performance, safety, reliability, cost, and schedule. These studies are based on the assessment of the risk of meeting each parameter goal, with full consideration of the uncertainties. Quantitative trade-off studies are essential, but without full identification, propagation, and display of uncertainties, poor decisions may result. PRA also can focus attention on risk drivers in situations where risk is too high. For example, if safety risk is unacceptable, the PRA prioritizes the risk contributors to guide the use of resources for risk mitigation. PRA is used in the Space Exploration Initiative (SEI) Program. To meet the stringent requirements of the SEI mission, within strict budgetary constraints, the PRA structure supports informed and traceable decision-making. This paper briefly describes the SEI PRA process.

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

The relationship between safety net activities and hospital financial performance

PubMed Central

2010-01-01

Background During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. Methods The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. Results We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. Conclusions Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population. PMID:20074367

Towards a Usability and Error "Safety Net": A Multi-Phased Multi-Method Approach to Ensuring System Usability and Safety.

PubMed

Kushniruk, Andre; Senathirajah, Yalini; Borycki, Elizabeth

2017-01-01

The usability and safety of health information systems have become major issues in the design and implementation of useful healthcare IT. In this paper we describe a multi-phased multi-method approach to integrating usability engineering methods into system testing to ensure both usability and safety of healthcare IT upon widespread deployment. The approach involves usability testing followed by clinical simulation (conducted in-situ) and "near-live" recording of user interactions with systems. At key stages in this process, usability problems are identified and rectified forming a usability and technology-induced error "safety net" that catches different types of usability and safety problems prior to releasing systems widely in healthcare settings.

Understanding patient safety performance and educational needs using the 'Safety-II' approach for complex systems.

PubMed

McNab, Duncan; Bowie, Paul; Morrison, Jill; Ross, Alastair

2016-11-01

Participation in projects to improve patient safety is a key component of general practice (GP) specialty training, appraisal and revalidation. Patient safety training priorities for GPs at all career stages are described in the Royal College of General Practitioners' curriculum. Current methods that are taught and employed to improve safety often use a 'find-and-fix' approach to identify components of a system (including humans) where performance could be improved. However, the complex interactions and inter-dependence between components in healthcare systems mean that cause and effect are not always linked in a predictable manner. The Safety-II approach has been proposed as a new way to understand how safety is achieved in complex systems that may improve quality and safety initiatives and enhance GP and trainee curriculum coverage. Safety-II aims to maximise the number of events with a successful outcome by exploring everyday work. Work-as-done often differs from work-as-imagined in protocols and guidelines and various ways to achieve success, dependent on work conditions, may be possible. Traditional approaches to improve the quality and safety of care often aim to constrain variability but understanding and managing variability may be a more beneficial approach. The application of a Safety-II approach to incident investigation, quality improvement projects, prospective analysis of risk in systems and performance indicators may offer improved insight into system performance leading to more effective change. The way forward may be to combine the Safety-II approach with 'traditional' methods to enhance patient safety training, outcomes and curriculum coverage.

78 FR 47804 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

..., ``Configuration Management Plans for Digital Computer Software used in Safety Systems of Nuclear Power Plants... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants.'' This...

76 FR 67201 - Information Collection Activities: Oil and Gas Production Safety Systems; Submitted for Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

.... BOEM-2011-0068; OMB Number 1014-0003] Information Collection Activities: Oil and Gas Production Safety... requirements in the regulations under Subpart H, ``Oil and Gas Production Safety Systems.'' This notice also... Gas Production Safety Systems. Abstract: The Outer Continental Shelf (OCS) Lands Act, as amended (43 U...

78 FR 979 - Petition for Positive Train Control Safety Plan Approval and System Certification of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

...] Petition for Positive Train Control Safety Plan Approval and System Certification of the Electronic Train... the Federal Railroad Administration (FRA) for Positive Train Control (PTC) Safety Plan (PTCSP...-based train control system safety overlay designed to protect against the consequences of train-to-train...

The Impact of Information Culture on Patient Safety Outcomes

PubMed Central

Mikkonen, Santtu; Saranto, Kaija; Bates, David W.

2017-01-01

Summary Background An organization’s information culture and information management practices create conditions for processing patient information in hospitals. Information management incidents are failures that could lead to adverse events for the patient if they are not detected. Objectives To test a theoretical model that links information culture in acute care hospitals to information management incidents and patient safety outcomes. Methods Reason’s model for the stages of development of organizational accidents was applied. Study data were collected from a cross-sectional survey of 909 RNs who work in medical or surgical units at 32 acute care hospitals in Finland. Structural equation modeling was used to assess how well the hypothesized model fit the study data. Results Fit indices indicated a good fit for the model. In total, 18 of the 32 paths tested were statistically significant. Documentation errors had the strongest total effect on patient safety outcomes. Organizational guidance positively affected information availability and utilization of electronic patient records, whereas the latter had the strongest total effect on the reduction of information delays. Conclusions Patient safety outcomes are associated with information management incidents and information culture. Further, the dimensions of the information culture create work conditions that generate errors in hospitals. PMID:28272647

The Impact of Information Culture on Patient Safety Outcomes. Development of a Structural Equation Model.

PubMed

Jylhä, Virpi; Mikkonen, Santtu; Saranto, Kaija; Bates, David W

2017-03-08

An organization's information culture and information management practices create conditions for processing patient information in hospitals. Information management incidents are failures that could lead to adverse events for the patient if they are not detected. To test a theoretical model that links information culture in acute care hospitals to information management incidents and patient safety outcomes. Reason's model for the stages of development of organizational accidents was applied. Study data were collected from a cross-sectional survey of 909 RNs who work in medical or surgical units at 32 acute care hospitals in Finland. Structural equation modeling was used to assess how well the hypothesized model fit the study data. Fit indices indicated a good fit for the model. In total, 18 of the 32 paths tested were statistically significant. Documentation errors had the strongest total effect on patient safety outcomes. Organizational guidance positively affected information availability and utilization of electronic patient records, whereas the latter had the strongest total effect on the reduction of information delays. Patient safety outcomes are associated with information management incidents and information culture. Further, the dimensions of the information culture create work conditions that generate errors in hospitals.

Transport company safety climate-The impact on truck driver behavior and crash involvement.

PubMed

Sullman, Mark J M; Stephens, Amanda N; Pajo, Karl

2017-04-03

The present study investigated the relationships between safety climate and driving behavior and crash involvement. A total of 339 company-employed truck drivers completed a questionnaire that measured their perceptions of safety climate, crash record, speed choice, and aberrant driving behaviors (errors, lapses, and violations). Although there was no direct relationship between the drivers' perceptions of safety climate and crash involvement, safety climate was a significant predictor of engagement in risky driving behaviors, which were in turn predictive of crash involvement. This research shows that safety climate may offer an important starting point for interventions aimed at reducing risky driving behavior and thus fewer vehicle collisions.

Critical Characteristics of Radiation Detection System Components to be Dedicated for use in Safety Class and Safety Significant System

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

DAVIS, S.J.

2000-05-25

This document identifies critical characteristics of components to be dedicated for use in Safety Class (SC) or Safety Significant (SS) Systems, Structures, or Components (SSCs). This document identifies the requirements for the components of the common radiation area monitor alarm in the WESF pool cell. These are procured as Commercial Grade Items (CGI), with the qualification testing and formal dedication to be performed at the Waste Encapsulation Storage Facility (WESF), in safety class, safety significant systems. System modifications are to be performed in accordance with the instructions provided on ECN 658230. Components for this change are commercially available and interchangeablemore » with the existing alarm configuration This document focuses on the operational requirements for alarm, declaration of the safety classification, identification of critical characteristics, and interpretation of requirements for procurement. Critical characteristics are identified herein and must be verified, followed by formal dedication, prior to the components being used in safety related applications.« less

Improving patient safety: lessons from rock climbing.

PubMed

Robertson, Nic

2012-02-01

How to improve patient safety remains an intractable problem, despite large investment and some successes. Academics have argued that the root of the problem is a lack of a comprehensive 'safety culture' in hospitals. Other safety-critical industries such as commercial aviation invest heavily in staff training to develop such a culture, but comparable programmes are almost entirely absent from the health care sector. In rock climbing and many other dangerous activities, the 'buddy system' is used to ensure that safety systems are adhered to despite adverse circumstances. This system involves two or more people using simple checks and clear communication to prevent problems causing harm. Using this system as an example could provide a simple, original and entertaining way of introducing medical students to the idea that human factors are central to ensuring patient safety. Teaching the buddy system may improve understanding and acceptance of other patient safety initiatives, and could also be used by junior doctors as a tool to improve the safety of their practice. © Blackwell Publishing Ltd 2012.

Total Diet Study: For a Closer-to-real Estimate of Dietary Exposure to Chemical Substances

PubMed Central

Lee, Jeeyeon; Kwon, Sungok; Yoon, Hae-Jung

2015-01-01

Recent amendment on the Food Sanitation Act in Korea mandated the Minister of Food & Drug Safety to secure the scientific basis for management and reevaluation of standards and specifications of foods. Especially because the current food safety control is limited within the scope of ‘Farm to Market’ covering from production to retail in Korea, safety control at the plane of true ‘Farm to Fork’ scope is urgently needed and should include ‘total diet’ of population instead of individual food items. Therefore, ‘Total Diet Study (TDS)’ which provides ‘closer-to-real’ estimates of exposure to hazardous materials through analysis on table-ready (cooked) samples of foods would be the solution to more comprehensive food safety management, as suggested by World Health Organization and Food and Agriculture Organization of the United Nations. Although the protection of diets from hazards must be considered as one of the most essential public health functions of any country, we may need to revisit the value of foods which has been too much underrated by the meaningless amount of some hazardous materials in Korea. Considering the primary value of foods lies on sustaining life, growth, development, and health promotion of human being, food safety control should be handled not only by the presence or absence of hazardous materials but also by maximizing the value of foods via balancing with the preservation of beneficial components in foods embracing total diet. In this regard, this article aims to provide an overview on TDS by describing procedures involved except chemical analysis which is beyond our scope. Also, details on the ongoing TDS in Korea are provided as an example. Although TDS itself might not be of keen interest for most readers, it is the main user of the safety reference values resulted from toxicological research in the public health perspective. PMID:26483882

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Safety control systems. 62.25-15 Section 62.25-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING VITAL SYSTEM AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

PubMed

Sawyer, Kelly N; Mooney, Michael; Norris, Gregory; Devlin, Thomas; Lundbye, Justin; Doshi, Pratik B; Hewett, Jonathan Kyle; Kono, Alan T; Jorgensen, Jesse P; O'Neil, Brian J

2018-06-08

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.

A Study of the System Safety Concept as it Relates to the New Walter Reed Army Medical Center, Washington, DC.

DTIC Science & Technology

1978-03-31

established the safety level of the% * originally designed facility and the extent of current safety * modifications. The objectives evaluated the...Program could identify many safety hazards thus leading to design improvements. The study provided several recommendations to formalize the Systems Safety... design , construction, and proposed systems management of the new Walter Reed Army Medical Center (WRAMC), Washington, D.C., was conducted during the

A safety-based decision making architecture for autonomous systems

NASA Technical Reports Server (NTRS)

Musto, Joseph C.; Lauderbaugh, L. K.

1991-01-01

Engineering systems designed specifically for space applications often exhibit a high level of autonomy in the control and decision-making architecture. As the level of autonomy increases, more emphasis must be placed on assimilating the safety functions normally executed at the hardware level or by human supervisors into the control architecture of the system. The development of a decision-making structure which utilizes information on system safety is detailed. A quantitative measure of system safety, called the safety self-information, is defined. This measure is analogous to the reliability self-information defined by McInroy and Saridis, but includes weighting of task constraints to provide a measure of both reliability and cost. An example is presented in which the safety self-information is used as a decision criterion in a mobile robot controller. The safety self-information is shown to be consistent with the entropy-based Theory of Intelligent Machines defined by Saridis.

"Chance favors only the prepared mind": preparing minds to systematically reduce hazards in the testing process in primary care.

PubMed

Singh, Ranjit; Hickner, John; Mold, Jim; Singh, Gurdev

2014-03-01

Testing plays a vital role in primary care. Failures in the process are common and can be harmful. As the great 19th century microbiologist Louis Pasteur put it "chance favors only the prepared mind." Our objective is to prepare minds in primary care practices to improve safety in the testing process. Various principles from safety science can be applied. A prospective methodology that uses an anonymous practice survey based on concepts from failure modes and effects analysis is proposed. Responses are used to rank perceived hazards in the testing process, leading to prioritization of areas for intervention. Secondary data analysis (using data from a study of medication safety) was used to explore the value of this approach in the context of assessing the testing process. At 3 primary care practice sites, a total of 61 staff members completed 4 survey items examining the testing process. Comparison across practices shows that each has a distinct profile of hazards, which would lead each on a different path toward improvement. The proposed approach treats each practice as a unique complex adaptive system aiming to help it thrive by inculcating trust, mutual respect, and collaboration. Implications for patient safety research and practice are discussed.

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

PubMed

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

2013-01-01

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

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

PubMed

Jones, Sarahjane

2015-12-01

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

Radiation safety considerations with therapeutic 90Y Zevalin.

PubMed

Zhu, Xiaowei

2003-08-01

ABSTRACT Radioimmunotherapy with the 90Y-labeled Zevalin radioimmunoconjugate is a new and promising modality in cancer treatment that combines the targeting power of monoclonal antibodies with the cytotoxicity of localized radiation. 90Y is a pure beta emitter, with different physical characteristics than traditional therapeutic radionuclides such as 131I. It is important that radiation safety professionals understand the characteristics of this radionuclide so that effective radiation safety procedures can be implemented with the Zevalin regimen. Because 90Y is a pure beta emitter, the Zevalin regimen is routinely administered as an outpatient procedure and is administered by using plastic shielding. Once the radioimmunoconjugate has been administered, the risk of radiation exposure to healthcare workers and family members is minimal. The primary route of biologic elimination of 90Y Zevalin is through the urinary system, with approximately 7% of the total activity administered eliminated over the course of 1 wk. Standard universal precautions, which should already be in place in healthcare facilities, should be sufficient to prevent radiation exposure to personnel working with patients who have been treated with Zevalin. Written radiation safety instructions for patients are not required, but basic instructions to the patient and his or her family may help further minimize the risk of radiation exposure and help alleviate patient and family concerns.